Rising Malpractice Premiums Price Small Clinics Out of Gender-Affirming Care for Minors

KFF Health News, January 9, 2024

Nearly half the states have banned medication or surgical treatment for transgender youth.

This article was published on Tuesday, January 9, 2023 in KFF Health News.

By Cecilia Nowell

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."

Older Americans Say They Feel Trapped in Medicare Advantage Plans

KFF Health News, January 5, 2024

The private plans serve 30.8 million people despite concerns about aggressive sales tactics and misleading coverage claims.

This article was published on Friday, January 5, 2024 in KFF Health News.

By Sarah Jane Tribble

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."

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

Can Family Doctors Deliver Rural America From Its Maternal Health Crisis?

KFF Health News, January 2, 2024

More than half of all rural counties in the United States have no hospital services for delivering babies.

This article was published on Tuesday, January 2, 2024 in KFF Health News.

By Sarah Jane Tribble

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.

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

Podcast: 'An Arm and a Leg': When Hospitals Sue Patients (Part 2)

KFF Health News, December 28, 2023

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.

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

KFF Health News, December 19, 2023

The manufacturer denied liability in two patient deaths.

This article was published on Tuesday, December 19, 2023 in KFF Health News.

By Daniel Chang and Holly K. Hacker

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 both cases, Thoratec, a subsidiary of Abbott Laboratories, confirmed a bent locking arm. But "a direct correlation" between the HeartMate 3 and the deaths "could not conclusively be established," the manufacturer reported to the FDA.

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

The men's deaths are among more than 4,500 reports since August 2017 in which the HeartMate 3 may have caused or contributed to a patient's death, according to a 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.

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

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

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

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

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

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

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

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

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

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

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

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

"That's why he took the chance to do it," she said.

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

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

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

Daniel Chang: dchang@kff.org, @dchangmiami

Holly K. Hacker: HHacker@kff.org, @hollyhacker

When a Quick Telehealth Visit Yields Multiple Surprises Beyond a Big Bill

KFF Health News, December 19, 2023

$660 for what was billed as a 45- to 59-minute visit. The insurer paid nothing, ruling it out of network.

This article was published on Tuesday, December 19, 2023 in KFF Health News.

By Darius Tahir

In September 2022, Elyse Greenblatt of Queens returned home from a trip to Rwanda with a rather unwelcome-back gift: persistent congestion.

She felt a pain in her sinuses and sought a quick resolution. 

COVID-19 couldn't be ruled out, so rather than risk passing on an unknown infection to others in a waiting room, the New Yorker booked a telehealth visit through her usual health system, Mount Sinai — a perennial on best-hospitals lists.

That proved an expensive decision. She remembers the visit as taking barely any time. The doctor decided it was likely a sinus infection, not COVID, and prescribed her fluticasone, a nasal spray that relieves congestion, and an antibiotic, Keflex. (The Centers for Disease Control and Prevention says antibiotics "are not needed for many sinus infections, but your doctor can decide if you need" one.)

Then the bill came.

The Patient: Elyse Greenblatt, now 38, had insurance coverage through Empire BlueCross BlueShield, a New York-based insurer.

Medical Services: A telehealth urgent care visit through Mount Sinai's personal record app. Greenblatt was connected with an urgent care doctor through the luck of the draw. She was diagnosed with sinusitis, prescribed an antibiotic and Flonase, and told to come back if there was no improvement.

All this meant a big bill. The insurer said the telehealth visit was deemed an out-of-network service — a charge Greenblatt said the digital service didn't do a great job of warning her about. It came as a surprise. "In my mind, if all my doctors are ‘in-insurance,' why would they pair me with someone who was ‘out-of-insurance'?" she asked. And the hospital system tried its best to make contesting the charge difficult, she said.

Service Provider: The doctor was affiliated with Mount Sinai's health system, though where the bill came from was unclear: Was it from one of the system's hospitals or another unit?

Total Bill: $660 for what was billed as a 45- to 59-minute visit. The insurer paid nothing, ruling it out of network.

What Gives: The bill was puzzling on multiple levels. Most notably: How could this be an out-of-network service? Generally, urgent care visits delivered via video are a competitive part of the health care economy, and they're not typically terribly expensive.

Mount Sinai's telehealth booking process is at pains to assure bookers they're getting a low price. After receiving the bill, Greenblatt went back to the app to recreate her steps — and she took a screenshot of one particular part of the app: the details. She got an estimated wait time of 10 minutes, for a cost of $60. "Cost may be less based on insurance," the app said; this information, Mount Sinai spokesperson Lucia Lee said, is "for the patient's benefit," and the "cost may differ depending on the patient's insurance."

