Weekend update

David Ermer

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

Weekend update

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
  • Congress is on a District/State work break this week.
  • Govexec tells us,
    • “Newly elected Rep. James Walkinshaw, D-Va., this week formally took over for his predecessor, the late Rep. Gerry Connolly, in leading advocacy for an array of bills aimed at improving the pay and civil service protections of federal workers.” * * *
    • “The House on Tuesday granted Walkinshaw’s unanimous consent request to become lead sponsor for four bills that Connolly had previously introduced, all relating to federal personnel policy.”
  • Plan Sponsor lets us know,
    • “The Senate confirmed Daniel Aronowitz as assistant secretary of labor for the Employee Benefits Security Administration on Thursday.
    • “EBSA is responsible for enforcement of the Employee Retirement Income Security Act and related laws and regulations, along with protecting employer-based retirement, health and welfare benefits for workers and retirees.
    • “During his June 5 confirmation hearing, the former president of Encore Fiduciary pledged to streamline retirement plan oversight and end the ‘war’ on employee stock ownership plans, also known as ESOPs.”
  • OPM typically announces the next year’s FEHB / PSHB government contributions in the second half of September. OPM shares this information with Congress before making the announcement which suggests that the announcement will be made next week when Congress returns to Capitol Hill.
  • Nextgov/FCW points out,
    • “The Office of Personnel Management is rolling out ChatGPT to its employees this week, its director told employees Tuesday. 
    • “This is part of our broader effort to equip you with AI tools that help you work faster, think bigger, and collaborate better,” the agency’s director, Scott Kupor, told staff in an email shared with Nextgov/FCW by the agency. 
    • “Employees already can access Microsoft 365 Copilot chat, the email says, but now they’ll have access to OpenAI’s ChatGPT-5, too. 
    • “AI is a great assistant, but you’re still the expert. I know some of you are excited, some are curious, and some are wary. In the coming weeks, [the Office of the Chief Information Officer] will host brown bag sessions to help clarify and ensure you get the most out of these tools,” the email reads. “Let’s lead the way in using AI thoughtfully and effectively — starting now.”

From the ACIP recommendations front,

  • The Pharmacy Times article offers more details about the Covid vaccination decisions made at the ACIP meetings last week. 
    • “The Advisory Committee on Immunization Practices (ACIP) has voted 12-0 to recommend COVID-19 vaccines be administered based on individual-based decision-making, also known as shared clinical decision making, for adults aged 65 and older, rather than a universal recommendation. 
    • “They voted to recommend the same language for individuals aged 6 months through 64 years, with an emphasis that risk-benefit for vaccination is most favorable for individuals at increased risk and lowest for individuals not at increased risk.1
    • “Another vote on the belief that state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccine failed 6-6, with the chair, Martin Kulldorff, PhD, breaking a tie to ensure the vote’s failure.
  • The Covid vaccine is not the first time that ACIP recommended shared decision making. The ACIP website includes an FAQ on shared decision making. A pharmacist is a healthcare provider for purposes of shared decision making. 
  • From a maintaining the status quo standpoint, it’s very important that ACIP rejected a recommendation to require a prescription for Covid vaccines. 
  • The New York Times reports yesterday,
    • Before the C.D.C. panel voted, CVS and Walgreens, the nation’s two largest pharmacy chains, were requiring prescriptions in some states because of laws forbidding pharmacists to administer vaccines in the absence of a recommendation from the panel.
    • But if the head of the C.D.C. adopts the panel’s recommendations, CVS will start providing the shots without prescriptions nationwide, including to people outside the F.D.A.-approved groups, according to a CVS spokeswoman, Amy Thibault.
    • Walgreens did not immediately confirm what it would do.
  • ACIP’s website explains
    • “The Advisory Committee on Immunization Practices (ACIP) develops recommendations on how to use vaccines to control disease in the United States.
    • “These recommendations become official CDC policy once adopted by CDC’s Director.
    • “This page provides resources related to ACIP recommendations and lists recommendations from ACIP meetings that are pending publication in CDC’s Morbidity and Mortality Weekly Report (MMWR).”
  • An HHS news release on Friday states,
    • “I commend the committee for bringing overdue scientific debate on vaccination to the American people,” said Deputy Secretary of Health and Human Services and CDC Acting Director Jim O’Neill. A recommendation from ACIP becomes part of the CDC immunization schedule if it is adopted by the CDC director.”
  • The CDC director typically adopts ACIP recommendations promptly. The FEHBlog will keep an eye out.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The FDA, under President Trump’s directive, is cracking down on direct-to-consumer pharmaceutical ads.
    • “The FDA sent letters to drugmakers citing issues with ads that potentially violate drug-marketing laws.
    • “The FDA is scrutinizing ads that it says overhype drug effectiveness, not just those omitting side effects, marking a shift in enforcement.”
  • The Washington Post informs us,
    • “The Trump administration is expected to unveil new efforts on Monday exploring how one medication may be linked to autism and another one can treat it, according to four people with knowledge of the plans who spoke on the condition of anonymity because the announcement was not yet public.
    • “Federal health officials are expected to raise concerns about pregnant women’s use of acetaminophen, the active ingredient in Tylenol and one of the most widely used medications globally. Officials have been reviewing previous research — including an August review by Mount Sinai and Harvard researchers — that suggests a possible link between Tylenol use early on in pregnancy and an increased risk of autism in children. They plan to warn pregnant women against using Tylenol early on unless they have a fever, according to the four individuals.
    • “In addition, officials plan to tout a lesser-known drug called leucovorin as a potential autism treatment. Leucovorin is typically prescribed to counteract some medications’ side effects and to treat vitamin B9 deficiency. Early double-blind, placebo-controlled trials administering leucovorin to children with autism have shown what some scientists describe as remarkable improvements in their ability to speak and understand others. Officials at the Food and Drug Administration have recently been reviewing new language that could apply to the drug.”

