Weekend update

COVID-19 vaccine

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

Congress has left Capitol Hill after the Congressional election on November 8. The Wall Street Journal reports from the Congressional campaign trail.

Tomorrow, the Supreme Court opens its October 2023 Term. The Journal discusses the legal issues that the Court will be considering this term.

Amy Howe adds

When the justices return to the bench next week to begin the 2022-23 term, members of the public will be able to attend oral arguments for the first time since the COVID-19 pandemic began in 2020. The court also announced on Wednesday that it will continue to provide a live audio feed of oral arguments, a practice that it began during the pandemic.

Masking will be optional at oral arguments, the court said in a press release, and the court’s building will otherwise remain closed to the public.

From the Omicron and siblings front, Forbes reports

As COVID-19 regulations continue to ease across the U.S., some Americans want more protection. Nearly two-thirds (63%) of adults familiar with the recently updated booster shot, which specifically targets the virus’ Omicron variant, say they are likely to get one.

That’s according to the latest Forbes Health-Ipsos Monthly Health Tracker, which polled 1,120 adults between Sept. 27 and 28, 2022. Of those in favor of the new shot, 25% say they are “somewhat likely” to get it, while 38% indicate they are “very likely” to get the booster.

Additionally, about 9% of polled individuals have already received the latest booster, and 28% say they aren’t likely to get this particular booster at all.

Perhaps it’s time for health plans to reach out to members on the bivalent booster.

From the healthcare costs front, the Congressional Budget Office offers “Policy Approaches to Reduce What Commercial Insurers Pay for Hospital and Physician Services.” How timely!

From the Rx coverage front —

Fierce Healthcare tells us

A new report finds that 1,216 pharmaceuticals increased their prices past the inflation rate of 8.5% from July 2021 to July 2022, with an average hike of 31.6%. 

The report and a second report on price trends released Friday by the Department of Health and Human Services (HHS) underline how a new provision in the Inflation Reduction Act—an inflationary cap on Part D costs—will affect prices right as the cap is implemented Oct. 1. 

NPR shots provides patient and expert reaction to the FDA’s decision to approve a new drug to treat amyotrophic lateral sclerosis (“ALS”).

The Food and Drug Administration has approved a controversial new drug for the fatal condition known as ALS, or Lou Gehrig’s disease. 

The decision is being hailed by patients and their advocates, but questioned by some scientists.

Relyvrio, made by Amylyx Pharmaceuticals of Cambridge, Mass., was approved based on a single study of just 137 patients. Results suggested the drug might extend patients’ lives by five to six months, or more. * * *

A much larger study of Relyvrio, the Phoenix Trial, is under way. But results are more than a year off.

The Institute for Clinical and Economic (ICER) review adds

Yesterday, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis (ALS). According to ICER’s analysis, the therapy would only achieve traditional thresholds of cost-effectiveness if priced between $9,100 to $30,700 per year.

We also recommended that manufacturers should seek to set prices of new medications that will foster affordability and access for all patients by aligning prices with the patient-centered therapeutic value of their treatments, and not based on the price of existing ALS medications. This is especially important for ALS since new drugs are anticipated to be used in combination with other very expensive drugs, creating the highest risk for financial toxicity due to health care costs.

From the telehealth front, mHealth Intelligence informs us

While researching the effects of telehealth and in-person care within a large integrated health system, a study published in JAMA Network Open found that virtual care methods can expand healthcare capabilities, performing on par or better than in-person care on most quality measures evaluated.

Researchers conducted a retrospective cohort study that included 526,874 patients, 409,732 of whom received only in-person care, and 117,142 participated in telehealth visits. Of those who received only in-person care, 49.7 percent were women, 85 percent were non-Hispanic, and 82 percent were White. Of those who received care via telehealth, 63.9 percent were women, 90 percent were non-Hispanic, and 86 percent were White.

Researchers noted that patients in the in-person-only group performed better on medication-based measures. But only three of the five measures had significant differences: patients with cardiovascular disease (CVD) receiving antiplatelets, those with CVD receiving statins, and those with upper respiratory infections avoiding antibiotics.

Researchers also noted that patients participating in telehealth performed better than those in the -person-only group on four testing-based measures. These four measures included patients with CVD with lipid panels, patients with diabetes with hemoglobin A1c testing, patients with diabetes with nephropathy testing, and blood pressure control.

Further, those participating in telehealth performed better than their counterparts on seven counseling-based measures, including cervical cancer screening, breast cancer screening, colon cancer screening, tobacco counseling and intervention, influenza vaccination, pneumococcal vaccination, and depression screening.

Based on these study findings, researchers concluded that telehealth could augment care for various conditions, especially chronic diseases. The study also supplies information that could assist providers in determining an ideal ratio of in-person and telehealth visits.

But researchers also noted several limitations associated with the study. These included their inability to control for the number of in-person and telehealth visits, potential inaccuracies associated with the EMR data used, and sampling limitations.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the American Hospital Association reports

The Senate today voted 72-25 to pass and send to the House a continuing resolution that would extend current federal funding levels for health care and other programs through Dec. 16. Current government funding expires at midnight Sept. 30.

The legislation also would extend through Dec. 16 two expiring programs that help maintain access to care in rural communities: the Medicare-dependent Hospital and enhanced Low-volume Adjustment programs. AHA will continue to advocate for long-term extension of these programs. Among other provisions, the continuing resolution would reauthorize the Food and Drug Administration’s user fee programs, and provide emergency funding for Ukraine and disaster assistance.

A proposal dealing with energy-permitting plans was dropped from the measure on Tuesday, speeding passage of the legislation. The House is expected to pass the measure by Friday. 

Roll Call provides more background on the CR.

The American Hospital Association also tells us

The House voted 220-205 today to pass legislation to hold employer-based health plans more accountable for improper denials of mental health and substance use benefits. The Mental Health Matters Act (H.R.7780) would give the Department of Labor more authority to enforce plan requirements under the Mental Health Parity and Addiction Equity Act and Employee Retirement Income Security Act, ban forced arbitration agreements when plans improperly deny benefits and ensure a fair standard of review by the courts. The bill also would provide grants to develop, recruit and retain school-based mental health professionals and link schools with local mental health systems, among other provisions.

Fierce Healthcare provides more color on this troubling bill.

The ERISA Industry Committee (ERIC)—which represents large employer plan sponsors—wrote a letter Monday to all House members calling for them to oppose (PDF) the Mental Health Matters Act when it comes up for a vote later this week. The letter comes as Congress is considering how to improve pay parity between behavioral and physical health amid reports of some insurers not following requirements in the Affordable Care Act. 

