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National Academies’ Report Took Pharma-Friendly Stance After Millions in Gifts From Drugmakers

Thu, 08/12/2021 - 5:00am

To several U.S. senators, it looked wasteful, even outrageous. Every year, taxpayers pay for at least $750 million worth of expensive pharmaceuticals that are simply thrown away. Companies ship many of the drugs in “Costco”-size vials, one lawmaker said, that once opened usually cannot be resealed or saved for other patients. Yet pharma gets paid for every drop.

So Congress turned to the prestigious National Academies of Sciences, Engineering and Medicine for advice, given its reputation for “independent, objective reports” on such matters. The national academies’ influential report, released in February, struck physicians who’ve tracked the issue as distinctly friendly to Big Pharma. It advised against an effort to recoup millions for the discarded drugs. It concluded that Medicare should stop tracking the cost of the drug waste altogether.

Yet the report left out a few key facts, a KHN investigation has found.

Among them: One committee member was paid $1.4 million to serve on the board of a pharmaceutical corporation in 2019 and in 2020 joined the board of a biotechnology company that lists government “cost containment” efforts as a risk to its bottom line.

Another committee member reported consulting income from 11 to 13 pharmaceutical companies, including eight that Medicare records show have earned millions billing for drug waste. His pharma ties were disclosed in unrelated publications in 2019 through this year.

Those committee members said they reported relevant relationships to the national academies and that the information is readily available outside of the report.

What’s more: The National Academy of Sciences itself for years has been collecting generous gifts from foundations, universities and corporations, including at least $10 million from major drugmakers since 2015, its treasurer reports show. Among the donors are companies with millions to retain or lose over the drug waste committee’s findings.

The fact that those relationships were not disclosed in the final report by an organization charted in 1863 to advise the nation amounts to “egregious” failures, said Sheldon Krimsky, a Tufts University professor and expert on conflicts of interest in science.

“The amount of money you’re reporting is really substantial,” he said. “It really raises questions about the independence” of the national academies.

In a statement emailed to KHN, the national academies said the two members with undisclosed board and consulting roles had “no current conflicts of interest during the time the [drug waste] study was being conducted” from January 2020 through February. The report did disclose conflicts for two others on the 14-member board. The report in question was paid for by federal officials, and “funds from for-profit organizations with a direct financial interest in the outcome of a study may not be used to fund advisory consensus studies, except in rare circumstances,” national academies spokesperson Dana Korsen said in the emailed statement.

She also said the organization is implementing a new conflict-of-interest policy that will be fully in place this fall.

“Protecting the integrity, independence, and objectivity of our study process is of the utmost importance to the National Academies,” her statement said.

The committee’s failure to call for concrete changes — and the millions in gifts from pharmaceutical companies to the national academies — looked familiar to David Mitchell, president of Patients for Affordable Drugs and a cancer patient who relies for his survival on a drug with high waste costs.

“We have found in our work that pharma is like an octopus,” he said, “and at the end of each tentacle is a wad of cash.”

Waste Shocked Policymakers in 2016

Dr. Peter Bach and colleagues published an explosive paper in 2016 that for the first time showed that taxpayers and health insurance rate payers were bankrolling an estimated $2.8 billion a year in drug waste. The findings encompassed all U.S. health care — not just what’s reported by doctor’s offices to Medicare — and were covered widely in the news.

Bach, a researcher with the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, found that medications infused in doctors’ offices often arrived in vial sizes fit for a linebacker but might be given to a waif. Given sterility and other concerns, the extra milligrams, often for cancer therapies that can cost thousands of dollars per dose, were typically discarded.

Congress and policymakers took notice.

In 2017, Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) introduced a bill urging health care agencies to develop a “joint action plan” to address the waste. Sens. Dick Durbin (D-Ill.) and Rob Portman (R-Ohio) introduced an even stronger measure in 2019 and again this year that would allow Medicare to recoup the cost of the wasted drugs. None of the bills has passed.

The refund mandate made it into a broader drug pricing measure that also failed, but not before the Congressional Budget Office took a close look in 2020 and estimated $9 billion could be saved over a decade.

Medicare officials also urged doctors to use a billing code to document the amount taxpayers were spending on wasted drugs each year — which amounted to $753 million in 2019 alone, Medicare data shows.

Before and while Bach’s paper was making waves, physicians who would eventually be on the national academies committee were forging alliances with the pharmaceutical industry.

Dr. Kavita Patel reported earning a speaking fee in 2015 from the Pharmaceutical Research and Manufacturers of America, or PhRMA, of $5,001 to $15,000. She also accrued assets valued at more than $50,000 for her role as a pharmaceutical company board member, according to 2015 and 2018 disclosures filed with the Government Accountability Office.

Dr. Anupam Jena, who also served on the committee, wrote a 2018 article with staff members of PhRMA arguing that medications should be valued not for their actual benefit, but rather for the potential for innovation that comes with making new therapies.

The ‘Kiss of Death’

In 2016, lawmakers called for an independent study of the drug waste. In September 2019, the National Academy of Sciences was awarded $1.2 million to complete the report.

At the outset of its study in January 2020, national academies committee members declared their potential conflicts of interest in a closed session, according to the meeting agenda.

Bach was among the physicians and other experts who later presented to the national academies committee. He said his team had laid out two possible solutions from the start: Have companies make a variety of vial sizes to minimize waste, or pursue refunds.

Former Medicare administrator Donald Berwickpresented to the committee at a June 2020, virtual meeting, exhorting its members to defy the expectation that they’d be one more committee that failed to do anything meaningful about health costs.

“Someone’s got to begin to set a standard and say, ‘Nope, this money is too important for … us to accede to this,’” Berwick told the committee.

The report’s recommendations were “the result of extensive fact-finding, full committee discussions and unanimous consensus,” said committee chairperson Dr. Edward Shortliffe, chair emeritus and adjunct professor in the Department of Biomedical Informatics at Columbia University.

The report, though, did not meet Berwick’s call to action. In a webinar summarizing the report findings, Jena described the drugs as valuable enough to justify the total cost of each vial, completely used or not. Patel and others summarized the findings in a STAT opinion piece, saying the committee argued against tracking the money wasted and instead called for a “whole of government” approach.

Bach said the conclusions were “better than pharma could have ever hoped for” and called the whole-of-government idea the “kiss of death.”

Berwick said that he was “disappointed” by the conclusions and that all committee members’ industry relationships should have been reported. He noted that, in his experience, committee members have been very open about conflicts and the national academies dismissed those who had them.

Presented with KHN’s findings about certain committee members’ undisclosed pharmaceutical company income and consulting relationships, Bach said they raise serious concerns.

“The conflicts align just way too closely with the results,” he said. “That’s what makes it hard to ignore.”

‘Current’ Conflicts Don’t Tell Full Story

Conflicts of interest became a hot topic more than a decade ago, amid a series of scandals over Big Pharma quietly backing influential doctors.

Reforms followed, with countless medical journals, nonprofits and government agencies strengthening their conflict-of-interest policies.

The national academies came under scrutiny in 2014 and 2016 for failing to disclose conflicts among committee members advising federal officials on opioid use and in 2017 on genetically modified crops.

Its webpage on conflicts underscores why strong disclosure rules are important: “The institution should not be placed in a situation where others could reasonably question, and perhaps discount or dismiss, the work of the committee simply because of the existence of such conflicting interests.”

Yet conflict-of-interest experts interviewed by KHN said the national academies stands out by considering only “current” conflicts and not those going back three years, as is more typical. Korsen said the National Academy of Sciences is working toward requiring five years of disclosures.

Several experts said that, given the trust placed in — and $200 million in federal funding awarded to — the national academies, a number of conflicts should have been disclosed in the report.

They include those of Patel, who is described in her report biography as a Brookings Institution fellow, a primary care physician in Washington, D.C., and former Obama administration policy adviser.

The national academies declined to provide the conflict-of-interest form that Patel or any other member filled out at the outset of the committee’s work in early 2020.

Unrelated Securities and Exchange Commission records show that, before she joined the committee in 2020, Patel’s role as a board member for Tesaro, a developer of cancer medications, became very lucrative when GlaxoSmithKline bought the company. At the time of the 2019 sale, Patel was in line to receive an estimated $1.4 million for her shares and stock options, according to a December 2018 Tesaro securities filing.

Also in 2020, Patel was appointed to the board of Sigilon Therapeutics, a biotech company with no product on the market. The company awarded her stock options then worth an estimated $369,000, an SEC filing shows.

Sigilon described state and federal efforts to control costs as a risk to its business in an annual report to investors: “Any cost containment measures could significantly decrease … the price we might establish for our products.”

The national academies’ lack of disclosure of those roles “to me is a violation of almost all the standards that I’m aware of for disclosing conflicts of interest,” said Krimsky, of Tufts.

Patel told KHN she “fully and transparently participated” in the disclosure process and “provided all of the information requested.” She said: “In addition, many of the financial relationships incurred over the course of my work had already been disclosed in the public record.”

Patel was the lead writer on the Feb. 25 opinion piece in STAT that summarizes the committee’s report as focusing on the need to reduce inefficiencies, “rather than on trying to recover from pharmaceutical companies the financial worth of the portion of drug that was not used.”

Patel said she was “objective in all of my contributions” to the national academies report.

The national academies — as an organization — reported in its 2016 treasurer report that while 84% of its funding in 2011 was from federal agencies, the amount was failing. So it was working to “grow the non-federally sponsored work.”

“It will be very important for the future of the institution to continue vigorous efforts to diversify its sources of income,” the treasurer report says.

A KHN review of treasurer reports from 2015 through 2020 shows that pharmaceutical companies have given consistently to the national academies. Drugmakers donated at least $10 million over those years. Their giving is reported in ranges, often $100,000 to $500,000, and that total assumes they gave the lowest amount in each range each year.

A 2018 treasurer report recognized Merck & Co. for more than $5 million in cumulative giving and 10 other drugmakers for donating more than $1 million.

None of those donations was listed in the drug waste report. But listing them would reassure readers, said Genevieve Kanter, a University of Pennsylvania assistant professor of medical ethics and health policy.

“If the national academies is interested in producing a credible, independent report,” she said, “I think they would report all of those donations in the report itself.”

Jena, a Harvard Medical School associate professor, physician at Massachusetts General Hospital and an economist, also had no conflicts disclosed in the report.

Jena has disclosed consulting fees from a dozen major pharmaceutical companies, articles in the Journal of the American Medical Association and The BMJ show. Most of those companies have a direct financial interest in the drug waste matter, a KHN review of Medicare data shows. He said he disclosed all his consulting relationships to the national academies.

After the report came out, he took the lead on a Health Affairs article that says Medicare should stop tallying the waste money.

“Attempts by public payers to recoup overpayments are unlikely to be successful since they may simply end up paying higher prices” if drugmakers raise the price tag for the medications.

That article initially omitted his consulting relationships with numerous pharmaceutical companies — but journal editors updated the disclosures after KHN inquired.

Jay Hancock and Megan Kalata contributed to this report.

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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Getting a Covid Vaccine During Pregnancy Even More Urgent as ICU Beds Fill Up

Thu, 08/12/2021 - 5:00am

The Centers for Disease Control and Prevention is doubling down on its recommendation that people who are pregnant get the covid-19 vaccine, in light of new data underscoring its safety and effectiveness throughout pregnancy.

This recommendation comes at a time when doctors across the country are reporting an uptick in the number of unvaccinated pregnant people getting hospitalized with severe cases of covid.

The low vaccination rate in this group is striking, doctors note. As of July 31, only 23% of those who are pregnant had received at least one dose of vaccine against the coronavirus, according to CDC statistics.

“CDC recommends that pregnant people should be vaccinated against COVID-19, based on new evidence about the safety and effectiveness of the COVID-19 vaccines,” the agency said in updated guidance that echoes the urgent recommendation of leading medical societies. “COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant, breastfeeding, or trying to get pregnant now or might become pregnant in the future.”

According to the agency, concerns among some people that the messenger RNA vaccines might increase the risk of miscarriage when given early in pregnancy are not borne out by the data.

Officials said miscarriage rates after getting vaccinated were similar to the expected rate of miscarriage in any group of pregnant people. Getting a covid vaccine is also safe later in pregnancy and while breastfeeding, the agency’s new analysis indicates.

Dr. Alison Cahill, a maternal-fetal medicine specialist and professor at the Dell Medical School at the University of Texas-Austin, said she has been telling all within earshot to get vaccinated. She works mostly with pregnant individuals who are sick with covid and sees the damage the coronavirus can do.

Cahill recalled treating an unvaccinated woman who came into her hospital with shortness of breath. Within 24 hours, she said, things got much worse, and the woman needed a tremendous amount of oxygen to stay alive.

“She was pregnant in her mid-trimester. So, if she had needed to be delivered, she would have had an extremely preterm baby with a high risk of having lifelong disability or even death,” Cahill said.

She said that within two days of being admitted to the hospital the woman could no longer breathe on her own. She was intubated and then put on a ventilator.

Eventually, the woman needed ECMO, extracorporeal membrane oxygenation, which is a machine that bypasses her lungs and oxygenates her blood for her. Cahill said she was on ECMO, which is often a bridge to a heart or lung transplant for critically ill people, for several weeks.

“She was eventually able to come off all of those things,” Cahill said. “She miraculously did not require a preterm delivery. She remained pregnant and after 2½ months in the hospital was able to go home.”

The baby was born healthy, but the woman was sent home and may face a lifetime of disabilities from covid. Cahill said it all could have been prevented if the woman had gotten vaccinated.

“I think that it’s just an incredible opportunity that we have in the United States, and everybody should avail themselves of this tremendous vaccine to prevent those types of things happening to people,” she said. “It’s really tragic.”

Such cases are why the American College of Obstetricians and Gynecologists, or ACOG, and the Society for Maternal-Fetal Medicine — the two leading organizations representing physicians and scientists who specialize in obstetric care — recommended on July 30 that all who are pregnant get a covid vaccine.

“It’s kind of a perfect storm situation,” said Dr. Mark Turrentine, an obstetrics professor at Baylor College of Medicine, who is also the co-chair of a covid workgroup for ACOG. “We have a highly infectious variant of covid-19 virus in a group of individuals that the majority are not immunized. So yeah, we are seeing a lot of sick people.”

“ACOG encourages its members to enthusiastically recommend vaccination to their patients,” Dr. J. Martin Tucker, president of ACOG, said in a written statement. “This means emphasizing the known safety of the vaccines and the increased risk of severe complications associated with COVID-19 infection, including death, during pregnancy.”

Vaccinating those who are pregnant has become especially urgent in states such as Texas, where the highly contagious delta variant currently makes up more than 75% of new cases. The percentage of people in Texas who are fully vaccinated is 44.6%, compared with 50.3% of the entire U.S. population. As infection rates climb in the state, Dr. Jessica Ehrig, obstetrics chief at Baylor Scott & White Medical Center in Temple, Texas, said she’s seen a significant increase in the number of pregnant women being hospitalized and intubated; some have died. And those severe cases of covid are also dangerous for the fetus, she noted.

“Complications include preterm birth and prematurity, increased risk of preeclampsia for these moms — which can require preterm delivery,” Ehrig said recently at an Austin press conference on the topic. “And, unfortunately, also increased risk of stillbirth.”

It’s an especially dangerous situation when someone who’s pregnant gets a symptomatic case of covid, Turrentine noted.

“There is a threefold increase of intensive care unit admission,” he said, “two-and-a-half-fold increased risk of being put on mechanical ventilation or bypass support, and there’s even, you know, a little over a one-and-a-half-fold increased risk of death.”

Medical professionals and scientists don’t know exactly why those who are pregnant are at such high risk when they become infected with the virus, but they are concerned this population is especially vulnerable because so many of them remain unvaccinated.

Since April, the CDC has recommended vaccines for those who are pregnant as the best way to protect them and their babies from the coronavirus. Although people who are pregnant were excluded from the initial clinical trials of the three covid vaccines authorized for emergency use in the U.S., significant data gathered since then has shown the shots to be safe and effective in this group.

Turrentine said it’s important to stress that the benefits of getting vaccinated far outweigh any kind of risk. Especially for someone who is pregnant, he said, the costs of not getting vaccinated are just too high.

“I have seen some pregnant women get really sick. I mean, I have seen some die,” he said. “And, you know, you go into this business as an obstetrician-gynecologist because patients are young and they are healthy. And most of the time you have great outcomes. This is a bad virus.”

This story is from a reporting partnership with KUT, NPR 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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Reading, ’Rithmetic and Resisting Covid: The New 3 R’s as Kids Head Back to School

Thu, 08/12/2021 - 5:00am

When kids head back to school this fall, for some it will be the first time they’ve been in a real classroom with other students since the pandemic began. Even if they attended classes in person last year, the spread of the highly transmissible delta variant of covid-19 will require a new safety calculation, particularly for parents of kids younger than 12, who can’t yet get a vaccine.

“You have a confluence of three unfortunate events,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “You have a group of children who are unlikely to have a vaccine available to them when they go back to school; you have the delta variant, which is far more contagious; and you have the winter months, with a cold, dry climate where the virus can spread more easily.”

Nearly all schools offered at least some in-person learning by the end of the last school year, and many schools plan to bring kids back full time this fall. And in more than a dozen states, schools are required to offer in-person classes either full or part time, according to an analysis in June by EducationWeek.

Parents have questions about how to navigate this new landscape. Here are answers to some common concerns.

Q: What should parents do if their child gets what seems like a bad cold, but they’re worried it could be covid?

It’s likely your school has protocols in place for handling these situations. But in general, if a child is sick, especially with symptoms of an upper respiratory infection like coughing or fever, keep them home until symptoms subside, doctors said. You should be doing that anyway.

“With the amount of covid that’s around, parents should definitely keep the child out of school and see their primary care doctor to make sure they don’t have covid,” said Dr. Tina Tan, a pediatric infectious disease physician at Lurie Children’s Hospital of Chicago.