From the public health front,

  • Per Medscape,
    • “Use of GLP-1 receptor agonists (GLP-1s) was associated with a reduction in fragility fractures among older women with type 2 diabetes (T2D) in a retrospective analysis of data from a global health network. The results suggest that GLP-1 therapy could contribute to bone health.”
  • Medscape also identifies benefits and risks to watch out for when older adults take GLP-1 drugs.
    • “In adults over 65, GLP-1 use has both potential benefits and risks for age-related health. Physicians should stay alert, monitor closely, and address side effects proactively.’
  • NPR notes,
    • “Doctors who perform skin cancer surgeries often recommend nicotinamide — which is a form of Vitamin B3 — to their patients. It’s been shown to protect cells from UV radiation damage.
    • “Now, a new study of nearly 34,000 veterans, finds this over-the-counter supplement is linked to a reduction in non-melanoma skin cancers among people who’ve already had skin cancer. The research was published in JAMA Dermatology.
    • “The biggest reduction was seen among people who began taking the supplement after being diagnosed with their first skin cancer. Researchers found those who took 500 mg of nicotinamide, also known as niacinamide, twice daily, for at least one month, had a 54% reduced risk of developing another skin cancer, compared to patients who did not take the supplement.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • The Wall Street Journal reports,
    • “The collapse on Friday [September 19] of an emergency federal funding bill leaves the fate of cybersecurity legislation that provides legal protection for companies sharing cyber-threat intelligence up in the air.
    • Without a reprieve of the expiring cyber legislation that had been included in the funding bill, companies face uncertainty on how to communicate about cyber threats as competing reauthorization bills work through a divided House and Senate.
    • “Both the private sector and the government need certainty, including the ability to allocate resources for long-term cybersecurity planning and implementation,” said Matthew Eggers, vice president of cybersecurity policy at the U.S. Chamber of Commerce. 
    • The 2015 Cybersecurity Information Sharing Act, or CISA, is set to expire at the end of September. Friday’s scuttled emergency funding measure, which applied to a number of federal programs and sought to avert a government shutdown, would have given lawmakers more time [until November 21] to iron out critical differences between House and Senate versions of CISA renewal bills. * * *
    • “A notable difference in the House bill is the forward-thinking inclusion of artificial intelligence in the renewal,” said Justine Phillips, a partner and co-chair of the data and cyber practice group at law firm Baker McKenzie. Despite these updates, she said, “the House bill is the functional equivalent of extending the act as is, because it leaves the legal liability protections intact.”
    • “The cyber bill’s renewal by the Senate may prove more problematic, cybersecurity experts say.”
  • Cyberscoop informs us,
    • “Federal agencies are increasingly incorporating artificial intelligence into the cyber defenses of government networks, and there’s more still to come, acting Federal Chief Information Security Officer Michael Duffy said Thursday.
    • “We’re at an exciting time in the federal government to see that we’re not only putting AI in production, but we’re finding ways to accelerate emerging technology across the government, across all missions and all angles,” Duffy said at FedTalks, produced by Scoop News Group. In his “role overseeing federal cybersecurity policy,” he said, he is “able to see these at the ground level, as agencies bring excitement and enthusiasm and hope for what they can optimize through artificial intelligence.”
    • “Cyber attackers are moving faster than ever, and on a much larger scale than before, he said. They’re also using technology in new ways. But it’s not all “doom and gloom” when it comes to the cybersecurity of federal networks, especially because of feds’ move toward AI, Duffy said.
    • “I’m pleased to say that the advancements that we’ve made over the past decade in the federal government have brought us to this point: Agencies are poised now, postured, positioned, to take advantage of new capabilities, bring them into federal agencies and make them work for the mission,” he said.”
  • In related news, Cybersecurity Dive tells us,
    • “The National Institute of Standards and Technology on Thursday [September 18] published guidance describing how implementation of post-quantum cryptography (PQC) both supports and relies on the safeguards in the agency’s major cybersecurity publications.
    • “The draft NIST document, derived from the output of the agency’s PQC migration project, is designed to illustrate the connections between the tools required for adopting quantum-resistant encryption and the security practices that NIST recommends in its Cybersecurity Framework and other guidance.
    • “The capabilities demonstrated in the project support several security objectives and controls identified” in other NIST guidance documents, the agency said in its new publication. “At the same time, responsible implementation of the demonstrated capabilities is dependent on adherence to several security objectives and controls identified in these risk framework documents.”
    • “Collecting information about which technologies use cryptography supports the Cybersecurity Framework practices of creating hardware and software inventories, the document notes. Similarly, analyzing cryptographic weaknesses supports the CSF practice of identifying vulnerabilities in technology assets.”
  • A September 19, 2025, NIST news release adds,
    • “To help organizations protect their data against possible future attacks from quantum computers, the National Institute of Standards and Technology (NIST) has released a publication offering guidelines for implementing a class of post-quantum cryptography (PQC) algorithms known as key-encapsulation mechanisms, or KEMs.
    • “A KEM is a set of algorithms that can be used by two parties to securely establish a shared secret key over a public channel — a sort of first handshake between parties that want to exchange confidential information. Recent examples of KEMs include ML-KEM and HQC.
    • The new publication, Recommendations for Key-Encapsulation Mechanisms (NIST Special Publication 800-227), describes the basic definitions, properties and applications of KEMs and provides recommendations for implementing and using KEMs securely.
  • Cyberscoop reports,
    • “Two teenagers were arrested in the United Kingdom this week, accused of associating with the sprawling criminal collective known as The Com, and participating in many high-profile and damaging cyberattacks on critical infrastructure globally.
    • “Thalha Jubair, 19 of London, and Owen Flowers, 18 of Walsall, England, were arrested at their residences Tuesday and charged with crimes related to the cyberattack on the Transport for London in September 2024, the U.K.’s National Crime Agency said.
    • “Jubair and Flowers were allegedly highly involved in many other cyberattacks attributed to Scattered Spider, a nebulous offshoot of The Com that commits ransomware and data extortion. The Com is composed of thousands of members, splintered into three primary subsets of interconnected networks that commit swatting, extortion and sextortion of minors, violent crime and various other cybercrimes, according to the FBI.
    • “The Justice Department on Thursday unsealed charges against Jubair, a U.K. national, accusing him of participating in at least 120 cyberattacks as part of Scattered Spider’s sweeping extortion scheme from May 2022 to September 2025, including 47 U.S.-based organizations. Victims of those attacks paid at least $115 million in ransom payments, authorities said.”

