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Rural Colorado Tries to Fill Health Worker Gaps With Apprenticeships

GRAND JUNCTION, Colo. — During her 12-hour overnight shift, Brianna Shelton helps residents at BeeHive Homes Assisted Living go to the bathroom. Many of them have dementia, and some can’t get out of bed on their own. Only a few can remember her name, but that doesn’t matter to her.

“They’re somebody’s mom, somebody’s grandma, somebody’s great-grandmother,” Shelton said. “I want to take care of them like I would take care of my family.”

Shelton trained to be a personal care aide through an apprenticeship program designed to meet the increasing need for health care workers in rural western Colorado. Here, far from Denver’s bustling urban corridor, worker shortages mount as baby boomers retire, young people move away from these older communities, and demand for health care in homes and facilities rises.

Rural areas often have larger shares of residents who are 65 or older than urban areas do. And the most rural regions have relatively fewer direct care workers, like personal care aides, to help people with disabilities than less-rural regions do, according to a recent study in the journal Health Affairs.

Besides increasing the number of direct care workers, the Colorado apprenticeship program offers opportunities for improving earning power to residents who live at or below the poverty line, who lost their jobs during the covid-19 pandemic, or who are unemployed or underemployed. They train to become personal care aides, who help patients with daily tasks such as bathing or housekeeping, or certified nursing assistants, who can provide some direct health care, like checking blood pressure.

Apprentices take training classes at Western Colorado Area Health Education Center in Grand Junction, and the center pays for students who live in more rural areas to attend classes at Technical College of the Rockies in Delta County. The apprentices receive on-the-job training with one of 58 local employers — an assisted living facility, for example — and they are required to work there for one year. Each apprentice has an employer mentor. Staff members at Western Colorado AHEC also provide mentorship, plus the center has a life coach on hand.

“We really just want students to get into health care, get jobs, and retain those jobs,” said Georgia Hoaglund, executive director of Western Colorado AHEC, which has 210 active apprentices and was bolstered by a $2 million grant from the U.S. Labor Department in 2021.

Some apprentices are recent high school graduates. Others are single mothers or veterans. They often have educational or economic barriers to employment. Hoaglund and her staff of 10 buy the apprentices scrubs so they can start new jobs with the right uniforms; otherwise, they might not be able to afford them. Staff members pay for apprentices’ gas if they can’t afford to fill up their tanks to drive to work. They talk to apprentices on the phone monthly, sometimes weekly.

Even though the apprenticeship program gives these workers a solid start, the jobs can be stressful, and burnout and low pay are the norm. Career advancement is another obstacle, said Hoaglund, because of the logistics or cost of higher education. Hoaglund, who calls her staff family and some of the apprentices her kids, dreams of offering more advanced training — in nursing, for example — with scholarship money.

Apprenticeships are perhaps better known as a workforce training tool among electricians, plumbers, carpenters, and other tradespeople. But they are also viewed as a way of building a needed pipeline of direct care health workers, said Robyn Stone, senior vice president for research at LeadingAge, an association of nonprofit providers of aging services.

“Traditionally, health care employers have hired people after they finish a training program,” said Susan Chapman, a registered nurse and a professor in the school of nursing at the University of California-San Francisco. “Now, we’re asking the employer to take part in that training and pay the person while they’re training.”

The pandemic exacerbated shortages of direct care workers, which could encourage employers to invest in apprenticeships programs, both Chapman and Stone said. Federal investment could help, too, and a Biden administration initiative to improve the quality of nursing homes includes $35 million in grants to address workforce shortages in rural areas.

Shelton had never worked in health care before moving to Fruita, a small town that is about 12 miles northwest of Grand Junction and is surrounded by red sandstone towers. She left Fresno, California, a year ago to take care of an uncle who has multiple sclerosis. She and her 16-year-old daughter live in a trailer home on her uncle’s property, where Blackie, her rescue Labrador retriever, roams with the chickens and cats.

Blackie also sometimes accompanies Shelton to BeeHive to visit with the residents. Shelton said that it is more than a job to her and that she is grateful to the apprenticeship program for helping her get there. “It opened a door for me,” Shelton said.

Shelton works three 12-hour shifts a week, in addition to taking care of her uncle and daughter. Yet, she said, she struggles to have enough money for gas, bills, and food and has taken out small loans to make ends meet.

She is not alone. Personal care aides are often underpaid and undervalued, said Chapman, who has found significantly higher poverty rates among these workers than among the general population.

Direct care workers nationwide, on average, make $13.56 an hour, according to a study by nonprofit policy group PHI, and these low wages make recruiting and retaining workers difficult, leading to further shortages and instability.

In an effort to keep workers in the state, Colorado raised the minimum wage for personal care aides and certified nursing assistants to $15 an hour this year with money from the American Rescue Plan Act. And the Colorado Department of Health Care Policy and Financing’s 2023-24 budget request includes a bump to $15.75. Similar efforts to raise wages are underway in 18 other states, including New York, Florida, and Texas, according to a recent paper from the National Governors Association.

Another way to keep apprentices in jobs, and encourage career and salary growth, is to provide opportunities for specialized training in dementia care, medication management, or behavioral health. “What apprenticeships offer are career mobility and advancement,” Stone said.

To practice in Colorado, new certified nursing assistants complete in-class training, do clinical rotations, and pass a certification exam made up of a written test and a skills test. Hoaglund said the testing requirements can be stressful for students. Shelton, 43, has passed the written exam but must retake the skills test to become licensed as a certified nursing assistant.

Hoaglund’s program started in 2019, but it really took off with the 2021 federal grant. Since then, 16 people have completed the program and have received pay increases or promotions. Twice as many people have left without finishing. The largest hospital in Grand Junction, Intermountain Healthcare-St. Mary’s Medical Center, recruits workers from the program.

Hoaglund said each person who enters the health care field is a win.

Brandon Henry, 23, was a student at Colorado Mesa University in Grand Junction and working at PetSmart before he joined the apprenticeship program in 2019. After enrolling, he trained and worked as a certified nursing assistant through the worst of the pandemic. As an apprentice, he said, he learned the importance of having grace while caring for patients.

He went back for more training at Western Colorado AHEC to earn a license that allows him to dispense medicine in accredited facilities, such as assisted living centers. He now works at Intermountain Healthcare-St. Mary’s Medical Center, where he took training classes in wound care and physical therapy hosted at the hospital. This winter, he’ll graduate from Colorado Mesa with a Bachelor of Science in nursing.

“At the hospital, I’ve found more opportunities for pay raises and job growth,” Henry said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Trickle of Covid Relief Funds Helps Fill Gaps in Rural Kids’ Mental Health Services

NELSONVILLE, Ohio — The Mary Hill Youth and Family Center’s building has long been at a crossroads overlooking this rural Appalachian city, but its purpose has evolved.

For 65 years, residents of Nelsonville and the rolling hills of southeastern Ohio traveled to the hilltop hospital seeking care. Then, in 2014, the 15-bed hospital, which was often without patients, closed.

Later, the three-story brick building reopened as a hub for health services. With the help of several funding sources, Integrated Services for Behavioral Health, a nonprofit social service agency, transformed the building into a site for mental health treatment, primary and dental care, and food pantry access.

In June, the organization opened a 16-bed residential mental health treatment program on the former hospital’s top floor. The program serves children in rural southeastern Ohio and gives families an option besides sending their kids far away — sometimes out of state — for residential care.

“For a long time, we’ve been trying to figure out, ‘How do we support services being delivered more locally?’” said Samantha Shafer, CEO of Integrated Services for Behavioral Health. “Because when you have the programs here, the work you can do with families is more successful, health outcomes are better.”

Efforts to offer residential mental health services at Mary Hill Center, and in other rural Ohio towns, were boosted, in part, by a tiny share of Ohio’s $5.4 billion allotment from the American Rescue Plan Act, a federal covid relief law that was passed in 2021.

Congress gave $350 billion to state, local, and tribal governments as part of ARPA, allowing states to decide how they would use the funds. So far, dozens of states have allotted a relatively small portion to improving mental health resources. Ohio is one of a small group of states that further divided their allocation to spend a portion on children’s mental health care.

Experts said that using ARPA funds is just one way for states to support children’s behavioral health during what health professionals have called “a national emergency in child and adolescent mental health,” which was worsened by the pandemic. In an effort led by the American Academy of Pediatrics, multiple organizations wrote to the Biden administration in October, urging it to declare a federal national emergency over children’s mental health.

