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Antibody Tests Were Hailed As Way To End Lockdowns. Instead, They Cause Confusion.

Aspen was an early COVID-19 hot spot in Colorado, with a cluster of cases in March linked to tourists visiting for its world-famous skiing. Tests were in short supply, making it difficult to know how the virus was spreading.

So in April, when the Pitkin County Public Health Department announced it had obtained 1,000 COVID-19 antibody tests that it would offer residents at no charge, it seemed like an exciting opportunity to evaluate the efforts underway to stop the spread of the virus.

“This test will allow us to get the epidemiological data that we’ve been looking for,” Aspen Ambulance District director Gabe Muething said during an April 9 community meeting held online.

However, the plan soon fell apart amid questions about the reliability of the test from Aytu BioScience. Other ski towns such as Telluride, Colorado, and Jackson, Wyoming, as well as the less wealthy border community of Laredo, Texas, were also drawn to antibody testing to inform decisions about how to exit lockdown. But they, too, determined the tests weren’t living up to their promise.

The allure of antibody tests is understandable. Although they can’t find active cases of COVID-19, they can identify people who previously have been infected with the coronavirus that causes the disease, which could give health officials important epidemiological information about how widely it has spread in a community and the extent of asymptomatic cases. In theory, at least, antibodies would be present in such people whether they had a severe case, little more than a dry cough or no complaints at all.

Even more enticing: These tests were billed as a path to restart local economies by identifying people who might be immune to the virus and could therefore safely return to the public sphere.

But, in these and other communities, testing programs initially slated to test hundreds or thousands have been scaled back or put on hold.

“I don’t think these tests are ready for clinical use yet,” said University of California-San Francisco immunologist Dr. Alexander Marson, who has studied their reliability. He and his team vetted 12 different antibody tests and found all but one turned up false positives — implying that someone had antibodies when they didn’t ― with false-positive rates reaching as high as 16%. (The study is preliminary and has not been peer-reviewed yet.)

More than 100 antibody tests are currently available in the U.S., including offerings by commercial labs, academic centers and small entrepreneurial ventures. As serious questions emerged earlier this month about the accuracy of the tests and the usefulness of the results, the U.S. Food and Drug Administration said it will require companies to submit validation data on their products and apply for emergency-use authorizations for their products. (Previously, companies were allowed to sell their tests without review from the FDA, as long as they did their own validation and included a disclaimer.) And the American Medical Association said on May 14 that the tests should not be used to assess an individual’s immunity or when to end physical distancing.

And this week, the Centers for Disease Control and Prevention released new guidelines warning that antibody test results can have high false positive rates and should not be used to make decisions about returning people to work, schools, dorms or other places where people congregate.

Once hailed as a solution, the current crop of tests, which have not been thoroughly vetted by any regulatory agency, now seem more likely to add chaos and uncertainty to a situation already fraught with anxiety. “To give people a false sense of security has a lot of danger right now,” said Dr. Travis Riddell, the health officer for Teton County, which includes Jackson, Wyoming.

Accuracy Questions Raised

The gold standard for confirming an active COVID-19 infection is to take a swab from the nasopharynx and test it for the presence of viral RNA. The antibody tests instead parse the blood for antibodies against the COVID-19 virus. It takes time for an infected person to produce antibodies, so these tests can’t diagnose an ongoing infection, only indicate that a person has encountered the virus.

In Aspen, county officials knew the FDA had not approved the Aytu BioScience test, which the Colorado-based company was importing from China. So they first conducted their own validation tests, said Bill Linn, spokesperson for the Pitkin County Incident Management Team. “We weren’t reassured enough by our own testing to feel like we should move ahead.”

In Laredo, officials had been told by one of the community members helping to arrange the purchase of 20,000 tests from the Chinese company Anhui DeepBlue Medical Technology that they were FDA-approved, but the city’s own validation trials revealed only about a 20% accuracy rate, said Laredo spokesperson Rafael Benavides. Before Laredo could pay for the tests, Benavides said, an arm of U.S. Immigration and Customs Enforcement seized them and launched an investigation.

Neither Anhui DeepBlue Medical Technology, nor Aytu returned requests for comment.

In March, Covaxx, a company led by two part-time Telluride residents, offered to test residents of the town and the surrounding county with an antibody test it had developed. But the project was suspended indefinitely when the company’s testing facility fell behind on processing them.

The county is committed to doing a second round of testing but is evaluating how to proceed, said San Miguel County spokesperson Susan Lilly. “The question is how do you target it to be the most relevant clinically and for the public health team’s decision-making moving forward?”

Officials Back Off, Community Members Step In

On May 4, the FDA updated its antibody test policy to require that manufacturers submit validation data, but it is still allowing the tests to be sold without the normal lengthy vetting and approval process, which includes demonstrating safety and effectiveness.

In some wealthy areas, government officials had been offering free tests from startups with local investors. In Jackson, for example, a venture capitalist with an investment in Covaxx, the test used in Telluride, offered to help the city obtain 1,000 tests. But after reviewing the offer, Teton County declined over concerns about the test’s accuracy. “If a person tests positive, what does that mean? And is that useful information? We just don’t know yet,” Riddell said.

Covaxx spokesperson John Schaefer said in a statement that the test had been validated on more than 900 blood samples and is being reviewed by the FDA.

After Teton County officials decided against community antibody testing, a private nonprofit, Test Teton Now, sprung up to provide free COVID-19 antibody testing using the Covaxx test for roughly 8,000 people, about a third of the county’s residents. As of May 22, they’d raised $396,000 and tested 843 samples. The group has “done a lot” to verify the Covaxx tests, said Test Teton Now president Shaun Andrikopoulos. “I don’t want to call it validation, because we didn’t go through an independent review board, but we have sent our samples out to other labs.”

Organizers of Test Teton Now don’t share others’ concerns about the test’s utility. “We don’t encourage people to make any decisions about what they’re going to do or how they’re going to behave based on the results,” said the nonprofit’s spokesperson, Jennifer Ford.

What good is a test that can’t be used for practical purposes? “We think knowledge is power, and data is the beginning of knowledge,” Ford said. But unreliable data doesn’t give knowledge, it gives an illusion of knowledge.

