At a time when the vaccination campaign is slowing, side effects in young people pose a conundrum for public health officials.

This article was published on Thursday, June 17, 2021 in Kaiser Health News.

By Arthur Allen

Lucien Wiggins, 12, arrived at Tufts Children's Hospital by ambulance June 7 with chest pains, dizziness and high levels of a protein in his blood that indicated inflammation of his heart. The symptoms had begun a day earlier, the morning after his second vaccination with the Pfizer-BioNTech mRNA shot.

For Dr. Sara Ross, chief of pediatric critical care at the Boston hospital, the event confirmed a doubt she'd been nursing: Was the country pushing its luck by vaccinating children against COVID at a time when the disease was relatively mild in the young — and skepticism of vaccines was frighteningly high?

"I have practiced pediatric ICU for almost 15 years and I have never taken care of a single patient with a vaccine-related complication until now," Ross told KHN. "Our standard for safety seems to be different for all the other vaccines we expose children to."

To be sure, cases of myocarditis like Lucien's have been rare, and the reported side effects, though sometimes serious, generally resolve with pain relievers and, sometimes, infusions of antibodies. And a COVID infection itself is far more likely than a vaccine to cause myocarditis, including in younger people.

Lucien went home, on the mend, after two days on intravenous ibuprofen in intensive care. Most of the 800 or so cases of heart problems among all ages reported to a federal vaccine safety database through May 31 followed a similar course. Yet the pattern of these cases — most occurred in young males after the second Pfizer or Moderna shot — suggested that the ailment was caused by the vaccine, rather than being coincidental.

At a time when the vaccination campaign is slowing, leading conservatives are openly spreading disinformation about vaccines, and scientists fear a possible upsurge in cases this fall or winter, side effects in young people pose a conundrum for public health officials.

On Friday, the Centers for Disease Control and Prevention's vaccine advisory committee is set to meet to discuss the possible link and whether it merits changing its recommendations for vaccinating teenagers with the Pfizer vaccine, which the Food and Drug Administration last month authorized for children 12 and older. A similar authorization for the Moderna vaccine is pending, and both companies are conducting clinical trials that will test their vaccines on children as young as 6 months old.

At a meeting last week of an FDA advisory committee, vaccine experts suggested that the agency require the pharmaceutical companies to hold larger and longer clinical trials for the younger age groups. A few said FDA should hold off on authorizing vaccination of younger children for up to a year or two.

Interestingly, Lucien and his mother, Beth Clarke, of Rochester, New Hampshire, disagreed. Her son's reaction was "odd," she said, but "I'd rather him get a side effect [that doctors] can help with than get COVID and possibly die. And he feels that way, which is more important. He thinks all his friends should get it."

Data regarding COVID's impact on the young is somewhat messy, but at least 300 COVID-related deaths and thousands of hospitalizations have been reported in children under 18, which makes COVID's toll as large or larger than any childhood disease for which a vaccine is currently available. The American Academy of Pediatrics wants children to receive the vaccine, assuming tests show it is safe.

But healthy people under 18 have generally not suffered major COVID effects, and the number of serious cases among the young has tumbled as more adults become vaccinated. Unlike other pathogens, such as influenza, children are generally not infecting older, vulnerable adults. Under these circumstances, said Dr. Cody Meissner — who as chief of pediatric infectious diseases at Tufts consulted on Lucien's case — the benefits of COVID vaccination at this point may not outweigh the risks for children.

"We all want a pediatric vaccine, but I'm concerned about the safety issue," Meissner told fellow advisory commission members last week. An Israeli study found a five- to 25-fold increase in the heart ailment among males ages 16-24 who were vaccinated with the Pfizer shot. Most recovered within a few weeks. Two deaths occurred in vaccinated men that don't appear to have been linked to the vaccine.

Young people could experience long-term effects from the suspected vaccine side effect such as scarring, irregular heartbeat or even early heart failure, Meissner said, so it makes sense to wait until the gravity of the problem becomes clearer.

"Could the disease come back this fall? Sure. But the likelihood I think is pretty low. And our first mandate is do no harm," he said.

Ross said the biggest pandemic threats to children that her ICU has witnessed are drug overdoses and mental illness brought on by the shutdown of normal life.

