FEHBlog

Monday Roundup

David Ermer–ACA, CDC, FDA, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Today, the Affordable Care Act (ACA) regulators issued ACA FAQ 68 and a related HHS fact sheet. This letter addresses ongoing preventive care coverage issues separate from the proposed ACA rule, also issued today along with an HHS fact sheet, to expand contraceptive coverage with no cost sharing to include the OTC contraceptive pill and more.  The proposed rule will be open for public comment for sixty days after publication in the Federal Register. Government actions like the proposed rule, in the FEHBlog’s opinion, are a principal cause of skyrocketing medical costs.
  • Govexec reports,
    • “More than 200,000 U.S. Postal Service employees will receive a nearly 5% pay raise over the next year if its largest letter carriers’ union agrees to the new contract its leaders have negotiated with agency management. 
    • “The employees will also have more opportunities for overtime and be able to reach the top slots of their pay scales more quickly, the National Association of Letter Carriers said of their new tentative agreement. The contract must still be approved by NALC members before it goes into effect. A failure to ratify the deal would likely result in arbitration. 
    • “The agreement would cover the period from May 2023 into November 2026, meaning the first two of the three scheduled 1.3% wage increases would apply retroactively. Employees would also receive a series of cost-of-living adjustments, the first three would also be paid retroactively and total around $2,300. 
    • “After almost 20 months of tireless negotiations, we are pleased to reach a fair agreement that rewards our members for their contributions to the Postal Service and their service to the American people,” NALC President Brian Renfroe said.” 
  • MedTech Dive informs us,
    • “Boston Scientific received Food and Drug Administration approval for Farawave Nav, a treatment for paroxysmal atrial fibrillation (AFib) that enables cardiac mapping and pulsed field ablation (PFA) therapy with a single integrated catheter.
    • “In tandem, the company gained 510(k) clearance for new software, called Faraview, to provide visualization for cardiac ablation procedures with its Farapulse PFA system, the medical device maker said Friday. Boston Scientific will immediately launch the Farawave Nav ablation catheter and Faraview software in the U.S. 
    • “In a race among medtech companies in the PFA space, Boston Scientific is now the first with mapping-integrated PFA, “a meaningful technology step-forward,” Stifel analyst Rick Wise said Sunday in a note to clients.”
  • and
    • “The Food and Drug Administration updated the recall notice for a Boston Scientific product that blocks blood flow.
    • “Boston Scientific recalled the product, Obsidio Conformable Embolic, in February in response to a problem then linked to seven injuries and two deaths. On Friday, the FDA updated its Class I recall notice, reporting an additional two deaths and eight injuries.
    • “The FDA provided the new information after Boston Scientific on Oct. 11 updated its instructions for use for the device, which stayed on the market after the recall. While the prior alert warned of risks for lower gastrointestinal (GI) bleeding, the revised instructions reflect evidence of risks when the product is used anywhere in the GI area.”

From the public health and medical research front,

  • Health Day tells us,
    • “Walking pneumonia cases are surging among young children in the United States, federal health officials warn.
    • “Bacterial infections caused by Mycoplasma pneumoniae increased in the United States since late spring and have remained high,” a statement issued Friday by the U.S. Centers for Disease Control and Prevention noted. “The proportion of patients discharged from emergency departments with a diagnosis of M. pneumoniae-associated pneumonia or acute bronchitis has been increasing over the past six months, peaking in late August.”
    • “The worst rates of the illness have been seen in young children ages 2 to 4, according to the agency.
    • “The increase in children ages 2–4 years is notable because M. pneumoniae historically hasn’t been recognized as a leading cause of pneumonia in this age group,” the CDC added.”
  • NBC News informs us,
    • “Since 2000, breast cancer incidence among Asian American and Pacific Islander women under 50 years old has increased by 50%, more than 2% every year since 2012, according to a new report from the American Cancer Society.
    • “Asian American and Pacific Islander women in this age cohort had the second-lowest rate of breast cancer among all racial groups in 2000. They now have the highest rate alongside white women, about 86 per 100,000.
    • “Breast cancer is still more common the older we get, but it’s alarming to see younger women being diagnosed,” said Dr. Helen Chew, director of the clinical breast cancer program at UC Davis Health.
    • “Breast cancer has risen sharply among younger Asian American women in the past quarter-century due in part to acculturation and greater awareness around screenings, though experts say more research is required to determine exact causes for specific ethnic groups.
    • “Asian women like Huang have a higher prevalence of dense breasts, meaning there are more glands and tissue than fat, than women of other races, likely due to genetic factors and lower body mass indexes, experts say. And women with dense breasts are four times as likely to develop breast cancer as those with fatty breasts, an issue experts say needs more awareness.”
  • MedPage Today points out,
    • “The American Heart Association and the American Stroke Association updated guidelines for the primary prevention of stroke, emphasizing primary care screening, lifestyle management, and risk factor control.
    • “The guideline, published in Stroke, replaced the 2014 version to guide management for individuals with no prior history of stroke.
    • “This guideline is important because new discoveries have been made since the last update 10 years ago. Understanding which people are at increased risk of a first stroke and providing support to preserve heart and brain health can help prevent a first stroke,” said writing group chair Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, in a press release.
  • The Wall Street Journal relates,
    • “Novo Nordisk’s once-daily pill to treat type 2 diabetes has shown it cuts the risk of heart attacks and strokes in patients by up to 14%, according to a new trial.
    • “Rybelsus is an oral form of semaglutide, the active ingredient in the company’s blockbuster Ozempic and Wegovy diabetes and weight-loss drugs, and was tested in the trial on diabetic patients who also suffered from established cardiovascular disease and/or chronic kidney disease.
    • “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
    • “The company said the drug appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials and showed it reduces the risk of major cardiovascular events such as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
    • “Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in both the U.S. and European Union around the turn of the year.”
  • The American Medical Association lets us know what doctors wish their patients knew about childhood obesity.
  • Consumer Reports discusses urinary tract infections that afflict older folks.
  • The Institute for Clinical and Economic Review published a Final Evidence Report on Treatments for Transthyretin Amyloid Cardiomyopathy.
    • An independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for tafamidis, acoramidis, and vutrisiran when compared to no disease-specific therapy; tafamidis and acoramidis would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Technology giant Amazon is partnering with a high-profile provider to expand its primary care offerings.
    • “Amazon One Medical will collaborate with Cleveland Clinic to open a primary care office in 2025, with plans for additional locations over the next few years, the organizations said Monday.
    • “We’re starting small with a couple of locations, … then we’ll see where it takes us,” said. Dr. Tomislav Mihaljevic, CEO and president at Cleveland Clinic. “We’re continuously evaluating potential partnerships, and this is the one that just rose to the top of what we think is the right thing for our patients.”
    • “Facilities will be staffed by One Medical clinicians. Although walk-in care will be publicly available, only One Medical members will be able to make appointments online or access telehealth, among other services.
    • “The affiliation will enable One Medical members to access specialty care at Cleveland Clinic via patient referrals, the organizations said.”
  • Per MedTech Dive,
    • “Intuitive Surgical is on track to take the da Vinci 5 robot from a limited rollout to a broader launch in mid-2025.
    • “Intuitive placed 110 da Vinci 5 systems in the third quarter, up from 70 in the second quarter, bringing the total installed base to 188, executives said on an earnings call Thursday. Customers so far have completed more than 12,000 procedures with the new platform over about the past six months, they added.
    • “Da Vinci 5 installations are “well ahead of lofty buy-side expectations,” said BTIG analyst Ryan Zimmerman. “Limited launch or not, that’s a lot of [da Vinci 5] demand,” the analyst wrote in a note to clients after the call. BTIG estimated the number of cases completed with da Vinci 5 equals nearly 32 procedures per system per quarter.”

Weekend Update

David Ermer–Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC

  • Congress remains on the campaign trail until the lame duck session begins on November 12.
  • Modern Healthcare reports,
    • “Humana Inc. sued U.S. health agencies seeking to reverse a cut to crucial Medicare quality ratings, linked to billions of dollars in revenue, that sent the company’s stock tumbling this month.
    • “The lawsuit argues that the U.S. Medicare program was “arbitrary and capricious” in how it calculated the metrics for Humana’s health plans. The scores, known as star ratings, are linked to billions in bonus payments in future years.
    • “The case was filed Friday in federal court in the Northern District of Texas before Judge Reed O’Connor, who has frequently ruled in favor of plaintiffs challenging government regulations.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The simple difference in the genetic code — two X chromosomes vs. one X chromosome and one Y chromosome — can lead to major differences in heart disease. It turns out that these genetic differences that usually distinguish women from men influence more than just sex organs and sex assigned at birth — they fundamentally alter the way cardiovascular disease develops and presents. * * *
    • “Women are more likely to die after a first heart attack or stroke than men. Women are also more likely to have additional or different heart attack symptoms that go beyond chest pain, such as nausea, jaw pain, dizziness and fatigue. It is often difficult to fully disentangle the influences of sex on cardiovascular disease outcomes vs. the influences of gender.
    • “While women who haven’t entered menopause have a lower risk of cardiovascular disease than men, their cardiovascular risk accelerates dramatically after menopause.
    • In addition, if a woman has Type 2 diabetes, her risk of heart attack accelerates to be equivalent to that of men, even if the woman with diabetes has not yet gone through menopause. Further data is needed to better understand differences in cardiovascular disease risk among nonbinary and transgender patients.
    • “Despite these differences, one key thing is the same: Heart attack, stroke and other forms of cardiovascular disease are the leading cause of death for all people, regardless of sex or gender.”
  • STAT News lets us know,
    • “Pascal Geldsetzer and his team looked at nearly 300,000 electronic health records gathered randomly from people born between 1925 and 1942, comparing those on either side of the birthday cut-off date. They found that individuals who received the vaccine, called Zostavax, had a 20% lower risk of later developing dementia. The single shot had no impact on a host of other health outcomes common in older people, including heart disease, lung infections, and cancer. When his team began looking at other places with similar vaccine rollouts, including the U.K. and Australia, they kept finding shingles shots were protecting people’s brains. 
    • “Wherever we look, we see this strong signal,” Geldsetzer said. “We’re looking at a causal effect. And it’s specific to dementia. There is something clearly going on here.”
    • “The idea that viral infections can play a role in at least some dementia cases goes back decades. But it’s still controversial in the Alzheimer’s field, where scientists who raised the possibility have faced frustrating, even career-ending obstacles to pursuing their research. In the last decade though, the connections between pathogens and dementia have been slowly strengthening, as more and more researchers and funders begin to take the idea more seriously. 
    • “Like most fields there is an orthodoxy; in Alzheimer’s disease it’s not infectious agents,” said Paul Harrison, a professor of psychiatry at Oxford University. “But I’ve always viewed it as very intriguing.” * * *
    • “For the past few years, a team Harrison leads has been combing through millions of electronic health records to understand how Covid-19 affects the brain. They’ve published several influential studies showing how rates of mood disorders, strokes, and dementia alarmingly increase following infection, risks that stay elevated for years. Harrison realized he could use this same massive medical database to look for a link between a newer version of the shingles vaccine and dementia incidence. 
    • ‘The results of their analysis of health records from 200,000 Americans, published in Nature Medicine in July, showed that Shingrix — the recombinant shingles vaccine approved in the U.S. in 2017 — decreased the risk of developing dementia in the six years following its approval by 17%, compared to people who’d received Zostavax, an older, less effective shingles shot. Compared to people who’d received shots against other infections (like flu and tetanus), Shingrix vaccination cut dementia risks by up to 25%.”
  • Fortune Well discusses the public health implications of food dyes.

