Health Industry

Organ Centers to Transplant Patients: Get a Covid Shot or Move Down on Waitlist

A Colorado kidney transplant candidate who was bumped to inactive status for failing to get a covid-19 vaccine has become the most public example of an argument roiling the nation’s more than 250 organ transplant centers.

Across the country, growing numbers of transplant programs have chosen to either bar patients who refuse to take the widely available covid vaccines from receiving transplants, or give them lower priority on crowded organ waitlists. Other programs, however, say they plan no such restrictions — for now.

At issue is whether transplant patients who refuse the shots are not only putting themselves at greater risk for serious illness and death from a covid infection, but also squandering scarce organs that could benefit others. The argument echoes the demands that smokers quit cigarettes for six months before receiving lung transplants or that addicts refrain from alcohol and drugs before receiving new livers.

“It is a matter of active debate,” said Dr. Deepali Kumar, an expert in transplant infectious diseases at the University of Toronto and president-elect of the American Society of Transplantation. “It’s really an individual program decision. In many programs, it’s in flux.”

Leilani Lutali, 56, a late-stage kidney disease patient from Colorado Springs, Colorado, learned in a Sept. 28 letter from UCHealth in Denver that if she didn’t begin a covid vaccine series within 30 days, she would lose her spot on the transplant waiting list. Both she and her living donor, Jaimee Fougner, 45, of Peyton, Colorado, refused to get vaccinated, citing religious objections and uncertainty about the safety and effectiveness of the vaccines.

Kidney patient Leilani Lutali (left) of Colorado Springs, Colorado, was placed on inactive status on a kidney transplant waiting list at UCHealth in Denver for refusing to get vaccinated against covid-19. Lutali and her would-be living donor, Jaimee Fougner, of Peyton, Colorado, are asking Texas transplant centers to consider performing the operations. (Jaimee Fougner)

“I have too many questions that remain unanswered at this point. I feel like I’m being coerced into not being able to wait and see and that I have to take the shot if I want this lifesaving transplant,” Lutali said.

She said she offered to be tested for covid before the surgery or to sign a waiver absolving the hospital of legal risk for her refusal of the vaccine. “At what point do you no longer become a partner in your own care regardless of your own concerns?” she said.

Lutali now hopes to take her transplant quest to Texas, where several hospitals, including Houston Methodist and Baylor University Medical Center in Dallas, said they don’t require covid vaccinations to approve active candidates for the national waiting list.

The difference between policies in Denver and Dallas — and elsewhere — underscore a tense national divide. As of late April, fewer than 7% of transplant programs nationwide reported inactivating patients who were unvaccinated or partially vaccinated against covid, according to research by Dr. Krista Lentine, a nephrologist at the Saint Louis University School of Medicine.

But that was just a snapshot in late spring, and like all covid-related practices, it’s “rapidly changing,” Lentine said.

UCHealth in Denver began requiring covid vaccinations for transplant patients in late August, citing the American Society of Transplantation’s August recommendation that “all solid organ transplant recipients should be vaccinated against SARS-CoV-2.”

Patients who undergo transplant surgery have their immune systems artificially suppressed during recovery, to keep their bodies from rejecting the new organ. That leaves unvaccinated transplant patients at “extreme risk” of severe illness if they are infected by covid, with mortality rates estimated at 20% to 30%, depending on the study, Dan Weaver, a spokesperson for UCHealth said. For the same reason, transplant patients who receive covid vaccines after surgery may fail to mount a strong immune response, research shows.

UW Medicine in Seattle began mandating covid vaccines this summer, said Dr. Ajit Limaye, director of the solid organ transplant infectious diseases program. Patients were already required to meet other stringent criteria to be considered for transplantation, including receiving inoculations against several illnesses, such as hepatitis B and influenza.

“For anyone who does not have a medical contraindication, basically, we’re requiring it,” he said. “There’s a very strong sense to make it a requirement, like all the other hoops, straight up.”

By contrast, Northwestern Medicine in Chicago, where doctors performed the first double-lung transplant on a covid patient in June 2020, is encouraging — but not requiring — vaccination against the pandemic disease.

