Seeking to Grow Market Share?

Get a FREE assessment of your CDH products —
a $3,000 value.
LEARN HOW >

City-Country Mortality Gap Widens Amid Persistent Holes in Rural Health Care Access

Kaiser Health News:States - April 09, 2024

In Matthew Roach’s two years as vital statistics manager for the Arizona Department of Health Services, and 10 years previously in its epidemiology program, he has witnessed a trend in mortality rates that has rural health experts worried.

As Roach tracked the health of Arizona residents, the gap between mortality rates of people living in rural areas and those of their urban peers was widening.

The health disparities between rural and urban Americans have long been documented, but a recent report from the Department of Agriculture’s Economic Research Service found the chasm has grown in recent decades. In their examination, USDA researchers found rural Americans from the ages of 25 to 54 die from natural causes, like chronic diseases and cancer, at wildly higher rates than the same age group living in urban areas. The analysis did not include external causes of death, such as suicide or accidental overdose.

The research analyzed Centers for Disease Control and Prevention death data from two three-year periods — 1999 through 2001 and 2017 through 2019. In 1999, the natural-cause mortality rate for people ages 25 to 54 in rural areas was only 6% higher than for city dwellers in the same age bracket. By 2019, the gap widened to 43%.

The researchers found the expanding gap was driven by rapid growth in the number of women living in rural places who succumb young to treatable or preventable diseases. In the most rural places, counties without an urban core population of 10,000 or more, women in this age group saw an 18% increase in natural-cause mortality rates during the study period, while their male peers experienced a 3% increase.

Within the prime working-age group, cancer and heart disease were the leading natural causes of death for both men and women in both rural and urban areas. Among women, the incidence of lung disease in remote parts of the nation grew the most when compared with rates in urban areas, followed by hepatitis. Pregnancy-related deaths also played a role, accounting for the highest rate of natural-cause mortality growth for women ages 25 to 54 in rural areas.

The negative trends for rural non-Hispanic American Indian and Alaska Native people were especially pronounced. The analysis shows Native Americans 25 to 54 years old had a 46% natural-cause mortality rate increase over those two decades. Native women had an even greater mortality rate jump, 55%, between the two studied time periods, while the rate for non-Hispanic White women went up 23%.

The rural-urban gap grew in all regions across the nation but was widest in the South.

The increased mortality rates are an indicator of worsening population health, the study authors noted, which can harm local economies and employment.

As access to and quality of health services in rural areas continue to erode, rural health experts said, the USDA findings should spur stronger policies focused on rural health.

Alan Morgan, CEO of the National Rural Health Association, said he found the report “shocking,” though, “unfortunately, not surprising.”

The disparity warrants greater attention from state and national leaders, Morgan said.

The study does not address causes for the increase in mortality rates, but the authors note that differences in health care resources could compromise the accessibility, quality, and affordability of care in rural areas. Hospitals in small and remote communities have long struggled, and continued closures or conversions limit health care services in many places. The authors note that persistently higher rates of poverty, disability, and chronic disease in rural areas, compounded by fewer physicians per capita and the closure of hospitals, affect community health.

Roach said his past job as an epidemiologist included working with social vulnerability indexes, which factor in income, race, education, and access to resources like housing to get a sense of a community’s resilience against adverse health outcomes. A map of Arizona shows that rural counties and reservations have some of the highest vulnerability rankings.

Janice C. Probst, a retired professor at the University of South Carolina whose work focused on rural health, said many current rural health efforts are focused on sustaining hospitals, which she noted are essential sources of health care. But she said that may not be the best way to address the inequities.

“We may have to take a community approach,” said Probst, who reviewed the report before its release. “Not how do we keep the hospital in the community, but how do we keep the community alive at all?”

The disparities among demographics stood out to Probst, along with something else. She said the states with the highest rates of natural-cause mortality in rural areas included South Carolina, Mississippi, Georgia, Alabama, and others that have not expanded Medicaid, the joint federal and state health insurance program for low-income people, though there are efforts to expand it in some states, particularly Mississippi.

It’s an observation the USDA researchers make as well.

“Regionally, differences in State implementation of Medicaid expansion under the 2010 Affordable Care Act could have increased implications for uninsured rural residents in States without expansions by potentially influencing the frequency of medical care for those at risk,” they wrote.

Wesley James, founding executive director of the Center for Community Research and Evaluation, at the University of Memphis, said state lawmakers could address part of the problem by advocating for Medicaid expansion in their states, which would increase access to health care in rural areas. A large group of people want it, but politicians aren’t listening to their needs, he said. James also reviewed the report before it was published.

According to KFF polling, two-thirds of people living in nonexpansion states want their state to expand the health insurance program.

Morgan added the study focused on deaths that occurred prior to the covid-19 pandemic, which had a devastating effect in rural areas.

“Covid really changed the nature of public health in rural America,” he said. “I hope that this prompts Congress to direct the CDC to look at rural-urban life expectancies during covid and since covid to get a handle on what we’re actually seeing nationwide.”

In Arizona, the leading cause of death for people 45 to 64 in 2021 in both rural and urban areas was covid, according to Roach.

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

USE OUR CONTENT

This story can be republished for free (details).

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

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

That raised concerns about the potential for misuse.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

USE OUR CONTENT

This story can be republished for free (details).

El tipo de alimentación está vinculado a tasas más altas de preeclampsia en latinas

Kaiser Health News:States - April 08, 2024

Para las latinas embarazadas, la elección de los alimentos podría reducir el riesgo de preeclampsia, un tipo especialmente peligroso de hipertensión. Un nuevo estudio muestra que es más probable que una dieta basada en preferencias alimentarias culturales, en lugar de las guías oficiales, ayude a prevenir esta enfermedad.

Investigadores de la Escuela de Medicina Keck de la USC encontraron que una combinación de grasas sólidas, granos refinados y queso se relacionaba con mayores tasas de preeclampsia entre un grupo de latinas de bajos ingresos de Los Ángeles. Por el contrario, las mujeres que consumían vegetales, frutas y comidas preparadas con aceites saludables tenían menos probabilidades de desarrollar la enfermedad.

La combinación de vegetales, frutas y aceites saludables, como el de oliva, mostró una correlación más fuerte con tasas más bajas de preeclampsia que el Índice de Alimentación Saludable-2015, una lista de recomendaciones nutricionales diseñadas por el Departamento de Agricultura de Estados Unidos (USDA) y el Departamento de Salud y Servicios Humanos (HHS).

El estudio, publicado en la edición de febrero de la revista de la Asociación Americana del Corazón (AHA), proporcionó información importante sobre qué combinaciones de alimentos afectan a las latinas embarazadas, explicó Luis Maldonado, investigador principal y becario postdoctoral del Departamento de Ciencias de la Población y Salud Pública de USC Keck. El trabajo sugiere que las recomendaciones dietéticas para estas latinas deberían incorporar más alimentos propios de sus culturas, apuntó.

“Muchos estudios que se han realizado con mujeres embarazadas en general han sido predominantemente blancos [no hispanos], y la dieta está muy ligada a la cultura”, dijo Maldonado. “Tu cultura puede facilitar cómo comes porque sabes cuál es tu comida favorita”.

En Estados Unidos, se estima que la preeclampsia ocurre en aproximadamente el 5% de los embarazos, y está entre las principales causas de morbilidad materna, según los Centros para el Control y Prevención de Enfermedades (CDC). Suele presentarse durante el tercer trimestre de gestación y está asociada con la obesidad, la hipertensión y la enfermedad renal crónica, entre otras afecciones.

No hay una forma de curar o predecir la preeclampsia. La enfermedad puede dañar el corazón y el hígado, y causar otras complicaciones tanto para la madre como para el bebé, incluido el parto prematuro e incluso la muerte.

Las tasas de preeclampsia han aumentado en las últimas dos décadas a nivel nacional. En California, aumentaron un 83%, y las tasas de hipertensión un 78% entre 2016 y 2022, según los datos más recientes disponibles, y son más altas entre los residentes negros y los habitantes de las islas del Pacífico.

Maldonado dijo que el 12% de las 451 mujeres latinas que participaron en el estudio desarrollaron preeclampsia, un número que representa casi el doble del promedio nacional. Más de la mitad de las participantes, de 28 años promedio, tenían factores de riesgo antes de embarazarse, como índice de masa corporal alto y diabetes.

Maldonado y su equipo utilizaron datos del Maternal and Developmental Risks from Environmental and Social Stressors Center, un grupo de investigación de la USC que estudia los efectos de las exposiciones ambientales y disparadores sociales de estrés en la salud de las madres y sus hijos.

Las participantes, que eran predominantemente latinas de bajos ingresos de Los Ángeles, completaron dos cuestionarios sobre su dieta durante el tercer trimestre de sus embarazos. Los investigadores identificaron dos patrones alimenticios significativos: uno en el que los alimentos más consumidos eran vegetales, aceites, frutas, granos enteros y yogur; y un segundo en el que la dieta de las mujeres consistía principalmente en grasas sólidas, granos refinados, queso, azúcar agregado y carne procesada.

El grupo de mujeres que siguió el primer patrón nutricional tuvo una tasa más baja de preeclampsia que el que se ajustó al segundo patrón.

Cuando Maldonado y su equipo buscaron una correlación entre tasas más bajas de preeclampsia y el Índice de Alimentación Saludable-2015, encontraron que no era estadísticamente significativa excepto en las mujeres que tenían sobrepeso antes del embarazo.

El Índice de Alimentación Saludable incluye combinaciones de nutrientes y alimentos, como lácteos y ácidos grasos. Maldonado dijo que se necesita más investigación para determinar el perfil exacto de frutas, vegetales y aceites que podría beneficiar a las mujeres latinas.

Cuando se trata de la dieta, el mensaje y las recomendaciones adecuadas son vitales para ayudar a las latinas embarazadas a tomar decisiones informadas, expresó A. Susana Ramírez, profesora asociada de comunicación de salud pública en la Universidad de California-Merced.

Ramírez ha realizado estudios sobre por qué los mensajes de alimentación saludable, aunque bien intencionados, no han tenido éxito en las comunidades hispanas. Encontró que estos mensajes han llevado a algunos latinos a creer que la comida mexicana es menos saludable que la comida estadounidense.

Ramírez dijo que necesitamos pensar en promover dietas que sean relevantes para una población particular. “Ahora entendemos que la dieta es tremendamente importante para la salud, y por lo tanto, en la medida en que cualquier asesoramiento nutricional sea culturalmente acorde, esto mejorará la salud en general”, dijo Ramírez.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

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

USE OUR CONTENT

This story can be republished for free (details).

Rising Complaints of Unauthorized Obamacare Plan-Switching and Sign-Ups Trigger Concern

Kaiser Health News:Insurance - April 08, 2024

Federal and state regulators aren’t doing enough to stop the growing problem of rogue health insurance brokers making unauthorized policy switches for Affordable Care Act policyholders, say consumers, agents, nonprofit enrollee assistance groups, and other insurance experts.

“We think it’s urgent and it requires a lot more attention and resources,” said Jennifer Sullivan, director of health coverage access for the Center on Budget and Policy Priorities.

The Centers for Medicare & Medicaid Services, which oversees the ACA, “has acknowledged the issue,” said former Oklahoma insurance commissioner John Doak. “But it appears their response is inadequate.”

The reactions follow a KFF Health News article outlining how licensed brokers’ easy access to policyholder information on healthcare.gov has led unscrupulous agents to switch people’s policies without express permission. Those agents can then take the commission that comes with signing a new customer. Dozens of people and insurance brokers responded to the earlier report recounting similar situations.

Some switched policyholders end up in plans that don’t include their doctors or the medications they regularly take, or come with higher deductibles than their original coverage choice. If their income or eligibility for premium tax credits is misrepresented, some people end up owing back taxes.

Agents whose clients have been affected say the switches ramped up last year and are continuing into 2024, although quantifying the problem continues to be difficult. The problem seems concentrated on the federal healthcare.gov website, which is the marketplace where people in 32 states buy ACA plans, which are also known as Obamacare. CMS declined to provide the number of complaints that have been filed.

Even so, CMS representatives said during a December committee meeting of the National Association of Insurance Commissioners that they were “acutely aware” of the problem and were working on solutions.

A similar NAIC gathering was held in March. During those meetings, state regulators urged CMS officials to look for unauthorized switches, rather than reacting only to filed complaints. State regulators also want the agency to tell them sooner about agents or brokers under investigation, and to be provided with the number of affected consumers in their regions.

In an April 4 written statement to KFF Health News, Jeff Wu, acting director of CMS’ Center for Consumer Information & Insurance Oversight, pointed to the agency’s sharp prohibition on agents enrolling people or changing their plans without getting written or recorded consent, and said his team is “analyzing potential additional system controls to block unauthorized or fraudulent activity.”

It is also working with state regulators and large broker agencies, Wu wrote, to identify “the most effective ways to root out bad actors.” He also said more agents and brokers are being suspended or terminated from healthcare.gov.

Wu did not provide, however, a tally of just how many have been sanctioned.

Low-income consumers are often targeted, possibly because they qualify for zero-premium plans, meaning they might not know they’ve been switched or enrolled because they aren’t paying a monthly bill.

Also, rules took effect in 2022 that allow low-income residents to enroll at any time of the year, not just during the annual open enrollment period. While the change was meant to help people who most need to access coverage, it has had the unintended effect of creating an opportunity for this scheme to ramp up.

“There have been bad apples out there signing people up and capturing the commissions to do so for a while, but it’s exacerbated in the last couple of years, turning it from a few isolated incidents to something more common,” said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.

Many victims don’t know they’ve been switched until they try to use their plans — either because agents changed the policy without talking to them or because the consumer unknowingly enrolled by responding to online advertisements promising gift cards, government subsidies, or free health insurance.

The challenge now is how federal regulators and their counterparts in the states can thwart the activity without diminishing enrollment — a top priority for the marketplace. In fact, Obamacare’s record-breaking enrollment figures are being touted prominently in President Joe Biden’s reelection campaign.

Thwarting the switches “really comes down to oversight and enforcement,” Corlette said. “As soon as regulators identify someone who is engaged in unauthorized plan-switching or enrollment, they need to cut them off immediately.”

That isn’t simple.

For starters, consumers or their agents must report suspected problems to state and federal regulators before investigations are launched.

Such investigations can take weeks and states generally don’t have access to complaints until federal investigators finish an inquiry, state regulators complained during the NAIC meetings.

Doak attended the December meeting, where he urged federal regulators to look for patterns that might indicate unauthorized switching — such as policyholders’ coverage being changed multiple times in a short period — and then quickly initiate follow-up with the consumer.

“All regulators have a duty to get on top of this issue and protect the most vulnerable consumers from unknowingly having their policies moved or their information mistreated,” Doak told KFF Health News. He is now executive vice president of government affairs for Insurance Care Direct, a health insurance brokerage.

Being more proactive requires funding.

Wu said the agency’s administrative budget has remained nearly flat for 13 years even as enrollment has grown sharply in the ACA and the other health programs it oversees.

And the complaint process itself can be cumbersome because it can involve different state or federal agencies lacking coordination.

Even after complaints are filed, state or federal officials follow up directly with the consumer, who might have limited English proficiency, lack an email address, or simply not answer their phone — which can stall or stop a resolution, said Katie Roders Turner, executive director of the Family Healthcare Foundation, a Tampa Bay, Florida, nonprofit that helps people enroll or deal with problems that arise with their plans.

