The Next Big COVID Variant Could Be a Triple Whammy Nightmare

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Even as daily new COVID cases set all-time records and hospitals fill up, epidemiologists have arrived at a perhaps surprising consensus. Yes, the latest Omicron variant of the novel coronavirus is bad. But it could have been a lot worse.

Even as cases have surged, deaths haven’t—at least not to the same degree. Omicron is highly transmissible but generally not as severe as some older variants—“lineages” is the scientific term.

We got lucky. But that luck might not hold. Many of the same epidemiologists who have breathed a sigh of relief over Omicron’s relatively low death rate are anticipating that the next lineage might be much worse.

The New Version of the Omicron Variant Is a Sneaky Little Bastard

Fretting over a possible future lineage that combines Omicron’s extreme transmissibility with the severity of, say, the previous Delta lineage, experts are beginning to embrace a new public health strategy that’s getting an early test run in Israel: a four-shot regimen of messenger-RNA vaccine.

“I think this will be the strategy going forward,” Edwin Michael, an epidemiologist at the Center for Global Health Infectious Disease Research at the University of South Florida, told The Daily Beast.

Omicron raised alarms in health agencies all over the world in late November after officials in South Africa reported the first cases. Compared to older lineages, Omicron features around 50 key mutations, some 30 of which are on the spike protein that helps the virus to grab onto our cells.

Some of the mutations are associated with a virus’s ability to dodge antibodies and thus partially evade vaccines. Others are associated with higher transmissibility. The lineage’s genetic makeup pointed to a huge spike in infections in the unvaccinated as well as an increase in milder “breakthrough” infections in the vaccinated.

That’s exactly what happened. Health officials registered more than 10 million new COVID cases the first week of January. That’s nearly double the previous worst week for new infections, back in May. Around 3 million of those infections were in the United States, where Omicron coincided with the Thanksgiving, Christmas, and New Year holidays and associated traveling and family gatherings.

But mercifully, deaths haven’t increased as much as cases have. Worldwide, there were 43,000 COVID deaths the first week of January—fewer than 10,000 of them in the U.S. While deaths tend to lag infections by a couple weeks, Omicron has been dominant long enough that it’s increasingly evident there’s been what statisticians call a “decoupling” of cases and fatalities.

“We can say we dodged a bullet in that Omicron does not appear to cause as serious of a disease,” Stephanie James, the head of a COVID testing lab at Regis University in Colorado, told The Daily Beast. She stressed that data is still being gathered, so we can’t be certain yet that the apparent decoupling is real.

Assuming the decoupling is happening, experts attribute it to two factors. First, Omicron tends to infect the throat without necessarily descending to the lungs, where the potential for lasting or fatal damage is much, much higher. Second, by now, countries have administered nearly 9.3 billion doses of vaccine—enough for a majority of the world’s population to have received at least one dose.

Omicron Shows the Unvaccinated Will Never Be Safe

In the United States, 73 percent of people have gotten at least one dose. Sixty-two percent have gotten two doses of the best mRNA vaccines. A third have received a booster dose.

Yes, Omicron has some ability to evade antibodies, meaning the vaccines are somewhat less effective against this lineage than they are against Delta and other older lineages. But even when a vaccine doesn’t prevent an infection, it usually greatly reduces its severity.

For many vaccinated people who’ve caught Omicron, the resulting COVID infection is mild. “A common cold or some sniffles in a fully vaxxed and boosted healthy individual,” is how Eric Bortz, a University of Alaska-Anchorage virologist and public health expert, described it to The Daily Beast.

All that is to say, Omicron could have been a lot worse. Viruses evolve to survive. That can mean greater transmissibility, antibody-evasion or more serious infection. Omicron mutated for the former two. There’s a chance some future Sigma or Upsilon lineage could do all three.

When it comes to viral mutations, “extreme events can occur at a non-negligible rate, or probability, and can lead to large consequences,” Michael said. Imagine a lineage that’s as transmissible as Omicron but also attacks the lungs like Delta tends to do. Now imagine that this hypothetical lineage is even more adept than Omicron at evading the vaccines.

2022’s Hottest New Illness: Flurona

That would be the nightmare lineage. And it’s entirely conceivable it’s in our future. There are enough vaccine holdouts, such as the roughly 50 million Americans who say they’ll never get jabbed, that the SARS-CoV-2 pathogen should have ample opportunities for mutation.

“As long as we have unvaccinated people in this country—and across the globe—there is the potential for new and possibly more concerning viral variants to arise,” Aimee Bernard, a University of Colorado immunologist, told The Daily Beast.

Worse, this ongoing viral evolution is happening against a backdrop of waning immunity. Antibodies, whether vaccine-induced or naturally occurring from past infection, fade over time. It’s not for no reason that health agencies in many countries urge booster doses just three months after initial vaccination. The U.S. Centers for Disease Control and Prevention is an outlier, and recommends people get boosted after five months.

A lineage much worse than Omicron could evolve at the same time that antibodies wane in billions of people all over the world. That’s why many experts believe the COVID vaccines will end up being annual or even semi-annual jabs. You’ll need a fourth jab, a fifth jab, a sixth jab, et cetera, forever.

