Video Reporter: Caresse Jackman, InvestigateTV; Video Editor: Scotty Smith, InvestigateTV

When three teenagers died of fentanyl overdoses last year in Larimer County, Colorado, it shocked the community and “flipped families upside down,” said Tom Gonzales, the county’s public health director.

Several schools began stocking naloxone, a medication that reverses opioid overdoses. Community organizations trained teens to use it. But county and school officials wanted to do more.

That’s when they turned to opioid settlement funds — money coming from national deals with health care companies like Johnson & Johnson, AmerisourceBergen, and CVS, which were accused of fueling the epidemic via prescription painkillers. The companies are paying out more than $50 billion to state and local governments over 18 years.

Much of that money is slated for addiction treatment and efforts to reduce drug trafficking. But some is going to school-based prevention programs to reduce the possibility of addiction before it begins. In some cases, school districts, which filed their own lawsuits that became part of the national settlements, are . In other cases, state or local governments are setting aside part of their share for school-based initiatives.

Many parents, educators, and elected officials agree that investing in prevention is crucial to address the rising rates of , , and .

“We have to look at the root causes,” said , a senior scientist at the University of North Carolina-Chapel Hill and leading expert on applying prevention science to public policy. Otherwise, “we’re going to be chasing our tails forever.”

But the question of how to do that is fraught and will involve testing the comfort levels of many parents and local officials.

For generations of Americans, addiction prevention was synonymous with D.A.R.E., a curriculum developed in the 1980s and taught by police officers in schools. It “dared” kids to resist drugs and was used in concert with other popular campaigns at the time, like “just say no” and a in a frying pan with the narration, “This is your brain on drugs.”

But found those approaches . In some cases, suburban students their drug use after participating in the D.A.R.E. program.

In contrast, prevention programs that today’s leading experts say teach kids how to manage their emotions, communicate with others, be resilient, and build healthy relationships. They can have while also saving society $18 for every dollar invested, per a . But that approach is less intuitive than simply saying “no.”

If you tell parents, “‘We’re going to protect your child from dying of a fentanyl poisoning by teaching them social skills in third grade,’ they’re going to be angry at you,” said , who leads prevention-oriented research at the nonprofit Partnership to End Addiction. Selling them on the most effective approaches takes time.

That’s one of the reasons prevention experts worry that familiar programs like D.A.R.E. will be the go-to for elected officials and school administrators deciding how to use opioid settlement funds. When ºÚÁϳԹÏÍø News and InvestigateTV looked for evidence of local spending on prevention, even a cursory review found examples across half a dozen states where governments have already allocated $120,000 of settlement cash to D.A.R.E. programs. The curriculum has been revamped since the ’80s, but the effects of those changes are still being studied.

Budgeting Choices Reflect Deeper Debate

Researchers say putting money toward programs with uncertain outcomes — when more effective alternatives exist — could cost not only valuable resources but, ultimately, lives. Although $50 billion sounds like a lot, when compared with the toll of the epidemic, each penny must be spent efficiently.

“There’s tremendous potential for these funds to be wasted,” said , executive director of the Colorado State University Prevention Research Center.

But he has reason to be hopeful. Larimer County officials awarded Riggs’ team $400,000 of opioid settlement funds to build a prevention program based on the latest science.

Riggs and his colleagues are developing training for school staff and helping implement the , a widely for students at risk of depression. The program, which will start in 10 middle and high schools this fall, teaches students about resilience and builds social support through six small group sessions, each an hour long. It’s been shown in multiple studies to decrease rates of depression and drug use among youth.

Natalie Lin, a 17-year-old senior at Fossil Ridge High School in Fort Collins, Colorado, is optimistic the program will help overcome the stigma her peers face with mental illness and addiction.

“Having it in school” prevents people from feeling “called out” for needing help, said Lin, who carries naloxone in her car so she’s prepared to reverse someone’s overdose. “It’s just acknowledging that anyone here could be battling” addiction, and “if you are, that’s all right.”

Across the country, investments in prevention run the gamut. Rhode Island is using about $1.5 million of settlement cash to increase the number of in middle and high schools. Moore County, North Carolina, is on a mentoring program for at-risk youth. Some communities are inviting guest speakers and, of course, many are turning to D.A.R.E.

New Hanover County, North Carolina, and the city of Wilmington, which it encompasses, pooled $60,000 of settlement money to train nearly 70 officers in the D.A.R.E. program, which they hope to launch in dozens of schools this fall.

County commissioner Rob Zapple said it’s one piece of a “multiprong approach” to show young people they can lead productive lives without drugs. Officials are also putting $25,000 of settlement cash toward public service announcements and $20,000 toward other outreach.

They acknowledged there’s little research on the updated D.A.R.E. curriculum but said the county views its investment as a pilot, which they will track closely. “Instead of committing everything at once, we’re going to let the spending of the money grow with the success of the program,” Zapple said.

Munster, Indiana, also decided to , using $6,000 — a small slice of its total settlement funds — annually. Jasper County, Iowa, is to cover materials for the program’s graduation ceremonies for several years.

