More than 180 members of the House of Representatives are urging the Biden administration to crack down on drugmakers restricting drug discounts in the 340B program.
Enforcement actions should include fines, the letter from a bipartisan group of House members to HHS Secretary Xavier Becerra and other administration officials said.
Currently, 18 drug manufacturers are limiting 340B discounts dispensed through pharmacies that contract with 340B providers, according to the letter.
Dive Insight:
The 340B program requires drugmakers to charge hospitals only the statutory ceiling prices for eligible outpatient drugs. The goal of the three-decade-old program is to have savings flow into care for low-income patients and underserved communities. But critics — notably, drugmakers and some lawmakers — argue the program doesn’t have enough oversight, as hospitals don’t need to account for what they do with any savings.
Drug manufacturers began imposing restrictions on 340B discounts as early as summer 2020, sparking legal challenges from regulators. The HHS sent nine warning letters to pharmaceutical companies, referring seven of them to the Office of the Inspector General for investigation and potential enforcement.
However, eight months later, the OIG has yet to take enforcement action, the new letter from 181 House members reads.
The letter asks the OIG to finish its ongoing review of seven drug manufacturers for potential noncompliance with federal law on 340B discounts “as soon as possible.”
The law allows the OIG to impose fines up to $6,000 per drug claim on companies that intentionally overcharge 340B providers, according to the Health Resources and Services Administration, which oversees the program.
Regulators should begin imposing civil monetary penalties against pharmaceutical companies found in violation, the congresspeople said.
The letter also argues that the Biden administration should pursue enforcement action against 11 drug companies restricting 340B pricing, which either haven’t received notice from the HHS that they’re in violation of law yet, or have received a notice but haven’t been referred to OIG for enforcement.
“Every day that drug manufacturers violate their obligation to provide these discounted drugs, vulnerable communities, federal grantees, and safety net health care providers are deprived of resources Congress intended to provide,” the letter reads.
A number of hospital associations came out in support of the letter, including the National Rural Health Association, the American Hospital Association, America’s Essential Hospitals and the National Association of Community Health Centers.
340B Health, which lobbies on behalf of hospitals in the 340B program, thanked the House members for the letter in a statement Monday, and reiterated calls for fines.
“HHS should impose steep financial penalties on all the companies that are ignoring their legal commitments to the health care safety net,” said Maureen Testoni, CEO of 340B Health, in a statement.
A survey of more than 500 hospitals by 340B Health released in May estimated that the annual financial impact from drug company restrictions has doubled since the end of 2021, costing hospitals millions of dollars per year.
Drugmakers that have imposed or announced restrictions on 340B discounts for drugs dispensed at community and specialty pharmacies include AbbVie, AstraZeneca, Johnson & Johnson, Merck and Pfizer.
What role should the federal government play in addressing major healthcare issues? And does the way you vote affect your prospects for a long and healthy life? We talked about it on today’s episode of the 4sight Friday Roundup podcast.
David Johnson is CEO of 4sight Health.
Julie Vaughan Murchinson is Partner of Transformation Capital and former CEO of Health Evolution.
David Burda is News Editor and Columnist of 4sight Health.
COVID-19 cases have risen in the U.S. to around 100,000 per day, and the real number could be as much as five times that, given many go unreported.
But the situation is far different from the early months of the pandemic. There are now vaccines and booster shots, and new treatments that dramatically cut the risk of the virus. So how much do cases alone still matter?
That question has prompted debate among experts, even as much of America goes on with their lives, despite the recent surge in cases.
How much concern high case numbers alone should prompt is “the trillion-dollar question,” said Bob Wachter, chair of the department of medicine at the University of California-San Francisco.
In the early days of the pandemic, dying of COVID-19 was a concern for him, but now, in an era of vaccines and treatments, “it doesn’t even cross my mind anymore,” he said.
But he noted there are other risks, including long COVID-19: symptoms like fatigue or difficulty concentrating that can linger for months.
“I think long COVID is pretty scary,” he said.
While cases have risen to around 100,000 reported per day, deaths have stayed flat, a testament to the power of vaccines and booster shots in preventing severe illness, as well as the Pfizer treatment pills Paxlovid, which cut the risk of hospitalization or death by around 90 percent.
Hospitalizations have risen, but only modestly, to around 27,000, one of the lowest points of the pandemic, according to a New York Times tracker.
Cases have now been “partially decoupled” from causing hospitalizations and deaths, said Preeti Malani, an infectious disease expert at the University of Michigan, such that hospitals are no longer overwhelmed.
“[Cases are] not without any consequence, but in terms of pressure on the health system, so far we’re not seeing that, which is really what drove all of this,” she said.
The behavior of much of America reflects a lessened concern about the risk of being infected. Restaurants and bars are packed. Many people do not wear masks even on airplanes or on the subway.
An Axios-Ipsos poll in May found just 36 percent of Americans said there was significant risk in returning to their “normal pre-coronavirus life.”
In the Biden administration, health officials are still advising people to wear masks in areas the Centers for Disease Control and Prevention classifies as at “high” risk. But President Biden himself is talking about the virus far less than he did at the start of his administration, and is not making sustained calls for people to wear masks.
White House COVID-19 response coordinator Ashish Jha touted progress in defanging cases on Thursday.
“We see cases rising, nearly 100,000 cases a day, and yet we’re still seeing death numbers that are substantially, about 90 percent lower, than where they were when the president first took office,” he told reporters.