"Young children are not the vectors of disease, nor are they driving the spread of the epidemic," Ross said. While eventually everyone should be vaccinated against COVID, use of the vaccines should not be expanded to children without extensive safety data, she said.

The government could authorize childhood vaccination against COVID without recommending it immediately, noted Dr. Eric Rubin, an advisory committee member who is editor-in-chief of the New England Journal of Medicine. "In September, when kids are back in school, people are indoors, and the vaccination rates are very low in certain parts of the country, who knows what things are going to look like? We may want this vaccine."

Moderna and Pfizer this summer began testing their vaccines in younger kids. A Pfizer spokesperson said the company expects to give about 2,250 children ages 6 months-11 years vaccine as part of its trial; Moderna said it would vaccinate about 3,500 children in the 2-11 age range.

Some members of the FDA advisory committee proposed that up to 10,000 kids be included in each trial. But Marion Gruber, leader of the FDA's vaccine regulatory office, pointed out that even trials that large wouldn't necessarily detect a side effect as rare as myocarditis seems to be.

At some point, federal regulators and the public must decide how much risk they are willing to accept from vaccines versus the risk of a COVID virus that continues to spread and mutate around the world, said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

"We're going to need a highly vaccinated population for years or perhaps decades," Offit said at the meeting. "It seems hard to imagine that we won't have to vaccinate children going forward."

Ross argued that it makes more sense to selectively vaccinate children who are most at-risk for serious COVID disease, such as those who are obese or have diabetes. Yet even to raise questions about the vaccination program can be a freighted decision, she said. While authorities have a duty to speak frankly about the safety of vaccines, there is also a responsibility not to frighten the public in a way that discourages them from seeking protection.

A 10-day pause in the Johnson & Johnson vaccination campaign in April, while authorities investigated a link to an occasionally fatal blood-clotting disorder, led to a major decline in public confidence in that vaccine, although as of late May authorities had detected only 28 cases among 8.7 million U.S. recipients of the vaccine. Because of the declining appetite for the Johnson & Johnson vaccine, millions of doses are in danger of passing their use-by date in refrigerators around the country.

Focusing too much attention on potential harms from the Pfizer and Moderna vaccines for children could have a tragic result, said Dr. Saad Omer, director of the Yale Institute for Global Health and an expert on vaccine hesitancy. "Very soon we could be in a situation where we really need to vaccinate this population, but it will be too late because you've already given the message that we should not be doing it," he said.

Eventually, perhaps next year, K-12 mandates might be called for, said Dr. Sean O'Leary, a professor of pediatric infectious diseases at the University of Colorado. "There's so much misinformation and propaganda spreading that people are reticent to go there, to further poke the hornet's nest," he said. But once there is robust safety data for children, "when you think about it, there's no logical or ethical reason why you wouldn't."

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

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

SpineFrontier allegedly paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.

This article was published on Thursday, June 17, 2021 in Kaiser Health News.

By Fred Schulte and Elizabeth Lucas

Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off.

Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines — generating $100 million for his company SpineFrontier, according to government officials.

Yet SpineFrontier's success arose not from the quality of its goods, these officials say, but because it paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.

In March 2020, the Department of Justice accused Chin and SpineFrontier of illegally funneling more than $8 million to nearly three dozen spine surgeons through "sham consulting fees" that paid them handsomely for doing little or no work. Chin had no comment on the civil suit, one of more than a dozen he has faced as a spine surgeon and businessman. Chin and SpineFrontier have yet to file a response in court.

Medical industry payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some of these transactions may violate federal anti-kickback laws, drive up healthcare spending and put patients at risk of serious harm, a KHN investigation has found. These payments come in various forms, from royalties for helping to design implants to speakers' fees for promoting devices at medical meetings to stock holdings in exchange for consulting work, according to government data.

Health policy experts and regulators have focused for decades on pharmaceutical companies' payments to doctors — which research has shown can influence which drugs they prescribe. But far less is known about the impact of similar payments from device companies to surgeons. A drug can readily be stopped if deemed harmful, while surgical devices are permanently implanted in the body and often replace native bone that has been removed.

Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year, the data shows.

"It is simply so much money that it is staggering," said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University Medical Center and critic of the medical device industry's influence. Much of the money is deemed to be compensation for consulting duties or medical research, or royalties for inventing, or fine-tuning, new surgical tools and techniques. In some cases, it pays for trips or splashy junkets or rewards surgeons for promoting products to their peers.