So many unknowns remain, and false data may be worse than none. Even a very accurate test will produce a large number of false positives when used in a population where few people have been infected. If only 4% of people have actually been infected, a test with 95% accuracy would produce nine positive results for every 100 tests, five of which are false positives.

And that creates a danger that the tests could lead people to incorrectly think that they have antibodies that make them immune, which could have disastrous consequences if they changed their behavior as a result. Consider, for example, a person falsely told she had antibodies going to work at a nursing home, believing she couldn’t catch or spread the virus to anyone.

It’s not even known for sure that having antibodies makes someone immune. Researchers are hopeful that exposure can confer some level of immunity, but how strong that immunity might be and how long it might last remain unknown, said Harvard epidemiologist Marc Lipsitch.

So, having been burned once, Aspen has put antibody testing on hold and is instead focusing on identifying and isolating people who are sick or at risk of becoming so. “It’s actually a step back to where we started,” Linn said.

Given the remaining unknowns about immunity and COVID-19, the best methods for addressing the pandemic in communities may be the most time-tested ones, Linn said. “Put the sick people in places where they can’t get anyone else sick. It’s the bread and butter of epidemiology.”

from Health Industry – Kaiser Health News

Pharma Cash To Congress

Every year, pharmaceutical companies contribute millions of dollars to U.S. senators and representatives as part of a multipronged effort to influence health care lawmaking and spending priorities. Use this tool to explore the sizable role drugmakers play in the campaign finance system, where many industries seek to influence Congress. Discover which lawmakers rake in the most money (or the least) and which pharma companies are the biggest contributors. Or use our search tool to look up members of Congress by name or home state, as well as dozens of drugmakers that KHN tracks.

Methodology

Kaiser Health News uses campaign finance reports from the Federal Election Commission (FEC) to track donations from political action committees (PACs) registered with the FEC by pharmaceutical companies. Totals include donations to the principal campaign committees and leadership PACs for current members of Congress. We include only donations to members for election cycles in which they hold office (even if they weren’t in office for the full cycle, in the case of special elections). Donations are assigned to the quarter in which they were given, regardless of when they are reported by the receiving committee or PAC. Exact amounts can change as amendments and refunds are reported; KHN will update the analysis quarterly. Occasionally, refunds are reported in a different cycle from the original contribution, resulting in a negative total for the cycle.

There is a legal limit to how much each PAC can give to a member of the Senate or House of Representatives: $5,000 per election (including primaries and general elections) and per committee, or $10,000 per cycle. Each cycle is two calendar years, e.g. Jan. 1, 2017-Dec. 31, 2018.

When calculating changes in contributions from one cycle to another, we compare the latest quarter in the current cycle to the same point in the previous cycle for all drugmakers and for members of the House, who run for re-election every two years. For senators, who run for re-election every six years, we compare the current cycle to the cycle six years prior. We use the ProPublica Congress API to gather some information about past and present members. We use both Open Secrets and CQ Political Moneyline to collect additional information about PACs and verify our work.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

from Health Industry – Kaiser Health News

COVID-Like Cough Sent Him To ER — Where He Got A $3,278 Bill

From late March into April, Timothy Regan had severe coughing fits several times a day that often left him out of breath. He had a periodic low-grade fever, too.

Wondering if he had COVID-19, Regan called a nurse hotline run by Denver Health, a large public health system in his city. A nurse listened to him describe his symptoms and told him to immediately go to the hospital system’s urgent care facility.

When he arrived at Denver Health — where the emergency room and urgent care facility sit side by side at its main location downtown — a nurse directed him to the ER after he noted chest pain as one of his symptoms.

Regan was seen quickly and given a chest X-ray and electrocardiogram, known as an EKG, to check his lungs and heart. Both were normal. A doctor prescribed an inhaler to help his breathing and told him he might have bronchitis. The doctor advised that he had to presume he had COVID-19 and must quarantine at home for two weeks. At the time, on April 3, Denver Health reserved COVID tests for sicker patients. Two hours after arriving at the hospital, Regan was back home. His longest wait was for his inhaler prescription to be filled.

Regan wasn’t concerned just about his own health. His wife, Elissa, who is expecting their second child in August, and their 1-year-old son, Finn, also felt sick with COVID-like symptoms in April. “Nothing terrible, but enough to make me worry,” he said.

When Timothy had coughing fits and a low-grade fever from late March into April, his COVID-19 worries weren’t only about himself. He was also concerned for his pregnant wife, Elissa, and their 1-year-old, Finn, both of whom also felt sick with COVID symptoms in April.(Ethan Welty for KHN)

Regan, who is an estimator for a construction firm, worked throughout his sickness — including while quarantined at home. (Construction in Colorado and many states has been considered an essential business and has continued to operate.) Regan said he was worried about taking a day off and losing his job.

“I was thinking I had to make all the money I could in case we all had to be hospitalized,” he said. “All I could do was keep working in hopes that everything would be OK.”

Within a couple of weeks, the whole family, indeed, was OK. “We got lucky,” Elissa said.

Then the bill came.

The Patient: Timothy Regan, 40, an estimator for a construction company. The family has health insurance through Elissa’s job at a nonprofit in Denver.

Total Bill: Denver Health billed Regan $3,278 for the ER visit. His insurer paid $1,042, leaving Regan with $2,236 to pay based on his $3,500 in-network deductible. The biggest part of the bill was the $2,921 general ER fee.

Service Provider: Denver Health, a large public health system

Medical Service: Regan was evaluated in the emergency room for COVID-like symptoms, including a severe cough, fever and chest pain. He was given several tests to check his heart and lungs, prescribed an inhaler and sent home.

What Gives: When patients use hospital emergency rooms — even for short visits with few tests — it’s not unusual for them to get billed thousands of dollars no matter how minor the treatment received. Hospitals say the high fees come from having to staff the ER with specialists 24 hours a day and keep lifesaving equipment up to date.

Denver Health coded Timothy’s ER visit as a Level 4 — the second-highest and second-most expensive — on a 5-point scale. The other items on his bill were $225 for the EKG, $126 for the chest X-ray and $6 for his albuterol inhaler, a medication that provides quick relief for breathing problems.