Israel, a world leader in global health, is already turning that expectation into policy. Citing multiple studies that showed a big boost in antibodies with an additional dose of mRNA and no safety concerns, the country’s health ministry this week began offering a fourth dose to anyone over the age of 60, who tend to be more vulnerable to COVID than younger people.

That should be the standard everywhere, Ali Mokdad, a professor of health metrics sciences at the University of Washington Institute for Health, told The Daily Beast. “Scientifically, they’re right,” he said of the Israeli health officials.

If there’s a downside, it’s that there are still a few poorer countries—in Africa, mostly—where many people still struggle to get access to any vaccine, let alone boosters and fourth doses. If and when other richer countries follow Israel’s lead and begin offering additional jabs, there’s some risk of even greater inequity in global vaccine distribution.

“The downside is for the rest of the world,” Mokdad said. “I’m waiting to get my first dose and you guys are getting a fourth?”

The solution isn’t to deprive people of the doses they need to maintain their protection against future—and potentially more dangerous—lineages. The solution, for vaccine-producing countries, is to further boost production and double down on efforts to push vaccines out to the least privileged communities.

A sense of urgency is key. For all its rapid spread, Omicron has actually gone fairly easy on us. Sigma or Upsilon might not.

The 1918 flu is even more relevant in 2022 thanks to omicron

Over the past two years, historians and analysts have compared the coronavirus to the 1918 flu pandemic. Many of the mitigation practices used to combat the spread of the coronavirus, especially before the development of the vaccines, have been the same as those used in 1918 and 1919 — masks and hygiene, social distancing, ventilation, limits on gatherings (particularly indoors), quarantines, mandates, closure policies and more.

Yet, it may be that only now, in the winter of 2022, when Americans are exhausted with these mitigation methods, that a comparison to the 1918 pandemic is most apt.

The highly contagious omicron variant has rendered vaccines much less effective at preventing infections, thus producing skyrocketing caseloads. And that creates a direct parallel with the fall of 1918, which provides lessons for making January as painless as possible.

In February and March 1918, an infectious flu emerged. It spread from Kansas, through World War I troop and material transports, filling military post hospitals and traveling across the Atlantic and around the world within six months. Cramped quarters and wartime transport and industry generated optimal conditions for the flu to spread, and so, too, did the worldwide nature of commerce and connection. But there was a silver lining: Mortality rates were very low.

In part because of press censorship of anything that might undermine the war effort, many dismissed the flu as a “three-day fever,” perhaps merely a heavy cold, or simply another case of the grippe (an old-fashioned word for the flu).

Downplaying the flu led to high infection rates, which increased the odds of mutations. And in the summer of 1918, a more infectious variant emerged. In August and September, U.S. and British intelligence officers observed outbreaks in Switzerland and northern Europe, writing home with warnings that went largely unheeded.

Unsurprisingly then, this seemingly more infectious, much more deadly variant of H1N1 traveled west across the Atlantic, producing the worst period of the pandemic in October 1918. Nearly 200,000 Americans died that month. After a superspreading Liberty Loan parade at the end of September, Philadelphia became an epicenter of the outbreak. At its peak, nearly 700 Philadelphians died per day.

Once spread had begun, mitigation methods such as closures, distancing, mask-wearing and isolating those infected couldn’t stop it, but they did save many lives and limited suffering by slowing infections and spread. The places that fared best implemented proactive restrictions early; they kept them in place until infections and hospitalizations were way down, then opened up gradually, with preparations to reimpose measures if spread returned or rates elevated, often ignoring the pleas of special interests lobbying hard for a complete reopening.

In places in the United States where officials gave in to public fatigue and lobbying to remove mitigation methods, winter surges struck. Although down from October’s highs, these surges were still usually far worse than those in the cities and regions that held steady.

In Denver, in late November 1918, an “amusement” lobby — businesses and leaders invested in keeping theaters, movie houses, pool halls and other public venues open — successfully pressured the mayor and public health officials to rescind and then revise a closure order. This, in turn, generated what the Rocky Mountain News called “almost indescribable confusion,” followed by widespread public defiance of mask and other public health prescriptions.

In San Francisco, where resistance was generally less successful than in Denver, there was significant buy-in for a second round of masking and public health mandates in early 1919 during a new surge. But opposition created an issue. An Anti-Mask League formed, and public defiance became more pronounced. Eventually anti-maskers and an improving epidemic situation combined to end the “masked” city’s second round of mask and public health mandates.

The takeaway: Fatigue and removing mitigation methods made things worse. Public officials needed to safeguard the public good, even if that meant unpopular moves.

The flu burned through vulnerable populations, but by late winter and early spring 1919, deaths and infections dropped rapidly, shifting toward an endemic moment — the flu would remain present, but less deadly and dangerous.

Overall, nearly 675,000 Americans died during the 1918-19 flu pandemic, the majority during the second wave in the autumn of 1918. That was 1 in roughly 152 Americans (with a case fatality rate of about 2.5 percent). Worldwide estimates differ, but on the order of 50 million probably died in the flu pandemic.

In 2022, we have far greater biomedical and technological capacity enabling us to sequence mutations, understand the physics of aerosolization and develop vaccines at a rapid pace. We also have a far greater public health infrastructure than existed in 1918 and 1919. Even so, it remains incredibly hard to stop infectious diseases, particularly those transmitted by air. This is complicated further because many of those infected with the coronavirus are asymptomatic. And our world is even more interconnected than in 1918.

