Home » Archive for Maret 2023

FDA Evaluates ‘Safety Concerns’ Over Dental Devices Featured in KHN-CBS Investigation

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.”

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

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

Decisión de un juez haría que algunas pruebas de detección de cáncer sin costo fueran cosa del pasado

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.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

Judge’s Decision Would Make Some No-Cost Cancer Screenings a Thing of the Past

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. In his September opinion, O’Connor wrote that members of the task force, which is convened by a federal health agency, are actually “officers of the United States” and should therefore be appointed by the president and confirmed by the Senate.

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.

Overall, preventive services can lead to better outcomes, said Lisa Lacasse, president of the American Cancer Society Cancer Action Network.

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.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

States Try to Obscure Execution Details as Drugmakers Hinder Lethal Injection

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.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

A Progress Check on Hospital Price Transparency

For decades, U.S. hospitals have generally stonewalled patients who wanted to know ahead of time how much their care would cost. Now that’s changing — but there’s a vigorous debate over what hospitals are disclosing.

Under a federal rule in effect since 2021, hospitals nationwide have been laboring to post a mountain of data online that spells out their prices for every service, drug, and item they provide, including the actual prices they’ve negotiated with insurers and the amounts that cash-paying patients would be charged. They’ve done so begrudgingly and only after losing a lawsuit that challenged the federal rule.

How well they’re doing depends on whom you ask.

The rule aims to pull back the curtain on opaque hospital prices that may vary widely by hospital for the same service or even within the same hospital. The expectation is that price transparency will boost competition, giving consumers and employers a way to compare prices and make informed choices, ultimately driving down the cost of care. Whether that will happen is not yet clear.

Insurers and large employers are also required to post their negotiated prices with all their providers, under separate rules that took effect last summer.

Hospitals have made “substantial progress,” according to an analysis by the federal Centers for Medicare & Medicaid Services of 600 randomly selected hospitals that was published in the journal Health Affairs last month. The agency looked at whether hospitals had met their obligation to post price information online in two key formats: a “shoppable” list of at least 300 services for consumers, and a comprehensive machine-readable file that incorporates all the services for which the hospital has standard charges. This file should be in a format that allows researchers, regulators, and others to analyze the data.

CMS found that 70% of hospitals published both lists in 2022. An additional 12% published one or the other. By contrast, the agency’s previous progress assessment in 2021 found that just 27% of 235 hospitals had both types of lists.

The 2022 analysis “represents a marked improvement,” said Dr. Meena Seshamani, deputy administrator and director of the Center for Medicare at CMS, in a statement. But she also said the advances are still “not sufficient” and CMS will continue to use “technical assistance and enforcement activity” so that all hospitals “fully comply with the law.”

The American Hospital Association said the CMS assessment demonstrated the progress hospitals had made under very challenging circumstances as they grappled with the covid-19 pandemic.

“These are complicated policies that went into effect in the most complicated time in hospitals’ history,” said Molly Smith, group vice president for policy at the trade association. “And we have seen increases in compliance over the past 18 months.”

Some groups that have looked at the hospitals’ posted price data, though, were less upbeat. In an analysis published last month, Patient Rights Advocate examined 2,000 hospitals’ listings and found that only 489 of them, 24.5% of the total, were compliant with all the requirements of the rule. An earlier analysis in August 2022 found that 16% met all the requirements.

The advocacy group’s analysis covered not only the two types of lists that CMS looked for but also checked whether the hospitals included required data on specific types of standard charges for every service offered, such as the gross or “chargemaster” charge before any discounts are applied, the discounted cash price, and the negotiated charge by insurer.

Although most hospitals have published files online, too often the data is incomplete, illegible, or not clearly associated with specific health plans or insurers, said Cynthia Fisher, founder and chair of Patient Rights Advocate, which promotes health care price transparency.

“As hospitals continue to post incomplete files with swaths of missing prices, patients are unable to accurately compare prices across hospitals and across plans to make the best health care decisions and protect themselves from overcharges,” Fisher said. Such hospitals were considered noncompliant in the PRA analysis.

The hospital association faulted PRA’s analysis. The contracts that hospitals have with health plans vary substantially from one to the next, and prices are not always based on a simple dollar amount, said Terry Cunningham, AHA’s director of policy. They might be based on a bundle of services or on volume, for example, he said.

“It’s both frustrating and problematic for these other organizations to be weighing in, saying, ‘This cell shouldn’t be blank,’” Cunningham said.

In their 2020 lawsuit, hospitals argued that they should not be required to disclose privately negotiated prices, and maintained that doing so would confuse patients and lead to anti-competitive behavior by insurers.

Last summer, price transparency requirements took effect in the health insurance industry as well, complementing and providing a cross-reference tool for what hospitals have posted. The insurer transparency requirements are even broader than those for hospitals: Insurers and self-funded employers must list every negotiated rate they have with every doctor, hospital, and other health care providers.

Some critics charge that data isn’t user-friendly either. Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) sent a letter March 6 to CMS Administrator Chiquita Brooks-LaSure encouraging the agency to take steps to close “technical loopholes” such as large files and a lack of standardization that make it difficult to use the data they’re reporting.

That’s where pricing platforms like Turquoise Health come in. The data becoming available from hospitals and insurers is a vast treasure trove the company is mining to devise user-friendly tools that consumers and businesses can use to discover and compare prices.