A $60 fee would be in line with, if not a bit cheaper than, many other telehealth services. Doctor on Demand, for example, offers visits from a clinician for $79 for a 15-minute visit, assuming the customer's insurance doesn't cover it. Amazon's new clinic service, offering telehealth care for a wide range of conditions, advertises that charges start at $30 for a sinus infection.

The Health Care Cost Institute, an organization that analyzes health care claims data, told KFF Health News its data shows an urgent care telehealth visit runs, on average, $120 in total costs — but only $14 in out-of-pocket charges.

So how did this visit end up costing astronomically so much more than the average? After all, one of the selling points of telemedicine is not only convenience but cost savings.

First, there was the length of the visit. The doctor's bill described it as moderately lengthy. But Greenblatt recalled the visit as simple and straightforward; she described her symptoms and got an antibiotic prescription — not a moderately complex visit requiring the better part of an hour to resolve.

The choice of description is a somewhat wonky part of health care billing that plays a big part in how expensive care can get. The more complex the case, and the longer it takes to diagnose and treat, the more providers can charge patients and insurers.

Greenblatt's doctor billed her at a moderate level of care — curious, given her memory of the visit as quick, almost perfunctory. "I think it was five minutes," she recalled. "I said it was a sinus infection; she told me I was right. ‘Take some meds, you'll be fine.'"

Ishani Ganguli, a doctor at Brigham and Women's Hospital in Boston who studies telehealth, said she didn't know the exact circumstances of care but was "a bit surprised that it was not billed at a lower level" if it was indeed a quick visit.

That leaves the out-of-network aspect of the bill, allowing the insurer to pay nothing for the care. (Stephanie DuBois, a spokesperson for Empire BlueCross BlueShield, Greenblatt's insurer, said the payer covers virtual visits through two services, or through in-network doctors. The Mount Sinai doctor fit neither criteria.) Still, why did Mount Sinai, Greenblatt's usual health care system, assign her an out-of-network doctor?

"If one gets their care from the Mount Sinai system and the care is within network, I don't think it is reasonable for the patients to expect or understand that one of the Mount Sinai clinicians is suddenly going to be out of network," said Ateev Mehrotra, a hospitalist and telehealth researcher at Beth Israel Deaconess Medical Center.

It struck the doctors specializing in telehealth research whom KFF Health News consulted as an unusual situation, especially since the doctor who provided the care was employed by the prestigious health system.

The doctor in question may have been in network for no insurers whatsoever: A review of the doctor's Mount Sinai profile page — archived in November 2022 — does not list any accepted insurance. (That's in contrast to other doctors in the system.)

Lee, Mount Sinai's spokesperson, said the doctor did take at least some insurance. When asked about the doctor's webpage not showing any accepted plans, she responded the site "instructs patients to contact her office for the most up-to-date information."

Attempting to solve this billing puzzle turned into a major league headache for Greenblatt. Deepening the mystery: After calling Mount Sinai's billing department, she was told the case had been routed to disputes and marked as "urgent."

But the doctor's office would seemingly not respond. "In most other professions, you can't just ignore a message for a year," she observed.

The bill would disappear on her patient portal, then come back again. Another call revealed a new twist: She was told by a staffer that she'd signed a form consenting to the out-of-network charge. But "when I asked to get a copy of the form I signed, she asked if she could fax it," Greenblatt said. Greenblatt said no. The billing department then asked whether they could put the form in her patient portal, for which Greenblatt gave permission. No form materialized.

When KFF Health News asked Mount Sinai about the case in mid-October of this year, Lee, the system's spokesperson, forwarded a copy of the three-page form — which Greenblatt didn't remember signing. Lee said the forms are presented as part of the flow of the check-in process and "intended to be obvious to the patient as required by law." Lee said on average, a patient signs two to four forms before checking into the visit.

But, according to the time stamp on the forms, Greenblatt's visit concluded before she signed. Lee said it is "not standard" to sign forms after the visit has concluded, and said that once informed, patients "may contact the office and reschedule with an ‘in-network provider.'"

"If it was provided after the service was rendered, that is an exception and situational," she concluded.

The business with the forms — their timing and their obviousness — is potentially a vital distinction. In December 2020, Congress enacted the No Surprises Act, designed to crack down on so-called surprise medical bills that arise when patients think their care is covered by insurance but actually isn't. Allie Shalom, a lawyer with Foley & Lardner, said the law requires notice to be given to patients, and consent obtained in advance.