Device makers say the long-established practice leads to higher-quality, safer products. "Doctors help develop and refine medical devices, and they even create new devices themselves, sharing their intellectual property with companies to help save and improve patients' lives," said Scott Whitaker, president and CEO of AdvaMed, the medical technology industry's trade group.

But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants. Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Renner, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.

The case of Chin's company, SpineFrontier, is among more than 100 federal fraud and whistleblower actions, filed or settled mostly in the past decade, that accuse implant surgeons of taking illegal compensation from device makers — from surgeon entrepreneurs like Chin to marquee names like Medtronic and Johnson & Johnson. In some cases, device makers have paid hundreds of millions of dollars in fines to wrangle out of trouble for their involvement, often without admitting any wrongdoing.

Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019.

The names of hundreds more surgeons were redacted in court filings or sealed by judges.

Court filings named 35 spine surgeons who used SpineFrontier's surgical gear, some for years. At least six of those surgeons have admitted wrongdoing and paid a total of $3.3 million in penalties. Another has pleaded guilty to criminal charges. It's illegal under federal law to accept anything of value from a device maker for using its wares, though most offenders don't face criminal prosecution.

Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.

"There is a court date [for the DOJ case] as ordered by a judge," Chin said via email. "If we get to that point the facts of the case will be litigated."

Back Surgeries Under Scrutiny

The nation's outlay for spine surgery to treat back pain, or to replace worn-out knees and hips, tops $20 billion a year, according to one industry report.

Taxpayers shoulder much of that cost through Medicare, the federal program for those 65 and older, and Medicaid, which caters to low-income people.

In one common spinal procedure, surgeons may replace damaged discs with an implant and screws and metal rods that hold it in place. The demand for surgery to replace worn-out knees and hips also has mushroomed as aging boomers and others seek relief from joint pain that restricts their movement.

Perhaps not surprisingly, the competition for sales of orthopedic devices is fierce: Some 250 companies proffer a dizzying array of products. Industry critics blame the Food and Drug Administration, which allows manufacturers to roll out new hardware that is substantially equivalent to what already is sold — though it often is marketed as more durable, or otherwise better for patients.

"The money is just phenomenal for this medical hardware," said Dr. James Rickert, a spine surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group. He said most of the products are "essentially the same," adding: "These are not technical instruments; [it's often] just a screw."

Hospitals can end up charging patients $20,000 or more for the materials, though they pay much less for them. Spine surgeons — who make upward of $500,000 a year — bill separately and may charge $8,000 to $20,000 for major procedures.

Which equipment hospitals choose may fall to the preference of surgeons, who are wooed by manufacturing sales reps possibly present in the operating room.

And it doesn't stop there. Whistleblower cases filed under the federal False Claims Act allege a startling array of schemes to influence surgeons, including compensating them for joining a medical society created and financed by a device company. In other cases, companies bought billboard space or other advertising to promote medical practitioners, hired surgeons' relatives, paid for hunting trips — even mailed checks to their homes.

Orthopedic and neurosurgeons collected more than half a billion dollars in industry consulting fees from 2013 through 2019, federal payment records show.

These gigs are legal so long as they involve professional work done at fair market value. But they have drawn fire as far back as 2007, when four manufacturers that dominated the hip and knee implant market, including a J&J division, agreed to pay $311 million to settle charges of violating anti-kickback laws through their consulting deals.

KHN found at least 20 whistleblower suits, some settled, others pending, that have since accused device makers of camouflaging kickbacks as consulting work, including paying doctors to sit on suspect "advisory boards" or other activities that entailed little work to justify the fees.

In November 2019, device maker Life Spine and two of its executives admitted to paying consulting fees to induce dozens of surgeons to use Life Spine's implants in the operating room. In all, 21 of the top 30 Life Spine adopters were paid and they accounted for about half its total device sales, according to the Justice Department. Life Spine and the executives paid a total of $6 million in penalties. The company did not respond to requests for comment.

