• Read Rayasam’s “High Price of Popular Diabetes Drugs Deprives Low-Income People of Effective Treatment”

Céline Gounder, 素人色情片Health News’ senior fellow and editor-at-large for public health, discussed whether enough doctors are trained in obesity medicine on CBS News’ “CBS Morning News” on May 29.

She also discussed the third confirmed case of bird flu in the United States 鈥� the first with respiratory symptoms 鈥� on “CBS Mornings” on May 31.

素人色情片Health News senior correspondent Noam N. Levey discussed how cancer patients face high medical debt on KCBS on May 28.

• Read Levey’s “In America, Cancer Patients Endure Debt on Top of Disease”

素人色情片Health News contributor Andy Miller discussed the drop in applications to medical residency programs in Georgia on WUGA’s “The Georgia Health Report” on May 24.

• Read Julie Rovner and Rachana Pradhan’s “Medical Residents Are Increasingly Avoiding States With Abortion Restrictions”

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Without Ozempic or a similar drug, Cooper Harris suffers blackouts, becomes too tired to watch her grandchildren, and struggles to earn extra money braiding hair. Marcus Harris, who works as a Waffle House cook, needs Trulicity to keep his legs and feet from swelling and bruising.

The couple’s doctor has tried prescribing similar drugs, which mimic a hormone that suppresses appetite and controls blood sugar by boosting insulin production. But those, too, are often out of stock. Other times, their insurance through the Affordable Care Act marketplace burdens the couple with a lengthy approval process or an out-of-pocket cost they can’t afford.

“It’s like, I’m having to jump through hoops to live,” said Cooper Harris, 46, a resident of Covington, Georgia, east of Atlanta.

Supply shortages and insurance hurdles for this powerful class of drugs, called GLP-1 agonists, have left many people who are suffering from diabetes and obesity without the medicines they need to stay healthy.

One root of the problem is the very high prices set by drugmakers. About 54% of adults who had taken a GLP-1 drug, including those with insurance, said the cost was “difficult” to afford, according to released this month. But it is patients with the lowest disposable incomes who are being hit the hardest. These are people with few resources who struggle to see doctors and buy healthy foods.

In the United States, Novo Nordisk charges about $1,000 for a month’s supply of Ozempic, and Eli Lilly charges a similar amount for Mounjaro. Prices for a month’s supply of different GLP-1 drugs before insurance coverage, according to the Peterson-素人色情片Health System Tracker. Medicare spending for three popular diabetes and weight loss drugs 鈥� Ozempic, Rybelsus, and Mounjaro 鈥� reached $5.7 billion in 2022, up from $57 million in 2018, according to .

The “” price has “the potential to bankrupt Medicare, Medicaid, and our entire health care system,” Sen. Bernie Sanders (I-Vt.), who chairs the U.S. Senate Committee on Health, Education, Labor and Pensions, wrote in a letter to Novo Nordisk in April.

The high prices also mean that not everyone who needs the drugs can get them. “They’re kind of disadvantaged in multiple ways already and this is just one more way,” said Wedad Rahman, an endocrinologist with Piedmont Healthcare in Conyers, Georgia. Many of Rahman’s patients, including Cooper Harris, are underserved, have high-deductible health plans, or are on public assistance programs like Medicaid or Medicare.

Many drugmakers have programs that help patients get started and stay on medicines for little or no cost. But those programs have not been reliable for medicines like Ozempic and Trulicity because of the supply shortages. And many insurers’ requirements that patients receive prior authorization or first try less expensive drugs add to delays in care.

By the time many of Rahman’s patients see her, their diabetes has gone unmanaged for years and they’re suffering from severe complications like foot wounds or blindness. “And that’s the end of the road,” Rahman said. “I have to pick something else that’s more affordable and isn’t as good for them.”

GLP-1 agonists 鈥� the category of drugs that includes Ozempic, Trulicity, and Mounjaro 鈥� were first approved to treat diabetes. In the last three years, the Food and Drug Administration has approved rebranded versions of Mounjaro and Ozempic for weight loss, leading demand to skyrocket. And demand is only growing as more of the drugs’ benefits become apparent.

In March, the FDA approved the weight loss drug Wegovy, a version of Ozempic, to , which will likely increase demand, and spending. Up to 30 million Americans, or 9% of the U.S. population, are expected to be on a GLP-1 agonist by 2030, the financial services company .

As more patients try to get prescriptions for GLP-1 agonists, drugmakers struggle to make enough doses.

Eli Lilly is urging people to avoid using its drug Mounjaro for cosmetic weight loss to ensure enough supplies for people with medical conditions. But the drugs’ popularity continues to grow despite side effects such as nausea and constipation, driven by their effectiveness and celebrity endorsements. In March, Oprah Winfrey released an hourlong special on the medicines’ ability to help with weight loss.

It can seem like everyone in the world is taking this class of medication, said Jody Dushay, an assistant professor of medicine at Harvard Medical School and an endocrinologist at Beth Israel Deaconess Medical Center. “But it’s kind of not as many people as you think,” she said. “There just isn’t any.”

Even when the drugs are in stock, insurers are clamping down, leaving patients and health care providers to navigate a thicket of ever-changing coverage rules. State Medicaid plans of the drugs for weight loss. Medicare if they are prescribed for obesity. And due to the drugs’ cost.

Health care providers are cobbling together care plans based on what’s available and what patients can afford. For example, Cooper Harris’ insurer covers Trulicity but not Ozempic, which she said she prefers because it has fewer side effects. When her pharmacy was out of Trulicity, she had to rely more on insulin instead of switching to Ozempic, Rahman said.

One day in March, Brandi Addison, an endocrinologist in Corpus Christi, Texas, had to adjust the prescriptions for all 18 of the patients she saw because of issues with drug availability and cost, she said. One patient, insured through a teacher retirement health plan with a high deductible, couldn’t afford to be on a GLP-1 agonist, Addison said.

“Until she reaches that deductible, that’s just not a medication she can use,” Addison said. Instead, she put her patient on insulin, whose price is capped at a fraction of the cost of Ozempic, but which doesn’t have the same benefits.

“Those patients who have a fixed income are going to be our more vulnerable patients,” Addison said.

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Sin Ozempic o un medicamento similar, Cooper Harris sufre desmayos, se cansa demasiado para cuidar a sus nietos y lucha por ganar dinero extra haciendo trenzas. Marcus Harris, que es cocinero en Waffle House, necesita Trulicity para evitar que sus piernas y pies se hinchen y se hagan moretones.

La médica de la pareja ha intentado recetarles medicamentos similares, que imitan una hormona que suprime el apetito y controla el azúcar en sangre al aumentar la producción de insulina. Pero no suele haber stock de estas drogas. Otras veces, el plan médico que tienen a través del mercado de la Ley de Cuidado de Salud a Bajo Precio (ACA) les impone un largo proceso de aprobación o un costo de bolsillo que no pueden pagar.

“Es como si tuviera que saltar obstáculos para vivir”, dijo Cooper Harris, de 46 años, residente de Covington, Georgia, al este de Atlanta.

La escasez de suministros y las barreras que ponen las aseguradoras para obtener esta poderosa clase de medicamentos, llamados agonistas de GLP-1, han dejado a muchas personas que viven con diabetes y obesidad sin los medicamentos que necesitan para mantenerse saludables.

Una de las raíces del problema es el precio muy establecido por las farmacéuticas que fabrican estos medicamentos. Alrededor del 54% de los adultos que habían tomado un medicamento GLP-1, incluidos aquellos con seguro, dijeron que el costo era “difícil” de pagar, según los resultados de publicada este mes.

Pero los más afectados son los pacientes con ingresos más bajos: personas con pocos recursos que luchan por ver a los médicos y comprar alimentos saludables.

En Estados Unidos, Novo Nordisk cobra alrededor de $1,000 por un suministro mensual de Ozempic, y Eli Lilly cobra una cantidad similar por Mounjaro. Los precios de un suministro mensual de diferentes medicamentos GLP-1 varían antes de la cobertura de la aseguradora, según el Peterson-素人色情片Health System Tracker.