In its own analysis of how effective hospital price transparency efforts were in 2022’s third quarter, Turquoise Health found that 55% of the more than 4,900 acute care hospitals that posted machine-readable files were “complete,” meaning they posted the cash, list, and negotiated rates for a “significant quantity” of items and services. Twenty-four percent of hospitals were judged to be “mostly complete.” (The analysis didn’t evaluate the second type of posting, the list of shoppable services.)

According to Chris Severn, Turquoise Health co-founder and CEO, the company uses a scoring algorithm of 60 variables to assess how complete a hospital’s file is.

“What you end up with is a more nuanced look at these files that hopefully takes into consideration shades of gray,” Severn said, rather than a simple pass-fail rating.

Regardless of the differences in how the hospital disclosures are evaluated, experts generally agree that CMS should require data be reported in a standardized format for ease of comparison and enforcement. CMS has developed a template, but hospitals aren’t required to use it.

For price transparency to work, enforcement also needs consistent attention, experts say. The Biden administration increased the maximum potential penalty to more than $2 million annually per hospital for 2022. Still, last year CMS penalized just two hospitals for noncompliance even though 30% of hospitals didn’t meet the requirement to post both a machine-readable file of prices as well as a shoppable list.

CMS provided technical assistance to many hospitals to help them come into compliance, said Seshamani, and it also plans stronger enforcement actions.

She said the agency will “continue to expedite” the time frame hospitals have to reach full compliance after submitting a corrective action plan, which indicates they have fallen short on some posting requirements. “CMS also plans to take aggressive additional steps to identify and prioritize action against hospitals that have failed entirely to post files,” she said.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

Congressman Seeks to Plug ‘Shocking Loophole’ Exposed by KHN Investigation

A U.S. lawmaker is taking action after a KHN investigation exposed weaknesses in the federal system meant to stop repeat Medicare and Medicaid fraud and abuse.

Rep. Lloyd Doggett (D-Texas) said he decided to introduce a bill in the House late last week after KHN’s reporting revealed what he called a “shocking loophole.”

“The ability of fraudsters to continue billing Medicare for services is outrageous,” Doggett said. “This is an obvious correction that is needed to safeguard our system. Wherever there are large amounts of government money available, someone tries to steal it.”

KHN found a laundry list of weaknesses that allows people accused or convicted of fraud to easily sidestep bans imposed by federal officials. Among those gaps is the Centers for Medicare & Medicaid Services’ lack of authority to deny or revoke National Provider Identifier, or NPI, numbers after federal regulators have prohibited a person or business from receiving payments from government programs.

Doctors, nurses, other practitioners, and health businesses use the unique, 10-digit NPI numbers to bill and file claims with insurers and others, including Medicare and Medicaid.

Taking away the NPI would “be equivalent of prohibiting a practitioner from practicing in total,” Dara Corrigan, director of CMS’ Center for Program Integrity, wrote in an email response to questions about KHN’s investigation. CMS declined to comment on Doggett’s proposed legislation.

The bill, HR 1745, would give CMS the authority to deactivate NPIs tied to anyone convicted of waste, fraud, or abuse and whose name appears on the exclusions list kept by the Office of Inspector General for the U.S. Department of Health and Human Services. The proposed law would also require CMS to implement recommendations that the inspector general has made to improve NPI reporting and provider transparency.

“This strikes me as what should be an easy bipartisan measure,” Doggett said, adding that he had presented the bill in a face-to-face meeting with Rep. Jason Smith (R-Mo.), who chairs the House Ways and Means Committee. Doggett also alerted that panel’s health subcommittee chair, Rep. Vern Buchanan (R-Fla.).

“They both talk about the need to eliminate fraud, and this is one modest but important way to do it,” Doggett said. Neither Smith’s nor Buchanan’s offices responded to requests for comment.

The OIG declined to comment.

Former Justice Department officials told KHN that repeat violators are savvy and find ways to circumvent the system. KHN examined a sample of 300 health care business owners and executives who are among more than 1,600 on the OIG’s exclusion list since January 2017. Journalists reviewed court and property records, social media, and other publicly available documents.

KHN found:

Eight people appeared to be serving or served in roles that could violate their bans;
Six transferred control of a business to family or household members;
Nine had previous, unrelated felony or fraud convictions, and went on to defraud the health care system;
And seven were repeat violators, some of whom raked in tens of millions of federal health care dollars before getting caught by officials after a prior exclusion.

Doggett’s bill is “a pretty smart step in the right direction in fixing this issue,” said John Kelly, a former assistant chief of health care fraud at the Department of Justice who is now a partner for the law firm Barnes & Thornburg. Kelly had previously recommended that NPIs should be “essentially wiped clean” when a person is on the exclusions list.

Kelly, who confirmed that Doggett’s office reached out to him after KHN’s investigation was published in December, said taking the NPI number away “certainly doesn’t eliminate all risk” but it’s a move “in the right direction.”

“If you want to bill Medicare, you have to have a valid NPI,” Kelly said.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

Banning Noncompete Contracts for Medical Staff Riles Hospitals

Dr. Jacqui O’Kane took a job with a hospital in southern Georgia in 2020, as the lone doctor in a primary care clinic in a small town that’s a medically underserved area. She soon attracted nearly 3,000 patients.

But she said the hospital pressed her to take more new patients, so she had to work nights and weekends — not ideal for the mother of two young daughters. She thought about opening her own practice in town, which would give her more control over her schedule.

The problem was that her three-year contract included a noncompete clause barring her from practicing within 50 miles of the hospital for two years after it ended.