But the legislation provides an exception. It applies only to hospitals, hospital outpatient facilities, critical access hospitals, and ambulatory surgery centers. Greenblatt's medical bill variously presents her visit as "Office/Outpatient" or "Episodic Telehealth," making it hard to "tell the exact entity that provided the services," Shalom said.

That, in turn, makes its status under the No Surprises Act unclear. The rules apply when an out-of-network provider charges a patient for care received at an in-network facility. But Shalom couldn't be sure what entity charged Greenblatt, and, therefore, whether that entity was in network.

As for Mount Sinai, Lee said asking for consent post-visit does not comply with the No Surprises Act, though she said the system needed more time to research whether Greenblatt was billed by the hospital or another entity.

The Resolution: Greenblatt's bill is unpaid and unresolved.

The Takeaway: Unfortunately, patients need to be on guard to protect their wallets.

If you want to be a smart shopper, consider timing the length of your visit. The "Bill of the Month" team regularly receives submissions from patients who were billed for a visit significantly longer than what took place. You shouldn't, for example, be charged for time sitting in a virtual waiting room.

Most important, even when you seek care at an in-network hospital, whose doctors are typically in network, always ask if a particular physician you've not seen before is in your network. Many practices and hospitals offer providers in both categories (even if that logically feels unfair to patients). Providers are supposed to inform you that the care being rendered is out of network. But that "informed consent" is often buried in a pile of consent forms that you auto-sign, in rapid fire. And the language is often a blanket statement, such as "I understand that some of my care may be provided by caregivers not in my insurance network" or "I agree to pay for services not covered by my insurance."

To a patient trying to quickly book care, that may not feel like "informed consent" at all.

"It's problematic to expect patients to read the fine print, especially when they feel unwell," Ganguli said.

Bill of the Month is a crowdsourced investigation by KFF Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Darius Tahir: DariusT@kff.org, @dariustahir

'They See a Cash Cow': Corporations Could Consume $50B of Opioid Settlements

KFF Health News, December 18, 2023

But as the dollars land in government coffers a swarm of private, public, nonprofit, and for-profit entities are eyeing the gold rush.

By Aneri Pattani

The marketing pitches are bold and arriving fast: Invest opioid settlement dollars in a lasso-like device to help police detain people without Tasers or pepper spray. Pour money into psychedelics, electrical stimulation devices, and other experimental treatments for addiction. Fund research into new, supposedly abuse-deterrent opioids and splurge on expensive, brand-name naloxone.

Opioid manufacturers and distributors are paying more than $54 billion in restitution to settle lawsuits about their role in the overdose epidemic, with little oversight on how the money is spent. We're tracking how state and local governments use — or misuse — the cash.

These pitches land daily in the inboxes of state and local officials in charge of distributing more than $50 billion from settlements in opioid lawsuits.

The money is coming from an array of companies that made, sold, or distributed prescription painkillers, including Johnson & Johnson, AmerisourceBergen, and Walgreens. Thousands of state and local governments sued the companies for aggressively promoting and distributing opioid medications, fueling an epidemic that progressed to heroin and fentanyl and has killed more than half a million Americans. The settlement money, arriving over nearly two decades, is meant to remediate the effects of that corporate behavior.

But as the dollars land in government coffers — more than $4.3 billion as of early November — a swarm of private, public, nonprofit, and for-profit entities are eyeing the gold rush. Some people fear that corporations, in particular — with their flashy products, robust marketing budgets, and hunger for profits — will now gobble up the windfall meant to rectify it.

"They see a cash cow," said JK Costello, director of behavioral health consulting for the Steadman Group, a firm that is being paid to help local governments administer the settlements in Colorado, Kansas, Oregon, and Virginia. "Everyone is interested."

Costello receives multiple emails a week from businesses and nonprofits seeking guidance on how to apply for the funds. To keep up with the influx, he has developed a standard response: Thanks, but we can't respond to individual requests, so here's a link to your locality's website, public meeting schedule, or application portal.

KFF Health News obtained email records in eight states that show health departments, sheriffs' offices, and councils overseeing settlement funds are receiving a similar deluge of messages. In the emails, marketing specialists offer phone calls, informational presentations, and meetings with their companies.

Alabama Attorney General Steve Marshall recently sent a letter reminding local officials to vet organizations that reach out. "I am sure that many of you have already been approached by a variety of vendors seeking funding for opioid initiatives," he wrote. "Please proceed with caution."

