After Billions of Dollars and Dozens of Wartime Declarations, Why Are Vaccines Still in Short Supply?

KFF Health News, February 23, 2021

U.S. officials have run headlong into the limits of the Defense Production Act.

This article was published on Tuesday, February 23, 2021 in Kaiser Health News.

By Rachana Pradhan and Arthur Allen

The U.S. government has invested billions of dollars in manufacturing, used a wartime act dozens of times to boost supplies and yet there's still not enough COVID vaccine on the way to meet demand — or even the government's own goals for national immunization.

President Joe Biden, in remarks at the National Institutes of Health this month, said the nation is "now on track to have enough supply for 300 million Americans by the end of July." But at the current rate of production, Pfizer and Moderna will miss their targets of providing at least 100 million doses each by the end of March, let alone 200 million more doses each has promised by July.

Moderna would need to more than double its vaccine production rate from January — when it made roughly 19 million doses — to meet its contractual obligations. Pfizer supplied 40 million vaccine doses by Feb. 17. It has roughly six weeks left to deliver the first 120 million doses it has promised.

Biden and officials from the two companies say they are rapidly expanding production capacity. But critics are lining up. They want to know whether the government did enough, fast enough, to guarantee that companies would meet the urgent challenges of the pandemic. As for the manufacturers bolstered by extraordinary sums of taxpayer money, why did they not share technology and know-how sooner, or move more quickly into strategic production partnerships?

Experts say it's complicated, noting that the output of raw materials and assembly lines can't be ratcheted up 10,000-fold at the push of a button — and that the effort thus far has been close to miraculous. They cite bottlenecks in at least three areas: the production of specialty lipids, fatty materials that are a primary component of the Moderna and Pfizer-BioNTech vaccines; the hundreds of millions of glass vials that hold the vaccine; and the sterile automated assembly lines where vaccine moves from bulk containers into vials before shipment.

U.S. officials have run headlong into the limits of the Defense Production Act, a Korean War-era law that allows the federal government to ramp up supplies of critical materials in times of national emergency. The vaccine manufacturing process relies on a complex supply chain, from sourcing raw materials and equipment to designing chemical processes, building production lines and hiring and training workers.

Also, experts note, no one knew which vaccines would prove effective.

"A year ago there was no commercial market for mRNA product. There was scientific research and pharma making small-volume clinical lots. Now we need billions of doses, in the space of a year. That's overloading the supply infrastructure," said Kevin Gilligan, a senior consultant with Biologics Consulting and a former official with the Biomedical Advanced Research and Development Authority, or BARDA, a federal agency created in 2006 to deal with pandemics and bioterrorism.

As of December, the Trump administration through its Operation Warp Speed initiative had obligated nearly $14 billion for vaccine development and manufacturing, including investments to expand U.S. capacity, according to a Government Accountability Office report in January. The administration invoked the Defense Production Act on at least 23 vaccine-related contracts, in part to prioritize the government's contracts over others, according to a KHN review of the federal contracts database, contracts obtained by the nonprofit group Knowledge Ecology International, GAO and government news releases.

They include the December contract that the Department of Health and Human Services signed with Pfizer for another 100 million doses, on top of the initial 100 million it committed to last summer. That contract, worth $1.95 billion, included DPA provisions to give the company priority access to raw materials and spare parts for factories, according to a former administration official.

The DPA has also been used in vaccine contracts with Moderna, Johnson & Johnson and other drug companies for hundreds of millions of doses. On top of that, the law has been invoked for at least 10 contracts with companies making needles or syringes. It's been used to require glass makers Corning and SiO2 Materials Science to prioritize vial production for vaccine production, and in contracts for aspects of manufacturing with companies like Emergent BioSolutions, Fujifilm Diosynth Biotechnologies and Grand River Aseptic Manufacturing.

Operation Warp Speed awarded Emergent BioSolutions $648 million last year to boost the manufacturing capacity it needed to enter agreements with Johnson & Johnson and AstraZeneca — worth at least $615 million and $261 million, respectively — to help make their vaccines. Grand River Aseptic Manufacturing won a $160 million award from BARDA and has contracted with Johnson & Johnson to fill vials and finish packaging of its single-shot COVID vaccine, which is expected to get emergency authorization from the Food and Drug Administration as soon as this month but will only have a few million doses available initially.

The Biden administration has expanded its use of the wartime act to prioritize equipment like filling pumps and filtration systems for Pfizer. "We told you that when we heard of a bottleneck on needed equipment, supplies or technology related to vaccine supply, that we would step in and help," Tim Manning, the White House official leading the administration's COVID supply efforts, said during a February press briefing.

Yet it can do only so much, according to medical supply chain experts. Prashant Yadav, a senior fellow at the Center for Global Development at Harvard University, said it could take months for the impact of that DPA action to be felt because of the time it takes to procure equipment and get it installed, with each step tightly regulated.

The U.S. is unlikely to get a meaningful bump in capacity "unless we think about co-production deals," in which a drug company agrees to manufacture a competitor's vaccine, said Tinglong Dai, an associate professor at Johns Hopkins University's Carey Business School.

So far, such arrangements have proliferated in Europe — which has less capacity to produce drugs than the United States does. Deals with other major vaccine manufacturers have been less common on the U.S. side of the pond.

"Though we have not partnered with, say, another large pharma for production, we have built strategic partnerships with a number of organizations that have been instrumental to our scaling up and meeting supply and commercialization plans," Moderna spokesperson Ray Jordan said in an email.

Moderna this month said that its manufacturing process would scale up rapidly in the coming weeks, that it would provide the U.S. between 30 million and 35 million doses in February and March and between 40 million and 50 million doses monthly from April to July. The company declined to elaborate on what made the boost possible.

Vaccine manufacturers long ago should have been sharing technology and expertise to boost production in the U.S. and Europe, and especially in developing countries, said James Love, director of Knowledge Ecology International, a nonprofit focused on patent rights.

"We've wasted about a year by not doing some of the obvious things," he said. "The rhetoric is that it's an emergency. But on the scale-up of manufacturing, you just don't see it."

It's not that simple, others say. "There wasn't any excess capacity available in the United States a year ago. Zero," Paul Mango, a former HHS official heavily involved in Operation Warp Speed, said regarding vaccines. "It's getting the equipment. It's quality control. It's getting the employees. People make it sound like this is easy. You can't just push 400 workers and say, go at it."

Each Pfizer-BioNTech or Moderna shot contains billions of lipid nanoparticles, each particle containing four lipids and a strand of the nucleic acid RNA, the five pieces assembled in a way that allows the RNA to enter our cells and create a particle that stimulates the immune system to defend against the COVID virus.

The lipids, which are made only in a handful of factories, have been a major supply problem. "No one has ever thought of a scenario where we would use lipid nanoparticle formulation for [billions of] doses," Yadav said. "We have not invented a process for doing lipid nanoparticles at scale."

Two of the lipids in the vaccine, cholesterol and DSCP, have long been used in industry to shape and buffer chemical formulations. A third lipid prevents the particles from clumping together. A fourth enables the lipid shell of the vaccine to fuse with human cells and, once inside the cell, to crack open so the RNA can move to a structure called a ribosome and make proteins that stimulate immunity.

All of these raw materials are produced under regulated conditions — in Massachusetts, Missouri, Colorado and Alabama by companies under license with Moderna, Pfizer or Acuitas Therapeutics, which was co-founded by Pieter Cullis, a University of British Columbia professor who is considered the grandfather of lipid nanoparticle technology.

Before the pandemic, these companies produced meager amounts for use in small clinical trials, laboratory experiments or in one licensed drug, patisiran, which is used to treat a rare genetic disease in about a thousand people worldwide. Now they are producing thousands of kilograms of the stuff, said Stefan Randl, a vice president at Evonik, a lipid maker. Evonik recently announced it would scale up production at two German sites, possibly in the second half of the year, to be used in the Pfizer-BioNTech vaccine. The company last year bought a U.S. lipid manufacturer in Alabama.

"All of a sudden the quantities had to be ramped up a thousand-fold or more," Randl said. "This is the biggest bottleneck."

Several elements of the vaccine, including lipids and enzymes used in making the mRNA, until recently were produced using animal products such as sheep's wool, said Andrew Geall, chief scientific officer at Precision NanoSystems, which designs equipment for mixing the mRNA and lipids. Animal products could cause contamination or disease, even in minute quantities, so manufacturers now use synthetic chemicals.

Luckily, the cosmetic industry — a major user of some of the same lipids used in the vaccines — has been switching from animal products in recent decades, noted Julia Born, an Evonik spokesperson.