In some places, officials are frank that they’re not getting enough money to do anything inventive.

Solon, Ohio, for example, received $9,500 in settlement funds this year and is expecting similar or smaller amounts in the future. “While the funding is welcome,” finance director Matt Rubino wrote in an email, it’s “not material enough to be transformational” to the budget. Putting it all toward the existing D.A.R.E. program made the most sense, he said.

Out With the Scare Tactics

, CEO and president of D.A.R.E., said though the program has been in place since the ’80s, “it’s really significantly different” today. The curriculum was redone in 2009 to move away from scare tactics and lectures on specific drugs to focus instead on decision-making skills. Officers undergo intensive training, which includes understanding how children’s brains develop.

“Telling somebody a drug is harmful isn’t going to change their behaviors,” Pegueros said. “You really need to deliver a curriculum that’s going to build those skills to help them change behaviors.”

With the rise of fentanyl and some , interest in D.A.R.E. has grown in recent years, Pegueros said. He believes it can be effective as part of a comprehensive, community approach to prevention.

“You’re not going to find one curriculum, one program, one action that’s going to achieve the results you want,” he said.

Still, D.A.R.E. can play an important role, he said, pointing to a that found the new curriculum had a “positive effect in terms of deterring the onset of alcohol use and vaping” among fifth graders.

But many public health experts remain skeptical. They worry the changes are superficial. The few studies of D.A.R.E.’s new curriculum have been short-term, yielded , and in some cases had high dropout rates due to the covid-19 pandemic, which raises questions about how applicable the findings are for schools nationwide. According to some law enforcement officials and advocates, even the revamped program is often taught alongside campaigns like “,” which warns youth that trying drugs can be fatal the first time.

That type of scare tactic seems futile to , executive director of Think Kids, a nonprofit that advocates for children’s health and well-being in West Virginia. “It’s not as if these kids are unsuspecting and have never seen the consequences of drug use before,” she said.

In 2017, West Virginia in the nation of children living with their own or a parent’s opioid addiction.

“We need stronger communities that are willing to just give those kids more guidance and support than fear,” Caseman said. “They’ve already got enough fear as it is.”

Some local governments are trying to straddle both paths.

Take Chautauqua County in western New York. Last September, the county and a local child-development collaborative spent $26,000 — including — to bring former NBA player Chris Herren to about his past addictions to alcohol, heroin, and cocaine. Herren recounted to more than 1,500 students the first day he had a beer, at age 14; how addiction ended his career; and how he landed on the streets before entering recovery.

, a physical education teacher and the head of the that organized Herren’s visit, said the basketball player’s story resonated with students, many of whom have parents with addiction. “When he talks about selling his kid’s Xbox to get drugs, I think he’s touching on facts that they’ve had to go through,” Smeraldo said.

But a one-time speaker event has , researchers and public health experts say.

That’s why the county is also investing opioid settlement funds in several other initiatives, said Steve Kilburn, who oversees addiction-related grants for Chautauqua County. A likely six-figure sum will go to , a local nonprofit that teaches a nationally acclaimed “” curriculum in 23 schools and runs a “” program that provides one-on-one coaching and support for students found using drugs or carrying drug paraphernalia in school.

, executive director of Prevention Works, said some students are scared to come to school because their parents might overdose without someone at home to revive them.

Smeraldo, the physical education teacher, is planning to build on Herren’s talk with an after-school program, in which students will be able to discuss their mental health and transform interests like cooking into internships to help break the cycle of poverty that often contributes to addiction.

Herren is “the catalyst to get the kid to services that exist in the county,” Smeraldo said. It’s a starting point, not the end.

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“No pretendo aumentar su carga”, escribió Brian Williams, teniente coronel retirado del ejército y veterano de combate en Tormenta del Desierto (Irak, 1991). Contó que su hospital, Labette Health, era “como una zona de guerra”, abarrotado de pacientes no vacunados. Un jefe de departamento había amenazado con renunciar, diciendo que no podía “ver cómo se llevaban un cuerpo más”.

Pero Williams no buscaba ayuda para la pandemia.

En su lugar, le pidió al presidente Joe Biden que se enfrentara a las farmacéuticas Eli Lilly, Novo Nordisk y otras por negarse a cumplir un programa federal de descuentos en medicamentos para hospitales y clínicas. El programa, explicó Williams, proporciona millones para pagar al personal, garantizar que las clínicas más alejadas permanezcan abiertas y proporcionar atención caritativa a los pacientes que no pueden pagar.

“Durante una pandemia global, creo que los trabajadores de salud merecen un poco más de respeto y que no se les quiten recursos”, declaró Williams en una entrevista con KHN e InvestigateTV. “Cada una de esas compañías [farmacéuticas], por lo que vi, no sufrían tremendas pérdidas [financieras], como los hospitales”.

El precio de las acciones de Eli Lilly aumentó casi un 40% y el valor de la compañía se incrementó en $59,000 millones en los primeros siete meses de 2021. En el mismo período, Labette Health perdió $1,2 millones en ingresos solo por el ahorro perdido en las recetas, señaló Williams.

