Monday Roundup

CDC

Monday Roundup

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call reports the FY 2023 National Defense Authorization Act is expected to rescind the Defense Secretary’s 2021 Covid vaccine mandate for U.S. service members. “Congressional leaders are aiming to introduce the final compromise NDAA version as soon as Tuesday, with House floor action possible later in the week.”

From the infectious disease front —

  • Bloomberg Prognosis tells about a study confirming the Paxlovid rebounds have been blown out of proportion.
  • Pfizer has asked the Food and Drug Administration for an emergency use authorization applicable to its bivalent Omicron vaccine designed for children at least six months old and not over four years old.
  • The Health and Human Services Secretary has confirmed reported plans to end the mpox public health emergency when the current declaration expires at the end of January 2023. “But we won’t take our foot off the gas – we will continue to monitor the case trends closely and encourage all at-risk individuals to get a free vaccine.”
  • MedPage Today interviews Demetre Daskalakis, MD, MPH, the deputy coordinator of the White House Monkeypox Response Team, about the course of the illness since it erupted in the summer

Influenza hospitalizations this early in the season are higher than they have been in a decade, according to the CDC, with 14 pediatric deaths reported so far.

“Since October 1, there have already been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu,” said CDC Director Rochelle Walensky, MD, MPH, on a call with reporters on Monday, held in part to kick off National Influenza Vaccination Week. * * *

This year, influenza vaccines are “well matched to the viruses currently circulating,” she added. The flu shots contain protection for two influenza A and two influenza B virus strains. Of influenza A viruses detected and subtyped this season, 79% have been A(H3N2) and 21% have been A(H1N1).

The CDC recommends influenza vaccination particularly for children, immunocompromised individuals, pregnant women, and people 65 and over.

It was not clear if the pediatric deaths reported so far this season involved unvaccinated children, but Fryhofer noted that previous data showed about 80% of influenza deaths occur in unvaccinated persons.

Pregnant women who get the flu shot also protect their newborns, who are not eligible for vaccination before they are 6 months of age, Fryhofer said. “If you’re not doing it for you, do it for your baby.”

  • For context, here are the flu case and death statistics from the last flu season before Covid struck, October 2019 through March 2020.
2019 – 2020 Winter CDC Fluview  3/28/20
Flu Deaths                  24,000 
Flu Cases             39,000,000 

The flu is a highly contagious, dangerous disease.

  • NPR Shots offers consumer advice should they counter pharmacy shelves with a low or no supply of anti-fever drugs.

From the telehealth front, Health Leaders Media tells us

According to a survey commissioned by America’s Health Insurance Plans, almost 70% used telehealth in the past year because it’s more convenient than in-person care, and almost 80% say telehealth makes it easier to seek out care.

Almost 50% used telehealth because they were unable to make an in-person appointment, while 24% said they wanted to save money.

Some 36% used telehealth just once over the past year, while 53% used it between two and five times.

From the mental healthcare front, Health Payer Intelligence reports

 CareFirst BlueCross BlueShield (CareFirst) is providing community-based organizations with nearly $8 million in grants to help improve behavioral healthcare access and quality for underserved youth.

The COVID-19 pandemic exacerbated the mental and behavioral health crisis among children, adolescents, and families. In response, CareFirst is investing in 19 community-based organizations in Maryland, Washington, DC, and Northern Virginia.

“CareFirst recognizes that behavioral health is an essential part of overall health, which includes a continuum of conditions ranging from severe mental health disorders to the emotional, psychological, and social factors that affect a person’s overall wellbeing,” Destiny-Simone Ramjohn, PhD, vice president of community health and social impact at CareFirst, said in the press release.

Kudos

From the Rx coverage front, Fierce Healthcare informs us

Express Scripts, which is part of Cigna’s Evernorth subsidiary, said Monday that it will add biosimilars for Humira to its largest formularies as preferred products available for patients with inflammatory conditions. Like other major PBMs, Express Scripts sees significant potential in biosimilars to help address the massive costs associated with specialty drugs.

Specialty drugs account for just 2% of prescriptions but drive half of drug spending.

In October 2021, Express Scripts announced that it would put Semglee, the first Food and Drug Administration-approved interchangeable insulin biosimilar, on its National Preferred Formulary for 2022. The company estimates that this move generated $20 million in savings in the first year.

From the federal government employee benefits front, Federal News Network relates

The Office of Personnel Management plans to suspend applications for the Federal Long Term Care Insurance Program for two years beginning Dec. 19, in anticipation of a sizeable rate hike.

OPM announced the unusual measure last month in the Federal Register, and noted that federal workers who submit their applications by the deadline will still be considered for enrollment. FLTCIP was created in 2002 and assists with health care costs for participants who need help with daily personal functions, or who have a severe cognitive illness, and covers home care, nursing home or assisted living benefits.

“OPM is suspending applications for coverage in FLTCIP to allow OPM and the FLTCIP carrier to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency wrote.

The program will continue to operate normally for current enrollees, although they will not be able to apply to increase their coverage. There are currently around 267,000 federal workers and retirees participating in the insurance plan, and OPM typically receives only a few thousand applications to enroll per year.

The decision to suspend applications for the program came after John Hancock Life and Health Insurance Co., the contractor that administers the program, informed OPM that it is likely that there will a premium increase sometime next year.

Finally, the Wall Street Journal offers an interesting article about medical research that is “uncovering links between your ‘subjective age’ [as opposed to your chronological age] and your future health and longevity.”

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, Medicare, Mental health care, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the Omicron and siblings front, the Centers for Disease Control’s weekly interpretative summary of its Covid statistics explains

Cases

As of November 30, 2022, the current 7-day average of weekly new cases (43,300) decreased 1.2% compared with the previous 7-day average (43,837). A total of 98,777,220 COVID-19 cases have been reported in the United States as of December 30, 2022.

Variant Proportions

CDC Nowcast projections* for the week ending December 3, 2022, estimate the proportion of lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6,and XBB. XBB is a recombinant of two BA.2 sublineages.

New Hospital Admissions

The current 7-day daily average for November 23–29, 2022, was 4,201. This is a 17.6% increase from the prior 7-day average (3,572) from November 16–22, 2022.

Vaccinations

As of November 30, 2022, 655.3 million vaccine doses have been administered in the United States. Overall, about 267.3 million people, or 80.5% of the total U.S. population, have received at least one dose of vaccine. About 228.4 million people, or 68.8% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 114.8 million people have received a booster dose,* and more than 39.7 million people have received an updated (bivalent) booster dose. But 48.3% of the total booster-eligible population has not yet received a booster dose. Learn more about who is eligible.