Still, only a limited number of companies globally have expertise and facilities to make the lipids, said Thomas Madden, CEO and a co-founder of Acuitas, and they've all struggled to move from quantities produced in a laboratory to industrial-scale production. For instance, he said, hazardous solvents and chemicals used in laboratory procedures need to be avoided in industrial processes, where they could give rise to workplace safety issues.

"This is a hugely complex supply chain," Madden said. "Once you address a bottleneck at one point, you identify the next bottleneck in the process. It's a bit of a game of whack-a-mole."

Although it's not particularly difficult to make the lipids used in vaccines, it takes time to get FDA authorization of a facility that can make them in high quantities, said Cullis, the UBC professor. It would take two to three years to start such a factory from scratch, so instead, Moderna and Pfizer-BioNTech have been hooking up with existing manufacturers and getting them to convert to lipid production, he said.

Another bottleneck is "fill/finish" — getting the finished vaccine into vials or syringes so the shots can be shipped to customers. Vaccine filling lines require extremely high levels of efficiency and sterility, and few companies in the world have this capacity, said Mike Watson, former president of Valera, a Moderna subsidiary. Moderna has hired Catalent, a contract manufacturer that recently experienced delays that slowed the release of some doses, to fill and finish U.S. doses at its facility in Bloomington, Indiana. At least two other companies will do the same for Moderna's vaccine supply abroad.

In January, the French multinational Sanofi — whose own COVID vaccine has been delayed by poor performance in producing immunity — agreed to offer its fill/finish line in Germany for the Pfizer-BioNTech vaccine. That line isn't expected to be running until July.

In the U.S., the number of vaccine doses shipped to states has ticked up in recent weeks, partly because Pfizer said its five-dose vials actually provide six shots. Moderna is seeking FDA permission to add up to five doses to its 10-dose vials.

Pfizer has said it is manufacturing raw materials in St. Louis, the active ingredients for the vaccine in Andover, Massachusetts, and filling vials in Kalamazoo, Michigan.

CEO Albert Bourla, with Biden at his side in Kalamazoo on Friday, said the company added lipid production capabilities at plants in Michigan and Connecticut, as well as fill/finish lines in Kansas. He said it has significantly cut the average time it takes to make doses — from 110 days to 60 days.

"Today, during this meeting, the president challenged us to identify additional ways in which his administration could help us potentially accelerate even further the delivery of the full 300 million doses earlier than July," Bourla said. "The challenge is accepted, and we will try to do our best."

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

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

It's Time to Get Back to Normal? Not According to Science.

KFF Health News, February 23, 2021

The science says "open the schools, stop wearing masks outside, and everyone at low risk should start living normal lives." — Blog post by conservative talk show host Buck Sexton posted on Facebook, Feb. 8.

This article was published on Tuesday, February 23, 2021 in Kaiser Health News.

By Victoria Knight

The science says “open the schools, stop wearing masks outside, and everyone at low risk should start living normal lives.”

— Blog post by conservative talk show host Buck Sexton posted on Facebook, Feb. 8.

This story was produced in partnership with PolitiFact.  It can be republished for free.

A popular Facebook and blog post by conservative radio host Buck Sexton claims scientific research indicates life should return to normal now despite the persistence of the covid-19 pandemic.

“Here’s what the science tells anyone who is being honest about it: open the schools, stop wearing masks outside, and everyone at low risk should start living normal lives. Not next fall, or next year — now,” reads the blog post, posted to Facebook on Feb. 8.

The post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about PolitiFact’s partnership with Facebook.)

KHN-PolitiFact messaged Sexton via his Facebook page to ask if he could provide evidence to back up the statement but got no response.

So we reviewed the scientific evidence and talked to public health experts about Sexton’s post. Overall, they disagreed, noting the ways in which it runs counter to current public health strategies.

Let’s take it point by point.

'Opening the Schools'

In March, when government and public health leaders realized the novel coronavirus was spreading throughout the U.S., many public institutions — including schools — were ordered to shut down to prevent further spread. Many students finished the 2020 spring semester remotely. Some jurisdictions did choose to reopen schools in fall 2020 and spring 2021, though others have remained remote.

Throughout the pandemic, researchers have studied whether in-person learning at schools contributes significantly to the spread of covid. The findings have shown that if K-12 schools adhere to mitigation measures — masking, physical distancing and frequent hand-washing — are adhered to, then there is a relatively low risk of transmission.

And getting kids back into the classroom is a high priority for the Biden administration.

n a Feb. 3 White House press briefing, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said data suggests “schools can safely reopen.” The CDC on Feb. 12 released guidance on how schools should approach reopening. It recommends the standard risk-mitigation measures, as well as universal masking, contact tracing, creating student learning cohorts or pods, conducting testing and monitoring community transmission of the virus.

Susan Hassig, associate professor of epidemiology at Tulane University, said science shows that schools can open safely if “mitigation measures are implemented and maintained in the school space.”

Here’s some of the latest research that tracks with these positions:

  • Only seven covid cases out of 191 were traced to in-school spread in 17 rural K-12 Wisconsin schools that had high mask-wearing compliance and were monitored over the 2020 fall semester.
  • Mississippi researchers found most covid cases in children and teenagers were associated with gatherings outside of households and a lack of consistent mask use in schools, but not associated with merely attending school or child care.
  • Thirty-two cases were associated with attending school out of 100,000 students and staff members in 11 North Carolina schools, where students were required to wear masks, practice physical distancing and wash hands frequently.

Of course, there are some limitations to these studies, which often rely on contact tracing, a process that can’t always pinpoint where cases originate. Some of the studies also rely on self-reporting of mask-wearing by individuals, which could be inaccurate.

Additionally, Hassig pointed out that not all school districts have the resources, such as physical space, personnel or high-quality masks, to open safely.

Sexton’s assertion that schools can reopen leaves out a key piece of information: that safe reopening is highly dependent upon use of mitigation measures that have been shown to tamp down on virus spread.

'Stop Wearing Masks Outside'

Because the coronavirus that causes covid is relatively new, the research on outdoor mask use is limited. But so far science has shown that masks prevent virus transmission.

The CDC study published Feb. 10 reported that a medical procedure mask (commonly known as a surgical mask) blocked 56.1% of simulated cough particles. A cloth mask blocked 51.4% of cough particles. And the effectiveness went up to 85.4% if a cloth mask was worn over a surgical mask.

Another experiment from the study showed that a person in a mask emits fewer aerosol particles that can be passed on to an unmasked person. And if both are masked, then aerosol exposure to both is reduced by more than 95%. A multitude of reports also show more generally that mask-wearing is effective at reducing the risk of spreading or catching other respiratory diseases.

Sexton’s post, however, advised that people should stop wearing masks outside. To be sure, public health experts agree the risk of transmitting covid is lower outdoors than indoors. But the experts also said that doesn’t mean people should stop wearing masks.

“The wind might help you a bit outside, but you are still at risk of breathing in this virus from people around you,” said Dr. Rachel Vreeman, director of the Arnhold Institute for Global Health at the Icahn School of Medicine at Mount Sinai.

Being outside is “not a guarantee of safety,” reiterated Stephen Morse, an epidemiology professor at Columbia University Medical Center. “Especially when those people without masks are close together.”

The CDC addressed the issue of whether masks are needed outside in the agency’s mask guidelines: “Masks may not be necessary when you are outside by yourself away from others, or with other people who live in your household. However, some areas may have mask mandates while out in public, so please check for the rules in your local area.”

Overall, the prevailing scientific opinion is that, while it may be OK to go maskless outside if you are physically distant from others, mask-wearing is still recommended if you are around others.

'Everyone at Low Risk Should Start Living Normal Lives'

All the public health experts we consulted agreed this part of the claim is absolutely false. It flies in the face of what scientists recommend should be done to get through the pandemic.

While it’s unclear what exactly the post means by “low-risk” people, let’s assume it’s referring to younger people or those without health conditions that make them more vulnerable to covid. And that “living normal lives” refers to no longer wearing masks, physical distancing or washing hands with increased frequency.

News reports and scientific evidence show that bars, parties and other large gatherings can quickly become spreader events. Moreover, even young people and those without preexisting health conditions have gotten severely ill with covid or died of it.

Even if a low-risk person doesn’t get severely sick, they could still infect others in higher-risk groups.

The sentiment of this post is similar to calls early in the pandemic to let life return to normal in an attempt to achieve herd immunity. But, on the way to achieving that goal, many would die, said Josh Michaud, associate director for global health policy at KFF.

“Everyone going back to ‘normal’ right now, especially in the presence of more transmissible and more deadly variants, would be a recipe for further public health disasters on top of what we’ve already experienced,” he added.

Already almost half a million Americans have died of covid.