So, she has decided to join a practice in South Carolina. That means she and her husband will sell their house, move hundreds of miles, and enroll their children in a new school.

“It sucks,” she said. “I know my patients very well, and I feel like I’m being forced to abandon them. But I can’t stay in this job because it’s unhealthy for me to work this much.”

In January, the Federal Trade Commission proposed to end predicaments like O’Kane’s by prohibiting noncompete clauses in employment contracts. “The freedom to change jobs is core to economic liberty and to a competitive, thriving economy,” said Lina Khan, the FTC chairperson.

The proposed rule would prohibit employment contract provisions that block employees or contractors from working for a competing employer when they move on, or from starting a competing business. Such contracts typically bar people from working within a certain geographic area for a period after the job ends.

The FTC estimates that 30 million workers are bound by noncompete clauses. It says ending those provisions would boost economic competition, reduce prices, and increase workers’ earnings overall by up to $296 billion a year.

Eliminating noncompete contracts would allow doctors to practice wherever their services are needed, which would improve patients’ access to care. They say it would free them to speak out about unsafe conditions for patients, since they wouldn’t have to worry about getting fired and not being able to continue working in their community.

But the FTC’s proposal faces resistance from employers in all industries, including hospitals and private equity-backed medical groups that employ thousands of physicians, nurse practitioners, and other medical professionals.

It’s about money for them, too. They say eliminating noncompetes would drive up the cost of hospital care because hospitals would have to pay physicians more to keep them. They also say noncompete clauses are necessary to protect proprietary information and investments in employee training, and to prevent employees from taking clients and patients with them when they leave.

Business and hospital groups are likely to sue to block the rule, arguing that Congress hasn’t authorized the commission to regulate noncompete clauses. While there is bipartisan support in Congress for legislation that would restrict noncompete clauses and authorize FTC action, the bill hasn’t advanced; similar legislation stalled in past years.

Health care industry groups hope to block any change with the argument that the FTC lacks statutory authority to regulate nonprofit, or tax-exempt, hospitals, which account for nearly 60% of all U.S. community hospitals. In the proposed rule, the FTC acknowledged that entities not conducting business for profit may not be subject to the rule because they are exempt from coverage under the Federal Trade Commission Act, the law that gives the agency its authority.

“The rule would create an unlevel playing field because we compete with nonprofit and public hospitals that wouldn’t be subject to it,” said Chip Kahn, CEO of the Federation of American Hospitals, which represents for-profit hospital systems.

But other experts aren’t sure the FTC lacks authority over nonprofits. While the FTC Act exempts nonprofits, the commission has acted many times under the Sherman Act and the Clayton Act, federal antitrust laws used to block anti-competitive conduct by nonprofit hospital systems. It’s not clear whether the FTC will clarify this issue before it finalizes the rule.

“We fully support having the noncompete ban apply to all hospitals,” said Dr. Jonathan Jones, president of the American Academy of Emergency Medicine, half of whose members are bound by noncompetes.

California, North Dakota, and Oklahoma already ban enforcement of noncompete clauses for all employees, while six other states prohibit enforcement of noncompete clauses for physicians. Even in states without bans, judges have invalidated noncompetes when they found them to be overbroad or unreasonable.

But it can cost tens of thousands of dollars in legal fees to challenge a noncompete clause, and other employers may not want to take the risk of hiring a person in the middle of a legal fight, said Luke Campbell, a Seattle attorney who represents physicians.

The FTC rule also would bar the use of nondisclosure or training repayment agreements in employment contracts if they functioned as de facto noncompetes.

Hospitals often require nurses to sign training repayment agreement provisions, called TRAPs, which nursing groups say lock nurses into jobs by demanding they pay as much as $20,000, for what’s essentially job orientation, if they leave before two years. National Nurses United, a labor union, wants the FTC to explicitly prohibit TRAPs.

As of last year, nearly three-quarters of all U.S. physicians were employed by hospital systems or other companies, with many working under noncompete agreements. A 2018 survey found that nearly half of primary care physicians in California, Illinois, Georgia, Pennsylvania, and Texas were bound by noncompetes.

Private equity-owned staffing firms such as TeamHealth, Envision Healthcare, and Sound Physicians, which provide emergency physicians and other medical professionals to work in hospitals, commonly use noncompete provisions. None of those three companies agreed to talk about their employment contracts. As for-profit employers, noncompete clauses in their contracts clearly would be barred even if their employees were working in nonprofit hospitals.

Hospitals, insurers, and physician-owned medical groups also use noncompetes in employing doctors and other medical professionals.

Hospital-based doctors — emergency physicians, anesthesiologists, hospitalists, radiologists, and pathologists — refute the industry’s argument that they would take patients or proprietary information with them.

“We don’t have any trade secrets and we don’t have the capability of stealing patients because we don’t have our own patient referral base,” said Dr. Robert McNamara, the chair of emergency medicine at Temple University.

Instead, he said, noncompetes are a way for the physician staffing firms to lock in their contracts with hospitals. “The private equity group can say to the hospital, ‘You might not like what we’re doing, but if you get rid of us, every single one of your doctors must be replaced,’” McNamara said.

Dr. Vanessa Urbina, a general practice physician in central Florida, also worries about the impact on patients. She left a corporate-owned medical practice in Altamonte Springs last year because of what she said was an abusive environment. Hobbled by a noncompete agreement she signed forbidding her from practicing within 15 miles of the clinic, she opened her own primary care clinic in rural Mount Dora, 19 miles away.

