Nearly half of recent COVID-19 cases in Seoul breakthrough infections: city gov't

 Nearly half of all recent COVID-19 cases in Seoul were breakthrough infections, a Seoul city official said Tuesday.

"Of the 646 new cases confirmed in Seoul on Sunday, 49.4 percent, or 319 cases, were breakthrough cases," Park Yoo-mi, a disease control official at the Seoul metropolitan government, said in a briefing.

"The rate of breakthrough infections in Seoul is higher than the nationwide average," she noted.

According to the city government, Seoul has recorded 12,663 breakthrough infections so far.

Of them, 5,164 cases involved those who were inoculated with the AstraZeneca vaccine, 4,818 with the Pfizer vaccine and 2,030 with the Janssen vaccine. The rest received Moderna or other kinds of COVID-19 vaccines.

The official advised senior citizens and those with underlying diseases, for whom a vaccine booster shot is currently available, to receive the additional dose.

As of Tuesday, 76.7 percent, or about 7.28 million, of all residents in Seoul have been fully vaccinated against COVID-19, the city government said.

https://www.koreatimes.co.kr/www/nation/2021/11/119_318072.html

Delta variant, AY.4.2, has been spotted in 8 states

 A potentially faster-spreading "sub-lineage" of the coronavirus Delta variant named AY.4.2 has been spotted by labs in at least 8 states, and health authorities in the United Kingdom say they are investigating a growing share of cases from this strain of the virus.

Labs in California, Florida, Maryland, Massachusetts, Nevada, North Carolina, Rhode Island and Washington state, plus the District of Columbia, have so far spotted at least one case of AY.4.2.

While it may spread somewhat faster, health authorities have not found evidence of more severe illness caused by the variant, and they say current vaccines remain effective against it.

The sub-lineage has remained a small fraction of circulating cases in the U.S. for several weeks, but American health officials say they are already ramping up efforts to study the new Delta variant descendant. 

"We have teams that are constantly reviewing the genetic sequence data and looking for blips, an increase in a certain proportion or just something that's completely new," says Dr. Summer Galloway, executive secretary of the U.S. government's SARS-CoV-2 Interagency Group. 

Galloway, who also serves as policy lead on the CDC's laboratory and testing task force, said U.S. labs began preparing last month to prioritize tests to assess whether AY.4.2 can evade antibodies from vaccinated Americans, or from currently authorized monoclonal antibody treatments for the virus.

That process can take up to four weeks, Galloway said, across several laboratories that will run tests with harmless "pseudoviruses" designed to impersonate the variant's characteristic mutations.

Scientists have already turned up worrying combinations of mutations in other sub-lineages of Delta called AY.1 and AY.2, which like AY.4.2 have also sometimes been interchangeably called "Delta plus" variants. 

Last month, the Biden administration temporarily halted distribution of a monoclonal antibody treatment in Hawaii after estimated cases of AY.1 climbed up to 7.7% in the state. The Food and Drug Administration said lab experiments with AY.1 suggested it was "unlikely" the drug would be effective against the variant.

The state has since resumed use of the antibody treatment, after AY.1 dropped below 5% in Hawaii. Nationwide, AY.1 has hovered around 0.1% of cases.

"Right now, I think there's not a lot that we know. But in terms of the risk that it poses to public health, the prevalence is very low in the U.S. and we don't really anticipate that the substitutions [of AY.4.2] are going to have a significant impact on either the effectiveness of our vaccines or its susceptibility to monoclonal antibody treatments," said Galloway.

In the U.K., AY.4.2 has climbed to more than 11% of cases of the Delta variant. Health officials there say the variant does not appear to have led to a "significant reduction" in vaccine effectiveness or an uptick in hospitalizations, but it could be spreading faster because of "slightly increased biological transmissibility." 

"Estimated growth rates remain slightly higher for AY.4.2 than for Delta, and the household secondary attack rate is higher for AY.4.2 cases than for other Delta cases," said a report published Friday by the U.K. Health Security Agency.

The Centers for Disease Control and Prevention estimates that AY.4.2 has made up less than 0.05% of circulating cases in the U.S. for several weeks, according to an agency spokesperson. Grouped together, CDC estimates that the Delta variant and its sub-lineages has been virtually 100% of cases in the U.S. for months.