Suggested improvements include creating a central form or portal for complaints and beefing up safeguards on the healthcare.gov site to prevent such unauthorized activity in the first place. 

Currently, licensed agents need only a name, date of birth, and state of residence to access policyholder information and make changes. That information is easy to obtain.

States that run their own marketplaces — there are 18 and the District of Columbia — often require more information, such as a one-time passcode sent to the consumer, who then gives it to their chosen agent.

In the meantime, the frustration is increasing.

Lauren Phillips, a sales agent in Georgia, said she reached out to an agent in Florida who was switching one of her clients, asking her to stop. When it happened again to the same client, she reported it to regulators.

“Their solution was for me to just watch the policy and fix it if it happens again, which is not a viable solution, “Phillips said.

Recently, after noticing the client’s policy had been switched again, she reported it and changed it back. When she checked two mornings later, the policy had been terminated.

“Now my client has no insurance at all,” Phillips said. “They say they are working on solutions. But here we are in the fourth month of the year and agents and consumers are still suffering at the hands of these terrible agents.”

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

USE OUR CONTENT

This story can be republished for free (details).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Appearance Issues

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

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

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

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

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

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

Unbridled Enthusiasm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

USE OUR CONTENT

This story can be republished for free (details).

Cada vez mueren más menores por sobredosis. ¿Podrían los pediatras ayudar más?

Kaiser Health News:States - April 08, 2024

Un joven de 17 años, con el pelo rubio desgreñado, se subió a la balanza del Centro de Salud Familiar Tri-River de Uxbridge, en Massachusetts.

Después que lo pesaran, caminó hacia un consultorio decorado con calcomanías de planetas y personajes de dibujos animados. Una enfermera le tomó la presión arterial. Un pediatra le preguntó por sus estudios, su vida familiar y sus amigos.

Parecía un examen de rutina para adolescentes, de los miles que se hacen a diario en consultas pediátricas en el país. Hasta que el doctor Safdar Medina le preguntó:

“¿Tienes deseos de consumir opioides?”. El paciente negó con la cabeza.

“¿Ninguno, en absoluto?”, volvió a preguntar Medina para confirmar.

“Ninguno”, respondió el adolescente, llamado Sam, con voz tranquila pero segura.

(En este artículo sólo se utiliza el nombre de pila de Sam porque, si se publicara su apellido, en el futuro podría ser discriminado en la búsqueda de vivienda y empleo por haber consumido drogas).

El doctor Medina está tratando a Sam por su adicción a estas drogas. Le receta un medicamento llamado buprenorfina, que reduce las ansias de consumir las píldoras de opioides más peligrosas y adictivas. Los análisis de orina de Sam no muestran signos de Oxycontin o Percocet, las pastillas que él compraba en Snapchat y que alimentaron su adicción.

“Lo que realmente me enorgullece de tí, Sam, es tu esfuerzo por estar mejor”, lo felicitó Medina, que trabaja en el UMass Memorial Health.

La Academia Americana de Pediatría recomienda ofrecer buprenorfina a los adolescentes adictos a los opiáceos. Sin embargo, según los resultados de una encuesta, solo el 6% de los pediatras informa haberlo hecho alguna vez.

De hecho, al mismo tiempo que las recetas de buprenorfina para adolescentes fueron disminuyendo, se duplicaron las muertes por sobredosis en niños y adolescentes entre 10 y 19 años. Estas sobredosis, junto con los envenenamientos accidentales por opioides en niños pequeños, se han convertido en la tercera causa de muerte infantil en Estados Unidos.

“Estamos realmente lejos de donde deberíamos estar y nos encontramos bastante atrasados en varios aspectos”, comentó Scott Hadland, jefe de Medicina para Adolescentes del Hospital General de Niños de Massachusetts y coautor de una encuesta entre pediatras sobre el tratamiento de adicciones.

Los resultados de las entrevistas mostraron que muchos pediatras no creen tener ni la formación adecuada ni el personal necesario para atender pacientes con adicciones, aunque Medina y otros médicos que sí lo hacen afirmaron que no han tenido que contratar más personal.

Algunos entrevistados explicaron que no atienden un número de pacientes que justifique formarse en esa especialización y otros piensan que la atención de adictos no es responsabilidad de la Pediatría.

“Gran parte de esas ideas son producto de la educación que reciben los médicos”, dijo Deepa Camenga, directora asociada al área pediátrica del Programa de Medicina de Adicciones de la Escuela de Medicina de Yale. “Como se considera algo muy especializado, no está incluido en la formación médica habitual”, explicó.

Camenga y Hadland mencionaron que las escuelas de Medicina y los programas de residencia pediátrica están trabajando para incorporar información sobre trastornos por consumo de sustancias a los planes de estudio. Esto incluye cómo abordar el consumo de drogas y alcohol con niños y adolescentes.

Sin embargo, los programas de estudio no cambian lo suficientemente rápido como para ayudar a la cantidad de jóvenes que luchan contra una adicción y mucho menos a los que mueren después de tomar una sola pastilla.

Es una paradoja perversa y mortífera: mientras disminuye el consumo de drogas entre los adolescentes, las muertes asociadas a las drogas han aumentado.

La principal causa es la falsificación de pastillas de Xanax, Adderall o Percocet, adulteradas con fentanilo, un poderoso opioide. Casi el 25% de las muertes recientes por sobredosis en jóvenes de 10 a 19 años se atribuyeron a estas pastillas.

“El fentanilo y las pastillas falsificadas realmente están complicando nuestros esfuerzos para frenar las sobredosis”, dijo Andrew Terranella, experto en Medicina de adicción y prevención de sobredosis en adolescentes de los Centros para el Control y Prevención de Enfermedades (CDC). “Muchas veces, estos jóvenes sufren una sobredosis sin siquiera darse cuenta de lo que están tomando.”

Terranella, que ejerce en Tucson, Arizona, opina que los pediatras pueden ayudar mucho si refuerzan la detección del consumo de drogas en sus pacientes y conversan con ellos sobre los riesgos.

También sugiere que receten más naloxona, el aerosol nasal que puede revertir una sobredosis. Está disponible sin receta, pero Terranella cree que una receta médica puede tener más relevancia para los pacientes.

De vuelta en el consultorio, Sam estaba a punto de recibir su primera inyección de Sublocade, una forma de buprenorfina que dura 30 días. Está cambiando a las inyecciones porque no le gusta el sabor de Suboxone, unas tiras orales de buprenorfina que debía disolver debajo de su lengua. Las escupía antes de recibir una dosis completa.

Muchos médicos prefieren recetar las inyecciones porque los pacientes no tienen que recordar tomarlas todos los días. Pero la inyección es dolorosa y Sam se sorprendió cuando le dijeron que se la aplicarían en el vientre durante 20-30 segundos.

“¿Ya casi terminamos?”, preguntó Sam, mientras una enfermera le pedía que respirara hondo. Cuando terminó, el personal bromeó en voz alta diciendo que incluso los adultos suelen decir palabrotas cuando les ponen esa inyección. Sam dijo que no sabía que eso estaba permitido. Lo que más lo preocupaba era si un dolor residual podría interferir con los planes que tenía esa noche.

“¿Cree que podré hacer snowboard esta noche?”, le preguntó al doctor.

“Estoy absolutamente seguro de que podrás hacer snowboard esta noche”, lo tranquilizó Medina.

Sam iba a ir con un nuevo amigo. Hacer nuevos amigos y cortar lazos con su antiguo círculo social de adolescentes que consumen drogas ha sido una de las cosas más difíciles, dijo Sam, desde que entró en rehabilitación hace 15 meses.

“Hay que concentrase en encontrar la gente adecuada”, dijo Sam. “Ese sería mi mayor consejo”.

Para Sam, encontrar un tratamiento contra la adicción en un consultorio repleto de rompecabezas, juguetes y libros ilustrados no ha sido tan extraño como imaginaba.

Su madre, Julie, lo había acompañado a la consulta. Dice que está agradecida de que la familia haya encontrado un médico que entiende a los adolescentes y a las adicciones.

Antes de empezar a ir el Centro de Salud Familiar Tri-River, Sam estuvo siete meses en tratamiento residencial y ambulatorio, sin que le ofrecieran buprenorfina para ayudarlo a controlar los impulsos de consumir y prevenir las recaídas. Sólo uno de cada cuatro tratamientos residenciales para jóvenes la ofrece. Cuando Sam volvió a sentir fuertes deseos de consumir opioides, un consejero le sugirió a Julie que llamara a Medina.

“Dios mío, ojalá hubiera traído a Sam aquí hace dos o tres años”, dijo Julie. “¿Habría cambiado lo que sucedió? No lo sé, pero hubiera sido un nivel de atención más adecuado para él”.

A algunos padres y pediatras les preocupa administrar buprenorfina a un adolescente, ya que puede producir efectos secundarios, incluida la dependencia a largo plazo. Los pediatras que la recetan evalúan el efecto de los posibles efectos secundarios en relación con la amenaza de una sobredosis de fentanilo.

“En esta época, en la que los jóvenes mueren a un ritmo realmente sin precedentes por sobredosis de opiáceos, es fundamental que salvemos vidas”, afirmó Hadland. “Y sabemos que la buprenorfina es un medicamento que salva vidas”, agregó.

El tratamiento de una adicción le puede insumir mucho tiempo a un pediatra. Sam y Medina se envían mensajes de texto varias veces a la semana y el pediatra recalca que no comparte ningún intercambio que Sam haya pedido que fuera confidencial.

Medina dice que tratar el trastorno por consumo de sustancias es una de las cosas más gratificantes que hace. “Si podemos solucionarlo”, dice, “habremos formado un adulto que ya no tendrá que preocuparse por estos problemas de por vida”.

Este artículo es producto de una asociación que incluye a WBUR, NPR y KFF Health News.

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

USE OUR CONTENT

This story can be republished for free (details).

Journalists Assess the Risks of Bird Flu and the Impacts of Medicaid ‘Unwinding’

Kaiser Health News:Insurance - April 06, 2024

KFF Health News senior fellow and editor-at-large for public health Céline Gounder discussed bird flu on CBS News’ “CBS Mornings” on April 2.

El Tímpano reporter Jasmine Aguilera, who has been reporting in collaboration with KFF Health News and California Healthline, discussed how Hispanic communities are affected by the process of Medicaid “unwinding” on Radio Bilingüe on April 4.

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

USE OUR CONTENT

This story can be republished for free (details).

More Kids Are Dying of Drug Overdoses. Could Pediatricians Do More to Help?

Kaiser Health News:States - April 05, 2024

A 17-year-old boy with shaggy blond hair stepped onto the scale at Tri-River Family Health Center in Uxbridge, Massachusetts.

After he was weighed, he headed for an exam room decorated with decals of planets and cartoon characters. A nurse checked his blood pressure. A pediatrician asked about school, home life, and his friendships.

This seemed like a routine teen checkup, the kind that happens in thousands of pediatric practices across the U.S. every day — until the doctor popped his next question.

“Any cravings for opioids at all?” asked pediatrician Safdar Medina. The patient shook his head.

“None, not at all?” Medina said again, to confirm.

“None,” said the boy named Sam, in a quiet but confident voice.

Only Sam’s first name is being used for this article because if his full name were publicized he could face discrimination in housing and job searches based on his prior drug use.

Medina was treating Sam for an addiction to opioids. He prescribed a medication called buprenorphine, which curbs cravings for the more dangerous and addictive opioid pills. Sam’s urine tests showed no signs of the Percocet or OxyContin pills he had been buying on Snapchat, the pills that fueled Sam’s addiction.

“What makes me really proud of you, Sam, is how committed you are to getting better,” said Medina, whose practice is part of UMass Memorial Health.

The American Academy of Pediatrics recommends offering buprenorphine to teens addicted to opioids. But only 6% of pediatricians report ever doing do, according to survey results.

In fact, buprenorphine prescriptions for adolescents were declining as overdose deaths for 10- to 19-year-olds more than doubled. These overdoses, combined with accidental opioid poisonings among young children, have become the third-leading cause of death for U.S. children.

“We’re really far from where we need to be and we’re far on a couple of different fronts,” said Scott Hadland, the chief of adolescent medicine at Mass General for Children and a co-author of the study that surveyed pediatricians about addiction treatment.

That survey showed that many pediatricians don’t think they have the right training or personnel for this type of care — although Medina and other pediatricians who do manage patients with addiction say they haven’t had to hire any additional staff.

Some pediatricians responded to the survey by saying they don’t have enough patients to justify learning about this type of care, or don’t think it’s a pediatrician’s job.

“A lot of that has to do with training,” said Deepa Camenga, associate director for pediatric programs for the Yale Program in Addiction Medicine. “It’s seen as something that’s a very specialized area of medicine and, therefore, people are not exposed to it during routine medical training.”

Camenga and Hadland said medical schools and pediatric residency programs are working to add information to their curricula about substance use disorders, including how to discuss drug and alcohol use with children and teens.

But the curricula aren’t changing fast enough to help the number of young people struggling with an addiction, not to mention those who die after taking just one pill.

In a twisted, deadly development, drug use among adolescents has declined — but drug-associated deaths are up.

The main culprits are fake Xanax, Adderall, or Percocet pills laced with the powerful opioid fentanyl. Nearly 25% of recent overdose deaths among 10- to 19-year-olds were traced to counterfeit pills.

“Fentanyl and counterfeit pills is really complicating our efforts to stop these overdoses,” said Andrew Terranella, the Centers for Disease Control and Prevention’s expert on adolescent addiction medicine and overdose prevention. “Many times these kids are overdosing without any awareness of what they’re taking.”

Terranella said pediatricians can help by stepping up screening for — and having conversations about — all types of drug use.

He also suggests pediatricians prescribe more naloxone, the nasal spray that can reverse an overdose. It’s available over the counter, but Terranella, who practices in Tucson, Arizona, believes a prescription may carry more weight with patients.

Back in the exam room, Sam was about to get his first shot of Sublocade, an injection form of buprenorphine that lasts 30 days. Sam is switching to the shots because he didn’t like the taste of Suboxone, oral strips of buprenorphine that he was supposed to dissolve under his tongue. He was spitting them out before he got a full dose.

Many doctors also prefer to prescribe the shots because patients don’t have to remember to take them every day. But the injection is painful. Sam was surprised when he learned that it would be injected into his belly over the course of 20-30 seconds.

“Is it almost done?” Sam asked, while a nurse coaches him to breathe deeply. When it was over, staffers joked out loud that even adults usually swear when they get the shot. Sam said he didn’t know that was allowed. He’s mostly worried about any residual soreness that might interfere with his evening plans.

“Do you think I can snowboard tonight?” Sam asked the doctor.

“I totally think you can snowboard tonight,” Medina answered reassuringly.

Sam was going with a new buddy. Making new friends and cutting ties with his former social circle of teens who use drugs has been one of the hardest things, Sam said, since he entered rehab 15 months ago.

“Surrounding yourself with the right people is definitely a big thing you want to focus on,” Sam said. “That would be my biggest piece of advice.”

For Sam, finding addiction treatment in a medical office jammed with puzzles, toys, and picture books has not been as odd as he thought it would be.

He mom, Julie, had accompanied him to this appointment. She said she’s grateful the family found a doctor who understands teens and substance use.

