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W.H.O. Broadens Definition of Airborne Diseases

After a drawn-out global controversy over the coronavirus, the W.H.O. has updated its classification of how pathogens spread through the air.

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The Path to a Better Tuberculosis Vaccine Runs Through Montana

A team of Montana researchers is playing a key role in the development of a more effective vaccine against tuberculosis, an infectious disease that has killed more people than any other.

The BCG (Bacille Calmette-Guérin) vaccine, created in 1921, remains the sole TB vaccine. While it is 40% to 80% effective in young children, its efficacy is very low in adolescents and adults, leading to a worldwide push to create a more powerful vaccine.

One effort is underway at the University of Montana Center for Translational Medicine. The center specializes in improving and creating vaccines by adding what are called novel adjuvants. An adjuvant is a substance included in the vaccine, such as fat molecules or aluminum salts, that enhances the immune response, and novel adjuvants are those that have not yet been used in humans. Scientists are finding that adjuvants make for stronger, more precise, and more durable immunity than antigens, which create antibodies, would alone.

Eliciting specific responses from the immune system and deepening and broadening the response with adjuvants is known as precision vaccination. “It’s not one-size-fits-all,” said Ofer Levy, a professor of pediatrics at Harvard University and the head of the Precision Vaccines Program at Boston Children’s Hospital. “A vaccine might work differently in a newborn versus an older adult and a middle-aged person.”

The ultimate precision vaccine, said Levy, would be lifelong protection from a disease with one jab. “A single-shot protection against influenza or a single-shot protection against covid, that would be the holy grail,” Levy said.

Jay Evans, the director of the University of Montana center and the chief scientific and strategy officer and a co-founder of Inimmune, a privately held biotechnology company in Missoula, said his team has been working on a TB vaccine for 15 years. The private-public partnership is developing vaccines and trying to improve existing vaccines, and he said it’s still five years off before the TB vaccine might be distributed widely.

It has not gone unnoticed at the center that this state-of-the-art vaccine research and production is located in a state that passed one of the nation’s most extreme anti-vaccination laws during the pandemic in 2021. The law prohibits businesses and governments from discriminating against people who aren’t vaccinated against covid-19 or other diseases, effectively banning both public and private employers from requiring workers to get vaccinated against covid or any other disease. A federal judge later ruled that the law cannot be enforced in health care settings, such as hospitals and doctors’ offices.

In mid-March, the Bill & Melinda Gates Medical Research Institute announced it had begun the third and final phase of clinical trials for the new vaccine in seven countries. The trials should take about five years to complete. Research and production are being done in several places, including at a manufacturing facility in Hamilton owned by GSK, a giant pharmaceutical company.

Known as the forgotten pandemic, TB kills up to 1.6 million people a year, mostly in impoverished areas in Asia and Africa, despite its being both preventable and treatable. The U.S. has seen an increase in tuberculosis over the past decade, especially with the influx of migrants, and the number of cases rose by 16% from 2022 to 2023. Tuberculosis is the leading cause of death among people living with HIV, whose risk of contracting a TB infection is 20 times as great as people without HIV.

“TB is a complex pathogen that has been with human beings for ages,” said Alemnew Dagnew, who heads the program for the new vaccine for the Gates Medical Research Institute. “Because it has been with human beings for many years, it has evolved and has a mechanism to escape the immune system. And the immunology of TB is not fully understood.”

The University of Montana Center for Translational Medicine and Inimmune together have 80 employees who specialize in researching a range of adjuvants to understand the specifics of immune responses to different substances. “You have to tailor it like tools in a toolbox towards the pathogen you are vaccinating against,” Evans said. “We have a whole library of adjuvant molecules and formulations.”

Vaccines are made more precise largely by using adjuvants. There are three basic types of natural adjuvants: aluminum salts; squalene, which is made from shark liver; and some kinds of saponins, which are fat molecules. It’s not fully understood how they stimulate the immune system. The center in Missoula has also created and patented a synthetic adjuvant, UM-1098, that drives a specific type of immune response and will be added to new vaccines.

One of the most promising molecules being used to juice up the immune system response to vaccines is a saponin molecule from the bark of the quillay tree, gathered in Chile from trees at least 10 years old. Such molecules were used by Novavax in its covid vaccine and by GSK in its widely used shingles vaccine, Shingrix. These molecules are also a key component in the new tuberculosis vaccine, known as the M72 vaccine.

But there is room for improvement.

“The vaccine shows 50% efficacy, which doesn’t sound like much, but basically there is no effective vaccine currently, so 50% is better than what’s out there,” Evans said. “We’re looking to take what we learned from that vaccine development with additional adjuvants to try and make it even better and move 50% to 80% or more.”

By contrast, measles vaccines are 95% effective.

According to Medscape, around 15 vaccine candidates are being developed to replace the BCG vaccine, and three of them are in phase 3 clinical trials.

One approach Evans’ center is researching to improve the new vaccine’s efficacy is taking a piece of the bacterium that causes TB, synthesizing it, and combining it with the adjuvant QS-21, made from the quillay tree. “It stimulates the immune system in a way that is specific to TB and it drives an immune response that is even closer to what we get from natural infections,” Evans said.

The University of Montana center is researching the treatment of several problems not commonly thought of as treatable with vaccines. They are entering the first phase of clinical trials for a vaccine for allergies, for instance, and first-phase trials for a cancer vaccine. And later this year, clinical trials will begin for vaccines to block the effects of opioids like heroin and fentanyl. The University of Montana received the largest grant in its history, $33 million, for anti-opioid vaccine research. It works by creating an antibody that binds with the drug in the bloodstream, which keeps it from entering the brain and creating the high.

For now, though, the eyes of health care experts around the world are on the trials for the new TB vaccines, which, if they are successful, could help save countless lives in the world’s poorest places.

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

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Taking Account of Rising Health Care Costs

Have your out-of-network insurance bills skyrocketed? Chris Hamby, an investigative reporter for The Times, may have an explanation.

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Women Talk Through Their Abortions on TikTok

At a time of heightened confusion and legal battles over access to abortion, women are looking to social media for answers.

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Paris Hilton Backs California Bill Requiring Sunshine on ‘Troubled Teen Industry’

Celebrity hotel heiress Paris Hilton is backing California lawmakers’ push to increase the transparency of residential teen therapeutic centers by requiring these programs to report the use of restraints or seclusion rooms in disciplining minors.

“We shouldn’t be placing youth in facilities without knowing what these children will be subjected to,” Hilton testified Monday to the Senate Human Services Committee in Sacramento. “The Accountability in Children’s Treatment Act is a simple transparency measure that would make a lasting impact and show the world what truly happens behind closed doors.”

Hilton, 43, has become a high-profile advocate for getting tough on what she describes as the “troubled teen industry,” which promises to rehabilitate teenagers struggling with substance abuse, mental illness, and problematic behavior. Such programs lack federal oversight and have been exposed for riots, assaults, and even deaths of minors, prompting a pushback to protect the rights of young people.

After releasing a documentary in 2020 detailing abuse she faced while attending Provo Canyon School in Provo, Utah, as a teenager, Hilton traveled back to the state, helping pass a bill strengthening inspection and oversight of the industry. Advocates have successfully passed related laws in Illinois, Missouri, Montana, and Oregon.

Last year, Hilton went to Washington, D.C., to advocate for the federal Stop Institutional Child Abuse Act, which would establish best practices and transparency in youth residential care programs. But national efforts have failed for more than a decade and the latest proposal has been stalled for a year.

Now, Hilton and others are eyeing the most populous state as an opportunity for change.

Senate Bill 1043 is a bipartisan bill by Republican state Sen. Shannon Grove and authored also by Democratic Sens. Aisha Wahab and Angelique Ashby. The bill aims to protect young people housed in short-term residential therapeutic programs licensed by the California Department of Social Services by requiring the agency to produce a public dashboard by 2026 on the use of restraint and seclusion rooms, and when it results in serious injuries or death. It would also require foster parents and guardians to be notified when restraints and seclusion rooms are used on minors.

“There are complaints of broken arms, slammed hands in doors,” said Grove, who noted that these facilities typically house vulnerable populations, including foster youth. “There’s no data to show what happened and what caused that. And so, the goal is to go after the data.”

There was no formal opposition. The National Association of Therapeutic Schools and Programs, the nation’s largest such member organization, told KFF Health News that it supports the California bill.

