In The News

Why the Omicron Offshoot BA.5 is a Big Deal

CNN | By Brenda Goodman

Once again, Covid-19 seems to be everywhere. If you feel caught off-guard, you aren't alone.

After the Omicron tidal wave washed over the United States in January and the smaller rise in cases in the spring caused by the BA.2 subvariant, it might have seemed like the coronavirus could be ignored for a while. After all, the US Centers for Disease Control and Prevention estimated in December that nearly all Americans had been vaccinated or have antibodies from a past infection. Surely all that immunity bought some breathing room.

But suddenly, many people who had recovered from Covid-19 as recently as March or April found themselves exhausted, coughing and staring at two red lines on a rapid test. How could this be happening again -- and so soon?

The culprit this time is yet another Omicron offshoot, BA.5. It has three key mutations in its spike protein that make it both better at infecting our cells and more adept at slipping past our immune defenses.

 

In just over two months, BA.5 outcompeted its predecessors to become the dominant cause of Covid-19 in the United States. Last week, this subvariant caused almost 2 out of every 3 new Covid-19 infections in this country, according to the latest data from the CDC.

Lab studies of antibodies from the blood of people who've been vaccinated or recovered from recent Covid-19 infections have looked at how well they stand up to BA.5, and this subvariant can outmaneuver them. So people who've had Covid as recently as winter or even spring may again be vulnerable to the virus.

 

"We do not know about the clinical severity of BA.4 and BA.5 in comparison to our other Omicron subvariants," CDC Director Dr. Rochelle Walensky said at a White House Covid-19 Response Team briefing Tuesday. "But we do know it to be more transmissible and more immune-evading. People with prior infection, even with BA.1 and BA.2, are likely still at risk for BA.4 or BA.5."

A 'full-on' wave

The result is that we're getting sick in droves. As Americans have switched to more rapid at-home tests, official case counts -- currently hovering around 110,000 new infections a day -- reflect just a fraction of the true disease burden

"We estimate that for every reported case there are 7 unreported," Ali Mokdad, professor of health metrics sciences at the University of Washington's Institute for Health Metrics and Evaluation, wrote in an email.

Other experts think the wave could be as much as 10 times higher than what's being reported now.

"We're looking at probably close to a million new cases a day," Dr. Peter Hotez said Monday on CNN. "This is a full-on BA.5 wave that we're experiencing this summer. It's actually looking worse in the Southern states, just like 2020, just like 2021," said Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston.

That puts us in the range of cases reported during the first Omicron wave, in January. Remember when it seemed like everyone everywhere got sick at the same time? That's the situation in the United States again.

It may not seem like a very big deal, because vaccines and better treatments have dramatically cut the risk of death from Covid-19. Still, about 300 to 350 people are dying on average each day from Covid-19, enough to fill a large passenger jet…

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Walk It Off: Exercise Therapy for Meniscal Tears on Par With Surgery — Arthroscopic Partial Meniscectomy Takes Another Hit

Exercise-based physical therapy remained noninferior to arthroscopic partial meniscectomy for treating degenerative meniscal tears, according to longer-term data from the ESCAPE trial, suggesting physical therapy be the preferred treatment over surgery.

By the 5-year mark, patient-reported knee function after 16 sessions of physical therapy was non-inferior to that observed after surgery, with a between-group difference of 3.5 points on the 100-point International Knee Documentation Committee Subjective Knee Form (95% CI 0.7-6.3, P<0.001 for noninferiority) on intention-to-treat analysis, according to movement scientist Julia Noorduyn, MSc, from OLVG Amsterdam, the Netherlands, and colleagues.

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Common Injections Don’t Help Knee Osteoarthritis More Than Placebo, Large Data Review Finds

State News | By Isabella Cueto

A commonly used treatment for people with knee osteoarthritis is barely more effective than the placebo effect in reducing pain and improving function, a new review of 50 years of data found. Yet despite decades of mounting evidence showing hyaluronic acid injections don’t help most osteoarthritis patients, the shots have become more widely used, costing the American health care system over $300 million each year in Medicare claims alone.

Osteoarthritis is an incurable, chronic condition that occurs as cartilage breaks down in the knees, hips, hands, or other joints, resulting in pain, limited range of motion, and swelling. More than 32 million adults in the United States have osteoarthritis, according to estimates from the Centers for Disease Control and Prevention. Since there is no cure, people with osteoarthritis often manage their condition with exercise, physical therapy, medications, and injected therapies. Since the 1970s, hyaluronic acid has been one of those injectables.