Lilly y otros fabricantes, sin embargo, se mantienen firmes. Se niegan a ofrecer descuentos a miles de farmacias contratadas por los hospitales, diciendo que el programa ha crecido más allá de su uso previsto y que carece de controles y equilibrios federales contra los descuentos duplicados y otros abusos.

En las demandas, sostienen que los miles de millones en descuentos que ofrecen rara vez se trasladan a los pacientes y, en cambio, son absorbidos por intermediarios como las farmacias contratadas y los administradores de terceros.

El Congreso creó el llamado programa 340B en 1992 para proporcionar financiación adicional a los hospitales y clínicas, especialmente a los que atienden a personas sin recursos y a los mayores. El propósito, escribieron los legisladores, es “estirar al máximo los escasos recursos federales, llegando a más pacientes elegibles y proporcionando servicios más completos”.

Las empresas que quieren que sus medicamentos estén cubiertos por Medicaid o Medicare Parte B están obligadas a ofrecer descuentos 340B, normalmente del 25% al 50% de lo que se podría pagar. Los hospitales y las clínicas compran los medicamentos con el descuento y luego la compañía de seguros, Medicare o Medicaid les reembolsa la tarifa negociada más alta. El hospital o la clínica se quedan con la diferencia para utilizarla como consideren oportuno.

La ley no exige que los pacientes se beneficien directamente, un matiz que ha alimentado un gran conflicto sobre el funcionamiento y la regulación del programa.

El alcance del programa 340B se disparó después que los reguladores federales dictaminaran en 2010 que los hospitales y las clínicas podían contratar con un número ilimitado de farmacias minoristas como Walgreens y CVS, a las que se paga una tarifa por dispensar los medicamentos con descuento. Según los expertos del sector, el crecimiento, unido a las dudas que desde hace tiempo se plantean sobre la autoridad reguladora, sitúa el programa en un punto de inflexión, con los pacientes atrapados en el medio.

El número de farmacias contratadas para trabajar con los hospitales 340B para dispensar los medicamentos con descuento se ha disparado. Este año ha llegado a más de 31,000 en todo el país, frente a las poco más de 1,700 de 2010, según un análisis de datos federales realizado por InvestigateTV y KHN.

Un dato llamativo: los medicamentos comprados bajo el programa 340B aumentaron a $38,000 millones en 2020, frente a los $5,300 millones de 2010, según la Administración de Recursos y Servicios de Salud (HRSA) que supervisa el programa.

Los interesados a ambos lados del programa —hospitales y farmacéuticas— dicen que están a merced de un programa diseñado con las mejores intenciones, ahora desbocado, secuestrado por empresas con fines de lucro y hospitales ricos que tratan de sacar provecho de su generosidad.

Adam J. Fein, director ejecutivo de la organización de investigación de la industria Drug Channels Institute, estima que casi la mitad de las farmacias minoristas, por correo y especializadas del país se benefician ahora del 340B: el programa, dijo, está “ de la industria farmacéutica”.

Las luchas legales sobre el programa han llegado al Tribunal Supremo de Estados Unidos, que escuchará los argumentos este mes de noviembre en . La industria hospitalaria ha desafiado una normativa de 2018 de la administración Trump para recortar el reembolso de ciertos medicamentos 340B en un 28,5%. Como secretario del HHS de Biden, Xavier Becerra ha mantenido la normativa.

Lo más importante, dice la administración, es asegurarse de que los proveedores utilicen los ahorros para beneficiar a los pacientes. En una entrevista con KHN e InvestigateTV, la contralmirante Krista Pedley, directora de la Oficina de Iniciativas de Salud Especiales, que supervisa el programa dentro de la agencia de Becerra, dijo: “Necesitamos cambios legislativos para ayudar a que eso ocurra y lo exija”.

“Profundamente preocupante”

Cuando el senador Joe Manchin (demócrata de West Virginia) preguntó durante una sobre las farmacéuticas que niegan los descuentos, Becerra respondió que los fabricantes estaban incumpliendo la ley.

“Espero que ustedes nos den más autoridad” para regular el programa, dijo Becerra.

Manchin respondió: “Realmente creo que podríamos hacerlo de manera bipartidista, porque le diré que nos afecta a todos”.

Como fiscal general de California, Becerra lideró una coalición de legisladores nacionales que responsabilizara a los fabricantes por sus acciones “profundamente preocupantes” para socavar el programa. Al llegar al HHS, Becerra puso a las empresas sobre aviso.

Los fabricantes de medicamentos —Lilly, AstraZeneca, Novo Nordisk, Sanofi, Novartis y United Therapeutics— llevaron el asunto a los tribunales y presentaron varias demandas. Este mes, un juez federal dictaminó que las empresas no están obligadas a realizar los descuentos. El juez del caso de Lilly criticó la acción “unilateral” de las farmacéuticas, pero que el esfuerzo del gobierno estadounidense para obligarles a respetar los descuentos no era válido.

