At US Hospitals, a Drug Mix-Up Is Just a Few Keystrokes Away

More than four years ago, Tennessee nurse RaDonda Vaught typed two letters into a hospital’s computerized medication cabinet, selected the wrong drug from the search results, and gave a patient a fatal dose.

Vaught was prosecuted this year in an extremely rare criminal trial for a medical mistake, but the drug mix-up at the center of her case is anything but rare. Computerized cabinets have become nearly ubiquitous in modern health care, and the technological vulnerability that made Vaught’s error possible persists in many U.S. hospitals.

Since Vaught’s arrest in 2019, there have been at least seven other incidents of hospital staffers searching medication cabinets with three or fewer letters and then administering or nearly administering the wrong drug, according to a KHN review of reports provided by the Institute for Safe Medication Practices, or ISMP. Hospitals are not required to report most drug mix-ups, so the seven incidents are undoubtedly a small sampling of a much larger total.

Safety advocates say errors like these could be prevented by requiring nurses to type in at least five letters of a drug’s name when searching hospital cabinets. The two biggest cabinet companies, Omnicell and BD, agreed to update their machines in line with these recommendations, but the only safeguard that has taken effect so far is turned off by default.

“One letter, two letters, or three letters is just not enough,” said Michael Cohen, the president emeritus of ISMP, a nonprofit that collects error reports directly from medical professionals.

“For example, [if you type] M-E-T. Is that metronidazole? Or metformin?” Cohen added. “One is an antibiotic. The other is a drug for diabetes. That’s a pretty big mix-up. But when you see M-E-T on the screen, it’s easy to select the wrong drug.”

A Five-Letter Fix: Making It Stick

Omnicell added a five-letter search with a software update in 2020. But customers must opt in to the feature, so it is likely unused in many hospitals. BD, which makes Pyxis cabinets, said it intends to make five-letter searches standard on Pyxis machines through a software update later this year — more than 2½ years after it first told safety advocates the upgrade was coming.

That update will be felt in thousands of hospitals: It will be much more difficult to withdraw the wrong drug from Pyxis cabinets but also slightly more difficult to pull the right one. Nurses will need to correctly spell perplexing drug names, sometimes in chaotic medical emergencies.

Robert Wells, a Detroit emergency room nurse, said the hospital system in which he works activated the safeguard on its Omnicell cabinets about a year ago and now requires at least five letters. Wells struggled to spell some drug names at first, but that challenge is fading over time. “For me, it’s become a bigger hassle to pull drugs, but I understand why they went there,” Wells said. “It seems inherently safer.”

Computerized medication cabinets, also known as automated dispensing cabinets, are the way almost every U.S. hospital manages, tracks, and distributes dozens to hundreds of drugs. Pyxis and Omnicell account for almost all the cabinet industry, so once the Pyxis update is rolled out later this year, a five-letter search feature should be within reach of most hospitals in the nation. The feature may not be available on older cabinets that are not compatible with new software or if hospitals don’t regularly update their cabinet software.

Hospital medication cabinets are primarily accessed by nurses, who can search them in two ways. One is by patient name, at which point the cabinet presents a menu of available prescriptions to be filled or renewed. In more urgent situations, nurses can search cabinets for a specific drug, even if a prescription hasn’t been filed yet. With each additional letter typed into the search bar, the cabinet refines the search results, reducing the chance the user will select the wrong drug.

The seven drug mix-ups identified by KHN, each of which involved hospital staff members who withdrew the wrong drug after typing in three or fewer letters, were confidentially reported by front-line health care workers to ISMP, which has crowdsourced error reports since the 1990s.

Cohen allowed KHN to review error reports after redacting information that identified the hospitals involved. Those reports revealed mix-ups of anesthetics, antibiotics, blood pressure medicine, hormones, muscle relaxers, and a drug used to reverse the effects of sedatives.

In a 2019 mix-up, a patient had to be treated for bleeding after being given ketorolac, a pain reliever that can cause blood thinning and intestinal bleeding, instead of ketamine, a drug used in anesthesia. A nurse withdrew the wrong drug from a cabinet after typing in just three letters. The error would not have occurred if she had been required to search with four.

In another error, reported mere weeks after Vaught’s arrest, a hospital employee mixed up the same drugs as Vaught did — Versed, a sedative, and vecuronium, a dangerous paralytic.

Cohen said ISMP research suggests requiring five letters will almost entirely eliminate such errors because few cabinets contain two or more drugs with the same first five letters.

Erin Sparnon, an expert on medical device failures at ECRI, a nonprofit focused on improving health care, said that although many hospital drug errors are unrelated to medication cabinets, a five-letter search would lead to an “exponential increase in safety” when pulling drugs from cabinets.

“The goal is to add as many layers of safety as possible,” Sparnon said. “I’ve seen it called the Swiss cheese model: You line up enough pieces of cheese and eventually you can’t see a hole through it.”

And the five-letter search, she said, “is a darn good piece of cheese.”

Vaught, a former nurse at Vanderbilt University Medical Center in Nashville, was arrested in 2019 and convicted of criminally negligent homicide and gross neglect of an impaired adult during a controversial trial in March. She could serve as much as eight years in prison. Her sentencing May 13 is expected to draw hundreds of protesters who feel her medical error should not have been prosecuted as a crime.

At trial, prosecutors argued Vaught made numerous mistakes and overlooked obvious warning signs while administering vecuronium instead of Versed. But Vaught’s first and foundational error, which made all other errors possible, was inadvertently withdrawing the vecuronium from a cabinet after typing just V-E. If the cabinet had required three letters, Vaught probably would not have pulled the wrong drug.

“Ultimately, I can’t change what happened,” Vaught said, describing the mix-up to investigators in a recorded interview that was played at her trial. “The best I can hope for is that something will come of this so a mistake like that can’t be made again.”

After the details of Vaught’s case became public, ISMP renewed its calls for safer searches and then held “multiple calls” with BD and Omnicell, Cohen said. ISMP said that, within a year, both companies confirmed plans to tweak their cabinets based on its guidance.

BD raised the default on Pyxis cabinets to a three-letter minimum in 2019 and intends to raise it to five in a software update expected “by the end of summer,” spokesperson Trey Hollern said. Cabinet owners will be able to turn off this feature because it’s “ultimately up to the health care system to configure safety settings,” Hollern said.

Omnicell added a “recommended” five-letter search through a software update in 2020 but left the feature deactivated, so its cabinets allow searches with a single letter by default, according to a company news release.

Perilous Typos: M-O-R-F-I-N-E

At least some hospitals must have activated the Omnicell safety feature because they’ve begun to alert ISMP to workflow problems — spelling errors or typos — made worse by requiring more letters. Omnicell declined to comment for this story.

Ballad Health, a chain of 21 hospitals in Tennessee and Virginia, activated the five-letter search while installing new Omnicell cabinets this year.

CEO Alan Levine said it was an easy choice to engage the safety feature after the Vaught case but that the transition has laid bare an unflattering truth: Lots of people, even highly trained professionals, are bad spellers. “We have people that try to spell morphine as M-O-R-F-I-N-E,” Levine said.

Ballad Health officials said one of the most common issues arose in emergency rooms and operating rooms where patients need tranexamic acid, a drug used to promote blood clotting. So many nurses were delayed at cabinets by misspelling the drug by adding an S or a Z that Ballad posted reminders of the proper spelling.

Even so, Levine said Ballad would not deactivate the five-letter search. Because of the pandemic and widespread staffing shortages, nurses are “stretched” and more likely to make a mistake, so the feature is needed more than ever, he said.

“I think, given what happened to the nurse at Vanderbilt, a lot of [nurses] have a better appreciation of why we are doing it,” Levine said. “Because we’re trying to protect them as we are the patient.”

Some nurses remain unconvinced.

Michelle Lehner, a nurse at a suburban Atlanta hospital that activated the five-letter search last year, said she believed hospitals would be better served by isolating dangerous medications like vecuronium, instead of complicating the search for all other drugs. Five-letter search, while well-intentioned, might slow nurses down so much that it causes more harm than good, she said.

As an example, Lehner said that about three months ago, she went to retrieve an anti-inflammatory drug, Solu-Medrol, from a cabinet with the safety feature. Lehner typed in the first five letters of the drug name but couldn’t find it. She searched for the generic name, methylprednisolone, but still couldn’t find it. She called the hospital pharmacy for help, but it couldn’t find the medication either, she said.

