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KHN’s ‘What The Health?’: Republicans in COVID Disarray

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President Donald Trump’s pivot to a more serious view of the coronavirus pandemic didn’t last long. This week, he was again touting hydroxychloroquine, an antimalarial drug that has not been shown to work against the virus. Meanwhile, on Capitol Hill, Republicans continue to struggle to come up with a proposal for the next round of COVID-19 relief even as earlier bills expire. That’s leaving millions of Americans without the ability to pay rent or meet other necessary expenses, as the economy continues to sink.

Also on the agenda, at least briefly, is the subject of high drug prices. Once considered a leading health issue for the 2020 elections, it has been all but wiped from the headlines by the pandemic. Trump issued a series of executive orders he said would produce an immediate impact, but experts point out they are mostly wish lists of things the president has already said he supports.

This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Mary Ellen McIntire of CQ Roll Call and Anna Edney of Bloomberg News.

Among the takeaways from this week’s podcast:

Despite much disarray on Capitol Hill about which coronavirus relief economic provisions Republican senators will agree on, there is largely agreement within the party and among Democrats on the health provisions, such as the need for more money for testing and for health care providers.
Senate Majority Leader Mitch McConnell insists the stimulus package must include liability protection for employers to protect businesses struck by a COVID-19 outbreak through no fault of their own. But Democrats are opposed and argue that the promise of liability waivers may keep employers from taking adequate safety precautions.
The Atlantic magazine recently explored the issue of “hygiene theater” in which people take measures they hope will keep the coronavirus at bay — such as excessive scrubbing, temperature checks, etc. — that science suggests have limited or no effect. These measures may give people comfort, but the efforts can also be dangerous in that they give a false sense of security and divert attention and resources from other, more complicated methods to stop the disease.
Much attention in recent weeks has been given to the development of a vaccine. Several options are in advanced stages of testing. But public health advocates fear that the speed of the testing and the administration’s past erroneous statements about the disease may raise fears among consumers about taking the vaccine. Nonetheless, Democrats looking ahead to the election worry that the administration will make a major announcement about vaccine availability as an October surprise.
COVID-19 has basically eclipsed efforts to make progress on several other key health issues that were expected before the election, including drug pricing and surprise medical bills.
With great fanfare this week, Trump announced orders for the administration to move toward new drug pricing policies. But the orders have little or no effect and haven’t created any momentum for advancing legislation in Congress.
The president surprised many people this week when he announced he was loaning Kodak millions of dollars to produce ingredients needed for the generic drug industry. Many of those chemicals have been made overseas, so the effort does follow the administration’s quest to establish more manufacturing in the U.S. But one reason few companies do the work here is that there is not a big profit margin on the drugs.

Also this week, Rovner interviews KHN’s Markian Hawryluk, who reported the July NPR-KHN “Bill of the Month” installment, about a surprise bill from a surprise participant in the operating room: a surgical assistant. If you have an outrageous medical bill you would like to share with us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: The New York Times’ “Disability Pride: The High Expectations of a New Generation,” by Joseph Shapiro

Alice Miranda Ollstein: Politico’s “Pelosi Mandates Wearing Masks on the House Floor After Gohmert Case,” by Heather Caygle and Sarah Ferris

Mary Ellen McIntire: The Atlantic’s “Why Can’t We Just Have Class Outside?” by Olga Khazan

Anna Edney: ProPublica’s “How to Understand COVID-19 Numbers,” by Caroline Chen

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Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

Public Health Experts Fear a Hasty FDA Signoff on Vaccine

The vaccine trial that Vice President Mike Pence kicked off in Miami on Monday gives the United States the tiniest chance of being ready to vaccinate millions of Americans just before Election Day.

It’s a possibility that fills many public health experts with dread.

Among their concerns: Early evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the Food and Drug Administration. That conflict between science and politics might cause some people to not trust the vaccine and refuse to take it, which would undermine the global campaign to stop the pandemic. Or it could lead to a product that is not fully protective. Confidence in routine childhood vaccinations, already shaken, could decline further.

“The fear is that you wind up doing to a vaccine what [Trump has] already done with [opening] school,” said Dr. Joshua Sharfstein, a former FDA deputy commissioner and a professor at Johns Hopkins University in Baltimore. “Take an important, difficult question and politicize it. That’s what you want to avoid.”

On Monday at 6:45 a.m., the first volunteer in the landmark phase 3 trial for the Moderna Therapeutics vaccine received a shot at a clinic in Savannah, Georgia. Clinicians at 88 other sites, stretching from Miami to Seattle, also administered the experimental shot in a trial that aims to enroll 30,000 people.

Dr. Anthony Fauci, the country’s leading infectious disease expert, told reporters he hoped 15,000 could be vaccinated by the end of the week, although he provided no information about progress toward that goal. All volunteers would receive a second shot 29 days after their first inoculation. (Half will receive a placebo containing saline solution.)

Another vaccine, produced by Pfizer with the German company BioNTech, also entered a large phase 3 U.S. trial this week. It’s being tested independently of the National Institutes of Health, which is partially funding the Moderna trial as well as tests for an Oxford University/AstraZeneca vaccine trial, and others in the future. AstraZeneca has said some doses of its vaccine might be ready as early as September.

Fauci said he expects the Moderna trial to provide an answer about whether that vaccine works by the end of the year — and it’s “conceivable” an answer could come in October. “I doubt that, but we are leaving an open mind that it is a possibility.”

Such a fast pace worries some experts.

“I don’t see how that’s remotely possible unless the thing I most fear happens, a truncated phase 3 trial with just an idea of efficacy, an idea of common side effects, and then it rolls out,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Pence downplayed such fears Monday, telling reporters: “There will be no shortcuts. There will be no cutting corners.”

Officials are pressing for an open and transparent process.

Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, is preparing to release a bill requiring the FDA to have an expert panel review any COVID vaccine and issue a recommendation before FDA Commissioner Stephen Hahn makes a decision.

With past vaccines, the FDA has generally relied on such a committee, made up mostly of vaccine experts and appointed by the FDA commissioner. They typically conduct a painstaking examination of all evidence before voting on whether the FDA should approve a vaccine. The commissioner has rarely, if ever, gone against the committee’s decisions.

Hahn undercut confidence in the FDA’s independence earlier in the year, many observers felt, when he issued an Emergency Authorization Use declaration for hydroxychloroquine, a drug used to treat malaria that President Donald Trump and members of his administration have continued to tout, erroneously, as a cure for COVID-19. The FDA later revoked the authorization, which was made without consulting an independent committee.

“FDA’s independence has been threatened, no question, by the hydroxychloroquine issue,” said Dr. Jesse Goodman, a Georgetown University professor who led the FDA’s biologics division and later was chief scientific officer.

The agency must give outside scientists and the public the opportunity to see the data and the FDA’s reasoning before coming to such a decision, he said.

Concerns about political interference arose recently when Trump talked excitedly about a vaccine, and Treasury Secretary Steven Mnuchin confidently told reporters there would be a vaccine by the end of the year for emergency use.

To be sure, it’s unlikely the FDA would be tempted to issue an emergency release without data that showed a vaccine was working and not causing serious side effects.

The massive coronavirus outbreaks in Texas and other hard-hit areas where the Moderna vaccine is being tested should provide an answer, although exactly when is an open question.

In theory, scientists might get a handle on a vaccine’s efficacy before all 30,000 people are enrolled, vaccinated and studied.

In fact, an answer could become clear after only 150 to 160 cases of disease are reported among the trial participants, Fauci said. If roughly two-thirds of those cases occurred in non-vaccinated people, it would show statisticians that the vaccine had above-60% efficacy, he said.

If the vaccine is 80% to 90% effective and the annual rate of infection in the places where it’s being tested is above 4%, scientists could get a signal of efficacy in such a trial with just 50 cases, or in as little as three months, said Ira Longini, a University of Florida biostatistician who designs vaccine trials.

The Moderna vaccine trial would hit that three-month threshold on Oct. 27.

The trial’s fate is partly in the hands of its 30-member Data and Safety Monitoring Board, whose members can see unblinded data about the participants in real time — pinpointing who was vaccinated with the actual vaccine and got sick, for example. The board will alert the NIH and vaccine maker if it sees surprising data — either dangerous side effects or powerful efficacy. Some fear that if the vaccine seems to work in an early review, the FDA would be pressured to stop the trial.

Offit said NIH should not accept anything less than a completed trial of 30,000 people. Fifty cases “is a very small number” to use as evidence for releasing a vaccine that could be administered to tens of millions, he said.