From the cybersecurity vulnerabilities and breaches front,

  • While CISA did not add any known exploited vulnerabilities to its catalog this week, SC Media lets us know,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) on Sept. 18 issued a malware analysis report on two sets of malicious code from an organization compromised by threat actors exploiting two bugs in the Ivanti Endpoint Manager Mobile (EPMM) tool.
    • “CISA said the malware exploited two CVEs – CVE-2025-4427 and CVE-2025-4428. After exploitation, the malware let the threat actors inject and run arbitrary code on the compromised server.
    • “Lawrence Pingree, technical evangelist at Dispersive Holdings, said malware that’s instrumented to target specific vulnerabilities in centralized endpoint management solutions like these Ivanti tools is incredibly important to defend against.
    • “Isolating and microsegmenting sensitive systems like this is essential. Patching rapidly, ideally with an automated process, is essential in defending against vulnerabilities,” said Pingree.”
  • Per Dark Reading,
    • “Security vendor SonicWall suffered a data breach that exposed customer firewall configuration file backups.
    • “On Sept. 17, SonicWall, a vendor best known for its network security appliances, published a knowledge base article disclosing what it described as a “cloud backup file incident.” The company said its security teams recently detected “suspicious activity targeting the cloud backup service for firewalls” and confirmed it to be a security event in the past few days.
    • “Unidentified threat actors accessed backup firewall preference files stored in the cloud representing “fewer than 5% of our firewall install base,” according to SonicWall. Attackers were able to access encrypted credentials as well as firewall configuration files “that could make it easier for attackers to potentially exploit the related firewall.”
    • “We are not presently aware of these files being leaked online by threat actors,” SonicWall said in its disclosure. “This was not a ransomware or similar event for SonicWall, rather this was a series of brute force attacks aimed at gaining access to the preference files stored in backup for potential further use by threat actors.”
  • Per Cyberscoop,
    • “Researchers warned that a maximum-severity vulnerability affecting GoAnywhere MFT bears striking similarities with a widely exploited defect in the same file-transfer service two years ago.
    • “Fortra, the cybersecurity vendor behind the product, disclosed and released a patch for the vulnerability — CVE-2025-10035 — Thursday. The deserialization vulnerability “allows an actor with a validly forged license response signature to deserialize an arbitrary actor-controlled object, possibly leading to command injection,” the company said in a security advisory.
    • “File transfer services are a valuable target for attackers because they store a lot of sensitive data. If cybercriminals exploit these services, they can quickly access information from many users at once, making these services especially attractive for large-scale attacks. 
    • “Fortra didn’t provide any evidence of active exploitation and researchers from multiple security firms said they haven’t observed exploitation but expect that to change soon. “We believe that it’s just a matter of time and are monitoring the situation closely,” Ryan Dewhurst, head of proactive threat intelligence at watchTowr, said in an email.
    • “The vulnerability, which has a CVSS rating of 10, is “virtually identical to the description for CVE-2023-0669,” a zero-day vulnerability exploited by Clop, resulting in attacks on more than 100 organizations, and at least five other ransomware groups, Caitlin Condon, vice president of security research at VulnCheck, said in a blog post.”
  • and
    • “Apple’s latest operating systems for its most popular devices — iPhones, iPads and Macs — include patches for multiple vulnerabilities, but the company didn’t issue any warnings about active exploitation. 
    • “Apple patched 27 defects with the release of iOS 26 and iPadOS 26 and 77 vulnerabilities with the release of macOS 26, including some bugs that affected software across all three devices. Apple’s new operating systems, which are now numbered for the year of their release, were published Monday as the company prepares to ship new iPhones later this week.
    • “Users that don’t want to upgrade to the latest versions, which adopt a translucent design style Apple dubs “liquid glass,” can patch the most serious vulnerabilities by updating to iOS 18.7 and iPad 18.7 or macOS 15.7. Most Apple devices released in 2019 or earlier are not supported by the latest operating systems.
    • “None of the vulnerabilities Apple disclosed this week appear to be under active attack, Dustin Childs, head of threat awareness at Trend Micro’s Zero Day Initiative, told CyberScoop.”
  • Cybersecurity Dive points out,
    • “Most companies worry their networks aren’t safe against cyberattacks powered by artificial intelligence.
    • “Only 31% of IT leaders are at least somewhat confident that they can defend their organizations against AI-powered attacks, according to a Lenovo report published on Thursday.
    • “The report delves into why IT and security leaders are worried about hackers’ use of AI — and why they see their companies’ own use of AI systems as vulnerable.”
  • and
    • “The number of healthcare organizations that have lost more than $200,000 to cyberattacks has quadrupled this year compared with the same period in 2024, data security firm Netwrix said in a report published Thursday [September 19].
    • “Nearly half of all healthcare organizations (48%) experienced at least one intrusion between March 2024 and March 2025, the report found.
    • “Healthcare organizations experienced more cyberattack-related losses of at least $500,000 than critical infrastructure firms did, on average: 12% of healthcare organizations, compared with 6% of all organizations.”

From the ransomware front,

  • Infosecurity Magazine reports,
    • “Fifteen well-known ransomware groups, including Scattered Spider, ShinyHunters and Lapsus$, have announced that they are shutting down their operations.
    • “The collective announcement was posted on Breachforums, where the groups claimed they had achieved their goals of exposing weaknesses in digital infrastructure rather than profiting through extortion.
    • “In their statement, the gangs said they would now shift to “silence,” with some members planning to retire on the money they had accumulated, while others would continue studying and improving the systems people rely on daily.” * * *
    • “Organizations should take these announcements with a pinch of salt,” Nivedita Murthy, senior staff consultant at Black Duck, said.
    • “It could be possible that some of these groups may have decided to step back and enjoy their payday, [but] it does not stop copycat groups from rising up and taking their place.”
  • IT Pro discusses the “top ransomware trends for businesses in 2025. A splintering of top groups and changing attitudes toward payments are changing attacker tactics at speed.”
  • Morphisec calls attention to “The Top Exploited Vulnerabilities Leading to Ransomware in 2025 — and How to Stay Ahead.” 