You may want to keep a few rapid covid tests at home as well. Keep in mind that the results are not completely reliable.

According to an analysis of 48 studies that evaluated rapid antigen tests’ accuracy, among people who had covid, the tests correctly identified the infection in 72% of those with symptoms but in only 58% of those without symptoms. Among uninfected people, the tests accurately ruled out covid in at least 99% of people, whether or not they had symptoms.

“It’s important to have the ability to do rapid testing,” said Dr. Sara Bode, a pediatrician who directs school health services at Nationwide Children’s Hospital in Columbus, Ohio, and helped write the American Academy of Pediatrics’ covid guidance for schools. “If positive, it allows the school to quickly identify, quarantine and contact-trace. If negative, it allows the child quickly back in school without losing … instructional time.”

Once you determine your child doesn’t have covid, keep them home until they have not had a fever for 24 hours and feel well enough to go back to school, similar to the way you would handle any other viral illness. Children infected with covid will need to stay home for at least 10 days after their symptoms started or, if they’re asymptomatic, 10 days after their first positive covid test.

Q: Should parents test unvaccinated kids regularly for covid?

“The simple answer is no,” Tan said. However, if the child is sick or has been exposed to someone known to have covid, they need to be tested.

In some school districts, if a child feels sick, nurses can do a rapid test to identify illness. Even if they can’t be tested, students falling ill will likely be sent to a nurse or administrator and separated from classmates.

“School nurses would assess the student, and if they had symptoms of covid they’d be isolated in a room” until a parent could be called and the student sent home, said Linda Mendonça, president of the National Association of School Nurses.

Q: Should parents follow the Centers for Disease Control and Prevention’s updated recommendation for all kids to wear masks at school this fall, regardless of vaccination status, even in areas that prohibit mask mandates and where mask-wearing isn’t routine?

Yes. “If other people aren’t concerned about the public health risk, that’s on them,” Tan said. “But you should do the best for you and your child.”

Mask-wearing should not be presented as a big deal, Bode said. Parents can calmly explain that masking is important to keep kids safe at school, and that it’s something the whole family does when they go somewhere indoors.

In areas where masks are optional, ask the school how it plans to handle the issue.

“As a parent, you can advocate for a mask mandate even if [politicians say] you shouldn’t,” Offit said.

Q: Should kids wear N95 masks to be safe?

That’s not necessary. Disposable surgical masks or cloth masks with at least two layers are fine, experts say.

“The best mask is one the child will keep on,” Bode said.

Q: What about playground time? Do kids need masks outside?

According to the CDC and the pediatrics academy, kids don’t generally need masks outdoors, unless they’re in a crowd or near others a long time.

Q: What about indoor activities like choir and band? Should parents discourage kids from participating in activities that involve close contact and where the risk of inhaling respiratory droplets is high?

No. Schools figured out safe ways to offer these activities last year and can do so again this year, Bode said. In these situations, it’s important that schools create layers of risk protection, she said. Practice outdoors if possible, and make sure students remain at least 3 feet apart.

Special masks for singers fit tightly around the face but bow out to leave more room for children to project their voices, she said. Likewise, there are masks with openings for band members’ mouths and also covers to catch droplets that might escape from the open ends of instruments.

Q: Do parents need to sanitize bookbags and other items when kids come home from school?

No. “At first, it looked like a virus that would spread on surfaces,” Offit said. “But now we know that it is primarily transmitted through respiratory droplets.”

Q: What else can parents do to make sure kids are as safe as possible at school?

Even if kids can’t get the covid vaccine, make sure they’re current on the rest of their shots, Tan said.

“We’ve seen a significant decline in the number of kids who aren’t up to date on routine immunizations,” Tan said. Avoiding outbreaks of vaccine-preventable illnesses is key to a healthy school year.

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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Familias apoyan máscaras en las aulas, pero se oponen a la vacunación obligatoria

Wed, 08/11/2021 - 9:25am

Mientras la propagación de la variante delta amenaza la seguridad de las aulas, una nueva encuesta reveló que casi dos tercios de los padres apoyan que las escuelas exijan a los alumnos de 5 años o más, que no estén vacunados, y a los profesores el uso de mascarillas. La mayoría de los padres, sin embargo, se opone a que se exija la vacunación a los alumnos elegibles para estas dosis.

Las fuertes opiniones públicas tienen lugar cuando la politización del debate sobre las máscaras en las aulas se vuelve más acalorada, coincidiendo con el inicio del año escolar, especialmente en Florida y Texas.

El gobernador republicano de Florida, Ron DeSantis, ha emitido una orden ejecutiva que otorga a los padres la autoridad para decidir si sus hijos deben usar mascarilla, pero algunos grandes distritos escolares mantienen la obligatoriedad de su uso. Los distritos escolares de Dallas y Austin también han desafiado la prohibición de obligar el uso de mascarillas emitida por el gobernador de Texas, el republicano Greg Abbott.

La encuesta de KFF sobre covid-19 encontró que, a nivel nacional, el 63% de los padres estaba a favor del uso obligatorio de la mascarilla para los niños y adolescentes, de 5 a 17 años, no vacunados.

Como era de esperar, las opiniones sobre las máscaras y la vacunación contra covid se dividen sistemáticamente en función de los partidos, con padres demócratas que, en general, las apoyan y republicanos, que se resisten.

El 69% de los padres republicanos se oponen al uso obligatorio de la mascarilla. Más de tres cuartas partes de padres hispanos y negros no hispanos apoyan la obligatoriedad de su uso, mientras que sólo una escasa mayoría de los padres blancos no hispanos la respalda.

En julio, el 41% de padres de menores entre 12 y 17 años dijeron que sus hijos habían sido vacunados. Un 6% adicional dijo que quería vacunarlos pronto, y un 23% expresó que quería “esperar y ver”.

El 9% dijo que los vacunaría sólo si fuera necesario y el 20% aseguró que no lo haría. “Creo que mi hijo está lo suficientemente sano como para luchar contra covid-19 sin necesidad de una vacuna”, les dijo a los encuestadores una madre hispana de Georgia.

Algunos padres explicaron que la resistencia a la vacunación venía de sus hijos y que eran reacios a obligarlos. “Le di a elegir”, explicó a los encuestadores un padre blanco no hispano de Idaho. “Eligió no hacerlo”. Una madre blanca no hispana de Wisconsin contó que, aunque había animado a su hijo adolescente a vacunarse, “no me siento cómoda obligándolo a hacerlo ya que tiene 17 años y es casi un adulto.”

Como era de esperar, la resistencia a vacunar a sus hijos es más fuerte entre padres no vacunados, ya que la mitad aseguró que no permitiría las vacunas bajo ninguna circunstancia. Casi tres cuartas partes de los padres no vacunados expresaron que consideraban la vacuna más peligrosa para la salud de sus hijos que covid.

La enfermedad ha matado a casi 613,000 estadounidenses hasta la fecha.

La oposición a la vacunación obligatoria en las escuelas fue alta, con sólo un 42% de los padres de estudiantes, entre 12 y 17 años, a favor. El apoyo fue mayor entre los hispanos, con un 51% a favor, pero sólo el 38% de los blancos no hispanos y el 32% de los negros no hispanos apoyaban la vacunación obligatoria en las escuelas.

La resistencia a las vacunas contra covid no indica una oposición a la inoculación en general, según la encuesta. Nueve de cada 10 padres afirmaron que, en general, mantienen a sus hijos al día con las vacunas recomendadas, como las del sarampión, las paperas o la rubeola. Sin embargo, entre los padres de niños, de 12 a 17 años, que dicen que sus hijos están al día con otras vacunas, menos de la mitad habían sido vacunados contra covid-19.

Entre los padres con adolescentes no vacunados, el 88% tenía la preocupación de que no se sabía lo suficiente sobre los efectos a largo plazo de la vacuna en los niños; al 79% le preocupaban los efectos secundarios; un 73% temía que la vacuna pudiera afectar negativamente a la fertilidad de sus hijos en el futuro; y al 65% le molestaba que se obligara a los niños a vacunarse aunque sus padres se opusieran.

En general, los reparos a la vacunación de los adolescentes eran comunes incluso entre los padres que se habían vacunado, pero eran más fuertes entre los padres que no habían recibido las dosis.

Los padres hispanos y afroamericanos de adolescentes no vacunados temían, más que los blancos no hispanos, tener que faltar al trabajo para vacunar a su hijo o quedarse en casa si su hijo experimentaba efectos secundarios. También eran más propensos a preocuparse de que fuera difícil llegar a un lugar de vacunación y de si podían confiar en los proveedores de la vacuna.

Hasta ahora, no se ha autorizado ninguna vacuna para niños menores de 12 años, pero la mayoría de sus padres se muestran cautos. Sólo el 26% aseguró que vacunará a sus hijos en edad escolar lo antes posible. Un 40% adicional planea esperar a ver qué pasa, y la mayoría de los demás dijo que se negará incluso si se requiere.

La encuesta, realizada entre 1,259 padres de menores de 18 años, se llevó a cabo por teléfono, entre el 15 de julio y el 2 de agosto. Los encuestadores señalaron que la mayoría de las entrevistas se realizaron antes de que se hicieran públicos los datos más recientes de los Centros para el Control y Prevención de Enfermedades (CDC) sobre la magnitud de la amenaza de la variante delta. El margen de error de la muestra completa es de más o menos 4 puntos porcentuales y de más o menos 5 puntos, para los padres de niños entre 12 y 17 años.

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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Public Favors Masks in Classrooms but Balks at Mandating Vaccinations for Students

Wed, 08/11/2021 - 5:01am

As the spread of the delta variant threatens the safety of classrooms, a poll released Wednesday found nearly two-thirds of parents support schools’ requiring unvaccinated students age 5 or older and teachers to wear masks. A majority of parents, however, oppose requiring students now eligible for a covid vaccine to get one, with one Black parent from Michigan telling pollsters that “my child is not a test dummy.”

The strong public opinions come as the politics over classroom masking grows more heated with the start of the school year, particularly in Florida and Texas. Florida’s Republican Gov. Ron DeSantis has issued an executive order giving parents the authority to decide whether their kids should be masked, but several large school districts are maintaining their masking mandates. The Dallas and Austin school districts are also defying a ban on mask mandates issued by Texas Gov. Greg Abbott, a Republican.

The KFF covid-19 poll found that, nationally, 63% of parents favored mandatory masking for unvaccinated children ages 5 to 17. (KHN is an editorially independent program of KFF.)

Predictably, views on masking and vaccination split consistently along party lines, with Democratic parents generally supporting them and Republicans much more resistant. Sixty-nine percent of Republican parents oppose mandatory masking. More than three-quarters of Black parents and Hispanic parents support mask requirements while only a slim majority of white parents back masks.

As of July, 41% of parents of children ages 12-17 said their kids had been vaccinated. An additional 6% said they wanted to get them vaccinated promptly, and 23% said they wanted to “wait and see.” Nine percent said they would get them vaccinated only if required and 20% said they would definitely not. “I think my child is healthy enough to battle the covid-19 virus without a vaccine,” a Hispanic mother from Georgia told pollsters.

Some parents said the resistance to vaccination sprung from their children and they were reluctant to compel them. “I gave him a choice,” one white parent from Idaho told the pollsters. “He chose not to.” A white mother from Wisconsin said that while she had encouraged her teenager to get vaccinated, “I don’t feel comfortable forcing him to get it since he is 17 and nearly an adult.”

Unsurprisingly, resistance to vaccinating their child was strongest among unvaccinated parents, with half saying they would not want to allow the shots under any circumstance. Nearly three-quarters of unvaccinated parents said they considered the vaccine more dangerous than covid to their child’s health. The disease has killed nearly 613,000 Americans to date.

Opposition to school-mandated vaccination was high, with only 42% of parents of students ages 12-17 favoring it. Support was strongest among Hispanics, with 51% in favor, but only 38% of whites and 32% of Blacks agreed with school-required vaccination.

The resistance to covid vaccines does not reflect opposition to inoculation in general, the poll found. Nine out of 10 parents said they normally keep their children up to date on recommended shots such as those for measles, mumps or rubella. Yet among parents of 12- to 17-year-olds who say their children are up to date on other vaccinations, fewer than half of the children had been vaccinated for covid-19.

Among parents with unvaccinated teens, 88% held concerns that not enough was known about the long-term effects of the vaccine in children; 79% were worried about side effects; 73% feared the vaccine might adversely affect their teens’ fertility later in life; and 65% were concerned children would be mandated to get vaccinated even if their parents objected.

Overall, qualms about vaccinating teens were common even among parents who had gotten a shot, but strongest among parents who themselves had not been inoculated.

Hispanic and Black parents of unvaccinated teens were more likely than white parents to fear they might have to take time off from work to get their child vaccinated or need to stay home if their child experienced side effects. They also were more likely to worry it would be difficult to get to a vaccination site and whether they could trust the vaccine providers.

So far, no vaccine has been authorized for children under 12, but most of their parents remain cautious. Just 26% said they will get their school-age children vaccinated as soon as possible. An additional 40% plan to wait and see, and most of the remainder said they will refuse even if it is required.

The survey of 1,259 parents of children under age 18 was conducted by telephone July 15-Aug. 2. The pollsters noted most of the interviews were conducted before the Centers for Disease Control and Prevention’s most recent data on the magnitude of the threat of the delta variant. The margin of error for the full sample is plus or minus 4 percentage points and plus or minus 5 points for parents of children ages 12 to 17.

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 Doesn’t Medicare Cover Services So Many Seniors Need?

Wed, 08/11/2021 - 5:00am

Sorry, Joe Namath. Despite what you keep saying in those TV ads, under Medicare, seniors are not “entitled to eliminate copays and get dental care, dentures, eyeglasses, prescription drug coverage, in-home aides, unlimited transportation and home-delivered meals, all at no additional cost.” But if Democratic lawmakers in Congress have their say, seniors could soon be entitled to some of those services.

Namath’s commercial is hawking private Medicare Advantage plans, which frequently do offer benefits traditional Medicare does not — in exchange for being limited to certain doctors and hospitals. “Traditional” Medicare does not cover many benefits used overwhelmingly by its beneficiaries, including most vision, dental and hearing care, and drug coverage is available only by purchasing a separate insurance plan — Medicare Part D.

But Democrats in the House and Senate plan to try to change that as soon as this fall. On Monday, Senate Majority Leader Chuck Schumer released an outline of a coming budget bill that includes a directive to the Senate Finance Committee to expand Medicare “to include dental, vision, hearing benefits.” The catch — all the Democrats in the Senate and almost all in the House will have to agree on the entire budget bill for it to become law.

Still, that raises a question about Medicare: Why has it taken so long to add such obviously needed benefits?

As with almost everything to do with the U.S. health system, the answer is complicated, and a combination of policy and politics.

“Medicare is the kind of program where you’d expect the benefits would be expanded over and over again. It’s popular, and benefits expansions poll well,” said Jonathan Oberlander, a professor of health policy at the University of North Carolina-Chapel Hill and author of the book “The Political Life of Medicare.” “It’s one of the great puzzles of Medicare politics: why benefit expansions have been so rare.”

In fact, in the 56 years since Medicare became law, only a few benefits have been added to the package, which was created to emulate a 1965 Blue Cross/Blue Shield plan. During the 1980s and ’90s some preventive care was added, like pneumonia vaccines and mammograms. Republicans spearheaded the addition of prescription drug coverage in 2003, when they controlled both Congress and the White House. But they decided to make that coverage separate from the program’s traditional benefit package.

Other efforts to expand benefits have not gone so well. In 1988, a bipartisan effort in Congress produced the Medicare Catastrophic Coverage Act, which would have added drug coverage to traditional Medicare and also would have plugged a hole: the fact that there is no limit on the amount patients can be charged for their share of covered services. That law, however, was repealed just a year later after seniors rebelled against being asked to foot most of the bill for the new benefits via a new income “surtax.” Today, Medicare beneficiaries still face the risk of unlimited expenses.

Medicare is funded by a combination of money paid directly to the government from paychecks and taxes paid by working Americans and their employers. That brings us to another big reason Medicare’s benefit package hasn’t been beefed up more — the cost of the current program.

“When Medicare was created, its architects assumed expansion, both in terms of population and in terms of benefits later,” said Oberlander. “They didn’t anticipate the shift in American politics to the right, and they didn’t anticipate that Medicare would be labeled a fiscal problem and that policymakers would be more concerned with avoiding the next trust fund shortfall than expanding benefits.”

Indeed, in the ’80s and ’90s, Medicare spending was more often restrained than expanded. A series of budget reconciliation bills trimmed millions of dollars out of Medicare — usually at the expense of payment to doctors, hospitals and other health providers.

As the years wore on, Medicare has remained popular, but it has grown less generous than most private insurance policies. Many Medicare patients, however, have been able to find supplemental coverage to fill in what Medicare does not cover, through private “Medigap” policies, employer-provided retiree plans or Medicaid for those with low incomes. Increasingly popular in recent years have been those Medicare managed-care plans, now known as Medicare Advantage, that were first authorized in 1982 and often provide extra benefits for members.

All of that “has taken some of the pressure off” lawmakers to expand the program, Oberlander said. And a final reason that vision, hearing and dental care have not been added to standard Medicare is that they are far from the most critical gaps in Medicare’s benefit package.

For example, Medicare does not cover long-term custodial care — the sort of non-nursing, personal care that provides assistance in activities of daily living such as bathing, dressing, eating, getting in or out of a bed or chair, using the bathroom or preparing food. Custodial care tends to be both very expensive ($50,000 to $100,000 a year or more) and needed by a large number of beneficiaries, particularly after age 80. Efforts over the years to create a government long-term care benefit have been largely unsuccessful. A very limited program, the CLASS Act, was part of the Affordable Care Act in 2010 but was repealed before it could take effect because its financing was deemed insufficient. President Joe Biden has called for Congress to include billions of dollars for caregiving in the infrastructure package Democrats will work on this fall.