Before he started visiting the Tri-River Family Health Center, Sam had seven months of residential and outpatient treatment — without ever being offered buprenorphine to help control cravings and prevent relapse. Only 1 in 4 residential programs for youth offer it. When Sam’s cravings for opioids returned, a counselor suggested Julie call Medina.

“Oh my gosh, I would have been having Sam here, like, two or three years ago,” Julie said. “Would it have changed the path? I don’t know, but it would have been a more appropriate level of care for him.”

Some parents and pediatricians worry about starting a teenager on buprenorphine, which can produce side effects including long-term dependence. Pediatricians who prescribe the medication weigh the possible side effects against the threat of a fentanyl overdose.

“In this era, where young people are dying at truly unprecedented rates of opioid overdose, it’s really critical that we save lives,” said Hadland. “And we know that buprenorphine is a medication that saves lives.”

Addiction care can take a lot of time for a pediatrician. Sam and Medina text several times a week. Medina stresses that any exchange that Sam asks to be kept confidential is not shared.

Medina said treating substance use disorder is one of the most rewarding things he does.

“If we can take care of it,” he said, “We have produced an adult that will no longer have a lifetime of these challenges to worry about.”

This article is from a partnership that includes WBUR, NPR, and KFF Health News.

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

USE OUR CONTENT

This story can be republished for free (details).

Dietary Choices Are Linked to Higher Rates of Preeclampsia Among Latinas

Kaiser Health News:States - April 05, 2024

For pregnant Latinas, food choices could reduce the risk of preeclampsia, a dangerous type of high blood pressure, and a diet based on cultural food preferences, rather than on U.S. government benchmarks, is more likely to help ward off the illness, a new study shows.

Researchers at the USC Keck School of Medicine found that a combination of solid fats, refined grains, and cheese was linked to higher rates of preeclampsia among a group of low-income Latinas in Los Angeles. By contrast, women who ate vegetables, fruits, and meals made with healthy oils were less likely to develop the illness.

The combination of vegetables, fruits, and healthy oils, such as olive oil, showed a stronger correlation with lower rates of preeclampsia than did the Healthy Eating Index-2015, a list of dietary recommendations designed by the U.S. Department of Agriculture and the Department of Health and Human Services.

The study, published in February by the Journal of the American Heart Association, yielded important information on which food combinations affect pregnant Latinas, said Luis Maldonado, the lead investigator and a postdoctoral scholar at the Department of Population and Public Health Sciences at USC Keck. It suggests that dietary recommendations for pregnant Latinas should incorporate more foods from their culture, he said.

“A lot of studies that have been done among pregnant women in general have been predominantly white, and diet is very much tied to culture,” Maldonado said. “Your culture can facilitate how you eat because you know what your favorite food is.”

Preeclampsia is estimated to occur in about 5% of pregnancies in the U.S. and is among the leading causes of maternal morbidity, according to the Centers for Disease Control and Prevention. It typically occurs during the third trimester of pregnancy and is associated with obesity, hypertension, and chronic kidney disease, among other conditions.

There isn’t a way to cure or predict preeclampsia. The disease can damage the heart and liver and lead to other complications for both the mother and the baby, including preterm birth and even death.

Rates of preeclampsia have increased in the past two decades nationally. In California, rates of preeclampsia increased by 83% and hypertension by 78% from 2016 to 2022, according to the most recent data available, and the conditions are highest among Black residents and Pacific Islanders.

Maldonado said 12% of the 451 Latina women who participated in the study developed preeclampsia, a number almost twice the national average. More than half of the participants, who averaged 28 years old, had pre-pregnancy risks, such as diabetes and high body mass index.

Maldonado and his team used data from the Maternal and Developmental Risks from Environmental and Social Stressors Center, a USC research group that studies the effects of environmental exposures and social stressors on the health of mothers and their children.

The subjects, who were predominantly low-income Latinas in Los Angeles, completed two questionnaires about their diet during the third trimester of their pregnancy. The researchers identified two significant patterns of eating: one in which the most consumed foods were vegetables, oils, fruits, whole grains, and yogurt; and a second in which the women’s diet consisted primarily of solid fats, refined grains, cheese, added sugar, and processed meat.

Women who followed the first eating pattern had a lower rate of preeclampsia than those who followed the second.

When Maldonado and his team tested for a correlation between lower rates of preeclampsia and the Healthy Eating Index-2015, they found it was not statistically significant except for women who were overweight before pregnancy.

The Healthy Eating Index includes combinations of nutrients and foods, like dairy and fatty acids. Maldonado said more research is needed to determine the exact profile of fruits, vegetables, and oils that could benefit Latina women.

When it comes to diet, the right messaging and recommendations are vital to helping pregnant Latinas make informed decisions, said A. Susana Ramírez, an associate professor of public health communication at the University of California-Merced.

Ramírez has conducted studies on why healthy-eating messages, while well intended, have not been successful in Hispanic communities. She found that the messaging has led some Latinos to believe that Mexican food is unhealthier than American food.

Ramírez said we need to think about promoting diets that are relevant for a particular population. “We understand now that diet is enormously important for health, and so to the extent that any nutrition counseling is culturally consonant, that will improve health overall,” Ramírez said.

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

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

USE OUR CONTENT

This story can be republished for free (details).

Biden Is Right About $35 Insulin Cap but Exaggerates Prior Costs for Medicare Enrollees

Kaiser Health News:Insurance - April 05, 2024

Insulin for Medicare beneficiaries “was costing 400 bucks a month on average. It now costs $35 a month.”

President Joe Biden, in a March 22 speech

The cost of insulin in the United States has risen considerably in recent years, with some estimates finding that Americans have paid around 10 times as much for the drug as people in other developed countries.

But recent changes by the federal government and drug manufacturers have started to drive insulin prices down, something President Joe Biden often mentions at campaign events.

Biden told the crowd at a March 19 campaign reception in Reno, Nevada, that he’s fought for years to allow Medicare to negotiate with drug companies.

“How many of you know someone who needs insulin?” Biden asked. “OK, well, guess what? It was costing 400 bucks a month on average. It now costs $35 a month.”

We’ve heard Biden make this point several times on the campaign trail — in other instances, he has said beneficiaries were paying “as much as” $400 a month — so we wanted to look into it.

The Inflation Reduction Act, which Biden signed in 2022, caps out-of-pocket insulin costs at $35 a month for Medicare enrollees. The cap took effect in 2023. In response, three drug manufacturers said they planned to reduce the price of insulin to $35 through price caps or savings programs.

The legislation also helped patients by clarifying how much they would have to pay for insulin and other drugs.

But Biden overstated the average monthly cost that Medicare beneficiaries were paying before the law.

One government estimate for out-of-pocket insulin costs found that people with diabetes enrolled in Medicare or private insurance paid an average of $452 a year — not a month, as Biden said. That’s according to a December 2022 report by the Department of Health and Human Services using 2019 data. Uninsured users, however, paid more than twice as much on average for the drug, or about $996 annually.

About Half of US Insulin Users Are on Medicare

More than 37 million Americans have diabetes, and more than 7 million of them need insulin to control their blood sugar levels and prevent dangerous complications. Of the Americans who take the drug, about 52% are on Medicare.

It’s unlikely that many Medicare enrollees were paying the $400 out-of-pocket monthly average Biden referred to, though it could be on target for some people, especially if they’re uninsured, drug pricing experts told us.

“It would be more accurate to say that it could cost people on Medicare over $400 for a month of insulin, but the average cost would have been quite a bit lower than $400 on Medicare,” said Stacie Dusetzina, a health policy professor at Vanderbilt University School of Medicine.

Medicare Part D, also called the Medicare prescription drug benefit, helps beneficiaries pay for self-administered prescriptions. The benefit has several phases, including a deductible, an initial coverage phase, a coverage gap phase, and catastrophic coverage. What Medicare beneficiaries pay for their prescriptions often depends on which phase they’re in.

“It is confusing, because the amount that a person was supposed to pay jumps around a lot in the Part D benefit,” Dusetzina said. For example, she said, Medicare beneficiaries would be more likely to pay $400 a month for insulin during months when they hadn’t yet met their deductible.

Mariana Socal, an associate scientist at Johns Hopkins Bloomberg School of Public Health, said it’s also difficult to estimate insulin’s precise cost under Medicare because individual prices hinge on other factors, such as how many other prescription medications patients take.

“Because the Medicare program has multiple instances where the patient is required to pay a coinsurance (percentage of the drug’s cost) to get their drug, it is very likely that patients were paying much more than $35 per month, on average, before the cap established by the Inflation Reduction Act went into effect,” Socal wrote in an email.

There are different ways to administer insulin, including through a pump, inhaler, or pen injector filled with the medicine.

In a 2023 report, HHS researchers estimated that about 37% of insulin fills for Medicare enrollees cost patients more than $35, and 24% of fills exceeded $70. Nationally, the average out-of-pocket cost for insulin was $58 per fill, typically for a 30-day supply, the report found. Patients with private insurance or Medicare paid about $63 per fill, on average.

For people with employer-sponsored insurance, the average monthly out-of-pocket spending on insulin in 2019 was $82, according to a report published in October 2021 by the Health Care Cost Institute, a nonprofit that studies health care prices. The study found that the majority of patients were spending an average of $35 a month, or lower, on the drug. But among the “8.7% of individuals in the highest spending category,” the median monthly out-of-pocket spending on insulin was about $315, the study said.

Our Ruling

Biden said Medicare beneficiaries used to pay an average of $400 per month for insulin and are now paying $35 per month.

The Inflation Reduction Act capped the monthly price of insulin at $35 for Medicare enrollees, starting in 2023. The change built in price predictability and helped insulin users save hundreds of dollars a year.

However, most Medicare enrollees were not paying a monthly average of $400 before these changes, according to experts and government data. Costs vary, so it is possible some people paid that much in a given month, depending on their coverage phase and dosage.

Research has shown that patients with private insurance or Medicare often paid more than $35 a month for their insulin, sometimes much more, but not as high as the $400 average Biden cited.

We rate Biden’s statement Half True.

PolitiFact copy chief Matthew Crowley contributed to this report.

our sources

WhiteHouse.gov, “Remarks by President Biden at a Campaign Event | Reno, NV,” video, March 19, 2024

U.S. Department of Health and Human Services, “New HHS Report Finds Major Savings for Americans Who Use Insulin Thanks to President Biden’s Inflation Reduction Act,” Jan. 24, 2023

U.S. Department of Health and Human Services, “Insulin Affordability and the Inflation Reduction Act: Medicare Beneficiary Savings by State and Demographics,” revised Oct. 26, 2023

Bloomberg Law, “Insulin Costs Remain Top Target Beyond Biden’s Drug Price Cuts,” Oct. 26, 2023

The American Diabetes Association, “State Insulin Copay Caps,” accessed March 28, 2024

NPR, “Eli Lilly Cuts the Price of Insulin, Capping Drug at $35 per Month Out-of-Pocket,” March 1, 2023

WhiteHouse.gov, “FACT SHEET: President Biden’s Cap on the Cost of Insulin Could Benefit Millions of Americans in All 50 States,” March 2, 2023

Health Care Cost Institute, “Capping Out-of-Pocket Spending on Insulin Would Lower Costs for a Substantial Proportion of Commercially Insured Individuals,” Oct. 15, 2021

Centers for Disease Control and Prevention, “National Diabetes Statistics Report,” updated November 2023

KFF, “Insulin Out-of-Pocket Costs in Medicare Part D,” July 28, 2022

KFF Health News, “America Worries About Health Costs — And Voters Want to Hear From Biden and Republicans,” March 8, 2024

USA Facts, “A Cap on Insulin Costs Benefits Millions of Americans With Diabetes,” April 15, 2023

The Associated Press, “Insider Q&A: What’s Behind Rising Insulin Prices?” Aug. 5, 2018

USA Today, “Insulin $35 Cap Price Now in Effect, Lowering Costs for Many Americans With Diabetes,” Jan. 3, 2024

Email interview with Mariana Socal, associate scientist at Johns Hopkins Bloomberg School of Public Health, March 28, 2024

Email interview with Stacie Dusetzina, professor of health policy at Vanderbilt University, March 29, 2024

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

USE OUR CONTENT

This story can be republished for free (details).

KFF Health News' 'What the Health?': Florida Limits Abortion — For Now

The Host Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

Florida this week became a major focus for advocates on both main sides of the abortion debate. The Florida Supreme Court simultaneously ruled that the state’s 15-week ban, passed in 2022, can take effect immediately before a more sweeping, six-week ban replaces it in May and that voters can decide in November whether to create a state right to abortion.

Meanwhile, President Joe Biden, gearing up for the general election campaign, is highlighting his administration’s health accomplishments, including drug price negotiations for Medicare.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins University schools of nursing and public health, Tami Luhby of CNN, and Lauren Weber of The Washington Post.

Panelists Joanne Kenen Johns Hopkins Bloomberg School of Public Health and Politico @JoanneKenen Read Joanne's articles. Tami Luhby CNN @Luhby Read Tami's stories. Lauren Weber The Washington Post @LaurenWeberHP Read Lauren's stories.

Among the takeaways from this week’s episode:

  • The Florida Supreme Court’s decisions this week will affect abortion access not only in the state, but also throughout the region. Florida’s six-week ban, which takes effect on May 1, would leave North Carolina and Virginia as the only remaining Southern states offering the procedure beyond that point in pregnancy — and, in North Carolina, abortion is banned at 12 weeks after a woman’s last menstrual period.
  • Since the U.S. Supreme Court overturned the constitutional right to an abortion in 2022, six states have voted on their own constitutional amendments related to abortion access. In every case, the side favoring abortion rights has won. But Florida’s measure this fall will appear on the ballot with the presidential race. Could the two contests, waged side by side, boost turnout and influence the results?
  • Former President Donald Trump made many attempts during his term to undermine the Affordable Care Act, and this week the Biden administration reversed another one of those lingering attempts. Under a new regulation, the use of short-term insurance plans will be limited to four months — down from 36 months under Trump. The plans, which Biden officials call “junk plans” due to their limited benefits, will also be required to provide clearer explanations of coverage to consumers.
  • In other Biden administration news, March has come and gone without the release of an anticipated ban on menthol flavoring in tobacco, and anti-tobacco groups are suing to force administration officials to finish the job. Menthol cigarettes are particularly popular in the Black community, and — like Trump’s decision as president to punt a ban on vaping to avoid alienating voters in 2020 — the Biden administration may be loath to raise the issue this year. Activists say, however, that it may be at the expense of Black lives.
  • “This Week in Medical Misinformation” looks at an article from PolitiFact about the health misinformation that persists even with the pandemic mostly in the rearview mirror.

Also this week, Rovner interviews health care analyst Jeff Goldsmith about the growing size and influence of UnitedHealth Group in the wake of the Change Healthcare hack.

Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too: 

Julie Rovner: Politico’s “Republicans Are Rushing to Defend IVF. The Anti-Abortion Movement Hopes to Change Their Minds,” by Megan Messerly and Alice Miranda Ollstein.

Tami Luhby: The Washington Post’s “Biden Summons Bernie Sanders to Help Boost Drug-Price Campaign,” by Dan Diamond.

Lauren Weber: The Washington Post’s “Bird Flu Detected in Dairy Worker Who Had Contact With Infected Cattle in Texas,” by Lena H. Sun and Rachel Roubein.  

Joanne Kenen: The 19th’s “Survivors Sidelined: How Illinois’ Sexual Assault Survivor Law Allows Hospitals to Deny Care,” by Kate Martin, APM Reports.

