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Updated: 15 hours 41 min ago

As Care Shifts From Hospital To Home, Guarding Against Infection Falls To Families

September 19, 2017

Jaycee Gray, 18, of Mapleton, Iowa, spent four days in the hospital in July after getting a bloodstream infection in her central line, which she uses to treat her rare blood cancer. Her mother, Angela Cooper, said that learning to clean the central line was “very nerve-wracking.” (Courtesy of Jaycee Gray)

Angela Cooper arrived home from work to discover her daughter’s temperature had spiked to 102 degrees — a sign that the teenager, who has cancer, had a potentially deadly bloodstream infection. As Cooper rushed her daughter to the hospital, her mind raced: Had she done something to cause the infection?

Cooper, who works at a Chevy dealership in Iowa, has no medical background. She is one of thousands of parents who perform a daunting medical task at home — caring for a child’s catheter, called a central line, that is inserted in the arm or torso to make it easier to draw blood or administer drugs.

Central lines, standard for children with cancer, lead directly to a large vein near the heart. They allow patients with cancer and other conditions to leave the hospital and receive antibiotics, liquid nutrition or chemotherapy at home. But families must perform daily maintenance that, if done incorrectly, can lead to blood clots, infections and even death.

As more medical care shifts from hospital to home, families take on more complex, risky medical tasks for their loved ones.

But hospitals have not done enough to help these families, said Dr. Amy Billett, director of quality and safety at the cancer and blood disorders center at Dana-Farber Cancer Institute/Boston Children’s Hospital.

This KHN story also ran in The Washington Post. It can be republished for free (details).

“The patient safety movement has almost fully focused all of its energy and efforts on what happens in the hospital,” she said. That’s partly because the federal government does not require anyone to monitor infections patients get at home.

Even at the well-resourced, Harvard-affiliated cancer center, parents told Billett in a survey that they did not get enough training and did not have full confidence in their ability to care for their child at home.

The center was overwhelming parents by waiting until the last minute to inundate them with instructions — some of them contradictory — on what to do at home, Billett said.

An external central line, which ends outside the body, must be cleaned every day. Caregivers have to scrub the hub at the end of the line for 15 seconds, then flush it with a syringe full of saline or anticoagulant.

If caregivers don’t scrub properly, they can flush bacteria into the tube, and — whoosh — the bacteria enter a major vein close to the heart, Billett said. One father, noting that the hub looked dirty, scrubbed it with a pencil eraser, sending three types of bacteria into his child’s bloodstream, she said.

Learning the cleaning steps was “very nerve-wracking,” recalled Cooper, whose 18-year-old daughter, Jaycee Gray, has had a central line since April to receive treatment for anaplastic large-cell lymphoma, a rare type of blood cancer.

“You can scrub and scrub and scrub, and it doesn’t feel like it’s clean enough,” she said. Parents must keep track of other rules, too, like covering up the central line before the child gets in the shower and changing the dressing if it gets dirty or wet.

Monitoring Infection Cases At Home

Bloodstream infections associated with central lines lead to thousands of deaths each year inside hospitals, costing billions of dollars, according to the Centers for Disease Control and Prevention. Research has also shown these infections are largely preventable: Hospitals have slashed infection rates when staff follow the CDC’s standardized safety steps.

But researchers recently discovered that more kids with central lines are getting bloodstream infections at home. In a three-year study of children with cancer and blood disorders at 15 hospitals, 716 such infections took place outside the hospital, compared with 397 inpatient infections. This is partly because children with central lines spend much less time in hospitals than not.

These hospitals belong to a national collaborative of 20 pediatric cancer centers, organized through the Children’s Hospital Association, that aims to keep kids out of the hospital by training families, visiting nurses and clinic staff on handling central lines.

At one of the hospitals, Johns Hopkins in Baltimore, researchers discovered that patients as young as 8 were cleaning their own central lines at home, even though the hospital had designed its training materials for adults.

Cooper said that when her daughter developed the fever July, she immediately started wondering if she was to blame: “It’s really hard,” she said. “I don’t want to put her in the hospital.”

When doctors confirmed that Jaycee had a bloodstream infection, Cooper asked them what caused it. Days later, after interviews and tests, no one knew for sure.

Jaycee was transferred to Children’s Hospital & Medical Center in Omaha, Neb., one of the other hospitals in the collaborative, where nurse Amanda Willits works with families to identify the likely causes of infections and practice safe techniques. Willits said the bacteria probably came through the skin, but there’s no sign Cooper is to blame, and Cooper demonstrated her line-care technique perfectly.