El gasto de Medicare en tres populares medicamentos para la diabetes y la pérdida de peso 鈥擮zempic, Rybelsus y Mounjaro鈥� alcanzó los $5.7 mil millones en 2022, frente a los $57 millones en 2018, según .

El precio tiene “el potencial de llevar a la quiebra a Medicare, Medicaid y todo nuestro sistema de salud”, escribió el senador Bernie Sanders (independiente de Vermont), presidente del Comité de Salud, Educación, Trabajo y Pensiones del Senado de EE.UU., en una carta a Novo Nordisk en abril.

Los precios altos también significan que no todos los que necesitan los medicamentos pueden obtenerlos. “Ya están en desventaja de múltiples maneras y esta es solo una más”, dijo Wedad Rahman, endocrinóloga de Piedmont Healthcare en Conyers, en Georgia. Muchos de los pacientes de Rahman, incluidos los Cooper Harris, están desatendidos, tienen planes de salud con deducibles altos o están en programas de asistencia pública como Medicaid o Medicare.

Muchos fabricantes de medicamentos tienen programas que ayudan a los pacientes a comenzar y mantenerse en tratamientos con medicamentos por poco o ningún costo. Pero esos programas no han sido confiables para drogas como Ozempic y Trulicity debido a la escasez de suministros. Y los requisitos de muchos aseguradoras, que los pacientes reciban autorización previa o primero intenten con medicamentos menos costosos, suman demoras en la atención.

Para cuando muchos de los pacientes de Rahman la ven, su diabetes no ha sido controlada durante años y están sufriendo complicaciones graves como heridas en los pies o ceguera. “Y ese es el final del camino”, dijo Rahman. “Tengo que elegir algo más que sea más asequible y que no sea tan bueno para ellos”.

Los agonistas de GLP-1, la categoría de medicamentos que incluye Ozempic, Trulicity y Mounjaro, fueron aprobados por primera vez para tratar la diabetes. En los últimos tres años, la Administración de Alimentos y Medicamentos (FDA) ha aprobado versiones con nuevas etiquetas comerciales de Mounjaro y Ozempic para la pérdida de peso, lo que ha llevado a que la demanda se dispare.

Y la demanda solo está creciendo a medida que se hacen más evidentes los beneficios de los medicamentos.

En marzo, la FDA aprobó el medicamento para la pérdida de peso Wegovy, una versión de Ozempic, para , lo que probablemente aumentará la demanda y el gasto. Hasta 30 millones de estadounidenses, o el 9% de la población, se espera que estén usando un agonista de GLP-1 para 2030, según estimó la .

A medida que más pacientes intentan obtener recetas de agonistas de GLP-1, los fabricantes se esfuerzan por producir suficientes dosis.

Eli Lilly está instando a las personas a evitar usar su medicamento Mounjaro para la pérdida de peso cosmética, para asegurar suficientes suministros para personas con afecciones médicas. Pero la popularidad de los medicamentos sigue creciendo a pesar de efectos secundarios como náuseas y constipación, impulsada por su efectividad y el respaldo de celebridades. En marzo, Oprah Winfrey lanzó un especial de una hora sobre la capacidad de los medicamentos para ayudar con la pérdida de peso.

Puede parecer que todo el mundo está tomando estos medicamentos, dijo Jody Dushay, profesor asistente de medicina en la Escuela de Medicina de Harvard y endocrinólogo en el Centro Médico Beth Israel Deaconess. “Pero no son tantas personas como piensas”, dijo. “Simplemente no hay suficientes”.

Incluso cuando los medicamentos están en stock, las aseguradoras están tomando medidas, dejando a los pacientes y proveedores de atención médica navegando por una maraña de reglas que cambian constantemente.

Los planes de Medicaid estatales de los medicamentos para la pérdida de peso. Medicare los medicamentos si se recetan para la obesidad. Y las aseguradoras comerciales debido su costo.

Los proveedores de atención médica están diseñando planes de atención en base a lo que está disponible y lo que los pacientes pueden pagar.

Por ejemplo, la aseguradora de Cooper Harris cubre Trulicity pero no Ozempic, que ella prefiere porque tiene menos efectos secundarios. Cuando su farmacia se quedó sin Trulicity, tuvo que depender más de la insulina en lugar de cambiar a Ozempic, dijo Rahman.

Un día en marzo, Brandi Addison, endocrinóloga en Corpus Christi, Texas, tuvo que ajustar las recetas de los 18 pacientes que vio debido a problemas de disponibilidad y costo de los medicamentos, dijo. Una paciente, con cobertura a través de un plan de salud para maestros jubilados con deducible alto, no podía permitirse un tratamiento con un agonista de GLP-1, dijo Addison.

“Hasta que alcance ese deducible, simplemente no es un medicamento que pueda usar”, dijo Addison. En cambio, puso a su paciente bajo tratamiento con insulina, cuyo precio está limitado a una fracción del costo de Ozempic, pero que no tiene los mismos beneficios.

“Esos pacientes que tienen un ingreso fijo serán nuestros pacientes más vulnerables”, concluyó Addison.

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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 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 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 鈥� in , he has said beneficiaries were paying “as much as” $400 a month 鈥� 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 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 鈥� not a month, as Biden said. That’s according to a 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 .

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.

, 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 , including through a pump, inhaler, or pen injector filled with the medicine.

, 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 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, “,” , March 19, 2024

U.S. Department of Health and Human Services, “,” Jan. 24, 2023

U.S. Department of Health and Human Services, “,” revised Oct. 26, 2023

Bloomberg Law, “,” Oct. 26, 2023

The American Diabetes Association, “,” accessed March 28, 2024

NPR, “,” March 1, 2023

WhiteHouse.gov, “,” March 2, 2023

Health Care Cost Institute, “,” Oct. 15, 2021

Centers for Disease Control and Prevention, “,” updated November 2023

KFF, “,” July 28, 2022

素人色情片Health News, “America Worries About Health Costs 鈥� And Voters Want to Hear From Biden and Republicans,” March 8, 2024

USA Facts, “,” April 15, 2023

The Associated Press, “” Aug. 5, 2018

USA Today, “,” 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

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Realiza diagnósticos rápidos, sin la presencia de un médico.

Sus clínicas, Tarzana Treatment Centers, son de las primeras en adoptar un sistema de IA que promete expandir drásticamente la detección de retinopatía diabética, la principal causa de ceguera entre adultos en edad laboral y una amenaza para muchos de los cerca de 38 millones de estadounidenses con diabetes.

“Ha sido una bendición para nosotros”, dijo Espinoza, citando los beneficios de un examen rápido y fácil que puede realizarse con poco entrenamiento y que brinda resultados inmediatos.

Y a sus pacientes también les gusta. Joseph Smith, quien tiene diabetes tipo 2, recordó la engorrosa tarea de tomar el autobús hasta el oftalmólogo, dilatar sus pupilas, y luego esperar una semana por los resultados. “Era horrible”, dijo. “Ahora, toma solo unos minutos”.

En medio de todo el revuelo en torno a la inteligencia artificial en la atención médica, la tecnología de exámenes de la vista está surgiendo como uno de los primeros casos de uso probados de diagnósticos basados en IA en un entorno clínico.

Si bien la Administración de Drogas y Alimentos (FDA) ha aprobado cientos de , la adopción ha sido lenta mientras los proveedores navegan por el proceso regulatorio, la cobertura del seguro, los obstáculos técnicos, las preocupaciones sobre la equidad y los desafíos de integrarlos en los sistemas de proveedores.

Los exámenes de la vista muestran que la capacidad de la IA para proporcionar resultados inmediatos, así como el ahorro de costos y la conveniencia de no necesitar hacer una cita adicional, pueden tener grandes beneficios tanto para los pacientes como para los proveedores.

De unos 700 exámenes de la vista realizados durante el último año en las clínicas de Espinoza, casi una cuarta parte detectaron retinopatía, y los pacientes fueron remitidos a un especialista para recibir atención adicional.