Also, as previously mentioned, traditional Medicare includes no limits on patient cost sharing — the percentage or amount of a medical bill that a beneficiary must pay. Its basic hospital benefit runs out after 90 days, and the 20% coinsurance (the percentage patients are responsible for) on outpatient care runs indefinitely.

So why are dental, vision and hearing coverage on the front burner now as lawmakers consider beefing up the program? Part may be self-serving for lawmakers tasked with appropriating funds. All three benefits “are less expensive than [adding] nursing home” coverage, said Oberlander.

But a big part is politics. On the campaign trail, Biden promised to lower Medicare’s eligibility age from 65 to 60. “Medicare for All” advocates like Senate Budget Committee Chair Bernie Sanders (I-Vt.) pledged to try to do the same, and lowering the eligibility age is included in the outline Schumer shared with Senate Democrats as an option.

But lowering the eligibility age is vehemently opposed by hospitals and other health providers, who fear they will lose money if people currently covered by higher-paying private insurance are covered by Medicare instead. That makes benefits expansion the much easier choice for Congress.

That is not saying it will happen. The Congressional Budget Office said the vision, hearing and dental benefits included in a bill passed by the House in 2019 would have cost an estimated $358 billion over 10 years. But this is the closest the benefits have gotten to enactment since Medicare’s inception.

HealthBent, a regular feature of Kaiser Health News, offers insight and analysis of policies and politics from KHN’s chief Washington correspondent, Julie Rovner, who has covered health care for more than 30 years.

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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DeSantis’ Executive Order Is Misleading About Lack of Scientific Support for Masking in Schools

Wed, 08/11/2021 - 5:00am

The Centers for Disease Control and Prevention’s recent guidance on students and masking “lacks a well-grounded scientific justification.”

Florida Gov. Ron DeSantis in a July 30 executive order

On July 30, Florida Gov. Ron DeSantis issued an executive order stating that schools couldn’t mandate that their students wear masks, and that it should be up to parents to decide whether they want their children masked in school buildings. The order also said the state can deny funding to districts that don’t comply.

One part of the order particularly caught our attention because of what it said about masks: “WHEREAS, despite recent Centers for Disease Control and Prevention (CDC) ‘guidance,’ forcing students to wear masks lacks a well-grounded scientific justification; indeed, a Brown University study analyzed COVID-19 data for schools in Florida and found no correlation with mask mandates.”

The executive order came on the heels of the CDC guidelines for reopening K-12 schools, which recommended that everyone age 2 and up should wear masks whether they are vaccinated or not. This guidance was issued partly because of the increase in covid cases due to the delta variant, which is more contagious than other versions of the virus. It was also issued because covid vaccines have not yet been authorized for use in children under age 12.

During the pandemic, DeSantis, a Republican, has consistently taken positions contrary to public health guidance from experts and said he wants Florida to remain open.

“In Florida, there will be no lockdowns, there will be no school closures, there will be no restrictions and no mandates,” DeSantis said during a speech introducing the executive order, which drew immediate pushback. President Joe Biden criticized his position and a group of Florida parents filed a lawsuit to block the order.

But the state is currently considered a covid hot spot. The Florida Department of Health reported there were 134,506 new cases of COVID-19 from July 30 to Aug. 5. That’s compared to 11,837 new cases over the earlier week-long period beginning June 4, before the delta variant surge. Hospitalizations have also increased. Total COVID-related hospitalizations were at almost 14,000 on Aug. 9, compared to a seven-day average of 229 hospitalizations as of June 6.

DeSantis’ executive order cites a Brown University study to support his argument that schools can’t mandate masks.

We reached out to DeSantis’ office to confirm the role of that study and to ask if any other research was involved in the development of the executive order.

Press secretary Christina Pushaw replied with a statement reiterating the governor’s position that studies have shown covid’s spread in schools is typically less than within the larger community and that science has yet to substantiate the effectiveness of masks in reducing what she said was “an already very low risk of COVID-19 in children.” She acknowledged that the delta variant has been shown to be more transmissible — which means it could increase children’s risk — “but that is only a working theory as no studies have shown that conclusively.”

That made us wonder about key elements of the executive order — specifically, whether the Brown study indeed illustrated that mask mandates didn’t prevent transmission of covid-19 and if it’s correct that “forcing students to wear masks lacks a well-grounded scientific justification.”

The Brown Study

We reached out to Emily Oster, a professor of economics at Brown University, and the lead author of the study that DeSantis’ order references. Oster became well known during the pandemic for issuing data-driven recommendations on parenting and schooling. Some experts, though, have taken issue with her being an economist and not an epidemiologist.

Oster told us she couldn’t participate in a direct interview about the study, but she sent us this statement:

“We did not consult with Gov. DeSantis on these issues. Our paper is currently a pre-print, undergoing peer review. It relies on data from the 2020-2021 school year, prior to the emergence of the more contagious delta variant. Current CDC guidance, taking into account the current virus situation and all available data on masking, suggests masking for all K-12 students and staff, regardless of vaccination status.”

The study analyzed whether mask mandates in school districts in Florida and other states influenced the number of covid cases among students and staff members by looking at mitigation strategies as well as covid case counts. The researchers found that staff rates of covid were slightly higher in districts without mask mandates, but the difference was not statistically significant. Overall, no correlation was found between mask mandates and covid cases in students.

But within the study itself, the authors wrote about the limitations of their methods.

For instance, the study looked only at whether mandates existed at particular schools — not at the mask-wearing behavior of students and staffers. The study also didn’t account for mitigation measures that might have been in place in the surrounding community, which would influence case counts.

At the end of the study, the authors offer a conclusion that undermines the executive order: “We would emphasize that in general this literature suggests in-person school can be operated safely with appropriate mitigation, which typically includes universal masking. It would be premature to draw any alternative conclusions about this question based on this preliminary data.”

Justin Lessler, an epidemiology professor at the University of North Carolina, who led a peer-reviewed study that found masking in schools was associated with a significantly reduced risk of covid transmission, said he didn’t think this Brown study showed any strong conclusions to support the governor’s position.

“I think the lack of correlation with mask mandates at the population level is pretty weak evidence,” Lessler wrote in an email. “Also, mechanistically, it is a little hard to believe masking would not have some effect.”

Other Studies on Masks in Schools and Covid in Children

Dr. Lynn Goldman, dean of the Milken Institute of Public Health at George Washington University, said masks are absolutely effective in reducing covid transmission in children.

“What the science actually shows is that for children ages 2 and above, masks are not only protective but needed,” said Goldman, who is also a pediatrician. Since “those kids who are below the age of 12 cannot yet have the vaccine so they don’t have that layer of protection.”

Goldman also said studies show masking is effective in preventing covid transmission in schools.

The CDC guidance also cites several CDC-led studies that show the benefits of masking in schools, while independent researchers have shown similar results. Masking was often combined with other efforts to reduce spread, including improved ventilation and filtration systems. 

These points counter a claim central to DeSantis’ executive order: that the CDC school-reopening guidance “lacks a well-grounded scientific justification.”

“I think this ‘whereas’ of DeSantis’ executive order is just false, it’s just patently false,” said Dr. Jeffrey Goldhagen, a pediatrics professor at the University of Florida Health in Jacksonville.

What About Infection Risks for Children?

Though studies early in the pandemic did seem to indicate children were less likely to get covid than adults, current CDC data suggests that no longer seems to be the case.

CDC data through March 2021 shows that covid infection and symptomatic illness in children ages 5 to 17 was comparable to infection and illness in adults ages 18 to 49. Studies have also shown that even if children have mild or asymptomatic cases of covid they can spread the disease to adults who may then develop more severe cases — meaning children can be significant vectors of disease.

Children also are susceptible to the delta variant, which is more transmissible than the alpha variant.

Goldhagen said he has already anecdotally heard and seen the spread of the delta variant among children in camps and in schools that have started their semesters.

Pediatric covid hospitalizations have also been increasing in Florida in the past week, likely due to the delta variant, and there are reports that some children are experiencing serious symptoms. “The increase in the number of patients that we have in our children’s hospital due to covid has increased 500%,” Goldhagen, who is also a pediatrician at Wolfson Children’s Hospital in Jacksonville, told us on Aug. 5.

Our Ruling

DeSantis’ July 30 executive order missed the mark with its claim that “forcing students to wear masks lacks a well-grounded scientific justification.”

It also cited a Brown University study as scientific evidence that there is no correlation between mask mandates and reduced covid spread. However, while that study didn’t show a correlation, its authors noted the study’s limitations and concluded that appropriate mitigation typically includes universal masking. It flatly stated it would be premature to draw other conclusions based on the researchers’ preliminary data. Multiple studies also show masking in schools does have an effect on preventing covid transmission.

DeSantis’ executive order cherry-picked a study that offers little basis for his position and includes a variety of elements that are not accurate. We rate this False.

Source List

ABC Science Collaborative, Final Report, June 2021

Bloomberg, “Florida Parents Sue DeSantis, Ask Court to Allow Mask Mandates,” Aug. 8, 2021

Centers for Disease Control and Prevention, Mask Use and Ventilation Improvements to Reduce COVID-19 Incidence in Elementary Schools — Georgia, November 16-December 11, 2020, May 28, 2021

Centers for Disease Control and Prevention, COVID-19 in Primary and Secondary School Settings During the First Semester of School Reopening — Florida, August-December 2020, March 26, 2021

Centers for Disease Control and Prevention, Trends in Number of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory, accessed Aug. 9, 2021

Centers for Disease Control and Prevention, Guidance for COVID-19 Prevention in K-12 Schools, updated July 9, 2021

Centers for Disease Control and Prevention, Science Brief: Transmission of SARS-CoV-2 in K-12 Schools and Early Care and Education Programs – Updated, July 9, 2021

Centers for Disease Control and Prevention, Estimated COVID-19 Burden, updated July 27, 2021

Department of Health and Human Services, Protect Public Data Hub — Hospital Utilization, accessed Aug. 9, 2021

Email interview with Justin Lessler, epidemiology professor at the University of North Carolina-Chapel Hill, Aug. 5, 2021

Email interview with Jill Roberts, associate professor at the University of South Florida College of Public Health, Aug. 3, 2021

Email statement from Emily Oster, economics professor at Brown University, Aug. 3, 2021

Email statement from Christina Pushaw, press secretary for Gov. Ron DeSantis, Aug. 4, 2021

Harvard Medical School, Coronavirus Outbreak and Kids, Aug. 2, 2021

medRxiv, COVID-19 Mitigation Practices and COVID-19 Rates in Schools: Report on Data From Florida, New York and Massachusetts, May 21, 2021

The Miami Herald, “Florida Children’s Hospitals See Pediatric COVID Cases Soar Amid Delta Variant Surge,” updated Aug. 9, 2021

National Bureau of Economic Research, School Reopenings, Mobility, and COVID-19 Spread: Evidence From Texas, May 2021

NBC 6 South Florida, “‘Governor Who?’ Biden Hits Back at DeSantis as Feud Continues,” Aug. 6, 2021

The New York Times, “She Fought to Reopen Schools, Becoming a Hero and a Villain,” June 22, 2021

Office of Gov. Ron DeSantis, “Governor DeSantis Issues an Executive Order Ensuring Parents’ Freedom to Choose,” July 30, 2021

Phone interview with Katherine Drabiak, associate professor at the University of South Florida College of Public Health, August 3, 2021

Phone interview with Dr. Jeffrey Goldhagen, pediatrics professor at the University of Florida Health in Jacksonville, Aug. 5, 2021

Phone interview with Dr. Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, Aug. 6, 2021

Reuters, “Florida Governor Blocks School Mask Mandates, Says Parents Can Choose,” July 31, 2021

Science, “Household COVID-19 Risk and In-Person Schooling,” June 4, 2021

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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A Quarter of US Hospitals, and Counting, Demand Workers Get Vaccinated. But Not Here.

Tue, 08/10/2021 - 5:00am

Hospitals coast to coast are demanding their employees get vaccinated against covid as the highly contagious delta variant tears through populations with low vaccination rates.

Nearly 1,500 hospitals — roughly a quarter of all hospitals in the U.S. —now require staffers to get a covid vaccine, said Colin Milligan, a spokesperson for the American Hospital Association. More follow suit every day as hospital leaders aim to head off staff shortages like those experienced last year and to keep employees from becoming vectors of the disease.

But that’s not an option in Montana, where a law passed this year amid a pandemic backlash prohibits employers, including most health care facilities, from mandating any vaccine for their staffs. Nor is it in Oregon, where a 32-year-old law similarly bans vaccine mandates for health workers.

At least seven states have enacted laws to prevent covid vaccine mandates or so-called vaccine passports that would provide proof of vaccination, according to the National Academy for State Health Policy. Most restrict only state and local governments or specifically exempt health care facilities, but Montana’s law goes further. It prohibits employers — including hospitals — from discriminating against a worker based on vaccination status. Employers can’t require vaccinations and workers don’t have to tell their bosses whether they’re vaccinated.

That worries hospital leaders as covid hospitalizations hit levels not seen nationally since February. In Montana, covid hospitalizations had nearly doubled at the beginning of August compared with two weeks before, and about 90% of covid patients hospitalized at the end of July hadn’t been vaccinated, according to the Montana health department’s most recent data.

“I cannot imagine passing any worse law than that,” said John Goodnow, CEO of Benefis Health in Great Falls. “Imagine if that would have been passed back when we were fighting polio, or smallpox before that.”

Benefis had announced plans to make the vaccine mandatory for its 3,400 staffers back in April, before state lawmakers passed the bill preventing the hospital from doing so.

Those who back the law said it’s an issue of personal rights.

“Your health care decisions are private, they’re protected by the constitution of the state of Montana,” Rep. Jennifer Carlson, a Republican, said in March as she introduced the bill. “And your religious rights are protected.”

Health care professionals are more likely to be vaccinated against covid than the general population. Nonetheless, there remain nurses, doctors and other hospital employees who work directly with patients who are hesitant or resistant to inoculation, especially in rural regions.

Dr. Greg Tierney, chief medical officer of Benefis, said he’s concerned about potential rancor between vaccinated and unvaccinated staff members as their workload rises with the caseload.

“You have the people who have been vaccinated looking at the person next to him who’s choosing not to,” Tierney said. “Whereas, they were literally brethren in arms.”

In northwestern Montana, a region with a 34% vaccination rate to date and the epicenter of the state’s latest surge, Logan Health officials said existing staffing shortages are worsening as health care workers become infected or must quarantine. Chief medical officer Dr. Doug Nelson said the shots have been proven safe and effective, and Logan would likely consider a staff vaccine mandate if state law allowed it.

“Wearing a mask whenever you’re in our facilities, that helps, but being able to vaccinate everyone would help more,” Nelson said.

In Billings, Montana’s most populated city, the Billings Clinic’s intensive care unit reached capacity the first week of August and officials started shifting patients to overflow beds. At that time, roughly 60% of the system’s employees reported being vaccinated.

Hospital leaders are hosting weekly town halls to answer clinic workers’ vaccine questions or try to dispel myths in between caring for a growing number of covid patients.

“Knowing there are solutions out there that can help prevent this from happening, like simple vaccination, makes you frustrated,” said Dr. Fernando Caceres, an intensivist in Billings Clinic’s ICU.

In July, nearly 60 major U.S. medical organizations called for employers to mandate all health and long-term care workers get vaccinated in a joint statement that included the American Medical Association and the American Nurses Association. The Department of Veterans Affairs gave health care personnel eight weeks to get the shot.

In August, California became the first state to order workers in health care settings to be fully vaccinated and for visitors in health settings to show proof of vaccination or a negative covid test. And in Massachusetts, Republican Gov. Charlie Baker ordered most nursing home workers to get the jab by October 10, citing a massive increase in cases among staffers and residents.

Some hospitals have had to enforce their mandates. In Texas in June, Houston Methodist fired or accepted the resignations of more than 150 health care workers who didn’t get the jab.

Trinity Health — a Catholic health system with 117,000 workers across 22 states — said employees without a shot or exemption would be fired.

“Trinity Health has counted our own colleagues and patients in the too-high coronavirus death toll,” Mike Slubowski, the organization’s president and CEO, said in the announcement. “Now that we have a proven way to prevent covid-19 deaths, we are not hesitating to do our part.”

How Trinity’s policy will work in Oregon, where the three-decade-old law prevents vaccine requirements, is unclear

Attempts to change the law won’t happen before next year’s legislative session, Democratic Gov. Kate Brown said. In the meantime, she issued a rule last week to pressure health care workers to get vaccinated, saying they will face weekly covid tests if they don’t — and their employers will foot the bill.

“This new safety measure is necessary to stop delta from causing severe illness among our first line of defense: our doctors, nurses, medical students and frontline health care workers,” Brown said in the statement. Before Brown’s announcement, Kaiser Permanente, a national health system based in California, had said all of its employees must be vaccinated against covid — even those in Oregon. (KHN, which produces California Healthline, is not affiliated with Kaiser Permanente.)

After Brown’s announcement, KP spokesperson Michael Foley said those who don’t get the vaccine in Oregon will undergo weekly testing; employees in other states, however, will have to apply for medical or religious exemptions or find a new job if they refuse to be vaccinated.

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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Surgeons Cash In on Stakes in Private Medical Device Companies

Tue, 08/10/2021 - 5:00am

Several orthopedic surgeons who invested in Renovis Surgical Technologies made big money when a Japanese technology giant snatched up the small California medical device company.

Kyocera Corp., which was eager to expand its U.S. spine and joint implant sales, bought Renovis’ assets in 2019. While the parties kept the sale price under wraps, Renovis’ physician stockholders held stakes valued at over $34 million by the end of that year, with nearly half that sum to company founder and chief executive Dr. John Steinmann, according to the federal government’s “Open Payments” database, which tracks payments to doctors from device and drug companies.

Hundreds of orthopedists and neurosurgeons have cashed in on stakes in companies that design, manufacture or distribute orthopedic implants — sometimes after investing little or no money — and despite ongoing ethical and legal concerns, a KHN investigation has found.