“We don’t decline care of transplant based on vaccine status,” said Jenny Nowatzke, Northwestern’s manager of national media relations. “The patient also doesn’t get any lower scores.”

The lack of consistent practice across programs sends a mixed message to the public, said Dr. Kapilkumar Patel, director of the lung transplant program at Tampa General Hospital in Florida, where covid vaccines are not required.

“We mandate hepatitis and influenza vaccines, and nobody has an issue with that,” he said. “And now we have this one vaccination that can save lives and make an impact on the post-transplant recovery phase. And we have this huge uproar from the public.”

Nearly 107,000 candidates are waiting for organs in the U.S.; dozens die each day still waiting. Transplant centers evaluate which patients are allowed to be placed on the national list, taking into account medical criteria and other factors like financial means and social support to ensure that donor organs won’t fail.

“We really make all kinds of selective value judgments,” said Dr. David Weill, former director of Stanford University Medical Center’s lung and heart-lung transplant program who now works as a consultant. “When we’re selecting in the committee room, I hear the most subjective, value-based judgments about people’s lives. This is just another thing.”

The centers can choose to place candidates on inactive status for a variety of reasons, including medical noncompliance, according to data from the United Network for Organ Sharing, which oversees transplants. As of Sept. 30, that category accounted for 738 of more than 47,000 registrants waiting in inactive status, though it’s not clear how many are tied to vaccination status.

A particularly thorny question involves unvaccinated people who need transplants specifically because covid infections destroyed their organs. As of late September, more than 200 lungs, as well as at least six hearts and two heart-lung combinations, had been transplanted for covid-related reasons in the U.S., according to UNOS data.

Many of those organs were transplanted earlier in the pandemic, before any covid vaccine was widely available. That’s no longer the case, Weill said. “If you’re just now getting vaccinated, you’ve done it at gunpoint, actually,” he said. “It’s not just a personal choice; they’re making some kind of a statement.”

Such patients are usually younger and healthier than other transplant candidates, aside from the covid-related damage, and they’re often acutely ill enough to go to the top of any transplant list. “The sick covid patient might go ahead of the stable cystic fibrosis patient,” Weill said.

Tampa General’s Patel said he performed a lung transplant on a patient who was transferred to Florida after being delisted at another center because he wasn’t vaccinated for covid. “I mandated with him basically on a handshake that he will get his vaccine post-transplant,” Patel said. “But his family? They haven’t agreed.”

Eventually, Patel said, he thinks nearly all transplant programs will mandate covid vaccination, largely because transplant centers are evaluated on the longer-term survival of their patients.

“I think it’s going to spread like wildfire across the country,” he said. “If you start losing patients in a year due to covid, it will be mandated sooner rather than later.

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Pfizer Court Fight Could Legalize Medicare Copays and Unleash ‘Gold Rush’ in Sales

Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.

By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.

Now Pfizer is suing Uncle Sam to legalize essentially the same practice it was accused of three years ago — a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices.

A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge’s ruling is expected any day.

“If this is legal for Pfizer, Pfizer will not be the only pharmaceutical company to use this, and there will effectively be a gold rush,” government lawyer Jacob Lillywhite said in oral arguments last month.

Pfizer’s legal argument “is aggressive,” said Chris Robertson, a professor of health law at Boston University. “But I think they’ve got such a political tailwind behind them” because of pocketbook pain over prescription medicine — even though it’s caused by pharma manufacturers. Pfizer’s message, “‘We’re just trying to help people afford their drugs,’ is pretty attractive,” he said.

That’s not all that’s working in Pfizer’s favor. Courts and regulations have been moving pharma’s way since the Food and Drug Administration allowed limited TV drug ads in the 1980s. Other companies of all kinds also have gained free speech rights allowing aggressive marketing and political influence that would have been unthinkable decades ago, legal scholars say.

Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.

“It’s infuriating to realize that, as outlandish as they seem, these types of claims are finding a good deal of traction before many courts,” said Michelle Mello, a professor of law and medicine at Stanford University. “Drug companies are surely aware that the judicial trend has been toward more expansive recognition of commercial speech rights.”