Some experts are pushing back on the deemphasis of case numbers, saying they still matter.
“The bunk that cases are not important is preposterous,” Eric Topol, professor of molecular medicine at Scripps Research, wrote last month. “They are infections that beget more cases, they beget Long Covid, they beget sickness, hospitalizations and deaths. They are also the underpinning of new variants.”
Even if one does not get severely ill oneself, more cases mean more chances for the virus to spread on to someone who is more vulnerable, like the elderly or immunocompromised.
While deaths are way down from their peak earlier in the pandemic, there are still around 300 people dying from the virus every day, a number that would have proved shocking in a pre-COVID-19 world.
Leana Wen, a public health professor at George Washington University, recommended that people take a rapid test before visiting a more vulnerable person, as a safeguard that avoids more burdensome restrictions.
“Cases alone do not tell the whole story,” she said, adding, “As a policy matter we need to stop using the same comparisons we were in 2020 and 2021.”
There is still much that is unknown about long COVID-19, one of the biggest risks remaining for healthy, younger people who are vaccinated.
A recent article in the Journal of the American Medical Association estimated 10 percent to 30 percent of COVID-19 infections result in long COVID-19 symptoms, but there is no precise estimate.
Experts also urge people who have not gotten their booster shots, or not been vaccinated at all, to do so, given that many are more vulnerable to the virus if they are not up-to-date on their shots.
A new variant also always holds the risk of upending the current risk-benefit calculations. The virus has continued to evolve to spread more easily, and a future mutation could cause more severe illness or more greatly evade vaccines.
Pfizer and Moderna are working on updated vaccines to better target the omicron variant, but the Biden administration warns it will not have enough money to purchase those new vaccines for all Americans this fall unless Congress provides more funding. The funding request has been stalled for months, though, itself a sign of the reduced sense of urgency around the virus fight.
At least for now, though, while many people are getting COVID-19, fewer are getting extremely sick.
“It’s a very risky time if you don’t want to get COVID [at all],” Wachter said. “But a relatively less risky time if your goal is to not get severe COVID or die.”
Healthy individuals who have been vaccinated, and especially those who have been boosted, appear unlikely to develop severe infections from the omicron variant that would land them in the hospital, say medical experts who have monitored the effects of the newest coronavirus variant since it was identified over four weeks ago.
While omicron has sent U.S. infections soaring to levels not seen since last winter’s wave, it appears to have less severe effects than the delta variant, according to a handful of international studies and early data from several U.S. hospitals.
Those infected by the omicron variant are 15 to 20 percent less likely to go to an emergency room, and 40 percent less likely to be hospitalized overnight, compared with those infected with delta, according to English data analyzed by scientists from Imperial College London. That aligns with early U.S. data from some hospitals.
At the Houston Methodist hospital system, about 15 percent of symptomatic individuals have ended up hospitalized — around a 70 percent reduction compared with those infected by the delta variant, said James Musser, chair of pathology and genomic medicine.
A separate study from Britain, which is not yet peer reviewed, found that people infected with omicron were almost 60 percent less likely to enter the hospital than those infected with delta.
“What is absolutely clear is there is lower rate of hospitalization with our omicron patients in our hospital system,” Musser said. “That does not necessarily mean that this variant is quote-unquote ‘less virulent.’ The jury’s still out on that. What we know now is that … if you are immunized and, more importantly, if you are boosted, you’re going to stay out of substantial trouble.”
He and other experts warn against complacency, however, cautioning that millions of Americans, particularly the unvaccinated, remain vulnerable to more serious disease from the most transmissible coronavirus variant to date.
Other factors that might lead to greater risk include an individual’s age, the type of vaccine or booster they received, and whether they have underlying health problems, such as heart disease or obesity, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and a member of President Biden’s covid-19 transition task force.
“Have you previously had infection? Were you vaccinated? How many doses of vaccine, and was it more than six months ago? So in some ways this is almost like a calculus problem. It’s got a lot of moving parts to it and we’re trying to figure it out,” Osterholm said.
Doctors also caution that far more people will become infected with omicron simply because of its transmissibility. If even a small fraction of those land in the hospital, they worry that health care systems that are already short-staffed because of delta infections could be overwhelmed — with potentially dire results for those needing critical care as a result of car accidents, heart attacks, strokes, or any number of things that bring people to emergency rooms.
“We need to be respectful of the fact that our hospital system has been under this kind of duress for such a long time,” said Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center in Seattle. “We need to do everything we can to not allow the situation, where there’s such crowding and such intensity that we can’t optimally take care of the people who get severe disease.”
Anthony S. Fauci, Biden’s chief medical adviser, said the rapid increase in the numbers of people getting infected with the omicron variant will invariably put additional strain on the system.
“We’re going to have a real challenge to the health-care delivery system — namely the number of beds, the number of ICU beds and even the number of health care providers,” Fauci said in an interview. “Even vaccinated people are getting breakthrough infections. So if you get enough nurses and doctors infected, they are going to temporarily be out of action. And if you get enough of them out of action, you could have a double stress on the health care system.”
The welcome news for most people who are vaccinated and boosted is that omicron infections often mimic the symptoms of the common cold. Those with two shots of vaccine, but no booster, also appear to fare relatively well, though they may develop more intense symptoms that may last longer, experts said.