The push to “return to normal” is precisely what let the new variants form and multiply, said Vreeman. “If we can ramp up getting people vaccinated and keep wearing masks in the meantime, only then will we have a chance at getting back to ‘normal.’”

Indeed, because of the new variants circulating in the U.S., Walensky and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have urged Americans not to relax their efforts to control the virus’s spread.

Our Ruling

A blog post by conservative talk show host Buck Sexton claims scientific evidence shows that right now we should “open the schools, stop wearing masks outside, and everyone at low risk should start living normal lives.”

Scientific research shows that in order for schools to reopen safely, risk mitigation measures must be put in place, such as requiring masks, rigorous hand-washing and limiting the number of students in classrooms. These changes, though, would not represent a return to normal, but a new normal for students and teachers.

The remainder of Sexton’s statement strays further from current science. Research indicates that you’re safer outdoors than indoors, but public health experts still recommend wearing masks in public, even outside. Science does not support the idea that the time is right for some people to resume life as normal. That would allow the virus to continue to spread and have a large human cost in hospitalizations and deaths, said the experts.

Sexton’s post is inaccurate. We rate it False.

The Do's and Don'ts on Social Media for Vaccine Haves and Have-Nots

KFF Health News, February 22, 2021

Is posting a vaccine selfie on your social media account a faux pas or still par for the course?

This article was published on Monday, February 22, 2021 in Kaiser Health News.

By Chaseedaw Giles

Posting about their day is a regular practice for Generations Y and Z, especially when they have something novel or exclusive to share. So, in the thick of a global pandemic, and with the shaky rollout of COVID vaccines making them somewhat of a holy grail, it's no surprise selfies featuring the coveted shot are infecting social media timelines.

It might engender envy, even outrage, especially if the person posting seems to have cut the line. But what if the intention was to encourage others to also get the shot? Does that make it OK?

Since the pandemic began, people around the world are increasingly living out significant portions of their lives online. But with 72% of the American public using some type of social media, according to the Pew Research Center, who sets the rules for proper social media etiquette?

"This is a totally new type of world to have a pandemic in," said Catherine Newman, the etiquette columnist at Real Simple and author of the book "How to Be a Person." One advantage of using social media, she said, is that people can create waves of public opinion from which everyone can benefit. Newman, who also volunteers at a hospice, was vaccinated and posted a selfie. She said the selfies can help address some of the public health mistrust issues that have contributed to vaccine hesitancy.

"I don't want to see a picture of your yacht on social media," she said. She'd rather see COVID vaccine selfies but cautions users to be mindful of the caption they choose.

After all, nearly 500,000 American lives have been lost in the pandemic and stark disparities have emerged in vaccination rates — especially among communities of color and older adults who are in the highest risk categories.

It raises the question: Is posting a vaccine selfie on your social media account a faux pas or still par for the course?

Elaine Swann, a lifestyle and etiquette expert, a certified mediator in the state of California and the founder of the Swann School of Protocol in Carlsbad, California, echoed those precautions. "RNs and front-line workers have a very different story to tell than a 20-something-year-old who got vaccinated for some obscure reason," she said.

At the same time, she said, it's not necessarily clear how someone came to be eligible for the vaccine. A person could present young and healthy at first glance but could have a health condition or other qualifying criteria. "We don't know," she said. She advises that posters follow what she calls the three core values of manners: respect, honesty and consideration.

And the same goes for people reacting to the posts.

George Francois, 35, a center director at Children's National Hospital in Washington, D.C., chronicled his COVID vaccination on Facebook. Looking at the overall death and infection rates in the African American community, he considered his post a public service. "I could inspire others to get it without having to talk to them directly," he said.

It's a sentiment shared by J. Shawn Durham, 44, an actor in Washington, D.C., and an unintentional "vaccine vulture." He got a call from a friend of a friend to get vaccinated after a scheduled patient missed their appointment — leaving a critical dose that otherwise might have gone to waste. "I am healthy. I am Black. I am scholastic, so I know about our history and the Tuskegee experiments," he said. And, given that history, Durham posted his selfies to "lead by example," he added. "The white and the wealthy are getting vaccinated. I want Black people to want to get vaccinated too."

Francois didn't receive any backlash from his post and didn't think it was a big deal. "A lot of people post their HIV and COVID test results," he said.

Bottom line: It's common among younger adults to publicly share things some older adults may consider to be far too personal.

"It's kind of tacky sometimes, I think, but there's a lot of misinformation out there," said Emilio Delgado, 31, who was born in Puerto Rico and now lives in D.C. He posted in part to foster confidence in the vaccine — to let his connections "see that someone they knew has taken it and didn't grow a third eyeball," he said of his hesitant followers. For that reason, he added, it was worth it.

Delgado, a local actor and patient instructor at the George Washington University School of Medicine and Health Sciences, had access to the vaccine because in this role of "standardized patient" he is often called in to role-play ultrasounds with fourth-year medical students. He makes the bulk of his income through such patient instruction and is frequently at the hospital — a place generally considered high-risk — so he'd rather be vaccinated.

For Signe Hawley, 34, a researcher and volunteer firefighter in the foothills of northwestern Boulder, Colorado, getting the vaccine — and posting about it — was an emotional experience.

Earlier in the pandemic, she made the difficult decision to pull back from her volunteer duties to protect her wife and 2-year-old daughter. But because she had been a first responder in her community, she became eligible for the vaccine sooner than expected. "I wouldn't cut the line," said Hawley. "But when given the opportunity, I wouldn't pass it up either."

For Hawley, the hardest side effect she faced after getting the vaccine was the depth of grief and sadness that surfaced surrounding the loss of her father, along with thoughts of all of the other lives lost "in the mismanagement of this," she said.

Her father, Joe Hawley Sr., 67, died in early April from complications of COVID-19 at Norwalk Hospital in southwestern Connecticut. His family was not allowed into the intensive care unit at any time during his bout with COVID. And her interest in volunteerism and service is something she inherited from her father, a "humanitarian at heart," who was involved and committed to the New England community where he lived.

"To be vaccinated for something that my father died from is so surreal," she said, her voice breaking. Sharing her story and the vaccine photo was a way to honor her father. "This is one step to lessening the impact of death and severe health complications with COVID, but it's not the end of it," she said.

Ultimately, she said, the more people vaccinated the better off we all are.

"We're all posting this hoping to get buy-in," said national etiquette expert Diane Gottsman, an author and founder of the Protocol School of Texas, a company specializing in corporate etiquette training based in San Antonio. Know your audience, she advised. And another important reminder: Follow Federal Trade Commission guidelines, which advise against posting vaccination cards containing identifying information that could expose you to identity theft.

Chaseedaw Giles: cgiles@kff.org, @cgonsocial

Countless Homebound Patients Still Wait for COVID Vaccine Despite Seniors' Priority

KFF Health News, February 22, 2021

Home care agencies and hospice organizations don't have access to COVID vaccines either for their staff or patients.

This article was published on Monday, February 22, 2021 in Kaiser Health News.

By Judith Graham

Opening another front in the nation's response to the pandemic, medical centers and other health organizations have begun sending doctors and nurses to apartment buildings and private homes to vaccinate homebound seniors.

Boston Medical Center, which runs the oldest in-home medical service in the country, started doing this Feb. 1. Wake Forest Baptist Health, a North Carolina health system, followed a week later.

In Miami Beach, Florida, fire department paramedics are delivering vaccines to frail seniors in their own homes. In East St. Louis, Illinois, a visiting nurse service is offering at-home vaccines to low-income, sick older adults who receive food from Meals on Wheels.

In central and northern Pennsylvania, Geisinger Health, a large health system, has identified 500 older homebound adults and is bringing vaccines to them. Nationally, the Department of Veterans Affairs has provided more than 11,000 vaccines to veterans who receive primary medical care at home.

These efforts and others like them recognize a compelling need: Between 2 million and 4.4 million older adults are homebound. Most are in their 80s and have multiple medical conditions, such as heart failure, cancer, and chronic lung disease, and many are cognitively impaired. They cannot leave their homes or can do so only with considerable difficulty.

By virtue of their age and medical status, these seniors are at extremely high risk of becoming seriously ill and dying if they get COVID-19. Yet, unlike similarly frail nursing home patients, they haven't been recognized as a priority group for vaccines, and the Centers for Disease Control and Prevention only recently offered guidance on serving them.

"This is a hidden group that's going to be overlooked if we don't step up efforts to reach them," said Dr. Steven Landers, president and CEO of Visiting Nurse Association Health Group, which provides home health and hospice care to over 10,000 people in New Jersey, northeastern Ohio and southeastern Florida. His organization plans to launch a pilot home vaccination program for frail patients this week.