From the cybersecurity defenses front,

  • The American Hospital Association News reports,
    • “Microsoft Sept. 16 announced it had disrupted a growing phishing service that had targeted at least 20 U.S. health care organizations. The company said it used a court order granted by the U.S. District Court for the Southern District of New York to seize 338 websites associated with RaccoonO365, a cyber threat group known for stealing Microsoft 365 credentials through phishing tactics. RaccoonO365 offers subscription-based phishing kits that allow individuals to steal Microsoft credentials by mimicking official Microsoft communications. The company said the phishing kits use Microsoft branding to create fraudulent emails, attachments and websites. Since July 2024, the kits have stolen at least 5,000 Microsoft credentials from individuals in 94 countries. The group was recently observed offering a new artificial intelligence-powered service in an attempt to scale their operations.
    • “Credentials stolen through RaccoonO365 enabled ransomware attacks against hospitals, posing a direct threat to patient and community safety,” said John Riggi, AHA national advisor for cybersecurity and risk. “This operation also highlights a disturbing trend — cybercriminals’ increased use of ‘initial access brokers’ to steal credentials and AI to accelerate the effectiveness, sophistication and impact of cyberattacks. The need for continued and evolving social engineering training for staff is essential to defend against the latest deception tactics used by hackers.”
  • Cybersecurity Dive tells us,
    • “Preemptive cybersecurity solutions will account for about half of all IT security spending by the year 2030, a significant increase from its 5% share in 2024, Gartner said in a report published Thursday.
    • “Preemptive cybersecurity will effectively replace standard detection and response technologies as the preferred defense against malicious hacking, Gartner predicted.
    • “The technology uses artificial intelligence and machine learning to anticipate threats and then neutralize them before they can compromise their targets, according to researchers.”
  • Security Week reflects on the fifteen anniversary of the Zero Trust strategy.
    • “The implementation of zero trust is essential for cybersecurity: but after 15 years, we’re still not there. Implementation is like the curate’s egg: good in parts.
    • “Zero Trust turned fifteen years old on September 14, 2025. Its invention was announced with Forrester’s publication of John Kindervag’s paper, No More Chewy Centers: Introducing The Zero Trust Model of Information Security, on that date in 2010 (archived here).
    • “Zero trust recognizes that treating cybersecurity like an M&M (a hard crunchy shell impenetrable to hackers protecting a soft chewy center where staff can work freely and safely) simply doesn’t work. “Information security professionals must eliminate the soft chewy center by making security ubiquitous throughout the network, not just at the perimeter,” wrote Kindervag.
    • “This is the basis of zero trust (or ZT): abandon the old concept of a barrier between two separate networks (one untrusted: the internet; and one trusted: the enterprise). Instead, trust nothing and verify everything, regardless of source or destination. The concept is sound and rapidly gained approval, culminating in EO14028 mandating that federal agencies must move toward a zero trust architecture while private companies should do similar – but never defining how it could be achieved.
    • “There’s the rub. Zero trust is fundamentally a concept where implementation will depend on individual different corporate ecospheres.”
  • Dark Reading recommends “Transforming Cyber Frameworks to Take Control of Cyber-Risk.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NCQA, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democrats blocked Republicans’ stopgap measure that would keep the government funded until late November and insisted that major healthcare spending be added to the bill, raising the odds for a partial shutdown in less than two weeks.
    • “Friday’s vote in the Republican-controlled Senate was 44 in favor and 48 against, short of the 60 votes required. Sens. Rand Paul of Kentucky and Lisa Murkowski of Alaska were the only Republicans to vote against the measure, while Democratic Sen. John Fetterman voted in favor. Several Republicans were absent. 
    • “The GOP-led House narrowly passed the measure earlier in the day in a 217-212 vote largely along party lines.
    • “The failure of the bill in the Senate set the stage for a down-to-the-wire standoff, with both parties standing firm and saying the other one would take the blame for a fall shutdown. * * *
    • Democrats proposed an alternative that would fund the government through Oct. 31 and reverse hundreds of billions of dollars in cuts to Medicaid enacted under the Republican tax-and-spending legislation that Republicans have rebranded the “working families tax cut.” The Democratic alternative would permanently extend certain ACA subsidies that expire at the end of this year. * * *
    • Republicans rejected the Democratic proposal as unserious. It failed in its own vote with 47 in favor and 45 opposed, short of the 60-vote requirement. Republicans control the Senate 53-47.
    • “The Democrats want a ransom payment of more than $1 trillion to keep the government open for only four more weeks,” said Senate Majority Whip John Barrasso (R., Wyo.).
    • [Senator Lisa] Murkowski [(R. AK), who voted against both the Republican plan and the Democratic proposal, said she wants a continuing resolution that extends enhanced ACA subsidies for two years, in addition to addressing some fiscal year 2026 appropriations and funding for the public media.
    • “Both of these were messaging bills,” she said. “They both did what everybody predicted was going to happen, which was, they were going to go down.
  • STAT News reports good news from Atlanta,
    • “A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.
    • “The decision, if signed off on by federal health leaders, would preserve insurance coverage for the shots, and is similar to the Food and Drug Administration’s approvals of the updated vaccines earlier this year. The Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, emphasized that for people under 65, the benefits of vaccination are most clear for people with risk factors for severe Covid-19.
    • “This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services spokesperson said.”
  • and
    • “A key government advisory committee voted Friday to postpone a vote on whether to delay infants’ first hepatitis B vaccine — temporarily alleviating fears that a new recommendation on shot timing could reverse the significant progress made in controlling the disease’s spread in recent decades.
    • “The decision followed a lengthy deliberation on Thursday by the newly reconstituted Advisory Committee on Immunization Practice, which pressed scientists from the Centers for Disease Control and Prevention on the necessity of the birth dose, and brought into question the veracity of the data presented on the risks and benefits of the vaccine. But ultimately, members voted to push the vote.”
    • “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” Robert Malone, a member of the committee, said on Friday. All of the members of the committee, except its chair, Martin Kulldorff, voted to table the vote.”
  • Per a Congressional news release.
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement on the Advisory Committee on Immunization Practices (ACIP) postponing a vote to change the recommendation for the hepatitis B vaccine for newborns. If a recommendation for a vaccine is altered without a scientific basis, insurance companies may decide to no longer cover it for patients free of charge. Additionally, doctors will lack the necessary information to counsel families, so they make the best health care decisions for their children.
    • “At Wednesday’s hearing, Cassidy underscored the importance of families having access to the hepatitis B vaccine at birth.”
  • Here is an informative Blue Cross link to an article about No Surprises Act abusive practices by providers particularly in the arbitration / IDR process.  In my opinion, which supplements the Blue Cross recommendations, the NSA arbitration process would be more equitable if the Tri-Agencies added more substance from the AAA baseball / final offer rules to its IDR procedures. 
  • Beckers Payer Issues informs us,
    • “CMS has finalized a rule requiring Medicare Advantage plans to submit provider directory data for inclusion in the Medicare Plan Finder. 
    • “The change, aimed at improving transparency and beneficiary decision-making, takes effect January 1, 2026.
    • “Under the rule, MA plans must make provider directory information available to CMS in a standardized format for online publication, update the data within 30 days of becoming aware of changes, and attest at least once a year to the accuracy of the information.
    • “CMS said the move is designed to allow beneficiaries to more easily compare provider networks across plans without having to navigate multiple websites. The agency expects to publish an operational guide in the coming months with technical specifications for plans to follow, along with a testing period before the data appears publicly online.”
  • The American Hospital Association News explains that this CMS rule was part of a larger rulemaking.