"Even based on the data in the U.K., if you look at the transmission advantage, it looks smaller. It's not like Delta, which as soon as they came in, it was almost a 50[%] to 60% advantage over all previous lineages," says Dr. Karthik Gangavarapu, a postdoctoral researcher at UCLA's Suchard group.

Gangavarapu was part of the team to lead Scripps Research's variant tracking effort at Outbreak.info, which has tracked variants like AY.4.2 as they have emerged in an international database of "sequenced" viruses maintained by a group called the GISAID Initiative.

"It could have a slight transmission advantage, but it could also have other factors that are important. For example, how is the population immunity in a given location? What is the vaccination rate? Those may have some sort of impact on how the variant is spreading," said Gangavarapu. 

The largest share of circulating virus in the U.S. remains closely related to the original Delta variant, among samples reported to GISAID. Scientists have speculated that the next major variant of concern could emerge as a mutation from the Delta variant, though Gangavarapu cautioned that highly-contagious strains have arisen largely independently from one another. 

Delta variant sub-lineages like AY.25, AY.3, and AY.44 also currently make up large U.S. proportions of cases, though not necessarily because they have an advantage over their siblings. 

Outbreak.info had previously counted AY.4.2 sightings in at least 35 states. However, Gangavarapu said a bug in the "Pangolin" system used to generate reports of variants had resulted in some false positives for the sub-lineage showing up in some tallies.

New sub-lineages are frequently re-categorized by scientists to "help researchers track the virus" clustered in certain regions, even when they sport mutations that end up having no meaningful impact on the public health risk of the variant.

"Probably over the next month or so we will get more data to actually see if there is the same sort of increase in prevalence that we see in the U.K. in the U.S. as of now," says Gangavarapu.

https://www.cbsnews.com/news/covid-delta-plus-variant-ay-4-2-states/

Who Are the Scientists Behind the COVID-19 Vaccines?

 There's the slick, turtleneck-loving CEO who's really good at raising cash for his company that has yet to release any data. There's the workaholic power couple focused on curing cancer. There's the researcher who co-invented a recombinant DNA technology but stays at a small biotech that's limping along.

All of these characters are the unlikely heroes who helped bring COVID-19 vaccines into the world, and their personalities are brought to life by Wall Street Journal reporter Greg Zuckerman in his new book, A Shot to Save the World: The Inside Story of the Life-or-Death Race for a COVID-19 Vaccine.

A lot went wrong in the race to develop a COVID-19 vaccine, but Zuckerman calls his book the story of what went right. He details the long and winding road of scientific advances that laid the groundwork for the vaccines, as well as the researchers, executives, and government officials who made it all happen.

Zuckerman spoke with MedPage Today about his new book by phone. The following is an edited transcript of that conversation.

What's missing from other accounts of the scientists and executives who made COVID vaccines a reality?

Zuckerman: We're all aware of the vaccines, but it struck me that the full story of how they were developed wasn't understood. What's important to understand is that there were a series of small breakthroughs over the years. I think some people are aware of Katalin Karikó and her work. Maybe some people are aware of Derrick Rossi and his work. But it was almost like a relay race. They ran strong races and they contributed a lot, but in some ways, they just sort of passed the baton.

It was my suspicion that there were breakthroughs that no one was aware of behind the scenes, so I wanted to shed some light on those. People like Kerry Benenato at Moderna. No one's ever really heard of her and she never gets much publicity. She's not a senior scientist. Yet she played a really important role [in modifying the lipid nanoparticle delivery system in order to diminish unwanted side effects of mRNA delivery].

How was it getting access to those people, in addition to the big names?

Zuckerman: Some were easier to speak with than others. Government and academic scientists are much easier. That's part of why they've gotten so much attention. There's a reason why most writers talk about Barney Graham or Kizzmekia Corbett. Academics and government scientists are usually easier to access, and as a result they get a lot of the limelight.

They clearly deserve the credit, but it takes some digging to figure out who are the young scientists or mid-level scientists within Moderna who contributed a lot.