Jane Gerechoff, 91, of Ocean Township, New Jersey, is waiting for the group to vaccinate her. She had a stroke more than a year ago and has difficulty breathing because of a serious lung disease. "I can't walk; I'm in a wheelchair. There's no way in the world I could get the vaccine if they didn't come out to me," she said in a phone interview.

Although Gerechoff doesn't go out, she lives with an adult son who interacts with people outside the house and she receives help from physical and occupational therapists at home. Any one of them could bring in the virus.

Reaching homebound seniors presents many challenges. At the top of the list: Home care agencies and hospice organizations don't have access to COVID vaccines either for their staff or patients.

"There is no distribution of vaccines to our members, and there has been no planning surrounding meeting the needs of the people we serve," said William Dombi, president of the National Association for Home Care & Hospice.

Organizations that administer vaccines also complain they're not being paid enough by Medicare to cover their costs — primarily staff time and effort. (The shots are free because the federal government is paying for them.) Making a vaccine house call requires about an hour on average, including travel, time interacting with patients and post-vaccination monitoring of people for potential side effects, according to program leaders.

Medicare reimbursement for the first shot is $16.94; for a second shot, it's $28.39, according to Shawna Ramey, a consultant who presented the data at a recent American Academy of Home Care Medicine webinar. "The actual cost of these visits is closer to $150 or $160," Dombi said.

Then, there are issues with cold storage and transportation for the Pfizer-BioNTech and Moderna vaccines. Both vaccines are fragile after being thawed and need to be handled carefully, according to the new CDC guidance on vaccinating homebound adults.. Once vaccine vials are opened, shots need to be delivered within six hours, according to instructions from Pfizer and Moderna.

Those requirements have proved too burdensome for Prospero Health, which serves 9,000 seriously ill patients in their homes in 20 states, including nearly 2,000 homebound patients. Fewer than 10% have been vaccinated, said Dr. Dave Moen, Prospero's medical group president.

Things will become easier if vaccines from Johnson & Johnson and AstraZeneca receive approval, as expected, he suggested. Both of those vaccine candidates are more stable than the Pfizer and Moderna vaccines and would be easier to administer in the home, Moen said.

Palmer Kloster, 84, of Bradley, Illinois, receives care from Prospero under a contract with his Medicare Advantage insurer, UnitedHealthcare. He's a largely immobile polio survivor who has undergone open-heart surgery and receives care from paid helpers for four hours a day.

"I really need someone to come here and give me a shot," he told me in a phone conversation. "I don't want that disease [COVID-19]. At my age, it would be very detrimental."

In Boston, Mary Gareffa, 84, is grateful that a physician she knows and trusts, Dr. Won Lee, came to her house in early February to vaccinate her. "I haven't been out of the house in about eight years, except by ambulance," said Gareffa, who has stomach cancer, weighs 73 pounds and broke her hip this summer after a bad fall.

It's essential to reach out to patients like Gareffa, said Lee, a geriatrician who works with the Boston Medical Center's home-based program. "It's worth providing quality of life and reducing suffering, and COVID-19 causes nothing but suffering," she said. The Boston program has vaccinated 84 people as of Feb. 12.

The vaccines come from the medical center's supply. Before going out, staff members call patients and address any concerns they might have about getting the shots. Most are African American and many families want to know whether the vaccine will make their frail parents or grandparents sick. "They need to hear that it's safe to get a shot from someone who knows their medical issues," Lee said.

Wake Forest's house call program is sending out a doctor, nurse or physician assistant paired with a pharmacy resident to deliver vaccines. About 200 people are served through the program, most of them in their late 70s or early 80s with five or more medical conditions, said Dr. Mia Yang, the program's director.

Wake Forest's goal is to provide vaccine house calls to up to 40 patients a week and include family caregivers if there's adequate supply, Yang said.

Robert Pursel, 69, who has severe osteoporosis and fluid retention in his feet and legs, and his wife Gail, 72, who has serious back problems, both received Pfizer vaccines in late January from Geisinger at their home in Millville, Pennsylvania. At first, Robert said he was skeptical, but now he's glad he said yes. If a Geisinger nurse hadn't come to them, he wouldn't have been able to get out on his own.

Because of his swelling, "I can't get my shoes on," Robert said, and "I'd have to walk barefoot through the snow and ice out there."

Judith Graham: khn.navigatingaging@gmail.com, @judith_graham

Organ Transplant Patient Dies After Receiving COVID-Infected Lungs

KFF Health News, February 22, 2021

Officials at the University of Michigan Medical School suggested it may be the first proven case of COVID in the U.S. in which the virus was transmitted via an organ transplant.

This article was published on Sunday, February 21, 2021 in Kaiser Health News.

By JoNel Aleccia Doctors say a woman in Michigan contracted COVID-19 and died last fall two months after receiving a tainted double-lung transplant from a donor who turned out to harbor the virus that causes the disease — despite showing no signs of illness and initially testing negative.

Officials at the University of Michigan Medical School suggested it may be the first proven case of COVID in the U.S. in which the virus was transmitted via an organ transplant. A surgeon who handled the donor lungs was also infected with the virus and fell ill but later recovered.

The incident appears to be isolated — the only confirmed case among nearly 40,000 transplants in 2020. But it has led to calls for more thorough testing of lung transplant donors, with samples taken from deep within the donor lungs as well as the nose and throat, said Dr. Daniel Kaul, director of Michigan Medicine's transplant infectious disease service.

"We would absolutely not have used the lungs if we'd had a positive COVID test," said Kaul, who co-authored a report about the case in the American Journal of Transplantation.

The virus was transmitted when lungs from a woman from the Upper Midwest, who died after suffering a severe brain injury in a car accident, were transplanted into a woman with chronic obstructive lung disease at University Hospital in Ann Arbor. The nose and throat samples routinely collected from both organ donors and recipients tested negative for SARS-CoV-2, the virus that causes COVID.

"All the screening that we normally do and are able to do, we did," Kaul said.

Three days after the operation, however, the recipient spiked a fever; her blood pressure fell and her breathing became labored. Imaging showed signs of lung infection.

As her condition worsened, the patient developed septic shock and heart function problems. Doctors decided to test for SARS-CoV-2, Kaul said. Samples from her new lungs came back positive.

Suspicious about the origin of the infection, doctors returned to samples from the transplant donor. A molecular test of a swab from the donor's nose and throat, taken 48 hours after her lungs were procured, had been negative for SARS-Cov-2. The donor's family told doctors she had no history of recent travel or COVID symptoms and no known exposure to anyone with the disease.

But doctors had kept a sample of fluid washed from deep within the donor lungs. When they tested that fluid, it was positive for the virus. Four days after the transplant, the surgeon who handled the donor lungs and performed the surgery tested positive, too. Genetic screening revealed that the transplant recipient and the surgeon had been infected by the donor. Ten other members of the transplant team tested negative for the virus.

The transplant recipient deteriorated rapidly, developing multisystem organ failure. Doctors tried known treatments for COVID, including remdesivir, a newly approved drug, and convalescent blood plasma from people previously infected with the disease. Eventually, she was placed on the last-resort option of ECMO, or extracorporeal membrane oxygenation, to no avail. Life support was withdrawn, and she died 61 days after the transplant.

Kaul called the incident "a tragic case."

While the Michigan case marks the first confirmed incident in the U.S. of transmission through a transplant, others have been suspected. A recent Centers for Disease Control and Prevention report reviewed eight possible cases of what's known as donor-derived infection that occurred last spring, but concluded the most likely source of transmission of the COVID virus in those cases was in a community or healthcare setting.

Before this incident, it was not clear whether the COVID virus could be transmitted through solid organ transplants, though it's well documented with other respiratory viruses. Donor transmission of H1N1 2009 pandemic influenza has been detected almost exclusively in lung transplant recipients, Kaul noted.

While it's not surprising that SARS-CoV-2 can be transmitted through infected lungs, it remains uncertain whether other organs affected by COVID — hearts, livers and kidneys, for instance — can transmit the virus, too.

"It seems for non-lung donors that it may be very difficult to transmit COVID, even if the donor has COVID," Kaul said.

Organ donors have been tested routinely for SARS-CoV-2 during the pandemic, though it's not required by the Organ Procurement and Transplantation Network, or OPTN, which oversees transplants in the U.S. But the Michigan case underscores the need for more extensive sampling before transplant, especially in areas with high rates of COVID transmission, Kaul said.

When it comes to lungs, that means making sure to test samples from the donor's lower respiratory tract, as well as from the nose and throat. Obtaining and testing such samples from donors can be difficult to carry out in a timely fashion. There's also the risk of introducing infection into the donated lungs, Kaul said.

Because no organs other than lungs were used, the Michigan case doesn't provide insight into testing protocols for other organs.