    • “The Centers for Medicare & Medicaid Services Sept. 18 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2026. Yesterday’s final rule follows one released in April on other changes for MA and prescription drug programs. In the latest final rule, CMS finalized a requirement aimed at increasing beneficiary access to provider directory data in the CMS Medicare Plan Finder platform.”
  • The Government Accountability Office released a report titled “Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services.”
    • “About half of U.S. hospitals are in urban areas. More urban hospitals closed than opened from 2019 to 2023.
    • “All of the 5 hospitals in our review struggled financially before they closed, with inpatient volumes decreasing at 4 of them. The anticipated cost of upgrading or maintaining aging facilities also contributed to the closures of all 5 hospitals.
    • “After closure, 2 of the hospitals still provided outpatient services, while the other 3 stopped all services.
    • “Representatives from local hospitals, providers, and community organizations told us some community residents continued having trouble getting health care after all 5 hospitals closed.”
  • Last but not least, OPM Director Scott Kupor released his regular Friday blog post which concerns OPM’s mine in Boyers, PA, that holds paper personnel records.
    • “The Boyers mine is but one of many examples of opportunities for modernization across the federal government. None of these challenges are rocket science – maybe with the exception of our friends at NASA – but they have been plagued for too long by a system that doesn’t demand inventiveness and efficiency as first-class citizens in the government vernacular. OPM aims to create fluency in this new language – and we are starting with one retirement piece of paper at a time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.
    • “To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.
    • “The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
    • “Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.”
  • Per MedPage Today,
    • “The FDA approved the Altaviva implantable nerve stimulator for urge urinary incontinence (UUI), a common symptom of overactive bladder (OAB), Medtronic announced.
    • “Inserted near the ankle in a minimally invasive procedure, the device generates low-level electronic impulses that stimulate the tibial nerve to restore bladder-brain communication. The device is the third tibial neuromodulator for UUI, joining the eCOIN device approved in 2022opens in a new tab or window and the Revi System approved in 2023.
    • “The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” Kevin Benson, MD, of Sanford Health in Sioux Falls, South Dakota, said in a statement. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
    • “Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients. 
    • “Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.”
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).
    • “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments,” said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Barth syndrome primarily affects males, typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance. The quality of life and daily functioning of patients with Barth syndrome are significantly affected throughout their lives.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in adults 65 years and older. Hospitalization numbers are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is very low nationally.
  • The AHA News points out,
    • “The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a public awareness and education campaign; the launch of an online platform for physicians, researchers and health systems to share best practices and clinical insights; and an Agency for Healthcare Research and Quality report also released Sept. 18 that covers the sources of health coverage for adults with long COVID.” 
  • Fierce Pharma lets us know,
    • “The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. 
    • “The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
    • “Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
  • Per Health Day,
    • “Aspirin can cut by more than half the risk that colon cancer will come back following initial treatment, a new clinical trial has found.
    • “Daily aspirin reduced by 55% the risk of cancer recurrence in patients whose colorectal cancer is driven by a genetic mutation, researchers reported Sept. 17 in the New England Journal of Medicine.
    • “Aspirin is a drug that is readily available globally and extremely inexpensive compared to many modern cancer drugs, which is very positive,” lead researcher Anna Martling, a professor of molecular medicine and surgery at Karolinska Institute in Sweden, said in a news release.
    • “The study focused on people whose colon cancer was driven by a mutation of the PIK3 gene, which helps regulate cell growth and division in the human body.
    • “Every year, about 107,320 new cases of colon cancer and 46,950 cases of rectal cancer are diagnosed in the United States, according to the American Cancer Society.”
  • NBC News reports,
    • “Wildfire smoke is responsible for tens of thousands of deaths each year and will do more harm to U.S. residents by midcentury than any other threat driven by climate change, including extreme heat. 
    • “That’s the conclusion of a new research paper that provides some of the most extensive modeling of the growing health toll of wildfire smoke on public health in the U.S. 
    • “The study, which was published in the journal Nature on Thursday, found that each year, on average, wildfire smoke is causing more than 41,400 excess deaths, or more than would be normally expected without smoke given the demographics of the U.S. That figure is more than twice what was previously recognized in other studies. 
    • “By midcentury, the study’s authors expect that number to grow by an additional 26,500 to 30,000 deaths as human-caused climate change worsens and the risk of wildfires igniting increases. 
    • “Wildfire smoke is a much larger health risk than we might have understood previously,” said Marshall Burke, a professor of environmental social sciences at Stanford University and a study author.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are working directly with employers to improve cancer care and lower costs as demand — and employers’ healthcare expenses — surge.
    • “Providers are gearing up to treat more cancer patients, hoping to ease employers’ mounting frustration with steep premium increases, long appointment wait times and unnecessary treatment, health system and care navigation company executives said. Cutting out insurers through direct contracts could add transparency to employers’ healthcare costs and help standardize treatment strategies, they said.
    • “Employers and unions have no choice but to take a really hard look at solutions that are going to steer patients to high-quality and lower-cost care,” said Emily Kauff, executive director of Memorial Sloan Kettering Cancer Center’s MSK Direct. “Employers are in crisis — they need lower costs and better value in cancer care.”
  • Beckers Payer Issues adds,
    • “Patients who get primary care from older adult-focused, value-based care organizations are more likely to use these services regularly, according to a study published in NEJM Catalyst: Innovations in Care Delivery, a digital journal published by The New England Journal of Medicine. 
    • “The study, produced by Humana Healthcare Research and Suhas Gondi, MD, attending physician at Boston-based Massachusetts General Hospital, covered 3.2 million Medicare Advantage members and included six older adult-focused facilities, most full-risk practices, according to Humana Chief Medical Officer Kate Goodrich, MD. The team found value-based care — as opposed to physicians offering a greater volume of services — is linked to increased use of primary care services.
    • “The exciting thing about this paper is that it shows that in those higher or more mature types of practices that are focused on seniors, they’re getting more primary care, and they’re getting more consistent primary care,” Dr. Goodrich told Becker’s.
    • “This research builds from a 2024 study on how older adult-focused organizations can increase access to primary care, particularly among underserved populations.”
  • Per Modern Healthcare,
    • “UnitedHealth Group has named Sandeep Dadlani CEO of its Optum Insight technology arm, Dadlani announced in a social media post Thursday. 
    • “Dadlani previously served as UnitedHealth’s executive vice president and chief digital and technology officer. He succeeds Dhivya Suryadevara, who had served in that role and CEO of the Optum Financial healthcare banking division since May.
    • “In a LinkedIn post, Dadlani wrote that it was his first week as CEO of Optum Insight, which includes the Change Healthcare claims processing division.” 
  • and
    • “VillageMD is selling 32 Texas clinics to Harbor Health, an Austin-based primary and specialty clinic group that also offers health plans.
    • “The deal includes 10 clinics in Austin, 10 in San Antonio, six in El Paso and six in Dallas. More than 80 clinicians will join Harbor as part of the transaction, according to a Thursday news release. 
    • “Financial details were not disclosed.”
  • Beckers Payers Issues looks into why Blue Cross of Massachusetts consistently achieves a very high NCQA scorecard.