“This bill includes provisions that weaponize the Department of Labor (DOL) to sue employers rather than helping them come into compliance,” the letter said. * * *

[I]t remains unclear whether the Senate will take it up. The Senate Finance Committee is considering action to tackle pay parity but so far has not released any legislation. Chairman Ron Wyden, D-Oregon, previously told Fierce Healthcare that he is still working on legislation to tackle the issue, including taking aim at “ghost networks” where providers listed in directories don’t take new patients.

Earlier this month, Healthcare Dive reported that

The Senate Finance Committee released a bipartisan-supported discussion draft bill that aims to increase mental health access and improve mental health workforce shortages.

The draft bill proposes to fill the gap in mental healthcare worker shortages by funding training for 400 additional Medicare Graduate Medical Education psychiatric slots for residencies per year beginning Oct. 1, 2024. Over a decade, 4,000 psychiatric residencies would be supported by the funding, according to the bill.

The Senate’s focus on access to care makes much more sense than the House’s punitive approach, particularly considering the unnecessary complexity of the federal mental health parity law.

From the Omicron and siblings front, MedPage Today discusses nasally administered Covid vaccines now under development. “The idea is that mucosal vaccines could bolster immunity at these viral entry points, stopping the pathogen from implanting, multiplying, and transporting itself throughout the body.” Finger crossed.

From the monkeypox front, CNBC reports

A single dose of the two-dose monkeypox vaccine provides some protection against the virus, according to CDC data.

People at risk of monkeypox who have not received a shot are 14 times more likely to get infected, the preliminary data found.

These are the first real-world findings on how well the vaccine is working in the current outbreak.

 The CDC is still recommending that everyone at risk receive two doses of the vaccine.

From the Food and Drug Administration front —

STAT News informs us

The Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals on Thursday, providing a desperately-needed new treatment option for a devastating disease.

The medicine, to be sold as Relyvrio, is not a cure for ALS but proved to moderately slow the progression of the neurological disease, which causes the destruction of neurons in the brain and spinal cord, resulting in weakened muscles, paralysis, and death.

Amylyx did not immediately disclose how much it will charge for Relyvrio. “Amylyx’s goal is that every person who is eligible for Relyvrio will have access as quickly and efficiently as possible,” the company’s co-CEOs said in a statement, “as we know people with ALS and their families have no time to wait.”

Healio relates

The FDA approved bevacizumab-adcd for the treatment of six cancer types, according to a press release from the biosimilar’s manufacturer.

Bevacizumab-adcd (Vegzelma, Celltrion USA), a biosimilar to bevacizumab (Avastin, Genentech), is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and prohibits it from binding to VEGFR-1 and VEGFR-2 on the surface of endothelial cells.

FDA approved bevacizumab-adcd for metastatic colorectal cancer; recurrent or metastatic nonsquamous non-small cell lung cancer; metastatic renal cell carcinoma; recurrent glioblastoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.

In medical research news, STAT News tells us

After a steep drop in its stock price and with mounting competition from rivals, genomics giant Illumina on Thursday launched a new line of high-powered DNA sequencers, ratcheting up the race to read genetic information accurately and cheaply.

The new instruments, dubbed the NovaSeq X Series, can churn out up to 20,000 human genomes in a year, 2.5 times the max output of the company’s current machines, executives announced. The cost of generating this data has dropped, too, from about $5 per billion DNA bases on Illumina’s last line of high-end sequencers to as low as $2 on the new products.

That will bring the cost of reading a whole human genome on the company’s equipment from about $600 to $200, which could help make sequencing more mainstream in everyday medicine. While the price of sequencing isn’t the only obstacle to using genomics to improve human health, it remains a major factor.

Intriguing.

From the Medicare front, the Centers for Medicare and Medicaid Services (CMS) announced 2023 Medicare Advantage plan and Part D prescription drug plan premiums in advance of the Medicare Open Enrollment, which runs from October 15 through December 7, 2022.

The projected average premium for 2023 Medicare Advantage plans is $18 per month, a decline of nearly 8% from the 2022 average premium of $19.52. Medicare Advantage plans will continue to offer a wide range of supplemental benefits in 2023, including eyewear, hearing aids, preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, and fitness benefits.

[T]he average basic monthly premium for standard Part D coverage is projected to be $31.50, compared to $32.08 in 2022. 

To view the premiums and costs of 2023 Medicare Advantage and Part D plans, please visit: https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin. Select the various 2023 landscape source files in the downloads section of the webpage. 

For state-by-state information, important dates and enrollment resources for Medicare Advantage and Part D in 2023, please visit: https://www.cms.gov/files/document/2023-medicare-advantage-and-part-d-state-state-fact-sheets.pdf

For more information on the Medicare Advantage Value-Based Insurance Design Model, including plan participation, please visit: https://innovation.cms.gov/innovation-models/vbid.

From the telehealth front, the Wall Street Journal reports a tragic story —

Cerebral treated a 17-Year-Old without His parents’ consent. They found out the day he died.
Telehealth startup didn’t use software to flag minors, according to employees and documents; company says it complies with state rules and the case is an outlier.

Anthony Kroll signed up for Cerebral in December and uploaded his Missouri intermediate driver’s license showing he was 17. Missouri law prohibits clinicians from providing mental-health treatment to people under 18 without parental consent. 

Anthony told a Cerebral clinician he had suicidal thoughts, and she prescribed him an antidepressant that carries a warning label for adolescents, according to medical records reviewed by the Journal. Cerebral didn’t notify his family. 

His parents, Wendi and Todd Kroll, said they didn’t know their son was suicidal or was seeking mental-health treatment. “I had no idea he was even on [medication] until the day he died,” Mrs. Kroll said, adding that she found the pill bottle at their home a few hours before her son died by suicide.

A Cerebral spokesman said Anthony misrepresented his age, the company regrets he received care without parental consent, and the treatment he received was appropriate. “This case is an unfortunate outlier,” the spokesman said. “Any loss of life is tragic, and we extend our deepest condolences to the family.” 

From the miscellany department

  • The GAO released a report titled “Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics.” ” Machine learning technologies can help identify hidden or complex patterns in diagnostic data to detect diseases earlier and improve treatments. We identified such technologies in use and development, including some that improve their own accuracy by learning from new data. But developing and adopting these technologies has challenges, such as the need to demonstrate real-world performance in diverse clinical settings.”
  • Federal News Network tells us

Agencies may soon get some more specific guidance on how best to implement President Joe Biden’s sweeping executive order on diversity, equity, inclusion and accessibility in the federal workforce.

The Chief Diversity Officers Executive Council, a governmentwide panel composed of agencies’ chief diversity officers and led by the Office of Personnel Management, held its first-ever meeting on Sept. 29.

“This has been a really long time coming,” OPM Director Kiran Ahuja said in an exclusive interview with Federal News Network.