Overall, viral transmissions from organ donors to recipients remain rare, occurring in fewer than 1% of transplant recipients, research shows. The medical risks facing ailing patients who reject a donor organ are generally far higher, said Dr. David Klassen, chief medical officer with the United Network for Organ Sharing, the federal contractor that runs the OPTN.

"The risks of turning down transplants are catastrophic," he said. "I don't think patients should be afraid of the transplant process."

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

New Single-Payer Bill Intensifies Newsom's Political Peril

KFF Health News, February 21, 2021

While the measure does not assign a price tag to the overhaul, a separate single-payer bill that failed in 2017 would have cost an estimated $400 billion each year.

This article was published on Friday, February 19, 2021 in Kaiser Health News.

By Angela Hart and Rachel Bluth

SACRAMENTO — A group of Democratic state lawmakers introduced legislation Friday to create a single-payer health care system to cover all Californians, immediately defining the biggest health policy debate of the year and putting enormous political pressure on Gov. Gavin Newsom.

The Democratic governor faces the increasingly likely prospect of a Republican-driven recall election later this year. The single-payer bill adds to his political peril from the left if he doesn’t express support, and from the right if he does.

State Assembly member Ash Kalra, author of AB 1400, said the coronavirus pandemic has exposed a broken health care system that has left millions without reliable and affordable health coverage. His bill would address those gaps in the system, he said, effectively eliminating private health insurance by shifting responsibility for administering and financing health coverage to the state government.

The new system, called CalCare, would expand coverage to nearly 3 million uninsured Californians and provide rich benefits, including dental care, generous prescription drug coverage and long-term care, according to the bill language, which was obtained by California Healthline before the measure was introduced.

The move, however, faces monumental financial and legal barriers, and would likely require new taxes. While the measure does not assign a price tag to the overhaul, a separate single-payer bill that failed in 2017 would have cost an estimated $400 billion each year.

“People are dying and suffering. They’re going bankrupt and starting GoFundMe pages just in order to survive in the wealthiest state in the wealthiest nation on earth,” said Kalra, a liberal Democrat from San Jose. “We now have a Democratic White House, and forward-thinking Democrats like Xavier Becerra going to Washington who can be incredibly helpful.”

Nearly 20 other Assembly Democrats signed on to the legislation, which is among the first state-based single-payer proposals to be introduced under the Biden administration. Massachusetts lawmakers this year introduced similar legislation, and other states are considering it.

Sponsored by the California Nurses Association, a powerful union and political force in Sacramento, the single-payer bill is expected to ignite a fierce health care fight among liberal and moderate Democratic lawmakers, and draw intense opposition from deep-pocketed health industry groups, including insurers, doctors and hospitals.

“Eliminating private health coverage in California will always be unworkable for a number of reasons. It would cost $400 billion a year, which we can’t afford,” said Ned Wigglesworth, spokesperson for Californians Against the Costly Disruption of our Healthcare, which includes major private health insurers and the state doctor and hospital lobbying groups, which also opposed the 2017 single-payer bill.

“Shifting to an entirely government-based health system would be especially harmful and disruptive now, as California’s health care community is focused on meeting the acute health care needs of our state during a pandemic,” Wigglesworth added.

Assembly member Jim Wood (D-Santa Rosa), who as chair of the Assembly Health Committee controls which health policy legislation gets a hearing, cast doubt on the feasibility of single-payer late last year, saying the state should instead build on the Affordable Care Act. Supporters fear his potential opposition could block the bill.

California’s proposal, if approved, could test the Biden administration’s willingness to grant states freedom to enact sweeping health care reforms such as a single-payer system. Becerra, California’s attorney general, has expressed unwavering support for single-payer and would be positioned to weigh in on the plan should he be confirmed as President Joe Biden’s Health and Human Services secretary. Becerra’s Senate confirmation hearings start Tuesday.

“The president himself doesn’t necessarily have to support single-payer on a national level to allow states to move forward,” Kalra said.

The introduction of a single-payer proposal this year forces Newsom into a delicate position. The first-term governor, who said he supported the creation of a state-based single-payer health care system when he ran for governor in 2018, has since distanced himself, expressing doubt that California can embark on such a massive transformation on its own.

Newsom’s office did not respond to a request for comment.

Newsom, once seen as a rising Democratic Party star, faces a burgeoning recall effort driven by state and national Republicans. The embattled governor is under fire for a clumsy and confusing vaccine rollout; backlogs and fraud at the state’s unemployment agency; and violating his own public health rules when he dined maskless last year at the ritzy French Laundry restaurant. Democrats have also criticized the governor for his pandemic response, including his inability to reach a legislative deal to open schools to in-person instruction.

With the March 17 deadline looming for the recall to qualify for the ballot, Newsom will undoubtedly be asked to weigh in on the single-payer proposal.

“It’s not a factor in this calculation,” said Stephanie Roberson, lead lobbyist with the California Nurses Association, which campaigned for Newsom during his gubernatorial run. “Our concern is people are dying and losing their health care. We’re sorry if this parallels some untimely political event for the governor.”

Last year, Newsom convened a commission to study the possibility of a single-payer system and other ways to cover more Californians. But the pandemic stalled its progress and the commission hasn’t met since August.

The exorbitant cost of developing a new system is a major hurdle. In 2017, the last time California lawmakers floated a single-payer proposal, a state legislative analysis pegged the projected cost at $400 billion a year. Assembly Speaker Anthony Rendon shelved the proposal, calling it “woefully incomplete,” in part because it was unveiled without a financing mechanism.

Kalra, who has not identified a way to pay for the massive transformation and said he’s unsure whether it would require higher taxes, will undoubtedly face similar skepticism over how to fund it.

His bill calls for CalCare to cover comprehensive health services far beyond what’s required under the Affordable Care Act, including traditional medical services, dental care, prescription drug coverage, long-term care, and mental health and substance use treatment.

It would also end all out-of-pocket patient costs — including premiums, copays and deductibles — and ban health care providers participating in CalCare from operating in the private marketplace. CalCare’s governing board would determine health care prices and set rules for providers.

While single-payer would require a significant initial investment, Kalra argued, the state might be able to reroute federal dollars for Medicare, Medicaid and other programs into CalCare. The system would also eventually cost less, he said, because it would simplify health care financing, end for-profit care and cut out private middlemen.

“Look, we’re already paying more than $400 billion a year for our current system,” Kalra said. “We currently have the most expensive health care system in the world, and our outcomes certainly don’t get us what we pay for.”

The latest estimates, based on federal data, show health care spending in California is about $450 billion a year, according to Gerald Kominski, a professor of health policy and management at the UCLA Fielding School of Public Health.

But switching to single-payer isn’t as simple as transferring those expenses to a new system, he said. Somehow, the money that employers and employees contribute to private health insurance plans needs to be funneled into a unified system.

“The mechanism you use to do that is almost certainly some form of taxation,” Kominski said. “It’s literally impossible for a single-payer system to move forward without capturing those current expenditures. They’re too substantial.”

While the proposal would not ban all private health insurance, it would allow only for coverage that supplements CalCare. The aim is to enroll all Californians, eliminating the need for private health coverage, said Carmen Comsti, a regulatory policy specialist with the California Nurses Association who is also on the state’s single-payer commission.

But that could present enormous challenges. Nearly 6 million Californians are enrolled in private health coverage regulated by the federal government. Enrolling them in CalCare could require a change in federal regulatory law, and would likely require changes to the state constitution — which, in addition to passing tax increases, could force single-payer backers to obtain voter approval.

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

Feds OK'd Export of Millions of N95 Masks as U.S. Workers Cried for More

KFF Health News, February 20, 2021

The disconnect between front-line workers going without better protection and federal officials suddenly exporting masks boils down to one thing, workplace-safety experts say: The government has not pivoted quickly enough to lift supply chain crisis-mode guidelines and force employers to take costly and sometimes cumbersome steps to better protect workers with top-quality gear.

This article was published on Friday, February 19, 2021 in Kaiser Health News. This story also ran on CNN.

By Christina Jewett

In the midst of a national shortage of N95 masks, the U.S. government quietly granted an exception to its export ban on protective gear, allowing as many as 5 million of the masks per month to be shipped overseas.

The Federal Emergency Management Agency issued the waiver in the final moments of Donald Trump’s presidency last month, allowing a Texas company to export its products after it failed to secure U.S. customers, according to the FEMA letter obtained by KHN.

National Nurses United president Zenei Triunfo-Cortez called the export waiver “unconscionable” and said N95s remain under lock and key in many hospitals. She said she still has to “beg” for a new N95 if hers gets soiled during a shift caring for covid-19 patients.

Health care employers “and a federal agency that is supposed to be protecting the people of America are not doing their jobs,” she said. “They have no regard for our safety.”