Jaycee spent four days in an isolated room at the hospital, two hours away from home. Doctors warned her that if the bacteria had colonized the plastic of her central line, she might have to go through surgery to have it removed and replaced.

As it turned out, Jaycee didn’t need surgery; she recovered with antibiotics. But about four times out of 10, children who get these infections do need their lines surgically removed, according to research by pediatric oncologist Dr. Chris Wong Quiles at Dana-Farber/Boston Children’s.

Looking at 61 patients there, Wong Quiles tackled basic questions that researchers don’t have national data on: When patients get these infections at home, what happens to them, what does it cost and how often do they die?

Wong Quiles found that in 15 percent of cases, children ended up in the intensive care unit. Four children died. Their median hospital stay was six days, and their median age was 3.

These episodes also cost a lot. Wong Quiles found that median hospital charges were $37,000 per infection. That’s not counting professional fees from hospital staff; the cost of going home with antibiotics and possibly nursing care; or the cost to families from losing days of work to be at the hospital with their kids.

Dan and Megan Kelley care for daughter Bridget, 8, who has leukemia, at home in Quincy, Mass. When Bridget was discharged from the hospital after treatment, it “felt like bringing a newborn baby home,” Megan Kelley says. (Melissa Bailey/Kaiser Health News)

Bringing In A Checklist Engineer

In Boston, Billett and Wong Quiles have enlisted extra staff and resources to try to help parents. The hospital hired a “checklist engineer” to clean up inconsistent messaging and created family-focused videos, flip charts and pocket-size brochures about handling central lines.

Now, patients and families start learning central line care five to 10 days before discharge, instead of just one or two days, Billett said. Parents first practice on a dummy called Chester Chest, then demonstrate their skills on their child.

Even after this training, bringing a child with cancer out of the hospital still felt scary, said Megan Kelley, whose 8-year-old daughter, Bridget, is being treated there for leukemia.

“It felt like bringing a newborn baby home — we’ve never done this before,” said Kelley, who lives in Quincy, Mass., with her husband, Dan, and their three daughters.

Bridget and her family have managed to avoid infection since she was first discharged last December.

Along the way, the family got support and was spot-checked: The hospital keeps track of who was trained and that person’s skill level, and sends a nurse home to see how the caregiver handles the line.

This approach to patient safety — helping families at home through standardized learning tools, hands-on training and tracking skill development — could have broad applications for caregivers of patients young and old, Billett said.

Some early work at Johns Hopkins has shown success: The hospital found a dramatic reduction in outpatient bloodstream infection rates after it trained families, home health nurses and clinic staff.

These infections “can exact such a harsh toll on some of our most vulnerable patients,” said Dr. Michael Rinke, who led that research and now works at Montefiore Medical Center in New York. “Preventing even one of these can help a kid have an important out-of-hospital time, and have an important being-a-kid experience.”

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

El ultimátum de Trump a los “soñadores” impacta en la industria de la salud

September 18, 2017

Yuriana Aguilar estuvo en los titulares el año pasado cuando se convirtió en la primera estudiante inmigrante indocumentada en obtener un doctorado de la Universidad de California-Merced.

Ahora está en medio de su beca postdoctoral en la Universidad Rush en Chicago, investigando formas de ayudar a prevenir el paro cardíaco súbito, una de las principales causas de muerte en los Estados Unidos.

La joven fue capaz de obtener esta beca sólo por su participación en el programa federal de Acción Diferida para los Llegados en la Infancia (DACA), que permite a los jóvenes que fueron traídos de niños los Estados Unidos sin la documentación apropiada, quedarse y trabajar aquí.

Aguilar, de 27 años, nació en México y llegó con su familia a Fresno, California, a los 5 años.

Pero su investigación podría detenerse si la administración del presidente Donald Trump mantiene su promesa de poner fin al programa DACA.

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Es irónico “que mi investigación podría eventualmente ayudar a salvar las vidas de las personas que están alterando mi vida”, dijo, refiriéndose a los miembros del Congreso, muchos de los cuales están en una edad en que la que el riesgo de enfermedad cardíaca es mayor.

“Pediría al Congreso que mirara… cuánto hemos logrado en estos últimos cinco años”, dijo Aguilar. “No estamos tomando el trabajo de nadie, simplemente estamos llenando las lagunas”.