During Monday’s hearing, Hilton shared that while she was housed at facilities in California, Utah, and Montana, she was subjected to abuse disguised as therapy. She said if she tried to tell her parents about the abuse, facility staff would rip the phone from her hand, restrain her, and force her into solitary confinement.

“When I close my eyes at night, I still have nightmares about solitary confinement 20 years later,” Hilton said. “The sounds of my peers screaming as they were physically restrained by numerous staff members and injected with sedatives will also never leave me.”

Zoe Schreiber, another survivor, said she was sent at age 13 to a Utah facility, where she was restrained face down in the mud by six adults for hours in the rain. Schreiber described enduring seclusion, hard labor, and humiliation for four years.

Democratic state Sen. Marie Alvarado-Gil, who chairs the Human Services Committee, said she had worked in such residential treatment facilities and noticed that staff often didn’t have proper training.

“I don’t think they’re all bad, but I do think the ones that are bad, that impact the trauma of our children, that are unregulated, that are unstructured, that do not have evidence-based programming — I wonder how we get away with that here in California,” Alvarado-Gil said.

Wahab said it’s important for California to act in the absence of a federal bill. California enacted related legislation in 2021 to prevent the state from sending foster children to out-of-state facilities.

“I’m hoping that we do some justice to the kids here,” Wahab said.

The Senate Human Services Committee passed SB 1043 on a 5-0 vote. The bill now goes to the Appropriations Committee.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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Lawsuit Alleges Obamacare Plan-Switching Scheme Targeted Low-Income Consumers

A wide-ranging lawsuit filed Friday outlines a moneymaking scheme by which large insurance sales agency call centers enrolled people into Affordable Care Act plans or switched their coverage, all without their permission.

According to the lawsuit, filed in U.S. District Court for the Southern District of Florida, two such call centers paid tens of thousands of dollars a day to buy names of people who responded to misleading advertisements touting free government “subsidies” and other rewards. In turn, sales agents used the information to either enroll them in ACA plans or switch their existing policies without their consent.

As a result, the lawsuit alleges, consumers lost access to their doctors or medications and faced financial costs, such as owing money toward medical care or having to repay tax credits that were paid toward the unauthorized coverage.

Some consumers were switched multiple times or had duplicative policies.

“We allege there was a plan that targeted the poorest of Americans into enrolling in health insurance through deceptive ads and unauthorized switching,” to gain compensation for the sign-ups or capture the commissions that would have been paid to legitimate insurance agents, said Jason Doss, one of two lawyers who filed the case following a four-month investigation.

Doss and Jason Kellogg, the other lawyer on the case, which was filed on behalf of several affected policyholders and agents, are seeking class action status.

KFF Health News has in recent weeks reported on similar concerns raised by consumers and insurance agents.

Named as defendants are TrueCoverage and Enhance Health, which operate insurance call centers in Florida and other states; Speridian Technologies, a New Mexico-based limited liability company that owns and controls TrueCoverage; and Number One Prospecting, doing business as Minerva Marketing, which is also a lead-generating company. The lawsuit also names two people: Brandon Bowsky, founder and CEO of Minerva; and Matthew Herman, CEO of Enhance Health. Attempts to reach the companies for comment were unsuccessful.

According to the lawsuit, the call centers had access to policyholder accounts through “enhanced direct enrollment” platforms, including one called Benefitalign, owned by Speridian.

Such private sector platforms, which must be approved by the Centers for Medicare & Medicaid Services, streamline enrollment by integrating with the federal ACA marketplace, called healthcare.gov. The ones included in this case were not open to the public, but only to those call center agencies granted permission by the platforms.

One of the plaintiffs, Texas resident Conswallo Turner, signed up for ACA coverage in December through an agent she knew, and expected it to go into effect on Jan. 1, according to the lawsuit. Not long after, Turner saw an ad on Facebook promising a monthly cash card to help with household expenses.

She called the number on the ad and provided her name, date of birth, and state, the lawsuit says. Armed with that information, sales agents then changed her ACA coverage and the agent listed on it five times in just a few weeks, dropping coverage of her son along with way, all without her consent.

She ended up with a higher-deductible plan along with medical bills for her now-uninsured son, the lawsuit alleges. Her actual agent also lost the commission.

The lawsuit contains similar stories from other plaintiffs.

The routine worked, it alleges, by collecting names of people responding to online and social media ads claiming to offer monthly subsidies to help with rent or groceries. Those calls were recorded, the suit alleges, and the callers’ information obtained by TrueCoverage and Enhance Health.

The companies knew people were calling on the promise “of cash benefits that do not exist,” the lawsuit said. Instead, call center agents were encouraged to be “vague” about the money mentioned in the ads, which was actually the subsidies paid by the government to insurers toward the ACA plans.

The effort targeted people with low enough incomes to qualify for large subsidies that fully offset the monthly cost of their premium, the lawsuit alleges. The push began after March 2022, when a special enrollment period for low-income people became available, opening up a year-round opportunity to enroll in an ACA plan.

The suit asserts that those involved did not meet the privacy and security rules required for participation in the ACA marketplace. The lawsuit also alleges violations of the federal Racketeer Influenced and Corrupt Organizations Act, known as RICO.

“Health insurance is important for people to have, but it’s also important to be sold properly,” said Doss, who said both consumers and legitimate agents can suffer when it’s not.

“It’s not a victimless crime to get zero-dollar health insurance if you don’t qualify for it and it ends up causing you tax or other problems down the road,” he said. “Unfortunately, there’s so much fraud that legitimate agents who are really trying to help people are also being pushed out.”

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5 Takeaways From a Year of Medicaid Upheaval

In the year after a pandemic-era policy preserving Medicaid coverage lapsed, more than 20 million people were dropped from the program at some point.

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When Rogue Brokers Switch People’s ACA Policies, Tax Surprises Can Follow

Tax season is never fun. But some tax filers this year face an added complication: Their returns are being rejected because they failed to provide information about Affordable Care Act coverage they didn’t even know they had.

While the concern about unscrupulous brokers enrolling unsuspecting people in ACA coverage has simmered for years, complaints have risen in recent months as consumers discover their health insurance coverage isn’t what they thought it was.

Now such unauthorized enrollments are also causing tax headaches. Returns are getting rejected by the IRS and some people will have to pay more in taxes.

“It’s definitely gotten worse over the past year. We’ve helped three to four dozen people this year already,” said Erin Kinard, director of systems and intake for the Health and Economic Opportunity Program at Pisgah Legal Services in North Carolina, which helps low-income families enroll in ACA plans and get tax help.

Neither the IRS nor the Centers for Medicare & Medicaid Services, which oversees the federal Obamacare marketplace, responded to questions about the problem.

The IRS did, however, issue an FAQ in February instructing consumers on what to do if their electronically filed returns are rejected because of ACA issues.

Unauthorized sign-ups can happen in several ways, Kinard and others said. Some rogue agents troll online enrollment portals that are accessible only to brokers but are integrated with the healthcare.gov website. When those agents open a new policy or switch an already enrolled policyholder to a different plan, they garner the associated monthly commissions. Other consumers unwittingly sign up when they respond to advertisements touting gift cards or government subsidies then are transferred to agents who enroll them in health coverage. It’s happening even after new rules were put in place requiring agents to get written or recorded consent from clients before making changes.

CMS has not released details on how many consumers have been affected or how many agents have been sanctioned for participating in such schemes.

There’s also no public tally of how many taxpayers are facing problems as a result. And the tax consequences can come as a surprise.

“Many people are finding out when they go to e-file their taxes and it bounces back and the IRS says it can’t accept your return,” said Christine Speidel, an associate professor and the director of the Federal Tax Clinic at Villanova University’s Charles Widger School of Law.

Returns are rejected if the IRS has information indicating the taxpayer has ACA coverage but the returns don’t include forms that help determine whether premium tax credits paid on the policyholder’s behalf to insurers were correct. If their income was misstated by the rogue broker who enrolled them, for example, they might not have qualified for the full amount paid. Or, if they had affordable employer coverage, they would not have been eligible for ACA subsidies at all.

Ashley Zukoski, an ultrasound technologist in Charlotte, North Carolina, had employer coverage but now faces a tax bill for an ACA plan she said she never signed up for. She reached out to KFF Health News after it reported on such unauthorized plan enrollments.