From the U.S. healthcare business front,

  • The Wall Street Journal considers why health insurers keep getting slammed with higher costs.
    • “[W]hat seems to have unnerved investors is how, after consecutive quarters of disappointing results, insurers still don’t seem to have a full understanding of what is going on or when it will improve. Many will choose to wait on the sidelines until the fog clears.”
  • Modern Healthcare notes,
    • “The HLTH 2024 conference kicked off Sunday, Oct. 20, in Las Vegas at the Venetian Expo Center, where all sorts of innovative companies from the healthcare industry will connect to share strategies, network and discuss their thoughts on the future. Speakers and presenters this year include leaders from Kaiser Permanente, Nvidia, Oracle, Walgreens and many more plus special appearances by Dr. Jill Biden, Halle Berry and Lenny Kravitz.”
  • Legal Dive tells us,
    • “Expect to spend twice as long preparing a filing under the Hart-Scott-Rodino merger review process under final guidelines released by the Federal Trade Commission and Department of Justice, an analysis says. 
    • “What typically took about 37 hours to comply with will likely take closer to 70 hours, Freshfields attorneys say in a memo on what in-house counsel can look forward to once the guidelines take effect, slated for mid-January. 
    • “The time, cost, and burden on all filing parties will increase significantly,” the attorneys say in their Oct. 16 analysis. “And [the increased burden] almost certainly underestimates the time required for strategic transactions.”
  • HR Dive informs us,
    • “As the global workforce continues to evolve, talent acquisition and retention will shift toward personalized employee experiences and expectations rather than typical rewards and physical work locations, according to an Oct. 11 report based on EY’s 2024 Work Reimagined Survey.
    • “For instance, 38% of employees said they’re likely to quit in the next year, which will require company flexibility and a plan for talent flow. This means untethered culture, expanded rewards and agile skill building will become more prevalent, the report found.
    • “Previous iterations of this survey showed the lenses through which employers and employees viewed the working world: employers driven mostly by cyclical concerns and employees fueled by structural transformation of how, where and why they work,” EY experts wrote. “Those lenses appear to be fracturing, as old thinking is shown as too rigid to navigate new terrain.”
    • “Instead, organizational success will rely on five dimensions: talent health and flow; work technology and generative AI; total rewards priorities; learning, skills and career pathways; and culture and workplaces. EY calls the combination a “Talent Advantage.” 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Security Week tells us,
    • “The US cybersecurity agency CISA and the FBI have released new guidance on security bad practices for software manufacturers and are inviting the public to provide feedback on it.
    • “The guidance urges the makers of software and services for the critical infrastructure or national critical functions (NCFs) to prioritize security throughout the development process and reduce customer security risks.
    • “It offers an overview of product security bad practices considered exceptionally risky and provides recommendations for mitigating them, in line with CISA’s Secure by Design initiative.
    • “The guidance contained in this document is non-binding and while CISA encourages organizations to avoid these bad practices, this document imposes no requirement on them to do so,” the agency notes.”
  • Cybersecurity Dive informs us,
    • “A federal grand jury on Wednesday unsealed charges and announced a prior operation to disrupt Anonymous Sudan, a prolific hacktivist group that was linked to some of the biggest DDoS attacks in the world, including a 2023 attack against Microsoft. 
    • “Federal officials indicted two Sudanese nationals, Ahmed Salah Yousif Omer, 22 and Alaa Salah Yusuuf Omer, 27, on charges of conspiracy to damage computers. Ahmed Salah was also charged with three counts of damaging protected computers. 
    • “In March, the FBI and U.S. Attorney’s Office, pursuant to a warrant, disabled and seized a DDoS tool the group used to conduct attacks against the U.S. State Department, the Department of Defense, the FBI, Microsoft, Riot Games, Cedars-Sinai Medical Center in Los Angeles and other organizations. The group also allegedly sold the DDoS tool to other threat actors.”
  • Per Fedscoop,
    • “National Institute of Standards and Technology Director Laurie Locascio will leave the administration in January after more than two-and-a-half years leading the standard-setting agency.
    • “Following her departure, Locascio will join the American National Standards Institute as its president and CEO. She has served as director of NIST and undersecretary of commerce for standards and technology at the Department of Commerce since April 2022. 
    • “In the meantime, Locascio “will continue to serve as Under Secretary of Commerce for Standards and Technology and NIST Director until then, providing leadership for important programs such as the CHIPS for America program and NIST’s extensive work in AI, including the U.S. AI Safety Institute,” a spokesperson for the Department of Commerce said in an emailed statement.”
  • Federal News Network lets us know,
    • “A new survey of federal cyber experts has found most agencies are mapping out their journey to post-quantum cryptography, but many feel hamstrung by a lack of formal guidance on an initiative that’s expected to cost billions of dollars in the coming decade.
    • “In a study released today, General Dynamics Information Technology found 50% of federal cyber experts have a strategy for post-quantum cryptography readiness, while 22% are engaged in pilot projects and 12% are preparing their workforce for a post-quantum future.
    • “Only 17% of those surveyed responded that they had “no defined strategy” and “PQC initiatives are not currently a priority.”
    • “But 37% of respondents also said a “lack of planning, guidance and strategy” poses a critical challenge to the post-quantum cryptographic transition.”

From the cyber vulnerabilities and breaches front,

  • Per a National Security Agency press release,
    • “The National Security Agency (NSA) is joining the Federal Bureau of Investigation (FBI), the Cybersecurity and Infrastructure Security Agency (CISA), and others in releasing a Cybersecurity Advisory (CSA), “Iranian Cyber Actors’ Brute Force and Credential Access Activity Compromises Critical Infrastructure Organizations,” to warn network defenders of malicious activity that can enable persistent access in sensitive systems.
    • ‘Since October 2023, Iranian cyber actors have used a technique known as brute force to compromise user accounts and obtain access to organizations to modify MFA registrations, enabling persistent access. 
    • “Our agencies are sharing detailed insight into this malicious cyber activity and what organizations can do to shore up their defenses,” said Dave Luber, NSA Cybersecurity Director. “We explain the tactics, techniques, and procedures used by the Iranian actors, as well as indicators of compromise.”  
  • Beckers Health IT notes,
    • “The costs of the Change Healthcare cyberattack continue to grow for parent company UnitedHealth Group.
    • “UnitedHealth estimated the company would absorb about an additional 10 cents a share in costs for the February ransomware attack that disrupted claims processing and breached patient data across the nation, bringing the total to 75 cents a share, according to a third-quarter earnings report.
    • “The healthcare conglomerate now estimates it will take a $2.87 billion hit from the cyberattack in 2024, after originally anticipating $1.6 billion in costs.
    • “After the cyberattack, we prioritized devoting resources to support care providers, over some activities such as share repurchase,” President and CFO John Rex said in an Oct. 15 earnings call.
    • “UnitedHealth has disbursed $8.9 billion in loans to providers affected by the IT outage, with $3.2 billion having been paid back.”
  • Cybersecurity Dive reports,
    • “Microsoft said it mitigated an issue that led to the partial loss of more than two weeks of security log data during September. 
    • “The company previously notified customers that some security logs were lost due to a bug in the company’s internal monitoring agents. The security logs provide critical information to Microsoft customers as they can be used to flag evidence of a malicious attack. 
    • ‘The lost security data impacted several Microsoft platforms, including Microsoft Entra, Sentinel, Purview and Defender for Cloud.” 
  • Furthermore,
    • Cybersecurity Dive adds,
      • “The Cybersecurity and Infrastructure Security Agency added a critical hardcoded credentials flaw in SolarWinds Web Help Desk to its known exploited vulnerabilities catalog on Tuesday, marking the second actively exploited CVE in the same product since August.
      • “The vulnerability, listed as CVE-2024-28987, allows a remote, unauthenticated attacker to access internal functionality and potentially modify data. The software defect has a CVSS score of 9.1.
      • “SolarWinds previously said the vulnerability impacted customers using Web Help Desk 12.8.3 HF1 and all prior versions, in an August security advisory. The company told customers to upgrade to the fixed version at that time.”  * * *
      • “It is not immediately clear what specific threat activity led CISA to add CVE-2024-28987 to the KEV catalog, however the listing requires federal civilian executive branch agencies to take mitigation steps to protect their systems from exploitation.” 
    • and
      • “Hackers are actively exploiting a critical format string vulnerability in four Fortinet products, federal authorities and security researchers said last week. 
      • “The Cybersecurity and Infrastructure Security Agency added the vulnerability, listed as CVE-2024-23113, to its known exploited vulnerabilities catalog on Wednesday. The vulnerability, originally disclosed in February, has a CVSS score of 9.8. 
      • “Exploitation of the vulnerability in FortiOS could allow a remote, unauthenticated hacker to execute arbitrary code or commands on a system, FortiGuard Labs said in a Friday blog post.”
    • The Record adds,
      • “The nation’s top cybersecurity agency has confirmed that ransomware gangs are using a vulnerability found last month in products from software company Veeam.  
      • “For weeks, experts have expressed alarm about CVE-2024-40711 — a bug Veeam rated critical and gave a severity score of 9.8 when it was disclosed in September.  
      • “CVE-2024-40711 could “allow an attacker to gain full control of a system, manipulate data, and potentially move laterally within a network, making it a relatively high-value target for threat actors,” according to researchers at Censys.  
      • “The Cybersecurity and Infrastructure Security Agency (CISA) confirmed on Thursday that the vulnerability has been exploited and took the rare step of specifying that it was being used in ransomware attacks.  
      • “Veeam released a fix on September 4 after the bug was discovered by Code White security researcher Florian Hauser. By September 15, proof-of-concept exploit code was released by watchTowr Labs. Veaam specializes in software for system backups and disaster recovery. 
      • “CISA gave federal civilian agencies until November 7 to patch the bug.  
      • “CISA added the “Known To Be Used in Ransomware Campaigns?” tab in the Known Exploited Vulnerabilities (KEV) Catalog almost exactly a year ago but has rarely used it.”

Also from the ransomware front,

  • The HHS Office for Civil Rights posted on You Tube a 45-minute-long video on Ransomware and the HIPAA Security Rule.
  • Hacker News reports,
    • “Cybersecurity researchers have gleaned additional insights into a nascent ransomware-as-a-service (RaaS) called Cicada3301 after successfully gaining access to the group’s affiliate panel on the dark web.
    • “Singapore-headquartered Group-IB said it contacted the threat actor behind the Cicada3301 persona on the RAMP cybercrime forum via the Tox messaging service after the latter put out an advertisement, calling for new partners into its affiliate program.
    • “Within the dashboard of the Affiliates’ panel of Cicada3301 ransomware group contained sections such as Dashboard, News, Companies, Chat Companies, Chat Support, Account, an FAQ section, and Log Out,” researchers Nikolay Kichatov and Sharmine Low said in a new analysis published today.”
  • Tripwire assesses the current ransomware landscape.

