The way Sheldon Haleck's parents see it, the 38-year-old's only crime was jaywalking. But that March night in 2015, after Honolulu police found him behaving erratically, they pepper-sprayed him, shocked him with a Taser, and restrained him. Haleck became unresponsive and was taken to a hospital. Before his parents could get from their home in Utah to Hawaii, the former Hawaii Air National Guardsman was taken off life support.
"Nobody's supposed to die from something like this," said Haleck's father, William.
An initial autopsy ruled Haleck's death a homicide and his family filed a civil lawsuit in federal court against the three officers who tried to remove him from the street. The case should have been "one of the easiest wrongful death cases" to win, said Eric Seitz, an attorney who represented Haleck's family.
But the officers' attorneys seized on a largely discredited, four-decade-old diagnostic theory called "excited delirium," which has been increasingly used over the past 15 years as a legal defense to explain how a person experiencing severe agitation can die suddenly through no fault of the police. "The entire use of that particular theory, I think, is what convinced the jury," Seitz said.
Haleck's case is just one legal battle in which the theory of excited delirium exonerated law enforcement despite mounting opposition to the term among most prominent medical groups. The theory has been cited as a defense in the 2020 deaths of George Floyd in Minneapolis; Daniel Prude in Rochester, New York; and Angelo Quinto in Antioch, California. It figures in a criminal trial against two police officers involved in the 2019 death of Elijah McClain in Aurora, Colorado, now underway. It has allowed defense attorneys to argue that individuals in police custody died not of restraint, not of a Taser shock, but of a medical condition that can lead to sudden death.
But now, the American College of Emergency Physicians will vote at an October meeting on whether to formally disavow its 2009 position paper supporting excited delirium as a diagnosis that helped undergird those court cases. The draft resolution also calls on ACEP to discourage physicians who serve as expert witnesses from promoting the theory in criminal and civil trials.
"It's junk science," said Martin Chenevert, an emergency medicine physician at UCLA Santa Monica Medical Center, who often testifies as an expert witness. The theory has been used to provide a cover for police misconduct, he said. "It had an agenda."
Passing the resolution wouldn't bring Haleck back, but his parents hope it would prevent other families from experiencing their agony. "May that excited delirium die here," said his mother, Verdell.
Democratic California Gov. Gavin Newsom is considering signing into law a bill passed Sept. 12 that would do much of the same in his state.
"If we don't fully denounce this now, it will be there for the grasping, again," said Jennifer Brody, a physician with the Boston Health Care for the Homeless Program, who co-authored a 2021 editorial calling on organized medicine to denounce excited delirium. "Historically, we know what happens: The pendulum swings the other way."
Most major medical societies, including the American Medical Association and the American Psychiatric Association, don't recognize excited delirium as a medical condition. This year, the National Association of Medical Examiners rejected excited delirium as a cause of death. No blood test or other diagnostic test can confirm the syndrome. It's not listed in the "Diagnostic and Statistical Manual of Mental Disorders," a reference book of mental health conditions, nor does it have its own diagnostic code, a system used by health professionals to identify diseases and disorders.
But the argument's pervasiveness in excessive-use-of-force cases has persisted in large part because of the American College of Emergency Physicians' 2009 white paper proposing that individuals in a mental health crisis, often under the influence of drugs or alcohol, can exhibit superhuman strength as police try to control them, and then die from the condition.
The ACEP white paper has been cited in cases across the U.S., and lawyers who file police misconduct cases said that courts and judges accept the science without sufficient scrutiny.
ACEP's position "has done a lot of harm" by justifying first responder tactics that contribute to a person's death, said Joanna Naples-Mitchell, an attorney who worked on a Physicians for Human Rights review of excited delirium. The term has also been used in cases in Australia, the United Kingdom, Canada, and other countries, according to the group.
"This is a really important opportunity for ACEP to make things right," she said of the upcoming vote.
ACEP officials declined KFF Health News requests for an interview.
Starting in the mid-1990s, the leading proponents of excited delirium produced research with funding from Taser International, a maker of stun guns used by police, which later changed its name to Axon. The research purported to show that the technique of prone restraint, in which suspects are lying face down on the ground with the police officer's weight on top of them, and Taser shocks couldn't kill someone. That research formed the basis of the white paper, providing an alternative cause of death that defense attorneys could argue in court. Many emergency physicians say the ACEP document never lived up to the group's standard for clinical guidelines.
Axon officials did not respond to a call or email seeking comment on the white paper or the upcoming ACEP vote. In 2017, Taser officials used the American College of Emergency Physicians' position on excited delirium as evidence that it is a "universally recognized condition," according to Reuters.
A recent review published in the journal Forensic Science, Medicine, and Pathology concluded no scientific evidence exists for the diagnosis, and that the authors of the 2009 white paper engaged in circular reasoning and faulty logic.
"Excited delirium is a proxy for prone-related restraint when there is a death," said Michael Freeman, an associate professor of forensic medicine at Maastricht University in the Netherlands, who co-authored the review. "You don't find that people get ‘excited delirium' if they haven't also been restrained."
Between 2009 and 2019, Florida medical examiners attributed 85 deaths to excited delirium, and at least 62% involved the use of force by law enforcement, according to a January 2020 report in Florida Today. Black and Hispanic people accounted for 56% of 166 deaths in police custody attributed to excited delirium from 2010 to 2020, according to a December 2021 Virginia Law Review article.
This year, ACEP issued a formal statement saying the group no longer recognizes the term "excited delirium" and new guidance to doctors on how to treat individuals presenting with delirium and agitation in what it now calls "hyperactive delirium syndrome." But the group stopped short of retracting the 2009 white paper. For the past 14 years, ACEP took no steps to withdraw the document or to discourage defense attorneys from using it in court.
Even now, lawyers say, they must continually debunk the theory.
"Excited delirium has continued to come up in every single restraint asphyxia case that my partner and I have handled," said Julia Sherwin, a California civil rights attorney. "Instead of acknowledging that the person died from the police tactics, they want to point to this alternate theory of deaths."
Now, plaintiffs' attorneys say, if ACEP passes the resolution it would be the most meaningful step yet toward keeping the theory out of the courtroom. The resolution calls on ACEP to "clarify its position in writing that the 2009 white paper is inaccurate and outdated," and to withdraw approval for it.
Despite the theory's lack of scientific underpinning, backers of the ACEP resolution expect heated debate before the vote scheduled for the weekend of Oct. 7-8. Emergency physicians often encounter patients with agitation and delirium, they say, and are sympathetic to other first responders who share the challenge of managing such patients. While they have tools like sedation to help them in the emergency room, law enforcement officials must often subdue potentially dangerous individuals without such help.
Most people won't die as a result of police tactics such as prone restraint or Taser use, but a small fraction do.
"It's a crappy, crappy situation, when you have someone who's out of control, who can't make decisions for himself, and is potentially a threat somewhere," said Jared Strote, an emergency medicine professor at the University of Washington. "It's not like they have a sticker on their head that says, ‘Hey, I'm at high risk. If you hold me down, then I could go into sudden cardiac arrest.'"
Nonetheless, sentiment is growing among emergency physicians that the 2009 ACEP white paper has resulted in real harm and injustices, and it's time to set it aside.
"We'll be able to close the chapter on it and move forward to recognize explicitly that this was in error," said Brooks Walsh, an emergency physician from Bridgeport, Connecticut, and a key player in bringing the resolution up for a vote. "We definitely have an ethical responsibility to address mistakes or evolutions in medical thinking."
Chris Vanderveen, KUSA-TV's director of special projects, contributed to this report.
A federal program to combat the alarming rates of rural women dying from pregnancy complications has marked a first: It's supporting an organization that serves predominantly Black counties in the Deep South.
The news came Sept. 27, three months after KFF Health News' reporting raised questions about why a federal Health Resources and Services Administration program targeting rural maternal mortality hadn't sent a grant to serve mothers in majority-Black rural communities.
Non-Hispanic Black women — regardless of income or education level — die of pregnancy-related causes at nearly three times the rate of non-Hispanic white women.
The Institute for the Advancement of Minority Health in Madison, Mississippi, was one of two winners in the latest round of an initiative administered by HRSA. Mary Hitchcock Memorial Hospital in Lebanon, New Hampshire, was the other winner, according to an agency announcement.
"Very happy to see Mississippi," said Peiyin Hung, deputy director of the University of South Carolina's Rural and Minority Health Research Center. Mississippi has the highest rate of maternal mortality in the U.S. and the highest proportion of Black births in the U.S., she said.
Hung, who is a member of the health equity advisory group for the maternal grant program, said the Mississippi nonprofit is an unusual awardee because it is not part of a larger health system.
In June, KFF Health News found that HRSA's Rural Maternity and Obstetrics Management Strategies Program, or RMOMS, had failed to fund any sites in the Southeast, where the U.S. Census Bureau shows the largest concentration of predominantly Black rural communities. The program began four years ago and had budgeted nearly $32 million to provide access and care for thousands of mothers and babies nationwide — including Hispanic women along the Rio Grande and Indigenous mothers in Minnesota.