La se produce cuando el alto nivel de azúcar en la sangre daña los vasos sanguíneos en la retina. Si bien el control de la diabetes de un paciente a menudo puede prevenir esta afección, y existen tratamientos para etapas más avanzadas, los médicos dicen que las evaluaciones regulares son cruciales para detectar los síntomas temprano.

Las tres compañías con exámenes de la vista con IA aprobados por la FDA para retinopatía diabética 鈥擠igital Diagnostics, con sede en Coralville, Iowa; Eyenuk, de Woodland Hills, California; y la empresa de software israelí AEYE Health鈥� han vendido sistemas a cientos de consultorios en todo el país.

Unas pocas docenas de compañías han realizado investigaciones en este campo específico, y algunas han obtenido autorización regulatoria en otros países, .

, antes Idx, recibió la aprobación de la FDA para su sistema en 2018, después de décadas de investigación y un ensayo clínico que involucró a 900 pacientes diagnosticados con diabetes. Fue el primer sistema de IA totalmente autónomo en cualquier campo médico, lo que hizo que su aprobación fuera “ en la historia de la medicina”, dijo Aaron Lee, especialista en retina y profesor asociado de la Universidad de Washington.

Al sistema, utilizado por Tarzana Treatment Centers, puede operarlo alguien con un diploma de escuela secundaria y unas horas de entrenamiento, y solo lleva unos minutos generar un diagnóstico, sin dilatación de los ojos la mayoría de las veces, dijo John Bertrand, CEO de Digital Diagnostics. Se puede instalar en cualquier habitación poco iluminada, y los pacientes apoyan su barbilla en un soporte, y miran fijo a la cámara mientras un técnico toma imágenes de cada ojo.

La Asociación Americana de Diabetes (ADA) recomienda que las personas con diabetes tipo 2 se hagan exámenes de la vista cada uno o dos años; sin embargo, solo alrededor del 60% de las personas con diabetes se los realizan cada año, dijo Robert Gabbay, director científico y médico de la ADA.

Las tasas pueden ser para los menores de 21 años con diabetes. En grandes áreas del país, la y oftalmólogos puede dificultar la programación de citas, por las que a veces hay que esperar meses. Además, las barreras de viajar a una cita adicional para dilatar los ojos 鈥攍o que significa tomar tiempo libre del trabajo o la escuela, y tener transporte鈥� pueden ser particularmente difíciles para pacientes de bajos ingresos, quienes también tienen .

“El 90% de nuestros pacientes son trabajadores manuales y de fábricas”, dijo Espinoza sobre sus clínicas del sur de California, que atienden principalmente a poblaciones minoritarias. “Si no trabajan, no comen”.

Un posible inconveniente de no tener un médico que realice el examen es que el algoritmo solo busca retinopatía diabética, por lo que podría pasar por alto otras enfermedades de cuidado, como el melanoma coroideo, dijo Lee. También los algoritmos generalmente “pecan de precavidos” y mandan demasiado a los pacientes a ver a especialistas.

Pero esta tecnología ha mostrado un gran beneficio: es tres veces más probable que el paciente haga un seguimiento después de un resultado positivo con el sistema de IA, según realizado por Universidad de Stanford.

Eso se debe a la “proximidad del mensaje”, dijo David Myung, profesor asociado de Oftalmología en el Instituto de Ojos Byers en Stanford. Cuando el resultado se entrega de inmediato, en lugar de en semanas o incluso meses, es mucho más probable que el paciente tome acciones.

Myung lanzó el , enfocándose originalmente en telemedicina y luego cambiando a IA en sus clínicas del área de la Bahía.

Ese mismo año, el National Committee for Quality Assurance amplió su estándar 听de detección de retinopatía diabética para incluir los sistemas de IA. Myung dijo que llevó alrededor de un año filtrar los sistemas de ciberseguridad y TI del sistema de salud de Stanford para integrar la nueva tecnología.

También se aprendió a tomar fotos de calidad que la IA pueda descifrar, dijo Myung. “Incluso alcanzando nuestro ritmo, siempre hay algo que mejorar”, agregó.

La prueba de IA ha sido reforzada por un código de reembolso de los Centros de Servicios de Medicare y Medicaid (CMS), que puede ser difícil y llevar mucho tiempo obtener para dispositivos innovadores. Pero los proveedores de atención médica necesitan esa aprobación gubernamental para obtener reembolsos.

En 2021, los CMS establecieron la tasa de pago nacional para exámenes de retinopatía diabética con IA en $45.36: bastante por debajo de la tasa promedio 听negociada de manera privada, que es de $127.81, según un estudio reciente del sobre IA.

Cada empresa tiene un modelo de negocio ligeramente diferente, pero en general cobran a los proveedores tarifas de suscripción o licencia por su software. Las compañías no quisieron compartir cuánto cobran por el programa.

Las cámaras y se compran por separado o se alquilan como parte de la suscripción del software.

El mayor cumplimiento de las recomendaciones, junto con las referencias a especialistas, hace que valga la pena, dijo Lindsie Buchholz, líder de informática clínica de Nebraska Medicine, que a mediados de diciembre comenzó a usar el sistema de Eyenuk. “De alguna manera, ayuda a que la cámara se pague por sí sola”, dijo.

Hoy en día, el sistema de Digital Diagnostics se encuentra en alrededor de 600 sitios en todo el país, según la compañía. AEYE Health dijo que a su examen de la vista lo utilizan cientos de proveedores en el país. Eyenuk se negó a compartir detalles sobre su alcance.

La tecnología continúa avanzando, con estudios clínicos para cámaras adicionales 鈥攊ncluyendo un dispositivo portátil que puede examinar a los pacientes fuera de las clínicas鈥� y diagnosticar otras enfermedades oculares, como el glaucoma.

Estas innovaciones ponen a la oftalmología, junto con la radiología, la cardiología y la dermatología, como especialidades en las que la innovación en IA está ocurriendo rápidamente.

“En un futuro cercano va a haber cámaras que se pueden usar en la medicina de calle, y van a ayudar a mucha gente”, dijo Espinoza.

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His clinics, Tarzana Treatment Centers, are among the early adopters of an AI-based system that promises to dramatically expand screening for diabetic retinopathy, the leading cause of blindness among working-age adults and a threat to many of the estimated 38 million Americans with diabetes.

“It’s been a godsend for us,” said Espinoza, the organization’s director of clinic operations, citing the benefits of a quick and easy screening that can be administered with little training and delivers immediate results.

His patients like it, too. Joseph Smith, who has Type 2 diabetes, recalled the cumbersome task of taking the bus to an eye specialist, getting his eyes dilated, and then waiting a week for results. “It was horrible,” he said. “Now, it takes minutes.”

Amid all the buzz around artificial intelligence in health care, the eye-exam technology is emerging as one of the first proven use cases of AI-based diagnostics in a clinical setting. While the FDA has approved hundreds of , adoption has been slow as vendors navigate the regulatory process, insurance coverage, technical obstacles, equity concerns, and challenges of integrating them into provider systems.

The eye exams show that the AI’s ability to provide immediate results, as well as the cost savings and convenience of not needing to make an extra appointment, can have big benefits for both patients and providers. Of about 700 eye exams conducted during the past year at Espinoza’s clinics, nearly one-quarter detected retinopathy, and patients were referred to a specialist for further care.

Diabetic retinopathy results when high blood sugar harms blood vessels in the retina. While managing a patient’s diabetes can often prevent the disease 鈥� and there are treatments for more advanced stages 鈥� doctors say regular screenings are crucial for catching symptoms early. An 听in the U.S. have the disease.

The three companies with FDA-approved AI eye exams for diabetic retinopathy 鈥� Digital Diagnostics, based in Coralville, Iowa; Eyenuk of Woodland Hills, California; and Israeli software company AEYE Health 鈥� have sold systems to hundreds of practices nationwide. A few dozen companies have conducted research in the narrow field, and some have regulatory clearance in other countries, including .