The Regans knew they had a high deductible and they try to avoid unnecessarily using the ER. But, with physician offices not seeing patients with COVID-type symptoms in April, Timothy said he had little choice when Denver Health directed him first to the urgent care, then to its ER. “I felt bad, but I had been dealing with it for a while,” he said.

Elissa said they were trying hard to do everything by the book, including using a health provider in their plan’s network.

“We did not anticipate being hit with such a huge bill for the visit,” Elissa said. “We had intentionally called the nurse’s line trying to be responsible, but that did not work.”

In an effort to remove barriers from people getting tested and evaluated for COVID-19, UnitedHealthcare is one of many insurers that announced it will waive cost sharing for COVID-19 testing-related visits and treatment. But it is not clear how many people who had COVID symptoms but did not get tested when tests were in short supply have been billed as the Regans were.

Timothy and Elissa try to avoid needlessly visiting the ER because of their high-deductible insurance plan, they say. Denver Health billed $3,278 for Timothy’s ER visit, leaving the Regans with a $2,236 tab based on their $3,500 in-network deductible. UnitedHealthcare officials reviewed his case at the request of KHN, and waived the couple’s cost sharing for the visit.(Ethan Welty for KHN)

Resolution: A Denver Health spokesperson said Regan was not tested for COVID because he was not admitted and did not have risk factors such as diabetes, heart disease or asthma. He was not billed as a COVID patient because he was not tested for the virus. The medical center has since expanded its testing capacity, the spokesperson said.

UnitedHealthcare officials reviewed Regan’s case at the request of KHN. Based on Regan’s symptoms and the tests performed, Denver Health should have billed them using a COVID billing code, an insurer spokesperson said. “We reprocessed Mr. Regan’s original claims after reviewing the services that he received,” a United Healthcare spokesperson said. “All cost share for that visit has been waived.”

The Regans said they were thrilled with UHC’s decision.

“That is wonderful news,” Elissa Regan said upon hearing from a KHN reporter that UHC would waive their costs. “We are very thankful. It is a huge relief.”

Timothy, Elissa and Finn all experienced COVID symptoms. Though they tried to do everything by the book, a trip to the ER for Timothy resulted in a $2,236 tab for the Regans, before their health insurer, UnitedHealthcare, subsequently waived it.(Ethan Welty for KHN)

The Takeaway: The Regans said they initially found no satisfaction in calling the hospital or the insurer to resolve their dispute ― but it was the right thing to do.

“He’s definitely not alone,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. “The takeaway here is both the provider as well as insurance company are still on a learning curve with respect to this virus and how to bill and pay for it.”

Corlette said Timothy should not have second-guessed his decision to use the Denver Health ER when directed there by a nurse. That, too, was the right call.

Insurers’ moves to waive costs associated with COVID testing and related treatment is vital to stemming the outbreak — but it works only if patients can trust they won’t get stuck with a large bill, she said. “It’s a critical piece of the public health strategy to beat this disease,” Corlette said.

To help with billing, she said, patients could ask their provider to note on their medical chart when they are seeking care for possible COVID-19. But it’s not the patient’s responsibility to make sure providers use the right billing code, she said. Patients need to know they have the right to appeal costs to their insurer. They can also seek assistance from their employer’s benefits department and state insurance department.

Bill of the Month is a crowdsourced investigation by Kaiser Health News 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!

from Health Industry – Kaiser Health News

Must-Reads Of The Week

The news this week did seem dominated a bit by President Donald Trump. And most of it was trivial: Do we believe he is really taking hydroxychloroquine? (Who knows?) How obese is he? (Not as obese as Nancy Pelosi said he was.) Would he wear a mask at the Ford plant he was touring? (He did when he wasn’t in public view.)

It should not go unnoticed that Jacinda Ardern, who has led New Zealand through the coronavirus pandemic with but a few deaths (21, per the tally by Johns Hopkins University researchers), is that country’s most popular prime minister in 100 years.

I’m Damon Darlin, your guest writer for this edition of the Friday Breeze. We will have a rotating cast of writers for a few weeks to give you a breezy rundown of the week’s health care news.

You know, there were other things happening this week that mattered a bit more. People are still dying of COVID-19. The toll is approaching 100,000 deaths in the United States. Many of the deceased aren’t being counted among the COVID-19 casualties, according to a number of analyses.

The New York Times reported, in one of the most attention-getting pieces this week, that 36,000 fewer people in the United States would have died if only the country had locked down just one week earlier. If the U.S. had done it two weeks earlier, on March 1, “the vast majority of the nation’s deaths — about 83 percent — would have been avoided,” it reported.

Science magazine looked at the so-called superspreaders of the coronavirus. They examined a number of studies done across the globe in an attempt to understand how, if most people don’t transmit the virus, it spreads so much. It’s those circumstances in which it spreads massively that most intrigue the scientists.

The race for a vaccine to prevent further infections accelerated. So far, the results were mostly seen in the stock market. Moderna, a little-known drug company, announced preliminary results of its vaccine testing and its stock price soared. The federal government’s Biomedical Advanced Research and Development Authority (BARDA), the agency overseeing the rapid production of a vaccine, gave Moderna $438 million. (One of its board members, Moncef Slaoui, was appointed the nation’s new “vaccine czar,” and his financial ties to the industry are being questioned. The New York Times called them “vast.”)

Such publicity over vaccine development has raised the question of “science by press release.” KHN’s Jay Hancock took a look at how the pharmaceutical companies are trying to use publicity about their search for a vaccine to improve their damaged reputations.

The Centers for Disease Control and Prevention, which has faced withering criticism throughout this epidemic, came under fire again this week. This time, it was for messing up a pretty basic rule of epidemiology, supposedly its specialty. The federal agency was combining the results of two different kinds of tests for the coronavirus, viral and antibody, which would mess up crucial metrics needed to determine if it is safe to reopen a state. Virginia was doing this same thing. The Atlantic said Georgia, Texas and Pennsylvania were also misreporting data.

By the way, the head of the CDC, Robert Redfield, said he wasn’t being muzzled by the White House.

In other fiddling-with-the-data news, a data analyst working for the Florida state government said she was fired because, the South Florida Sun-Sentinel reported, “her bosses told her to remove the raw data from the website, meaning that users could no longer download it for analysis.”

Meanwhile, an assistant professor at the University of North Carolina in Wilmington said on Twitter that that state isn’t manipulating the data, just the graphic representation of it, so the results looked better.