From the cybersecurity defenses front,

  • Cybersecurity Dive points out,
    • “More than 4 in 5 CISOs believe their role needs to be split into two separate positions, as regulatory and financial risks consume a greater part of their job responsibilities, according to a report released Tuesday by Trellix and Vanson Bourne. 
    • “A majority of CISOs are calling for the job to be separated into a technical, hands-on-keyboard security role and another position that focuses on regulatory compliance and boardroom disclosure. 
    • “Regulatory changes from the Securities and Exchange Commission and other bodies have been a mixed blessing for CISOs, according to Harold Rivas, CISO at Trellix.”
  • Cyberscoop mentions that “SecureWorks has released research that dives into the tell-tale behaviors behind remote employees that may be working on behalf of North Korea.”
  • Dark Reading notes that “A survey shows three-quarters of CISOs are drowning in threat detections put out by a sprawling stack of tools, yet still lack the basic visibility necessary to identify breaches,” and shares “four ways to address Zero-Days in AI/ML security. As the unique challenges of AI zero-days emerge, the approach to managing the accompanying risks needs to follow traditional security best practices but be adapted for AI.”
  • Here’s a link to Dark Reading’s CISO corner.
  • Security Week asks us to “be aware of eight underrated phishing techniques. There are a number of lesser-known phishing techniques that are often overlooked or underestimated yet increasingly being employed by attackers.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC

  • An HHS fact sheet lets us know,
    • ‘Following storm damage from Hurricane Helene at Baxter International Inc.’s facility in North Carolina, the U.S. Department of Health and Human Services (HHS) and its subagencies continue taking action to support access to intravenous (IV) fluids, including ensuring restoration of key production sites, protecting products, and opening imports, in partnership with manufacturers, distributors, hospitals, and other stakeholders. As a result of these steps, hospitals have 50% more product available to them now compared to right after the hurricane. Baxter has moved and begun distributing more than 450 truckloads of product from their North Carolina facility over the past 10 days and is already importing additional product from their foreign plants. FDA acted quickly to conduct scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and peritoneal (PD) fluids from five Baxter facilities around the world. Baxter communicated that supply availability is continually improving, and they expect to further increase customer allocations to 90%-100% of historical levels for many IV solution product codes no later than the end of the year. These supply improvements, combined with increased output from other manufacturers, will help hospitals get more of the product they need over the coming weeks.
    • ‘HHS, Food and Drug Administration (FDA), the Administration for Strategic Preparedness and Response (ASPR), and the Centers for Disease Control and Prevention (CDC) continue to use all available authorities to protect patients, support supply, and keep stakeholders informed, in partnership with manufacturers, distributors, hospitals, and other stakeholders. Additionally, HHS is announcing additional information about the airlift of Baxter products into the U.S. from international facilities, with first flights scheduled for October 19.‘
  • The New York Times reports,
    • “The Veterans Affairs Department is investigating whether Acadia Healthcare, one of the country’s largest chains of psychiatric hospitals, is defrauding government health insurance programs by holding patients longer than is medically necessary, according to three people with knowledge of the inquiry.
    • “The investigation, led by the agency’s inspector general, comes three weeks after Acadia told investors that it was facing scrutiny for its admissions practices from several other federal investigators, including prosecutors in Manhattan and a grand jury in Missouri. The company, which relies on government insurance programs like Medicare and Medicaid for much of its revenue, said it was also expecting to receive inquiries from the Securities and Exchange Commission and other agencies.
    • “Acadia told investors that it was “fully cooperating with authorities and, at this time, cannot speculate on whether the outcome of these investigations will have any impact on its business or operations.” The company has denied claims that it was improperly holding patients and has said that all decisions about care are made by licensed medical professionals.”
  • STAT News informs us,
    • “Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $63 billion in 2023, a 23.4% increase from the previous year, according to the Health Resources & Services Administration, which oversees the program.
    • “The data mark a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — off all outpatient drugs to hospitals and clinics that primarily serve lower-income patients. There are more than 12,000 entities participating in the program, a number that has grown substantially.
    • “Since it began more than 30 years ago, the program has ballooned and fed into the national clash over the cost of medicines. Some $38 billion in prescription medications were purchased under the 340B program in 2020, for instance, which was up from $16.2 billion in 2016. And this fast-paced trajectory has triggered a battle between the pharmaceutical and hospital industries.”

From the public health and medical research front

  • The Center for Disease Control and Prevention announced,
    • “COVID-19 activity is declining in all areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in all areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels.
      • “The XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • Nationally, RSV activity is low. However, signs of increased RSV activity have been detected in the southeastern U.S., particularly in young children.
    • Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • “CDC wastewater tracking shows that [COVID] viral levels remain low, with levels currently highest in the northeast. The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are in the medium category nationally, with a downward trend over the last 3 weeks. It said the South and West are currently at the low level.”
  • The AP tells us,
    • “Teen smoking hit an all-time low in the U.S. this year, part of a big drop in the youth use of tobacco overall, the government reported Thursday.
    • “There was a 20% drop in the estimated number of middle and high school students who recently used at least one tobacco product, including cigarettes, electronic cigarettes, nicotine pouches and hookahs. The number went from 2.8 million last year to 2.25 million this year — the lowest since the Centers for Disease Control and Prevention’s key survey began in 1999.
    • “Reaching a 25-year low for youth tobacco product use is an extraordinary milestone for public health,” said Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health, in a statement. However, “our mission is far from complete.”
    • “A previously reported drop in vaping largely explains the overall decline in tobacco use from 10% to about 8% of students, health officials said.”
  • The UMN CIDRAP mentions,
    • “Including preset treatment orders in the electronic medical records of children with ear infections dramatically improved compliance with antibiotic treatment guidelines, researchers reported at IDWeek 2024.
    • “In a study conducted at the University of Colorado/Children’s Hospital Colorado, researchers analyzed data on 34,324 children aged 61 days to 18 months who visited emergency and urgent care centers in the health system for acute otitis media (AOM) from January 2019 to September 2023. Their aim was to assess the effectiveness of a bundled intervention for AOM that included an electronic health record (EHR) order set (implemented in April 2021) that pre-selected a 5-day antibiotic course for children 24 months and older and a local clinical care pathway (implemented in December 2022) that encouraged observation and pain management for children with non-severe AOM. 
    • “Presenting author Joana Dimo, DO, a doctoral fellow at the University of Colorado, said the bundle was developed to address a common problem in antibiotic prescribing for AOM: while most cases (up to 75%) resolve without antibiotics, most children receive antibiotics, often for longer than needed.
    • “We noticed at our institution that children were being prescribed a lot of antibiotics for ear infections, and that the duration of antibiotics was longer than we thought necessary,” Dimo said at a press briefing.”
  • Per Fierce Pharma,
    • “After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy.
    • “The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up as a first-line treatment for adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
    • “With the green light, Vyloy becomes the first U.S.-approved anti-CLDN18.2 drug. The transmembrane protein, also known as Claudin-18.2, has become a red-hot target in the oncology field, ginning up interest from the likes of AstraZeneca, Leap Therapeutics, Legend, Moderna and other companies.
    • ‘Friday’s approval specifically covers Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy. Patients must have the CLDN18.2 positivity of their tumors confirmed through testing, and, to that end, the FDA has simultaneously approved a new companion diagnostic from Ventana Medical Systems and Roche.”
  • Per BioPharma Dive,
    • “An experimental antibody drug developed by Merck & Co. significantly reduced the incidence of disease due to respiratory syncytial virus infections as well as related hospitalizations in infants, the company said Thursday.
    • “Called clesrovimab, the antibody met all the goals of a Phase 2b/3 study testing it in more than 3,600 healthy pre- and full-term infants. A dose of clesrovimab lowered RSV disease incidence by 60%, and RSV-associated hospitalizations by 84%, compared to placebo through five months post-treatment.
    • “While three RSV vaccines are approved in the U.S. for older adults, only one antibody drug — Sanofi and AstraZeneca’s Beyfortus — is cleared for all infants entering their first RSV season. If approved, clesrovimab would compete with Beyfortus.”
  • and
    • “Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed with the Food and Drug Administration to withdraw it following negative trial results.
    • “The FDA granted Trodelvy accelerated approval for bladder cancer in 2021, based on results that found it shrank tumors in people whose disease had progressed following treatment with chemotherapy and immunotherapies like Merck & Co.’s Keytruda. But a confirmatory study, titled TROPiCS-04, failed to show the medicine helped people live longer.
    • “Trodelvy’s withdrawal is one of several conditional approvals that have been rescinded in recent years, most notably among the “PD-1” class of drugs that includes Keytruda and Bristol Myers Squibb’s Opdivo. The Trodelvy decision, however, came months after negative trial results, a sign the FDA has become more vigilant about resolving so-called “dangling” accelerated approvals.’

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “CVS Health replaced CEO Karen Lynch on Thursday as the healthcare and pharmacy giant’s financial challenges mount.
    • “CVS’ new chief executive is David Joyner, a company veteran who most recently headed up CVS’ pharmacy benefit manager Caremark. Lynch, who held the top spot at CVS since 2021 and previously led insurer Aetna, stepped down “in agreement with the company’s Board of Directors,” according to a release. 
    • “The company also pulled earnings guidance provided last quarter due to higher medical costs in its Aetna health benefits segment. CVS’ stock fell more than 7% in early morning trade Friday following the news.”
  • The Wall Street Journal adds,
    • “Roger Farah, chairman of CVS’s board of directors, will also become executive chair.” * * *
    • “Joyner and Farah said in an interview with the Journal that CVS will now move forward intact. 
    • “We believe that we have a really important part to play in terms of simplifying and delivering a better healthcare experience for this country,” Joyner said. CVS’s assembled assets will allow it “to actually deliver on the promises that we’ve made, and now it’s all about execution.” * * *
    • “CVS will also report that medical costs are still running higher than expected, an issue that has come up in other insurers’ recent reports. Aetna’s medical loss ratio, or the share of premiums spent on healthcare costs, will be around 95.2%, compared with analysts’ expected 91.1%.”
  • Modern Healthcare reports,
    • “Cigna Group has revived efforts to combine with its smaller rival Humana Inc. after merger talks fell apart late last year, according to people familiar with the matter. 
    • “The two health insurance giants have held informal discussions recently about a potential deal, said the people who asked to not be identified because the talks aren’t public. The discussions are in early stages, they added.
    • Cigna is looking to close the sale of its Medicare Advantage business in the coming weeks before committing to any other transactions, one of the people said.
  • Beckers Hospital Review lets us know,
    • “Shifting care from in-person to virtual settings could reduce total medical claims spending by 2.3% to 3.1%, according to an Oct. 17 study from Solera Health.
    • “The research analyzed longitudinal medical claims data from 50 million commercially insured U.S. adults. The study first identified patients eligible for virtual care based on an outpatient visit for a qualifying diagnosis over a six-month period. Researchers then reviewed the previous 12 months of claims to assess whether patients’ conditions were uncomplicated or complex, followed by a 12-month forward analysis to evaluate whether their conditions remained controlled or became uncontrolled after their initial in-person visit. 
    • “According to estimates from CMS on private insurer spending in 2022, this shift to virtual care could result in cost savings of over $50 billion each year.”
  • Per Fierce Healthcare,
    • “Cancer continues to be employers’ biggest treatment cost, driving up healthcare spending. 
    • “Costs for cancer-related medical services and drugs are expected to reach nearly $250 billion in the U.S. by 2030—a 34% increase since 2015, according to a study by the American Association for Cancer Research.
    • “And, while oncology accounts for only 1% of claims volumes, it makes up 15% of the overall employer healthcare spend, according to a report by The Mahoney Group.
    • “Health tech company Color Health is doubling down on its play for employer-sponsored cancer care, building on its work with the American Cancer Society (ACS) to offer comprehensive cancer management.
    • The company developed a fully integrated virtual cancer clinic for employers, unions and health plans that is designed to support individuals from screening and early detection through diagnosis, treatment and survivorship.
    • “Color, a platform for large-scale care delivery, is rolling out its virtual cancer clinic to more than 45 employers, health plans and unions across the country. The offering will be made available to customers starting January 2025.”