After almost 20 minutes, Lehner abandoned the dispensing cabinet and pulled the drug from a non-powered, “old school” medication cart the hospital normally reserves for power outages.

Then she realized her mistake: She forgot the hyphen.

“If this had been a situation where we needed to give the drug emergently,” Lehner said, “that would have been unacceptable.”

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

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Frente al patio de comidas: sistemas de salud abren consultorios y clínicas en centros comerciales

El enorme centro comercial Hickory Hollow, un total de 1,1 millones de pies cuadrados en el sureste de Nashville, fue una vez el mall más grande de Tennessee. Pero como muchos otros, ha estado cayendo en picada por más de una década.

Ahora, el gigantesco complejo rodeado de acres de estacionamiento está en camino de unirse a las filas de los centros comerciales que hacen la transición a un sector económico en auge: la medicina.

El Centro Médico de la Universidad de Vanderbilt planea agregar clínicas médicas en el antiguo Hickory Hollow Mall, rebautizado hace una década como Global Mall at the Crossings.

“Las posibilidades de ofertas de servicios en una instalación de esta escala son infinitas”, dijo en marzo el doctor Jeff Balser, director ejecutivo del centro médico. Lo que más necesitan los sistemas de salud de grandes ciudades es algo que los centros comerciales tienen en abundancia: espacio y estacionamiento. Ofrecen comodidad para los pacientes y los médicos, además de costar menos que expandir un campus hospitalario existente.

En todo el país, 32 centros comerciales albergan servicios de atención médica en al menos parte de su espacio, según una base de datos creada por Ellen Dunham-Jones, profesora de diseño urbano de Georgia Tech.

Uno de los primeros fue Jackson Medical Mall en Mississippi, fundado por el doctor Aaron Shirley en 1996. Casi un tercio de esas transformaciones médicas se han anunciado desde el comienzo de la pandemia de covid-19.

Las adiciones más recientes incluyen Capital Hill Mall en Helena, Montana, donde Benefis Health System está construyendo una clínica de atención primaria y especializada de 60,000 pies cuadrados en parte del sitio de 13 acres que comenzó su debacle en 2019.

En Alexandria, Virginia, Inova Health System es parte de un desarrollo de uso mixto de mil millones de dólares en el sitio de Landmark Mall, que incluye planes para un hospital de servicio completo y un centro de trauma.

Los cierres por covid, tanto obligatorios como voluntarios, forzaron a cerrar a muchos minoristas tradicionales que ya estaban al borde de la quiebra. Pero la reutilización médica del espacio comercial es más que un oportunismo pandémico, según un artículo de noviembre en Harvard Business Review. Los autores sugieren que el aumento de la telemedicina y el impulso continuo hacia los procedimientos ambulatorios harán que los centros comerciales sean lugares cada vez más atractivos para la atención médica.

La propuesta también tiene sentido para los inversionistas de bienes raíces. Todos los propietarios de centros comerciales ahora buscan oportunidades de uso mixto, dijo Ginger Davis de Trademark Properties en Charleston, Carolina del Sur.

En 2017, su empresa comenzó a remodelar el centro comercial Citadel, cuyo inquilino principal es ahora la Universidad Médica de Carolina del Sur. Las clínicas y los centros de cirugía se encuentran en la antigua tienda departamental de J.C. Penney.

“En este momento están realizando cirugías en donde la gente solía comprar sábanas y toallas”, dijo Davis.

En muchos casos, la transición a la medicina pretende complementar lo que queda del comercio minorista. En Citadel Mall, mientras uno de los miembros de una pareja se somete a una cirugía ambulatoria, el otro espera haciendo compras en Target.

“Sentimos que este modelo puede funcionar en comunidades de todo el país que están luchando con centros comerciales similares que tienen un desempeño deficiente”, dijo.

Desde 2009, Vanderbilt Health ha agregado 22 clínicas especializadas a casi medio millón de pies cuadrados de One Hundred Oaks, un centro comercial que aún es propiedad de inversionistas. El centro comercial conserva a los grandes minoristas en la planta baja, pero ahora el resto del espacio es prácticamente todo médico.

En algunos de estos acuerdos, como los de los centros comerciales Landmark de Alexandria y Hickory Hollow de Nashville, el gobierno local ha comprado la propiedad del centro comercial que rentan al sistema hospitalario, por lo que esas partes ya no generan impuestos sobre la propiedad.

Algunos centros comerciales en quiebra como Hickory Hollow en Nashville se encuentran en vecindarios de minorías que necesitan un mayor acceso a los servicios de salud. Los códigos postales circundantes tuvieron las tasas más altas de infecciones por covid de Nashville al principio de la pandemia y tienen algunas de las tasas más bajas de visitas de atención primaria, según los datos de la encuesta de la organización sin fines de lucro NashvilleHealth.

Las ubicaciones de los centros comerciales siguen siendo deseables. Muchas son incluso más convenientes para poblaciones densas e interestatales que cuando se construyeron hace casi 50 años, antes de que los suburbios circundantes se superpoblaran.

Cuando la jubilada Jennifer Johnson se mudó a Nashville para estar más cerca de su nieto, su familia le advirtió que no viera a un médico en el campus principal de Vanderbilt, que está en constante construcción. Rápidamente entendió por qué.

“Es un zoológico”, dijo. “Primero tienes que conducir a través del laberinto del estacionamiento, que está en construcción. Luego debes averiguar qué ascensor tomar, a qué piso vas a llegar”.

En One Hundred Oaks, dijo, “puedes subir por la escalera mecánica y seguir recto por el pasillo, fácil”.

A pesar del tamaño y la antigüedad de muchos centros comerciales, son bastante fáciles de recorrer en comparación con muchos hospitales. En Charleston, el Citadel Mall usa yardas al estilo del fútbol americano marcadas en el piso para ayudar a los pacientes a encontrar la clínica adecuada.

Por el contrario, muchos campus hospitalarios confunden a los pacientes. El sitio principal de Vanderbilt en el área de West End de Nashville se ha ampliado dos docenas de veces desde que se construyó el primer edificio en 1925.

“La mayoría de estos hospitales están en áreas donde simplemente no hay espacio para crecer. Y si lo hacen, es muy costoso”, dijo Andrew McDonald, ex administrador del hospital que dirige la consultoría de atención médica para la firma de consultoría y contabilidad LBMC. “Estos edificios son viejos. Son anticuados. Son muy caros de mantener”.

Los centros comerciales encajan bien, al menos para los grandes sistemas de salud, dijo McDonald. Esencialmente, pueden mover todo menos la sala de emergencias y la unidad de cuidados intensivos, incluidos los centros de cirugía e imágenes, y mantenerlos agrupados. La resonancia magnética puede estar al otro lado del pasillo.

“Simplemente crea un flujo mucho más eficiente para el paciente que pasa por el sistema de atención médica con cualquier enfermedad que pueda tener”, dijo McDonald.

La renovación de Vanderbilt del antiguo centro comercial Hickory Hollow también creará una fuente de empleo para técnicos médicos de Nashville State Community College, que ya tiene una instalación en lo que anteriormente era una tienda de Dillard.

La atención agrupada en centros comerciales suburbanos también tiene sentido debido a la demografía que los rodea, dijo Dunham-Jones. Estas áreas ya no están ocupadas principalmente por familias jóvenes, que fueron en masa a los vecindarios y centros comerciales construidos en la década de 1970.

“Los adultos todavía están en los suburbios, pero los niños han crecido hace mucho tiempo”, dijo Dunham-Jones. Y ahora los padres mayores que se quedaron son “consumidores constantes de atención médica”.

Esta historia es parte de una asociación que incluye la Radio Pública de Nashville y KHN.

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

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Shopping for Space, Health Systems Make Over Malls

The hulking Hickory Hollow Mall — a full 1.1 million square feet of retail space in southeastern Nashville — was once the largest shopping center in Tennessee. But like many malls, it’s been in a downward death spiral for more than a decade.

Now the mammoth complex surrounded by acres of parking is on track to join the ranks of malls making a transition into a booming economic sector: medicine. Vanderbilt University Medical Center has had such success reviving a different mall that its health system, Vanderbilt Health, plans to add medical clinics at the former Hickory Hollow Mall, rebranded a decade ago as the Global Mall at the Crossings.