The disconnect between front-line workers going without better protection and federal officials suddenly exporting masks boils down to one thing, workplace-safety experts say: The government has not pivoted quickly enough to lift supply chain crisis-mode guidelines and force employers to take costly and sometimes cumbersome steps to better protect workers with top-quality gear.

The FEMA letter references the challenge that Fort Worth-based Prestige Ameritech faced in finding customers for its government-approved, high-end respirators: Hospitals did not want to “fit test” employees to its N95s, a 15-minute process per employee to ensure that a new N95 model seals to the face, according to company president Mike Bowen.

Bowen said he ramped up N95 production during the pandemic from 75,000 to 9.6 million per month. Lately, he said, he can’t sell them to major buyers, does not have the infrastructure to sell them to small buyers and has so many in storage that he may need to lay off workers and wind down production.

The FEMA letter references those challenges and says the waiver was granted in the “national defense interest” to ensure he keeps production running at pace. The letter was transmitted to Border Patrol officials who oversee exports 103 minutes before Joe Biden was sworn into office.

Yet even with the waiver, Bowen said, he hasn’t been able to find an overseas buyer. He said he can’t understand the contradictory information he’s getting: Front-line workers say they need more N95s, but hospitals say they don’t.

“There is a disconnect someplace, and I don’t know where it is,” Bowen said. “Why aren’t my phones ringing off the hook if there’s a shortage?”

A FEMA official said by email that the waiver could be revoked at any time if U.S. demand increases and that the agency could require the company to “satisfy domestic demand” before exporting N95s.

Although prices fall considerably for those buying in bulk, prices for smaller lots of N95s have reached $4 to $7 each, according to Get Us PPE, a nonprofit meant to match front-line workers with needed gear.

The requirement for employers to perform fit tests annually was set aside amid the public health emergency, giving employers little incentive to veer from the industry-standard models like 3M that were used for years. And the Centers for Disease Control and Prevention has left guidelines in place that say a limited cadre of health care workers should get N95s, which can be reused and rationed.

That adds up to an unusual situation in which U.S. mask supplies have surged, but employers’ motivation to buy the best protective gear has not, said Peg Seminario, a former union health and safety official who recently signed a letter urging the CDC to update its guidelines to reflect the risk of inhaling the virus.

“This is crazy,” she said. “We could … crush this pandemic where the biggest risks of infection are and we’re not doing it.”

Started by a group of emergency room doctors in March, Get Us PPE said it gets 89% of requests for gear — often N95s — from health workers outside of hospitals, like community clinics, covid testing sites and psychiatric care facilities. Demand rose throughout January, with 28% of front-line workers seeking N95s reporting that their site had none.

Yet the volunteer-run group has been able to fulfill only about 15% of the requests it receives. Dr. Ali Raja, a founder of the group and executive vice chair of the emergency department at Massachusetts General Hospital, said the need is vast outside of hospitals, but small facilities scrambling for gear are not connecting to bulk sellers like Bowen’s firm.

“There was nothing out there — no centralized place for all facilities to report PPE needs,” Raja said. “We don’t want to be the website with the best data on this. We want that to be the federal government.”

On the last day of 2020, FEMA extended its rule prohibiting anyone from exporting PPE, including N95s, without first getting express approval from the agency. The rule says the fall and winter surge in covid cases meant “domestic supply of the allocated PPE has not kept pace with demand and is not anticipated to do so.”

The U.S. Strategic National Stockpile has not yet met its goal for N95 respirators, according to a U.S. Government Accountability Office report. The report said that as of Dec. 18, there were 190 million N95 respirators in storage — well short of its goal of 300 million.

“GAO remains deeply troubled that agencies have not acted on recommendations to more fully address critical gaps in the medical supply chain,” the government watchdog report says.

Another twist to the saga is that millions of counterfeit N95s stamped “3M,” an industry standard that has long been used in previously required annual fit tests, have flooded hospital shelves even as federal agents rush to seize them at U.S. ports.

A prominent group of scientists wrote to the CDC on Monday to point out guidelines that urgently need to be changed to protect workers from inhaling tiny airborne virus particles. Their letter noted that the “CDC does not recommend the use of N95 respirators” outside health care settings, even though outsize risks are documented for bus drivers, prison guards and meatpacking staffers.

CDC guidelines also allow hospitals to limit which workers get the N95s, leaving out those in community settings and lower-level workers who typically spend the most time next to patients.

In the Lost on the Frontline project, KHN and The Guardian have documented the deaths of hundreds of more than 3,440 front-line health workers, of whom 2 in 3 were workers of color and 56% worked outside of hospitals. For more than 120 who died, family members had concerns about PPE, including the extensive reuse of N95s or the use of surgical masks for direct care of covid patients.

KHN senior correspondent JoNel Aleccia contributed to this report.

Spurred by Pandemic, Little Shell Tribe Fast-Tracks Its Health Service Debut

KFF Health News, February 19, 2021

The Little Shell Tribe of Chippewa Indians of Montana is building its health services largely from scratch roughly a year after becoming the United States' 574th federally recognized Indigenous tribe.

This article was published on Friday, February 19, 2021 in Kaiser Health News.

By Katheryn Houghton Linda Watson draped a sweater with the words "Little Shell Chippewa Tribe" over her as she received the newly recognized tribal nation's first dose of covid-19 vaccine.

"I wanted to show my pride in being a Little Shell member," Watson, 72, said. "The Little Shell are doing very good things for the people."

Watson has diabetes and a heart condition. The shot brought some peace of mind during a time when that isn't fully possible. One of her sons is among those who have died of covid.

The Little Shell Tribe of Chippewa Indians of Montana is building its health services largely from scratch roughly a year after becoming the United States' 574th federally recognized Indigenous tribe. Because of the pandemic, it's doing it on hyperdrive.

The long-sought recognition came just months before the pandemic took hold, arriving in time to guarantee the right to crucial healthcare and a tribal supply of protective covid vaccines. Federal pandemic relief dollars are speeding up the Little Shell Tribe's ability to build its own clinic.

Without the CARES Act funds, Indian Health Service and Little Shell officials said it would have likely taken years using only IHS resources to establish a clinic. The IHS already has a list of new and replacement healthcare facility projects nationwide estimated to cost more than $14.5 billion, yet it reported in 2019 it receives roughly $240 million each year to get that work done. At that pace, it would take 60 years to get through its current needs.

Now, in Great Falls, roughly 2 miles from where Watson got her shot, a brick building under renovation bears a banner announcing the Little Shell Tribal Health Clinic: "Coming 2021." The former animal hospital site that the tribe purchased will provide medical, dental, vision and behavioral care, alongside traditional medicine, a pharmacy and a lab. The goal is to open the clinic by late summer.

When Watson drives by the future clinic's site on her way to work as the tribal nation's enrollment officer, she said, she feels proud.

"To have a Little Shell name on it, to see the results of what our ancestors had worked so hard for," Watson said. "It's their descendants that are now experiencing it."

The Little Shell have advocated for their place as a sovereign nation for more than 150 years. Although Montana formally recognized the tribe in 2000, not having federal recognition until December 2019 kept it from accessing many vital services and programs.

And without a recognized homeland, the tribe's more than 5,700 members had scattered across Northern Plains states and Canada. The vast majority live in Montana.

Because of the federal recognition, Little Shell tribal enrollment has surged and its Ojibwe language course has a lengthening waitlist.

But this newfound strength is tempered by the deep challenges of the pandemic. The coronavirus has stalled in-person celebrations and planning in the tribe's first year of federal recognition.

Worst yet, covid has disproportionately infected and killed Indigenous people nationwide, exposing long-standing health inequities caused by a history of colonization and underinvestment in Indian Country. In Montana, Native Americans make up roughly 7% of the population yet account for 11% of the state's covid cases and 17% of related deaths.

The Little Shell tribal healthcare system is so new, it doesn't have electronic health records set up and hasn't tracked the statistics.

In October, the tribal nation hired its first health director, who had to create a covid vaccination plan while juggling other immediate needs, such as helping establish a transportation service for members to get to doctor appointments. Setting up infrastructure for a sovereign nation without a reservation presents challenges. The tribe's service area encompasses four counties — Blaine, Cascade, Glacier and Hill — that together would span an area larger than Maryland. Only two of those counties share a border, so the distances are even greater.

Little Shell members now have access to any IHS facility nationwide, but, until their clinic is ready, some services such as dental and vision care are far-flung even for those close to the nation's Great Falls headquarters.

"Without our clinic, members would have to drive 118 miles one way to get some basic services — and try doing that in January and February in Montana," Tribal Chairman Gerald Gray said.