Aguilar es una de los 220.000 beneficiarios de DACA en California, el grupo más grande del país. A nivel nacional, hay cerca de 800.000 niños y adultos jóvenes con DACA, un estatus que les ofrece protección temporal contra la deportación y la posibilidad de recibir permisos de trabajo. El ex presidente Barack Obama estableció el programa en 2012 a través de una orden ejecutiva.

No hay estadísticas firmes que demuestren cuántos de estos inmigrantes, conocidos como “soñadores”, trabajan en el sector de la salud, pero los líderes de la industria han sugerido que la terminación de DACA podría tener un impacto significativo, especialmente entre los estudiantes de medicina y asistentes de salud en el hogar.

“Las implicaciones de esta acción para los estudiantes de medicina, los médicos residentes y los investigadores con el estatus de DACA son graves, e interferirán con su capacidad para completar su formación y contribuir de manera significativa a la salud de la nación”, declaró la Asociación de Colegios Médicos Americanos (AAMC) a través de un comunicado.

Robert Espinoza, vicepresidente de políticas de PHI, un grupo de defensa de la atención médica a largo plazo, dijo que la terminación del programa podría tener consecuencias importantes para la fuerza laboral en salud. “Cuanto más amenace la administración a los inmigrantes y a sus familias y comunidades, más se está amenazando al suministro de mano de obra”, agregó.

El 5 de septiembre, el fiscal general Jeff Sessions anunció que el presidente Trump cancelaría la orden ejecutiva que creó DACA. La administración dijo que no cree que Obama tuviera la autoridad para establecer el programa, y que anticipa demandas de los estados.

La administración está brindando un período de gracia de seis meses antes de que estas protecciones terminen, dándole tiempo al Congreso para aprobar una legislación para tratar el estatus legal de los soñadores. Trump y legisladores demócratas han acordado trabajar en un plan para ampliar el programa DACA, pero hay pocos detalles, y los conservadores ya han planteado preocupaciones.

El lunes 18 de septiembre, varios beneficiarios de DACA demandaron a Trump por su decisión de poner fin al programa, con el respaldo de eminencias legales, entre ellos el profesor de derecho de Harvard, Laurence Tribe, y el decano de la facultad de derecho de la Universidad de California-Berkeley, Erwin Chemerinsky.

Uno de los demandantes, un inmigrante que llegó de niño desde Tailandia, ahora es un estudiante de cuarto año de medicina en la Universidad de California-San Francisco quien teme que poner fin a DACA también podría poner fin a su “sueño de convertirse en médico y proporcionar atención a las comunidades marginadas y desamparadas”, según indica el texto de la demanda.

Cerca de 20 estados y el sistema de la Universidad de California ya han presentado desafíos legales.

Los graduados de medicina nacidos en el extranjero tienden a trabajar en áreas desatendidas, dijo Matthew Shick, director de relaciones gubernamentales y asuntos regulatorios de la AAMC. La eliminación de DACA podría romper una conexión vital entre médicos y poblaciones que necesitan desesperadamente atención médica, apuntó.

Karla Ornelas es una estudiante de tercer año de medicina en la Universidad de California-Davis, y beneficiaria de DACA. Su meta es convertirse en médica de familia y volver al Valle Central. (Cortesía de Karla Ornelas)

Karla Ornelas planea convertirse en médica de medicina familiar y trabajar en el Valle Central de California, donde hay una gran necesidad de médicos, especialmente bilingües.

Ornelas, de 20 años, es licenciada en psicología y biología en la Universidad de California-Davis. Nació en México y llegó a los Estados Unidos a los 9 años.

La joven recientemente acompañó a su madre a una cita médica, como siempre lo hace, para traducir. Su madre tenía preguntas sobre los resultados de laboratorio, y como las decía en español y Ornelas las traducía al inglés, el médico se impacientó, les dijo que dejaran de hacer preguntas y que salieran del consultorio, contó Ornelas.

“Mi mamá quería llorar, y yo estaba sorprendida”, dijo Ornelas, quien creció en Turlock, California. “Fue entonces cuando me di cuenta de que no era sólo mi mamá, era toda una comunidad que confiaba en este médico para su atención médica”.

No está claro si hay soñadores que practican la medicina, dada la edad del grupo demográfico. Se les exigió tener menos de 31 años en el momento de la orden ejecutiva de Obama, dijo Kurt Mosley, vicepresidente de alianzas estratégicas de Merritt Hawkins, una empresa de reclutamiento de médicos.

Pero 65 soñadores fueron matriculados en escuelas de medicina en toda la nación durante el último año académico, dijo Shick.

“Suena como un pequeño número”, dijo, “pero están tratando entre 1.000 y 2.000 pacientes”.