Deaths

The current 7-day average of new deaths (254) decreased 32.4% compared with the previous 7-day average (376). As of November 30, 2022, a total of 1,077,303 Covid-19 deaths have been reported in the United States

The CDC also released an encouraging report about Paxlovid’s efficacy.

Summary

What is already known about this topic?

Nirmatrelvir-ritonavir (Paxlovid) is an outpatient antiviral medication recommended for adults with mild-to-moderate COVID-19 who have elevated risk of severe illness.

What is added by this report?

Among U.S. adults diagnosed with COVID-19, including those with previous infection or vaccination, persons who were prescribed Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within 30 days after diagnosis than those who were not prescribed Paxlovid.

What are the implications for public health practice?

Paxlovid should be offered to eligible adults irrespective of vaccination status, especially in groups with the highest risk for severe COVID-19 outcomes, such as older adults and those with multiple underlying health conditions.

Also from the public health front, the CDC’s Fluview tells us

  • Seasonal influenza activity is high and continues to increase across the country.
  • Of influenza A viruses detected and subtyped this season, 79% have been influenza A(H3N2) and 21% have been influenza A(H1N1).
  • Two influenza-associated pediatric deaths were reported this week, for a total of 14 pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 47 during every previous season since 2010-2011.
  • The number of flu hospital admissions reported in the HHS Protect system during week 47 almost doubled compared with week 46.
  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.
  • All viruses collected and evaluated this season have been susceptible to influenza antivirals.
  • An annual flu vaccine is the best way to protect against flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.
  • CDC recommends that everyone ages 6 months and older get a flu vaccine annually. Now is a good time to get vaccinated if you haven’t already.
  • There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

The Wall Street Journal offers a helpful overview of the tripledemic situation.

From the Alzheimer’s Disease front —

STAT News reports

Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success.

This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-long cycle of disappointment.

A packed audience repeatedly burst into applause during Eisai’s lecanemab presentation on Tuesday — with onlookers clapping even when they learned that the results had been concurrently published in the New England Journal of Medicine. Supplemental figures don’t usually don’t draw cheers, but the warm reception underscored how overjoyed researchers were to have any kind of success against Alzheimer’s, even a modest one. * * *

Several researchers compared this moment in Alzheimer’s research to the early days of cancer therapy or HIV treatment — the first drugs aren’t smash hits, but they’re something for scientists and doctors to build on and learn from.

“It’s not like you’ve won the war with lecanemab,” said Eric Siemers, chief medical officer of Acumen Pharma. “We’ve got a lot of work to do. But this is an inflection point. There’s no question about it.”

In that regard, BioPharma Dive points out lessons learned from testing a Roche drug similar to lecanermab.

After one year of treatment, [the Roche drug] gantenerumab reduced amyloid burden in patients only half as well as the trials’ designers had expected based on previous research, said researcher Randall Bateman, a neurology professor at Washington University in St. Louis who helped lead the studies.

Moreover, around half as many gantenerumab patients as predicted tested negative for amyloid over the course of the trial. Almost none tested negative after one year of treatment, and only around a quarter did after more than two years, researchers revealed.

Data for lecanemab and donanemab presented at CTAD, meanwhile, showed stronger amyloid clearance, helping boost confidence in those drugs.

Bateman also pointed to a post-study analysis researchers conducted of Roche’s trials that hinted at better outcomes for trial participants who had higher reductions in amyloid, although this finding wasn’t statistically conclusive.

Taken together with data from other trials, gantenerumab’s results should help researchers as they try to optimize available therapies and develop new ones, Bateman said.

“I see this as one of the missing essential pieces of the puzzle of figuring out how to optimally treat along this pathway for amyloid removal,” he said.

Meanwhile, the New York Times tells us about “A Promising Trial Targets a Genetic Risk for Alzheimer’s
Preliminary results offer hope that gene therapy can protect people with a version of the brain disease driven by a particular gene variant.”

From the U.S. healthcare business front, Healthcare Dive reports

Advocate Aurora Health and Atrium Health announced Friday the two providers have closed their merger deal, becoming the nation’s fifth-largest nonprofit health system by revenue.

The new system, Advocate Health, will generate revenue of more than $27 billion and operate 67 hospitals and more than 1,000 sites of care in six states. The system expects to treat nearly 6 million patients each year. * * *

The two systems do not have any geographic overlap, an aspect that has tripped up prior hospital mergers.

Instead, economists told Healthcare Dive, the FTC is likely to examine insurer overlap in the case of Advocate Health. The combined entity operates in Illinois, Wisconsin, Georgia, North Carolina, South Carolina and Alabama.

From the federal employment front —

Govexec informs us

The Biden administration will allow agencies to hire employees in certain positions on a temporary basis for up to 10 years, more than doubling the current cap limiting the assignments for those workers.

The Office of Personnel Management issued the rule on Thursday, finalizing a proposal first put forward by the Trump administration. The rule will enable federal agencies to appoint employees in STEM jobs for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects. Previous regulations required agencies to get special permission from OPM to keep any term employee on staff for longer than four years.

Viet Tran, an OPM spokesman, said the rule showed the administration’s “commitment to STEM hiring.” He added it would allow for more federal, rather than outsourced, hiring. 

“With this final rule, agencies have more flexibility and support (and less administrative burden) to hire employees—rather than contractors—for non-permanent STEM positions that agencies expect from the outset to last longer than 4 years but not more than 10 years,” Tran said. “This is another tool to help agencies better compete for talent.”

As the FEHBlog has explained, federal employees can expect a 4.6% pay raise for 2023 with 4.1% of the increase being distributed across the GS schedule and the remaining 0.5% allocated to locality pay. As it turns out, the Society for Human Resource Management tells us

Employers in the U.S. plan to boost salaries an average of 4.6 percent in 2023, up from 4.2 percent this year, according to a new study.

Employers say inflationary pressures and the ongoing challenges of finding and keeping workers are the main reasons for the higher projected increases. Indeed, 3 in 4 of the 1,550 U.S. employers in the latest Salary Budget Planning Report by consultancy WTW say they continue to experience problems attracting and retaining workers. The survey was conducted from Oct. 3 to Nov. 4, 2022.

From the plan design front, a recent Kaiser Family Foundation report explains the growing use of all sizes of employers to provide retiree health benefits through Medicare Advantage plans.

This analysis uses data from the 2022 KFF Employer Health Benefits Survey to examine the extent to which large private and non-federal public employers that offer retiree health benefits are turning to Medicare Advantage and why they are making this shift. However, the Survey does not include information about union-administered benefits. For additional information about methods, see Survey Design and Methods.

Based on the Survey, we find:

  • Half (50%) of large employers offering retiree health benefits to Medicare-age retirees offer coverage to at least some retirees through a contract with a Medicare Advantage plan, nearly double the share in 2017 (26%).
  • About 44% of large employers that offer Medicare Advantage coverage to their retirees do not give retirees a choice in coverage options. 
  • Among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most commonly cited reason they elected this option was the lower cost.