In the meantime, the tribe is partnering with the Cascade City-County Health Department to administer about 100 vaccine doses each week, according to the tribal health department. The effort has attracted tribal members from out of state.

Many questions remain as to how the new clinic will operate. Gray said the tribe has been told IHS will operate the clinic for at least three years before the tribal nation has the chance to completely run its services. Bryce Redgrave, the Billings-area IHS director, said in a statement the agency is discussing the possibilities but "no plan has been finalized at this time."

Little Shell leaders plan to model the clinic after an Alaska Native-owned nonprofit called Southcentral Foundation that has been emulated by other tribes, including the Eastern Cherokee in North Carolina.

"The model is about treating the whole person and prioritizing Indigenous interventions," said Little Shell tribal council member Kim McKeehan.

What that looks like for the Little Shell is still being decided, said Molly Wendland, the Little Shell tribal health director. She said one idea is to grow plants for traditional medicines behind the clinic. The tribe also plans to have a smudge room, she said, in which members can burn sage and ask for healing.

Linda Wilmore, 51, a Little Shell member who lives in Great Falls, said the new clinic would mean she wouldn't put off care such as going to the dentist anymore. Without an option close to home, she said, she has often waited until she's in enough pain to warrant the three-hour round trip to an IHS healthcare facility that offers dental care, where her insurance won't leave her with unwieldy out-of-pocket costs.

She is also excited about having a clinic designed for, and by, the Little Shell Tribe. Growing up, Wilmore remembers her family having to ask permission to use IHS facilities in Montana before state recognition in 2000 guaranteed it.

"You felt like the redheaded stepchild asking, 'We're Little Shell, can we use your clinic?'" Wilmore said.

The Great Falls clinic will also fill gaps in care for other Indigenous people in nearby rural communities and the city itself.

Little Shell members who live far from Great Falls are sorting through how to tap into newly granted services or how to access specialty treatment they can't get at an IHS clinic.

Little Shell member Jonni Kroll, 55, lives in Deer Park, Washington, some 380 miles from the tribe's future clinic. Her closest IHS alternative is a roughly 50-minute drive. Her first call was to book an eye appointment, only to find the clinic doesn't have an optometrist.

"So then I go to the next clinic on my list," Kroll said. "That's a problem across the board with IHS nationwide, and I think that will affect Little Shell people trying to figure out: How do we utilize this when we are scattered?"

Little Shell people are spread out largely because they weren't recognized, she noted, and now they're having to play catch-up to understand how to access the services that recognition ensures. She said members, some of whom have never met, are connecting by phone or online to work through those questions together.

"The Little Shell are so resilient," Kroll said. "We've gotten to the point of federal recognition and so now we find a way to come past that. There are lots of doors that opened, but we have a lot to learn."

Katheryn Houghton: khoughton@kff.org, @K_Hought

To Vaccinate Veterans, Healthcare Workers Must Cross Mountains, Plains and Tundra

KFF Health News, February 19, 2021

About 2.7 million veterans who use the VA health system are classified as "rural" or "highly rural" patients, residing in communities or on land with fewer services and less access to healthcare.

This article was published on Friday, February 19, 2021 in Kaiser Health News.

By Patricia Kime

A Learjet 31 took off before daybreak from Helena Regional Airport in Montana, carrying six Veterans Affairs medical providers and 250 doses of historic cargo cradled in a plug-in cooler designed to minimize breakage.

Even in a state where 80-mph speed limits are normal, ground transportation across long distances is risky for the Moderna mRNA-1273 vaccine, which must be used within 12 hours of thawing.

The group's destination was Havre, Montana, 30 miles from the Canadian border. About 500 military veterans live in and around this small town of roughly 9,800, and millions more reside in similarly rural, hard-to-reach areas across the United States.

About 2.7 million veterans who use the VA health system are classified as "rural" or "highly rural" patients, residing in communities or on land with fewer services and less access to health care than those in densely populated towns and cities. An additional 2 million veterans live in remote areas who do not receive their health care from VA, according to the department. To ensure these rural vets have access to the covid vaccines, the VA is relying on a mix of tools, like charter and commercial aircraft and partnerships with civilian health organizations.

The challenges of vaccinating veterans in rural areas — which the VA considers anything outside an urban population center — and "highly rural" areas — defined as having fewer than 10% of the workforce commuting to an urban hub and with a population no greater than 2,500 — extend beyond geography, as more than 55% of them are 65 or older and at risk for serious cases of covid and just 65% are reachable via the internet.

For the Havre event, VA clinic workers called each patient served by the Merril Lundman VA Outpatient Clinic in a vast region made up of small farming and ranching communities and two Native American reservations. And for those hesitant to get the vaccine, a nurse called them back to answer questions.

"At least 10 additional veterans elected to be vaccinated once we answered their questions," said Judy Hayman, executive director of the Montana VA Health Care System, serving all 147,000 square miles of the state.

The Havre mission was a test flight for similar efforts in other rural locations. Thirteen days later, another aircraft took off for Kalispell, Montana, carrying vaccines for 400 veterans.

In Alaska, another rural state, Anchorage Veterans Affairs Medical Center administrators finalized plans for providers to hop a commercial Alaska Airlines flight on Thursday to Kodiak Island. There, VA workers expected to administer 100 to 150 doses at a vaccine clinic conducted in partnership with the Kodiak Area Native Association.

"Our goal is to vaccinate all veterans who have not been vaccinated in and around the Kodiak community," said Tom Steinbrunner, acting director of the Alaska VA Healthcare System.

VA began its outreach to rural veterans for the vaccine program late last year, as the Food and Drug Administration approached the dates for issuing emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines, according to Dr. Richard Stone, the Veterans Health Administration's acting undersecretary. It made sense to look to aircraft to deliver vaccines. "It just seemed logical that we would reach into rural areas that, [like] up in Montana, we had a contract with, a company that had small propeller-driven aircraft and short runway capability," said Stone, a retired Army Reserve major general.

Veterans have responded, Stone added, with more than 50% of veterans in rural areas making appointments.

As of Wednesday, the VA had tallied 220,992 confirmed cases of covid among veterans and VA employees and 10,065 known deaths, including 128 employees. VA had administered 1,344,210 doses of either the Pfizer or Moderna vaccine, including 329,685 second vaccines, to veterans as of Wednesday. According to the VA, roughly 25% of those veterans live in rural areas, 2.81% live in highly rural areas and 1.13% live on remote islands.

For rural areas, the VA has primarily relied on the Moderna vaccine, which requires cold storage between minus 25 degrees Centigrade (minus 13 degrees Fahrenheit) and minus 15 degrees C (5 degrees F) but not the deep freeze needed to store the Pfizer vaccine (minus 70 degrees C, or minus 94 degrees F). That, according to the VA, makes it more "transportable to rural locations."

The VA anticipates that the one-dose Johnson & Johnson vaccine, if it receives an emergency use authorization from the FDA, will make it even easier to reach remote veterans. The vaccines from Moderna and Pfizer-BioNTech both require two shots, spaced a few weeks apart. "One dose will make it easier for veterans in rural locations, who often have to travel long distances, to get their full vaccination coverage," said VA spokesperson Gina Jackson. The FDA's vaccine advisory committee is set to meet on Feb. 26 to review J&J's application for authorization.

Meanwhile, in places like Alaska, where hundreds of veterans live off the grid, VA officials have had to be creative. Flying out to serve individual veterans would be too costly, so the Anchorage VA Medical Center has partnered with tribal health care organizations to ensure veterans have access to a vaccine. Under these agreements, all veterans, including non-Native veterans, can be seen at tribal facilities.

"That is our primary outreach in much of Alaska because the tribal health system is the only health system in these communities," Steinbrunner said.

In some rural areas, however, the process has proved frustrating. Army veteran John Hoefen, 73, served in Vietnam and has a 100% disability rating from the VA for Parkinson's disease related to Agent Orange exposure. He gets his medical care from a VA location in Canandaigua, New York, 20 miles from his home, but the facility hasn't made clear what phase of the vaccine rollout it's in, Hoefen said.

The hospital's website simply says a staff member will contact veterans when they become eligible — a "don't call us, we'll call you," situation, he said. "I know a lot of veterans like me, 100% disabled and no word," Hoefen said. "I went there for audiology a few weeks ago and my tech hadn't even gotten her vaccine yet."

VA Canandaigua referred questions about the facility's current phase back to its website: "If you're eligible to get a vaccine, your VA health care team will contact you by phone, text message or Secure Message (through MyHealtheVet) to schedule an appointment," it states. A call to the special covid-19 phone number established for the Canandaigua VA, which falls under the department's Finger Lakes Healthcare System, puts the caller into the main menu for hospital services, with no information specifically on vaccine distribution.