En particular, la jueza del Tribunal de Distrito de Estados Unidos en Indianápolis, Sarah Evans Barker, escribió que los fabricantes creen que están “a merced de un sistema desbocado” y que el programa “ya no puede mantenerse unido y aplicarse de forma justa” basándose únicamente en las orientaciones de la agencia y los mensajes inconsistentes.

Becerra solicitó $17 millones anuales para la supervisión del programa 340B, un aumento de $7 millones. El dinero establecería un panel de revisión de disputas y aumentaría las auditorías que la agencia realiza a los fabricantes, así como a los proveedores.

Williams, desde su pequeño hospital en el rural de Parsons, Kansas, señaló que los casi $4,3 millones que el hospital obtiene cada año del 340B le han permitido añadir un puesto a tiempo completo para la gestión de casos, aumentar las horas de trabajo, desarrollar programas extraescolares y abrir clínicas en pueblos empobrecidos que carecían de atención sanitaria.

El hospital cuenta con unas 20 farmacias con contratos activos, según la base de datos federal. Williams dijo que incluye establecimientos de propiedad local como Bowen Pharmacy, y también gigantes corporativos como Walgreens y Walmart, lugares de fácil acceso para los pacientes. Una farmacia añadida en 2019 está en Frisco, Texas. Se trata de una tienda de pedidos por correo que envía medicamentos especializados directamente a los hogares de los pacientes.

Los pacientes, argumentó Williams, se benefician directamente del programa federal: “Me encantaría que el CEO de Eli Lilly viniera aquí, le llevaría a conocer un pueblo de 1,200 habitantes donde el 40% de la población vive por debajo del nivel de pobreza”.

“Algunos de nuestros pacientes llegan en bicicleta o en silla de ruedas”, contó Williams. “Puedo viajar 30 minutos en cualquier dirección y encontrar personas fuertes que viven en circunstancias bastante… bastante austeras”.

Un hospital, 300 farmacias

El Centro Médico de la Universidad de Vanderbilt (VUMC), con sede en Nashville, ha añadido tres hospitales, clínicas y proveedores regionales en los últimos años, un crecimiento que ha impulsado el aumento de sus farmacias contratadas, que han pasado de cero en 2010 a 300 este año. Las farmacias, que se extienden por todo Tennessee y hasta California, “en cada caso sirven a los pacientes de VUMC”, dijo el portavoz de Vanderbilt, John Howser.

La documentación financiera no revela cuánto gana Vanderbilt anualmente del programa 340B, y Howser se negó a proporcionar la cantidad. Los ingresos operativos del sistema médico crecieron $649 millones, o un 13%, hasta los $5,500 millones en el año fiscal 2021 en comparación con 2020, según su último reporte público. Su beneficio operativo aumentó un 25%, hasta $177 millones en 2021 en comparación con 2020.

Según un informe “amicus curiae” (escrito realizado por terceros ajenos al caso), presentado en marzo para el caso de la American Hospital Association v. Becerra, Vanderbilt gasta más de $500 millones anuales en beneficios comunitarios, como la atención caritativa. Los ingresos del programa 340B apoyan los programas de bajos ingresos, incluyendo la asistencia de medicamentos, la medicación a domicilio y un programa de farmacia en una clínica de salud dirigida por estudiantes.

En el escrito, Vanderbilt afirma que el recorte del gobierno en el reembolso de Medicare ha costado al sistema $12,4 millones en ahorros de 340B y “afectará a la capacidad de VUMC para seguir financiando los programas de beneficios comunitarios a niveles históricos”.

Los grandes sistemas de salud regionales han sido especialmente activos en la ampliación de sus redes de farmacias contratadas. Los tres principales —Hospitales y Centros de Salud de la Universidad de Michigan, la Comisión de Salud Pública de Cambridge en Massachusetts y el Hospital Henry Ford en Detroit— no tenían ningún contrato con farmacias externas en 2010, y ahora cada uno tiene más de 500.

InvestigateTV y KHN se pusieron en contacto con los 10 proveedores con más farmacias contratadas y les preguntaron por la causa de tal crecimiento, cuántos ingresos genera el programa 340B y cómo se utiliza el dinero.

Mientras que algunos dijeron que el dinero se destinaba a la atención caritativa y a programas comunitarios, otros no respondieron.

¿Por qué no exigir a los hospitales que informen con precisión de cómo utilizan el ahorro en beneficio de los pacientes?

Sería “oneroso”, dijo Maureen Testoni, directora ejecutiva de 340B Health, que representa a los sistemas de salud.

Testoni señaló que su organización no apoya la obligación de presentar nuevos informes para los hospitales sin fines de lucro, que ya están obligados a presentar informes anuales de costos y declaraciones de impuestos. 340B Health ha financiado investigaciones que demuestran que el ahorro de los descuentos beneficia a los pacientes. Los hospitales inscritos en el programa son mucho más propensos a proporcionar atención gratuita y servicios especializados, como el transporte, que “no es lo que se haría para llenarte los bolsillos”, dijo.