Unbeknownst to her, she said, a broker in Florida enrolled her family in an ACA plan in late February 2023, even though Zukoski had coverage starting that January through her job. The broker listed an income that qualified the household for a full subsidy, so Zukoski never received a premium bill.

Her first inkling that something was amiss came early in 2024 when she received a special form, called a 1095-A, which showed she had an ACA plan. After reporting the problem to the federal marketplace, she sought to get the 1095-A voided so she would not be liable for the plan’s premium subsidies paid by the government to the insurer.

But, because Zukoski’s pharmacy had billed the ACA plan instead of her job-based coverage, her request was denied. She plans to appeal.

In the meantime, the family has filed an extension on their taxes.

“Instead of getting a $4,100 refund, we now owe almost $700 in taxes based on the 1095-A and premium tax credit applied,” Zukoski said.

With the April 15 federal tax filing deadline upon us, there are some important steps for affected consumers to take, tax and insurance experts said.

First, because it could take weeks to get corrected forms, experts recommend filing for an extension to buy more time. When consumers file for that extension, they should also pay any taxes owed to avoid penalties and interest.

In general, consumers who at any point in the year think they are victims of an unauthorized enrollment or plan switch should report it immediately to the relevant federal or state ACA marketplace and request a corrected Form 1095-A. But move fast. Appeals to cancel coverage retroactively must be made within 60 days of discovering the fraudulent enrollment, Speidel said.

Consumers can ask for help filing a complaint with federal or state regulators by contacting their own insurance agents or seeking help from assisters or “navigator” programs, which are government-funded nonprofit groups that help people enroll or deal with insurance problems.

Navigators and assisters are fielding many such cases this year and can submit what are called “complex case forms,” which help federal officials investigate such complaints, said Lynn Cowles, program manager for Prosper Health Coverage, a navigator program in Texas.

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U.S. Scrutiny of Chinese Company Could Disrupt U.S. Supply Chain for Key Drugs

Lawmakers raising national security concerns and seeking to disconnect a major Chinese firm from U.S. pharmaceutical interests have rattled the biotech industry. The firm is deeply involved in development and manufacturing of crucial therapies for cancer, cystic fibrosis, H.I.V. and other illnesses.

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National Academy Asks Court to Strip Sackler Name From Endowment

Millions in Sackler donations sat dormant, rising in value as the opioid epidemic raged and as other institutions distanced themselves from the makers of a notorious painkiller.

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California Fails to Adequately Help Blind and Deaf Prisoners, US Judge Rules

SACRAMENTO, Calif. — Thirty years after prisoners with disabilities sued the state of California and 25 years after a federal court first ordered accommodations, a judge found that state prison and parole officials still are not doing enough to help deaf and blind prisoners — in part because they are not using readily available technology such as video recordings and laptop computers.

U.S. District Judge Claudia Wilken’s rulings on March 20 centered on the prison system’s need to help deaf, blind, and low-vision prisoners better prepare for parole hearings, though the decisions are also likely to improve accommodations for hundreds of other prisoners with those disabilities.

“I believe I should have the same opportunity as hearing individuals,” a prisoner, deaf since birth, said in court documents.

The lawsuit is one of several class-action proceedings that have led the courts to assume oversight of the prison system’s treatment of those who are sick or suffer from mental illnesses.

“It is difficult not to despair,” a blind prisoner said in written testimony. “I am desperate for some kind of assistance that will let me prepare adequately for my parole hearing.”

The parole process can begin more than a year before an incarcerated person’s hearing and last long afterward. And the consequences of rejection are great: People denied parole typically must wait three to 15 years before they can try again.

Prisoners are expected to review their prison records and a psychologist’s assessment of whether they are at risk for future violence, write a release plan including housing and work plans, write letters of remorse, and prepare a statement to parole officials on why they should be released.

“It is a very time-consuming and important process,” said Gay Grunfeld, one of the attorneys representing about 10,000 prisoners with many different disabilities in the federal class-action lawsuit. “All of these tasks are harder if you are blind, low-vision, or deaf.”

The California Department of Corrections and Rehabilitation and its Board of Parole Hearings “remain committed to conducting fair hearings and ensuring access to the hearings for all participants. We are assessing the potential impact of the order and exploring available legal options,” said spokesperson Albert Lundeen.

The department counts more than 500 prisoners with serious vision problems and about 80 with severe hearing problems, though Grunfeld thinks both are undercounts.

California’s prison system has lagged in adopting technological accommodations that are commonly used in the outside world, Wilken found in her ruling.

For instance, California gives prisoners digital tablets that can be used for communications and entertainment, and since late 2021 has gradually been providing secure laptops to prisoners who are enrolled in college, GED, and high school diploma programs.

But officials balked at providing computers that Wilken decided are needed by some prisoners with disabilities. She required the department to develop a plan within 60 days of her order to, among many things, provide those individuals with laptops equipped with accommodations like screen magnification and software that can translate text to speech or Braille.

“It would make a huge difference to me to have equipment that would let me listen to and dictate written words, or produce written documents in another accessible manner,” testified the blind prisoner. He added that such accommodations “would finally let me properly prepare for my parole hearing with the privacy, independence, and dignity that all humans deserve.”

Similarly, California routinely uses video cameras during parole proceedings, including when it conducted hearings remotely during the coronavirus pandemic. But prison policy has prohibited videotaping the hearings, including sign language translations that some deaf prisoners rely on to understand the proceedings.

The deaf-since-birth prisoner, for example, testified that he also doesn’t speak, his primary method of communication is American Sign Language, and his English is so poor that written transcripts do him no good. He advocated for recorded sign language translations of the hearings and related documents that he could review whenever he wanted, in the same way that other inmates can review written text.

Wilken ordered prison officials to comply.

“They need to be able to watch it later, not read it later,” said Grunfeld. “It’s going to make a huge difference in the lives of deaf signers.”

The department recently acquired 100 portable electronic video magnifiers, at a cost of $1,100 each, that prisoners with low vision can check out to use in their cells. The technology will augment similar devices in prison libraries that prisoners say aren’t private and can be used only during libraries’ limited hours.

Wilken said officials acquired the magnifiers only after prodding by prisoners and their attorneys.

Grunfeld said the judge’s detailed order, which includes requirements like better assistance from attorneys, will “make sure that people with disabilities are on an equal footing as people who don’t have disabilities.”

“My colleagues and I have been working for several years to persuade CDCR to adopt this technology, and it’s been slow-going. But they’ve gradually accepted that they do need to do this,” Grunfeld said. “It’s long past due, but at least it’s coming.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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After Uphill Battle, Company Is Poised for Takeover of Bankrupt California Hospital

MODESTO, Calif. — When American Advanced Management made a bid for the bankrupt Madera Community Hospital last year, many local officials and others involved in trying to reopen the facility didn’t take the company seriously.

The 11-year-old firm, based in Modesto, was already running a handful of small, rural hospitals, but Madera had far larger and more prestigious suitors, including Trinity Health and then Adventist Health.

After those two entities had backed out, the bankruptcy judge tentatively greenlighted the AAM proposal. But a nonprofit community group later objected in a court filing, citing concerns about AAM’s commitment to fully reopen the hospital and airing allegations of “dishonesty, fraud, perjury, and maladministration.”

The Madera Coalition for Community Justice and other critics of the AAM deal hoped that Adventist and the University of California-San Francisco, which made a last-minute joint proposal in February to take over the hospital, might get another look.

But Gov. Gavin Newsom all but ended the drama on April 8 by announcing the state had approved the AAM plan and would provide a $57 million loan from a fund for distressed hospitals to help reopen and operate the Madera facility.

The same day, AAM, along with the Madera hospital and its creditors, asked the court to strike MCCJ’s objection from the record and requested an April 11 hearing for the judge to consider the motion. MCCJ pushed back with its own filing objecting to the request.

The closure of the hospital in January 2023 left Madera County, home to 160,000 people, largely Hispanic agricultural workers, without a general acute care facility. Like many rural hospitals in California and around the country, the Madera hospital had suffered financial and demographic challenges, including a large proportion of patients on low-paying government insurance programs, low patient volumes, and difficulty attracting talent, in addition to pandemic-related pressures.

AAM has committed to pay up to $30 million to creditors and reopen the hospital as soon as late summer. The company has a portfolio of nine hospitals, many of them in underserved regions of California.