KHN found that surgeons had stakes in more than 200 privately owned device companies from 2013 through 2019. At the end of 2019, their holdings topped $300 million in value. Doctors can dispute the payments but rarely do so.

Device makers often reach out to orthopedic surgeons for help designing or evaluating new implants, a practice they say spurs innovation and leads to safer, more durable devices. Offering feedback can land surgeons lucrative royalty and consulting deals or stock holdings that escalate in value when startup device companies are sold. In other cases, surgeons have owned a piece of distributorships that buy implants from manufacturers and resell them at a profit.

Whistleblowers and government fraud fighters have argued for years that money passing from industry to doctors can corrupt medical judgment, inflate costs and lead to unnecessary operations or otherwise harm patients.

Some of the harshest criticism has been directed at surgeons who profit from the sale of orthopedic devices — from spinal implants and screws and other hardware to artificial knees and hips that typically cost thousands of dollars. Federal officials warned as far back as 2013 that these sales could violate federal anti-kickback laws.

Steinmann, a Southern California orthopedic surgeon, has been a staunch defender of the profitable distribution companies and has held a stake in at least nine of them, according to Open Payments data. He and four other surgeons at Arrowhead Orthopedics in Redlands, California, were paid nearly $2.5 million in “dividend, profit or other return on investment” by a single distributorship of implants in 2019, according to the database.

The biggest surgeon investors in implant maker Renovis also owned a stake in distributorships. Steinmann received $16.4 million in “ownership and investment interest” from Renovis in 2019, according to Open Payments data, which says he invested $6.7 million in the company. Five other surgeons had holdings worth $1 million or more, according to the data.

Steinmann told KHN that he and the other surgeons invested millions in Renovis and worked for years building it. “We earned every dollar that we made,” he said. Renovis developed innovative products over a decade and the investment return was “good, but not out of line in any respect,” Steinmann said. He added: “I didn’t do any better than if I invested in the stock market. I don’t think it is fair to say otherwise.”

In testimony before Congress, Steinmann has conceded that a few “bad apples” may have endangered patients by performing needless, or overly complex, operations for quick profits on implant sales, but testified his distribution companies have operated legally and ethically and have saved hospitals millions of dollars on implants.

Critics counter that surgeons should collect only professional fees for operating on patients — and steer clear of taking profits from devices they choose to implant in patients. Orthopedic and neurosurgeons typically earn upward of $500,000 annually for their professional services and are among the highest-paid specialists in medicine.

“Doing surgery is a loss leader for what you can get for selling your own products,” said Dr. James Rickert, an orthopedic surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group.

A ‘Crowded and Cutthroat Field’

The orthopedic surgery industry is awash in cash; more than $3.1 billion flowed from device makers to surgeons from August 2013 through 2019, according to KHN’s analysis of payments that device makers reported to the government-run website.

Much of that money paid surgeons for consulting work, including helping to market new products to their peers, or royalties for inventing or fine-tuning surgical tools.

“Orthopedic surgeons are the type who design things. That is inherent in their nature,” said Mark Weiss, a California lawyer who represents physicians.

They also accounted for nearly a third of physicians with stakes in device and drug companies of $250,000 or more during 2019. While some surgeons lost money, many saw their stakes in these companies shoot up in value.

Consider Parcus Medical, a Sarasota, Florida device maker with a self-described “lust for innovation and creativity.” Parcus, which takes its name from the Latin word for “thrifty,” specializes in implants for repairing sports injuries. Massachusetts-based Anika Therapeutics swallowed it for $35 million in January 2020, and 22 surgeon investors saw their Parcus holdings at least triple in value, Open Payments records show.

Dr. Brian McKeon, a Waltham, Massachusetts, orthopedic surgeon and former head physician for the Boston Celtics of the NBA, held Parcus stock in 2019 valued at just over $1.4 million based on an investment of $146,000, according to the Open Payments database. The site states that McKeon did not dispute the figures as posted. But in an email to KHN, McKeon called the Open Payments numbers “way off,” adding “if you find that money please forward to me.” He said he invested in the company in 2006 and has disclosed ownership interest to his patients.

Also in January 2020, Anika Therapeutics paid $60 million for implant company Arthrosurface, which had about 20 surgeon investors; nine paid just $1 for their shares of stock, according to the company. These investments grew in value from $12,600 to $151,200 in 2019, depending on the surgeon, Open Payments records show.

Mark Namaroff, Anika’s executive director for investor relations and corporate communications, said that most of the surgeons invested in the companies prior to the acquisition.

“It was also our understanding that Arthrosurface granted certain surgeons (likely those referenced as paying $1 for stock) common stock in the company during the company’s early years as compensation for services rendered or inventions assigned to the company. As the investments by these individuals all took place prior to our purchase of the companies, we can’t provide additional information about them,” he wrote in an email.

Both Parcus and Arthrosurface had prominent sports orthopedists among their owners, including a dozen who have served as medical consultants to professional sports or U.S. Olympic teams.

It is legal for doctors to work for, or own a piece of, a medical business as long as their compensation is not tied to the volume of its products they use and provided that medical decisions are made in the best interests of patients. Several surgeons’ organizations encourage members to keep detailed records of the services they provide, accept only “fair market” compensation from device makers, and fully disclose industry ties to patients and their peers in scientific journal articles and professional meetings.

Device companies are not required to specify what work surgeons did to justify their stock awards, which more than 100 companies have granted to one or more surgeons who invested $100 or less, according to Open Payments data.

Stock can skyrocket in value after a device company’s sale.

That happened with Titan Spine, a titanium implant maker in Mequon, Wisconsin, bought by industry giant Medtronic in June 2019. In all, two dozen physician investors received more than $17 million in payments. The company reported that a few who put up no money of their own between 2014 and 2019 gained shares worth hundreds of thousands of dollars. One was Dr. Andrew Cappuccino, an orthopedic surgeon and team doctor for the NFL’s Buffalo Bills, who received “vested LLC units” valued at $387,500, according to the company’s report to Open Payments for 2019. Cappuccino had no comment.

A spokesman for Medtronic said: “Collaboration with physicians is critical to innovation and the development of medical devices that save and improve the lives of patients, as well as the training of surgeons who use them.”

Not all investors were happy with their financial gains, however. Utah orthopedic surgeon Dr. Kade Huntsman is among a group of doctors and former Titan sales executives suing the company, for which he once worked as a consultant. The lawsuit calls Titan a “glittering Cinderella success story in an otherwise crowded and cutthroat spinal implant field.”

Huntsman argues he dwelt on the “dark side” of the fairy tale after spending years providing “the voice, prestige and reputation” that made Titan’s products appealing to surgeons.

In legal filings, Huntsman said a Titan sales executive brought him into the fold in April 2014 and persuaded him to try out a Titan device in the operating room. He was so impressed with it that he quickly became “one of the company’s top utilizers” of hardware, according to the suit. Through his lawyer, Huntsman declined to comment.

Huntsman said in the lawsuit that Titan regarded him as a “potential game-changing advocate” for its implants. He talked up Titan’s products at spinal surgery conferences and later taught other surgeons how to use them, according to the suit.

Huntsman agreed to help develop a new spinal fusion implant for Titan and was “certain it would be groundbreaking” — so much so that he declined a salary in favor of company “membership units,” according to the suit.

But he alleged that Titan executives restructured his holdings, so that upon the sale to Medtronic for more than $150 million he saw a return of $180,000, “far less than the $828,750 he calculated he was entitled to receive,” according to the suit. Medtronic denied the allegations and filed a motion to dismiss the case. In June, a judge in Milwaukee dismissed most of the case. Medtronic and Titan are opposing a bid by the plaintiffs to amend their complaint, calling it “futile,” court records state.

‘Corruption of Their Medical Judgment’

More than a decade ago, then-New Jersey Attorney General Anne Milgram investigated global device maker Synthes for failing to disclose stock payments to surgeons conducting pre-market trials on orthopedic hardware. She called that a conflict of interest and a “betrayal of the public trust [that] has the potential to jeopardize patient well-being.”

The case centered on a spinal implant from Spine Solutions, a company partly financed by New York investment firm Viscogliosi Brothers. According to Milgram, Viscogliosi Brothers had offered the researchers “substantial investment opportunities in Spine Solutions, as well as consulting contracts that included gifts of company stock and stock options.”

Milgram argued that Synthes failed to tell the Food and Drug Administration about the stock payments after it bought Spinal Solutions for $350 million in February 2003. The FDA approved the device in 2006 largely on the basis of research results. In May 2009, Synthes settled the New Jersey investigation by agreeing to disclose any payments to physician researchers.

Viscogliosi Brothers, which went on to help finance other spinal device startups, was not a defendant in the New Jersey case. But one of its companies, Paradigm Spine, later was accused by a former sales executive of paying kickbacks through “investor opportunities” offered to dozens of spine surgeons.

The surgeons were selected “because they are in a position to generate substantial business for Paradigm, and they have done so,” according to the whistleblower’s suit, which said four of Paradigm’s top 10 users were investors. “This is a corruption of their medical judgment,” according to the suit.

The whistleblower also accused Paradigm of prompting surgeons to try an implant for an unapproved use and bill for the operation improperly, allegations the company denied. In May 2016, Paradigm agreed to pay the government $585,000 to settle the errant billing claims, court records show. It denied any wrongdoing.

Paradigm Spine was sold to RTI Surgical, a Florida device company, in March 2019 for $300 million. A few surgeon investors wound up with $1 million or more in “ownership and investment interest,” though the company reported that many of the surgeons saw their holdings shrink in value.

When Surgeons Profit Off Implant Sales

The Front Range Center for Brain & Spine Surgery in Fort Collins, Colorado, uses implants supplied by Highline Surgical Solutions LLC, whose owners include three of the center’s surgeons, according to Open Payments filings.

The doctors say their stakes in the implant company and other medical businesses, including two local surgery centers and a diagnostic imaging center, assure them of a “strong influence on the quality, cost and effectiveness” of medical services.

Highline Surgical Solutions also generated a total of more than $3 million for five surgeons from 2016 through 2020, according to Open Payments data. The Front Range Center discloses the ownership ties and notes patients “will not be treated any differently” should they ask for products from other sources. The Front Range Center had no comment.

A few companies have joined the American Association of Surgeon Distributors, a nonprofit group advised by Steinmann that has set standards for “ethical and legal” physician-owned implant distributors. Most of the distributorships with ties to Steinmann have been members, according to the distributors’ association website. As of 2018, Renovis was listed on the association’s website as a “corporate member.”

The association argues that the nation’s five largest orthopedic device companies have established an “oligopoly” that its members fight to compete with, offering “meaningful” cost savings. Steinmann has presented state and federal regulators with research papers that he says document these savings and show how these companies can be run legally and ethically, by taking steps such as forbidding a distributorship from pressuring physician owners to use its products. “There is a right way and a wrong way,” Steinmann said.

Yet the U.S. Department of Health and Human Services Office of Inspector General has argued that physician ownership in device distributors tends to prompt costlier and more-complex surgeries, calling the practice “inherently suspect” in 2013. Last December, officials said these deals could violate anti-kickback laws and “induce physician owners to perform more procedures (or more extensive procedures)” and use its products “in lieu of other, potentially more clinically appropriate devices.”

KHN identified more than three dozen implant supply companies that generated millions of dollars for surgeons from 2013 through 2019. Farallon Surgical LLC, for instance, earned three California surgeons more than $7 million from 2014 through 2020, Open Payments records show. The surgeons had no comment.

About three dozen surgeons have bought stock in the Orthopaedic Implant Co., of Reno, Nevada. Most put in $1,250, an investment the company valued at $31,250 for each of those investors in 2019.

Company president Itai Nemovicher said the doctors would make money only if the company were sold. He said the company offers “high-quality implants at a lower price” to benefit patients. “We are aboveboard in everything we do,” he said in an interview.

Thomas Bulleit, a Washington lawyer who has represented device makers opposed to doctor-owned distributorships, said he sees no reason for physicians to have a stake in the implant supply trade. “The problem is doctors steering patients to products that make them money,” he said.

For their part, federal officials told KHN in interviews that they could not comment on any company’s business practices without first reviewing “all of the facts and circumstances on a case-by-case basis.” But they said the inspector general’s office has repeatedly warned physicians about ownership deals that among other things distribute “extraordinary returns on investment compared to the level of risk involved.”

Just what is permissible could be clarified by a Justice Department civil case in California that has dragged on for nearly a decade. The suit alleges that Reliance Medical Systems LLC and its non-physician owners paid kickbacks to orthopedic surgeons who agreed to use its products. One surgeon paid nothing for a 20% ownership in one of Reliance’s companies and was paid “an average of more than $500,000 per year between 2007 and 2012,” according to the suit. The suit alleges that 25 of Reliance’s 35 physician investors increased their rate of complex spinal fusions and, in some cases, elderly patients on Medicare suffered complications from operations that were “more extensive than necessary.”

Reliance and its owners have repeatedly denied violating any laws. “Our clients will never settle. They believe they have done nothing wrong and they want their day in court,” said Reliance attorney Patric Hooper.

The trial is set for early 2022.

Payments Less Than Transparent

While device companies must report physician ownership stakes, patients are largely on their own in deciphering what it all means.

The federal Centers for Medicare & Medicaid Services, or CMS, which runs the Open Payments website, offers little help. CMS “is unable to speak to how the public should interpret the data,” according to an agency spokesperson. Though it has the authority to do so, CMS has not conducted an audit to verify the accuracy of the reports it receives. One action CMS took in 2018 suggests that, at least in past years, tens of millions of dollars in orthopedic surgery-related payments was not reported.

Responding to written questions, CMS said that in 2018 it contacted about 38,000 orthopedic or neurosurgeons to remind them of the reporting requirements. The action “identified 388 new ownership records associated with 235 physicians, totaling $162,301,018 in reported payments and financial transactions,” according to the agency. “CMS considered this outreach a success,” the spokesperson said.

Much remains less than transparent, however. Some companies report paying thousands of dollars to surgeon owners one year only to disappear from the database the next. And it is rarely clear what percentage of a device company’s total stock is owned by surgeons who may influence hardware sales, an important legal and ethical distinction.

The Open Payments website refers to an ownership interest as a “payment” expressed in dollars but does not always say whether it was paid out in cash or exists only on paper — or how the surgeons obtained their holdings in the company. Some surgeons apparently invested cash, sometimes hundreds of thousands of dollars. Yet there is no explanation of how some surgeons put up $100 or less for stakes that later soared in value. That makes it all but impossible to know whether the compensation paid to a surgeon was reasonable as required by ethics standards and federal anti-kickback laws.

“There are legitimate arrangements and possibly illegitimate ones,” said Richard Saver, a University of North Carolina School of Law professor who has studied the reporting system. “Separating the two is proving very difficult.”

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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“La reina de la vacunación”: enfermera lleva las dosis contra covid de casa en casa en Puerto Rico

Mon, 08/09/2021 - 5:00am

MAYAGÜEZ, PUERTO RICO – Abigail Matos-Pagán llegó a una casa de color azul brillante en Mayagüez, en donde la recibió Beatriz Gastón, quien en silencio la condujo a la pequeña habitación de su madre. Matos-Pagán llevaba una vacuna contra covid-19 para Wildelma Gastón, de 88 años, quien está confinada en una cama por su artritis y otros problemas de salud.

Wildelma Gastón pidió que le pusieran su rosario en el pecho y señaló su “brazo bueno”, donde Matos-Pagán le inyectó la primera dosis de la vacuna de Moderna. La familia Gastón, compuesta por cinco miembros, respiró con alivio. Aunque la vacuna estaba disponible desde hacía meses, Wildelma no había podido ir a un centro de vacunación.

Según el rastreador de datos de covid de los Centros para el Control y la Prevención de Enfermedades (CDC), la tasa de vacunación de Puerto Rico en marzo fue una de las más bajas entre los estados y territorios de Estados Unidos, a pesar de haber recibido más de 1,3 millones de dosis de vacunas. El despliegue puso de manifiesto las disparidades en el acceso a los servicios médicos, y los retos que supone el seguimiento y la comunicación con ciudadanos que viven en lugares lejanos, como Wildelma.

Cada vez que regresaban de la escuela o del trabajo, a los familiares les preocupaba la posibilidad de llevar el virus a su hogar, y la amenaza que suponía para la vida de Wildelma. Durante su visita, Matos-Pagán también vacunó a dos de los hijos de Beatriz, que son estudiantes de la Universidad de Puerto Rico-Mayaqüez.

“Llevamos mucho tiempo esperando este momento”, dijo Beatriz Gastón mientras se despedía con un abrazo de Matos-Pagán, expresando su gratitud por la visita a domicilio. Para ella la vacuna es algo más que una protección contra el coronavirus: le permite a la familia estar junto a su madre.

Para Matos-Pagán, es una nueva misión. La enfermera, que ha liderado tareas de ayuda tras los huracanes y terremotos en Puerto Rico y otros lugares, se ha propuesto vacunar al mayor número posible de personas contra covid en este territorio estadounidense. Algunos residentes de Mayagüez, ciudad situada en la costa occidental de la isla principal, la llaman cariñosamente “La reina de la vacunación” y se presentan en su casa pidiendo ayuda para vacunarse.

Según el rastreador de casos de The New York Times, hasta el 5 de agosto, Puerto Rico suma cerca de 182,000 casos dSegún el rastreador de casos de The New York Times, hasta el 5 de agosto, Puerto Rico suma cerca de 182,000 casos de covid y 2,594 muertes. Algo más del 59% de la población está totalmente vacunada, pero muchos de los que no están vacunados son difíciles de localizar porque viven en comunidades montañosas alejadas, o tienen enfermedades crónicas que les obligan a quedarse en casa.

Hasta ahora, Matos-Pagán ha vacunado a unas 1,800 personas en Puerto Rico, incluidas 1,000 con enfermedades crónicas o postradas en cama.