Thursday Miscellany

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Office of Personnel Management tells us,
    • “OPM today released the 2024 OPM Federal Employee Viewpoint Survey (FEVS) results, the largest worldwide survey of government employees that annually tracks how employees view workforce management, policies, and new initiatives. This year’s results show steady improvement in nearly all areas and the highest-ever Employee Engagement Index (EEI) score since OPM began tracking the metric in 2010. The EEI assesses the critical aspects of an engaged workforce including perception of leadership, supervisors, and intrinsic work experience.” * * *
    • “For the full collection of data, see the OPM FEVS dashboard. This tool provides the public with a dynamic way to access and visualize governmentwide and agency-size survey results and trends of the past five years. New content in the 2024 dashboard release features inclusion of results by Federal Executive Board region and will enhance each Board’s ability to address specific challenges within their geographical area.   
    • “For more information on OPM FEVS methods, see the OPM FEVS Technical Report.”   
  • Federal News Network adds,
    • Many federal human capital experts have said receiving the results of FEVS each year is only the first step for long-term workforce planning. To actually make improvements for their employees, experts say agency leaders have to then analyze the FEVS results and make adjustments as necessary. Later this fall, the Chief Human Capital Officers (CHCO) Council plans to publish a FEVS “toolkit” including recommendations for how leaders can make changes based on FEVS, as well as strategies for action planning and better communication with employees.”
  • Tammy Flanagan, writing in Govexec, points out ten important facts about Medicare that folks approach age 65 need to know.
  • Federal News Network is offering a Federal Benefits Open Season feature
  • The American Hospital Association News lets us know,
    • “A report released Oct. 17 by the Senate Homeland Security Committee’s investigative subcommittee scrutinizes some of the nation’s largest Medicare Advantage insurers for their use of prior authorization and high rates of denials for certain types of care. The subcommittee sought documents and information from the three largest MA insurance companies — UnitedHealthcare, Humana and CVS — and investigated their practice of “intentionally using prior authorization to boost profits by targeting costly yet critical stays in post-acute care facilities.”  
    • “The report found that between 2019 and 2022, UHC, Humana and CVS denied prior authorization requests for post-acute care at far higher rates than other types of care. In 2022, UHC and CVS denied prior authorization requests for post-acute care at approximately three times higher than the companies’ overall denial rates, while Humana’s prior authorization denial rate for post-acute care was more than 16 times higher than its overall denial rate. The report also found increases in post-acute care service requests subjected to prior authorization and denial rates for long-term acute care hospitals, among other findings.”
  • In the past, such practices were praised as cost containment, a now forgotten policy.
  • Thompson Reuters delves into “HHS FAQs [that] elaborate on HIPAA Administrative Simplification Enforcement and Compliance.”

From the public health and medical research front,

  • The Washington Post reports the latest news about the ongoing massive meat recall over a Listeria concern.
    • The recalled products include about 11,765,285 pounds of ready-to-eat meat and poultry items [prepared by BrucePac] that have been sold at stores across the country, including Walmart, Target, Aldi, Trader Joe’s, Kroger, Publix, Wegmans and more.
    • Initially, the [USDA Food Safety and Inspection Service] FSIS said the recalled goods have the establishment numbers 51205 or P-51205 inside or under the USDA mark of inspection on their labels, but it cautioned later that some recalled products could bear a different number “due to further distribution and processing by other establishments.”
    • The FSIS is encouraging consumers to review a more than 340-page list of labels and products included in the recall. The list has images of labels with 7-Eleven, Amazon Kitchen, Boston Market, Dole, Taylor Farms, Giant Eagle and ReadyMeals branding, among several other name brands.
    • Among the recalled items are chicken-based salad bowls, wraps, sandwiches, burritos and pastas.
    • In an Oct. 15 update, the FSIS said that the recalled foods had been distributed to schools, in addition to restaurants and institutions, but that a school distribution list was not yet available. “These products should be thrown away or returned to the place of purchase,” it said.
  • The NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Proteins are vital to our bodies. They serve as structural building blocks for our tissues and organs and are responsible for their functioning in both health and disease. Genes, like recipes, contain instructions for making proteins. Usually, each essential protein is produced from a single gene. Now, new research shows that some bacteria can actually produce two or more proteins from a single gene by “flipping” underlying stretches of DNA.
    • “While scientists have long known that DNA inversions can occur in bacteria, this study is the first to describe these inversions, or “invertons,” within individual genes. What’s more, the findings, from research supported by NIH and reported in the journal Nature , suggest that this flipping happens more often than scientists suspected.
    • “The findings, from Ami S. Bhatt at Stanford Medical School in Stanford, CA, and her colleagues, may have important implications, not only for bacteria, but also for human health. For example, bacteria’s ability to flip genes and alter proteins on their surfaces may restrict the ability of our immune systems to recognize and effectively respond to infectious microbes. Invertons also likely play roles in how our microbiomes, the communities of microorganisms that live in and on us, develop and change within our bodies. Our microbiomes influence our metabolisms, immune responses, and more. * * *
    • “The researchers now want to investigate the mechanisms causing inversions. They expect that these findings are just the tip of the iceberg for understanding the role of invertons in bacteria’s ability to adapt and thrive. They also suggest that, as we learn more about links between this process in bacteria and human diseases, we might find ways to harness it for improving human health.”
  • The Wall Street Journal reports,
    • “Feel like it takes longer to recover from everything these days—whether it’s an injury or poor sleep? That’s the reality of what time is doing to our bodies.
    • “Researchers call our ability to bounce back from health stress “biological resilience.” Evidence suggests that it declines with age, driven by biological and other factors, including parenting, work stress, changes in exercise habits and menopause.
    • “Often, these stresses pile up from early life and can reach a tipping point in our 30s and 40s. 
    • “There are these moments where the whole system seems to undergo like a vibe shift,” says Dr. Heather Whitson, a geriatrician and clinical investigator who directs the Duke University Aging Center.
    • “These midlife declines in resilience parallel emerging science suggesting that aging itself doesn’t happen in a linear way, doctors and researchers say. A small study out of Stanford that looked at biomolecular shifts in the body found two aging “waves” appear to occur around ages 44 and 60. 
    • “While the Stanford study’s findings are difficult to generalize to the broader adult population, family-medicine doctors report seeing similar age-related changes in their patients. The first shift often happens for patients in their late 30s and early 40s, says Dr. Benjamin Missick, family medicine doctor at Novant Health in North Carolina.”
  • and
    • “Drugs such as Novo Nordisk’s blockbuster Ozempic can cut drug and alcohol abuse by up to 50% according to a new study, adding to mounting evidence that the drugs yield health benefits beyond diabetes and weight loss.
    • “In a study published Thursday in scientific journal Addiction, around 500,000 people with a history of opioid use disorder were analyzed, of which just more than 8,000 were taking either GLP-1 drugs such as Ozempic or the similar GIP class of drugs that Eli Lilly’s Mounjaro belongs to.
    • “GLP-1 drugs work by mimicking a gut hormone to control blood sugar and suppress appetite while GIP medications take a dual-target approach by mimicking both the GLP-1 hormone and a second gut hormone that is believed to enhance the drug’s effectiveness.
    • “The study found that those taking the drugs had a 40% lower rate of opioid overdose compared with those who didn’t.
    • “Similarly, an analysis of more than 5,600 people with a history of alcohol use disorder and who took the drugs showed they had a 50% lower rate of intoxication compared with those who didn’t take them.
    • “Our study… reveals the possibilities of a novel therapeutic pathway in substance use treatment,” the study’s lead researcher Fares Qeadan and co-authors of the research report Ashlie McCunn and Benjamin Tingey said.
  • Per BioPharma Dive,
    • “People with advanced Parkinson’s disease have a new treatment option, as the Food and Drug Administration on Thursday approved a combination therapy from AbbVie that’s designed to provide longer-lasting movement control.
    • “Parkinson’s is hallmarked by unintentional muscle movements like shaking or stiffness — the result of nerve cells progressively breaking down and dying. Two drugs, carbidopa and levodopa, have become mainstay treatments for the motor symptoms associated with the disease. AbbVie’s now-approved Vyalev pairs these medications together, but in a unique way.
    • “Vyalev uses “prodrug” versions of carbidopa and levodopa, meaning their therapeutic effects aren’t felt until they’re metabolized. Additionally, Vyalev is the first and only levodopa-based therapy given as a 24-hour infusion, similar to an insulin pump. That could be particularly useful for people with advanced Parkinson’s, who often have trouble swallowing pills because of their impaired motor function.”
  • HCP Live relates,
    • Low-dose oral food challenges in infants with allergies are safe, with skin symptoms as the most common reaction, and no cases of anaphylaxis reported.
    • The study supports early introduction of allergenic foods to build tolerance, aligning with guidelines for early peanut introduction.
  • Beckers Clinical Research notes,
    • “University of Pennsylvania and Children’s Hospital of Philadelphia researchers have developed the first mRNA Clostridioides difficile vaccine — and it’s shown promising results in animal models.
    • “The mRNA vaccine was found to protect against first-time C. diff infections and relapsing infections, promote clearance of existing C. diff bacteria in the gut and overcome deficits in host immunity to protect animals from infection, according to an Oct. 17 system news release. The study was published in Science and could pave the way for clinical trials.
    • “Researchers used the mRNA-LNP vaccine platform — the same that provided the COVID-19 vaccines — to create the C. diff vaccine.” 

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Elevance Health lowered its profit guidance for 2024 on Thursday as the insurer manages “unprecedented challenges” in its Medicaid business.
    • “The company expects net income per diluted share to be approximately $26.50, down from at least $34.05 it projected last quarter. 
    • “But CEO Gail Boudreaux said the increased costs pressuring its Medicaid segment would alleviate as states updated their payment rates to better match member acuity. “We remain confident in the long-term earnings potential of our diverse businesses as we navigate a dynamic operating environment and unprecedented challenges in the Medicaid business,” she said in a statement.” 
  • Modern Healthcare adds
    • “Elevance Health took a hit on its Medicare Advantage star ratings for 2025 and plans to do something about it, President and CEO Gail Boudreaux told investor analysts Thursday.
    • “The for-profit Blue Cross and Blue Shield licensee is the latest Medicare Advantage insurer to push back on the lower quality scores the Centers for Medicare and Medicaid Services announced last week. UnitedHealthcare parent company UnitedHealth Group already sued the agency and Humana is appealing to CMS before taking other actions.
    • “We have challenged our initial score with CMS and are considering all of our options,” Boudreaux said when announcing the company’s third-quarter financial results.”
  • Fierce Healthcare tells us,
    • “Evernorth has tapped Transcarent to power its Oncology Benefit Services offering, which aims to offer end-to-end support for cancer patients for the course of their care journey.
    • “The companies announced Thursday that the program is built on a digital platform that unites key cancer services across the patients’ medical and pharmacy benefits and connects them to a dedicated care team for personalized support and outreach.
    • “This digital platform makes it easier for employers to offer a “streamlined” experience to workers, according to the announcement. Through it, members can reach dedicated oncology nurse navigators who have an American Cancer Society Leadership in Oncology Navigation (ACS LION) certification, find and schedule appointments with cancer centers of excellence, connect to virtual care or have key drug consultations.
    • “Nurse navigators are also trained to provide support to the patients’ caregivers. They’re able to provide educational materials, assistance in appointment scheduling and answers to key questions.”
  • Beckers Hospital Review points out,
    • “Changing consumer trends and market dynamics are leading to hundreds of pharmacy store closures in the U.S.
    • “Brick-and-mortar locations are losing to mail-order and digital options, according to a J.D. Power study of pharmacy customers. Between 2023 and 2024, overall customer satisfaction in physical drug stores declined 10 points on a 1,000-point scale, and satisfaction scores for mail-order pharmacies increased six points.” 
  • “Deloitte research indicates that by ensuring virtual health offerings prioritize convenience and address consumer preferences, health systems could gain a competitive advantage.”
  • Per MedTech Dive,
    • “CMR Surgical won Food and Drug Administration authorization for its Versius robot with an initial indication for gallbladder removal surgery. CMR will partner with select hospitals as the first part of a multistage strategic plan to introduce the robot in the U.S.
    • “The authorization is the first granted through the FDA’s de novo pathway for a multiport, soft tissue general surgical robot, CMR said in a Monday announcement. The de novo process brings new medical devices to market that may serve as predicates for other 510(k) submissions.
    • “The company announced the milestone less than a week after it named Massimiliano Colella as interim CEO, replacing Supratim Bose, who stepped down for personal reasons after less than two years in the job.” 