Similarly, SpineFrontier received "the vast majority" of its sales, more than $100 million worth, from surgeons who were compensated, the Justice Department alleges. Often, they were paid by way of a "sham" company run by Chin's wife, Vanessa, from a mail drop in Fort Lauderdale, according to the Justice Department. Vanessa Dudley Chin, a defendant in the DOJ civil case, had no comment.

Kingsley Chin told KHN via email that he takes no salary from SpineFrontier, based in Malden, Massachusetts. In 2013, Chin received $4.3 million in income from the company, according to court filings in a divorce case in Philadelphia from an earlier marriage. In 2018, SpineFrontier valued Chin's interest in the company at $75 million, according to government records, though its current worth is unclear.

SpineFrontier's management thought paying doctors was "the only reliable way to steadily increase its market share and stave off competition," Charles Birchall, a former business associate of Chin's, alleged in a whistleblower complaint. The case is one of two whistleblower suits filed against SpineFrontier that the DOJ has joined and consolidated. Chin has yet to file a response in court.

From March 2013 through December 2018, the company offered some surgeons $500 or more an hour for "consulting," which could include the time they spent operating on patients — even though they already were being paid by Medicare or other health insurers. Other surgeons were paid repeatedly to "evaluate" the same products, though their feedback was "often minimal or nonexistent," according to the DOJ complaint.

Patient Injuries Pile Up

While the payments have piled up for doctors, so have injuries for patients, according to lawsuits against device makers and whistleblower testimony.

Orthopedic surgeon-turned-whistleblower Dr. Manuel Fuentes is suing his former employer, Florida device maker Exactech, alleging it offered "phony" consulting deals to surgeons who had complained about alarming defects in one of its knee implants.

Their findings should have been forwarded to the FDA to protect the public, Fuentes and two former Exactech sales reps alleged in their suit. Instead, the company paid the surgeons "to retain their business and secure their silence" about patients needlessly undergoing a second operation to address the defects implanted in the first, according to the suit. Lawyer Thomas Beimers, who represents Exactech in the case, said the company "emphatically denies the allegations and looks forward to presenting the real facts to the court." In a court filing, the company said the suit was "full of conclusory, vague and immaterial facts" and said it should be dismissed.

In Maryland, spine surgeon Dr. Randy F. Davis faces a lawsuit filed in early 2020 by 14 former patients who claim he implanted counterfeit hardware from a device distributor that had paid him hundreds of thousands of dollars in consulting fees and other compensation.

Davis used the hardware, which had not been FDA-approved, on about 250 patients at the University of Maryland Baltimore Washington Medical Center in Glen Burnie, Maryland, according to the suit. Several patients say screws or other implants failed and they sustained permanent injuries as a result. One woman said she was left with little feeling in her right foot and needs a cane or walker to get around. Others claim "extreme mental anguish" for fear the hardware inside them will fail, according to the suit.

The patients allege that Davis improperly disposed of defective screws and other hardware he removed rather than send the items for analysis or report the failures to authorities. Instead, the University of Maryland hospital sent "hush" letters to patients that falsely told them that no defects had been found, according to the suit. A spokesperson for the hospital, which also is a defendant in the suit, denied the allegations, noting: "We will vigorously defend this lawsuit and at its conclusion are quite confident we will prevail." Davis and his lawyer didn't respond to repeated requests for comment. The lawsuit is pending in Anne Arundel County state court.

Surgeons are free to implant devices they helped bring to market or promoted, though doing so can prompt criticism when injuries or defects occur.

That happened when three patients filed lawsuits in 2018 against Arthrex, a Florida device company. The patients argued they were forced to undergo repeat operations to replace defective Arthrex knee devices implanted by Pennsylvania orthopedic surgeon Dr. Thomas Meade.

Meade was not a defendant in the cases. But the patients accused him of misleading them about the product's safety and a recall. One noted that Meade had served as a prominent consultant to Arthrex and had "participated in the design, testing, marketing, promotion and sales" of the knee implant. The patient alleged that Arthrex had paid Meade more than $250,000 for work that included "promotional speaking, travel, lodging, and consulting."

In court filings, Arthrex admitted making payments to Meade for "consulting and royalties" but denied wrongdoing. The cases were settled in 2020. Meade did not respond to requests for comment.

Chin's dual roles as SpineFrontier's CEO and user of its hardware was called a "huge" conflict of interest by a judge in a pending malpractice case filed against him and the company in South Florida.