Thursday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NCQA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “Top Senate Republicans and Democrats reached a deal Thursday night to tee up two votes on Friday on the two parties’ competing approaches to averting a partial government shutdown when current agency funding expires at the end of the month.
    • “Under the agreement announced by Senate Majority Leader John Thune, R-S.D., and Minority Leader Charles E. Schumer, D-N.Y., assuming the House passes the GOP-drafted, seven-week continuing resolution, then the Senate would take up Democrats’ alternative proposal first. That would be subject to a 60-vote threshold for passage.
    • “If Democrats can’t get 60 votes for their bill — which they aren’t expecting — then the chamber would proceed to a vote on the House-passed CR, also with a 60-vote threshold. That vote is also not expected to succeed.”
    • “However, the idea is for the two sides to head home for the weekend armed with proof that they have to start talking to each other about a compromise that can get 60 votes and get to President Donald Trump’s desk in time to prevent a shutdown.
    • “Schumer had proposed the arrangement earlier in the day, with an eye toward getting the initial votes over with in time for senators to attend conservative activist Charlie Kirk’s funeral in Arizona on Sunday.”
  • Roll Call adds,
    • “Democratic and Republican congressional leaders were engaging in a game of shutdown chicken Thursday, the day before the House’s expected vote on a seven-week stopgap bill due Sept. 30 to prevent a lapse in federal agency funding.
    • “House GOP leaders were feeling good about their odds of getting the bill through their chamber Friday morning, although they still had a little work to do on their side shoring up concerns about added member security funds in the continuing resolution being too skimpy, at $30 million. 
    • “Optimistic, but not certain,” House Appropriations Chairman Tom Cole, R-Okla., responded Thursday when asked for his outlook on passage.”
  • Per Congressional news releases
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, highlighted the importance of delivering President Trump and Secretary Kennedy’s mission to restore radical transparency at the U.S. Centers for Disease Control and Prevention (CDC) to protect children’s health.
    • “This comes after the HELP Committee held a hearing with former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. To deliver on the President’s mission of radical transparency, the Committee is inviting U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and HHS officials to respond by speaking with Committee members.”
  • and
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement following the U.S. Senate passage of the SUPPORT for Patients and Communities Reauthorization Act, which bolsters prevention, treatment, and recovery services for Americans with substance use disorders and mental illness. Earlier this year, the U.S. House of Representatives passed the bill with strong bipartisan support. The SUPPORT Reauthorization Act now heads to President Trump’s desk for signature.
    • “The opioid and mental health crisis is tearing apart families,” said Dr. Cassidy. “The SUPPORT Act equips communities with vital tools to combat this scourge and save lives. I’m grateful to my colleagues for their work to pass this bill and look forward to it being signed into law.”
  • MedTech Dive tells us,
    • “A House of Representatives committee has advanced a bill that would give eligible breakthrough devices four years of Medicare coverage.
    • “The House Ways and Means Committee debated the bill Wednesday, revealing concerns about the risk of fraud, the type of evidence required and the weakening of the Centers for Medicare and Medicaid Services’ authority.
    • “Despite the concerns, the bill received bipartisan support and was passed in a 38 to 3 vote. Two medtech trade groups welcomed progress on a topic that they have lobbied about for years.”
  • Beckers Payer Issues notes,
    • “Senate and House [Democrat] lawmakers have introduced a bill that would bar health insurers from buying independently owned clinics and require existing conglomerates to divert their provider businesses.  
    • “The Patients Over Profits Act would:
      • “Prohibit insurance companies or their subsidiaries from owning Medicare Parts B and C providers 
      • “Require insurers and their subsidiaries who also own Parts B or C providers to divest, and if they do not, a civil lawsuit can be brought by the Federal Trade Commission, state attorneys general, HHS inspector general or the Justice Department’s antitrust division. 
      • “Bars the HHS secretary from contracting with a Medicare Advantage organization that also owns a Part B or C provider.” 
  • and
    • “Three Medicare Advantage plans scored a full five stars in this year’s health plan rankings from the National Committee for Quality Assurance.
      • Kaiser Foundation Health Plan in Southern California – HMO
      • Kaiser Foundation Health Plan in Northern California – HMO
      • Network Health in Wisconsin – PPO
    • “An additional 17 plans, including six more Kaiser Foundation Health Plans from around the country, scored 4.5 stars in 2025.”
  • The Wall Street Journal reports,
    • Health secretary Robert F. Kennedy Jr.’s handpicked slate of vaccine advisers voted [8-3] to no longer recommend a combined shot for measles, mumps, rubella and varicella [chickenpox (MMRV)] for children under age 4. 
    • The move came as some states, insurers, public health leaders and a U.S. senator called into question whether Americans should rely on the committee’s decisions.
  • The FEHBlog listened to a good chunk of today’s meeting, and the ACIP decision was based on a concern about children under age 4 suffering febrile seizures as a result of the MMRV shot.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) today announced it is moving to decertify a major organ procurement organization (OPO) after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. In one 2024 case, a mistake led a surgeon to decline a donated heart for a patient awaiting transplant surgery.
    • “CMS’s decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, is part of Secretary Robert F. Kennedy, Jr.’s reform initiative announced in July. At that time, an HHS investigation into another OPO found that at least 28 patients may not have been deceased at the time of organ preparation, 73 patients showed neurological signs incompatible with donation, and the Biden administration had closed its own investigation without action.”
  • OPM Director Scott Kupor added to his blog last Monday September 15 with a post titled “Sorry, Not Everyone Gets an A.” In a related news release, OPM explains Director Kupor’s latest blog post explains why an OPM final rule published September 15 “promotes excellence and accountability.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is putting a pause on plans to relocate some of its employees, but said “new efforts” to do so are underway.
    • “In February, OPM gave remote employees more than 50 miles away from the office an ultimatum: Agree to a “management-directed reassignment” (MDR) and relocate to office space in another geographic region, or face termination.
    • “OPM said it would cover relocation expenses for employees who accept reassignment and gave employees until March 7 to make their decision.
    • “But in a new memo, obtained by Federal News Network, the agency states “relocation efforts for OPM employees are on pause.”
    • “The memo said all employees should continue to work at their current duty station, and that “there is no longer an expectation that the first cohort of employees will be relocated to their new duty station by December 2025.”
    • “The memo suggests OPM is taking a fresh look at relocation plans under OPM Director Scott Kupor, who took office in July.“
  • Tammy Flanagan writing in Govexec, follows up on her article from last week about picking the best date for federal retirement in 2026.