“American Advanced Management has a proven track record of reopening closed hospitals in California and saving others from the brink of closure,” said Matthew Beehler, the company’s chief strategy officer.

It remains uncertain whether AAM can make the Madera hospital financially viable. Reopening alone will cost millions, and many of the same constraints that led to the bankruptcy remain. In its final two years of operations, the Madera hospital lost $14 million.

Beehler said AAM would aim for “operational efficiency” through centralized administration and “elevate the quality of care” to attract more patients. “These strategic investments and improvements are designed to stabilize the hospital’s financial footing and ensure its sustainability in the long term,” he said.

According to a recent study by the Pittsburgh-based Center for Healthcare Quality and Payment Reform, 30% of California’s 56 rural hospitals and the same percentage of rural hospitals nationwide are at risk of closing.

“The economics of small hospitals is such that it is unlikely they are going to be highly profitable,” said Harold Miller, the center’s CEO.

The group objecting to AAM, along with many members of the community, are particularly worried that the company won’t reopen the Madera hospital’s labor and delivery department, where over 700 babies were born in 2022.

Labor and delivery at many rural hospitals are among the first services new owners cut because they tend to lose money, said Ge Bai, professor of health policy and management at Johns Hopkins University’s Bloomberg School of Public Health.

Beehler said a reopened Madera would provide “many of the ancillary services” related to pregnancy and that AAM would “regularly evaluate” whether it makes financial and clinical sense to have a labor and delivery unit at the hospital.

‘Someone Has to Take a Stand’

AAM is the brainchild of Gurpreet Singh Randhawa, who says he is its sole owner.

Singh, a gastroenterologist-turned-entrepreneur, has amassed hospitals and other health care-related companies, as well as numerous real estate holdings. Public records show dozens of businesses that are or have been associated with Singh.

After graduating from medical school in India in 2000, Singh completed further training in New York and New Jersey before moving to California in 2008. In an interview, Singh said he was inspired to open his first hospital after seeing a friend drive three hours round trip to the Sacramento area every day to visit his father in a long-term acute care hospital because Modesto didn’t have one of its own.

Singh said he thought “‘someone has to take a stand,’ so I took that stand.” He said he spent $36 million to open Central Valley Specialty Hospital at the site of a shuttered facility in Modesto. It opened in mid-2013, marking the beginning of AAM.

Since then, AAM has acquired numerous hospitals and clinics in Northern California and the Central Valley, including Colusa Medical Center and Glenn Medical Center in 2017, Sonoma Specialty Hospital in 2019, and Coalinga Regional Medical Center in 2020.

In 2023, the firm took over management of the troubled Orchard Hospital in Gridley, California. Last September, AAM announced it had taken over operations of Kentfield Specialty Hospital, with locations in San Francisco and Marin County. It also owns a rehabilitation hospital in Amarillo, Texas.

AAM lost a combined $22.3 million in 2021 and 2022, state data shows. But Beehler said the company returned to profitability in 2023 and expects profit margins in the high single digits this year. He estimated that AAM’s total operating revenue will jump to approximately $400 million in 2024 from $290 million in 2023, mainly due to the addition of three hospitals.

The source of the funds to finance the company’s growth is not entirely clear. Singh cited family wealth and real estate, but he declined to discuss his family’s money. The firm’s agreement with the Madera hospital says AAM will have “immediately available funds in cash” to meet its obligations. The $57 million approved by the state this week will be a key source of funding.

Beehler said another source of cash to finance growth is AAM’s earnings on longer-term care. Central Valley Specialty Hospital has been profitable since its first full year of operations in 2014, posting cumulative earnings of over $66 million through 2022, according to data from the state’s Department of Health Care Access and Information. Coalinga Regional Medical Center has a 99-bed skilled nursing facility in addition to its acute care beds, and Sonoma Specialty Hospital recently added 21 beds, according to Beehler.

Acute vs. Long-Term Care

Critics fear AAM might take the Madera hospital in the direction of long-term care, depriving the community of a viable acute care facility. Cece Gallegos, who recently lost her bid for a seat on the Madera County Board of Supervisors, said in a campaign mailer that the firm would turn Madera into “a glorified nursing home.”

Beehler rebuffed that notion, saying the company couldn’t do that even if it wanted to. He said the conditions imposed by the state attorney general “require an acute care hospital with fully functional ER and ancillary services.” The attorney general’s conditions, however, require AAM only to make “commercially reasonable efforts” to provide those services.

Singh and his health care businesses have hit plenty of bumps as they’ve grown.

In 2018, AAM took over management of Sonoma West Medical Center, a publicly owned hospital in the city of Sebastopol that had declared bankruptcy. In 2019, AAM acquired it outright and changed its name to Sonoma Specialty Hospital. Later that year, a bankruptcy trustee sued Singh, AAM, and the hospital for allegedly taking money that belonged to its predecessor, and the parties settled for $1.15 million. Beehler said AAM did not retain any of the money but used it for hospital operations and became “an unintended victim.” The company chose to settle, he said, “to bring finality to this complex issue.”

In 2021, the state fined AAM’s Pacific Gardens Medical Center $276,000 for four situations that put patients in “immediate jeopardy,” including one in which inadequate training caused an intravenous dose of fentanyl to drip into a patient nearly seven times as rapidly as the doctor had ordered.

AAM had reopened the hospital in January 2021, about three years after buying it out of bankruptcy. Its license was suspended less than five months later, according to the California Department of Public Health. Beehler said the hospital had reopened as a pandemic surge hospital with support, including the provision of nurses and physicians, from the state’s Emergency Medical Services Authority. “By its nature, a surge facility opening is temporary,” he said.

The accelerated timeline for getting it open contributed to the patient-jeopardy situations, he said.

In 2022, the California Department of Health Care Services sued Sonoma Specialty Hospital, Singh, and AAM, accusing them of illegitimately seeking, and accepting, $270,000 from a program that provides federal financing for certain public hospitals.

DHCS said it had told AAM that it wasn’t eligible for the money, because it was now a for-profit facility, but that the company refused to pay it back. In February, a Sonoma County judge sided with DHCS. DHCS spokesperson Leah Myers said in an emailed statement that the state does not typically have to sue to recover money. Beehler said AAM “disputes that there is any liability” and is appealing the decision.

Another Singh venture was Advanced College, a private vocational school for health care professionals with three locations in central and Southern California. After receiving numerous complaints, state regulators ordered the school to cease operations in December 2022, alleging it had falsified records and test results, and “failed to provide documentation of sufficient financial resources.”

Joshua Maruca, the school’s custodian of records, said Advanced College disagreed with the state’s allegations but had already been planning to shut down for other reasons, so it did not contest them.

Bank of the West also sued Singh and several of his businesses for repeated defaults on over $4.7 million in loans, mostly related to the college. The lawsuit was settled, but one of the bank’s lawyers, Wayne Terry, said he could not discuss the settlement. Beehler said the loans were not part of AAM’s financials. The bank was “paid fully,” he said.

The company’s critics say the state didn’t sufficiently scrutinize AAM before approving the loan and the operating plan this week.

“The state agencies and the Attorney General, all tasked here with protecting the public interest, have utterly failed to do the basic due diligence that would ensure Madera Community Hospital is resurrected as a viable going concern, under the stewardship of a reliable, trustworthy, and capable operator,” the MCCJ said in the court filing opposing the challenge to its objection.

AAM said in a statement that it was “grateful” to Newsom and the state for approving the deal, and “honored to serve the Madera community.” The bankruptcy court is likely to give its final blessing next week.

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An Arm and a Leg: Attack of the Medicare Machines

Covering the American health care system means we tell some scary stories. This episode of “An Arm and a Leg” sounds like a real horror movie.

It uses one of Hollywood’s favorite tropes: machines taking over. And the machines belong to the private health insurance company UnitedHealth Group.

Host Dan Weissmann talks to Stat News reporter Bob Herman about his investigation into Medicare Advantage plans that use an algorithm to make decisions about patient care. The algorithm is owned by a subsidiary of UnitedHealth Group.

Herman tells Weissmann that some of UnitedHealth’s own employees say the algorithm creates a “moral crisis” in which care is unfairly denied.

Scary stuff! Such reporting even has caught the eye of powerful people in government, putting Medicare Advantage plans under scrutiny.

Dan Weissmann @danweissmann Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting.