North Carolina is trying to justify #Phase2, which starts on Friday. The top graph is from a few days ago, and the bottom graph is from today. They're no longer displaying any data before 4/18, and they've stretched out the x-axis so the shape of the curve looks flatter. pic.twitter.com/gekggd2qNO

— Julia Buck, PhD (@Buckette84) May 20, 2020

We aren’t done yet with the data category. An article that broke late last Friday night said that the Stanford University study you undoubtedly read about suggesting the coronavirus was not as deadly as was thought was sponsored by David Neeleman, the JetBlue Airways founder who has been saying the pandemic isn’t deadly enough to justify lockdowns. Stanford didn’t disclose the financial ties, according to BuzzFeed, or that scientists were concerned about the accuracy of the antibody tests the study was based on.

This report from NBC was intriguing. It casts strong doubts on the much-touted technology for washing and reusing face masks that health care workers use. The federal government contracted with an Ohio research company to be the nation’s laundromat. NBC said the potential cost to taxpayers is $413 million.

Finally, because it’s a national holiday on Monday — no, really, check your calendar, it’s Memorial Day — I leave you with a host of things to worry about as the country struggles to reopen.

Wearing gloves may do more harm than good.
Reopened office buildings may give you a disease.
Then there are the risks in using shared bathrooms in public buildings.
Loud talking, as people do in bars or restaurants, can leave the coronavirus in the air for 14 minutes.

Enjoy your long weekend. The ultraviolet light in sunshine is useful.

from Health Industry – Kaiser Health News

El Congreso dijo que los tests de COVID-19 debían ser gratuitos, pero ¿quién paga?

Los hospitales de todo el país tienen miedo de enviar cientos de miles de facturas relacionadas con las pruebas para COVID-19, porque el Congreso ordenó que no hubiera copagos ni costos de bolsillo para los pacientes.

Pero muchos empleadores con planes de salud autofinanciados parecen creer que están exentos de estas reglas.

Cuando los kits de pruebas aún eran escasos, el Centro Médico de la Universidad de Vanderbilt (VUMC) en Nashville, Tennessee, puso en acción sus laboratorios clínicos. Se hizo cargo de casi todas las pruebas en gran parte de Tennessee.

Otros sistemas de salud ni siquiera intentaron competir, aunque las pruebas debían estar cubiertas por los seguros.

A fines de marzo, el Congreso aprobó dos leyes, el Families First Coronavirus Response Act y el CARES Act, que esencialmente establecieron no solo que las pruebas para COVID tenían que estar cubiertas, sino que los pacientes no debían pagar un centavo. Sin embargo, VUMC ha descubierto que con frecuencia ese no es el caso.

“Cerca de la mitad de estos pacientes potencialmente tienen algún costo de bolsillo, ya sea por las pruebas o por servicios complementarios”, dijo Cecelia Moore, directora financiera de VUMC.

VUMC está reteniendo las facturas de estos pacientes, en lugar de enfrentar una reacción violenta por la facturación sorpresa durante la pandemia, explicó Moore.

El problema se reduce a una interpretación de si la nueva legislación federal aplica a los planes de salud ofrecidos por los empleadores más grandes.

Esas compañías, que cientos o miles de empleados, generalmente usan su propio dinero para pagar reclamos, como una forma de reducir los costos. Una encuesta realizada por la Kaiser Family Foundation (KFF) revela que la mayoría de los estadounidenses con cobertura de salud están en este tipo de planes.

Por ejemplo, BlueCross BlueShield of Tennessee puede ser la aseguradora que figura en la tarjeta del empleado, pero solo administra los pagos: el empleador paga los reclamos. Estos planes a menudo se denominan autofinanciados o autoasegurados, y puede que esto no esté claro para los empleados bajo estos planes.

Según múltiples fuentes, muchas de las compañías con estos planes están operando como si estuvieran exentas de las nuevas reglas federales.

“Pareciera que la ley puede haber dejado a estos empleadores fuera de ciertos detalles”, dijo Mike Thompson, CEO de la National Alliance of Healthcare Purchaser Coalitions.

Esta alianza representa a empleadores con planes de salud autofinanciados. Dijo que algunos no renuncian a los copagos y otras facturas, aunque la mayoría solo factura por la prueba para COVID-19 en sí y no por la visita al médico o la prueba para descartar la gripe.

“Muchos de ellos han optado por cubrir el primer dólar, pero de diferentes maneras. Es posible que hayan incluido o no los tratamientos relacionados”, dijo Thompson, quien admite que hay mucha confusión.

Otras asociaciones que representan planes de salud financiados por el empleador, incluido el Business Group on Health, dijeron que sus miembros generalmente siguen el espíritu de la ley.

Pero los expertos en políticas de salud no ven espacio para la interpretación.

“No importa si es un plan autofinanciado o cubierto totalmente por la aseguradora, si es de un pequeño empleador o de un gran empleador, o si lo compras por tu cuenta en el mercado”, dijo Karen Pollitz, analista senior de KFF. “Todo seguro privado debe cubrir el 100% del costo de las pruebas para COVID-19”.

Pollitz dijo que le molesta que los empleadores estén tratando de argumentar lo contrario.

Aun así, está sucediendo, y no solo en Tennessee.

Duke Health en Carolina del Norte confirma que no está facturando reclamos relacionados con las pruebas o el tratamiento de COVID, citando una falta de claridad sobre lo que el paciente tiene que pagar.

En California, el Centro Médico UCSF también está retrasando la facturación, y el Centro Médico UCLA está presionando a los planes de salud para que paguen su parte.

“UCLA Health no factura a los pacientes por las pruebas para COVID-19, incluso si el plan de salud no paga por error”, dijo el vocero Enrique Rivero en un comunicado por escrito. “Nosotros notificamos a las aseguradoras de su error y solicitamos que vuelvan a procesar los reclamos de conformidad con las pautas de la Ley CARES”.

La NYU Langone Health y la Clínica Cleveland dijeron que no facturarán a los pacientes ningún costo compartido por las pruebas, incluso si eso significa que tienen que pagar el costo.

El problema se extiende más allá de los centros médicos académicos.