También aseguró que el crecimiento del programa es bueno porque significa que se puede proporcionar más atención en ambulatorios y por proveedores de la red de seguridad para las poblaciones de bajos ingresos. El aumento de las ventas podría deberse a un mayor número de recetas o a la subida de los precios de los medicamentos. La información detallada sobre cualquiera de las dos métricas no es pública.

“¿Nos preocupa que de alguna manera las farmacéuticas se vean perjudicadas por esto?” se preguntó Testoni. “Pues nunca he visto ninguna prueba de ello en términos de que sus ingresos bajen o que tengan problemas para mantener sus puertas abiertas”.

Sin información sobre los más necesitados

Los hospitales no están obligados a demostrar que las grandes redes de farmacias atienden a pacientes sin seguro o a los más necesitados. Las redes más grandes enriquecen a los hospitales y a las farmacias, indicó Fein de Drug Channels.

Un de la Oficina de Rendición de Cuentas del Gobierno (GAO) de 2018 encontró que un hospital o clínica generalmente paga una tarifa plana de dispensación —típicamente de $6 a $15— por cada receta elegible tramitada por una farmacia. Y las farmacias pueden contratar a múltiples proveedores de atención médica: Un centro de suministro de Walmart en Spring, Texas, contrató a 1,842 hospitales y clínicas 340B, según el análisis de InvestigateTV y KHN.

Las recientes declaraciones de valores de Walmart, Walgreens y CVS Health —los mayores actores del mercado de las farmacias por contrato— no proporcionan detalles sobre cuántas recetas 340B se procesan o los ingresos que generan esas transacciones. Walmart no respondió a las solicitudes de comentarios. CVS declinó hacer comentarios.

CVS en una presentación financiera de agosto que los ingresos operativos aumentaron un tercio, entre marzo y junio, en comparación con el año anterior y señaló que el negocio 340B contribuyó a ese aumento, pero no proporcionó más detalles. La compañía adquirió el administrador de farmacias por contrato 340B, Wellpartner, en 2017.

Walgreens mencionó el programa en su presentación financiera anual de 2020, señalando que los cambios en los precios y las regulaciones del gobierno “también podrían reducir significativamente nuestra rentabilidad.” La portavoz de Walgreens, Rebekah Pajak, afirmó que muchas de las tiendas de la compañía están en áreas desatendidas y que está orgullosa de ayudar a cumplir los objetivos del programa. Se negó a revelar las tarifas de dispensación o los términos de sus contratos con hospitales y clínicas.

Karyn Schwartz, vicepresidenta de política e investigación de PhRMA, calificó el programa 340B de “caja negra” y dijo que a las farmacéuticas les gustaría que hubiera más transparencia porque “realmente no tienen forma de saber” cómo los hospitales y las farmacias utilizan sus descuentos.

Los fabricantes de medicamentos afirmaron que siguen participando en el programa enviando descuentos directos a los hospitales, pero que han eliminado algunos o todos los descuentos que pasan por las farmacias contratadas porque no confiaban en las transacciones, según los correos electrónicos que las empresas enviaron a KHN e InvestigateTV. Novartis, que anunció el año pasado que vendería medicamentos con descuento solo a las farmacias situadas en un radio de 40 millas de un hospital, dijo que hay una “ausencia total de transparencia” en los contratos entre hospitales y farmacias.

“Los acuerdos de farmacia por contrato benefician a las farmacias con fines de lucro, a los administradores de terceros, a otros intermediarios y a los hospitales”, escribió en un correo electrónico la portavoz de Novartis, Caryn Marshall.

“Lilly da la bienvenida a las reformas en las que los pacientes son identificados como elegibles para el programa 340B en el punto de venta y comparten los descuentos del programa”, dijo Tarsis López, portavoz de Eli Lilly.

Salir adelante con “media dosis”

Mientras las empresas libran su guerra por los beneficios, los pacientes están atrapados. Andrew Kosowski, un policía jubilado de 75 años con diabetes, se vio sorprendido el año pasado cuando perdió el acceso a los medicamentos con descuento del 340B.

Kosowski es paciente de UnityPoint Health en Peoria, Illinois, que utiliza los fondos del programa para complementar los precios de las recetas para pacientes de bajos ingresos y de Medicare. Con el programa 340B, muchas de sus recetas costaban $15 cada una.

Sin el descuento, la insulina y otros medicamentos de Kosowski le costaban cada mes más de lo que le daba su cheque de la Seguridad Social. “No iba a gastar esa cantidad de dinero”, dijo. Tomaba “media dosis para salir del paso”.

Recordó cómo le dolían los pies y cómo se veía afectada su mente al no poder tomar las dosis que debía.

Schwartz, de PhRMA, declinó hablar sobre la crisis de Kosowski, pero dijo que la industria participa en el 340B y que le gustaría ver un beneficio directo para el paciente. “Esperamos que los responsables políticos intervengan y aclaren realmente el papel que se supone que desempeñan las farmacias con ánimo de lucro en este programa y se aseguren de que los pacientes se benefician”, expresó Schwartz.