Credits

Emily Pisacreta Producer Adam Raymonda Audio Wizard Ellen Weiss Editor Click to open the Transcript Transcript: Son of Medicare: Attack of the Machines

Note: “An Arm and a Leg” uses speech-recognition software to generate transcripts, which may contain errors. Please use the transcript as a tool but check the corresponding audio before quoting the podcast.

Dan: Hey there–

So this is kind of a horror story. But it’s not quite the kind of story it might sound like at first.

Because at first, it might sound like a horror story about machines taking over, making all the decisions– and making terrible, horrifying choices. Very age-of-Artificial Intelligence.

But this is really a story about decisions made by people. For money.

It’s also kind of a twofer sequel– like those movies that pit two characters from earlier stories against each other. Like Godzilla vs King Kong, or Alien vs Predator.

Although in this case, I’ve gotta admit, the two monsters are not necessarily fighting each other.

Let’s get reacquainted with them.

On one side, coming back from our very last episode, we’ve got Medicare Advantage: This is the version of Medicare that’s run by private insurance companies.

It’s got a bright and appealing side, compared to the traditional Medicare program run by the federal government, because: It can cost a lot less, month to month — saving people money on premiums. And it often comes with extra benefits, like dental coverage, which traditional Medicare doesn’t offer. [I know.]

But Medicare Advantage can have a dark side, which is basically: Well, you end up dealing with private insurance companies for the rest of your life. You need something — a test, a procedure, whatever — they might decide not to cover it.

Which can be scary.

Our other returning monster — am I really calling them a monster? — well, last time we talked about them, in 2023, we had an expert calling them a behemoth. That’s United HealthGroup. You might remember, they’re not only one of the biggest insurance companies

— and maybe not-coincidentally the very biggest provider of Medicare Advantage plans —

they’ve also got a whole other business– under the umbrella name Optum. And Optum has spent the last bunch of years buying up a gazillion other health care companies of every kind.

That includes medical practices — they employ more doctors than anyone else, by a huge margin. It includes surgery centers, and home-health companies, and every kind of middleman company you can imagine that works behind the scenes — and have their hands in a huge percentage of doctor bills and pharmacy visits.

A few years ago, United bought a company called NaviHealth, which provides services to insurance companies that run Medicare Advantage plans.

NaviHealth’s job is to decide how long someone needs to stay in a nursing home, like if you’re discharged from a hospital after surgery, but you’re not ready to go home yet.

And the horror story– the stories, as dug up by reporters — starts after United bought NaviHealth.

And according to their reports, it involves people getting kicked out of those nursing homes who aren’t ready to go home.

People getting sent home who can’t walk up the stairs in their house. Who can’t walk at all. Who are on feeding tubes. People who NaviHealth’s own employees are saying, “Wait. This person isn’t ready to go home.”

But their new bosses have told them: You’re not really making these decisions anymore.

This is where machines do enter the picture.

NaviHealth’s distinctive offering has always been its proprietary algorithm– an algorithm that makes predictions about how long any given patient might need to stay.

Before United bought the company, that algorithm was used as a guide, a first-guess. Humans weighed in with their own judgment about what patients needed.

After United bought the company, people inside have told reporters, that changed: The new owners basically told their employees, If the algorithm says someone can go home after x days, that’s when we’re cutting them off.

Like pretty much any horror movie, this story’s got people running around trying to tell everyone: HEY, WATCH OUT! THERE’S SOMETHING BIG AND DANGEROUS HAPPENING HERE.

And in this case, they’ve actually gotten the attention of some people who might have the power to do something about it. Now, what those people will do? We don’t know yet.

And, by the way: Yes, I said at the end of our last episode that we’d be talking about Medicaid this time around. That’s coming! But for now, strap in for this one.

This is An Arm and a Leg, a show about why health care costs so freaking much, and what we can maybe do about it. I’m Dan Weissmann. I’m a reporter, and I like a challenge. So our job on this show is to take one of the most enraging, terrifying, depressing parts of American life, and bring you something entertaining, empowering, and useful.

So. I said that, like every horror movie, this one has people who are seeing what’s going on and are trying to warn everybody?

Like those movies, we’re gonna follow one of those people, watch them discover the problem, see how deep it goes, and start ringing alarm bells. Let’s meet our guy.

Bob Herman: My name is Bob Herman. I’m a reporter at STAT News

Dan: Stat is an amazing medical news publication. Bob covers the business of medicine there. Bob started working on this story in November 2022, after talking to a source who runs nursing homes. Bob’s source was complaining about Medicare Advantage.

Bob Herman: There were a lot of payment denials. They just weren’t able to get paid. And just offhandedly, the source mentioned like, um, you know, and they’re attributing everything to this algorithm. This algorithm said, You know, only 17 days for our patients and then time’s up and I went running to Casey Ross

Dan: Casey is a reporter at Stat who focuses on tech and AI in healthcare. Bob said, hey, what do you think of this? Wanna team up?

Bob Herman: And he was hooked.

Dan: They started talking to people who worked at nursing homes, talking to experts, and talking to families. And it was clear: They were onto something.

Bob Herman: It took so many families by surprise to be like, what do you mean we’re going home? The, you know, my husband, my wife, my grandma, my grandpa, they can’t go to the bathroom on their own. Like, what do you? It was just, it was so confusing to people. It seemed like such a, a cold calculation,

Dan: One person they ended up talking with was Gloria Bent. Her husband Gary was sent to a nursing home for rehab after brain surgery for cancer. He was weak. He couldn’t walk. And he had something called “left neglect”: His brain didn’t register that there was a left side of his body. Here’s Gloria testifying before a Senate committee about how — when Gary arrived at the nursing home — the first thing he got was a discharge date. That is…

Gloria Bent: Before the staff of the facility could even evaluate my husband or develop a plan of care, I was contacted by someone who identified themselves as my Navi Health Care Coordinator

Dan: Gloria says when she told the nursing home staff she’d heard from NaviHealth, they groaned. And told her what to expect.

Gloria Bent: I was told that I had just entered a battlefield, that I could expect a series of notices of denial of Medicare payment accompanied by a discharge date that would be two days after I got that notice.

Dan: Yeah, they said she’d get two days notice. Gloria says the nursing home staff told her she’d have 24 hours to appeal each of those, but even if she won, the denials would keep coming. In fact, they said,

Gloria Bent: If we won a couple of appeals, then we could expect that the frequency with which these denials were going to come would increase.

Dan: All of which happened. NaviHealth started issuing denials July 15, 2022, after Gary had been at the home for a month.

Gloria appealed. She told senators what the doctor who evaluated the appeal found: Gary couldn’t walk. He couldn’t even move — like from bed to a chair — without help from two people.. That reviewer took Gloria’s side.

Her husband’s next denial came a week after the first. Gloria won that appeal too. She says the reviewer noted that Gary needed maximum assistance with activities of daily living.

The third denial came four days later, and this time Gloria lost.

Gary came home in an ambulance: As Gloria testified, he couldn’t get into or out of a car without assistance from someone with special training.

And when he got into the ambulance, he had a fever. The next morning, he wound up in another ambulance — headed to a hospital with meningitis. He lost a lot of the functioning he’d picked up at the nursing home.

He died at home a few months later. When Gloria testified in the Senate, all of it was still fresh. She told them that as awful as Gary’s illness and decline had been, the fights with insurance were an added trauma.

Gloria Bent: This should not be happening to families and patients. It’s cruel. Our family continues to struggle with the question that I hear you asking today. Why are people who are looking at patients only on paper or through the lens of an algorithm

making decisions that deny the services judged necessary by health care providers who know their patients.

Dan: Bob Herman calls Gloria’s story heartbreaking, like so many others he’s seen.

And his attention goes to one part of Gloria’s story beyond denial-by-algorithm.

Because: It’s not just one denial. It’s that series of denials. You can appeal, but as Gloria testified, the denials speed up. And you have to win every single time. The company only has to win once.

I mean, unless you’re ready to get a lawyer and take your chances in court– which, in addition to being a major undertaking, also means racking up nursing home bills and legal bills you may never get reimbursed for, while the court process plays out.

Bob Herman: This appeal system is designed in such a way that people will give up. If you have a job, you know, even if you don’t, and you’re, and you’re also trying to take care of a family member, um, it’s a rigorous monotonous process that will chew people up and spit them out and then the people are inevitably going to give up. And I think in some ways insurers know that.