For instance, I was struck by Jason Schrum, the early Moderna scientist who didn't even stay there that long. He was their first employee. He's the one who came up with ... the actual modification [to the mRNA molecule itself that is currently used in Moderna's vaccine].

That modification is the one that BioNTech uses also. It's not the one from Karikó and [Drew] Weissman. They're really important and they're pioneers, and I'm not sure we would have these vaccines without them. But I also don't know if we would have them without Jason's work.

This book gets at the personalities behind the science. Who are some of the most interesting ones?

Zuckerman: I don't think enough attention has been paid to the Chinese scientist who was struggling with whether to share the genetic sequence [of SARS-CoV-2] in early January 2020, Zhang Yongzhen. The guy's a hero. He risked so much. The Chinese did share the genetic sequence subsequently, like a day later, but I'm not sure they would have done it without him. I think he doesn't get enough credit.

Juan Andres, the head of manufacturing at Moderna, is one of my favorites. Very early on, he's freaking out [about COVID-19] and his family thinks he's nuts.

He also encapsulates this theme of how a lot of Moderna people are just emotionally shot from the past year. I don't think people appreciate that. We all think they're focused on the stock price and how wealthy they are, and that they're not giving enough vaccines for the rest of the world. There are reasons to criticize that. But they've never had a partner and I don't think that's been emphasized enough. They tried to get Merck on board, and they couldn't, so they've had to go all out over the past year. There are people who are just killing themselves working so hard.

Yet Juan Andres doesn't feel like he's done enough. I'm not saying they're perfect human beings and I'm sure they want to get wealthy as much as the next guy. But there are a lot of really caring people who really do seem to want to do good for the world.

Novavax's first big product was an estrogen cream that was done in by side effects seen with hormone replacement therapy in the early 2000s. The company has almost made a comeback but they're not quite there yet. What happened?

Zuckerman: I found the Novavax story just fascinating. We dismiss companies, dozens and dozens of them, whose stock prices are $5 a share. They say they're making progress even though there's no proof, so we tend to dismiss them.

What I've learned is that there are credible, serious scientists within these companies, including Novavax. They're just plugging away. They're resilient, they're stubborn. Maybe they're deluding themselves, or maybe they are making slow progress.

A lot of them could have left, like Gale Smith [who developed the insect baculovirus system used to make proteins for recombinant DNA products]. He could have worked elsewhere and done well. Yet these people just liked the work. They believed in their approach. Sure, maybe nine times out of 10 it won't work out, but there's a lesson in having respect for the bench scientists at the company that's selling at under $5 a share.

Novavax hasn't quite succeeded yet. There's that Politico story from last week. ... They had to sell their manufacturing assets right before 2020. ... They got kicked out of the Emergent BioSolutions plant. The manufacturing is what hobbled them. I find them easy to root for.

Why was Katalin Karikó, now of BioNTech, treated so terribly for most of her academic career?

Zuckerman: Karikó was treated as a second-class citizen at the University of Pennsylvania for too many years. ... She was up against all kinds of skepticism and career setbacks, and she just persisted and believed.

She illustrates a larger theme that for decades the conventional wisdom was that mRNA sure would be a great molecule to work with, but there's no way anyone should waste their time on it. It's hard to handle, it's unstable. You can't get it where it needs to go in the cell. The skepticism about Karikó reflects just the broader skepticism about mRNA, how the conventional wisdom can be so wrong, and how it takes some really determined, innovative scientists to overcome it.

It's interesting that Pfizer almost didn't go with the full spike protein for their vaccine. Would things have been different for that vaccine if they had chosen something else?

Zuckerman: I asked them, and they weren't sure themselves. It would have been great if I could have said, you know, that change had saved the day. It's not clear what would have happened. Truth be told, COVID-19 isn't as much of a challenge relative to other diseases. So maybe it would have been fine.

But it is fascinating that so late in the game, they were still debating that. Maybe you do have to give Pfizer a lot of credit for putting its foot down and saying, alright we have to make a decision here. We're taking too long and we need to speed things up. So maybe that was the important role they played.

Why wasn't Moderna the most likely candidate to respond to the global challenge of COVID-19?

Zuckerman: Among my colleagues in journalism, but also in the world of science too, we have a rearview mirror, and everyone was scarred by the Elizabeth Holmes/Theranos experience. People didn't want to be burned again, so we all looked for the next Theranos.