In a series of Twitter posts, Craig Spencer, who teaches emergency medicine at Columbia University Medical Center, said every boosted patient he has seen in the emergency room has had no difficulty breathing or shortness of breath. Those who have had two doses of either the Pfizer or Moderna vaccines also have had mild symptoms, he said, “but more than those who had received a third dose.”
But almost every patient who had to be hospitalized was unvaccinated, he said.
“No matter your political affiliation, or thoughts on masks, or where you live in this country, as an ER doctor you’d trust with your life if you rolled into my emergency room at 3am, I promise you that you’d rather face the oncoming Omicron wave vaccinated,” Spencer wrote.
Children are also filling up hospital beds in many parts of the country, especially in New York. State officials issued a warning on Christmas Eve after a fourfold increase in hospitalizations in children under 18 in New York City between Dec. 5 and last week. About half of the admissions were children under 5, who are not eligible for vaccination, according to the New York Department of Health.
Experts cautioned that those at higher risk of severe infection to previous variants probably remain vulnerable to this one.
It’s not yet clear whether older, boosted individuals and those with underlying conditions, such as diabetes and heart disease, face the same lowered risk with omicron. Answering such questions is key to assessing the likely trajectory of the variant in the U.S. since it is older and less healthy than many of its global peers.
So far, though, early U.S. data echoes what has been seen in South Africa and Britain, where omicron waves are slightly ahead of this country’s.
A group of Scottish scientists said recently that vaccinated people appear to have some protection against symptomatic infection from omicron, although less than they did against delta. A third dose or booster of an mRNA vaccine was associated with a 57 percent reduction in the odds of developing a symptomatic omicron case.
In the Johns Hopkins Hospital emergency department, physicians are seeing more infections than atany other point in the pandemic, but most of the cases are not severe, said Stuart Ray, a professor of medicine in the division of infectious diseases. But he warned that there is not yet “reassuring evidence” the United States will be spared from a disruptive wave of infections and complications.
The country faces other challenges with omicron in terms of its medicine cabinet. Two of the three existing intravenous treatments called monoclonal antibodies — those from Regeneron and Eli Lilly — do not work against the variant. Some Republican governors had touted the ability of those with covid-19 to receive monoclonal antibodies, spurring some Americans to see those treatments as an alternative to getting vaccinated.
The only monoclonal antibody that does work, sotrovimab from Vir Biotechnology and GlaxoSmithKline, is in short supply and will not be available to many of those who become infected. The Food and Drug Administration authorized two easy-to-take antiviral pills last week and one has high efficacy against omicron, but it will be in initial short supply. Distribution of the pills is expected to begin shortly.
It is also unclear whether the surge in the United States will follow the same pattern as South Africa’s, which rapidly passed the peak of omicron cases last week.
South Africa’s population is significantly younger and has far lower vaccination rates, with about 35 percent of the population immunized, and virtually no oneboosted.The country also grappled with a delta variant wave that infected a far greater portion of the population than it did in the United States.
The significant number of South African residents infected with delta compared with the United States could prove to be an important distinction that might make more Americans vulnerable to omicron, said Chris Beyrer, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.
Beyrer also noted that infections in the United States, Britain and Germany seemed to be increasing at a significantly faster rate than they were in South Africa.
“This is an incredibly infectious virus and it is moving right along,” Beyrer said. He added that the United States has numerous tools — including ready access to vaccines and booster shots, the new antiviral medicines, testing and masking — that could help curb its effects.
But referring to those who have refused to follow public health guidelines, Beyrer said, “We have a lot of resistance so that makes us vulnerable to infection.”
America was not prepared for COVID-19 when it arrived. It was not prepared for last winter’s surge. It was not prepared for Delta’s arrival in the summer or its current winter assault. More than 1,000 Americans are still dying of COVID every day, and more have died this year than last. Hospitalizations are rising in 42 states. The University of Nebraska Medical Center in Omaha, which entered the pandemic as arguably the best-prepared hospital in the country, recently went from 70 COVID patients to 110 in four days, leaving its staff “grasping for resolve,” the virologist John Lowe told me. And now comes Omicron.
Will the new and rapidly spreading variant overwhelm the U.S. health-care system? The question is moot because the system is already overwhelmed, in a way that is affecting all patients, COVID or otherwise. “The level of care that we’ve come to expect in our hospitals no longer exists,” Lowe said.
The real unknown is what an Omicron cross will do when it follows a Delta hook. Given what scientists have learned in the three weeks since Omicron’s discovery, “some of the absolute worst-case scenarios that were possible when we saw its genome are off the table, but so are some of the most hopeful scenarios,” Dylan Morris, an evolutionary biologist at UCLA, told me. In any case, America is not prepared for Omicron. The variant’s threat is far greater at the societal level than at the personal one, and policy makers have already cut themselves off from the tools needed to protect the populations they serve. Like the variants that preceded it, Omicron requires individuals to think and act for the collective good—which is to say, it poses a heightened version of the same challenge that the U.S. has failed for two straight years, in bipartisan fashion.
The coronavirus is a microscopic ball studded with specially shaped spikes that it uses to recognize and infect our cells. Antibodies can thwart such infections by glomming onto the spikes, like gum messing up a key. But Omicron has a crucial advantage: 30-plus mutations that change the shape of its spike and disable many antibodies that would have stuck to other variants. One early study suggests that antibodies in vaccinated people are about 40 times worse at neutralizing Omicron than the original virus, and the experts I talked with expect that, as more data arrive, that number will stay in the same range. The implications of that decline are still uncertain, but three simple principles should likely hold.