In that case, Miami resident Patrick Chapoteau alleges Chin performed back surgery in 2014 using SpineFrontier hardware even though it had little chance of success. According to the suit, a Chin-designed screw implanted to stabilize Chapoteau's spine broke in half, causing him pain and disabling injuries.

In a legal brief, Chin's lawyers argued that he regularly operates on people with disabling back problems, noting: "The surgery is sophisticated and challenging. On a few rare occasions, his patients have not obtained the relief they expected or experienced unanticipated complications that required additional care."

Joseph Wooten, a former Chin patient and Florida power company employee, alleged in a 2014 lawsuit in Broward County Circuit Court that Chin had 15 previous malpractice claims that had ended in more than $8 million in settlements, an assertion Chin's lawyers disputed.

"He never told me of his bad record injuring people," Wooten, 64, wrote in a court filing. He and his wife, Kim, said the surgery caused "debilitating and life-altering injuries." The case has since been settled. Chin acknowledged no wrongdoing and the terms are confidential.

KHN reviewed court pleadings in nine settled malpractice cases in Philadelphia, where Chin served on the faculty of the University of Pennsylvania Medical School from 2003 to 2007, and six in South Florida filed since 2012. Details of the settlements are confidential. Five of the six South Florida cases are pending, including one filed in December by the widow of a man who died shortly after spine surgery. In all the cases and settlements, Chin has denied negligence.

In her lawsuit pending against Chin in South Florida, Nancy Lazo of Hialeah Gardens, Florida, said she slipped and tumbled down the stairs outside her Miami office, landing on her back and arm. When the pain would not go away, she turned to Chin and had two operations, in 2014 and 2015. Her lawyers allege that a SpineFrontier screw Chin implanted in her spine in the second procedure caused nerve damage. Lazo, 51, a former billing clerk with two adult sons, said she can no longer work and remains in "constant" pain. "Based on what my doctors have told me," she said, "I will never get back to normal." Chin denied any negligence and the case is pending.

Government Struggles to Keep Pace

Concerns that industry payments can corrupt medical practice have been aired repeatedly at congressional hearings, in media exposés and in federal investigations. The recurring scandals led Congress to require that device makers and pharmaceutical companies report the payments, starting in August 2013, to a government-run website called Open Payments. That website shows that payments to all doctors have risen from $8.6 billion in 2014 to just over $10 billion last year. A recent study found payments by device makers exceeded those of pharmaceutical companies by a wide margin.

Both the North American Spine Society and the American Academy of Orthopaedic Surgeons told KHN that close ties with the industry, while seeming to generate huge payouts to some surgeons, lead to the design of safer and better implants. "These interactions are really essential for good outcomes in patient care and that needs to be preserved," said Dr. Joshua J. Jacobs, who chairs the orthopedic surgery department at Rush University Medical Center in Chicago and the AAOS' ethics committee.

Although more than 600,000 American doctors lap up industry largesse, most do so through small payments that cover the cost of food, drinks and travel to industry-sponsored events. When it comes to big money, however, orthopedists and neurosurgeons dominate, collecting 25% of the total — even though they represent only 5% of the doctors accepting payments, according to the KHN analysis of Open Payments data.

Dr. Charles Rosen, a spine surgeon and co-founder of the advocacy group Association for Medical Ethics, said he was once offered $2,000 just to show up and watch an industry-sponsored panel. "It was quite unbelievable," he said.

Rosen said while he believes a "relatively small number" of surgeons cash whopping industry checks, many who do so are influential figures who can "help direct medical care."

Government data confirms that even as several orthopedic and neurosurgeons received tens of millions of dollars in 2019, 81% of them got less than $5,000 from industry.

Federal officials recently signaled their displeasure with the hefty fees paid to doctors who promote their products to peers, especially at restaurants, entertainment or sports venues that feature free food and booze but little educational content. In November, the inspector general at the Department of Health and Human Services issued a special fraud alert that such gestures could violate anti-kickback laws.