“At the time that ARPA came out, we were really trying to figure out, as a country, how the mental health, behavioral health systems could be bolstered, because, in my opinion, the systems are really broken,” said Isha Weerasinghe, a senior policy analyst at the Center for Law and Social Policy, a national, nonpartisan group that advocates for policies that help people with low incomes. “And what ARPA was able to do was to provide some foundational dollars to help bolster the systems.”

The center has said that ARPA’s funding provisions are “insufficient to counter deep systemic and historic inequities” in mental health care. Nonetheless, Weerasinghe said an opportunity exists for the money to have a long-term impact on children’s mental health care if applied to organizations that have demonstrated a commitment to maintaining children’s well-being in their communities.

States have until 2024 to allocate their ARPA funding and until 2026 to use it. According to the latest quarterly analysis by the Center on Budget and Policy Priorities, a left-leaning think tank in Washington, D.C., most states have either completed or nearly completed their allocations. Among states, the median allocation to support mental health services is about 0.5%, based on the CBPP data. For states in the Midwest region, the median is about 3%.

The CBPP numbers showed that by August the mental health allocations varied widely in the mostly rural states where suicide rates repeatedly eclipse the national average by double or more. In some of those, including Montana, South Dakota, and Wyoming, officials allocated less than the nationwide median. Meanwhile, lawmakers in Colorado steered nearly 11% of the state’s money toward mental health.

Of the $84 million Ohio officials dedicated to pediatric behavioral health facilities, $10 million will go to rural counties in the state’s southeast. That is less than half a percent of the state’s $5.4 billion ARPA allotment. But clinicians hope it will help address gaps in Appalachian Ohio’s mental health services for children.

In recent studies, the Public Children Services Association of Ohio, a nonprofit advocacy group, found that because of gaps in services, some children with behavioral health needs in Ohio were placed out of state or in a distant county for care. The association surveyed the public children’s services agencies in 19 counties and found that for most of their cases in 2021, the agencies made many calls before finding a residential treatment facility placement for a child.

In April, Ohio Gov. Mike DeWine signed an executive order providing $4.5 million to youth residential treatment facilities to increase their capacity.

In Nelsonville and the rural, hilly country that surrounds it, ARPA money has played a minor role in expanding services.

The new residential treatment facility at Mary Hill Center, which serves 10- to 17-year-olds, was designed for 16 beds. But as of September, because of staffing shortages, the facility operated at limited capacity and had served a maximum of five children at once.

Shafer said non-ARPA money paid for most of the renovations needed to open the floor, but about $1 million from ARPA will help upgrade elevators and bathrooms.

Her organization will use an additional $7 million to build another residential treatment facility — its program modeled after Mary Hill Center’s — in Chillicothe, a city about 55 miles west of Nelsonville. That facility will have capacity for 30 beds, but it will start with a cap of 15. Construction is set to begin in January.

Services at the residential facility in Chillicothe will primarily be reimbursed under a new Medicaid program called OhioRISE, which will pay for behavioral health treatment at psychiatric facilities for young people. But the facility will also treat children who aren’t enrolled in Medicaid.

Before the rural Ohio projects were approved for ARPA funding, they were each reviewed by Randy Leite, executive director of the Appalachian Children Coalition, a nonprofit that advocates for children’s health. He decided which proposals for ARPA-funded projects from the Appalachian region were presented to Ohio’s Department of Mental Health and Addiction Services.

“I told people in Columbus I could give them $300 million of ideas to spend money on, but a lot of that wasn’t practical and doable,” Leite said. Instead, he focused on ideas that were “shovel-ready” — so they could be completed within the ARPA spending time frame — and sustainable.

“A lot of the sustainability is tied to services that are reimbursable,” he said.

Leite and the coalition presented Ohio officials with about $30 million in ARPA investment recommendations, including a project meant to expand telehealth capacity in schools. State officials approved only about a third of the total requested. The money went to the Integrated Services for Behavioral Health facilities and Hopewell Health Centers, a federally qualified health center that received about $1.5 million. That money will pay for renovations to its 16-bed child crisis stabilization unit in Gallia County, south of Nelsonville; an expansion of its day treatment program; and enhancements to its school-based mental health programs — including one in Nelsonville’s school district.

“For students to learn, they have to have good physical and mental health,” said Sherry Shamblin, chief strategy officer of Hopewell Health Centers. “Those supports are really needed for kids to be able to take good advantage of their education opportunities.”

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California Aims to Maximize Health Insurance Subsidies for Workers During Labor Disputes

This spring, Chevron workers testified that the company revoked health coverage for hundreds of members of the United Steelworkers Local 5 at the Richmond, California, refinery during a strike that ultimately lasted two months. Thousands of nurses at Stanford Health Care were told in April they would lose their health insurance if they did not return to work during their weeklong strike. More than 300 workers at Sequoia Hospital in Redwood City received a similar message after going on strike in mid-July as contract negotiations stalled.

Freezing health insurance benefits is a common tactic in a labor dispute because without them, workers might be more easily persuaded to concede to management’s demands. But California lawmakers are giving an edge to strikers.

Assembly member Jim Wood, a Democrat, is hoping a new California law he authored will dissuade employers from cutting off health benefits during labor disputes by allowing private-industry workers to maximize state subsidies for coverage purchased through Covered California, the state’s health insurance marketplace. The bill, which takes effect in July, was sponsored by the California Labor Federation, California Teamsters Public Affairs Council, and the Los Angeles County Federation of Labor.

“The goal of the legislation is to say, ‘No you can’t do this,’” Wood said. “Never try it again.”

According to Covered California spokesperson Kelly Green, eligible workers will have their premiums covered as if their incomes were just above the Medicaid eligibility level. The state would factor in the worker’s federal subsidy and cover the difference. For example, a single person making $54,360 a year may pay 8.5% of their income, or about $385 a month, on premiums under a middle-tier health plan. Under the new law for striking workers, that person selecting the same plan would pay nothing in premiums — as if that person made $20,385 a year — for the duration of the strike.

The federal government authorized an enhanced subsidy under the American Rescue Plan Act. The enhanced subsidy will continue through 2025 under the Inflation Reduction Act. The state’s share of the subsidy could increase once the federal boost ends.

One estimate that unions shared with the state suggested the law would cost California an average of $341 a month per worker — with strikes lasting one to two months. Labor groups estimate the bill will affect fewer than 5,000 workers a year. California has nearly 15 million workers in the private sector, and strikes are generally a tool of last resort in labor negotiations.

It’s not clear how businesses will respond. Chevron, Stanford Health Care, and Sequoia Hospital’s operator, Dignity Health, did not respond to requests for comment. The bill met no formal opposition from businesses or taxpayer groups. Covered California’s subsidies are footed by a mix of federal and state funds as part of the Affordable Care Act, so there’s no direct cost to businesses.

Last year, Gov. Gavin Newsom, a Democrat, signed the Public Employee Health Protection Act, which bars public employers from terminating health coverage during an authorized strike. The new law for the private industry is different: There’s no ban on — or financial penalty for — revoking health benefits during strikes.

Nationally, Democrats in the House and Senate have pushed for an outright ban on this practice, but neither bill has advanced out of committee.

When California workers lose their employer-sponsored health benefits, they may become eligible for the state’s Medicaid program, known as Medi-Cal, or qualify to purchase health insurance through Covered California. With the latter option, workers could receive a range of subsidies to help pay for their monthly premiums. Generally, the lower a household’s income, the bigger the subsidy.

But even when workers do qualify for Covered California, that insurance can be much more expensive than the plans they had through their job — sometimes consuming 30% to 40% of their income, proponents said. And striking workers may experience delays since coverage may not take effect until the following month.

“This is one of the drawbacks of having a health care system that is tied to employment,” said Laurel Lucia, health care program director at the University of California-Berkeley Labor Center. “We saw during the pandemic, when there were furloughs or layoffs, people lost job-based coverage when they needed it most.”

Striking Sequoia workers reached an agreement with Dignity Health and returned to the 208-bed facility before health coverage stopped on Aug. 1, but some said they might have stayed on the picket line longer if not for fear of losing their benefits.

“That was pretty scary,” said Mele Rosiles, a certified nursing assistant and a member of the union’s bargaining team who was pregnant at the time. “A majority of our workers felt threatened by this move from our employer to strip our family’s health insurance if we didn’t return to work.”

The California Association of Health Plans raised concerns over an early version of the bill that sought to establish a category for striking workers, but the industry group dropped its opposition once it was determined that Covered California could administer the change without it.

Covered California estimates it will spend about $1.4 million to launch this benefit. The agency said it will create application questions to screen for eligible workers and remind them to stop coverage once they go back to work.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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Audits — Hidden Until Now — Reveal Millions in Medicare Advantage Overcharges

Newly released federal audits reveal widespread overcharges and other errors in payments to Medicare Advantage health plans for seniors, with some plans overbilling the government more than $1,000 per patient a year on average.