, formerly Idx, received FDA approval for its system in 2018, following decades of research and a clinical trial involving 900 patients diagnosed with diabetes. It was the first fully autonomous AI system in any field of medicine, making its in medical history,” said Aaron Lee, a retina specialist and an associate professor at the University of Washington.

The system, used by Tarzana Treatment Centers, can be operated by someone with a high school degree and a few hours of training, and it takes just a few minutes to produce a diagnosis, without any eye dilation most of the time, said John Bertrand, CEO of Digital Diagnostics.

The setup can be placed in any dimly lit room, and patients place their face on the chin and forehead rests and stare into the camera while a technician takes images of each eye.

The American Diabetes Association recommends that people with Type 2 diabetes get screened every one to two years, yet only about 60% of people living with diabetes get yearly eye exams, said Robert Gabbay, the ADA’s chief scientific and medical officer. The rates can be for people with diabetes age 21 or younger.

In swaths of the U.S., a and ophthalmologists can make appointments hard to schedule, sometimes booking for months out. Plus, the barriers of traveling to an additional appointment to get their eyes dilated 鈥� which means time off work or school and securing transportation 鈥� can be particularly tricky for low-income patients, who also have a .

“Ninety percent of our patients are blue-collar,” said Espinoza of his Southern California clinics, which largely serve minority populations. “They don’t eat if they don’t work.”

One potential downside of not having a doctor do the screening is that the algorithm solely looks for diabetic retinopathy, so it could miss other concerning diseases, like choroidal melanoma, Lee said. The algorithms also generally “err on the side of caution” and over-refer patients.

But the technology has shown another big benefit: Follow-up after a positive result is three times as likely with the AI system, according to a by Stanford University.

That’s because of the “proximity of the message,” said David Myung, an associate professor of ophthalmology at the Byers Eye Institute at Stanford. When it’s delivered immediately, rather than weeks or even months later, it’s much more likely to be heard by the patient and acted upon.

Myung launched Stanford’s in 2020, originally focusing on telemedicine and then shifting to AI in its Bay Area clinics. That same year, the National Committee for Quality Assurance expanded its screening standard for diabetic retinopathy to include the AI systems.

Myung said it took about a year to sift through the Stanford health system’s cybersecurity and IT systems to integrate the new technology. There was also a learning curve, especially for taking quality photos that the AI can decipher, Myung said.

“Even with hitting our stride, there’s always something to improve,” he added.

The AI test has been bolstered by a reimbursement code from the Centers for Medicare & Medicaid Services, which can be difficult and time-consuming to obtain for breakthrough devices. But health care providers need that government approval to get reimbursement.

In 2021, CMS set the national payment rate for AI diabetic retinopathy screenings at $45.36 鈥� quite a bit below the median privately negotiated rate of $127.81, according to a . Each company has a slightly different business model, but they generally charge providers subscription or licensing fees for their software.

The companies declined to share what they charge for their software. The cameras can and are either purchased separately or wrapped into the software subscription as a rental.

The greater compliance with screening recommendations that the machines make possible, along with a corresponding increase in referrals to specialists, makes it worthwhile, said Lindsie Buchholz, clinical informatics lead at Nebraska Medicine, which in mid-December began using Eyenuk’s system.

“It kind of helps the camera pay for itself,” she said.

Today, Digital Diagnostics’ system is in roughly 600 sites nationwide, according to the company. AEYE Health said its eye exam is used by “low hundreds” of U.S. providers. Eyenuk declined to share specifics about its reach.

The technology continues to advance, with clinical studies for additional cameras 鈥� including that can screen patients in the field 鈥� and looking at other eye diseases, . The innovations put ophthalmology alongside radiology, cardiology, and dermatology as specialties in which AI innovation is happening fast.

“They are going to come out in the near future 鈥� cameras that you can use in street medicine 鈥� and it’s going to help a lot of people,” said Espinoza.

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But getting your hands on this card 鈥� and persuading a pharmacist to accept it 鈥� can be a hassle.

In this episode of “An Arm and a Leg,” producer Emily Pisacreta speaks with “insulin activists” and pharmaceutical experts to find out what this change in prices means for people with diabetes and why the fight for affordable insulin isn’t over yet.

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

Dan: Hey there. Right after the holidays, I got an email from a listener named Brianna.It started, “Happy new year Dan! I was just reading the news about the price of insulin going down to $35! Is that for everyone?”

And I was like, Huh. I had a sense that there was some news about the price of insulin, but 35 dollars a month for everyone? That sounded like a BIG reduction. And big news.I googled the latest stories, and I was鈥� not totally sure what I was seeing.

I was definitely seeing some new stories about people paying 35 bucks from here on out. And there seemed to be some federal law involved, and politicians were patting themselves on the back. But it just wasn’t totally clear: Was insulin now 35 dollars for everyone? Did the outrageous price of insulin get solved while I wasn’t looking?

And I mean, I’ve kinda been looking. We’ve done a couple of episodes about the price of insulin already 鈥� because insulin is iconic. It represents the wild cost of prescription drugs in this country. More than 8 million Americans take insulin to treat their diabetes – and for some, going without it could actually kill you.

And its price got jacked up so much 鈥� huge multiples over like ten years 鈥� 鈥� that one in four of those people who couldn’t go without鈥� took to rationing: Seeing how much they could go without, short of actually dying.

So I asked our senior producer Emily Pisacreta to take the case.

Emily: I feel more like the senior insulin correspondent, which is fine with me as the resident type 1 diabetic! And a lot has happened since the last time we talked about insulin on this show. We really do need an update.

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

Today we have a question: what’s going on with insulin? Is it $35 now?

Emily: Well, there have been some BIG improvements 鈥� bigger than I thought when I started reporting. A lot of people can get their monthly supply of insulin for just $35. But it is oversimplified to say it just costs $35 now. And the people who have been fighting to lower the price of insulin over the past decade? They’re still very pissed. So let me walk you through what changed, what led to those changes, and what’s still unresolved.

Dan: OK!

Emily: For years now, there’s been a giant push from people with diabetes to get the federal government to do something about the high cost of insulin. In 2022, finally something came through. I’m talking about a provision in Inflation Reduction Act.

Dan: Yes– I remember this– the Inflation Reduction Act was a big infrastructure bill that included, like renewable energy subsidies, and– honestly, this is the reason that I remember the bill, because we did an episode about this part–听 letting medicare negotiate some drug prices?

Emily: Exactly. It said people on Medicare would be able to get a month’s supply of insulin for no more than $35 out of pocket. But of course that left a big gaping hole. BECAUSE that’s cool for people on Medicare, but what about the rest of us? And the pharma companies were feeling the heat. Here’s President Biden in his State of the Union last year:

President Biden: Big pharma has been unfairly charging people hundreds of dollars, four to $500 a month making record profits. Not anymore. Not anymore.

Emily: By the way, those pharma companies? There’s three of them who make insulin.

That’s the American company Eli Lilly, the Danish company Novo Nordisk, and the French company Sanofi. OK so: not long after听 Joe Biden talked about their record profits, the insulin makers were back in the news. 鈥�

Eli Lilly was the first to announce they were going to slash prices on several of their most popular insulins, and limit out of pocket spending to $35 a month.

Fox News: This is a big story.

听Next, Novo Nordisk and Sanofi made similar announcements.听

CNN: Millions of Americans are affected by this major news this morning for millions of people suffering from diabetes and high prescription drug costs.

Basically, the insulin manufacturers all said hey, you’re not covered by this Medicare thing? We’re going to bring your copay down to $35 ourselves. So if you have commercial insurance Print out this card, take it to the pharmacy, and your copay will be no more than $35 for a month’s supply of insulin.

Dan: And what if you’re uninsured?

Emily: Well, they have a card for that, too.

Dan: OK so what I’m hearing is you need a card.

DAN: Yes. How do you get one?

Emily: The insulin makers set special phone numbers you can call. Or you can visit their websites, fill out a little form, and download the card.