The rural Southeast was omitted despite a White House declaration to make Black maternal health a priority, and despite statistics showing America's maternal mortality rate rising sharply in recent years.
Rep. Robin Kelly (D-Ill.) introduced the "CARE for Moms Act" in mid-September and — in response to KFF Health News' reporting ― called for accountability and reporting requirements for maternal health grants under the Department of Health and Human Services.
"Where is the money going?" she said during a September press conference. "Is it going where it's needed or is it going to bigger organizations who have the people who can write the grants?" She added that "maybe smaller areas or more rural areas" need it more.
HRSA spokesperson Martin Kramer declined to provide more information about the rural maternity grant awards and did not respond when asked about Kelly's bill. The legislation also would establish regional "centers of excellence," Kelly said, to address implicit bias and cultural competency in healthcare providers. She said the bill would also "build up the doula workforce" and establish a state-based perinatal quality collaborative to improve care nationwide.
In an interview with KFF Health News, Kelly, co-chair of the House Maternity Care Caucus and a congressional leader in expanding Medicaid for postpartum care, suggested the lack of grants to the predominantly Black rural South could be because of "implicit bias," and she said her bill would help "get to the heart of the matter and get [the money] to the people that really need it."
The roughly $2 million in new rural grants are part of nearly $90 million in maternal health funding announced in late September by HRSA, an agency within HHS.
The Mississippi-based Institute for the Advancement of Minority Health was created in 2019 to reduce health disparities through partnerships, according to federal filings. Chief executive Sandra Melvin confirmed in an email that this is the first time the institute has applied for the grant, but also noted that it has been working to reduce maternal and infant health disparities since 2019.
Work performed with the grant "will be successful," she said, because the organization plans to take a community-based approach that includes partnering with health centers, hospitals, and a university.
In past years, the grant application process skewed toward large health systems because they "have much higher capacity to form a statewide network," Hung said. That's, in part, because grant winners were required to create a network of specific healthcare clinics, hospitals, and the state Medicaid office. In recent years, the agency has "become much more flexible," Hung said.
The success of the Mississippi application is a "promising signal" for states that don't have large rural health systems focusing on maternal care, said Hung, who hopes a South Carolina applicant receives a grant in the future.
In New Hampshire — where awardee Mary Hitchcock Memorial Hospital is part of the larger Dartmouth Health system in New England ― three rural hospital labor and delivery units have closed in recent years. The closures forced pregnant women to drive up to an hour and a half to appointments or delivery services, said Greg Norman, senior director of community health at Dartmouth Hitchcock Medical Center.
Its HRSA application included the North Country Maternity Network, a collaboration of hospitals and clinics created in late 2021, Norman said. The New Hampshire group did not win the federal maternity grant the first time it applied. But this time the network was more established , he said.
The money from the New Hampshire grant — up to $1 million a year for four years — will help create standardized medical and social screening for pregnant people. It will also pay for a shared high-risk coordinator and increased use of doulas and community health workers who could do home visits, he said.
The whole project, Norman said, is "a step in the direction of more equitable care."
JOHNSON CITY, Tenn. — Five years ago, rival hospital companies in this blue-collar corner of Appalachia made a deal. If state lawmakers let them merge, leaving no competitors, the hospitals promised not to gouge prices or cut corners. They agreed to dozens of quality-of-care conditions, spelled out with benchmarks, and to provide hundreds of millions of dollars in charity care to patients in need.
Today, Ballad Health's 20 hospitals remain the only option for hospital care for most of about 1.1 million residents in a 29-county region at the nexus of Tennessee, Virginia, Kentucky, and North Carolina. But Ballad has not met many of the quality benchmarks nor provided much of the charity, spurring discontent among those with no choice but to rely on Ballad for their care.
Two dozen states, from Florida to Washington, have at some point passed so-called COPA laws that allow hospital systems to merge into monopolies, disregarding warnings from the Federal Trade Commission that such mergers can become difficult to control and may decrease the overall quality of care. In the case of Ballad, the nation's largest-known COPA deal, public records suggest that is exactly what happened.
Documents released by the Tennessee Department of Health show:
Ballad has not fulfilled the annual charity care obligation it made to Tennessee, falling short by about $148 million over a four-year span. In those same years, Ballad took thousands of patients to court to collect unpaid bills.
Ballad failed to meet about 80% of benchmarks designed to monitor and improve its quality of care — including rates of infection and death — in the most recent year for which data is available. Federal health officials cited some of these same problems this year in issuing one-star ratings to three Ballad hospitals, including a flagship, Johnson City Medical Center.
"The state of Virginia and the state of Tennessee took a chance on [Ballad] to do the right thing," said Michele Johnson, executive director of the Tennessee Justice Center, a nonprofit focused on healthcare for the poor. "And they've proven that they are not worthy of that chance."
In a two-hour interview with KFF Health News, Ballad Health CEO Alan Levine defended the merger as "hugely successful" for a region rife with poverty and sickness, saying his company had planted seeds of better health that "you can't quantify today." More specifically, Levine said the enormous pressure of the coronavirus pandemic caused Ballad's slumping quality of care. He attributed charity care shortfalls to Medicaid changes beyond Ballad's control and new preventive care programs that keep patients out of the hospital so they don't need charity.
Levine said the Ballad merger had likely prevented at least three hospital closures and kept giant corporations from swooping into Appalachia to buy up the scraps.
"Our critics say, ‘No Ballad. We don't want Ballad.' Well, then what?" Levine said. "Because the hospitals were on their way to being closed."
Ballad is centered in Tennessee and Virginia's Tri-Cities region, a cluster of hardscrabble towns and wooded foothills that is home to the famous Bristol Motor Speedway and recognized by Congress as "the birthplace of Country Music." Census data shows the Tri-Cities poverty rate is about 30% higher than the national average, and residents' general health is below average for the nation and their respective states, according to the BlueCross BlueShield National Health Index.
Ballad launched in 2018 after state officials approved the nation's largest-known Certificate of Public Advantage, or COPA, agreement, which waived anti-monopoly laws so the region's only two hospital systems — Mountain States Health Alliance and Wellmont Health System — could merge. To offset the perils of a monopoly, the COPA requires Ballad to agree to increased oversight by the state and a long list of special conditions, including limiting price increases, maintaining quality, and providing charity care. Ballad also committed to investing $308 million over 10 years to improve the health of the region, some of which it has spent on a low-to-no-cost care network for the uninsured and expanded addiction treatment services.
Even with this spending, Ballad has turned a profit. The company generated net income of more than $143 million and $63 million in fiscal years 2022 and 2021, respectively, while receiving $175 million in pandemic relief funds, according to an S&P Global Ratings independent analysis, which excludes items like gains and losses separate from hospital operations.
The merger was profitable for Levine too. His total compensation has nearly doubled to about $4.3 million since the merger, including some deferred retirement payments, according to reports filed with the IRS. Prior to Ballad, Levine worked as a high-level health official in Florida and Louisiana and was an executive at two larger hospital corporations, HCA Healthcare and Health Management Associates. Federal prosecutors accused both companies of widespread healthcare fraud during some of the years when Levine was one of their leaders, claims the companies denied but later paid hundreds of millions of dollars to settle.
Nationwide, the COPA model is uncommon but gaining momentum. COPAs have been used in about 10 hospital mergers over the past three decades, including two in Texas and one in Louisiana in just the past three years, and another is being proposed in Indiana. Nineteen states have laws on the books allowing for COPAs, although not all have approved a specific merger, and five other states passed COPA laws and later repealed them, according to The Source on HealthCare Price & Competition, a website by the University of California College of the Law-San Francisco.
Rahul Rao, a deputy director of the Bureau of Competition at the Federal Trade Commission, which consistently opposes COPAs, said removing hospital competition leads to predictable results — rising prices, decreasing quality, and monopolies that are very hard to break up.
Rao said the FTC has for years studied how the Ballad merger is affecting healthcare in the region but that it is not yet ready to publish its findings.
"States should be very wary and distrustful of COPAs in general," Rao said. "It's very hard to unscramble the eggs."
Tennessee began to pave the way for Ballad in 2015 when state Sen. Rusty Crowe (R-Johnson City) co-sponsored a bill allowing for the merger, which was later mirrored in Virginia. Crowe was also working as a contractor for Mountain States Health Alliance when the bill was introduced, and since the merger he has been similarly contracted with Ballad, the lawmaker said.
Tennessee financial disclosure records confirm Crowe was paid by both hospital systems but don't say how much or for what. Crowe, who did not agree to an interview, said in an email that he was hired to "help in the development of wound care and hyperbaric medicine" and that he "complied with all the Senate ethics code requirements regarding any potential conflict of interest."
Tennessee and Virginia health officials have concluded annually that the merger remains beneficial to the public and, in reports and interviews, credited Ballad for weathering the pandemic and keeping hospitals open.
Dennis Barry, one of the state monitors hired to keep tabs on Ballad, said he believed Ballad had largely lived up to the agreement, or at least the "intent." Barry dismissed the FTC's position that hospital competition is necessarily beneficial and said no one knows how the region would have fared without the merger.
"In a sense, we'll never be able to determine whether or not this was a good idea or a bad idea," Barry said. "I view it as an experiment."
