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In the wake of a KHN-CBS News investigation, the FDA on Thursday said it is “evaluating safety concerns” over the use of a dental appliance that multiple lawsuits allege caused grievous harm to patients.
The federal agency told the public in a “safety communication” posted on its website that it is looking not only at that product, the Anterior Growth Guidance Appliance, or AGGA, but other similar dental devices as well, including the Anterior Remodeling Appliance, or ARA, identified in a recent KHN and CBS News article.
The FDA said it is “aware of reports of serious complications with use of these devices” and asked that patients and health care providers report any complications experienced with them to the agency.
The agency said it is aware the devices have been used to treat conditions including sleep apnea and temporomandibular joint disorder of the jaw, also known as TMD or TMJ, but noted that “the safety and effectiveness of these devices intended for these uses have not been established.”
The AGGA device alone has been fitted on more than 10,000 dental patients, according to court records.
The KHN-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented at least 23 other patients — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. The FDA confirmed Thursday that the devices “are not cleared or approved by the FDA.”
The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a sworn court deposition that the AGGA was never submitted to the FDA, which he believes wouldn’t have jurisdiction over it.
At least 20 AGGA patients have in the past three years filed lawsuits against Galella and other defendants claiming the AGGA did not — and cannot — work. Plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.
Additionally, KHN and CBS News reported that the Las Vegas Institute, a company that previously taught dentists to use the AGGA, now trains dentists to use another device its CEO has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.
KHN and CBS News reached out Thursday to attorneys for Galella, the Las Vegas Institute, and the manufacturers of the AGGA and the ARA but received no immediate response.
Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA “is safe and can achieve beneficial results.”
All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings. Cara Tenenbaum, a former senior policy adviser in the FDA’s device center, said reports of complications from these devices are of critical importance and can be submitted through FDA’s MedWatch portal.
“Whether that’s a dentist, an orthodontist, a surgeon, a patient, family member, or caregiver,” Tenenbaum said in a recent interview, “anyone can and should submit these reports so the FDA has a better understanding of what’s happening.”
In a court deposition, Galella said he personally used the AGGA on more than 600 patients and has for years trained other dentists how to use it. In video footage of one training session, produced in discovery in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” forward, making them more attractive and “curing” common ailments, such as sleep apnea and TMJ.
“It’s OK to make a crapload of money,” Galella told dentists in the video. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”
In its Thursday announcement, the FDA said it is aware the devices have been used “to remodel the jaw in adults” but pointed out that devices like these called “fixed (non-removable) palatal expanders” are generally used on children and adolescents, “whose upper jaw bones are not yet fused.” By contrast, the FDA said, “an adult’s upper jaw bones are fused, and when a fixed palatal expansion device applies force, the palate is resistant to expansion. If forces are applied incorrectly to the teeth, serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss.”
Patients interviewed by KHN and CBS News described experiencing many of those problems. One patient who has sued, former professional clarinetist Boja Kragulj, said specialists later had to pull her four front teeth. She now wears false teeth.
Reached Thursday, Kragulj said: “While it’s too late for me and many others, there is some comfort in knowing the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope other patients are spared the injuries and lost years that many of us have now suffered.”
The FDA said it plans “to investigate potential violations” in connection with the use of the devices, and that it is “identifying and contacting responsible entities to communicate [its] concerns.”
The American Dental Association, which has 159,000 dentist members, said it “will inform dentists of the FDA’s evaluation, and will continue to monitor for FDA updates regarding these devices and issues.”
In reading about the AGGA (Anterior Growth Guidance Appliance) dental appliance and the associated problems (“This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth,” March 1), I noted in your article no reference to a similar problem with the proplast-teflon product to treat TMJ, or temporomandibular joint disorder, from the 1980s and ’90s, which caused equivalent damages. It amazes me that essentially the same story happened again. The proplast-teflon product even resulted in congressional-level investigations. And the product was summarily removed by FDA order throughout the United States.
Thank you for your good investigative work.
— Dr. Abbey Strauss, Boca Raton, Florida
— Dr. Joseph Ross, New Haven, Connecticut
This problem seems to expand beyond the AGGA device to the Las Vegas Institute’s entire methodology. The same thing was promised/done to me with braces by LVI-trained dental professionals. I was in braces for six years, and my teeth have spaces they cannot fill now — all while I’m still paying off my debt and unable to afford additional work.
— Chrystal Wilson, Roanoke, Virginia
— Doug Hirsch, CEO of GoodRx, Santa Monica, California
Slipping Through a Billing Loophole
I help support the type of network that this article references (“Bill of the Month: Surprise-Billing Law Loophole: When ‘Out of Network’ Doesn’t Quite Mean Out of Network, Feb. 28). I think it is important for KHN to educate people on narrow-network products, which was the product the Laskey family selected for their medical insurance benefits. These products have lower monthly premium costs for people who select into them, like the Laskeys, but reduce their in-network provider options, hence the term “narrow network.”
These narrow networks may carry out educational webinars, attend open-enrollment fairs, and have a website (in addition to the payer’s website) so that members are educated about the narrow-network offering. With the adoption of more value-based care in the USA, narrow networks are likely to become more prevalent, and more people will need to understand the insurance products, and their networks.
Just wanted to chime in that I am having the exact same problem. I have chronic pain, arthritis throughout my body, a degenerative disc disorder, and even more documented medical problems. I recently broke my collarbone and was given only a two-day supply of opioid medication for it. And my pain doctor’s office doesn’t even prescribe me opioids.
I’ve also been treated horribly in the past when I was on an opioid. And if it weren’t for my family doctor’s understanding, I would still be living in so much pain that life seemed too hard to live with this much misery. I’m on what they call Tylenol 4, with codeine; it barely holds the pain back, but I still cannot handle cold weather (and I hate the heat) or even doing normal chores around my house without going into such a bad pain state I have to stay in bed. If I were able to get the pain medicine appropriate for my condition, I could actually enjoy things again. But because of the “opioid crisis,” that would make me an addict, by most doctor’s opinions. I know the CDC didn’t mean to make many chronic pain patients live in misery, but in my experience, that’s exactly what has happened. And there’s nothing I can do about it.
So I wanted to thank you for the article because I don’t think society or the medical community truly understands what the guidelines did to people like those in your article, or like me either. Thank you so much for writing that!
— Michelle Shivpuri, Cedar Hill, Texas
Great to see other journalists finally picking this story up https://t.co/b3BN48vE8o but so many are still enthusiastically repeating myths about pain and opioids
I am a 66-year-old female who had a colonoscopy and polyps removed at a hospital. This was my first screening of this kind, and upon completion I was billed $882 out-of-pocket. Luckily I was listening to your “Bill of the Month” coverage on South Carolina public radio. It educated me of my rights to preventive care under Obamacare. I was able to dispute the bill with success. But I must add here that my health insurance company tried to discourage me from challenging this bill. It made me feel that the bill was correct and that I should feel lucky that it was only that much. I was very disappointed, so I persisted to fill out another dispute in which I quoted KHN and threatened further action. Within a few weeks, my insurer rescinded the bill I had to pay $0. Big thanks to KHN-NPR’s “Bill of the Month”!
— Angela Thomas, Myrtle Beach, South Carolina
‘The veterinary tranquilizer xylazine – the choice du jour of local drug dealers to cut fentanyl – can lead to necrotic ulcers and leaves street medics and physicians confused about how best to deal with this wave of the opioid crisis’ https://t.co/pP1AQUHkmn#Xylazine
I recently came across your Kensington “tranq dope” article (“Postcard from a Philadelphia neighborhood: As Opioids Mixed With Animal Tranquilizers Arrive in Kensington, So Do Alarming Health Challenges,” Feb. 15). I have been in the health care field for 20-plus years and recently married a recovering addict, so it brought back a bad and vivid memory I’d like to share with the community of Kensington — the users, as well as the first responders, and health care providers, and wound care treatment teams who so graciously step in and up to help individuals suffering from xylazine’s horrific effects.