Midweek Update

David Ermer–ACA, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–

From Washington, DC

  • CBS News lets us know,
    • “The Biden administration says it has invoked the wartime powers of the Defense Production Act to speed rebuilding of a major American factory of intravenous fluids that was wrecked by Hurricane Helene last month. Damage to the plant in North Carolina has worsened a nationwide shortage of IV fluids, and hospitals say they are still postponing some surgeries and other procedures as a result. 
    • “Some 60% of the nation’s IV supplies had relied on production from the plant, run by medical supplier Baxter, before it was damaged by the storm.”
  • CMS released its “Final 2026 Actuarial Value Calculator Methodology.”
  • CMS announced,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), approved section 1115 demonstration amendments that allow, for the first time ever, Medicaid and Children’s Health Insurance Program (CHIP) coverage of traditional health care practices provided by Indian Health Service (IHS) facilities, Tribal facilities, and urban Indian organizations (UIO). Today’s action is expected to improve access to culturally appropriate health care and improve the quality of care and health outcomes for tribal communities in Arizona, California, New Mexico, and Oregon, and will support IHS, Tribal, and UIO facilities in serving their patients. 
    • “Traditional health care practices have been a way of life in many communities. And they are extremely important for American Indian and Alaska Native populations,” said HHS Secretary Xavier Becerra. “But, too often, health insurance does not cover them. With Medicaid and CHIP’s inclusion of traditional health care practices at certain IHS facilities, we are extending access to culturally appropriate, quality health care in Tribal communities.”
  • The Wall Street Journal reports,
    • “Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and stand-alone flu inoculation, sending shares down sharply.
    • “The vaccine maker on Wednesday said the Food and Drug Administration placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S., who received the vaccine in January of 2023.
    • “This participant was part of a Phase 2 trial for the combination vaccine that was completed in July 2023 and reported the adverse event in September of this year, the Gaithersburg, Md., company said.
    • “While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax Chief Medical Officer Robert Walker said. “Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible.”
  • Reg Jones, writing in FedWeek, explains how court orders can impact federal retirement benefits.

From the public health and medical research front,

  • The Wall Street Journal tells us
    • “Frozen shoulder, a painful condition that immobilizes the shoulder joint, tends to strike midlife women.
    • “Treatments for frozen shoulder include steroid injections and physical therapy.
    • “Preliminary data suggests that hormone therapy might help prevent frozen shoulder in midlife women.”
  • and
    • “Scientists hope body tissues grown in labs will become a familiar sight in medicine. 
    • “Researchers around the world are working to grow heart valves, lungs and more from human cells. They have succeeded in bringing some to market such as knee cartilage and skin grafts, but advances for more complicated anatomy have been slow-going for years. 
    • “Now scientists are gaining ground in tissue engineering that could help a host of people who deal with circulatory-system problems.”
  • The American Medical Association offers “four steps to care for patients with prolonged symptoms of Lyme disease.”
  • BioPharma Dive notes,
    • “The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo.
    • “Approval was based on results from “Lunar,” a Phase 3 trial in which people who used the device with standard therapies had a 26% reduced risk of death over a median follow up of around 10 months. The results were controversial, however, because the trial included concurrent care with immunotherapies, which are typically used as a first-line treatment, as well as chemo.”
  • Per MedPage Today,
    • The long-term risk of distant recurrence for women with early breast cancer has declined significantly, a decades-long analysis of clinical trial data showed, largely a result of patients enrolling with lower-risk disease along with improved adjuvant therapy.
  • KFF discusses how “More Mobile Clinics Are Bringing Long-Acting Birth Control to Rural Areas.”
  • Per Health Day,
    • “Most Americans 50 and older don’t place much trust in health advice generated by artificial intelligence, a new survey finds.
    • “About 74% of middle-aged and senior Americans would have very little to no trust in health info generated by AI, the University of Michigan poll found.
    • “At the same time, these older adults have a lot of confidence in their ability to suss out bad info about health matters.
    • “Only 20% said they had little to no confidence they could spot misinformation about a health topic if they came across it.
    • “Among all older adults who’d scanned the web recently for health info, only 32% said it’s very easy to find accurate advice.
    • “Amid this lack of trust, our findings also highlight the key role that health care providers and pharmacists play as trusted health messengers in older adults’ lives, and even the role that friends or family with medical backgrounds can play,” said poll director Dr. Jeffrey Kullgren, an associate professor of internal medicine at the University of Michigan.”

From the U.S. healthcare business front,

  • Fierce Healthcare alerts us that U.S. News and World Report has released its Medicare Advantage and Part D plan ratings.
  • Beckers Hospital Review reports,
    • “UnitedHealth Group is seeing “unusually aggressive and high unit cost asks” from hospitals, CEO Andrew Witty said. 
    • “On an Oct. 15 call with investors, Mr. Witty said UnitedHealth wants to find a “new way of working with hospitals.” 
    • “We want to see less abrasion in the marketplace,” Mr. Witty said. “We believe that ought to come with more competitive rates in the marketplace.” 
    • “UnitedHealth reported its third-quarter earnings Oct. 15. CFO John Rex said medical costs rose in the third quarter, driven by increased pharmacy costs, Medicaid rates and an increase in coding intensity by hospitals.” * * *
    • “Mr. Witty told investors UnitedHealth wants to collaborate with hospitals to drive better value for the healthcare system. The company’s newly launched gold card program, which relaxes prior authorization requirements for some providers, is one example of this collaboration, Mr. Witty said. 
    • “The company is also seeking out partnerships with drug manufacturers to bring down prescription spending, Mr. Witty said. 
    • “Whether that be with drug companies that are interested in new ways of working to bring down costs, or whether that’s with hospital systems who want to work with us to reimagine what the patient experience, what the doctor experience is — [that’s] all part of bringing down the unit cost. Those are areas that are super important for the long run,” Mr. Witty said.” 
  • Per Fierce Pharma,
    • “With Gilead Sciences sprinting to a likely approval next year for its long-acting pre-exposure prophylaxis (PrEP) drug for HIV, the California company has a chance to one-up GSK. While the British company’s long-acting Apretude is injected every two months, Gilead’s answer is dosed just twice a year.
    • “Later this decade, GSK hopes to launch PrEP options that have four and six months of staying power. But, until then, it will do battle with Apretude (cabotegravir long-acting), which has just excelled in several real-world studies.
    • “In two real-world evidence studies of nearly 1,300 people, Apretude has shown better than 99% effectiveness in preventing HIV infections. GSK’s ViiV Healthcare unit also presented findings from the PILLAR implementation study, which show reductions in stigma and anxiety among users of the treatment. The new results are being presented Wednesday through Saturday in Los Angeles during IDWeek 2024.
    • “The results add to the positive momentum for Apretude, which was approved in December 2021 as the first long-acting PrEP option for HIV. The drug offers an alternative to daily pills such as Gilead’s Truvada and its follow-on Descovy.”
  • Investing.com relates,
    • “Aetna, a CVS Health company (NYSE: NYSE:CVS), has introduced a new health plan option called SimplePay Health, aimed at self-insured customers to potentially lower health care costs, enhance health outcomes, and streamline the health care experience. This plan offers a unique payment approach and tools for selecting high-quality health care providers.
    • “SimplePay Health, which is part of Aetna’s expanding portfolio, is designed to offer price certainty and simplicity for members. It features a copay-only structure with no deductibles or coinsurance, providing members with clear cost information for services prior to visits or treatments. The copay encompasses all aspects of a service, such as hospital visits or specialty services like labs.
    • “The plan claims to have resulted in a 60 percent increase in the use of top-quality providers and a 12 percent reduction in total care costs for employers and members. Members are equipped with an app to find providers based on cost and outcome quality, and they receive a single monthly statement summarizing all medical and pharmacy claims, similar to a credit card statement but with no interest and no payment due at the time of service.
    • “Aetna asserts that SimplePay Health enhances the overall health care experience by offering transparent cost insights and quality information to aid members in making informed decisions. Additionally, the plan includes a 0% interest rate line of credit benefit for paying balances, which is integrated into the medical plan.”

Tuesday Tidbits

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • MedPage Today tells us,
    • “A majority of House members urged House leaders to not only reverse a proposed 2.8% cut in the Medicare Physician Fee Schedule (MPFS), but also to pass a law that would avoid such cuts in the future.
    • “Increased instability in the healthcare sector due to looming cost hikes impacts the ability of physicians and clinicians to provide the highest quality of care and threatens patient access to affordable healthcare,” read a bipartisan letter signed by 233 House members and spearheaded by Reps. Mariannette Miller-Meeks, MD (R-Iowa) and Jimmy Panetta (D-Calif.). “In lieu of these harmful cuts, which, absent federal legislation, will take effect on January 1, 2025, Congress must pass a bill providing physicians and other clinicians with a payment update that takes into account the cost of actually delivering care to patients.” The letter, which was dated October 11 and made public on Tuesday, was sent to House Speaker Mike Johnson (R-La.) and House Minority Leader Hakeem Jeffries (D-N.Y.).”
  • KFF issued a report on trends in Medicaid outpatient prescription drug spending. Medicaid drug spending is a bellwether because federal law requires that Medicaid receives best pricing from drug manufacturers.
  • The Wall Street Journal offers advice on navigating the Medicare open enrollment period which began today.