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “The FDA gave premarket approval to the first medical device for the treatment of women with symptomatic moderate-to-severe intrauterine adhesions, known as Asherman syndrome, maker Womed announced on Tuesday.
    • “The resorbable adhesion barrier device (Womed Leaf) is intended for women undergoing hysteroscopic surgery for Asherman syndrome.
    • “Asherman syndrome is caused by scarring of the uterus after procedures such as dilation and curettage or fibroid removal and can occur in 20% to 45% of those procedures. The condition can cause female infertility, pelvic pain, and recurrent miscarriages. Current treatment options for intrauterine adhesions have high recurrence rates.” * * *
    • “Womed said the device will be available in the U.S. in early 2026.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 federal district court decision that also vacated the FDA’s 2024 final rule. The AHA previously urged the FDA to not apply the 2024 final rule to hospital and health system LDTs when it was proposed. 
    • “The AHA appreciates that FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care,” said Roslyne Schulman, AHA director of outpatient payment, emergency readiness and public health policy. “The return to enforcement discretion for LDTs rightly recognizes that applying the device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely. This action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government.”
    • “Today’s final rule will become effective following official publication in the Federal Register Sept. 19.”

From the public health and medical/Rx research front,

  • The Wall Street Journal relates,
    • “Novo Nordisk’s daily Wegovy pill led to similar weight loss as the weekly injection in a late-stage trial.
    • “The Wegovy pill, already under review, could be the first GLP-1 pill approved for weight loss.
    • “Trial results showed improved cardiovascular risk factors and increased daily activity for patients.
    • “Currently, less than 2% of individuals with obesity in the U.S. receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” Martin Holst Lange, chief scientific officer and head of research & development at Novo Nordisk, said.
    • “Pending FDA approval, ample supply will be available to meet the expected U.S. demand as we hope to set a new treatment benchmark for oral weight loss medications,” he added.”
  • and
    • “Lilly and Novo Nordisk haven’t disclosed specific pricing plans for their pills, but some analysts expect them to be priced at a discount to the injectables.
    • “The leading weekly injected medicines, Novo Nordisk’s Wegovy and Lilly’s Zepbound, have been highly effective at helping people lose significant weight. Zepbound’s highest dose has been shown to help people lose an average of more than 22% of their body weight after more than a year of treatment, while Wegovy can help people lose about 17%. 
    • “Yet their manufacturers have struggled to make enough to meet demand, partly because of limited manufacturing capacity for the complex task of making sterile injectable drugs packaged in an auto-injector device. Making pills is less complex, and there is more global capacity. And, pills don’t require cold-chain distribution and storage, while the injectables need to be kept refrigerated.” * * *
    • “Novo Nordisk may be constrained in how much of its new weight-loss pill it can manufacture because it must cram a lot of the main ingredient into each pill to ensure each person absorbs enough by ingestion, analysts have noted. That is because, like injected semaglutide, the pill is made up of peptides, which are larger than the small molecules that pills are traditionally made of.” * * *
    • Lilly took a different approach than Novo Nordisk. The main ingredient for its GLP-1 pill, orforglipron, is a small molecule, meaning the pills can be manufactured in a more traditional way.
  • Fierce Pharma adds,
    • “Over the last six years, three GLP-1 drugs have been approved for children aged 10 and older with type 2 diabetes. Now this rapidly growing patient population is a step closer to gaining access to Eli Lilly’s dual-action GLP-1/GIP treatment Mounjaro, as its effectiveness in controlling blood sugar has been demonstrated in a phase 3 trial of kids ages 10-17.
    • “The SURPASS-PEDS study—which enrolled 99 children with type 2 diabetes who do not get adequate blood sugar control with metformin, insulin or a combination of both—achieved its primary and secondary endpoints. After 30 weeks of treatment, Mounjaro provided improvements over placebo in the blood sugar measurement, A1C, and in patients’ body mass index (BMI).
    • “The study’s primary endpoint was accomplished, with Mounjaro-treated patients experiencing an average A1C reduction of 2.2% versus .05% for those on placebo from a mean baseline of 8.05%.
    • “Lilly said that it has submitted the results to regulators in a bid to gain an expanded indication for the juggernaut diabetes medication.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “Researchers led by a team at INSERM and King’s College London have shown how stretching the skin stimulates immune cells and increases the skin’s ability to absorb large molecules, including those present in vaccines.
    • “Using a device that applies suction pressure to stretch the skin, the researchers reported that skin stretching activated a local immune response and increased skin permeability without tissue damage via the opening of hair follicles. They also reported that applying vaccines topically while stretching the skin resulted in more effective immunization than subcutaneously injecting the vaccine in mice.”