As Ballad fell short of its COPA benchmarks, state officials took steps to relax the oversight of its hospitals, particularly in Tennessee. Both Tennessee and Virginia gave Ballad more time to spend tens of millions to benefit the region, and Tennessee officials have repeatedly waived Ballad's annual charity care obligation. Tennessee in 2021 stopped publishing a "final score" for Ballad's adherence to the COPA terms and in 2022 revised COPA rules so Ballad could oppose the opening of competing hospitals or other medical facilities in the region, according to state documents. A local COPA advisory council, created to hear complaints from residents, no longer hosts public hearings.
Ballad Cites Pandemic Amid Quality Decline
Ballad has failed to meet quality-of-care benchmarks established in the COPA agreement in recent years, according to public reports from the Tennessee government and the hospital system itself. For example, a Tennessee report shows that from July 2021 through June 2022, Ballad hospitals fell short of 61 of 75 benchmarks, including some about sepsis, surgery-related infections, emergency room speed, and rates of readmission and death from heart failure.
The Centers for Medicare & Medicaid Services this year issued one-star ratings to three Ballad hospitals, all of which had ratings of at least two stars before the merger. Because CMS calculates star ratings from data collected over several years, the ratings released this year are the first to grade the Ballad hospitals entirely on post-merger data.
Levine, citing arguments similar to those of other hospital leaders, insisted the CMS five-star rating system is broken because it judges hospitals on a sliver of patients and doesn't account for poor health in the region. He said Ballad fell short of the COPA benchmarks because the coronavirus overwhelmed hospitals and sparked an unprecedented nursing turnover.
But Ballad's hospitals have since rebounded, Levine said, pointing to partial data on the company website — not yet reported by the states — that appears to show improving performance as of this summer. And Levine said internal data showed Ballad was now tracking with the top 10% of U.S. hospitals on some quality-of-care metrics.
"We went way backwards during covid, no question about it. And now we've emerged out of covid," Levine said. "We're recovering faster than other people."
Erik Bodin, a Virginia Department of Health official who oversees the agreement with Ballad, said the pandemic caused quality issues at hospitals across the state, including Ballad's, which were "not acceptable" but "to some extent understandable." Bodin said Virginia still has "concerns" and is "watching very closely" because not all of Ballad's metrics are rebounding.
The Tennessee Department of Health, which has the most robust role in regulating Ballad, declined an interview request and did not answer questions submitted in writing.
Ballad has also cut back on facilities for patients with life-threatening conditions. Citing redundancy with other hospitals, it downgraded the capabilities of trauma centers at Bristol Regional Medical Center and Holston Valley Medical Center and closed the intensive care unit at Sycamore Shoals Hospital. Ballad also shuttered the Holston Valley neonatal ICU. Residents were so angry that protesters gathered outside Holston Valley for eight months.
"I packed a sleeping bag, a backpack, and my laptop bag. I made two signs in my living room," said Dani Cook, the protest leader and grandmother of a former Holston Valley NICU patient. "And next thing you know, 50 people showed up."
One month after Holston Valley's trauma center was downgraded, Jeremiah Shane Fields, 37, died at the hospital from chest injuries sustained in a car crash. According to a CMS investigation report obtained by KFF Health News, Fields' blood pressure dropped for hours before his death, but his doctor did not come to his bedside as his condition deteriorated.
Holston Valley's chief medical officer, who is quoted in the report but not named, called the case a "fundamental failure of basic trauma care" in which Fields' doctor was "not following essential standards," according to the report. Holston Valley was cited for "deficiencies" that were likely to harm patients, which the hospital immediately corrected, the report states.
Fields' family has filed an ongoing lawsuit alleging negligent care, and Ballad Health has denied all wrongdoing in court filings. Molly Luton, a spokesperson for Ballad, said that Fields' death was "an outlier" and "not the result of a systemic issue."
Fields' mother, Penny Meade, 59, said she believed the hospital could have done more to save her son.
"It used to be wonderful," Meade said. "But then everything changed. They took it all away, after that merger."
‘Helping People' vs. ‘Coming After Them'
Ballad has fallen short of the annual charity care commitment in the COPA agreement by about $20 million to $48 million each year, according to Tennessee Department of Health documents. The agency waived this obligation each year after it wasn't met, the documents show.
Charity care comes in two forms: free or discounted care for low-income patients, or the amount left over when Medicaid patients are treated but their entire cost is not covered. Most of Ballad's charity care is from the second scenario, the documents show.
Ballad said in its annual reports it is unable to meet its charity care obligation because after the COPA was negotiated both Tennessee and Virginia increased their Medicaid reimbursement and Virginia expanded Medicaid to cover more people, leaving fewer people uninsured and in need of charity. (Tennessee has not expanded Medicaid.)
"We are doing everything we can, for instance, to manage their diabetes so that they don't end up with a spike and end up in the ER," Levine said. "That reduces your charity care."
Some are unconvinced. Chris Garmon, a former FTC economist and a leading expert on COPAs at the University of Missouri-Kansas City, said Ballad had put forth a "strange defense" for its lack of charity care in a state where so many are uninsured.
"Last time I checked, Tennessee had not expanded Medicaid," Garmon said. "This sounds like Ballad is pushing the envelope, like a toddler, trying to see when their parents will actually institute some discipline."
As it was falling short of its charity commitment, Ballad filed thousands of debt collection lawsuits against patients in its first two years of operation, according to reporting from The New York Times and Modern Healthcare.
Levine said that Ballad does not sue patients who qualify for charity care and that its lawsuits slowed significantly after it adopted a more generous charity care policy in 2020. Ballad now offers free care to those who live at or below 225% of the federal poverty level, or an income of less than $67,500 for a family of four.
But the company still takes many patients to court. For example, in Tennessee's Sullivan County, one of the most populous areas in Ballad's market, the company has filed about 500 lawsuits since enacting the new charity care policy, court records show.
Wendy McClanahan, 44, said Ballad started garnishing her paycheck this summer over a lingering debt from a 2017 surgery. McClanahan said she was unemployed and unable to afford the bill at the time and she believed it was written off until court papers arrived in the mail.
Ballad will take 25% of McClanahan's paycheck until she has paid off $2,747, court records show. McClanahan said she's working overtime at her office job to make up for the lost income.
"They're supposed to be helping people instead of coming after them," she said. "It's a lot of money to me, you know, and nothing to them."
KFF Health News correspondent Bram Sable-Smith contributed to this report.
As Medicare Advantage continues to gain popularity among seniors, three Southern California companies are pioneering new types of plans that target cultural and ethnic communities with special offerings and native-language practitioners.
Clever Care Health Plan, based in Huntington Beach, and Alignment Health, based in nearby Orange, both have plans aimed at Asian Americans, with extra benefits including coverage for Eastern medicines and treatments such as cupping and tui na massage. Alignment also has an offering targeting Latinos, while Long Beach-based SCAN Health Plan has a product aimed at the LGBTQ+ community. All of them have launched since 2020.
While many Medicare Advantage providers target various communities with their advertising, this trio of companies appear to be among the first in the nation to create plans with provider networks and benefits designed for specific cultural cohorts. Medicare Advantage is typically cheaper than traditional Medicare but generally requires patients to use in-network providers.
"This fits me better," said Clever Care member Tam Pham, 78, a Vietnamese American from Westminster, California. Speaking to KFF Health News via an interpreter, she said she appreciates the dental care and herbal supplement benefits included in her plan, and especially the access to a Vietnamese-speaking doctor.
"I can always get help when I call, without an interpreter," she said.
Proponents of these new culturally targeted plans say they can offer not only trusted providers who understand their patients' unique context and speak their language, but also special products and services designed for their needs. Asian Americans may want coverage for traditional Eastern treatments, while LGBTQ+ patients might be especially concerned with HIV prevention or management, for example.
Health policy researchers note that Medicare Advantage tends to be lucrative for insurers but can be a mixed bag for patients, who often have a limited choice of providers — and that targeted plans would not necessarily solve that problem. Some also worry that the approach could end up being a new vector for discrimination.
"It's strange to think about commodifying and profiting off people's racial and ethnic identities," said Naomi Zewde, an assistant professor at the UCLA Fielding School of Public Health. "We should do so with care and proceed carefully, so as not to be exploitive."
Still, there's plenty of evidence that patients can benefit from care that is targeted to their race, ethnicity, or sexual orientation.
A November 2020 study of almost 118,000 patient surveys, published in JAMA Network Open, underscored the need for a connection between physician and patient, finding that patients with the same racial or ethnic background as their physicians are more likely to rate the latter highly. A 2022 survey of 11,500 people around the world by the pharmaceutical company Sanofi showed a legacy of distrust in health care systems among marginalized groups, such as ethnic minorities, LGBTQ+ people, and people with disabilities.
Clever Care, founded by Korean American health care executive Myong Lee, aimed from the start to create Medicare Advantage plans for underserved Asian communities, said Peter Winston, the senior vice president and general manager of community and provider development at the company. "When we started enrollments, we realized there is no one ‘Asian,' but there is Korean, Chinese, Vietnamese, Filipino, and Japanese," Winston added.