La terminación de DACA también podría afectar la capacidad del país para atender a los pacientes de una manera culturalmente sensible, dijo Mosley. Las estadísticas apuntan a la necesidad: se espera que las minorías constituyan la mayoría de la población estadounidense para 2044, según la Oficina del Censo de los Estados Unidos. Para 2060, se espera que los hispanos, que constituyen la mayor parte de los soñadores, representen casi el 29% de la población.

“Somos una nación de diversidad, y nuestra fuerza de trabajo debe reflejar eso”, dijo Mosley. “Y [la disolución del DACA] es un paso atrás”.

Jennifer Rodríguez, de 28 años, dijo que frecuentemente ve la necesidad de mano de obra multicultural en un centro de atención psiquiátrica en Elkhart, Indiana, donde trabaja como asistente administrativa.

Los clientes latinos a menudo se acercan a ella para pedir ayuda, reconociendo una cara amistosa y preguntándole en cortadas palabras en inglés, si ella habla español.

Interpretar para los clientes no está dentro de sus tareas, y su jefe a veces le dice que diga que no, cuando la ve abrumada de trabajo.

“Pero nunca le haría eso a mi gente”, dijo Rodríguez, quien llegó a Goshen, Indiana, desde México, cuando tenía 3 años, y no recuerda su lugar de nacimiento.

“Esto es todo lo que sabemos, y sólo queremos ser ciudadanos productivos”, dijo. “Es hiriente que yo considere que éste es mi hogar, pero para otras personas soy ilegal”.

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

Trump’s Deadline On ‘Dreamers’ Reverberates Through Health Industries

September 18, 2017

Karla Ornelas said she has “always had the idea of being a doctor, I’ve never seen myself doing anything else.” The third-year pre-medical student at the University of California-Davis said she plans to become a family medicine physician and work in California’s Central Valley, where there is a great need for doctors and especially bilingual doctors.

But that dream could be uprooted if the Trump administration goes forward with its plan to end the Deferred Action for Childhood Arrivals (DACA) program, which allows young people brought to the U.S. by their parents without proper documentation to stay and work here. Ornelas, 20, was born in Mexico and came arrived to the U.S. at age 9.

Across the country, Jennifer Rodriguez, 28, faces the same problem. Rodriguez, who works at a psychiatric care facility in Elkhart, Ind., as an administrative assistant, arrived in Goshen, Ind., from Mexico when she was 3, with no recollection of her birthplace and no documents to prove she belonged in the nation she  calls home. Now she is worried that she will be able to stay.

“It’s hurtful that I consider this my home, yet to other people I am an illegal,” she said.

This KHN story also ran in USA Today. It can be republished for free (details).

In 2012, President Barack Obama established the DACA policy that gave a group of about 800,000 children and young adults freedom from concerns about being deported and the opportunity to earn a living.

On Sept. 5, Attorney General Jeff Sessions announced that President Donald Trump would cancel Obama’s executive order that set up DACA. Explaining the decision, the administration said that it did not believe Obama had the authority to set up the program and that it anticipated lawsuits from states seeking to end the program.

The administration is providing a six-month grace period until these protections end, giving Congress time to pass legislation to address the legal status of these immigrants, known as “Dreamers.”  Trump and Democratic lawmakers have agreed to work on a plan to extend the DACA program, but there are few details and conservatives have raised concerns.

There are no firm statistics showing how many Dreamers work in the health care sector, but industry leaders suggested that DACA’s end could have an impact, especially among medical students and home health aides.

Multiple health care groups denounced the administration’s move. A statement released by the Association of American Medical Colleges (AAMC) said its members are “extremely dismayed” by the decision.

“Even with the ‘wind down process’ described by the administration, the implications of this action for medical students, medical residents, and researchers with DACA status are serious, and will interfere with their ability to complete their training and contribute meaningfully to the health of the nation,” the group wrote.

The American Medical Association (AMA) said the administration’s announcement “could have severe consequences for many in the health care workforce, impacting patients and our nation’s health care system.” It urged Congress to pass a permanent solution.

“The more the administration threatens immigrants and their families and their communities,” said Robert Espinoza, vice president of policy at PHI, a long-term care advocacy group, “the more we threaten that workforce supply.”

One segment of the health care workforce that could be affected are medical students.

Students and residents may have to cut their training short, the AAMC said, and researchers may have to leave the country before completing their experiments. Foreign-born and international medical graduates also tend to work in underserved areas, said Matthew Shick, director of government relations and regulatory affairs at AAMC. Phasing out DACA could also sever a lifeline connection between doctors and populations in sore need of health care.