Midweek update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, the Hill catches us up on the news surrounding the continuing resolution funding the federal government through December 16. The CR remains on track to be signed into law by the weekend. Here are links to the Senate Appropriations Committees’ text of the continuing resolution, which is a substitute for HR and a section-by-section bill summary.

From the Omicron and siblings front, David Leonhardt, writing in his Morning column for the New York Times, answers current questions about Covid vaccinations and boosters.

From the Rx coverage front, Fierce Pharma reports

Japanese ophthalmology specialist Santen has earned an FDA approval for its eye drops. The U.S. regulator has signed off on Santen’s Omlonti to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Santen developed the drug, otherwise known as omidenepag isopropyl ophthalmic solution, along with another century-old Japanese firm, UBE Industries of Tokyo.

As a selective prostaglandin EP2 receptor agonist, Omlonti provides patients with primary open-angle glaucoma or ocular hypertension—both of which can cause blindness—a treatment with a unique mechanism of action, Santen said. 

“This approval is an important milestone in our ambition to tackle unmet needs in eye health,” Peter Sallstig, the chief medical officer of Santen, said in a release.

Known as Eybelis in Japan, the drops won approval there in 2018. On top of that, five more countries in Asia sanctioned the treatment last year. It is Santen’s first glaucoma offering in the U.S. Approximately 3 million people in the U.S. and 76 million worldwide have the two conditions, with numbers increasing as the global population ages, Santen said.

In other FDA developments, the agency today announced

proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans. 

More than 80% of people in the U.S. aren’t eating enough vegetables, fruit and dairy. And most people consume too much added sugars, saturated fat and sodium. The proposed rule is part of the agency’s ongoing commitment to helping consumers improve nutrition and dietary patterns to help reduce the burden of chronic disease and advance health equity. 

From the healthcare technology front, Fierce Healthcare tells us

Cigna is launching a new concierge care platform that aims to harness both the strengths of its health plan and its sister company, Evernorth.

The new offering, called Pathwell, integrates Evernorth’s data analytics, clinical expertise and digital solutions with the medical benefits and network of its health plan with the goal of providing a personalized, comprehensive care experience for members who are managing high-cost conditions. Pathwell will first target patients with musculoskeletal conditions and patients who take injectable or infused biologic drugs.

The Cigna team expects to build Pathwell out to other conditions in the future. The solution is now available in many U.S. commercial plans and will grow over the course of 2023.

Shawna Dodds, vice president of product development at Cigna, told Fierce Healthcare that combining the powers of the health plan and Evernorth allows the insurer to offer the choices members need to take charge of managing their own conditions.

“It’s combining the strategic assets that exist across those two companies to really bring the integrated experience to the consumer,” she said.

From the drug research front, STAT News warns that the positive trial results on Biogen’s new Alzheimer’s drug are not a reason by itself to pop the Champagne bottles.

The trumpeting from the companies Eisai and Biogen relied on data that showed that people receiving the therapy, lecanemab, saw a slower decline versus those on a placebo. That finding was based on a .45-point difference between the groups on an 18-point scale called the Clinical Dementia Rating sum of boxes, amounting to a 27% reduction in the rate of cognitive decline.

But translating what that statistical gobbledygook could mean for patients living with Alzheimer’s is a different challenge, one that physicians will have to navigate as they weigh whether to prescribe the treatment (presuming it wins regulatory approval) and for which patients.

The clinical significance of the trial data — as opposed to the statistical significance, which was proven by the study — will continue to be debated among neurologists and geriatricians as lecanemab moves through the regulatory approval process and into doctors’ offices. Insurers could also weigh in, assessing how widely they’re willing to cover the treatment and for which patients based on what kind of perceptible outcomes they think the data point to.

After all, what people want from any Alzheimer’s therapy is not measured by some “sum of boxes” or questionnaire but by the details of an individual life. Would this mean they could keep driving or working? Could they keep taking the dog for a walk without their family worrying about them getting lost? Could they hold on to the knowledge of who those family members are — and who they themselves are — for longer?

Mia Yang, a geriatrician at Wake Forest, noted that the impact of a .45-point difference on the scale depended on where someone was. Someone with a CDR score of 0.5, for example, might have some memory problems but could still keep up with daily activities. Someone with a score of 1, however, might start encountering some functional losses.

A half-point difference wouldn’t mean much for someone with more advanced Alzheimer’s, Yang said.

“I’m cautiously optimistic that it could be potentially meaningful for those folks who are in the mild stage,” Yang said about lecanemab. Indeed, the trial focused on people with early-stage Alzheimer’s.

From the US healthcare business front, Beckers Hospital CFO Report explores why nine hospitals closed this year. “From cash flow and staffing challenges to dwindling patient volumes, many factors lead hospitals to shut down.”

From the federal employee benefits front, Reg Jones, writing in Fedweek, discusses the Federal Employee Group Life Insurance Program known as FEGLI.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Sven Read on Unsplash

Federal News Network reports that its popular journalist on federal employment matters, Mike Causey, passed away at age 82 shortly after completing a broadcast.

Causey was a popular figure in the newsroom, who loved to share a funny story or joke, often approaching with a mischievous gleam in his eye. Colleagues appreciated his soft-spokenness and gentle demeanor. “Mike was someone who offered kindness and a warm smile to everyone he encountered,” said federal workforce reporter Drew Friedman.

A peerless reporter, Causey cultivated a large and devoted readership that followed him from medium to medium. He knew nuances of topics such as the best day to retire or the shrewdest Thrift Savings Plan strategy better than anyone. His writing was marked by an easy, accessible, occasionally humorous style undergirded by thorough, factual reporting. Causey is widely acknowledged as having coined the term, “inside the beltway.”

Now there’s a phrase that the FEHBlog frequently used without knowing its connection to Mike Causey. RIP.

Fierce Healthcare released its list of the most influential minority executives in healthcare for 2022. Congratulations to the winners.

From the healthcare cost front —

  • The Segal Company released its 2023 Health Care Costs Survey. “Health care spending in 2021 spiked an average of 14% per covered participant, the highest increase in a decade. The surge was primarily driven by the return of previously deferred medical care and the uptick of COVID-19 vaccines and therapeutics, according to data released” by Segal in this survey.
  • RevCycle Intelligence informs us “Inflation and rising labor costs will increase US national healthcare spending by $370 billion in the next five years, according to a McKinsey report. Consumer prices are rising faster than healthcare inflation, but general inflation has recently driven up healthcare supply input costs.”

Whoa, Nelly, the FEHBlog sees a common theme here. The cost curve is up.

From the Omicron and siblings front, WebMD tells us

Pfizer/BioNTech and Moderna, the two biggest COVID vaccine makers for the United States, are both seeking emergency authorization from the FDA for bivalent vaccine boosters for children.

Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series, the company said in a Monday news release. Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series, the company tweeted on Friday. 

For the Moderna booster, children 12 to 17 would receive the same dose as older people, while children 6 to 11 would get a half dose from the same vial, the CDC said in a Sept. 20 update to its fall vaccination planning guide.

“If authorized by FDA, CDC anticipates a recommendation for bivalent COVID-19 vaccine as a booster for pediatric age groups in early to mid-October,” the CDC document said.

From the substance use disorder front, the Hill reports

President Biden on Friday announced that his administration would distribute $1.5 billion to states and territories, including tribal lands, to fund responses to opioid overdoses and support recovery.

The U.S. Department of Health and Human Services (HHS) will disseminate the funding through the Substance Abuse and Mental Health Services Administration’s (SAMHSA) State Opioid Response and Tribal Opioid Response grant programs as part of National Recovery Month. * * *

Along with the new funding, the Biden administration published new guidance to facilitate greater access to FDA-approved naloxone products, which treat opioid overdoses in emergency situations, and guidance for employers to create “Recovery-Ready Workplaces.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Yesterday, the FEHBlog welcomed the first day of autumn when the autumnal equinox was at 9:04 pm today. To compound his error, the FEHBlog overlooked that yesterday was World Gratitude Day. The FEHBlog is grateful for his readers.

From Capitol Hill, Roll Call reports on the state of the continuing resolution to fund the federal government into mid-December.

Congressional leaders and appropriators are expected to spend the weekend haggling over the last details of the text Schumer is aiming to unveil Tuesday [following the Jewish New Year holiday], which he would offer as a substitute amendment.

On Thursday, authorizing committees agreed on a five-year reauthorization of FDA user fee programs, which could potentially be attached to the continuing resolution. Numerous other authorizations, funding “anomalies” and a supplemental aid package for Ukraine and other purposes were still being negotiated. 

The House of Representatives is capable of acting quickly.

From the Omicron and siblings’ front

  • Beckers Hospital Review reports, “Retooled COVID-19 booster shots that target omicron subvariants could be authorized and available for children to receive within a month, the CDC said in a vaccination planning guide released Sept. 20.”

In other public health news, STAT News tells us

As some of us wonder how we’ll know when the coronavirus pandemic is over, a new report from the WHO called “Invisible Numbers” reminds us that noncommunicable diseases take more lives than infectious diseases (and make Covid-19 worse). To wit: Cardiovascular diseases including heart disease and stroke, cancer, diabetes, chronic respiratory diseases, and mental illness cause nearly three-quarters of deaths in the world and kill 41 million people every year. Some of the more striking findings:

* Every year 17 million people under age 70 die of noncommunicable diseases, 86% of whom live in low- or middle-income countries.

* Preventable risk factors include tobacco use, unhealthy diets, harmful use of alcohol, physical inactivity, and air pollution.

* NCDs cause 74% of all deaths, but interventions known to work could avert at least 39 million NCD deaths by 2030.

In that regard, ABC News reports

Cancer deaths in the United States are continuing to decline, according to a new report from the American Association for Cancer Research.

The report, published Wednesday, found that deaths from cancer have decreased by 2.3% every year between 2016 and 2019.

Overall, there has been a 32% reduction in the U.S. cancer death rate since 1991, which translates into approximately 3.5 million lives being saved, the report said.

Additionally, in 2022, there are more than 18 million cancer survivors living in the U.S., equivalent to 5.4% of the population, the report found. Fifty years earlier, there were just 3 million cancer survivors.

That’s remarkable.

In related medical research news,

Medscape reports

New results from a large prospective trial give a better idea of how a blood test that can detect multiple cancers performs in a “real-life” setting.

“As this technology develops, people must continue with their standard cancer screening, but this is a glimpse of what the future may hold,” commented study investigator Deborah Schrag, MD, MPH, chair, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City.

STAT News relates

The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations.

Scientists across the country are involved, from teams at the Salk Institute to Duke University to the Broad Institute of MIT and Harvard, among other places. If successful, they will help answer fundamental questions about the body’s most complex organ. What are all the cell types in the brain? How are they connected to one another? How do the workings of the brain change during disease, and what can we do about that?

So far, those questions have proven easier to ask than to answer, with researchers gleaning bits of information from individual studies, but the hope is that a broad-based effort will jump-start new revelations.

Hope springs eternal.

From the mental healthcare front —

Health Payer Intelligence explains

CVS Health is making progress toward its behavioral health goal of decreasing the suicide rate among Aetna members by 20 percent by 2025, but progress among adolescent members is lagging, the healthcare organization announced.

“Our members are not immune to the national suicide crisis reported by the CDC. Though we are on track lowering suicide attempts in adults, our goal will not be reached until we can say the same for adolescents,” said Sree Chaguturu, MD, executive vice president and chief medical officer at CVS Health.

The organization has been working toward this goal since 2017, its work running parallel to that of the American Foundation for Suicide Prevention (AFSP) which had the same goal.

As of March 2022, CVS Health saw suicide attempts among Aetna members drop by 15.7 percent when compared to the company’s 2019 rate.

CVS Health broke down the overall rate by age and found that the reductions were largely driven by decreases among members ages 18 and older. For individuals in this age range, suicide attempts dropped by 17.5 percent in 2021 and dropped another 34.1 percent through March 2022.

Having made progress toward the goal, however, the organization does not intend to slow down.

“We are doubling down on efforts to prevent suicide in teens by identifying those most at-risk and in need of intervention, reaching out to those discharged from the ER after a suicide attempt with resources and supporting parents and loved ones in prioritizing the mental health of their kids,” Chaguturu explained.

Specifically, Aetna saw an upward trend in suicide attempts among its adolescent members.

Members between the ages of 13 and 17 saw increases in suicide attempts. In 2021, the suicide rate among this population grew 43 percent. In the first three months of 2022, the suicide rate jumped another 32 percent.

“We are implementing evidence-based therapies and outreach programs to prevent suicidal ideation before it starts and get adolescents the clinical care they need when they are at risk,” said Cara McNulty, president of behavioral health and mental well-being at CVS Health. “Every suicide attempt prevented, life saved, and mental health resource sought is an important step to reducing death by suicide in the United States.”

Mazaal Tov to CVS Health for those successful and ongoing efforts.

The Society for Human Resources offers guidance on suicide prevention in the workplace.

From the No Surprises Act litigation front, STAT News explains

During a hearing yesterday, the Association of Air Medical Services indicated it was following in the footsteps of AHA and AMA and would likewise dismiss its claims now that the final rules are out. But the AAMS also said it was deliberating whether it would file a different lawsuit in a different court, while attorneys for AMA and AHA backpedaled and said they have no intentions of filing any new lawsuits anywhere.