Of course, not all marketing efforts should prompt concern. Emails and calls are one way people in power learn about innovative products and services. The country's addiction crisis is too large for the public sector to tame alone, and many stakeholders agree that partnering with industry is crucial. After all, pharmaceutical companies manufacture medications to treat opioid addiction. Corporations run treatment facilities and telehealth services.

"It's unrealistic and even harmful to say we don't want any money going to any private companies," said Kristen Pendergrass, vice president of state policy at Shatterproof, a national nonprofit focused on addiction.

The key, agree public health and policy experts, is to critically evaluate products or services to see if they are necessary, evidence-based, and sustainable — instead of flocking to companies with the best marketing.

Otherwise, "you end up with lots of shiny objects," Costello said.

And, ultimately, failure to do due diligence could leave some jurisdictions holding an empty bag.

Take North Carolina. In 2022, state lawmakers allotted $1.85 million of settlement funds for a pilot project using the first FDA-approved app for opioid use disorder, developed by Pear Therapeutics. There were high hopes the app would help people stay in treatment longer.

But less than a year later, Pear Therapeutics filed for bankruptcy.

The state hadn't paid the company yet, so the money isn't lost, according to the North Carolina Department of Health and Human Services. But the department and lawmakers have not decided what to do with those dollars next.

$1M for Drug Disposal Pouches

Jason Sundby, CEO of Verde Environmental Technologies, said the Deterra pouches his company sells are a low-cost way to prevent expensive addictions.

Customers place their unused medications in a Deterra pouch and add water, deactivating the drugs before tossing them, ensuring they cannot be used even if fished out of the trash. A medium Deterra pouch costs $3.89 and holds 45 pills.

The goal is to "get these drugs out of people's homes before they can be misused, diverted, and people start down the path of needing treatment or naloxone or emergency room visits," Sundby said.

Sundby's company ran an ad about spending settlement dollars on its product in a National Association of Counties newsletter and featured similar information online.

It may be paying off, as Deterra is set to receive $1 million in settlement funds from the health department in Delaware County, Pennsylvania, and $12,000 from the sheriff's office in Henry County, Iowa. The company also has partnerships with St. Croix and Milwaukee counties in Wisconsin, and is working on a deal in Connecticut.

Several other companies with similar products have also used their product sites to urge jurisdictions to consider the settlements as a funding stream — and they're seeing early success.

DisposeRx makes a drug deactivation product — its version costs about a dollar each — and received $144,000 in South Carolina for mailing 134,000 disposal packets to a program that educated high school football players, coaches, and parents about addiction.

SafeRx makes $3 pill bottles with a locking code to store medications and was awarded $189,000 by South Carolina's opioid settlement council to work with the Greenville County Sheriff's Office and local prevention groups. It also won smaller awards from Weld and Custer counties in Colorado.

None of the companies said they are dependent on opioid settlements to sustain their business long-term. But the funds provide a temporary boost. In a 2022 presentation to prospective investors, SafeRx called the opioid settlements a "growth catalyst."

Critics of such investments say the products are not worthwhile. Today's crisis of fatal overdoses is largely driven by illicit fentanyl. Even if studies suggest the companies' products make people more likely to safely store and dispose of medications, that's unlikely to stem the record levels of deaths seen in recent years.

"The plausible mechanism by which they would even be able to reduce overdose is a mystery because prescription medications are not driving overdose," said Tricia Christensen, policy director with the nonprofit Community Education Group, which is tracking settlement spending across Appalachia.

Safe storage and disposal can be accomplished with a locking cabinet and toilet, she said. The FDA lists opioids on its flush list for disposal and says there is no evidence that low levels of the medicines that end up in rivers harm human health.

But Milton Cohen, CEO of SafeRx's parent company, Caring Closures International, said keeping prescription medicines secure addresses the root of the epidemic. Fentanyl kills, but often where people start, "where water is coming into the boat still, is the medicine cabinet," he said. "We can bail all we want, but the right thing to do is to plug the hole first."

Products to secure and dispose of drugs also provide an opportunity for education and destigmatization, said Melissa Lyon, director of the Delaware County Health Department in Pennsylvania. The county will be mailing Deterra pouches and postcards about preventing addiction to three-quarters of its residents.

"The Deterra pouch is to me a direct correlation" to the overprescribing that came from pharmaceutical companies' aggressive marketing, she added. Since the settlement money is to compensate for that, "this is a good use of the funds."