FEHB plans also are implementing integrated Medicare Advantage plans as a cost-saving measure.

From the HHS front, “Today, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra marked the one-year anniversary of HHS’s Overdose Prevention Strategy (Strategy) by announcing the progress the nation has made since the release of the Strategy, showing expanded treatment capacity, lives saved from an overdose, and commitment to long term recovery supports.” Kudos. Here is the fact sheet.

Midweek Update

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

From the federal employment front —

  • Govexec discusses the outstanding steps that must be taken before a projected 4.6% federal employee pay raise can take effect next month. The FEHBlog expects those steps to be taken.
  • Reg Jones, writing in FedWeek, reviews the federal retirement process.
  • Federal News Network reports that “Federal employees forced to work without pay during government shutdowns need to be made whole eventually. But the government’s late payments don’t mean those workers are entitled to damages, [the U.S. Court of Appeals for the Federal Circuit] ruled Wednesday.

From the Omicron and siblings front, the Wall Street Journal informs us

The Food and Drug Administration said a Covid-19 antibody treatment from Eli Lilly & Co. is no longer authorized for use because it isn’t likely to be effective against certain Omicron offshoots now dominant in the U.S.

The subvariants, called BQ. 1 and BQ. 1.1, now cause more than half of new Covid-19 cases in the U.S., the FDA said on Wednesday. Yet Lilly’s drug, bebtelovimab, doesn’t retain neutralizing activity against the subvariants, the company said. 

“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate Covid-19 with bebtelovimab in the U.S.,” Lilly said.

Bebtelovimab was among the Covid-19 antibody drugs still authorized for use as a treatment for sick patients, after the FDA pulled clearances of others. Roche Holding AG’s Actemra antibody drug is also still in use as a treatment, though it wasn’t developed specifically for Covid-19.

Evusheld, an antibody drug from AstraZeneca PLC, is still cleared to prevent infections.

The FDA said other Covid-19 treatments are still expected to retain activity against BQ. 1 and BQ. 1.1, including PfizerInc.’s Paxlovid and Gilead Sciences Inc.’s Veklury.

In other public health news, STAT News tells us

With growing concern about the circulation of vaccine-derived polioviruses in the United States, the Centers for Disease Control and Prevention said Wednesday that it would work with select communities across the country to conduct wastewater surveillance for the viruses.

The launch of the initiative follows the discovery over the summer of vaccine-derived polioviruses circulating in the sewage of a number of counties in and around New York City. That discovery was made after an unvaccinated man in his 20s was partially paralyzed by polioviruses in July. Since then at least 82 genetically linked viruses have been recovered in sewage samples collected from five counties in and around New York.

The CDC said the work will start in two communities: Oakland County, Mich., and an as-yet-unnamed county in the Philadelphia area. The surveillance may later extend to other parts of the country where polio vaccination rates are low or to locations that have ties to the communities in New York state where polioviruses have been found in wastewater.

From the U.S healthcare business front —

Healthcare Dive reports

Heightened expenses, ongoing staffing shortages and fewer patient discharges have hospitals facing negative margins near the end of the year, according to Kaufman Hall’s monthly national flash report out Wednesday.

Median operating margins have been in the red for 10 consecutive months and were down 2% in October from September. Median operating margins were down 13% year over year in October, according to the report.

Total labor expenses rose 3% from September and total expenses rose 1%, while supply and drug expenses did fall slightly during the month.

In that regard, Beckers Hospital CFO Report relates

Cleveland Clinic has reported a more than $1 billion loss for the first nine months of 2022 as salaries increase and inflationary pressures mount.

The 20-hospital health system reported $469.2 million in third quarter net losses, a significant drop from $422.2 million net income last year. Cleveland Clinic’s investment returns were nearly $682 million lower for the third quarter this year than last due to “unfavorable financial markets,” according to the health system’s financial report.

In contrast, Fierce Healthcare reports

Highmark Health posted a $268 million net loss through the first nine months of 2022 as multiple headwinds drag its finances.

Highmark reported $19.5 billion in revenue, up 22% year-over-year, and $594 million in operating gain. The performance of its equity investment portfolio is a key challenge facing the integrated system, as its financial report includes $670 million in unrealized investment impact driven by a decline in the portfolio.

Saurabh Tripathi, chief financial officer and treasurer of Highmark Health, told Fierce Healthcare that Hihghmark expects to turn that unrealized impact around as the market improves.

Other major headwinds include ongoing supply chain issues, inflation and high labor costs, particularly at its Allegheny Health Network health system. Strong performance at its health plan arm is helping to bolster AHN as it weathers these challenges that providers nationwide are staring down.

“This is where the strength of our portfolio comes in,” Tripathi said. “The insurance side is helping offset those pressures.”

Ah, the benefits of diversification.

From the medical research and development front,

  • The NIH HEAL Project Initiative’s Director delves into HEAL’s research on preventing opioid addiction.
  • BioPharma Dive examines “What to make of Eisai and Biogen’s latest Alzheimer’s drug data.” Given the FEHB Program’s demographics, FEHB carriers should keep an eye on this drug which is bound to be an expensive hot seller if the manufacturers can overcome the blowback from their Aduhelm failure.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, Mental health care, NIH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports

Congressional leaders and top appropriators are set to meet as early as Wednesday to work through differences on a potential omnibus spending agreement, Senate Majority Leader Charles E. Schumer said Tuesday.

President Joe Biden and Vice President Kamala Harris, along with a few top White House aides, met with Speaker Nancy Pelosi, House Minority Leader Kevin McCarthy, Senate Minority Leader Mitch McConnell and Schumer earlier Tuesday to discuss the lame-duck agenda.

Schumer said the leaders had a “productive discussion” about funding the government, and said all four leaders aim to come together to pass an omnibus.

“We all agreed that it should be done this year, we all agreed we have to work together and everyone has to give a little bit,” he said. “We also…said we would all work toward getting an omnibus as opposed to a CR.”

The prospects of a lame duck omnibus remain murky as Republicans and Democrats have not reached a topline spending agreement. The current continuing resolution runs out Dec. 16, though lawmakers have discussed a stopgap extension of perhaps a week to buy extra time.

The FEHBlog sees these developments as a good sign.

From the Omicron and siblings front, MedPage Today informs us

What happens to people who get reinfected with SARS-CoV-2, the virus that causes COVID-19? A recent paper in Nature Medicinehas been misinterpreted by some as providing evidence that repeat infections are somehow worse than first-time infections.

Here’s the actual situation: second infections are far less dangerous than first infections, with respect to severe, critical, and fatal COVID-19. This is true regardless of vaccination status.