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Baxter International started to import IV fluids last week from two of its international manufacturing facilities to address supply shortages in the U.S. 
    • “In coordination with HHS, the FDA and the Administration for Strategic Preparedness and Response, Baxter said it has activated seven plants globally to increase inventory. Recent FDA authorization permits the temporary importation from five Baxter facilities located in Canada, China, Ireland and the U.K., covering 19 IV solution and dialysis production codes. 
    • “The company is also ramping up production and utilizing air and other transportation methods to expedite delivery, according to an Oct. 14 update from the company.”
  • The Washington Post offers more details on “10 million pounds of meat recalled over listeria concern. BrucePac, which produces precooked meat and poultry items, is recalling some products from retailers including Walmart, Target, Aldi, Trader Joe’s and Kroger.”
  • STAT New shares eleven expert opinions “on why gains in cardiovascular disease are stalling and what we can do about it.”
    • “[T]he consensus of the experts interviewed — including Pinney — is that heart disease is far higher than it should be given the tools we have. This is compounded by a disconnect that has formed in the public’s mind between threat and perception. This year, an American Heart Association survey revealed that just over half of Americans are unaware that heart disease remains the leading cause of death, outstripping cancer. 
    • “Nor are most people aware of the vulnerability of particular groups.  “People don’t know that cardiovascular disease is actually the leading cause of mortality in pregnant or postpartum women,” said Janet Wei, assistant medical director of the Biomedical Imaging Research Institute at Cedars-Sinai Medical Center in Los Angeles.
    • “If current trends continue, the heart association estimates, by 2050 at least 6 in 10 U.S. adults will live and die with cardiovascular disease of some type, reflecting an older population burdened by high blood pressure and obesity, despite what we know about those conditions predicting disease.”
  • The Washington Post reports on “digital twinning” of human body organs.
    • “Doctors can create a “digital twin” of your heart and other organs to reduce guesswork during surgery. The technology may transform health care.
    • “Digital twinning has come of age in medicine during the last several years, moving into models for lungs, livers, brains, joints, eyes, blood vessels and other body parts. A virtual twin of an entire human being is somewhere in the future. The technology is also being used to test new medical devices and even drugs, with computer models powerful enough to predict a new molecule’s impact on organs and cells. It holds the potential to scale back, or even replace, the use of animals in experiments and humans in clinical trials.
    • “The technology “is revolutionary,” said Ellen Kuhl, a Stanford University professor of engineering, who is modeling the way a heart translates electrical impulses into physical pumping. “If you do this right, the models you create generalize to a wide population.”
  • Per NIH press releases,
    • “Alzheimer’s disease may damage the brain in two distinct phases, based on new research funded by the National Institutes of Health (NIH) using sophisticated brain mapping tools. According to researchers who discovered this new view, the first, early phase happens slowly and silently — before people experience memory problems — harming just a few vulnerable cell types. In contrast, the second, late phase causes damage that is more widely destructive and coincides with the appearance of symptoms and the rapid accumulation of plaques, tangles, and other Alzheimer’s hallmarks.
    • “One of the challenges to diagnosing and treating Alzheimer’s is that much of the damage to the brain happens well before symptoms occur. The ability to detect these early changes means that, for the first time, we can see what is happening to a person’s brain during the earliest periods of the disease,” said Richard J. Hodes, M.D., director, NIH National Institute on Aging. “The results fundamentally alter scientists’ understanding of how Alzheimer’s harms the brain and will guide the development of new treatments for this devastating disorder.”
  • and
  • NIH also shares “Research in Context: Can we slow aging?”
  • KFF released an issue brief about “Teens, Drugs, and Overdose: Contrasting Pre-Pandemic and Current Trends.”
    • “This issue brief analyzes CDC WONDER data – including provisional data from 2023 – and data from national surveys of adolescent youth to highlight trends in substance use and overdose deaths. It explores how and where teenagers receive substance use information and treatment and how school settings can be leveraged to enhance prevention measures. Lastly, it examines federal and state prevention efforts and social media’s role in the drug crisis.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “UnitedHealth Group lowered the top end of its adjusted profit guidance for 2024 on Tuesday as the healthcare giant continues to deal with the fallout from a cyberattack on subsidiary Change Healthcare.
    • “The company decreased its adjusted net earnings outlook to $27.50 to $27.75 per share for this year, compared with its previous $27.50 to $28 range. The updated guidance includes $0.75 per share in impacts from the cyberattack on technology firm and claims professor Change, about a $0.10 per share increase from UnitedHealth’s estimate last quarter. 
    • “But the insurer still beat investor expectations on revenue and earnings per share in the third quarter, driven by expansion in people served in UnitedHealthcare and its health services unit Optum.”
  • and
    • “CVS Health is discontinuing certain infusion services offered through its Coram business and also plans to close or sell 29 pharmacies in the coming months, a spokesperson confirmed to Healthcare Dive.
    • “The retail giant stopped accepting new patients for its antibiotics, inotropic medications, total parenteral nutrition and acute home infusion therapies programs last week. Coram will continue to provide infusion services for specialty medications and enteral nutrition. 
    • “CVS Health may conduct layoffs as part of the reduction in services. Impacted employees would be notified in mid-November and terminated in the new year, according to the spokesperson. Any workforce reductions are separate from CVS Health’s announcement last month that it would lay off 2,900 employees.”
  • and
    • “Continuing its belt-tightening, Walgreens will close about 1,200 storesover the next three years, starting with about 500 in the current fiscal year, which just commenced.
    • “That’s more than half the number of stores the drugstore retailer acquired from Rite Aid seven years ago, after they called off their planned merger.
    • “Retail operations were a drag on results: Q4 retail sales fell 3.5% year over year, with comps down 1.7%, while full-year retail sales fell 4.6%, with comps down 3.4%, per an earnings presentation. Beauty, seasonal and general merchandise siphoned about 150 basis points from Q4 comps, and elevated shrink levels offset positive impacts on retail adjusted gross margin from category mix and private labels.”
  • Per BioPharma Dive,
    • “Sales of Johnson & Johnson’s cancer therapy Carvykti and immune disease drug Tremfya grew strongly during the third quarter, the pharmaceutical company reported Tuesday, as new approvals helped broaden the two medicines’ market reach.
    • “The growth from Carvykti and Tremfya comes as J&J prepares for biosimilar competition to its second best-selling drug, Stelara, in January 2025. Biosimilars have already arrived in Europe and, alongside larger-than-expected insurer rebates, drove Stelara’s third quarter sales down 7% compared to last year.
    • “While analysts viewed the performance of J&J’s medical device division as underwhelming, J&J was still confident enough in its outlook to raise operational sales guidance for the full year slightly.”
  • Beckers Hospital CFO Report offers 22 statistics on inpatient length of stay.
    • “The average length of stay at hospitals across the U.S. is dropping slightly, while observation days have big declines year over year, according to Kaufman Hall’s National Hospital Flash Report. 
    • “The report includes data from 1,300 hospitals in August, which are tracked monthly for operational and financial trends. The length of stay dropped one to two percentage points on average for most hospitals, regardless of region and size. There was a wider variation in the observation days as a percentage of patient days, as patients are leaving the hospital quicker this year compared to last year.
    • “This development indicates less severe patient acuity and efficient care transition pathways,” the report authors noted.”