My husband, Joshua, who became addicted to opioids after being prescribed painkillers for shoulder surgery 20 years ago, was a previous xylazine user only because it was in just about all of the supposed “heroin” bags he bought. One day he said to me, “Why does it feel like something is crawling under my skin?” After looking at his arms, with big nasty-looking sores on them, I replied, “I have no clue.” Thinking he was just “high” and making it up or just hallucinating, I went back to bed. A few hours later, he woke me saying there were worms or maggots coming out of his arms. So, again, I go into the bathroom with him to see what he was talking about, and sure enough it certainly looked exactly like what he had described. Clearly, he needed to be checked out, but being a stubborn, bullheaded man — along with being labeled, judged, and treated poorly previously when seeking medical attention — he did not seek care. A few days later, he was still pulling these things out of his arms and, finally, I persuaded him to be seen by a doctor. The entire doctor’s office couldn’t believe what they were looking at, so after going over everything it could have been, we learned that it was, in fact, a parasite. The doctor’s best explanation was that the drug Josh had injected must have been contaminated with larvae, and it was producing parasites.
Now let’s take a minute and think about this. Hmm. Horse tranquilizer, horseflies, maggots, or worms … whichever you’d like to call them. It makes sense, doesn’t it? So just use caution when treating individuals and please watch for any possible parasites that may not be treated properly. My husband was given antibiotics, a steroid, and a cream to treat the problem and is doing fine now, but the critters have left nasty scars on his arms for him to have a daily reminder of, for sure.
“Tranq dope” is so hard to get off of, and the detox and withdrawal symptoms are extremely hard to handle and overcome, my husband says. Also, there’s not enough information on how to treat or counteract the symptoms. After being clean for just over a year, he relapsed again and went back to the streets of Philly. He is currently incarcerated at a Montgomery County correctional facility, helping his fellow inmates become aware of how serious and dangerous xylazine really is. Our dream is to someday open a fully functional safe house and outreach program within the Philadelphia area to assist as many individuals as possible and show them a better way of life and help them start their new journey.
— Jill Romanishan, Williamsport, Pennsylvania
I don’t know if anyone remembers the drug that Russians were addicted too in the 2000-2010 era. #Krokodil — highly addictive, flesh eating sores which led to amputations, most often: death. Now it’s #tranqhttps://t.co/jCkPJd6xwg
Millions of Americans could lose Medicaid coverage soon (“Medicaid Health Plans Try to Protect Members — And Profits — During Unwinding,” March 9). This problem could be solved seamlessly by Congress expanding public option health insurance in all states in 2023. Do petition the White House, the entire U.S. Senate, and the entire House of Representatives to expand it in all 50 states to provide health care to millions of Americans still without health care or who are about to lose state Medicaid coverage soon.
— Piotr Sliwka, Manassas Park, Virginia
Medicaid Health Plans Try to Protect Members — And Profits — During Unwinding https://t.co/fv5GyqWXzu via @khnews // Get help from the health plan during Medicaid unwinding. they don’t want to lose members or continuity of care either.
Victoria Ferrell Ortiz learned she was pregnant during summer 2017. The Dallas resident was finishing up an AmeriCorps job with a local nonprofit, which offered her a small stipend to live on but no health coverage. She applied for Medicaid so she could be insured during the pregnancy.
“It was a time of a lot of learning, turnaround, and pivoting for me, because we weren’t necessarily expecting that kind of life change,” she said.
Ferrell Ortiz would have liked a little more guidance to navigate the application process for Medicaid. She was inundated with forms. She spent days on end on the phone trying to figure out what was covered and where she could go to get care.
“Sometimes the representative that I would speak to wouldn’t know the answer,” she said. “I would have to wait for a follow-up and hope that they actually did follow up with me. More than 476,000 pregnant Texans are currently navigating that fragmented, bureaucratic system to find care. Medicaid provides coverage for about half of all births in the state — but many people lose eligibility not long after giving birth.
Many pregnant people rely on Medicaid coverage to get access to anything from prenatal appointments to prenatal vitamins, and then postpartum follow-up. Pregnancy-related Medicaid in Texas is available to individuals who make under $2,243 a month. But that coverage ends two months after childbirth — and advocates and researchers say that strict cutoff contributes to rates of maternal mortality and morbidity in the state that are higher than the national average.
They support a bill moving through the Texas legislature that would extend pregnancy Medicaid coverage for a full 12 months postpartum.
Texas is one of 11 states that has chosen not to expand Medicaid to its population of uninsured adults — a benefit offered under the Affordable Care Act, with 90% of the cost paid for by the federal government. That leaves more than 770,000 Texans in a coverage gap — they don’t have job-based insurance nor do they qualify for subsidized coverage on healthcare.gov, the federal insurance marketplace. In 2021, 23% of women ages 19-64 were uninsured in Texas.
Pregnancy Medicaid helps fill the gap, temporarily. Of the nearly half a million Texans currently enrolled in the program, the majority are Hispanic women ages 19-29.
Texans living in the state without legal permission and lawfully present immigrants are not eligible, though they can get different coverage that ends immediately when a pregnancy does. In states where the Medicaid expansion has been adopted, coverage is available to all adults with incomes below 138% of the federal poverty level. For a family of three, that means an income of about $34,300 a year.
In Texas, childless adults don’t qualify for Medicaid at all. Parents can be eligible for Medicaid if they’re taking care of a child who receives Medicaid, but the income limits are low. To qualify, a three-person household with two parents can’t make more than $251 a month.
For Ferrell Ortiz, the hospitals and clinics that accepted Medicaid near her Dallas neighborhood felt “uncomfortable, uninviting,” she said. “A space that wasn’t meant for me” is how she described those facilities.
Later she learned that Medicaid would pay for her to give birth at an enrolled birthing center.
“I went to Lovers Lane Birth Center in Richardson,” she said. “I’m so grateful that I found them because they were able to connect me to other resources that the Medicaid office wasn’t.”
Ferrell Ortiz found a welcoming and supportive birth team, but the Medicaid coverage ended two months after her daughter arrived. She said losing insurance when her baby was so young was stressful. “The two-months window just puts more pressure on women to wrap up things in a messy and not necessarily beneficial way,” she said.
In the 2021 legislative session, Republican Gov. Greg Abbott signed a bill extending pregnancy Medicaid coverage from two months to six months postpartum, pending federal approval.
Last August, The Texas Tribune reported that extension request had initially failed to get federal approval, but that the Centers for Medicare & Medicaid Services had followed up the next day with a statement saying the request was still under review. The Tribune reported at the time that some state legislators believed the initial application was not approved “because of language that could be construed to exclude pregnant women who have abortions, including medically necessary abortions.”The state’s application to extend postpartum coverage to a total of six months is still under review.
The state’s Maternal Mortality and Morbidity Review Committee is tasked with producing statewide data reports on causes of maternal deaths and intervention strategies. Members of that committee, along with advocates and legislators, are hoping this year’s legislative session extends pregnancy Medicaid to 12 months postpartum.
Kari White, an associate professor at the University of Texas-Austin, said the bureaucratic challenges Ferrell Ortiz experienced are common for pregnant Texans on Medicaid.
“People are either having to wait until their condition gets worse, they forgo care, or they may have to pay out-of-pocket,” White said. “There are people who are dying following their pregnancy for reasons that are related to having been pregnant, and almost all of them are preventable.”
In Texas, maternal health care and Pregnancy Medicaid coverage “is a big patchwork with some big missing holes in the quilt,” White said. She is also lead investigator with the Texas Policy Evaluation Project (TxPEP), a group that evaluates the effects of reproductive health policies in the state. A March 2022 TxPEP study surveyed close to 1,500 pregnant Texans on public insurance. It found that “insurance churn” — when people lose health insurance in the months after giving birth — led to worse health outcomes and problems accessing postpartum care.