Tools for Law Enforcement That Superheroes Would Envy

Other businesses making pitches for settlement funds have a less clear relationship to opioids.

Wrap Technologies creates tools for law enforcement to reduce lethal uses of force. Its chief product, the BolaWrap, shoots a 7½-foot Kevlar tether more than a dozen feet through the air until it wraps around a person's limbs or torso — almost like Wonder Woman's Lasso of Truth.

Terry Nichols, director of business development for the company, said the BolaWrap can be used as an alternative to Tasers or pepper spray when officers need to detain someone experiencing a mental health crisis or committing crimes related to their addiction, like burglary.

"If you want to be more humane in the way you treat people in substance use disorder and crisis, this is an option," he said.

The company posts body camera footage of officers using BolaWrap on YouTube and says that out of 192 field reports of its use, about 75% of situations were resolved without additional use of force.

When officers de-escalate situations, people are less likely to end up in jail, Nichols said. And diverting people from the criminal justice system is among the suggested investments in opioid settlement agreements.

That argument convinced the city of Brownwood, Texas, where Nichols was police chief until 2019. It has spent about $15,000 of opioid settlement funds to buy nine BolaWrap devices.

"Our goal is to avoid using force when a citizen is in need," said James Fuller, assistant police chief in Brownwood. "If we're going to take someone to get help, the last thing we want to do is poke holes in them with a Taser."

After Brownwood's purchase, Wrap Technologies issued a press release in which CEO Kevin Mullins encouraged more law enforcement agencies to "take the opportunity afforded by the opioid settlement funds to empower their officers." The company has also sent a two-page document to police departments explaining how settlement funds can be used to buy BolaWraps.

Language from that document appeared nearly word-for-word in a briefing sheet given to Brownwood City Council before the BolaWrap purchase. The council voted unanimously in favor.

But the process hasn't been as smooth elsewhere. In Hawthorne, California, the police department planned to buy 80 BolaWrap devices using opioid settlement funds. It paid its first installment of about $25,000 in June. However, it was later informed by the state Department of Health Care Services that the BolaWrap is not an allowable use of these dollars.

"Bola Wraps will not be purchased with the Settlement Funds in the future," Hawthorne City Clerk Dayna Williams-Hunter wrote in an email.

Carolyn Williams, a member of the advocacy group Vocal-TX, said she doesn't see how the devices will address the overdose crisis in Texas or elsewhere.

Her son Haison Akiem Williams dealt with mental health and addiction issues for years. Without insurance, he couldn't afford rehab. When he sought case management services, there was a three-month wait, she said. Police charged him with misdemeanors but never connected him to care, she said.

In February, he died of an overdose at age 47. His mother misses how he used to make her laugh by calling her "Ms. Carol."

She wants settlement funds to support services she thinks could have kept him alive: mental health treatment, case management, and housing. BolaWrap doesn't make that list.

"It's heartbreaking to see what the government is doing with this money," she said. "Putting it in places they really don't need it."

Aneri Pattani: apattani@kff.org, @aneripattani

Rift Over When to Use N95s Puts Health Workers at Risk Again

KFF Health News, December 14, 2023

The pandemic illustrated how a rift between the CDC and workplace safety officials can have serious repercussions.

This article was published on Thursday, December 14, 2023 in KFF Health News.

By Amy Maxmen

Three years after more than 3,600 health workers died of covid-19, occupational safety experts warn that those on the front lines may once again be at risk if the Centers for Disease Control and Prevention takes its committee's advice on infection control guidelines in health care settings, including hospitals, nursing homes, and jails. In early November, the committee released a controversial set of recommendations the CDC is considering, which would update those established some 16 years ago.

The pandemic illustrated how a rift between the CDC and workplace safety officials can have serious repercussions. Most recently, the giant hospital system Sutter Health in California appealed a citation from the state's Division of Occupational Safety and Health, known as Cal/OSHA, by pointing to the CDC's shifting advice on when and whether N95 masks were needed at the start of the pandemic. By contrast, Cal/OSHA requires employers in high-risk settings like hospitals to improve ventilation, use air filtration, and provide N95s to all staff exposed to diseases that are — or may be — airborne.

The agencies are once again at odds. The CDC's advisory committee prescribes varying degrees of protection based on ill-defined categories, such as whether a virus or bacteria is considered common or how far it seems to travel in the air. As a result, occupational safety experts warn that choices on how to categorize covid, influenza, and other airborne diseases — and the corresponding levels of protection — may once again be left to administrators at hospitals, nursing homes, and jails or prisons.