Monday Roundup

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

From Washington, DC

  • BioPharma Dive lets us know,
    • “The Food and Drug Administration has temporarily deflected a lawsuit alleging it violated federal law by removing Eli Lilly’s obesity and diabetes drugs Zepbound and Mounjaro from an agency shortage list. But in the process, the regulator agreed to evaluate objections from the companies selling compounded copycats of Lilly’s fast-selling medicines.
    • “A ruling issued Friday in the U.S. District Court for the Northern District of Texas permits the makers of compounded versions of tirzepatide, the active ingredient in Zepbound and Mounjaro, to temporarily keep selling their medicines. In the meantime, the FDA and a group of compounders, led by a trade group called the Outsourcing Facilities Association, will continue negotiations. They will file a status report on Nov. 21, according to court documents.
    • “The decision is the latest twist in a saga over the supply of so-called GLP-1 medicines like Zepbound, Mounjaro and Novo Nordisk’s Wegovy, which can help people quickly lose weight. Demand for the medicines has been so strong it’s outstripped supply, leading to manufacturing shortages that have made it possible for direct-to-consumer companies to step in and offer compounded alternatives.”
  • The National Academies of Science tells us,
    • “Most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences, the 2015 National Academies report Improving Diagnosis in Health Care found. Diagnostic errors are a contributing factor in approximately 10 percent of patient deaths.
    • “A recent workshop hosted by the National Academies explored some of the potential benefits and risks involved in using artificial intelligence and other digital tools to improve medical diagnoses.
    • “Daniel Yang, vice president of AI and emerging technologies at Kaiser Permanente and chair of the workshop planning committee, noted that his current role and his prior work in philanthropy have given him a front-row seat to witness “both the incredible opportunity and the perils of applying new technology to diagnosis.”
  • Kevin Moss writing in Federal News Network advises federal and postal employees and annuitants to “Choose wisely: Not all healthcare premiums are increasing.” Mr. Moss notes “Health plan premiums will rise by an average of 13.5% next year, marking the largest increase in recent memory.” The 13.5% increase is overstated because it assumes no enrollment changes occur in Open Season.
    • For 2025, 20% of the enrollment is moving to the PSHB Program which has somewhat lower premiums. It also should be understood that FEHB premiums have been increasing because OPM required FEHB carriers to cover GLP-1 drugs for obesity in January 2023 without any advance notice. At that point, FEHB plans could not raise their premiums for almost 12 months.
    • This expensive decision came on top of healthcare cost inflation which has afflicted the economy since 2022. While OPM did allow carriers to offer Part D EGWPs for 2024, relatively large cadres opted out which lowered the new savings. Fortunately, the number of opt outs should decrease for 2025 due to the attractive, expanded Part D 2025 benefit package.
  • Bloomberg reports,
    • “Blue Cross Blue Shield agreed Monday to pay $2.8 billion to resolve antitrust claims alleging hospitals, physician groups, and other healthcare providers were shortchanged on reimbursements.
    • “The payment is the largest in a healthcare antitrust case, the healthcare providers say in their motion for preliminary approval. In addition to the funds, the settlement provides for reforms to Blue Cross’s BlueCard program, which is the company’s system of electronic claims processing for providers throughout the US and abroad. * * *
    • “Blue Cross said in a statement Monday that “we deny the allegations made in the lawsuit. However, to reach a settlement and put years of litigation behind us, we have agreed to make some operational changes and a monetary payment to the provider class involved in the case.”
    • “The case is In Re Blue Cross Blue Shield Antitrust Litigation , N.D. Ala., No. 2:13-cv-20000, motion for preliminary approval 10/14/24.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Children and teenagers infected with the coronavirus are significantly more likely to develop Type 2 diabetes than their peers afflicted with other respiratory illnesses, according to research published Monday.
    • “As the public heads into another viral season, health experts said the findings highlight how the virus continues to reveal new ways to pose detrimental long-term consequences.
    • “Children were 50 percent more likely to be diagnosed with diabetes at the six-month mark if they had endured a coronavirus infection compared with children who had another respiratory infection, according to findings published in JAMA Network Open.
    • “The subset of patients in the study who were obese were 100 percent more likely to have a Type 2 diabetes diagnosis compared with their peers beset with other respiratory infections.”
  • STAT News informs us,
    • “When the U.S. health care system pivoted to meet Covid-19 in 2020, routine health visits and screenings where many cancer cases would have been caught didn’t happen. It wasn’t ideal, but many health experts thought that as the country opened back up, screenings would help “catch up” to these missed cases. A new paper published Monday in JAMA Network Open suggests that didn’t happen as quickly as experts had hoped.
    • “Instead, the new analysis suggests that cancer diagnoses recovered to pre-pandemic levels by the end of 2021 — but didn’t make up for any of the lost cases from earlier in the pandemic. That leaves a troubling mystery for epidemiologists, as it means experts still don’t know what happened with the roughly 130,000 cancer cases that were missed in 2020.
    • “It’s still an unwritten story as to what exactly is going on,” said Uriel Kim, a population health scientist at Case Western Reserve University and the lead author on the study.”
  • Per Beckers Hospital Review,
    • Effective Sept. 10, the FDA required healthcare facilities providing breast imaging services to notify patients of their breast density in mammography reports. Now, some experts are expressing concern over the new mandate, according to an Oct. 12 report from NBC News. 
    • The majority of concerns stem from the lack of guidance over how to proceed once a patient has been identified as having dense breasts, particularly recommendations on additional imaging procedures. 
    • “You cannot counsel an entire population of women with dense breasts with one policy that’s going to be appropriate for everybody,” Mark Pearlman, MD, emeritus professor at Ann Arbor-based University of Michigan Medical School, told NBC News.
  • The American Medical Association lets us know what doctors wish their patients knew about ADHD in children.
  • Per Healio,
    • “Researchers observed an increase in heart rate and atrial tachycardias as alcohol consumption increased in young adults.
    • “Some participants experienced notable arrhythmia episodes including atrial fibrillation.”
  • MedPage Today notes,
    • “More than $100 million could be saved annually on discarded lecanemab (Leqembi), a simulation study suggested.
    • “Current vial sizes may result in 5.8% of the Alzheimer’s disease drug being thrown away, representing $1,619 in wasted Medicare spending per patient per year, reported researchers led by John Mafi, MD, MPH, of the David Geffen School of Medicine at UCLA.
    • “This translates to an estimated $133 million to $336 million worth of lecanemab discarded every year, assuming uptake rates of 1.1% to 2.9%, Mafi and co-authors said in a JAMA Internal Medicine research letter.”
  • Consumer Reports, writing in the Washington Post, advises year-round use of sunscreen products by adults.
    • “You’ve probably heard that the sun does most of its dirty work on our skin when we’re children. Even though that myth was debunked decades ago, the idea persists. That may be why only 57 percent of people 55 and older use sunscreen when they’re in the sun, according to a March CR nationally representative survey of 2,000 U.S. adults. And 14 percent of older adults don’t take any steps to protect their skin from the sun.
    • “That’s a mistake. “Sun damage is cumulative,” says Henry Lim, a dermatologist at Henry Ford Health in Detroit. “If you continue to expose your skin to the sun’s ultraviolet rays, the damage will continue — no matter what age you are.”
    • “Taking action now can help protect your skin from further harm and possibly even reverse some damage. The first step: finding an effective sunscreen, one you don’t mind wearing every day.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Hospitals across the United States are reeling from a shortage of IV fluids after Hurricane Helene struck a major manufacturing plant in North Carolina, prompting some to postpone elective surgeries and others to conserve supply by restricting use.
    • “The Food and Drug Administration formally declared a shortage for three fluid products Friday, allowing some hospitals and facilities to manufacture their own supply. The FDA last week had allowed shipments of IV fluids from other countries. But complications make it difficult to immediately end the shortage.
    • “Compounding facilities that typically don’t manufacture IV fluids need access to sterile water and supplies such as bags to make their own products. The American Hospital Association estimates less than a fifth of hospitals are able to do so.
    • “If you turn off a hospital supply of IV fluids, it’s like turning off the water supply to your house,” Chris DeRienzo, the hospital association’s chief physician executive, said. “We need to have a continuous, consistent flow to the hospitals, especially as we are walking into the winter respiratory virus season.”
  • The American Hospital Association News adds,
    • “As part of its regular updates on the IV solution supply disruption as a result of the temporary closure of a manufacturing plant in North Carolina, Baxter Oct. 14 launched a new webpage with resources that hospitals can use for product management and conservation strategies. The webpage contains resources from Baxter, the federal government and other groups. In addition, Baxter said shipments to the U.S. from two Baxter sites abroad that were already able to export products “started last week and more are on the way.” The AHA is continuing efforts on multiple fronts to provide updates and assist members related to the supply chain issues caused by damage from Hurricane Helene.
  • Beckers Payer Issues ranks payers by average Medicare Stars scores.
  • WTW explains why the annual enrollment period / open season is a perfect opportunity to build a more resilient workforce.
  • STAT News tells us,
    • “Biotech investors have been buzzing around new areas of drug development this year, such as the red-hot obesity market. But there’s one field that has seen an even more significant amount of activity: autoimmune diseases.
    • “Companies that are developing new medicines for autoimmune conditions, as well as other immune system disorders, have brought in more money and closed more deals so far this year than most other areas, including the cardiometabolic field, data from investment bank Oppenheimer show. (Oncology remains king when it comes to investment, driven in part by interest in new approaches like radiopharmaceuticals).
    • “In the first half of 2024, venture capitalists pledged more than $1.7 billion to companies developing treatments for conditions in which the body’s own immune system goes haywire, attacking healthy cells and tissues and causing widespread damage. If the trend continues, autoimmune companies could raise double the amount of money that they raised at the height of the biotech market in 2021, according to data compiled by HSBC.
    • “Ask investors why, and most will point to research that’s come out of a German academic laboratory in the last two years, showing that a treatment called CAR-T can potentially reset the immune system in patients with lupus and other conditions.  
    • “That was revolutionary in the field, because … it was unexpected data that no one had ever seen,” said Arjun Goyal, managing director at Vida Ventures. Others described it as an earthquake that shook people to attention. One executive told STAT that his wife, a rheumatologist specializing in lupus, commented that the research could put her out of work.”
  • Per MedTech Dive,
    • “Danish drugmaker Lundbeck has agreed to spend $2.6 billion acquiring a young biotechnology company with an experimental brain medicine that could become a blockbuster product.
    • “The acquisition, announced Monday, has Lundbeck paying $60 in cash for each outstanding share of Longboard Pharmaceuticals, a 54% premium to the biotech’s stock price Friday. The companies expect their deal to close before the end of the year.
    • “Should it go through, the deal would hand Lundbeck a possible treatment for a series of rare brain disorders characterized by seizures and developmental delays. There are more than 20 types of these disorders, known as developmental and epileptic encephalopathies, or DEEs. And according to Lundbeck, they affect around 220,000 people in the U.S., half of whom don’t have an approved therapy to try.
    • “Lundbeck thinks the answer to that problem lies in a Longboard drug called bexicaserin. The drug entered late-stage clinical testing last monthfor one of the more prominent DEEs, Dravet syndrome, and is also being evaluated against another, Lennox-Gastaut syndrome. But Lundbeck believes it has the ability to address all DEEs and estimates the peak annual sales potential could reach $1.5 billion to $2 billion.”

Weekend Update

David Ermer–Congress, Mental health care, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The Senate and the House of Representatives remain on a State / District work break until the lame duck session begins on November 12.
  • Govexec tells us,
    • “For the second time in as many weeks, the Office of Personnel Management has announced that it will establish a temporary leave-sharing program to help employees who need time off from work to recover following Hurricane Milton’s landfall in Florida Wednesday.
    • “After a brief dalliance with Category 5 winds, Milton struck as a Category 3 storm near Tampa, creating tornadoes and other storm damage as it crossed the state before entering the Atlantic Ocean, killing at least 18 Americans as of Friday.
    • “In a memo to agency heads Thursday, Acting OPM Director Rob Shriver announced that, as the agency did in connection with Hurricane Helene, which inundated several states across the southeast last month, OPM will establish an emergency leave transfer program for federal workers in Florida. Such programs allow federal employees to donate unused paid leave so that colleagues who need to take time off to recover from a natural disaster can do so without dipping into their own paid or unpaid leave.”
  • Per an NIH press release,
    • “Throughout the week of October 13–19, the U.S. Department of Health and Human Services’ Office on Women’s Health (OWH) will be raising awareness about high blood pressure, also known as hypertension, to improve women’s health outcomes. Information provided during National Women’s Blood Pressure Awareness Week (NWBPAW) aims to help women understand and manage their heart health with suggested strategies and highlighted resources that can help prevent or control high blood pressure.  
    • “This year’s NWBPAW theme, “Empower Every Era: Blood Pressure Control Across the Lifespan,” emphasizes the importance of monitoring and controlling blood pressure across every stage of life, from young adulthood through menopause and beyond. The theme also focuses on heart health disparities, particularly for women in underserved and underrepresented communities.” 