First, the bad news: In terms of catching the virus, everyone should assume that they are less protected than they were two months ago. As a crude shorthand, assume that Omicron negates one previous immunizing event—either an infection or a vaccine dose. Someone who considered themselves fully vaccinated in September would be just partially vaccinated now (and the official definition may change imminently). But someone who’s been boosted has the same ballpark level of protection against Omicron infection as a vaccinated-but-unboosted person did against Delta. The extra dose not only raises a recipient’s level of antibodies but also broadens their range, giving them better odds of recognizing the shape of even Omicron’s altered spike.In a small British study, a booster effectively doubled the level of protection that two Pfizer doses provided against Omicron infection.
Second, some worse news: Boosting isn’t a foolproof shield against Omicron. In South Africa, the variant managed to infect a cluster of seven people who were all boosted. And according to a CDC report, boosted Americans made up a third of the first known Omicron cases in the U.S. “People who thought that they wouldn’t have to worry about infection this winter if they had their booster do still have to worry about infection with Omicron,” Trevor Bedford, a virologist at Fred Hutchinson Cancer Research Center, told me. “I’ve been going to restaurants and movies, and now with Omicron, that will change.”
Third, some better news: Even if Omicron has an easier time infecting vaccinated individuals, it should still have more trouble causing severe disease. The vaccines were always intended to disconnect infection from dangerous illness, turning a life-threatening event into something closer to a cold. Whether they’ll fulfill that promise for Omicron is a major uncertainty, but we can reasonably expect that they will. The variant might sneak past the initial antibody blockade, but slower-acting branches of the immune system (such as T cells) should eventually mobilize to clear it before it wreaks too much havoc.
To see how these principles play out in practice, Dylan Morris suggests watching highly boosted places, such as Israel, and countries where severe epidemics and successful vaccination campaigns have given people layers of immunity, such as Brazil and Chile. In the meantime, it’s reasonable to treat Omicron as a setback but not a catastrophe for most vaccinated people. It will evade some of our hard-won immune defenses, without obliterating them entirely. “It was better than I expected, given the mutational profile,” Alex Sigal of the Africa Health Research Institute, who led the South African antibody study, told me. “It’s not going to be a common cold, but neither do I think it will be a tremendous monster.”
That’s for individuals, though. At a societal level, the outlook is bleaker.
Omicron’s main threat is its shocking speed, as my colleague Sarah Zhang has reported. In South Africa, every infected person has been passing the virus on to 3–3.5 other people—at least twice the pace at which Delta spread in the summer. Similarly, British data suggest that Omicron is twice as good at spreading within households as Delta. That might be because the new variant is inherently more transmissible than its predecessors, or because it is specifically better at moving through vaccinated populations. Either way, it has already overtaken Delta as the dominant variant in South Africa. Soon, it will likely do the same in Scotland and Denmark. Even the U.S., which has much poorer genomic surveillance than those other countries, has detected Omicron in 35 states. “I think that a large Omicron wave is baked in,” Bedford told me. “That’s going to happen.”
More positively, Omicron cases have thus far been relatively mild. This pattern has fueled the widespread claim that the variant might be less severe, or even that its rapid spread could be a welcome development. “People are saying ‘Let it rip’ and ‘It’ll help us build more immunity,’ that this is the exit wave and everything’s going to be fine and rosy after,” Richard Lessells, an infectious-disease physician at the University of KwaZulu-Natal, in South Africa, told me. “I have no confidence in that.”
To begin with, as he and others told me, that argument overlooks a key dynamic: Omicron might not actually be intrinsically milder. In South Africa and the United Kingdom, it has mostly infected younger people, whose bouts of COVID-19 tend to be less severe. And in places with lots of prior immunity, it might have caused few hospitalizations or deaths simply because it has mostly infected hosts with some protection, as Natalie Dean, a biostatistician at Emory University, explained in a Twitter thread. That pattern could change once it reaches more vulnerable communities. (The widespread notion that viruses naturally evolve to become less virulent is mistaken, as the virologist Andrew Pekosz of Johns Hopkins University clarified in The New York Times.) Also, deaths and hospitalizations are not the only fates that matter. Supposedly “mild” bouts of COVID-19 have led to cases of long COVID, in which people struggle with debilitating symptoms for months (or even years), while struggling to get care or disability benefits.
And even if Omicron is milder, greater transmissibility will likely trump that reduced virulence. Omicron is spreading so quickly that a small proportion of severe cases could still flood hospitals. To avert that scenario, the variant would need to be substantially milder than Delta—especially because hospitals are already at a breaking point. Two years of trauma have pushed droves of health-care workers, including many of the most experienced and committed, to quit their job. The remaining staff is ever more exhausted and demoralized, and “exceptionally high numbers” can’t work because they got breakthrough Delta infections and had to be separated from vulnerable patients, John Lowe told me. This pattern will only worsen as Omicron spreads, if the large clusters among South African health-care workers are any indication. “In the West, we’ve painted ourselves into a corner because most countries have huge Delta waves and most of them are stretched to the limit of their health-care systems,” Emma Hodcroft, an epidemiologist at the University of Bern, in Switzerland, told me. “What happens if those waves get even bigger with Omicron?”