Dan: Going out on a limb to say: I think so too. So Bob and Casey’s first story on NaviHealth came out in March of 2023. They were the characters in the movie who go, “HEY, I THINK THERE’S SOMETHING REALLY BAD HAPPENING HERE.”

And people started paying attention. Like the U.S. Senate. which held that hearing where Gloria Bent told her story.

And like the federal agency that runs Medicare — the Centers for Medicare and Medicaid Services, CMS.

CMS finalized a rule that told insurers: You can’t deny care to people just from using an algorithm.

And something else happened too: Bob and Casey started suddenly getting a lot MORE information.

Bob Herman: We received so many responses from people and it just opened the floodgates for former employees, just patients and family members, just everyone across the board.

Dan: And not just former employees. Current employees. And what they learned was: There was absolutely a strategy at work in how this algorithm was being used. It was strategy some people on the inside didn’t feel good about.

And this strategy got developed after United HealthGroup — and its subsidiary, Optum– bought NaviHealth in 2020. And here’s what NaviHealth employees started telling Casey and Bob about that strategy.

Bob Herman: For some of us, it’s creating this moral crisis. Like we know that we are having to listen to an algorithm to essentially kick someone out of a nursing home, even though we know that they can barely walk 20 feet.

Dan: What Bob and Casey learned from insiders– and how it connects to United’s role as a health care behemoth– that’s next.

This episode of An Arm and a Leg is produced in partnership with KFF Health News. That’s a nonprofit newsroom covering healthcare in America. Their reporters do amazing work, and I’m honored to work with them. We’ll have a little more about KFF Health News at the end of this episode.

So, NaviHealth — the company with the algorithm — got started in 2015.. And the idea behind it was to use data to get people home faster from nursing homes if they didn’t actually need to be there.

Because there was a lot of evidence that some people were being kept longer than they needed.

Bob Herman: There is some validity to the idea that there’s, there’s wasteful care in Medicare, like, you know, there’s been cases in the past proving that people stay in a nursing home for way longer than is necessary. And obviously there’s financial incentives for nursing homes to keep people as long as possible.

Dan: Traditional Medicare does have limits on nursing home care — but if you need “post-acute care” — help getting back on your feet after leaving a hospital traditional Medicare pays in full for 20 days– pretty much no questions asked. One of the selling points of Medicare Advantage — like selling points to policy nerds and politicians — was that it could cut waste, by asking those kinds of questions. NaviHealth and its algorithm were designed to help Medicare Advantage plans ask those questions in a smart way.

Bob Herman: There were… a lot of believers within NaviHealth that were like, okay, I think we’re doing the right thing. We’re trying to make sure people get home sooner because who doesn’t want to be at home.

Dan: And as those employees told Bob and Casey: Before United and Optum came in, the algorithm had been there as a guide — a kind of first guess — but not the final word.

NaviHealth has staff people who interact directly with patients. And back in the day, the pre-United day, Bob and Casey learned that those staff could make their own judgments.

Which made sense, because the algorithm doesn’t know everything about any individual case. It’s just making predictions based on the data it has.

Bob Herman: And there was just, just this noticeable change after United and OptiMentor that it felt more rigid. There’s no more variation.

Dan: If the algorithm says you go, you are pretty much going.

Bob Herman: United has said, no, that’s not the case, but obviously these documents and other communications that we’ve gotten kind of say otherwise.

Dan: Because these employees weren’t just talking. They were sharing. Internal memos. Emails. Training materials. All making clear: The company wanted people shipped out on the algorithm’s timetable.

Bob Herman: Documents came in showing that like this was a pretty explicit strategy. You know, UnitedHealth was telling its employees. Listen, we have this algorithm. We think it’s really good. So when it tells you how many, how many days someone should be in a nursing home, stick to it.

Dan: Stick to it or maybe be fired. Bob and Casey got documents — employee performance goals– saying: How close you stick to the algorithm’s recommendations? That’s part of how we’re evaluating your job performance.

Bob Herman: It’s okay. Algorithm said 17 days, you better not really go outside of that because your job is on the line.

Dan: Here’s how closely people were expected to stick to it. In 2022, employee performance goals shared with STAT showed that workers were expected to keep actual time in nursing homes to within three percent of what the algorithm said it should be. Across the board.

So, say you had 10 patients, and the algorithm said they each should get 10 days. That’s 100 days. Your job was to make sure that the total actual days for those patients didn’t go past 103 days.

Then, in 2023, the expectations got more stringent: Stay within one percent of the algorithm’s predictions. 10 patients, the algorithm says 100 days total? Don’t let it get past a hundred and one.

Bob Herman: Like that is, almost nothing. Like what, what, your hands are tied. If you’re that employee, what are you going to do? Are you going to get fired? Are you going to do what you’re told?

Dan: And one person who ended up talking, to did get fired.

Bob Herman: Correct. Yes. Uh, Amber Lynch did get fired And what she said was what we had also heard just more broadly was it, it created this internal conflict, like, Oh my God, what I’m doing doesn’t feel right.

Dan: Amber Lynch was a case manager. She told Bob and Casey about onepatient who couldn’t climb the stairs in his home after knee surgery. But the algorithm said he was ready. Amber’s supervisor said, “Have you asked the nursing home staff if they’ve tried to teach him butt bumping?” Amber grit her teeth and made the suggestion to the rehab director.

Amber Lynch: And she looked at me like I had two heads. She’s like, he is 78 years old. He’s not going to do that. He’s not safe to climb the stairs yet. He’s not doing it. We’re not going to have it butt bump the stairs.

Dan: Amber told Bob and Casey that when she got fired, it was partly for failing to hit the one percent target and partly for being late with paperwork– which she told Bob and Casey she fell behind because her caseload was so heavy.

She wasn’t the only one with that complaint.

Bob and Casey’s story shows another NaviHealth case manager– not named in the story because they’re still on the job — in their home office, struggling to keep up.

That week, they were supposed to work with 27 patients and their families. Gather documents, hold meetings. Another week, shortly before, they’d had 40 patients.

“Do you think I was able to process everything correctly and call everyone correctly the way I was supposed to?” the case manager asked. “No. It’s impossible. No one can be that fast and that effective and capture all of the information that’s needed.”

Bob and Casey watched this case manager fill out a digital form, feeding the algorithm the information it asked for on a man in his 80s with heart failure, kidney disease, diabetes and trouble swallowing, who was recovering from a broken shoulder.

A few minutes later, the computer spat out a number: 17 days.

The case manager didn’t have a lot of time or leeway to argue, but they were skeptical that the algorithm could get that number exactly right based on only the data it had.

And what data is the algorithm working with? What’s it comparing the data on any given patient TO? Bob Herman says that’s a big question.

Bob Herman: It’s something that for sure, like Casey and I, it’s been bothering us. Like, what, how is this whole system? Like, what is it based on? And we were never really given straight answers on that. NaviHealth and Optum and United have said it’s based on millions of patient records over time. The sources of that, it’s, it’s a little unclear, where all that’s coming from.

Dan: Bob and Casey talked with an expert named Ziad Obermeyer, a professor at the University of California Berkeley School of Public Health, who is not anti-algorithm. He actually builds algorithmic tools for decision making in public health.

AND he’s done research showing that some widely-used algorithms just scale up and automate things like racial bias.

He told Bob and Casey: Using an algorithm based on how long other, earlier patients have stayed in a nursing home — that’s not a great idea.

Because people get forced out of nursing homes, in his words, “because they can’t pay or because their insurance sucks.” He said, “So the algorightm is basically learning all the inequalities of our current system.”

And leaving aside that kind of bias, it seems unlikely to Bob that any algorithm could predict exactly what every single patient will need every single time.

No matter how much data it’s got, it’s predicting from averages.

Bob Herman: It reminds me of, like, a basketball game where let’s say someone averages 27 points per game. They don’t have 27 points every single, the game they go out there. It just varies from time to time.

Dan: But the NaviHealth algorithm doesn’t have to be right every time for United to make money using it.

Using it to make decisions can allow United to boost profits coming and going.

Bob Herman: United health and the other insurance companies that use Navi health. Are using this technology to more or less kick people out of nursing homes before they’re ready. And that is the claims denial side where it’s like, okay, let’s save as much money as we can instead of having to pay it to a nursing home.

Dan: And that’s just one side of it. The insurance side. Claims denial. But United isn’t just in the insurance business.

United’s Optum side is in every other part of health care.