Summaries of the 90 audits, which examined billings from 2011 through 2013 and are the most recent reviews completed, were obtained exclusively by KHN through a three-year Freedom of Information Act lawsuit, which was settled in late September.

The government’s audits uncovered about $12 million in net overpayments for the care of 18,090 patients sampled, though the actual losses to taxpayers are likely much higher. Medicare Advantage, a fast-growing alternative to original Medicare, is run primarily by major insurance companies.

Officials at the Centers for Medicare & Medicaid Services have said they intend to extrapolate the payment error rates from those samples across the total membership of each plan — and recoup an estimated $650 million as a result.

But after nearly a decade, that has yet to happen. CMS was set to unveil a final extrapolation rule Nov. 1 but put that decision off until February.

Ted Doolittle, a former deputy director of CMS’ Center for Program Integrity, which oversees Medicare’s efforts to fight fraud and billing abuse, said the agency has failed to hold Medicare Advantage plans accountable. “I think CMS fell down on the job on this,” said Doolittle, now the health care advocate for the state of Connecticut.

Doolittle said CMS appears to be “carrying water” for the insurance industry, which is “making money hand over fist” off Medicare Advantage. “From the outside, it seems pretty smelly,” he said.

In an email response to written questions posed by KHN, Dara Corrigan, a CMS deputy administrator, said the agency hasn’t told health plans how much they owe because the calculations “have not been finalized.”

Corrigan declined to say when the agency would finish its work. “We have a fiduciary and statutory duty to address improper payments in all of our programs,” she said.

The 90 audits are the only ones CMS has completed over the past decade, a time when Medicare Advantage has grown explosively. Enrollment in the plans more than doubled during that period, passing 28 million in 2022, at a cost to the government of $427 billion.

Seventy-one of the 90 audits uncovered net overpayments, which topped $1,000 per patient on average in 23 audits, according to the government’s records. Humana, one of the largest Medicare Advantage sponsors, had overpayments exceeding that $1,000 average in 10 of 11 audits, according to the records.

CMS paid the remaining plans too little on average, anywhere from $8 to $773 per patient.

Auditors flag overpayments when a patient’s records fail to document that the person had the medical condition the government paid the health plan to treat, or if medical reviewers judge the illness is less severe than claimed.

That happened on average for just over 20% of medical conditions examined over the three-year period; rates of unconfirmed diseases were higher in some plans.

As Medicare Advantage’s popularity among seniors has grown, CMS has fought to keep its audit procedures, and the mounting losses to the government, largely under wraps.

That approach has frustrated both the industry, which has blasted the audit process as “fatally flawed” and hopes to torpedo it, and Medicare advocates, who worry some insurers are getting away with ripping off the government.

“At the end of the day, it’s taxpayer dollars that were spent,” said David Lipschutz, a senior policy attorney with the Center for Medicare Advocacy. “The public deserves more information about that.”

At least three parties, including KHN, have sued CMS under the Freedom of Information Act to shake loose details about the overpayment audits, which CMS calls Risk Adjustment Data Validation, or RADV.

In one case, CMS charged a law firm an advance search fee of $120,000 and then provided next to nothing in return, according to court filings. The law firm filed suit last year, and the case is pending in federal court in Washington, D.C.

KHN sued CMS in September 2019 after the agency failed to respond to a FOIA request for the audits. Under the settlement, CMS agreed to hand over the audit summaries and other documents and pay $63,000 in legal fees to Davis Wright Tremaine, the law firm that represented KHN. CMS did not admit to wrongfully withholding the records.

High Coders

Most of the audited plans fell into what CMS calls a “high coding intensity group.” That means they were among the most aggressive in seeking extra payments for patients they claimed were sicker than average. The government pays the health plans using a formula called a “risk score” that is supposed to render higher rates for sicker patients and lower ones for healthier ones.

But often medical records supplied by the health plans failed to support those claims. Unsupported conditions ranged from diabetes to congestive heart failure.

Overall, average overpayments to health plans ranged from a low of $10 to a high of $5,888 per patient collected by Touchstone Health HMO, a New York health plan whose contract was terminated “by mutual consent” in 2015, according to CMS records.

Most of the audited health plans had 10,000 members or more, which sharply boosts the overpayment amount when the rates are extrapolated.

In all, the plans received $22.5 million in overpayments, though these were offset by underpayments of $10.5 million.

Auditors scrutinize 30 contracts a year, a small sample of about 1,000 Medicare Advantage contracts nationwide.

UnitedHealthcare and Humana, the two biggest Medicare Advantage insurers, accounted for 26 of the 90 contract audits over the three years.

Eight audits of UnitedHealthcare plans found overpayments, while seven others found the government had underpaid.

UnitedHealthcare spokesperson Heather Soule said the company welcomes “the program oversight that RADV audits provide.” But she said the audit process needs to compare Medicare Advantage to original Medicare to provide a “complete picture” of overpayments. “Three years ago we made a recommendation to CMS suggesting that they conduct RADV audits on every plan, every year,” Soule said.

Humana’s 11 audits with overpayments included plans in Florida and Puerto Rico that CMS had audited twice in three years.

The Florida Humana plan also was the target of an unrelated audit in April 2021 by the Health and Human Services inspector general. That audit, which covered billings in 2015, concluded Humana improperly collected nearly $200 million that year by overstating how sick some patients were. Officials have yet to recoup any of that money, either.

In an email, Humana spokesperson Jahna Lindsay-Jones called the CMS audit findings “preliminary” and noted they were based on a sampling of years-old claims.

“While we continue to have substantive concerns with how CMS audits are conducted, Humana remains committed to working closely with regulators to improve the Medicare Advantage program in ways that increase seniors’ access to high-quality, lower cost care,” she wrote.

Billing Showdown

Results of the 90 audits, though years old, mirror more recent findings of a slew of other government reports and whistleblower lawsuits alleging that Medicare Advantage plans routinely have inflated patient risk scores to overcharge the government by billions of dollars.

Brian Murphy, an expert in medical record documentation, said collectively the reviews show that the problem is “absolutely endemic” in the industry.

Auditors are finding the same inflated charges “over and over again,” he said, adding: “I don’t think there is enough oversight.”

When it comes to getting money back from the health plans, extrapolation is the big sticking point.

Although extrapolation is routinely used as a tool in most Medicare audits, CMS officials have never applied it to Medicare Advantage audits because of fierce opposition from the insurance industry.

“While this data is more than a decade old, more recent research demonstrates Medicare Advantage’s affordability and responsible stewardship of Medicare dollars,” said Mary Beth Donahue, president of the Better Medicare Alliance, a group that advocates for Medicare Advantage. She said the industry “delivers better care and better outcomes” for patients.

But critics argue that CMS audits only a tiny percentage of Medicare Advantage contracts nationwide and should do more to protect tax dollars.

Doolittle, the former CMS official, said the agency needs to “start keeping up with the times and doing these audits on an annual basis and extrapolating the results.”

But Kathy Poppitt, a Texas health care attorney, questioned the fairness of demanding huge refunds from insurers so many years later. “The health plans are going to fight tooth and nail and not make this easy for CMS,” she said.

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Hay más infecciones sexuales y empresas producen más tests caseros… ¿son confiables?

Uno de los legados más remarcables de la pandemia de covid-19 es la rapidez con la que los reguladores federales y los laboratorios se movieron para producir tests caseros, una herramienta confiable para manejar una crisis de salud pública.

Pero esa rápida acción falta en otra epidemia menos publicitada: una explosión de enfermedades de transmisión sexual (ETS) que pueden causar dolor crónico e infertilidad en adultos, y discapacidad y muerte en recién nacidos.

Investigadores, defensores de salud y compañías de atención médica están implorando al gobierno federal que de luz verde a los kits de pruebas en el hogar que podrían multiplicar enormemente la cantidad de estadounidenses que se hacen pruebas de ETS.

En internet ya hay docenas de autopruebas, que oscilan entre $69 y $500, dependiendo de la marca y de la variedad de infecciones que pueden detectar.

Pero, salvo las pruebas de VIH, la Administración de Alimentos y Medicamentos (FDA) no ha aprobado los kits de pruebas de ETS para usarlos fuera de entornos médicos. Esto genera inseguridad en los consumidores sobre su confiabilidad, incluso cuando su uso no autorizado está creciendo dramáticamente.