The company has separate customer service lines by language and gives members flexibility on how and where to spend their allowances for benefits like fitness programs.
Winston said the plan began with 500 members in January 2021 and is now up to 14,000 (still very small compared with mainstream plans). Herbal supplement benefit dollars vary by plan, but more than 200 products traditionally used by Asian clients are on offer, with coverage of up to several hundred dollars per quarter.
Sachin Jain, a physician and the CEO of SCAN Group, said its LGBTQ+ plan serves 600 members.
"This is a group of people who, for much of their lives, lived in the shadows," Jain added. "There is an opportunity for us as a company to help affirm them, to provide them with a special set of benefits that address unmet needs."
SCAN has run into bias issues itself, with some of its employees posting hate speech and one longtime provider refusing to participate in the plan, Jain recounted.
Alignment Health offers a plan targeting Asian Americans in six California counties, with benefits such as traditional wellness services, a grocery allowance for Asian stores, nonemergency medical transportation, and even pet care in the event a member has a hospital procedure or emergency and needs to be away from home.
Alignment also has an offering aimed at Latinos, dubbed el Único, in parts of Arizona, Nevada, Texas, Florida, and California. The California product, an HMO co-branded with Rite Aid, is available in six counties, while in Florida and Nevada, it's a so-called special needs plan for Medicare beneficiaries who also qualify for Medicaid. All offer a Spanish-speaking provider network.
Todd Macaluso, the chief growth officer for Alignment, declined to share specific numbers but said California membership in Harmony — its plan tailored to Asian Americans — and el Único together has grown 80% year over year since 2021.
Alignment's marketing efforts, which include visiting places where prospective members may shop or socialize, are about more than just signing up customers, Macaluso said.
"Being present there means we can see what works, what's needed, and build it out. The Medicare-eligible population in Fresno looks very different from one in Ventura."
"Just having materials in the same language is important, as is identifying the caller and routing them properly," Macaluso added.
Blacks, Latinos, and Asians overall are significantly more likely than white beneficiaries to choose Medicare Advantage plans, according to recent research conducted for Better Medicare Alliance, a nonprofit funded by health insurers. (Latino people can be of any race or combination of races.) But it's not clear to what extent that will translate into the growth of targeted networks: Big insurers' Medicare Advantage marketing efforts often target specific racial or ethnic cohorts, but the plans don't usually include any special features for those groups.
Utibe Essien, an assistant professor of medicine at UCLA, noted the historical underserving of the Black community, and that the shortage of Black physicians could make it hard to build a targeted offering for that population. Similarly, many parts of the country don't have a high enough concentration of specific groups to support a dedicated network.
Still, all three companies are optimistic about expansion among groups that haven't always been treated well by the health care system. "If you treat them with respect, and bring care to them the way they expect it, they will come," Winston said.
St. Louis' largest health system, BJC HealthCare, plans to merge with Kansas City's second-largest, Saint Luke's Health System, uniting more than 28 hospitals on both sides of Missouri by the end of this year.
The merger, which would span markets 250 miles apart and include facilities in neighboring Kansas and Illinois, is just one of the latest in a quickly consolidating hospital industry. Cross-market deals accounted for more than half of all hospital mergers and acquisitions during the last decade, according to a paper from experts on antitrust law. Today, nearly 60% of health systems operate multiple hospitals in different geographic markets.
Not only are such deals more common, they can increase costs for patients. Merged hospitals in the same state but in different markets raised prices as much as 10% compared with other hospitals, researchers found after analyzing past deals. A separate study found stand-alone hospitals raised prices 17% after they were acquired by a hospital company in another market.
But for some 50 years, federal regulators have not stepped in to prevent hospitals from merging with systems in other markets, according to antitrust law experts. Without federal intervention, states that have seen such megamergers, such as Michigan and California, are often left to wrestle with the complex question of how to respond, given the likelihood of higher prices for their residents.
The Federal Trade Commission and the Justice Department are reviewing public comments on draft merger guidelines designed to crack down on mergers in multiple sectors, including healthcare. It's not yet clear if or how cross-market hospital mergers within a state could be affected. Still, the draft says consolidation should not "entrench or extend a dominant position" by extending into "new markets."
But such cross-market mergers aren't quite a textbook case of a monopoly. When hospitals have bought up local rivals, knocking out their competition, federal regulators have intervened to block these traditional mergers to protect patients from the resulting loss of competition. In recent years, they helped stop proposed mergers in New Jersey, Utah, and Rhode Island. The thinking is that without local competition, prices increase and the quality of care decreases.
It's harder to prove how cross-market mergers, like the one planned in Missouri, reduce competition if the hospitals do not operate within a single market, said Chris Garmon, an assistant professor at the University of Missouri-Kansas City, who researches hospital mergers. Regulators would have to prove the mergers don't just raise prices but also run afoul of the law by suppressing competition.
"That's why we haven't seen a cross-market merger challenge yet. It's because it's hard to tell the story of why this would be a problem," he said.
The Federal Trade Commission did not answer questions from KFF Health News on its broader strategy around such deals or the BJC-Saint Luke's merger. Whether an investigation is underway is not public information, said Mitchell Katz, an agency spokesperson.
After the FTC didn't stop cross-market hospital mergers in California and Michigan, those states landed poles apart in handling the deals. California won concessions after challenging a deal, while Michigan did not intervene.
The FTC did closely examine the 2020 deal in Michigan between Spectrum Health, based in Grand Rapids, and the Detroit area's Beaumont Health. Still, it ultimately didn't oppose the marriage that created the state's largest hospital chain, Corewell Health, with 22 hospitals in regions more than 150 miles apart.
The lack of intervention frustrated some, including Bret Jackson, CEO of the Economic Alliance for Michigan, a nonprofit that helps employers wrangle health costs. Spectrum was already the more expensive operator, said Jackson. He worries Beaumont prices will rise to match Spectrum's once the insurance contracts with the individual hospital systems expire.
"They're not going to want to take a pay cut," Jackson said of Spectrum. "We're really concerned about it."
Jackson said that he was already fed up with rising hospital prices and that so are the automotive companies and laborers he represents. Health costs consume about 10% of a typical U.S. family's income.
Ellen Bristol, a Corewell Health spokesperson, did not address KFF Health News' questions about patient costs but said that the collaboration is improving quality statewide and creating efficiencies that help the company navigate economic headwinds.
Even though regulators did not step in, FTC staffers and Michigan's Department of the Attorney General volleyed emails back and forth for months, according to communications obtained by KFF Health News through a public records request from the state.
The FTC asked the attorney general's office to connect its staffers to employers and state officials, plus provide information and data on the healthcare landscape in the state, the emails show. The FTC interviewed executives from BorgWarner, an automotive supplier, and CMS Energy, a utility company.
Jackson said he, too, was interviewed by the FTC, which he said was less interested in his thoughts on the deal than in Michigan's market dynamics.
It's hard to glean much from the FTC's assessment of the merger because many of the emails the state supplied to KFF Health News are redacted. But they do illustrate what information and which people the FTC consulted to reach a decision.
The emails also suggest state officials were made aware of the FTC's findings. On the evening of Jan. 13, 2022, an assistant AG sent a lengthy email to Michigan Attorney General Dana Nessel about the FTC's review of possible antitrust implications, according to the subject line. In the version provided to KFF Health News, though, the entire email — except for the greeting and the signature — was blacked out.
The next day, other emails show, hospital officials began discussing final language with the AG's office for a press release announcing the deal would soon close.
Michigan did not move to block the deal or investigate further. Danny Wimmer, a spokesperson for Nessel, a Democrat, said the deal fell outside the authority of her office, further frustrating Jackson, of the Economic Alliance for Michigan.
"We need to give state regulators the tools to at least assess mergers in the healthcare system," Jackson said.
Nessel's position is not the attitude taken in all states. A 2020 merger agreement in California between Huntington Hospital in Pasadena and Cedars-Sinai Health System, with its flagship hospital in Los Angeles, attracted the attention of then-state Attorney General Xavier Becerra, who imposed conditions, such as price caps to protect consumers.
Becerra, a Democrat who is now Health and Human Services secretary, had argued the cross-market merger would lead to higher prices.
Employers relied on having both Cedars-Sinai and Huntington Hospital in their networks to ensure adequate access to all employees scattered across the massive Los Angeles region — with a population larger than that of most states — which California officials said has several distinct markets serving patients. If the two were to combine, employers would have to accept price hikes to maintain access to both entities, according to an analysis the AG's office commissioned. Health systems can "threaten to create important holes in a health plan's provider network," the analysis said, by refusing to include all hospitals, giving the system greater leverage to extract higher prices from the health plan.
Ultimately, the parties settled on revised conditions, which included a 10-year ban on all-or-nothing contracting with insurers and a cap on price increases for five years.
The settlement allowed Cedars-Sinai to expand access while reflecting a shared goal of "keeping healthcare affordable," said Duke Helfand, a spokesperson for Cedars-Sinai. Still, it was considered a win for antitrust enforcers, with implications that could reverberate across the country, some health economists said.
In Missouri, the key question is whether state officials will intervene. Attorney General Andrew Bailey, a Republican, is reviewing the merger, which requires his office's approval before it can close, said Madeline Sieren, a spokesperson for the AG.