Also mentioned on this week’s podcast:

click to open the transcript Transcript: Florida Limits Abortion — For Now

KFF Health News’ ‘What the Health?’Episode Title: Florida Limits Abortion — For NowEpisode Number: 341Published: April 4, 2024

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.] 

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, April 4, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this, so here we go.

We are joined today via video conference by Tami Luhby of CNN.

Tami Luhby: Good morning.

Rovner: Joanne Kenen of the Johns Hopkins University Schools of Nursing and Public Health and Politico magazine.

Joanne Kenen: Hi, everybody.

Rovner: And Lauren Weber, the Washington Post.

Lauren Weber: Hello.

Rovner: Later in this episode, we’ll have an interview with Health Policy Analyst and Consultant Jeff Goldsmith about the continuing fallout from the Change Healthcare hack. But first, this week’s news. One of these weeks, we won’t have to lead with abortion news, but this is not that week. On Monday, the Florida Supreme Court ruled separately, but at the same time, that state voters could decide this November whether to make a right to abortion part of the state’s constitution and that the state’s constitution currently does not guarantee that right.

So the state’s 15-week abortion ban signed by Gov. Ron DeSantis in April of 2022 can take immediate effect. But wait, there’s more. First, the decision on the 15-week ban overruled years of precedent that Florida’s Constitution did, in fact, protect the right to abortion. And second, allowing the 15-week ban to take effect automatically triggers an even more sweeping six-week ban that Gov. DeSantis signed in 2023. That will take effect May 1. That’s the one he signed in the middle of the night without an audience people may remember. And this is going to affect far more people than just the population of Florida, right?

Kenen: The whole South. This is it. If you count the South as North Carolina and what we think of as the South, North Carolina is the only state that still has legal abortion, and that is only up to 12 weeks. And there are some conditions and hurdles, but you can still get an abortion in North Carolina.

But to get from a place, people were going to Florida, it’s easier to get from Alabama to Florida than it is from Alabama to even Charlotte. I think I read it’s a 17-hour drive from Florida or something like that. I don’t remember. It’s long. So it’s not just people who live within Florida, but people who live in 11 or 12 states in the American South have far fewer options.

Rovner: And even though the Florida ban feels less than a complete ban because it allows abortions up to six weeks, the fine print actually makes this one of the most restrictive bans in the country. It looks, in effect, like most people won’t be able to get abortions in Florida at all.

Weber: I would say that’s right, Julie. And just to reiterate what Joanne said, 80,000 women get abortions in Florida every year. That’s about one in 12 women in America that get abortions per year, and they will no longer have that kind of access because, at six weeks, a lot of women don’t know they’re pregnant. So, I mean, that’s a very restrictive abortion ban.

Rovner: Remember that six weeks isn’t really six weeks of having been pregnant. Six weeks is six weeks since your last menstrual period, which can be as little as two weeks in some cases.

Kenen: And I also think that even if you do know within six weeks, getting an appointment, given how few places there are in the entire South, even if you know and you get on the phone right away, can you get an appointment before your six weeks is an additional challenge because access is really limited …

Rovner: Right.

Kenen: … intentionally.

Rovner: Yes, and we’ve seen this with other six-week bans. We should point out that some people consider Virginia the South still, and you can go to Virginia, but that’s basically the last place that a good chunk of the country, geographically, if not population-wise, would need to turn to in order to get an abortion.

Well, if that’s not all confusing enough, even if voters do approve the ballot measure in November, the Florida Supreme Court suggested it could still strike down a right to abortion based on a majority of justices findings that the state’s constitution could include personhood rights for fetuses.

I’m having trouble wrapping my head around why the justices would allow a vote whose results they might then overturn. But I guess this is part of the continuing evolution, if you will, to use that word, of this concept of personhood for fetuses and embryos, and what has us talking about IVF, right?

Weber: Yeah, absolutely. I think, as many conservative Christian groups will say, this is the natural line that pro-life is. I mean, they argue, and while they’re pushing this view is not necessarily held by the majority of constituents, but this is their argument that a fetus, an embryo, such as one that could be used in IVF, is a person.

And so, I mean, I think that’s kind of the natural conclusion of pro-life ideology as we’re seeing it right now. And I think it will have a lot of political effects going forward because that IVF is obviously much more popular than abortion. I think we’ll see a lot of voting firepower potentially used on that.

Rovner: Well, I’m so glad you said that because I want to turn to politics. Some Democrats are suggesting that this could boost turnout for Democrats and help, if not put Florida in play for president, maybe the Democrat running to unseat Senator Rick Scott, the Republican.

On the other hand, while abortion ballot questions have done very well around the country, as we know, even in states redder than Florida, there is evidence that some Republicans vote for abortion rights measures and then turn around and vote at the same time for Republicans who would then vote to overturn them.

There are in fact Florida abortion rights advocates who don’t want Democrats to make this issue partisan because they want Republicans to come and vote for the ballot measure, which needs a 60% majority to pass, even if those Republicans then go on to vote for other Republicans. So, who really is helped by this entire mess, or is it impossible to tell at this point?

Weber: I think it’s impossible to tell, but I do think what is complicating is we haven’t seen the presidential race thrown into these abortion ballots. I mean, what we’re looking at is two candidates who potentially are facing a lot of low turnout due to lack of enthusiasm in their bases for both of them. And I am curious if the abortion ballot measures could have much more of an impact on the presidential race than maybe some of these other lower-office races that we’ve seen. I think that’s the main question that I guess we’ll see in November.

Rovner: As we have spoken about many times, President Biden is not super comfortable talking about this issue. He’s an 81-year-old Catholic. It does not come naturally to him to be in favor of abortion rights, which he now is. But Vice President Harris has been sent out. She’s sort of become the standard-bearer for this administration on reproductive health issues, and she’s been very active. And Joanne, you wanted to say something?

Kenen: There are a couple of points. In addition to the abortion ballot initiative. There’s also a marijuana legalization. I think we will see higher turnout and particularly among younger people who have been pretty disaffected this election. So that’s one, whether it affects the presidential race, whether it affects the Senate race. I mean, just as Democrats feel really strong about abortion, Republicans feel really strong about immigration. We don’t know what’s going to happen in November, but I do think this boosts turnout. The second thing to remember, though, is in terms of abortion ballot initiatives have passed every time they’ve come up since the fall of Roe [v. Wade].

This is a 60% threshold, and I do not believe that any state has reached that. I think the highest was about 57%. So even though it may get well over 50, it could get 59.9, the Florida ballot initiative needs 60%. That is a tall order. So you might end up seeing a big turnout, a big pro-abortion rights vote, maybe a big legal weed vote, and the abortion measure could still fail. But I do think it definitely changes the dynamics of Florida from the presidential race on down the ballot. I do think it is a different race than we would’ve seen beforehand.

Rovner: And I will point out, since she didn’t, that Joanne has spent time covering Florida and covering the politics in Florida. So you know where of you speak on this.

Kenen: Well, I lived there for a while, though it was a while ago. The state has, in fact, changed like everything else, including me, right? But I’m somewhat familiar with Florida. I was just there a few weeks ago in fact.

Rovner: And I want to underscore something that Lauren said, which is that we’ve seen all of these ballot measures since Roe was overturned, but we have not seen these ballot measures stacked on top of the presidential race. So I think that will be interesting to watch as we go forward this year.

Well, back here in D.C., the Biden administration issued a long-awaited rule reigning in the use of those short-term health plans that Democrats like to call junk insurance and that President Trump had expanded when he was in office. Tami, what is the new rule, and what will it do?

Luhby: Well, it’s actually curtailing the short-term plans and pretty much reversing the Trump administration rule. So it’s the latest move by the president to contrast his approach to health care with that of former President Donald Trump. Trump extended the duration of the short-term health insurance plans to just under a year and allowed them to be renewed for a total of 36 months. And it was seen as an effort to weaken the Affordable Care Act, draw out younger people, make it more difficult for the marketplace, probably send the older, sicker people there, which would raise premiums, basically cause more chaos in the marketplace.

Rovner: Yeah. And remind us why these plans can be problematic.

Luhby: I will tell you that the short-term plans do not have to adhere to Obamacare’s consumer protections, which is the big difference. For instance, they’re not required to provide comprehensive coverage, and they can discriminate against people with pre-existing conditions, charge them more, deny them, et cetera. As I’d said, the Trump administration heralded them as a cheaper alternative because since they can underwrite, they have typically cheaper premiums. But they also have very limited benefits, or they can have limited benefits depending on the patient or the consumer.

So the Biden rule, which was proposed last month as a series of actions aimed at lowering health care costs, limits the duration of new sales of these controversial plans to three months, with the option of renewal for a maximum of four months. So it’s going on these new plans from 36 months potentially to four months, which was the original idea of these plans because originally they were thought to be for people who might be switching jobs or have a temporary lapse in coverage. They were not intended to be a substitute for full insurance. And it also requires, notably, that the plans provide consumers with a clear explanation of their benefits and inform them of how to find more comprehensive coverage.

Rovner: And obviously this will continue to be controversial, but I think the Democrats, in general, who support the Affordable Care Act feel pretty strongly that this is something that’s going to help them. And as we talked about, we’re not sure yet how the administration is going to play the abortion issue in the campaign, but it is pretty clear that they are doubling down on health care.

One problem for the administration, as we have talked about, is that particularly on really popular things like Medicare drug price negotiations, lots of the public has no idea that that’s happened or if it’s happened that it’s because the Democrats did it. So, in part of an effort to overcome that, Biden invited Bernie Sanders to the White House this week. What was that about?

Luhby: Well, that’s my extra credit. Would you like me to discuss that now?

Rovner: Sure, let’s do that now.

Luhby: OK. So my extra credit is a Washington Post story titled “Biden Summons Bernie Sanders to Help Boost Drug-Price Campaign,” by Dan Diamond. And I have to admit, I hope I can do that here, that I am a fangirl of Dan Diamond’s stories, and even more so now because apparently, the Biden administration gave Dan a heads-up in advance, that since he published a pretty in-depth story an hour before the embargo lifted for the rest of us who were only given a few tidbits of information about what this meeting or what this speech was going to be about at the uncharacteristically late hour of 8:30 at night.

So Dan’s story looked at how the two former rivals, Joe Biden and [Sen.] Bernie Sanders, who were rivals in the 2020 Democratic presidential nomination, how they had very different views on how the nation’s health care system should operate and Dan’s story looked at how they were uniting to improve awareness of Biden’s efforts to lower drug prices and improve his chances in November. Biden invited Sanders to the White House to discuss the administration’s actions on drug prices, including the latest effort to reduce the out-of-pocket cost of inhalers, which really hasn’t gotten a lot of press.

Sanders brings his progressive credentials and his two-decade-plus track record of fighting for lower drug prices and, “naming and shaming individual pharmaceutical companies and executives.” He’s known to be pretty outspoken and fiery. So the story’s a good example of policy meets politics in an election year. It relays that most Americans still don’t know about the administration’s efforts despite the numerous speeches, news releases, and officials’ trips around the country, hence the need to tap Sanders, and it also provides a nice walk down memory lane, revisiting the duo’s battles in the 2020 primary as well as some of former President Trump’s drug price efforts.

Rovner: Yeah. And a little peek behind the journalistic curtain. I think we all got this sort of mysterious note from Sanders’ press people the night before saying, “If you’ll agree to our embargo, we’ll tell you about this secret thing that’s going to happen,” followed by an advisory from the White House saying that Bernie Sanders was coming to the White House to talk about drugs. [inaudible 00:13:30] …

Luhby: Right. And also, uncharacteristically, when I asked for a comment from Sanders directly, they said tomorrow, which is not like Sanders at all.

Kenen: Sanders and Biden were obviously opponents in the primary, but Sanders has really been very supportive of Biden. I think he’s really sort of highlighted the progressive things that Biden has done and stayed quiet about the more centrist things that Biden has done. He’s been a real ally, and he still has a lot of credibility, and I think they sort of like each other in a funny way. You can sort of see it, but that’s their issue.

Luhby: Biden has also been able to do things that other people have not been able to do with the congressional Democrats. Biden has been able to do things that congressional Democrats have tried to for years and have not been able to, and they may not be the extent to which the Democrats would like. If you remember the 2019 Medicare Drug Negotiation bill, I think, was 250 drugs a year. What ended up passing in the IRA [Inflation Reduction Act] was 10 drugs and ramping up, but at least it’s something.

Kenen: And it’s more than 20 years in the making. I mean, this goes way, way back.

Luhby: Mm-hmm.

Rovner: And I was going to underscore something that Joanne said earlier about Florida, which is that both sides are trying to gin up their base, and young people are really fond of Bernie Sanders in a lot of the things that he says, and this may be a way that Biden can ironically use the Medicare drug price negotiation issue to stir up his young person base to get them out to vote. So I was interested in the combination.

Kenen: So it’s Bernie Sanders and legal weed.

Rovner: That’s right. It’s Bernie Sanders and legal weed, at least in Florida.

Kenen: I’m not implying anything about Bernie Sanders’ use of it. It’s just the dynamic for the young voters.

Rovner: Yes. Things to draw young people out to the polls in November. Well, while the Biden administration is doing lots of things using its regulatory power, one thing it is not doing, at least not yet, is banning menthol flavoring in tobacco.

This is a regulation that’s now been sitting around for nearly two years and that officials had promised to finalize by the end of March, which of course was last week and which didn’t happen. So now three anti-tobacco groups have sued to try to force the regulation over the finish line. Somebody remind us why banning menthol is so very controversial.

Weber: It’s controversial in part because a lot of industry will say that banning menthol will lead to over-policing in Black communities. The jury is very much out on if that is an accurate representation or part of the cigarette playbook to keep cigarettes on the market. Look, a presidential election year and things to do with smoking is not new.

When I was at KFF Health News with Rachel Bluth back in the day, we wrote a story about how Trump postponed a vape ban to some extent because he was worried about vaping voters. So I mean, I think what you’re seeing is a pretty clear political calculus by the Biden folks to push this off into the new year, but as activists and public health advocates will say, it’s at the expense of, potentially, Black lives.

Rovner: That’s right.

Weber: So banning menthol cigarettes would really… what it would do is statistically save Black Americans who die from, predominantly from smoking these types of cigarettes. So it’s a pretty weighty decision to put off with a political calculus.

Rovner: He’s taking incoming from both sides. I mean, obviously, there are members of the Black community who say, as you point out, this could lead to an unnecessary crackdown on African American smokers who use menthol more statistically than anybody else does. Although, there’s some young people who use it too. On the other hand, you have people representing public health for the Black community saying, “We want you to ban this” because, as you point out, people are dying from smoking-related illnesses by using this product. So it’s a win-win, lose-lose here that is continuing on. We’ll be interested to see what, if the lawsuit can produce anything.

Well, speaking of things that are controversial, we also have Medicare Advantage. The private plan alternative to traditional Medicare now enrolls more than half of those in the program, many who like the extra benefits that often come with the plans and others who feel that they can’t afford traditional Medicare’s premiums and other cost-sharing. Except one reason those extra benefits exist is because the government is overpaying those Medicare Advantage plans. That’s a vestige of Republican plans to discourage enrollment in original Medicare that date back to the early part of this century.