La epidemia de ETS está “fuera de control”, dijo el doctor Amesh Adalja, investigador principal del Centro para la Seguridad de la Salud de la Universidad Johns Hopkins. “Sabemos que nos faltan diagnósticos. Sabemos que el rastreo de contactos se realiza tarde o no se realiza en absoluto. Si realmente queremos abordar la crisis de las ETS, tenemos que diagnosticar a más personas”.

Datos preliminares para 2021 mostraron cerca de 2.5 millones de casos reportados de clamidia, gonorrea y sífilis en el país, según los Centros para el Control y Prevención de Enfermedades (CDC). Los casos reportados de sífilis y gonorrea han estado aumentando por alrededor de una década. En el estimado más reciente de prevalencia, la agencia dijo que en un día determinado, uno de cada 5 estadounidenses está infectado con cualquiera de las ocho ETS más comunes.

El impulso para hacer que las pruebas de detección de ETS en el hogar sean tan fáciles y comunes como las de covid y de embarazo proviene de varios sectores. Funcionarios de salud pública dicen que su personal sobrecargado no puede manejar la asombrosa necesidad de pruebas y vigilancia. Las empresas de diagnóstico y las farmacéuticas ven en la demanda insatisfecha una oportunidad de negocio.

Las bases científicas que sustentan las pruebas de ETS no son particularmente nuevas ni misteriosas. Dependiendo de la prueba, puede implicar recolectar una muestra de orina, pinchar un dedo en busca de sangre o un hisopado de la boca, los genitales o el ano en busca de secreciones o muestras de células. Los centros médicos y las clínicas de salud comunitarias han realizado este tipo de pruebas durante décadas.

El problema para los reguladores es si los kits pueden adaptarse de manera confiable para su uso casero. A diferencia de los tests rápidos para covid, que ofrece un resultado en 15 a 20 minutos, los tests caseros para ETS en el mercado requieren que los pacientes tomen sus propias muestras, las pongan en un sobre y las envíen a los laboratorios para su análisis.

En los últimos tres años, mientras las clínicas que proveen estos servicios reducían drásticamente las visitas en persona, algunos departamentos de salud —entre ellos los de Alabama, Alaska y Maryland— comenzaron a enviar pruebas de ETS por correo a los residentes. Universidades y organizaciones sin fines de lucro también están encabezando estos esfuerzos.

Y docenas de empresas están abordando el negocio de la venta directa. Everly Health, una compañía digital de salud que vende una variedad de pruebas de laboratorio por internet, informó que las ventas de su kit para ETS aumentaron un 120% en la primera mitad del año, comparado con la primera mitad de 2021.

CVS Health comenzó a vender su propia marca de kit para ETS en octubre, por $99.99. A diferencia de otros tests caseros, los de CVS están disponibles en sus tiendas.

Hologic, Abbott, y Molecular Testing Labs están entre las empresas desarrollando kits con rapidez. Y Cue Health, que vende pruebas de antígenos para covid, está a punto de lanzar un ensayo clínico para una prueba casera rápida para la clamidia y la gonorrea que establecería un nuevo estándar, proporcionando resultados en unos 20 minutos.

Alberto Gutiérrez, quien anteriormente dirigió la oficina de la FDA que supervisa las pruebas de diagnóstico, dijo que los funcionarios de la agencia han estado preocupados por la confiabilidad de las pruebas caseras durante años. La FDA quiere que las empresas demuestren que los kits de recolección en el hogar son tan precisos como los que se usan en las clínicas y que las muestras no se degradan durante el envío.

“La agencia no cree que estas pruebas se comercialicen legalmente en este momento”, dijo Gutiérrez, socio de NDA Partners, una firma consultora que asesora a empresas que buscan sacar al mercado productos para el cuidado de la salud.

“CVS no debería vender esa prueba”, agregó.

En respuesta a las preguntas de KHN, la FDA dijo que considera que los kits de recolección en el hogar, que pueden incluir hisopos, lancetas, tubos y productos químicos para estabilizar las muestras, son dispositivos que requieren revisión de la agencia. La FDA “generalmente no comenta” si planea tomar medidas en algún caso específico, según el comunicado.

Mary Gattuso, vocera de CVS, dijo que la cadena de farmacias está siguiendo la ley. “Estamos comprometidos a garantizar que los productos que ofrecemos sean seguros, funcionen según lo previsto, cumplan con las regulaciones y satisfagan a los clientes”, dijo Gattuso.

Everly Health y otras compañías describieron sus kits como pruebas desarrolladas en laboratorio, similares a los diagnósticos que algunos hospitales crean para uso interno. Y afirman que pueden comercializarse legalmente porque sus laboratorios han sido certificados por una agencia diferente, los Centros de Servicios de Medicare y Medicaid (CMS).

“Los instrumentos y análisis que utilizan los laboratorios con los que trabajamos son comparables, y generalmente iguales, a los del consultorio de un médico”, dijo la doctora Liz Kwo, directora médica de Everly Health. “Nuestros métodos de recolección de muestras en el hogar, como gotas de sangre seca y saliva, se han utilizado ampliamente durante décadas”.

Los kits de recolección en el hogar atraen a Uxmal Caldera, de 27 años, de Miami Beach, Florida, quien prefiere realizar la prueba en la privacidad de su hogar. Caldera, que no tiene auto, dijo que las pruebas caseras le ahorran el tiempo y los gastos de ir a una clínica.

Caldera se ha estado haciendo pruebas de VIH y otras ETS cada tres meses durante más de un año, como parte del control de rutina para las personas que toman PrEP, un régimen de píldoras diarias para prevenir la infección por VIH.

“Hacerlo solo no es nada difícil”, dijo Caldera, quien no tiene seguro pero recibe las pruebas gratis a través de una fundación comunitaria. “Las instrucciones son muy claras. Obtengo los resultados en unos cuatro días. Por supuesto, lo recomendaría a otras personas”.

El doctor Leandro Mena, director de la División de Prevención de ETS de los CDC, dijo que le gustaría ver que las pruebas de ETS en el hogar se vuelvan tan rutinarias como las pruebas caseras de embarazo. Se estima que cada año se realizan entre 16 y 20 millones de pruebas de gonorrea y clamidia en el país, dijo Mena.

Señaló que los médicos tienen años de experiencia en el uso de kits de recolección en el hogar.

El Centro Johns Hopkins para la Investigación de Tecnologías de punto de atención para Enfermedades de Transmisión Sexual ha distribuido aproximadamente 23,000 kits de ETS en el hogar desde 2004, dijo Charlotte Gaydos, investigadora principal del centro. La FDA generalmente permite este uso si es parte de una investigación supervisada por profesionales médicos. Estas pruebas se usan el departamento de salud de Alaska, y en reservas nativas en Arizona y Oklahoma.

Gaydos ha publicado docenas de estudios que establecen que los kits de recolección domiciliaria para enfermedades como la clamidia y la gonorrea son precisos y fáciles de usar.

“Hay una gran cantidad de datos que muestran que las pruebas en el hogar funcionan”, dijo Gaydos.

Pero Gaydos anotó que sus estudios se han limitado a muestras pequeñas. Dijo que no tiene los millones de dólares en fondos que se necesitarían para realizar el tipo de ensayo integral que la FDA normalmente requiere para su aprobación.

Jenny Mahn, directora de salud clínica y sexual de la Coalición Nacional de Directores de ETS, dijo que muchos laboratorios de salud pública son reacios a manejar kits caseros. “Los laboratorios de salud pública no los tocarán sin la aprobación de la FDA”, dijo Mahn.

Las clínicas de salud pública a menudo brindan pruebas de ETS a bajo costo o sin costo alguno, mientras que el seguro de salud generalmente cubre las pruebas en persona en una práctica privada. Pero la mayoría de los consumidores pagan de su bolsillo los kits directos al consumidor. Los precios comerciales los ponen fuera del alcance de muchas personas, en particular adolescentes y adultos jóvenes, que representan casi la mitad de las ETS.

Adalja, de Johns Hopkins, dijo que la FDA tiene un historial de avanzar lentamente con las pruebas caseras. La agencia pasó siete años evaluando la primera prueba casera del VIH que aprobó, que salió al mercado en 2012.

“Las pruebas en el hogar son el camino hacia el futuro”, dijo Laura Lindberg, profesora de salud pública en la Universidad de Rutgers. “La pandemia abrió la puerta a estas pruebas y al tratamiento en el hogar sin viajar a un proveedor de atención médica, y no podremos volver a poner al genio en la botella”.

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As STDs Proliferate, Companies Rush to Market At-Home Test Kits. But Are They Reliable?