“The possibilities for service offerings in a facility of this scale are endless,” Dr. Jeff Balser, the medical center’s CEO, announced in March. What big-city health systems need most is something shopping malls have plenty of: space and parking. They offer convenience for patients and practitioners, as well as costing less than expanding an existing hospital campus.

Nationwide, 32 enclosed malls house health care services in at least part of their footprint, according to a database kept by Ellen Dunham-Jones, a Georgia Tech urban design professor. One of the first was Jackson Medical Mall in Mississippi, founded by Dr. Aaron Shirley in 1996. Nearly a third of those medical transformations have been announced since the start of the covid-19 pandemic.

The more recent additions include the Capital Hill Mall in Helena, Montana, where Benefis Health System is building a 60,000-square-foot primary care and specialty clinic on part of the 13-acre site that was razed in 2019. In Alexandria, Virginia, Inova Health System is part of a billion-dollar mixed-use development on the Landmark Mall site, which includes plans for a full-service hospital and trauma center.

The lockdowns brought by covid — both required and voluntary — pushed many bricks-and-mortar retailers already on the brink out of business. But medicine’s reuse of retail space is more than pandemic opportunism, according to a November article in the Harvard Business Review. The three authors suggest the rise of telemedicine and continued push toward outpatient procedures will make malls increasingly attractive locations for health care.

The proposition makes sense for commercial real estate investors, too, especially as mall owners struggle. A few went bankrupt during the pandemic. Every mall owner is now looking for mixed-use opportunities, said Ginger Davis of Trademark Properties in Charleston, South Carolina.

In 2017, her company started redeveloping the Citadel Mall, whose anchor tenant is now the Medical University of South Carolina. The clinics and surgery centers are housed in the old J.C. Penney department store.

“Right now they’re doing surgery where people used to buy sheets and towels,” Davis said.

In many cases, the transition to medicine is intended to complement what remains of the retail. At Citadel Mall, a spouse with a partner having outpatient surgery must stay on-site. But browsing Target, Davis said, still counts as on-site.

“We feel like this model can work in communities across the country that are struggling with similar malls that are underperforming,” she said.

Since 2009, Vanderbilt Health has added 22 specialty clinics to nearly a half-million square feet of One Hundred Oaks, a mall still owned by investors. The mall retains big-box retailers on the ground floor, but the mall interior is now virtually all medical.

In some of these deals, such as those for Alexandria’s Landmark and Nashville’s Hickory Hollow malls, the local government has bought the mall property that the hospital system leases, so those portions no longer generate property taxes.

Some failing malls like Hickory Hollow in Nashville are in diverse neighborhoods that need increased access to health services. The surrounding ZIP codes had Nashville’s highest rates of covid infections early in the pandemic and they have some of the lowest rates of primary care visits, according to survey data from the nonprofit NashvilleHealth.

Mall locations remain desirable. Many are even more convenient to dense populations and interstates than when they were built nearly 50 years ago, before surrounding suburbs filled in.

When retiree Jennifer Johnson moved to Nashville to be closer to her grandchild, her family warned her not to see a doctor at Vanderbilt’s main campus, which is under perpetual construction. She quickly understood why.

“It’s a zoo,” she said. “First you get to drive through the maze of the parking garage, which is under construction. Then you try to find out which elevator you’re going to get to, get to what floor you’re going to get to.”

At One Hundred Oaks, she said, “you can go straight up the escalator and straight down the hall — easy peasy.”

Despite the size and age of many malls, they are fairly easy to navigate compared with many hospitals. In Charleston, the Citadel Mall uses football-style yardage marked on the floor to help patients find the right clinic (a detail that its owner insisted on and dubbed the “secret sauce”).

By contrast, many hospital campuses confound patients. Vanderbilt’s main site in the West End area of Nashville has been expanded two dozen times since the first building was constructed in 1925.

“Most of these hospitals are in areas where there’s just no room to grow. And if you do, it’s so expensive,” said Andrew McDonald, a former hospital administrator who leads health care consulting for accounting and consulting firm LBMC. “These buildings are old. They’re antiquated. They’re very expensive to maintain.”

Malls make for a nice fit, at least for big health systems, McDonald said. They can essentially move everything short of the emergency room and intensive care unit — including surgery and imaging centers — and keep them clustered. While doctor offices are often scattered around a hospital district, in a mall setting, if someone needs an MRI, it’s right beyond the food court under the same sprawling roof.

“It just creates a whole lot more efficient flow for the patient going through the health care system with whatever infirmity they may have,” McDonald said.

Vanderbilt’s renovation of the former Hickory Hollow Mall will also create an employment pipeline for medical technicians from Nashville State Community College, which already has a location in what was previously a Dillard’s department store.

The mall has been mostly empty for years, which makes no sense to nearby resident Ricky Grigsby. The area around it is otherwise booming.

“Somebody needs to do something with it,” he said. “It could be jobs for somebody.”

Grigsby just retired from Vanderbilt after a career spent managing surgical instruments for busy operating rooms on the main campus. Now he’s a patient along with everyone else — looking for a more convenient place to receive care.

Bundling care in suburban shopping mall sites also makes sense because of their surrounding demographics, Dunham-Jones said. These areas are no longer filled primarily with young families, who first flocked to the planned neighborhoods and shopping centers built in the 1970s.

“The adults are still in the suburbs, but the kids have long since grown,” Dunham-Jones said. And now those aging parents who remain are “pretty heavy-duty health care consumers.”

This story is from a partnership that includes Nashville Public Radio and KHN.

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

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Physicians Are Uneasy as Colorado Collects Providers’ Diversity Data

Shaunti Meyer, a certified nurse-midwife and medical director at STRIDE Community Health Center in Colorado, doesn’t usually disclose her sexual orientation to patients. But at times it feels appropriate.

After telling a transgender patient that she is a lesbian, Meyer learned the woman had recently taken four other trans women, all estranged from their birth families, under her wing. They were living together as a family, and, one by one, each came to see Meyer at the Aurora clinic where she practices. Some were at the beginning of their journeys as transgender women, she said, and they felt comfortable with her as a provider, believing she understood their needs and could communicate well with them.

“They feel more connected because I’m part of the community,” Meyer said.

Research shows that when patients see health providers who share their cultural background, speak the same language, or mirror their experiences, their health care outcomes improve. Now, Colorado is trying to help patients find such providers. As part of this effort, the state is asking insurers offering certain health plans to collect demographic information, such as race, ethnicity, disability status, sexual orientation, and gender identity, from both health professionals and enrollees — a move that some health care workers say could threaten their safety.

A new state law takes effect later this year that requires insurers to offer the “Colorado Option,” a plan on the state-run Affordable Care Act marketplace with benefits that have been standardized by the state. Colorado is requiring those plans to build out culturally responsive provider networks, with a diverse set of health practitioners who can meet the needs of a diverse population.

Some other states — including California — and Washington, D.C., require plans sold on their health insurance marketplaces to collect demographic data from patients, although not providers, and patients are generally asked only about their race and ethnicity, not their sexual orientation or gender identity.

“Nobody knows how many particular racial or ethnic identities they might have among their providers, what the percentages are, and how they correspond with the communities that they serve,” said Kyle Brown, Colorado’s deputy commissioner for affordability programs. “Traditionally, data like this isn’t collected.”

The state and insurers will be able to see how similar the plans’ patient and provider populations are and then work on ways to narrow the gap, if needed. For example, a plan might find that 30% of its enrollees are Black but that only 20% of its providers are.

Colorado had considered including providers’ demographic data in directories so patients could use it to choose their doctors. But after physician groups raised privacy concerns, the state opted to make reporting of the demographic data by providers voluntary and confidential. That means insurers must ask, but the providers can decline to answer. And the data collected will be reported to the state only in aggregate.

State officials and consumer advocates hope that the demographic data could eventually help inform patients. But, for now, the physician groups and other stakeholders fear that making the data public could subject some providers, particularly LGBTQ+ people, to harm.

“There are a lot of really conservative parts of Colorado,” said Steven Haden, a mental health therapist and CEO of Envision:You, a Denver-based nonprofit focusing on LGBTQ+ behavioral health services. “In lots of communities outside of our metropolitan areas, it’s not safe to be out.”