Companies that ignore the reporting law can be fined up to $1 million, though no fines were levied from 2014 through spring 2020, according to a CMS report. That changed in October, when device giant Medtronic agreed to pay the government $9.2 million to settle allegations that it paid kickbacks to Sioux Falls, South Dakota, neurosurgeon Dr. Wilson Asfora to promote its goods. Officials said the company sponsored more than 100 events at a Brazilian restaurant owned by the surgeon to clinch the sales. Just over $1 million of the fine was assessed for failing to report the transactions. A Medtronic spokesperson said the company fired or took other disciplinary action against the sales employees involved and "remains committed to maintaining the highest standards of ethical conduct."

KHN identified four spinal device makers — including SpineFrontier — that have been accused in whistleblower cases of scheming to hide consulting payments from the government.

Responding to written questions, a CMS spokesperson said the agency "has multiple formal compliance actions pending which it is unable to discuss further at this time."

But penalties for paying, or accepting, kickbacks often are small compared with the profits they can generate.

"Some people would say if you penalize companies enough, they won't be making these offers," said Genevieve Kanter, an assistant professor at the University of Pennsylvania Perelman School of Medicine. She said small fines may be chalked up to the "cost of doing business."

The Federation of State Medical Boards does not keep data on how often its members discipline doctors for civil kickback offenses, according to spokesperson Joe Knickrehm. The federation has "long advocated for stronger reporting requirements," Knickrehm said.

Justice Department officials would not discuss whether they are seeking fines from more surgeons. But in a statement in April 2020, then-U.S. Attorney for the District of Massachusetts Andrew E. Lelling noted that the government will investigate any doctor "who accepts money from a device manufacturer simply for using that company's products."

Fred Schulte: fschulte@kff.org, @fredschulte  Elizabeth Lucas: elucas@kff.org, @eklucas

Most people are unaware of a FEMA program that offers up to $9,000 to funeral expenses of COVID victims.

This article was published on Wednesday, June 16, 2021 in Kaiser Health News.

By Heidi de Marco

As a funeral director at Ingold Funeral and Cremation in Fontana, California, Jessica Rodriguez helps families say goodbye to their loved ones. "We serve predominantly Latino families, most of them second- and third-generation" residents, said Rodriguez. "We do have quite a few that are first-generation, that don't speak any English."

Most are unaware of a federal program that offers up to $9,000, she said. And even when they know about the aid from the Federal Emergency Management Agency, the process is daunting and the bureaucracy confusing. The lack of English skills hinders some families of people who died of COVID from receiving reimbursement from FEMA for funeral expenses, so her office offers them help in Spanish.

Rodriguez herself is one of the applicants. "My father passed away from COVID. That's why I really wanted to push the program," she said. "I know firsthand what it's like to have to come up with that type of money without having planned to do so."

Rodriguez said her funeral home, in a city where nearly 70% of its 215,000 residents are Latino, kept a running list since the start of the pandemic of all of the deceased they took care of who died of COVID. "Originally, the reason we compiled a list was to see the impact," she said. "But when FEMA first announced the funeral assistance program, we made it a point to call every family that was on that list and let them know about it."

As of Monday, FEMA has approved more than $278 million for more than 41,000 eligible applicants, with the average amount per application standing at $6,756. FEMA said it does not consider ethnicity when determining eligibility, so the agency does not track that data.

Offering clients help to get some of that money is important because California's Latinos suffered more COVID deaths than any other race or ethnic group and the Latino population has faced a greater risk of exposure to COVID-19 and undergone testing at a lower rate, according to a study by Stanford University researchers. Latinos are also far more likely than non-Hispanic whites to live in a household with an essential worker, who might not have had the luxury of protecting themselves at home during the ravaging months of the pandemic.

"In my career of 35 years, I've never been in this type of situation where I have seen so much death," said Rafael Rodriguez, a funeral director in the city of Bell at Funeraria del Angel Bell, part of Dignity Memorial.

The cost of an average funeral can be as much as $15,000, he said, so the FEMA reimbursement program offers financial relief for many clients. But it isn't easy to get the money.

Rodriguez and the funeral home's office manager, Norma Huerta, said they have been receiving calls daily from people confused about how to apply. "These are humble people who don't have access to the internet or know how to use a computer," said Huerta. "They already trust me since I helped them with the funeral process. How could I say no?"

Even though the FEMA helpline offers instructions in Spanish, uploading, emailing or even faxing the necessary documents has been a challenge, said Huerta. "I can spend three to four hours a day helping families with their applications." Just sending over a fax cover sheet is frustrating, she said. "I tell them it takes a while, but to have patience and I'll help them get it done."