Among the more remarkable legacies of the covid-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the U.S., according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, 1 in 5 Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home covid and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for covid, which produce results in 15 to 20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past three years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments — among them state agencies in Alabama, Alaska, and Maryland — have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells covid tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to — and often the same as — those used by the labs a doctor’s office uses,” said Dr. Liz Kwo, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, Florida, who prefers to test in the privacy of his home. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Caldera has been testing himself for HIV and other STDs every three months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe four days. For sure, I would recommend it to other people.”

Dr. Leandro Mena, director of the CDC’s Division of STD Prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed in the U.S. each year, Mena said. Widespread use of at-home STD testing, he said, could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Gaydos.

But Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing,” Mahn said.

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja, at Johns Hopkins, said the FDA has a history of moving slowly on home testing. The agency spent seven years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, a professor of public health at Rutgers University. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

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How Banks and Private Equity Cash In When Patients Can’t Pay Their Medical Bills

Patients at North Carolina-based Atrium Health get what looks like an enticing pitch when they go to the nonprofit hospital system’s website: a payment plan from lender AccessOne. The plans offer “easy ways to make monthly payments” on medical bills, the website says. You don’t need good credit to get a loan. Everyone is approved. Nothing is reported to credit agencies.

In Minnesota, Allina Health encourages its patients to sign up for an account with MedCredit Financial Services to “consolidate your health expenses.” In Southern California, Chino Valley Medical Center, part of the Prime Healthcare chain, touts “promotional financing options with the CareCredit credit card to help you get the care you need, when you need it.”

As Americans are overwhelmed with medical bills, patient financing is now a multibillion-dollar business, with private equity and big banks lined up to cash in when patients and their families can’t pay for care. By one estimate from research firm IBISWorld, profit margins top 29% in the patient financing industry, seven times what is considered a solid hospital margin.

Hospitals and other providers, which historically put their patients in interest-free payment plans, have welcomed the financing, signing contracts with lenders and enrolling patients in financing plans with rosy promises about convenient bills and easy payments.

For patients, the payment plans often mean something more ominous: yet more debt.

Millions of people are paying interest on these plans, on top of what they owe for medical or dental care, an investigation by KHN and NPR shows. Even with lower rates than a traditional credit card, the interest can add hundreds, even thousands of dollars to medical bills and ratchet up financial strains when patients are most vulnerable.

Robin Milcowitz, a Florida woman who found herself enrolled in an AccessOne loan at a Tampa hospital in 2018 after having a hysterectomy for ovarian cancer, said she was appalled by the financing arrangements.

“Hospitals have found yet another way to monetize our illnesses and our need for medical help,” said Milcowitz, a graphic designer. She was charged 11.5% interest — almost three times what she paid for a separate bank loan. “It’s immoral,” she said.

MedCredit’s loans to Allina patients come with 8% interest. Patients enrolled in a CareCredit card from Synchrony, the nation’s leading medical lender, face a nearly 27% interest rate if they fail to pay off their loan during a zero-interest promotional period. The high rate hits about 1 in 5 borrowers, according to the company.

For many patients, financing arrangements can be confusing, resulting in missed payments or higher interest rates than they anticipated. The loans can also deepen inequalities. Lower-income patients without the means to make large monthly payments can face higher interest rates, while wealthier patients able to shoulder bigger monthly bills can secure lower rates.

More fundamentally, pushing people into loans that threaten their financial health runs against medical providers’ first obligation to not harm their patients, said patient advocate Mark Rukavina, program director at the nonprofit Community Catalyst.

“We’re dealing with sick people, scared people, vulnerable people,” Rukavina said. “Dangling a financial services product in front of them when they’re concerned about their care doesn’t seem appropriate.”

Debt Upon Debt

Nationwide, about 50 million people — or 1 in 5 adults — are on a financing plan to pay off a medical or dental bill, according to a KFF poll conducted for this project. About a quarter of those borrowers are paying interest, the poll found.

Increasingly, those interest payments are going to financing companies that promise hospitals they will collect more of their medical bills in exchange for a cut.

Hospital officials defend these arrangements, citing the need to offset the cost of offering financing options to patients. Alan Wolf, a spokesperson for the University of North Carolina’s hospital system, said that the system, which reported $5.8 billion in patient revenue last year, had a “responsibility to remain financially stable to assure we can provide care to all regardless of ability to pay.” UNC Health, as it is known, has contracted since 2019 with AccessOne, a private equity-backed company that finances loans for scores of hospital systems across the country.

This partnership has had a substantial impact on patient debt, according to a KHN analysis of billing and contracting records obtained through public records requests.

UNC Health, which as a public university system touts its commitment “to serve the people of North Carolina,” had long offered payment plans without interest. And when AccessOne took over the loans in September 2019, most patients were in no-interest plans.

That has steadily shifted as new patients enrolled in one of AccessOne’s plans, several of which have variable interest rates that now charge 13%.

In February 2020, records show, just 9% of UNC patients in an AccessOne plan were in a loan with the highest interest rate. Two years later, 46% were in such a plan. Overall, at any given time more than 100,000 UNC Health patients finance through AccessOne.

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The interest can pile on debt. Someone with a $7,000 hospital bill, for example, who enrolls in a five-year financing plan at 13% interest will pay at least $2,500 more to settle that debt.

Rukavina, the patient advocate, said adding this burden on patients makes little sense when medical debt is already creating so much hardship. “It may seem like a short-term solution, but it leads to longer-term problems,” he said. Health care debt has forced millions of Americans to cut back on food, give up their homes, and make other sacrifices, KHN found.

UNC Health disavowed responsibility for the additional debt, saying patients signed up for the higher-interest loans. “Any payment plans above zero-interest terms/conditions in place with AccessOne are in place at the request of the patient,” Wolf said in an email. UNC Health would only provide answers to written questions.

UNC Health’s patients aren’t the only ones getting routed into financing plans that require substantial interest payments.

At Atrium Health, a nonprofit system with roots as Charlotte’s public hospital that reported more than $7.5 billion in revenues last year, as many as half of patients enrolled in an AccessOne loan were in one of the company’s highest-interest plans, according to 2021 billing records analyzed by KHN.

At AU Health, Georgia’s main public university hospital system, billing records obtained by KHN show that two-thirds of patients on an AccessOne plan were paying the highest interest rate as of January.

‘Empathetic Patient Financing’

AccessOne chief executive Mark Spinner, who in an interview called his firm a “compassionate, empathetic patient financing company,” said the range of interest rates gives patients and medical systems valuable options. “By offering AccessOne, you’re creating a much safer, more mission-aligned way for consumers to pay and help them stay out of medical debt,” he said. “It’s an alternative to lawsuits, legal action, and things like that.”

AccessOne, which doesn’t buy patient debt from hospitals, doesn’t run credit checks on patients to qualify them for loans. Nor will the company report patients who default to credit bureaus. The company also frequently markets the availability of zero-interest loans.

Some patients do qualify for no-interest plans, particularly if they have very low incomes. But the loans aren’t always as generous as company and hospital officials say.

AccessOne borrowers who miss payments can have their accounts returned to the hospital, which can sue them, report them to credit bureaus, or subject them to other collection actions. UNC Health refers unpaid bills to the state revenue department, which can garnish patients’ tax refunds. Atrium’s collections policy allows the hospital system to sue patients.

Because AccessOne borrowers can get low interest rates by making larger monthly payments, this financing system can also deepen inequalities. Someone who can pay $292 a month on a $7,000 hospital bill, for example, could qualify for a two-year, interest-free plan. But a patient who can pay only $159 a month would have to take a five-year plan with 13% interest, according to AccessOne.

“I see wealthier families benefiting,” said one former AccessOne employee, who asked not to be identified because she still works in the financing industry. “Lower-income families that have hardship are likely to end up with a higher overall balance due to the interest.”

Andy Talford, who oversees patient financial services at Moffitt Cancer Center in Tampa, said the hospital contracted with AccessOne to make it easier for patients to manage their medical bills. “Someone out there is helping them keep track of it,” he said.

But patients can get tripped up by the complexities of managing these plans, consumer advocates say. That’s what happened to Milcowitz, the graphic designer in Florida.

Milcowitz, 51, had set up a no-interest payment plan with Moffitt to pay off $3,000 she owed for her hysterectomy in 2017. When the medical center switched her account to AccessOne, however, she began receiving late notices, even as she kept making payments.

Only later did she figure out that AccessOne had set up two accounts, one for the cancer surgery and another for medical appointments. Her payments had been applied only to the surgery account, leaving the other past-due. She then got hit with higher interest rates. “It’s crazy,” she said.

Growing Business Opportunities

While financing plans may mean more headaches and more debt for patients, they’re proving profitable for lenders.