State officials say the Colorado Option will be the first health plan in the nation built specifically to advance health equity, a term used to describe everyone having the same opportunity to be healthy. The framework includes better coverage for services that address health disparities. It requires anti-bias training for providers, their front-office staffers, and health plan customer service representatives. Plans must increase the number of community health centers — which treat more patients from underserved communities than other clinics — in their networks, as well as certified nurse-midwives, to help reduce maternal mortality.

Health plans’ directories will have to list the languages spoken by providers and their front-office staffers, say whether offices are accessible for those with physical disabilities, and note whether a provider has evening or weekend hours.

But officials are trying to figure out how they might use demographic data to guide patients to practitioners with similar identities while avoiding unintended consequences, particularly around sexual orientation or gender identity.

Dr. Mark Johnson, president of the Colorado Medical Society, said more doctors than ever feel comfortable disclosing their sexual orientation or gender identity, but incidents of disgruntled patients who lash out by referencing a physician’s personal characteristics do still occur.

“Even though we’re a purple state, there’s still a lot of bias here and there,” he said. “There could be some real problems that come out of this, so I am hoping they will be very, very sensitive to what they’re doing.”

LGBTQ+ patients often deal with stigma in health settings, which can result in negative experiences that range from feeling uncomfortable to being outright mistreated.

“There are lots of marginalized and disenfranchised people that when they don’t have a good experience, they disengage from care. They don’t go back to that provider,” Haden said. “So needs remain unmet.”

As a result, Haden said, LGBTQ+ people have rates of depression, anxiety, overdose, and suicide that are two to four times the rate of straight, cisgender people.

Many people in the LGBTQ+ community share information about which doctors and clinics are welcoming and competent and which to avoid. Finding medical professionals who are themselves LGBTQ+ is a way of increasing the likelihood that a patient will feel comfortable. But many experts stress that being trained in LGBTQ+ health care is more important for a provider than being part of that community.

“The best doctor to go to is someone who’s done the work to understand what it means to be a safe, affirmative practice,” said Jessica Fish, director of the Sexual Orientation, Gender Identity and Health Research Group at the University of Maryland.

Many health plans allow enrollees to search for providers who have such training but don’t identify which ones are part of the LGBTQ+ community themselves. Deciding to self-identify to patients or colleagues can be difficult and often depends on a provider’s circumstances.

“There are multiple variables that contribute to one’s comfort level and decision whether or not disclosure is safe for them,” said Nick Grant, a clinical psychologist and president of GLMA: Health Professionals Advancing LGBTQ Equality, formerly the Gay and Lesbian Medical Association. “In different areas of the country, it depends on what the climate is. National politics have influenced those conversations.”

Grant said the debate over transgender laws in conservative states like Florida and Texas has a chilling effect on doctors across the country, making them less willing to come out. In contrast, the moves toward culturally responsive networks being made by Colorado, he said, help signal that the state is much more protective of LGBTQ rights.

“I’ve never seen anything similar in the other states,” he said.

The new data collection requirement will apply only to Colorado Option plans, which become available in 2023 and are likely to enroll just a portion of the more than 200,000 people who purchase plans through the state’s health insurance marketplace. But state officials hope that health plans will use some of the same network-building strategies for their other plans.

Colorado’s approach has caught the eyes of other states. And as part of a new federal health equity initiative, the Centers for Medicare & Medicaid Services recently announced it would collect more demographic data — covering race, ethnicity, language, sexual orientation, gender identity, disability, income, geography, and other factors — across all CMS programs, which cover 150 million people.

“We have learned from bits and pieces of what other states have been doing and what the national leading experts have been talking about in terms of health equity and cultural competence, and we have synthesized that into something that we think is really leading the nation,” said Brown, the Colorado affordability programs official. “People are going to look at Colorado as an example.”

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

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Despite Losing Federal Money, California Is Still Testing Uninsured Residents for Covid — For Now

SACRAMENTO, Calif. — California is still offering free covid testing to uninsured residents even though the federal government ran out of money to pay for it.

While Congress debates whether to put more money into free testing, California is leaning on programs it already had in place: special state-based coverage for uninsured Californians, school testing, and free tests offered by clinics, counties, and other groups. Absent free options, people without health insurance could pay as much as several hundred dollars out-of-pocket depending on where they get tested.

At the same time, demand for community testing — from residents with and without insurance — has dropped precipitously.

On a recent Thursday, only three people could be found getting tested at seven testing sites in Sacramento County. Staffers at these locations — from the formerly bustling mass-testing site at the state fairgrounds to a tiny kiosk in a church parking lot — said hardly anyone shows up anymore even though testing is still important for monitoring and reducing the spread of covid-19. They mostly see regulars who come in for routine testing required by their employer or school.

Dr. Olivia Kasirye, the public health officer for Sacramento County, said the county sends specimens to a state lab at no cost to the county, which has helped keep free testing services up and running. California is quietly ending its contract with a central lab, but the state says it will shift testing to a network of commercial labs. State officials told KHN there will be no changes for patients.

“I think we can maintain services” for now, but the future is uncertain, Kasirye said.

Since the beginning of the pandemic, the federal government had reimbursed providers for testing, treating, and vaccinating uninsured people for covid-19. But the Health Resources and Services Administration stopped accepting reimbursement claims for tests and treatments March 22, and for vaccinations April 5, saying the money had run out. The government had been reimbursing providers $36 to $143 per test.

Since then, states and counties have been watching their case rates and coffers to see whether they can keep testing uninsured residents.

In Alabama, Dr. Scott Harris, the state health officer, said offering free testing to people five days a week through county health departments is “probably not something we’re going to be able to sustain much longer,” especially in pockets of the state with large uninsured populations.

“We’re going to have zero services for those people,” Harris said. “And no ability to incentivize providers to see them.”

Congress returns from recess in late April but may not renew the program. Lawmakers previously considered extending it but chose not to include money for it in a $10 billion covid funding deal that’s been pending since early April.

The Covid-19 Uninsured Group

Health care advocates say California has been able to continue free testing for the uninsured, including for residents without legal documentation, because of how it used a separate pot of federal funding. Although 15 other states also leveraged pandemic support, advocates believe California expanded benefits the most.

In August 2020, California created an insurance program with pandemic relief money to cover covid-related treatments, testing, and vaccines for uninsured people or those whose insurance plans don’t cover those services. The Covid-19 Uninsured Group essentially acts as Medicaid for covid, but with no income requirements. That’s different from traditional Medi-Cal, California’s Medicaid program, which is for low-income people.

Coverage will end when the federal public health emergency does. On April 13, the U.S. Department of Health and Human Services renewed the emergency declaration for 90 days, extending it to mid-July.

The state program is a clever way to use federal dollars, said David Kane, a senior attorney at the Western Center on Law & Poverty. But he noted there are drawbacks. People must be enrolled before they can obtain services, and they can’t enroll themselves. Only certain health care providers, mostly hospitals and clinics, can sign people up.

“The program was never designed to exist in isolation,” Kane said, “but now it does.”

About 291,000 people were enrolled in the program as of April 4, according to Anthony Cava, a spokesperson for the state Department of Health Care Services, which administers Medi-Cal. An estimated 3.2 million Californians, or around 9.5% of people younger than 65, are uninsured.

Kane suggested that people find a qualified provider from a database maintained by the Department of Health Care Services or by calling the Medi-Nurse line and get enrolled as soon as possible, especially if they are used to walking up to a testing site and paying nothing.

The challenge is getting people to sign up before they get sick or need a test, Kane said, and keeping the program going with the added patient load.

Screening Students

Another major source of free testing in California is public schools.

California distributed more than 14.3 million at-home tests to schools before students left for spring break. The schools in turn handed out the rapid tests to families so they can screen students before sending them back to campus. The state had a similar program for the winter holidays.

The winter testing was “incredibly effective,” according to Primary Health, the company running the program for the state. About 77% of K-12 families voluntarily reported their results back to a sampling of schools, according to the company.

In addition, the state is paying Primary Health to operate more than 7,000 free testing sites — most of which are in schools — by using leftover federal covid relief money disbursed to states at the beginning of the pandemic.

How long that funding will last isn’t clear.

“It seems like the federal government is stepping back and saying this portion of health care is going back to health care as we know it,” said Abigail Stoddard, Primary Health’s general manager of government and public programs.