That is why, given the contagiousness of omicron, the lessons of the past are even more important today than they were a year ago. The new surge threatens to overwhelm our public health infrastructure, which is struggling after almost two years of fighting the pandemic. Hospitals are experiencing staff shortages (like in fall 1918). Testing remains problematic.

And ominously, as in the fall of 1918, Americans fatigued by restrictions and a seemingly endless pandemic are increasingly balking at following the guidance of public health professionals or questioning why their edicts have changed from earlier in the pandemic. They are taking actions that, at the very least, put more vulnerable people and the system as a whole at risk — often egged on by politicians and media figures downplaying the severity of the moment.

Public health officials also may be repeating the mistakes of the past. Conjuring echoes of Denver in late 1918, under pressure to prioritize keeping society open rather than focusing on limiting spread, the Centers for Disease Control and Prevention changed its isolation recommendations in late December. The new guidelines halved isolation time and do not require a negative test to reenter work or social gatherings.

Thankfully, we have an enormous advantage over 1918 that offers hope. Whereas efforts to develop a flu vaccine a century ago failed, the coronavirus vaccines developed in 2020 largely prevent severe illness or death from omicron, and the companies and researchers that produced them expect a booster shot tailored to omicron sometime in the winter or spring. So, too, we have antivirals and new treatments that are just becoming available, though in insufficient quantities for now.

Those lifesaving advantages, however, can only help as much as Americans embrace them. Only by getting vaccinated, including with booster shots, can Americans prevent the health-care system from being overwhelmed. But the vaccination rate in the country remains a relatively paltry 62 percent, and only a scant 1 in 5 have received a booster shot. And as in 1918, some of the choice rests with public officials. Though restrictions may not be popular, officials can reimpose them — offering public support where necessary to those for whom compliance would create hardship — and incentivize and mandate vaccines, taking advantage of our greater medical technology.

As the flu waned in 1919, one Portland, Ore., health official reflected that “the biggest thing we have had to fight in the influenza epidemic has been apathy, or perhaps the careless selfishness of the public.”

The same remains true today.

Vaccines, new treatments and century-old mitigation strategies such as masks, distancing and limits on gatherings give us a pathway to prevent the first six weeks of 2022 from being like the fall of 1918. And encouraging news about the severity of omicron provides real optimism that an endemic future — in which the coronavirus remains but poses far less of a threat — is near. The question is whether we get there with a maximum of pain or a minimum. The choice is ours.

Many Americans Remain Uninsured Following Layoffs

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See if Coverage Loss Qualifies for Special Enrollment Period Today |  HealthCare.gov

Job losses from the COVID-19 pandemic are the highest since the Great Depression. A year and a half later, most Americans who lost their health insurance along with their job remain uninsured.

Most Americans who lost their jobs and health insurance more than a year ago remain uninsured.

Over 1,200 Americans who are still unemployed due to COVID-19 were surveyed by AffordableHealthInsurance.com. At least four out of five in all participants don’t have insurance coverage.

To be exact, 56% of Americans who remain unemployed since being laid off due to the COVID-19 pandemic lost their health insurance along with their job. In addition, 23% of workers did not have employer-provided health insurance prior to losing their jobs.

Even before the pandemic, small businesses struggled to absorb the cost of providing health insurance to their employees, said health insurance advisor and nursing consultant Tammy Burns in the Affordable Health Insurance study.

“Companies have cut costs by going with high-deductible plans and sharing less of the cost towards the insurance,” Burns said. “This makes it cheaper for employees to get their own health insurance through the Affordable Care Act (ACA) marketplace. At larger companies, health care costs are growing faster than worker wages, so a large amount of an employee’s check goes to insurance. Therefore, many workers opt out because they can’t afford it.”

Majority of Those Who Lost Health Insurance Still Lack Coverage

Of the 56% of unemployed Americans who lost their health insurance along with their job, 81% are still uninsured.

This lack of coverage is impacting certain groups more than others. There are also several contributing factors to why the number of unemployed Americans without health insurance remains high.

These factors are:

  • Men more likely to remain uninsured than women

When broken down by gender, men are more likely than women to have lost their health insurance when they lost their jobs at 66% and 44%, respectively. However, women are twice as likely as men to have not had health insurance in the first place at 31% and 16%, respectively.

Currently, men are slightly more likely to still be uninsured. Eighty-four percent of male survey respondents do not currently have health insurance, compared to 75% of women.

  • Majority of unemployed Millennials, Gen Xers still uninsured

Our survey also found that certain age groups are more likely than others to still be uninsured after a pandemic-related job loss.

Eighty-six percent of individuals ages 35 to 44, and 84% of both 25 to 34 year-olds and 45 to 54 year-olds remain without health insurance after being laid off. Comparatively, 67% of unemployed individuals 18 to 24, and 58% of those older than 55 are still uninsured.

Americans ages 25 to 44 are also the age group most likely to have lost their health insurance when they were let go from their jobs (66%).

  • Inability to Afford Private Insurance The Top Reason to Remain Uninsured

The high cost of individual insurance is the number one reason Americans still unemployed from the pandemic remain uninsured.