Neither BJC nor Saint Luke's answered questions from KFF Health News about potential price increases or plans to improve quality. The hospitals have estimated the merged system will generate annual revenue topping $10 billion.
The Missouri systems ought to explain how this merger will benefit patients by lowering costs and improving quality, Garmon said.
"Whether they actually do them or not depends on whether they actually have the incentive to do them," Garmon said.
For the first time since 2019, congressional gridlock is poised to at least temporarily shut down big parts of the federal government — including many health programs.
If it happens, some government functions would stop completely and some in part, while others wouldn't be immediately affected — including Medicare, Medicaid, and health plans sold under the Affordable Care Act. But a shutdown could complicate the lives of everyone who interacts with any federal health program, as well as the people who work at the agencies administering them.
Here are five things to know about the potential impact to health programs:
1. Not all federal health spending is the same.
"Mandatory" spending programs, like Medicare, have permanent funding and don't need Congress to act periodically to keep them running. But the Department of Health and Human Services is full of "discretionary" programs — including at the National Institutes of Health, Centers for Disease Control and Prevention, community health centers, and HIV/AIDS initiatives — that must be specifically funded by Congress through annual appropriations bills.
The appropriations bills (there are 12 of them, each covering various departments and agencies) are supposed to be passed by both chambers of Congress and signed by the president before the start of the federal fiscal year, Oct. 1. This almost never happens. In fact, according to the Pew Research Center, Congress has passed all the appropriations bills in time for the start of the fiscal year only four times since the modern budget process was adopted in the 1970s; the last time was in 1997.
Congress usually keeps the lights on for the government by passing short-term funding bills, known as "continuing resolutions," or CRs, until lawmakers can resolve their differences on longer-term spending.
This year, however, a handful of conservative Republicans in the House have said they won't vote for any CR, in an attempt to force deeper spending cuts than those agreed to this spring in a bipartisan bill to raise the nation's borrowing authority. House Speaker Kevin McCarthy and his allies could join with Democrats to keep the government running, but that would almost certainly cost McCarthy his speakership. Several of the rebellious conservatives are already threatening to force a vote to oust him.
2. The Biden administration decides what stays open.
The White House Office of Management and Budget is responsible for drawing up contingency plans in case of a government shutdown and publishes one for each federal department. The plan for Health and Human Services estimates that 42% of its staff would be furloughed in a shutdown and 58% retained.
The general rule is that two types of activities may continue absent annual spending authority from Congress. One is activities needed "for safety of human life or the protection of property." At HHS, that would include caring for patients at the hospital on the campus of the National Institutes of Health — though new patients generally would not be admitted — as well as the agency's laboratory animals, and CDC investigations of disease outbreaks.
Other activities that may continue are those with funding sources that aren't dependent on annual appropriations. Medicare and Social Security, for example, are entitlements funded by taxes and premiums. Drug approvals at the FDA are largely funded by user fees paid by drugmakers, so they could continue as usual.
Also unaffected are programs that have been funded in advance by Congress. For example, the Indian Health Service is already funded through the 2024 fiscal year.
3. What happens to enrollment in Medicare and Affordable Care Act plans?
It depends on how long the shutdown lasts. In the short term, mandatory spending programs would be mostly, but not completely, unaffected by a government shutdown. Benefits would continue under programs like Medicare, Medicaid, and the Affordable Care Act, and doctors and hospitals could continue to submit bills and get paid. But federal staffers not considered "essential" would be furloughed.
That means initial Medicare enrollment could be temporarily stopped. According to the Committee for a Responsible Federal Budget, an independent group that tracks federal spending, during the 1995-96 federal shutdown, "more than 10,000 Medicare applicants were temporarily turned away every day of the shutdown."
A shutdown shouldn't much affect Medicare's annual open enrollment period, which starts Oct. 15 and allows current beneficiaries to join or change private Medicare Advantage or prescription drug plans. That's because much of the funding to help seniors and other beneficiaries choose or change Medicare health plans has already been allocated.
Rebecca Kinney, who runs the HHS office that oversees the federal program that counsels Medicare beneficiaries about their myriad choices, said Sept. 22 that funding for both the 1-800-MEDICARE hotline and federally funded state counseling agencies has already been distributed for this year, so neither would be affected, at least in the short run.
The same is true for Affordable Care Act plans, which open for enrollment Nov. 1. The HHS contingency documents say the Centers for Medicare & Medicaid Services, which oversees the federal health exchange, healthcare.gov, "will continue Federal Exchange activities, such as eligibility verification," using fees paid by insurers left over from the previous year.
Still, about half of CMS staffers would be furloughed in a shutdown. That could complicate a lot of other activities there, starting with drug price negotiations set to begin Oct. 1. HHS Secretary Xavier Becerra told reporters at the White House last week that a shutdown would likely push back the timeline for negotiations.
A shutdown would also threaten HHS oversight of the Medicaid "unwinding" process, as states reevaluate the eligibility of those enrolled in the program for low-income people. State workers would be unaffected, according to the Georgetown University Center for Children and Families, so eligibility reviews would continue regardless. But because of federal furloughs, "technical assistance to help states address unwinding problems and adopt mitigation strategies could cease," wrote the center's Kelly Whitener and Edwin Park. "Efforts to determine if there are further renewal processes that are out of compliance with federal requirements could be limited or ended."
4. What if the shutdown is prolonged?
More programs could be affected. For example, the HHS shutdown contingency document says that "CMS will have sufficient funding for Medicaid to fund the first quarter" of fiscal year 2024. The government has never been shut down long enough to know what would happen after that. The 2013 shutdown, which included HHS, lasted just over two weeks. Most of the agency wasn't affected by the 2018-19 shutdown because its annual appropriations bill had already been signed into law. (The FDA is funded under the appropriations bill that covers the Agriculture Department rather than the one that funds HHS.)
5. Do federal employees get paid during a shutdown?
It depends. Employees whose programs are funded continue to work and be paid. Those considered "essential" but whose programs are not funded would continue to work, but they wouldn't get paid until after the shutdown ends. A 2019 law now requires federal workers to get back pay when funding resumes, which was not always the case. However, federal contractors, including those who work in food service or maintenance jobs, have no such guarantee.
Kaiser Permanente and union representatives pledged to continue negotiating a new contract up until the last minute as the threat of the nation's latest large-scale strike looms next month.
Unless a deal is struck, more than 75,000 health workers will walk out for three days from Oct. 4-7, disrupting care for KP patients in California, Colorado, Oregon, Virginia, Washington, and Washington, D.C. The unions represent a wide range of KP health workers, including lab technicians, phlebotomists, pharmacists, optometrists, social workers, orderlies, and support staff.
A strike, if it occurs, would affect most of Kaiser Permanente's 39 hospitals and 622 medical offices across the U.S., and would disrupt care for many of its nearly 13 million patients. If workers walk off their jobs, "it will start to impact patient care right away," said John August, director of healthcare and partner programs at Cornell University's Scheinman Institute on Conflict Resolution, who is a former head of the union coalition currently negotiating with KP.
"You are immediately subject to problems with not being able to get patients in and out of the hospital. You risk problems with infection control. You're not going to get meals," August said.
Arlene Peasnall, Kaiser Permanente's senior vice president for human resources, said the Oakland, California-based healthcare giant's goal is "to reach a mutually beneficial agreement before any work stoppage occurs." But she also said the nonprofit has plans in place to blunt the impact of a walkout.
"We will be bargaining with Kaiser up until the day we go on strike," said Caroline Lucas, executive director of the Coalition of Kaiser Permanente Unions, which represents about 40% of KP's workforce. "Our front-line healthcare workers are fed up, and we really need Kaiser executives to seize the initiative and move forward on resolving the contract."
The current contract expires Sept. 30 and, after months of talks, the two sides still disagree over pay and staffing. The coalition wants a $25-an-hour minimum wage across the company. KP executives agree there should be an organization-wide floor, but they've proposed $21.
KP prefers varying wage increases across regions, since the cost of living can vary sharply. The coalition, which is pushing for uniform wage increases across all regions, contends that management's proposal is part of a "divide-and-conquer strategy." Peasnall said the union's stance "would prevent us from addressing fair market wages where we need to pay more to attract and retain the best people."
The unions say their lowest-paid workers can barely make ends meet in the face of soaring prices for food, gasoline, and other essentials. And, they say, KP hospitals and clinics are severely understaffed, forcing workers to put in long hours and fill multiple roles. They argue that management is not moving quickly enough to fill positions and that the quality of care has suffered as patients, some with serious illnesses, often wait months for appointments, face extremely long waits in the emergency room, and experience delays in hospital admissions.
An industrywide labor shortage hangs heavily over the contract talks. The pandemic was particularly brutal for healthcare workers who often worked long hours in grueling conditions, as colleagues fell ill, died, or quit. Workers say many of the positions that became vacant during the pandemic still have not been filled.
Miriam De La Paz, a secretary in the labor and delivery department of KP's Downey Medical Center in Southern California and a union steward, said when she is alone on a shift, she is responsible for two labor and delivery stations as well as triage, where patients are prioritized based on the acuity of their cases.