Envision Health, una empresa con sede en Nashville que opera con personal propio cientos de salas de emergencia en todo el país, está reteniendo 200,000 facturas relacionadas con las pruebas para COVID-19 debido a la confusión sobre quién cubre los costos compartidos.

Por lo que, muchas facturas médicas que serían “sorpresa” todavía están esperando ser enviadas. Solo en Vanderbilt, el centro médico ha retenido más de $6 millones en facturación desde mediados de marzo.

“Seguramente sorprenderemos, pero no en este momento”, dijo Heather Dunn, vicepresidenta de servicios de ingresos de VUMC.

Dado el creciente desdén por las facturas médicas sorpresa, Dunn espera una reacción violenta de los pacientes vulnerables.

“Mi mayor temor es por los pacientes que ya tienen COVID o enfrentan problemas después, o han perdido su trabajo. No les diría: ‘su aseguradora ha transferido este copago de $50’”, dijo.

A veces, el paciente también se queda con un gran deducible, que puede sumar cientos de dólares.

Dunn dijo que no puede retrasar la facturación para siempre y que el hecho de que las pruebas sean gratuitas para los pacientes no significa que no tengan costo.

Por Blake Farmer

Esta historia es parte de una asociación que incluye WPLN, NPR y Kaiser Health News.

from Health Industry – Kaiser Health News

Científica genera imágenes del coronavirus para que todos vean al “enemigo invisible”

Desde su laboratorio en Montana, Elizabeth Fischer está tratando de ayudar a que las personas vean a qué se enfrentan con COVID-19.

Durante las últimas tres décadas, Fischer, de 58 años, y su equipo en los Rocky Mountain Laboratories, parte del Instituto Nacional de Alergias y Enfermedades Infecciosas de los Institutos Nacionales de Salud (NHI), han capturado y creado algunas de las imágenes más dramáticas de los patógenos más peligrosos del mundo.

“Me gusta obtener imágenes para tratar de transmitir que se trata de una entidad, para desmitificarla, que sea algo más tangible para las personas”, dijo Fischer, una autoridad en el manejo de microscopios electrónicos.

Ahora, con sus representaciones del coronavirus destellando en las pantallas de todo el mundo, Fischer le ha puesto “rostro” al que “muchos llaman el enemigo invisible”.

Fischer trabaja en uno de los 13 laboratorios de “Bioseguridad Nivel 4” de la nación, aquéllos equipados para manejar con seguridad patógenos letales. Junto con su equipo, visualiza las plagas más mortales del mundo, desde el Ébola hasta el VIH, desde la salmonella hasta el SARS-CoV-2, el coronavirus que causa COVID-19.

Las impresionantes imágenes permiten a las personas ver un virus como estructuras biológicas elaboradas con debilidades que pueden atacarse, proporcionando pistas para los investigadores sobre cómo desarrollar tratamientos y vacunas.

“Si hay una enfermedad, la hemos visto”, dijo Fischer.

Originaria de Evergreen, Colorado, Fischer obtuvo una licenciatura en biología en la Universidad de Colorado-Boulder y contempló ir a la escuela de medicina, antes de decidir unirse a los Cuerpos de Paz. Enseñó matemáticas y ciencias durante dos años en Liberia, y luego se tomó un tiempo para viajar por África Oriental y Asia, incluida una caminata por el Himalaya.

Al regresar a Colorado, trabajó como guía de rafting en el río Arkansas durante varios veranos, y como instructora de esquí para niños en la estación Monarch Mountain durante los inviernos.

Más tarde se matriculó en la escuela de posgrado, pensando que podría enseñar biología. Pero cuando tomó cursos de microscopía electrónica, encontró su verdadera vocación.

Era otro tipo de aventura exótica. “Estás viendo un mundo que la mayoría de la gente no puede ver”, explicó. Así fue que completó una maestría en biología.

Al graduarse, envió su currículum a una oficina nacional de empleos en microscopía y pronto recibió una llamada de los Rocky Mountain Laboratories. En 1994 se mudó con su familia a Hamilton, una ciudad de menos de 5,000 personas a unas 50 millas al sur de Missoula, y avanzó hasta convertirse en jefa de la unidad de microscopía del laboratorio.

Algunas de las imágenes más impresionantes del coronavirus, que es 10,000 veces más pequeño que el ancho de un cabello humano, provienen del microscopio de Fischer.

Elizabeth Fischer usa un microscopio electrónico para capturar imágenes del coronavirus, que es aproximadamente 10,000 veces más pequeño que el ancho de un cabello humano. (Courtesy of Elizabeth Fischer)

"Me gusta obtener imágenes para tratar de transmitir que se trata de una entidad, para desmitificarla, que sea algo más tangible para las personas", dijo Fischer, una autoridad en el manejo de microscopios electrónicos. (Courtesy of Elizabeth Fischer)

Una es la fotografía de las partículas virales que se liberan de una célula moribunda infectada con el virus.

Como destacó recientemente en su blog el doctor Francis Collins, director de los NIH, la foto muestra los pliegues y protuberancias de color naranja amarronado en la superficie de la célula renal de un primate infectado con SARS-CoV-2.

Las docenas de pequeñas esferas azules que emergen de la superficie son las partículas virales. (Las imágenes producidas por los microscopios electrónicos son en blanco y negro, por lo que Fischer las entrega a artistas visuales, que colorean la imagen para ayudar a identificar diferentes partes de la célula y distinguir el virus de su huésped).

“Esta imagen nos abre una ventana para ver cuán devastadoramente eficaz parece ser el SARS-CoV-2 al entrar en su huésped”, escribió Collins. “Solo una célula infectada es capaz de liberar miles de nuevas partículas de virus que, a su vez, pueden transmitirse a otros”.

Científicos como Fischer han utilizado microscopios electrónicos para descubrir el mundo invisible de virus y bacterias que datan de los años ‘30.

Sin embargo, en las últimas dos décadas, las nuevas tecnologías han desencadenado una revolución en la resolución de estas imágenes, permitiendo a los investigadores verlas a un nivel casi atómico.

Los expertos han ideado mejores formas de preparar muestras para su visualización y han diseñado sofisticados programas de software para enfocar las imágenes.

A través de su laboratorio, Fischer recibe muestras de todo el mundo y a principios de febrero se le envió material viral de uno de los primeros pacientes de los Estados Unidos en infectarse con el nuevo coronavirus.