Pfizer’s lawsuit, in the Southern District of New York, seeks a judge’s permission to directly reimburse patient expenses for two of its heart-failure drugs each costing $225,000 a year. An outside administrator would use Pfizer contributions to cover Medicare copays, deductibles and coinsurance for those drugs, which otherwise would cost patients about $13,000 a year.

Letting pharma companies put money directly into patients’ pockets to pay for their own expensive medicines “does induce people to get a specific product” instead of shopping for a cheaper or more effective alternative, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University. “It’s kind of the definition of a kickback.”

Government rule-makers have warned against such payments since the launch of Medicare’s Part D drug benefit in 2006. Drug companies routinely help privately insured patients with cost sharing through coupons and other means, but private carriers can negotiate the overall price.

Because Congress gave Medicare no control over prescription drug prices, having patients share at least part of the cost is the only economic force guarding against unlimited price hikes and industry profits at taxpayer expense.

At the same time, however, regulators have allowed the industry to help patients with copays by routing money through outside charities — but only as long as the charities are “bona fide, independent” organizations that don’t match drugmaker money with specific drugs.

Several charities have blatantly violated that rule in recent years by colluding with pharma companies to subsidize particular drugs, the Justice Department has alleged. A dozen companies have paid more than $1 billion to settle allegations of kickback violations.

Pfizer set up an internal fund at one of the charities, the Patient Access Network Foundation, to cover patient costs for a heart arrhythmia drug at exactly the same time it was raising the wholesale cost from $220 to $317 for a package of 40 capsules, the Justice Department said. Pfizer referred Medicare patients who needed the drug to the PAN Foundation, the government said.

Under such arrangements, every $1 million channeled through a charity “has the potential to generate up to $21 m[illion] for the sponsor company, funded by the U.S. government,” Andrew Baum, a Citi pharma stock analyst, wrote in 2017.

Pfizer settled the case, saying it was not an admission of wrongdoing but resulted from its “desire to put this legal matter behind us.”

The PAN Foundation and three other charities also made deals to resolve allegations that they functioned as disallowed conduits for patient assistance for multiple pharma companies. One organization, the Virginia-based Caring Voice Coalition, shut down after government scrutiny.

PAN’s settlement did not mention the alleged Pfizer transactions. Those were described in the separate government deal with Pfizer.

The 2019 PAN agreement related to “legacy matters” and “did not involve any of PAN’s current operations or disease funds,” organization CEO Dan Klein said via a spokesperson. “Nonprofit patient assistance programs like PAN are necessary to help people access the critical medications they need to stay healthy.”

But legal troubles have hardly slowed the pharma-funded patient assistance business.

Four penalized nonprofits agreed to stop directing money to specific drugs, but they continue to accept hundreds of millions of dollars in pharma donations to indirectly cover copays and other patient drug costs, organization reports and IRS filings show. HHS regulators allow the practice because the drug companies are not involved in deciding which patients and which drugs are subsidized.

Donations to six pharma-funded patient assistance charities reached $1.8 billion in 2019, only slightly less than the year before, a KHN analysis of their IRS filings shows. That was nearly 50% higher than the amount from five years previously, before the Justice Department started cracking down.

Last year Pfizer donated $39.7 million to PAN and five other charities helping patients with out-of-pocket drug costs, company disclosures show.

If Pfizer’s lawsuit seeking to earmark such donations for its tafamidis heart-failure drugs opens the way for similar practices industrywide, it would drive up Medicare costs through rising prices and numbers of prescriptions, said Gerard Anderson, an economist and health policy professor at Johns Hopkins University’s Bloomberg School of Public Health. Such a program for tafamidis alone would increase Medicare costs by $30 billion, the Health and Human Services Department’s inspector general estimated.

Pharma companies can “learn which patients are using the drug, and they can market [and offer financial assistance] directly to that patient,” Anderson said. “You get a huge return.”

Pfizer argues that its proposal, which the HHS inspector general called “highly suspect” in an advisory opinion before the company filed its lawsuit, is legal and sensible.

“Providing copay assistance to middle-income patients who have been prescribed tafamidis is an efficient and equitable way to lower their out-of-pocket costs,” company spokesperson Steven Danehy said.