Dan: Sounds simple, unless I’m missing something?

Emily: In all honesty, I had no problem with those steps. But I wouldn’t assume that’s the case for everyone. And I’m also not rationing insulin right now.

Zoe Witt: When you are rationing insulin, maybe you aren’t even fully rationing insulin yet, but you don’t know how you’re going to get Your next prescription, your next fill of insulin鈥ou are in crisis. Like, you, you do not have the capability to sift through these websites. It’s very confusing. It’s very overwhelming.

Emily: This is someone who frequently speaks to people struggling to afford insulin.

Zoe Witt: my name is Zoe Witt. I work with Mutual Aid Diabetes.

Emily: Mutual Aid Diabetes. That’s an all volunteer group that has banded together to help diabetics get what they need, when they need it. They help people with cash and with free diabetes supplies, including insulin, no questions asked. That means Zoe knows the ins and outs of every obstacle to getting insulin.

Zoe Witt: Our healthcare system is like a whack a mole from hell.

贰尘颈濒测:听 And Zoe reminds me: if you’re not taking enough insulin, you probably feel awful. Maybe not even thinking straight. And it can affect your eyes, making it hard to read.

Zoe Witt: It just is unmanageable

Emily: Zoe says they talk with people all the time who are too stressed out or too debilitated to download these cards and use them.听 Diabetes folks walk people through the process. And once someone has the card鈥� Mutual Aid Diabetes gives people the 35 bucks, too, if they say they need it. Because $35 can be a barrier for a lot of people. And it’s actually $70 sometimes if you use 2 types of insulin at once, which lots of people do鈥� myself included.

Dan: Wow. OK. But then once people have the cards they typically have no problem?

Emily: Well, your pharmacist has to know what they’re doing, too. So sometimes it means a patient having to educate their pharmacist– or even bring the doctor in to help troubleshoot 鈥� which is no picnic. And people with diabetes are always having to deal with insurance roadblocks at the pharmacy, so I don’t want to make anything sound simpler than it is.听

Dan: It’s like a whack a mole from hell!

Emily: Exactly! And the cards don’t solve everything. Especially this: if you have insurance, these cards only apply to the insulin your insurance plan already covers. If you normally need a prior authorization to get the right insulin for you鈥� that is still the case.

Dan: Right. Okay.听 like prior authorization is this roadblock to getting all kinds of treatment, that you and your doctor agree that you should have, and your insurance company can say, we disagree. We’re s not authorizing this. And then you’re stuck.听

Emily: Right.听

Dan:But in terms of what the pharma companies. can do to kind of offer you a deal. They’re basically doing it. Is that right?听

Emily: I think that’s fair to say.听

Dan: That’s super interesting. All right. So it’s not solved, but this is a big step forward. And what’s not solved is: some people are still on the hook for the list price for insulin 鈥� the price without any discounts or insurance or whatever. But you found big improvements there too, right?听

Emily: Yes! When the companies announced all these discount cards, they announced a whole other big change, too. Slashing the list prices of a bunch of different insulins by up 75%. So a vial that once was north of $300 is now being listed at around $70.

Dan: OK, that sounds like a big improvement.

Emily: It’s a big, big deal. Actual price reductions are what diabetes advocates have been demanding all along. And鈥� while these are still the highest prices in the world for these same insulins, to see them drop from triple to double digits, it’s wild.

Dan: I sense that there’s a “but” here.

Emily: Well, the Big Three didn’t lower the price of every type of insulin, only ones that have been around since the 1990s or early 2000s. Newer insulins that work faster or last longer are not included here.

Dan: And I’m guessing not all insulins work the same way.

Emily: Right. Some people can switch between types or brands of insulin easily. For other people, there can be allergies or one works better with their body with another kind. It’s complicated. It’s medicine! AND鈥� there have been some issues with pharmacies actually stocking lower list price insulin. That is a whole 鈥榥other saga鈥� an episode for another day. But the important thing is鈥� a bunch of insulin is a lot cheaper now.

Dan: Wow. Emily, you said right at the top: The changes here are bigger and better than you realized before you started reporting.听

Emily: Yes but there’s still a lot more to say.听

Right. After the break, we’ll’ hear from you about why these changes happened NOW. And what it means for people with diabetes and really all of us鈥�

[midroll]

So. We have seen some big changes in the last year 鈥� including DRUG COMPANIES expanding their discount programs and lowering the sticker prices on insulin, dramatically. Why now? I’m guessing this wasn’t because they had a big change of heart.

Emily: I can’t speak to what’s in pharma’s hearts. But I did talk to someone who knows a lot about pharma’s brain.

Ed Silverman: my name is Ed Silverman, and I work at Stat News, a health and life sciences website,

Emily: I’m a big fan of Stat News

Dan: Me too, man! Their reporting is great.

Emily:听 And Ed Silverman. He’s been covering the pharmaceutical industry for almost 30 years. He thinks activism from people with diabetes over the years created political pressure that played a big role in the decision to slash prices. But there was also something kind of hidden at work.

Ed Silverman: It’s not altruism, here was a real mechanism, government mechanism in place that helped change the equation and therefore the thinking back at the companies.

Dan: OK鈥� what is he talking about?

Emily: So, Dan: do you remember the stimulus bill, the American Rescue Plan?

Dan: I’m starting to feel like this episode is a quiz on recent-ish legislation. And I think I’m gonna do pretty well here:.The American Rescue Plan was a trillion dollar stimulus that Joe Biden got passed right after he got into office– am I right?

Emily: OK, hotshot. Do you remember how in part 8 section 9816 they sunsetted the limit on the maximum rebate for single source drugs and innovator multiple source drugs?

Dan:听 Um, busted. No.听

Emily: Ok so here’s the deal: it’s obviously kinda wonky so I’ll simplify– in that little section Congress made a tweak to Medicaid, basically raising penalties on drug-makers for jacking up prices too far, too fast. So if you’re a pharma company who has raised the price of a drug by a lot very quickly, which is true of insulin, and a lot of people on Medicaid use your drug, which is also true of insulin, then you have to pay a big penalty. In the case of insulin, that penalty would be more than you’d make selling the insulin to Medicaid. A LOT more: So, unless you bring the price back down, you’re going to owe Medicaid a lot of moolah. And those penalties were set to kick in January 1st 2024.

Dan: So you’re telling me: Part of what the pharma companies did here came right out of a small part of a giant federal law from 2021.

Emily: Yep. And there’s another big wheel turning in the background here. Novo Nordisk and Eli Lilly, two companies who really got their start by selling insulin, now make other diabetes drugs 鈥� drugs that are now increasingly used for weight loss. And it’s a bonanza.

GMA: It is literally the hottest drug in the country right now.

Fox News: all people are talking about these days is Ozempic, wegovy. Oh my gosh, this person lost 20 pounds. This person lost 50 pounds.

Ozempic Ad: [Jingle:] “Oh, Oh, Oh, Ozempic![Announcer:] Once weekly Ozempic is helping many people with type 2 diabetes like James lower their blood sugar.

Emily: Drugs like Ozempic, Wegovy, Mounjaro. They’ve been in super high demand. And there’s been a ton of hype about their various potential health benefits. For weight loss, for heart health. Scientists are even interested in whether it can help people with substance use disorders. Meanwhile, for Eli Lilly and Novo Nordisk, the returns on these drugs dwarf anything else they’re selling. Novo Nordisk even became the biggest company in Europe – for like a minute鈥� but still.

Dan: OK, this is interesting, but what does it have to do with the price of insulin?

Emily: I’d wondered鈥� maybe these companies can just better afford to buy some political peace by lowering insulin prices, because they are making so much bank on these new drugs, ? Ed Silverman had a take on that.

Ed Silverman: It makes perfect sense that these cash cows, these medicines that are used for diabetes and, weight loss are going to become increasingly important to their bottom line more than other medicines

Emily: More than insulin. And they’re selling so much so fast, they can hardly keep up with demand. Which could end up affecting people who need insulin.