The Omicron wave won’t completely topple America’s wall of immunity but will seep into its many cracks and weaknesses. It will find the 39 percent of Americans who are still not fully vaccinated (including 28 percent of adults and 13 percent of over-65s). It will find other biologically vulnerable people, including elderly and immunocompromised individuals whose immune systems weren’t sufficiently girded by the vaccines. It will find the socially vulnerable people who face repeated exposures, either because their “essential” jobs leave them with no choice or because they live in epidemic-prone settings, such as prisons and nursing homes. Omicron is poised to speedily recap all the inequities that the U.S. has experienced in the pandemic thus far.
Here, then, is the problem: People who are unlikely to be hospitalized by Omicron might still feel reasonably protected, but they can spread the virus to those who are more vulnerable, quickly enough to seriously batter an already collapsing health-care system that will then struggle to care for anyone—vaccinated, boosted, or otherwise. The collective threat is substantially greater than the individual one. And the U.S. is ill-poised to meet it.
America’s policy choices have left it with few tangible options for averting an Omicron wave. Boosters can still offer decent protection against infection, but just 17 percent of Americans have had those shots. Many are now struggling to make appointments, and people from rural, low-income, and minority communities will likely experience the greatest delays, “mirroring the inequities we saw with the first two shots,” Arrianna Marie Planey, a medical geographer at the University of North Carolina at Chapel Hill, told me. With a little time, the mRNA vaccines from Pfizer and Moderna could be updated, but “my suspicion is that once we have an Omicron-specific booster, the wave will be past,” Trevor Bedford, the virologist, said.
Two antiviral drugs now exist that could effectively keep people out of the hospital, but neither has been authorized and both are expensive. Both must also be administered within five days of the first symptoms, which means that people need to realize they’re sick and swiftly confirm as much with a test. But instead of distributing rapid tests en masse, the Biden administration opted to merely make them reimbursable through health insurance. “That doesn’t address the need where it is greatest,” Planey told me. Low-wage workers, who face high risk of infection, “are the least able to afford tests up front and the least likely to have insurance,” she said. And testing, rapid or otherwise, is about to get harder, as Omicron’s global spread strains both the supply of reagents and the capacity of laboratories.
Omicron may also be especially difficult to catch before it spreads to others, because its incubation period—the window between infection and symptoms—seems to be very short. At an Oslo Christmas party, almost three-quarters of attendees were infected even though all reported a negative test result one to three days before. That will make Omicron “harder to contain,” Lowe told me. “It’s really going to put a lot of pressure on the prevention measures that are still in place—or rather, the complete lack of prevention that’s still in place.”
The various measures that controlled the spread of other variants—masks, better ventilation, contact tracing, quarantine, and restrictions on gatherings—should all theoretically work for Omicron too. But the U.S. has either failed to invest in these tools or has actively made it harder to use them. Republican legislators in at least 26 states have passed laws that curtail the very possibility of quarantines and mask mandates. In September, Alexandra Phelan of Georgetown University told me that when the next variant comes, such measures could create “the worst of all worlds” by “removing emergency actions, without the preventive care that would allow people to protect their own health.” Omicron will test her prediction in the coming weeks.
The longer-term future is uncertain. After Delta’s emergence, it became clear that the coronavirus was too transmissible to fully eradicate. Omicron could potentially shunt us more quickly toward a different endgame—endemicity, the point when humanity has gained enough immunity to hold the virus in a tenuous stalemate—albeit at significant cost. But more complicated futures are also plausible. For example, if Omicron and Delta are so different that each can escape the immunity that the other induces, the two variants could co-circulate. (That’s what happened with the viruses behind polio and influenza B.)
Omicron also reminds us that more variants can still arise—and stranger ones than we might expect. Most scientists I talked with figured the next one to emerge would be a descendant of Delta, featuring a few more mutational bells and whistles. Omicron, however, is “dramatically different,” Shane Crotty, from the La Jolla Institute for Immunology, told me. “It showed a lot more evolutionary potential than I or others had hoped for.” It evolved not from Delta but from older lineages of SARS-CoV-2, and seems to have acquired its smorgasbord of mutations in some hidden setting: perhaps a part of the world that does very little sequencing, or an animal species that was infected by humans and then transmitted the virus back to us, or the body of an immunocompromised patient who was chronically infected with the virus. All of these options are possible, but the people I spoke with felt that the third—the chronically ill patient—was most likely. And if that’s the case, with millions of immunocompromised people in the U.S. alone, many of whom feel overlooked in the vaccine era, will more weird variants keep arising? Omicron “doesn’t look like the end of it,” Crotty told me. One cause for concern: For all the mutations in Omicron’s spike, it actually has fewer mutations in the rest of its proteins than Delta did. The virus might still have many new forms to take.
Vaccinating the world can curtail those possibilities, and is now an even greater matter of moral urgency, given Omicron’s speed. And yet, people in rich countries are getting their booster six times faster than those in low-income countries are getting their first shot. Unless the former seriously commits to vaccinating the world—not just donating doses, but allowing other countries to manufacture and disseminate their own supplies—“it’s going to be a very expensive wild-goose chase until the next variant,” Planey said.
Vaccines can’t be the only strategy, either. The rest of the pandemic playbook remains unchanged and necessary: paid sick leave and other policies that protect essential workers, better masks, improved ventilation, rapid tests, places where sick people can easily isolate, social distancing, a stronger public-health system, and ways of retaining the frayed health-care workforce. The U.S. has consistently dropped the ball on many of these, betting that vaccines alone could get us out of the pandemic. Rather than trying to beat the coronavirus one booster at a time, the country needs to do what it has always needed to do—build systems and enact policies that protect the health of entire communities, especially the most vulnerable ones.