But the real affordability problem for patients is that tafamidis is too expensive, federal attorney Lillywhite said in court arguments last month. (HHS’ Office of Inspector General declined to comment.)

Pfizer has “priced itself out of the market,” he said. The company is seeking to “do something that’s unprecedented, to upend decades of settled law and agency guidance” to boost sales of “what is the most expensive cardiovascular drug ever launched in the United States.”

After the oral arguments, Pfizer dropped claims that HHS rules violate its free speech rights. Judge Mary Kay Vyskocil is considering only the company’s contention that a dedicated fund for tafamidis would not violate kickback prohibitions because, among other arguments, it is the doctor who decides to prescribe the drug and create revenue for Pfizer, not the patient getting the financial assistance.

But legal analysts still see the case as part of a broad movement toward deregulation and corporate rights.

A 1970s Supreme Court case, viewed as paving the way for an explosion of drug, lawyer and liquor ads as well as corporate campaign donations, was about speech rights for prescription drug sellers in Virginia. In 2011 the court found that the First Amendment allows data miners to buy and sell prescription records from pharmacies, provided the patients aren’t identified.

A year later, a federal appeals court cited speech protections when it overturned the conviction of a pharma sales rep who had been promoting a drug for uses not approved by the FDA.

Even if Pfizer loses its case, the climate may be ripe for similar challenges by other drugmakers, especially after the appointment of more than 200 federal judges by business-friendly President Donald Trump, legal scholars said.

The federal kickback law doesn’t mention copay assistance charities “and wasn’t designed with these programs in mind,” said Mello, of Stanford. Pfizer’s lawsuit “should be a loud, clanging call to Congress” to explicitly define drug assistance subsidies as illegal kickbacks, she said.

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The Hard Realities of a ‘No Jab, No Job’ Mandate for Health Care Workers

Christopher Richmond keeps a running tab on how many workers at the ManorCare skilled nursing facility he manages in western Pennsylvania have rolled up their sleeves for a covid-19 vaccine.

Although residents were eager for the shots this year, he’s counted only about 3 in 4 workers vaccinated at any one time. The excuses, among its staff of roughly 100, had a familiar ring: Because covid vaccines were authorized only for emergency use, some staffers worried about safety. Convenience mattered. In winter, shots were administered at work through a federal rollout. By spring, though, workers had to sign up online through a state program — a time-sucking task.

ManorCare urges every worker to be immunized against covid but turnover has vexed that effort. Managers at ProMedica, a nonprofit health system that operates ManorCare and senior care facilities in 26 states, faced a workforce conundrum familiar to all manner of providers during the pandemic: how to persuade essential workers to get vaccinated — and in a way that didn’t drive them away. Raises and bonuses, costing millions of dollars, did not move the needle to 100%.

Animus toward the vaccine created turmoil for some providers. Dr. Eric Berger, a pediatrician in Philadelphia who opened his practice more than a dozen years ago, enforced mandatory shots in May and saw six of his 47 staff members walk out. Berger said he worked for months to educate resistant workers. In April, he learned that several, women in their 20s and 30s, had attended a private karaoke party. Within days, four staffers were infected with covid.

Berger, who had seen in-office costs for protective equipment soar, then set a deadline for shots. He looks back with steely resolve over the last-minute “I quit” texts he received — and the hassle of finding a new receptionist and billing and medical assistants.

“Fortunately, we had some wonderful people who put in extra time,” he said. “It’s been stressful, but I think we did the right thing.”

Brittany Kissling, 33 and a mother of four, was one of the hesitant workers at Berger’s practice who decided — largely for financial reasons — to get vaccinated. The clinic manager couldn’t afford to lose her job. But she said she was nervous and that most of the workers who left recoiled at being told vaccinations were not negotiable. “I was a no-show my first time,” Kissling said about her first vaccine appointment. “I was scared. There were a lot of unknowns.”

But Kissling said Berger’s practice has spent “thousands and thousands and thousands of dollars” on masks and even paid workers for five days a week when they worked only two during the pandemic’s worst months. She said she understood how and why the karaoke episode prompted a mandate. “I get it from the business side,” said Kissling, about the requirement. “I do think it’s fair. I do think it is tough.”