She had to stay in the area because of a child custody agreement. Fighting the noncompete cost her $25,000 in legal fees and lost income. Even though she now must drive farther to transport her daughter to school and back, she’s happier in her new practice. But she’s angry she can’t take care of her former patients.

“They forced me to abandon my patients,” she said. “Now they have to wait three months for an appointment. Noncompetes should be illegal.”

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair

Sen. Bernie Sanders, who rose to national prominence criticizing big business in general and the pharmaceutical industry in particular, claimed the spotlight Wednesday on what might at first seem a powerful new stage from which to advance his agenda: chairmanship of the Senate health committee.

But the hearing Sanders used to excoriate a billionaire pharmaceutical executive for raising the price of a covid-19 vaccine showed the challenges the Vermont independent faces.

Though its formal name is the Committee on Health, Education, Labor, and Pensions (HELP), the panel Sanders chairs has little if any authority over drug prices. In the Senate, most of that leverage lies with the Finance Committee, which oversees Medicaid, Medicare, and Obamacare.

As far as drug prices go, the platform Sanders commands is essentially a bully pulpit. So Sanders was left to bully his way toward results. And while some committee Republicans sympathized with his complaints, others bristled at his approach.

By the end of the hearing, seeming to acknowledge the limits of his power, the former presidential candidate was pleading with Moderna chief executive Stéphane Bancel for a relatively modest concession on vaccine pricing.

The CEO made no promises. Then again, pulpit proclamations can lead to corporate action, even if delayed and informal; in the weeks following President Joe Biden’s State of the Union call for cheaper insulin, the companies that make it drastically cut their prices.

Sanders began Wednesday’s hearing with his usual fire and brimstone.

“All over this country people are getting sicker, and in some cases dying, because they can’t afford the outrageous cost of prescription drugs, while companies make huge profits and executives become billionaires,” Sanders thundered.

Bancel had won his place in the witness chair with federal assistance. Moderna, which was founded in 2010 and had not brought a drug to market before the pandemic, received billions in government funds for research, guaranteed purchases, and expert advice to help develop and produce its successful covid vaccine. The payoff has been handsome. As of March 8, Bancel held $3 billion in Moderna stock. He also held options to buy millions of additional shares.

Government research and support are foundational to many of the expensive drugs and vaccines in use today. But Bancel made himself the perfect foil for Sanders when he announced in January that Moderna planned to increase the price of its latest covid shot from about $26 to $110 — or as much as $130.

Denouncing greed, Sanders expounded on his dream of a system in which the government fully funds drug development — and in exchange controls drug prices. “Is there another model out there where, when a lifesaving drug is made, it becomes accessible to all those who need it?” he asked. “What am I missing in thinking that it’s cruel to make a medicine that people can’t afford?’”

Sanders’ overt moralizing and harsh attacks on big business make him an outlier in the Senate, even in his own party. Yet distaste for soaring drug prices extends across the aisle. On the HELP Committee, at least, Republican politicians seem about evenly split between populist and pro-business takes on the problem, showing both the possibilities and the pitfalls that Sanders faces.

Sen. Mike Braun (R-Ind.) expressed disgust with the lack of transparency in the health care system and called Moderna’s planned price hike “preposterous.” Sen. Roger Marshall (R-Kan.) called it “outrageous.”

Sen. Rand Paul (R-Ky.), who often bucks mainstream GOP views and has expressed rancor for the biomedical establishment, claimed Bancel was downplaying vaccine injuries to make money. (Paul vastly exaggerated those risks.)

Ranking member Bill Cassidy (R-La.), who has pledged to work with Sanders, responded to the chairman’s opening remarks with both a hedge and a warning. “I’m not defending salaries or profits,” Cassidy said, but he added that he hoped the hearing’s goal wasn’t to “demonize capitalism.”

Only Sen. Mitt Romney (R-Utah), a former private equity executive, came heartily to Bancel’s defense. “If I’m an investor, I have to expect that if a product I’m backing works, I get to make an awful lot of money,” he said. “I’ve heard people say, ‘That’s corporate greed.’ Yeah, that’s how it works.”

Sanders’ idealized vision of the pharmaceutical industry is, in any case, moot. Even the Biden administration, which successfully browbeat insulin makers into drastically lowering prices in March, revealed this week it would not use “march-in” rights to lower the price of a cancer drug, Xtandi, developed with government-licensed patents.

March-in rights were established in the 1980 Bayh-Dole Act, which enabled companies to license federally funded research and use it to develop drugs. But federal courts and administrations have consistently said the government can seize a product only if the license holder has failed to make it available — not because the price is too high. The administration did, however, announce a review of whether price might be considered in future march-in decisions.

Sanders said before the hearing that he was “extremely disappointed” with the Xtandi decision. But he was ultimately realist enough to aim his bully pulpit at a lower target. Late in Wednesday’s hearing, Sanders pushed for a minimal gimme from Moderna. “Will you reconsider your decision to quadruple the price of your vaccine to the U.S. government and its agents?” he asked politely.

Bancel dodged, saying pricing was more complex now that Moderna faced an uncertain market, had to fill separate syringes with its vaccine, and needed to sell and distribute the vaccine to thousands of pharmacies, where previously the government did all that work. Later, he left open the possibility that negotiations could drive down the price paid by some government agencies or private insurers.