Families call to request duplicate contracts and receipts and ask for clarification about death certificates. The hardest part for some has been proving their family member's death was COVID-related, said Huerta. If the death certificate doesn't specifically state that, they won't qualify. Death certificates can be amended to receive reimbursement, but that process is also complicated and time-consuming.

Manuela Galvez, a 61-year-old originally from Sinaloa, Mexico, is one of the applicants Huerta helped. She lost her son Luis Alberto Vasquez to COVID on April 22, 2020. The 36-year-old managed a cleaning crew that disinfected assisted living facilities, which is where Galvez suspects her son got COVID.

Galvez said she heard about the FEMA checks from family members but didn't understand the process. "Norma did me a huge favor filling out that paperwork," Galvez said in Spanish. "I wouldn't have been able to do it myself because I'm completely lost when it comes to technology."

Those who need help the most are the most disconnected, said Rafael Fernández de Castro Medina, director of University of California-San Diego's Center for U.S.-Mexican Studies. "Many times they are people who not only don't speak English, but at times, don't even speak Spanish well," said Medina. "Like people who come from Yucatán who speak Maya."

Isaias Hernandez, executive director of Eastmont Community Center in East Los Angeles, said many of the people asking him for help feel overwhelmed by the process. "Most have never buried a loved one, so they're emotional and still dealing with the trauma," said Hernandez. "Just gathering the documents seems complicated to them."

Undocumented immigrants and those who hold temporary visas are not eligible for FEMA's funeral assistance, even though advocates like Hernandez say these are the people who kept the country afloat during the pandemic. "They work in the grocery stores, the day cares and schools," he said. "They're the essential workers." Hernandez said his office has received only a few calls from people inquiring about legal-status qualifications.

He said it's not just about having access to technology, but also access to people who can support them. "People in our community are extremely dependent on the younger generation who can help them navigate basic computer functions," he said.

For Galvez, that person was her late son, Luis Alberto. "He was the one who was the most patient with me," she said.

Galvez is waiting to hear back from FEMA on whether she qualifies to be reimbursed for the $5,400 she spent on her son's funeral. "If they can't give me any money, that's OK," said Galvez. "It's help they're offering that I wasn't expecting to get anyway. It's in God's hands."

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

Heidi de Marco: heidid@kff.org, @Heidi_deMarco

The biggest impact you can have is persuading friends and loved ones to get the vaccine – and then urging them to persuade others.

This article was published on Tuesday, June 15, 2021 in Kaiser Health News.

By Bernard J. Wolfson

For more than a year, public health officials have repeatedly told us that masks save lives. They've warned us to keep our distance from our neighbors, who've morphed into disease vectors before our eyes.

Now they are telling us that if we're vaccinated, we no longer need to wear masks or physically distance ourselves in most cases — even indoors. To many people, myself included, this seems hard to reconcile with so many long months of masking and physical distancing and sacrificing our social lives for fear of COVID-19.

What is an anxious, pandemic-weary (and wary) soul to do?

First, it's important to stress that the dramatic rollback of mask-wearing and physical distancing recommended last month by the Centers for Disease Control and Prevention — a policy California has adopted starting Tuesday as part of a broader reopening — applies only to people who have been fully vaccinated.

Even if you are vaccinated, though, you don't need to change your behavior one iota if doing so makes you uncomfortable.

"Nothing in the CDC guidelines says to stop wearing a mask," says Dr. José Mayorga, executive director of the UCI Health Family Health Centers. "It's a recommendation, but if you choose to wear one, that's OK. You shouldn't be stigmatized."

Mayorga has lost five relatives to COVID, including a favorite aunt, and he knows from personal experience how hard it can be to rush back into so-called normalcy.

"Many people have not been directly impacted by COVID," he says. "But for those of us who have been, it's natural to have concern or fear, thinking, 'Oh, I can take my mask off? But is it really safe?'"

Some people are just cautious by nature and won't be rushing to jettison their masks and rub elbows with unmasked strangers. "I know that, realistically, I can do pretty much anything once I'm fully vaccinated, but mentally it's scary," says 36-year-old Sacramento resident Shannon Albers, who got her second dose of the Pfizer vaccine on May 27. "It's going to be weird, after a year of them drilling into us 'Wear a mask, wear a mask, wear a mask,' to be around a bunch of people who aren't wearing masks."