The public might clamor for the release of any vaccine that seemed to work. Moderna said it has already begun producing millions of doses of vaccine “at risk,” banking on the vaccine’s success. The FDA could release those under powers provided when the country declared a public health emergency in March.

With more than half the country deeply mistrustful of Trump, according to recent polls, any federal decision could be resisted and lead to widespread rejection of even a promising vaccine. Sharfstein worries about a “knee-jerk” reaction against the vaccine by Democrats if Trump touts it before the election.

Experts also worry about releasing a vaccine that shows some positive effects but isn’t robustly protective. A slide presented by FDA deputy director Philip Krause at the World Health Organization earlier this month said a weak vaccine could fail to protect the public adequately, leading to a false sense of security in those who’ve received it, while making it harder to test future vaccines.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

El color de COVID: ¿los ensayos de vacunas reflejan la diversidad de Estados Unidos?

Cuando los científicos estadounidenses comiencen a lanzar este verano los primeros ensayos clínicos a gran escala de una vacuna contra COVID-19, Antonio Cisneros quiere asegurarse de que participen personas como él.

Cisneros, hispano de 34 años, forma parte de la primera ola de un millón y medio de voluntarios dispuestos a recibir las dosis, para ayudar a determinar si las vacunas que son principales candidatas pueden derrotar al virus que ha causado una pandemia mortal.

“Si me piden que participe, lo haré”, dijo Cisneros, cineasta de Los Ángeles que se ha inscrito en dos grandes ensayos. “Parece ser parte de nuestro deber”.

Sin embargo, se necesitará más que un impulso para garantizar que los ensayos clínicos que evalúan la seguridad y efectividad de una vacuna realmente incluyan un número representativo de afroamericanos, latinos y otras minorías raciales y étnicas. También a personas mayores y a otras con afecciones médicas subyacentes, como enfermedad renal.

Las personas de raza negra y las latinas (que pueden ser de cualquier raza) tienen tres veces más probabilidades de infectarse con el coronavirus que causa COVID-19 que las personas blancas no hispanas, y el doble de probabilidades de morir, según datos federales obtenidos por The New York Times a través de una demanda.

Los estadounidenses de origen asiático parecen representar menos casos, pero tienen mayores tasas de mortalidad. Ocho de cada 10 muertes por COVID reportadas en los Estados Unidos han sido de personas de 65 años o más. Y los Centros para el Control y Prevención de Enfermedades (CDC) advierten que la enfermedad renal crónica se encuentra entre los principales factores de riesgo de infección grave.

Sin embargo, históricamente, a estos grupos se los ha incluido menos en ensayos clínicos, a pesar de las normas federales que requieren la participación de minorías y personas mayores, y los esfuerzos continuos de los defensores de pacientes para diversificar estos estudios médicos críticos.

En un verano dominado por COVID-19 y por protestas contra la injusticia racial, el reclamo a los fabricantes de drogas e investigadores para que garanticen que los ensayos de vacunas reflejen a toda la comunidad es más potente.

“Si las personas de raza negra estamos siendo sido víctimas de COVID-19, seremos la clave para descubrir el misterio de COVID-19”, dijo el reverendo Anthony Evans, presidente de la National Black Church Initiative (NBCI), una coalición de 150,000 Iglesias afroamericanas.

Evans y su equipo se reunieron a mediados de julio con funcionarios de Moderna, la compañía de biotecnología de Massachusetts que lanzó el primer ensayo de una vacuna contra COVID en los Estados Unidos, para discutir una colaboración en la que el NBCI ayudaría a reclutar a participantes afroamericanos. Pero este encuentro fue menos de dos semanas antes del comienzo de la fase 3 del ensayo, que esperaba inscribir 30,000 personas, y Evans dijo que la reunión fue idea suya.

“La industria no se acercó a mí. Yo fui a la industria”, dijo.

Investigaciones muestran que las personas de raza negra representan aproximadamente el 13% de la población del país, pero en promedio el 5% de los participantes en ensayos clínicos. Para los hispanos, la participación en ensayos es de aproximadamente 1% en promedio, aunque representan cerca del 18% de la población.

Antonio Cisneros, cineasta de Los Angeles, se registró para dos grandes ensayos de vacunas contra COVID-19. Es de los primeros de la primera ola de voluntarios. "Si me dicen de participar, lo haré. Es nuestro deber", dijo.(Photo by Steven Shea)

Cuando se trata de ensayos de medicamentos y vacunas, la diversidad es importante. Estudios muestran que, por razones que no siempre se entienden completamente, las personas de diferentes razas y etnias pueden responder de manera diferente a las drogas o terapias. La respuesta inmune disminuye con la edad, por eso hay una vacuna contra la gripe en dosis altas para las personas mayores de 65 años.

Aún así, la presión por desarrollar una vacuna eficaz en tiempo récord, en medio de la pandemia, podría dejar de lado los esfuerzos para garantizar la diversidad, dijo la doctora Kathryn Stephenson, directora de la unidad de ensayos clínicos en el Centro de Investigación de Virología y Vacunas en el Centro Médico Beth Israel Deaconess, en Boston.

“Una de las preguntas que surgió es: ¿qué hacer si eres un investigador y tienes a 250 personas golpeando a tu puerta, y todos son blancos no hispanos?”, reflexionó.

¿Inscribes a esas personas, siguiendo el razonamiento de que, cuanto más rápido avance el ensayo, más rápido estará disponible una vacuna para todos? ¿O los rechazas y retrasas el estudio?

“Estás acelerando el desarrollo de una vacuna, y si alcanzas un hito, ¿cuál es el significado de ese hito si no sabes si es muy segura o efectiva para una población [determinada]? ¿Realmente el logro es para todos?”, se preguntó Stephenson.

Incluir a las personas de edad avanzada o que tienen afecciones médicas subyacentes es vital para la ciencia de las vacunas y otros tratamientos, incluso si es más difícil reclutarlos.

“Tenemos que admitir que los adultos mayores son los que tienen más probabilidades de desarrollar efectos secundarios a los tratamientos y vacunas”, dijo la doctora Sharon Inouye, directora del Aging Brain Center y profesora en la Escuela de Medicina de Harvard. “Por otro lado, esa es la población que la usará”.

Las personas con enfermedad renal, que afecta a 1 de cada 7 adultos en el país, han sido excluidos de la investigación clínica durante décadas, dijo Richard Knight, quien recibió un órgano y es presidente de la Asociación Americana de Pacientes Renales. Casi el 70% de los más de 400 pacientes con enfermedad renal que la organización encuestó en julio dijeron que nunca se les había pedido participar de un ensayo clínico.

Excluyendo el ensayo de la vacuna, una población vulnerable a COVID tan amplia no tiene sentido, sostuvo Knight. “Si estás tratando de manejar esto desde el punto de vista de la salud pública, quieres asegurarte de estar inoculando a tus poblaciones de mayor riesgo”, explicó.

La nueva guía de la Administración de Drogas y Alimentos (FDA), que regula las vacunas, “alienta” la diversidad en el desarrollo de vacunas clínicas. Eso incluye minorías raciales y étnicas, personas mayores y personas con problemas médicos subyacentes, así como mujeres embarazadas.

Pero la FDA no exige que los fabricantes de medicamentos e investigadores cumplan con esos objetivos, y no rechazará los datos de pruebas que no cumplan con esta recomendación. Y aunque el gobierno federal está derivando miles de millones de dólares para acelerar más de media docena vacunas candidatas para COVID, las farmacéuticas que las producen no están obligadas a revelar públicamente sus objetivos demográficos.

“Esto es lo de siempre”, dijo Marjorie Speers, directora ejecutiva de Clinical Research Pathways, un grupo sin fines de lucro de Atlanta que trabaja para aumentar la diversidad en la investigación. “Es muy probable que estos ensayos no incluyan minorías porque no es mandatorio”.

Los ensayos de vacunas se coordinan a través de la Red de Prevención de COVID-19 (CoVPN), con sede en el Centro de Investigación del Cáncer Fred Hutchinson, en Seattle. Se basa en cuatro redes de ensayos clínicos de larga data financiadas por el gobierno federal, incluidas tres dirigidas al VIH y al SIDA.

Esas redes de pruebas fueron elegidas en gran parte porque tienen relaciones ricas en comunidades minoritarias de raza negra, latinas y otras, dijo Stephaun Wallace, director de relaciones externas de CoVPN. La esperanza es aprovechar las conexiones existentes basadas en la confianza y la colaboración.

“Nuestros sitios de ensayos clínicos están preparados y listos para involucrar a personas de distintas comunidades”, dijo Wallace.