Originally sourced from cartilage in the fleshy, flamboyant-red crown atop a rooster’s head, the treatment has been dubbed the “rooster comb injection,” and thought to offer a gelatinous cushion for worn-down joints. In 2018, it was administered as the first treatment to an estimated one in seven patients with osteoarthritic knee pain, according to a paper published in The BMJ medical journal on Wednesday.

That broad look at the scientific literature concluded that injecting hyaluronic acid — called viscosupplementation — offers such a small reduction in knee osteoarthritis pain and stiffness when compared to placebo shots that it makes no meaningful difference in the lives of patients. Moreover, the shots were also linked to a greater risk of experiencing a wide range of negative side effects, the paper reported.

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FDA Authorizes Novavax Covid Vaccine, in Hopes the Traditional Shot Will Convince Holdouts

StatNews | By Matthew Herper

The Food and Drug Administration on Wednesday authorized the Covid-19 vaccine developed by Novavax, a small Maryland biotech firm, for people 18 and over, voicing hope that the availability of a more traditional vaccine might help convince those skeptical of the Covid shots using new mRNA technology to get inoculated.

As with other Covid vaccines, the Novavax shot will be free to consumers, because the U.S. government will purchase the doses. But before the vaccine will be widely available, it must also be recommended by the director of the Centers for Disease Control and Prevention. That recommendation will likely follow a July 19 meeting of an expert committee convened by the CDC.

“Authorizing an additional Covid-19 vaccine expands the available vaccine options for the prevention of Covid-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf in a prepared statement. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The U.S. has received 3.2 million doses of the vaccine that are ready to be shipped to states once the vaccine is authorized and recommended by the CDC.

“Today’s FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine,” said Stanley C. Erck, Novavax’s CEO. “This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”

Unlike the vaccines from Pfizer/BioNTech and Moderna, the Novavax vaccine has had a bumpy path to the market. Novavax received $1.6 billion in support from the U.S. government’s Operation Warp Speed project in July 2020. At the time, the hope was that the company might begin making a vaccine by the beginning of 2021. But while the Moderna and Pfizer/BioNTech shots released data in November of 2020, results were not available for the Novavax vaccine until June of 2021.

There were also questions about the ability to produce the vaccine in large amounts. The original deal between Novavax and Operation Warp Speed would entitle the U.S. to 100 million doses of the vaccine. In the press release announcing the vaccine’s emergency use authorization, FDA officials emphasized that the vaccine had not only met the FDA’s bar for safety and efficacy but also “assessment of the manufacturing processes and information.”

In June, a panel of FDA advisers voted 21 to 0, with one abstention, that the Novavax vaccine’s benefits outweigh its risks.

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Home Health Leaders Call for Bill Abolishing Medicare Payment Cut 

McKnights Home Care / By Diane Eastabrook

Home health leaders descended on Capitol Hill Tuesday to protest the Centers for Medicare & Medicaid Services’ proposed 7.69% Medicare payment cut to home health firms. The Partnership for Quality Home Healthcare and the National Association for Home Care & Hospice called on Congress to enact legislation that would prevent the cuts.

“We urge Congress to step in and advance legislation to prevent these severe cuts from being implemented in 2023,” Joanne Cunningham, CEO of the Partnership, said in a statement. “Home health is widely preferred by patients and their families. At a time when home-based care is needed for the health and safety of seniors, we will work with our champions in Congress to ensure that the delivery of quality patient care and the stability of our community are protected.”

CMS last month announced the proposed rule, which would cost providers up to $1.33 billion in 2023 and up to $2 billion in 2024 in clawback payments for home health services delivered during the COVID-19 pandemic to seniors and people with disabilities. 

Home health advocates say the proposed cut could financially decimate providers at a time when inflation is driving up the cost for everything from worker wages to energy. Just days after CMS announced the cut, NAHC President and CEO William Dombi threatened possible legal action if the cuts went into effect. 

The public has until mid-August to file formal comments on the proposal to CMS. The agency is expected to make a decision on the rule in the fall.

Resources


CY 2023 HH PPS Proposed Rule - Public Comment Period Now Open

The CY 2023 HH PPS proposed rule is now available for viewing and download on the Federal Register. The public comment period is open until Tuesday, August 16, 2022 at 11:59 PM ET. Instructions on how to submit comments are available on the Federal Register

 
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