So now taxpayers are footing more of the Medicare bill than they should. This week’s news is that the federal government is effectively trimming back some of those overpayments. And investors in the insurance companies, who make money from the overpayments, are going crazy. This is the subhead on a story from the Wall Street Journal, “Managed care stocks are set to fall due to disappointment with the government’s decision not to revise the 2025 Medicare payment proposal.” How is this ever going to get sorted out? Somebody always is going to be a loser in this game, either the patients or the insurance companies or the taxpayers. Everybody cannot win here.

Luhby: Right. And Humana got hit really hard when the rule came out because it is really focused on Medicare Advantage. So yeah, the insurers were hit, but as everything with the market, it’s not forever.

Rovner: I’m continually puzzled by … if the payments were equivalent, which was what they were originally supposed to be. Originally, originally back in the 1980s, insurance companies came to Congress and said, “We can provide managed care and Medicare cheaper, so you can pay us 95% of the average that you pay for a fee for service patient. We can make a profit on that.”

Well, that is long since gone. The question is how much more they will make. And as I point out, when they get overpaid, they do have to rebate those back effectively to the patients in terms of higher benefits. And that’s why many of them offer dental coverage and eyeglasses coverage and other types of, quote-unquote, extra benefits that Medicare doesn’t offer.

But also you get this lack of choice, and so we see when people try to leave these plans and go back to traditional Medicare, they can’t, which is only one of the sort of things that I think a lot of people don’t know about how Medicare Advantage works. Another place with an awful lot of small print.

Weber: It’s a lot of small print under a very good marketing name. The name itself implies that you’re making a better choice, but that isn’t necessarily what the small print would say.

Kenen: And there are people who are very satisfied with it and who get great care. I mean, it’s not monolithic. I mean, it is popular. It is growing and growing and growing. It’s partly economic, and there’s some plans that patients like, and there’s word of mouth or that were negotiated as part of union agreements and are actually pretty strong benefits. But they’re also people who are really encountering a lot of trouble with prior authorization, and limited networks, and your doctor’s no longer in it, et cetera, et cetera.

I think that those things, I actually checked with somebody about the provider networks, what we know about who’s dropping out, and I don’t think there’s really up-to-date data, but there is a perception, and you’re hearing it and seeing it online. But they do an incredible amount of marketing, an incredible amount of marketing. And if you’re in it and you like it and you save money and you’re getting great health care, terrific. You’re going to stay in it.

If you’re in it and you don’t like it and you’re not getting great health care and a lot of hassles or you can’t see the right doctors, it’s hard to get out and get back into it depending on what state you’re living … It’s not monolithic. But I think we might be between the financial pressures from the government and some of the debates about some of these things they’re doing there may be some reconsideration. But they have strong backers in Congress and not just Republicans.

Rovner: Oh, yeah. I mean, and as you point out, more than half of the people in Medicare are now on Medicare Advantage. I did want to sort of highlight my colleague Susan Jaffe, who has a story this week about the fact that patients can’t change plans in the middle of the year, but plans can drop providers in the middle of the year, so people may sign up for a health plan because their doctor or their hospital is in it and then suddenly find out mid-year that their doctor and their hospital is no longer in it.

There are occasionally, if you’re in the middle of treatment, there are opportunities sometimes to change, but often there aren’t. People do end up in these plans, and they can be happy for, basically, until they’re not, that there are trade-offs when you do it. And I think, as we point out, there’s so much marketing, and the marketing somehow doesn’t ever talk about the trade-offs that you make when you go into Medicare Advantage.

Luhby: Well, one also thing is that this is the peak 65 year, where the most baby boomers, and where are they coming from? They’re coming from private commercial insurance, so they’re familiar with it, and they were like, “Oh, OK, that’s seemingly very much like my employer plan. Sure, that sounds great. I know how to deal with that.” So that’s one of the things. And one cudgel that the insurers have is they say, “Oh, government, you’re going reduce our payments. We’re going to reduce the benefits and increase the premiums because we’re not going to have all of that extra government funding.” And that can scare the government because they don’t want the insurers to tell their patients, who are older patients who vote, “Oh, because of the government, we can no longer offer you all of these benefits, or we’ve had to raise your premium because of that.” So we’ll see if they actually do that.

Kenen: Joe Biden took away your gym, right?

Luhby: Exactly.

Rovner: [inaudible 00:22:11].

Luhby: And your dental benefits. So that’s always the threat that the insurers roll out. That’s the first thing that they say often, but we’ll see what happens. We don’t know yet until the fall, when enrollment starts, what will actually happen?

Rovner: We saw exactly that in the late ’90s after Congress balanced the budget. They took a big whack out of the payments for what was then, I think, called Medicare Plus Choice. It was the previous version of Medicare Advantage, and a lot of the companies just completely dropped out of the program. And a lot of the people, who as Joanne said, had been in those plants had been very happy, threw a fit and came to Congress to complain, and lo and behold, a lot of those payments got increased again. In fact, that was what led to the big increase in payments in 2003 was the huge cut that they made to payments, which drove a lot of the insurers out of the program. So we do know that the insurers will pack up and leave if they’re not paid what they consider to be enough to stay in the program.

Moving on. One of the things that Jeff Goldsmith talks about in this week’s interview is that our health system has become one of deep distrust between patients, providers, and insurers. Speaking of Medicare Advantage. That is sad and dysfunctional, except that sometimes there are good reasons for that distrust. One example comes this week from my KFF Health News colleague Julie Appleby. It seems that unscrupulous insurance brokers are disenrolling people in Obamacare plans from their health plans and putting them in different plans, which is unbeknownst to them until they find their doctor is no longer in their network or their drug isn’t covered.

The brokers who are doing this can earn bigger commissions. But patients can end up not just having to pay for their own medical care but owing the government money because suddenly they’re in plans getting subsidies that don’t match their incomes. It is a big mess. And it seems that the obvious solution, which would be making it harder for agents to access people’s enrollment information so they can switch them, would delay legitimate enrollment. It has to be easy for agents to basically manipulate people’s applications. So how do you guard against bad actors without inconveniencing everyone? This seems to be the question here and the question for Medicare Advantage, Lauren.

Weber: I was going to say, I mean, I think that’s the question Medicare itself has been dealing with for years. I mean, there’s a reason that many federal prosecutors call this a pay-and-chase situation in which there is rampant Medicare fraud. They prioritize the ease of patients accessing care to the disadvantage of some folks, or in this case, the American taxpayer, in this case, actual patients, being swindled.

But I don’t have an answer. I don’t think anyone really has an answer, considering we’re seeing things like the $2 billion catheter fraud that we’ve talked about here. So I think again, this is one of these things where the government’s been left a little flat-footed in trying to protect against bad actors.

Rovner: Yeah, well, the health sector is what a fifth of the economy now, so I guess it shouldn’t come as much of a surprise that you have not just bad actors, people who are making a lot of money from doing illegal things and find it to be worth their while and that some of them get caught, but presumably most of them don’t. I guess that’s what happens when you have that much money in one place, you need sort of better watchdogs. All right. Well, finally, this week in medical misinformation comes from PolitiFact in a story called “Four Years After Shelter-in-Place, Covid-19 Misinformation Persists.” That’s an understatement.

That last part was mine. At the top of the list says, “We have discussed before is growing resistance to vaccines in general, not just the covid vaccine,” which is not all that surprising considering how many people now believe fictitious stories about celebrities dropping dead immediately after receiving vaccines. There’s even a movie called “Died Suddenly.” Or that government leaders and the superrich orchestrated the pandemic. That’s another popular story that goes around. Or that Dr. Tony Fauci brought the virus to the United States a year before the pandemic. Lauren, health misinformation is your beat. Is it getting any better now that the pandemic is largely behind us, or is it just continuing unabated?

Weber: No, I would argue it’s possibly getting worse because the trust in institutions is at an all-time low. Social media has allowed for fire hose. I mean, it’s made everything … it’s made the public square that used to be more limited, all corners of the country.

I would say that misinformation has led to mistrust about basic medical things, including childhood vaccinations, but also other medical treatment and care. And I think you’re really seeing this kind of post-truth world post-covid, this distrust, this misinfo is going to continue for some time. And there’s too much to cover on my beat. There’s constantly stories around the bend, and I don’t expect that improving anytime soon.

Kenen: Every single time a celebrity, not just dies, because it’s always no matter what happens, it’s blamed on the covid vaccine, but also gets sick. I mean, Princess Kate. We don’t know everything about her health, but I mean, all of us know it wasn’t. Whatever it is, it’s not because the covid vaccine. But if you go online, you hear that that’s whatever she has it’s because she’s vaccinated.

And the other thing is it’s fed into this general vaccine mistrust. So when I wrote about the RSV vaccine, which we talked about a few weeks ago, it wasn’t so much that there’s a campaign against the RSV vaccine. There is somewhat of that. But it’s just this massive, “vaccines are bad.” So it’s spilling over into anything with a needle attached is part of this horrible plot to kill us all. So it’s just sort of this miasma of anti-vaccination that’s hovering over a lot of health care.

Rovner: Well, at the risk of getting a little too bleak, that will be the news for this week. Now, we will play my interview with Jeff Goldsmith, and then we’ll come back and do our extra credits. I am pleased to welcome back to the podcast Jeff Goldsmith, one of my favorite big-picture health system analysts. Jeff has been writing of late about the Change Healthcare hack and the growing size and influence of its owner, UnitedHealth Group, and what that means for the country’s entire health enterprise. Jeff, thanks for joining us again.

Jeff Goldsmith: You bet.

Rovner: So the lead of your latest piece gives a pretty vivid description of just how big United has become, and I just want to read it. “Years ago, the largest living thing in the world was thought to be the blue whale. Then someone discovered that the largest living thing in the world was actually the 106-acre, 47,000-tree Pando aspen grove in central Utah, which genetic testing revealed to be a single organism.

With its enormous network of underground roots and symbiotic relationship with a vast ecosystem of fungi, that aspen grove is a great metaphor for UnitedHealth Group. United, whose revenues amount to more than 8% of the U.S. health system, is the largest health care enterprise in the world.” Let’s pick up from there for people like me who haven’t been paying as much attention as maybe they should have, and still think that United is mainly a health insurance company. That is not true and hasn’t been for some time, has it?

Goldsmith: The difference between United and a health insurance company is that it also has $226 billion worth of care system revenues in it, some of which are services rendered to United and other, believe it or not, services rendered to United competitors. So, there isn’t anything remotely that size in the health insurance world. That $226 billion is more than double the size of Kaiser. Just to give you an idea of the scale.

Rovner: Which, of course, is the other companies that are both insurers and providers. That’s pretty much the only other really big one, right?

Goldsmith: Yes. I have a graphic in the piece that shows the Optum Health part, which is the care delivery part of Optum, is just about the same size as Kaiser, but it generates six and a half billion dollars in profit versus Kaiser’s $323 million. So it dwarfs Kaiser in terms of profitability even though it’s about the same size top line.

Rovner: So split it up for people who don’t know. What are sort of the main components that make up UnitedHealth Group?

Goldsmith: Well, there’s a very large health insurance business, $280 billion health insurance business. Then, there is a care system called Optum Health, which is about $95 billion. It has 90,000 affiliated or employed docs, a huge chain of MedExpress urgent care centers, surgery centers, a couple of very large home health care agencies. So that’s the care delivery part of United.

There’s Optum Insight, which is about $19 billion. That’s the part that Change Healthcare was inside of. It’s a business intelligence and corporate services business, and consulting business, that also manages care systems financials. And then, finally, there’s Optum Rx, which is about $116 billion, so a little bit more than half of Optum’s total, and that is a pharmacy benefit management company. Believe it or not, the third-largest one. So there are bigger pharmacy benefits management companies than Optum, but those are the three big pieces.

Rovner: I feel like this is almost as big as a lot of the government health programs, isn’t it?

Goldsmith: Yeah. I mean, I can’t remember top line how big the VA [Department of Veterans Affairs] is these days, but it’s VA scale, but it’s in a bunch of little pieces scattered all over the United States. I mean, that’s the big part of all of this. The care system is in at least 30 states. I have a map showing where some of the locations are. That map took me months to find. There isn’t a real registry of what the company owns, but it is a vast enterprise. And they’re great assets, if you’ll pardon a financial term for them.

Some of the finest risk-bearing multispecialty group practices in the United States are a part of Optum: Healthcare Partners based in Los Angeles; The Everett Clinic; the former Fallon Clinic, and Atrius in New England, which are the two finest risk-bearing, multispecialty physician groups in the Northeast. They weren’t dredging the bottom here at all. They got a tremendous number of high-quality groups that they’ve pulled together in the organization. The issue is it really an organization or is it a collection of assets that have been acquired at a very rapid pace over a period of the last 15 years.

Rovner: One of the things that I think the Change Healthcare hack proved for a lot of people is that nobody realized what a significant percentage of claims processing could go through one company. You have to wonder, have regulators, either at the state or federal level, kind of fallen down on this and sort of let this happen so that when somebody hacks into it, half the system seems to go down?

Goldsmith: The federal government challenged the Change acquisition and basically lost in court. They were unable to make the case. They were arguing that Change controlling all of these transactions of not only United but a lot of other insurers gave them access to information that enabled United to have some type of unfair competitive advantage. It was a difficult argument to make that didn’t make it. But the result of the Change acquisition was that about a third of the U.S. health system’s money flowed through one company’s leaky pipes.

And what we’re sort of learning as we learn more about Change is that there were something like a hundred separate programs inside Change, all of which somehow were vulnerable to this hack. And I think that’s one of the things that I think when [Sen.] Ron Wyden and [Sen.] Mark Warner get around to getting some facts about this, they’re going to wonder how did that happen. How could you have that many applications, that loosely tied together, that they were vulnerable to something like this?

And what my spies tell me is that a hacker, and it could have been a single hacker, not a country, but one guy was able to drop down into all of those data silos, vacuum out the data, and then delete the backups, so that United was basically left with no claims trail, no provider directories, nothing, and has had to reconstruct them; panicky reconstruction here in the last six weeks.

Rovner: Which I imagine is what’s taking so long for some of these providers to get back online.

Goldsmith: Julie, the part I don’t understand, is if it is true that that Change was processing a trillion and a half dollars worth of claims a year, a month interruption is $125 billion. That’s $125 billion that didn’t get paid to providers of care after the fact of them rendering the care. So the extent of the damage done by this is difficult to comprehend.

I mean, I have a lot of provider contacts and friends. Some of them, believe it or not, had no Change exposure at all because their main payers didn’t use Change. Some of them, it was all their payers used, and cash flow just ceased, and they had to go to the bank and borrow money to make their payrolls. None of this, for some reason, has made it in its full glory out into the press, and it isn’t that there aren’t incredibly high-quality business reporters in this field. There are.

Rovner: I know. I live in Maryland. I’ve driven over the Francis Scott Key Bridge in Baltimore. I know what it means. I mean, basically took apart the Baltimore Beltway. I mean, no longer goes in a circle. And I know how big the Port of Baltimore is, and I feel like everybody can understand that because it’s visceral. You can see it. There’s video of the bridge falling down. There isn’t video of somebody hacking into Change Healthcare and stopping a lot of the health system in its tracks.

Goldsmith: The metaphor that occurred to me, as you know, I’m a metaphor junkie, was actually Deepwater Horizon, and of course, we had a camera on that gushing well the whole time. This is like a gusher of red ink, a Deepwater Horizon-sized gusher of red ink that went on for a month. From what I’m able to understand, people are able to file the claims now. How many people have actually been paid for the month or six weeks’ worth of work they’ve done is elusive. And I still don’t have access to really good facts on how much of what they owed people they’ve actually paid.