Early in the pandemic, the CDC said masks were not necessary. Then, it changed its guidance so emphatically that masks became an indispensable part of our wardrobes. Now the advice has changed again.

"For scientists, it is very understandable that there is this revision of recommendations based on new research," says Roxane Cohen Silver, a professor of psychology, public health and medicine at the University of California-Irvine. "But for the general public, that could sound very confusing."

Early on, many people feared catching the coronavirus from surfaces and even disinfected groceries before putting them away. Now, the virus is believed to spread mainly through the air, and the notion of spraying or wiping down everything you bring into the house seems silly.

We don't know how long the vaccines' protection lasts, but it is increasingly clear that being vaccinated reduces the risk of infecting others.

"Vaccinated people have very little risk of infection; they can do what they want to do," says Dr. George Rutherford, a professor of epidemiology at the University of California–San Francisco. "I think we're in pretty good shape, and I think it's going to be pretty much a disease-free summer."

In California, the rate of positive COVID tests has dropped from a seven-day average of over 17% in early January, at the peak of the winter surge, to under 1% now. The number of hospitalized COVID patients statewide has fallen from over 22,000 to below 1,300 in the same period.

Around 46% of Golden State residents have been fully vaccinated, lagging behind numerous other states but ahead of the national rate of just under 43%. Some millions more have built up immunity after a COVID infection.

As more people get protection, the COVID virus finds fewer susceptible bodies, further reducing transmission and producing a downward spiral in the number of cases.

If you are indoors with other people you know to be vaccinated, you can dispense with masks. Want to cook dinner for a group of vaccinated friends you haven't seen for several months? Carpe diem — and don't worry about wearing masks or sitting spaced apart.

But if you are in a mixed crowd — say, a grocery store — and don't know who's vaccinated, wear a mask, even though your personal risk is low. If the workers are wearing masks, it's a matter of respect to wear one yourself. Some people may be nervous about being there — those who are immune-compromised, for example, or can't get vaccinated for some other health reason — and they won't know if you've had your shots.

"Forget about the medical benefit," says Bradley Pollock, associate dean for Public Health Sciences at the UC-Davis School of Medicine. "If you are wearing a mask, people who are not vaccinated don't need to feel uncomfortable around you. So, it's kind of a courtesy issue."

The presence of children is another good reason to mask up. Most kids ages 12 to 16 haven't been vaccinated yet, and those under 12 can't be, yet. They'll probably have to wear masks in school this fall.

And though children have not been hit by COVID nearly as hard as adults, and are not efficient transmitters of the virus, thousands of kids have been hospitalized with it nonetheless — including about 4,000 nationwide diagnosed with a frightening multisystem inflammatory syndrome.

Mayorga, who is fully vaccinated and has young children, says he wears a mask "to protect them and to model good behavior."

Public health experts agree that vaccinating as many people as possible, including children, is the way out of the pandemic.

But the rate of vaccinations has slowed recently. One of the biggest contributions you can make to the public good right now is to get vaccinated — and help others do the same.

Some people aren't vaccinated because they lack mobility and can't get to an appointment. Check in with elderly neighbors, and if they haven't been vaccinated and need a ride, offer to drive them. You can also check with your local department on aging, community groups that serve the elderly, public health agencies or hospitals to ask if they are seeking drivers.

Perhaps the biggest impact you can have is persuading friends and loved ones to get the vaccine – and then urging them to persuade others.

If they think the vaccines were rolled out too fast to be safe, tell them that related coronavirus vaccine research has been going on for more than a decade. Point out that hundreds of millions of COVID shots have now been given and serious side effects are rare — and are being carefully monitored by officials.

You might also need to rebut the widespread notion that the vaccine could suddenly produce some terrible, unforeseen health impact a few years down the road. "That just doesn't happen," Pollock says.

Expect to encounter resistance at first, but be persistent. It can take numerous conversations to assuage anxieties, but your close friends will listen.

"If your best friend tells you they did this, that's highly influential — more than some talking head," Pollock says.

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

Bernard J. Wolfson: bwolfson@kff.org, @bjwolfson