No one really was sure it was Moderna, but they raised suspicions, and for good reason. They weren't very transparent. They didn't share their work. They raised money, and often it was from these kinds of "tourist" investors who weren't really biotech investors and didn't have the greatest track record in this space -- sovereign wealth funds, people with maybe too much money.

[CEO Stéphane Bancel] raised so much money that it reminded people of Theranos and of Holmes. He never had people outright accusing him of fraud. There was no evidence of that. But he did raise suspicions. There were reminders of Holmes. He had the black turtleneck, he wasn't a scientist. He's an MBA, he's an engineer. He's super smart and very, very smooth.

There was jealousy, too. There was envy in the industry. Here's Bancel raising all this money, so others are wondering, why can't I raise this money? There's got to be something wrong, he's got to be doing something fishy.

It's striking that these are the people who partly saved the world. They're not the most likely candidates. It wasn't Merck, GlaxoSmithKline, Sanofi, the vaccine giants. Johnson & Johnson is a household name but it's not a vaccine giant. Pfizer had closed down its infectious disease business, they weren't a vaccine giant.

The J&J/Janssen vaccine has a long history using its Ad26 adenoviral vector technology in vaccines. Why is that history important?

Zuckerman: The average vaccine skeptic is a little concerned that we produced these vaccines so quickly. They think there's got to be something rushed here, so it's unsafe. I understand that impulse. Part of the reason I wrote this book is to reassure them that these techniques, these approaches ... took years and years of hard work and honing and improving.

Dan Barouch dedicated his life to the Ad26 approach and also to an HIV vaccine. It hasn't worked for HIV.

There's been failure after failure with HIV. I kept hearing, we learned this back with HIV, and we learned that with HIV. We don't have a vaccine yet, but we learned so much, and it's paid off with COVID.

Ad26 was honed [in HIV research], as was the chimpanzee adenovirus approach that led to the Oxford/AstraZeneca vaccine. It's important to underscore that these vaccine approaches took years and years to develop, not a matter of months.

The book ends with BioNTech's Ugur Sahin saying that the work has just begun. What do you see as some of the most promising applications coming out of the COVID-19 work?

Zuckerman: I'm a journalist, I'm inherently a skeptic. I have seen biotech and other companies be over-optimistic too frequently. I know that, historically, there's a reason why there's such frustration with mRNA. My book is all about the success of mRNA, among other vaccine approaches, but I'm also keenly aware that at one point Moderna was called Moderna Therapeutics, and they had to shift from therapeutics. Broadly, I think one needs to be somewhat cautious about having optimism about some of the diseases and illnesses they're looking at.

That all said, BioNTech and Moderna have made so much money from these vaccines. They're going to take all that cash and plow it into cancer and immune-mediated conditions like multiple sclerosis and lupus.

You can't count these people out, Ugur Sahin and Stéphane Bancel and their teams. I know how hard they're all working and how [they] don't see COVID-19 as the end, but the beginning. It gives one encouragement that they will figure things out. They have the resources now, and they have the will.

For Moderna it was always about dominating the mRNA space broadly and developing lots of applications. Ugur Sahin's a cancer guy so this is one step in a long journey. His whole goal in life has been to tackle cancer.

So you could potentially see that this past year or two, as awful as it's been, may be a net positive for society, if it allows us to make real headway on things like cancer and multiple sclerosis and lupus and malaria. It is fascinating to envision that this has been just the first chapter of other breakthroughs.

https://www.medpagetoday.com/special-reports/exclusives/95403

COVID Vaccine Mandates and the Question of Medical Necessity

 COVID-19 vaccination policy in the U.S. is highly variable, whether in regard to boosters, vaccinations for children, or workplace requirements. While many states require vaccination for state employees and workers at state-funded institutions, other states are banning vaccination requirements. Despite the political nature of vaccination policy, best practices should be based on scientific evidence. So, what does the evidence say regarding people who have previously been infected with SARS-CoV-2?