En los primeros días de la pandemia, la salud de Carmen Blas empeoró y empezó a utilizar una silla de ruedas. Blas, de 78 años, estaba confinada en su casa, en el tercer piso de un edificio de apartamentos, lo que la mantenía a salvo de contraer covid, pero más tarde no pudo encontrar transporte para ir a vacunarse. En junio, sus dos hijos, Lisette y Raymond, vinieron desde Wisconsin para ayudar y llamaron inmediatamente a funcionarios de salud pública para que Blas se vacunara.

“Suelo volver todos los años y esta ha sido la vez que más tiempo he estado fuera. Fue especialmente duro porque la salud de mi madre empeoró y me preocupaba no volver a verla”, contó Raymond, que pensaba prolongar su visita todo el tiempo que fuera necesario.

Matos-Pagán fue a la casa de Blas, en Aguadilla, para administrarle la vacuna. La familia celebró con alegría la vacunación.

“Ha sido muy especial tener momentos personales en la casa de alguien durante la vacunación. Se nota lo mucho que significa para toda la familia”, comentó Matos-Pagán.

La movilización durante una crisis no es algo nuevo para Matos-Pagán. Tras el paso del huracán María, que cortó el agua y la electricidad en toda la isla y se cobró más de 3,000 vidas, Matos-Pagán llevó a cabo evaluaciones comunitarias iniciales en las ciudades más remotas y afectadas de Puerto Rico.

Muchas carreteras eran inaccesibles debido a las inundaciones y a los escombros, lo que impedía a estas comunidades satisfacer necesidades básicas como alimentos, agua, recetas médicas y transporte. Después, tras una serie de terremotos que sacudieron la isla en 2020, dejando a más personas sin vivienda o en estructuras deficientes, Matos-Pagán organizó a las enfermeras locales para que prestaran atención sanitaria a la comunidad. Suministraron a las poblaciones en riesgo sus medicamentos cuando las farmacias cerraron y los equipos instalaron tiendas médicas móviles junto a hospitales que estaban saturados.

“Soy hiperactiva y estoy siempre ocupada en mi vida diaria, pero cuando hay una crisis, estoy tranquila y calmada. Con los pies en la tierra. Siento que estoy donde debo estar”, expresó.

Matos-Pagán nació en Nueva York. Se interesó por la medicina después de ver cómo las enfermeras ayudaban a su madre, que murió por complicaciones de un aneurisma cuando Matos-Pagán tenía 9 años. La muerte de su madre le enseñó que “nada era permanente”, dijo, lo que la ha inspirado a actuar cuando ocurre un desastre y a apoyar a las personas ante la tragedia y la pérdida.

Matos-Pagán regresó a Puerto Rico para estudiar enfermería y posteriormente obtuvo un máster y un doctorado en la Universidad de Puerto Rico-Mayagüez. Gracias a su trabajo, ostenta varios títulos: primera comandante del Equipo de Respuesta a Desastres de Puerto Rico, y directora y fundadora de la Coalición de Enfermeras para Comunidades en Desastre.

Su experiencia en la gestión de profesionales y recursos médicos durante los huracanes la ha llevado a lugares de la costa atlántica estadounidense y del Caribe. Durante la pandemia de covid, fue contratada para ayudar a dirigir el triage (sistema para seleccionar a los pacientes prioritarios que llegan a urgencias) de una unidad de cuidados intensivos, escasa de recursos, en El Paso, Texas, y en una residencia de mayores muy afectada en Maryland.

“No todo el mundo está hecho para esto. Es un trabajo realmente triste y deprimente”, señaló Matos-Pagán. “Pero incluso cuando hay miles de víctimas, se pueden salvar vidas y satisfacer las necesidades básicas de las personas. He visto a las comunidades unirse de manera increíble. Es un reto, pero eso es lo que me hace seguir adelante”.

Y mientras trabaja para inyectar con rapidez más vacunas contra covid en los brazos de los residentes de Puerto Rico, Matos-Pagán se prepara para la próxima crisis. La temporada de huracanes comenzó oficialmente en junio, y estará en alerta para otro posible desafío sanitario hasta finales de noviembre.

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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A California Bill Would Limit Protests at Vaccination Sites. Does It Violate the First Amendment?

Mon, 08/09/2021 - 5:00am

[UPDATED at 6:15 p.m. ET]

SACRAMENTO, Calif. — A proposal sailing through the California legislature that aims to stop people from getting harassed outside of vaccination sites is raising alarms among some First Amendment experts.

If it becomes law, SB 742 would make it punishable by up to six months in jail and/or a maximum fine of $1,000 to intimidate, threaten, harass or prevent people from getting a covid-19 — or any other — vaccine on their way to a vaccination site.

The measure was introduced after protesters briefly shut down a mass vaccination clinic at Los Angeles’ Dodger Stadium in January. Now that mass vaccination clinics have mostly folded up, lawmakers worry that vaccination sites with less security than Dodger Stadium — like pharmacies and mobile clinics in parks or fast-food parking lots — are vulnerable.

It’s a sign of how toxic the issue of vaccination has become in a state with a long history of intense and divisive vaccine wars.

State Sen. Richard Pan (D-Sacramento), a pediatrician who administers vaccines to his patients, wrote the bill. He has been the target of anti-vaccination harassment since writing and championing laws that made it harder for parents to refuse routine vaccines for their children by eliminating personal belief exemptions and tightening rules around medical ones.

He was shoved by someone who opposed the medical exemption bill in 2019, the same year in which an anti-vaccine protester threw menstrual blood onto the state Senate floor.

Pan was also among the lawmakers threatened at a committee hearing earlier this year.

Last month, Pan volunteered at a vaccination clinic at a Sacramento park that he said was disrupted by anti-vaccine protesters with a bullhorn who made it hard for medical personnel to converse with patients and answer their questions.

And while he said he can handle threats, ordinary citizens “shouldn’t have to run a gauntlet to get vaccinated.” That includes walking through a group likely made up of unvaccinated protesters and possibly getting exposed to covid to get protected, he said.

His measure prohibits obstructing, injuring, harassing, intimidating or interfering with people “in connection with any vaccination services.” The bill passed the state Senate with just four no votes and faces one more committee hurdle before it heads to the Assembly floor.

The bill defines harassment as getting within 30 feet of someone to hand them a leaflet, display a sign, participate in any kind of verbal protesting like singing or chanting, or conduct any education or counseling with that person.

Blocking someone or impeding them from getting a vaccine is an obvious problem, and it’s good that the proposal would try to stop that, said Glen Smith, litigation director for the First Amendment Coalition, a California-based nonprofit that promotes the First Amendment, which guarantees rights such as free speech and assembly. But he thinks the proposal goes too far with its definition of harassment.

“To say you can’t get within 30 feet of them just to hand them a pamphlet or ask them a question? That seems to be overkill for me,” Smith said.

It’s worse than overkill, said Eugene Volokh, a professor of First Amendment law at the UCLA School of Law.

“That law is clearly unconstitutional,” Volokh said.

He has two primary concerns with the proposal:

First, though it’s modeled on similar laws that create zones around abortion clinics to protect patients from harassment, this bill goes beyond what courts have upheld in the past, he said. In 2000, the U.S. Supreme Court upheld a Colorado law that created an 8-foot “bubble zone” around a person entering or exiting an abortion clinic, but in 2014 the high court struck down a Massachusetts law that created a 35-foot “buffer zone” around clinics.

A 30-foot zone around a person getting a vaccine is bigger than the court would allow, Volokh believes.

His second concern is that the bill specifically prohibits someone from leafletting or talking to someone only about vaccines.

That violates the First Amendment, Volokh said, because it targets certain content. Someone could hand out an anti-war or anti-fur leaflet and not run afoul of the law, he said.

“I think it’s pretty shocking that a state legislature would try to enact this kind of restriction on fully protected speech this way,” Volokh said.

The Right to Life League, which has opposed the measure from the start, advocated to get “in connection with vaccination services” added to the bill language.

Once the bill was amended to include that phrase, that limited “the negative impact of the bill on pro-life activities,” like anti-abortion sidewalk counseling outside Planned Parenthood clinics, which provide abortions and vaccines, Elisabeth Beall, media coordinator for the Right to Life League, wrote in a statement.

The group still believes the bill is unconstitutional.

Not all free speech advocates share Volokh’s interpretation of the bill. The American Civil Liberties Union said it has no issues with it as written.

“It’s not necessarily the case that the freedom to express our views is unrestricted,” said Kevin Baker, director of governmental relations at ACLU California Action. “They can be balanced with important governmental objectives” like letting people get vaccinated in peace.

Part of that objective is stopping disinformation about vaccines, which Pan said is the primary reason people are not getting the shots.

“Frankly, any gains we make to try to get more people vaccinated are going to be incremental because of disinformation,” Pan said. And when protesters show up claiming they’re there to educate patients, “they’re talking about disinformation.”

Joshua Coleman, co-founder of the group V is for Vaccine, which advocates for informed consent before vaccinations and says vaccines carry risk, said he brought the bullhorn to Pan’s clinic to “educate those coming to receive the vaccine on important facts they deserve to know” and object to Pan’s bill.

“The intent in attending Senator Pan’s vaccination clinic was to protest the censorship of important information and his egregious and erroneous attack on free speech,” he said via email.

Pan said his bill was “carefully crafted” to stop the “obstruction, harassment and intimidation” of people seeking vaccines, and is confident that it is well within the bounds of the First Amendment.

“There’s precedent for saying you can protest. This law doesn’t say you can’t protest. There’s certain rules around the protest,” Pan said. “Especially as we’re trying to deal with this pandemic, we need to do what we can to be sure people feel safe getting themselves vaccinated.”

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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Injuries Mount as Sales Reps for Device Makers Cozy Up to Surgeons, Even in Operating Rooms

Mon, 08/09/2021 - 5:00am

Cristina Martinez’s spinal operation in Houston was expected to be routine. But after destabilizing her spine, the surgeon discovered the implant he was ready to put in her back was larger than he wanted to use — and the device company’s sales rep didn’t have a smaller size on hand, according to a report he filed about the operation.

Dr. Ra’Kerry Rahman went ahead with the operation, and Martinez awoke feeling pain and some numbness, she alleges. When Rahman removed the plastic device four days later and replaced it with a smaller one, Martinez suffered nerve damage and loss of feeling in her left leg, she claims.

Martinez is suing the surgeon, implant maker Life Spine Inc., and its distributor and sales representatives, alleging their negligence led to her injuries because the right part wasn’t available during her first surgery. All deny wrongdoing. The case is set for trial in November.

The lawsuit takes aim at the bustling sales networks that orthopedic device manufacturers have built to market ever-growing lines of costly surgical hardware — from spinal implants to replacement knees and artificial hips commonly used in operations. Sales in 2019 topped $20 billion, though covid-19 forced many hospitals to suspend elective surgeries for much of last year.

Device makers train sales reps to offer surgeons technical guidance in the operating room on the use of their products. They pay prominent surgeons to tout their implants at medical conferences — and athletes to offer celebrity endorsements. The industry says these practices help ensure that patients receive the highest-quality care.

But a KHN investigation found these practices also have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability and whistleblower lawsuits filed over the past decade.

Some patients allege they were injured after sales reps sold or delivered wrong-size or defective implants, while others accuse device makers of misleading doctors about the safety and durability of their products. Six multi-district federal cases have consolidated more than 28,000 suits by patients seeking compensation for injuries involving hip implants, including painful redo operations.

In other court actions, patients and whistleblowers repeatedly have accused device companies of failing to report injury-causing defects to federal regulators as required — or of doling out millions of dollars in illegal kickbacks to surgeons who agreed to use their products. Device makers have denied the allegations and many such cases are settled under confidential terms.

At least 250 companies sell surgical hardware, and many more distribute it to doctors and hospitals across the country. Spine companies alone obtained more than 1,200 patents for devices in 2018, according to an industry report. Many come to market through a streamlined Food and Drug Administration process that approves their use because they are essentially the same as what is already being sold.

“In orthopedics, we are inundated with a multitude of new implants that debut each year,” Dr. James Kang, chairman of the orthopedic surgery department at Brigham and Women’s Hospital, remarked at a Harvard Medical School roundtable discussion published in 2019.

Kang said surgeons often rely on industry “reps” in the operating room for guidance because it is “usually burdensome and difficult” for surgeons to know “all of the intricate details and nuances” of so many products.

Martinez’s lawsuit says the process went awry during her May 2018 spinal fusion in Houston, an operation in which an implant is inserted into the spinal column to replace a worn or damaged disc.

Martinez was under anesthesia, with her spine destabilized, when Rahman discovered the Life Spine surgical kit did not contain any implants shorter than 50 millimeters, or about 2 inches. That was too large, according to the complaint. Martinez, a former day care worker, blames her injuries on the redo operation, which replaced the implant with a 40 mm version Life Spine supplied later.

Through his lawyer, Rahman declined to comment. In court filings, the surgeon has denied responsibility. His operating notes, according to court pleadings, say he had ordered “all lengths available” of the implant through a Life Spine distributor and its sales reps. In a June court filing, Rahman contends the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery … and was not the result of any alleged negligence.”

In the court filing, Rahman also argues it was “appropriate” for him to rely on the sales reps and hospital staff to “inform him as to whether all materials and equipment needed for surgery were available.”

Illinois-based Life Spine also denies blame. In court filings, it says the sales reps initially ordered a sterile kit that included only implants from 50 mm to 55 mm long, which it duly shipped to Houston.

At the time of Martinez’s operation, Life Spine was the target of a sealed whistleblower lawsuit accusing it of paying improper consulting fees and other kickbacks to more than 60 surgeons who agreed to use its wares. Court records in the whistleblower case identify Rahman as one of the company’s paid consultants, although he and the other surgeons were not named as defendants. Life Spine and two of its executives settled the matter in November 2019 by paying a total of nearly $6 million. An orthopedic surgery expert hired by Martinez for her suit faulted Rahman for not making sure he had the right gear “prior to the start of surgery,” according to his report. The expert also criticized the sales rep for failing to bring “all available lengths to the procedure or to inform Dr. Rahman that the necessary implants were not available,” court records show. The sales rep and distributor denied any blame, arguing in court filings that they “met all applicable standards of care.”

Frenzied Competition for Sales

Major device makers train a corps of sales agents, some recruited right out of college, to cultivate and work closely with surgeons — one likened the relationship to a caddy and an avid golfer. Duties can include lugging 20-pound sets of surgical hardware to the operating room, assuring it is sterile and knowing its specifications, though the reps are not required to have medical training or credentials.

Stryker, one of the nation’s top four spine implant manufacturers, spends what it calls “a significant amount of time and money” to train reps. When hired, they typically “shadow” other reps for three to six months, then attend a 10-day intensive “Spine School” and other training. In all, the company said in a court filing, it typically takes eight to 18 months, often longer, to develop “long-term relationships” with customers.

For those who do, the jobs can pay handsomely. Veteran reps who influence which brands of hardware surgeons select command salaries and bonuses that can stretch into the low six figures and beyond, court records show.

The market is so hotly competitive that device makers typically require reps to sign contracts that prohibit them from working for a rival company in the same territory for a year or more — and aren’t shy about suing to fend off raids on their staffs, court records show.

In 2019, DePuy Synthes sued an Alabama sales rep who jumped ship, blaming him for stealing away accounts “worth millions of dollars practically overnight.” An arm of health care giant Johnson & Johnson, DePuy Synthes filed at least two dozen similar suits from 2014 through the end of 2020, court records show. Most, including the case of the Alabama sales rep, have been settled under confidential terms.

Some companies have spent lavishly to poach experienced sales agents — practices that can violate business conduct laws. One allegedly paid a New York sales pro a “staggering, seven-figure signing bonus.” Another is said to have dangled an $800,000-a-year job as “director of surgeon education,” while a gambit to make inroads in the Phoenix market dubbed “Sun Devil” guaranteed a branch manager a $500,000 annual salary, court records show. Another promised a sales agent $900,000 paid out over three years.

Whistleblowers and government investigators have argued for years that so much money changing hands can lead to kickbacks or other marketing schemes that corrupt medical judgment and endanger patients. Some injury suits also have blamed sales reps and distributors for staying mum about product deficiencies they observed in the operating room. These cases often are settled with no admission of wrongdoing.

Sometimes, surgeons help promote implants at medical meetings and other gatherings. Orthopedic surgeons and neurosurgeons received a total of about $511 million in industry consulting fees from 2013 through 2019 and nearly $300 million more for “serving as faculty or speaker” at industry-sponsored events, a KHN analysis of government data found. AdvaMed, the device industry’s trade group, says doctors often take “primary responsibility” for training other doctors to use new devices. “Unlike a pill or injection, procedures to implant or equip medical devices for patients can be extremely technical and complex,” said Scott Whitaker, the group’s president and CEO.

Some prominent surgeons who touted products that later were recalled, or who helped train surgeons to use implants, have been criticized in pending injury lawsuits.

One is Dr. Brad Penenberg, an orthopedic surgeon in Beverly Hills, California, paid by Wright Medical Technology as a “key opinion leader,” according to court filings. Multiple lawsuits cite a webinar for orthopedic surgeons that featured Penenberg and said hip surgery patients could resume “activities and lifestyles that include such things as tennis, horseback riding and snow skiing.”

Injured patients are arguing in court filings that Penenberg and several other experts paid by the company knew of significant failures of the hip device. Penenberg did not respond to numerous requests for comment but in court papers denied the allegations.

Hundreds of patients are claiming injuries they blame at least partly on overly aggressive marketing by Wright Medical. In one 2020 lawsuit, a Montana man who had received a hip implant said he was taking a walk while in Arizona on vacation when he “felt a severe jolt in his groin and fell.” He was out of cell range and could not get up or call for help. A “good Samaritan” called for an ambulance, which took him to a hospital in Gilbert, Arizona, where X-rays showed a fracture of the implant. It was removed and replaced. Wright Medical has denied the allegations.