Today we got some clarity when the Texas Medical Association filed a new lawsuit challenging the revised final independent dispute resolution rule issued in the summer. In addition, the American Hospital Association and the American Medical Association have announced that they are joining the case as friends of the court in support of the Texas Medical Association. The lawsuit was filed in the U.S. District Court for the Eastern District of Texas. And the beat goes on.

From the U.S. healthcare business front, the Wall Street Journal reports

Humana Inc. HUM 0.67%▲ and CVS Health Corp. CVS 0.06%▲ are circling Cano Health Inc., CANO 32.17%▲ according to people familiar with the situation, as healthcare heavyweights scramble to snap up primary-care providers.

The talks are serious and a deal to purchase Cano could be struck in the next several weeks, assuming the negotiations don’t fall apart, some of the people said. Cano shares, which had been down nearly 7%, turned positive and closed up 32% after The Wall Street Journal reported on the talks with Humana and other unnamed parties, giving the company a market value of roughly $4 billion.

Bloomberg subsequently reported CVS’s interest.

It couldn’t be learned which other potential buyers might be in the mix, but Cano could be Humana’s to lose as the health insurer has a right of first refusal on any sale, part of an agreement that was originally struck in 2019.

Miami-based Cano operates primary-care centers in California, Florida, Nevada, New Mexico, Texas, Illinois, New York, New Jersey and Puerto Rico, according to documentation from the company. It mainly serves Medicare Advantage members, a private-sector alternative to Medicare for seniors.

Beckers Payer Issues tells us

Healthcare startup Curative, best-known for providing COVID-19 testing, is introducing a health plan with no copays or deductibles. 

The company is offering the new plan in the Austin, Texas, area, with plans to expand throughout Texas over the next year, Curative said Sept. 21. The announcement comes as the startup lays off 109 employees from its testing business in California.

In a news release, Fred Turner, co-founder and CEO of Curative, said the startup is on a mission to “drastically remake” the U.S. healthcare system. 

“The only way to achieve true cost transparency is for all in-network services to be covered at $0 cost, so members actually know where they stand and can get the care they need without surprise bills or medical debt,” Mr. Turner said in the release. 

According to the news release, Curative plan members will not owe any copay costs if they complete a baseline visit to evaluate preventive care and health literacy. 

From the Postal Service front, Federal News Network reports

Postmaster General Louis DeJoy announced Wednesday that all Executive and Administrative Schedule (EAS) and Pay Band Non-bargaining unit employees will soon receive a 3% salary increase, “regardless of their current salary maximum.”

DeJoy, in a memo to USPS officers Wednesday, said the pay increase will go into effect Sept. 24 and will reflect on the employees’ Oct. 14 pay statement.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, NIH, Wellness–

Happy First Day of Autumn!

From Capitol Hill, Roll Call discusses the Senate Majority Leader’s plans for successfully passing the continuing resolution funding the federal government through December 16, 2022.

[I]n theory the tentative plan to start the process this Thursday could lead to a final Senate vote by next Friday, when the current fiscal year expires. It might even enable the House to take up the Senate-passed bill and clear it in time to beat the midnight deadline.

All that assumes everything goes according to plan and that there’s an acceptable stopgap funding package that can pass in both chambers. None of those details have been released, but top appropriators and other lawmakers said Wednesday there’s no talk yet of a very short-term CR to buy more time.

From the Omicron and siblings’ front —

  • Fierce Healthcare tells us about the possible blossoming of another Omicron variant BF.7
  • The Wall Street Journal reports on the rollout of nasal Covid vaccines in Asia “though just how effective they are remains to be seen.” These are adenovirus, not mRNA-based, vaccines. Nonetheless

Delivering a vaccine through the nose has the potential to build up a type of immune response known as mucosal immunity, or immunity in the upper airway tract, said David Curiel, professor of radiation oncology at Washington University School of Medicine who co-developed the Bharat vaccine. That is important because mucosal immunity could more effectively block infection and transmission of the coronavirus than the type of immunity induced by injected vaccines, he said.

In other virus news, Forbes offers an illuminating article by Gayle Smith, the CEO of the ONE Campaign, which fights to end extreme poverty and preventable disease. Ms. Smith writes on the emergence of polio.

The re-emergence of polio is worrisome, particularly considering the politicization of and uneven response to the Covid-19 pandemic. Panic, however, is unwise. What is needed is vigilance and vaccination coverage. Fortunately, there are millions of people who are living proof that polio vaccines work.

This is a moment when the world can do the right thing and eradicate a preventable disease. Since the mid-1950s, a concerted global effort has confined endemic polio to only two countries and proven that this is a virus we can defeat. 

Going all the way is a moonshot and a win for the world. It is not without its challenges, of course. But it is far easier right now than defeating Covid, or malaria, or AIDS. One can only hope that ridding the world of a disease known as “infantile paralysis” might be something we can all agree on — if not for ourselves then for the children whose lives continue to be at risk.

Also, from the public health front, the National Institutes of Health helpfully informs us

In a large clinical trial that directly compared four drugs commonly used to treat type 2 diabetes, researchers found that insulin glargine and liraglutide performed the best of four medications approved by the U.S. Food and Drug Administration to maintain blood glucose levels in the recommended range. Blood glucose management is a key component of keeping people with type 2 diabetes healthy. All four medications evaluated were added to treatment with metformin, which is the first-line drug to treat type 2 diabetes. The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.

More than 37 million Americans have diabetes, and approximately 90 to 95% of them have type 2 diabetes. People with diabetes who keep their blood glucose levels in the near-normal range generally have a much lower risk of developing diabetes complications such as nerve, kidney, and eye diseases. Most people with type 2 diabetes require more than one medication to control blood sugar levels over time. 

While there is general agreement among health care professionals that metformin combined with diet and exercise is the best early approach in diabetes care, there is no consensus on what to do next to best keep high blood glucose in check.

From the wellness front, Fierce Health relates that United Healthcare is expanding its relationship with exercise machine marker Peleton. As a result, UHC will be making Pelton’s fitness services available to as many as 10 million of its members.

From the federal compensation and benefits front

  • Govexec reports on locality pay developments, and Social Security changes that Congress may approve this year.
  • Reg Jones writing in FedWeek provides a personal story about federal survivor benefits worth a gander.

Monday Roundup

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, NIH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omnicron and siblings front —

The Wall Street Journal and STAT News consider when the Covid pandemic will be over in the United States in response to the President’s comment to a 60 Minutes interviewer Sunday night.

STAT News also offers an interview with the President’s science advisor Francis Collins, MD. Dr. Collins “revealed his pain at seeing people spurn mRNA Covid vaccines developed with breathtaking speed and lamented that he and other health officials failed to communicate the ever-changing science behind Covid recommendations.”