"Imagine if I'm putting this baby in the system and your wife shows up in pain, crying, but I'm not there to register her," De La Paz said. "I can't break myself in two."
Unions want KP to invest more in education, training, and recruitment to fill current openings and create a pipeline of future workers. KP says it is doing so.
Peasnall said KP has already filled more than 9,700 out of 10,000 new coalition-represented jobs the two sides had agreed to create this year. And she said KP's turnover rate is one-third the industry rate, in part because of "excellent pay and benefits."
Earlier this month, California lawmakers passed legislation to gradually raise the minimum wage for healthcare workers in the state to $25 an hour. If Democratic Gov. Gavin Newsom signs the bill into law, KP will have to comply. And nearly 80% of workers represented by the coalition in the current contract talks are in California.
On Sept. 22, as bargaining continued in San Francisco, the unions announced that more than 75,000 of the 85,000 workers they represent would stage the three-day walkout if there's no deal. Federal law requires 10 days' notice of strikes at healthcare facilities. The coalition said it is "prepared to engage in another longer, stronger strike in November," if no agreement is reached by then.
A coalition spokesperson, Betsy Twitchell, said workers would welcome the Biden administration's involvement in the talks "because of the importance of these negotiations to millions of patients and 75,000 frontline healthcare workers."
The unions say KP can afford to be more generous, citing its robust financial health.
Although KP reported a net loss of almost $4.5 billion in 2022, it generated a cumulative net income of nearly $22 billion over the three preceding years — both results driven largely by investment performance. In the first half of this year, KP posted profits of over $3 billion. And it is in a strong position to manage its debt, according to a report earlier this year by Fitch Ratings.
The unions note that Kaiser Permanente's CEO, Greg Adams, received almost $16 million in compensation in 2021 and that dozens of others in KP management made more than $1 million, according to a KP filing with the IRS.
Peasnall said the compensation of KP's senior management is less than that of their peers at other healthcare companies.
A KP walkout would be the latest in a string of worker movements. Strikes have hit Hollywood, hotels, auto manufacturers, and other industries. Public approval of unions is at a nearly 60-year high, according to a Gallup Poll released in August 2022.
Health workers are increasingly engaged, too. Several hospital groups have been hit by strikes, including Cedars-Sinai Medical Center in Los Angeles and numerous facilities belonging to Sutter Health in Northern California, as well as healthcare organizations in other states.
"There is an atmosphere in the country: It's labor summer, it's strike summer, it's all that," August said. "That definitely has an influence on union leadership that says, ‘We need to be a part of that.'"
Abby Madore covers a lot of ground each day at work.
A staffer at a community health center in Carson City, Nevada, Madore spends her days helping low-income residents understand their health insurance options, including Medicaid. Her phone is always ringing, she said, as she fields calls from clients who dial in from the state's remote reaches seeking help.
It's a big job, especially this year as states work to sort through their Medicaid rolls after the end of a pandemic-era freeze that prohibited disenrollment.
A few dozen specialists work for seven navigator organizations tasked with helping Nevadans enroll in or keep their coverage. Madore said she mostly works with people who live in rural Nevada, a sprawling landmass of more than 90,000 square miles.
Katie Charleson, communications officer for Nevada's state health marketplace, said it's always a challenge to reach people in rural areas. Experts say this problem isn't unique to the state and is causing concern that limited resources will throw rural Americans into jeopardy as the Medicaid unwinding continues.
KFF's Medicaid Enrollment and Unwinding Tracker shows that 72% of people who have lost Medicaid coverage since states began the unwinding process this year were disenrolled for procedural reasons, not because officials determined they are no longer eligible for the joint state-federal health insurance program.
By late August, federal officials directed state Medicaid overseers to pause some procedural disenrollments and reinstate some recipients whose coverage was dropped.
Experts say those procedural disenrollments could disproportionately affect rural people.
A brief recently published by researchers at the Georgetown University Center for Children and Families noted that rural Medicaid recipients face additional barriers to renewing coverage, including longer distances to eligibility offices and less access to the internet.
Nationwide, Medicaid and CHIP, the Children's Health Insurance Program, covered 47% of children and 18% of adults, respectively, in small towns and rural areas, compared with 40% of children and 15% of adults in metropolitan counties.
"As is clear from our research, rural communities rely on Medicaid to form the backbone of their health care system for children and families," said Joan Alker, who is one of the brief's co-authors, the executive director of the Center for Children and Families, and a research professor at Georgetown's McCourt School of Public Policy. "So if states bungle unwinding, this is going to impact rural communities, which are already struggling to keep enough providers around and keep their hospitals."
A lack of access to navigators in rural locales to help Medicaid enrollees keep their coverage or find other insurance if they're no longer eligible could exacerbate the difficulties rural residents face. Navigators help consumers determine whether they're eligible for Medicaid or CHIP, coverage for children whose families earn too much to qualify for Medicaid, and help them enroll. If their clients are not eligible for these programs, navigators help them enroll in marketplace plans.
Navigators operate separately from Nevada's more than 200 call center staffers who help residents manage social service benefits.
Navigators are required by the federal government to provide their services at no cost to consumers and give unbiased guidance, setting them apart from insurance broker agents, who earn commissions on certain health plans. Without them, there would be no free service guiding consumers through shopping for health insurance and understanding whether their health plans cover key services, like preventive care.
Roughly 30 to 40 certified enrollment counselors like Madore work at navigator organizations helping consumers enroll in plans through Nevada Health Link, the state health marketplace, which sells Affordable Care Act plans, said Charleson. One of these groups is based in the small capital city of Carson City, 30 miles south of Reno, where fewer than 60,000 people live. The rest are in the urban centers of Reno and Las Vegas.
Availability of navigators and their outreach tactics vary from state to state.
In Montana, which is larger than Nevada but has one-third the population, six people work as navigators. They cover the entire state, reaching Medicaid beneficiaries and people seeking help with coverage by phone or in person by traveling to far-flung communities. For example, a navigator in Billings, in south-central Montana, has worked with the Crow and Northern Cheyenne Tribes, whose reservations lie relatively nearby, said Olivia Riutta, director of population health for the Montana Primary Care Association. But officials struggle to reach northeastern Montana, with its Fort Peck Reservation.
Having navigators in rural communities to help people in person is an ongoing challenge the country faces, said Alker. But the unwinding circumstances make it an especially important moment for the role navigators play in guiding people through complex insurance processes, she said.
This became clear following a recent survey regarding what consumers encounter when independently searching for health coverage on Google. "The results are really concerning," said survey co-author JoAnn Volk, a research professor and the founder and co-director of the Georgetown University Center on Health Insurance Reforms.
The researchers found that former Medicaid enrollees looking for health plans on the private market face aggressive, misleading marketing of limited-benefit products that don't cover important services and fail to protect consumers from high health costs.
Researchers shopped for coverage using two profiles of consumers who were losing Medicaid coverage and were eligible for a plan with no premiums or deductibles on the ACA marketplace.
The team reported, though, that none of 20 sales representatives who responded to their queries mentioned that plan, and more than half pushed the limited-benefit products. The representatives also made false and misleading statements about the plans they were touting and misrepresented the availability or affordability of the marketplace plans.
The sales reps and brokers quoted limited plans that cost $200 to $300 a month, Volk said. Such an expense could prove unaffordable for consumers who may still be low-income despite being ineligible for Medicaid.
"If they can't get to a navigator, I would not trust that they would get to their best coverage option in the marketplace, or to the marketplace at all, frankly," Volk said.
Making a difficult problem more challenging, the federal government does not require states to break down Medicaid disenrollment data by county, making it harder for experts and researchers to track and differentiate rural and urban concerns. The Center for Children and Families does so with data from the Census Bureau, which Alker pointed out won't be available until next fall.
A data point that will be important to watch as states continue the redetermination process, Alker said, is call center statistics. People in rural areas rely more heavily on that method of renewing coverage.
"Call abandonment rate" is one such statistic. CMS defines it as the percentage of calls that drop from the queue in two separate measures — calls dropped up to and including 60 seconds, and calls dropped after 60 seconds. In August, the agency sent a letter to the Nevada Department of Health and Human Services about its rate: An average of 56% of calls dropped in May, the first month after Nevada's unwinding began.
The agency "has concerns that your average call center wait time and abandonment rate are impeding equitable access to assistance and the ability for people to apply for or renew Medicaid and CHIP coverage by phone and may indicate non-compliance with federal requirements," said Anne Marie Costello, deputy director of CMS.
In the letter, Costello also cited the 45% of Medicaid enrollees whose coverage was terminated for procedural reasons in May.
All 50 states received letters about early data, but only Idaho, South Carolina, Texas, and Utah had higher disenrollment rates than Nevada, and no state had a higher rate of call abandonment.
Officials at Nevada's Division of Welfare and Supportive Services said its call center, staffed by 277 family service specialists, receives more than 200,000 calls a month. A spokesperson said the phone system offers self-service options whereby customers can obtain information about their Medicaid renewal date and benefit amounts by following prompts. Because those calls aren't handled by a case manager, they are considered "abandoned," the spokesperson said, raising the rate even though callers' questions may have been fully addressed.