For all the theatrics of such hearings and the mix of opinions among the senators, interrogations of figures like Bancel may help inspire a shift in how the National Institutes of Health “does business in giving away its science to the private sector,” said Tahir Amin, co-executive director of I-MAK, a nonprofit that advocates for equitable access to medicines.

“You have to prosecute it so you at least get these public comments on record,” Amin said. Eventually, he said, this type of hearing could lead to a recognition that, ‘Hey, we need to do this.’”

Despite the HELP Committee’s lack of direct jurisdiction over drug prices, said John McDonough, a Harvard professor who was senior adviser for health reform on the HELP Committee from 2008 to 2010, Sanders “uses his position of authority and influence to draw attention to this in a way that has been helpful.”

KHN correspondent Rachana Pradhan contributed to this report.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

Legal Questions, Inquiries Intensify Around Noble Health’s Rural Missouri Hospital Closures

A year after private equity-backed Noble Health shuttered two rural Missouri hospitals, patients and former employees grapple with a broken local health system or missing out on millions in unpaid wages and benefits.

The hospitals in Audrain and Callaway counties remain closed as a slew of lawsuits and state and federal investigations grind forward.

In March, Missouri Attorney General Andrew Bailey confirmed a civil investigation. He had previously told local talk radio that there was an “ongoing” investigation into “the hospital issue.”

Bailey’s comment came weeks after the U.S. Department of Labor’s Employee Benefits Security Administration notified executives tied to Noble Health, a startup, that they had violated federal laws and asked them to pay $5.4 million to cover unpaid employee health insurance claims, according to a 13-page letter detailing “interim findings” that was obtained by KHN.

The January letter confirms KHN’s previous reporting, which was informed by employees and patients who described missing paychecks; receiving unexpected, high-dollar medical bills; and going without care, including cancer treatment. According to the letter from federal investigators, the Noble hospitals and their corporate owners collected employee contributions for medical, dental, and vision insurance in 2021 and 2022 but then failed to fund the insurance plans.

The owners and executives were “aware of the harm to participants and, in some cases, were attempting to resolve individual participant complaints,” the letter states, adding that “despite the volume and gravity of complaints and bills received,” they failed to respond.

‘Tomfoolery’ and Doing ‘Everybody Dirty’

Marissa Hagedorn, who worked as a hospital laboratory technician, has spent much of the past year starting a new job, caring for her 2-year-old son who was born with spina bifida, and haggling over unpaid medical bills. She told KHN the family owes at least $8,000 for son Ryder’s specialty care in St. Louis, with $6,000 of that in collections. As a Noble employee, Hagedorn said, she was told repeatedly that her employee health insurance would cover Ryder’s care. It didn’t.

Noble has “done everybody dirty,” she said. “We just would like for some responsibility to be taken by this company that didn’t feel the need to get their act together.” Hagedorn’s story of unpaid bills, which was first reported by the local newspaper, the Mexico Ledger, is common among former Noble employees a year after the hospitals closed.

A former employee of the Fulton hospital has filed a class-action lawsuit intended to represent hundreds of employees from both hospitals.

The Jan. 13 letter from federal officials called for responses by Jan. 27 from Noble corporate and hospital executives as well as Platinum Neighbors, which last April bought the hospitals and assumed all liabilities. The letter instructs executives to contact the agency “to discuss how you intend to correct these violations, fund participant claims, and achieve compliance.”

Former employees say their claims have not yet been paid. A Labor Department spokesperson, Grant Vaught, said the agency could not comment on an ongoing investigation.

Separately, the Kansas Department of Labor is reviewing Noble and Platinum’s failure to pay wages and severance to corporate employees. Agency spokesperson Becky Shaffer confirmed that hearings took place in early February on a half-dozen cases totaling more than $1 million in claims for unpaid wages and severance.

Dave Kitchens was among those who filed claims against Noble Health. Kitchens worked briefly as a contract employee and then was hired in October 2021 as a corporate controller, an accounting role in which he was responsible for financial reporting and data analytics. Kitchens provided an audio recording of his hearing to KHN and hopes to eventually get paid more than $90,000 in lost wages, benefits, and severance pay. During the hearing, Kitchens told the administrative judge: “I would just like to be paid what I’m owed.”

Kitchens, who is also named as a fiduciary on the federal investigation, said he was not on Noble’s executive team. When asked by Kansas Administrative Law Judge James Ward whether he expected Noble or the secondary buyer Platinum to pay his wages, Kitchens responded he had “no idea who was in charge.”

“I believe there was some tomfoolery,” Kitchens said.

A ‘Rabbit Hole’ of Responsibility

Noble launched in December 2019 with executives who had never run a hospital, including Donald R. Peterson, a co-founder who prior to joining Noble had been accused of Medicare fraud. Peterson settled that case without admitting wrongdoing and in August 2019 agreed to be excluded for five years from Medicare, Medicaid, and all other taxpayer-funded federal health programs, according to the Health and Human Services Office of Inspector General.

By March 2022, the hospitals had closed and Noble offered explanations on social media, including “a technology issue” and a need to “restructure their operations” to keep the hospitals financially viable. In April, Texas-based Platinum Neighbors paid $2 for the properties and all liabilities, according to the stock purchase agreement.

Despite receiving approval for nearly $20 million in federal covid-19 relief money before it closed the hospitals — funds whose use is still not fully accounted for — Noble had stopped paying its bills, according to court records. Contractors, including nursing agencies, a lab that ran covid tests and landscapers, have filed lawsuits seeking millions.