Karla Ornelas is a third-year pre-medical student at the University of California-Davis who registered for the DACA program. Her goal is to become a family medicine physician and return to the Central Valley. (Courtesy of Karla Ornelas)

Ornelas, whose family settled in Turlock, Calif., feels that need. For example, she said she accompanied her mother to a doctor’s appointment, as she usually does to help translate. Her mother, she said, had questions about lab results, and as her mother asked in Spanish and Ornelas repeated in English, the doctor grew impatient, told them to stop asking questions and walked out of the room.

“My mom wanted to cry, and I was shocked,” Ornelas said. “That’s when I realized that it wasn’t just my mom, it was an entire community that was relying on this doctor for health care.”

Sixty-five Dreamers were enrolled in medical schools across the nation during the last academic year, Shick said.

“It sounds like a small number,” he said, “but they’re treating anywhere between 1,000 and 2,000 patients in their clinical panel.”

Those medical students are needed to serve neglected communities as well as to alleviate the shortage of doctors. The AAMC projects a shortage of between 40,800 and 104,900 physicians by 2030. More than 43,000 of the empty slots are for primary care physicians.

Kurt Mosley, vice president of strategic alliances for Merritt Hawkins, a physician recruitment company, said he is unsure if there are any Dreamers practicing medicine given that group’s age (recipients were required to be younger than 31 at the time of the executive order).

DACA’s end could also have a large impact on the country’s ability to care for patients in a culturally sensitive manner, he said. And statistics point to the need — minorities are expected to constitute the majority of the U.S. population by 2044, according to the U.S. Census Bureau. By 2060, Hispanics — who make up the bulk of Dreamers — are expected to account for nearly29 percent of the U.S. population.

“You know we’re a nation of diversity, and our workforce should reflect that,” Mosley said. “And [dissolving DACA] is a step backwards.” Health care already relies on immigrants to fill the ranks. Over a fifth of Dreamers work in the health care or education industries, according to a 2016 survey by groups including the National Immigration Law Center and the Center for American Progress. Moreover, based on a separate 2015 survey by the immigrant advocacy organization United We Dream, nearly 23 percent want to pursue a career in health care.

Another sector of the workforce that heavily relies on foreign-born employees is direct care, which includes nurse aides, home health aides and personal care assistants. According to Espinoza, one-quarter of all employees are immigrants.

As the population ages, those jobs will continue to be in high demand. It’s hard to tell whether the vacancies that may be created by immigrants forced out of their jobs could be filled by the remaining population, he said.

“What our sector needs most is care,” Espinoza said. “And these kinds of federal decisions impede that — it impedes our ability to provide care.”

Rodriguez said she sees that need at her job often. The Latino clients frequently approach her for help, she said, recognizing a friendly face and asking in bits of broken English whether their native Spanish is familiar to her.

Interpreting for clients doesn’t fall under her job description, and her boss sometimes tells her to say no when she’s overwhelmed.

“But I would never do that to my people,” Rodriguez said. She wants to stay in the country and continue her work and life here.

Without DACA, Rodriguez said, she would have trouble caring for her family. She has two daughters and just purchased a home.

She is married to an American citizen, so she has petitioned for residency. However, the application is still being processed, she said, which means she relies on DACA to stay employed and keep her driver’s license. Many of her family members also depend on the program for legal protection, and she said she is worried what will happen to them.

Rodriguez identifies herself as a Mexican-American who considers Indiana home.

“This is all we know, and we just want to be productive citizens,” she said. “That’s all.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

This Gift Voucher Might Just Get You A Kidney 

September 15, 2017

Seven-year-old Quinn Gerlach got a gift certificate from his grandpa a few years back — not for a toy, a book or a game. It was for a kidney.

Gerlach was born with a single kidney, instead of the usual two, and it doesn’t fully function. So, one day, he may need a transplant.

Quinn’s grandfather, retired Tulare County Superior Court judge Howard Broadman, 68, of Visalia, Calif., learned he has the right blood and tissue types to be a donor for Quinn. But Broadman feared he might die or be too sick to donate a kidney when it was needed.

The former judge tried to think creatively, as he had on the bench — where he was known for unconventional and sometimes highly controversial sentencing.

This KHN story also ran on It can be republished for free (details).

He came up with what might be called the delayed kidney swap: He gave his kidney three years ago to Kathy DeGrandis, a retired airport manager in her 50s, at Ronald Reagan UCLA Medical Center. In exchange, Quinn was given a voucher that gives him priority to receive a live donor kidney, provided a match can be found when a transplant is necessary.