That’s drawn the interest of private equity firms, which have bought several patient financing companies in recent years. Since 2017, AccessOne’s majority owner has been private equity investor Frontier Capital.

Synchrony, which historically marketed its CareCredit cards in patient waiting rooms, is now also inking deals with medical systems to enroll patients in loans when they go online to pay bills.

“They’re like pilot fish eating off the back of the shark,” said Jonathan Bush, a founder of Athenahealth, a health technology company that has developed electronic medical records and billing systems.

As patient bills skyrocket, hospitals face mounting pressure to collect more, which can make financing arrangements seem appealing, industry experts say. But as health systems go into business with lenders, many are reluctant to share details. Only a handful of hospitals contacted by KHN agreed to be interviewed about their contracts and what they mean for patients.

Several public systems, including Atrium and UNC Health, disclosed information only after KHN submitted public records requests. Even then, the two systems redacted key details, including how much they pay AccessOne.

AU Health, which did not redact its contract, pays AccessOne a 6% “servicing fee” on each patient loan the company administers. But like Atrium and UNC Health, AU Health refused to provide any on-the-record interviews.

Other hospital systems were even less transparent. Mercyhealth, a nonprofit with hospitals and clinics in Illinois and Wisconsin that routes its patients to CareCredit, would not discuss its lending practices. “We do not have anyone available for this,” spokesperson Therese Michels said. Allina Health and Prime Healthcare also wouldn’t talk about their patient financing deals.

Bush said there’s a reason so few hospitals want to discuss their financing deals: They’re embarrassed. “It’s like they quietly write someone’s name on a piece of paper and slide it across the table,” he said. “They don’t want to be a part of it because they have in their institutional memory that they are supposed to look after patients’ best interests.”

Some Hospitals Choose Another Path

Not all hospitals expose their patients to extra costs to finance medical bills.

Lake Region Healthcare, a small nonprofit with hospitals and clinics in rural Minnesota that contracts with Missouri-based Commerce Bank, charges no interest or fees on payment plans. That’s a decision that spokesperson Katie Johnson said was made “for the benefit of our patients.”

Even some AccessOne clients such as the University of Kansas Health System shield patients from interest. But as providers look to boost their bottom lines, it’s unclear how long these protections will last. Colette Lasack, who oversees financing for the Kansas system, noted: “There’s a cost associated with that.”

Meanwhile, large national lenders such as Discover Financial Services are looking at the patient financing business.

“I’ve had to become more of a health care marketer,” said Matt Lattman, vice president for personal loans at Discover, which is pitching the loans to people with unexpected medical bills. “In a world where many people are ill prepared to cover their health care costs, the personal loan can provide an opportunity.”

About This Project

“Diagnosis: Debt” is a reporting partnership between KHN and NPR exploring the scale, impact, and causes of medical debt in America.

The series draws on the “KFF Health Care Debt Survey,” a poll designed and analyzed by public opinion researchers at KFF in collaboration with KHN journalists and editors. The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current health care debt and 382 adults who had health care debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.

Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health status to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.

The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how customers’ balances may be affected by major medical expenses.

Reporters from KHN and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.

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Fight Over Health Care Minimum Wage Yields a Split Decision in Southern California

An expensive fight over health worker pay in two Southern California cities appears to have ended in a draw, with each side claiming a victory and a loss.

Inglewood residents were poised to approve a ballot measure that would boost the minimum wage to $25 at private hospitals, psychiatric facilities, and dialysis clinics. The latest vote count showed Measure HC leading 54% to 46%, according to Los Angeles County election officials. In Duarte, roughly 35 miles away, voters were on track to decisively reject a similar proposal, Measure J, 63% to 37%.

Los Angeles County election officials plan to release final results Dec. 5.

The contests were the first ballot-box fight in what seems likely to be a multiyear battle between a powerful labor union and the influential hospital industry. Similar proposals are scheduled to go before voters in Los Angeles, Downey, Long Beach, and Monterey Park in 2024.

All were spearheaded by the Service Employees International Union-United Healthcare Workers West, which represents roughly 100,000 workers, including medical assistants, food service workers, and custodial staff.

Suzanne Jimenez, the union’s political director, said the union still plans to pursue a $25 minimum wage in other cities and, eventually, statewide.

“We’re still moving forward on all fronts,” she said.

George Greene, president of the Hospital Association of Southern California, said in a statement that hospitals support “fair wages” for health workers but that their pay should be discussed at a “state or regional level.”

“Deeply flawed” local ordinances, he said, are “bad policy and the wrong approach.”

The union used Inglewood and Duarte, both in Los Angeles County, as test cases for raising wages, particularly for some of the lowest-paid health facility workers, such as nursing assistants, security guards, and janitors. Because the measures are city ordinances, they wouldn’t apply to state- and county-run medical facilities, just private hospitals and clinics.

Union officials argue that a $25 minimum wage is necessary to retain and attract workers in a sector that has been understaffed and overworked throughout the covid-19 pandemic.

The minimum wage in most of Los Angeles County is $16.04 per hour. But for a single adult with no children, the living wage — the amount that person would need to cover typical expenses such as food, housing, and transportation in the county — is $21.89 hourly, or about $45,500 a year, according to a tool from the Massachusetts Institute of Technology. Occupations such as “healthcare support” generally pay around $33,000 annually in the county, according to the same tool.

Hospitals campaigned heavily against the union’s proposal and argued it would create “unequal pay” for staff at private and public facilities. An analysis commissioned by the California Hospital Association estimated that instituting a $25 minimum wage in the 10 cities originally targeted by the union would have raised costs for private facilities in those communities by $392 million a year, a 6.9% increase.

In Inglewood — a working-class city of about 107,000 people southwest of Los Angeles — Measure HC will apply to Centinela Hospital Medical Center and several for-profit dialysis clinics if it prevails. About 315 employees of the hospital would see their wages rise, according to Jimenez, who said she doesn’t know how many dialysis clinic employees would be affected.

In Duarte, a wealthier suburb of about 21,000 people east of Los Angeles, Measure J would have applied only to City of Hope, a cancer hospital.

Jimenez said the differences between those communities, and their residents’ experiences with the health care system, could account for how the measures fared. She said she noticed that Inglewood voters had more direct experience with Centinela — they may have visited the emergency room or had a baby — than Duarte voters had with City of Hope.

The union has taken two approaches to seeking a $25 minimum wage. It attempted to secure a statewide minimum wage during negotiations with hospitals this year in Sacramento. But the negotiations were complicated by competing hospital and union priorities, and the deal fell apart in August. The union has also pursued a city-by-city strategy, targeting 10 communities in Los Angeles and Orange counties, including Inglewood and Duarte, where internal polling showed minimum wage proposals could pass.

Earlier this year, city councils in Los Angeles, Downey, Monterey Park, and Long Beach adopted $25 minimum-wage ordinances for private facility health workers, but hospitals and health care facilities challenged them, pushing the issue to the 2024 ballot. Meanwhile, the union dropped its effort in Anaheim and failed to gather enough signatures in Culver City, Lynwood, and Baldwin Park to place measures before voters this year.

Both sides spent heavily. According to state campaign finance filings, the union spent about $11 million across all 10 cities from February through the week before the election. Hospitals and health care facilities spent $12 million during the same time frame.

Many labor economists said that the health care workforce deserves higher wages and better working conditions but that increasing the minimum wage could cause ripple effects.

Neighboring towns or facilities that aren’t subject to the new minimum wage and other sectors of the local economy might have to compete for workers, said Joanne Spetz, director of the Philip R. Lee Institute for Health Policy Studies at the University of California-San Francisco. And facilities that increase pay may have to do more with fewer staffers, she said.

“To have a minimum wage that is specific to a limited category of workers, in a limited set of organizations, in a single city is really unusual,” Spetz said. “I cannot think of any other circumstances where this has happened.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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Watch: As Health Costs Spike, the Role of Hospitals Often Gets Overlooked

The documentary “InHospitable” explores the role hospitals play in a fractured U.S. health care system and how they have driven up costs. It presents stories of patients and activists who protested practices at the University of Pittsburgh Medical Center, a behemoth health system headquartered in Pittsburgh. They asserted that UPMC was making vital care unaffordable and sometimes unattainable for hundreds of thousands of vulnerable patients as it fought a business dispute with a rival health system.

(Spoiler alert: The dispute was finally resolved, and care restored, due to a settlement negotiated by Pennsylvania’s then-attorney general, Josh Shapiro, who is now the governor-elect.)