From the public health and medical research front,

  • Fierce Healthcare alerts us,
    • “In the last 30 years, HIV rates have gone down, in large part because of the game-changing prescription drug pre-exposure prophylaxis (PrEP), which reduces the risk of contracting HIV through sex by 99%. Since the FDA approved the drug in 2012, more people have started to use it, and HIV rates have steadily decreased. But not everyone is seeing the same results.
    • “From 2019 to 2022, 94% of white people who could benefit from PrEP were prescribed it, while only 13% of Black and 24% of Latino people were. HIV— which has claimed an estimated 42.3 million lives to date and remains a global public health issue—continues to have a disproportionate impact on people of color, men who have sex with men, and trans women. The lifetime risk of acquiring HIV is still 1 in 3 for Black gay and bisexual men, according to data from the Centers for Disease Control and Prevention (CDC).
    • “Ending the HIV epidemic hinges on both treatment and prevention, particularly through access to PrEP. For at-risk individuals living in the U.S. South—where HIV is a daunting reality—PrEP use is very low compared to the number of new HIV cases.
    • “The South had 53% of new HIV diagnoses in 2022 but represented only 39% of PrEP users in 2023. Regionally, Black people made up 48% of new HIV diagnoses in 2022, but only 22% of PrEP users in 2023. While PrEP is more accessible in metropolitan areas, educational barriers, healthcare costs and anti-LGBTQ+ stigma still hinder access, particularly in rural areas and the Bible Belt.”
  • Fortune Well adds,
    • “Men are more open about depression and anxiety than even a decade ago—in part thanks to celebrities who have been open about their own mental-health struggles, including Prince Harry, singer-songwriter Noah Kahan, Dwayne “the Rock” Johnson, Michael Phelps, and Ryan Reynolds, to name just a few. “We all have mental health in the same way that we all have physical health,” Harry, co-founder of the Heads Together campaign to end mental health stigma in the UK, once said. “It’s OK to have depression, it’s OK to have anxiety, it’s OK to have adjustment disorder.”
    • “Still, the stigma persists—especially for men: In the U.S., only 40% of men with a reported mental illness received mental health care services in the past year, as compared to 52% of women with a reported mental illness, according to 2022 statistics from the National Institute of Mental Health. Yet men are nearly four times more likely to die by suicide than women, according to the American Foundation for Suicide Prevention.
    • “There is a drastic need for men to address their mental health, but that stigma of ‘It’s going to make me weak’ is holding them back” licensed mental health counselor Ryan Kopyar, author of the book Big Boys Do Cry, tells Fortune.
    • The article explains “Kopyar and other mental health experts suggest that slight shifts in perspective could do a world of good when it comes to allowing men to feel more open to receiving support, whether through therapy or just a good friend.”
  • Healio offers an interview between Susan Weiner, MS, RDN, CDN, CDCES, FADCES, and Judy Simon, MS, RDN, CD, CHES, FAND, about “how women seeking to conceive, whether naturally or with assisted reproduction, can optimize nutrition to boost fertility.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • Some 80 percent of U.S. emergency rooms are not fully prepared to handle children’s emergencies, a recent analysis suggests.
    • Writing in Health Affairs, a national group of researchers says the quality of care for kids in U.S. emergency rooms is “highly variable,” but that achieving high readiness nationwide is “highly cost-effective.” * * *
    • “Increasing pediatric readiness would reduce mortality, increase life expectancy and improve pediatric patients’ lives, the researchers write, cutting ED and hospital mortality by 33.47 deaths per 100,000 children.
    • “Achieving and maintaining high pediatric readiness for all EDs in the US could save the lives of thousands of children each year, at an annual cost of approximately $260 million,” the researchers conclude. It would be more cost-effective than other interventions such as routine hepatitis A vaccination, hepatoblastoma screening for children with extremely low birth weight and other programs, the researchers note, calling a nationwide investment in pediatric ER readiness “robustly cost-effective.”
  • Fortune Well lets us know,
    • The nonprofit Physicians Committee for Responsible Medicine teamed up with business intelligence firm Morning Consult to survey more than 2,200 U.S. adults about weight-loss methods. Results of the poll, conducted in September, were released Oct. 8.
    • People were asked to rate their level of agreement with this statement: “If I wanted to lose weight, I would rather take an injectable weight-loss drug, rather than make a diet change.” More than half (62%) disagreed, with 14% reporting the statement didn’t apply to them because they don’t need to lose weight. Nearly three-fourths (73%) of applicable respondents disagreed.
    • Among people who were interested in weight loss, these groups most strongly disagreed:
      • Men: 75%
      • Baby boomers: 78%
      • Asian or “other”: 77%
      • Postgraduate-degree holders: 79%
      • Household income exceeds $100K: 78%
      • Urban dwellers: 75%
      • Northeasterners: 77%
      • Registered voters: 73%
      • Independent voters: 74%
    • “The new findings do not mean that Americans do not want to lose weight,” PCRM president Dr. Neal Barnard said in a news release about the survey. “Rather, most would prefer to change their eating habits than inject a medication.”
  • The Hill informs us,
    • “Microsoft unveiled several new artificial intelligence (AI) tools on Thursday aiming to support health care organizations through medical imaging models, health care agent services and an AI-driven workflow solution for nurses.
    • “The announcement detailed how each tool will improve workflow for busy health care professionals.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop tells us,
    • “Members of Congress are pressing federal agencies and telecommunications companies for more information about a reported Chinese government-backed hacking campaign that breached the networks of at least three major U.S. telecoms.
    • “Earlier this month, the Wall Street Journal reported that a hacking group tied to Beijing successfully broke into the networks of Verizon, AT&T and Lumen Technologies. The hackers reportedly went undetected for months, possibly gaining access to systems and infrastructure used to process court-authorized wiretaps.
    • ‘On Thursday, Republican and Democratic leaders on the House Energy and Commerce Committee wrote to the three telecommunication firms asking for more information on their response, calling the incident “extremely alarming for both economic and national security reasons.” * * *
    • “The members requested a briefing with the telecoms to learn more about when they became aware of the compromise, findings from any internal investigations and subsequent engagement with law enforcement, their plans to notify affected customers and what if any corrective steps have been taken to harden cybersecurity in the wake of the incident.
    • “The House Homeland Security Committee has also requested a briefing on the hack from the Cybersecurity and Infrastructure Security Agency, according to a committee aide.”
  • Federal News Network lets us know,
    • “The Defense Department released the final rule for the long-awaited Cybersecurity Maturity Model Certification program today [October 11], further paving the way for CMMC requirements to show up in contracts starting next year.
    • “The final CMMC program rule was released for public inspection today. It’s expected to officially publish in the Federal Register on Tuesday, Oct. 15.
    • “The rule establishes the mechanisms for the CMMC program. The goal of CMMC is to verify whether defense contractors are following cybersecurity requirements for protecting critical defense information. Many contractors will be required to receive a third-party audit under the program, a significant departure from the current regime of relying on self-attestation.”
  • Per an October 3, 2024, HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a $240,000 civil monetary penalty against Providence Medical Institute in Southern California, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, following a ransomware attack breach report investigation by OCR. Ransomware and hacking are the primary cyber-threats in health care. There has been a 264% increase in large breaches reported to OCR involving ransomware attacks since 2018.
    • “Failures to fully implement all of the HIPAA Security Rule requirements leaves HIPAA covered entities and business associates vulnerable to cyberattacks at the expense of the privacy and security of patients’ health information,” said OCR Director Melanie Fontes Rainer. “The health care sector needs to get serious about cybersecurity and complying with HIPAA. OCR will continue to stand up for patient privacy and work to ensure the security of health information of every person. On behalf of OCR, I urge all health care entities to always stay alert and take every precaution and steps to keep their systems safe from cyberattacks.” * * *
    • “The Notice of Final Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/pmi-nfd/index.html“
  • Fedscoop notes,
    • “The Department of Health and Human Services is working on a new strategic plan for the use of artificial intelligence across the entire breadth of its mission, the department’s top AI official said Tuesday.
    • “Micky Tripathi — HHS’s acting chief AI officer and its assistant secretary for technology policy — said at the NVIDIA AI Summit in Washington, D.C., that the AI strategic plan should arrive sometime in January and that it will span “the entire, you know, sort of breadth of what the department covers.”
    • “During a panel discussion, Tripathi detailed the complex web of mission sets spanning “the value chain of life sciences and health care” that HHS oversees that the new strategic plan will attempt to wrap its arms around. Those include medical research and discovery, preclinical work, measuring the safety and effectiveness of medical products, health care delivery, health technology standards setting, human services, public health and more, he said.”

From the cybersecurity vulnerabilities and breaches front,

  • Beckers Health IT informs us,
    • “In the past 12 months, 92% of healthcare organizations reported experiencing at least one cyberattack, up from 88% in 2023, an Oct. 8 survey from Proofpoint and Ponemon Institute found.
    • “Of those cyberattacks, 69% reported disruptions to patient care as a direct consequence.”
  • The American Hospital Association News reports,
    • “The FBI, along with the National Security Agency, Cyber National Mission Force and United Kingdom’s National Cyber Security Centre, today released a joint agency advisory on cyber operations by the Russian Federation’s Foreign Intelligence Service (SVR), also known as APT29, Midnight Blizzard, Cozy Bear, and the Dukes, targeting U.S. and global entities. The agencies recommend prioritizing rapid patch deployment and keeping software up to date to protect against cyberattacks.
    • “This alert highlights the SVR’s aggressive targeting of U.S. critical infrastructure for espionage and possible future offensive cyber operations,’ said John Riggi, AHA national advisor for cybersecurity and risk. “Although health care is not cited as being intentionally targeted by this SVR campaign, it is noted that any entity could become a target of opportunity if it has internet-facing vulnerabilities. The SVR takes advantage of opportunistic tactics to host malicious infrastructure, conduct follow-on operations from compromised accounts, or attempt to pivot to other networks on unprotected victim infrastructure. To mitigate this threat and other types of cyberattacks, such as ransomware attacks, it is imperative that health care entities prioritize patching internet-facing vulnerabilities, employ multi-factor authentication and follow the voluntary cybersecurity performance goals.”
  • HHS’s Health Section Cybersecurity Coordination Center issued its September report on vulnerabilities of interest to the health sector.
  • Cyberscoop points out,
    • “The number of malicious packages found in the open-source ecosystem has dramatically grown in the past year, according to a new report from Sonatype.
    • “The cybersecurity firm found that the number of malicious packages intentionally uploaded into open-source repositories has jumped by more than 150% compared to last year. Open-source software, a transparent development process where almost anyone can contribute to the code and components, is the bedrock of the digital age that can be found in most modern digital technologies.
    • “Sonatype, a firm that specializes in the open-source supply chain, looked at more than 7 million open-source projects and found that more than 500,000 contained a malicious package.
    • “Vulnerabilities in open-source packages and the developers who maintain them have become a hot topic following a spree of high-profile bugs and cyberattacks in recent years. Earlier this year, the maintainer of the data-compression tool XZ Utils was the focus of a yearslong campaign by hackers with the aim of inserting a vulnerability that would have been found in Linux servers throughout the world.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) alerted us on October 10,
    • CISA has observed cyber threat actors leveraging unencrypted persistent cookies managed by the F5 BIG-IP Local Traffic Manager (LTM) module to enumerate other non-internet facing devices on the network. F5 BIG-IP is a suite of hardware and software solutions designed to manage and secure network traffic. A malicious cyber actor could leverage the information gathered from unencrypted persistence cookies to infer or identify additional network resources and potentially exploit vulnerabilities found in other devices present on the network.
    • CISA urges organizations to encrypt persistent cookies employed in F5 BIG-IP devices and review the following article for details on how to configure the BIG-IP LTM system to encrypt HTTP cookies. Additionally, F5 has developed an iHealth heuristic to detect and alert customers when cookie persistence profiles do not have encryption enabled. BIG-IP iHealth is a diagnostic tool that “evaluates the logs, command output, and configuration of a BIG-IP system against a database of known issues, common mistakes, and published F5 best practices” to help users verify the optimal operation of their BIG-IP systems.
  • CISA added six more known exploited vulnerabilities to its catalog this week.
  • Cybersecurity Dive adds,
    • “Ivanti released updates for three actively exploited zero-day vulnerabilities in Ivanti Cloud Service Appliance, which hackers are chaining together with a previously disclosed path traversal vulnerability, the company said in a Tuesday blog post. 
    • “Successful exploitation of the flaws can allow an attacker to gain administrative privileges to bypass restrictions, obtain remote code execution or run arbitrary SQL statements. The vulnerabilities are listed as CVE-2024-9379, CVE-2024-9380, CVE-2024-9381. 
    • “Ivanti previously disclosed and issued a patch that would address the prior critical vulnerability, listed as CVE-2024-8963, on Sept. 10. The company said it discovered the path traversal vulnerability when it was investigating exploitation of an OS command injection vulnerability, listed as CVE-2024-8190.”

From the ransomware front,

  • Tech Radar reports,
    • “The number of active ransomware groups over the last 12 months is on the rise as criminals look for more ways to target businesses, new research has claimed.
    • “The 2024 State of Threat Report from Secureworks has revealed a rise in the number of active ransomware groups over the last 12 months – identifying a 30% rise in the number of active groups.
    • “The figures represents a diversification of the landscape rather than a particularly drastic increase in criminals. Since the notorious Lockbit disruption, in which the most prolific group was briefly shut down, the ransomware ecosystem has evolved, with 31 new groups being established.” * * *
    • “One of the key findings from the report is that unpatched vulnerabilities remain the top Initial Access Vector (IAV) in ransomware attacks, making up almost 50% of all IAVs. This outlines more than ever the importance of staying on top of cybersecurity and software updates.”
  • Per Security Affairs,
    • “Sophos researchers warn that ransomware operators are exploiting the critical vulnerability CVE-2024-40711 in Veeam Backup & Replication to create rogue accounts and deploy malware.
    • “In early September 2024, Veeam released security updates to address multiple vulnerabilities impacting its products, the company fixed 18 high and critical severity flaws in Veeam Backup & Replication, Service Provider Console, and One.
    • “The most severe flaw included in the September 2024 security bulletin is a critical, remote code execution (RCE) vulnerability tracked as CVE-2024-40711 (CVSS v3.1 score: 9.8) impacting Veeam Backup & Replication (VBR).”
  • Palo Alto Networks Unit 24 tells us,
    • “In July 2024, researchers from Palo Alto Networks discovered a successor to INC ransomware named Lynx. Since its emergence, the group behind this ransomware has actively targeted organizations in various sectors such as retail, real estate, architecture, and financial and environmental services in the U.S. and UK.
    • “Lynx ransomware shares a significant portion of its source code with INC ransomware. INC ransomware initially surfaced in August 2023 and had variants compatible with both Windows and Linux. While we haven’t confirmed any Linux samples yet for Lynx ransomware, we have noted Windows samples. This ransomware operates using a ransomware-as-a-service (RaaS) model.”

From the cybersecurity defenses front,

  • American Hospital Association cybersecurity expert John Riggi offers his perspective on this year’s cybersecurity challenges in the healthcare sector.
  • “Moffitt Cancer Center was one of many health systems impacted by the Change Healthcare ransomware attack earlier this year. The organization’s VP of RCM operations [Lynn Ansley] explains [in Health Leaders] how she navigated the disaster.”
  • Here is a link to Dark Reading’s CISO Corner.
  • HHS’s 405(d) program shares an endpoints security poster with the public.