At a certain point, it was no longer a matter of if the United States would reach the gruesome milestone of 1 in 500 people dying of covid-19, but a matter of when. A year? Maybe 15 months? The answer: 19 months.
Given the mortality rate from covid and our nation’s population size, “we’re kind of where we predicted we would be with completely uncontrolled spread of infection,” said Jeffrey D. Klausner, clinical professor of medicine, population and public health sciences at the University of Southern California’s Keck School of Medicine. “Remember at the very beginning, which we don’t hear about anymore, it was all about flatten the curve.”
The idea, he said, was to prevent “the humanitarian disaster” that occurred in New York City, where ambulance sirens were a constant as hospitals were overwhelmed and mortuaries needed mobile units to handle the additional dead.
The goal of testing, mask-wearing, keeping six feet apart and limiting gatherings was to slow the spread of the highly infectious virus until a vaccine could stamp it out. The vaccines came but not enough people have been immunized, and the triumph of science waned as mass death and disease remain. The result: As the nation’s covid death toll exceeded 663,000 this week, it meant roughly 1 in every 500 Americans had succumbed to the disease caused by the coronavirus.
While covid’s death toll overwhelms the imagination, even more stunning is the deadly efficiency with which it has targeted Black, Latino, and American Indian and Alaska Native people in their 30s, 40s and 50s.
Death at a younger age represents more lost years of life. Lost potential. Lost scholarship. Lost mentorship. Lost earnings. Lost love.
Neighborhoods decimated. Families destroyed.
“So often when we think about the majority of the country who have lost people to covid-19, we think about the elders that have been lost, not necessarily younger people,” said Abigail Echo-Hawk, executive vice president at the Seattle Indian Health Board and director of the Urban Indian Health Institute. “Unfortunately, this is not my reality nor that of the Native community. I lost cousins and fathers and tribal leaders. People that were so integral to building up our community, which has already been struggling for centuries against all these things that created the perfect environment for covid-19 to kill us.”
Six of Echo-Hawk’s friends and relatives — all under 55 — have died of covid.
“This is trauma. This is generational impact that we must have an intentional focus on. The scars are there,” said Marcella Nunez-Smith, chair of President Biden’s COVID-19 Health Equity Task Force and associate dean for health equity research at Yale University. “We can’t think that we’re going to test and vaccinate our way out of this deep pain and hurt.”
The pandemic has brought into stark relief centuries of entwining social, environmental, economic and political factors that erode the health and shorten the lives of people of color, putting them at higher risk of the chronic conditions that leave immune systems vulnerable to the coronavirus. Many of those same factors fuel the misinformation, mistrust and fear that leave too many unprotected.
Take the suggestion that people talk to their doctor about which symptoms warrant testing or a trip to the hospital as well as the safety of vaccines. Seems simple. It’s not.
Many people don’t have a physician they see regularly due in part to significant provider shortages in communities of color. If they do have a doctor, it can cost too much money for a visit even if insured. There are language barriers for those who don’t speak English fluently and fear of deportation among undocumented immigrants.
“Some of the issues at hand are structural issues, things that are built into the fabric of society,” said Enrique W. Neblett Jr., a University of Michigan professor who studies racism and health.
Essential workers who cannot avoid the virus in their jobs because they do not have the luxury of working from home. People living in multigenerational homes with several adult wage-earners, sharing housing because their pay is so low. Even the fight to be counted among the covid casualties — some states and hospitals, Echo-Hawk said, don’t have “even a box to check to say you are American Indian or Alaskan Native.”
It can be difficult to tackle the structural issues influencing the unequal burden of the pandemic while dealing with the day-to-day stress and worry it ignites, which, Neblett said, is why attention must focus on both long-term solutions and “what do we do now? It’s not just that simple as, ‘Oh, you just put on your mask, and we’ll all be good.’ It’s more complicated than that.”
The exacting toll of the last year and a half — covid’s stranglehold on communities of color and George Floyd’s murder — forced the country to interrogate the genealogy of American racism and its effect on health and well-being.
“This is an instance where we finally named it and talked about structural racism as a contributing factor in ways that we haven’t with other health disorders,” Neblett said.
But the nation’s attention span can be short. Polls show there was a sharp rise in concern about discrimination against Black Americans by police following Floyd’s murder, including among White Americans. That concern has eroded some since 2020, though it does remain higher than years past.
“This mistaken understanding that people have, almost this sort of impatience like, ‘Oh, we see racism. Let’s just fix that,’ that’s the thing that gives me hives,” Nunez-Smith said. “This is about generational investments and fundamental changes in ways of being. We didn’t get here overnight.”
The American public’s attitude toward COVID-19 vaccination has evolved rapidly since the end of last year. The share of adults who report they have either already been vaccinated or intend to get the vaccine as soon as possible continues to rise (currently about 62 percent), while the share who say they will “wait and see” continues to shrink (now 17 percent). Importantly, however, the share who say they will either “definitely not” get vaccinated or only do so “if required” (currently 20 percent) has remained stubbornly consistent since December.