Sin embargo, reconoció que atraer a una población diversa requiere que los investigadores sean flexibles e innovadores. Puede haber problemas prácticos. Las horas de la clínica pueden ser limitadas o el transporte puede ser un problema. Las personas mayores pueden tener problemas de vista o audición y requerir de ayuda adicional para seguir los protocolos.

La desconfianza en el establecimiento médico también puede ser una barrera. Por ejemplo, los afroamericanos, tienen una cautela bien fundada con los ensayos médicos después del infame Estudio Tuskegee y la explotación de Henrietta Lacks. La sospecha se extiende a las vacunas recomendadas, dijo Wallace.

“No quieren sentirse como conejillos de indias o sentir que se está experimentando con ellos”, agregó.

Moderna, que lanza su prueba de fase 3 el lunes 27de julio, dijo que la compañía está trabajando para garantizar que los participantes “representen a las comunidades con mayor riesgo de COVID-19 y a nuestra sociedad diversa”.

Sin embargo, los resultados del ensayo de fase 1 de la compañía, publicados a mediados de julio, mostraron que de 45 personas incluidas en esa prueba de seguridad, seis eran hispanos, dos eran de raza negra (no hispanos), una era asiática y una era nativa americana. Cuarenta eran blancos no hispanos.

Los ensayos clínicos de fase 1 y fase 2 tienen como objetivo evaluar la mejor dosis y la seguridad de las vacunas en pequeños grupos de personas. Los ensayos de fase 3 evalúan la eficacia del medicamento en decenas de miles.

Los investigadores en casi 90 sitios en los Estados Unidos se están preparando para reclutar participantes para el ensayo de fase 3 de Moderna. El doctor Carlos del Río, decano ejecutivo asociado de la Escuela de Medicina de la Universidad Emory, buscará 750 voluntarios en tres sitios del área de Atlanta. La mitad recibirá la vacuna; la otra mitad, inyecciones de placebo.

Del Río ha tenido un éxito notable en el reclutamiento de minorías para ensayos de VIH y espera resultados similares con el ensayo de la vacuna. “Estamos haciendo nuestro mejor esfuerzo para llegar a las comunidades que están en mayor riesgo”, dijo.

Mientras tanto, los voluntarios como Cisneros solo quieren que comiencen los ensayos avanzados.

Cisneros se inscribió en los ensayos de CoVPN. Pero primero lo hizo en 1 Day Sooner, un esfuerzo para lanzar lo que se llama “ensayos de desafío en humanos”, cuyo objetivo es acelerar el desarrollo de la vacuna al infectar deliberadamente a los participantes con el virus. Estos ensayos pueden completarse en semanas en lugar de meses, pero corren el riesgo de exponer a los voluntarios a enfermedades graves o a la muerte, y los funcionarios federales siguen siendo recelosos de esta estrategia.

Cisneros está dispuesto a correr ese riesgo para ayudar a frenar a COVID-19, que ya ha matado a 143,000 estadounidenses. Dijo que es una forma de actuar en un momento en el que el gobierno de los Estados Unidos no ha podido proteger a las minorías, los adultos mayores y otras personas vulnerables.

“Se supone que el gobierno debe ayudar a aquellos que no pueden protegerse”, dijo. “Me parece que lo único que quieren proteger es a las personas con dinero, a las personas con armas de fuego, y no a las personas de minorías como yo”.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

Biden Is Right. Pay for Home Health Workers Is Paltry.

In a speech this month, former Vice President Joe Biden, the presumptive Democratic presidential nominee, offered the third installment of a four-part economic plan being rolled out in advance of the Democratic National Convention in August. This set of proposals focused on caregivers — whether for children, older adults or people with disabilities — and is about “easing the squeeze on working families who are raising their kids and caring for aging loved ones at the same time,” Biden said.

His campaign’s sweeping set of initiatives, which represent a $775 billion expenditure in a variety of programs, aims to get significant traction among middle-class voters, whose struggles with caregiving issues have been exacerbated during the coronavirus pandemic.

When it came to home health workers, Biden zeroed in on their paychecks. “They’re doing God’s work,” he said. “But home health workers aren’t paid much, they have few benefits. Forty percent are still on SNAP or Medicaid. So my plan is direct. It gives caregivers and early childhood educators a much-needed raise.”

That 40% is a striking number.

After all, there are an estimated 3.3 million home health and personal care aides in the United States, according to the Bureau of Labor Statistics. These workers provide a range of daily living services to millions of older Americans and people with disabilities, chronic illness or cognitive impairment — making them an important part of the health care continuum. As baby boomers age, demand for home health workers is expected to increase rapidly. And, because Biden put a spotlight on the role caregivers could have in boosting the economy, we decided to investigate further.

We contacted the Biden campaign to find out the source for the 40% statistic. A spokesperson pointed us to information from PHI National’s Workforce Data Center. PHI is a New York-based advocacy organization that studies the direct-care workforce and is frequently cited as a source on this topic.

The group indicated that in 2017 42% of direct care workers, a category composed of personal care aides, home health aides and nursing assistants, received some form of public assistance — defined by PHI as food and nutrition assistance, public health insurance or cash assistance. A further breakdown of this broad job category showed that 53% of home care workers received public assistance, with 30% having received food and nutrition assistance and 33% Medicaid insurance coverage.

Based on these figures, Robert Espinoza, PHI’s vice president of policy, said Biden was certainly in the ballpark.

More Numbers, and Some Context

But there’s more.

The two programs Biden mentioned by name — SNAP, or the Supplemental Nutritional Assistance Program, and Medicaid, the state-federal health insurance program for low-income people — peg eligibility to income limits at or near the federal poverty level, which for an individual is $12,760. Those eligibility limits vary by program and state.

Medicaid for adults depends on where they live, and ranges from 138% of poverty in states that chose to expand the program under the Affordable Care Act to a median of 40% of poverty in those states that didn’t. For SNAP, those limits are set at 130% percent of the poverty level for gross monthly income and 100% for net monthly income. For an individual, that’s $1,354 and $1,041, respectively.

According to the Bureau of Labor Statistics, the median pay for home health workers is about $24,060 per year, and a 2019 report by PHI concluded that 47% of home health workers have incomes at or below 138% of the poverty level. These numbers further back up Biden’s assertion about the number of home health workers on Medicaid or SNAP. If anything, they suggest his 40% figure may be a lowball estimate.

And one more bit of evidence that Biden was on the right track: The National Employment Law Project noted that many of these workers “supplement their home care work with other jobs to make ends meet.” That PHI report asserted that half of home care workers have only a high school education and often work part time or inconsistent schedules. These jobs are also marked by high turnover rates.

Our Ruling

Biden said home health workers were paid very little, citing a statistic that 40% of these workers relied on public assistance programs like SNAP and Medicaid as evidence.

According to the experts with whom we spoke, and the documents we consulted, Biden accurately described home health workers’ income and their reliance on these programs. His number appears to represent the low end of the spectrum.

We rate this statement True.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

Dental and Doctors’ Offices Still Struggling with COVID Job Loss

California’s outpatient health care practices largely shrugged off two recessions, adding more than 400,000 jobs during a two-decade climb from the start of 2000 to early 2020. It was an enviable growth rate of 85% and a trend largely mirrored on the national level.

Then came COVID-19.

Anecdotal stories abound about the crushing impact the pandemic has had on a range of outpatient medical services, from pediatric and family medical practices to dental offices, medical labs and home health care. In California, as in many other states, thousands of doctors, dentists and other health care providers temporarily closed offices this spring as state health officials directed them to suspend non-urgent visits. Many others sat open but largely idle because patients were too scared to visit the doctor given the risk of running into someone with COVID-19 in the waiting room.

As the economy has reopened, so have many medical offices. But the latest state and federal employment data underscores the lingering toll the pandemic has taken on the health care sector.

In California, employment in medical offices providing an array of outpatient care fell by 159,300 jobs, or 18%, from February to April, according to California’s Employment Development Department. The sector has recovered some, but job totals in June remained 7% below pre-crisis levels, the latest figures show. Data is not yet available for July, when COVID-19 cases in California again began to rise sharply and communities across much of the state reverted to partial shutdowns.

Nationwide, employment in outpatient care fell by about 1.3 million jobs, or 17%, from February to April, and in June also remained 7% below pre-crisis levels.

Doctors’ offices typically rely on patient volume for revenue. Without it, they can’t make payroll. Many small medical clinics weren’t flush with cash before the crisis, making COVID-19 an existential threat.