A recent conversation on Facebook about the film was moderated by KHN chief Washington correspondent Julie Rovner and featured the film’s director, Sandra Alvarez; Elisabeth Rosenthal, KHN’s editor-in-chief; and patient Beth McCracken. Both Rosenthal and McCracken were featured in the film.

The participants discussed how some nonprofit hospital systems have recorded billions of dollars in surplus funds while also accumulating political sway. Yet the institutions maintain their nonprofit status while community benefits often are lacking. What can be done to hold these systems accountable? In the “land of the giants,” as Rosenthal put it, it is hard to ensure that patients are protected.

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Sick Profit: Investigating Private Equity’s Stealthy Takeover of Health Care Across Cities and Specialties

Two-year-old Zion Gastelum died just days after dentists performed root canals and put crowns on six baby teeth at a clinic affiliated with a private equity firm.

His parents sued the Kool Smiles dental clinic in Yuma, Arizona, and its private equity investor, FFL Partners. They argued the procedures were done needlessly, in keeping with a corporate strategy to maximize profits by overtreating kids from lower-income families enrolled in Medicaid. Zion died after being diagnosed with “brain damage caused by a lack of oxygen,” according to the lawsuit.

Kool Smiles “overtreats, underperforms and overbills,” the family alleged in the suit, which was settled last year under confidential terms. FFL Partners and Kool Smiles had no comment but denied liability in court filings.

Private equity is rapidly moving to reshape health care in America, coming off a banner year in 2021, when the deep-pocketed firms plowed $206 billion into more than 1,400 health care acquisitions, according to industry tracker PitchBook.

Seeking quick returns, these investors are buying into eye care clinics, dental management chains, physician practices, hospices, pet care providers, and thousands of other companies that render medical care nearly from cradle to grave. Private equity-backed groups have even set up special “obstetric emergency departments” at some hospitals, which can charge expectant mothers hundreds of dollars extra for routine perinatal care.

As private equity extends its reach into health care, evidence is mounting that the penetration has led to higher prices and diminished quality of care, a KHN investigation has found. KHN found that companies owned or managed by private equity firms have agreed to pay fines of more than $500 million since 2014 to settle at least 34 lawsuits filed under the False Claims Act, a federal law that punishes false billing submissions to the federal government with fines. Most of the time, the private equity owners have avoided liability.

New research by the University of California-Berkeley has identified “hot spots” where private equity firms have quietly moved from having a small foothold to controlling more than two-thirds of the market for physician services such as anesthesiology and gastroenterology in 2021. And KHN found that in San Antonio, more than two dozen gastroenterology offices are controlled by a private equity-backed group that billed a patient $1,100 for her share of a colonoscopy charge — about three times what she paid in another state.

It’s not just prices that are drawing scrutiny.

Whistleblowers and injured patients are turning to the courts to press allegations of misconduct or other improper business dealings. The lawsuits allege that some private equity firms, or companies they invested in, have boosted the bottom line by violating federal false claims and anti-kickback laws or through other profit-boosting strategies that could harm patients.

“Their model is to deliver short-term financial goals and in order to do that you have to cut corners,” said Mary Inman, an attorney who represents whistleblowers.

Federal regulators, meanwhile, are almost blind to the incursion, since private equity typically acquires practices and hospitals below the regulatory radar. KHN found that more than 90% of private equity takeovers or investments fall below the $101 million threshold that triggers an antitrust review by the Federal Trade Commission and the U.S. Justice Department.

Spurring Growth

Private equity firms pool money from investors, ranging from wealthy people to college endowments and pension funds. They use that money to buy into businesses they hope to flip at a sizable profit, usually within three to seven years, by making them more efficient and lucrative.

Private equity has poured nearly $1 trillion into nearly 8,000 health care transactions during the past decade, according to PitchBook.

Fund managers who back the deals often say they have the expertise to reduce waste and turn around inefficient, or moribund, businesses, and they tout their role in helping to finance new drugs and technologies expected to benefit patients in years to come.

Critics see a far less rosy picture. They argue that private equity’s playbook, while it may work in some industries, is ill suited for health care, when people’s lives are on the line.

In the health care sphere, private equity has tended to find legal ways to bill more for medical services: trimming services that don’t turn a profit, cutting staff, or employing personnel with less training to perform skilled jobs — actions that may put patients at risk, critics say.

KHN, in a series of articles published this year, has examined a range of private equity forays into health care, from its marketing of America’s top-selling emergency contraception pill to buying up whole chains of ophthalmology and gastroenterology practices and investing in the booming hospice care industry and even funeral homes.

These deals happened on top of well-publicized takeovers of hospital emergency room staffing firms that led to outrageous “surprise” medical bills for some patients, as well as the buying up of entire rural hospital systems.

“Their only goal is to make outsize profits,” said Laura Olson, a political science professor at Lehigh University and a critic of the industry.

Hot Spots

When it comes to acquisitions, private equity firms have similar appetites, according to a KHN analysis of 600 deals by the 25 firms that PitchBook says have most frequently invested in health care.

Eighteen of the firms have dental companies listed in their portfolios, and 16 list centers that offer treatment of cataracts, eye surgery, or other vision care, KHN found.

Fourteen have bought stakes in animal hospitals or pet care clinics, a market in which rapid consolidation led to a recent antitrust action by the FTC. The agency reportedly also is investigating whether U.S. Anesthesia Partners, which operates anesthesia practices in nine states, has grown too dominant in some areas.

Private equity has flocked to companies that treat autism, drug addiction, and other behavioral health conditions. The firms have made inroads into ancillary services such as diagnostic and urine-testing and software for managing billing and other aspects of medical practice.

Private equity has done so much buying that it now dominates several specialized medical services, such as anesthesiology and gastroenterology, in a few metropolitan areas, according to new research made available to KHN by the Nicholas C. Petris Center at UC-Berkeley.

Although private equity plays a role in just 14% of gastroenterology practices nationwide, it controls nearly three-quarters of the market in at least five metropolitan areas across five states, including Texas and North Carolina, according to the Petris Center research.

Similarly, anesthesiology practices tied to private equity hold 12% of the market nationwide but have swallowed up more than two-thirds of it in parts of five states, including the Orlando, Florida, area, according to the data.

These expansions can lead to higher prices for patients, said Yashaswini Singh, a researcher at the Bloomberg School of Public Health at Johns Hopkins University.

In a study of 578 physician practices in dermatology, ophthalmology, and gastroenterology published in JAMA Health Forum in September, Singh and her team tied private equity takeovers to an average increase of $71 per medical claim filed and a 9% increase in lengthy, more costly, patient visits.

Singh said in an interview that private equity may develop protocols that bring patients back to see physicians more often than in the past, which can drive up costs, or order more lucrative medical services, whether needed or not, that boost profits.

“There are more questions than answers,” Singh said. “It really is a black hole.”

Jean Hemphill, a Philadelphia health care attorney, said that in some cases private equity has merely taken advantage of the realities of operating a modern medical practice amid growing administrative costs.

Physicians sometimes sell practices to private equity firms because they promise to take over things like billing, regulatory compliance, and scheduling — allowing doctors to focus on practicing medicine. (The physicians also might reap a big payout.)

“You can’t do it on a scale like Marcus Welby used to do it,” Hemphill said, referring to an early 1970s television drama about a kindly family doctor who made house calls. “That’s what leads to larger groups,” she said. “It is a more efficient way to do it.”

But Laura Alexander, a former vice president of policy at the nonprofit American Antitrust Institute, which collaborated on the Petris Center research, said she is concerned about private equity’s growing dominance in some markets.

“We’re still at the stage of understanding the scope of the problem,” Alexander said. “One thing is clear: Much more transparency and scrutiny of these deals is needed.”

‘Revenue Maximization’

Private equity firms often bring a “hands-on” approach to management, taking steps such as placing their representatives on a company’s board of directors and influencing the hiring and firing of key staffers.

“Private equity exercises immense control over the operations of health care companies it buys an interest in,” said Jeanne Markey, a Philadelphia whistleblower attorney.

Markey represented physician assistant Michelle O’Connor in a 2015 whistleblower lawsuit filed against National Spine and Pain Centers and its private equity owner, Sentinel Capital Partners.

In just a year under private equity guidance, National Spine’s patient load quadrupled as it grew into one of the nation’s largest pain management chains, treating more than 160,000 people in about 40 offices across five East Coast states, according to the suit.

O’Connor, who worked at two National Spine clinics in Virginia, said the mega-growth strategy sprang from a “corporate culture in which money trumps the provision of appropriate patient care,” according to the suit.

She cited a “revenue maximization” policy that mandated medical staffers see at least 25 patients a day, up from 16 to 18 before the takeover.