Kosowski tuvo la suerte de contar con una aliada en Anne Webster, una enfermera de UnityPoint que le ayudó durante meses con los formularios para poder recibir la ayuda financiera directamente de Novo Nordisk.

La ayuda, sin embargo, no cubre los medicamentos de otras empresas que había conseguido a precio de descuento 340B, medicamentos que le habían ayudado a controlar mejor su diabetes.

Webster dijo que el enfrentamiento de las farmacéuticas llegó en el peor momento posible: “Una persona que vive con diabetes de tipo 2 tiene un riesgo muy alto de mortalidad por coronavirus. Y necesitan más insulina si están enfermos por el virus”.

Kosowski no es el único paciente al que le faltan recetas.

“Creo que he enviado más de 2,000 recetas en un año al programa 340B para mis pacientes con un seguro médico insuficiente, para los que no están asegurados y para los que tienen dificultades económicas”, concluyó Webster.

La editora de datos de KHN, Holly Hacker, colaboró con este informe.

InvestigateTV es el equipo de investigación nacional de Gray Television y ofrece un periodismo innovador y original a cargo de un equipo de investigación y de sus socios. InvestigateTV está disponible en AppleTV, Roku, Amazon Fire, en InvestigateTV.com y en todas las propiedades de medios digitales y de difusión de Gray. Gray Television, con sede en Atlanta, es el mayor propietario de emisoras de televisión locales y activos digitales de primera categoría en Estados Unidos. Tras la prevista adquisición de las emisoras de televisión de Meredith Corp., Gray se convertirá en la segunda emisora de televisión más grande del país, con emisoras de televisión que dan servicio a 113 mercados que llegan a aproximadamente el 36% de los hogares de televisión de Estados Unidos.

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“I do not intend to add to your burden,” said Brian Williams, a retired Army lieutenant colonel and Desert Storm combat veteran. He said his hospital, Labette Health, was “like a war zone,” inundated with unvaccinated patients. A department head had threatened to resign, saying he could not “watch one more body be carried out.”

But Williams wasn’t seeking pandemic relief.

Instead, he asked President Joe Biden to confront pharmaceutical manufacturers Eli Lilly and Co., Novo Nordisk and others for refusing to honor a federal drug discount program for hospitals and clinics. The program gives Williams millions to pay staff members, ensure remote clinics remain open and provide charity care for patients unable to pay, he said.

“During a global pandemic, I think health care workers deserve a little bit more respect than to have resources taken away,” Williams said in an interview with KHN and InvestigateTV. “Every one of those [drug] companies, I looked them up, and they were not suffering tremendous [financial] losses, as hospitals were.”

Eli Lilly’s stock price increased nearly 40% and the company’s value rose by $59 billion in the first seven months of 2021. In the same period, Labette Health lost $1.2 million in revenue just from the missed savings on prescriptions, Williams said.

Lilly and other manufacturers, though, are holding their ground. They refuse to offer discounts to thousands of hospital-contracted pharmacies, saying the program has grown beyond its intended use and lacks federal checks and balances against duplicate discounts and other abuses. In lawsuits, they contend the billions in discounted sales they provide are rarely passed on to patients and instead are swallowed up by middlemen like contract pharmacies and third-party administrators.

Congress created the so-called 340B program in 1992 to provide extra funding for hospitals and clinics, especially those serving the poor and elderly. The purpose, lawmakers wrote, is to “stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”

Companies that want their drugs covered by Medicaid or Medicare Part B are required to offer 340B discounts, typically 25% to 50% off what they might otherwise pay. Hospitals and clinics buy the drugs at the discount and then are reimbursed by an insurance company, Medicare or Medicaid at the higher negotiated rate. The difference is kept by the hospital or clinic to use as it sees fit.

The law does not require patients to benefit directly, a nuance that has fueled great conflict about how the program works and should be regulated.

The 340B program’s reach exploded after federal regulators ruled in 2010 that hospitals and clinics could contract with an unlimited number of retail pharmacies such as Walgreens and CVS, which are paid a fee to dispense the discounted drugs. The growth, coupled with long-held questions about regulatory authority, puts the program at a tipping point, with patients stuck in the middle, industry experts say.

The number of pharmacies contracted to work with 340B hospitals to dispense the discounted drugs has soared. It’s reached more than 31,000 nationwide this year from just over 1,700 in 2010, according to an analysis of federal data by InvestigateTV and KHN.

One eye-popping statistic: The drugs purchased under 340B climbed to $38 billion in 2020 from $5.3 billion in 2010, according to the Health Resources and Services Administration, or HRSA, which oversees the program.

Interests on both sides of the program — hospitals and drugmakers — say they are at the mercy of a program designed with the best of intentions, now run amok, hijacked by for-profit companies and wealthy hospitals trying to profit from its largesse.

Adam J. Fein, chief executive of the industry research organization Drug Channels Institute, estimates that nearly half the nation’s retail, mail and specialty pharmacies now profit from 340B: The program, he said, is “ the pharmacy industry.”