“Never in our history have we had more than a month’s cash on hand,” said Dr. Sumana Reddy, owner of the Acacia Family Medical Group in Monterey County. “Think of it that way.”

Reddy operates two clinics, one in Salinas and the other in the town of Prunedale. Many of her clients come from rural areas where poverty is common. When COVID-19 hit and stay-at-home orders took effect, the number of patients coming to the practice fell by about 50%, Reddy said. To keep her patients safe and her business afloat, Reddy largely shifted to telehealth so she could provide care online.

She also turned to federal aid. “I took the stimulus money,” she said. “I asked for advances from anywhere I could get that. So, now I’m tapped out. I’ve done every single thing that I can think of to do. And there’s nothing more to do.”

By late June, patient volume at Reddy’s practice stood at roughly 70% of the level seen before the crisis.

Many dental offices have been hit even harder. From February to April, the number of dental office employees in California fell by 85,000, or 60%, a rate of decline that outpaced even job losses in the state’s restaurant industry. Nationwide, dental employment fell by about 546,000 from February to April, a 56% decline.

“March, April, mid-May — we were pretty much closed except for emergency care,” said Dr. Natasha Lee, who owns Better Living Through Dentistry, a practice in San Francisco’s Inner Sunset neighborhood. “While dental offices were considered essential, most were closed due to guidance from health departments and the CDC to postpone routine and preventative medical and dental care and just to limit things to emergency.”

Lee has reopened her clinic but is doing less business. She and her staff need extra time to clean tools and change their personal protective equipment.

“With the social distancing, the limiting [of] patients in the office at a time and the slowdown we’ve had, we’re probably seeing about, I’d say, two-thirds of our normal capacity in our practice,” she said in late June.

As for employment, California hospitals have fared better than outpatient medical offices. Hospitals shed about 2% of jobs from February to June.

“They have more capacity in a large organization to withstand the same shock,” said John Romley, a professor and economist at the University of Southern California’s Leonard D. Schaeffer Center for Health Policy and Economics.

Romley said he is optimistic the health care sector overall will recover faster than some other sectors of the economy, since health care remains a necessity.

Still, red flags abound. The recent spike in COVID-19 cases and deaths in many parts of the nation raises the specter of future shutdowns and, with them, additional health care layoffs. In California, Gov. Gavin Newsom recently ordered a second shutdown for dine-in restaurants, movie theaters and bars statewide, as well as churches, gyms and barbershops in much of the state. For now, dental and doctors’ offices can continue operating.

But it’s uncertain when patients will feel comfortable returning to the doctor for routine and preventive care. A series of Census Bureau surveys conducted between June 11 and July 7 found that 42% of Californians who responded had put off medical care in the previous four weeks because of the pandemic. About 33% said they needed medical care for something unrelated to COVID-19 but did not get it.

“I’ve been telling my staff and patients that we should prepare for things to stay not too different for six months to a year,” Reddy said, “which is pretty depressing for most people to think about.”

Phillip Reese is a data reporting specialist and an assistant professor of journalism at California State University-Sacramento.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

Watch: When a Surprise Helper During Surgery Is Out-of-Network

Gayle King of “CBS This Morning” spoke with KHN Editor-in-Chief Elisabeth Rosenthal about the latest installment of KHN-NPR’s Bill of the Month. College student Izzy Benasso underwent surgery for a torn meniscus after a tennis injury last summer and was surprised to be contacted afterward by a surgical assistant, who said he would be billing her insurance more than a thousand dollars.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

The Color of COVID: Will Vaccine Trials Reflect America’s Diversity?

When U.S. scientists launch the first large-scale clinical trials for COVID-19 vaccines this summer, Antonio Cisneros wants to make sure people like him are included.

Cisneros, who is 34 and Hispanic, is part of the first wave of an expected 1.5 million volunteers willing to get the shots to help determine whether leading vaccine candidates can thwart the virus that sparked a deadly pandemic.

“If I am asked to participate, I will,” said Cisneros, a Los Angeles cinematographer who has signed up for two large vaccine trial registries. “It seems part of our duty.”

It will take more than duty, however, to ensure that clinical trials to establish vaccine safety and effectiveness actually include representative numbers of African Americans, Latinos and other racial minorities, as well as older people and those with underlying medical conditions, such as kidney disease.

Black and Latino people have been three times as likely as white people to become infected with COVID-19 and twice as likely to die, according to federal data obtained via a lawsuit by The New York Times. Asian Americans appear to account for fewer cases but have higher rates of death. Eight out of 10 COVID deaths reported in the U.S. have been of people ages 65 and older. And the Centers for Disease Control and Prevention warns that chronic kidney disease is among the top risk factors for serious infection.

Antonio Cisneros, a Los Angeles cinematographer, signed up for two COVID-19 vaccine trial registries. He is among the first wave of volunteers. “If I am asked to participate, I will,” says Cisneros. “It seems part of our duty.”(Photo by Steven Shea)

Historically, however, those groups have been less likely to be included in clinical trials for disease treatment, despite federal rules requiring minority and elder participation and the ongoing efforts of patient advocates to diversify these crucial medical studies.

In a summer dominated by COVID-19 and protests against racial injustice, there are growing demands that drugmakers and investigators ensure that vaccine trials reflect the entire community.

“If Black people have been the victims of COVID-19, we’re going to be the key to unlocking the mystery of COVID-19,” said the Rev. Anthony Evans, president of the National Black Church Initiative, a coalition of 150,000 African American churches.

Evans and his team met in mid-July with officials from Moderna, the Massachusetts biotech firm that launched the first COVID vaccine trial in the U.S., to discuss a collaboration in which NBCI would supply African American participants. But that was less than two weeks before the start of a phase 3 trial expected to enroll 30,000 people, and Evans said the meeting was his idea.

“It’s not that the industry came to me,” he said. “I went to the industry.”

Blacks make up about 13% of the U.S. population but on average 5% of clinical trial participants, research shows. For Hispanics, trial participation is about 1% on average, though they account for about 18% of the population.

When it comes to trials for drug treatments and vaccines, diversity matters. For reasons not always fully understood, people of different races and ethnicities can respond differently to drugs or therapies, research shows. Immune response wanes with age, so there’s a high-dose flu shot for people 65 and older.

Still, the pressure to produce an effective vaccine quickly during a pandemic could sideline efforts to ensure diversity, said Dr. Kathryn Stephenson, director of the clinical trials unit in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.

“One of the questions that has come up is, What do you do if you’re a site investigator and you have 250 people banging on your door — and they’re all white?” she said.

Do you enroll those people, reasoning that the faster the trial progresses, the faster a vaccine will be available for everyone? Or do you turn away people and slow down the study?

“You’re accelerating development of a vaccine, and if you hit a milestone, what is the meaning of that milestone if you don’t know if it’s very safe or effective in [a given] population? Is that really hitting the milestone for everyone?” she said.

Including people who are elderly or have underlying medical conditions is vital to the science of vaccines and other treatments, even if it’s more difficult to recruit patients otherwise healthy enough to participate, advocates said.

“We have to admit that older adults are the ones who are likely to develop side effects” to treatments and vaccines, said Dr. Sharon Inouye, director of the Aging Brain Center and a professor of medicine at Harvard Medical School. “On the other hand, that is the population that will be using it.”

People with kidney disease, which affects 1 in 7 U.S. adults, have been left out of clinical research for decades, said Richard Knight, a transplant recipient and president of the American Association of Kidney Patients. Nearly 70% of more than 400 kidney disease patients the organization surveyed in July said they’d never been asked to join a clinical trial.

Excluding from the vaccine trial such a large population vulnerable to COVID doesn’t make sense, Knight contended. “If you’re trying to manage this from a public health standpoint, you want to make sure you’re inoculating your highest-risk populations,” he said.

New guidance from the federal Food and Drug Administration, which regulates vaccines, “strongly encourages” the inclusion of diverse populations in clinical vaccine development. That includes racial and ethnic minorities, elderly people and those with underlying medical problems, as well as pregnant women.

But the FDA does not require drugmakers and researchers to meet those goals, and will not refuse trial data that doesn’t comply. And while the federal government is rushing billions of dollars to fast-track more than a half-dozen leading candidates for COVID vaccines, the pharmaceutical firms producing them are not required to publicly disclose their demographic goals.

“This is business as usual,” said Marjorie Speers, executive director of Clinical Research Pathways, a nonprofit group in Atlanta that works to increase diversity in research. “It’s very likely these [COVID] trials will not include minorities because there’s not a strong statement to do that.”