Including — in the years since United took over NaviHealth — home health services. The kind of services you’re likely to need when you leave a nursing home.

In 2022, Optum bought one top home health company in what one trade publication called a “monster, jaw-dropping mega-deal” — more than 5 billion dollars. In 2023, Optum made a deal to buy a second mega-provider.

Bob and Casey’s story says NaviHealth’s shortening nursing home stays is integral to United’s strategy for these acquisitions. It does seem to open up new opportunities.

Bob Herman: You’re out of the nursing home because our algorithm said so. Now we’re going to send you to a home health agency or we’re going to send some home health aides into your home. And by the way, we own them.

Dan: Oh, right, because: If you’re in a Medicare Advantage plan, your insurer can tell you which providers are covered.

Bob Herman: So the real question becomes, how much is United potentially paying itself?

Dan: That is: How much might United end up taking money out of one pocket — the health insurance side — and paying itself into another pocket, Optum’s home-health services?

We don’t know the answer to how much United is paying itself in this way, or hoping to. And United has said its insurance arm doesn’t favor its in-house businesses.

But it seems like a reasonable question to ask. Actually, it’s a question the feds seem to be asking.

Optum hasn’t wrapped up its purchase of that second home-health company yet, and in February 2024, the Wall Street Journal and other outlets reported that the U.S. Department of Justice had opened an anti-trust investigation.

And you don’t have to be in a Medicare Advantage plan run by United to get kicked out of a nursing home on an algorithm’s say-so.

Bob Herman says NaviHealth sells its algorithm-driven services to other big insurance companies

He says, put together, the companies that use NaviHealth cover as many as 15 million people — about half of everybody in Medicare Advantage.

Bob Herman: Odds are, if you’re in a Medicare Advantage plan, there’s a, there’s a really good shot that your coverage policies, if you get really sick and need nursing home care, for example, or any kind of post acute care, an algorithm could be at play at some point.

Dan: This is the dark side of Medicare Advantage.

Bob Herman: Everyone loves their Medicare Advantage plan when they first sign up, right? Because it’s offering all these bells and whistles. It’s, here’s a gym membership. It’s got dental and vision, which regular Medicare doesn’t have. And it’s also just, it’s, it’s cheaper. Like, if it’s just from a financial point of view, if, if you’re a low income senior, How do you turn it down? There’s, there’s so many plans that offer like free, there’s no monthly premiums in addition to all the bells and whistles. But Nobody understands the trade offs , When you’re signing up for Medicare and Medicare Advantage, you’re on the healthier side of, of being a senior, right?

Dan: And none of us can count on staying healthy forever. When you sign up for Medicare you’re signing up your future self — whether that’s ten or twenty or more years out. That future you, might really need good medical care.

And at that point, as we explained in our last episode, if Medicare Advantage isn’t working for you, you may not be able to get out of it.

Bob Herman: You could potentially not fully get the care that you need. We shouldn’t assume that, that this couldn’t happen to us because it can.

Dan: So, yeah. Kind of a horror story. But: Unlike some horror movies, when Bob and Casey started publishing their stories, they started getting people’s attention.

We mentioned the new rules from the feds and the senate hearings after Bob and Casey’s first story in March 2023

Later in the year, when Bob and Casey published their story with documents and stories from inside NaviHealth, a class-action lawsuit got filed.

Since then, CMS has said it will step up audits under its new rules.

Bob Herman: There was a memo that CMS sent out to Medicare advantage plans that said, Hey, listen, we’re telling you again, do not deny care solely on any AI or algorithms. Like just don’t do it.

Dan: And in February 2024, the Senate held another hearing.

Here’s Senator Elizabeth Warren at that hearing, saying these CMS rules aren’t enough. We need stronger guardrails.

Elizabeth Warren: Until CMS can verify that AI algorithms reliably adhere to Medicare coverage standards by law, then my view on this is CMS should prohibit insurance companies from using them in their MA plans for coverage decisions. They’ve got to prove they work before they put them in place.

Dan: So people — people with at least some power– are paying some attention.

Bob Herman: I don’t think this is necessarily going to escape. Political scrutiny for a while.

Dan: So, basically, the story isn’t over.

This isn’t one of those horror movies where the monster’s been safely defeated at the end, and everybody just starts cleaning up the mess. And it’s not one where the monster is just on the loose, unleashing the apocalypse.

Because it’s not a movie. There’s no ending. There’s just all of us trying to figure out what’s going on, and what we can maybe do about it.

One last thing: I got a lot of emails after our last episode, where we laid out a lot of information about Medicare Advantage and traditional Medicare. Most of it was along the lines of, Thank you! That was really helpful! Which made me feel really good.

And we got a couple notes about things we could have done better. Especially this: We said Traditional Medicare leaves you on the hook for 20 percent of everything, without an out of pocket limit.

Which is true — but only for Medicare Part B: Doctor visits, outpatient surgeries and tests. Which can add up, for sure.

Medicare Part A — if you’re actually hospitalized — covers most services at 100 percent, after you meet the deductible. In 2024 that’s one thousand, six hundred thirty-two dollars.

Thanks to Clarke Lancina for pointing that out.

There have been a bunch of other, amazing notes in my inbox recently, and I want to say: Please keep them coming.

If you go to arm and a leg show dot com, slash, contact, whatever you type there goes straight to my inbox. You can attach stuff too: documents… voice memos.

Please let me hear from you. That’s arm and a leg show dot com, slash contact.

I’ll catch you in a few weeks.

Till then, take care of yourself.

This episode of an arm and a leg was produced by me, Dan Weissmann, with help from Emily Pisacreta, and edited by Ellen Weiss.

Adam Raymonda is our audio wizard. Our music is by Dave Weiner and blue dot sessions. Extra music in this episode from Epidemic Sound.

Gabrielle Healy is our managing editor for audience. She edits the first aid kit newsletter.

Bea Bosco is our consulting director of operations. Sarah Ballama is our operations manager.

And Arm and a Leg is produced in partnership with KFF Health News. That’s a national newsroom producing in depth journalism about healthcare in America and a core program at KFF, an independent source of health policy research, polling and journalism.

Zach Dyer is senior audio producer at KFF Health News. He’s editorial liaison to this show.

And thanks to the Institute for Nonprofit News for serving as our fiscal sponsor, allowing us to accept tax exempt donations. You can learn more about INN at INN. org.

Finally, thanks to everybody who supports this show financially– you can join in any time at arm and a leg show dot com, slash, support — and thanks for listening.

“An Arm and a Leg” is a co-production of KFF Health News and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and the social platform X. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

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Should Alcoholic Beverages Have Cancer Warning Labels?

Ireland will require them starting in 2026, and there are nascent efforts elsewhere to add more explicit labeling about the health risks of drinking.

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After Public Push, CMS Curbs Health Insurance Agents’ Access to Consumer SSNs

Until last week, the system that is used to enroll people in federal Affordable Care Act insurance plans inadvertently allowed access by insurance brokers to consumers’ full Social Security numbers, information brokers don’t need.

That raised concerns about the potential for misuse.

The access to policyholders’ personal information was one of the problems cited in a KFF Health News article describing growing complaints about rogue agents enrolling people in ACA coverage, also known as Obamacare, or switching consumers’ plans without their permission in order to garner the commissions. The consumers are often unaware of the changes until they go to use their plan and find their doctors are not in the new plan’s network or their drugs are not covered.

Agent Joshua Brooker told KFF Health News it was relatively easy for agents to access full Social Security numbers through the federal insurance marketplace’s enrollment platforms, warning that “bad eggs now have access to all this private information about an individual.”

On April 1, the morning the article was posted on NPR’s website, Brooker said, he got a call from the Centers for Medicare & Medicaid Services questioning the accuracy of his comments.

A CMS representative told him he was wrong and that the numbers were hidden, Brooker said April 7. “I illustrated that they were not,” he said.

After he showed how the information could be accessed, “the immediate response was a scramble to patch what was acknowledged as ‘problematic,’” Brooker posted to social media late last week.

Brooker has followed the issue closely as chair of a marketplace committee for the National Association of Benefits and Insurance Professionals, a trade group.

After some phone calls with CMS and other technical experts, Brooker said, the federal site and direct enrollment partner platforms now mask the first six digits of the SSNs.

“It was fixed Wednesday evening,” Brooker told KFF Health News. “This is great news for consumers.”