Stoddard’s conversations with schools outside California are changing. Instead of conducting surveillance testing to determine whether the virus is circulating on campus, as California is doing, many are moving toward testing only kids with symptoms, she said.

For example, Primary Health operates in Minnesota, where schools are applying for grants to fund testing and will decide whether tests will be for sick students, healthy ones, or just staffers.

Local Free Testing

Free testing is still available in California through some hospitals, community clinics, local health departments, and private companies working with the state, although how long those options will remain is unclear.

In Sacramento County, the loss of federal funding for testing uninsured people has gone mostly unnoticed so far. “Our hope is that we have enough services and resources in the community that the additional coverage going away will not have a huge impact,” Kasirye said.

The county health department still offers free community testing to uninsured people every day at churches or community centers.

But they may get harder to find. The testing company Curative used to offer free lab-run PCR and rapid antigen tests around the state, but now that the federal funding has run out, it offers only PCR tests to the uninsured for free. The company has also reduced the number of its sites, from 283 on April 14 to 135 on April 19.

In some states, Curative has either stopped testing uninsured people — or is charging them $99 to $135 per test.

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

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

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Se desploma la asistencia a eventos de vacunación contra covid en Los Ángeles

Los Ángeles.- La enfermera Angel Ho-king mueve la cabeza al son de música de salsa mientras espera que la gente se arremangue para recibir una inyección. Ho-king es parte de un equipo de cuatro personas que trabaja en una mesa de vacunación contra covid-19 en una feria de salud en Rampart Village, un vecindario predominantemente inmigrante a unos 10 minutos del Dodger Stadium.

Durante tres horas de un sábado reciente, Ho-king y Brenda Rodríguez, una asistente médica, vacunaron a 16 personas, mucho menos de lo que habían anticipado. Casi todos los que asistieron a la feria organizada por Saban Community Clinic eran adultos que buscaban vacunas de refuerzo o niños pequeños que recibían una primera dosis (los menores de 5 a 11 años pueden vacunarse desde finales del año pasado).

A medida que las infecciones por covid han ido disminuyendo, también lo ha hecho el interés en las vacunas, a pesar de que estas dosis son altamente efectivas para evitar enfermarse de gravedad y morir a causa del virus.

En el condado más poblado de California, donde más de 1,7 millones de personas no han recibido ni una sola dosis, las campañas de vacunación se han vuelto desoladoras. Alrededor de 46,000 residentes del condado recibieron su primera dosis en marzo, una disminución del 79% con respecto a enero, según el Departamento de Salud Pública del Condado de Los Ángeles.

Aquellos que siguen sin vacunarse son más difíciles de convencer, y les dicen a los trabajadores de salud y a los coordinadores de vacunación que no sienten que sea algo urgente.

Según una encuesta de enero realizada por el Public Policy Institute de California, aproximadamente 1 de cada 10 adultos en California dijo que definitivamente no se vacunaría, lo que no ha cambiado desde enero de 2021, y el 86% de los adultos no vacunados dijo que la variante ómicron no era suficiente para persuadirlos.

Los empleadores y las empresas están eliminando o revirtiendo los mandatos de vacunación. Y aunque la prueba de vacunación alguna vez ofreció beneficios, como permitir que las personas entraran sin máscara, generalmente ya no se requieren cubrebocas en California.

En una reciente campaña de vacunación coordinada por un grupo de defensa de inmigrantes en Palmdale, cerca de Lancaster, en el norte del condado de Los Ángeles, solo dos personas se presentaron durante cuatro horas, ambas para tener su segunda dosis.

Al 1 de abril, el 25% de los residentes de Palmdale mayores de 5 años no estaba vacunado, en comparación con el 17% de los residentes del condado, según datos oficiales.

Jorge Pérez, coordinador de vacunas de la Organización Salva, pasó una semana promocionando el evento con su equipo, yendo de puerta en puerta, visitando comercios locales y promoviéndolo o en las redes sociales. En campañas de vacunación anteriores, “tuvimos 42 personas, luego 20, luego cuatro”, dijo Pérez decepcionado. “Ahora dos”.

Pérez redujo el número de empleados en las campañas de vacunación de cinco a dos en febrero a medida que la cantidad de personas comenzó a bajar.

Queda mucho trabajo por hacer para combatir la desinformación sobre las vacunas, especialmente dada la propagación de BA.2, una subvariante de ómicron que es altamente transmisible, dijo el doctor Richard Seidman, director médico de L.A. Care, un plan de seguro público de Medicaid que sirve a los residentes del condado. El número de casos covid y las hospitalizaciones habían disminuido desde febrero, pero el condado está viendo de nuevo un aumento en los casos, según datos publicados la semana del 11 de abril.

La gente tiene varias razones para no vacunarse, dijo Seidman. “Para algunos, es desconfianza del gobierno o de los proveedores de atención médica en general”, indicó. “Algunos son más cautelosos y quieren tomar un enfoque de esperar y ver. Otros simplemente no creen en la ciencia.”

Un estudio publicado el 11 de abril por JAMA Internal Medicine muestra cuán arraigadas son estas opiniones. Muchas personas que se negaron a vacunarse desde el principio dijeron que estaban esperando que las vacunas obtuvieran la aprobación completa de la FDA. Pero cuando la agencia aprobó por primera vez una vacuna contra covid en agosto de 2021, el estudio concluyó que eso sirvió poco para cambiar la opinión de esas personas y “tuvo poco impacto inmediato en las intenciones de vacunación”.

En California, los no vacunados tenían casi 14 veces más probabilidades de morir de covid que los que habían sido vacunados por completo y recibieron una dosis de refuerzo, según datos estatales correspondientes al período del 7 al 13 de marzo.

Pérez dijo que las personas que reciben sus primeras vacunas ahora lo hacen principalmente porque se sienten obligadas, por ejemplo, para cumplir con un requisito laboral o entrar en lugares como restaurantes, bares y gimnasios que requieren prueba de vacunación.

Ese fue el caso de Modesto Araizas, una de las dos personas que se presentaron en el evento de vacunas de Palmdale. A pesar de contraer covid dos veces, faltar al trabajo y tener dificultades para respirar, no se vacunó hasta que necesitó presentar su tarjeta de vacunación para comer en su restaurante de mariscos favorito.

“No he tenido miedo”, dijo Araizas, de 46 años. “Tomo vitaminas, como alimentos saludables y hago ejercicio”.

Hasta hace poco, el gobierno federal reembolsaba a médicos, hospitales y otros proveedores por pruebas, tratamientos y vacunas para personas sin seguro. Pero la Administración de Recursos y Servicios de Salud dejó de aceptar reclamos de reembolso por pruebas y tratamientos el 22 de marzo, y por vacunas el 5 de abril.

Es probable que ahora muchas personas sin seguro deban pagar de su bolsillo las pruebas y otros servicios. Pérez espera que la gente sea más receptiva a las vacunas si las pruebas de covid se vuelven demasiado caras para ellos. Nadie va a querer seguir pagando por las pruebas cuando pueden recibir una dosis, razonó.

La enfermera Roxanna Segovia trabaja en una clínica temporal de pruebas y vacunas al otro lado de la calle de South LA Cafe en South Central Los Ángeles.

Recientemente pasó 45 minutos tratando de persuadir a un hombre que había visitado la clínica regularmente para hacerse pruebas gratuitas para que se vacunara.

“Me dio todas las razones por las que no se había vacunado, como que se violaron sus derechos civiles y hasta versículos de la Biblia”, dijo Segovia. “Su trabajo lo requiere ahora, y dijo que estaba perdiendo dinero al faltar esperando los resultados de las pruebas. Si continuaba así, no podría alimentar a su familia, pero con todo y eso, todavía no estaba seguro de si estaba tomando la decisión correcta”.

Al final de la conversación, se vacunó.

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

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

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Heartbeat-Tracking Technology Raises Patients’ and Doctors’ Worries

If someone’s heart skips a beat, tech companies want to let them know about it.

Gadget firms — starting with Apple and now Fitbit, which is owned by Google — are selling wearable devices that check heartbeat rhythms and alert users when something is out of sync.

These products involve some feats of technology. Many use sophisticated optical sensors that peer beneath the skin to monitor how blood volume changes — almost like tracking the tides — and thereby tally heartbeats. Other devices have a miniature electrocardiogram — which records the heart’s electrical activity — embedded. Either method can detect irregular heartbeats — and potentially atrial fibrillation, a condition that affects an estimated 2.7 million Americans and drives up the risk of stroke and heart failure. When a person has it, the beating in the heart’s upper chambers is erratic, and blood doesn’t flow as well as it should to the heart’s lower chambers.