The vaccine trials are being coordinated through the COVID-19 Prevention Network, or CoVPN, based at the Fred Hutchinson Cancer Research Center in Seattle. It draws on four long-standing federally funded clinical trial networks, including three that target HIV and AIDS.

Those trial networks were chosen in large part because they have rich relationships in Black, Latino and other minority communities, said Stephaun Wallace, director of external relations for CoVPN. The hope is to leverage existing connections based on trust and collaboration.

“Our clinical trial sites are prepped and ready to engage diverse people,” Wallace said.

Wallace acknowledged, however, that attracting a diverse population requires investigators to be flexible and innovative. There can be practical problems. Clinic hours may be limited or transportation may be an issue. Older people may have problems with sight or hearing and require extra help to follow protocols.

Distrust of the medical establishment also can be a barrier. African Americans, for instance, have a well-founded wariness of medical experiments after the infamous Tuskegee Study and the exploitation of Henrietta Lacks. That extends to suspicion about recommended vaccines, said Wallace.

“Part of the consideration for many groups is not wanting to feel like a guinea pig or feel like they’re being experimented on,” he said.

Moderna, which plans to launch its phase 3 trial Monday, said the company is working to ensure participants “are representative of the communities at highest risk for COVID-19 and of our diverse society.”

However, results of the company’s phase 1 trial, released in mid-July, showed that of 45 people included in that safety test, six were Hispanic, two were Black, one was Asian and one was Native American. Forty were white.

Phase 1 and phase 2 clinical trials aim to test the best dose and safety of vaccines in small groups of people. Phase 3 trials assess the efficacy of the drug in tens of thousands of people.

Investigators at nearly 90 sites across the U.S. are preparing now to recruit participants for Moderna’s phase 3 trial. Dr. Carlos del Rio, executive associate dean at the Emory University School of Medicine, will seek 750 volunteers at three Atlanta-area sites. Half will receive the vaccine; half, placebo injections.

Del Rio has had marked success recruiting minorities for HIV trials and expects similar results with the vaccine trial. “We’re trying to do our best to get out to the communities that are most at risk,” he said.

Meanwhile, vaccine volunteers like Cisneros just want the advanced trials to start. He signed up for the CoVPN trials. But earlier, he also signed up for 1 Day Sooner, an effort to launch human challenge trials, which aim to speed up vaccine development by deliberately infecting participants with the virus. Such trials can be completed in weeks rather than months but risk exposing volunteers to severe illness or death, and federal officials remain leery.

Cisneros is willing to take that risk to help halt COVID-19, which has killed 143,000 Americans. He said it’s a way to take action at a time when the U.S. government has failed to protect minorities, the elderly and other vulnerable people.

“Government is supposed to help those who can’t protect themselves,” he said. “It appears to me the only thing they want to protect is people with money, people with guns — and not brown people like me.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

COVID Runs Amok in 3 Detroit-Area Jails, Killing At Least 2 Doctors

When Diana Trueblood visited the Wayne County Jail’s medical unit in Detroit in early March, she encountered a gentle and kind physician, Dr. Angelo Patsalis.

Halfway through her incarceration for a probation violation, Trueblood remembered sitting “knee to knee” with Patsalis, who pulled down his face mask to speak to her about a tuberculosis skin test. She and other inmates were not provided with face masks, she said, and they pulled up their T-shirts to shield their mouths.

“He was blunt, but he was concerned about my health,” Trueblood said. In jail, usually, “they just don’t care.”

Trueblood and other inmates knew something serious was going on. Cramped in their cluttered cells, they tried to watch the news about the pandemic on “a little TV way up high,” she said. “But you could barely hear it … and we could just see their lips move. Most of what we found out was through our families.”

The jail system, they would learn, was at the center of a coronavirus outbreak.

Within four weeks of Trueblood’s first appointment with Patsalis, the doctor died of COVID-19. The coronavirus soon claimed another doctor, as well as the commander and a sheriff’s deputy at the Wayne County Sheriff’s Office (WCSO), a three-facility maximum-security jail system in the Detroit area for inmates charged with violent and nonviolent crimes.

Amid overcrowding and a shortage of personal protective equipment (PPE), at least 208 employees and 83 inmates have tested positive for COVID-19 at WCSO to date.

Public health experts have for months warned that U.S. jails and prisons face catastrophe. At least 100,000 people in U.S. jails and prisons have been infected, and almost 800 inmates and staffers have died, according to The New York Times.

Failures at the Detroit-area jails echo those in neighboring Oakland County and across the U.S., including facilities in Miami; the notorious Angola prison in Louisiana; and California’s San Quentin State Prison, where over 2,000 inmates have had the coronavirus and 10 have died.

Wayne County jails have long been in disrepair, with issues ranging from hot-water boilers in need of maintenance to black mold, rust, a recent failed fire inspection and reports of rats and cockroaches. Plans for upgrades have been delayed due to the pandemic.

The problems jails face are clear. First is “rapid turnover … of new detainees who could be infected,” said Dr. Fred Rottnek, a professor and the director of community medicine at St. Louis University, who inspected the three jails as part of a lawsuit lodged against WCSO over allegedly inadequate COVID-19 protections. In addition, “in both jails and prison settings, officers, medical staff and vendors can act like vectors, bringing the infection into the facility, or back out into the community, with each shift change.”

While touring the medical clinic, Rottnek witnessed two correctional officers sitting side by side without face masks. The officers later put them on once Rottnek introduced himself.

Detroit had its first confirmed case of COVID-19 on March 11. That same day, the WCSO jail commander, Donafay Collins, 63, became ill. He had attended an annual gathering of current and former WCSO employees at Bert’s Marketplace in Detroit almost a week earlier. A handful of other attendees also developed COVID-19.

Collins, the jail commander, died on March 25 followed by medical deputy Dean Savard on April 3.

The deputies’ union became concerned and criticized the jail system and county officials for downplaying the crisis, for lacking proper PPE for inmates and for neglecting social distancing requirements. Inmates even took to social media to voice concerns.

“The union called on everyone to be tested in the sheriff department,” said Reginald Crawford, the president of the Wayne County Deputy Sheriffs’ Association. “The deputies, the civilian employees, the doctors, the nurses and the inmates. We wanted all to be tested so we knew how to deal with this.”

Patsalis, the doctor, had trouble breathing and developed a terrible cough.

“The next thing I know [his fiancée] called me and said he was on a ventilator in a medically induced coma,” said his cousin John Patsalis.

Born in Detroit, Patsalis graduated from Wayne State University and the University of Ioannina Medical School in Greece. As a child, he often spent summers in Platsa, a village in southern Greece and the birthplace of his father, Nicholas Patsalis. As an adult, he loved to hunt and was dedicated to his Greek Orthodox faith, patients and family.

He had been working at the Wayne County jail system’s medical department for at least six years and was about to marry. “He was a wonderful and irreplaceable person,” his fiancée, Denise Bargon, told The Guardian. “He just put everything into being a doctor.”

Five days after being intubated, Angelo Patsalis died on April 6. He was three weeks away from celebrating his 64th birthday. His father, 86, died of COVID-19 two days after his only son.

Some inmates particularly vulnerable to COVID-19 because of health issues, or who were accused of nonviolent crimes, were released in order to ease the burden on the jails. Trueblood was one of them. They were not tested for the virus, however, and former inmate Michael Meshinski, who fell ill during his detainment, died at home days later from COVID-19.

On April 16, Patsalis’ colleague Dr. Richard Miles also died as a result of the coronavirus. Miles had been a doctor for 36 years. Before working in the jail system, he was a physician who helped elderly patients with complex health issues on home visits.

“With his knowledge and experience and his understanding of what these older, chronically ill patients were experiencing, he was doing his very best to help them deal with that,” said Michael Flannery, a social worker, recalling a time Miles telephoned him to discuss a patient, which few other doctors did. “He had a passion for home care and he had a passion for all his patients.”

Patsalis and Miles were both contract physicians employed by Wellpath, a controversial Nashville-based corporation that provides inmate health care. In an email to The Guardian, Judy Lilley, a Wellpath spokesperson, said the company followed the latest guidance from the Department of Public Health and the Centers for Disease Control and Prevention, “including numerous changes to training, policy and practice.”

Widespread testing of WCSO employees, which was essential in order to slow transmission, began on April 21. Testing for inmates began on May 7.

Several civil rights groups have sued Wayne County jails to obtain the immediate release of vulnerable inmates, and have alleged the jail is not providing adequate safeguards against the threat of the coronavirus, requesting the release of some unhealthy inmates, who would be fitted with GPS tethers. Nurses at the jail system recently spoke out about how staff shortages limit their ability to treat inmates, to the point that not all inmates are receiving their medications.