Dan: Wait, how?

Emily:听 Look, for example, in November, Novo Nordisk said they were investing 3 and half billion dollars into ramping up production of injection pens for听 Wegovy, one of their top drugs in this category. Less than a week later, Novo announced they would be phasing out one of their insulin products听 from the US market – an insulin called Levemir. It’s one of the insulins whose prices they just dropped. And鈥� coincidence鈥� Levemir also comes in a pen.

Dan: So Novo Nordisk is phasing out an insulin pen so they can make more Wegovy pens?

Emily: Well, we don’t know that for sure. But Novo Nordisk did tell me that “manufacturing constraints” were part of why they’re dumping Levimir. They said it was one of several reasons and also wrote: “We made this decision after careful consideration and are confident that given the advanced notice, U.S. patients will have access to alternative treatments and can transition to other options. 鈥��听

Dan: Huh. OK.

Emily: But even if pulling this insulin Levemir off the market had nothing to do with their trouble meeting the demand for their big blockbuster drug鈥� it brings to mind an important question about all the changes we talked about today 鈥� whether it’s the copay savings or the lowered list prices. Here’s Ed Silverman.

Ed Silverman there’s no guarantee that the companies will keep these in place. Maybe after time, some of the attention on insulin is diverted and maybe eighteen months from now, one company might quietly roll back some of the Benefits, if you want to use that word, there’s nothing requiring them to maintain the steps they’ve taken.

Emily: I asked all three insulin makers about this. None of them promised there would never be any backsies. Lilly wrote back “Lilly is committed to ensuring all patients can access any Lilly medicine they need” 鈥� and touted their efforts to date. Similarly, Sanofi wrote “We continually review our affordability offerings to support our aim that no one should struggle to pay for their insulin. Novo Nordisk’s response was “Novo Nordisk increases the price of some of our medicines each year, in response to changes in the healthcare system, market conditions, and the impact of inflation.”听

Dan: Yeah, that especially does not sound like a pinky-swear, no-backsies kind of response.听听听

Emily: AND听 that’s not much comfort for insulin activists. Folks like Shaina Kasper, who works for T1International. They’re a group that’s been at the forefront of this fight for years.听 I Asked her鈥�

Emily-on-tape: So is this issue of high insulin prices just resolved now?

Shaina Kasper: No, it hasn’t been. It’s been really frustrating鈥�

Emily Shaina and others are worried that the announcements from the manufacturers about savings cards and voluntary list price reductions will take the pressure off the government to do something more sweeping. Because for now鈥�

Shaina: The manufacturers really hold all of the power here And if patients are counting on these programs to literally be able to survive, that has life and death consequences

Dan: This question about who holds the power, it reminds me of a story we did a few months ago鈥� the one about how the writer John Green led a kind of online crusade targeting the drug-maker Johnson & Johnson. And how, even though the pressure campaign worked 鈥� J & J ended up allowing lower-priced versions of an important tuberculosis drug 鈥� activists who worked on the issue were like: It’s a problem that Johnson & Johnson has the power to say yes or no here..

Emily: Exactly. That which pharma giveth, pharma can taketh. At least the way things are set up now. Now I should say, all three companies told me they plan to continue their affordability offerings. But if insulin continues to be the poster child for high drug prices, prices virtually everyone in America agrees are too high鈥t does raise the question: are voluntary programs from pharmaceutical companies the solution we want? To Zoe from Mutual Aid Diabetes, the answer is no. They find these manufacturer savings cards kind of a bitter pill鈥� no pun intended.

Zoe Witt: there’s certainly no justice in these programs,听

Emily: And zoe for one would say that justice is overdue.听

Zoe Witt: These companies have price gouged us. for years, making obscene amounts of money. Then, presumably, as, we’re often told is the justification for these ridiculous prices, they did research and development for more diabetes drugs, which are Ozempic, Monjoro, etc. And now, these companies, for, the next 15 years, are set to make, billions and billions of dollars, on these drugs,

Emily: I asked the big three insulin manufacturers about what Zoe said – about how angry folks like them are over the cost of insulin. Novo Nordisk said “we continually review and revise our offerings as well as work with diverse stakeholders to create solutions for differing patient needs.鈥�”鈥� And Sanofi and Lily both said something very similar.

Emily: So鈥� in the end– or at least for now– here’s the answer to our listener’s question鈥�. There are more avenues than ever to get a month’s supply of insulin for $35. Great. It may be a lot easier to avoid rationing your insulin now than it was a couple years ago. That’s also really great. But people with diabetes do not think this fight is over.

Dan: So what DO they want?

Emily: Some people still want the federal government to just put a cap on what people pay for insulin, like by law.. Others are working to build alternatives to the existing pharmaceutical industry, like California’s CalRx program.

Dan: Cal Rx鈥� now you’re calling back our story from the last time we talked about insulin.

Emily: Yep, Cal Rx is the state of California’s attempt to enter the insulin market, to introduce some low priced generics and sell them essentially at cost. Other states are joining in. Even if some of these specific plans fall apart 鈥� even if California somehow can’t get its government-sponsored insulin to market, even if Pharma rolls back some of the discounts鈥he past few years have been enormous for people with diabetes. Mostly because they’ve found each other.

Zoe Witt: I was rationing insulin in 2018, I didn’t even know that there was a term for it. I didn’t know other people were doing it. I know a lot of people died that year. And there were multiple occasions where I, in retrospect, definitely almost died. And the one good thing that has, that has happened between now and then is that people have been talking about it and People are now more comfortable telling others that they’re struggling, that they can’t get their insulin.

Emily: Connecting with Mutual Aid Diabetes or other networks to get or give help.

Zoe Witt: We’re all keeping each other alive, like to me, that’s the number one thing that has changed.

Emily: I think that’s a huge lesson here, and a takeaway that’s not new on this show. Keeping each other alive 鈥� or even just keeping each other from getting bankrupted by the medical system 鈥� is up to us. And while a mutual aid group modeled exactly like Mutual Aid Diabetes may not work for every disease or every drug, Zoe says they’re more than willing to talk to anyone who might be interested in trying.

Zoe Witt: I mean, we’ve even had people ask, like, is there like a mutual aid asthma or something like for inhalers?听

Emily: Their advice?听

Zoe Witt: I think that, you know, to start,听 you would want, like,听 probably at least, like, five to ten ”ride-or dies,” like, people that are really willing to, like, go the extra mile,听

Dan: Five to ten– that just does not sound like that many! (I mean, I think.) One thing I’m taking away is:听 This is a lot of activism over a long time, that eventually had a big effect. Another thing I’m taking away here? Sneaky policy changes 鈥� like lifting the Medicaid rebate cap 鈥� can make a huge difference. God bless whatever nerds are writing the next little bit of law to sneak into a giant bill, like a hacker with a virus.

Emily: Totally. OK. I gotta take a shot, and eat my lunch.

Dan: Go for it. We’ll be back with a new episode in a few weeks. Till then, take care of yourself.

This episode of an arm and a leg was produced by Emily Pisacreta and me, Dan Weissman and edited by Ellen Weiss.听

Adam Raymonda is our audio wizard. Our music is by Dave Weiner and blue dot sessions.听

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

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

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

Zach Dyer is senior audio producer at 素人色情片Health News. He’s editorial liaison to this show.听

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

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

“An Arm and a Leg” is a co-production of 素人色情片Health News and Public Road Productions.

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But when his doctor followed the and increased his dose of Mounjaro 鈥� a drug with a wholesale list price of a month 鈥� Marks’ health insurer declined to pay for it.

Marks had Cigna insurance that he purchased on the federal health insurance marketplace, . After two appeals over a month and a half, Cigna agreed to cover the higher dose. A few months later, he said, when it was time to up his dose once more, he was denied again. By November, he decided it wasn’t worth sparring with Cigna anymore since the insurer was leaving at the start of this year. He decided to stay on the lower dose until his new insurance kicked in.

“That is beyond frustrating. People shouldn’t have to be like, 鈥業t’s not worth the fight to get my medical treatment,’” Marks said.