Sixty-seven percent of those uninsured can’t afford private health insurance. Eleven percent of people who still lack health insurance say they did not qualify for government-funded health insurance, despite the fact that a number of states expanded access to Medicaid during the pandemic.

A lack of understanding about how the ACA marketplace works may also play a role in why uninsured Americans are not pursuing all possible avenues to get health insurance.

“People are scared of the ACA because it involves a lot of personal information, like taxes,” Burns said. “I have found that many people are afraid it is ‘the government being in my business.’ There is a lack of knowledge about how helpful and affordable the ACA is now. There needs to be better education about this program.”

  • One in five uninsured Americans choose not to have health insurance

The survey also found 20% of unemployed Americans who are uninsured choose to forgo health insurance altogether.

This is particularly true for men, 22% of whom are choosing not to have health insurance, compared to 15% of women.

Younger adults are also more likely than older Americans to opt out of health insurance if they are unemployed. Twenty-five percent of 25 to 34 year-olds, and 20% of 25 to 34 year-olds choose not to have health insurance.

  • Medication, Routine Checkups Skipped Due to Lack of Insurance

A lack of insurance has serious short- and long-term implications for individuals’ health and well-being. The biggest impact: 58% of uninsured individuals are no longer getting routine care, which could hinder their ability to identify more serious underlying issues.

Other impacts include no longer taking doctor-prescribed medication (56%); delaying planned medical procedures (46%); not seeking treatment for chronic issues (44%), and no longer receiving mental health treatment (41%).

  • Three-quarters of older Americans not getting regular check-ups

Our survey also found that those at greater risk for medical issues, based on age, are the most likely to be skipping their routine check-ups. Three-fourths of uninsured individuals over the age of 55 (76%) say they are not going for regular doctor visits because of their lack of insurance, the highest percentage of any age group.

Meanwhile, 64% of individuals 35 to 44 are not taking doctor-prescribed medication, which can have both short- and long-term negative effects.

  • Majority of Uninsured Americans “Very likely” to be Financially Devastated by Medical Emergency

Given that so many individuals are already hard-pressed to afford health insurance, it’s not surprising that many of them will also be in a dangerous place financially if there is a medical emergency.

Fifty-nine percent of uninsured people are “very likely” to be financially devastated by a medical emergency, while another quarter are “somewhat likely” to face financial ruin in the event of a medical emergency.

We’ll Never Be Rid of COVID, Fauci Says

A photo of Anthony Fauci, MD

On the spectrum from active outbreak to eradication, control is the most likely path forward for COVID-19 in the U.S., NIAID Director Anthony Fauci, MD, said during a National Press Club briefing today.

Fauci’s words served as a reality check for those holding out hope that COVID-19 one day might be as rare as measles or polio in America.

“We’re never going to eradicate this,” he said. “We’ve only eradicated one virus, and that’s smallpox. Elimination may be too aspirational, because we’ve only done that with infections for which we’ve had a massive vaccination campaign like polio and measles. Even though we haven’t eradicated [those viruses] from the planet, we have no cases, with few exceptions, in the U.S.”

Fauci said the country should focus on control — a level of infection “that isn’t zero, but that with the combination of the vast majority of the population vaccinated and boosted, together with those who recovered from infection and also are hopefully boosted, that we will get a level of control that will be non-interfering with our lives, our economy, and the kinds of things we would do, namely to get back to some degree of normality.”

“It’s not going to be eradication, and it’s likely not going to be elimination,” he said again later in the briefing. “It’s going to be a low, low, low level of infection that really doesn’t interfere with our way of life, our economy, our ability to move around in society, our ability to do things in closed indoor spaces.”

Fauci said the only way to achieve this will be with vaccinations, boosters, and mitigation strategies such as wearing masks in congregate settings.

“Over time, we feel confident we will get this under control,” he said. While he said he “hopes” this comes in the “next several months,” he cautioned that he “never predict[s], because you never get it right. Sure enough, someone will come back and say, ‘You said this in December and you were wrong.'”

In terms of boosters, Fauci said it’s possible that a third shot — “and maybe an additional one” — will be enough to provide durable immunity, but that “we’ll just have to wait and see. We don’t know yet.”

Kids under age 5 who have yet to be vaccinated will have to wait a few more months to get their shots, he added. While the lower, 3 μg dose of the Pfizer vaccine looked sufficient for children ages 6 months up to 2 years, that dose was not sufficient for those ages 2 to 5, he said.

“The company decided that they believe this is really a three-dose vaccine, and there’s no doubt if you give three doses you’re going to get an effective and safe vaccine,” he said. “But they haven’t proven it yet, so that’s the delay.”

“I can guarantee you it’s going to be effective,” Fauci added.

Data aren’t expected until the end of the first quarter of 2022, he said, meaning vaccines for this pediatric population likely won’t be available until “a few months into 2022.”

Health officials say omicron variant likely to cause record-high coronavirus cases, hospitalizations in U.S.

Top government health officials on Sunday warned that the United States will probably see record numbers of coronavirus cases and hospitalizations as the omicron variant spreads rapidly and forces Americans to again grapple with the dangers of a pandemic that has upended life around the globe.

“Unfortunately, I think that that is going to happen. We are going to see a significant stress in some regions of the country on the hospital system, particularly in those areas where you have a low level of vaccination,” Anthony S. Fauci, the nation’s leading infectious-disease specialist, said on CNN’s “State of the Union” when asked whether the United States could see record numbers of cases, hospitalizations and deaths.