People shopping around for coverage after a lapse might go into a panic, Madore said, and the best part of her job is providing relief by helping them understand their options after disenrollment from Medicaid or CHIP.
When people find out the wide range of free services navigators like Madore offer, they're shocked, she said.
"They're unaware of how much support we can provide," Madore said. "I've had people call me back and they say, ‘It's my first time using insurance. Where do I go to urgent care?'"
Tennessee last year spent $48 million on a single drug, Humira — about $62,000 for each of the 775 patients who were covered by its employee health insurance program and receiving the treatment. So when nine Humira knockoffs, known as biosimilars, hit the market for as little as $995 a month, the opportunity for savings appeared ample and immediate.
But it isn't here yet. Makers of biosimilars must still work within a healthcare system in which basic economics rarely seems to hold sway.
For real competition to take hold, the big pharmacy benefit managers, or PBMs, the companies that negotiate prices and set the prescription drug menu for 80% of insured patients in the United States, would have to position the new drugs favorably in health plans.
They haven't, though the logic for doing so seems plain.
Humira has enjoyed high-priced U.S. exclusivity for 20 years. Its challengers could save the healthcare system $9 billion and herald savings from the whole class of drugs called biosimilars — a windfall akin to the hundreds of billions saved each year through the purchase of generic drugs.
The biosimilars work the same way as Humira, an injectable treatment for rheumatoid arthritis and other autoimmune diseases. And countries such as the United Kingdom, Denmark, and Poland have moved more than 90% of their Humira patients to the rival drugs since they launched in Europe in 2018. Kaiser Permanente, which oversees medical care for 12 million people in eight U.S. states, switched most of its patients to a biosimilar in February and expects to save $300 million this year alone.
Biologics — both the brand-name drugs and their imitators, or biosimilars — are made with living cells, such as yeast or bacteria. With dozens of biologics nearing the end of their patent protection in the next two decades, biosimilars could generate much higher savings than generics, said Paul Holmes, a partner at Williams Barber Morel who works with self-insured health plans. That's because biologics are much more expensive than pills and other formulations made through simpler chemical processes.
For example, after the first generics for the blockbuster anti-reflux drug Nexium hit the market in 2015, they cost around $10 a month, compared with Nexium's $100 price tag. Coherus BioSciences launched its Humira biosimilar, Yusimry, in July at $995 per two-syringe carton, compared with Humira's $6,600 list price for a nearly identical product.
"The percentage savings might be similar, but the total dollar savings are much bigger," Holmes said, "as long as the plan sponsors, the employers, realize the opportunity."
That's a big if.
While a manufacturer may need to spend a few million dollars to get a generic pill ready to market, makers of biosimilars say their development can require up to eight years and $200 million. The business won't work unless they gain significant market share, they say.
The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.
"We're not seeing a lot of takeup of the biosimilar," said Keith Athow, pharmacy director for Tennessee's group insurance program, which covers 292,000 state and local employees and their dependents.
The ongoing saga of Humira — its peculiar appeal to drug middlemen and insurers, the patients who've benefited, the patients who've suffered as its list price jumped sixfold since 2003 — exemplifies the convoluted U.S. healthcare system, whose prescription drug coverage can be spotty and expenditures far more unequal than in other advanced economies.
Biologics like Humira occupy a growing share of U.S. healthcare spending, with their costs increasing 12.5% annually over the past five years. The drugs are increasingly important in treating cancers and autoimmune diseases, such as rheumatoid arthritis and inflammatory bowel disease, that afflict about 1 in 10 Americans.
Humira's $200 billion in global sales make it the best-selling drug in history. Its manufacturer, AbbVie, has aggressively defended the drug, filing more than 240 patents and deploying legal threats and tweaks to the product to keep patent protections and competitors at bay.
The company's fight for Humira didn't stop when the biosimilars finally appeared. The drugmaker has told investors it doesn't expect to lose much market share through 2024. "We are competing very effectively with the various biosimilar offerings," AbbVie CEO Richard Gonzalez said during an earnings call.
How AbbVie Maintains Market Share
One of AbbVie's strategies was to warn health plans that if they recommended biosimilars over Humira they would lose rebates on purchases of Skyrizi and Rinvoq, two drugs with no generic imitators that are each listed at about $120,000 a year, according to PBM officials. In other words, dropping one AbbVie drug would lead to higher costs for others.
Industry sources also say the PBMs persuaded AbbVie to increase its Humira rebates — the end-of-the-year payments, based on total use of the drug, which are mostly passed along by the PBMs to the health plan sponsors. Although rebate numbers are kept secret and vary widely, some reportedly jumped this year by 40% to 60% of the drug's list price.
The leading PBMs — Express Scripts, Optum, and CVS Caremark — are powerful players, each part of a giant health conglomerate that includes a leading insurer, specialty pharmacies, doctors' offices, and other businesses, some of them based overseas for tax advantages.
Yet challenges to PBM practices are mounting. The Federal Trade Commission began a major probe of the companies last year. Kroger canceled its pharmacy contract with Express Scripts last fall, saying it had no bargaining power in the arrangement, and, on Aug. 17, the insurer Blue Shield of California announced it was severing most of its business with CVS Caremark for similar reasons.
Critics of the top PBMs see the Humira biosimilars as a potential turning point for the secretive business processes that have contributed to stunningly high drug prices.
Although list prices for Humira are many times higher than those of the new biosimilars, discounts and rebates offered by AbbVie make its drug more competitive. But even if health plans were paying only, say, half of the net amount they pay for Humira now — and if several biosimilar makers charged as little as a sixth of the gross price — the costs could fall by around $30,000 a year per patient, said Greg Baker, CEO of AffirmedRx, a smaller PBM that is challenging the big companies.
Multiplied by the 313,000 patients currently prescribed Humira, that comes to about $9 billion in annual savings — a not inconsequential 1.4% of total national spending on pharmaceuticals in 2022.
The launch of the biosimilar Yusimry, which is being sold through Mark Cuban's Cost Plus Drugs pharmacy and elsewhere, "should send off alarms to the employers," said Juliana Reed, executive director of the Biosimilars Forum, an industry group. "They are going to ask, ‘Time out, why are you charging me 85% more, Mr. PBM, than what Mark Cuban is offering? What is going on in this system?'"
Cheaper drugs could make it easier for patients to pay for their drugs and presumably make them healthier. A KFF survey in 2022 found that nearly a fifth of adults reported not filling a prescription because of the cost. Reports of Humira patients quitting the drug for its cost are rife.
Convenience, Inertia, and Fear
When Sue Lee of suburban Louisville, Kentucky, retired as an insurance claims reviewer and went on Medicare in 2017, she learned that her monthly copay for Humira, which she took to treat painful plaque psoriasis, was rising from $60 to $8,000 a year.
It was a particularly bitter experience for Lee, now 81, because AbbVie had paid her for the previous three years to proselytize for the drug by chatting up dermatology nurses at fancy AbbVie-sponsored dinners. Casting about for a way to stay on the drug, Lee asked the company for help, but her income at the time was too high to qualify her for its assistance program.
"They were done with me," she said. Lee went off the drug, and within a few weeks the psoriasis came back with a vengeance. Sores covered her calves, torso, and even the tips of her ears. Months later she got relief by entering a clinical trial for another drug.
Health plans are motivated to keep Humira as a preferred choice out of convenience, inertia, and fear. While such data is secret, one Midwestern firm with 2,500 employees told KFF Health News that AbbVie had effectively lowered Humira's net cost to the company by 40% after July 1, the day most of the biosimilars launched.
One of the top three PBMs, CVS Caremark, announced in August that it was creating a partnership with drugmaker Sandoz to market its own cut-rate version of Humira, called Hyrimoz, in 2024. But Caremark didn't appear to be fully embracing even its own biosimilar. Officials from the PBM notified customers that Hyrimoz will be on the same tier as Humira to "maximize rebates" from AbbVie, Tennessee's Athow said.
Most of the rebates are passed along to health plans, the PBMs say. But if the state of Tennessee received a check for, say, $20 million at the end of last year, it was merely getting back some of the $48 million it already spent.
"It's a devil's bargain," said Michael Thompson, president and CEO of the National Alliance of Healthcare Purchaser Coalitions. "The happiest day of a benefit executive's year is walking into the CFO's office with a several-million-dollar check and saying, ‘Look what I got you!'"
Executives from the leading PBMs have said their clients prefer high-priced, high-rebate drugs, but that's not the whole story. Some of the fees and other payments that PBMs, distributors, consultants, and wholesalers earn are calculated based on a drug's price, which gives them equally misplaced incentives, said Antonio Ciaccia, CEO of 46Brooklyn, a nonprofit that researches the drug supply chain.
"The large intermediaries are wedded to inflated sticker prices," said Ciaccia.
AbbVie has warned some PBMs that if Humira isn't offered on the same tier as biosimilars it will stop paying rebates for the drug, according to Alex Jung, a forensic accountant who consults with the Midwest Business Group on Health.
AbbVie did not respond to requests for comment.