The idea caught on. Now about 30 hospitals around the country participate in this voucher program, administered by the National Kidney Registry. At least 21 kidneys have been donated by people in the U.S. in exchange for vouchers, according to the registry.

“If Quinn had needed the kidney right away, I was going to donate my kidney,” said Broadman. “But once he didn’t need it right away, I thought, why not pay it forward and maybe karma would come about.”

Still Waiting, But Worrying Less

More than 93,000 people await kidney transplants in the United States, and each year 4,500 people die before they can get one.

Most patients seeking a transplant join the long waiting list for kidneys from deceased donors. Some are able find a living person willing to donate a kidney. Live donor kidneys are most desirable — the organs last up to 12 years longer — but are less available.

Another limiting factor for a successful transplant is that the donor kidney must be a good “match,” carrying a compatible complement of genetic markers with the patient in need.

To address that problem, doctors more than a dozen years ago devised a process known as donation “chains.” If a friend or relative wanted to donate to a patient but was not a good match, he could donate to another kidney patient in the same predicament, with a willing but incompatible donor.

Each transplant patient in the chain must have a donor who matches someone who currently needs a kidney in the U.S. and is willing to donate to that stranger. Hospitals and transplant centers have matched up to 35 pairs in such chains.

Broadman, the Visalia grandfather, took that idea further, proposing that donors be able to give their organs in advance — essentially to save a person today so that a relative might be saved down the road.

“Sometimes [a patient] may be heading toward transplantation in the next few years, but it would be more convenient for a friend or family member to donate a kidney now,” said Dr. Jeffrey Veale, a transplant surgeon who initiated the voucher program at UCLA.

Maybe the donor is planning a pregnancy, travel or a new job or is worried about growing older — any of which could prevent a donation later, Veale said. Arranging the transaction early takes some — but not all — worry out of the situation.

Another possibility is for one compatible parent to directly donate a kidney to his or her child now while the other parent donates to a stranger for a voucher. That way, if the child’s first donated kidney fails — not uncommon — a second kidney might be obtained quickly.

Broadman’s idea was taken up by the National Kidney Registry, one of two registries in the U.S. that matches patients, through computer algorithms, with potential live donors. The registry works with participating hospitals such as UCLA, alerting them when a voucher holder matches a live donor in their system.

Experts and ethicists underscored that such surgeries can put donors at risk without benefiting their loved ones.

Christina Strong, an adjunct professor of health law at Rutgers in New Jersey who has worked extensively on health laws and policies for organ donation, says it has to be absolutely clear to everyone involved that having the donor give a kidney right now in no way guarantees that a compatible kidney will be found later for the intended recipient.

Contracts with donors contain a disclaimer to that effect.

UCLA officials say they have received dozens of inquiries from potential voucher donors, as well as from hospitals around the country, that want to set up voucher programs. Additional participating hospitals include those at UCSF, Georgetown, Emory and Cornell.

“We solve this problem one kidney at a time,” says Dr. Chris Freise, interim chief of the transplant division at UC-San Francisco Medical Center, which participates in the voucher program.

Freise and other kidney experts and advocates say the program also gives a boost to patients who don’t have a potential live donor or voucher. That’s because each time someone gets a live kidney, that almost always moves someone else up a notch on the deceased donor list.

Some researchers working on the holy grail of kidney transplantation, a bioengineered one, also are rooting for the success of voucher transplants.

“We’re a decade or more from being able to repair, restore or replace a kidney, so novel ideas like the voucher transplants are critical,” says Dr. Giuseppe Orlando, a transplant surgeon at Wake Forest Baptist Medical Center in Winston-Salem, N.C.

The voucher is earmarked and issued to a specific person, who is the only one who can use it, making it unlikely to be bought or sold. The recipient is required to provide U.S. government identification before any transplant can occur, and his or her blood and tissue types are checked to ensure they match what’s in the medical records.

‘Fully Engaged In The World’

Broadman’s grandson hasn’t had to use his voucher yet. Maybe he never will. But the retired judge has no regrets.

Months after his surgery, he met with the recipient, DeGrandis, at a barbecue the two families arranged.

“How has your life changed since the transplant?” he recalls asking DeGrandis.

She replied: “Where do you want me to start?”