While COVID-19 vaccination is safe and highly effective, several studies show that people who have recovered from COVID-19 are at least equally protected compared to fully vaccinated COVID-naive people. Therefore, vaccination in those who have recovered may not be medically necessary. Rather than blanket mandates requiring vaccination, it may be more politically tenable and scientifically sound to focus on the documentation of immunity -- whether through infection or vaccination -- to control the pandemic and stratify persons at risk. Identifying immunity is not challenging, and several other countries already have models on which the U.S. could base its approach.

Immune System Protection From COVID-19

After SARS-CoV-2 infection or vaccination, the body's immune system reacts to the presence of foreign SARS-CoV-2 molecules by producing antibodies and expanding immune system cells to clear the foreign material. Within a period of weeks to months, the newly produced antibodies decline and the recently created immune system cells go into various tissues, lymph nodes, or bone marrow, waiting for the next exposure to the virus or viral proteins. Observed reinfection in people with healthy immune systems who have recovered from COVID-19 is uncommon, on the order of 0 to 1 per 100 persons per year, showing high levels of protection in this population.

One argument some have put forth in favor of vaccination after recovery from infection is that antibody levels increase with vaccination after recovery. Indeed, recent studies have found that people who had SARS-CoV-2 and later received one dose of the Pfizer mRNA vaccine were more highly protected against reinfection than those who once had the virus and were still unvaccinated. However, the benefit is generally modest. Also, it is well known that repeat exposure to the virus or viral proteins created by vaccination will quickly boost antibodies and at least temporarily further reduce risk for reinfection. What remains unknown is whether that antibody increase truly adds additional long-term protection against getting infection or illness.

Researchers at the Cleveland Clinic Health System conducted a study of 52,238 employees with and without a history of COVID-19, with or without vaccination. They found that those who recovered from COVID-19 and were vaccinated had equally low rates of repeat infection when compared with those who recovered and were unvaccinated. The investigators concluded that those previously infected were unlikely to benefit from COVID-19 vaccination. In another study looking at the duration of immunity among the COVID-19-recovered, researchers found that the immune response against SARS-CoV-2 was persistent and relatively stable for at least a year. While a recent CDC study concluded that mRNA vaccination provides stronger protection against COVID-19 hospitalization than prior infection, there were several study limitations, including that it was not a randomized controlled trial and that the follow-up period was short. The findings also don't negate the robust protection from prior infection. In fact, in a CDC science report published last week that reviews the totality of evidence, agency staff found that both infection-induced and vaccine-induced immunity are durable for at least 6 months.

However, for select groups of people, such as the immunocompromised or those with a history of low antibody response to vaccination, getting at least one dose of vaccination after recovery from COVID-19 may be beneficial. That brings us to the question of medical necessity.

What Is Medical Necessity?

The definition of medical necessity describes a broad standard for medical insurance coverage. While the term is not formally defined by the federal government and varies by state, medical necessity generally refers to services that improve health or lessen the impact of a condition, prevent a condition, or restore health.

For those who have not been infected with COVID-19, vaccination is an absolute medical necessity. But for those who already have protection against SARS-CoV-2 from prior infection, vaccination or vaccine boosters after initial vaccination may not be medically necessary.

There is currently a lot of tension regarding vaccination requirements for essential workers. One way to reduce that tension, and possibly increase public confidence in government, would be for policymakers to explore alternatives to blanket mandates -- they could allow those who can prove prior COVID-19 infection to qualify for a medical exemption or perhaps only be required to get one mRNA dose.

Diagnosis of Previous COVID-19 Infection

To establish a COVID-19 diagnosis, accurate and reproducible tests are needed to detect the causative virus, SARS-CoV-2. Most high-quality COVID-19 testing relies on the polymerase chain reaction (PCR). Other methods use the presence of proteins of SARS-CoV-2 (antigen) in clinical specimens or antibodies that are specific for viral proteins. However, antigen and antibody tests may be less accurate than PCR tests, although when positive, they are highly likely to correctly indicate current or past infection.

Demonstrating prior infection is not medically difficult. Prior infection can be documented with: a previous positive PCR test, clinic or a laboratory-based antigen test, a positive antibody test, or a T-cell test. A physician can easily interpret those test results and confirm that an individual was previously infected. While some have expressed concern that we haven't yet established a definitive antibody titer that guarantees protection, quantitative testing isn't necessary. Studies clearly show that those with prior infection are highly protected.