Legal fights about the program have landed before the U.S. Supreme Court, which is slated to hear arguments this month in . The hospital industry is challenging a 2018 rule by the Trump administration to cut reimbursement on certain 340B drugs by 28.5%. As Biden’s HHS secretary, Xavier Becerra has upheld the rule.

Most important, the administration says, is to make sure providers use the savings to benefit patients. In an interview with KHN and InvestigateTV, Rear Adm. Krista Pedley, director of the Office of Special Health Initiatives, which oversees the program within Becerra’s agency, said, “We need legislative changes to help make that happen and require that.”

‘Deeply Troubling’

When Sen. Joe Manchin (D-W.Va.) asked during a about pharmaceutical companies denying the discounts, Becerra said the drugmakers are violating the law.

“I hope what you’ll do is give us more authority” to regulate the program, Becerra said.

Manchin responded: “I really think we could do that in a bipartisan way, because I’ll tell ya, we’re all being affected.”

As California’s attorney general, Becerra led a coalition of national lawmakers federal government to hold the manufacturers accountable for their “deeply troubling” actions to undermine the program. At HHS, Becerra put the companies on notice.

Drugmakers — Lilly, AstraZeneca, Novo Nordisk, Sanofi, Novartis and United Therapeutics — took the matter to court, filing several lawsuits. This month, a federal judge ruled that the companies are not required to provide the discounts. A judge in Lilly’s case criticized the “unilateral” action by drugmakers but that the U.S. government’s effort to force them to honor the discounts was invalid.

Notably, U.S. District Court Judge Sarah Evans Barker in Indianapolis wrote that manufacturers believe they are “at the mercy of a system run amok” and that the program “can no longer be held together and implemented fairly” solely through the agency’s guidance and inconsistent messaging.

Becerra requested $17 million annually for 340B program oversight, a $7 million bump. The money would establish a dispute review panel and increase the audits the agency does on manufacturers as well as the providers.

Williams — at his small hospital in rural Parsons, Kansas — said the nearly $4.3 million the hospital gains each year from 340B has allowed him to add a full-time position for case management, increase staffing hours, develop after-school programs and open clinics in impoverished towns that lacked health care.

The hospital has about 20 pharmacies under active contracts, according to the federal database. Williams said it includes locally owned shops like Bowen Pharmacy as well as corporate giants like Walgreens and Walmart, sites that are convenient for patients. A pharmacy added in 2019 is in Frisco, Texas — a mail-order facility that ships specialty drugs directly to patients’ homes.

Patients, Williams said, directly benefit from the federal program: “I’d love to have the CEO of Eli Lilly come here and I’ll take him around and I’ll show him a town of 1,200 where 40% of the population live below the poverty level.”

“Some of our patients come there on a bicycle or in a wheelchair,” Williams said. “I can go 30 minutes in any direction and find pretty tough people living in pretty … pretty austere circumstances.”

One Hospital, 300 Pharmacies

Vanderbilt University Medical Center, based in Nashville, has added three regional hospitals, clinics and providers in recent years — growth that has fueled its rise in contract pharmacies from zero in 2010 to 300 this year. The pharmacies, which reach across Tennessee and all the way to California, “in each instance serve VUMC patients,” Vanderbilt spokesperson John Howser said.

Financial filings do not disclose how much Vanderbilt gains annually from the 340B program, and Howser declined to disclose the amount. The medical system’s operating revenue grew $649 million, or 13%, to $5.5 billion in fiscal year 2021 compared with 2020, according to its latest financial disclosure. Its operating profit rose 25% to $177 million in 2021 compared with 2020.

According to an amicus brief filed in March for the American Hospital Association v. Becerra case, Vanderbilt spends more than $500 million annually on community benefits, such as charity care. Revenue from the 340B program supports low-income programs including medication assistance, home infusion medications and a pharmacy program at a health clinic run by students.

In the brief, Vanderbilt states the government’s cut in Medicare reimbursement has cost the system $12.4 million in 340B savings and will “impact VUMC’s ability to continue to fund community benefit programs at historic levels.”

Large regional health systems have been particularly active in expanding their contract pharmacy networks. The top three — University of Michigan Hospitals and Health Centers, Cambridge Public Health Commission in Massachusetts and Henry Ford Hospital in Detroit — had zero contracts with outside pharmacies in 2010, and each now has more than 500.

InvestigateTV and KHN contacted the 10 providers with the most contract pharmacies and asked why they saw such growth, how much revenue 340B generates and how the money was used.

While some said the money went for charity care and community programs, others did not respond.

Why not require hospitals to report precisely how they use the savings to benefit patients?

It would be “burdensome,” said Maureen Testoni, chief executive of 340B Health, which represents health systems.

She said her organization does not support mandating new reporting for nonprofit hospitals, which are required to submit annual cost reports and tax filings. The advocacy group has funded research that shows the savings from discounts go to patients. Hospitals enrolled in the program are much more likely to provide free care and specialty services, such as transportation, that are “typically not the ones you can use to pad your pockets,” she said.