The pain clinics also overcharged Medicare by billing up to $1,100 for “unnecessary and often worthless” back braces and charging up to $1,800 each for urine drug tests that were “medically unnecessary and often worthless,” according to the suit.

In April 2019, National Spine paid the Justice Department $3.3 million to settle the whistleblower’s civil case without admitting wrongdoing.

Sentinel Capital Partners, which by that time had sold the pain management chain to another private equity firm, paid no part of National Spine’s settlement, court records show. Sentinel Capital Partners had no comment.

In another whistleblower case, a South Florida pharmacy owned by RLH Equity Partners raked in what the lawsuit called an “extraordinarily high” profit on more than $68 million in painkilling and scar creams billed to the military health insurance plan Tricare.

The suit alleges that the pharmacy paid illegal kickbacks to telemarketers who drove the business. One doctor admitted prescribing the creams to scores of patients he had never seen, examined, or even spoken to, according to the suit.

RLH, based in Los Angeles, disputed the Justice Department’s claims. In 2019, RLH and the pharmacy paid a total of $21 million to settle the case. Neither admitted liability. RLH managing director Michel Glouchevitch told KHN that his company cooperated with the investigation and that “the individuals responsible for any problems have been terminated.”

In many fraud cases, however, private equity investors walk away scot-free because the companies they own pay the fines. Eileen O’Grady, a researcher at the nonprofit Private Equity Stakeholder Project, said government should require “added scrutiny” of private equity companies whose holdings run afoul of the law.

“Nothing like that exists,” she said.

Questions About Quality

Whether private equity influences the quality of medical care is tough to discern.

Robert Homchick, a Seattle health care regulatory attorney, said private equity firms “vary tremendously” in how conscientiously they manage health care holdings, which makes generalizing about their performance difficult.

“Private equity has some bad actors, but so does the rest of the [health care] industry,” he said. “I think it’s wrong to paint them all with the same brush.”

But incipient research paints a disturbing picture, which took center stage earlier this year.

On the eve of President Joe Biden’s State of the Union speech in March, the White House released a statement that accused private equity of "buying up struggling nursing homes” and putting “profits before people.”

The covid-19 pandemic had highlighted the “tragic impact” of staffing cuts and other moneysaving tactics in nursing homes, the statement said.

More than 200,000 nursing home residents and staffers had died from covid in the previous two years, according to the White House, and research had linked private equity to inflated nursing costs and elevated patient death rates.

Some injured patients are turning to the courts in hopes of holding the firms accountable for what the patients view as lapses in care or policies that favor profits over patients.

Dozens of lawsuits link patient harm to the sale of Florida medical device maker Exactech to TPG Capital, a Texas private equity firm. TPG acquired the device company in February 2018 for about $737 million.

In August 2021, Exactech recalled its Optetrak knee replacement system, warning that a defect in packaging might cause the implant to loosen or fracture and cause “pain, bone loss or recurrent swelling.” In the lawsuits, more than three dozen patients accuse Exactech of covering up the defects for years, including, some suits say, when “full disclosure of the magnitude of the problem … might have negatively impacted” Exactech’s sale to TPG.

Linda White is suing Exactech and TPG, which she asserts is “directly involved” in the device company’s affairs.

White had Optetrak implants inserted into both her knees at a Galesburg, Illinois, hospital in June 2012. The right one failed and was replaced with a second Optetrak implant in July 2015, according to her lawsuit. That one also failed, and she had it removed and replaced with a different company’s device in January 2019.

The Exactech implant in White’s left knee had to be removed in May 2019, according to the suit, which is pending in Cook County Circuit Court in Illinois.

In a statement to KHN, Exactech said it conducted an “extensive investigation” when it received reports of “unexpected wear of our implants.”

Exactech said the problem dated to 2005 but was discovered only in July of last year. “Exactech disputes the allegations in these lawsuits and intends to vigorously defend itself,” the statement said. TPG declined to comment but has denied the allegations in court filings.

‘Invasive Procedures’

In the past, private equity business tactics have been linked to scandalously bad care at some dental clinics that treated children from low-income families.

In early 2008, a Washington, D.C., television station aired a shocking report about a local branch of the dental chain Small Smiles that included video of screaming children strapped to straightjacket-like “papoose boards” before being anesthetized to undergo needless operations like baby root canals.

Five years later, a U.S. Senate report cited the TV exposé in voicing alarm at the "corporate practice of dentistry in the Medicaid program.” The Senate report stressed that most dentists turned away kids enrolled in Medicaid because of low payments and posed the question: How could private equity make money providing that care when others could not?

“The answer is ‘volume,’” according to the report.

Small Smiles settled several whistleblower cases in 2010 by paying the government $24 million. At the time, it was providing “business management and administrative services” to 69 clinics nationwide, according to the Justice Department. It later declared bankruptcy.

But complaints that volume-driven dentistry mills have harmed disadvantaged children didn’t stop.

According to the 2018 lawsuit filed by his parents, Zion Gastelum was hooked up to an oxygen tank after questionable root canals and crowns “that was empty or not operating properly” and put under the watch of poorly trained staffers who didn’t recognize the blunder until it was too late.

Zion never regained consciousness and died four days later at Phoenix Children’s Hospital, the suit states. The cause of death was “undetermined,” according to the Maricopa County medical examiner’s office. An Arizona state dental board investigation later concluded that the toddler’s care fell below standards, according to the suit.

Less than a month after Zion’s death in December 2017, the dental management company Benevis LLC and its affiliated Kool Smiles clinics agreed to pay the Justice Department $24 million to settle False Claims Act lawsuits. The government alleged that the chain performed “medically unnecessary” dental services, including baby root canals, from January 2009 through December 2011.

In their lawsuit, Zion’s parents blamed his death on corporate billing policies that enforced “production quotas for invasive procedures such as root canals and crowns” and threatened to fire or discipline dental staff “for generating less than a set dollar amount per patient.”

Kool Smiles billed Medicaid $2,604 for Zion’s care, according to the suit. FFL Partners did not respond to requests for comment. In court filings, it denied liability, arguing it did not provide “any medical services that harmed the patient.”

Covering Tracks

Under a 1976 federal law called the Hart-Scott-Rodino Antitrust Improvements Act, deal-makers must report proposed mergers to the FTC and the Justice Department antitrust division for review. The intent is to block deals that stifle competition, which can lead to higher prices and lower-quality services.

But there’s a huge blind spot, which stymies government oversight of more than 90% of private equity investments in health care companies: The current threshold for reporting deals is $101 million.

KHN’s analysis of PitchBook data found that just 423 out of 7,839 private equity health care deals from 2012 through 2021 were known to have exceeded the current threshold.

In some deals, private equity takes a controlling interest in medical practices, and doctors work for the company. In other cases, notably in states whose laws prohibit corporate ownership of physician practices, the private equity firm handles a range of management duties.

Thomas Wollmann, a University of Chicago researcher, said antitrust authorities may not learn of consequential transactions “until long after they have been completed” and “it's very hard to break them up after the fact.”

In August, the FTC took aim at what it called “a growing trend toward consolidation” by veterinary medicine chains.

The FTC ordered JAB Consumer Partners, a private equity firm based in Luxembourg, to divest from some clinics in the San Francisco Bay and Austin, Texas, areas as part of a proposed $1.1 billion takeover of a rival.

The FTC said the deal would eliminate “head-to-head” competition, “increasing the likelihood that customers are forced to pay higher prices or experience a degradation in quality of the relevant services.”

Under the order, JAB must obtain FTC approval before buying veterinary clinics within 25 miles of the sites it owns in Texas and California.

The FTC would not say how much market consolidation is too much or whether it plans to step up scrutiny of health care mergers and acquisitions.

“Every case is fact-specific,” Betsy Lordan, an FTC spokesperson, told KHN.

Lordan, who has since left the agency, said regulators are considering updates to regulations governing mergers and are reviewing about 1,900 responses to the January 2022 request for public comment. At least 300 of the comments were from doctors or other health care workers.

Few industry observers expect the concerns to abate; they might even increase.

Investors are flush with “dry powder,” industry parlance for money waiting to stoke a deal.

The Healthcare Private Equity Association, which boasts about 100 investment companies as members, says the firms have $3 trillion in assets and are pursuing a vision for "building the future of healthcare.”

That kind of talk alarms Cornell University professor Rosemary Batt, a longtime critic of private equity. She predicts that investors chasing outsize profits will achieve their goals by “sucking the wealth” out of more and more health care providers.

“They are constantly looking for new financial tricks and strategies,” Batt said.

KHN’s Megan Kalata contributed to this article.

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