The Wall Street Journal adds

More than a year-and-a-half after the first Covid-19 vaccines became available, people are trickling in every day to get their first doses. 

As health officials and physicians roll out retooled boosters targeting substrains of the Omicron variant, federal data suggest there are still thousands of people a day getting shots of the original vaccines for the first time. 

All together, the seven-day average for adults getting first shots each day ranged between roughly 15,000 and 18,000 in late August, according to a Wall Street Journal analysis of data from the U.S. Centers for Disease Control and Prevention. 

The data can overestimate first-shot recipients, because there are times where the agency can’t link follow-up shots, including boosters, to people who received an initial series. The same effect can lead to an undercount of booster shots, according to the CDC.

People who recently got the first jab cited a range of reasons. Some said they were ordered to do so, such as to start a new job or travel for a vacation. Others waited until a vaccine using a more-traditional technology, instead of the newer mRNA versions, became available. Some went ahead after getting sick with Covid-19, or after a family member vouched that the shots worked. 

Perhaps this news will reassure Dr. Collins.

Moreover, Paxlovid helps people who contract Omicron whether or not they are vaccinated. However, STAT News cautions that advances in treating the sickest Covid patients have stalled since February 2021.

From January 2020 to February 2021, researchers proved four different effective therapies for patients hospitalized with Covid-19 — a lightning pace for drug research, where progress is often measured in decades.

That picture has changed starkly. Advances in treating the sickest Covid patients have stalled. Since February 2021, no new therapies for the hospitalized have emerged as decisively effective, even as over 2,000 patients continue to die daily around the globe, including 300 to 500 in the U.S. * * *

[The stall is due to the fact that m]ost trials have been too small to generate decisive results. Breakthroughs in treating hospitalized patients have come exclusively from large coordinated studies run by governments, NGOs, or consortiums, often testing multiple therapies at once. 

As severe Covid grows rarer, those large studies become harder to do. The U.K.’s landmark Recovery trial, which early on demonstrated steroids were effective and hydroxychloroquine was not, is still ongoing and has expanded to new countries. But it hasn’t issued results since May and hasn’t shown a new therapy was effective since 2021. 

Quite a conundrum.

In monkeypox news, Fierce Healthcare tells us

New cases of monkeypox are down 50% since early August, the Center for Disease Control and Prevention announced in a press briefing.

The nation’s seven-day average for new cases peaked on Aug. 10, with 461 cases, and on Sept. 14 was 170, according to federal health officials. Credit for the decrease was given to education and vaccination efforts.

“We approach this news with cautious optimism,” said Rochelle Walensky, M.D., director of the CDC, at a Sept. 15 press briefing. “We continue to closely monitor data on this outbreak, those at risk, and how prevention measures are being used.”

Walensky stated that while overall growth was down, geographical pockets of the U.S. still showed an increase in cases. Over 23,000 cases of the virus have been confirmed in the U.S. as of Sept. 16.

From the maternal health front, the American Hospital Association reports

An estimated 84% of pregnancy-related deaths in 36 states between 2017 and 2019 were preventable, according to a new Centers for Disease Control and Prevention report based on data from interdisciplinary committees that review deaths during and up to one year after pregnancy.

Among deaths with information on timing, 22% occurred during pregnancy, 25% on or within seven days of delivery, and 53% seven days to one year after pregnancy. The leading underlying causes of pregnancy-related death were cardiac and coronary conditions among Black people, mental health conditions among Hispanic and white people, and hemorrhage among Asian people.

The first data released under a CDC-funded program to support these Maternal Mortality Review Committees, the report “paints a much clearer picture of pregnancy-related deaths in this country,” said Wanda Barfield, M.D., director of CDC’s Division of Reproductive Health at the National Center for Chronic Disease Prevention and Health Promotion. “The majority of pregnancy-related deaths were preventable, highlighting the need for quality improvement initiatives in states, hospitals, and communities that ensure all people who are pregnant or postpartum get the right care at the right time.”

From the healthcare costs front, Health Leaders Media discusses a Buck Consultants survey of health insurers and administrators finding rising costs in employer-sponsored plans.

In US healthcare business news –

The Wall Street Journal reports

A federal judge Monday ruled against a Justice Department antitrust challenge to UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc., rejecting government claims that the deal would unlawfully suppress competition and limit innovation in health-insurance markets.

U.S. District Judge Carl Nichols ruled for the companies in an opinion that he kept under seal for now because he said it “may contain competitively sensitive information.” The judge said he would release a redacted public version of the ruling in the coming days. In a one-page public order, he denied the Justice Department’s request to block the companies from completing the deal.

The lawsuit, filed in February, is an early blow to stepped-up antitrust enforcement by the Biden administration. The department didn’t immediately respond to a request for comment.

The decision is a triumph for UnitedHealth, which owns the largest U.S. health insurer and a healthcare operation that comprises thousands of doctors as well as clinics, surgery centers and other assets, along with a powerful conglomeration of health data.

Healthcare Dive adds

Humana expects to pay between $450 million and $550 million to acquire the first group of senior-focused primary care centers that it developed through a joint venture with Welsh, Carson, Anderson & Stowe, Chief Financial Officer Susan Diamond said Friday during the insurer’s investor day.

The agreement inked with Welsh Carson in 2020 included options for Humana to acquire the private equity firm’s interest in the joint venture in stages over the next five to 10 years. The venture was expected to open 67 clinics by early 2023. “We are planning for the full acquisition of centers built in partnership with Welsh Carson through our put and call options beginning in 2025,” Diamond said.

In mid-May, Humana and Welsh Carson announced a second joint venture that will spend up to $1.2 billion to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 under the CenterWell Senior Primary Care brand.

From the Medicare front, STAT News relates

Chronic kidney disease, already a problem affecting millions of Americans, is only expected to become more prevalent as the country ages. For those with end-stage disease, a transplant is the ideal treatment, but dialysis is their reality. Hundreds of thousands of Americans flock to clinics three times a week to have their blood filtered through — in the absence of a functioning kidney — a machine.

As a medical treatment, dialysis is a stopgap measure that fails to fix a chronic problem (average life expectancy on dialysis is five to 10 years). As an industry, dialysis has significant flaws, including a lag in home dialysis use. Critics argue dialysis clinics have for decades shirked a responsibility to help patients get on the kidney transplant waitlist and receive organs from living donors — the gold standard. 

Now federal health officials are trying to fix those problems with a big policy experiment, using one of their biggest hammers: how dialysis providers are paid. 

That should get the dialysis providers’ attention.