Testoni said program growth is good because it means more care can be provided in outpatient settings and by safety-net providers for low-income populations. The bigger sales numbers, she said, could stem from more prescriptions or from higher drug prices. Detailed information about either metric is not public.

“Are we concerned that somehow pharmaceutical companies are being hurt by this?” Testoni said. “Because I’ve never seen any evidence of that in terms of their revenue going down or them having trouble keeping their doors open.”

‘Essentially Taking Over’

Hospitals aren’t required to prove that the large pharmacy networks serve uninsured or needy patients. The larger networks enrich the hospitals and the pharmacies, said Fein of Drug Channels.

A 2018 Government Accountability Office found that a hospital or clinic generally pays a flat dispensing fee — typically from $6 to $15 — for each eligible prescription a pharmacy processed. And pharmacies can contract with multiple health care providers: One Walmart central fill facility in Spring, Texas, contracted with 1,842 340B hospitals and clinics, the InvestigateTV and KHN analysis found.

Recent securities filings for Walmart, Walgreens and CVS Health — the biggest players in the contract pharmacy market —- do not provide line-item detail on how many 340B prescriptions are processed or the revenue those transactions generate. Walmart did not respond to requests for comment. CVS declined to comment.

CVS in an August financial filing that operating income increased by a third between March and June compared with a year ago and noted that 340B business contributed to that increase but provided no further detail. The company acquired 340B contract pharmacy administrator Wellpartner in 2017.

Walgreens mentioned the program in its 2020 annual financial filing, noting that changes to government pricing and regulations “could also significantly reduce our profitability.” Walgreens spokesperson Rebekah Pajak said that many of the company’s stores are in underserved areas and that it is proud to help fulfill the program’s goals. She declined to disclose the dispensing fees or terms of its contracts with hospitals and clinics.

Karyn Schwartz, vice president of policy and research at PhRMA, called the 340B program a “black box” and said drug companies would like more transparency because they “really have no way of knowing” how hospitals and pharmacies use their discounts.

Drugmakers said they continue to participate in the program by sending direct discounts to the hospitals but have eliminated some or all of the discounts passed through contract pharmacies because they didn’t trust the transactions, according to emails the companies sent to KHN and InvestigateTV. Novartis, which announced last year that it would sell drugs at a discount only for pharmacies within 40 miles of a hospital, said there is a “complete absence of transparency” in the contracts between hospitals and pharmacies.

“Contract pharmacy arrangements benefit for-profit pharmacies, third-party administrators, other middlemen and hospitals,” Novartis spokesperson Caryn Marshall wrote in an email.

“Lilly welcomes reforms where patients are identified as 340B eligible at the point-of-sale and share in discounts under the program,” said Tarsis Lopez, Eli Lilly spokesperson.

Getting By on ‘Half a Dose’

Meanwhile, as businesses wage war over profits, patients are stuck. Andrew Kosowski, a 75-year-old retired police officer with diabetes, was shocked last year when he lost access to discounted drugs from 340B.

Kosowski is a patient at UnityPoint Health in Peoria, Illinois, which uses funds from the program to supplement the prescription costs of low-income and Medicare patients. Under 340B, many of his prescriptions were $15 each.

Without the discount, Kosowski’s insulin and other drugs had cost more each month than his Social Security check delivered. “I wasn’t going to spend that kind of money,” he said. He took “half a dose to get me by.”

He recalled how his feet hurt and his mind was affected without his full prescriptions.

PhRMA’s Schwartz declined to speak to Kosowski’s crisis but said the industry participates in 340B and would like to see direct patient benefit. “We hope policymakers step in and really clarify the role that for-profit pharmacies are supposed to be playing in this program and ensure that patients benefit,” Schwartz said.

Kosowski was fortunate to have an ally in Anne Webster, a nurse practitioner at UnityPoint who guided him through months of filling out forms to eventually qualify for financial assistance directly from Novo Nordisk.

The assistance, though, does not cover medications from other companies that he had gotten at the 340B discount price — medications that had helped him better manage his diabetes.

Webster said pharma’s standoff came at the worst possible time: “A Type 2 diabetic is so high-risk for mortality from coronavirus. And they require more insulin if they are ill with the virus.”

Kosowski is not her only patient missing prescriptions.

“I think I prescribed over 2,000 prescriptions in one year to the 340B program for my patients who are underinsured, not insured and are financially challenged,” Webster said.

KHN data editor Holly Hacker contributed to this report.

InvestigateTV is Gray Television’s national investigative team and provides innovative, original journalism from a dedicated investigative team and partners. InvestigateTV is available on AppleTV, Roku, Amazon Fire, at InvestigateTV.com and across Gray broadcast and digital media properties. Gray Television, headquartered in Atlanta, is the largest owner of top-rated local television stations and digital assets in the United States. Upon its anticipated acquisition of the television stations of Meredith Corp., Gray will become the nation’s second-largest television broadcaster, with television stations serving 113 markets that reach approximately 36% of U.S. television households.

ºÚÁϳԹÏÍø 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 .

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