“I’m very confident that those allegations that were lodged in that lawsuit will prove to be untrue,” said Robert Dunlap, the chief of jails. “It is not indicative of the care, concern, commitment and compassion that the men and women of the Wayne County sheriff department have about the care and custody of human beings.”

Crawford, the head of the deputies’ union, said that most of all he wanted to know the full picture.

“All we want is transparency and truth. We want to know the truth because we can deal with the truth. Everyone needs to be transparent. And that’s not only Wayne County, everyone in government needs to tell everyone the truth. What are the real numbers? What are we really dealing with here?”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

Ever Heard of a Surgical Assistant? Meet a New Boost to Your Medical Bills

Izzy Benasso was playing a casual game of tennis with her father on a summer Saturday when she felt her knee pop. She had torn a meniscus, one of the friction-reducing pads in the knee, locking it in place at a 45-degree angle.

Although she suspected she had torn something, the 21-year-old senior at the University of Colorado in Boulder had to endure an anxious weekend in July 2019 until she could get an MRI that Monday.

“It was kind of emotional for her,” said her father, Steve Benasso. “Just sitting there thinking about all the things she wasn’t going to be able to do.”

At the UCHealth Steadman Hawkins Clinic Denver, the MRI confirmed the tear, and she was scheduled for surgery on Thursday. Her father, who works in human resources, told her exactly what to ask the clinic regarding her insurance coverage.

Steve had double-checked that the hospital; the surgeon, Dr. James Genuario; and Genuario’s clinic were in her Cigna health plan’s network.

“We were pretty conscious going into it,” he said.

Isabel met with Genuario’s physician assistant on Wednesday, and the following day underwent a successful meniscus repair operation.

“I had already gotten a ski pass at that point,” she said. “So that was depressing.” But she was heartened to hear that with time and rehab she would get back to her active lifestyle.

Then the letter arrived, portending of bills to come.

The Patient: Izzy Benasso, a 21-year-old college student covered by her mother’s Cigna health plan.

College student Izzy Benasso tore a meniscus in her knee while playing tennis with her father a year ago. The charges for her subsequent outpatient knee surgery totaled $96,377.(Rachel Woolf for KHN)

The Total Bill: $96,377 for the surgery was billed by the hospital, Sky Ridge Medical Center in Lone Tree, Colorado, part of HealthONE, a division of the for-profit hospital chain HCA. It accepted a $3,216.60 payment from the insurance company, as well as $357.40 from the Benassos, as payment in full. The surgical assistant billed separately for $1,167.

Service Provider: Eric Griffith, a surgical assistant who works as an independent contractor.

Medical Service: Outpatient arthroscopic meniscus repair surgery.

What Gives: The Benassos had stumbled into a growing trend in health care: third-party surgical assistants who aren’t part of a hospital staff or a surgeon’s practice. They tend to stay out-of-network with health plans, either accepting what a health plan will pay them or billing the patient directly. That, in turn, is leading to many surprise bills.

Even before any other medical bills showed up, Izzy received a notice from someone whose name she didn’t recognize.

“I’m writing this letter as a courtesy to remind you of my presence during your surgery,” the letter read.

It came from Eric Griffith, a Denver-based surgical assistant. He went on to write that he had submitted a claim to her health plan requesting payment for his services, but that it was too early to know whether the plan would cover his fee. It didn’t talk dollars and cents.

Steve Benasso said he was perplexed by the letter’s meaning, adding: “We had never read or heard of anything like that before.”

Surgical assistants serve as an extra set of hands for surgeons, allowing them to concentrate on the technical aspects of the surgery. Oftentimes other surgeons or physician assistants — or, in teaching hospitals, medical residents or surgical fellows — fill that role at no extra charge. But some doctors rely on certified surgical assistants, who generally have an undergraduate science degree, complete a 12- to 24-month training program, and then pass a certification exam.

Surgeons generally decide when they need surgical assistants, although the Centers for Medicare & Medicaid Services maintains lists of procedures for which a surgical assistant can and cannot bill. Meniscus repair is on the list of allowed procedures.

A Sky Ridge spokesperson said that it is the responsibility of the surgeon to preauthorize the use and payment of a surgical assistant during outpatient surgery, and that HealthOne hospitals do not hire surgical assistants. Neither the assistant nor the surgeon works directly for the hospital. UC School of Medicine, the surgeon’s employer, declined requests for comment from Genuario.

Steve Benasso says he was perplexed after receiving a letter from the surgical assistant who was in the operating room during daughter Izzy Benasso’s knee surgery. The letter, from Eric Griffith, a Denver-based surgical assistant, stated it was “a courtesy to remind you of my presence” during Izzy’s surgery. “We had never read or heard of anything like that before,” Steve says.(Rachel Woolf for KHN)

Karen Ludwig, executive director of the Association of Surgical Assistants, estimates that 75% of certified surgical assistants are employed by hospitals, while the rest are independent contractors or work for surgical assistant groups.

“We’re seeing more of the third parties,” said Dr. Karan Chhabra, a surgeon and health policy researcher at the University of Michigan Medical School. “This is an emerging area of business.”

And it can be lucrative: Some of the larger surgical assistant companies are backed by private equity investment. Private equity firms often target segments of the health care system where patients have little choice in who provides their care. Indeed, under anesthesia for surgery, patients are often unaware the assistants are in the operating room. The private equity business models include keeping such helpers out-of-network so they can bill patients for larger amounts than they could negotiate from insurance companies.

Surgical assistants counter that many insurance plans are unwilling to contract with them.

“They’re not interested,” said Luis Aragon, a Chicago-area surgical assistant and managing director of American Surgical Professionals, a private equity-backed group in Houston.

Chhabra and his colleagues at the University of Michigan recently found that 1 in 5 privately insured patients undergoing surgery by in-network doctors at in-network facilities still receive a surprise out-of-network bill. Of those, 37% are from surgical assistants, tied with anesthesiologists as the most frequent offenders. The researchers found 13% of arthroscopic meniscal repairs resulted in surprise bills, at an average of $1,591 per bill.

Colorado has surprise billing protections for consumers like the Benassos who have state-regulated health plans. But state protections don’t apply to the 61% of American workers who have self-funded employer plans. Colorado Consumer Health Initiative, which helps consumers dispute surprise bills, has seen a lot of cases involving surgical assistants, said Adam Fox, director of strategic engagement.

Izzy Benasso shows her scar from the surgery she had to repair a torn meniscus.(Rachel Woolf for KHN)

Resolution: Initially, the Benassos ignored the missive. Izzy didn’t recall meeting Griffith or being told a surgical assistant would be involved in her case.

But a month and a half later, when Steve logged on to check his daughter’s explanation of benefits, he saw that Griffith had billed the plan for $1,167. Cigna had not paid any of it.

Realizing then that the assistant was likely out-of-network, Steve sent him a letter saying “we had no intention of paying.”

Griffith declined to comment on the specifics of the Benasso case but said he sends letters to every patient so no one is surprised when he submits a claim.

“With all the different people talking to you in pre-op, and the stress of surgery, even if we do meet, they may forget who I was or that I was even there,” he said. “So the intention of the letter is just to say, ‘Hey, I was part of your surgery.’”

After KHN inquired, Cigna officials reviewed the case and Genuario’s operative report, determined that the services of an assistant surgeon were appropriate for the procedure and approved Griffith’s claim. Because Griffith was an out-of-network provider, Cigna applied his fee to Benasso’s $2,000 outpatient deductible. The Benassos have not received a bill for that fee.

Griffith says insurers often require more information before determining whether to pay for a surgical assistant’s services. If the plan pays anything, he accepts that as payment in full. If the plan pays nothing, Griffith usually bills the patient.

The Takeaway: As hospitals across the country restart elective surgeries, patients should be aware of this common pitfall.

Chhabra said he’s hearing more anecdotal reports about insurance plans simply not paying for surgical assistants, which leaves the patient stuck with the bill.

Chhabra said patients should ask their surgeons before surgery whether an assistant will be involved and whether that assistant is in-network.

“There are definitely situations where you need another set of hands to make sure the patient gets the best care possible,” he said. But “having a third party that is intentionally out-of-network or having a colleague who’s a surgeon who’s out-of-network, those are the situations that don’t really make a lot of financial or ethical sense.”

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

from Health Industry – Kaiser Health News

Another Problem on the Health Horizon: Medicare Is Running Out of Money

Everyone involved even tangentially in health care today is completely consumed by the coronavirus pandemic, as they should be. But the pandemic is accelerating a problem that used to be front and center in health circles: the impending insolvency of Medicare.