Health Payer Intelligence offers three interesting survey findings about health insurance in our country

  • “Health insurance coverage disruptions were associated with higher mortality risks for people with private and public insurance, a JAMA Health Forum study found.”
  • “In two-adult families with and without children, the majority of members had the same type of health insurance coverage, whether they had group plans, non-group plans, or Me,dicaid” according to a brief from the Employee Benefit Researcher Institute (EBRI).

From the public health front, the FEHBlog ran across The PCORI Health Care Horizon Scanning System identifies and monitors developing innovations with potential to change health care. This database can be used by patients, care partners, and others to track advancements in care options.

The Wall Street Journal reports

The rate of gun deaths in the U.S. reached a 28-year high in 2021 after sharp increases in homicides of Black men and suicides among white men, an analysis of federal data showed.

A record 48,953 deaths in the U.S., or about 15 fatalities per 100,000 people, were caused by guns last year, said the analysis published Tuesday in the journal JAMA Network Open. Gun deaths declined in the 1990s, but have been rising steadily over the past decade and skyrocketed during the Covid-19 pandemic, said researchers who conducted the analysis.

Gun-related deaths of women and children have risen, the analysis said, but men remain far more likely to die from guns.

“The disparities are so marked,” said Chris Rees, a co-author of the study and an assistant professor of pediatrics and emergency medicine at Emory University School of Medicine.

On a related note, Federal News Network relates

The Pentagon is looking to hire hundreds of clinicians and mental health professionals in the coming months, as part of the initial cohort of its worldwide suicide prevention workforce.

Deputy Defense Secretary Kathleen Hicks, speaking Tuesday at a Washington Post Live event, said DoD is building up a “first of its kind” suicide prevention workforce that will eventually reach an end strength of 2,000 personnel.

Hicks said hiring, onboarding and training the suicide prevention workforce is “at the top of the list” of priorities for Defense Secretary Lloyd Austin. This DoD workforce, she added, is expected to outpace any similar effort led by universities or state governments.

“This prevention workforce will be a first of its kind, and we’re going to do it right here in the United States military, because that’s what we owe our people and their families,” Hicks said.

From the medical research and development front, the Wall Street Journal reports

Researchers released new details from a study of a closely watched drug for Alzheimer’s disease on Tuesday, shedding more light on the drug’s risks and benefits as U.S. health regulators weigh approving it. 

Eisai Co. and Biogen Inc.’s drug, called lecanemab, slowed cognitive decline by 27% compared with a placebo over 18 months in a study of more than 1,700 people with early-stage Alzheimer’s, researchers reported in the New England Journal of Medicine on Tuesday. 

The drug’s effect was moderate, and was associated with swelling and bleeding in the brain, the researchers said. They recommended further, longer study of the drug.

Some 17.3% of patients taking lecanemab had signs of brain bleeding, compared with 9% in the placebo group. Brain swelling occurred in 12.6% of people getting the drug, versus 1.7% who got placebos. 

The study data have been eagerly anticipated by Alzheimer’s researchers since Eisai disclosed high-level results in September, raising the hopes of doctors and patients that a new treatment proven to help Alzheimer’s patients is on the horizon.

The companies have asked the U.S. Food and Drug Administration to conditionally approve lecanemab based on an earlier study showing that the drug reduced levels of a protein in the brain called amyloid associated with Alzheimer’s. The agency is expected to make a decision by Jan. 6. 

Eisai, which is leading the development of lecanemab, has said it plans to seek full approval using the new study data. 

The NIH DIrector’s Blog tells us about the NIH clinical center doctors who are testing 3D-printed miniature, single-use ventilators. Cool.

Healthcare Dive informs us

Google’s health division has inked its first commercial agreement to use its mammography AI research model in real-world clinical practice, with the goal of improving breast cancer screening, Google Health announced Monday.

Google Health has partnered with cancer detection and therapy medtech iCAD on the 5-year deal. Under the agreement, iCAD will work to validate and incorporate Google’s mammography AI — which Google has been building and testing for several years — into its products for use in clinical practices.

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

Apoorva Mehta, a co-founder of Instacart Inc., is working on his next act after saying earlier this year that he would step down as executive chairman from the startup he built into a grocery delivery giant once it goes public.

Mr. Mehta earlier this month raised $30 million for Cloud Health Systems, a new healthcare startup aiming to offer consumers medical consultations and other health-related services, according to people familiar with the matter. 

Good luck.

Monday Roundup

David Ermer–CDC, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, NIH, OPM, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, Federal News Network is offering a free e-book on this timely topic.

Fierce Healthcare adds

When many people are looking to enroll in health benefits, they turn to Google as a source of key information on eligibility, the application process and in-network providers.

In this spirit, the Google Search team has quietly rolled out multiple features for its search engine that aim to make it easier for users to access key information about obtaining Medicaid and Medicare benefits, as well as which doctors locally accept those types of coverage.

The article offers more details on these new Google tools.

From the Omicron and siblings front

  • Beckers Hospital Review informs us “The CDC has begun tracking omicron subvariant XBB, which is now estimated to account for 3.1 percent of U.S. cases”[, somewhat higher in New York, New Jersey and New England states]. * * * Health experts anticipate the U.S. will see an increase in COVID-19 cases in the winter months as a collection of omicron subvariants circulates, though they have remained optimistic it will be less severe than last winter’s omicron surge.”
  • The National Institutes of Health discusses its research on the ability of the human body’s immune system to remember a previous Covid infection or vaccination to help ward off, or minimize symptoms during, a future infection.
  • Fierce Healthcare reports “The U.S. came in dead last compared to 20 other countries when it came to preventing deaths from COVID-19 as well as all-cause deaths, and it appears that relatively low vaccination rates might have played a part in those poor showings, a new study finds. * * * The U.S. continued to experience significantly higher COVID-19 and excess all-cause mortality compared with peer countries during 2021 and early 2022, a difference accounting for 150,000 to 470,000 deaths,” authors of the research letter published in JAMA Network wrote. ‘This difference was muted in the 10 states with highest vaccination coverage; remaining gaps may be explained by greater vaccination uptake in peer countries, better vaccination targeting to older age groups, and differences in health and social infrastructure.’”

From the public health front

  • Axios tells us “The RSV season normally runs from December to April, peaking in February and March, but this year has seen an earlier onset. [Dr.] Fauci noted that both the RSV and flu seasons have arrived earlier than usual this year.  Asked by [Meet the Press host Margaret] Brennan whether the U.S. is “in the worst of it” right now, Fauci replied, “I hope so.”
  • The American Hospital Association relates “The World Health Organization today recommended a new name for monkeypox that is intended to mitigate a rise in related racist and stigmatizing language associated with the ailment. The WHO’s newly recommended preferred term is “mpox.” The organization recommends a one-year transition period to mitigate confusion that could be caused by the change and allow for ICD and publication updates. The Biden administration voiced its support for the change, stating, ‘We welcome the change by the World Health Organization. We must do all we can to break down barriers to public health, and reducing stigma associated with disease is one critical step in our work to end mpox.’” The FEHBlog also will begin to refer to chickenpox as cpox.