Still, although the gadgets are a technical achievement, some cardiologists say the information the devices produce isn’t always useful. Notifications from the devices aren’t definitive diagnoses.

It’s a conundrum, and a consequential one, for the health care system. Tens of millions of people are armed with these devices, and if even a small fraction of those get a ping, it could mean much more care and costs for the system.

“The technology has outpaced us,” said Rod Passman, a cardiologist at Northwestern University who’s assisting with a study examining the Apple Watch’s ability to screen for the heart rhythm condition. “Industry came out with these things because they could. Now we’re playing catch-up and trying to figure out what to do with this information.”

Heart rhythm sensors are among many tools packed into these wearables. Users can have their steps counted, their sleep tracked, and their gaits analyzed. Some products will call 911 if the wearer has been in a car crash or had a bad fall.

Those features are meant to make patients the protagonists in maintaining their health. During an event touting Fitbit’s atrial fibrillation function, company co-founder James Park said it was one of several features of the brand’s fitness-tracking bands that are “making users effortlessly in control of health and wellness.”

The wearable’s atrial fibrillation ping — a “test [doctors] didn’t order,” Passman said — tells patients there’s something potentially irregular. Ultimately, though, any treatment is left to the doctor.

The initial visits don’t always provide quick answers. To corroborate a notification, a cardiologist outfits patients with medical-grade diagnostics — a patch or bulky monitor — that are more accurate than wearables. (The Apple Watch, for example, is cleared by the FDA for “informational use only.”) That fancier device may have to operate for a while to catch a momentary missed beat. That waiting means more time and money, spent on more visits to the doctor.

Getting a diagnosis “can be quite the odyssey,” said Ethan Weiss, a cardiologist at the University of California-San Francisco. Patients can become anxious along the way. Social media forums like Reddit show that many users wonder whether their watches or their doctors are more reliable. “It is still freaking me out,” one user wrote, even after a doctor told him he was likely fine.

“There’s going to be a period of uncertainty,” acknowledged Tony Faranesh, a research scientist at Fitbit. He said the company provides educational material to users warned of a potential arrhythmia.

Studies about the prevalence of anxiety that results from atrial fibrillation pings are hard to come by. Fitbit collected such information, Faranesh told KHN, as part of a survey submitted to the FDA for clearance of its device. But the full results of the study — which collected information from 455,000 patients — aren’t yet available.

Diagnosis isn’t the same as knowing what the best treatment should be. For example, treating otherwise healthy patients with anticoagulants — the standard treatment for atrial fibrillation — may expose them to unnecessary side effects.

According to doctors interviewed by KHN, atrial fibrillation is a broad condition. Some patients have many bouts in a given year and symptoms like fatigue or shortness of breath. Some patients don’t notice a thing.

In the past, fleeting fibrillation wouldn’t have been detected, let alone treated. And wearable technology users are healthier and wealthier than the typical atrial fibrillation patient. A new Apple Watch costs around $400; the cheapest Fitbit is $50. (Company officials couldn’t say which Fitbit devices would have the atrial fibrillation detection function, although they said they were committed to making the tech widely available.)

The combination of the health condition’s low burden and healthier patients means cardiologists aren’t entirely sure what to do with this cohort of patients.

Between the anxiety and the unknowns, the tech companies have nonetheless started the health system on a massive science experiment.

Huge swaths of people have embraced wearable gadgets. Analysts at Counterpoint Research said the Apple Watch — which has included the atrial fibrillation-scanning feature since 2018 — crossed 100 million users worldwide last summer. Fitbit likely has tens of millions more users. How many of them will have the new feature once it’s available isn’t yet clear.

More companies are coming. “Everyone wants to add higher- and higher-caliber medical-grade sensors” to their consumer gadgets, said Dr. Justin Klein, managing partner of Vensana Capital, a venture capital firm. It’s “going to drive patients to clinics to get these diagnoses confirmed,” Klein said.

Companies are broadening the capabilities of the wearables even further. Klein said big tech and startups alike are eyeing more conditions for gadgets to passively alert users about, from blood oxygen levels to high blood pressure.

Figuring out what to do with these new doodads is up to patients and doctors.

Northwestern’s Passman considers himself an optimist when it comes to the potential of the devices. In an interview — sporting an Apple Watch on his wrist — he said the devices can help doctors and patients manage conditions and respond quickly when there’s a funny flutter. And doctors can use the devices to confirm whether their treatments for atrial fibrillation are working, cardiologists like Passman say.

Still, the feature is likely to lead to headaches for cardiologists. “It’s caused some increased burden, handling phone calls, office visits,” Weiss said — and all for an as-yet-unclear benefit.

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

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Why Cheap, Older Drugs That Might Treat Covid Never Get Out of the Lab

In March 2020, Dr. Joseph Vinetz left the contemplative world of his Yale University infectious-disease laboratory and plunged into the covid ward at Yale New Haven Hospital, joining an army of health care workers who struggled to treat the deadly viral disease.

There were no drugs against covid-19, and no way to predict which infected patients would develop pneumonia or fall into an inflammatory tailspin leading to severe illness or death. In desperation, Vinetz and countless other doctor-scientists trawled the literature for existing medicines that might help.

“We were in the hospital. We had nothing,” Vinetz said. “I was one of tens of thousands of doctors around the world who said, ‘We gotta figure out what to do.’”

On April 16, 2020, Vinetz saw an article in the journal Cell about a drug called camostat, licensed in Japan in 1985 to treat inflammation of the pancreas. Research during the first SARS epidemic, in 2004, had shown the drug had a plausible biochemical mechanism for slowing coronavirus infections, so Vinetz and his colleagues quickly organized a small clinical trial on outpatients with mild to moderate symptoms.

In those days, before covid vaccines and covid-specific treatments appeared on the market, Vinetz’s experiment was one of thousands conducted by doctors who hoped older vaccines and drugs, usually cheap and off-patent, might provide them with options.

Mostly, the drugs were too toxic or had no clear effect. Of the more than 1,500 trials for potential covid drugs listed on the website of the National Institutes of Health — including antivirals, anti-inflammatories, and drugs used for cancer, asthma, heart disease, and dozens of other conditions — few have produced helpful medicines.

In fact, only one older drug is routinely used to fight covid. That’s the steroid dexamethasone, proven by British scientists to help keep hospitalized patients from requiring supplemental oxygen or intubation.

Drugs like hydroxychloroquine and ivermectin showed hints of value initially but failed in clinical trials — only to remain in circulation, at least partly because their use symbolized affinity in the culture war for some of President Donald Trump’s followers.

A few old drugs still show promise, but they’ve had trouble getting traction. The ivermectin and hydroxychloroquine fiascoes soured doctors on repurposed medications, and the pharmaceutical industry has shown little interest in testing them, especially when it can earn billions from even mediocre new ones, scientists tracking the field say.

American and European scientists have confirmed the theoretical basis for camostat’s impact on covid. But evidence for its effects is weak; last year the drug was dropped from a big NIH trial comparing various treatments.

A more promising story emerged with fluvoxamine, licensed under the brand name Luvox in 1994 to treat obsessive-compulsive disorder. The drug is in the same class as common antidepressants such as Prozac, Lexapro, and Zoloft.

A child psychiatrist noticed fluvoxamine might be good for covid. In March 2020, while recovering from a bout of covid, Dr. Angela Reiersen of Washington University in St. Louis saw a 2019 study in mice that showed how fluvoxamine could activate a protein similar to one missing in patients with Wolfram syndrome, a genetic disease that causes diabetes, neurological issues, and, eventually, death.

Reiersen and her colleague Dr. Eric Lenze, a geriatric psychiatrist, began a clinical trial of the drug in people with symptoms of covid. Of the 80 in the fluvoxamine group, none suffered a serious decline, while six of 72 patients given sugar pills got pneumonia, and four were hospitalized.

In a follow-up 1,500-patient trial in Brazil, people who took at least 80% of their fluvoxamine pills were 66% less likely to require emergency care or hospitalization than those who got sugar pills. Only one died, compared with 11 in the placebo group.