Eric Berg, deputy chief of health at Cal/OSHA, warned the CDC in November that, if it accepted its committee's recommendations, the guidelines would "create confusion and result in workers being not adequately protected."

Also called respirators, N95 masks filter out far more particles than looser-fitting surgical masks but cost roughly 10 times as much, and were in short supply in 2020. Black, Hispanic, and Asian health workers more often went without N95 masks than white staffers, which helped explain why members of racial and ethnic minorities tested positive for covid nearly five times as often as the general population in the early months of the pandemic. (Hispanic people can be of any race or combination of races.)

Cal/OSHA issued dozens of citations to health care facilities that failed to provide N95 masks and take other measures to protect workers in 2020 and 2021. Many appealed, and some cases are ongoing. In October, the agency declined Sutter's appeal against a $6,750 citation for not giving its medical assistants N95 masks in 2020 when they accompanied patients who appeared to have covid through clinics. Sutter pointed to the CDC's advice early in the pandemic, according to court testimony. It noted that the CDC called surgical masks an "acceptable alternative" in March 2020, "seemed to recommend droplet precautions rather than airborne precautions," and suggested that individuals were unlikely to be infected if they were farther than 6 feet away from a person with covid.

This is a loose interpretation of the CDC's 2020 advice, which was partly made for reasons of practicality. Respirators were in short supply, for example, and physical distancing beyond 6 feet is complicated in places where people must congregate. Scientifically, there were clear indications that the coronavirus SARS-CoV-2 spread through the air, leading Cal/OSHA to enact its straightforward rules created after the 2009 swine flu pandemic. Workers need stiffer protection than the general population, said Jordan Barab, a former official at the federal Occupational Safety and Health Administration: "Health workers are exposed for eight, 10, 12 hours a day."

The CDC's advisory committee offers a weaker approach in certain cases, suggesting that health workers wear surgical masks for "common, often endemic respiratory pathogens" that "spread predominantly over short distances." The draft guidance pays little attention to ventilation and air filtration, and advises N95 masks only for "new or emerging" diseases and those that spread "efficiently over long distances." Viruses, bacteria, and other pathogens that spread through the air don't neatly fit into such categories.

"Guidelines that are incomplete, weak, and without scientific basis will greatly undermine CDC's credibility," said a former OSHA director, David Michaels, in minutes from an October meeting where he and others urged CDC Director Mandy Cohen to reconsider advice from the committee before it issues final guidance next year.

Although occupational safety agencies — not the CDC — have the power to make rules, enforcement often occurs long after the damage is done, if ever. Cal/OSHA began to investigate Sutter only after a nurse at its main Oakland hospital died from covid and health workers complained they weren't allowed to wear N95 masks in hallways shared with covid patients. And more than a dozen citations from Cal/OSHA against Kaiser Permanente, Sharp HealthCare, and other health systems lagged months and years behind health worker complaints and protests.

Outside California, OSHA faces higher enforcement obstacles. A dwindling budget left the agency with fewer workplace inspectors than it had in 45 years, at the peak of the pandemic. Plus, the Trump and Biden administrations stalled the agency's ongoing efforts to pass regulations specific to airborne infections. As a result, the agency followed up on only about 1 in 5 covid-related complaints that employees and labor representatives officially filed with the group from January 2020 to February 2022 — and just 4% of those made informally through media reports, phone calls, and emails. Many deaths among health care workers weren't reported to the agency in the first place.

Michaels, who is now on the faculty at the George Washington University School of Public Health, said the CDC would further curtail OSHA's authority to punish employers who expose staff members to airborne diseases, if its final guidelines follow the committee's recommendations. Such advice would leave many hospitals, correctional facilities, and nursing homes as unprepared as they were before the pandemic, said Deborah Gold, a former deputy chief of health at Cal/OSHA. Strict standards prompt employers to stockpile N95 masks and improve air filtration and ventilation to avoid citations. But if the CDC's guidance leaves room for interpretation, she said, they can justify cutting corners on costly preparation.

Although the CDC committee and OSHA both claim to follow the science, researchers arrived at contradictory conclusions because the committee relied on explicitly flawed trials comparing health workers who wore surgical masks with those using N95s. Cal/OSHA based its standards on a variety of studies, including reviews of hospital infections and engineering research on how airborne particles spread.

In decades past, the CDC's process for developing guidelines included labor representatives and experts focused on hazards at work. Barab was a health researcher at a trade union for public sector employees when he helped the CDC develop HIV-related recommendations in the 1980s.