Fauci described the variant as “extraordinary” in its transmissibility, with a doubling time of two to three days. It accounts for 50 percent of coronavirus cases in parts of the country, which meant it would almost certainly take over as the dominant variant in the United States, he added.

“It is going to be a tough few weeks, months, as we get deeper into the winter,” Fauci said.

On CBS News’s “Face the Nation,” Francis Collins, director of the National Institutes of Health, said that cases will rise steeply over the next couple of weeks and that the country could soon see 1 million new cases a day tied to the omicron variant, dramatically exceeding the record of about 250,000 new cases per day set in January.

“The big question is, are those million cases going to be sick enough to need health care and especially hospitalization?” Collins said. “We’re just holding our breath to see how severe this will be.”

Fauci and Collins painted a stark but realistic picture of the winter ahead, on the heels of a week of coronavirus-related setbacks. Coronavirus cases, hospitalizations and deaths rose across much of the country last week, with officials warning of a surge just as millions of Americans — already weary after nearly two years of the pandemic — are expected to travel for Christmas and New Year’s. On Friday, Pfizer and BioNTech announced that coronavirus vaccines for children younger than 5 would be pushed back further into 2022, as the companies modified their trials to include a third dose. On Sunday, New York, one of the country’s early epicenters in the pandemic, reported 22,478 cases.

Health officials have continued to urge the unvaccinated to get their shots and those who have received only two doses of either the Pfizer or Moderna mRNA vaccines to get booster doses. Vaccines cannot be the only layer of protection against the omicron variant, Fauci said, but defeating the pandemic would not be possible without them.

There are still safe ways for vaccinated people to get together for the holidays, including wearing a mask while traveling, testing beforehand and knowing the vaccination status of everyone present at indoor celebrations, Fauci said on “Face the Nation.”

“If you do these things, I do believe that you can feel quite comfortable with a family setting,” he said. “Nothing is 100 percent risk-free, but I think if you do the things that I just mentioned, you’d actually mitigate that risk enough to feel comfortable about being able to enjoy the holiday.”

Collins stopped short of urging people to cancel holiday plans but said travel will be risky even for vaccinated people.

“This virus is going to be all around us,” he said. “I’m not going to say you shouldn’t travel, but you should do so very carefully. … People are going, ‘I’m so sick of hearing this,’ and I am, too. But the virus is not sick of us, and it is still out there looking for us, and we’ve got to double down on these things if we’re going to get through the next few months.”

Doctors, nurses and others are warning that the nation’s health system continues to be strained by an unending stream of coronavirus cases. Confirmed U.S. coronavirus infections have surpassed more than 128,000 per day and confirmed virus deaths are near 1,300 per day, according to The Washington Post’s rolling seven-day average.

“For people trained to save lives, this moment is frustrating, exhausting and heartbreaking,” the American Hospital Association, the American Medical Association and the American Nurses Association said in a joint statement on Friday, urging more Americans to get booster shots.

Public health experts are bracing for a winter surge of cases driven by the omicron variant, which can evade some protection conferred by vaccinations and prior infections, as well as cases linked to the delta variant. Officials caution that they are still relying on preliminary data about the omicron variant’s severity compared with earlier forms of the virus.

President Biden plans to address the nation Tuesday on the status of the country’s fight against the virus, the White House said Saturday.

“We are prepared for the rising case levels,” White House press secretary Jen Psaki wrote on Twitter, adding that Biden “will detail how we will respond to this challenge. He will remind Americans that they can protect themselves from severe illness from COVID-19 by getting vaccinated and getting their booster shot when they are eligible.”

The speech, coming just before Christmas and New Year’s Day, underlines Biden’s struggle to contain the pandemic nearly a year into office. On top of the emergence of new variants and attendant challenges, the administration has at times faced criticism for what some have described as mixed signals.

Biden won high marks from the public during the first half of the year as cases declined, the country opened up from shutdowns and vaccines became widely available. But the past few months have been more difficult. After he gave a speech on July 4 saying the country was “closer than ever to declaring our independence from a deadly virus,” the situation started changing. Case rates increased as the delta variant gained a foothold and many Americans refused to get vaccinated.

And despite Biden’s promise that at-home rapid tests would become a widely available tool to fight the coronavirus, the tests remain hard to find in many parts of the country and are more expensive than in some other places across the globe.

Fauci conceded Sunday that the administration needed to do better on increasing the availability of at-home coronavirus rapid tests, though he emphasized that the country was in a much better place than it was a year ago, with 200 million to 500 million tests available per month, many of them free.

“We’re going in the right direction,” he said on CNN. “We really need to flood the system with testing. We need to have tests available for anyone who wants them, particularly when we’re in a situation right now where people are going to be gathering.”

The omicron variant also has challenged the nation’s coronavirus medicine cabinet, with evidence that mutations will wipe out or weaken the effectiveness of treatments that can reduce the virus’s severity and keep people out of hospitals. As a result, the Biden administration around Thanksgiving paused distribution of sotrovimab, the one monoclonal antibody that remains effective against the omicron variant, with senior officials such as David Kessler calculating that the drug should be maximally deployed when the variant becomes more prevalent.