Since October, when the Brazilian study was published, fluvoxamine’s future has dimmed. Neither the NIH nor the Infectious Diseases Society of America recommends fluvoxamine to prevent respiratory distress. The NIH panelists noted that the better outcomes in the Brazilian trial were only statistically significant among those who remained in the trial. (Because of nausea and other side effects, only 74% of trial participants in the fluvoxamine wing took all their pills, compared with 82% in the placebo wing.)

The NIH panel also was put off by the fact that the Brazilian trial counted hospitalizations as well as people put under a doctor’s care for six hours or more — not a standard measure. Trial organizers said that was necessary because Brazilian hospitals were so packed with covid patients that many people got their care in makeshift outdoor shelters.

Regulators and experts are awaiting results from two other big trials, one organized by a consortium of universities and hospitals, the other by the NIH. But both studies are using doses of 100 milligrams of fluvoxamine a day, compared with 200 or 300 milligrams in the successful trials.

“I have concerns that they are not using a high-enough dose,” Reiersen said, given that fluvoxamine operates on a different biochemical pathway to fight covid than the one involved in psychiatric treatment.

The concern is shared by Craig Rayner, a former drug company scientist who worked on the Brazilian trial and other big tests of repurposed drugs. “You can do the largest, most well-funded study in the world,” he said, “but if you choose the wrong dose, it’s rubbish in, rubbish out.”

The team overseeing NIH’s trial opted for a lower dose because higher doses had already been used in the earlier trials — and often caused side effects, said Sarah Dunsmore, a program director at NIH’s National Center for Advancing Translational Sciences.

On Dec. 21, David Boulware, a University of Minnesota infectious-disease expert, petitioned the FDA to approve a change in fluvoxamine’s label stating it can be used to prevent respiratory distress in at-risk patients with mild to moderate covid. He hasn’t received a response yet.

It’s a different story for big drug companies. Two days after Boulware’s submission, FDA authorized Merck to market its drug molnupiravir, which in its clinical trial showed about as much effectiveness as fluvoxamine, and also had side effects like nausea and dizziness. Fluvoxamine also can cause insomnia and anxiety; molnupiravir is not recommended for pregnant women or anyone, male or female, having unprotected sex, because it caused genetic and fetal damage in test animals.

Still, federal guidelines recommend molnupiravir in certain settings, and the government has bought more than 3 million doses for about $2.2 billion, or $733 per dose. Fluvoxamine, a generic, goes for less than $5 a pill.

“You hate to say that Big Pharma has a lot of influence, but clearly they do,” Boulware said. “The molnupiravir data was not that great, but we’re spending billions on the drug and it got fast-track emergency use authorization” while fluvoxamine remains in a gray area.

With the arrival of effective vaccines and the trickle of antiviral treatments, the urgency of rehabilitating old drugs for U.S. patients has ebbed. But the need remains high in lower- and middle-income countries where vaccines and new covid treatments remain unavailable.

It’s not rare for a pharmaceutical company to synthesize or study a drug for one purpose, only to discover it works better for something else. The classic instance is sildenafil, or Viagra, which was being developed as a drug for hypertension when scientists noticed a remarkable side effect. Remdesivir, now a front-line drug against covid, was aimed at treating Ebola.

It’s less common for a drug marketed for one use to acquire an entirely different purpose, but the pandemic drove scientists to try. They tested thousands of compounds in petri dishes for their virus-killing power, but the journey from test tube to human remedy is long, said Rayner, who is also a professor of pharmaceutical sciences at Monash University in Melbourne, Australia.

If fluvoxamine were a new drug, the company sponsoring it would have spent the money needed to get the drug approved and to show the FDA it has the means to monitor the drug’s safety and efficacy. Since it’s an old drug, it will be up to independent scientists, or perhaps a reluctant generics manufacturer, to sponsor safety monitoring should the FDA provide an emergency use authorization, Rayner said.

An EUA or approval “comes with strings. You have to continue to monitor the safety, to make sure no signals pop up when you move it from thousands to millions of patients,” he said. “That’s very expensive.”

U.S. physicians can prescribe drugs off label, but most are leery of doing so until a drug has won approval for the new use. That’s especially true now.

Definitive answers on some repurposed drugs were slow in coming because there were too many small, poorly designed studies by “every man and his dog,” Rayner said. He calculates up to $5.6 billion has been wasted on hydroxychloroquine clinical trials alone.

A recent World Health Organization resolution called for better coordination and information-sharing among those organizing trials so that definitive answers can be obtained quickly with big pots of data.

As for camostat, Vinetz said those who took the drug felt better than those who got a placebo. “It basically prevented loss of smell and taste, which people really bitterly care about,” he said. “That means there’s a real biological effect. That merits further exploration.”

But will that happen? Vinetz’s team has sought publication of their research for five months with no success. He’d like to see whether camostat can prevent long covid, but such investigations cost millions. Camostat’s Japanese manufacturer apparently lost interest in it as a covid drug after its own small, unsuccessful trial.

“When there’s no profit motive, it’s tough,” Vinetz said. Meanwhile, he’s resumed his research into controlling a neglected tropical disease: leptospirosis.

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

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Attendance Plummets at LA Covid Vaccination Events

LOS ANGELES — Nurse Angel Ho-king sways her head to the sound of salsa music as she waits for people willing to roll up their sleeves to get a shot. Ho-king is part of a four-person crew staffing a covid-19 vaccine table at a health fair in Rampart Village, a predominantly immigrant neighborhood about 10 minutes from Dodger Stadium.

In three hours on a recent Saturday, Ho-king and Brenda Rodriguez, a medical assistant, vaccinated 16 people — far fewer than they had anticipated. Nearly everyone who showed up at the fair, organized by Saban Community Clinic, was an adult seeking a booster shot or a young child getting a first dose (children ages 5 to 11 became eligible for a vaccine late last year).

As covid infections have declined so too has interest in covid vaccines — even though the shots are highly effective at preventing serious illness and death from the virus.

In California’s most-populous county, where more than 1.7 million people have not received even one dose, vaccination events have turned desolate. About 46,000 county residents got their first dose in March, a 79% decline from January, according to the Los Angeles County Department of Public Health.

Those who remain unvaccinated are harder to convince, telling health care workers and vaccination coordinators that they don’t feel a sense of urgency.

According to a January survey by the Public Policy Institute of California, about 1 in 10 California adults said they definitely won’t get vaccinated, which has remained consistent since January 2021, and 86% of unvaccinated adults said the omicron variant wasn’t enough to persuade them. Employers and businesses are dropping or rolling back vaccination mandates. And although proof of vaccination once offered perks like allowing people to go maskless indoors, face coverings are generally no longer required in California.

At a recent vaccination drive coordinated by an immigrant advocacy group in Palmdale, near Lancaster in northern LA County, only two people showed up over four hours, both for second doses. As of April 1, 25% of Palmdale residents ages 5 and up were unvaccinated, compared with 17% of county residents, according to county data.

Jorge Perez, Salva Organization’s vaccine coordinator, spent a week promoting the event with his team, going door to door, visiting local businesses, and publicizing it on social media. At previous vaccine drives, “we got 42 people, then 20, then four,” said a disappointed Perez. “Now two.”

Perez reduced the number of staffers at vaccination events from five to two in February as the numbers started to dwindle.

Much work remains to be done to combat vaccine misinformation, especially given the spread of BA.2, an omicron subvariant that is highly transmissible, said Dr. Richard Seidman, chief medical officer for L.A. Care, a public Medicaid insurance plan that serves county residents. The number of covid cases and hospitalizations had been declining since February, but the county is again seeing a bump in cases, according to data released this week.

People have various reasons for remaining unvaccinated, Seidman said. “For some, it’s distrust of the government or health care providers in general,” he said. “Some are more cautious and want to take a wait-and-see approach. Others simply don’t believe the science.”

A study published April 11 by JAMA Internal Medicine shows just how entrenched views are. Many people who refused to get vaccinated early on said they were waiting for the shots to get full approval from the FDA. But when the agency’s first full approval of a covid vaccine came in August 2021, the study concluded, it did little to change people’s minds and “had little immediate impact on vaccination intentions.”

In California, unvaccinated people were nearly 14 times as likely to die from covid as people who had been fully vaccinated and received a booster dose, according to state data from March 7-13.