"I remember asking about how to protect health care workers and correction officers who get urine or feces thrown at them," Barab said. Infectious disease researchers on the CDC's committee initially scoffed at the idea, he recalled, but still considered his input as someone who understood the conditions employees faced. "A lot of these folks hadn't been on hospital floors in years, if not decades."

The largest organization for nurses in the United States, National Nurses United, made the same observation. It's now collecting signatures for an online petition urging the CDC to scrap the committee's guidelines and develop new recommendations that include insights from health care workers, many of whom risked their lives in the pandemic.

Barab attributed the lack of labor representation in the CDC's current process to the growing corporate influence of large health systems. Hospital administrators prefer not to be told what to do, particularly when it requires spending money, he said.

In an email, CDC communications officer Dave Daigle stressed that before the guidelines are finalized, the CDC will "review the makeup of the workgroups and solicit participation to ensure that the appropriate expertise is included."

Podcast: When Hospitals Sue Patients (Part 1)

KFF Health News, December 14, 2023

Judgments against patients in these suits can derail someone's life but, according to experts, they don't bring hospitals much money. So why do they do it?

This podcast was published on Thursday, December 14, 2023 at KFF Health News.

Some hospitals sue patients over unpaid medical bills in bulk, sometimes by the hundreds of thousands. The defendants are often already facing financial hardship or even bankruptcy.

Judgments against patients in these suits can derail someone's life but, according to experts, they don't bring hospitals much money.

So why do hospitals do it?

Host Dan Weissmann investigates this practice with The Baltimore Banner and Scripps News and speaks to patients who've found themselves on the receiving end of such lawsuits.

Weissmann also speaks with Nick McLaughlin, an entrepreneur who’s making the business case for hospitals to stop trying to collect money from people who simply don't have it.

Dan Weissmann

@danweissmann

Millions in Opioid Settlement Funds Sit Untouched as Overdose Deaths Rise

KFF Health News, December 13, 2023

The money is part of the approximately $50 billion that states and local governments will receive nationwide in opioid settlement funds over nearly two decades.

This article was published on Wednesday, December 13, 2023 in KFF Health News.

By Katheryn Houghton and Aneri Pattani

Nearly a year after Montana began receiving millions of dollars to invest in efforts to combat the opioid crisis, much of that money remains untouched. Meanwhile, the state's opioid overdose and death counts continue to rise.

Opioid manufacturers and distributors are paying more than $54 billion in restitution to settle lawsuits about their role in the overdose epidemic, with little oversight on how the money is spent. We're tracking how state and local governments use — or misuse — the cash.

The money is part of the approximately $50 billion that states and local governments will receive nationwide in opioid settlement funds over nearly two decades. The payments come from more than a dozen companies that made, distributed, or sold prescription opioid painkillers that were sued for their role in fueling the overdose epidemic.

Many places have begun deciding where that money will go and making payments to schools, public health departments, and local governments. South Carolina, for example, has awarded more than $7 million to 21 grantees. Wisconsin has posted two years' worth of spending plans that total nearly $40 million.

Montana, West Virginia, and Hawaii are among the states moving slower.

Montana began receiving its first settlement payments in January, and, by fall, payments totaled roughly $13 million. As of early December, the Montana Opioid Abatement Trust — a private nonprofit created to oversee 70% of the state's share — had met once to agree to its rules of operation, and its money remained locked behind an inactive grant portal. The remainder, divided among the state and local governments, either hadn't been spent or wasn't publicly recorded.

Those charged with distributing the money say they're building a framework to spend it in ways that last. Meanwhile, some addiction treatment providers are eager to use the funds to plug gaps in services.

The tension in Montana reflects a nationwide push-pull. Those handling settlement dollars say governments should take their time planning how to use the enormous windfall. Others argue for urgency as the drug supply has become increasingly deadly. More than 100,000 Americans died of overdoses in 2022, surpassing the previous year's record-setting death toll.

Nearly 200 Montanans died of a drug overdose in 2021, the latest year state data is available. That number, likely an undercount, is roughly 40 more deaths than the year before. Emergency medical responders have continued to record an increasing number of opioid-related emergencies this year.

In Billings, the Rimrock Foundation, one of the state's largest behavioral health providers, has seen its number of clients with opioid use dependency more than triple since 2021. Like other treatment facilities, Rimrock has a waitlist, and addiction treatment providers worry about the limited community resources that exist for patients once they are discharged. "The result of not addressing this is a lot of deaths," said Jennifer Verhasselt, Rimrock Foundation's chief clinical officer.