As the US reaches a vaccine tipping point, with more COVID vaccines available than people willing to be vaccinated, it will be important to understand this vaccine-hesitant population more clearly. A recent consumer segmentation analysis found that this group falls into four major behavioral profiles, shown on the right side of the graphic above.
The next phase of vaccine rollout must specifically address the key concerns of individuals in each of these different segments. For example, the “watchful” group, the easiest to persuade, will likely respond to a more transparent vaccination process and the amplification of positive vaccination testimonials. On the other hand, “system distrusters,” generally comprised of younger, lower-income minorities, would benefit most from hearing community leaders discuss vaccine safety. Unfortunately, the largest segment of vaccine-hesitant Americans, the “misinformation believers”, will also be the most difficult to turn. These individuals are more likely to hold rigid, politically driven beliefs.
While countering misinformation by leveraging trusted influencers may help convince some, this group may be the hardest to persuade—although their participation will be crucial to hitting any goal of “herd immunity” by this fall.
For some time, we’ve been focused on the efforts of Walmart to launch and grow a care delivery business, especially as it has piloted an expanded primary care clinic offering in a handful of states. We’ve long thought that access to basic care at the scale that Walmart brings could be transformative, given that more than half of Americans visit a Walmart store every week. Along those same lines, we’ve always wondered why Dollar General and Dollar Tree—each with around four times as many retail locations as Walmart—haven’t gotten into the retail clinic or pharmacy businesses.
(Part of the answer is ultra-lean staffing—this piece gives a good sense of the basic, and troubling, economics of dollar stores.) Now, as the federal government ramps up its efforts to widely distribute the COVID vaccines, it turns out that the CDC is actively discussing a partnership with Dollar General to administer the shots.
A fascinating new paper (still in preprint) from researchers at Yale shows why this could be a true gamechanger. The Biden administration, through its partnership with national and independent pharmacy providers, aims to have a vaccination site within five miles of 90 percent of the US population by next week. Compared to those pharmacy partners, researchers found,Dollar General stores are disproportionately located in areas of high “social vulnerability”, with lower income residents and high concentrations of disadvantaged groups. Particularly in the Southeast, a partnership with Dollar General would vastly increase access for low-income Black and Latino residents, allowing vaccine access within one mile for many, many more people. And the partnership could form the basis for future expansions of basic healthcare services to vulnerable and rural communities, particularly if some of the $7.5B in funding for COVID vaccine distribution went to helping dollar store locations bolster staffing and equipment to deliver basic health services. We’ll be watching with interest to see if the potential Dollar General partnership comes to fruition.
There’s widespread agreement that it’s important to help older adults and people with disabilities remain independent as long as possible. But are we prepared to do what’s necessary, as a nation, to make this possible?
That’s the challenge President Joe Biden has put forward with his bold proposal to spend $400 billion over eight years on home and community-based services, a major part of his $2 trillion infrastructure plan.
It’s a “historic and profound” opportunity to build a stronger framework of services surrounding vulnerable people who need considerable ongoing assistance, said Ai-jen Poo, director of Caring Across Generations, a national group advocating for older adults, individuals with disabilities, families and caregivers.
It comes as the coronavirus pandemic has wreaked havoc in nursing homes, assisted living facilities and group homes, killing more than 174,000 people and triggering awareness of the need for more long-term care options.
“There’s a much greater understanding now that it is not a good thing to be stuck in long-term care institutions” and that community-based care is an “essential alternative, which the vast majority of people would prefer,” said Ari Ne’eman, senior research associate at Harvard Law School’s Project on Disability.
“The systems we do have are crumbling” due to underfunding and understaffing, and “there has never been a greater opportunity for change than now,” said Katie Smith Sloan, president of LeadingAge, at a recent press conference where the president’s proposal was discussed. LeadingAge is a national association of more than 5,000 nonprofit nursing homes, assisted living centers, senior living communities and home care providers.
But prospects for the president’s proposal are uncertain. Republicans decry its cost and argue that much of what the proposed American Jobs Plan contains, including the emphasis on home-based care, doesn’t count as real infrastructure.
“Though this [proposal] is a necessary step to strengthen our long-term care system, politically it will be a challenge,” suggested Joseph Gaugler, a professor at the University of Minnesota’s School of Public Health, who studies long-term care.
Even advocates acknowledge the proposal doesn’t address the full extent of care needed by the nation’s rapidly growing older population. In particular, middle-income seniors won’t qualify directly for programs that would be expanded. They would, however, benefit from a larger, better paid, better trained workforce of aides that help people in their homes — one of the plan’s objectives.
“This [plan] isn’t everything that’s needed, not by any step of the imagination,” Poo said. “What we really want to get to is universal access to long-term care. But that will be a multistep process.”
Understanding what’s at stake is essential as communities across the country and Congress begin discussing Biden’s proposal.
The services in question.Home and community-based services help people who need significant assistance live at home as opposed to nursing homes or group homes.
Services can include home visits from nurses or occupational therapists; assistance with personal care such as eating or bathing; help from case managers; attendance at adult day centers; help with cooking, cleaning and other chores; transportation; and home repairs and modifications. It can also help pay for durable medical equipment such as wheelchairs or oxygen tanks.
The need. At some point, 70% of older adults will require help with dressing, hygiene, moving around, managing finances, taking medications, cooking, housekeeping and other daily needs, usually for two to four years. As the nation’s aging population expands to 74 million in 2030 (the year all baby boomers will have entered older age), that need will expand exponentially.