Chronic disease accounted for almost 20% of pregnancy-related deaths in Texas in 2019, according to a partial cohort review from the Texas Maternal Mortality and Morbidity Review Committee’s report. Chronic disease includes conditions such as high blood pressure and diabetes. The report determined at least 52 deaths were related to pregnancy in Texas during 2019. Serious bleeding (obstetric hemorrhage) and mental health issues were leading causes of death.
“This is one of the more extreme consequences of the lack of health care,” White said.
Black Texans, who make up close to 20% of pregnancy Medicaid recipients, are also more than twice aslikely to die from a pregnancy-related cause than their white counterparts, a statistic that has held true for close to 10 years with little change, according to the MMMRC report.
Stark disparities such as that can be traced to systemic issues, including the lack of diversity in medical providers; socioeconomic barriers for Black women such as cost, transportation, lack of child care and poor communication with providers; and shortcomings in medical education and providers’ implicit biases — which can “impact clinicians’ ability to listen to Black people’s experiences and treat them as equal partners in decision-making about their own care and treatment options,” according to a recent survey.
Diana Forester, director of health policy for the statewide organization Texans Care for Children, said Medicaid coverage for pregnant people is a “golden window” to get care.
“It’s the chance to have access to health care to address issues that maybe have been building for a while, those kinds of things that left unaddressed build into something that would need surgery or more intensive intervention later on,” she said. “It just feels like that should be something that’s accessible to everyone when they need it.”
Extending health coverage for pregnant people, she said, is “the difference between having a chance at a healthy pregnancy versus not.”
As of February, 30 states have adopted a 12-month postpartum coverage extension so far, according to a KFF report, with eight states planning to implement an extension.
“We’re behind,” Forester said of Texas. “We’re so behind at this point.”
Many versions of bills that would extend pregnancy Medicaid coverage to 12 months have been filed in the legislature this year, including House Bill 12 and Senate Bill 73. Forester said she feels “cautiously optimistic.”
“I think there’s still going to be a few little legislative issues or land mines that we have to navigate,” she said. “But I feel like the momentum is there.”
Ferrell Ortiz’s daughter turns 5 this year. Amelie is artistic, bright, and vocal in her beliefs. When Ferrell Ortiz thinks back on being pregnant, she remembers how hard a year it was, but also how much she learned about herself.
“Giving birth was the hardest experience that my body has physically ever been through,” she said. “It was a really profound moment in my health history — just knowing that I was able to make it through that time, and that it could even be enjoyable — and so special, obviously, because look what the world has for it.”
She just wishes people, especially people of color giving birth, could get the health support they need during a vulnerable time.
“If I was able to talk to people in the legislature about extending Medicaid coverage, I would say to do that,” she said. “It’s an investment in the people who are raising our future and completely worth it.”
This story is part of a partnership that includes KERA, NPR, and KHN.
Un juez federal anuló el jueves 30 de marzo una parte de la Ley de Cuidado de Salud a Bajo Precio (ACA) que hace que los servicios preventivos, como algunos exámenes de detección de cáncer, sean gratuitos para los miembros, una decisión que podría afectar a los titulares de planes médicos en todo el país.
La decisión del Tribunal de Distrito de Estados Unidos para el Distrito Norte de Texas podría abrir la puerta para que las aseguradoras o los empleadores restablezcan los copagos para algunos de esos servicios preventivos, aunque muchos pueden mostrarse reacios o no podrían hacerlo, al menos de inmediato.
El fallo del juez federal de distrito Reed O’Connor se basa en otro previo, de septiembre, en el que también dijo que el requisito de ACA de que los empleadores cubran el tratamiento PrEP (profilaxis previa a la exposición) para prevenir el VIH viola la Ley de Restauración de la Libertad Religiosa (Religious Freedom Restoration Act).
Su fallo es la última de muchas batallas legales por ACA. “Casos anteriores amenazaron la existencia misma de la ley y las protecciones fundamentales. Esta decisión no hace eso”, dijo Larry Levitt, vicepresidente ejecutivo de políticas de salud de KFF. Pero “anula una parte de la ley, aunque muy popular, que utiliza mucha gente”.
Es casi seguro que este fallo será apelado, posiblemente por ambas partes: los grupos conservadores que presentaron el caso y esperaban que la decisión fuera más amplia, y la administración Biden, que apoya ACA.
“Hay mucho en juego”, porque la decisión final podría afectar a millones de estadounidenses, dijo Andrew Twinamatsiko, director asociado de política de salud e iniciativa legal en el Instituto O’Neill de la Universidad de Georgetown.
“Los estadounidenses deben tener la tranquilidad de que no habrá una interrupción inmediata en la cobertura de atención”, dijo Matt Eyles, presidente y director ejecutivo de AHIP, el principal grupo de cabildeo de la industria de seguros de salud.
Ahora, el Departamento de Justicia debe decidir si busca una orden de emergencia que suspenda el fallo durante el proceso de apelación.
La decisión podría afectar los exámenes de detección sin copago y servicios preventivos similares que la mayoría de los estadounidenses con seguro tienen como parte de sus planes de salud. Pero al principio, los consumidores pueden sentir poco impacto.
“La palabra prevención aparece un par de cientos de veces en ACA”, dijo Timothy Jost, profesor de derecho emérito de la Facultad de Derecho de la Universidad Washington and Lee, quien sigue de cerca a ACA. “Parte de la idea de ACA fue que pensamos en tratar de prevenir la enfermedad, o al menos identificarla antes, cuando es más curable”.
Hacer que esta atención sea gratuita para los afiliados fue una forma de fomentar la detección de enfermedades.
Pero el fallo de O’Connor dijo que una de las formas en que se seleccionan esos servicios sin costo, tarea que realiza el Grupo de Trabajo de Servicios Preventivos de EE.UU., un grupo asesor no gubernamental, es inconstitucional.
En su opinión de septiembre, O’Connor escribió que los miembros del grupo de trabajo, que es convocado por una agencia federal de salud, son en realidad “funcionarios de los Estados Unidos” y, por lo tanto, deben ser designados por el presidente y confirmados por el Senado.
El juez agregó que su decisión no se aplica específicamente a los anticonceptivos o vacunas sin copago, que son seleccionados por otras agencias, aunque los grupos conservadores que presentaron el caso también habían buscado su inclusión.
Las mamografías se encuentran entre esos servicios preventivos que pueden estar en una categoría especial porque también son recomendadas por una de esas otras agencias, por lo que los expertos de KFF dicen que probablemente seguirán cubiertas sin costo compartido para el paciente, incluso con esta decisión.
O’Connor emitió un juicio sumario en el caso en septiembre. En ese momento, la decisión se aplicaba únicamente a los empleadores que presentaron el caso.
El fallo del jueves amplía eso a todos los empleadores y aseguradoras en todo el país.
Por ahora, es probable que los consumidores, especialmente aquellos que compran su propia cobertura a través del mercado de seguros establecido por ACA, continúen recibiendo atención preventiva sin costo en muchos planes, dijeron expertos.
Eso se debe a que la mayoría de estos planes se ejecutan en el año calendario y los afiliados esencialmente han firmado contratos “que cubrirán esos servicios hasta fin de año”, explicó Jost.
Aún así, dependiendo del resultado de las apelaciones, con el tiempo cada aseguradora probablemente sopesará los pros y los contras de restablecer los copagos para el paciente.
Comenzarán a tomar “decisiones comerciales para continuar cubriendo sin costo o imponer costos compartidos”, dijo Twinamatsiko.
En los planes basados en el trabajo, a través de los cuales la mayoría de los estadounidenses asegurados obtienen su cobertura, el impacto inicial también puede no sentirse.
El 80% de los directores de recursos humanos dijeron que no restaurarían los costos compartidos para la atención preventiva, según una encuesta no científica reciente de 25 directores de recursos humanos en empresas con un total de alrededor de 600,000 trabajadores.
Hacerlo podría molestar a los empleados, señaló Paul Fronstin, director de investigación de beneficios de salud en el Employee Benefit Research Institute, que realizó la encuesta. Y cubrir completamente la atención preventiva de los afiliados, sin requerir copagos, es relativamente económico.
En otro estudio, descubrió que incluso uno de los tratamientos de atención preventiva más costosos, la PrEP, de casi $14,000 al año, para prevenir el VIH, agrega solo un 0.4% al gasto anual del empleador en atención médica. Incluso si un empleador agregara un copago del 20% para el trabajador, reduciría el gasto general en menos de una décima parte del 1%, según el estudio.
Aparte de unos pocos empleadores que podrían querer restringir la cobertura sin costo por motivos religiosos para tratamientos como PrEP, James Gelfand dijo que dudaba que muchas compañías fueran a restablecer los copagos. Gelfand es presidente del Comité de Industria de ERISA, que representa a grandes empleadores autoasegurados.
Los servicios respaldados por el Grupo de Trabajo de Servicios Preventivos de EE.UU. fueron seleccionados porque funcionan y “pueden prevenir condiciones más agudas más adelante”, que son mucho más costosas, dijo Gelfand.
Si bien la mayoría de las recomendaciones del grupo de trabajo no son controversiales, algunas han provocado la protesta de algunos empleadores, incluidas las partes en la demanda, quienes argumentan que no deberían verse obligados a pagar por servicios o tratamientos con los que no están de acuerdo, como medicamentos para la prevención del VIH. .
El fallo de O’Connor confirmó la afirmación del demandante Braidwood Management, una corporación cristiana con fines de lucro propiedad de Steven Hotze, que se opone a proporcionar la PrEP gratuita a sus 70 empleados, diciendo que, al hacerlo, entra en conflicto con sus creencias religiosas.
El juez estuvo de acuerdo y dijo que obligar a Braidwood a brindar tal atención gratuita en su plan autoasegurado viola la Ley de Restauración de la Libertad Religiosa.
El fallo que elimina la cobertura preventiva sin costos compartidos para la PrEP por motivos religiosos muestra un “claro sesgo”, dijo Carl Schmid, director ejecutivo del HIV+Hepatitis Policy Institute.
Algunos estados han aprobado leyes que seguirán exigiendo la cobertura de los servicios preventivos exigidos por ACA incluso si se eliminan las protecciones federales.
Al menos 15 estados tienen leyes que exigen que las aseguradoras que venden planes individuales cubran los servicios preventivos que requiere ACA, según un análisis realizado por investigadores del Centro de Reformas de Seguros Médicos de Georgetown.
Al igual que ACA, esas leyes estatales exigen la cobertura sin costo para los consumidores.
En algunos de los estados, los trabajadores en planes de seguro grupales regulados por el estado, llamados planes “totalmente asegurados”, también reciben esas protecciones, encontró el análisis.
Esas leyes estatales no se aplican al 65% de los trabajadores cubiertos en todo el país cuyos empleadores pagan sus reclamos de atención médica directamente, en lugar de comprar un seguro para ese fin.
En general, los servicios preventivos pueden conducir a mejores resultados, dijo Lisa Lacasse, presidenta de la Red de Acción contra el Cáncer de la Sociedad Americana del Cáncer.
Agregó que millones de personas se someten a pruebas de detección de cáncer de mama, colorrectal, de pulmón o de cuello uterino cada año, y que hay evidencia que muestra que cualquier tipo de copago o deducible disuade a las personas de realizarse las pruebas.
Lacasse dijo que espera que las aseguradoras continúen sin cobrar copagos porque un cambio tan drástico a mitad de año sería destructivo, y que los afiliados deberían seguir recibiendo atención preventiva.
“Si tiene una evaluación, debe seguir adelante con eso”, dijo.
A federal judge on Thursday overturned a portion of the Affordable Care Act that makes preventive services, such as some cancer screenings, free to enrollees, a decision that could affect health insurance policyholders nationwide.
The decision from the U.S. District Court for the Northern District of Texas could open the door for insurers or employers to reinstate copayments for some of those preventive services, although many may be reluctant or unable to do so, at least immediately.
The ruling by U.S. District Judge Reed O’Connor builds on a September judgment in which he also said the ACA requirement that employers cover preexposure prophylaxis treatment to prevent HIV violates the Religious Freedom Restoration Act.
His ruling is the latest shot in the legal battle over the ACA. “Previous cases threatened the very existence of the law and fundamental protections. This decision does not do that,” said Larry Levitt, KFF executive vice president for health policy. But “it strikes down a portion of the law, albeit a very popular one, that is used by a lot of people.”
It is almost certain to be appealed, possibly by both sides: the conservative groups that brought the case and had hoped the decision would be broader, and the Biden administration, which supports the ACA.
“The stakes are really high,” because the ultimate decision could affect millions of Americans, said Andrew Twinamatsiko, associate director of the health policy and the law initiative at the O’Neill Institute at Georgetown University.
“Americans should have peace of mind there will be no immediate disruption in care coverage,” said Matt Eyles, president and CEO of AHIP, the health insurance industry’s leading lobbying group.
Now, the Department of Justice must decide whether to seek an emergency order putting the ruling on hold during the appeal process.
The decision could affect the no-copay screenings and similar preventive services that most insured Americans have as part of their health plans. But consumers may see little impact initially.
“The word prevention appears a couple hundred times in the ACA,” said Timothy Jost, law professor emeritus at Washington and Lee University School of Law, who closely follows the ACA. “Part of the idea of the ACA was we thought to try to prevent disease or at least identify it earlier when it’s more curable.”
Making such care free to enrollees was a way to encourage screening for disease.
But O’Connor’s ruling said one of the ways those no cost-services are selected — by the U.S. Preventive Services Task Force, a nongovernmental advisory group — is unconstitutional.
The judge said his decision specifically does not apply to no-copay contraceptives or vaccines, which are selected by other agencies, although the conservative groups that brought the case had sought their inclusion as well.
Mammograms are among those preventive services that may be in a special category because they, too, are recommended by one of those other agencies, so experts at KFF say they will probably continue to be covered without patient cost sharing, even with this ruling.
O’Connor issued a summary judgment in the case in September. At the time, the decision applied only to the employers that brought the case.
Thursday’s ruling expands that to all employers and insurers nationwide.
For now, consumers, especially those who buy their own coverage through the ACA marketplace, are likely to continue to get no-cost preventive care in many plans, experts said.
That’s because most such plans run on the calendar year and enrollees have essentially signed contracts “which will cover those services through the end of the year,” said Jost.
Still, depending on the outcome of the appeals, over time each insurer will likely weigh the pros and cons of reinstituting such patient cost sharing.
They will start to make “business decisions to either continue to cover without cost or to impose cost sharing,” said Twinamatsiko at Georgetown.
In job-based plans, through which most insured Americans get their coverage, initial impact may also be muted.
Eighty percent of human resources directors said they would not restore cost sharing for preventive care, according to a recent nonscientific survey of 25 human resources directors at companies with a collective total of about 600,000 workers.
Doing so could upset employees, noted Paul Fronstin, director of health benefits research at the Employee Benefit Research Institute, which ran the survey. And fully covering enrollees’ preventive care, without requiring copayments, is relatively inexpensive. In a separate study, he found that even one of the more costly preventive care treatments — the nearly $14,000-a-year PrEP, to prevent HIV — adds only 0.4 percent to annual employer spending on health care. Even if an employer were to add a 20% copayment for the worker, it would reduce overall spending by less than one-tenth of 1%, according to the study.
Outside of a few employers that might want to restrict no-cost coverage on religious grounds for treatments like PrEP, James Gelfand said he doubted many companies would reinstitute copayments. Gelfand is president of the ERISA Industry Committee, which represents large, self-insured employers.
Services endorsed by the U.S. Preventive Services Task Force were selected because they work and “can prevent more acute conditions later,” which are far more costly, said Gelfand.
While most of the task force’s recommendations are noncontroversial, a few have elicited an outcry from some employers, including the parties to the lawsuit, who argue they should not be forced to pay for services or treatments they disagree with, such as HIV-prevention drugs.
O’Connor’s ruling upheld the contention by plaintiff Braidwood Management, a Christian for-profit corporation owned by Steven Hotze, which objects to providing free PrEP to its 70 employees, saying it runs afoul of its religious beliefs to do so.
The judge agreed, saying that forcing Braidwood to provide such free care in its self-insured plan violates the Religious Freedom Restoration Act.
The ruling eliminating preventive coverage without cost sharing for PrEP on religious grounds shows “clear bias,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.
Some states have passed laws that will continue to require coverage of ACA-mandated preventive services even if the federal protections are eliminated.
At least 15 states have laws requiring insurers that sell individual plans to cover the preventive services that the ACA requires, according to an analysis by researchers at Georgetown’s Center on Health Insurance Reforms.
Like the ACA, those state laws mandate the coverage at no cost to consumers.
In some of the states, workers in group insurance plans regulated by the state — called “fully insured” plans — also receive those protections, the analysis found.
Those state laws do not apply to the 65% of covered workers nationwide whose employers pay their health care claims directly rather than buy insurance for that purpose.
Millions of people get screened for breast, colorectal, lung, or cervical cancer each year, she said, adding there is evidence showing any kind of copayment or deductible deters people from getting such testing.
Lacasse said she hopes insurers will continue not to charge copays because such a sharp change midyear would be disruptive, and that enrollees should keep going in for preventive care.
“If you have a screening, you should move forward with that,” she said.
Opponents of the Affordable Care Act may have stopped trying to overturn the entire law in court, but they have not stopped challenging pieces of it — and they have found an ally in Fort Worth, Texas: U.S. District Judge Reed O’Connor. In 2018, O’Connor held that the entire ACA was unconstitutional — a ruling eventually overturned by the Supreme Court. Now the judge has found that part of the law’s requirement for insurers to cover preventive care without copays violates a federal religious freedom law.
In a boost for the health law, though, North Carolina has become the 40th state to expand the Medicaid program to lower-income people who were previously ineligible. Even though the federal government will pay 90% of the cost of expansion, a broad swath of states — mostly in the South — have resisted widening eligibility for the program.
This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sandhya Raman of CQ Roll Call.
Among the takeaways from this week’s episode:
Thursday’s decision out of Texas affects health plans nationwide and is expected to disrupt the health insurance market, which for years has provided preventive care without cost sharing under the ACA. Even if the decision survives a likely appeal, insurers could continue offering the popular, generally not-so-costly benefits, but they would no longer be required to do so.
The decision, which found that the U.S. Preventive Services Task Force cannot mandate coverage requirements, hinges on religious freedom objections to plans covering PrEP, the HIV medication, alongside other preventive care.
Speaking of the ACA, this week North Carolina became the latest state to expand Medicaid coverage under the health law, which will render an estimated 600,000 residents newly eligible for the program. The development comes amid reports about hospitals struggling to cover uncompensated care, particularly in the 10 states that have resisted expanding Medicaid.
Pushback against Medicaid expansion has contributed over the years to a yawning coverage divide between politically “blue” and “red” states, with liberal-leaning states pushing to cover more services and people, while conservative-leaning states home in on policies that limit coverage, like work requirements.
On the abortion front, state attorneys general are challenging the FDA’s authority on the abortion pill — not only in Texas, but also in Washington state, where Democratic state officials are fighting the FDA’s existing restrictions on prescribing and dispensing the drug. The Biden administration has adopted a similar argument as it has in the Texas case challenging the agency’s original approval of the abortion pill: Let the FDA do its job and impose restrictions it deems appropriate, the administration says.
The FDA is poised to make a long-awaited decision on an over-the-counter birth control pill, an option already available in other countries. One key unknown, though, is whether the agency would impose age restrictions on access to it.
And as of this week, 160 Defense Department promotions have stalled over one Republican senator’s objections to a Pentagon policy regarding federal payments to service members traveling to obtain abortions.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
More than $50 billion in settlement funds is being delivered to thousands of state and local governments from companies accused of flooding their communities with opioid painkillers that have left millions addicted or dead.
But how that massive windfall is being deployed and how future dollars will be spent seem to be shrouded in mystery. Reporting requirements are scant, and documents filed so far are often so vague as to be useless.
Most of the settlements stipulate that states must spend at least 85% of the money they will receive over the next 15 years on addiction treatment and prevention. But defining those concepts depends on stakeholders’ views — and state politics. To some, it might mean opening more treatment sites. To others, buying police cruisers.
Those affected by the opioid epidemic and those working to fight it have an array of ideas: To Marianne Sinisi, who lost her 26-year-old son, Shawn, to overdose in western Pennsylvania, the settlement funds are “blood money” that she hopes can spare other parents similar grief. To Steve Alsum, who works with people who use drugs in Grand Rapids, Michigan, it’s a chance to finally reach all those in need. And to David Garbark, who is in recovery from opioid addiction, it’s a way to give others in his eastern North Carolina community a second chance, too.
Sinisi wants opioid settlement dollars to be spent in ways that help spare other parents similar grief. (Nancy Andrews for KHN)
A framed photograph of Michael and Marianne Sinisi with son Shawn in 2013, when he was forced into a recovery house by court order. (Nancy Andrews for KHN)
Spending the money effectively and equitably is a tall order, given the persistence and complexity of addiction, which affects individuals and communities, and is the topic of heated debates in scientific research, social services, politics, criminal justice, and even at kitchen tables.
What’s more, many states are not being transparent about where the funds are going and who will benefit. An investigation by KHN and Christine Minhee, founder of OpioidSettlementTracker.com, concluded only 12 states have committed to detailed public reporting of all their spending.
The analysis involved scouring hundreds of legal documents, laws, and public statements to determine how each state is divvying up its settlement money among state agencies, city and county governments, and councils that oversee dedicated trusts. The next step was to determine the level and detail of public reporting required. The finding: Few states promise to report in ways that are accessible to the average person, and many are silent on the issue of transparency altogether.
More than $3 billion has gone out to state and local governments so far. KHN will be following how that cash — and the billions set to arrive in coming years — is used.
Per most of the settlements, governments are required to report only on the 15% of the money that can be used for things unrelated to the epidemic, like offsetting budget shortfalls or fixing old roads. As of March 28, only three states and counties had filed such reports. Although they listed dollar amounts, none said precisely how the money was spent.
State and local governments can enact more rigorous reporting protocols — for example, requiring a publicly available list of every place that receives money and for what purpose — but few have so far.
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Left in the Dark
More than 250,000 Americans have died of overdoses from prescription opioids, which were aggressively promoted as painkillers and distributed by a host of health care companies, including Johnson & Johnson, AmerisourceBergen, McKesson, and Walmart. The settlements are meant to compensate and remediate the effects of that corporate behavior.
But many people whose lives have been upended are again feeling traumatized.
Sinisi said she and other parents who’ve lost kids to addiction have been left in the dark or, worse, treated like nuisances by officials in charge of the money.
“They want to look at you as this angry parent who lost a child,” she said, “rather than a concerned citizen who wants to see a difference made for other mothers, fathers, and their children.”
In Michigan, even the state’s Opioid Advisory Commission, which is tasked with evaluating the use of settlement money, has struggled to track the cash.
For six months after the state legislature allotted $39 million of settlement funds to the health department last summer, little information was made public about how that money would be spent. No news releases. No way for organizations to apply for funds.
“We can’t really identify the impact of those dollars if we don’t know how they’re being used,” said Dr. Cara Poland, the commission’s chair and an addiction-medicine doctor.
A family photo of Josh and Shawn Sinisi (right) as children, taken by their mother, Marianne, in 1994. (Nancy Andrews for KHN)Sinisi has been asking elected officials to allow her and other families to be part of decisions on how to spend opioid settlement dollars. Without public input, Sinisi fears, the funds will be wasted or cause harm.(Nancy Andrews for KHN)
With scant oversight nationwide, many people fear dollars may flow to efforts that research has proven mostly useless but jibe with the local political bent, like arresting people who use drugs, expanding jails, and favoring abstinence-only recovery over medications. They may go to the loudest bidder, with companies promising to find the next groundbreaking treatment and rehab facilities — some with shoddy track records — eyeing the cash.
Not to mention concerns that money will flow to activities that have little to nothing to do with opioid treatment: building new stadiums or public schools. Back in the ’90s, these day-to-day budget priorities consumed most of what states won from cigarette companies in the national tobacco settlement, leaving little for anti-smoking programs.
The opioid settlement funds will be different, say state attorneys general who fought for them. In addition to requiring at least 85% of the money be used on opioid-related expenses, most agreements include a list of suggested interventions like increasing addiction treatment for the uninsured and expanding recovery housing.
“We wanted to give states flexibility on what approaches they wanted to adopt,” while ensuring money didn’t go to “provide corporate tax relief” as the tobacco dollars did, said North Carolina Attorney General Josh Stein, who led negotiations for the national settlements.
But enforcement of the 85% standard is, oddly, left to the companies that paid out the money. They are unlikely to be vigilant, legal experts say. The money is committed already and, for many of these multibillion-dollar companies, the settlements are chump change. For example, Johnson & Johnson is set to pay $5 billion over nine years, but the company reported sales of nearly $95 billion in the past year alone.
After her son died of an overdose, Marianne Sinisi led the creation of the Circle of Hope statue at Tuckahoe Park in Altoona, Pennsylvania. (Nancy Andrews for KHN)
The statue is a place of support for those affected by addiction. (Nancy Andrews for KHN)
An Emerging Picture
As the checks start to trickle in, a handful of states are committed to transparency while others seem to be falling short. Missouri has promised to report all its spending in online reports so that anyone can see who receives money, how much, and for what programs. New Hampshire already has posted reports online, and Colorado has created a public dashboard to track how funds are used.
Other states, like Nevada, have taken a middle-of-the-road approach, requiring that recipients report to the legislature or another oversight body, but not ensuring the reports will go public. Some states require audits but don’t promise to list specific expenses. And others allow the public to request records but won’t provide them automatically.
Then there are states hit hard by the opioid epidemic like Michigan and Ohio, where problems with transparency are already emerging. Each state is expecting to receive at least $1 billion.
When Poland, of Michigan’s Opioid Advisory Commission, realized she was getting little information on how the state’s funds were being spent, her commission decided to use its first annual report — published this month — to demand better. “Timely and transparent reporting” to the public is “an ethical responsibility,” it said, calling on lawmakers to enact greater oversight for settlement cash recipients and create a public dashboard to track spending.
KHN interviewed nearly a dozen people and filed a public records request to uncover how the state health department is spending the initial settlement funds allocation of $39 million.
A budget document obtained by KHN shows that as of Jan. 9, the Michigan Department of Health and Human Services had contracted $3.9 million in settlement funds to 35 grantees. Most are local health departments or syringe service programs that the state health department has previously funded.
An additional $27 million is set aside for particular interventions, such as growing the addiction treatment workforce, expanding recovery housing, and mitigating the harms of opioid use with medications like naloxone.
And, after KHN’s inquiries, the department released a statement that listed similar priorities.
Jonathan Stoltman is the director of the Michigan-based Opioid Policy Institute, which researches digital privacy in addiction treatment and discrimination against people who use drugs. “Anything that is backdoor scares me,” Stoltman says about the process of applying for settlement funds. (Ellen Manegold)
Those initiatives make sense to Jonathan Stoltman, director of the Michigan-based Opioid Policy Institute, which researches stigma and digital privacy in addiction treatment. But he would have liked to have known about them in advance and to have had a clear process laid out for groups to apply for the funds. Otherwise, organizations that are well positioned to use the money to help those most in need may miss a once-in-a-lifetime chance to scale up their work and save lives.
Last summer, when Stoltman inquired about applying for the funds, the health department told him to submit a “high level proposal” to “share around,” according to emails reviewed by KHN.
“Anything that is backdoor scares me,” said Stoltman. “I got lucky that I found who to talk to, even if it didn’t go anywhere.”
Steve Alsum, executive director of the Grand Rapids Red Project, which was awarded about $266,000 to improve the health of people who use drugs, said he expected the state to have an application process with scoring criteria to explain why certain groups were chosen. But, he said, “it hasn’t been clear who is making the decision and how it’s made.”
Jared Welehodsky, who leads the department’s efforts related to the settlement, said it is in the process of releasing several competitive grant applications for the bulk of the money. That didn’t happen sooner because most payments didn’t arrive until the end of 2022 and “we didn’t want to comment on how the money was going out when we didn’t have money to go out,” he said.
Talk of Keeping the Public Out
In Newark, Ohio, Linda Mossholder, 75, has been inquiring about the settlement dollars at City Council meetings since last summer. As a volunteer with Newark Homeless Outreach, which serves weekly free lunches, she encounters many people who use drugs and wants to see the money help them.
The proud owner of a T-shirt that reads, “Your first mistake is thinking I’m just an old lady,” Mossholder has followed up with emails, voicemails, and public records requests. But she hasn’t gotten a clear answer about how the city plans to use the nearly $50,000 it’s already received.
In January, Mossholder said, the city’s director of public service finally told her the plan was to allocate settlement cash to first responders for naloxone. But when KHN filed public records requests to confirm, City Auditor Ryan Bubb wrote, “No funds have been allocated or spent.”
Meanwhile, in northeastern Ohio, a regional board that will control millions of settlement dollars spent a February meeting discussing whether the public should be allowed to access meeting recordings at all.
“I wouldn’t open it up to the public, honestly,” said Judy Moran, a board member who represents Eastlake, according to a recording of the meeting obtained by KHN. Other board members asked if their gatherings were subject to the state’s open-meeting laws.
Moran later told KHN, “Of course the public has a right to know how these funds are disbursed,” but she said she worried recordings would allow people to take words “out of context.”
In Ohio at least, that may not be a choice for much longer.
A lawsuit brought by Harm Reduction Ohio to open the meetings of a separate board — the OneOhio Recovery Foundation, which oversees the lion’s share of the state’s expected $1 billion — is working its way through the courts. A local judge this month rejected the foundation’s request to dismiss the lawsuit, writing that “the public deserves transparency.”
In Ohio, the lion’s share of settlement funds will be controlled by the OneOhio Recovery Foundation. Dennis Cauchon, president of the nonprofit Harm Reduction Ohio, sued the foundation board for violating the state’s open-meeting and public records laws. (Maddie McGarvey for KHN)
But OneOhio spokesperson Connie Luck said the foundation is a “private, nonprofit organization, and not a government agency.” It has so far allowed public attendance at meetings, but has said it is not required to do so.
The final ruling in this lawsuit, which is the first of its kind on opioid settlement funds, will set a precedent for the public’s right to information nationally.
In some parts of the country, the prospect of dollars to treat a long-underfunded epidemic brings hope, said Tricia Christensen, who works at a nonprofit tracking settlement funds across Appalachia. When people know what’s happening, it not only deters misuse but can reveal surprising successes, she said.
Crystal Glass is in recovery from opioid and meth use and now works as a peer recovery specialist in southwestern Virginia, supporting others with substance use disorders. “These funds are the cavalry coming in,” she says of the opioid settlements. “You’re finally getting relief after suffering alone for so long.”(Kayla Davidson)
That knowledge is empowering.
“These funds are the cavalry coming in. You’re finally getting relief after suffering alone for so long,” said Crystal Glass, of southwestern Virginia, who is in recovery from opioid and meth use and now works as a peer recovery specialist.