An April 8 written statement from CMS said the agency places the highest priority on protecting consumer privacy.

“Upon learning of this system vulnerability, CMS took immediate action to reach out to the direct enrollment platform where vulnerability was identified to make sure it was addressed,” wrote Jeff Wu, acting director of the Center for Consumer Information & Insurance Oversight at CMS.

He added that the Social Security numbers were not accessible through routine use of the platform but were in a portion of the site called developer tools. “This issue does not impact healthcare.gov,” Wu wrote.

Brooker’s concern about Social Security numbers centered on access by licensed agents to existing policyholder information though the federal marketplace, not including the parts of healthcare.gov used by consumers, who cannot access anything but their own accounts.

While consumers can enroll on their own, many turn to agents for assistance. There are about 70,000 licensed agents nationwide certified to use the healthcare.gov site or its partner enrollment platforms. They must meet certain training and licensing requirements to do so. Brooker has been quick to say it is a minority of agents who are causing the problem.

But agents increasingly are frustrated by what they describe as a sharp increase during the second half of 2023 and into 2024 of unscrupulous rivals switching people from one plan to another, or at least switching the “agent of record” on the accounts, which directs the commission to the new agent. Wu’s statements have so far not included requested information on the number of complaints about unauthorized switching, or the number of agents who have been sanctioned as a result.

The changes shielding the Social Security numbers are helpful, Brooker said, but won’t necessarily slow unauthorized switching of plans. Rogue agents can still switch an enrollee’s plan with simply their name, date of birth, and state of residence, despite rules that require agents to collect written or recorded consent from consumers before making any changes.

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Paying Off People’s Medical Debt Has Little Impact on Their Lives, Study Finds

A nonprofit group called R.I.P. Medical Debt has relieved Americans of $11 billion in hospital bills. But that did not improve their mental health or their credit scores, a study found.

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Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company

When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.

One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.

The government database, called “Open Payments,” records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. KFF Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.

The panel voted almost unanimously that the benefits of the device outweigh its risks. Abbott announced on April 2 that the FDA had approved TriClip, which is designed to treat leakage from the heart’s tricuspid valve.

The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.

The payments do not reflect wrongdoing on the part of the agency, its outside experts, or the device manufacturer. The database does not show that any of the payments were related directly to the TriClip device.

But some familiar with the process, including people who have served on FDA advisory committees, said the payments should have been disclosed at the Feb. 13 meeting — if not as a regulatory requirement, then in the interest of transparency, because the money might call into question committee members’ objectivity.

“This is a problem,” Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, said by email. “They should or must disclose this due to bias.”

The Open Payments database records several kinds of payments from drug and device makers. One category, called “associated research funding,” supports research in which a physician is named a principal investigator in the database. Another category, called “general payments,” includes consulting fees, travel expenses and meals connected to physicians in the database. The money can flow from manufacturers to third parties, such as hospitals, universities, or other corporate entities, but the database explicitly connects doctors by name to the payments.

At the public meeting to consider the TriClip device, an FDA official announced that committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.

FDA spokesperson Audra Harrison said by email that the agency doesn’t comment on matters related to individual advisory committee members.

“The FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place,” she said. “This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest.”

Abbott “has no influence over who is selected to participate in FDA advisory committees,” a spokesperson for the company, Brent Tippen, said in a statement.

Diana Zuckerman, president of the National Center for Health Research, a think tank, said the FDA shouldn’t have allowed recipients of funding from Abbott in recent years to sit in judgment of the Abbott product. The agency takes too narrow a view of what should be disqualifying, she said.

One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.

Asked in an interview if a reasonable person could question the impartiality of committee members based on the Abbott payments, Selzman said: “People from the outside looking in would probably say yes.”

He noted that Abbott’s money went to the university, not to him personally. Participating in industry-funded clinical trials benefits doctors professionally, he said. He added: “There’s probably a better way to provide transparency.”

The FDA has a history of appointing people to advisory committees who had relationships with manufacturers of the products under review. For example, in 2020, the doctor who chaired an FDA advisory committee reviewing Pfizer’s covid-19 vaccine had been a Pfizer consultant.

Appearance Issues

FDA advisory committee candidates, selected to provide expert advice on often complicated drug and device applications, must complete a confidential disclosure report that asks about current and past financial interests as well as “anything that would give an ‘appearance’ of a conflict.”

The FDA has discretion to decide whether someone with an “appearance issue” can serve on a panel, according to a guidance document posted on the agency’s website. Relationships more than a year in the past generally don’t give rise to appearance problems, according to the document, unless they suggest close ties to a company or involvement with the product under review. The main question is whether financial interests would cause a reasonable person to question the member’s impartiality, the document says.

The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that “may be impacted” by their work on the committee, an FDA explainer says.

If the FDA finds a conflict of interest but still wants the applicant on a panel, it can issue a public waiver. None of the panelists voting on TriClip received a waiver.

The FDA’s approach to disclosure contrasts with rules for conferences at which doctors earn credit for continuing medical education. For example, for a recent conference in Boston on technology for treatment of heart failure, including TriClip, the group holding the meeting directed speakers to include in their slide presentations disclosures going back 24 months.

Those disclosures — naming companies from which speakers had received consulting fees, grant support, travel expenses, and the like — also appeared on the conference website.

‘Unbridled Enthusiasm’

The FDA has designated TriClip a “breakthrough” device with “the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease” compared with current treatments, an agency official, Megan Naber, told the advisory committee.

Naber said that for breakthrough devices, the “totality of data must still provide a reasonable assurance of safety and effectiveness” but the FDA “may be willing to accept greater uncertainty” about the balance of risks and benefits.

In a briefing paper for the advisory committee, FDA staff pointed out findings from a clinical trial that didn’t reflect well on TriClip. For example, patients treated with TriClip had “numerically higher” mortality and heart failure hospitalization rates during the 12 months after the procedure compared with a control group, according to the report. Tippen, the Abbott spokesperson, didn’t respond to a request for comment on those findings.

The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.

The committee member to whom the database attributes the most money from Abbott, Paul Hauptman, cast one of the votes against the device on effectiveness and the sole vote against the device on the bottom-line question of its risks versus benefits.

Hauptman said during the meeting that the question of safety was “very, very clear” but added: “I just felt the need to pull back a little bit on unbridled enthusiasm.” Who will benefit from the device, he said, “needs better definition.”

Hauptman, dean of the University of Nevada-Reno School of Medicine, is connected to 268 general payments from Abbott totaling about $197,000 in the Open Payments database. Some payments are listed as going to an entity called Keswick Cardiovascular.

Hauptman said in an email that he followed FDA guidance and added, “My impartiality speaks for itself based on my vote and critical comments.”

Some committee members voted in favor of the device despite concerns.

Marc Katz, chief of the Division of Cardiothoracic Surgery at the Medical University of South Carolina, is linked to 77 general payments totaling about $53,000 from Abbott and worked on research supported by about $10,000 from the company, according to Open Payments.

“I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks,” he said in the meeting.

In an email, he said of his Abbott payments: “All was disclosed and reviewed by the FDA.” He said that he “can be impartial” and that he “openly expressed … concerns about the treatment.”

Mitchell Krucoff, a professor at Duke University School of Medicine, is connected to 100 general payments totaling about $105,000. Some went to a third party, HPIC Consulting. He also worked on research supported by about $51,000 from Abbott, according to Open Payments.

He said during the meeting that he voted in favor of the device on all three questions and added that doctors have “a lot to learn” once it’s on the market. For instance: By using the device to treat patients now, “do we set people up for catastrophes later?”

In an email, Krucoff said he completed a “very thorough conflict of interest screening by FDA for this panel,” which focused not only on Abbott but also on “any work done/payments received from any other manufacturer with devices in this space.”

John Hirshfeld Jr., an emeritus professor of medicine at the University of Pennsylvania, is linked by the database to six general payments from Abbott totaling $6,000. Two of the payments linked to him went to a nonprofit, the Cardiovascular Research Foundation, according to the database. He voted yes on all three questions about TriClip but said at the meeting that he “would have liked to have seen more rigorous data to support efficacy.”

In an email, Hirshfeld said he disclosed the payments to the FDA. The agency did not deem him to have a conflict because he had no stake in Abbott’s success and his involvement with the company had ended, he said. Through the conflict-of-interest screening process, he said, he had been excluded from prior advisory panels.

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