Kathy DeGrandis holds a photo of herself with her parents right before she was selected to receive a kidney transplant through a new kidney voucher program at Ronald Reagan UCLA Medical Center in Los Angeles. (Heidi de Marco/KHN)

DeGrandis had been diagnosed decades earlier with polycystic kidney disease, a genetic condition causing the organs to fail over time. She remembers telling Broadman that she is healthier than she’s been in years, no longer “chained to dialysis,” that her singing voice came back. “And I feel fully engaged in the world around me rather than trying to struggle from moment to moment.”

At that point, Broadman said, his eyes welled up.

Sure, the recovery from surgery was painful, he tells would-be donors. Then he adds: “When you think of the downside, that is small, compared to the goodness.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Reporter’s Notebook: In Health Care, A Good Price (Or Any Price) Is Hard To Find

September 14, 2017

A recent story about why Northern California is the most expensive place in the country to have a baby began as a tip from an obstetrician. Dr. Sarah Azad told me that insurers were paying her just a third of what they pay doctors employed by large hospital systems in her town of Mountain View, Calif.

Unfortunately, she explained, she could speak only in general terms. She couldn’t share her actual payment rates with me because she was barred from doing so by a gag clause in her contracts with insurers.

So, I called the insurers who pay her, and the hospital systems that employ most of the other obstetricians in Mountain View. They all had the same answer: It would be illegal for them to tell me the dollars and cents.

Use Our ContentThis KHN story can be republished for free (details).

As it turns out, the vast majority of contracts between doctors or hospitals and insurance companies are subject to a gag clause, which prohibits either party from disclosing negotiated rates. That means it’s almost impossible for consumers, researchers or journalists to find actual, accurate numbers, despite the fact that cost differentials among doctors can be so stark. And it’s particularly problematic for the growing number of people who have insurance plans with deductibles that can run more than $10,000 for a family.

The underlying problem of our health care system — beyond the corrosive partisan politics — is its high cost. I have long understood that the lack of price transparency is one reason our system stays so expensive. It was a surprise, though, to find out that this opacity is cemented by legally binding contracts.

Think about what this would look like for a mundane purchase, say, a gallon of milk. Advertisements and price tags would disappear, so you couldn’t compare prices at different stores. And you wouldn’t even know how much you had paid for the milk until you got a bill in the mail weeks or months later. On top of that, the store and the dairy farmer would be barred from telling a journalist or an economist what you had paid.

It’s absurd, but I wasn’t going to let the absurdity kill my story.

I started by asking all of the health policy analysts, researchers and economists I could find, “How can I find these rates, by physician, for an uncomplicated vaginal delivery?” Everyone told me the same thing: You can’t get that.

I searched online, but most of the websites claiming to offer health price transparency offered only “average costs” for specific services in your area. Not much help if you’re trying to compare the costs of individual doctors.

Next, I asked Castlight, a “transparency tool” that gathers payment data and allows employees of certain companies to estimate the costs of their medical care. But Castlight told me that as a journalist, I wasn’t allowed to have access to the exact pricing information of individual providers. It, too, was subject to the gag clause.

So I turned to the consumers who might have access to those tools. I asked friends and colleagues, and put out social media requests: Would anyone be willing to share the information from the cost estimators they got from their employers or insurers? I found a few willing sources and was able to mine the results of their inquiries to find out the basic cost differentials between independent doctors and those employed by large systems, including Sutter Health.

Unfortunately, these estimators are difficult to use and often provide incomplete data. And when I tried to confirm that information, I ran up against the gag clauses again.

Finally, I found out about a health data company called Amino that was willing to send me the claims data it had been gathering. At last! The Holy Grail! It had hundreds of claims for vaginal births performed by obstetricians in the Bay Area. KHN data correspondent Sydney Lupkin helped me decipher a Medicare provider database to determine where each doctor worked. In cases where the doctor’s employment status was unclear, I called the health system or physician directly. We then calculated the median billing amount, on average, for a routine vaginal birth for each health system.

Weeks of digging and data analysis confirmed the imbalance Dr. Azad had told me about at the start of my quest. The few independent doctors left in the Bay Area receive a median amount of $2,408.45 for a routine vaginal delivery, which includes prenatal and postnatal visits. That compares with $5,238.13 for the same bundle of services provided by Stanford physicians and $8,049.84 when the doctors are employed by University of California-San Francisco — a fourfold difference.

Hard data, hard won.

The database we built gave us a strong sense of the cost variation between doctors who work at other health systems and those who have remained independent. But it did not include enough claims from the largest hospital system in the region, Sutter Health. For Sutter, I used the data from the online cost estimators, and found that obstetricians employed by the system are reimbursed about $6,452 for a vaginal delivery.