With record numbers of Americans out of work, fewer payroll taxes are rolling in to fund Medicare spending, the numbers of beneficiaries are rising, and Congress dipped into Medicare’s reserves to help fund the COVID-19 relief efforts this spring.

“I think we have a real, impending health care crisis,” said Dr. David Shulkin, who was undersecretary for health at the Department of Veterans Affairs under President Barack Obama for two years and led the VA for a year under Donald Trump.

In April, Medicare’s trustees reported that the Part A Trust Fund, which pays for hospital and other inpatient care, would start to run out of money in 2026. That is the same as the projection in 2019. But the trustees cautioned at the time that their projections did not include the impact of COVID-19 on the trust fund.

“Given the uncertainty associated with these impacts, the Trustees believe that it is not possible to adjust the estimates accurately at this time,” said the report.

So Shulkin, now a senior fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania, did his own projections. Given even a conservative estimate of how many workers and businesses would not be contributing payroll taxes that finance Part A spending, he said, the trust fund could become insolvent as early as 2022 or 2023.

“I think this is something that needs more immediate attention,” he said.

Others who make projections agree the insolvency date is getting closer, maybe not as close as 2022.

The Committee for a Responsible Federal Budget, a nonpartisan group of budget experts focused on fiscal policy, estimates that the pandemic will cause the Part A Trust Fund to be unable to pay all of its bills starting in late 2023 or early 2024. “But we’re still very close,” said Marc Goldwein, the group’s senior vice president.

There are two ways the Trust Fund can get into trouble: Either the money flowing in is too little, or the payments going out for care are too much.

Most of those who watch Medicare finances agree that the larger problem right now is how much money is being collected for the Trust Fund. That money largely comes from the 1.45% payroll tax paid by employees and employers. With so many people out of work due to pandemic-related shutdowns, cash flowing in has dropped dramatically.

It’s far less clear what is happening on the spending side of Medicare Part A. (Medicare Part B, which pays physicians and other outpatient costs, is funded by beneficiary premiums and general tax funding, so it cannot technically become insolvent.)

While COVID-related hospital expenses for those on Medicare are expected to be substantial, Medicare hasn’t been reimbursing as much care of other sorts. In some cases, that’s because hospitals in COVID hot spots temporarily stopped doing elective procedures like joint replacements. In other cases, patients with non-COVID ailments have been afraid to go to hospitals for fear of catching the virus.

Also, said Goldwein, health care use tends to fall in recessions, even for Medicare, whose beneficiaries are largely retired.

In the end, he said, “we basically threw our hands up and said we don’t have the information” to estimate how health costs will affect the Trust Fund’s financing.

There is one other COVID-related policy that could hasten the depletion of the Trust Fund. At least $60 billion of the funding provided as part of the CARES Act to help hospitals weather the pandemic came not from the general treasury, but from the Trust Fund itself.

That money in “accelerated and advance payments” is supposed to be paid back, via a reduction in future payments. But there is a push in some quarters for that funding to be forgiven, which would make the Trust Fund’s hole even bigger.

It is not exactly clear what would happen if the Trust Fund were to become insolvent because it has never happened before. As the Congressional Research Service pointed out, “There are no provisions in the Social Security Act that govern what would happen if insolvency were to occur.”

It is important to remember that the fund becoming insolvent is not the same as being bankrupt. Insolvent means the Trust Fund would still have money flowing in, but not enough to pay for all the care Medicare patients will consume.

Most budget experts think that Medicare would reimburse hospitals and other Part A providers 100% of their claims until the fund truly runs out of money. Then it would pay claims only as more money flows in. Others think Medicare might reimburse only a percentage of those claims, but that might require congressional action.

Meanwhile, one would expect the hospital industry to be ringing the alarm bells as potential insolvency approaches. But that’s not happening.

“They’re more concerned with next month than with 2023 at this point,” said Goldwein.

Chip Kahn, president and CEO of the Federation of American Hospitals, agreed. “I’m not going to worry about this right this minute,” he said. “At this point, my focus is completely on COVID.”

from Health Industry – Kaiser Health News

Watch: COVID Patients and Families Battle to Get Benefits

As COVID cases in the U.S. continue to soar, health care workers on the front lines are increasingly getting sick and even dying of the disease. KHN’s Christina Jewett and Hari Sreenivasan of PBS NewsHour discuss what often happens and how some employers evade paying benefits.

from Health Industry – Kaiser Health News

For COVID Tests, the Question of Who Pays Comes Down to Interpretation

In advance of an upcoming road trip with her elderly parents, Wendy Epstein’s physician agreed it would be “prudent” for her and her kids to get tested for COVID-19.

Seeing the tests as a “medical need,” the doctor said insurance would likely pay for them, with no out-of-pocket cost to Epstein. But her children’s pediatrician said the test would count as a screening test — since the children were not showing symptoms — and she would probably have to foot the bill herself.

It made no sense. “That’s two different responses for the exact same scenario,” said Epstein, a health law professor at DePaul University in Chicago, who deferred the tests as she clarified the options.

Early on in the coronavirus pandemic — when scarce COVID testing was limited to those with serious symptoms or serious exposure — the government and insurers vowed that tests would be dispensed for free (with no copays, deductibles or other out-of-pocket expense) to ensure that those in need had ready access.

Now, those promises are being rolled back in ways that are creating turmoil for consumers, even as testing has become more plentiful and more people — like Epstein — are being advised to get them.

Late last month, the Trump administration issued guidance saying insurers had to waive patient costs only for “medically appropriate” tests “primarily intended for individualized diagnosis or treatment of COVID-19.” It made clear that insurers do not have to fully waive cost sharing for screening tests, even when required for employees returning to work or for assisting in public health surveillance efforts.

Left unclear are situations like that faced by Epstein — and others who seek a test to clear a child for summer camp or day care. Public health officials have been unanimous in the opinion that widespread, readily available testing is crucial for getting businesses and schools open again, and society back on its feet.

But who should bear the costs of that testing — or a share of them — is an unresolved question.

Who pays when all employees are required to have a negative COVID test in order to return to work? Or if a factory tests workers every two weeks? Or just because someone wants to know for their own peace of mind?

The questions may be compounded in some cities and states where tests are widely available at clinics or drive-thru centers. In New York, CityMD clinics bill insurers $300 for the service, according to an explanation-of-benefits document given to KHN by a patient. The related charge from the lab that processed the test, according to the same patient’s insurance statement, was $55. Most patients don’t have to pay a share of those amounts.

The clinic has a partnership with the city allowing anyone who wants a test for the virus to get one. Still, no test is truly free, as labs bill insurers or submit for reimbursement from government programs.

Until a recent spike in virus cases created long delays in many areas, some other regions also took a test-everyone-who-wants-a-test approach. While that is one way to get a picture of where the virus is spreading, it can also become a cash cow providing income to clinics and labs, as residents seek multiple “free” tests after each potential exposure.

In an email, a spokesperson for CityMD would not say how much the clinic is reimbursed for testing. The clinics do not bill for lab testing, she wrote, referring questions about those costs to the laboratories that process them.

Insurers will be making judgment calls — likely on a case-by-case basis — about how they will handle cost sharing for screening tests under the new Trump administration guidance.

What is clear: Insurers have argued against requirements that they waive all cost sharing for workplace COVID testing, noting they don’t do that for other screening efforts, such as drug-testing programs. For now, insurers will “continue to pay for tests recommended by a doctor,” Kristine Grow, spokesperson for AHIP, an industry group, wrote in an email to KHN.

But AHIP also sent a clear signal that it would not embrace cost sharing waivers for workplace or public health screening efforts. Earlier this month, the organization lobbied federal lawmakers to include funding in the next stimulus package for public health surveillance and workplace testing programs — a cost estimated between $6 billion and $25 billion annually in an earlier study commissioned by the group.

The Evolving Rules for Free Testing

The coronavirus relief legislation passed by Congress in March, and April guidance from the Trump administration implementing it, agreed that patients should not be burdened with payments for COVID testing and treatment that is “medically appropriate.”

But as the pandemic has evolved and grown, the definition of that term has both broadened and become fuzzier.

The Centers for Disease Control and Prevention says testing is appropriate for people who fall into five broad categories, including those with suspected exposure and those required to be tested for “purposes of public health surveillance,” which it defines as checking for disease hot spots or trends.

“There’s definitely a disconnect between what public health experts are recommending for testing and how it’s going to be paid for,” said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.