In Audrain County, where community members still hope to reopen the hospital or build a new one, county leaders filed suit for the repayment of a $1.8 million loan they made to Noble. Former Missouri state senator Jay Wasson also filed suit in September, asking for repayment of a $500,000 loan.

Two Noble Health real estate entities filed bankruptcy petitions this year. One Chapter 11 bankruptcy filing names the Fulton hospital property in Callaway County as an asset and lists nearly $4.9 million in liabilities. A third bankruptcy filing by FMC Clinic includes Noble Health as a codebtor.

In the U.S. District Court of Kansas, Central Bank of the Midwest is suing Nueterra Capital over a $9.6 million loan Noble used to buy the Audrain hospital. The bank alleges Nueterra, a private equity and venture capital firm that in 2022 included Noble as part of its portfolio, signed off as the guarantor of the loan.

Federal investigators listed nearly a dozen people or entities connected to Noble Health as fiduciaries who they say are personally responsible for paying back millions in unpaid medical claims. The letter also detailed Noble Health’s ownership for the first time. The owners included William A. Solomon with a 16.82% share, Thomas W. Carter with a 16.82% share, The Peterson Trust with a 19.63%, and NC Holdings Inc. with 46.72%.

NC Holdings is also listed on the stock sale agreement with Platinum along with several signatures including Jeremy Tasset, chief executive of Nueterra Capital.

Tasset did not respond to a request for comment for this article. In an email to KHN in March 2022, the Nueterra Capital CEO wrote, “We are a minority investor in the real estate and have nothing to do with the operations of the hospitals.” In May 2022, Tasset wrote in an email to KHN that “everything was sold (real estate included) to Platinum Neighbors, a subsidiary of Platinum Team Management.”

It is unclear who owns and controls The Peterson Trust, which federal investigators identified. Peterson, who is listed on Noble’s state registration papers as a director and in other roles, didn’t respond to requests for comment for this article. He previously told KHN that his involvement in Noble didn’t violate his exclusion, in his reading of the law.

He said he owned 3% of the company, citing guidance from the Office of Inspector General for the U.S. Department of Health and Human Services. Federal regulators may exclude companies if someone who is banned has ownership of 5% or more.

In March 2022, Peterson created Noble Health Services, which federal investigators note in their letter was “established to restructure the ownership of multiple Noble entities.” Peterson dissolved that company in July 2022, according to a Missouri business filing.

In September, Peterson posted on LinkedIn that he was “sitting in the Emirates Air lounge in Dubai” to finish up due diligence on “launching a new business.”

A 2013 OIG advisory states that “an excluded individual may not serve in an executive or leadership role” and “may not provide other types of administrative and management services … unless wholly unrelated to federal health care programs.”

KHN examined the federal system meant to stop health care business owners and executives from repeatedly bilking government health programs and found that it failed to do so.

The OIG keeps a public list of people and businesses it has banned from all federal health care programs, such as Medicare and Medicaid. KHN’s review found a system devoid of oversight and rife with legal gray areas.

In the wake of KHN’s reporting, Oregon Sen. Ron Wyden, a Democrat who is the chair of the powerful Senate Finance Committee, said “it’s imperative that federal watchdogs can ensure bad actors are kept out of Medicare.” Sen. Chuck Grassley (R-Iowa) said the government needs to do more and “it’s also up to private-sector entities to do a better job checking against the exclusions list.”

“We can’t just depend on one or the other to do everything,” Grassley said.

In recent months, the Missouri hospitals appear to have been sold twice more, according to public records. Oregon-based Saint Pio of Pietrelcina notified state officials of a change of ownership in December and requested an extension of the hospital licenses, which was denied. In January, Audrain County officials, in its lawsuit, revealed another owner named Pasture Medical, which registered as a Wyoming company on Dec. 27, 2022.

“We haven’t come out of the rabbit hole on this one,” said Steve Bollin, director of the division of regulation and licensure for the Missouri Department of Health and Senior Services. Bollin’s agency, which conducts inspections and approves hospital changes in ownership, said he would support his agency doing financial reviews.

“It’s probably not a bad idea that someone takes a little bit deeper dive. We don’t have that many changes of ownership, but we would need appropriate staffing to do that, including some really good CPAs [certified public accountants].”

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

End of Covid Emergency Will Usher in Changes Across the US Health System

The Biden administration’s decision to end the covid-19 public health emergency in May will institute sweeping changes across the health care system that go far beyond many people having to pay more for covid tests.

In response to the pandemic, the federal government in 2020 suspended many of its rules on how care is delivered. That transformed essentially every corner of American health care — from hospitals and nursing homes to public health and treatment for people recovering from addiction.

Now, as the government prepares to reverse some of those steps, here’s a glimpse at ways patients will be affected:

Training Rules for Nursing Home Staff Get Stricter

The end of the emergency means nursing homes will have to meet higher standards for training workers.

Advocates for nursing home residents are eager to see the old, tougher training requirements reinstated, but the industry says that move could worsen staffing shortages plaguing facilities nationwide.

In the early days of the pandemic, to help nursing homes function under the virus’s onslaught, the federal government relaxed training requirements. The Centers for Medicare & Medicaid Services instituted a national policy saying nursing homes needn’t follow regulations requiring nurse aides to undergo at least 75 hours of state-approved training. Normally, a nursing home couldn’t employ aides for more than four months unless they met those requirements.