From the regulatory front, MedPage Today informs us

In an effort to enhance care coordination for patients with substance use disorder (SUD), HHS, acting through its Office for Civil Rights and in collaboration with the Substance Abuse and Mental Health Services Administration, proposed changes to “Part 2” rules to better align privacy measures with those of HIPAA on Monday.

If implemented, the proposed rule would allow Part 2 programs to use and share patients’ records following a single signed consent by the patient “for all future uses and disclosures for treatment, payment, and healthcare operations.”

The proposal also aims to strengthen protections around disclosure of SUD treatment records to guard against discrimination and stigma.

The changes were initially called for in the CARES Act of 2020, provisions of which required the HHS secretary to better align the 42 CFR part 2 rule, better known as “Part 2,” with HIPAA’s Privacy, Security, Breach Notification, and Enforcement Rules.

“This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure,” said HHS Secretary Xavier Becerra in a press release.

HHS adds

From the medical research front, we learn from STAT News that

A drug developed by Axsome Therapeutics significantly reduced a common side effect of Alzheimer’s disease — agitation — the company announced Monday.

The therapy, AXS-05, met its primary goal of delaying time to relapse and preventing patients from relapsing. Patients taking the drug had a 3.6-fold lower risk of relapse overall, compared to placebo.

People with Alzheimer’s disease can get restless, upset, or even aggressive as the disease gets worse. Axsome’s trial also showed an improvement on a scale commonly used to measure overall agitation.

* * *

The Food and Drug Administration has granted Axsome breakthrough therapy status for AXS-05 in Alzheimer’s agitation, which could help the company secure an accelerated, additional approval. Company officials said they plan to wait to see data from another Phase 3 trial called ADVANCE-2 before filing a drug application, according to a third-quarter earnings call transcript from Sentieo.

and

Dr. Thomas Perls has for decades studied so-called super agers, people who live deep into their 90s and beyond, essentially unburdened by the typical diseases of old age. He is convinced that the secret to this remarkable longevity is buried in people’s genes and passed down through generations.

But which genes harbor this power? And if researchers pinpoint the right genes amid thousands in a person’s body, could that knowledge be harnessed to develop drugs that mimic those genes and allow more people to enjoy longer, healthier lives?

That’s the premise behind an ambitious new trial, the SuperAgers Family Study, (superagersstudy.org) that aims to enroll 10,000 people who are 95 years old or older and their children.

From the benefit design front, Beckers Payer Issues offers more insights from a recent AHIP study of prior authorization practices:

Gold-card programs give providers exemptions from certain prior authorization requirements, but providers who have discontinued these programs have found them administratively difficult to implement, according to a Nov. 14 America’s Health Insurance Plans survey.  * * *

Here are the top three reasons insurers said they discontinued gold card programs, according to the report:

1. Administratively difficult to implement: 75 percent

2. Reduced quality/patient safety: 50 percent 

3. Higher costs without improved quality: 25 percent

From the healthcare business front, Healthcare Dive reports

[Telehealth vendor] Amwell is in advanced discussions to acquire online therapy app Talkspace for roughly $200 million, according to a report from Israeli business publication Calcalist.

The telemedicine company is in talks to pay $1.50 per share for Talkspace, Calcalist reported on Sunday. The price tag would represent a 150% premium over Talkspace’s share price at Friday’s close.

The reported transaction reflects a sharp decline in Talkspace’s value since the therapy company went public last summer at a $1.4 billion valuation.

Monday Roundup

David Ermer–CDC, COVID-19, Federal employment benefits, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, Govexec offers Open Season guidance to annuitants. Annuitants make up half of the FEHB’s enrollment.

From the Omicron and siblings front —

STAT News offers epidemiologist / infectious disease expert views on our situation nearly three years since the beginning of the Covid pandemic.

[W]e wondered if people who work in the infectious diseases sphere are still taking steps to try to avoid catching the virus, and if so, which ones. We also wondered whether — maybe even hoped — they are feeling less stressed about Covid and are starting to lower their guard.

The short answer: Some appear to be, a little. But most are still using multiple measures to try to avoid Covid.

The International Foundation of Employee Benefit Plans reports

The Department of Health and Human Services (HHS) issued the Health+ Long COVID Report highlighting patients’ experience of Long COVID to better understand its complexities and drive creative responses by government leaders, clinicians, patient advocates and others.

The Health+ Long COVID Report builds on the President’s Memorandum on Addressing the Long-Term Effects of COVID-⁠19 and the two previously issued HHS Long COVID reports. 

The report:

  • Provides recommendations on how to deliver high-quality care, and relevant and intentional resources and supports to individuals and families impacted by Long COVID;
  • Compliments the existing landscape of Long COVID scientific literature with the narratives and expertise of caregivers, frontline workers, and people experiencing Long COVID and its associated conditions; and
  • Offers a variety of short-term and longer-term recommendations that come directly from the patient experience. For example, insurance providers should update plan guidelines that align coverage with medical treatments that improve health outcomes for people with Long COVID. Employers should support accommodations for people living with Long COVID that allow them to continue to work and study. Federal agencies should disseminate Long COVID messaging to let people know Long COVID is real and is a serious public health issue.

Fierce Healthcare tells us

Pharmaceutical companies are aiming to continue evolving COVID-19 vaccines as the virus mutates, but the jury is still out on the effectiveness of an annual booster strategy.

For example, Moderna this week announced that it has developed a new booster to battle subvariants BA.5 and BA.4 of omicron that the company said will prove more effective than the booster the government rolled out in September, partly because the new version includes data from human beings, not just animals, as Fierce Pharma reports.

As payers are going to be on the hook for coverage of these products, they’re going to have to push for critical data on how these vaccines are working for members, experts say.

Paul Offit, M.D., the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said insurance companies should hold pharmaceutical companies’ feet to the fire. “They should say, ‘Show me the data. Show me the data as to why everyone needs another dose of vaccine. A yearly dose of vaccine. Who benefits? You’ve done those three or four initially. But prove that you need another dose of vaccine. Prove it.’ Because right now it should always be about the data,” he said in an interview.

He added that payers should ask the same questions of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

The FEHBlog does not expect that this financial burden will shift soon because he expects Congress to provide more Covid funding next month. Nevertheless it’s better to be safe than sorry.