A menudo, sus muestras provienen de viales que se han almacenado en un congelador durante décadas, o de cultivos de laboratorio. “Es muy impactante saber que proviene de un paciente humano”.

En 2014, Elizabeth Fischer recibió una muestra de ébola de una niña de 2 años que se contagió en Malí. El borde celular y la forma del núcleo se asemejan a la forma de África. (Courtesy of Elizabeth Fischer)

Por ejemplo, en 2014, un laboratorio hermano en Malí envió una muestra de Ebola de una niña de 2 años que estaba viviendo en Guinea cuando su madre murió de la enfermedad.

Su abuela viajó desde Malí para asistir al funeral, que incluyó el ritual de bañar el cuerpo, y llevar a la niña de regreso a su casa. Ambas se infectaron y portaban el virus cuando regresaron a Mali en transporte público. Abuela y nieta murieron.

“Esta célula en particular, se parecía al continente africano”, recordó Fischer. “Fue un momento muy poderoso. Tomas conciencia del trabajo que haces y del impacto que tiene en la salud humana”.

Sin embargo, a pesar de la naturaleza mortal de los virus, todavía aprecia la “hermosa simetría en muchos de ellos”, dijo. “Son muy elegantes y no son maliciosos en sí mismos. Simplemente hacen lo que hacen”.

from Health Industry – Kaiser Health News

Congress Said COVID-19 Tests Should Be Free — But Who’s Paying?

Hospitals around the country are afraid to send out hundreds of thousands of bills related to COVID-19 testing. That’s because Congress mandated there would be no copays and no out-of-pocket costs for patients. But many employers with self-funded health plans seem to believe they’re exempt from the rules.

When testing kits were still scarce, Vanderbilt University Medical Center in Nashville, Tennessee, fired up its clinical labs. It almost single-handedly took over testing in much of Tennessee. Other health systems didn’t even try to compete, although the tests were supposed to be covered by insurance.

In late March, Congress passed two laws, the Families First Coronavirus Response Act and the CARES Act, that essentially stated that not only does testing have to be covered, but patients shouldn’t have to pay a dime. Yet VUMC has found that’s frequently not the case.

“As many as half of those patients potentially have some out-of-pocket [cost], either for the tests or for companion services with the test,” VUMC Chief Financial Officer Cecelia Moore said.

VUMC is holding back bills for these patients, Moore said, rather than face a backlash of anger at surprise billing during the pandemic.

The issue comes down to an interpretation of whether the new federal legislation applies to health plans offered by larger employers. Those companies, which usually have at least a few hundred employees, often use their own money to pay claims as a way to drive down costs. A survey by the Kaiser Family Foundation finds a majority of Americans with health coverage are in this type of plan. (Kaiser Health News is an editorially independent program of the foundation.)

So BlueCross BlueShield of Tennessee may be on an employee’s insurance card, but the insurer is just managing the payments. The employer’s money pays the claims; these plans are often called self-funded or self-insured, and it may not be clear to employees that they are in such a plan.

According to multiple sources, many of the companies with those plans are operating as if they’re exempt from the new federal rules.

“In this case, it appears that the law may have left self-insured employers out of certain elements,” said Mike Thompson, CEO of the National Alliance of Healthcare Purchaser Coalitions.

The National Alliance represents employers with self-funded health plans. He said some are not waiving copays and other bills. Most are, he said, though sometimes only bills for the COVID-19 test itself and not for the doctor’s visit or the test to rule out the flu.

“Many of them have opted to cover on a first-dollar basis, but in different ways. They may or may not have included the related treatment elements,” Thompson said. He acknowledges the distinction would be lost on patients. “I get why it’s causing confusion.”

Other associations representing employer-funded health plans, including the Business Group on Health, said their members are generally following the spirit of the law.

Health policy experts don’t see any room for interpretation.

“It doesn’t matter if it’s a self-funded plan or a fully insured plan, if you get it from a small employer or a large employer, if you buy it on your own in the marketplace,” said Karen Pollitz, a senior fellow with KFF. “All private insurance has to cover 100% of the cost of COVID-19 testing.”

Pollitz said she is miffed that employers are trying to argue otherwise.

Still, it’s happening, and not only in Tennessee.

Duke Health in North Carolina confirms it’s not billing claims related to COVID testing or treatment, citing a lack of clarity in what the patient is responsible for paying. In California, UCSF Medical Center is also holding off on billing, and UCLA Medical Center is pressing health plans to pay their part.

“UCLA Health does not bill COVID-19 patients for testing even if their health plan erroneously does not pay,” spokesperson Enrique Rivero said in a written statement. “Our practice is to notify insurers of their error and request that they reprocess claims consistent with CARES Act guidelines.”

NYU Langone Health and Cleveland Clinic said they won’t bill patients any cost sharing for testing, even if that means they have to bear the cost.

The issue extends beyond academic medical centers. Envision Health, a Nashville-based firm that staffs and operates hundreds of emergency rooms around the country, is holding back 200,000 bills related to COVID-19 testing because of confusion about coverage of cost sharing.

So, many would-be surprise medical bills are still waiting to be sent out. At Vanderbilt alone, the medical center has held back more than $6 million in billing since mid-March.

“I know I’m supposed to be shaking everybody down, but we’re not right now,” said Heather Dunn, VUMC’s vice president of revenue cycle services.

Given the growing disdain for surprise medical bills, she expects a backlash from vulnerable patients.

“My greatest fear is [for] patients who are already suffering from the COVID virus or issues after or have lost their job. I’m hesitant to also say, ‘Your insurance company has passed along this $50 copay,’” she said.

Sometimes, the patient is also left with a large deductible to pay, in the hundreds of dollars.

Dunn said that she can’t delay billing forever and that just because the tests are supposed to be free to patients doesn’t mean they have no cost.

This story is part of a partnership that includes WPLN, NPR and Kaiser Health News.

from Health Industry – Kaiser Health News

Scientist Has ‘Invisible Enemy’ In Sights With Microscopic Portraits Of Coronavirus

From her laboratory in the far western reaches of Montana, Elizabeth Fischer is trying to help people see what they’re up against in COVID-19.