I do know a lot of my investor analyst friends are waiting for United’s first-quarter financials to drop, which will probably show a four- or five-day drop in their medical loss ratio because of all the claims they were not able to pay, and therefore money was sitting in their coffers earning, what, 5% interest. That’s going to be kind of a festival when the first-quarter financials drop. And, of course, it isn’t just United, Humana, the Elevance, Cigna, all the rest of them. A lot of these folks use Change to process their claims. So there’s going to be a swollen offer here on the health insurance side from a month of not paying their bills.

Rovner: Well, is it the next Standard Oil? Is it going to have to be taken apart at some point?

Goldsmith: Yeah, but I mean, the question is, on what basis? Our health care system is so vast and fragmented, even a generous interpretation of antitrust laws, you’d have trouble finding a case. The Justice Department or FTC [Federal Trade Commission] is going to try again. But I’ll tell you, I think they’ve got their work cut out for them. I think the real issue isn’t anti-competitiveness, it’s a national security issue. If you have a third of the health systems dollars flowing through one company’s leaky pipes, that’s not an antitrust problem. It’s a national security problem, and I think there are some folks in the U.S. Senate that are righteously pissed about this.

There’s a lot of fact-finding that needs to happen here and a lot of work that needs to be done to make this system more secure. And I’ve also argued to make it simpler. Change was processing 15 billion transactions a year. That’s 44 transactions for every man, woman, and child in the country, and that was only a third of them. What are we doing with 100 billion transactions? What’s up with that? It beggars the imagination to believe that we to minutely manage every single one of those transactions. That is just an astonishing waste of money. It’s also an incredible insult to our care system. The assumption that there at any moment, every one of those folks could potentially be ripping us off, and we can’t have that.

Rovner: So we’re spending all of this money to try and not be ripped off for presumably less money.

Goldsmith: Hundreds of billions of dollars, but who’s counting?

Rovner: It’s kind of a depressing picture of what our health system is becoming, but I feel like it is kind of an apt picture for what our health system has become.

Goldsmith: It’s the level of mistrust. The idea that every one of his patients is trying to get a free lunch, and every doctor is trying to pad his income. We’ve built a system based on those twin assumptions. And when you think about them for a minute, they really are appalling assumptions. Most of what motivated me when I had cancer was fear.

I wasn’t trying to get stuff I wasn’t entitled to or didn’t need. I wanted to figure out a way to not be killed by the thing in my throat. And my doctors were motivated by a fear that if they let me go, maybe my heirs would sue them. I guess this idea that we are just helpless pawns of a behaviorist model of incentives, I think the economists ran wild with this thesis. And I think it’s given us a system that doesn’t work for anybody.

Rovner: Is there a way to fix it?

Goldsmith: I think we ought to cut the number of transactions in half. We ought to go and look at how many prior authorizations are really needed. Is this a model we really want to continue with, effectively universal surveillance of every clinical decision? We ought to be paying in bundles. We ought to pay our primary care physicians monthly for every patient that they see that’s a continuing patient and not chisel them over every single thing they do. We ought to pay for complex care in bundles where a cancer treatment is basically one transaction instead of hundreds.

I think we could get a long way to simplifying and reducing the absurd administrative overburden by doing those things. I also think that the idea that we have 1,100 health insurers. United’s the biggest, but it’s not by any means the only health insurer. There’s 1,100 rule sets that determine what data you need in order to pay a claim and whether a claim is justified or not. I think that’s a crazy level of variation. So I think we need to attack the variation. We’ve had health policy conversations about this for years and not done anything, and I think it’s really time to do it.

Rovner: Maybe this will give some incentive to some people to actually do something. Jeff Goldsmith, thank you so much.

Goldsmith: Julie. It’s good talking to you.

Rovner: OK. We are back, and time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Tami, you’ve already done yours this week. Lauren, why don’t you go next?

Weber: Yeah. I think we’re all keeping an eye on this in this podcast, but the title of this story is “Bird Flu Detected in Dairy Worker Who Had Contact With Infected Cattle in Texas,” which was written by my colleagues, Lena Sun and Rachel Roubein. Also, great pieces by Helen Branswell in the Texas Tribune on this as well.

But, essentially, just so listeners know, there has been a case of human bird flu detected, which is very concerning. As all of us on this podcast know, avian human flu is one of the worst-case scenarios in terms of a pathogen and infectiousness. As of right now, this is only one person. It seems to be isolated. We don’t know. We’ll see how this continues to mutate, but definitely something to keep an eye on for potential threat risk. TBD.

Rovner: Yeah. It is something I think that every health reporter is watching with some concern. Although, as you point out, we really don’t know very much yet. And so far, we have not seen. I think what the experts are watching for is human-to-human transmission, and we haven’t seen that yet.

Kenen: And this person seems to have a mild case, from the limited information we have, which is also a good sign for both that individual and everybody else in terms of spreadability.

Rovner: But we will continue to watch that space. Joanne.

Kenen: Well, you said enough bleak, but I’m afraid this is somewhat bleak. This is a piece by Kate Martin from APM Reports, which is part of American Public Media, and it was published in cooperation with The 19th, and the headline is “Survivors Sidelined: How Illinois’ Sexual Assault Survivor Law Allows Hospitals to Deny Care.” So there’s a very, very strong sort of everybody points to it as great law in Illinois saying that what kind of care hospitals have to provide to sexual assault victims and what kind of testing and counseling and everything. This whole series of services that legally they must do, and they’re not doing it. Even in cases of children being assaulted, they’re sending people 40 miles away, 80 miles away, 40 miles away. They’re not doing rape kits. They’re not connecting them to the counselors, et cetera. It is a pretty horrifying story. It begins with a story of a 4-year-old because they didn’t do what they were supposed to do. The father was the suspected perpetrator, and because the hospital didn’t do what they should have done he still has joint custody of this little girl.

Rovner: My story this week is from our podcast colleague, Alice [Miranda] Ollstein, and her Politico colleague, Megan Messerly, and it’s called “Republicans Are Rushing to Defend IVF. The Anti-Abortion Movement Hopes to Change Their Minds.” And it’s about the fact that while maybe not trying to outlaw IVF entirely, the anti-abortion movement does want to dramatically change how it’s practiced in the U.S.

For example, they would like to decrease the number of embryos that can be created and transplanted, both of which would likely make the already expensive treatment even more expensive still. Anti-abortion activists also would like to ban pre-implantation genetic testing so that, “Defective embryos can’t be discarded.” Except that couples with genes for deadly diseases often turn to IVF exactly because they don’t want to pass those diseases on to their children, and they would like to test them before they are implanted.

In other words, the anti-abortion movement may or may not be coming for contraception, but it definitely is coming for IVF. OK, that is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our technical guru, Francis Ying, and our editor Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, @jrovner, or @julierovner at Bluesky and @julie.rovner at Threads. Tami, where can we find you?

Luhby: I’m at cnn.com.

Rovner: There you go. Joanne.

Kenen: @JoanneKenen on X, and @joannekenen1 on Threads. 

Rovner: Lauren.

Weber: @LaurenWeberHP on X

Rovner: We will be back in your feed next week. Until then, be healthy.

Credits Francis Ying Audio producer Emmarie Huetteman Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on SpotifyApple PodcastsPocket Casts, or wherever you listen to podcasts.

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

USE OUR CONTENT

This story can be republished for free (details).

Unauthorized Sign-Ups Cast Shadow on Obamacare’s Record Enrollment

Kaiser Health News:Insurance - April 04, 2024

The Biden administration faces what looks like a growing problem for the federal Affordable Care Act’s insurance exchange: disreputable insurance brokers enrolling people who don’t need coverage or switching them to new plans without their authorization.

It happened to Michael Debriae, a restaurant server who lives in Charlotte. Unbeknownst to him, an agent in Florida with whom he’d never spoken enrolled him in an ACA plan in March 2023. Debriae had insurance through his job and discovered the Obamacare coverage only when his longtime pharmacy rejected a 90-day refill because the ACA plan didn’t allow it.

He filed a complaint with the federal marketplace and canceled the plan. But because the pharmacy had billed the ACA plan for other prescriptions, federal investigators told him they couldn’t retroactively cancel his coverage. He got stuck with a $700 tax bill — his entire tax refund, he said — for some of the tax credits the IRS paid his Obamacare insurer from March until July.

The ACA saw record enrollment for this year of more than 21 million people, but growing complaints from consumers like Debriae and agents who say they’ve lost clients to unauthorized switches cast a shadow on that achievement, a KFF Health News investigation found.

On Feb. 26, the Centers for Medicare and Medicaid Services sent an “unauthorized plan switch” update to insurance industry representatives acknowledging “a large number” of 2024 cases and outlining technical efforts to resolve problems.

“CMS is committed to protecting consumers in the marketplace,” Jeff Wu, deputy director for policy for the Center for Consumer Information & Insurance Oversight at CMS, said in a March statement.

Wu’s office didn’t disclose the number of complaints that have been filed or how many brokers it has sanctioned. CMS reports enforcement actions to state insurance departments, whose authority includes revoking licenses, Wu’s statement said.

Brokers say the ease with which unscrupulous agents can get into policyholder accounts in the 32 states served by the federal marketplace plays a major role in the problem. With only a person’s name, date of birth and state, a licensed agent can access a policyholder’s coverage through the federal exchange or its direct enrollment platforms. It’s harder to do in ACA marketplaces run by states, which often require additional information.

Federal regulators imposed new rules in June that require brokers to get policyholders’ written or recorded verbal consent before making changes to their coverage. But brokers say they’re rarely asked to provide that documentation to regulators.

CMS is “actively considering further regulatory and technological solutions,” Wu said.

Many state-run exchanges do more than the federal marketplace to secure accounts. In Colorado, for example, customers specify which brokers can have access. California sends a one-time passcode to enrollees to provide to their agents.

Jonathan Kanfer, an insurance broker in West Palm Beach, Fla., says his agency lost 700 clients to unauthorized plan switches. He said he’s had telemarketers offer him lists of potential clients, telling him, “You don’t even have to speak with the people.”

He turns them down, but he said rival agents might be enticed by the opportunity to collect the monthly commissions that insurers pay.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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

USE OUR CONTENT

This story can be republished for free (details).

The Horrors of TMJ: Chronic Pain, Metal Jaws, and Futile Treatments

A TMJ patient in Maine had six surgeries to replace part or all of the joints of her jaw.

Another woman in California, desperate for relief, used a screwdriver to lengthen her jawbone daily, turning screws that protruded from her neck.

A third in New York had bone from her rib and fat from her belly grafted into her jaw joint, and twice a prosthetic eyeball was surgically inserted into the joint as a placeholder in the months it took to make metal hinges to implant into her jaw.

“I feel like Mr. Potato Head,” said Jenny Feldman, 50, of New York City, whose medical records show she’s had at least 24 TMJ-related surgeries since she was a teenager. “They’re moving ribs into my face, and eyeballs, and I feel like a toy … put together [by] somebody just tinkering around.”

These are some of the horrors of temporomandibular joint disorders, known as TMJ or TMD, which afflict up to 33 million Americans, according to the National Institutes of Health. Dentists have attempted to heal TMJ patients for close to a century, and yet the disorders remain misunderstood, under-researched, and ineffectively treated, according to an investigation by KFF Health News and CBS News.

Dental care for TMJ can do patients more harm than good, and a few fall into a spiral of futile surgeries that may culminate in their jaw joints being replaced with metal hinges, according to medical and dental experts, patients, and their advocates speaking in interviews and video testimony submitted to the FDA.

TMJ disorders cause pain and stiffness in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Dentists have commonly treated the disorder with splints and orthodontics. And yet these treatments are based on “strongly held beliefs” and “inadequate research” — not compelling scientific evidence nor consistent results — according to the National Academies of Sciences, Engineering and Medicine, which reviewed decades of research on the topic. The NIH echoes this message, warning that there is “not a lot of evidence” that splints reduce pain and recommends “staying away” from any treatment that permanently changes the teeth, bite, or jaw.

“I would say that the treatments overall have not been effective, and I can understand why,” said Rena D’Souza, director of the NIH’s National Institute of Dental and Craniofacial Research. “We don’t understand the disease.”

For this investigation, journalists with KFF Health News and CBS News interviewed 10 TMJ patients with severe symptoms who said they felt trapped by an escalating series of treatments that began with splints or dental work and grew into multiple surgeries with diminishing returns and dwindling hope.

In every interview, the patients said the TMJ pain worsened throughout their treatment and they regretted some, if not all, of the care they received.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

TMJ has become an umbrella term for about 30 disorders that afflict roughly 5% to 10% of Americans. Minor symptoms may not require treatment at all, and many cases resolve by themselves over time. Severe symptoms include chronic pain and may limit the ability to eat, sleep, or talk.

In a comprehensive study of TMJ disorders by the national academies, including input from more than 110 patients, experts found that most health care professionals, including dentists, have received “minimal or no training” on TMJ disorders and patients are “often harmed” by “overly aggressive” care and the lack of proven treatments.

Almost 100 years this has been in dentistry, and look at what we have… A whole ton of people pretending they know everything, and we don’t know anything.

Terrie Cowley, TMJ patient

The American Dental Association, which represents about 160,000 dentists nationwide and establishes guidelines for the profession, declined an interview request. In a written statement, ADA President Linda Edgar said that TMJ disorders are “often managed rather than cured” and that it sees “great potential” in new efforts to research more treatment options.

Terrie Cowley, a longtime TMJ patient who leads the TMJ Association, an advocacy group that has spoken with tens of thousands of patients, said she was so disillusioned with dental care for TMJ that she advises many patients to avoid treatment entirely, potentially for years.

“Almost 100 years this has been in dentistry, and look at what we have,” Cowley said. “A whole ton of people pretending they know everything, and we don’t know anything.”

‘Not Taken Seriously’

Scientific studies have found that TMJ disorders arise up to nine times as often in women, particularly those in their 20s and 30s, leading to theories that the cause may be linked to reproductive hormones. But a true understanding of TMJ disorders remains elusive.

Kyriacos Athanasiou, a biomedical engineering professor at the University of California-Irvine, said it was because TMJ disorders are more prevalent among women that they were historically dismissed as neither serious nor complex, slowing research into the cause and treatment.

The resulting dearth of knowledge, which is glaring when compared with other joints, has been “a huge disservice” to patients, Athanasiou said. In a 2021 study he co-authored, researchers found that the knee, despite being a much simpler joint, was the subject of about six times as many research papers and grants in a single year than the jaw joint.

D’Souza agreed that TMJ disorders were “not taken seriously” for decades, along with other conditions that predominantly affect women.

“That has been a bias that is really long-standing,” she said. “And it’s certainly affected the progress of research.”

Patients have felt the effect too. In interviews, female patients said they felt patronized or trivialized by male health care providers at some point in their TMJ treatment, if not throughout. Some said they felt blamed for their own pain because they were viewed as too stressed and clenching their jaw too much.

“We desperately need research to find the reasons why more women get TMJ disease,” wrote Lisa Schmidt, a TMJ Association board member, in a 2021 newsletter from the organization. “And surgeons need to stop blaming this condition on women.”

Every time you have a surgery, your pain gets worse… If I could go back in time and go talk to younger Lisa, I would say ‘Run!’