By Thursday, administration officials decided to resume shipments of the drug, amid indicators that the omicron variant was spreading faster in states such as New York and Washington than data published by the Centers for Disease Control and Preventionearlier in the week indicated, said two officials with knowledge of the deliberations.

“Shipment of product will begin soon, and jurisdictions will see product arrive as early as Tuesday, December 21, 2021,” the federal health agency said in a statement on Friday, announcing that about 55,000 doses of sotrovimab would soon go out.

Doctors said they were desperate for treatments like sotrovimab as emergency rooms begin to crowd and case numbers soar.

“Too slow! We are already seeing widespread omicron,” texted one infectious-disease doctor at a large New York City hospital, who estimated that at least 50 percent of patients had contracted the variant and requested confidentiality to discuss patient care. “It’s a lot of hospitalizations that could have potentially [been] averted because of slow response.”

Fauci said Sunday that he expected it to be months before antiviral drugs can be mass-produced and available to anyone who needs them. While he did not foresee the kind of shutdowns that were put in place in the early days of the pandemic, Fauci also noted that it would be difficult to keep the virus under control when there remained “about 50 million people in the country who are eligible to be vaccinated who are not vaccinated.”

Similarly, several governors on Sunday shied away from the possibility of implementing more shutdowns to fight the spread of the new variant. Maryland Gov. Larry Hogan (R) said on “Fox News Sunday” that his state, which has seen a 150 percent increase in hospitalizations over the past two weeks, was not considering shutdowns and instead was putting more resources into testing and encouraging vaccinations and boosters. New Jersey Gov. Phil Murphy (D) said on the same show that shutdowns remained “on the table” but that he didn’t think such a move was likely because a high percentage of the state’s population was vaccinated.

Colorado Gov. Jared Polis (D) emphasized that people in his state should keep themselves safe with “individual freedom and local control.” He also said Colorado officials were looking to change the definition of “fully vaccinated” to include three shots, as health officials in the country and around the world have signaled in recent days they are also considering.

“That’s certainly where it’s headed,” Polis said on NBC News’s “Meet the Press.” “I wish they’d stop talking about [the third shot] as a booster. It really is a three-dose vaccine.”

CDC: Omicron accounted for 73% of recent COVID-19 cases

COVID testing in NYC

The Omicron variant accounted for more than 73% of recent COVID-19 cases in the U.S., according to Centers for Disease Control and Prevention’s updated data released on Monday.

The big picture: The data showed nearly a six-fold increase in Omicron’s share of COVID-19 infections in just one week.

What they’re saying: “These numbers are stark, but they’re not surprising,” said Rochelle Walensky, the CDC’s director, adding that the growing infections reflect what has been seen in other countries.

  • While the Delta variant still drives up a lot of new infections, Walensky told AP she anticipates “that over time that Delta will be crowded out by Omicron.”

What’s next: President Biden on Tuesday will deliver a speech outlining new steps the administration will take to address the rapid spread of the new variant.

Federal appeals court revives Biden’s vaccine mandate for health workers in 26 states

https://www.fiercehealthcare.com/hospitals/federal-appeals-court-revives-biden-s-vax-mandate-for-health-workers-26-states?utm_source=email&utm_medium=email&utm_campaign=HC-NL-FierceHealthcare&oly_enc_id=8564C4000334E5C

A federal appeals court has reinstated in 26 states a Biden administration vaccination mandate for health workers at hospitals that receive federal funding.

A three-judge panel of the 5th U.S. Circuit Court of Appeals in New Orleans ruled (PDF) that a lower court had the authority to block the mandate in only the 14 states that had sued and was wrong to impose a nationwide injunction.

It marks a modest win for the Biden administration’s pandemic strategy following a series of legal setbacks to the health worker vaccine mandate. Numerous lawsuits have been filed seeking to block vaccine mandates issued by governments and businesses as public health measures amid a pandemic that has killed more than 800,000 Americans.

The Centers for Medicare & Medicaid Services (CMS) announced in early November that it would be requiring applicable healthcare facilities to have a policy in place ensuring that eligible staff receive their first dose of a COVID-19 vaccine series by Dec. 5 and to have completed their series by Jan. 4, 2022. Failure to comply with the requirement, which covers 17 million healthcare workers, would place an organization’s Medicare funding in jeopardy.

But the mandate was blocked before the deadline and remains temporarily blocked in 24 states: the 14 states involved in the case reviewed by the New Orleans appeals court and 10 states where the mandate was blocked by a Nov. 29 ruling from a federal judge in St. Louis.

The 14 states that sued are Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah and West Virginia.

In the lawsuits, states argued that CMS exceeded its authority with the rule and did not have good cause to forego the required notice and comment period. States that sued the Biden administration over the vaccine mandate also cited the ongoing workforce shortages affecting healthcare providers in their states.

In explaining its ruling, the 5th Circuit noted that the Louisiana-based federal judge had given “little justification for issuing an injunction outside the 14 states that brought this suit.”

As it stands, the vaccine requirement for Medicare and Medicaid providers is blocked by courts in about half of U.S. states but not in the other half, creating the potential for patchwork enforcement across the country.

Healthcare associations, individual experts and the Biden administration have all stood firm on the importance of vaccination mandates, with the novel omicron variant only adding to the president’s urgency to get shots in arms.  