Retired California psychologist Herb Glazeroff is suing Penenberg and Wright Medical Technology over a hip replacement that allegedly failed about five years after the surgeon installed it. In May 2019, Glazeroff was walking when he “suddenly dropped to his knees as his left leg gave out on him,” according to the suit. He alleges that the hip had fractured, which required a painful second operation and “a long and arduous rehabilitation program” from which he has “yet to fully recover.” Glazeroff argues that Penenberg failed to warn him about the implant’s dangers even though the surgeon had been named in “multiple lawsuits” alleging device defects. Penenberg has denied the allegations.

Dozens of lawsuits have taken aim at Indiana device maker Biomet’s advertising a hip replacement for “younger, more active patients” that showcased Olympic gold medal gymnast Mary Lou Retton. One ad says “Mary Lou lives pain-free, and so should you.” Yet Retton suffered painful heavy-metal poisoning requiring the implant’s removal and sued the company for damages, according to court records.

In a January 2020 court filing in Houston, Retton tried to block a subpoena seeking her deposition in a product liability lawsuit filed against Biomet by two patients in King County, Washington. The Washington case has since been settled and the deposition did not occur. But in a court filing opposing the subpoena, Retton confirmed she had a Biomet implant put in her left hip in 2005 and one on her right side about six years later. She said she promoted Biomet products from April 2006 through April 2013 and sued the company in January 2018, alleging the implants were defective. Retton said she and Biomet settled the suit in early 2019 “under confidential terms the parties find favorable to their respective positions. [Ms. Retton] values her long relationship with Biomet and her continued use of her [Biomet hip implants] and [Biomet] appreciates the support it has received over the years from [Ms. Retton].”

Defects Ignored, Downplayed

Whether touted by renowned surgeons or celebrities, orthopedic surgery marketing materials stress quick improvement in a person’s quality of life. That proves true for most patients. Yet researching how often implants fail or cause life-changing injuries — and which brands have the best safety records — can be daunting.

The FDA requires device makers to advise the agency of information “that reasonably suggests” a device they sell “may have caused or contributed to a death or serious injury or has malfunctioned” in a way that could recur. The FDA posts the reports on a public website, with the caveat that they may convey “incomplete, inaccurate, untimely, unverified, or biased data.”

KHN found that thousands of malpractice and product liability lawsuits have accused device marketers of concealing or downplaying hardware defects, leaving patients and their doctors in the dark about possible risks. In many cases, these claims are bolstered by company records, or actions by state or federal regulators. In 2019, for instance, DePuy Synthes paid $120 million to settle a lawsuit filed by 46 state attorneys general; the suit accused the company of advertising that a replacement hip it sold lasted three years in 99.2% of operations, when it knew of data showing that 7% had failed within that time. The company did not admit wrongdoing in settling the case.

British device company Smith & Nephew faces a federal civil proceeding comprising nearly 1,000 injury suits, including one that says the company “underreported and withheld” notices of malfunctions and “willfully ignored the existence of numerous complaints about [its] failures.” An expert hired by the patients cites a company audit showing “significant adverse events” were logged from two days to 142 days late, while a corporate memo circulated among executives to push sales was titled “Milk the Cash Cow,” according to court records. Smith & Nephew has denied the allegations and in one court paper called the expert’s opinions “speculative.”

A cluster of Florida injury cases pertaining to a knee implant from German manufacturer Aesculap alleges that the FDA cited the company for failing to report 25 adverse incidents — in some cases for a year or more — as a result of an inspection at its Hazelwood, Missouri, plant in September 2015. Aesculap has denied the allegations and the suits are pending in Florida’s Indian River County Circuit Court.

John Saltis is suing spinal device company NuVasive over its handling of his complaint that a screw holding his spinal implant in place snapped in May 2016, about 17 months after his operation.

Saltis, 68, was two hours into his workday as a toolmaker at General Electric in Rutland, Vermont, when he felt sharp pain in his neck and shoulder, bad enough to send him to the hospital emergency room. A few days later, X-rays revealed the screw had broken and, according to Saltis, fractured vertebrae in the process.

Saltis said the San Diego-based device company told the FDA the incident caused no harm. But Saltis said he has lingering numbness and pain in his right hand. As a result, he said, his lifestyle has “changed dramatically.” He sold his motorcycle and stopped biking and now relies on his left hand for simple tasks like opening doors and shaking hands — even plucking chips out of a bag.

“I miss things like bowling and playing toss with my grandkids,” he said.

In 2019, Saltis sued NuVasive without a lawyer, hoping to show the $600 screw was defective. In a court filing, NuVasive said Saltis is arguing “the screw is defective because it broke.” That’s not good enough, according to NuVasive, which argues that Saltis must show the screw was “unreasonably dangerous” to press his claim. In late June, a federal judge agreed and dismissed the suit, though she allowed Saltis to amend his complaint, which he is pursuing. The case is pending.

“I was pain-free for a few months and would have stayed that way if the screw hadn’t broken,” Saltis said. “This can change somebody’s life completely.”

A Push for Change as Pandemic Eases

As hospitals resume elective operations stalled by the coronavirus, some industry critics see an opportunity to rethink orthopedic surgery practices — from sales to tracking of injuries.

Some want to keep industry reps out of operating rooms and place tighter restrictions on their access to hospitals. They say the current system needlessly drives up health care costs and exposes patients to risks such as infection from extra people in the operating room. Reps counter that their incomes have been dropping due to global purchasing arrangements that give hospitals greater say over prices for surgical equipment.

Sales reps say their technical knowledge and skills make operations safer for patients and note that many surgeons enjoy the security of having them present in the operating room. Reps also say they perform tasks that hospitals would need to hire additional personnel to do, such as keeping track of device inventories.

“The industry has embedded reps into the supply chain, and it is a hard culture to break,” said Itai Nemovicher, president of the Orthopaedic Implant Co., which seeks to produce lower-cost implants.

Yet guidelines for “reentry” after covid put out by AdvaMed and the American Hospital Association say medical device reps should deliver “services, information and support remotely whenever possible.” The guidelines advise hospitals to use videoconferencing gear when it “does not compromise patient safety or privacy.”

Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University, said device reps are viewed as part of the operating room team even though they are there “to sell products. That is pretty horrifying from a patient’s point of view.” She said hospitals should train staff to perform these functions. “Relying on sales reps in the OR is appalling. We need to come up with a better system.”

Greater transparency might have helped Little Rock, Arkansas, resident Christopher Paul Bills. He sued Consensus Orthopedics, the maker of a hip implant system that he alleged failed and sent metal through his hip joint that his surgeon said in 2016 looked “as if a bomb had gone off.” An Australian registry that tracks outcomes of operations had in September 2014 identified the implant as having a “higher number” of hip failures compared with other manufacturers, according to the suit.

Bills underwent four operations and spent more than a year in the hospital and in rehabilitation, costs borne by Medicare and private insurance.

“Mr. Bills was left with no right hip at all and his surgeon does not plan to install a replacement hip,” the suit says. Bills uses an electric scooter to get around and hopes to graduate to hand-held crutches. “Since his right leg is useless, he will require a vehicle with hand-controls to drive,” according to the suit. The company disputed Bills’ claims and denied its hip system had any defects.

The case ended in 2019 when Bills died of cancer unrelated to his operations, said his lawyer, Joseph Saunders.

“He never did get justice,” Saunders said.

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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‘The Vaccination Queen’: Nurse Practitioner Takes Covid Shots House to House in Puerto Rico

Mon, 08/09/2021 - 5:00am

MAYAGÜEZ, PUERTO RICO — Abigail Matos-Pagán entered a bright-blue house in Mayagüez earlier this summer and was met by Beatriz Gastón, who quietly led the way to her mother’s small room. Matos-Pagán had come to provide a covid-19 vaccine for Wildelma Gastón, 88, whose arthritis and other health concerns confine her to bed.

Wildelma Gastón asked for her rosary to be placed on her chest and motioned to her “good arm,” where Matos-Pagán injected a first dose of the Moderna vaccine. The Gastón household, made up of five family members, breathed a collective sigh of relief. Though the vaccine had been available for months, Wildelma had been unable to reach a vaccination site. According to the Centers for Disease Control and Prevention’s COVID Data Tracker, Puerto Rico’s vaccination rate in March was one of the lowest among U.S. states and territories despite receiving more than 1.3 million vaccine doses. The rollout highlighted disparities in access to medical services, and the challenges of tracking and reaching remote citizens, such as Wildelma.

With each trip to school or work, family members worried about bringing the virus into their home and the threat to Wildelma’s life. Matos-Pagán also vaccinated two of Beatriz’s children, who are students at the University of Puerto Rico-Mayaqüez, during her visit.

“We have been waiting a long time for this moment,” Beatriz Gastón said as she hugged Matos-Pagán goodbye, expressing gratitude for the home visit. To her, the vaccine is more than protection from the coronavirus — it clears the way for the family to be together with her mother.

To Matos-Pagán, it is her latest calling. The nurse practitioner, who has guided relief efforts after hurricanes and earthquakes in Puerto Rico and elsewhere, has made it her mission in the U.S. territory to vaccinate as many people as possible against covid. Some residents of Mayagüez, a city on the western shore of the main island, candidly call her “The Vaccination Queen” and show up at her home asking for help in getting a shot.

According to The New York Times’ case tracker, as of Friday, Puerto Rico has had more than 182,000 covid cases and at least 2,594 deaths. About 57% of the population is fully vaccinated, but many of the unvaccinated are hard to reach because they live in remote mountainous communities or have chronic illnesses that leave them homebound. Matos-Pagán has vaccinated around 1,800 people in Puerto Rico so far, including 1,000 who have chronic illnesses or are bedridden.

In the pandemic’s early days, Carmen Blas’ health declined, and she began using a wheelchair. Blas, 78, was confined to her home, on the third story of an apartment building, which kept her safe from contracting covid, but later she couldn’t find transportation to a vaccination site. In June, her two children, Lisette and Raymond, visited from Wisconsin to help and immediately called the public health officials to get Blas inoculated.

“I usually come back every year and this was the longest I’ve ever been away. It was especially hard as my mother’s health worsened, and I worried I might never see her again,” said Raymond, who planned to extend his visit for as long as he was needed.

Matos-Pagán came to Blas’ home in Aguadilla, Puerto Rico, to give her the vaccine. The family cheered the moment the vaccination was over.

“It’s been really special to have intimate moments in someone’s home during vaccinations. You can tell how much it means to their entire family,” Matos-Pagán said afterward.

Mobilizing during a crisis is nothing new for Matos-Pagán. In the aftermath of Hurricane Maria, which cut off water and electricity to the entire island and claimed more than 3,000 lives, Matos-Pagán conducted initial community assessments in Puerto Rico’s remotest and hardest-hit cities. Flooding and debris made many roads inaccessible, blocking these communities from basic needs such as food, water, prescription medications and transportation. Then, after a series of earthquakes in 2020 rocked the island, leaving even more people without housing or in substandard structures, Matos-Pagán organized local nurse practitioners to provide community health care. They supplied at-risk populations with their medicines when pharmacies closed, and teams set up mobile medical tents near overcrowded hospitals.

“I’m hyper and busy in my daily life, but when there is a crisis, I am calm and still. Grounded. I feel like I’m where I belong,” she said.

Matos-Pagán was born in New York City. She became interested in medicine after watching nurses support her mother, who died of complications from an aneurysm when Matos-Pagán was 9. Her mother’s death taught her “nothing was permanent,” she said, which has inspired her to act when disaster strikes and support people through personal tragedy and loss.

Matos-Pagán returned to Puerto Rico to study nursing and later earned a master’s degree and a doctorate at the University of Puerto Rico-Mayagüez. Through her work, she holds various titles: first commander of the Puerto Rican Disaster Response Team, and director and founder of the Coalition of Nurses for Communities in Disaster.

Her experiences managing medical professionals and resources during hurricanes have taken her to locations across the U.S. Atlantic coast and the Caribbean. During the covid pandemic, she was recruited to assist in triage leadership for an ICU floor short on resources in El Paso, Texas, and a hard-hit senior living facility in Maryland.

“Not everyone is built for this. It’s really sad, depressing work,” Matos-Pagán said. “But even when there are mass casualties, you can still save lives and get people’s basic needs met. I’ve seen communities come together in the most incredible ways. It’s a challenge, but that’s what keeps me going.”

And, even as she is rapidly trying to get more covid shots into the arms of Puerto Ricans, Matos-Pagán is preparing for the next crisis. Hurricane season officially began in June, and she will be on disaster-ready duty until the end of November.

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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Journalists Assess the Latest Covid Surge and the Nation’s Vaccination Effort

Sat, 08/07/2021 - 5:00am

KHN freelancer Mark Kreidler discussed why professional athletes are not taking a more affirmative role in pushing covid vaccines on Newsy on Tuesday.

KHN Midwest correspondent Cara Anthony discussed masking mandates, vaccine efficacy and breakthrough covid cases on Illinois Public Media’s “The 21st Show” on Monday.

KHN chief Washington correspondent Julie Rovner discussed the recent surge in covid cases on Axios’ “Axios Today” podcast and WAMU/NPR’s “1A” on Monday and July 30, respectively.

KHN Montana correspondent Katheryn Houghton explored the phenomenon of folks visiting radon mines in Montana as a treatment for various ills on “Voices of Montana” on July 30.

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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Déjà Vu? Consumers Scramble for Covid Tests in Hard-Hit Areas

Fri, 08/06/2021 - 1:00pm

Andrea Mosterman, an associate professor of history at the University of New Orleans, was already dismayed that she had to wait three days to secure a covid-19 test at a Walgreens near her home after being in contact with someone who had tested positive.

But on Sunday, when she showed up at the pharmacy drive-thru, she was told the store had run out of test kits and none was available anywhere in the city. “I told them I had a reservation, but they said it didn’t matter,” she said.

On Monday, eager to know her status and get back to work, she waited at an urgent care center for four hours to get tested. Within minutes, she was told she had tested negative.

While relieved, Mosterman said the process upset her. “It was incredibly irresponsible for them to promise me a test and have me wait three days to have the test and then to say, ‘We don’t have it.’ That was so frustrating,” she said.

As the nation confronts its latest and worsening surge of covid cases, consumers are again facing delays getting tested, many turning to social media to complain. The problem appears mostly in the South and Midwest, where infections driven by the virus’s delta variant are proliferating the fastest.

About 100,000 new cases of covid are being reported each day this week, up from about 12,000 a day in early July. Testing is up 41% in the past two weeks, to nearly 770,000 tests a day, according to The New York Times’ analysis of federal and state data.

Walgreens spokesperson Phil Caruso said the company has seen demand for tests “rise significantly, as testing volume across our stores doubled chainwide from June to July.” Overall, Walgreens has met the demand, he said, despite minor delays at some locations.

The shrinking supply of tests becomes clear when checking the websites of the nation’s two largest pharmacy chains, CVS and Walgreens — which have become popular test sites since cities and states curtailed testing to focus on vaccinations this spring.

On Wednesday, not a single appointment was available through Friday at 52 Walgreens locations in and around Jacksonville, Florida, which has one of the country’s highest infection rates. The earliest option was Thursday morning in Brunswick, Georgia, 70 miles away.

At CVS stores around Jacksonville, tests weren’t widely available until Tuesday, nearly one week later, when 21 of the closest 35 stores had appointments. If someone was willing to drive 15 to 20 miles, a handful of slots were available Monday, but nothing sooner.

Jacksonville’s Duval County had one public test site open this week, but health officials said they were weighing opening more because of increasing demand.

In Hillsborough County, home to Tampa, officials planned to open testing sites after reports from residents that they were waiting up to three days.

Experts say testing is vital for identifying patients to treat or isolate, as well as for tracking the disease’s spread.

“It’s understandable that resources have been pulled away, but testing is still a really important part of the pandemic,” said Gigi Gronvall, a senior scholar at the Johns Hopkins Bloomberg School of Public Health.

States closed many of their mass test sites over the past several months because of declining demand and the need to focus on vaccination.

Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, said pharmacies likely have an adequate supply of tests, although they may have to redistribute them to keep up with increased demand in hard-hit areas.

“It’s no surprise there has been a little bit of a backup,” he said.

CVS Health spokesperson Tara Burke said her company is largely keeping up with demand, but she would not comment on consumer complaints about waiting three days or more to have a test.

“We continue to be able to meet the demand for COVID-19 testing, even with increasing numbers of patients seeking out tests at one of our more than 4,800 CVS Pharmacy locations across the country offering testing with same day and future day appointments in most geographies,” she said in an email response to KHN.

The nation’s largest pharmacies have been popular test sites, although consumers have other options, including going to their doctor, urgent care facilities or outpatient clinics. The tests at all these locations are available at no out-of-pocket expense.

Consumers can also test themselves at home with kits that cost as little as $25 and give results in 20 minutes.

But these tests aren’t as accurate as molecular tests analyzed in a lab. Rapid tests come with a higher risk of a false negative result, especially for people without symptoms; that is, the test shows you don’t have covid when you actually do.

A spokesperson for Abbott, which makes BinaxNOW, one of the home tests, said the company is working with retailers to meet “increased demand in certain areas of the country as case rates rise, and as testing needs and guidance changes.”

Even areas of the country that have not seen huge surges in covid cases have seen appointment slots fill up at the major pharmacies and other testing sites.

In San Diego County, California, on Wednesday, CVS appointments weren’t widely available until the weekend, and 13 of 20 Walgreens locations in the city of San Diego had no appointments before Friday.

San Diego County is running walk-up testing sites every day of the week, in addition to locations where appointments are required or recommended. In early July, the county — California’s second-most populous — recorded an average of 7,200 tests a day. By the end of the month, it averaged more than 11,800, with more than 15,000 tests on an especially busy day. To meet increasing demand, the county added four new testing locations this week and is working on a fifth, according to Sarah Sweeney, communications officer for the Health and Human Services Agency.