In other vaccine news, MPR relates

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has published an updated recommendation to include the use of Priorix  (measles, mumps and rubella vaccine, live) as an additional option for active immunization for the prevention of measles, mumps and rubella in individuals 12 months of age and older. * * *

The recommendation was based on safety data from 4 randomized controlled clinical studies, 4 observational studies and 1 systematic review. In the randomized controlled trials, participants received at least 1 dose of either Priorix or a US-licensed MMR virus vaccine, live (M-M-R® II).

Results showed that immune responses after Priorix administration were noninferior to those observed with M-M-R II. Additionally, no significant difference in the frequency of vaccine-related serious adverse events was reported in these studies.

Based on these findings, the CDC considers Priorix and M-M-R II to be fully interchangeable. Either vaccine may be administered when an MMR virus-containing vaccine is indicated.

In healthcare executive news, Bloomberg reports

Walmart Inc. health-care executive Cheryl Pegus [a cardiologist with a master’s in public health]  will join JPMorgan Chase & Co.’s Morgan Health venture as a managing director, with aims to improve employer-sponsored health care.

The move creates a vacancy at the nation’s largest retailer, as rivals like Amazon.com Inc. and CVS Health Corp. broaden their reach into the $4 trillion US health-care industry. It’s also a high-profile hire for Morgan Health, which the bank launched last year after shutting its joint venture with Amazon and Berkshire Hathaway Inc, known as Haven.

From the innovations front, the Wall Street Journal informs us

Vending machines stocked with overdose-reversing nasal spray are part of the latest attempt to diminish a record tide of drug deaths.

The Food and Drug Administration and some states have loosened restrictions on drugs including Narcan that are sprayed into the nose to reverse an opioid overdose.

Nonprofits that work with opioid users are distributing more of the drugs as a result. Getting Narcan as close as possible to people at risk for an overdose is essential to saving lives, they said.

“If we hadn’t had that vending machine, I might not have had my brother alive today,” said LuDene LoyaltyGroves, who works at a homeless shelter in Moses Lake, Wash. People staying with her brother in a nearby encampment retrieved Narcan from a vending machine at the shelter and used it to revive him repeatedly, she said.

Weekend update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, OPM, U.S. Healthcare–

As we barrel toward Thanksgiving, the House of Representatives and the Senate will be on a District / State work break this week.

Concerning Thanksgiving, Bloomberg Prognosis tackles a burning question.

Does turkey actually make you sleepy? It feels like everyone always says that because turkey contains tryptophan it makes you tired, but is that actually true? Madison, New York, New York

The answer to this question is somewhat counterintuitive: Tryptophan can indeed make you sleepy, but the desire for a post-Thanksgiving dinner nap probably isn’t caused by the bird.

The more likely culprit is the very large meal, says Kat Lederle, a sleep therapist in the UK. * * *

[T]he best way to avoid the post-dinner food coma is to pace yourself at the table. Just be sure to save room for dessert. 

From the Federal Employee Benefits Open Season front —

From the Omicron and siblings front, the New York Times reports

As winter looms and Americans increasingly gather indoors without masks or social distancing, a medley of new coronavirus variants is seeding a rise in cases and hospitalizations in counties across the nation.

The Biden administration’s plan for preventing a national surge depends heavily on persuading Americans to get updated booster shots of the Pfizer-BioNTech and Moderna vaccines. Now some scientists are raising doubts about this strategy.

Older adults, immunocompromised people and pregnant women should get the booster shots, because they offer extra protection against severe disease and death, said John Moore, a virologist at Weill Cornell Medicine in New York.

But the picture is less clear for healthy Americans who are middle-aged and younger. They are rarely at risk of severe illness or death from Covid, and at this point most have built immunity through multiple vaccine doses, infections or both.

The newer variants, called BQ.1 and BQ.1.1, are spreading quickly, and boosters seem to do little to prevent infections with these viruses, as they are excellent evaders of immunity.

The Centers for Disease Control reported on Friday

CDC Nowcast projections* for the week ending November 19, 2022, estimate the proportion of ten lineages designated as Omicron with estimates above 1%: BA.5—and five of its sublineages (BQ.1, BQ.1.1, BF.7, BA.5.2.6, and BF.11)—BA.4.6, BA.2, and BA.2.75.

The predominant Omicron lineage is BQ.1, projected to be 25.5% (95% PI 22.1-29.1%). Additionally, other variants represent 3.1% of circulating viruses, largely composed of the Omicron-derived XBB lineage.

The New York Times adds

Diminishing returns from tinkering with the Pfizer-BioNTech and Moderna vaccines call for a new approach to protecting Americans altogether, Dr. Moore and other experts said. A universal vaccine that targets parts of the coronavirus that do not mutate would be ideal, for example. A nasal vaccine might be better at preventing infections than an injected one.

“Chasing variants by tweaking the mRNA vaccines is not a sustainable strategy,” Dr. Moore said. “There’s a need for better vaccine designs, but that needs a change of attitude at the government level.”

NPR Shots discusses the available treatment options for the predominant variants, which include Paxlovid.

Healthcare Dive informs us

A group of 22 states led by Montana Attorney General Austin Knudsen filed a petition Thursday calling on the CMS to repeal its COVID-19 vaccination mandate for healthcare workers, according to a release.

The states argued the requirement has led to worsening staff shortages in the sector, particularly in rural areas.

The federal vaccine mandate covering healthcare workers has faced a flurry of legal challenges since it was first announced last year.

Unfortunately, the government continues to fight last year’s pre-Paxlovid battle in court.

From the U.S. healthcare business front, Fierce Healthcare tells us

Centene has agreed to sell Magellan Specialty Health to Evolent Health, the latest move in its broad value creation plan.

The government insurer said in an announcement that it expects to bank $750 million in the aggregate from the deal. Centene added Magellan Specialty Health, a leading specialty benefit management company, as part of its acquisition of Magellen Health, which closed in January.

Magellan Specialty Health provides utilization management tools to insurers, including for radiology, musculoskeletal, physical medicine and genetic testing. When the transaction closes, Centene and Evolent will enter a multiyear partnership that enables the insurer to extend and build on its work with Magellan Specialty.

“This transaction is another significant milestone in our ongoing portfolio review and value creation plan,” said Sarah London, CEO of Centene, in the release.

Friday Items

David Ermer–AHRQ, CDC, COVID-19, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

The FEHBlog apologizes for the fact that his Grammarly program made a hash out of yesterday’s Miscellany post. The FEHBlog discovered and fixed the problems this afternoon if anyone cares to go back to read that post. Lo siento.

Going forward, the FEHBlog will be posting Covid stats on the first Friday of the month. Here is the CDC’s weekly interpretation of its Covid statistics which focuses on a CDC report on Covid mortality dated November 16, 2022, and summarized below:

The Wall Street Journal adds

Uptake of fall Covid-19 booster shots remains anemic well into November, frustrating public-health experts who blame the lackluster interest on pandemic fatigue and insufficient outreach from officials.

About 31 million people in the U.S. have gotten the updated shots, or roughly 10% of people ages five and older, according to data from the Centers for Disease Control and Prevention. The federal government purchased more than 170 million doses of the new bivalent boosters that target two Omicron subvariants and the original virus strain.

“It has been pretty dismal,” said Rupali Limaye, an associate professor at the Johns Hopkins Bloomberg School of Public Health, who studies vaccine demand and acceptance. * * *

[U]ptake of the modified booster is slow due in part to the limited amount of outreach and type of messaging from health officials, some public-health experts say.

Anecdotally, it sounds like a lot of people are still not aware that the bivalent boosters are available,” said Angela Rasmussen, a virologist at Georgetown University. “If they are, many don’t seem to understand the importance of getting boosted at all—with bivalent or original recipe—and there is a decided lack of urgency in communications about it.” 

Some public-health experts say there must be not just more, but also targeted outreach. Celine Gounder, a senior fellow at the Kaiser Family Foundation, said messaging needs to be more targeted at people age 50 and over who are most at risk. Among adults 65 and older, some 27% have gotten an updated booster dose, CDC data show. 

“You should be thinking of who is most vulnerable and target the efforts there,” said Dr. Gounder, an infectious-disease specialist and epidemiologist.

The following are the key points from this week’s CDC Fluview:

  • Seasonal influenza activity is elevated across the country.
  • The majority of influenza viruses detected this season have been influenza A(H3N2) viruses, but the proportion of subtyped influenza A viruses that are A(H1N1) is increasing slightly.
  • Two more influenza-associated pediatric deaths were reported this week, for a total of seven pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 4.4 million illnesses, 38,000 hospitalizations, and 2,100 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 45 during every previous season since 2010-2011.
  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.

Medscape offers expert opinions on the “perfect storm” of rampant flu and RSV.

In OPM news, the agency posted its Fiscal Year 2022 Performance and Accountability report this week. The Director’s response to the Inspector General’s list of top management challenges is worth a gander. That response begins on page 125.

From the No Surprises Act front, Beckers Payer Issues tells us

The No Surprises Act has prevented millions of surprise medical bills since January, according to new data from AHIP and the Blue Cross Blue Shield Association. 

The payer associations gathered their data, published Nov. 17, by surveying 84 health insurance providers representing around 57 percent of the national market. 

“Thanks to the No Surprises Act, millions of Americans no longer face a complicated, confusing billing bureaucracy, being harassed by collection agencies, or even potential legal action,” AHIP President Matt Eyles said in a press release. 

AHIP and the BCBS Association also surveyed plans for the number of claims submitted to arbitration under the act. They estimated 275,000 claims have been submitted since January 2022, more than the 17,000 claims predicted by government agencies. 

and

AHIP is backing HHS in a lawsuit over surprise billing arbitration from Texas providers, who have support from the largest associations of providers. 

The trade association filed an amicus brief in Texas Medical Association v. HHS on Nov. 16. 

The lawsuit, filed by the Texas Medical Association in September, challenges the arbitration process established under the No Surprises Act. 

The FEHBlog appreciates AHIP’s amicus brief filing. In the FEHBlog’s opinion, the medical association plaintiffs in the Texas case are making a mountain out of a molehill.

A surprising legal development was the Justice Department’s 11th hour notice of appeal filed today in the antitrust challenge to United Healthcare’s acquisition of Change Healthcare which a federal district judge approved last September.

In other Friday items —

Endpoints reports

The emergence of interchangeable biosimilars since the pathway opened up has been slow. But the FDA on Thursday approved the fourth interchangeable biosimilar, which is also the second interchangeable biosimilar insulin product.

Eli Lilly’s Rezvoglar (insulin glargine-aglr), which converted to an interchangeable after an earlier biosimilar approval in December 2021, follows Viatris’ Semglee in seeking out a niche to compete with Sanofi’s blockbuster Lantus (insulin glargine). * * *

These interchangeable designations mean Semglee and Rezvoglar may be substituted at the pharmacy level for Lantus, without a doctor’s prescription, and as long as the state pharmacy law permits the switch.

USA Today reports

Preterm births last year reached their highest peak since 2007 – with more than 383,000 born before 37 weeks of gestational age in the United States, according to a new report.

In 2021, roughly 10.5% of U.S. babies were born premature, according to the annual March of Dimes “Report Card,” which rated the United States at D+. The score dropped from its C- rating in 2020, when the preterm birth rate saw its first decline in six years, a slight decrease to 10.1%.

The report released this week found disparities widened between white mothers and Native and Black mothers, who are already 62% more likely to have a preterm birth and nearly three times as likely as white moms to die of childbirth-related causes. In 2021, Black mothers saw a 3% increase and Native mothers a 6% increase in preterm births, according to the analysis.

Of all groups, Asian and Pacific Islander mothers saw the largest preterm birth increase – an 8% surge  – even though births to Asian mothers decreased that year, and they have the lowest preterm birth rate overall.

HHS’s Agency for Healthcare Quality and Research capped off antibiotic awareness week by releasing antibiotic stewardship kits for the acute hospital, long-term care, and ambulatory care settings.

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage–
Photo by Josh Mills on Unsplash

Today, November 17, is National Rural Health Day.

Let’s follow up on two posts from this week:

  • On Tuesday, the FEHBlog mentioned that the Internal Revenue Service issued Notice 2022-59 which adjusts the PCORI fee for years “that end on or after October 1, 2022, and before October 1, 2023.” The FEHBlog referenced an adjusted PCORI fee of $2.79 per covered life. Whoops. The FEHBlog referenced the current PCORI fee. The adjusted PCORI fee is $3.00 per covered life. Lo siento.
  • Yesterday, the FEHBlog called to readers’ attention a Congressional Research Service report on federal healthcare laws enacted in the current Congress that expire at the end of 2022. The FEHBlog thought “I should go back and read that report.” Today an email from the Wagner Law firm identified one of these expiring laws, to wit

During the pandemic, Congress allowed telehealth services to be provided to HSA-eligible individuals without cost-sharing and without regard to whether they had met their deductibles under their High Deductible Health Plans. That authorization expired December 31, 2021. Congress then again allowed deductible-free telehealth services to resume from April 1, 2022, through December 31, 2022. Unless this authorization is extended again, plans covering HSA-eligible individuals will have to require that telehealth services be provided to those individuals on the same terms as in-person care, i.e., the deductible must be met before telehealth can be provided without further charge to the patient. [The American Benefits Council has asked Congress to extend this consumer protection.]

From Capitol Hill, Politico brings us up to date on medical association efforts to block or at least reduce a 4.5% cut in Medicare Part B payments to physicians.

From the federal employee benefits front, Tammy Flanagan writing in Govexec discusses the health benefit options available to federal employees who are veterans.

“From the public health front —

  • The Labor Department’s Department’s Occupational Safety and Health Administration offers guidance to employers on controlling seasonal flu outbreaks in the office or plant.
  • The New York Times examines anti-depressant drugs. “The most commonly prescribed medications for depression are somewhat effective — but not because they correct a “chemical imbalance.”

Hospitals have made progress in reducing preventable errors, accidents and injuries over the past decade, according to the Leapfrog Group’s fall 2022 hospital safety grades released Wednesday.

Incidents of falls and trauma and of objects unintentionally left in a body after surgery decreased by about 25% since 2012, according to Leapfrog.

In this year’s fall rankings, 30% of hospitals earned an A grade, 28% earned a B, 36% earned a C, 6% earned a D and 1% earned an F.

From the Rx coverage front,

Today the U.S. Food and Drug Administration approved [Provention Bio’s] Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. 

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.” 

“From the plan design front, MedCity News tells us “Historically having worked with Medicaid and Medicare Advantage populations, Uber Health is now expanding its services to self-insured employers. The company made the announcement at the HLTH conference in Las Vegas.”

Tuesday’s Tidbits

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal Employees Benefit Open Season front —

  • My Federal Retirement discusses the availability of high deductible plans coupled with health savings accounts in the FEHB.
  • A Federal Times expert, Reg Jones, explains the differences between Open Season and special enrollment periods.

In related news, Federal News Network tells us

Over 200 members of the Senior Executive Service this year will receive Presidential Rank Awards, considered the highest honor for career civil servants.

President Joe Biden picked 233 winners across a total of 33 different agencies for the 2022 awards program, the Office of Personnel Management announced on Nov. 15.

“Each and every day, our federal employees are working to address the nation’s most pressing issues, developing technologies to improve millions of lives, and ultimately, achieving the seemingly unachievable on behalf of the American public,” OPM Director Kiran Ahuja said in a press statement. “This year’s Presidential Rank Awards reflect the Biden-Harris administration’s support for hardworking civil servants who exemplify strength, integrity, industry and a relentless commitment to public service through their exceptional leadership, contributions and accomplishments.”

Kudos to the winners.

From the Omicron and siblings front, the Wall Street Journal reports

Moderna Inc.’s new updated Covid-19 booster shot for the U.S. generated strong immune responses in people against Omicron subvariants, according to the first data from a company-sponsored study testing the new doses in volunteers.

Moderna said Monday that people receiving the updated booster shot had more than five times the neutralizing antibodies against Omicron subvariants BA.4 and BA.5 than people who received Moderna’s original booster shot, which targeted an earlier strain of the coronavirus.

“That really bodes well for the vaccine and public health,” Moderna President Stephen Hoge said in an interview.

From the conferences’ front —

  • The American Medical Association explains what happened on the closing day of the AMA’s interim meeting.
  • Healthcare Dive offers Dive Briefs from the HLTH conference about Included Health and Elevance Health. Fierce Healthcare adds “Mental health provider SonderMind acquired neuroscience company Total Brain with the goal of revolutionizing personalized therapeutic care and providing individual insights into mental wellbeing.”

In other U.S. Healthcare business news

Healthcare Dive informs us

  • “Amazon has launched a message-based virtual health service called Amazon Clinic a little more than two months after the retail giant shuttered its primary care delivery business Amazon Care.
  • “Amazon Clinic, which is currently live and available 24/7 through Amazon’s website and mobile app, is a marketplace for telemedicine providers, connecting consumers with virtual doctors who can diagnose, treat and prescribe medication for a range of common health conditions like acne, birth control and migraines, the retail giant said.
  • “Amazon Clinic will be available in 32 states at launch, with plans to expand to additional states in the coming months, according to a Tuesday blog post announcing the news. * * *
  • “Consultation cost will vary by provider, including follow-up messages with a clinician for up to two weeks after the consultation. Consultations start at $30.
  • “Amazon Clinic does not accept insurance. The company didn’t disclose whether that would change in the future.”

Minnesota Public Radio tells us

Nearly a decade after unsuccessfully attempting a merger, South Dakota-based Sanford Health and Minnesota’s Fairview Health Services said Tuesday they’re again in talks to combine.

The two regional health care giants say they intend to complete a merger next year. The new entity would be called Sanford Health and be run by Sanford’s current CEO. The deal would include the University of Minnesota hospitals, which Fairview purchased in 1997.

Financial details and any cost-cutting plans tied to the proposed merger were not immediately disclosed.

From the Food and Drug Administration front —

On Thursday [November 10], the FDA, in conjunction with the CDC, released results on youth tobacco use from the 2022 National Youth Tobacco Survey. Findings show that in 2022, more than one in 10 middle and high school students (3.08 million) had used a tobacco product during the past 30 days – including 16.5% of high school and 4.5% of middle school students. The full results are available here. 

Today, the FDA announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace contaminated food through the food supply, whether sourced in the U.S. or abroad. 

Also [t]oday, the FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

From the No Surprises Act front, today was the deadline for the public to submit comments to the NSA regulators concerning two unnecessarily complicated consumer protections found in the law — the good faith estimate and the advance explanation of benefits. In the FEHBlog’s view, the NSA regulators would be well served if they limited those protections to surprise billing situations not elsewhere covered by the law, for example, (1) complicated procedures and (2) reoccurring services that take place over a prolonged period, e.g. chiropractor care, mental health care. The WEDI group, which is an advisor to the HHS Secretary, also offers useful comments on the matter.

From the Affordable Care Act front, the U.S. Preventive Services Task Force gave an inconclusive (I) grade today to screening for obstructive sleep apnea in adults. “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for obstructive sleep apnea in the general adult population.” The USPSTF previously graded the apnea screening service an I grade in January 2017.

In closing, here’s a tidbit from the Wall Street Journal

The Earth is now home to eight billion people, the United Nations said, because people are living longer and fertility rates have surged in some countries. * * *

There were about 300 million people on Earth two millennia ago, according to the U.N. The population fluctuated in the centuries after that, largely because of plagues and natural disasters. Then the population accelerated, reaching one billion in 1804, four billion in 1974 and seven billion in 2011. * * *

Demographers project the world will reach its next population milestone—nine billion—around 2037.

The U.N. predicts that the global population will peak at around 10.4 billion during the 2080s and remain near that level until the start of the next century. Another forecast, from the Wittgenstein Centre for Demography and Global Human Capital at the University of Vienna, has it peaking at 9.67 billion in 2070, before a slow decline as fertility rates drop.