Because many symptoms of COVID-19 are non-specific, an individual's "word" that they were previously infected would not be sufficient.

Requirements Abroad

Several countries have introduced COVID-19 workplace, travel, or access mandates based on vaccination or infection history or the absence of current infection. In the European Union, Greece requires employees to carry a vaccination certificate to gain access to their place of work. Additionally, Greece allows for documentation by a healthcare professional or authorized laboratory of prior COVID-19 within 30 days after the day of the first positive COVID-19 test as sufficient for travel within 180 days. France requires documentation of vaccination to enter cafes, bars, and restaurants. If one has recovered from infection, only one vaccination dose is required.

Some countries have used history of prior COVID-19 as equivalent to vaccination to obtain COVID-19 certificates/passports. Italy requires all workers to be either vaccinated, recovered from COVID-19, or have a recent negative test result to avoid suspension from employment. Switzerland will grant COVID-19 certificates -- needed to enter bars, restaurants, and fitness centers -- to people who have been either vaccinated or recovered from COVID-19 within the past 365 days as documented by a prior positive PCR test or current positive antibody test.

We unequivocally support vaccination as a critical individual and public health intervention to control the COVID-19 pandemic. But the case for mandating vaccination in those who have recovered is much less strong. It is likely unethical to mandate a medical intervention in people who may not benefit, and may only be exposed to the risks, however small. Public health policy must be updated to recognize that recovery from prior infection is equivalent to vaccination. Healthcare professionals can play a key role in advocating for equivalence by understanding the evidence, educating the public, and knowing how to confirm prior infection.

Jeffrey D. Klausner, MD, MPH, is a former CDC medical officer and current professor of medicine and population public health science at the University of Southern California Keck School of Medicine. Noah Kojima, MD, is an internal medicine resident at University of California Los Angeles.

Disclosures

Klausner is medical director of Curative, a testing company, and disclosed fees from Danaher, Roche, Cepheid, Abbott, and Phase Scientific. He has previously received funding from the NIH, CDC, and private test manufacturers and pharmaceutical companies to study new ways to detect and treat infectious diseases. Kojima has received payments from Curative for clinical research services.

https://www.medpagetoday.com/opinion/second-opinions/95399

Texas Medical Association Sues Feds Over Surprise Billing

 The Texas Medical Association (TMA) is challenging a federal law designed to shield patients from surprise medical bills, arguing in a new lawsuit that regulators have stacked the deck against healthcare providers in their implementation of the No Surprises Act.

Essentially, TMA takes issue with the arbitration process for settling out-of-network bills, arguing that the regulation favors insurers over providers.

"This is a fight about money," said David Hyman, MD, JD, a professor of health law and policy at the Georgetown University Law Center who researches the regulation and financing of healthcare. "The providers who could use out-of-network billing strategies to get sizable additional amounts are not very happy that the legislation plus the regulation is going to clip their ability to do that far more severely than they thought it would."

The No Surprises Act, which is set to go into effect in January 2022, seeks to relieve the burden of unexpected bills on patients. Surprise billing can happen if a patient ends up with an out-of-network provider at an in-network hospital. The provider may receive only a portion of what they bill the insurance, and may pass the remainder to the patient.

Hyman said surprise billing (also called "balance billing") arose because physicians who provide one-time services learned they could be better off remaining out-of-network. "The patient is never going to go back to this provider," he said. "There's a big incentive to exploit your disparities in bargaining power, like [sending] a huge bill and balance billing for it."

In 2016, as many as 42.8% of emergency department visits resulted in an out-of-network bill, and these have gotten more costly over time. According to one study, emergency physicians recovered a higher portion of what they charged for services for likely surprise bills compared to other cases. The Kaiser Family Foundation showed that two-thirds of Americans reported being worried about unexpected medical bills.

Under the No Surprises Act, patients would only pay the amount they would have for an in-network copay or deductible. Then, the provider and insurer must agree on the rest of the cost. If they can't agree on an amount, they can engage in arbitration, where a third-party -- an "independent dispute resolution" or IDR entity -- steps in to resolve the dispute for them. Each side must propose an amount, and the arbitrator then determines which of the two is the fairest for the insurer to pay the out-of-network provider.