Over the past three decades, Fischer, 58, and her team at the Rocky Mountain Laboratories, part of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, have captured and created some of the more dramatic images of the world’s most dangerous pathogens.

“I like to get images out there to try to convey that this is an entity, to try to demystify it, so this is something more tangible for people,” said Fischer, one of the country’s leading electron microscopists.

Now, as her renderings of the coronavirus flash across screens worldwide, she said: “You often hear people call it the invisible enemy. It’s trying to put that face out there.” Working in one of the nation’s 13 “Biosafety Level 4” labs — those equipped to safely handle the most dangerous pathogens — Fischer and her team visualize the world’s deadliest plagues from Ebola to HIV, salmonella to SARS-CoV-2, the coronavirus that causes COVID-19.

The breathtaking images allow people to see a virus as elaborate biological structures with weaknesses that can be exploited, yielding clues for researchers about how to develop treatments and vaccines.

“If there is a disease, we have seen it,” she said.

Originally from Evergreen, Colorado, Fischer completed a degree in biology at the University of Colorado-Boulder and contemplated going to medical school, before deciding instead to join the Peace Corps. She taught math and science for two years in Liberia, and then took time to travel through East Africa and Asia, including a trek into the Himalayas.

Returning to Colorado, she immersed herself in the outdoor world she loved. She worked as a rafting guide on the Arkansas River for several summers, and as a children’s ski instructor at the Monarch Mountain ski resort during the winters.

She later enrolled in graduate school, thinking she might teach biology. But when she took courses in electron microscopy, she was hooked.

It appealed to her sense of exotic adventure. “You’re looking at a world that most people don’t get to see,” she said. She switched gears and completed a master’s degree in biology.

Upon graduation, she sent her résumé to a national microscopy job placement office and soon received a call from Rocky Mountain Laboratories. In 1994, she moved with her family to Hamilton, a city of fewer than 5,000 people about 50 miles south of Missoula, then worked her way up to become chief of the lab’s microscopy unit.

Some of the more stunning images of the coronavirus — about 10,000 times smaller than the width of a human hair — have come from Fischer’s microscope.

Elizabeth Fischer uses an electron microscope to capture images of the coronavirus, which is about 10,000 times smaller than the width of a human hair.(Courtesy of Elizabeth Fischer)

“I like to get images out there to try to convey that this is an entity, to try to demystify it, so this is something more tangible for people,” Fischer says.(Courtesy of Elizabeth Fischer)

One is Fischer’s photograph of viral particles being released from a dying cell infected with the virus.

As NIH Director Dr. Francis Collins recently highlighted in his blog, the photo shows the orange-brown folds and protrusion on the surface of a primate’s kidney cell infected with SARS-CoV-2. The dozens of small, blue spheres emerging from the surface are the virus particles themselves. (The images produced by the electron microscopes are black-and-white, so Fischer hands them over to visual artists who colorize the image to help identify different parts of the cell and to distinguish the virus from its host.)

“This image gives us a window into how devastatingly effective SARS-CoV-2 appears to be at co-opting a host’s cellular machinery,” Collins wrote. “Just one infected cell is capable of releasing thousands of new virus particles that can, in turn, be transmitted to others.”

Scientists like Fischer have used electron microscopes to uncover the unseen world of viruses and bacteria dating to the 1930s. In the past two decades, however, new technologies have unleashed a resolution revolution, allowing researchers to see down to the near-atomic level. Microscopists have come up with better ways to prepare samples for viewing and have written sophisticated software programs to sharpen images.

Through her lab, Fischer receives samples from all over the world, and was sent viral material in early February from one of the first U.S. patients to be infected with the novel coronavirus. Often, her samples come from vials that have been stored in a freezer for decades, or from cultures routinely grown in a lab. “It’s very sobering when you know it came from a human patient.”

In 2014, Elizabeth Fischer received a sample of Ebola from a 2-year-old girl in Mali. The cell border and nucleus shape resemble the shape of Africa.(Courtesy of Elizabeth Fischer)

For example, in 2014, a sister lab in Mali sent over an Ebola sample from a 2-year-old girl who had lived in Guinea when her mother died of the disease. Her grandmother traveled from Mali to attend the funeral, which involved touching and bathing the body, and to take the girl home with her. Both got infected and brought the virus back with them as they returned to Mali by public transportation. They both died.

“This one particular cell, it looked like the continent of Africa,” Fischer recalled. “It was a very powerful moment. You see that virus growing in there, it takes you back around to not only the lab work we do, but that there’s an impact on human health.”

Despite the deadly nature of the viruses, she still appreciates the “beautiful symmetry in many of them,” she said: “They’re very elegant, and they’re not malicious in and of themselves. They’re just doing what they do.”

from Health Industry – Kaiser Health News

Por la cuarentena, hay menos accidentes de tránsito y escasean órganos para donaciones

En marzo, en el segundo día en el que los habitantes del área de la Bahía de San Francisco debían quedarse en sus casas, Nohemi Jiménez se subió a su automóvil en San Pablo, California, se despidió de su hijo de 3 años y se dirigió a su cita de diálisis de cada miércoles.

Las calles estaban desiertas. Sin tráfico. Jiménez, de 30 años, dijo que es difícil admitir lo que pensó: sin autos no hay accidentes. Y eso significaba que estaría en la lista de espera para un trasplante de riñón por más tiempo.

“No quise ser mala, pero pensé: Dios mío, nadie se va a morir”, contó. “No voy a recibir mi trasplante”.

Jiménez tenía 20 años y estaba embarazada de su primer hijo cuando los médicos descubrieron que había nacido con un solo riñón, y que éste estaba fallando. A los 29, le dijeron que necesitaba un nuevo órgano. Resultó extraño y aterrador, esperar que alguien muriera para poder vivir, contó.

“El pensamiento está en tu mente todo el tiempo, nunca te abandona”, agregó.

Las muertes por accidentes son la principal fuente de órganos para trasplantes, y representan el 33% de las donaciones, según la United Network for Organ Sharing (UNOS), que gestiona el sistema de donaciones de la nación.