For the most part, the VA is using Centers for Disease Control and Prevention guidelines to determine priority groups for vaccines. Having vaccinated the bulk of its health care workers and first responders, as well as residents of VA nursing homes, it has been vaccinating those 75 and older, as well as those with chronic conditions that place them at risk for severe cases of covid. In some locations, like Anchorage and across Montana, clinics are vaccinating those 65 and older and walk-ins when extra doses are available.

According to Lori FitzGerald, chief of pharmacy at the VA hospital in Fort Harrison, Montana, providers have ended up with extra doses that went to hospitalized patients or veterans being seen at the facility. Only one dose has gone to waste in Montana, she said.

To determine eligibility for the vaccine, facilities are using the Veterans Health Administration Support Service Center databases and algorithms to help with the decision-making process. Facilities then notify veterans by mail, email or phone or through VA portals of their eligibility and when they can expect to get a shot, according to the department.

Air Force veteran Theresa Petersen, 83, was thrilled that she and her husband, an 89-year-old U.S. Navy veteran, were able to get vaccinated at the Kalispell event. She said they were notified by their primary care provider of the opportunity and jumped at the chance.

"I would do anything to give as many kudos as I can to the Veterans Affairs medical system," Petersen said. "I'm so enamored with the concept that 'Yes, there are people who live in rural America and they have health issues too.'"

The VA is allowed to provide vaccines only to veterans currently enrolled in VA health care. About 9 million U.S. veterans are not enrolled at the VA, including 2 million rural veterans.

After veterans were turned away from a VA clinic in West Palm Beach, Florida, in January, Rep. Debbie Wasserman Schultz (D-Fla.) wrote to Acting VA Secretary Dat Tran, urging him to include these veterans in their covid vaccination program.

Stone said the agency does not have the authorization to provide services to these veterans. "We have been talking to Capitol Hill about how to reconcile that," he said. "Some of these are very elderly veterans and we don't want to turn anybody away."

Patricia Kime: PatriciaNKime@gmail.com, @patriciakime  

Companies Pan for Marketing Gold in Vaccines

KFF Health News, February 19, 2021

But some object to facilities using vaccines as a marketing tool.

This article was published on Friday, February 19, 2021 in Kaiser Health News.

By Sarah Kwon

For a decade, Jennifer Crow has taken care of her elderly parents, who have multiple sclerosis. After her father had a stroke in December, the family got serious in its conversations with a retirement community — and learned that one service it offered was covid-19 vaccination.

"They mentioned it like it was an amenity, like 'We have a swimming pool and a vaccination program,'" said Crow, a librarian in southern Maryland. "It was definitely appealing to me." Vaccines, she felt, would help ease her concerns about whether a congregate living situation would be safe for her parents, and for her to visit them; she has lupus, an autoimmune condition.

As the coronavirus death toll soars and demand for the covid vaccines dwarfs supply, an army of hospitals, clinics, pharmacies and long-term care facilities has been tasked with getting shots into arms. Some are also using that role to attract new business — the latest reminder that health care, even amid a global pandemic, is a commercial endeavor where some see opportunities to be seized.

"Most private sector companies distributing vaccines are motivated by the public health imperative. At some point, their DNA also kicks in," said Roberta Clarke, associate professor emeritus of marketing at Boston University.

Among senior living facilities — which saw their largest drop in occupancy on record last year — some companies are marketing vaccinations to recruit residents. Sarah Ordover, owner of Assisted Living Locators Los Angeles, a referral agency, said many in her area are offering vaccines "as a sweetener" to prospective residents, sometimes if they agree to move in before a scheduled vaccination clinic.

Oakmont Senior Living, a high-end retirement community chain with 34 locations, primarily in California, has advertised "exclusive access" to the vaccines via social media and email. A call to action on social media reads: "Reserve your apartment home now to schedule your Vaccine Clinic appointment!"

Although the vaccine offer was a selling point for Crow, it wasn't for her parents, who have not been concerned about contracting covid and didn't want to forgo their independence, she said. Ultimately, they moved in with her sister, who could arrange home care services.

This marketing approach might sway others. Oakmont Senior Living, based in Irvine, reported 92 move-ins across its communities last month, a 13% increase from January 2020, noting the vaccine is "just one factor among many" in deciding to become a resident.

But some object to facilities using vaccines as a marketing tool. "I think it's unethical," said Dr. Michael Carome, director of health research at consumer advocacy group Public Citizen. While he believes that facilities should provide vaccines to residents, he fears attaching strings to a vaccine could coerce seniors, who are particularly vulnerable and desperate for vaccines, into signing a lease.

Tony Chicotel, staff attorney at California Advocates for Nursing Home Reform, worries that seniors and their families could make less informed decisions when incentivized to sign by a certain date. "You're thinking, 'I've got to get moved in in the next week or otherwise I don't get this shot. I don't have time to read everything in this 38-page contract,'" he said.

Oakmont Senior Living responded by email: "Potential residents and their families are always provided with the information they need to be confident in a decision to choose Oakmont."

Some people say facilities are simply meeting their demand for covid vaccines. "Who is going to put an elderly person in a place without a vaccine? Congregate living has been a hotbed of the virus," said retired philanthropy consultant Patti Patrizi. She and her son recently chose a retirement community in Los Angeles for her ex-husband for myriad reasons unrelated to the vaccines. However, they accelerated the move by two weeks to coincide with a vaccination clinic.

"It was definitely not a marketing tool to me," said Patrizi. "It was my insistence that he needs it before he can live there."

The concept of using vaccines to market a business isn't new. The 2009 H1N1 pandemic ushered in drugstore flu shots, and pharmacies have since credited flu vaccines with boosting storefront sales and prescriptions. Many offer prospective vaccine recipients coupons, gift cards or rewards points.

A few pharmacies have continued these marketing activities while rolling out covid shots. On its covid vaccine information site, CVS Pharmacy encouraged visitors to sign up for its rewards program to earn credits for vaccinations. Supermarket and pharmacy chain Albertsons and its subsidiaries have a button on their covid vaccine information sites saying, "Transfer your prescription."

But the pandemic isn't business as usual, said Alison Taylor, a business ethics professor at New York University. "This is a public health emergency," she said. Companies distributing covid vaccines should ask themselves "How can we get society to herd immunity faster?" rather than "How many customers can I sign up?" she said.

In an email response, CVS said it had removed the reference to its rewards program from its covid vaccination page. Patients will not earn rewards for receiving a covid shot at its pharmacies, the company said, and its focus remains on administering the vaccines.

Albertsons said via email that its covid vaccine information pages are intended to be a one-stop resource, and information about additional services is at the very bottom of these pages.

Boston University's Clarke doesn't see any harm in these marketing activities. "As long as the patient is free to say 'no, thank you,' and doesn't think they'll be penalized by not getting a vaccine, it's not a problem," she said.

At least one health care provider is offering complimentary services to people eligible for covid vaccines. Membership-based primary care provider One Medical — now inoculating people in several states, including California — offers a free 90-day membership to groups, such as people 75 and older, that a local health department has tasked the company with vaccinating, according to an email from a company spokesperson who noted that vaccine supply and eligibility requirements vary by county.

The company said it offers the membership — which entails online vaccine appointment booking, second dose reminders and on-demand telehealth visits for acute questions — because it believes it can and should do so, especially when many are struggling to access care.

While these may very well be the company's motives, a free trial is also a marketing tactic, said Silicon Valley health technology investor Dr. Bob Kocher. Whether it's Costco or One Medical, any company offering a free sample hopes recipients buy the product, he said.

Offering free trial memberships could pay off for providers like One Medical, he said; local health departments can refer many patients, and converting a portion of vaccine recipients into members could offer a cheaper way for providers to get new patients than finding them on their own.

"Normally, there's no free stuff at a provider, and you have to be sick to try health care. This is a pretty unique circumstance," said Kocher, who doesn't see boosting public health and taking advantage of an uncommon marketing opportunity as mutually exclusive here. "Vaccination is a super valuable way to help people," he said. "A free trial is also a great way to market your service."

One Medical insisted the membership trial is not a marketing ploy, noting that the company is not collecting credit card information during registration or auto-enrolling trial participants into paid memberships. But patients will receive an email notifying them before their trial ends, with an invitation to sign up for membership, said the company.

Health equity advocates say more attention needs to be paid to the people who slip under the radar of marketers — yet are at the highest risk of getting and dying from covid, and the least likely to be vaccinated.

Kathryn Stebner, an elder-abuse attorney in San Francisco, noted that the high cost of many assisted living facilities is often prohibitive for the working class and people of color. "African Americans are dying [from covid] at a rate three times as much as white people," she said. "Are they getting these vaccine offers?"

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

Sarah Kwon: @skwonjournalist  

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