Debbie Knutson, Rimrock's medical unit and nursing supervisor, said there is widespread confusion about how and when the state's settlement dollars can be used.

"It's very concerning if we have money available that we could use to help people that is just kind of sitting, waiting for somebody to decide where it should go," Knutson said.

Rusty Gackle, the Montana Opioid Abatement Trust executive director, said a lot of work has happened behind the scenes to get local governments ready to accept their initial payments and for regional leaders to form systems to request money from the trust. That included hosting a series of town hall-style meetings to share information about the process. He said many of those local regions are still finalizing their governance structures.

"I would love to progress a little bit faster," Gackle said. "But I'd rather do it right so that we're not having to go backwards."

Montana officials got a late start too, he added. Some states began receiving settlement dollars last year, but Montana was toward the tail end of the line.

Montana is dividing its money three ways: 15% to the state, 15% to local governments, and the rest to the Montana Opioid Abatement Trust, with some money set aside for attorneys' fees.

As of late November, the state hadn't begun spending the $2.4 million it had in hand for state agencies. Officials also aren't tracking how and when local governments spend their direct payments.

Similarly, West Virginia and Hawaii hadn't — by late November — begun spending the largest shares of their funding. In West Virginia, the makeup of the foundation board that will oversee roughly 70% of the state's settlement dollars was announced only in August, six weeks after the state's deadline, and the board is now sitting on more than $217 million.

Nationwide, state and local governments have received more than $4.3 billion as of Nov. 9. How much of that has been used remains uncertain due to states' lack of public reporting. But from what is known, it varies.

Colorado, whose spending plan is similar to Montana's but received its settlement money earlier, has allocated millions toward school and community-based programs, recovery housing services, and expanded treatment services.

Sara Whaley, a Johns Hopkins researcher who tracks states' uses of opioid settlement funds, said a slower start isn't inherently wrong. She prefers governments take time to spend the money well rather than fund outdated or untested practices. In some cases, governments are building entirely new systems to dole out the money. Several waited until the courts finalized the settlement amounts and details.

"There are definitely states that were like, 'We are going to get money at some point. We don't know how much or when, but let's start setting up our system,'" Whaley said. "Other folks were like, 'We have a lot going on already. We'll just wait until we get it and then we'll know what the settlement terms are.'"

Even once committees start meeting, it can take months for the money to reach front-line organizations.

Connecticut's opioid settlement advisory committee made its first allocation in November, eight months after it was formed. Maine's recovery council, which controls half the state's settlement funds, has been meeting since November 2022, but just recently voted on priorities for the more than $14 million it has on hand and still needs to establish a grant application process.

Tennessee's Opioid Abatement Council accepted grant applications this fall. Stephen Loyd, council chair, said the process — from picking awardees to processing payments — will take roughly six months. Within that time, he said, 2,808 Tennesseans are likely to die of drug overdoses.

As an interim step, Loyd proposed at an October meeting to award $7.5 million to an emergency six-month initiative to flood the state with naloxone, a medication that reverses opioid overdoses.

But his proposal was met with protests from council members, who pushed back on what they saw as a circumvention of the grant process they had spent months establishing. The council didn't vote on the emergency initiative but instead created an expedited review process to consider fast-tracking future applications.

Gackle said he doesn't think Montana is far behind others. Now that spending systems are almost in place, he said, things should move faster.

Lewis and Clark County, home to the state capital, Helena, has a yearlong plan and budget for opioid settlement funds. A cohort of 17 counties in rural eastern Montana defined its regional settlement decision-makers in November and, by early December, had yet to begin official talks about where the money should go.

Brenda Kneeland, CEO of Eastern Montana Community Mental Health Center and an advisory committee member for the Montana Opioid Abatement Trust, said eastern Montana has one inpatient treatment center for substance use disorders and zero detox facilities, so emergency rooms end up serving as a fallback resource.

Kneeland said local officials want to ensure they understand the rules to avoid trouble later and to stretch the funding.

"You don't get an opportunity to try to correct such a wrong very often," Kneeland said. "It's just a huge job at a county level. I've never seen an undertaking like this in my career."

The Montana Opioid Abatement Trust advisory committee will meet quarterly, meaning its next chance to review any submitted grants will be next spring.

Katheryn Houghton: khoughton@kff.org, @K_Hought

Aneri Pattani: apattani@kff.org, @aneripattani

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