But TMA takes issue with the HHS rules for the IDR, which they say are different from what Congress intended when they passed the law. While TMA's president, E. Linda Villarreal, MD, said in a press release that the organization "supports the patient protection intent of the No Surprises Act," their lawsuit argues the HHS interim final rule gives insurers an unfair advantage, which would have outsize consequences for Texas providers.

In particular, they point to using a "rebuttable presumption" of the Qualifying Payment Amount (QPA), or the insurance plan's median contracted rates, to determine payment. That is, arbitrators should presume first that the insurance plan's median in-network payment for a given medical service is appropriate.

In their lawsuit, TMA states that the law doesn't allow for regulatory agencies to dictate how arbitrators decide cases. They add that the rules "will unfairly skew IDR results in the payors' favor, granting them a windfall they were unable to obtain in the legislative process."

"This is a big change from the status quo, and it may be a financial loss to some practices," said Erin Duffy, PhD, a research scientist at the USC Schaeffer Center for Health Policy and Economics and a scholar with the USC-Brookings Schaeffer Initiative for Health Policy. "So I'm not surprised to see legal challenges."

Staff from the TMA's general counsel wrote in an email to Medpage Today, via a public relations representative, "TMA's request under the lawsuit is that the court strike the rebuttable presumption from the rule and to, instead, restore the fair, balanced dispute resolution process that Congress created."

TMA argues that the independent arbitrators should consider equally -- instead of prioritizing the median rate -- all factors that might influence the price of medical services. These include the level of training or expertise of the provider, the market share of the provider in the area, the "acuity" of the patient or how difficult it was to provide the service, the status of the facility that provided the service, and previous efforts made by the provider to enter into a network agreement.

Wrapped up in the lawsuit is a larger debate over the cost of healthcare, and who should determine the price tag. With balance billing or surprise bills, providers can, and are, paid more for a service than they would in-network, because the patient ends up covering the difference.

The new law, which removes the patient from the equation, leaves providers to battle it out with insurers or turn to arbitration. Using the QPA to establish the price marks "a substantial shift in the payment landscape for ancillary physicians and emergency medicine physicians," said Duffy.

Regulators argue that by emphasizing the QPA, out-of-network rates will become more predictable over time, which will ultimately discourage the use of the arbitration process. But TMA says the rules "undermine providers' ability to obtain adequate reimbursement for their services" at a time when they are "facing strained resources as they battle the virus."

The TMA also argues that emphasis on qualifying payment amounts "will make it harder for patients to access care by driving down reimbursement rates and encouraging insurance companies to continue narrowing their networks."

In other words, they argue that because out-of-network physicians might make less money, they'd leave the workforce (or fewer would enter it), leaving fewer physicians for patients to access. "I have not seen quantitative evidence of surprise billing laws leading to physician shortage," said Duffy, "but that is a common concern that is raised by medical associations."

In states that have implemented their own surprise billing legislation, like New York, regulatory guidance dictated that arbitrators prioritize not the QPA but the 80th percentile of charges, or the top end of what out-of-network providers would normally ask for. An arrangement like this might mean higher payment for emergency and ancillary physicians.

Lower payment for out-of-network providers is exactly what the TMA is worried about, says Hyman. In the case of California, for example, which passed a surprise billing law that sets reimbursement amounts based on insurer's average in-network rates, "there was downward pressure on payments," Hyman said. "But, you know, if your baseline is, 'I'm gouging you currently and I can't do it anymore,' that's exactly what you're trying to do, thank you very much."

https://www.medpagetoday.com/special-reports/exclusives/95406

Kids 5-11 Can Now Get Pfizer's COVID Vaccine

 Children ages 5-11 should be vaccinated against COVID-19 with the Pfizer/BioNTech vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) said on Tuesday.

ACIP voted 14-0 to recommend vaccinating this population with a two-dose regimen of 10 μg apiece, 21 days apart, citing the favorable benefit-risk association, the idea of restoring normalcy to children, and especially the extensive data presented by FDA and CDC staff.

"Today is a monumental day in the course of this pandemic and one that many of us will be very eager to see," said CDC Director Rochelle Walensky, MD, once again addressing the panel. She added that since the first vaccines were authorized for ages 16 and up, the question has been when protection might be expanded to younger children.