Berger saw no other choice. “Vaccines are fundamental to our practices. That’s what we do,” he said. “Some got it in their heads that it could cause infertility; some had other reasons. It’s frustrating … [and] I don’t think it was political. If anything, most of these people are apolitical.”

At ManorCare, managers decided money could make a difference. Bonuses — up to $200 per employee — were added as an incentive, which in Pennsylvania alone cost ProMedica $3 million, said Luke Pile, vice president and general manager for ProMedica Senior Care skilled nursing centers.

Richmond, at ManorCare, said the resident council has been pivotal in keeping the focus on the risks of covid to the elderly — and no one there needs a reminder about the stress of the past year. According to Medicare records, the facility had 107 cases of covid among staffers and residents — and 14 deaths among residents beginning in March 2020.

“I constantly wear a mask. Not out of fear, but I don’t want to spread it by being asymptomatic,” Richmond said. “I tell people here: Whatever is happening in the community, that is what is happening in the community. But we are a health care institution and caring for the elderly. We need to be constantly vigilant.”

Richmond and other administrators admit it can be a struggle to understand why some health workers are unmoved by the science.

“Everything has been so polarized this past year. I don’t know that there is a single reason that individuals don’t get the vaccine,” Pile said. “In trying to educate people, personally and professionally, we talk about the history and science. Unfortunately, individual opinions don’t always align with that.”

Medical workers and pedestrians cross an intersection outside the Houston Methodist Hospital on June 9 in Houston. A judge dismissed a lawsuit this month from more than 100 hospital system staffers who objected to its compulsory vaccination.(Brandon Bell / Getty Images)

Mandating vaccines is a step that ProMedica has yet to take, even as more businesses, universities and health care providers do so. A few long-term care operators, such as Atria Senior Living, operating in the United and Canada, and Juniper Communities, announced mandates. Some have been met with lawsuits from workers aligned with conservative groups. In May, more than 100 staffers at Houston Methodist Hospital filed suit to dispute and derail the hospital system’s compulsory vaccination. A judge dismissed the challenge this month on the grounds that the hospital’s requirement did not violate state or federal law or public policy.

Last week, the U.S. Labor Department issued a temporary emergency standard for health care workers, saying they face “grave danger” in the workplace when “less than 100 percent of the workforce is fully vaccinated.”

In Pennsylvania, whose population ranks among the oldest according to 2019 census data, statistical snapshots published in April underscored the need for vigilance. Two state agencies overseeing skilled nursing care and personal care homes reported that only half of their workers were vaccinated. Covid was notably devastating to long-term care facilities nationwide in 2020; some of Pennsylvania’s deadliest outbreaks were reported by local media in places shown later to have low staff vaccination rates.

A survey by the Delphi Group, begun in March 2020 with over 700,000 Facebook respondents ages 18 to 64, recently was analyzed by researchers from Carnegie Mellon and the University of Pittsburgh, who found that health care workers were largely leading the vaccine uptake. But there were notable differences over the winter among people working, side by side, in health care settings.

Pharmacists, physicians and registered nurses were the least hesitant to get vaccinated. Home health care aides, EMTs and nursing assistants showed the highest hesitancy among front-line health workers. Overall hesitancy across professions decreased from January to March 2021, as much as 5 percentage points, as vaccinations expanded, according to the analysis by the university researchers.

University of Pittsburgh researcher Wendy King said people indicated they were receptive to the vaccine if they were familiar with its science. Educators, overall, displayed the least hesitancy; workers in construction, mining and oil/gas extraction showed the greatest. Half of those who were hesitant cited possible side effects — a fear that could be eased by education, King said. A third among the hesitant gave other reasons: They didn’t believe they needed the vaccine. They didn’t trust the government. Or they didn’t trust the covid-19 vaccines.

“We expected hesitancy to vary by group, but how much they varied was surprising,” King said. “These were not people who were anti-vaccine, but they were worried about the effect of the vaccine.”