Younger adults and children with conditions such as cerebral palsy, blindness or intellectual disabilities can similarly require significant assistance.
The burden on families. Currently, 53 million family members provide most of the care that vulnerable seniors and people with disabilities require — without being paid and often at significant financial and emotional cost. According to AARP, family caregivers on average devote about 24 hours a week, to helping loved ones and spend around $7,000 out-of-pocket.
This reflects a sobering reality: Long-term care services are simply too expensive for most individuals and families. According to a survey last year by Genworth, a financial services firm, the hourly cost for a home health aide averages $24. Annually, assisted living centers charge an average $51,600, while a semiprivate room in a nursing home goes for $93,075.
Medicare limitations. Many people assume that Medicare — the nation’s health program for 61 million older adults and people with severe disabilities — will pay for long-term care, including home-based services. But Medicare coverage is extremely limited.
In the community, Medicare covers home health only for older adults and people with severe disabilities who are homebound and need skilled services from nurses and therapists. It does not pay for 24-hour care or care for personal aides or homemakers. In 2018, about 3.4 million Medicare members received home health services.
In nursing homes, Medicare pays only for rehabilitation services for a maximum of 100 days. It does not provide support for long-term stays in nursing homes or assisted living facilities.
Medicaid options. Medicaid — the federal-state health program for 72 million children and adults in low-income households — can be an alternative, but financial eligibility standards are strict and only people with meager incomes and assets qualify.
Medicaid supports two types of long-term care: home and community-based services and those provided in institutions such as nursing homes. But only care in institutions is mandated by the federal government. Home and community-based services are provided at the discretion of the states.
Although all states offer home and community-based services of some kind, there’s enormous variation in the types of services offered, who is served (states can set caps on enrollment) and state spending. Generally, people need to be frail enough to need nursing home care to qualify.
Nationally, 57% of Medicaid’s long-term care budget goes to home and community-based services — $92 billion in the 2018 federal budget year. But half of states still spend twice as much on institutional care as they do on community-based care. And 41 states have waiting lists, totaling nearly 820,000 people, with an average wait of 39 months.
Based on the best information available, between 4 million and 5 million people receive Medicaid-funded home and community-based services — a fraction of those who need care.
Workforce issues. Biden’s proposal doesn’t specify how $400 billion in additional funding would be spent, beyond stating that access to home and community-based care would be expanded and caregivers would receive “a long-overdue raise, stronger benefits, and an opportunity to organize or join a union.”
Caregivers, including nursing assistants and home health and personal care aides, earn $12 an hour, on average. Most are women of color; about one-third of those working for agencies don’t receive health insurance from their employers.
By the end of this decade, an extra 1 million workers will be needed for home-based care — a number of experts believe will be difficult, if not impossible, to reach given poor pay and working conditions.
“We have a choice to keep these poverty-wage jobs or make them good jobs that allow people to take pride in their work while taking care of their families,” said Poo of Caring Across Generations.
Next steps.Biden’s plan leaves out many details. For example: What portion of funding should go to strengthening the workforce? What portion should be devoted to eliminating waiting lists? What amount should be spent on expanding services?
How will inequities of the current system — for instance, the lack of accessible services in rural counties or for people with dementia — be addressed? “We want to see funding to states tied to addressing those inequities,” said Amber Christ, directing attorney of the health team at Justice in Aging, an advocacy organization.
Meanwhile, supporters of the plan suggest it could be just the opening of a major effort to shore up other parts of the safety net. “There are huge gaps in the system for middle-income families that need to be addressed,” said David Certner, AARP’s legislative counsel.
Reforms that should be considered include tax credits for caregivers, expanding Medicare’s home health benefit and removing the requirement that people receiving Medicare home health be homebound, said Christ of Justice in Aging.
”We should be looking more broadly at potential solutions that reach people who have some resources but not enough to pay for these services as well,” she said.
Coronavirus cases are on the rise again in several states, partially a result of variants of the virus becoming more widespread, experts say.
Why it matters:Even though a remarkable 72% of Americans 65 and older have received at least one dose of the vaccine, millions of Americans — particularly younger Americans with underlying conditions — remain vulnerable.
Driving the news: Coronavirus cases are rapidly rising in places including Michigan, New York, New Jersey and other Northeastern states.
In Michigan, the number of hospitalized younger adults has dramatically increased this month. Coronavirus hospitalizations increased by 633% for those aged 30 to 39 and by 800% for those aged 40 to 49, the Detroit Free Press reports.
The variant that originated in the U.K., which is partially driving the new surge, appears to be more transmissible and deadlier.
The big picture: “There are certainly many people who are not vaccinated who are still at severe risk themselves because of underlying medical issues,” said Leana Wen, a visiting professor at the Milken Institute School of Public Health at the George Washington University.
Because of vaccination demographics and who’s at highest risk of exposure, “the proportion of people who are hospitalized and who will die will likely skew toward a younger subset,” she said.
Between the lines: Those still vulnerable to the virus are disproportionately people of color.
That’s because prioritizing people for vaccines based on age disproportionately benefits white Americans, who tend to be older than people of color.
But younger people of color are tend to be at higher risk of severe infections because of underlying conditions.
What they’re saying: “To address areas of outbreak, we should allocate more of the increased vaccine supply coming into the market to places where penetration is low and infection rates high, like metro Detroit,” former FDA commissioner Scott Gottlieb tweeted.
HENRY KOTULA 