In Sacramento, the county-run sites accept only walk-ins, although some locations are hitting capacity and must refer people elsewhere, a county spokesperson said.

Going to one of the thousands of pharmacies advertising covid testing remains the first option for many people. Yet these days it can be frustrating.

Patricia Rowan said she struggled to find a pharmacy with an available appointment for her 67-year-old mother, Karen Liever. Liever had recently traveled to a conference and wanted to get tested near her home in Palm Bay, Florida, before visiting Rowan, who has young children who are not eligible to be vaccinated.

Rowan finally found a CVS about 25 miles from her mom’s home on Thursday.

In Florida, where covid hospitalizations are higher than ever, mass testing sites run by the state closed at the end of May and Gov. Ron DeSantis said local governments could use their CARES Act funding to restart testing operations if they want. DeSantis, a Republican, has spent this week trying to play down the surge in hospitalizations, saying most admissions are of younger adults and death rates are lower than a year ago. He also blamed the rise in cases on unvaccinated immigrants crossing the border illegally into Texas and the Southwest.

“People obviously have the opportunity to get a test,” DeSantis said Tuesday, the same day Orlando’s main public testing site closed early — for the 16th day in a row — because it had reached capacity. The governor noted that at-home rapid tests are available in pharmacies and criticized the effectiveness of past testing campaigns. “Quite frankly, we spent a lot of money on the testing. … I don’t think it did anything to bend the viral curve.”

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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Hard Lessons From a City That Tried to Privatize Public Health

Fri, 08/06/2021 - 5:00am

If you were growing up in Detroit in the 1970s or ’80s, chances are you knew the city’s Herman Kiefer public health complex by both sight and reputation.

Opened at the turn of the century and later enhanced by renowned industrial architect Albert Kahn, the imposing brick complex was named after a local infectious disease doctor. As the city grew, so did the complex and the services offered within, becoming synonymous with public health in the eyes of many families and residents.

For decades, it was where you went to pick up birth records, get tested for tuberculosis, get vaccines or undergo discreet diagnosis and services for sexually transmitted diseases.  It was even a place some parents told their children to go to if they needed help — the way other parents tell their kids to go to the police if they’re in trouble.

That was before the lean years that led into the Great Recession of 2008. By the time the complex was abandoned more or less overnight in 2013, it had fallen into vermin-infested disrepair and held a fraction of the dedicated employees who had once walked its halls. City officials gave up on the building — and dismantled the public health department it had come to represent. Eventually, the city sold Herman Kiefer to an out-of-town developer, who has marketed it as a commercial complex.

Across the nation, public health departments have seen dramatic cuts over the past decade. It is a nationwide phenomenon, hitting communities big and small, rich and poor. When state and local government revenues falter, health departments are often the first to lose funding.

When politicians shutter a school or close a subway stop, the impacts are immediate and visible, sparking sharp public blowback. But when a health department fires its contact tracers or closes its infectious diseases lab or stops testing children for lead exposure, the impact is more subtle.

At least at first.

Detroit often experiences a magnified version of the nation’s economic and health woes, and the same holds true of its experiment to streamline and privatize public health services. A health department that had 700 employees in 2008 had just five by the end of 2012. Though it has slowly been rebuilding since 2014 — it now employs approximately 270 people — damage done during the leanest years has been on stark display amid the ravages of the covid-19 pandemic.

***

Vernice Davis Anthony loves thinking back on the good years. In the 1970s, she was one of dozens of public health nurses working for the Detroit Health Department. Originally from Pennsylvania, Davis Anthony moved to Detroit to attend nursing school at Wayne State University, where, as a young Black woman, she’d heard she could get a fair shot at an education and career in the majority-Black city.

She and her co-workers walked the neighborhoods building connections and trust, visited the home of every new mom, and worked in schools, tracking cases of infectious diseases and making sure kids got immunized. Wearing health department badges and uniforms, she particularly liked doing home visits in vibrant Southwest Detroit, then home to Puerto Ricans, Mexicans, Middle Easterners, Appalachian whites and Southern Blacks. The power dynamic captivated her: Unlike a hospital, where doctors and administrators ran the show, the families ultimately decided whether she could come in. “When you are in their home, the balance of power has shifted,” she said.

In those days, she said, the health department had resources to back up its mission, including a world-class laboratory and a pharmacy that provided discounted medicines to residents. It ran clinics throughout the city’s sprawling neighborhoods.

It also had political clout. When AIDS emerged as a devastating public health threat in the early 1980s, at the same time intravenous drug use had become rampant in some neighborhoods, the health department funded community groups to educate residents on the dangers of the human immunodeficiency virus and sharing needles.

George Gaines, then the city’s deputy health director, recalled a conversation in the 1980s when he pleaded with Mayor Coleman Young to let him hand out clean needles to drug users, a controversial topic even today. “Give them the needles,” he said Young told him. “Just keep your name out of the paper.”

For years, Gaines dedicated resources to drug treatment programs aimed at helping poor inner-city families, even as federal funding for drug addiction was slashed.

While there’s no way to prove those early efforts prevented an explosion of HIV, said Eve Mokotoff, who handled HIV data for Michigan from 1986 through 2012, that work was clearly vital in turning attention to the threat HIV posed in low-income Black communities even as much of the nation’s medical community focused primarily on the threat to gay white men.

The people leading the health department at the time had “a fierce love for that city, and fierce in the most positive sense of the word,” Mokotoff said. “When they saw this was going to happen, they weren’t going to close their eyes to it. They weren’t sitting ducks. They wanted to prevent it.”

Those were the gratifying years when Detroit health officials were often called in by other cities to teach strategies for lowering rates of child lead poisoning, HIV infections and Black infant mortality.

Gaines can hardly fathom how it all fell apart so fast.

***

In the final decades of the 20th century, white flight to the suburbs, the struggles of the auto industry and offshoring of manufacturing all hit Detroit hard. Then came the predatory lending that helped trigger the Great Recession.

From 2008 to 2010, with the city’s tax base shrinking, the health department shed more than 70% of its employees. By 2012, Mayor Dave Bing, a professional basketball player turned businessman, was preparing the city for bankruptcy. Told they had to cut costs further, leaders of the stripped-to-the-bone health department made a radical proposal: privatize and outsource services by handing nearly all their work to a nonprofit to be assembled from scratch and dubbed the Institute for Population Health.

Health departments around the country have survived perennial funding declines by turning to grants and private entities to carry out some of their work. What was unprecedented about Detroit was that it wasn’t just a few programs to be outsourced; it was essentially all of the city’s health services.

Those involved say it was a necessary step to save the department from the volatility of the municipal bankruptcy and the weight of union and pension obligations. In theory, it would allow the city to maintain its core health mission, even as it went through a financial overhaul.

But critics say the arrangement had nothing to do with the well-being of residents. “It was not a decision made to improve the health of people. It was purely an economic decision,” said Phyllis Meadows, director of the city health department from 2004 to 2009. “This was political health; it wasn’t public health.”

Though a messy battle over the plan ensued — by Michigan law, the city was obligated to provide certain public health services — Bing won. By October 2012, health services were no longer housed at Herman Kiefer and nearly all the department’s duties had been outsourced to the new nonprofit. The following year, the governor installed an “emergency manager” whose powers superseded those of elected officials.

Davis Anthony, who had moved on to other health agencies, initially supported the reorganization and returned to run the stripped-down, five-person city department that remained from 2012 to 2014. But her experience ultimately led her to believe public health at its very core must be a government function. The skeletal city staff was too small to provide proper oversight of public funds. “When you have public health funding that’s going directly from the state to a nonprofit without any accountability, that was a problem,” she said.

Community organizers and former employees say the nonprofit may have been well-meaning, but public health all but disappeared from many Detroiters’ lives. Residents had no say in funding priorities. And there was no government agency with expertise and political support to serve as a backstop for the health of residents.

A local health department is charged with prevention, protection and health promotion, said Robert Pestronk, former health officer for Genesee County, Michigan, home to Flint, and former executive director of the National Association of County and City Health Officials. “It’s not about conducting business. It’s to make sure there’s a place in our society where the roots are nourished by those concepts.” Underfunding undermines that role, he said. “We live in a culture where, if you have resources, you gain some respect.”

After the privatization, health officials lost the political influence needed to protect residents from basic threats, said former employees and city residents. That includes remaining largely silent as Detroit’s Water and Sewerage Department, struggling with its own bankruptcy filing, began shutting off water to the homes of people late paying their bills. From 2014 to 2020, an estimated 141,000 customers lost water at some point. The shutoffs were crushing for low-income residents, many of them Black families, living in neighborhoods already buckling under the weight of the city’s economic collapse.

“How are they going to use the restrooms? How are they going to cook? How are they going to prepare formula for babies?” said Dr. Kanzoni Asabigi, who held top public health positions with the city before abruptly retiring in May 2020 over disappointment at city officials’ response to the pandemic. “Everybody needs water to live.”

Gaines was so disgusted by the water shutoffs that at 90 years old he conducted research on the health effects in hopes elected officials would end the policy. Instead, it took a global pandemic. As officials nationwide advised Americans to wash their hands to fight the new coronavirus, Michigan Gov. Gretchen Whitmer issued a temporary moratorium on water shutoffs. In mid-December, Detroit Mayor Mike Duggan announced a plan to extend the moratorium through 2022.

***

It was Duggan who initiated the return of public health services to government control when he took office in 2014, less than two years after the department was all but shuttered. But rebuilding has been a painful process.

Duggan hired as executive health director Abdul El-Sayed, a native of the Detroit suburbs who was then a professor of public health at Columbia University. His first order of business was to move the department out of a conference room in the back of the city parking department. He then was tasked with revamping animal control, yet another of the department’s duties, to combat negative headlines generated by the shelter’s high kill rate.

From there, his job became contentious, as he got into public feuds with his boss over a range of health issues: refineries that were spewing toxic fumes in a city overburdened by asthma, sweeping neighborhood demolitions that communities believed were causing increases in child lead poisoning, and the water shutoffs to tens of thousands of Detroiters. He said he didn’t play the politics well but felt compelled to weigh in.

“There’s not that much money in making sure that babies have what they need to thrive. There’s not that much money in making sure that restaurants are up to code,” said El-Sayed. “If there was, private industry would hop to do it.”

After less than two years with the department, he resigned to wage an unsuccessful run for governor.

El-Sayed was succeeded in 2017 by Dr. Joneigh Khaldun. She had joined the department as medical director the previous year, coming home to Michigan after serving as chief medical officer in the Baltimore City Health Department, which has 900 employees for a population 10% smaller than Detroit’s. When Detroit was hit by an outbreak of hepatitis A in 2016 during her first week on the job, she recalled, the city had no public health lab; she didn’t know where to find its contact tracers, who were state employees, and there was no protocol for a vaccination campaign.

“That infrastructure of, how do you quickly respond to an outbreak? How do you stand up clinics? How do you get the communications out so that people know where to go? That was not there,” Khaldun said.

Khaldun left in 2019 to become the chief medical executive for Michigan’s Department of Health and Human Services. When covid arrived in March 2020, the fledgling system she had set up with colleagues was Detroit’s first line of defense. Amid the feeble response, the coronavirus cut a broad and deadly swath through the city, quickly overwhelming area hospitals and hitting hard in tightknit communities of health care workers, churchgoers and ballroom dancers.

In the year since, 1 in 10 Detroiters have been infected with covid and more than 2,400 have died — more than twice the number in Baltimore. Detroit’s covid death rate is roughly double the national rate.

The pandemic has raised the department’s profile, but officials are struggling to win back the community’s trust. When the Centers for Disease Control and Prevention updated its mask guidance in May, saying indoor masking was no longer necessary among fully vaccinated people, just 20% of Detroit residents met that definition. Nearly three months later, just 34% of the city’s residents are vaccinated, compared with 54% of Michigan residents and 50% of U.S. residents overall.

And with all hands on deck to fight covid, neglected public health issues have plunged into deeper obscurity. Programs to prevent and treat childhood lead poisoning were put on hold. The childhood vaccination rates against diseases like measles and mumps have dipped below 50%.

On nearly every health measure — HIV rates, health insurance coverage, drug-related deaths, smoking, STDs, vaccination rates, asthma and obesity — Detroiters are faring worse than Michiganders as a whole. While the average life expectancy in Michigan is 78, it is 72 in Detroit, with some neighborhoods falling as low as 62. Maternal mortality is nearly triple the state average, as is infant mortality. A 2018 health needs assessment found that 9% of children under age 6 have blood lead levels elevated above accepted thresholds, a figure that jumps to 22% in some neighborhoods.

For all the federal relief money that came pouring in for covid, the health department still lacks the resources for even the most basic services. In May, the Detroit City Council approved an $87,000 contract to outsource testing related to sexual and reproductive health. Residents who are tested at a city clinic for HIV, STDs or pregnancy-related concerns will have their labs sent to San Antonio for processing.

Today, Detroit’s health department has an operating budget of $41.7 million, money that mostly comes from state and federal funds or grants.

“The pandemic really put the issue of health care disparities in everybody’s face,” said Davis Anthony, and that gives her hope that the city and state will continue to reinfuse the department with resources. But even if that happens, restoring its place in city life after years of absence isn’t a given. “It’s going to be a difficult road to travel,” she said.

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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Pharmacies Face Extra Audit Burdens That Threaten Their Existence

Fri, 08/06/2021 - 5:00am

[UPDATED on Aug. 10]

The clock was about to strike midnight, and Scott Newman was desperately feeding pages into a scanner, trying to prevent thousands of dollars in prescription payments from turning into a pumpkin.

As the owner of Newman Family Pharmacy, an independent drugstore in Chesapeake, Virginia, he was responding to an audit ordered by a pharmacy benefit manager, an intermediary company that handles pharmacy payments for health insurance companies. The audit notice had come in January as he was scrambling to become certified to provide covid-19 vaccines, and it had slipped his mind. Then, a month later, a final notice reminded him he needed to get 120 pages of documents supporting some 30 prescription claims scanned and uploaded by the end of the day.

“I was sure I’d be missing pages,” he recalled. “So I was rescanning stuff for the damn file.”

Every page mattered. Pharmacy benefit managers, or PBMs, suspended in-person audits because of covid last year, shifting to virtual audits, much as in-person doctor visits shifted to telehealth. Amid added pandemic pressure, that means pharmacists such as Newman are bearing significantly more workload for the audits. It also has allowed benefit managers to review — and potentially deny — more pharmacy claims than ever before.

According to data from PAAS National, a pharmacy audit assistance service, while the number of pharmacy audits in 2020 declined nearly 14% from the year before, the overall number of prescriptions reviewed went up 40%. That meant pharmacies had to provide more documentation and stood to lose much more money if auditors could find any reason — even minor clerical errors — to deny payments.

The average audit in 2020 cost pharmacies $23,978, 35% more than the annual average over the previous five years, the PAAS data shows. And the number of prescriptions reviewed in September and October was fourfold over what PAAS members had seen in previous years.

Pharmacists have long complained that audits seem to have little to do with rooting out fraud, waste and abuse, but have become a way for these intermediary companies to enrich themselves. According to business analysts at IbisWorld, the pharmacy benefit manager market in the U.S. has grown to nearly $458 billion this year, up from less than $300 billion eight years ago.

Even before the pandemic, independent pharmacies were struggling financially with reimbursement rates they say are too low, the loss of customers to mail-order services or chain pharmacies, and a variety of measures by the benefit managers, including charging pharmacies fees and keeping manufacturer rebates for themselves.

Adding insult to injury: Many independent pharmacies report having received buyout offers from the large drugstore chains that own the PBMs, which pharmacists see as the primary reason for their financial struggles.

At a minimum, pharmacists say, virtual audits increase wait times and drive up costs for customers. At worst, the audits cost pharmacies thousands of dollars in payments for drugs already dispensed to customers, and may ultimately drive them out of business.

“It’s definitely pulling pharmacy staff away from their duties, and it’s become an administrative burden, which does have a direct impact on patient safety,” said Garth Reynolds, executive director of the Illinois Pharmacists Association. “They have to be the de facto audit team for the pharmacy benefit managers.”

Trent Thiede, president of PAAS National, said many of the more than 5,000 pharmacies he works with stepped up to offer covid testing and shots and to become an even bigger resource for customers during this health crisis. “With vaccinations in full swing, priorities should be focused on serving patients and our communities, not responding to audit requests,” Thiede said.

When auditors come in person, they primarily do the review themselves, occasionally asking pharmacists to pull additional documentation.

“In these virtual audits, you have to pull the prescription, put it through a copier of some kind, get everything aggregated, get all the signature logs. They want your license off the wall. They want all the employee licenses faxed,” Thiede said. “It’s a lot more laborious for these pharmacies.”

Express Scripts, one of the nation’s largest benefit managers, moved to virtual audits as a safety measure, said spokesperson Justine Sessions. “The virtual experience is very similar to the in-person audits in both scope and scale, and are conducted with the same frequency,” she wrote in an email. “When it is safe to do so, we intend to resume on-site audits.”

Phil Blando, a spokesperson with CVS Caremark, a benefit manager affiliated with the CVS pharmacy chain, said in an email that the company has heard positive feedback from its pharmacy network since going virtual.

“We were one of the first PBMs to simplify processes for our network pharmacies — such as relaxing previous requirements for paper patient signature logs,” he wrote, “when we knew many pharmacies and members were social distancing during the pick-up or delivery process.”

Dave Falk, who owns 15 Illinois pharmacies, said the largest audit he had ever seen before the pandemic was for 60 to 70 prescriptions, valued at $30,000 to $40,000. Then, last fall, his pharmacy in Robinson had to defend $200,000 in prescriptions in a virtual audit.

“None of these prescriptions were below $450,” he said. “These audits are not random. It’s a money grab by PBMs.”

He was appalled when the auditor asked his pharmacist to report the temperature of the refrigerator for perishable medications. The information has no bearing on whether prescriptions filled months earlier were appropriate.