One of the low-cost Humira biosimilars, Organon's Hadlima, has made it onto several formularies, the ranked lists of drugs that health plans offer patients, since launching in February, but "access alone does not guarantee success" and doesn't mean patients will get the product, Kevin Ali, Organon's CEO, said in an earnings call in August.
If the biosimilars are priced no lower than Humira on health plan formularies, rheumatologists will lack an incentive to prescribe them. When PBMs put drugs on the same "tier" on a formulary, the patient's copay is generally the same.
In an emailed statement, Optum Rx said that by adding several biosimilars to its formularies at the same price as Humira, "we are fostering competition while ensuring the broadest possible choice and access for those we serve."
Switching a patient involves administrative costs for the patient, health plan, pharmacy, and doctor, said Marcus Snow, chair of the American College of Rheumatology's Committee on Rheumatologic Care.
Doctors' Inertia Is Powerful
Doctors seem reluctant to move patients off Humira. After years of struggling with insurance, the biggest concern of the patient and the rheumatologist, Snow said, is "forced switching by the insurer. If the patient is doing well, any change is concerning to them." Still, the American College of Rheumatology recently distributed a video informing patients of the availability of biosimilars, and "the data is there that there's virtually no difference," Snow said. "We know the cost of healthcare is exploding. But at the same time, my job is to make my patient better. That trumps everything."
"All things being equal, I like to keep the patient on the same drug," said Madelaine Feldman, a New Orleans rheumatologist.
Gastrointestinal specialists, who often prescribe Humira for inflammatory bowel disease, seem similarly conflicted. American Gastroenterological Association spokesperson Rachel Shubert said the group's policy guidance "opposes nonmedical switching" by an insurer, unless the decision is shared by provider and patient. But Siddharth Singh, chair of the group's clinical guidelines committee, said he would not hesitate to switch a new patient to a biosimilar, although "these decisions are largely insurance-driven."
HealthTrust, a company that procures drugs for about 2 million people, has had only five patients switch from Humira this year, said Cora Opsahl, director of the Service Employees International Union's 32BJ Health Fund, a New York state plan that procures drugs through HealthTrust.
But the biosimilar companies hope to slowly gain market footholds. Companies like Coherus will have a niche and "they might be on the front end of a wave," said Ciaccia, given employers' growing demands for change in the system.
The $2,000 out-of-pocket cap on Medicare drug spending that goes into effect in 2025 under the Inflation Reduction Act could spur more interest in biosimilars. With insurers on the hook for more of a drug's cost, they should be looking for cheaper options.
For Kaiser Permanente, the move to biosimilars was obvious once the company determined they were safe and effective, said Mary Beth Lang, KP's chief pharmacy officer. The first Humira biosimilar, Amjevita, was 55% cheaper than the original drug, and she indicated that KP was paying even less since more drastically discounted biosimilars launched. Switched patients pay less for their medication than before, she said, and very few have tried to get back on Humira.
Prescryptive, a small PBM that promises transparent policies, switched 100% of its patients after most of the other biosimilars entered the market July 1 "with absolutely no interruption of therapy, no complaints, and no changes," said Rich Lieblich, the company's vice president for clinical services and industry relations.
AbbVie declined to respond to him with a competitive price, he said.
Nurses, researchers, and workplace safety officers worry new guidelines from the Centers for Disease Control and Prevention might reduce protection against the coronavirus and other airborne pathogens in hospitals.
A CDC advisory committee has been updating its 2007 standards for infection control in hospitals this year. Many healthcare professionals and scientists expressed outrage after the group released a draft of its proposals in June.
The draft controversially concluded that N95 face masks are equivalent to looser, surgical face masks in certain settings — and that doctors and nurses need to wear only surgical masks when treating patients infected by "common, endemic" viruses, like those that cause the seasonal flu.
The committee was slated to vote on the changes on Aug. 22, but it postponed action until November. Once the advice is final, the CDC begins a process of turning the committee's assessment into guidelines that hospitals throughout the United States typically follow. After the meeting, members of the public expressed concern about where the CDC was headed, especially as covid-19 cases rise. Nationwide, hospital admissions and deaths due to covid have been increasing for several consecutive weeks.
"Healthcare facilities are where some of the most vulnerable people in our population have to frequent or stay," said Gwendolyn Hill, a research intern at Cedars-Sinai Medical Center in Los Angeles, after the committee's presentation. She said N95 masks, ventilation, and air-purifying technology can lower rates of covid transmission within hospital walls and "help ensure that people are not leaving sicker than they came."
"We are very happy to receive feedback," Alexander Kallen, chief of the Prevention and Response Branch in the CDC's Division of Healthcare Quality Promotion, told KFF Health News. "It is our goal to develop a guideline that is protective of patients, visitors, and health workers." He added that the draft guidelines are far from final.
In June, members of the CDC's group — the Healthcare Infection Control Practices Advisory Committee — presented a draft of their report, citing studies that found no difference in infection rates among health providers who wore N95 masks versus surgical masks in the clinic. They noted flaws in the data. For example, many health workers who got covid in the trials were not infected while wearing their masks at work. But still, they concluded the masks were equivalent.
Their conclusion runs contrary to the CDC's 2022 report, which found that an N95 mask cuts the odds of testing positive for the coronavirus by 83%, compared with 66% for surgical masks and 56% for cloth masks. It also excludes a large clinical trial published in 2017 finding that N95 masks were far superior to surgical masks in protecting health workers from influenza infections. And it contradicts an extensive evaluation by the Royal Society, the United Kingdom's national academy of sciences, finding that N95 masks, also called N95 respirators, were more effective against covid than surgical masks in healthcare settings around the world.
"It's shocking to suggest that we need more studies to know whether N95 respirators are effective against an airborne pathogen," said Kaitlin Sundling, a physician and pathologist at the University of Wisconsin-Madison, in a comment following the June meeting. "The science of N95 respirators is well established and based on physical properties, engineered filtered materials, and our scientific understanding of how airborne transmission works."
Her assertion is backed by the California occupational safety agency, Cal/OSHA, whose rules on protecting at-risk workers from infections might be at odds with the CDC's if the proposals are adopted. "The CDC must not undermine respiratory protection regulation by making the false and misleading claim that there is no difference in protection" between N95 masks and surgical masks, commented Deborah Gold, an industrial hygienist at Cal/OSHA, at the August meeting.
Researchers and occupational safety experts were also perplexed by how the committee categorized airborne pathogens. A surgical mask, rather than an N95, was suggested as protection for a category they created for "common, endemic" viruses that spread over short distances, and "for which individuals and communities are expected to have some immunity." Three committee representatives, researchers Hilary Babcock, Erica Shenoy, and Sharon Wright, were among the authors of a June editorial arguing that hospitals should no longer require all healthcare workers, patients, and visitors to wear masks in hospitals. "The time has come to deimplement policies that are not appropriate for an endemic pathogen," they wrote.
However, in a call with KFF Health News, Kallen clarified that the committee put coronaviruses that cause colds in that category, but not yet the coronavirus causing covid.
The committee's next tier consisted of viruses in a "pandemic-phase," when the pathogen is new and little immunity through infection or vaccination exists. It recommended that health workers wear an N95 mask when treating patients infected by bugs in this category. Its third, highest tier of protection was reserved for pathogens like those causing measles and tuberculosis, which, they claimed, can spread further than lower-tier threats and require an N95.
Virologists said the committee's categories hold little water, biologically speaking. A pathogen's mode of spreading isn't affected by how common it is; common viruses can still harm vulnerable populations; and many viruses, including SARS-CoV-2, can travel significant distances on microscopic droplets suspended in the air.
"Large COVID outbreaks in prisons and long-term healthcare facilities have demonstrated that the behavior of infectious aerosols is not easily classified, and these aerosols are not easily confined," wrote the deputy chief of health at Cal/OSHA, Eric Berg, in a letter of concern to the CDC committee, obtained by KFF Health News.
The committee pitted its assessment of N95 masks against their drawbacks. Its draft cites a study from Singapore in which nearly a third of healthcare personnel, mostly nurses, said wearing such masks negatively affected their work, causing acne and other problems exacerbated by hot and humid conditions and prolonged shifts. Rather than discard the masks, the authors of that study recommend better-fitting masks and rest breaks.
Noha Aboelata, a doctor and the CEO of Roots Community Health Center in Oakland, California, agrees. "There are other strategies to bring to bear, like improved mask design and better testing," she said, "if we decide it's unacceptable to give a patient covid when they go to the hospital."
Aboelata is one of hundreds of doctors, researchers, and others who signed a letter to CDC Director Mandy Cohen in July, expressing concern that the CDC committee will weaken protections in hospitals. They also warned that scaling back on N95 masks could have repercussions on emergency stockpiles, rendering doctors and nurses as vulnerable as they were in 2020 when mask shortages fueled infections. More than 3,600 health workers died in the first year of the pandemic in the United States, according to a joint investigation by KFF Health News and The Guardian.
The concerned clinicians hope the committee will reconsider its report in light of additional studies and perspectives before November. Referring to the draft, Rocelyn de Leon-Minch, an industrial hygienist for National Nurses United, said, "If they end up codifying these standards of care, it will have a disastrous impact on patient safety and impact our ability to respond to future health crises."