From the National Institutes of Health front, the NIH Center for Alzheimer’s and Related Dementias issued an update on its work and operations.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Government Contracting, Mental health care, SDOH–

As we wrap up the last weekend of summer, we can look forward to the House of Representatives and the Senate holding Committee business and floor voting. Yahoo Finance adds

Once again, the threat of a government shutdown looms at the end of the fiscal year, which arrives on September 30. Lawmakers have two weeks to provide funding to keep large swaths of the federal government open and functioning, and the most likely result at this point is a short-term bill called a continuing resolution that funds the government for about 10 weeks, or until mid-December. Lawmakers would then look to pass an omnibus spending package to cover the rest of the 2023 fiscal year.

From the Omicron and siblings front, the Wall Street Journal offers an engaging interview with Moderna’s CEO Stéphane Bancel who “discusses the company’s latest Covid shot and research on using mRNA in seasonal flu vaccines and personalized treatments for cancer.”

From the social determinants of health front, Health Affairs discusses best practices to improve the collection and distribution of race, ethnicity, and language data for use by health care providers and payers. Healthcare payers, in particular, cannot address SDOH issues strategically without having REL data. The FEHBlog’s idea, which he has floated unsuccessfully to date, is to add REL codes to the AMA’s CPT 4 code system, thereby allowing the ready distribution of that data via reliable coders.

Speaking of the distribution of healthcare data, EHR Intelligence reports that “Large Health IT Networks Unveil Plans to Become Qualified Health Information Network (“QHIN”) Under TEFCA.” TEFCA will act as the Electronic Health Records “backbone” to vastly improve health record interoperability, which has long been a national EHR goal.

From the mental healthcare front, last Friday, “the U.S. Department of Health and Human Services (HHS) released the HHS Roadmap for Behavioral Health Integration (Roadmap), which details policy solutions that would help to better integrate mental health and substance use care into the larger health care system and other systems. The Roadmap is based on feedback Secretary Becerra received from patients and providers during more than two dozen stops on his National Tour to Strengthen Mental Health.”

Finally, a government contract expert discusses in Federal News Network why the 1994 federal acquisition reform law (actually the related 1994 and 1996 laws) aiming to simplify the federal procurement process needs a reboot. The FEHBlog heartily agrees.

Labor Day Weekend Update

David Ermer–Congress, COVID-19 vaccine, U.S. Healthcare, Uncategorized–
Photo by Jim Stapleton on Unsplash

Happy Labor Day!

The Senate returns to Capitol Hill for committee business and floor voting tomorrow. The Wall Street Journal adds “Between now and Election Day, senators are scheduled to be back in Washington for four weeks, then gone a week, and then back for two weeks in October.” The House of Representatives will be engaged in committee business but not floor voting this week. The House resumes floor voting next week.

The Wall Street Journal informs us

The White House is asking Congress for $47.1 billion in emergency funding for Covid-19 and monkeypox and to back Ukraine in its war with Russia, as well as spending for natural disasters, according to administration officials.

Congress must vote on a spending bill by the end of September to avoid a partial government shutdown. Lawmakers are expected to use a stopgap funding measure that will maintain funding levels for the short term.

The White House is asking Congress to add the emergency funding on top of that, with about $22.4 billion for Covid-19 vaccines, testing programs, clinical trials and research; $4.5 billion to bolster efforts to fight monkeypox; and $6.5 billion to help areas of the country prepare for and recover from natural disasters. * * *

The emergency funds wouldn’t be paid for with new or shifted revenue, and would be new money that hasn’t been previously appropriated.

[As of last Friday, September 2] Senate Republican leadership didn’t immediately respond to a request for comment about the White House’s request for emergency funding. Spending bills require 60 votes, and in the 50-50 Senate at least 10 Republicans would need to back any bill that contained the administration’s request.

Govexec notes

[President] Biden intends to nominate Richard Revesz, the AnBryce Professor of Law and Dean Emeritus at the New York University School of Law, to be administrator of the Office of Information and Regulatory Affairs, which is housed within the White House Office of Management and Budget. Biden has not had a permanent OIRA head since taking office.

From the U.S. healthcare business front, the Wall Street Journal reports this afternoon that CVS Health has struck a deal to purchase Signify Health:

The drugstore giant’s deal to acquire home-healthcare company Signify Health Inc., announced Monday, will add 10,000 contracted doctors and clinicians and give CVS a hand in coordinating medical care for millions of Americans.

CVS, the nation’s biggest healthcare company by revenue, said that it agreed to acquire Signify for $30.50 per share in an all-cash deal, confirming earlier Wall Street Journal reports. CVS said it expects the deal, finalized over the weekend after a sales process that drew interest from companies from Amazon.com Inc. to UnitedHealth Group Inc., to close in the first half of 2023.

CVS for years has worked to transform itself from a pharmacy chain to an integrated provider of medical services, with the biggest step being its 2018 acquisition of insurer Aetna. Initially, CVS envisioned a model centered on pharmacists, in-store clinics and a giant insurance business.

But Karen Lynch, who took over as CVS CEO last year, determined that the company needs doctors on its payroll to fulfill those ambitions. She also set out to expand CVS’s presence in home healthcare, demand for which has been rising as the U.S. population has aged.

Signify’s model is based on an analytics-and-technology platform, used by doctors that go into homes equipped with connected iPads, that allows the clinicians to assess patient needs and connect them with follow-up services.

The clinicians “operate much like Uber drivers,” said Kyle Armbrester, Signify Health chief executive. “We’re in a gig economy and this is a flexible model.”

The deal is the latest for a home-health company. Rival Walgreens Boots Alliance Inc. last week finalized a deal to purchase a majority stake in CareCentrix, Inc., another home-healthcare platform.

This spring, UnitedHealth agreed to buy LHC Group Inc., one of the country’s largest home-health firms, for about $5.4 billion. Last year, Humana Inc. agreed to take full control of home-health provider Kindred at Home. Both LHC and Kindred provide continuous home-healthcare services.

Signify has grown to serving more than 2.5 million homes from around 300,000 five years ago, said Mr. Armbrester, who is set to remain CEO of Signify Health after the acquisition.

From the public health front, NPR Shots discusses the new Covid boosters and Precision Vaccinations discusses flu shots. The FEHBlog checked chain pharmacies in his locality in Dripping Springs, TX. Flu shots are already available, and the new Covid boosters will be available mid-week.

Thursday Miscellany

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, SDOH, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the omicron and siblings front, AHIP informs us

Today the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the bivalent mRNA COVID-19 vaccines as a single-dose booster for all individuals ages 12 and older (Pfizer-BioNTech) and 18 and older (Moderna), at least two months following primary series or previous booster dose.  The ACIP recommendation for the bivalent boosters was approved by a vote of 13-1.