Perez said people getting their first shots now are doing so mainly because they feel obligated — to meet a work requirement, for example, or enter places such as restaurants, bars, and gyms that require proof of vaccination.

That was the case for Modesto Araizas, one of the two people who showed up at the Palmdale vaccine event. Despite contracting covid twice, missing work, and having a hard time breathing, he didn’t get vaccinated until he needed proof of vaccination to eat at his favorite seafood restaurant.

“I haven’t been scared,” said Araizas, 46. “I take vitamins, eat healthy food, and I work out.” 

Until recently, the federal government reimbursed doctors, hospitals, and other providers for tests, treatments, and vaccines for uninsured people. But the Health Resources and Services Administration stopped accepting reimbursement claims for tests and treatments March 22, and for vaccinations April 5.

Many uninsured people now will likely need to pay out-of-pocket for tests and other services.

Perez is hoping people might become more open to vaccines if covid tests become too expensive for them. No one will want to keep paying for tests when they can just get a shot, he reasoned.

Nurse Roxanna Segovia works at a pop-up vaccine and testing clinic in front of South LA Cafe in South Central LA. She recently spent 45 minutes trying to persuade a man who had visited the clinic regularly for free tests to get vaccinated.

“He gave me all the reasons he has not been vaccinated, like his civil rights were being violated and Bible verses,” Segovia said. “His job requires it now, and he said he was losing money by missing work waiting for test results. If he continued this way, he wouldn’t be able to feed his family, but even so, he still wasn’t sure if he was making the right choice.”

At the end of their conversation, he got the shot.

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

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

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Battle Lines Are Drawn Over California Deal With Kaiser Permanente

[Editor’s note: KHN is not affiliated with Kaiser Permanente.]

California counties, health insurance plans, community clinics, and a major national health care labor union are lining up against a controversial deal to grant HMO giant Kaiser Permanente a no-bid statewide Medicaid contract as the bill heads for its first legislative hearing Tuesday.

The deal, hammered out earlier this year in closed-door talks between Kaiser Permanente and Gov. Gavin Newsom’s office and first reported by KHN, would allow KP to operate Medi-Cal plans in at least 32 counties without having to bid for the contracts. Medi-Cal’s other eight commercial health plans must compete for their contracts.

Medi-Cal is California’s version of Medicaid, the federal-state program that provides health coverage to low-income people.

Opponents of the KP proposal say they were blindsided by it after having spent months planning for big changes happening in Medi-Cal, which serves more than 14 million Californians. They say the deal would largely allow KP to continue picking the enrollees it wants, and they fear that would give it a healthier and less expensive patient population than other health plans.

Currently, the state allows KP to limit its Medi-Cal membership by accepting only those who have been its members in the recent past, primarily in employer-based or Affordable Care Act plans, and their immediate family members.

“A closed system that excludes vulnerable populations is inequitable,” the heads of 10 county boards said in a letter to Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee, which will consider the proposal. They questioned whether Kaiser Permanente would be assigned patients with “more complex physical, behavioral, and socio-economic needs versus giving the existing safety net system and local plans, who do not exclude populations, a disproportionate share of complex and costly patients.”

Kaiser Permanente said in an emailed statement that, under the terms of the deal, it would take more Medi-Cal patients with high needs and would collaborate with counties and other health plans on patient care.

Michelle Baass, director of the Department of Health Care Services, which runs Medi-Cal, told KHN in early February that the deal would “ensure that more low-income patients have access to Kaiser’s high quality services” and “lead to better health care for more Medi-Cal enrollees.”

The deal must win state legislative and federal approval. Opposition to the bill that would codify it, AB 2724, is being spearheaded by Local Health Plans of California, which represents the 16 local, publicly governed Medi-Cal plans that cover most of the 12 million Medi-Cal beneficiaries in managed care. The proposal would make many of them direct competitors of Kaiser Permanente, and they could lose hundreds of thousands of enrollees and millions of dollars in Medi-Cal revenue.

Among them are some of the state’s largest Medi-Cal health plans, including L.A. Care, by far the biggest, with 2.4 million members; and the Inland Empire Health Plan, with about 1.5 million members in San Bernardino and Riverside counties.

In addition, the boards of supervisors of 16 counties had registered their opposition as of April 15, as had the California State Association of Counties, at least two community clinic groups, and the National Union of Healthcare Workers, which represents thousands of KP clinicians.

The other commercial Medi-Cal plans are lying low as they bid for the state’s Medi-Cal business. The two largest, Health Net and Anthem Blue Cross, declined to comment.

The public health plans and many of the counties said the proposal was sprung on them after they spent months preparing for major Medi-Cal shifts — for example, a more demanding contract with the state, scheduled to take effect in 2024, and an ambitious $6 billion project to provide enrollees with nontraditional services, such as food assistance, home modifications, and help with housing.

Some medical providers are also critical of the proposal.

Leslie Conner, CEO of Santa Cruz Community Health, which operates three clinics in Santa Cruz County, said her group is building a $19 million primary care clinic based on estimates — available at the time the plan was drawn up — of the number of uninsured residents and Medi-Cal members who don’t have a doctor.

“It’s just not helpful to have to recalculate when Kaiser comes in taking more primary care lives,” Conner said. “We didn’t get a chance to talk through that with the state or with Kaiser.”

Conner said that KP, which currently doesn’t have Medi-Cal members in Santa Cruz County, has generously collaborated with Santa Cruz Community Health in the past and that she expects that to continue.

“I’m more disturbed by the state doing this negotiation with a private company,” she said. “That’s just wrong.”

Kaiser Permanente said in its emailed statement that the Department of Health Care Services approached it with the proposal and that it agreed to collaborate “because we recognize, fundamentally, the benefits to the enrollees.” The proposal, it said, “meets the fundamental objectives the state has for Medi-Cal: to improve quality, reduce complexity and improve patient outcomes.”

KP, which covers 9.4 million Californians, the vast majority in its commercial plans, has 912,000 Medi-Cal enrollees. Most of them are through subcontracts with other Medi-Cal health plans in 17 counties, and the rest are in the five counties where KP already contracts directly with the state.

Kaiser Permanente calls its current enrollment-limiting arrangement continuity of care, but critics say it leaves other health plans at a disadvantage — and they worry about it becoming enshrined in state law. In addition to leaving them with a disproportionate share of sicker, costlier patients, they say, it could saddle them with lower quality ratings from the state.

But KP said its mix of sick and healthy Medi-Cal patients is “comparable to other Medi-Cal managed care plans.” It added that the proposal calls on it to increase the number of its Medi-Cal enrollees, including those from “more vulnerable populations.”

Under the proposal, KP has committed to increasing its Medi-Cal membership 25% over the five years of the contract. It would accomplish this partly by taking previous KP enrollees in counties where it currently doesn’t have Medi-Cal members, according to an 11-page document released in March by the Department of Health Care Services. KP would also take, for the first time, a limited number of the enrollees who don’t choose a plan when they sign up for Medi-Cal. And it would enroll children in foster care and the typically complex, expensive patients who are eligible for both Medi-Cal and Medicare.

As of April 15, many details were not yet in the bill language, which will be fleshed out and debated over the next several months.

For instance, the bill makes no mention of the 25% enrollment growth target. And although the Department of Health Care Services document says KP’s direct contract would cover 32 counties, the bill leaves that number open.

“The state clearly has to disclose a lot more information and detail about how this will work,” said Edwin Park, a California-based research professor with Georgetown University’s Center for Children and Families.

Felicia Matlosz, a spokesperson for the bill’s author, Assembly member Joaquin Arambula (D-Fresno), said his office is “working to reconcile the language” with the state’s proposal.

Arguably, the health plans that would be most affected by this proposal are those that are the sole Medi-Cal plan in their counties, known as county organized health systems, or COHS.

They were created by the boards of their counties and operate in partnership with the counties, their safety-net health facilities, and private-sector medical providers. In the 40 years since they were established in California, they have been the only state-contracted Medi-Cal plan in their counties.

“It’s the end of the model,” said Stephanie Sonnenshine, CEO of the Central California Alliance for Health, a county organized health system for Santa Cruz, Monterey, and Merced counties. “It’s a significant policy change that hasn’t been vetted as a policy change.”

KHN correspondent Rachel Bluth contributed to this report.

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

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

USE OUR CONTENT

This story can be republished for free (details).



from Health Industry – Kaiser Health News

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