However, the administration’s broader requirements have so far faced stiff competition from courts as well as right-leaning lawmakers and governors alike.

A Texas judge Wednesday separately granted a preliminary injunction to the state of Texas against the vaccine mandate, The Hill reported.

The Supreme Court this week also blocked a challenge to New York’s requirement that healthcare workers be vaccinated against COVID-19 even when they cite religious objections.

America Is Not Ready for Omicron

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 endgameendemicitythe 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

Individualism couldn’t beat Delta, it won’t beat Omicron, and it won’t beat the rest of the Greek alphabet to come.

Self-interest is self-defeating, and as long as its hosts ignore that lesson, the virus will keep teaching it.

Supreme Court hears 340B rate cut case

https://mailchi.mp/016621f2184b/the-weekly-gist-december-3-2021?e=d1e747d2d8

Earlier this week, the American Hospital Association (AHA) made its case before the US Supreme Court, in opposition to Medicare reimbursement cuts to hospitals that participate in the 340B Drug Pricing Program. The program allows hospitals that serve low-income patients to purchase outpatient drugs at a discount.

In the graphic above, we look at what’s at stake for hospitals in the case. Beginning in 2018, Medicare cut reimbursement for 340B-eligible drugs purchased by most hospitals by 28.5 percentage points, amounting to roughly $1.6B annually—which was a significant hit to hospitals’ 340B revenue. As we recently discussed, that revenue has become essential for many hospitals’ financial sustainability. However, the true impact on hospital bottom lines is more nuanced, as the savings from 340B rate cuts are being redistributed to all hospitals that participate in the Outpatient Prospective Payment System (OPPS), regardless of their 340B status, via a 3.2 percent payment bump for non-drug Part B services. While the cut negatively impacts those with large 340B programs—generally larger hospitals located in urban areas—the resulting redistribution actually provides a net benefit to about four in five hospitals.

Although 340B program revenues are at stake, the broader legal question before the Court centers on the level of authority federal agencies like the Centers for Medicare & Medicaid Services (CMS) have to create regulations to interpret ambiguous laws. (If the justices rule against CMS, it will overturn a key legal doctrine known as the Chevron Defense, which compels courts to defer to an agency’s interpretation of unclear statutes.)

A ruling isn’t expected until next spring, but regardless of the outcome, the 340B program faces other threats, chiefly from several lawsuits involving large pharmaceutical manufacturers’ moves to restrict discounted product sales to contract pharmacies. Undoubtedly, the ongoing scrutiny of the 340B program will continue to raise questions about whether there are better ways to subsidize the operations of hospitals serving low-income patients and ensure that underserved patients have access to lifesaving treatments.

Chevron deference at stake in fight over payments for hospital drugs

Chevron deference at stake in fight over payments for hospital drugs -  SCOTUSblog

How much should we pay for drugs? That’s the question at the center of American Hospital Association v. Becerra, a sleeper of a case involving billions of dollars in federal spending and a chance to reshape two doctrines at the heart of administrative law.

Drugs, money, and the law: Sounds sexy, right? Still, you could be forgiven for never having heard of the case, which will be argued on Tuesday. It arises out of a technical dispute over how Medicare, the federal program that insures 63 million elderly and disabled people, pays for some of the drugs that hospitals dispense to patients in outpatient departments — in particular, chemotherapy drugs and other expensive anti-cancer medications.

The case centers on part of a 2003 law that gives Medicare two options for how to pay for those drugs. Under the first option, Medicare would survey hospitals about what it cost them to acquire the drugs. Medicare would then draw on the survey data and reimburse hospitals for their “average acquisition costs,” subject to variations for different types of hospitals. It’s a rough-cut way to make hospitals whole without requiring them to submit receipts for every drug purchase.

But Medicare immediately encountered a problem: It just wasn’t practical to survey hospitals about their acquisition costs. Fortunately, the law anticipated that possibility and gave Medicare a second option. In the absence of survey data, Medicare could pay the “average price” for the drug, “as calculated and adjusted by the Secretary [of Health and Human Services] as necessary for purposes of this [option].”

This approach turned out to be costly. A drug’s “average price” is fixed elsewhere in the Medicare statute, typically at 106% of the drug’s sale price. As a policy matter, this “average sales price plus 6%” approach is hard to defend. Because 6% of a large number is bigger than 6% of a small number, hospitals have an incentive to dispense more expensive drugs, even when there are cheaper and equally effective therapies.

Other developments soon made the payment policy look even more dubious. Back in 1992, Congress created something called the 340B program to support health-care providers that serve poor and disadvantaged communities. Eligible providers get steep discounts on the drugs that they purchase — anywhere between 20% and 50% of the normal price.

Initially, few hospitals qualified for the 340B program. Today, more than two-thirds of nonprofit hospitals participate. (For-profits are excluded from the program.) For years, Medicare kept paying those 340B hospitals 106% of the average sales price of their outpatient drugs. The upshot was that hospitals were buying highly discounted drugs and then charging the federal government full price. That heightened the incentive to prescribe very expensive medications — which is partly why Medicare spending on outpatient drugs has ballooned, growing an average of 8.1% per year from 2006 through 2017.