And tension is mounting among insurers, employers and consumers over who should pay. While insurers say employers should cover the cost for back-to-work testing, many employers are struggling financially and may not be able to do so. At the same time, workers, especially those in lower-wage jobs, also cannot afford out-of-pocket costs for testing, particularly if it is required regularly.

Among those waiting to hear if their insurance will cover the test is Enna Allen of Glencoe, Illinois, who urged her au pair to get a test after the young woman traveled to New Orleans. She had been on a plane, after all, and New Orleans has its share of COVID cases.

“I wanted her to have a test before she returned to work with my kids,” said Allen.

As Allen called around to find a testing site, she explained the test was needed for employment — for someone with no symptoms. After some effort, she found a clinic that, for $275, offered a 15-minute rapid test and said it would accept her au pair’s insurance.

“I’m assuming they [the insurer] will cover it unless I get a bill weeks from now,” said Allen, who said she would pay the bill for her employee if that happens.

There is also a great gray area in deciding who should qualify for free testing after “suspected” exposure. What is suspected exposure? Sharing a small office with an infected co-worker? Participating in a protest? Or simply living in or visiting the Sun Belt, where community spread is accelerating?

“If the au pair went to a clinic and said she was just in New Orleans, and the doctor said that’s enough of a risk to order a test, even though she doesn’t have symptoms, my read of the guidance is the health plan has to cover it 100%,” said Corlette.

Yet a child who’s mainly been sheltering at home who needs a test before being admitted to summer camp probably would not meet the definition.

“That’s a different story because it’s harder to argue there’s been exposure or potential exposure,” said Corlette. “At the end of the day, there’s many ways to interpret the guidance.”

Congressional Democrats have accused the Trump administration in its new guidance of “giving insurance companies loopholes instead of getting people the free testing they need.”

Insurers, patients and politicians have locked horns before when screening tests were billed differently than those same tests for diagnostic purposes, since the boundary is often unclear. Under the Affordable Care Act, for example, colonoscopy screening for cancer is “free,” meaning no patient copayment. But if a polyp is found, doctors sometimes code the procedure as a diagnostic test, which can lead to hundreds or even thousands of dollars in copayments.

While vital, testing is costly — or can be. Medicare reimburses up to $100 for the COVID test. On top of that, there may also be costs associated with the office or clinic visit. And the price is widely variable in the private market, according to a report out last week by KFF, the Kaiser Family Foundation. Prices ranged from $20 to $850 for a single test. (KHN is an editorially independent program of the foundation.)

Media reports have shown tests average $100, but some labs bill insurers for thousands of dollars for each one.

Without a copay, many patients never learn how much their tests actually cost their insurers, which could lead to overuse.

Also, when patients are entirely shielded from the cost, test makers, labs and medical providers are more likely to seek price increases, said Heather Meade, a principal at Washington Council Ernst & Young.

In the end, consumers may still feel a resulting pinch in the form of higher premiums.

Wondering about the sharply different views of her doctors on whether her insurance would fully cover the cost, law professor Epstein called her insurer, which assured her the tests would be covered 100% at in-network providers with no copay or deductible, as long as they were coded correctly. The family will be tested soon, and it appears she’s dodged a financial bullet. But Epstein cautioned in an email: “It’s unclear to me how many insurers will maintain this policy.”

from Health Industry – Kaiser Health News

Must-Reads of the Week

While you, loyal reader, wait for a wonderful new permanent Friday Breeze writer to start breezing, welcome to this week’s rundown brought to you from St. Louis by me, Midwest correspondent Lauren Weber.

I’m sadly here to inform you the news is … still bad. So bad, in fact, that “doomscrolling” — the act of not being able to escape your smartphone feed of misery — was examined by The New York Times.

And that’s because all you need to know about the current state of the coronavirus can be aptly summed up in renowned infectious disease reporter Helen Branswell’s latest piece for Stat, titled “How to Fix the Covid-19 Dumpster Fire in the U.S.”

The Week’s Latest

But to be more precise: New coronavirus cases in the U.S. shattered a single-day record with over 75,000 Thursday. That number of daily cases has more than doubled since June 24. Deaths from COVID-19 are rising yet again while hot spots across the Sun Belt continue to flare. The Center for Public Integrity uncovered an unreleased federal document saying 18 states are in the “red zone” for COVID-19 cases and should consider stricter protective measures.

And as outbreaks strain lab capacity nationwide, some people are waiting seven or more days to get test results, hobbling potential containment responses. Now, the CDC is urging people to not be retested.

Masks, Schools and Tony Fauci

Mass mask confusion continued to drive the week, with Georgia Gov. Brian Kemp suing Atlanta Mayor Keisha Lance Bottoms over her mandatory mask order. Later, he urged all citizens to wear masks for four weeks — but said he would not support a mandate. Meanwhile, Georgia hospital workers are sounding the alarm and attempting to send patients out of state as hospitals fill up. Across the country, more than half of states have issued mandatory mask orders at this time. And this detailed map of just who is wearing masks in the U.S. is worth your time.

The sharp divide over back-to-school plans for those in public and private school came into focus (private schools have the money to hire their own epidemiologists!), all while Bloomberg reported the percentage of cases of children and teens with COVID-19 is on the rise. The Centers for Disease Control and Prevention postponed releasing further guidance on how students could safely return to school this week. That follows previous complaints from President Donald Trump, who said on Twitter the CDC’s initial recommendations were too tough. Or, as White House press secretary Kayleigh McEnany said Thursday, “The science should not stand in the way of this.”

The big distraction of the week had to be the attacks on the reputation of America’s favorite scientist, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. He withstood a White House attack on his credibility, led by Peter Navarro, Trump’s trade adviser, in an op-ed in USA Today — one that USA Today has since said “did not meet its fact-checking standards.” To his credit, Fauci called to “stop this nonsense” and focus on the coronavirus. For more of a deep dive on the ongoing fireworks, check out this week’s amazing-as-usual episode of KHN’s “What the Health?” podcast. And never forget that Fauci did manage to sneak in this InStyle digital cover with some killer shades and he read a college kid’s thesis on the side during his tenure.

Speaking of op-eds, here’s one worth reading. Larry Hogan, Maryland’s Republican governor, an op-ed about how he felt the Trump administration left his state to fend for itself amid the pandemic. Best part: how he and his wife, who was born and raised in South Korea, were able to secure half a million tests by going outside of the federal response, tapping into her contacts and then protecting them from the feds with the state National Guard.

The disappearance of public data from the CDC website created another firestorm this week. While the data has been restored, it’s another chapter in the saga of tension among the CDC, the administration and public access.

Pocket Change

The insurer UnitedHealthcare posted its most profitable quarter — EVER — proving that, yes, you can get rich during the pandemic. Meanwhile, hospitals face the harsh reality of a surge colliding with their plans to resume profitable elective surgery.

And, no, you won’t be getting on a cruise ship anytime soon — the “no sail” order from the CDC has been extended through September 2020.

Long Reads and Graphics Worth Your Time

Racial inequities in COVID exposure, treatment and care persist at every level, as this piece zeroing in on East St. Louis shows. And this week, over 1,000 employees of the CDC sent a letter to its head calling out systemic racism within the agency.

I still can’t stop thinking about this profile of Lorna Breen, an ER doc who took her own life after becoming overwhelmed not only by the coronavirus crisis but by an exacting medical culture.

These New York Times graphics stress how drug overdose deaths hit a new high in 2019 — many worry the coronavirus is exacerbating their continued rise.

Finally, What’s Abuzz

In case you didn’t have anything else to worry about, mosquitoes are flying into the blind spots of health departments overwhelmed with COVID-19. The CDC is buzzing with concern, as Anna Maria Barry-Jester and I reported yesterday as part of our Underfunded and Under Threat series with the AP.

And for a speed round, these guys tried really hard to hand out free masks at Huntington Beach, California; the inside tale of how a Qatari prince had USC at his beckoning takes many a turn; and you just may have been using hand sanitizer wrong this whole time.

Try to lay off the booze, folks — experts say it’s only supposed to be a drink a day. Also maybe, just maybe, think about staying away from the bars altogether.

If we have a football season — a big IF — here’s what the “mouth shield” helmets would look like.

Plus superhero heartthrob Henry Cavill somehow spent his quarantine staying swole AND learning how to build computers?

But our favorite British superhero might just be Tom Moore, newly knighted by Queen Elizabeth II. The centenarian captured the world’s heart after raising millions for British health care workers by walking laps in his garden with his walker.

from Health Industry – Kaiser Health News

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