Lisa Schmidt, TMJ patient

Schmidt, 52, of Poway, California, said she was diagnosed with TMJ disorder in 2000 due to headaches, and an orthodontist immediately recommended her for a splint, braces, and surgery.

After wearing the splint for only three days, Schmidt said, she was in “excruciating pain” and could no longer open her mouth far enough to eat solid food. Schmidt said she spent the next 17 years stuck on a “surgery carousel” with no escape, and eventually was in so much pain she abandoned her career as an aerospace scientist who worked alongside NASA astronauts.

Schmidt said her low point came in 2016. In an attempt to restore bone that had been cut away in prior surgeries, a surgeon implanted long screws into Schmidt’s jaw that protruded downward out of her neck. Schmidt said she was instructed to tighten those screws with a screwdriver daily for about 20 days, lengthening the corners of her jaw to restore the bone that had been lost. It didn’t work, Schmidt said, and she was left in more pain than ever.

“Every time you have a surgery, your pain gets worse,” Schmidt said. “If I could go back in time and go talk to younger Lisa, I would say ‘Run!’”

Lack of Sufficient Evidence

Many of the shortcomings of TMJ care were laid bare in the 426-page report published by the national academies in March 2020 that received limited public attention amid the coronavirus pandemic. The report’s 18 authors include medical and dental experts from Harvard, Duke, Clemson, Michigan State, and Johns Hopkins universities.

Sean Mackey, a Stanford professor who co-led the team, said it found that patients were often steered toward costly treatments and “pathways of futility” instead of being taught to manage their pain through strategies and therapies with “good evidence.”

“We learned it’s a quagmire,” Mackey said. “There is a perverse incentive in our society that pays more for things we do to people than [for] talking and listening to people. … Some of those procedures, some of those surgeries, clearly are not helping people.”

Among its many findings, the national academies said it has been widely assumed in the field of dentistry that TMJ disorders are caused by a misaligned bite, so treatments have focused on patients’ teeth and bite for more than 50 years. But there is a “notable absence of sufficient evidence” that a misaligned bite is a cause of TMJ disorders, and the belief traces back to “inadequate research” in the 1960s that has been repeated in “poorly-designed studies” ever since, the report states.

Therefore, TMJ treatment that makes permanent changes to the bite — like installing braces or crowns or grinding teeth down — has “no supporting evidence,” according to the national academies report. The NIH warns that these TMJ treatments “don’t work and may make the problem worse.”

Dental splints, the most common TMJ treatment, also known as night guards or mouth guards, are removable dental appliances that are molded to fit over the teeth and can cost hundreds or even thousands of dollars out-of-pocket, according to the TMJ Association. Like most medical devices, splints generally go through the FDA’s 510(k) clearance process, which does not require each splint to be proven effective before it can be sold, according to the agency.

The national academies’ report states that splints produce “mixed results” for TMJ patients, and even when splints succeed at reducing jaw pain it is not understood why they work. Hundreds of splint designs exist, the report states, and some dentists reject research that challenges the use of splints unless it focuses on the specific design they prefer.

“Because of the hundreds of variations in [splint] design, it is unlikely that any study could ever be conducted that will be considered sufficient to a particular dentist with a pre-existing belief about the effectiveness of one appliance,” the report states.

Other treatments fare no better. The FDA has not labeled any drugs specifically for TMJ disorders, and pain medicines can be too weak or addictive to be a long-term solution, according to the TMJ Association. Botox injections may ease pain but have raised concerns about bone loss during animal testing. The NIH warns that minor surgeries that flush the jaw with liquid bring only temporary pain relief and that more complex surgeries should be reserved for severe cases because they have yet to be proved safe or effective in the long term.

To improve care, the national academies called for better education about TMJ disorders across medicine and dentistry and more research funding from the NIH, which has a “ripple effect” on research and training across the nation.

Since the 2020 report, the NIH has launched a TMJ research collaborative and increased annual research funding from about $15 million to about $34 million, D’Souza said. TMJ care was added to the standards that dental schools must teach to be accredited in 2022. The national academies launched an ongoing forum on TMJ disorders last year.

But TMJ funding still pales in comparison to other ailments. The NIH spends billions each year to research deadly diseases, like cancer and heart disease, that also afflict large numbers of Americans. It spends millions more on research of non-life-threatening conditions like arthritis, back pain, eczema, and headaches.

Mackey noted that much of the NIH’s spending is allocated by Congress.

“If Congress comes in and says, ‘We want to devote X amount of money to [TMJ],’ all of the sudden you will see an increase in money,” Mackey said. “So that’s my message to people out there: Raise your voices. Write your legislator.”

Total Jaw Replacements

Plagued by TMJ symptoms, and after failed treatments, some patients turn to a last resort: replacing their jaw joint with synthetic implants. Surgeons might replace the cartilage disk at the core of the joint or use “total joint replacement surgery” to fasten a metal hinge to the bones of the skull.

But the implants have a harrowing history: Several disk implants were recalled or discontinued in the ’90s due to dangerous failures. The FDA now classifies TMJ implants among its most closely monitored medical devices because the products on the market today can cause “adverse health consequences” if the devices fail, according to the agency’s website.

Two companies, Zimmer Biomet and Stryker, make the only total jaw replacement implants currently sold in the U.S.

Zimmer Biomet, which has made its implant for more than two decades, described it in email statements as “a safe and efficacious solution” for patients who need their jaw joint replaced, either due to TMJ disorders, failed surgeries, injuries, or other ailments. An FDA-mandated study completed in 2017 found about 14% of patients who get the Zimmer Biomet implant require additional surgery or removal within 10 years, said agency spokesperson Carly Pflaum.

Stryker, which in 2021 bought a company that made a total jaw replacement implant and now makes the implant itself, declined to comment. Although the NIH has advised TMJ patients to avoid surgery since at least 2022, Stryker launched a “patient-facing website” for the implant last year and is recruiting surgeons to be added to a “surgeon locator” feature on the site, according to posts on Facebook and LinkedIn.

A study of the Stryker implant’s success rate was mandated by the FDA and completed in 2020, but the agency has yet to make the results public.

D’Souza, the NIH official, said that based on her professional experience, she estimates that most total jaw replacement surgeries are ultimately ineffective.

“The success rate is low,” D’Souza said. “It is not very encouraging.”

Multiple patients provided KFF Health News and CBS News with medical records showing their total jaw replacement implants had to be removed due to malfunction, infection, or previously unknown metal allergies. Several patients said that since their implants were removed months or years ago, they have lived with no hinge in their jaw at all.

Kalinowski, the TMJ patient in Maine, has had portions of her jaw joint replaced six times, including receiving four implants. Her medical records show that the cartilage disk on her right side was replaced in 1986 with an implant that was later recalled and again in 1987 with another that was later discontinued. Her left and right disks were replaced in 1992 with a muscle flap and rib graft, respectively, and her entire right joint was replaced with yet another implant that was later discontinued in 1998. Both joints were replaced again in 2015, her records show.

Since then, Kalinowski said, her artificial jaw has functioned properly, although she remains in pain and cannot move her jaw from side to side. Her mouth hangs open when her face is at rest, and she drinks protein shakes for lunch because it’s easier than struggling with solid food.

But the “worst part,” Kalinowski said, is that her surgeries caused nerve damage on her lower face, and so she has not felt her husband’s kisses since the ’90s.

“If there was one moment in my life I could take back and do over again, it would be that first surgery. Because it set me on a trajectory,” Kalinowski said. “And it never goes away.”

CBS News producer Nicole Keller contributed to this article.

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

USE OUR CONTENT

This story can be republished for free (details).

End of Internet Subsidies for Low-Income Households Threatens Telehealth Access

Kaiser Health News:States - April 04, 2024

For Cindy Westman, $30 buys a week’s worth of gas to drive to medical appointments and run errands.

It’s also how much she spent on her monthly internet bill before the federal Affordable Connectivity Program stepped in and covered her payments.

“When you have low income and you are living on disability and your daughter’s disabled, every dollar counts,” said Westman, who lives in rural Illinois.

More than 23 million low-income households — urban, suburban, rural, and tribal — are enrolled in the federal discount program Congress created in 2021 to bridge the nation’s digital connectivity gap. The program has provided $30 monthly subsidies for internet bills or $75 discounts in tribal and high-cost areas.

But the program is expected to run out of money in April or May, according to the Federal Communications Commission. In January, FCC Chairwoman Jessica Rosenworcel asked Congress to allocate $6 billion to keep the program running until the end of 2024. She said the subsidy gives Americans the “internet service they need to fully participate in modern life.”

The importance of high-speed internet was seared into the American psyche by scenes of children sitting in parking lots and outside fast-food restaurants to attend school online during the covid-19 pandemic. During that same period, health care providers and patients like Westman say, being connected also became a vital part of today’s health care delivery system.

Westman said her internet connection has become so important to her access to health care she would sell “anything that I own” to stay connected.

Westman, 43, lives in the small town of Eureka, Illinois, and has been diagnosed with genetic and immune system disorders. Her 12-year-old daughter has cerebral palsy and autism.

She steered the $30 saved on her internet toward taking care of her daughter, paying for things such as driving 30 minutes west to Peoria, Illinois, for two physical therapy appointments each week. And with an internet connection, Westman can access online medical records, and whenever possible she uses telehealth appointments to avoid the hour-plus drive to specialty care.

“It’s essential for me to keep the internet going no matter what,” Westman said.

Expanding telehealth is a common reason health care providers around the U.S. — in states such as Massachusetts and Arkansas — joined efforts to sign their patients up for the federal discount program.

“This is an issue that has real impacts on health outcomes,” said Alister Martin, an emergency medicine physician at Massachusetts General Hospital. Martin realized at the height of the pandemic that patients with means were using telehealth to access covid care. But those seeking in-person care during his ER shifts tended to be lower-income, and often people of color.

“They have no other choice,” Martin said. “But they probably don’t need to be in the ER action.” Martin became a White House fellow and later created a nonprofit that he said has helped 1,154 patients at health centers in Boston and Houston enroll in the discount program.

At the University of Arkansas for Medical Sciences, a federal grant was used to conduct dozens of outreach events and help patients enroll, said Joseph Sanford, an anesthesiologist and the director of the system’s Institute for Digital Health & Innovation.

“We believe that telehealth is the great democratization to access to care,” Sanford said. New enrollment in the discount program halted nationwide last month.

Leading up to the enrollment halt, Sen. Peter Welch (D-Vt.) led a bipartisan effort to introduce the Affordable Connectivity Program Extension Act in January. The group requested $7 billion — more than the FCC’s ask — to keep the program funded. “Affordability is everything,” Welch said.

In December, federal regulators surveyed program recipients and found that 22% reported no internet service before, and 72% said they used their ACP-subsidized internet to “schedule or attend healthcare appointments.”

Estimates of how many low-income U.S. households qualify for the program vary, but experts agree that only about half of the roughly 50 million eligible households have signed on.

“A big barrier for this program generally was people don’t know about it,” said Brian Whitacre, a professor and the Neustadt chair in the Department of Agricultural Economics at Oklahoma State University.

Whitacre and others said rural households should be signing up at even higher rates than urban ones because a higher percentage of them are eligible.

Yet, people found signing up for the program laborious. Enrollment was a two-step process. Applicants were required to get approved by the federal government then work with an internet service provider that would apply the discount. The government application was online — hard to get to if you didn’t yet have internet service — though applicants could try to find a way to download a version, print it, and submit the application by mail.

When Frances Goli, the broadband project manager for the Shoshone-Bannock Tribes in Idaho, began enrolling tribal and community members at the Fort Hall Reservation last year, she found that many residents did not know about the program — even though it had been approved more than a year earlier.

Goli and Amber Hastings, an AmeriCorps member with the University of Idaho Extension Digital Economy Program, spent hours helping residents through the arduous process of finding the proper tribal documentation required to receive the larger $75 discount for those living on tribal lands.

“That was one of the biggest hurdles,” Goli said. “They’re getting denied and saying, come back with a better document. And that is just frustrating for our community members.”

Of the more than 200 households Goli and Hastings aided, about 40% had not had internet before.

In the tribal lands of Oklahoma, said Sachin Gupta, director of government business and economic development at internet service provider Centranet, years ago the funding may not have mattered.

“But then covid hit,” Gupta said. “The stories I have heard.”

Elders, he said, reportedly “died of entirely preventable causes” such as high blood pressure and diabetes because they feared covid in the clinics.

“It’s really important to establish connectivity,” Gupta said. The end of the discounts will “take a toll.”

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

USE OUR CONTENT

This story can be republished for free (details).

Feds Join Ranks of Employers with Generous Fertility Benefits

Companies have increasingly offered generous fertility benefits to attract and keep top-notch workers. Now, the federal government is getting in on the act. Starting this year, federal employees can choose plans that cover several fertility services, including up to $25,000 annually for in vitro fertilization procedures and up to three artificial insemination cycles each year.

With about 2.1 million civilian employees, the federal government is the nation’s largest employer. Now, just as businesses of every stripe prioritize fertility benefits, in vitro fertilization — a procedure in use for more than 40 years — has become a tricky topic for some anti-abortion Republican members of Congress and even presidential candidates.

It was inevitable that disagreements over IVF among abortion opponents would eventually break into the open, said Mary Ziegler, a legal historian and expert on reproductive health.

“The anti-abortion movement from the 1960s onward has been a fetal personhood movement,” said Ziegler, a law professor at the University of California-Davis. Since the U.S. Supreme Court’s Dobbs decision eliminated the constitutional right to abortion, anti-abortion groups and the Republican Party are grappling with what “fetal personhood” means and how that fits into their position on IVF and other technologies that help people have babies.

The Alabama Supreme Court set the stage for the recent brouhaha with a ruling last month that frozen embryos created through IVF are children under state law. A pair of Democratic senators advanced legislation that would override state laws by establishing a statutory right to access IVF and other such technologies. The bill was blocked on the Senate floor by a Republican opponent.

These events highlight the tough spot in which Republicans find themselves. Many support IVF, and they are keenly aware that it’s extremely popular: 86% of adults in a recent CBS News-YouGov poll said IVF should be legal. The outcry over the Alabama ruling and Republicans’ inability to coalesce around a federal response, however, has exposed fault lines in the party.

Some anti-abortion groups have strenuously objected to measures like that Senate bill, arguing that lawmakers must balance IVF with the responsibility to respect life.

Republicans “are trying to finesse it, which is very hard,” Ziegler said.

About 10% of women and men face fertility problems, according to the National Institute of Child Health and Human Development. IVF, a process in which an egg is fertilized in a laboratory and later implanted in the uterus, is among the most expensive fertility treatments, costing about $20,000 for one round. Even with insurance coverage, the procedure is pricey, but for some people it’s the only way to conceive.

In recent years, the number of companies offering fertility benefits to employees has grown steadily. In the early 2000s, fewer than a quarter of employers with at least 500 workers covered IVF, according to benefits consultant Mercer’s annual employer survey. In 2023, that figure had roughly doubled, to 45%. Employers typically cap IVF benefits. In 2023, employers had a median lifetime maximum benefit of $20,000 for IVF, according to the Mercer survey.

The federal government’s IVF benefit — paying up to $25,000 a year — is more generous than that of a typical employer. Coverage is available through the popular Blue Cross and Blue Shield Federal Employee Program’s standard option. Altogether, two dozen 2024 health plans for federal workers offer enhanced IVF coverage, with varying benefits and cost sharing, according to the federal Office of Personnel Management, which manages the federal health plans.