Last year, CMS decided the relaxed training rules would no longer apply nationwide, but states and facilities could ask for permission to be held to the lower standards. As of March, 17 states had such exemptions, according to CMS — Georgia, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, and Washington — as did 356 individual nursing homes in Arizona, California, Delaware, Florida, Illinois, Iowa, Kansas, Kentucky, Michigan, Nebraska, New Hampshire, North Carolina, Ohio, Oregon, Virginia, Wisconsin, and Washington, D.C.

Nurse aides often provide the most direct and labor-intensive care for residents, including bathing and other hygiene-related tasks, feeding, monitoring vital signs, and keeping rooms clean. Research has shown that nursing homes with staffing instability maintain a lower quality of care.

Advocates for nursing home residents are pleased the training exceptions will end but fear that the quality of care could nevertheless deteriorate. That’s because CMS has signaled that, after the looser standards expire, some of the hours that nurse aides logged during the pandemic could count toward their 75 hours of required training. On-the-job experience, however, is not necessarily a sound substitute for the training workers missed, advocates argue.

Adequate training of aides is crucial so “they know what they’re doing before they provide care, for their own good as well as for the residents,” said Toby Edelman, a senior policy attorney for the Center for Medicare Advocacy.

The American Health Care Association, the largest nursing home lobbying group, released a December survey finding that roughly 4 in 5 facilities were dealing with moderate to high levels of staff shortages.

Treatment Threatened for People Recovering From Addiction

A looming rollback of broader access to buprenorphine, an important medication for people in recovery from opioid addiction, is alarming patients and doctors.

During the public health emergency, the Drug Enforcement Administration said providers could prescribe certain controlled substances virtually or over the phone without first conducting an in-person medical evaluation. One of those drugs, buprenorphine, is an opioid that can prevent debilitating withdrawal symptoms for people trying to recover from addiction to other opioids. Research has shown using it more than halves the risk of overdose.

Amid a national epidemic of opioid addiction, if the expanded policy for buprenorphine ends, “thousands of people are going to die,” said Ryan Hampton, an activist who is in recovery.

The DEA in late February proposed regulations that would partly roll back the prescribing of controlled substances through telemedicine. A clinician could use telemedicine to order an initial 30-day supply of medications such as buprenorphine, Ambien, Valium, and Xanax, but patients would need an in-person evaluation to get a refill.

For another group of drugs, including Adderall, Ritalin, and oxycodone, the DEA proposal would institute tighter controls. Patients seeking those medications would need to see a doctor in person for an initial prescription.

David Herzberg, a historian of drugs at the University at Buffalo, said the DEA’s approach reflects a fundamental challenge in developing drug policy: meeting the needs of people who rely on a drug that can be abused without making that drug too readily available to others.

The DEA, he added, is “clearly seriously wrestling with this problem.”

Hospitals Return to Normal, Somewhat

During the pandemic, CMS has tried to limit problems that could arise if there weren’t enough health care workers to treat patients — especially before there were covid vaccines when workers were at greater risk of getting sick.

For example, CMS allowed hospitals to make broader use of nurse practitioners and physician assistants when caring for Medicare patients. And new physicians not yet credentialed to work at a particular hospital — for example, because governing bodies lacked time to conduct their reviews — could nonetheless practice there.

Other changes during the public health emergency were meant to shore up hospital capacity. Critical access hospitals, small hospitals located in rural areas, didn’t have to comply with federal rules for Medicare stating they were limited to 25 inpatient beds and patients’ stays could not exceed 96 hours, on average.

Once the emergency ends, those exceptions will disappear.

Hospitals are trying to persuade federal officials to maintain multiple covid-era policies beyond the emergency or work with Congress to change the law.

Surveillance of Infectious Diseases Splinters

The way state and local public health departments monitor the spread of disease will change after the emergency ends, because the Department of Health and Human Services won’t be able to require labs to report covid testing data.

Without a uniform, federal requirement, how states and counties track the spread of the coronavirus will vary. In addition, though hospitals will still provide covid data to the federal government, they may do so less frequently.

Public health departments are still getting their arms around the scope of the changes, said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

In some ways, the end of the emergency provides public health officials an opportunity to rethink covid surveillance. Compared with the pandemic’s early days, when at-home tests were unavailable and people relied heavily on labs to determine whether they were infected, testing data from labs now reveals less about how the virus is spreading.

Public health officials don’t think “getting all test results from all lab tests is potentially the right strategy anymore,” Hamilton said. Flu surveillance provides a potential alternative model: For influenza, public health departments seek test results from a sampling of labs.

“We’re still trying to work out what’s the best, consistent strategy. And I don’t think we have that yet,” Hamilton said.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

California eligió a la compañía de genéricos Civica para producir insulina de bajo costo

SACRAMENTO, CA. — El gobernador Gavin Newsom anunció el sábado 18 de marzo que se había seleccionado al fabricante de medicamentos genéricos Civica, con sede en Utah, para producir insulina de bajo costo para el estado, una medida sin precedentes que cumple su promesa de poner al gobierno estatal en competencia directa con las versiones de marca de las farmaceúticas que dominan el mercado.

“La gente no debería verse obligada a endeudarse para obtener recetas que salvan vidas”, dijo Newsom. “Los californianos tendrán acceso a algunas de las insulinas más económicas disponibles, lo que les ayudará a ahorrar miles de dólares cada año”.

El contrato, con un costo inicial de $50 millones que Newsom y los legisladores demócratas aprobaron el año pasado, estipula que Civica produzca insulina de marca estatal y ponga el medicamento a disposición de cualquier californiano que lo necesite, por correo y en las farmacias locales, independientemente de si tenga o no seguro de salud.