She hopes officials will involve people affected by addiction in their decisions.
As she put it: Transparency “is letting everyone — I mean everyone — know they can be part of this.”
People sometimes leave painted rocks and other remembrances at the Circle of Hope statue in Tuckahoe Park in Altoona, Pennsylvania.(Nancy Andrews for KHN)
KHN’s Colleen DeGuzman and Megan Kalata contributed to this report.
State and local governments will, over the next nearly two decades, receive billions of dollars from companies accused of sparking the opioid epidemic. KHN recently published an investigation showing these jurisdictions have promised little to no public reporting on how that money is spent.
The investigation is based on a detailed analysis of hundreds of written plans, statutes, executive orders, and public statements, first conducted by Christine Minhee of OpioidSettlementTracker.com and bolstered by KHN’s reporting. The information has been compiled into an interactive map and a detailed spreadsheet that we hope can help others investigate opioid settlement stories in their communities.
KHN’s story provides the national perspective. You can run our story in full or use it as context if you pursue a local angle. Please always credit KHN for the reporting and Minhee for the data.
Tips to get started:
1.Find out what information your state or local governments are required to report about their use of settlement funds.
Start with the interactive map. It shows how your state compares with others on public reporting. Click on a state to see details, including:
The percentage of funds an average person would be able to track.
The percentage of funds that will be reported to some oversight body but not necessarily shared with the public.
To see the language that underpins these numbers — including the specific laws and legal documents that require reporting on the money — check out this table at OpioidSettlementTracker.com.
2. Access those reports.
Once you know what your state is required to report, go find it. If reports are displayed online, links are shown via the interactive map. If reports are kept by an agency, that agency is identified in the table. Reach out and ask for the reports, citing the legal requirements listed in the table if necessary.
If you cannot find a report — despite it being mandated in legal language — that may be a story itself.
3. Dig into the spending decisions.
Once you have reports on how the funds were used, dig into specifics. The national settlements came with a list of recommended strategies. Check if your community’s use aligns with them.
Ask how these spending decisions were made. Were community members involved in identifying priorities? Was there a fair and open process to apply for grants?
The settlement dollars will be paid out over nearly two decades. Do these reports reflect one-off spending decisions or ongoing allocations over that time? Is there a plan to evaluate the impact of the money after a few years and reshape future priorities?
4. If your state or local government has no public reporting requirement, that might be its own story.
The KHN investigation found nearly half of all states have not enacted any specific reporting requirements. If yours is one of them, ask why. Some have called settlement funds “blood money” for those who died of overdoses and feel they have a right to know how the payouts are used.
You can use the interactive map to compare the level of transparency in your state to that of similar or neighboring states. Pay attention to not only the public reporting but also the reporting required to an oversight body; ask why that information is not made public as well.
Talk to people in recovery, family members who have lost loved ones to overdoses, treatment providers, advocates, and others in the field about what consequences the lack of transparency is having in your community.
5. Check for any reports suggesting your state or local government spent money in ways unrelated to the opioid crisis.
Even states that have no reporting requirements of their own are subject to a bare minimum national standard: reporting how much money they use on expenses unrelated to the opioid epidemic. (This can be at most 15% of the state’s settlement cash.)
Reports from state and local governments can be found here. Governments are required to submit reports only if they determine they’ve used funds for non-opioid purposes, so you may not see a report from your community. Those that do file reports list only a dollar amount, so you’ll need to contact the person who signed off for details about how that money was used. New reports are filed approximately every six months.
In 2011, Jeffrey Motts was executed in South Carolina. More than a decade later, the state hasn’t carried out another execution because officials have struggled to obtain the drugs needed for lethal injection.
Now, to resume executions, lawmakers are debating a bill that would further shroud the state’s lethal injection protocols from public scrutiny by shielding the identities of the drug suppliers.
More than a dozen states have passed such “shield” laws that conceal key details about the lethal injection process, including the identities of the execution team or drug suppliers, according to the Death Penalty Information Center, a nonprofit research organization. All 17 states that carried out executions between January 2011 and August 2018 withheld some information about the process. Georgia even calls information about its executions a “state secret.”
Backers of such laws say they are needed to protect suppliers and medical professionals involved in executions. But Austin Sarat, a political science and law professor at Amherst College, who teaches courses on the death penalty, said such policies conceal the problems connected to lethal injection.
“The legitimacy of capital punishment has been tied up with the promise that it’s safe and humane,” he said. Secrecy hinders “the public’s ability to judge what is being done in its name.”
Still, it’s far from clear whether — or how — South Carolina and other states will be able to obtain the needed drugs, even with a cloak of secrecy. For more than a decade, many U.S., European, and Asian pharmaceutical companies have opposed the use of their medications in executions, arguing the drugs they manufacture should be used to heal, not kill, people. Some pharmaceutical companies have even sued states to prevent their drugs from being used on death row.
“With increasing frequency, drug companies don’t want to be associated with this process,” said Eric Berger, a constitutional law professor at the Nebraska College of Law who researches the death penalty.
That opposition has brought executions in many states to a grinding halt. Only six of the 27 states that allow the death penalty carried out executions in 2022, totaling just 18 executions nationwide, down from 98 in 1999.
But it’s still often the method of choice for state prisons. Since 1982, when Texas became the first state to use lethal injection, more than 88% of U.S. executions have been carried out by lethal injection, according to the Death Penalty Information Center.
The U.S. Supreme Court has upheld the lethal injection procedures that have come before it as constitutional, said Berger. Some states authorize other protocols including electrocution, lethal gas, hanging, and firing squads. But lower courts have said some of those execution methods violate state law or the Eighth Amendment’s ban on cruel and unusual punishment. In South Carolina, for example, a state court halted executions by electric chair or firing squad after state lawmakers approved those methods in 2021.
The proposed South Carolina shield law would help the state restart executions after a more than decade-long pause, Republican state Sen. Greg Hembree, who sponsored the bill, said during a committee hearing.
“You’ve got a law and can’t carry it out because of some corporate policy,” he said.
Even if approved, the measure does not guarantee the state will be able to obtain the drugs. Idaho instituted a similar shield law last year, but the state has had so much trouble finding supplies that Republican Gov. Brad Little signed a law on March 24 that allows execution by firing squad — a method last used in the U.S. by Utah in 2010.
In Ohio, pharmaceutical companies threatened to stop selling drugs to the state if they found any of their medications had been diverted for lethal injections. In 2020, the state’s Republican governor, Mike DeWine, placed a moratorium on executions because state officials had been unable to find execution drugs, despite Ohio’s secrecy law.
To circumvent drugmaker opposition, some states have resorted to elaborate practices to obtain the drugs. In 2011, federal agents seized doses of a lethal injection sedative used in South Carolina and other states for being illegally imported, while Idaho officials boarded private planes that year and the next with thousands of dollars in cash to buy drugs from compounding pharmacies in Utah and Washington.
In 2018, an Oklahoma official admitted to calling pharmacies “on the Indian subcontinent” and turning to what he described as “seedy” people to find such drugs. In 2021, Oklahoma resumed executions by lethal injection after a six-year hiatus but did not disclose where it obtained the drugs.
And Texas has executed five people so far this year after an unsuccessful legal challenge from three of the men on death row who argued that the state extended the use-by dates of the lethal injection drugs.
The U.S. is one of at least 18 countries where one or more executions took place in 2021, according to Amnesty International, a human rights advocacy group headquartered in London that opposes the death penalty. Most U.S. executions take place in the South and Black men are disproportionately executed, according to the Death Penalty Information Center.
Lethal injection protocols usually include a sedative, followed by a drug that paralyzes the body and one that stops the heart. But some states use only one drug, dosed to be lethal. The drugs that states use for executions have been approved for uses such as anesthesia, but their off-label use for lethal injection has not been tested.