It’s no accident that data on physician costs are so hard to find. Its inaccessibility allows hospitals to keep raising their prices. It’s simply not in their interest for the public to know how much they’re charging. And insurers don’t want other doctors or hospitals to see the high prices they’ve agreed to pay, for fear they would demand the same.

In the end, all of us — through our insurance premiums and our taxes — pay a price for non-transparency.

FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program

September 13, 2017

The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

In a blog post Tuesday, FDA Commissioner Scott Gottlieb said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user fee waivers and seven years of market exclusivity if they developed medicines for rare diseases.

A KHN investigation earlier this year, which was published and aired by NPR, found many drugs that now have orphan status aren’t entirely new. Of about 450 drugs that have won orphan approval since 1983, more than 70 were drugs first approved by the FDA for mass-market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders and rheumatoid arthritis drug Humira, the world’s best-selling drug.

Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children. He also signaled that bigger changes are being considered, announcing a public meeting to explore issues raised by scientific advances, such as the increase in precision medicine and biologics.

This KHN story also ran on NPR. It can be republished for free (details).

“We need to make sure our policies take notice of all of these new challenges and opportunities,” he wrote. Gottlieb, through his agency, declined multiple requests for interviews.

Over the years, drugmakers have fueled a boom in orphan drugs, which often carry six-figure price tags. Nearly half of the new drugs approved by the FDA are now for rare diseases — even though many of them also treat and are marketed for common diseases.

Gottlieb became commissioner in May, a few months after three key Republican senators called for a federal investigation into potential abuses of the Orphan Drug Act, and the Government Accountability Office agreed to investigate.

The GAO has yet to begin its investigation, saying it doesn’t expect to start work until late this year, when staff is available. Regardless, in late June, Gottlieb announced what would be the first in a series of updates that shift the way the FDA handles orphan drugs.

Those include:

  • Eliminating a backlog in drug applications for orphan designation or status. Getting a “designation” is a critical first step if a company wants to win orphan incentives once the drug is approved for treatment use. And, much like the rise in approvals, the requests by companies to get drugs designated with orphan status has also skyrocketed. Gottlieb said in June that he wanted to get rid of the backlog; on Tuesday, he said the effort was complete. About half of the 200 applications from drugmakers won orphan status.
  • Mandating that drugmakers prove their medicine is clinically superior before getting the market exclusivity that comes with being an orphan. The agency had lost a lawsuit in which a company said it was owed the exclusivity period regardless of whether its medicine was better. And two more lawsuits had been filed by Eagle Pharmaceuticals and, more recently, another by United Therapeutics. The FDA Reauthorization Act, which passed last month, made it law that a drug has to be clinically superior to get the incentives.
  • Closing the loophole for pediatric orphan drugs by requiring all drugs approved for common adult diseases, like inflammatory bowel disease, undergo pediatric testing when getting approval as a pediatric orphan drug. Pediatric testing is not required for orphan drugs, and last month Congress mandated that orphan drugs for cancer be tested for children. Still, the American Academy of Pediatrics celebrated the proposed change but warned it was only a “first step.” Dr. Bridgette Jones, chair of American Academy of Pediatrics Committee on Drugs, said late Tuesday that orphan drugs are “still mostly exempt from pediatric study requirements … children deserve access to safe, effective medications.”

Dr. Martin Makary, who wrote a critical 2015 paper on orphan approvals, said the changes at the agency indicate that Gottlieb seems “concerned about all the right things.”

“The government does a lot of lip service in general,” Makary said. “This is not lip service.”

The restructuring has been swift in some ways.

Sandra Heibel, a senior consultant at Haffner Associates, a firm that helps companies submit orphan drug applications, noted that the approval process for designations definitely sped up over the summer, and “we are absolutely getting responses from the FDA back in 90 days. That has come through.”

Other changes to the agency, though, will evolve slowly. For example, the orphan drug office has begun reaching across the FDA’s divisions for help in reviewing drugs. In May, the FDA’s orphan reviews began to work with the office of pediatric therapeutics to review pediatric applications — ideally increasing the expertise applied when considering a company’s request for orphan drug use in children.

In an emailed note Tuesday, the agency confirmed that Gottlieb’s orphan modernization plan is part of a larger effort to increase competition and decrease drug prices. One focus is on targeted drugs — especially those that affect rare diseases or diseases for which there is no effective therapy, the agency said.

“Such drugs present some of the biggest opportunities in medicine to treat and cure debilitating and very costly diseases,” the agency stated.

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