Pero desde que el coronavirus obligó a los californianos a atrincherarse, las fatalidades han disminuido. Los accidentes de tránsito y las muertes en el estado se redujeron a la mitad en las primeras tres semanas de la cuarentena, según un estudio de la Universidad de California-Davis. Y las muertes por ahogamiento cayeron hasta un 80%, según datos recopilados por la organización sin fines de lucro Stop Drowning Now.

En abril, las organizaciones que obtienen órganos suelen ver un aumento en las donaciones relacionadas con actividades al aire libre, las vacaciones de primavera y los viajes. Pero no este año.

Del 8 de marzo al 11 de abril, el número de donantes de órganos que murieron en accidentes de tránsito disminuyó un 23% en todo el país, en comparación con el mismo período del año pasado, mientras que los donantes que murieron en otros tipos de accidentes bajó un 21%, según UNOS.

“Los accidentes que suelen ocurrir durante las vacaciones de primavera, en la playa, al andar en moto o ir de caza son casi inexistentes porque no hay vacaciones de primavera “, dijo Janice Whaley, CEO de Donor Network West, que administra las donaciones de órganos para el norte de California y Nevada.

Janice Whaley (sentada) es la directora ejecutiva de Donor Network West, que administra donaciones de órganos de donantes fallecidos en el norte de California y Nevada. Su equipo atiende llamadas de hospitales sobre posibles donantes de órganos.(Andye Daley/Donor Network West)

Médicos dijeron que también observan una disminución en las visitas a la sala de emergencias en general, no solo por accidentes, y esto también podría estar limitando el suministro de órganos.

“¿Dónde están todas las personas con ataques cardíacos? ¿Con accidentes cerebrovasculares?, se preguntó George Rutherford, profesor e infectólogo en la Universidad de California-San Francisco. “¿Estos pacientes no llegan a las salas de emergencias por temor a COVID?”.

Los accidentes cerebrovasculares y los ataques cardíacos son la segunda y tercera fuente más común de donaciones de órganos, y representan el 27% y el 20% de los órganos, respectivamente, según UNOS.

Cuando las personas mueren de un derrame cerebral o ataque cardíaco en el hogar en lugar de un hospital, sus órganos no pueden usarse para trasplantes debido a la pérdida de flujo sanguíneo. La mayoría de las donaciones de órganos se producen después que una persona sufre un evento casi mortal y las medidas para salvar vidas no funcionan.

Para que los órganos sean viables, las personas deben morir o ser declaradas con muerte cerebral mientras están en un respirador, para que la sangre siga bombeando al corazón, los pulmones, el hígado y los riñones.

COVID complica el proceso de donación

Una serie de otras complicaciones logísticas están dificultando los trasplantes durante la pandemia de coronavirus. Los hospitales han tenido que reducir las cirugías de todo tipo para preservar los escasos suministros de equipos de protección personal y ventiladores. Y muchos no han tenido la capacidad para manejar el delicado y complejo proceso de la donación, recuperación, transporte y trasplante de órganos.

Los trasplantes en todo el país se desplomaron un 52% del 8 de marzo al 11 de abril, según datos de UNOS.

“Hay muchas cosas que tienen que ocurrir a la perfección, y ahora estamos en una situación imperfecta, tratando de lidiar con tantas otras cosas”, dijo Whaley.

A medida que los centros médicos se preparaban para una ola de pacientes con COVID-19, buscaron tener disponibles la mayor cantidad de ventiladores posible. Además de los donantes que deben morir con ventiladores para mantener sus órganos viables, los médicos a menudo los mantienen con ventiladores durante dos o tres días mientras los equipos de trasplante y los receptores se organizan. Luego, los que reciben el órgano deben estar en ventiladores durante la cirugía.

“La gente estaba muy inquieta por tener pacientes que no son de COVID-19 en ventiladores, ocupando espacio”, dijo Whaley. “Querían asegurarse de que estaban listos para el próximo paciente”.

Muchos pacientes con COVID que murieron ofrecieron sus órganos para donación, pero fueron rechazados por temor a que los recipientes pudieran infectarse, dijo.

Y la escasez de suministros para pruebas de coronavirus dificultó que los centros de trasplantes hicieran pruebas a donantes potenciales, que luego murieron por otras causas, para asegurarse que no estuvieran infectados con el virus.

Nohemi Jiménez el 18 de abril, el día después de su exitosa operación de trasplante de riñón en el Centro Médico UCSF en San Francisco.(Courtesy of Nohemi Jimenez)

“Por lo tanto, puede haber habido una reducción de órganos que normalmente no hubiéramos visto”, dijo el doctor Chris Freise, profesor y cirujano de trasplantes de la UCSF.

Como política, los hospitales cancelaron prácticamente todos los trasplantes de órganos de donantes vivos, donde un miembro de la familia u otra persona dona un riñón o una sección de su hígado.

“Eso implica llevar a dos pacientes al hospital, el donante y el receptor, y ciertamente no queríamos poner a los donantes en un riesgo adicional significativo”, dijo Freise. “El trasplante de riñón de donante vivo se frenó casi por completo en la mayoría de los programas en todo el país”.

Algunos hospitales reanudaron estos procedimientos a principios de mayo, mientras que las donaciones de donantes fallecidos comenzaron a aumentar lentamente a mediados de abril.

Fue entonces cuando Jiménez recibió la llamada del equipo de Freise en UCSF. Una condición relacionada con los tres embarazos de Jiménez hizo que encontrar un donante compatible fuera muy difícil, “como una aguja en un pajar”, explicó Freise. Eso también la colocó arriba en la lista de espera en caso de que se encontrara un órgano compatible.

El teléfono de Jiménez sonó a las 2 am del 17 de abril. Le dijeron que fuera al hospital de inmediato.

“Estaba emocionada”, dijo Jiménez. “Pero entonces mi mente sonó: alguien murió”.

Todo lo que sabe es que el donante tenía 19 años y murió en un accidente en Los Ángeles. Jiménez escribió una carta a la familia del donante.

“Les dije que siempre estaré pensando en ellos”, dijo. “Lo o la tendré en mi cuerpo por el resto de mi vida y viviré para los dos”.

Jiménez tiene seis meses de recuperación por delante. Dijo que está ansiosa por volver a trabajar y tener más energía para jugar con sus hijos.

Esta historia es parte de una asociación que incluye a KQED, NPR y Kaiser Health News.

from Health Industry – Kaiser Health News

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