Y la insulina es solo el comienzo. Newsom dijo que el estado también buscará producir naloxona, el fármaco que revierte las sobredosis de opioides.

Allan Coukell, vicepresidente sénior de políticas públicas de Civica, le dijo a California Healthline que el fabricante de medicamentos sin fines de lucro también está en conversaciones con la administración de Newsom para producir potencialmente otros medicamentos genéricos. Pero se negó a dar más detalles y dijo que la compañía se enfoca primero en hacer que la insulina económica esté ampliamente disponible.

“Estamos muy entusiasmados con esta asociación con el estado de California”, dijo Coukell. “No buscamos tener el 100% del mercado, pero sí queremos que el 100% de las personas tenga acceso a insulina a un precio justo”.

A medida que los costos de la insulina para los consumidores se han disparado, los legisladores y activistas demócratas han pedido a la industria que los controle. Apenas unas semanas después que el presidente Joe Biden atacara a las grandes farmacéuticas por aumentar los precios de la insulina, los tres fabricantes de medicamentos que controlan ese mercado, Eli Lilly and Co., Novo Nordisk y Sanofi, anunciaron que reducirían drásticamente los precios de lista de algunos productos.

Newsom, quien anteriormente acusó a la industria farmacéutica de estafar a los californianos con “precios altísimos”, argumentó que el lanzamiento de la marca de genéricos estatal, CalRx, sumará competencia y ejercerá presión sobre la industria.

Funcionarios de la administración no dijeron cuándo estarían disponibles los productos de insulina de California, pero expertos dicen que podría ser tan pronto como en 2025. Coukell remarcó que el medicamento de marca estatal aún requerirá la aprobación de la Administración de Drogas y Alimentos (FDA), lo que puede demorar unos 10 meses.

La Pharmaceutical Research and Manufacturers of America, que cabildea en nombre de las empresas de marca, criticó la medida de California. Reid Porter, director senior de asuntos públicos estatales de PhRMA, dijo que Newsom solo “quiere sumar puntos políticos”.

“Si el gobernador quiere tener un impacto significativo en lo que los pacientes pagan por las insulinas y otros medicamentos, debería expandir su enfoque a otros en el sistema que a menudo hace que los pacientes paguen más por los medicamentos”, dijo Porter, culpando a las empresas intermediarias, conocidas como administradores de beneficios de farmacia, que negocian con los fabricantes en nombre de las aseguradoras para reembolsos y descuentos.

La Pharmaceutical Care Management Association, que representa a estos administradores, argumentó a su vez que son las compañías farmacéuticas las culpables de los altos precios.

Expertos en precios dicen que los administradores de beneficios farmacéuticos y los fabricantes de medicamentos comparten la culpa.

Funcionarios de la administración Newsom dicen que los costos inflados de la insulina obligan a algunos a pagar hasta $300 por vial o $500 por una caja de plumas inyectables, y que demasiados californianos con diabetes se saltan o racionan sus medicamentos. Esto puede provocar ceguera, amputaciones y afecciones potencialmente mortales, como enfermedades cardíacas e insuficiencia renal. Casi el 10% de los adultos de California tienen diabetes.

Civica está desarrollando tres tipos de insulina genérica, conocida como biosimilar, que estarán disponibles tanto en viales como en plumas inyectables. Se espera que sean intercambiables con productos de marca, incluidos Lantus, Humalog y NovoLog. Coukell dijo que la compañía pondría a disposición el medicamento por no más de $30 por vial, o $55 por cinco plumas inyectables.

Newsom dijo que la insulina estatal le ahorrará a muchos pacientes entre $2,000 y $4,000 al año, aunque siguen sin respuesta preguntas críticas sobre cómo California pondrá los productos en manos de los consumidores, incluida la forma en que persuadiría a las farmacias, las aseguradoras y los minoristas para que distribuyan los medicamentos.

El año pasado, Newsom también obtuvo $50 millones en capital inicial para construir una instalación para fabricar insulina; Coukell dijo que Civica está explorando la construcción de una planta en California.

El movimiento de California, aunque nunca antes lo había intentado un gobierno estatal, podría verse afectado por las recientes decisiones de la industria para reducir los precios de la insulina. En marzo, Lilly, Novo Nordisk y Sanofi se comprometieron a reducir los precios. Con Lilly ofreciendo un vial a $25 por mes, Novo Nordisk prometió importantes reducciones que llevarían el precio de un vial genérico particular a $48, y Sanofi fijó un vial a $64.

La oficina del gobernador dijo que le costará al estado $30 por vial para fabricar y distribuir insulina y se venderá a ese precio. Si lo hace, argumenta la administración, “evitará el atroz cambio de costos que ocurre en los juegos de precios farmacéuticos tradicionales”.

Expertos en precios de medicamentos dijeron que la producción de genéricos en California podría reducir aún más los costos de la insulina y beneficiar a las personas con planes médicos con deducibles altos o sin seguro.

“Este es un movimiento extraordinario en la industria farmacéutica, no solo para la insulina, sino potencialmente para todo tipo de medicamentos”, dijo Robin Feldman, profesor de la Facultad de Derecho de la Universidad de California en San Francisco. “Es una industria muy difícil de quebrantar, pero California está lista para hacer precisamente eso”.

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

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry – Kaiser Health News

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts: