Tuesday’s Tidbits

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal Employee Benefits Open Season front, FedSmith provides advice to federal and postal employees and FedWeek provides guidance to all interested parties.

In the Federal Times, Reg Jones answers a reader’s question about whether an annuitant can suspend their FEHBP coverage.

From the Omicron and flu front –

MedPage Today expresses expert views that developing vaccines that prevent the spread of Covid require human challenge trials in which fully informed, vaccinated people are exposed to Omicron.

[M]any experts agree: we need new vaccines to limit the spread of the virus. The current generation of vaccines offers strong protection against serious illness and death, but their edge has dulled against new variants, and they do not always prevent infection and transmission of the virus.

The White House hosted a summit on the issue in July, showcasing the myriad ways researchers are going about developing new vaccines. There are hundreds of candidates in early stages around the world, but the resources devoted to COVID-19 vaccine research are a fraction of what they were 2 years ago. Human challenge trials can greatly speed the selection of the most promising in this field of candidates, providing scientific and economic benefits over uniform reliance on large field studies.

Time will tell.

The Wall Street Journal provides a background story of this year’s flu that compares the spread of the flu vs. the spread of Covid.

How contagious is flu?

Covid-19 is more contagious than influenza, doctors say. One reason is that most people have had flu multiple times and many have gotten multiple flu shots over the years. 

The most common calculation of a virus’s infectiousness is a measure called the R0 (pronounced “R naught”). This metric estimates how many people one contagious person will infect on average. The R0 of influenza is between one and two. R0 data for Covid-19 isn’t definitive, especially as the virus continues to mutate, but studies indicate the number for many Covid strains is higher than for flu. 

From the tidbits department

  • Healthcare Dive offers “five takeaways from the FDA’s list of AI-enabled medical devices. As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.”
  • The Patient-Centered Outcomes Research Institute (PCORI), which the Affordable Care Act requires health insurers and plans to fund, shares its strategic plan.
  • The Segal Company helpfully reminds cafeteria plan sponsors that “As part of COVID-19 relief, the Consolidated Appropriations Act, 2021 (CAA) permitted plan sponsors to immediately implement certain mid-year changes to their cafeteria plans during the 2020 and/or 2021 plan years without first having to adopt plan amendments. Employers that implemented such relief are required to adopt certain retroactive plan amendments by December 31, 2022.”
  • The Centers for Disease Control calls attention to its U.S. Diabetes Surveillance System website. Check it out.
  • Beckers Hospital Review lists the ten most expensive States for healthcare. The only state with a top 10 population included on Becker’s list is Florida.

Monday Roundup

David Ermer–AHRQ, CDC, COVID treatment, COVID-19, FDA, Federal employment benefits, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, the Federal Times offers a detailed report on FEHB infertility coverage. The article answered one of the FEHBlog’s outstanding questions:

In October, the White House Office of Personnel Management, which acts the human relations department for the federal workforce, unveiled four new plan options that will provide some form of assisted reproductive technology, or ART, for a total of 18 FEHB plan options in 2023.

Those are offered by carriers Triple S-Salud, UPMC Health Plan, Indiana University Health Plan, Foreign Service Benefit Plan, and Health Net of California Southern.

One new plan option, under CDPHP, will provide a non-FEHB benefit for discounted ART.

From the Omicron and siblings front —

The New York Times tells us “People who took the antiviral drug Paxlovid within a few days after being infected with the coronavirus were less likely to be experiencing long Covid several months later, a large new study found.” The federal government should be promoting Paxlovid and flu treatments at least as much as it promotes vaccines.

Because winter is coming the Centers for Disease Control reminds us about the importance of home ventilation.

Improving ventilation can help you reduce virus particles in your home and keep COVID-19 from spreading. You may or may not know if someone in your home or if a visitor to your home has COVID-19 or other respiratory viruses. Good ventilation, along with other preventive actions, can help prevent you and others from getting and spreading COVID-19 and other respiratory viruses.

Health IT Analytics reports

Researchers from New York University’s Machine Learning for Good Laboratory (ML4G Lab), Carnegie Mellon University, and the New York City Department of Health and Mental Hygiene (NYC DOHMH) have developed an automated machine-learning system designed to detect rare or previously unseen disease clusters.

According to the press release shared with HealthITAnalytics via email, current automated systems used to identify public health threats rely on “syndromic surveillance” to detect existing threats but can fall short of identifying new ones.

“Existing systems are good at detecting outbreaks of diseases that we already know about and are actively looking for, like flu or COVID,” said NYU Professor Daniel B. Neill, PhD, director of the ML4G Lab, in the press release. “But what happens when something new and scary comes along? Pre-syndromic surveillance provides a safety net to identify emerging threats that other systems would fail to detect.”

Bravo.

With the new year less than two months away, Med City New informs us “Consumer research firm Forrester recently predicted major trends that would shape healthcare in 2023. Healthcare stakeholders should prepare for key changes, such as care becoming even more inaccessible for rural patients[, more remote patient monitoring for chronically ill patients] and additional retail entrants into the clinic space.

On a related note, Becker’s Hospital Review identifies the ten states with the most rural hospitals at immediate risk of closure — 1. Mississippi 24; 2. Tennessee 17, and 3. Kansas 16.

In other U.S. healthcare business news

Healthcare Dive reports

  • VillageMD has agreed to acquire medical practice Summit Health for $8.9 billion including debt, the primary care provider announced Monday.
  • VillageMD, which is majority owned by pharmacy chain Walgreens, and Summit Health, the parent company of CityMD, plan to combine their provider locations and VillageMD’s experience with value-based care to help accelerate the transition to risk for payer clients.
  • Cigna’s health services division Evernorth is also taking a stake in the deal, and will become a minority owner in VillageMD at the deal’s close, expected in the first quarter of 2023.

Fierce Healthcare summarizes 3rd quarter earnings reports from major health insurers.

Fierce Healthcare also announced its ten 2022 Women of Influence in Health award winners.

This year’s honorees cover the breadth of the industry, from providers to payers to health tech, and represent some of the industry’s largest companies as well as up-and-coming innovators. Each has been pivotal in helping their organizations—and their patients—navigate some of the most complicated years that we’ve ever faced.

Kudos to the winners.

The Goverment Accountability Office released a report titled “Private Health Insurance: Markets Remained Concentrated through 2020, with Increases in the Individual and Small Group Markets.”

Several companies may be selling health insurance in a given market, but, as we previously reported, most people usually enroll with one of a small number of insurers. Known as market concentration, this can result in higher premiums due to less competition in the market.

We found this pattern continued in 2019 and 2020, with the markets for individuals and for small employers generally becoming more concentrated. Specifically, three or fewer health insurers held at least 80% of the market share for both of these markets in at least 42 states.

From the healthcare quality front, the HHS Agency for Healthcare Quality and Research released

  • a draft Evidence Map of Social and Structural Determinants of Health Risk Factors for Maternal Morbidity and Mortality; the public comment deadline is December 4, 2022.

Also, Fierce Healthcare tells us

The Center for Medicare and Medicaid Innovation (CMMI) released a report Monday updating its strategic vision for implementing value-based care, including detailing its progress since the vision was released last year. One of the key new strategies focused on creating greater care coordination between primary care doctors and specialists, especially surrounding the types of models the center puts out.

From the mental healthcare front, the National Institutes of Health’s NIH in the News for November 2022 features an article on clinical depression for patients.

From the medical device front, the Wall Street Journal reports

A Medtronic PLC medical device reduced the blood pressure of people with tough-to-treat hypertension in a closely watched study, but not significantly beyond what medications achieved.

The device cut a crucial measure of blood pressure by only about two points more than the average reduction in study volunteers who didn’t get the procedure, researchers said Monday.

Despite falling short of the study’s main efficacy goal, Medtronic said it has completed its application to the Food and Drug Administration for approval of the device, based on its safety and ability to meet certain secondary goals in the latest study as well as positive data from earlier studies.

If the FDA approves it, the device could offer a new, nonmedication treatment option for people with blood pressure that remains high despite treatment with drugs. It could also be a big-selling product for Medtronic. * * *

Medtronic’s experimental device, Symplicity Spyral, is used to perform a minimally invasive procedure known as renal denervation. 

In renal denervation, doctors insert a spiral-shaped catheter into an artery near the patient’s groin, through which a generator delivers radio-frequency energy to nerves in arteries near the kidneys. These nerves can become overactive and fuel high blood pressure. The device essentially burns these nerves so that they don’t contribute to high blood pressure.

Renal denervation has potential to be a one-time treatment, though researchers are still following patients to see how the benefit lasts.

Weekend update

David Ermer–Congress, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Congressional election day is Tuesday. The lame duck session will be next Monday.

Also next Monday, the Federal Employee Benefit Open Season will kick off. OPM has made the 2023 FEHBP and FEDVIP plan comparison tools available. Check them out.

Govexec reports on OPM Director Kiran Ahuja’s speech last Wednesday Wednesday at the annual meeting of the National Academy of Public Administration.” Ms. Ahuja said “the federal government’s HR agency is hard at work finding ways to improve the federal government’s personnel systems and shifting toward becoming a modern leader on strategic human capital issues.”

From the Rx coverage front, NPR Shots tells us

If you were prescribed medicine to lower your risk of a heart attack or stroke, would you take it? 

Millions of Americans are prescribed statins such as Lipitor, Crestor or generic formulations to lower their cholesterol. But lots of people are hesitant to start the medication. 

Some people fret over potential side effects such as leg cramps, which may be – or may not be – linked to the drug. As an alternative, dietary supplements, often marketed to promote heart health, including fish oil and other omega-3 supplements (Omega-3’s are essential fatty acids found in fish and flaxseed), are growing in popularity. 

So, which is most effective? Researchers at the Cleveland Clinic set out to answer this question by comparing statins to supplements in a clinical trial. They tracked the outcomes of 190 adults, ages 40 to 75. Some participants were given a 5 mg daily dose of rosuvastatin, a statin that is sold under the brand name Crestor for 28 days. Others were given supplements, including fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice for the same period.

The maker of Crestor, Astra Zeneca sponsored the study, but the researchers worked independently to design the study and run the statistical analysis.

“What we found was that rosuvastatin lowered LDL cholesterol by almost 38% and that was vastly superior to placebo and any of the six supplements studied in the trial,” study author Luke Laffin, M.D. of the Cleveland Clinic’s Heart, Vascular & Thoracic Institute told NPR. He says this level of reduction is enough to lower the risk of heart attacks and strokes. The findings are published in the Journal of the American College of Cardiology.

“Oftentimes these supplements are marketed as ‘natural ways’ to lower your cholesterol,” says Laffin. But he says none of the dietary supplements demonstrated any significant decrease in LDL cholesterol compared with a placebo. LDL cholesterol is considered the ‘bad cholesterol’ because it can contribute to plaque build-up in the artery walls – which can narrow the arteries, and set the stage for heart attacks and strokes.

“Clearly, statins do what they’re intended to do,” the study’s senior author Steve Nissen, M.D., a cardiologist and Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic told NPR.

Forbes informs us

In healthcare contexts, American consumers have historically tended to abandon their consumerism skills, often entering the doctor’s office or insurance process helpless, overwhelmed, and at the mercy of the system. Even when consumers have high expectations for their healthcare experiences, they’re often disappointed.

New research suggests that those days may be over. According to the 2022 Patient Access Journey Report, released last week from Kyruus, “Patients are consumers first.”

For the sixth year in a row, Kyruus has surveyed 1,000 consumers across geographies and generations to understand their preferences for selecting and accessing healthcare services. This year’s report focuses on three aspects of the healthcare consumer experience: search, selection, and action. 

The latest findings suggest consumers, in fact, now weigh similar factors in choosing their healthcare providers and service sites as they do with other types of services. * * *

Healthcare provider websites have a two-to-one advantage in consumer trust compared with health insurance sites. Forty-four percent of consumers surveyed said that they view healthcare provider websites as the most trustworthy source for information about healthcare providers or services, compared with 20% who rated health insurance providers as the most trustworthy. But the percentage of respondents who said health insurance providers were the most trustworthy sources of information jumped nine points since 2021.

From the miscellany department

  • NPR Shots explains what to watch for in the RSV surge and answers about treatment options
  • MedPage Today calls our attention to models leading to a favorable Covid conclusion

The U.S. probably won’t see a major surge in COVID deaths this winter, according to new models from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle.

By Feb. 1, 2023, daily deaths are projected to be at a high point of 335, which pales in comparison to the approximate 2,500 daily deaths seen during the Omicron surge around the same time last year, according to a recently published IHME policy brief.

  • The Wall Street Journal discusses the Menty B (mental breakdown) hashtag in use in Instagram and Tik Tok and a boarding high school in Massachusetts which replaced their students smart phones with light phones. The school also banned teachers from using smart phones while teaching. Everyone’s happier.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front —

Health IT Security informs us

President Biden issued a proclamation declaring November as Critical Infrastructure Security and Resilience Month. The President highlighted ways in which the Administration has taken action to protect critical infrastructure from cyber and physical threats and underscored the importance of security awareness and action to maintain critical infrastructure resilience.

The Cybersecurity and Infrastructure Security Agency applauded the President’s action.

Throughout November, CISA will be bringing the world of infrastructure security and resilience to life with interviews and blogs featuring CISA staff and external industry partners, as well as other activities. We encourage everyone to visit CISA’s Infrastructure Security Month webpage for more information and resources. Be sure to follow CISA on social media throughout the month for resources, tools, and tips you can use to help identify and reduce risk to infrastructure facilities, their internet and operational technology systems, employees, visitors and more.

Cybersecurity Dive adds

Officials at the Cybersecurity and Infrastructure Security Agency are optimistic that U.S. companies will embrace its efforts to boost cooperation on raising cybersecurity performance goals, sharing intelligence and building resiliency.  * * *

“We need to ensure that we’re coming together to really protect the technology ecosystem instead of putting the burden on those least able to defend themselves,” [CISA Director Jen] Easterly said during the forum [hosted by the Center for Strategic and International Studies on November 1]. “So [I’m] very excited about what I’m seeing from the technology companies.”

Another objective is to get more large companies to embrace cybersecurity as a corporate governance, not just technology concern, Easterly said.

From the cyber vulnerabilities front

The Healthcare Sector Cybersecurity Coordination Center issued a PowerPoint presentation about Iranian Threat Actors and Healthcare.

CISA added one more known exploited vulnerability to its catalog.

Last Tuesday, CISA announced

OpenSSL has released a security advisory to address two vulnerabilities, CVE-2022-3602 and CVE-2022-3786, affecting OpenSSL versions 3.0.0 through 3.0.6.

Both CVE-2022-3602 and CVE-2022-3786 can cause a denial of service. According to OpenSSL, a cyber threat actor leveraging CVE-2022-3786, “can craft a malicious email address to overflow four attacker-controlled bytes on the stack. This buffer overflow could result in a crash (causing a denial of service) or potentially remote code execution,” allowing them to take control of an affected system.

CISA encourages users and administrators to review the OpenSSL advisory, blog, OpenSSL 3.0.7 announcement, and upgrade to OpenSSL 3.0.7. For additional information on affected products, see the 2022 OpenSSL vulnerability – CVE-2022-3602 GitHub repository, jointly maintained by the Netherland’s National Cyber Security Centrum (NCSC-NL) and CISA.

From the ransomware front

The Wall Street Journal reports

U.S. banks flagged ransomware-related transactions adding up to more than $1 billion in 2021, the Treasury Department said, although risk experts said that barely scratches the surface of cybercrime’s true economic scale.

Data released by the Financial Crimes Enforcement Network, or FinCEN, this week showed the number and value of transactions that banks had flagged as related to ransomware in 2021 reached $1.2 billion, spread across 1,489 reports to regulators. In 2020, such transactions totaled $416 million across 487 reports.

“I think we’re seeing the tip of the iceberg in terms of what these actual payments are,” said Paul Benda, senior vice president for operational risk and cybersecurity at the American Bankers Association, a trade group for banks. 

Wow.

Cyberscoop tells us

On Tuesday [November 1], the White House wrapped up a two-day ransomware summit, where participants agreed to stand up a voluntary International Counter Ransomware Task Force to serve as a base for coordinated disruption and threat sharing. The initiative, which will launch sometime early next year, will start with a fusion center operated out of Lithuania’s Regional Cyber Defense Center as a test case for a bigger information-sharing program.

From the cybersecurity defenses front

HIPAA Journal relates

The Department of Health and Human Services (HHS)’ Office for Civil Rights (OCR) has released a video presentation on its YouTube channel that explains in detail how the 2021 HITECH Act amendment regarding “Recognized Security Practices” applies to HIPAA-regulated entities, and how HIPAA-regulated entities can demonstrate to OCR that Recognized Security Practices have been in place for the 12 months prior to a security breach. * * *

In the video, Nick Heesters, senior advisor for cybersecurity at OCR, explains how the HITECH Act was amended, what constitutes Recognized Security Practices, and how they can be implemented to reduce liability. * * *

Heesters confirmed that in the event of an audit or investigation into potential HIPAA Security Rule violations, OCR will send a data request to the regulated entity to inform them they can voluntarily provide evidence that Recognized Security Practices have been in place. * * *

Heesters explained how HIPAA-regulated entities can demonstrate to OCR that Recognized Security Practices have been in place and the types of evidence that they can consider submitting.

Heesters confirmed that organizations that have implemented Recognized Security Practices, and are able to demonstrate that sufficiently, will not avoid financial penalties, but OCR will consider the Recognized Security Practices as a mitigating factor. These practices only mitigate against HIPAA Security Rule investigations and audits, not other investigations and audits, such as investigations into potential HIPAA Privacy Rule violations. Heesters also confirmed that the lack of Recognized Security Practices will not be considered an aggravating factor and will not result in increased penalties.

CISA released guidance on phishing-resistant multifactor authentication this week. Cybersecurity Dive adds

Phishing-resistant multifactor authentication isn’t just the strongest form of MFA — it’s “the gold standard for MFA,” according to the Cybersecurity and Infrastructure Security Agency.

The federal agency this week published a fact sheet to clarify its definition of phishing-resistant MFA and provide guidance and prioritization schemes for organizations to implement the safeguards in logical phases. 

  • Three key recommendations from CISA.
  • Stick to FIDO standards and the Web Authentication API (WebAuthn) protocol.
  • Take stock of your IT systems, determine which platforms support MFA and start there.
  • Roll out phishing-resistant MFA in phases, placing early emphasis on high-value targets and resources.

FIDO standards and the WebAuthn protocol are the only widely available phishing-resistant forms of MFA, according to CISA. The protocol and standard, both developed by the FIDO Alliance, can work together to bolster MFA.

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

The Wall Street Journal again warns us about an impending tripledemic of Covid, the flu, and RSV.

The New York Times adds

As it gets colder and more people move their activities indoors, the recent decline in Covid-19 cases across the United States has started to level off. Coronavirus-related hospitalizations are ticking up in a number of states, including Arizona, Indiana, Illinois, Nevada, Nebraska, Oklahoma, South Dakota and Wisconsin. And there have been a variety of unnerving headlines about the immune evasion and increased transmissibility of the next round of coronavirus subvariants.

At least half a dozen versions of the virus are competing to become the next dominant strain in the United States, but they are part of the same family tree. “They are all offspring of Omicron,” said Dr. Albert Ko, a physician and epidemiologist at the Yale School of Public Health. Though each subvariant has slightly different mutations, none of them seem to be creating significant waves just yet, the way the Delta and Omicron variants did when they first appeared, Dr. Ko said.

From the Omicron and siblings front, the Center for Disease Control’s weekly interpretation of its Covid statistics tells us

Cases

As of November 2, 2022, the current 7-day average of weekly new cases (39,016) increased 4.7% compared with the previous 7-day average (37,261). A total of 97,604,763 COVID-19 cases have been reported in the United States as of November 2, 2022.

Variant Proportions

CDC Nowcast projections for the week ending November 5, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. 

The Wall Street Journal points out

Two BA.5 offshoots, BQ.1 and BQ.1.1, are gaining ground in the U.S., now accounting for an estimated 35% of cases this past week, CDC data show. Researchers and health officials have flagged both BQ variants and another variant called XBB as strains to watch, in part because they might heighten the risk for reinfection or evade certain treatments.

Hospitalizations

The current 7-day daily average for October 26–November 1, 2022, was 3,272. This is a 1.0% decrease from the prior 7-day average (3,306) from October 19–25, 2022.

Deaths

The current 7-day average of new deaths (358) decreased 3.0% compared with the previous 7-day average (369). As of November 2, 2022, a total of 1,068,667 COVID-19 deaths have been reported in the United States.

Vaccinations

As of November 2, 2022, 640.9 million vaccine doses have been administered in the United States. Overall, about 266.4 million people, or 80.2% of the total U.S. population, have received at least one dose of vaccine. About 227.4 million people, or 68.5% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 112.5 million people have received a booster dose, and more than 26.38 million people have received an updated (bivalent) booster dose. But 49.1% of the total booster-eligible population has not yet received a booster dose. 

STAT News adds

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday.

The companies said the levels of neutralizing antibodies that target the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus were four-fold higher in people aged 55 and older who received the bivalent booster than in similarly aged people who received a monovalent booster. 

The CDC’s Fluview tells us that for the week ended last Saturday

Early increases in seasonal influenza activity continue nationwide. The southeastern and south-central areas of the country are reporting the highest levels of activity followed by the Mid-Atlantic and the south-central West Coast regions.

CDC estimates that, so far this season, there have been at least 1,600,000 illnesses, 13,000 hospitalizations, and 730 deaths from flu.

The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 43 during every previous season since 2010-2011.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.

There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

Forbes informs us about the availability of an RSV immune agent

While clinical trials are currently underway to provide RSV vaccines to pregnant women in order to protect their soon-to-be newborns from RSV infections, pediatric specialists have been administering an RSV “vaccine” for years. This vaccine, called palivizumab (Synagis) isn’t actually a vaccine. It is a preventative monoclonal antibody injection which has been available to high-risk infants since 1998. 

This therapy is administered as an injectable agent, thus was given the vernacular “vaccine” term, even though it is not a vaccine, nor does it act as one. It is an immune agent, providing antibody protection from severe RSV infections in vulnerable infants. It is given as an injection every month for five consecutive months. It was shown to reduce hospitalization by an average of 50% in two large placebo-controlled double-blind studies which included a total of nearly 3,000 high-risk babies. 

[T]he American Academy of Pediatrics has presented updated guidelines for use of Synagis during any time where a particular region is experiencing a surge of RSV cases:

“With the shift in seasonality noted in 2021 and the current regional variability in interseason RSV cases, the AAP continues to support the use of palivizumab in eligible infants in any region experiencing rates of RSV activity at any time in 2022 similar to a typical fall-winter season. The AAP recommends initiating the standard administration of palivizumab, which consists of 5 consecutive monthly doses.”

From the healthcare cost front, Employee Benefits News reports

The Business Group on Health named cancer as the top driver of employer healthcare costs, a spot previously held by musculoskeletal conditions. In fact, 13% of employers surveyed say they have seen more late-stage cancers impacting their workforce, and 44% predict they will see an increase in cancer diagnoses in the future. 

Again, Kelsay points out that delays in screenings, such as mammograms and prostate exams, left many Americans to unknowingly live with cancer. An estimated 64% of Americans deferred cancer screenings in 2021, according to the American Society of Clinical Oncology. And as a condition that can take months or years to treat, cancer is incredibly costly. The National Cancer Institute estimates the average cost of medical care and drugs is approximately $42,000 in the year following a cancer diagnosis.

“A lot of cancer treatments require immunotherapies, which are very expensive pharmaceuticals, as well as hospital stays and surgeries,” says Kelsay. “Cancer is just a terribly expensive condition to have.”

EBRI offers a detailed report on out of pocket spending in employer sponsored plans.

From the U.S. healthcare business front, Fierce Healthcare relates

Kaiser Permanente posted a $1.6 billion profit for the third quarter, which is down by nearly half from the $3 billion it generated in the previous quarter.

The 39-hospital system and health plan’s earnings, reported Friday, were affected by a major surge of COVID-19 that caused expenses to increase. Kaiser Permanente’s hospital system and health plan reported total operating revenue of $23.2 billion and expenses of $23 billion.

From the virtual care front, mHelath Intelligence reports

 Recent survey results released by Elevance Health found that most Americans who participated in virtual primary care said their experience was satisfactory and that the service effectively enabled them to manage their health.

Formerly known as Anthem Inc., Elevance Health is a health insurer. Through the survey, Elevance aimed to gather data on virtual primary care, its outcomes, and what patients think. The payer commissioned the Harris Poll to conduct an online survey of more than 5,000 US adults aged 18 and over.

Researchers found that 79 percent of study participants believed virtual primary care allowed them to take charge of their health, and 94 percent were satisfied with their experience. * * *

These survey findings come on the heels of a report released at the end of October, which found that telehealth was highly used among those engaging in primary care and mental health services. It also showed that patient satisfaction with telehealth was high.

From the miscellany department, The New York Times offers advice to insomniacs.

A good night’s sleep can make us more empathetic, more creative, better parents and better partners, according to Aric Prather, a psychologist at the University of California, San Francisco who treats insomnia and is the author of the new book “The Sleep Prescription.” Sleep can help us manage stress; it can make us competent and capable and better able to take on the day. But Dr. Prather says we too often view sleep as an afterthought — until we find ourselves frozen in the middle of the night, our thoughts racing, fumbling for rest or relief.

Thursday Miscellany

David Ermer–CDC, Congress, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, we find guidance from FedSmith, FedWeek, and My Federal Retirement.

From the unusual viruses front —

The American Hospital Association reports that

The Department of Health and Human Services today renewed the nation’s monkeypox public health emergency declaration for another 90 days. When the PHE was announced in August, Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., said the declaration would provide access to resources and flexibilities, expedite state data sharing, and provide more detailed data on testing and hospitalizations. CDC yesterday reported over 28,000 U.S. monkeypox cases since the first confirmed case May 18.

For a more current information on monkeypox, check out these articles from the Hill and MedPage Today.

From the Rx coverage front., Bloomberg reports

Hundreds of community pharmacies are having trouble filling prescriptions for amoxicillin, a common antibiotic that’s often used to treat bacterial infections in children.

Two-thirds of 333 pharmacy owners and managers who responded at the end of October to a National Community Pharmacists Association survey about drug shortages said they were having difficulty getting the antibiotic. The liquid form of the drug has been in limited supply in the US since October, according to the Food and Drug Administration, and it’s also in shortage in other countries

 

Another Bloomberg article attributes the shortage to demand due the RSV epidemic and school age children illnesses plus the generic drug’s low price.

“A lot of that risk is driven by market factors, particularly price,” explained Matt Christian, USP’s director of supply chain insights. In general, antibiotics are generic drugs that have existed for years and tend to be cheaper and have lower margins than newer drugs. That means drug companies have a lot less incentive to set up robust, resilient supply chains  and may be caught short if something goes wrong at a competing supplier.

“Lower priced drugs have a higher risk of shortage,” Christian said. “No margin, no inventory.”

An analysis by the FDA found a similar correlation: Drugs in short supply typically cost less than other medicines. * * *

“If you run out of an antibiotic as ubiquitous as amoxicillin, there is a concern that unnecessarily moving [to a more aggressive antibiotic] can further cause antimicrobial resistance,” Christian said.

Why doesn’t the federal government manufacture amoxicillin?

In other medical development news —

MedPage Today tells us

Hard thresholds for pain medication doses and duration are no longer promoted through the CDC’s new Clinical Practice Guideline for Prescribing Opioids for Pain.

The new guidance — which covers acute, subacute, and chronic pain for primary care and other clinicians — updates and replaces the controversial 2016 CDC opioid guideline for chronic pain. The 2016 guideline was interpreted as imposing strict opioid dose and duration limits and was misapplied by some organizations, leading the guideline authors to clarify their recommendations in 2019.

The 2022 recommendations are voluntary and give clinicians and patients flexibility to support individual care, said Christopher Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control in a CDC press briefing. They should not be used as an inflexible, one-size-fits-all policy or law, or applied as a rigid standard of care, or replace clinical judgement about personalized treatment, he emphasized.

More details can be found in the STAT News article.

Bloomberg informs us

In just 15 minutes, a small, handheld blood test can tell doctors whether a patient has likely suffered a concussion or traumatic brain injury — no brain scan required.    

After more than a decade of research, the Abbott Laboratories test is being used for the first time in a real-world setting to evaluate patients at Tampa General Hospital in Florida. Doctors using the test say it’s better at evaluating concussions than the brain scans that have been widely used for the last 30 years.  * * *

[Abbott Labs’] test, called the i-STAT TBI Plasma test, was greenlit by the Food and Drug Administration in 2021 to rule out the need for a CT scan when evaluating mild traumatic brain injuries. * * *

Though Abbott’s test is not yet ready to be used on the sidelines of sporting events, the ultimate goal for Abbott is for every hospital, urgent care clinic, ambulance, school and sporting event to have a portable test available. The company is also working on research that will help doctors know the severity of a concussion or brain injury, for both adults and kids, to aid in diagnoses.

Abbott worked with the Department of Defense to develop the test, which supported development with millions of dollars in funding. More than 450,000 US service members were diagnosed with a traumatic brain injury from 2000 to 2021, according to the CDC. It’s an area the DOD is “very concerned about,” said Beth McQuiston, a neurologist and chief medical officer for Abbott’s diagnostic business.  

Bravo.

From the U.S. healthcare business front

Beckers Payer Issues reports

Cigna raised its annual earnings outlook and reported a 70 percent boost in third quarter profits compared to the same period last year, according to the company’s earnings report published Nov. 3.

“We built on our momentum from the first half of 2022 with strong execution in the third quarter across our businesses and a continued focus on serving customers and clients with our differentiated health and well-being solutions,” CEO David Cordani said.

Healthcare Dive offers an M&A perspective on the Cigna announcement.

The Wall Street Journal reports

Moderna Inc.’s third-quarter revenue fell by nearly a third and the pharmaceutical company cut its outlook, saying as part of its earnings report that supply constraints for its Covid-19 vaccines might sap as much as $3 billion in sales this year.

The Cambridge, Mass.-based company said Thursday that higher costs and a decline in demand for its original Covid-19 vaccine also hit its performance.

Moderna, which three months ago said it projected $21 billion in product sales of its Spikevax vaccine for anticipated delivery this year, now expects between $18 billion and $19 billion. The company said short-term supply constraints will delay some sales into 2023.

Beckers Hospital Review cautions

The third quarter brought little relief to hospitals in what is shaping up to be one of their worst financial years.  

Kaufman Hall’s October National Hospital Flash Report — based on data from more than 900 hospitals — found slightly lower hospital expenses in September did not outweigh lower revenue across the board, with decreases in discharges, inpatient minutes and operating minutes.

The median year-to-date operating margin index for hospitals was -0.1 percent in September, marking a ninth straight month of negative operating margins and a dimmer outlook for their climb back into the black by year’s end. 

Kaufman Hall noted that expense pressures and volume and revenue declines could force hospitals to make “difficult decisions” about service reductions and cuts. 

Meanwhile according to MedCity News, the American Medical Association “blasted the Centers for Medicare and Medicaid Services Tuesday for its 2023 Physician Fee Schedule final rule, which would cut the Medicare payment rate to physicians by nearly 4.5%.” The AMA is demanding that Congress prevent the cut from occuring January 1, 2023.

The article adds

[O]ther organizations applauded it for areas that reflected their respective priorities. For instance, the National Association of ACOs (NAACOS) praised changes to the Medicare Shared Savings Program for 2023 that included providing more time to Accountable Care Organizations before they have to assume financial risk. The final rule also gave advance shared savings payments to ACOs that care for underserved communities. CMS said it expects these changes to increase participation in rural and underserved areas. * * *

[T]he final rule made changes to policies related to telehealth. This includes extending several telehealth services that were temporarily made available during the public health emergency through at least 2023. This will “allow additional time for the collection of data that may support their inclusion as permanent additions to the Medicare Telehealth Services List,” CMS said. The change is in line with comments CMS Administrator Chiquita Brooks-LaSure made at a recent conference. 

The Telehealth Access for America (TAFA), which includes the American Hospital Association, applauded the changes to telehealth, though the group called on Congress to make permanent actions.

In other telehealth news, Healthcare Dive reports

  • COVID-19 diagnoses fell by about 1% to 2% as a share of telehealth claims nationally in August, according to Fair Health’s monthly tracker data out Thursday.
  • In the South and West, COVID-19 fell from the second top diagnosis to the third from July to August. It remained in second place in the Midwest and Northeast.
  • Mental health conditions stayed as the top telehealth diagnoses nationally and in every region, and one hour of psychotherapy remained the top telehealth procedure code.

Midweek update

David Ermer–CDC, FDA, Rx coverage, Telehealth, U.S. Healthcare–

From the alcohol abuse front, MedPage Today tells us

One out of every eight deaths in Americans ages 20 to 64 resulted from drinking too much alcohol, according to a U.S. population-based study.

Nationally, 12.9% of total deaths per year among adults in this age group were attributed to excessive alcohol consumption from 2015 to 2019, and that number rose to 20.3% of total deaths per year when restricted to people ages 20 to 49, reported Marissa Esser, PhD, MPH, of the CDC in Atlanta, and colleagues.

Alcohol-attributed deaths ranged from 9.3% in Mississippi to 21.7% in New Mexico and were more common among men than women (15% vs 9.4%), the authors wrote in JAMA Network Open.

That is startling.

From the unusual viruses front, Beckers Hospital Review explains

Wastewater testing has found polioviruses genetically tied to a case that left an unvaccinated Rockland County, N.Y., resident paralyzed this summer in at least five of the state’s counties, according to a new CDC report. 

The report, published Oct. 28, is based on wastewater testing from samples collected from March 9 through Oct. 11 from 28 sewersheds serving parts of Rockland County and 12 other counties. Eighty-nine samples, or 8.3 percent of 1,076 samples collected, tested positive for poliovirus type 2. Of those, 82 were linked to the virus isolated from the Rockland County patient who was left paralyzed 

“Although most persons in the United States are sufficiently immunized, unvaccinated or undervaccinated persons living or working in Kings, Orange, Queens, Rockland, or Sullivan counties, New York should complete the polio vaccination series to prevent additional paralytic cases and curtail transmission,” the CDC report said. 

CDC officials recently told CNBC they are considering the use of a novel oral polio vaccine not used in 20 years to halt the outbreak. 

From the opioid epidemic front, Healthcare Dive informs us

CVS Health agreed on Wednesday to pay $5 billion to settle almost all opioid-related lawsuits and claims the company been battling over the past decade that alleged it mishandled prescriptions of the painkillers.

If the deal is finalized, CVS will pay $4.9 billion to states and political entities such as counties and cities, and $130 million to U.S. tribes.

The payments, which depend partially on the number of government entities that agree to join the settlement, will be spread out over the next 10 years beginning in 2023.

Cities, counties and states have filed more than 3,000 lawsuits against drugmakers, distributors and pharmacies for their role in perpetrating the opioid epidemic in the U.S. According to government data, three-fourths of the 92,000 drug overdose deaths in 2020 involved an opioid.

Walgreens and Walmart also have reached deals to settle opioid-related claims, Reuters reported, citing people familiar with the matter. Walgreens will pay $5.7 billion over 15 years and Walmart will pay $3.1 billion, mostly up front, according to the report.

If the settlements from the three companies, which are the largest retail pharmacies in the U.S., become final, it may end much of the yearslong litigation over opioids. Cases still are pending against smaller pharmacies such as Rite Aid.

The deals follow some victories for plaintiffs against the chains. 

In related healthcare business news, Beckers Hospital Review reports

CVS Health raised its annual earnings outlook after beating investor expectations in the third quarter, but the company reported $3.4 billion in losses after agreeing to pay into a global opioid lawsuit settlement starting next year.

The $5 billion settlement will be paid out over 10 years and “substantially resolve all opioid lawsuits and claims against the company by states, political subdivisions, such as counties and cities, and tribes in the United States,” the company said in its Nov. 2 earnings report.

The company’s third quarter EPS is $2.09 and $6.71 for 2022. It also raised its full year guidance and expects adjusted EPS to rise from a range of $8.40-$8.60 to $8.55-$8.65.

“We delivered another outstanding quarter, and have raised full-year guidance as a result. We continue to execute on our strategy with a focus on expanding capabilities in health care delivery, and the announced acquisition of Signify Health will further strengthen our engagement with consumers,” President and CEO Karen Lynch said.

and

Humana reported $1.2 billion in profits during the third quarter and is expecting major increases in Medicare Advantage membership, according to the company’s Nov. 2 earnings report.

The company reported $22.8 billion in third quarter revenues, increasing 10.2 percent from $20.7 billion year over year. Total revenues in 2022 are $70.4 billion

The company expects an annual adjusted EPS guidance of $25 and raised its 2022 earnings outlook to $91.6 billion – $93.2 billion.

Healthcare Dive adds

Los Angeles-based Heal, a provider of primary care through house calls, telemedicine visits and remote patient monitoring, said it has partnered with Cigna Medicare Advantage plans in four states as it continues its national expansion.

The organization is now an in-network provider for Cigna MA enrollees in Illinois, North Carolina, South Carolina and Georgia, effective immediately, it said. Its markets also include Louisiana, New Jersey, New York and Washington.

Heal works with Humana, WellCare, Aetna and UnitedHealthcare insurance plans, according to its website.

Fierce Healthcare relates

Nearly 334,000 physicians, nurse practitioners, physician assistants and other clinicians left the workforce in 2021 due to retirement, burnout and pandemic-related stressors, according to new data [found in the Definitive Healthcare report]. * * *

Hospitals and health systems are spending more money to hire and retain healthcare workers, the report found. These facilities are increasing salaries, offering sign-on bonuses, and expanding benefits to lure in new workers. Hospitals nationwide spent a total of about $97.3 million on employees and physician salaries in 2020, compared with $82.7 million in 2016, according to data from the October 2021 Medicare Cost Report.

From the medical devices front, STAT News tells us

A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The widely used instruments monitor blood oxygen levels and have been shown to work less well on patients with darker skin, possibly exacerbating health disparities in many racial and ethnic groups. 

Healthcare Dive points out

Optical sensor solution in fingertip monitors gives medical-grade accuracy of oxygen level measurement across skin tones and while in motion.

A patented SpO2 sensor chipset, integrated processing and reference design capability has uses in other wearable devices, according to BioIntelliSense.

The inability of many fingertip monitors to accurately read blood oxygen levels has caused people with darker skin to wait hours for supplemental oxygen and in some cases has caused deaths.

That’s good news for you.

Moreover, Health IT Analytics reports

A team of Yale University researchers has developed a machine learning (ML)-based clinical decision support tool to personalize recommendations for pursuing intensive or standard blood pressure treatment goals among individuals with and without diabetes.

The tool, described in a study published earlier this week in The Lancet Digital Health, is designed to facilitate shared decision-making between providers and patients with hypertension through a data-driven approach. Hypertension is defined as a sustained blood pressure greater than 140/90 mm Hg and is a leading cause of heart disease and mortality.

From the Rx coverage front, STAT News tells us

A blockbuster weight-loss medicine led to dramatic effects for adolescents diagnosed with obesity, a result that will likely widen the use of an in-demand drug — and fan a debate over whether someone’s body weight should be treated as a disease.

The drug, a weekly injection called semaglutide, led to a 17% reduction in body mass index compared to placebo in a study of about 200 people between the ages of 12 and 18. On average, adolescents treated with semaglutide lost 34 pounds, or 15% of their body weight, over the course of the 68-week study, which was published in the New England Journal of Medicine on Wednesday. Those on placebo gained an average of five pounds, or 3% of their baseline weight.

The trial’s relatively small size and short duration leave outstanding questions about whether semaglutide’s side effects, which include nausea and rare cases of gallstones, will lead to long-term problems, said Julie Ingelfinger, a pediatric nephrologist at Massachusetts General Hospital who was not involved in the study. But the results suggest semaglutide, sold by the Danish drug company Novo Nordisk, could be a powerful tool for adolescents unable to lose weight through diet and exercise.

From the post Dobbs front, the New York Times surveys the landscape and finds increasing use of telemedicine services, such as Aid Access, to obtain abortion pills.

‘

Tuesday Tidbits

David Ermer–ACA, CMS, FDA, Federal employment benefits, Medicare, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

November is awareness month for diabetes and C. Diff. Looking back at October, Medscape informs us

Maintaining a healthy body weight, being physically active, and following a healthy dietary pattern can help women live longer after breast cancer diagnosis, according to a major new analysis of the latest research.

From the Federal Employee Benefits Open Season front, the Federal Times offers its consumer guide.

It was a big day on the Medicare front —

The American Hospital Association reports

The Centers for Medicare & Medicaid Services [CMS] late today posted a final rule on its website that will increase Medicare hospital outpatient prospective payment system rates by a net 3.8% in calendar year 2023 compared to 2022. This update is based on a market basket percentage increase of 4.1%, reduced by 0.3 percentage points for productivity. [AHA calls the increase insufficient.] * * *

CMS finalized the payment policy for CY 2023 of average sales price (ASP) +6% for drugs and biologicals acquired through the 340B Program as a result of the unanimous Supreme Court decision in American Hospital Association v. Becerra.

CMS also finalized proposals to establish the Rural Emergency Hospital (REH) model, a new provider type for eligible critical access hospitals and small rural hospitals beginning in Jan. 1, 2023. The rule finalized proposals related to model payment, covered services, conditions of participation, and quality measurements.

[and]

The Centers for Medicare & Medicaid Services today released on its website its calendar year 2023 final rule for the physician fee schedule. The rule will cut the conversion factor to $33.06 in CY 2023 from $34.61 in CY 2022, which reflects the expiration of the temporary 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment.

From HHS.gov

For a fact sheet on the CY 2023 OPPS/ASC Payment System Final Rule (CMS-1772-FC), please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-2

For a fact sheet on Rural Emergency Hospitals, please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-1

For a fact sheet on the CY 2023 Physician Fee Schedule Final Rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule

For a fact sheet on final changes to the CY 2023 Quality Payment Program, please visit: https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2136/2023%20Quality%20Payment%20Program%20Final%20Rule%20Resources.zip 

For a fact sheet on final changes to the Medicare Shared Savings Program, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule-medicare-shared-savings-program

For a CMS blog on behavioral health poliices, please visit: https://www.cms.gov/blog/strengthening-behavioral-health-care-people-medicare-0?check_logged_in=1

What’s more, Beckers Hospital Review informs us

CMS evaluated two and a half years of readmission cases for Medicare patients through the Hospital Readmissions Reduction Program and penalized 2,273 hospitals that had a greater-than-expected rate of return, according to a Nov. 1 report from Kaiser Health News.

The average payment reduction was 0.43 percent, the lowest rate reduction since 2014. Reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 through next September. It is expected to cost the hospitals $320 million over the 12-month period. 

The report notes that the COVID-19 pandemic caused turmoil in hospitals and that CMS decided to exclude the first half of 2020 from the report due to the chaos. CMS also excluded Medicare patients who were readmitted with pneumonia across all three years because of the difficulty distinguishing them from COVID patients. 

From the Affordable Care Act preventive services front, Healio tells us

The U.S. Preventive Services Task Force has released two final recommendations on the use of hormone therapy for the primary prevention of chronic conditions in postmenopausal people.

The recommendations advocate against the use of menopausal hormone therapy (MHT) through a combination of estrogen and progestin in postmenopausal people, and MHT through estrogen alone in postmenopausal people who have had a hysterectomy.

Both are D-grade recommendations and are consistent with the USPSTF’s previous recommendations on the treatment made back in 2017.

James Stevermer, MD, MSPH, a task force member, also noted in the press release that the recommendations are only for those who are considering hormone therapy to prevent chronic conditions following menopause. 

“Those who wish to manage symptoms of menopause with hormone therapy are encouraged to talk with their health care professional,” he said.

From the prescription drug and vaccine development front —

STAT News reports

Pfizer’s maternal vaccine against the respiratory syncytial virus [RSV] reduced the rate of severe illness in newborns by 81.8%, the company said Tuesday, meeting the goal of a pivotal study.

The company said that it plans to file the data on the vaccine with regulators by the end of the year and that it expects an eight-month review.

RSV is a common cause of illness and infection in young infants. By giving the vaccine during pregnancy, researchers hope antibodies generated by mothers would be transferred to infants. Currently, the pertussis vaccine and the influenza vaccine are given during pregnancy for this reason.

Bloomberg Prognosis tells us

Vertex Pharmaceuticals, a Boston-based biotech company, * * * is testing a non-opioid drug for acute pain. Vertex’s drug, VX-548, aims to block the Nav1.8 sodium channel, which acts like a gate allowing pain signals to travel from the nerves to the brain.

VX-548 met its goals in late-stage trials evaluating the drug in people who underwent a bunionectomy or an abdominoplasty, the formal name for a tummy tuck. Vertex will run the same studies with more patients before seeking regulatory approval. The company hasn’t disclosed when data will be available beyond saying the trials will be quick since patients receive the drug for only 48 hours. Vertex is also testing VX-548 in nerve pain and eventually wants to see if it works for chronic pain.

If VX-548 passes its next big tests, it could offer a new option for people recovering from surgery or other medical procedures. Of course, plenty of other pain drugs that looked promising early on in testing never reached the market.

Fortunately, scientists are investing time and money on a variety of alternatives for pain.

From the Rx coverage front, BioPharma Dive relates

Eli Lilly’s new diabetes medicine Mounjaro outpaced Wall Street sales forecasts during the third quarter, fueled by strong patient demand and widening insurer coverage.

U.S. sales of the drug totaled $97 million between July and September, Mounjaro’s first full quarter on the market since its May 13 approval by the Food and Drug Administration. Payments related to a collaboration agreement with Mitsubishi Tanabe Pharma in Japan pushed global revenue for the quarter to $187 million, well above the consensus analyst forecast of $82 million.

“We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the U.S.,” said Anat Ashkenazi, Lilly’s chief financial officer, on a Tuesday call with analysts. 

Lilly is also conducting a study to support an FDA marketing application for Mounjaro to be prescribed for weight loss.

Notably, Mounjaro showed a potent effect in reducing trial participants’ weight, a benefit that was also observed in a large study specifically assessing it as an obesity treatment. While it’s currently only approved to treat Type 2 diabetes, its potential as a medicine for both chronic conditions has made it one of Lilly’s most important products.

Lilly is currently conducting a second study in obesity and plans to complete an approval application in that indication should results, expected in April next year, also prove positive. 

In U.S. healthcare business news, MedTech Dive reports

Johnson & Johnson agreed to acquire Abiomed, a Danvers, Mass.-based maker of heart pumps, for $16.6 billion. 

The deal will contribute to J&J’s cardiovascular portfolio, complementing its Biosense Webster electrophysiology business, BTIG Analyst Marie Thibault wrote in a research note on Tuesday. 

The deal has already been approved by both companies’ boards of directors and is expected to close before the end of the first quarter of 2023.

Finally, check out the NIH Director’s blog discussing “How the Brain Differentiates the ‘Click,’ ‘Crack,’ or ‘Thud’ of Everyday Tasks.”

If you’ve been staying up late to watch the World Series, you probably spent those nine innings hoping for superstars Bryce Harper or José Altuve to square up a fastball and send it sailing out of the yard. Long-time baseball fans like me can distinguish immediately the loud crack of a home-run swing from the dull thud of a weak grounder. 

Our brains have such a fascinating ability to discern “right” sounds from “wrong” ones in just an instant. This applies not only in baseball, but in the things that we do throughout the day, whether it’s hitting the right note on a musical instrument or pushing the car door just enough to click it shut without slamming.

Now, an NIH-funded team of neuroscientists has discovered what happens in the brain when one hears an expected or “right” sound versus a “wrong” one after completing a task. It turns out that the mammalian brain is remarkably good at predicting both when a sound should happen and what it ideally ought to sound like. Any notable mismatch between that expectation and the feedback, and the hearing center of the brain reacts.

Monday Roundup

David Ermer–COVID-19, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Kaiser Health News announced the winner of their fourth annual Halloween haiku contest.

Covid, Ebola,
Monkeypox, seasonal flu —
Who needs Halloween?

— Paul Hughes-Cromwick

The Department of Health and Human Services reminds us that the federal healthcare / Obamacare marketplace will be open for business tomorrow. Professor Katie Keith, writing in Health Affairs Forefront, provides all the details.

The U.S. Office of Personnnel Management issued a press release today with a list of senior staff transitions and additional key staff appointments.

From the Omicron and siblings front, Medscape reports

The U.S. National Institutes of Health’s $1 billion RECOVER Initiative has picked Pfizer Inc’s antiviral drug Paxlovid as the first treatment it will study in patients with long COVID, organizers of the study said on Thursday.

The complex medical condition involves more than 200 symptoms ranging from exhaustion and cognitive impairment to pain, fever and heart palpitations that can last for months and even years following a COVID-19 infection.

According to details of the study, posted on Clinicaltrials.gov, the randomized, placebo-controlled trial will test Pfizer’s treatment or a placebo in 1,700 volunteers aged 18 and older.

The Duke Clinical Research Institute is supervising the study, which is scheduled to start on Jan. 1.

The New York Times offers readers background on the RSV epidemic and related matters.

R.S.V. is a common winter virus that typically causes mild cold-like illness in most people, but can occasionally be very dangerous for young children and older adults, said Emily Martin, an associate professor of epidemiology at the University of Michigan School of Public Health.

“The youngest infants have a high risk of coming into the hospital in what we call their first R.S.V. season,” Dr. Martin said. “If a child is born in the summer and they get exposed for the first time in the winter, they are at risk of having more serious disease. But many infants didn’t experience the first R.S.V. season on the regular schedule that they would have, particularly if they were born in or after 2020.”

In a normal prepandemic year, 1 to 2 percent of babies younger than 6 months with an R.S.V. infection may need to be hospitalized. And virtually all children have gotten an R.S.V. infection by the time they are 2 years old.

But many experts believe masking, social distancing, school closures and other precautions taken during the first year or two of the pandemic protected most children from exposure to the virus and other germs. “As a result, there are still many children who are less than 3 years old who’ve never been exposed to R.S.V.,” said Dr. James Antoon, an assistant professor of pediatrics and pediatric hospitalist at Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, Tenn. “The virus is now playing catch-up in all these kids.”

No good deed, etc.

From the virtual care front, mHealth Intelligence informs us

In collaboration with Mayo Clinic, Memora Health has launched the first phase of a research program focused on virtual postpartum care.

The program aims to improve communication between patients and providers through the addition of new technology to enhance postpartum care.

Memora Health, which offers digital and automated care programs, is working with Mayo Clinic to implement the virtual care program, which will provide the health system’s maternal care teams access to technology that can help them extend care for postpartum patients in the home and between clinic visits.

From the healthcare cost front, Health Payer Intelligence tells us

Dialysis increased monthly spending for privately-covered members with chronic diseases by approximately 292 percent, according to a study published in JAMA Open Network.

The researchers drew their insights from a sample of nearly 12,400 private insurance enrollees over the course of 309,800 enrollee-months. The data from Health Care Cost Institute spanned 2012 to 2019 and was analyzed from late August 2021 to mid-August 2022. Enrollees had employer-sponsored insurance for a year after starting dialysis.

Most enrollees were in preferred provider organization health plans that were self-funded. * * *

Medicare beneficiaries had much lower costs than their employer-sponsored health plan counterparts. The mean spending for enrollees on Medicare in the year after starting dialysis was $80,509, compared to $238,126 for individuals with private healthcare coverage.

“The large costs borne by private insurers to cover enrollees with kidney failure underscore the importance of Medicare becoming a primary payer after 30 months,” the study indicated. “The differences in spending between enrollees receiving dialysis with private insurance and those with Medicare are especially important given growing concerns about the market power of large dialysis organizations and recent policy proposals.”

The level of spending increase post-dialysis initiation that the researchers discovered in this study was higher than previous studies indicated.

The Wall Street Journal adds

Rival drugmakers are seeking to upend Pfizer Inc.’s dominance of the $7 billion worldwide market for pneumonia vaccines, launching what is shaping up to be one of the industry’s fiercest battles.

Merck & Co. has already introduced a new competitor to Pfizer’s Prevnar vaccine franchise, while GSK PLC and VaxcyteInc. are among companies developing shots that aim to win sales by protecting against even more strains of the pneumonia virus.

The companies are all vying for a piece of a lucrative market that Pfizer has commanded for more than a decade and is forecast to reach more than $10 billion annually by 2028, according to Wall Street analysts.

“It is kind of an all-out battle to see who can get this $10 billion that’s out there on the table,” said Louise Chen, an analyst at Cantor Fitzgerald & Co.

Weekend update

David Ermer–Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–

Congress remains on the campaign trail with the November 8 election just nine days away.

The Federal Employees Benefits Open Season starts two weeks from tomorrow.

From the Omicron and siblings front, Fortune Well tells us about the Zoe Health Study, a study of Covid symptoms among five million people.

Getting vaccinated against COVID reduces your risk of severe illness, hospitalization, and death if you do catch the disease—but according to new research, it could also dictate which batch of the milder, more common symptoms of the virus you end up getting. It’s thought that a large proportion of cases are still asymptomatic.

In an update to the ongoing Zoe Health Study, which has collected data from almost 5 million participants since 2020, researchers said they had identified symptoms that had emerged in recent weeks, noting that they appeared to differ depending on vaccination status. 

“Generally, we saw similar symptoms of COVID-19 being reported overall in the app by people who had and hadn’t been vaccinated,” the research team said in its update. “However, fewer symptoms were reported over a shorter period of time by those who had already had a jab, suggesting that they were falling less seriously ill and getting better more quickly.”

Precision Vaccinations informs us

As World Pneumonia Day approaches on November 12th, the ongoing effort to reduce fatalities from infectious diseases has never been more urgent.

Pneumonia is an infection of the lungs that needlessly affects millions worldwide each year. Most of the people affected by pneumonia in the U.S. are adults.

Previous U.S. CDC data indicates 47,000 people died from pneumonia in the U.S. in 2020.

And that negative trend continues today.

According to the National Center for Health Statistics (NCHS) Mortality Surveillance data available on October 27, 2022, 9.2% of infectious disease fatalities that occurred during week #42 were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 2,128 PIC deaths reported last week, 1,164 listed pneumonia as an underlying or contributing cause of death on the death certificate, 949 had COVID-19, and 15 listed influenza.

Pneumonia always has been a killer. The FEHBlog’s Dad referred to the disease as “the old man’s friend.” He was not alone. A 2018 medical editorial explains

The term “old man’s friend” is often used when referring to pneumonia. Searching for it on Google yields 16,400 results in 0.33 s for this combination.

The term is attributed to William Osler, who in the first edition of his book The Principles and Practice of Medicine (1892) wrote:

In children and in healthy adults the outlook is good. In the debilitated, in drunkards and in the aged the chances are against recovery. So fatal is it in the latter class [i.e. the elderly] that it has been termed the natural end of the old man [1].

In the 9th edition, published after Osler himself already died (in 1919 from pneumonia at the age of 70 years [2]), this excerpt was rephrased as “.. . one may say that to die of pneumonia is almost the natural end of old people” [3]. But that was 100 years ago. Fortunately, a lot changed for the better in the century that followed.

Today, pneumonia still affects many ‘old’ men. Medical progress made since William Osler’s time has resulted in survival rate for hospitalized pneumonia that now sits above 90–95%. However, longer-term mortality is high. The reasons for this are still largely unknown. A hypothesis from the editors of Pneumonia? Perhaps chronic inflammation leading to silent progression of cardiac disease is an underlying mechanism.

In mental healthcare news, the Wall Street Journal reports

Mental-health screenings for kids are expanding across the country. But as more children are identified as needing assistance, families can face a tough time getting help from resources that are already stretched thin.

and

Startups [i.e., this site] are prescribing ketamine online to treat serious mental-health conditions, raising concern among psychiatrists about the safety of taking the mind-altering anesthetic without medical supervision, sometimes at high doses that raise risks of side effects.

The first story illustrates an issue for which telehealth is a solution, while the story shows why telehealth cannot replace in-person care.

In U.S. healthcare business news, Bloomberg relates

VillageMD, which is majority owned by Walgreens Boots Alliance Inc., is exploring a deal to merge with Warburg Pincus-backed Summit Health, according to people familiar with the matter. 

The acquisition by primary-care provider VillageMD of Summit, a health-care network and the parent of CityMD, would value the combined entity at between $5 billion to $10 billion, said the people, who asked to not be identified because the matter isn’t public.

An agreement could be reached in the coming weeks, though talks could still fall apart, the people added. Representatives for VillageMD, Walgreens and Warburg Pincus declined to comment, while Summit Health didn’t immediately respond to a request for comment.