Still, King said the percentage who didn’t trust the government was alarming. “If somebody doesn’t understand the vaccine, that’s one thing. If you don’t trust that government, that is a much more difficult issue to address.”

That may change as two prominent vaccine makers approach full approval by the Food and Drug Administration. Pfizer and BioNTech applied for approval in May; Moderna applied in early June. A recent KFF poll found nearly a third of unvaccinated adults said they would be more likely to get a vaccine once it was fully approved by the FDA.

At ProMedica, Pile described a multipronged approach in such states as Florida and Pennsylvania, home to large elderly populations. On-site counseling in groups, with familiar doctors and staff, helped persuade some who were reluctant, he said. Short videos on why and how the vaccine worked were readied. ProMedica senior medical staff flew to Florida to advise as the National Guard arrived at its facility in Pinellas County, the health system’s first to receive the vaccine.

Falon Blessing, a nurse, manages other practitioners at ManorCare Health Services Center throughout the Tampa region. She recounted how employees had wondered aloud how such newly created vaccines could be safe.

“I think people at first just wanted to know: I’m not going to grow a tail in five years,” she said. “But then there was a momentum. It wasn’t so much ‘Are you going to get vaccinated?’ but rather ‘Of course, I’m going to get vaccinated.’”

During three vaccinations sessions ended in January, though, the facility reached about the same rate as Pennsylvania overall — about 76% of its workers were vaccinated. That rate has fallen to 62% this month because of attrition. An education effort continues, a ProMedica spokesperson said.

“My takeaway was it mattered to have one-on-one discussions,” Pile said. “If you talk to 10 people, why they wouldn’t get the vaccine, you’d get 10 different reasons.”

“And there were political opinions — what they heard on Facebook — and then they’d say: I want to see how it goes,” he said.

The questions and qualms about vaccines came at the end of a deeply distressing pandemic year for health care workers, and facilities are now finding fewer applicants for essential care.

By spring, ProMedica had 1,500 job postings in Pennsylvania alone, compared with a typical 400 openings. Pile said ProMedica raised wages in dozens of locations, though he declined to provide wage ranges or rates. It spent $4.5 million in Pennsylvania from March through last week — and still supplemented its workforce across the U.S. by hiring through staffing agencies.

“In 2020, we spent over $32 million on staffing agencies,” he said. Through this spring, ProMedica was on course to spend $66 million on staffing agencies for 2021, said Pile, who has worked in the care sector for 18 years.

“I have less employees than ever before,” he said. “I have never seen anything like it.”

The Pennsylvania Health Care Association, an advocacy group, surveyed members in April to better understand vaccine reluctance. Zachary Shamberg, the group’s president, said it found that defining “hesitancy is not that simple.”

Shamberg said PHCA focused on why people had yet to be immunized and the characteristics of the workforce were telling: About 92% of all its workers are women; 65% are between ages 16 and 44. Among them, some worried early on about possible infertility from the new vaccine, he said, and some wanted to wait for the single-shot Johnson & Johnson vaccine. Others were sick with covid and were advised, once recovered, not to get a vaccine for 90 days.

Shamberg was also critical of the state data. Those surveys, taken in March and released in April, reflected a time when the vaccine was new to many people.

Pennsylvania, a battleground state in recent presidential elections, remains politically charged, and Shamberg noted that politics likely plays a role among holdouts. In recent months, PHCA enlisted churches and doctors’ consortiums to change minds. Keeping residents and workers safe should be a priority in a state that, in a few years, will face a “silver tsunami” of residents in their 80s, Shamberg said.

In recent weeks, there has been clear momentum among the general population for shots in Pennsylvania. The state now ranks among the top 10 states in the nation to administer first doses of vaccines, according to data from the Centers for Disease Control and Prevention.

“Pennsylvania is a big and diverse state,” Shamberg said. “And it’s interesting why some of our staff in western Pennsylvania were hesitant versus workers in the city of Philadelphia.”

“The vast majority of workers in Philadelphia are female and, among them, minority populations that have some inherent distrust based on historical experience. Then you go out west and you have a more conservative viewpoint — and a distrust of government today and a distrust of government vaccine.”

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