Federal regulators were troubled by the gap between hospital costs and Medicare payments. In their view, the point of the 2003 statute was to cover hospitals’ costs, not to subsidize 340B hospitals. That jibes with the Medicare statute more generally: Its “overriding purpose” is to provide “reasonable (not excessive or unwarranted) cost-based reimbursement.”

So Medicare adopted a rule that, starting in 2018, slashed the reimbursement rate for 340B hospitals’ outpatient drugs (or, more precisely, a subset of them) to 22.5% less than the average sales price. That was still generous, since on average the 340B discount is about one-third of a drug’s price. But it was much less generous than before, and Medicare estimated that the change would save taxpayers $1.6 billion every year.

The American Hospital Association, together with two hospital trade groups and three hospitals, filed suit. Had Medicare chosen option one, the plaintiffs argued, it could have focused on acquisition costs and even distinguished among hospital groups in setting payment rates. Instead, it chose option two, which says that Medicare must pay a drug’s “average price” — not its acquisition price — and doesn’t provide for discriminating between hospitals. While the plaintiffs acknowledged that Medicare could “adjust” the average price, they argued that a cut from 106% to 77.5% of the average sales price was not really an adjustment. It was a wholesale revision of the statutory scheme.

The plaintiffs encountered an obstacle right out of the gate. To prevent courts from second-guessing Medicare’s choices about how much to pay for outpatient care, the Medicare statute says that “[t]here shall be no administrative or judicial review” of those choices. In the government’s telling, Congress precluded review because Medicare has a fixed annual budget for outpatient care. Increasing payments for one type of care thus requires cutting payments for other types of care.

That linkage means that, if the plaintiffs win, it’s not just that they should have been paid more for certain drugs. It’s that all hospitals should have been paid less for other services. (That helps explains why coalitions representing rural and for-profit hospitals have filed amicus briefs in support of Medicare.) Unwinding that decision would be an administrative nightmare — which is why Congress precluded review in the first place.

As the plaintiffs see it, however, the government simply misreads the scope of the preclusion language. Though it generally precludes review of reimbursement decisions relating to outpatient care, it doesn’t cross-reference the subsection relating to outpatient drugs. Both the district court and the U.S. Court of Appeals for the District of Columbia Circuit agreed, invoking the strong presumption favoring judicial review of agency action.

On the merits, the plaintiffs fared less well. Though they won in the district court, the D.C. Circuit held that Medicare reasonably read the 2003 law to allow it to align hospital reimbursement with hospital acquisition costs. Medicare’s interpretation — and the scope of its authority to “adjust” payment rates — was thus owed deference under Chevron U.S.A. Inc. v. Natural Resources Defense Council, a 1984 decision holding that courts generally should defer to agencies’ reasonable interpretations of ambiguous statutes. Judge Cornelia Pillard dissented, arguing that the statute unambiguously foreclosed Medicare’s interpretation.

The plaintiffs asked the Supreme Court to review a single question: whether Medicare should receive Chevron deference for interpreting the 2003 law in the manner that it did. Tantalizingly, the plaintiffs noted that “[i]t is no secret that members of this Court have raised concerns about whether Chevron deference, particularly when applied as indiscriminately as it was in this case, violates the separation of powers.”

The Supreme Court bit. In its order granting certiorari, however, the court instructed the parties to brief an additional question: whether the Medicare statute precludes the lawsuit. What that means is that — in addition to resolving whether hospitals are entitled to billions of taxpayer dollars — the court will have the chance to address two foundational doctrines of administrative law: the presumption of reviewability and Chevron deference.

Arguably, AHA v. Becerra offers an unusually vivid example of the costs of a strong presumption of reviewability. If the plaintiffs win, what’s the remedy? Is Medicare supposed to reopen every outpatient payment decision that it’s made since 2018, given that paying more for 340B drugs means it should have paid less for other services? The plaintiffs say no, arguing that Medicare wouldn’t be required to make any retroactive adjustments. But the government fears otherwise and the answer is not at all clear. Isn’t that the kind of mess that preclusion is meant to avoid?

I’ve called in my academic work for abandoning the presumption of reviewability precisely because it disrespects Congress’ reasonable desire to shield some administrative decisions from judicial review. In recent years, however, the Supreme Court has evinced no interest in doing so — the presumption of reviewability remains “strong.” We may soon find out just how strong it is.

But the big question about the case is whether the court will use it as a vehicle to reconsider Chevron deference. In the plaintiffs’ view, it is galling — “an affront to the separation of powers” — that the courts would defer when Medicare has exploited a purported ambiguity to sidestep Congress’ clear instructions about how much to pay hospitals. Several of the conservative justices, including in particular Justices Clarence Thomas and Neil Gorsuch, may be receptive to the argument. If so, the right wing of the court could use the case to narrow or even overturn Chevron, with potentially dramatic implications for the scope of executive-branch power.

Whether the court will do so is anyone’s guess. The justices could easily resolve the case on narrower grounds. Maybe the statute unambiguously forecloses Medicare’s interpretation of the law, as the plaintiffs argue. Or maybe, as the government claims, Medicare properly exercised its explicit authority to “adjust” prices for outpatient drugs.

Neither of those holdings would be the sexiest decision that the Supreme Court has ever issued. It would be technical, arcane — even boring. Given the financial stakes, however, it would be significant nonetheless.

https://ballotpedia.org/Chevron_deference_(doctrine)