“They’re looking for any reason to recoup funds,” Falk said.

After Falk and his pharmacist spent hours providing the documentation, the auditor initially denied $36,000 in drug payments, mostly because of missing patient signatures. Like most pharmacies during the pandemic, Falk’s had stopped collecting patient signatures last year for safety reasons. Major trade associations representing the PBM companies and pharmacies had come to an agreement last year that patients wouldn’t need to sign for medications provided through mail order, delivery or curbside pickup.

Nonetheless, Falk’s staff had to track down dozens of patients to have them sign affidavits that they had received the prescriptions, reducing the auditor’s denial to $12,000.

“That’s $12,000 for ridiculous reasons,” Falk said.

In Newman’s eight years as a pharmacist, he said, he has undergone six audits, all but the most recent done in person. In the virtual one, conducted on behalf of the health insurer Humana, Newman uploaded his documentation before the deadline. But he, too, was flagged for missing signatures.

Dan Strause, president and CEO of Hometown Pharmacy in Madison, Wisconsin, said his pharmacies received more than 1,000 pages of audit requests last year, covering more than $3 million in prescription claims. That represented 1.5% of his company’s total annual revenue. He said pharmacists saw a surge last year of what they call predatory audits, which look for ways to deny legitimate payments for prescriptions.

“What they did in 2020 was reprehensible,” Strause said. “While we were taking care of patients, they’re sitting back in their comfy offices figuring out ‘How can we make money off this? Can we find a loophole? Can we find a missing document? Can we find a reason to take back stuff?’”

Lisa Dimond, a spokesperson for Humana, said the company is required by the government to perform audits to see if pharmacies are adhering to regulations, but conducted fewer audits and reviewed fewer prescriptions in 2020 than in 2019.

“We have worked to reduce as much administrative burden as possible on our network pharmacies, offering extensions, when needed, while still working to ensure pharmacies are filling prescriptions appropriately for the safety of our members,” she said in a statement.

Pharmacists bristle when large pharmacy chains that operate their own benefit managers offer to buy their stores, acknowledging that times are tough. Joe Craft owns the Happy Druggist chain of pharmacies in central Ohio. He said he regularly receives letters seeking to buy his business from the same companies that cause him to lose an average of $6,000 in payments with every audit, about a week’s worth of revenue for a single drugstore.

“When you read that letter, you’re thinking to yourself, ‘Hell, yeah, times are tough,’” he said. “Of all people, they should know.”

And oftentimes, when independents are sold to bigger chains, those drugstores are shut down, and the chain pharmacy directs customers to one of its locations miles away.

Thiede and many pharmacists believe that, while in-person audits may resume after the pandemic, virtual audits may be here to stay as well.

“They can do more because they don’t have to travel and fly across the country and sit in your pharmacy all day long,” Thiede said. “They can just do it from their home and accomplish more.”

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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Clarity on Covid Count: Pandemic’s Toll on Seniors Extended Well Beyond Nursing Homes

Fri, 08/06/2021 - 5:00am

As covid-19 resurges across the country, driven by the highly infectious delta variant, experts are extending our understanding of the pandemic’s toll on older adults — the age group hit hardest by the pandemic.

New research offers unexpected insights. Older adults living in their own homes and apartments had a significantly heightened risk of dying from covid last year — more than previously understood, it shows. Though deaths in nursing homes received enormous attention, far more older adults who perished from covid lived outside of institutions.

The research addresses essential questions: Which conditions appear to put seniors at the highest risk of dying from covid? How many seniors in the community and in long-term care institutions might have died without the pandemic? And how many “excess deaths” in the older population can be attributed to covid?

Of course, it’s already known that older adults suffered disproportionately. As of Aug. 4, more than 480,000 people age 65 and older perished from covid — 79% of more than 606,000 deaths in the U.S. overall, according to the latest data from the Centers for Disease Control and Prevention. (This is likely an undercount because it relies on death certificate data that may not be up-to-date or accurately reflect the true toll of the virus.)

Still, new information about older adults’ vulnerabilities is useful as covid cases climb again and unvaccinated people remain at risk. Some key results from studies published over the past few months:

Death rates varied among groups of seniors. In a study published in Health Affairs in June, experts from the Department of Health and Human Services analyzed data for more than 28 million people with traditional Medicare coverage from February 2020 (the approximate start of the pandemic) to September 2020. (Excluded were about 24 million people in Medicare Advantage plans because data crucial to the study wasn’t available.) The researchers compared data for this period with previous years, dating to 2015.

The study examines deaths among individuals with covid and reaffirms headlines that have trumpeted the toll among older Americans. Medicare members diagnosed with covid had a death rate of 17.5% — more than six times the death rate of 2.9% for Medicare members who evaded the virus.

A notable finding in the study: Medicare members with dementia were especially vulnerable. If diagnosed with covid, their death rate was 32%, compared with nearly 14% for those with dementia who weren’t infected. Also at substantially increased risk of death from covid were older adults with serious and chronic kidney disease, immune deficiencies, severe neurological conditions and multiple medical conditions.

Most of the seniors who died of covid lived outside of nursing homes. The HHS experts’ study reported 110,990 “excess deaths” due to covid during the eight-month period it examined — most likely an undercount because many older adults who died may not have been tested or treated for the virus. The term “excess deaths” refers to a death count higher than the number expected based on historical data. It is a core measure of the pandemic’s impact.

Of the excess deaths HHS experts documented, 40% occurred in nursing homes but a larger portion, nearly 60%, were seniors living in other settings.

Other studies suggest far more excess deaths. Estimates of excess deaths in the older population vary widely depending on the period studied, the data sources used and the type of analysis conducted. Another study, published in May in the BMJ (formerly known as the British Medical Journal), calculated 458,000 “excess deaths” in 2020 in the United States. About 72% were people 65 and older, according to the British and American authors.

About two-thirds of these deaths can probably be attributed directly to covid, the authors noted. Others might be due to acute medical care that was delayed during the pandemic, poor management of chronic medical conditions, the effects of isolation and other factors.

Assisted living residents were significantly affected. Data about the impact of the pandemic on assisted living residents has been scarce, in part because these facilities are regulated by states, not the federal government. A study out in June in JAMA Network Open found the death rate for assisted living residents in 2020 — as the pandemic unfolded — was 17% higher than in 2019. In the 10 states with the greatest community spread of covid, the death rate for assisted living residents rose by 24%.

“Efforts must be made to support assisted living communities as they work to address infection prevention and control to keep their residents safe,” said Kali Thomas, a study co-author and associate professor of health services, policy and practice at Brown University.

Underlying medical conditions played a major role. A study by researchers from the Cleveland Clinic and the Health Data Analytics Institute in Dedham, Massachusetts, is one of the first to suggest how many older adults who caught covid would have died from underlying medical conditions even if the pandemic had not been underway. It, too, examined 28 million people with traditional Medicare coverage from the approximate start of the pandemic (the end of February) through November 2020. (Of 28 million people in the study, more than 2.4 % had a confirmed covid diagnosis and 10% had a “probable covid” diagnosis.)

Other studies estimate excess deaths by looking at population-wide data. This study looked at individual data, using a highly complex methodology to calculate a preexisting risk of death for each person based on his or her age, sex, medical conditions and other demographic characteristics. Actual deaths in 2020 were then compared with expected deaths based on those preexisting risks. The report has been published as a preprint without peer review.

About 4% of Medicare members with confirmed or probable covid who were living in the community, in their own homes and apartments, would have died anyway from underlying medical issues, the authors estimated. With covid, the actual death rate climbed to 7.5%.

In nursing homes and other long-term care facilities, 20.3% of residents diagnosed with confirmed or probable covid would have died due to underlying medical issues; with covid, that rose to 24.6%, the authors calculated.

“This is a more accurate picture of the true toll of covid,” said Dr. Daniel Sessler, chair of the department of outcomes research at the Cleveland Clinic. “As it turns out, the greatest increase in deaths [from the virus], in terms of both raw numbers and an increased risk of dying, was in the community, not in long-term care residents.”

The bottom line. About 80% of people 65 and older have been fully vaccinated, leaving millions of seniors still at risk of covid. Special attention should be paid to older adults with dementia and other serious neurological conditions, kidney disease and multiple medical conditions. Older adults, especially the eldest groups, who are frail and who live alone or with little support in areas where the virus is spreading rapidly also deserve special outreach and attention.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

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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KHN’s ‘What the Health?’: Delta Blues

Thu, 08/05/2021 - 1:50pm

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The U.S. is experiencing another surge of covid-19, particularly in Southern states where vaccination rates are generally lower than in other regions. But partisan fights rage on over what role government should play in trying to tamp down the highly contagious delta variant.

Meanwhile, Democrats spent the week fighting amongst themselves about how to extend a moratorium on evictions, after the Supreme Court said Congress would need to act.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat and Sarah Karlin-Smith of the Pink Sheet.

Among the takeaways from this week’s episode:

  • The surge caused by the delta variant has put public health officials in a difficult position. While extolling the value of the vaccines and urging people to get a shot, they have suggested it would allow the public to go back to a more normal life. But now — because large pockets of the country have low vaccination rates, which is allowing the delta variant to take hold — officials are urging mask-wearing again. The switch in messaging has the potential to undermine confidence in the inoculations.
  • The Biden administration’s move this week to extend the covid eviction moratorium appears to be an effort to buy time so that federal officials can push states to get money already approved by Congress out to tenants and landlords. But the Supreme Court has already said the administration doesn’t have authority to extend the moratorium, so it may be a race between federal officials trying to get money moving and opponents of the moratorium trying to get their case before the high court.
  • Food and Drug Administration officials say they are working furiously on an application by drugmaker Pfizer to grant its vaccine final approval. All the vaccines being used in the U.S. have received only emergency authorizations, not the more formal and rigorous full FDA approval. But that process is always time-consuming because federal officials must comb through a manufacturer’s data, re-crunch the numbers and inspect production sites. FDA had said they would try to get that done in six months — a fairly rapid pace for normal approvals. But the hope that final approval will persuade more people to get a shot is pushing the agency to speed up even more.
  • All that work is ongoing even though the Biden administration still has not named anyone to be the next FDA commissioner.
  • Tension is building over the need for covid vaccine boosters. Several countries, including Israel and Germany, have said they will begin using booster shots for vulnerable populations, but the World Health Organization has asked countries to not begin giving boosters until more people around the globe have access to the vaccine. U.S. officials and drugmakers said evidence suggests the initial shots are still working well and boosters are not required at this time.
  • Despite playing down the need for boosters, government officials and industry are preparing behind the scenes for the possibility of starting a campaign and getting additional vaccines to people who need them.
  • The FDA last week approved allowing pharmacists to automatically substitute a biosimilar — or copy of a brand-name insulin — for patients’ prescriptions. Although the biosimilar is like a generic drug, it’s not clear whether this move will quickly lead to lower costs for patients.

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

Julie Rovner: NPR’s “Vaccination Status Questions Do Not Violate HIPAA, Consumer Health Expert Explains,” by Kelsey Snell and Deven McGraw

Rachel Cohrs: Axios’ “Justice Department Goes After Kaiser Permanente’s Medicare Advantage Plans,” by Bob Herman

Sarah Karlin-Smith: KHN’s “12,000 Square Miles Without Obstetrics? It’s a Possibility in West Texas,” by Charlotte Huff

Alice Miranda Ollstein: Task & Purposes’ “‘We Are All Suffering in Silence’ – Inside the US Military’s Pervasive Culture of Eating Disorders,” by Haley Britzky

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

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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2+2=? Senate Uses Murky Math as It Shelves Drug Pricing Rule to Fund Infrastructure

Thu, 08/05/2021 - 5:00am

The Senate’s release of its bipartisan infrastructure plan signals that lawmakers are poised to throw former President Donald Trump’s belated bid to lower Medicare drug prices under the bus — not to mention trains, bridges, tunnels and broadband connections.

That’s because the massive spending bill is the first of two likely to at least delay the so-called Medicare rebate rule released at the end of the Trump administration, which has yet to take effect. Congress would use the projected costs of that rule to help pay for more than half a trillion dollars in new spending on infrastructure.

What has infrastructure spending got to do with Medicare drug rebates?

Bear with us as we explain the mad logic of how Congress intends to pay for a spending program with money that doesn’t really exist. Tossing Trump’s reform under the steamroller to offset other costs offers a window into the convoluted process of congressional budgeting: Senators say the plan will provide billions of dollars of savings, even though the federal government has never spent a dime on the rebate rule. And it focuses attention on the intractable problem of bringing down drug prices: The rule would take money from drug industry brokers and provide refunds to consumers, which would suggest it was saving them and Medicare money. Yet budget analysts said the process would cost the government billions of dollars.

Let’s start with the Medicare drug rebates.

The way things work now, pharmacy benefit managers, which are often owned by insurance companies, negotiate with drugmakers to get significant reductions on a drug’s list price. They pass the bulk of that savings along to Medicare and the insurers, who can pocket some of it and use it to lower overall premiums for customers who buy drug plans in Medicare Part D.

While customers benefit from a lower premium, it doesn’t mean they actually get a better price for their drugs, said Gerard Anderson, a professor of health policy at Johns Hopkins Bloomberg School of Public Health.

That’s because a patient’s price is not based on the rebate but on a share of the original list price of the drug. If a drug costs $100, and a patient’s share is 25%, they pay $25, regardless of how big a rebate the PBM got for the insurer.

It thus serves the interest of the PBM for the drugmaker to raise prices. “When the list price goes up, your patient responsibility goes up, so the patient ends up paying more,” Anderson said. “The PBM makes money because, when the list price goes up, the rebate is larger. But the patient loses, because their cost sharing is based often on the list price.”

Since the PBM controls the formulary that says which drugs are covered in a given plan, Anderson and others point out, it is also in the interest of a drug company to raise list prices if it wants the PBM to give its drugs preferential treatment.

“If you’ve got two drugs that are available to take care of some heart disease, the PBM wants the drug that’s going to pay them the most money, and the money is the difference between the list price and the actual transaction price,” Anderson said. “So the higher the list price, the higher the profit margin for the PBM. So the drug company who wants their drug on the formulary has to raise their price in order to give the PBM a greater profit.”

A wrinkle in federal law allows that to happen. Typically in federal contracting, if someone sets a high price to give the buyer a cut, it’s considered a bribe or a kickback, and it’s illegal. But the law that created the Part D drug program carved out what’s known as a safe harbor to allow such deals in the hope that negotiations would lower overall costs.

The Trump administration’s rule attempts to end the perverse incentive by taking the safe harbor away from the PBMs and giving the rebate to customers at the pharmacy counter. Then-Health and Human Services Secretary Alex Azar said costs would fall by about 30%.

But the effort had two major problems. First, the rule was challenged in court by the PBMs on procedural grounds. Second, the Congressional Budget Office predicted that, rather than save money, it would end up costing the federal government $177 billion over 10 years because drugmakers would be less likely to provide as many discounts, causing a spike in Medicare drug coverage premiums.

The Biden administration delayed the rule, and could scrap it, making that $177 billion cost more theoretical than real. But that’s where congressional budgeting comes in.

A chief selling point of the infrastructure proposal is that it is “paid for,” meaning it taps new revenue streams or ends other things that cost money so that the $550 billion in new spending in the plan doesn’t add to the federal deficit.

Even though Trump’s rebate rule has already been delayed and is likely to be killed, it is, at this moment, on the books. Since the infrastructure bill would delay the rule and its costs until 2026, the savings get counted as offsetting the new spending. Confused yet?

Delaying the rule, instead of killing it outright, means there’s still another $130 billion on the books that can be used to offset other spending — almost certainly likely to help fund the even bigger budget reconciliation measure that Senate Democrats intend to pursue as soon as the Senate passes the bipartisan infrastructure bill.

Sen. Bill Cassidy (R-La.), who liked Trump’s rule and also supports the bipartisan infrastructure bill, explained the reasoning to reporters shortly before the infrastructure legislation was released.

“The Medicare rebate rule — you know, I actually agree with the policy, but it was a $182 billion cost to the Treasury,” Cassidy said, citing a slightly different figure for the savings. “And so, it’s been signaled that it was going to be used for something. … Just speaking practically, if something’s going to score that high, and here with a party, Democrats, that don’t like it, it’s going to go away, right? So that was just a good take.”

The move is essentially painless in congressional budget terms, and PBMs are thrilled. They argue they do not actually profit from the rebates they negotiate in Part D and pass all the rebate cash along to Medicare and plan sponsors already.

They say their ability to negotiate those rebates is part of what makes them valuable, and the rule interferes. “That’s sort of the bread and butter of the work that our companies do, and undermining the ability to provide that value is obviously a real challenge,” Pharmaceutical Care Management Association CEO JC Scott said in a call with KHN and PCMA spokesperson Charles Coté.

They favor not just delaying it but spiking it completely. “From our perspective, that is the action that’s needed,” said Coté. “To create certainty for Part D and for beneficiaries, it should just be fully repealed.”

Repealing Trump’s rebate rule is not painless for people who have high drug costs, though, because, as Johns Hopkins professor Anderson explained, the 10% or so of people who would get significant rebates at the pharmacy counter would be better off.

“It helps the people that have the large bills; it harms the most the people that don’t have the large bills,” Anderson said.

Benefiting from Trump’s rule would be drugmakers, according to the CBO data and other sources. In a statement from the Pharmaceutical Research and Manufacturers of America, the industry’s lobby group, spokesperson Debra DeShong cast ending the rule as a windfall for PBMs and a cynical raid on cash meant for sick, older Americans.

“Lawmakers are threatening to gut a rule that would provide patients meaningful relief,” DeShong said. “This would be an unconscionable move that robs patients of the prescription drug savings they deserve to help fill potholes and fund other infrastructure projects.”

Senate lawmakers were hoping to pass the infrastructure bill by Thursday, then move quickly on the reconciliation bill, both paid for in part with the ill-fated rebate rule. The legislation would then go to the House when it returns from its August recess.

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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