The Committee reviewed modeling data showing the vaccine has the potential to reduce hospitalizations and deaths, especially among high-risk groups.  The bivalent boosters are recommended for all those over age 12 who have completed a primary series, at least 2 months after the most recent dose. The modeling data indicates that the vaccine is safe and effective, and that booster strategies will be executed in an equitable manner.  Models also indicate that waiting until more trial data is available (in two to three months) could lead to preventable hospitalizations and deaths.

ACIP members expressed concern that many assumptions had been made with the modeling, and that the vaccine being recommended – which includes protections specific to the BA.4/BA.5 variants – has not been tested in humans.  Mouse models were used for data on this vaccine, in addition to extrapolations from human trials using the BA.1-specific vaccine. CDC pointed out that annual influenza vaccines are modified based on projected variants without direct clinical evidence. ACIP members also expressed concerns that the bivalent booster makes assumptions about future variants, which this booster may not protect against.

Earlier this week, the Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for both the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent Moderna vaccine is authorized for use as a single booster dose in individuals 18 years of age and older and the Pfizer bivalent vaccine is authorized for use as a single booster dose in individuals 12 years of age and older.  FDA also released fact sheets on both the Pfizer-BioNTech vaccine and the Moderna vaccine.

With the authorization, FDA has revised the EUAs to remove the use of the monovalent versions of the vaccines for booster administration for the age groups now covered by the bivalent booster products. ACIP also rescinded its recommendations for the monovalent booster vaccines.

Bivalent boosters may be available as early as next week.

The FEHBlog finds it noteworthy that the new bivalent booster replaces the monovalent booster.

STAT News offers FAQs on the new boosters.

STAT News also discusses the Omicron outlook for this autumn.

In a way, some physicians have said, Covid is becoming more like the other respiratory pathogens that most of us shake off but that can occasionally cause severe illness and death among the oldest adults or people who are already sick. So many more people are dying from Covid than from those other viruses, however, because of the massive number of cases that are still occurring overall.

Another trend that has continued into 2022 has been the racial and ethnic disparities associated with Covid. The gaps between different demographic groups’ death rates have shrunk over time, but at the peak of this summer’s wave, for example, death rates by age group among Hispanic adults were notably higher than those among white adults, federal data indicate.

One of the silver linings of the pandemic is that, unlike with some viruses, SARS-2 did not pose a particularly serious threat to children. That’s not to minimize the hospitalizations and deaths — as well as incidents of long Covid and MIS-C — that the virus did cause in pediatric populations. But overall, kids have faced much lower risks of severe outcomes from Covid than adults.

Still, something worrisome occurred this summer with kids and Covid, as hospitalizations reached their second highest peak of the entire pandemic, surpassing last summer’s Delta wave and only trailing the initial Omicron spike early this year.

The article’s experts encourage vaccinating children to stem this tide.

From the FEHB front, Govexec provides a handy just before and just after federal retirement checklist, and Fedweek helpfully delves into “What Counts and What Doesn’t for Keeping FEHB Coverage in Retirement,” which should be a key consideration for career feds.

From the public health front, the CDC reminds us September is Sepsis Awareness Month

Anyone can get an infection, and almost any infection, including COVID-19, can lead to sepsis. Sepsis is the body’s extreme response to an infection and is a life-threatening medical emergency.

September is Sepsis Awareness Month and CDC encourages patients and healthcare professionals to share Get Ahead of Sepsis resources, below, to learn how to protect themselves, their loved ones, and their patients from sepsis:

Patients and families:
* New this year is an updated patient and family brochure.
* Download and share any of CDC’s FREE patient education materials with your friends and loved ones to learn how to prevent infections, be alert to the signs and symptoms of sepsis, and act fast if sepsis is suspected.
* Share updated sepsis graphics on social media to educate friends and loved ones about sepsis.
* Are your children back to school? Talk to your child’s healthcare professional and school nurse about steps you can take to prevent infections that can lead to sepsis. Some steps include taking good care of chronic conditions and getting recommended vaccines.
Healthcare professionals:
New this year are two fact sheets for long-term care nurses and certified nurse assistants.
Download and share CDC’s FREE healthcare professional education materials with your colleagues to educate them about how to recognize signs and symptoms of worsening infection and sepsis, how to get ahead of sepsis, and what to do if they suspect sepsis.
Educate your patients and their families about:
o Preventing infections
o Keeping cuts clean and covered until healed
o Managing chronic conditions
o Recognizing early signs and symptoms of worsening infection and sepsis
o Seeking immediate care if signs and symptoms are present

This Sepsis Awareness Month, spread the word about sepsis—you can help save lives.

To learn more about sepsis and how to prevent infections, visit www.cdc.gov/sepsis or call 1-800-CDC-INFO.

From the miscellany department —

  • Medpage Today offers a special report about a ” New Behavioral Health Database Reveals Gaps in Care — Researchers behind it hope to provide the data needed to remedy the problem.”
  • STAT News reports “Drug treatment of veterans with opioid use disorder increased during the first year of the pandemic, according to a new study, suggesting that the rapid shift from in-person to telehealth visits at VA medical centers enabled patients to get access to care despite Covid-related disruptions.”
  • Fierce Healthcare tells us “Cigna’s Evernorth subsidiary is expanding its diabetes care value program to combine traditional pharmaceutical interventions with devices, tools and resources to help patients better understand and manage their diabetes.”
  • Healthcare Dive informs us that “To staunch the losses of rural hospital closures that endanger access to care for millions, federal regulators are hoping some facilities opt in to a new payment model, but providers say they want more flexibilities and clarity before making the pivot. * * * The new rule ‘maybe gets halfway there,’ Jennifer Findley, vice president of education and special projects at the Kansas Hospital Association, told Healthcare Dive. ‘It’s not as much as we were hoping for but it does give some more flexibility than what you have today.’”
  • Health Payer Intelligence reports “Chronic diseases are common among emergency department patients, particularly among seniors and those ages 45 to 64, according to a National Health Statistics Report. ‘Monitoring ED visits made by adults at highest risk of severe COVID-19-related illness is important for understanding the health burden of COVID-19 and for planning prevention strategies,’ the researchers explained. ‘Ongoing monitoring of the presence of these underlying chronic conditions at ED visits will continue to inform COVID-19 response efforts.’”
  • Also Health Payer Intelligence notes that “Three major social determinants of health factors are particularly predominant barriers to care for America’s seniors: economic instability, loneliness, and food insecurity, according to a study sponsored by Alignment Healthcare. Researchers from Toluna conducted an online survey from July 24 to August 13, 2022, which reached 2,600 seniors ages 65 and older. Most respondents identified as white. Half were in Medicare Advantage and this population was divided primarily between preferred provider organizations and health maintenance organizations.”