The process Marks encountered is called “prior authorization,” or sometimes “pre-certification,” a tool insurers say they use to rein in costs and protect patients from unnecessary or ineffective medical treatment. But the practice has prompted backlash from patients like Marks, as well as groups representing medical professionals and hospitals that say prior authorization can interfere with treatment, cause medical provider burnout, and .

In January, the Biden administration announced new rules to streamline the process for patients with certain health plans, after attempts stalled out in Congress, including a in 2022. But states are considering prior authorization bills that go even further. Last year, lawmakers in 29 states and Washington, D.C., considered some 90 bills to limit prior authorization requirements, , with notable victories in and The physicians association expects more bills this year, many with provisions spelled out in the group drafted.

In 2018, health insurers signed a with various medical facility and provider groups that broadly laid out areas for improving the prior authorization process. But the lack of progress since then has shown the need for legislative action, said , past president of the AMA and a current trustee.

“They have not lived up to their promises,” Resneck said.

Resneck, a California dermatologist, emphasized pending bills in , , , , and that include several policies backed by the AMA, including quicker response times, requirements for public reporting of insurers’ prior authorization determinations, and programs to reduce the volume of requests, sometimes called “gold carding.” Legislation has come from both Democratic and Republican lawmakers, and some is bipartisan, .

In Missouri, by Republican state Rep. aims to establish one of those gold carding programs for treatment and prescriptions. Stinnett said she regularly was frustrated by prior authorization hurdles in her work as a speech pathologist before joining the legislature in 2023.

“The stories all kind of look similar: It’s a big fight to get something done on the insurance side for approval,” Stinnett said. “Then sometimes, even after all of that fight, it feels like it may have not been worthwhile because some people then have a change at the beginning of the year with their insurance.”

Under her bill, a medical provider’s prior authorization requests during a six-month evaluation period would be reviewed. After that period, providers whose requests were approved at least 90% of the time would be exempt from having to submit requests for the next six months. The exemptions would also apply to facilities that meet that threshold. Then, she said, they would need to continue meeting the threshold to keep the “luxury” of the exemption.

Five states have passed some form of gold carding program: Louisiana, Michigan, Texas, Vermont, and West Virginia. The AMA is tracking active gold carding bills in 13 states, including Missouri.

A of 26 health insurance plans conducted by the industry trade group AHIP found that just over half of those plans had used a for medical services while about a fifth had done so for prescriptions. They gave mixed reviews: 23% said patient safety improved or stayed the same, while 20% said the practice increased costs without improving quality.

The new federal finalized by the Centers for Medicare & Medicaid Services stop short of gold carding and don’t address prior authorizations for prescription drugs, like Marks’ Mounjaro prescription. Beginning in 2026, the new rules establish response time frames and public reporting requirements 鈥� and ultimately will mandate an electronic process 鈥� for some insurers participating in federal programs, such as Medicare Advantage or the health insurance marketplace. Manual submissions accounted for 39% of prior authorization requests for prescriptions and 60% of those for medical services, according to the 2022 insurance survey.

In Missouri, state and national organizations representing doctors, nurses, social workers, and hospitals, among others, back Stinnett’s bill. Opposition to the plan comes largely from pharmacy benefit managers and the insurance industry, including the company whose prior authorization process Marks navigated last year. A Cigna Healthcare executive saying the company’s experience showed gold card policies “increase inappropriate care and costs.”

The , which represents dozens of employers that purchase health insurance for employees, also opposes the bill. Members of the coalition include financial services firm Edward Jones, coal company Peabody Energy, and aviation giant Boeing, as well as several public school districts and the St. Louis city and county governments.

Louise Probst, the coalition’s executive director, said the prior authorization process has issues but that the coalition would prefer that a solution come from insurers and providers rather than a new state law.

“The reason I hate to see things just set in stone is that you lose the flexibility and the nuance that could be helpful to patients,” Probst said.

On the other side of the state, Marks purchased insurance for this year on the federal marketplace from Blue Cross and Blue Shield of Kansas City. In January, his doctor re-prescribed the higher dose of Mounjaro that Cigna had declined to cover. A little over a week later, Marks said, his new insurance approved the higher dose “without any fuss.”

Cigna spokesperson Justine Sessions said the company uses prior authorizations for popular drugs such as Mounjaro to help ensure patients get the right medications and dosages.

“We strive to make authorizations quickly and correctly, but in Mr. Marks’ case, we fell short and we greatly regret the stress and frustration this caused,” she said. “We are reviewing this case and identifying opportunities for improvement to ensure this does not happen in the future.”

Marks’ aim with this higher dose of Mounjaro is to get off his other diabetes medications. He particularly hopes to stop taking insulin, which for him requires multiple injections a day and carries a risk of from low blood sugar.

“I don’t really use the word 鈥榣ife-changing,’ but it kind of is,” Marks said. “Getting off insulin would be great.”

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Deroze, a 31-year-old English professor at the time, was confused about which images were meant to depict her. Initially, she was diagnosed with Type 2 diabetes, as shown on the pamphlet with older adults. It would be eight years before she learned she had a different form of diabetes 鈥� one that didn’t fit neatly on either pamphlet.

The condition is often called latent autoimmune diabetes of adults, or LADA for short. Patients with it can be misdiagnosed with Type 2 diabetes and spend months or years trying to manage the wrong condition. As many as 10% of patients diagnosed with Type 2 diabetes might actually have LADA, said , an endocrinologist at the Joslin Diabetes Center in Boston.

Deroze and three other LADA patients who spoke with 素人色情片Health News, all Black women, are among those who were initially misdiagnosed. Without the correct diagnosis 鈥� which can be confirmed through blood tests 鈥� they described being denied the medicines, technology, and tests to properly treat their diabetes. Three of them wonder if their race played a role.

“That does seem to happen more frequently for African American patients and for other minoritized groups,” said , a pediatric endocrinologist at the University of Chicago who researches atypical forms of diabetes. “Doctors, like any other person walking this planet, we all have implicit biases that impact our patient experiences and our patient care delivery.”

Black patients have long struggled with bias across the U.S. health care system. In a recent , for example, 55% of Black adults said they believed they needed to be careful at least some of the time about their appearances to be treated fairly during medical visits. Hospital software used to treat patients has been investigated for discrimination. Even a common test used to manage diabetes can for patients who have sickle cell trait, which is present in nearly 1 in 10 African Americans.

LADA ostensibly has nothing to do with race, but misconceptions about race, weight, and age can all lead doctors to misdiagnose LADA patients with Type 2 diabetes, said , an endocrinologist who leads the adult Type 1 diabetes program at Ohio State University.

Type 2 diabetes develops in people, often over age 45, whose bodies cannot properly regulate their blood sugar levels. Type 2 accounts for at least 90% of diabetes cases in the U.S. and has a high prevalence among African Americans, Native Americans, and Hispanic populations. It can often be managed with lifestyle changes and oral medications.

LADA is more akin to, or even thought to be another form of, Type 1 diabetes, an autoimmune condition once dubbed “juvenile diabetes” because it was most often diagnosed in children. Type 1 occurs when the body attacks its cells that produce insulin 鈥� the naturally occurring hormone that regulates blood sugar by helping turn food into energy. Without insulin, humans can’t survive.

LADA is difficult to diagnose because it progresses slowly, Gaglia said. Typical LADA patients are over 30 and don’t require injectable insulin for at least six months after diagnosis. But, like Type 1 patients, most will eventually depend on injections of pharmaceutical insulin for the rest of their lives. That delay can lead physicians to believe their patients have Type 2 diabetes even as treatment becomes less effective.

“If you have someone who comes into your office who is obese and/or overweight and may have a family history of Type 2 diabetes 鈥� if you’re a betting person, you bet on them having Type 2 diabetes,” Gaglia said. “But that’s the thing with LADA: It unmasks itself over time.”