This is a "recommendation likely to have tremendous impact," Walensky said. She said she was eager to see how committee members "interpret what we know and acknowledge areas of uncertainty."

Walensky also said that 745 children have died of COVID during the pandemic, including 94 children ages 5-11, and over 2,300 children in this population have been diagnosed with multi-system inflammatory syndrome (MIS-C).

Many committee members spoke as parents and grandparents and explained how they have vaccinated their children and grandchildren. Consumer representative Veronica McNally, JD, got a bit choked up when talking about how she would vaccinate her child after this recommendation, and would do so to prevent "the 95th death" in a child.

In an unusual move, several liaison representatives from the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), National Association of Pediatric Nurse Practitioners (NAPNAP), and the Pediatric Infectious Diseases Society (PIDS) read statements in support of vaccination for this age group prior to the ACIP vote.

Even normally skeptical ACIP members were on the side of the vaccine. Sarah Long, MD, of Drexel University in Philadelphia, who previously expressed hesitation about risk of vaccine-associated myocarditis in other age groups, said she was "very supportive" of this recommendation, given the large amount of data presented by the FDA and manufacturer, as well as because of the lower dose.

"We have one more vaccine that saves the lives of children and we should be very confident to employ it to the maximum to do what it was meant to do without significant concerns of serious adverse events," she said.

All eyes were on one rare side effect, vaccine-associated myocarditis. CDC staff presented data on vaccine-associated myocarditis showing that it occurs less frequently in younger children, and no cases of myocarditis were observed within the clinical trial.

Matthew Oster, MD, of the CDC, noted the incidence of vaccine-associated myocarditis would be about one in every 10,000 to 20,000 individuals for this age group. McNally asked Oster point-blank if given the information today, in his medical opinion, do the benefits outweigh the risks of vaccination.

"In my opinion, yes," Oster said.

While ACIP members were united in their support for the vaccine, Matthew Daley, MD, of Kaiser Permanente Colorado in Aurora, acknowledged those who are against this recommendation.

"I feel like collectively we're stronger when we hear from dissenting voices," he said. "Of course, you only want what's best for your child. It's understandable that you have questions given" the disinformation campaign against the vaccine, Daley said.

Several ACIP members stressed the importance of talking to pediatricians about the vaccine, and pediatricians recommending the vaccine to their patients.

This interim recommendation will go into effect when Walensky signs it, which she is expected to do later tonight.

We will "end this pandemic with science leading the charge," Walensky said.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95410

Colorado governor warns of rationed care as state hits 80% vaccination threshold

 Gov. Jared Polis (D-Colo.) on Monday warned that surging COVID-19 cases in unvaccinated people was bringing Colorado closer to rationing hospital care, even as the state has reached a partial vaccination rate of 80 percent.

“It’s the 20% who haven’t been vaccinated that are filling up our hospital wards,” said Polis at a news briefing, according to Bloomberg. “We would have none of these hospital capacity issues, or orders would be operative, if everybody was vaccinated.”

The governor said Colorado may soon have to ask the Federal Emergency Management Agency (FEMA) to assist with overrun hospitals.

Polis lamented that these problems are particularly tragic because they are "essentially entirely preventable."

On Sunday, Polis signed two executive orders in an effort to help his state's hospitals. One order allows hospitals emergency departments to turn away patients, directing them to other facilities, while the other clarifies when "Crisis Standards of Care" can be activated to ration care. Both orders are set to expire in a month, though they can be reactivated, Colorado Public Radio (CPR) reported.

As Bloomberg noted, Colorado's vaccination rates is one of the highest in the country. Its hospital bed occupancy rate, however, has been averaging around 90 percent for the past few weeks.

According to CPR, 80 percent of hospitalized COVID-19 patients are unvaccinated.

On Sunday, the Colorado Department of Public Health and Environment also issued a new health order to ease hospital capacity issues. The order instituted a pause on cosmetic procedures that can be put off for six months without causing "harm to life, limb or function."

https://thehill.com/homenews/state-watch/579634-colorado-governor-warns-of-rationed-care-as-state-hits-80-percent