“OPM’s mission is to attract and retain the workforce of the future,” said Viet Tran, OPM’s press secretary, in written answers to questions. He noted that surveys have found that federal health benefits have influenced employees’ decisions to stay with the federal government.

Starting this year, plans offered to federal employees are required to offer fertility benefits, according to OPM.

But it’s unclear how the emerging political debate surrounding IVF and other reproductive health issues could affect national benefit and coverage trends.

Last month, after the Alabama Supreme Court ruled that frozen embryos left over following IVF procedures are considered children under state law, the state legislature quickly passed and Republican Gov. Kay Ivey signed a bill that grants immunity to patients and providers who participate in IVF services. During the ensuing dust-up, a coalition of more than a dozen anti-abortion groups signed a letter drawing a clear line in the sand. “Both science and logic have made it clear that embryos must be accorded the same human rights” as other human beings, it read. The Alabama law didn’t address the underlying issue of the “personhood” of the embryos, leaving open the door for further litigation and potential restrictions on IVF in Alabama and other states, some legal analysts say.

More than a third of states have laws on the books that classify fetuses as people at some stage of pregnancy, according to an analysis by Politico.

It’s unclear whether the turmoil surrounding the Alabama case will have long-term repercussions for employee benefits there or in other states.

“If this were something that were to happen in multiple states, employers would have to figure out how to navigate around that,” said Jim Winkler, chief strategy officer of the Business Group on Health, a nonprofit that represents the interests of large employers. At this point, employers will want to keep a watchful eye on the issue but probably not plan any changes, Winkler said.

A Mercer blog post advised businesses with Alabama employees to review health plan policies related to medical travel and leave benefits. Further, “employers should monitor other states that broadly define fetal personhood and restrict reproductive healthcare,” the blog post advised.

The situation is reminiscent of what happened with abortion coverage following the Supreme Court’s Dobbs decision in 2022. As states imposed restrictions on access to abortions, many companies began providing travel expenses for their workers to seek them.

But what happened with abortion may not be a good predictor of what will happen with IVF, said Dorianne Mason, director of health equity at the National Women’s Law Center.

Following the Alabama judge’s ruling, “the legislature in Alabama moved so quickly to respond to the outcry,” Mason said. “When we look at the legislative response to IVF, it’s moving in a markedly different direction on access to care” than has occurred with other types of reproductive care.

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

USE OUR CONTENT

This story can be republished for free (details).

Readout of HHS Secretary Xavier Becerra’s Roundtable on Fortifying Corn Masa Products

HHS Gov News - April 03, 2024
Secretary Xavier Becerra hosted a roundtable with representatives of large manufacturers and distributors of corn masa flour products.

The GOP Keeps Pushing Medicaid Work Requirements, Despite Setbacks

Kaiser Health News:States - April 03, 2024

Work requirements in Medicaid expansion programs are back on the agenda in many statehouses — despite their lackluster track record.

In Mississippi, the idea has momentum from GOP lawmakers advancing legislation to expand Medicaid. In Kansas, the Democratic governor proposed work requirements to try to soften Republican opposition to expansion. (She’s had little luck, so far.)

The controversial policy even has fresh traction in states that expanded Medicaid years ago, including Idaho and Louisiana.

Just two states have implemented a special program to require low-income adults to prove they’re working in exchange for health coverage under Medicaid. In 2019, a court ended Arkansas’s initiative, but not before 18,000 people lost coverage.

Since then, only the signature Medicaid experiment of Georgia Gov. Brian Kemp (R), called Pathways to Coverage, has survived legal challenges and gotten off the ground.

Yet it’s off to a rocky start, with low enrollment and mounting administrative costs already exceeding $20 million. “It doesn’t work, and it’s perfectly clear in Georgia,” said Joan Alker, executive director and co-founder of the Georgetown Center for Children and Families.

Only about 3,500 people have enrolled so far. That’s a small fraction of the Georgians who would be eligible if the state adopted the Affordable Care Act’s Medicaid expansion without work requirements.

Some Georgia Republicans blocked a bill in March that would have authorized a full Medicaid expansion, arguing that Pathways needs more time. The program is just one part of an overall plan to move people into private insurance, Kemp spokesperson Garrison Douglas told us.

Work requirements can come with big administrative price tags, according to a 2019 report from the Government Accountability Office, which recommended that the Centers for Medicare & Medicaid Services consider administrative costs in waiver applications.

States have to set up technology to check compliance, plus hire staff to keep all the paperwork straight. Under Georgia’s plan, people earning up to the federal poverty level — $15,060 for an individual adult — must document that they’re working, in school, doing community service or performing other qualifying activities. Taking care of a child or parent doesn’t count.

Documents obtained by KFF Health News show that administrative costs along with consulting fees have absorbed more than 90 percent of the Georgia program’s spending. As of Dec. 31, about $2 million went to Medicaid managed-care companies; $24 million was spent on administration and consultants. The administrative costs are expected to balloon to $122 million over four years.

Critics argue that the red tape keeps people from getting health care. And while work requirements don’t significantly boost employment, simply providing health coverage can, according to a 2023 KFF brief.

But don’t expect the idea to disappear — especially if former president Donald Trump returns to the White House. The first Trump administration approved Medicaid work-requirement programs in 13 states.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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

USE OUR CONTENT

This story can be republished for free (details).

Attacks on Emergency Room Workers Prompt Debate Over Tougher Penalties

Kaiser Health News:States - April 03, 2024

Patients hurl verbal abuse at Michelle Ravera every day in the emergency room. Physical violence is less common, she said, but has become a growing threat.

Ravera, an ER nurse at Sutter Medical Center in Sacramento, recalled an incident in which an agitated patient wanted to leave. “Without any warning he just reached up, grabbed my glasses, and punched me in the face,” said Ravera, 54. “And then he was getting ready to attack another patient in the room.” Ravera and hospital security guards subdued the patient so he couldn’t hurt anyone else.

Violence against health care workers is on the rise, including in the ER, where tensions can run high as staff juggle multiple urgent tasks. Covid-19 only made things worse: With routine care harder to come by, many patients ended up in the ER with serious diseases — and brimming with frustrations.

In California, simple assault against workers inside an ER is considered the same as simple assault against almost anyone else, and carries a maximum punishment of a $1,000 fine and six months in jail. In contrast, simple assault against emergency medical workers in the field, such as an EMT responding to a 911 call, carries maximum penalties of a $2,000 fine and a year in jail. Simple assault does not involve the use of a deadly weapon or the intention to inflict serious bodily injury.

State Assembly member Freddie Rodriguez, who worked as an EMT, has authored a bill to make the punishments consistent: a $2,000 fine and one year in jail for simple assault on any on-the-job emergency health care worker, whether in the field or an ER. The measure would also eliminate the discrepancy for simple battery.

Patients and family members are assaulting staff and “doing things they shouldn’t be doing to the people that are there to take care of your loved ones,” said Rodriguez, a Democrat from Pomona. The bill passed the state Assembly unanimously in January and awaits consideration in the Senate.

Rodriguez has introduced similar measures twice before. Then-Gov. Jerry Brown vetoed one in 2015, saying he doubted a longer jail sentence would deter violence. “We need to find more creative ways to protect the safety of these critical workers,” he wrote in his veto message. The 2019 bill died in the state Senate.

Rodriguez said ERs have become more dangerous for health care workers since then and that “there has to be accountability” for violent behavior. Opponents fear stiffer penalties would be levied disproportionately on patients of color or those with developmental disabilities. They also point out that violent patients can already face penalties under existing assault and battery laws.

Data from the California Division of Occupational Safety and Health shows that reported attacks on ER workers by patients, visitors, and strangers jumped about 25% from 2018 to 2023, from 2,587 to 3,238. The rate of attacks per 100,000 ER visits also increased.

Punching, kicking, pushing, and similar aggression accounted for most of the attacks. Only a small number included weapons.

These numbers are likely an undercount, said Al’ai Alvarez, an ER doctor and clinical associate professor at Stanford University’s Department of Emergency Medicine. Many hospital staffers don’t fill out workplace violence reports because they don’t have time or feel nothing will come of it, he said.

Ravera remembers when her community rallied around health care workers at the start of the pandemic, acting respectfully and bringing food and extra N95 masks to workers.

“Then something just switched,” she said. “The patients became angrier and more aggressive.”

Violence can contribute to burnout and drive workers to quit — or worse, said Alvarez, who has lost colleagues to suicide, and thinks burnout was a key factor. “The cost of burnout is more than just loss of productivity,” he said. “It's loss of human beings that also had the potential to take care of many more people.”

The National Center for Health Workforce Analysis projects California will experience an 18% shortage of all types of nurses in 2035, the third worst in the country.

Federal legislation called the Safety From Violence for Healthcare Employees Act would set sentences of up to 10 years for assault against a health care worker, not limited to emergency workers, and up to 20 years in cases involving dangerous weapons or bodily injury. Though it was introduced in 2023, it has not yet had a committee hearing.

Opponents of the California bill, which include ACLU California Action, the California Public Defenders Association, and advocates for people with autism, argue it wouldn’t deter attacks — and would unfairly target certain patients.

“There's no evidence to suggest that increased penalties are going to meaningfully address this conduct,” said Eric Henderson, a legislative advocate for ACLU California Action. “Most importantly, there are already laws on the books to address assaultive conduct.”

Beth Burt, executive director of the Autism Society Inland Empire, said the measure doesn’t take into account the special needs of people with autism and other developmental disorders.

The smells, lights, textures, and crowds in the ER can overstimulate a person with autism, she said. When that happens, they can struggle to articulate their feelings, which can result in a violent outburst, “whether it’s a 9-year-old or a 29-year-old,” Burt said.

She worries that hospital staff may misunderstand these reactions, and involve law enforcement when it’s not necessary. As “a parent, it is still my worst fear” that she’ll get a phone call to inform her that her adult son with autism has been arrested, she said.

Burt would rather the state prioritize de-escalation programs over penalties, such as the training programs for first responders she helped create through the Autism Society Inland Empire. After implementing the training, hospital administrators asked Burt to share some strategies with them, she said. Hospital security staffers who do not want to use physical restraints on autistic patients have also sought her advice, she said.

Supporters of the bill, including health care and law enforcement groups, counter that people with mental health conditions or autism who are charged with assault in an ER may be eligible for existing programs that provide mental health treatment in lieu of a criminal sentence.

Stephanie Jensen, an ER nurse and head of governmental affairs for the Emergency Nurses Association, California State Council, said her organization is simply arguing for equity. “If you punch me in the hospital, it’s the same as if you punch me on the street,” she said.

If lawmakers don’t act, she warned, there won’t be enough workers for the patients who need them.

“It’s hard to keep those human resources accessible when it just seems like you’re showing up to get beat up every day,” Jensen said. “The emergency department is taking it on the chin, literally and figuratively.”

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

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

USE OUR CONTENT

This story can be republished for free (details).

Heat Protections for California Workers Are in Limbo After Newsom Abandons Rules

Kaiser Health News:States - April 03, 2024

SACRAMENTO, Calif. — California Gov. Gavin Newsom’s administration has abandoned proposed protections for millions of California workers toiling in sweltering warehouses, steamy kitchens, and other dangerously hot workplaces — upending a regulatory process that had been years in the making.

The administration’s eleventh-hour move, which it attributed to the cost of the new regulations, angered workplace safety advocates and state regulators, setting off a mad scramble to implement emergency rules before summer.

But it’s unclear how, when, or if the emergency rules will come down, and whether they’ll be in place in time to protect workers from the intensifying heat.

“It’s the administration’s moral obligation to fix this,” said Lorena Gonzalez Fletcher, a former state lawmaker and the chief officer of the California Labor Federation, which represents more than 1,300 unions. “There needs to be emergency regulations or legislation quickly, because we can’t stop summer.”

California has had heat standards on the books for outdoor workers since 2005, and indoor workplaces were supposed to be next. The proposed standards would have required work sites to be cooled below 87 degrees Fahrenheit when employees are present and below 82 degrees in places where workers wear protective clothing or are exposed to radiant heat, such as furnaces. Buildings could be cooled with air conditioning, fans, misters, and other methods.

The rules would have allowed workarounds for businesses that couldn’t cool their workplaces sufficiently, such as laundries or restaurant kitchens.

Despite concerns from the administration, the California Occupational Safety and Health Standards Board approved the rules at its March 21 meeting, prompting a tense political standoff between workplace safety advocates and Newsom, the second-term Democratic governor who has sought to elevate his national profile and claim progressive leadership on climate change and worker rights — key platforms for the Democratic Party.

State Department of Finance spokesperson H.D. Palmer said the issue isn’t the state’s ballooning budget deficit — estimated between $38 billion and $73 billion — but a legal requirement to nail down the cost of the rules to the state government.

“It wasn’t, ‘We’re trying to sink these regulations,’” Palmer said.

Palmer said the administration received a murky cost estimate from the California Department of Corrections and Rehabilitation indicating that implementing the standards in its prisons and other facilities could cost billions. The board’s economic analysis, on the other hand, pegged the cost at less than $1 million a year.

“Without our concurrence of the fiscal estimates, those regulations in their latest iteration will not go into effect,” he said.

According to Corrections spokesperson Albert Lundeen, the rules would entail major spending that could require the legislature to fund “extensive capital improvements.” He added that the agency is committed to discussing “how these regulations could be implemented cost-effectively at our institutions to further bolster worker safety.”

Board members argue the state has had years to analyze the cost of the proposed standards, and that it must quickly impose emergency regulations. But it’s not clear how that might happen, whether in days by the administration or months via the state budget process — or another way.

“This is a public health emergency,” said Laura Stock, a board member who is also an expert on workplace safety and health at the University of California-Berkeley.

Newsom spokesperson Erin Mellon defended the move to halt permanent regulations, saying approving them would be “imprudent” without a detailed cost estimate.

“The administration is committed to implementing the indoor heat regulations and ensuring workplace protections,” she said in a statement. “We are exploring all options to put these worker protections in place, including working with the legislature.”

Only Minnesota and Oregon have adopted heat rules for indoor workers. Legislation has stalled in Congress, and even though the Biden administration has initiated the long process of establishing national heat standards for outdoor and indoor work, they may take years to finalize.

Seven workers died in California from indoor heat between 2010 and 2017. Heat stress can lead to heat exhaustion, heatstroke, cardiac arrest, and kidney failure. In 2021, the Centers for Disease Control and Prevention reported, 1,600 heat-related deaths occurred nationally, which is likely an undercount because health care providers are not required to report them. It’s not clear how many of these deaths are related to work, either indoors or outdoors.

The process to adopt California’s indoor head standards started in 2016 and involved years of negotiations with businesses and labor advocates.

Several board members acknowledged that they were frustrated by the administration’s lack of support when they adopted the regulations in March — after their meeting was temporarily halted by angry, chanting warehouse workers — knowing they would not go into effect. Instead, they said, they wanted to amplify pressure on Newsom.

“Every summer is hotter than the last, and workers who aren’t protected are going to suffer heat illness or death,” said Dave Harrison, a board member and powerful union leader with Operating Engineers Local 3. “Our hope was that the vote would be symbolic in sending a message to the state government that, listen, this is important, so we decided to vote on it anyway and put it back into the state’s court.”

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

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

USE OUR CONTENT

This story can be republished for free (details).

Pages