Mila Clarke, who lives in Houston, finally saw an endocrinologist in November 2020, more than four years after being diagnosed with Type 2 diabetes. During that visit, she recounted her struggles to manage her blood sugar despite taking oral medications and making significant changes to her diet and exercise regimens.

“鈥榃hat you just explained to me, I believe, is a classic case of LADA,’” Clarke recalled being told. “鈥楬as anybody ever tested you for Type 1 antibodies?’”

Because both Type 1 diabetes and LADA are autoimmune conditions, patients will have antibodies that Type 2 patients typically don’t. But, as Clarke recounted, getting tested for those various antibodies isn’t always easy.

Clarke, now 34, had leaned into her Type 2 diagnosis when she received it in 2016 at age 26. She started a blog with nutrition and lifestyle tips for people with diabetes called “,” and garnered tens of thousands of . Clarke said she wanted to fight the stigma around Type 2 diabetes, which stereotypes often associate with being overweight.

“Some of the harshest comments that I had gotten were from people with Type 1 who were like, 鈥榃e’re not the same. I didn’t cause this. I didn’t do this to myself,’” Clarke said. “Well, neither did I.”

Clarke also felt her initial doctor thought she just wasn’t working hard enough.

When she learned about continuous glucose monitors, wearable electronic devices that allow patients to track their blood sugar around the clock, she asked her primary care doctor to prescribe one. The monitors are recommended for patients with Type 1 and, more recently, some with Type 2. “He flat-out told me, 鈥楴o. It’s going to be too much information, too much data for you,’” she recalled.

Clarke switched to a different primary care doctor who she felt listened better and who prescribed a continuous glucose monitor. (Clarke later became a paid ambassador for the company that manufactures her device.) The new doctor eventually referred Clarke to the endocrinologist who asked if she’d been tested for antibodies. The test came back positive. Clarke had LADA.

“In the health care system, it’s really hard to vocalize your needs when you are a woman of color because you come off as aggressive, or you come off as a know-it-all, or you come off as disrespectful,” Clarke said. “My intuition was right this whole time, but nobody believed me.”

Immediately, Clarke noticed an “eye-opening” difference in how she was treated. She started insulin injections and was referred to a dietitian and a diabetes educator. She wondered: Why wasn’t it easier to get tested for antibodies?

Those tests are imperfect and can have false positives, said Gaglia of the Joslin center. Still, Ohio State’s Wyne argued that every diabetes patient should be tested for at least associated with Type 1.

“Aren’t you saving lives if you’re identifying the Type 1 before they come in with DKA and die?” Wyne asked, referring to diabetic ketoacidosis, a serious complication of diabetes most commonly associated with Type 1.

Deroze started asking her doctor for antibodies tests in 2017 after reading about a being newly diagnosed with LADA.

Her endocrinologist denied her requests. She thinks the doctor thought it was impossible for her to have an autoimmune form of diabetes because of her race and weight. She sought a second opinion from a different endocrinologist, who also refused to test her.

“I just felt unseen,” Deroze said.

After a bout with diabetic ketoacidosis in 2019, Deroze finally persuaded her gynecologist to test her for antibodies. The results came back positive. One of the endocrinologists apologetically prescribed insulin and, later, an insulin pump, another ubiquitous piece of technology for people with Type 1.

And for the first time, she encountered the words “diabetes is not your fault” while reading about Type 1 diabetes. It felt like society was caring for her in a way it hadn’t when she was misdiagnosed with Type 2. That’s troubling, she said, and so is how long it took to get what she needed.

“My PhD didn’t save me,” said Deroze, who now lives in the Miami area. “You just see the color of my skin, the size of my body, and it negates all of that.”

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Her blood sugar was plummeting, and the beep came from a attached to her abdomen. The small but powerful device alerts Voros when her blood sugar is dangerously high or low.

“My blood sugar is at 64. It’s too low and still dropping,” Voros, 32, said on a bright October afternoon. She checks the monitor up to 80 times a day to help prevent complications from Type 1 diabetes.

But the monitor means little without the supplies that make it work, including a receiver, a sensor, and a transmitter 鈥� some of which must be replaced every 10 to 30 days. Voros also has an insulin pump, which delivers a steady supply of that hormone to her body, and it requires supplies too.

Until recently, Voros 鈥� who is covered by Medi-Cal, California’s Medicaid program for people with low incomes or disabilities 鈥� spent countless hours on the phone with her endocrinologists, her Medi-Cal insurer Health Net, and a medical supply company to obtain separate approvals for each item. At times, her authorizations expired too quickly, leaving her short on supplies and forcing her to ration and seek donations on social media from other diabetes patients.

Last year, she received only enough supplies to last six months.

“I’ve had to put in hundreds of hours over the phone in the past few years, and I’ve changed my insurance group twice because of this,” Voros said before slugging apple juice in her studio apartment in the Mission Hills neighborhood, a suburban neighborhood in the San Fernando Valley. “It’s exhausting. It makes you want to give up. But I can’t. I’ll literally die.”

Starting in October, Medi-Cal began that have caused life-threatening delays for Voros and others with diabetes.

Previously, authorizations for medications and supplies lasted six months, though for some patients, like Voros, they expired sooner. Under the new rules, authorizations are supposed to last one year from the date of approval and can include all needed supplies 鈥� ending the scramble to secure separate authorizations for each piece of equipment. Patients can receive 90 days’ worth of supplies and medications at once.

The state is also formalizing a policy that allows patients to obtain approvals from their health care providers by phone or video.

“Before, California’s requirements were four pages long, and now it’s just a little more than a page,” said Lisa Murdock, chief advocacy officer for the American Diabetes Association, who helped push for the changes. “This is a really important step forward. It means not having to constantly guess how blood sugars are doing.”

Over the past two years, the state also started making continuous glucose monitors and related supplies available to many more people, including all patients with , a chronic autoimmune disease that attacks insulin-producing cells in the pancreas, and those with , , and , or chronic low blood sugar. Before last year, the monitors were available to only some patients on a case-by-case basis, according to the state Department of Health Care Services, which administers Medi-Cal.

The enhanced coverage extends to newer, more advanced devices, such as the popular , which retail for about $700 on Amazon for a 30-day supply without insurance. Medi-Cal pays for the same equipment.

Diabetes and prediabetes are . About have been diagnosed with diabetes. The Department of Health Care Services says about 1.2 million Medi-Cal enrollees have the disease, according to the latest data available.

Before these changes, Medi-Cal recipients had a harder time securing medication and supplies than people with private insurance, Murdock said.

“Diabetes is a really heartbreaking and costly disease, and to take care of themselves, people with diabetes need easy access to insulin, but also the supplies to manage the disease,” she said.

Patient advocates and state health officials say the changes will save money and lives by giving those with diabetes more control over their blood sugar, and by preventing complications such as organ failure and foot and toe amputations.

This expansion in coverage “improves access and member outcomes, reduces hospitalizations and comorbidities, and improves members’ quality of life with better disease management and less finger sticks,” said Ann Carroll, a Medi-Cal spokesperson. The state, she said, wants to ensure all diabetes patients get “the care they need to lead healthy, fulfilling lives.”

Before Voros got her monitor about three years ago, she had to visit an emergency room and was hospitalized with . She also lost nerve function in her stomach 鈥� which prevents digestion of high-fiber foods like vegetables 鈥� as her disease advanced.

“I haven’t had to go to the intensive care unit in almost two years. It has literally saved my life,” she said.

But the bureaucratic hurdles that kept Voros from getting supplies for her monitor were a constant source of stress. That’s changing since she switched to a new medical supply company and Medi-Cal has debuted its new preauthorization process, amid a broader revamp of its pharmacy system.

Getting her supplies on time means peace of mind, Voros said.

“I used to be so afraid to go to sleep at night because of the seizures I’d get from low blood sugar,” she said. “I’ve been really close to death, but now I feel better than I ever have.”

This article is part of “,” a California Healthline series exploring the impact of the state’s safety-net health program on enrollees.

This article was produced by 素人色情片Health News, which publishes , an editorially independent service of the .听

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

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