The drug doses are determined without considering a person’s medical condition or history. Often things go wrong. Last year, seven out of 20 execution attempts in the U.S. were “visibly problematic,” according to the Death Penalty Information Center, including cases in which executioners couldn’t find a person’s vein or failed to follow protocol.
Typically courts and legislatures, not medical professionals, determine lethal injection protocols. In Montana, lawmakers are trying to broaden the types of substances that can be used in lethal injection after a state court said the previous protocol violated state law. One lawmaker suggested using fentanyl, something the Trump administration also reportedly considered doing.
“Lethal injection is not a medical act, but it’s designed to impersonate one,” said Dr. Joel Zivot, an anesthesiology professor at Emory University who reviews autopsies of people who die by lethal injection and is a critic of the practice.
Zivot’s research sparked an NPR review of more than 200 lethal injection cases. In 84% of them, the deceased showed signs of pulmonary edema, which causes a feeling of drowning and suffocating. “That is very painful,” said Zivot.
Last year, two men in Oklahoma asked to be executed by a firing squad rather than lethal injection because they argued the former would be quicker.
Of all the ways to execute people, lethal injection has been the method most riddled with problems, said Sarat, the Amherst professor.
Missouri passed its shield law, concealing who participates in executions and where the state obtains drugs, in 2007, after a doctor testified that he had made mistakes while administering lethal injection drugs.
Alabama recently announced it would resume executions after three botched lethal injections last year. One person’s arm was cut open to find a vein to deliver lethal injection drugs. Two other executions were halted when officials couldn’t find the men’s veins at all. Yet an internal state review revealed little about what went wrong, including whether a medical professional was involved.
“It’s not surprising that every time the secrecy veil has been pierced something illegal or immoral or unethical has been discovered,” said Robert Dunham, who stepped down in January as the executive director of the Death Penalty Information Center.
SACRAMENTO, Calif. — Republican lawmakers say that, before California spends even more money battling homelessness, the public deserves to know exactly how the tens of billions of dollars already put toward the epidemic are being spent and whether the state is getting results. Among the GOP lawmakers calling for greater accountability is state Sen. Roger Niello, a businessman who returned to the Capitol in December after a 12-year hiatus.
As a fiscal conservative from the Sacramento suburbs, with more than a decade of experience in local and state politics, Niello wants to work with Democrats. But he characterized the volume of money poured into fighting homelessness in recent years as runaway spending, saying Democratic Gov. Gavin Newsom hasn’t yet proved the money is working adequately to place homeless people into services and permanent housing.
“There’s nothing more urgent for us to address, in some successful way, than homelessness,” Niello told KHN. “But I do believe that just spending money without actually measuring those achievements is generally a waste of money.”
He argues that Newsom and his fellow Democrats, who control the legislature, shouldn’t allocate any more taxpayer funding for homelessness policies unless the state can show that current spending is reducing homelessness. Niello and other Republicans have pushed for an audit of homelessness spending — and this year were joined by some Democratic lawmakers, who increasingly are also calling for more accountability. A legislative committee in late March approved their audit request.
Newsom says that the state has already placed 68,000 homeless people into temporary or permanent housing and that California can reduce homelessness by 15% in two years. Yet more low-income people are falling into homelessness, and many are living with untreated mental health conditions and addiction disorders.
Since Newsom took office in 2019, he and state lawmakers have dedicated more than $20 billion to move people off the streets and into shelters or housing. That’s on top of more than $12 billion in additional state spending slated for new behavioral health and social services, largely aimed at serving vulnerable low-income residents experiencing homelessness or those at risk of falling into crisis on the streets. And Newsom is proposing more spending, including a 2024 ballot initiative that would allocate as much as $6 billion for new behavioral health treatment beds and mental health housing for homeless people.
Niello sees opportunities for bipartisanship on homelessness and behavioral health. The Republican supports one of the governor’s more controversial initiatives, passed last year to compel people with serious mental illness into court-ordered treatment: the Community Assistance, Recovery, and Empowerment Act, or CARE Court. And Niello is working with the Democratic chair of the Senate Health Committee, Sen. Susan Talamantes Eggman, on bills that would expand the state’s ability to put people into court-ordered conservatorships by redefining who is gravely disabled.
Eggman said it’s important to work across the aisle on solutions that can benefit not just seriously mentally ill individuals and their families but also the community.
“The level of vitriol and blame we’re seeing contributes to the angst and anxiety people are feeling,” Eggman said. “It’s important to work with Republicans to alleviate that and help people who are unwilling, or unable, to help themselves.”
Niello, who believes Republicans should work with Democrats to find solutions, discussed the state’s homelessness crisis with KHN senior correspondent Angela Hart. The interview has been edited for length and clarity.
Q: Are Californians seeing the results of this unprecedented investment and how do you think the governor is handling the crisis so far?
What we’re doing is not working. Homelessness has never really existed outside the urban core before. It’s getting worse, not better.
When the governor talks about his efforts on homelessness, he often talks about all of the money that has been spent under his administration. But spending is not a metric. We spent $20 billion, but I can’t find any measure of results that relates the spending on programs showing people actually getting out of homelessness and into supportive programs — or, aspirationally, even, to self-sufficiency. What Republicans would like to see is some measurement of the results.
The problem is we don’t know if it’s being well spent; it appears, based on evidence on the streets, that it’s not being well spent. The homeless counts have increased rather substantially.
If you’re not going to measure results more effectively, you may as well hold back on the money completely until you’re willing to do that.
Q: How can California improve its homelessness response?
One of the problems that we have with homelessness, both federally and in the state of California, is we have a policy called “Housing First,” which was adopted in California in 2016, and it eliminates any public money to any program that requires treatment for the entry to the program, and we’ve only seen the homeless counts explode since then.
It’s hard to deny that there isn’t some relationship there. And I believe there is. I think it’s too restrictive and compromises getting results. Under the Housing First approach, the philosophy is you offer housing and shelter, and you offer services, but don’t require it. And people can stay in the shelter and continue to use substances or not get mental health treatment. I think we should do more to allow for programs that require treatment and sobriety within those programs.
And for the people who have been touched by this dizzying array of different programs, we need to try to assess the successes in terms of getting people into housing, getting people into treatment, and getting people out of homelessness and into self-sufficiency.
Q: Your Senate Bill 232 expands the definition of “gravely disabled” in the context of mental health treatment, which could compel more people into court-ordered conservatorship. Why is this important?
While not all homelessness is caused by substance abuse and mental illness, I think that is probably the largest single contributor. And it is virtually impossible to compel mentally ill people into treatment.
There is a definition of “gravely disabled” in California’s Lanterman-Petris-Short Act that if somebody is gravely disabled, they can be compelled to treatment. But it’s a rather simple and limited definition.
So I have a bill, just like Sen. Susan Eggman has a bill. And we intend to work together in a way that redefines gravely disabled, to include what we think is a better definition of somebody who truly is gravely disabled. It includes redefining it with a clinical condition explaining that somebody is literally severely disabled.
We think that if we have this new definition, then we will be able to compel more people into treatment or, if needed, conservatorship. Then they can work toward a recovery, whereas the alternative is they continue to languish on the streets with a severe and disabling condition.
It is consistent with the governor’s CARE Court initiative that compels treatment for people like those who are homeless living under freeway overpasses or rummaging through garbage cans.
Counties have to provide the services, but they need more money. Here is a fiscally conservative Republican who is going to say that treating mental illness is very expensive. And we have to fund it.
Q: Newsom has called on cities to make more progress on ending homelessness before giving them more money. But separately from direct homelessness funding, you’re saying counties need more money for treatment and services?
We can’t expect counties to be the service delivery of health treatment, which they are, unless they have the resources to provide the service. And I think that with the revised definition of gravely disabled, I think it would be easier for CARE Court to be implemented.
There’s one definition of a good society, and you judge it by how a society takes care of the least advantaged of their citizens. And this is a good example of that, and to allow people to continue to live in unhealthy conditions is going to cause them to die at a much earlier age. So not trying to help is just plain wrong.