    • “Just stretching the skin was more effective than delivering the same vaccine with a needle, which shows the practical relevance of this immune activation,” said Stuart Jones, PhD, at King’s College London. “This new pathway into the skin could be used in lots of different ways—we showed its potential for vaccine delivery, but we’re also starting to think about delivering cell therapies and whether it could be used for diagnostics.”
  • Per Healio,
    • “People with obesity and diabetes who undergo bariatric surgery face a significantly lower risk for several adverse health outcomes vs. those treated with GLP-1s, new data show.
    • “Surgery should not be reserved as a last resort; it should be part of early, shared decision-making for patients with type 2 diabetes and obesity,” Ali Aminian, MD, director of Cleveland Clinic’s Bariatric and Metabolic Institute, told Healio. “Evidence shows that surgery provides added, durable benefits beyond medications alone.”
  • Per MedPage Today,
    • “Oral bacteria and fungi may help reshape the pancreatic microbiome and promote carcinogenesis.
    • “Earlier research has connected periodontal disease and clinical candidiasis with greater pancreatic cancer risk.
    • “Altogether, the study identified a more than threefold increase in cancer risk for everyone standard deviation rise in a microbial risk score comprised of 27 bacteria and fungi.”
  • and
    • “One in 10 childhood blood cancers may result from medical imaging-associated radiation exposure.
    • “Cancer risk increased with cumulative radiation dose, ranging from 1.41 times higher to 3.59 times higher.
    • “Children exposed to at least 30 mGy had 25.6 excess blood cancers per 10,000 by age 21.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ascension wrapped its 2025 fiscal year with a $490.9 million operating loss (-1.9% operating income) but a $917.7 million net income, an improvement over the prior year it attributed to greater volumes, improved labor productivity and a tighter rein on non-labor spending.
    • “The major Catholic nonprofit is coming off of a $1.8 billion operating loss in fiscal 2024 and a $3 billion operating loss in fiscal 2023, though those dip to $1.4 billion and $1.5 billion, respectively, when removing impairment and nonrecurring losses. It’d also suffered a major cybersecurity incident at the end of fiscal 2024, the recovery from which leadership said spanned multiple quarters and included consistent volume recovery.
    • “We have been intentional in directing resources toward initiatives that generate measurable impact, from service line growth to process redesign, while also ensuring both stewardship and sustainability,” Saurabh Tripathi, executive vice president and chief financial officer, said in a statement. “This combination of operational discipline and strategic investment increases our flexibility to expand access, enhance services, and ensure the commitment to our mission.”
    • Ascension, which owns or has interests in about 120 hospitals and other healthcare facilities across 16 states, logged $25.3 billion of total operating revenue in fiscal 2025, a roughly $3.2 billion decline (-11.3%) largely reflecting the system’s recent divestments.”
  • The Wall Street Journal relates,
    • “Roche ROG Holding said it agreed to buy 89bio ETNB for up to $3.5 billion, seeking to bolster its drug pipeline by adding an experimental treatment for a liver disease linked to obesity.
    • “The Swiss drugmaker has been looking to enter the weight-loss drug field, a key target of its recent dealmaking activity. With Eli Lilly and Novo Nordisk ahead in the race due to approved drugs that are generating billions of dollars in sales, Roche is betting that a new generation of treatments and potential drug combinations for adjacent conditions can help it to carve out a future role in the market.
    • “The main asset in the pipeline of San Francisco-based 89bio is a drug candidate for a fatty liver disease known as MASH, or metabolic dysfunction-associated steatohepatitis, that is mostly due to obesity.
    • “We intend to be a leader in the cardiovascular space going forward, and being a player in the obesity space is important to make that happen,” Teresa Graham, chief executive of Roche Pharmaceuticals said in an interview.”
  • Per Modern Healthcare,
    • “Cigna aims to strengthen its grip on the specialty pharmacy market through a recent deal with Shields Health Solutions.
    • “The company’s Evernorth Health Services subsidiary, which includes the pharmacy benefit manager Express Scripts and the specialty pharmacy Accredo, announced a $3.5 billion investment into Shields Health Solutions on Sept. 2.
    • “The move shores up a slice of the specialty pharmacy market Cigna wanted to bolster, President and Chief Operating Officer Brian Evanko said during the Morgan Stanley Global Healthcare Conference Sept. 10.” * * *
    • “What caught a lot of people off guard by the [Cigna] transaction is it’s not intuitively the best fit with a retail-oriented PBM,” said Aryeh Sand, a partner at investment banking firm Solomon Partners. “Shields historically is more aligned with health systems.”
  • and
    • “Ten Wisconsin rural hospitals formed a clinically integrated network, following dozens of rural providers that have joined similar initiatives over the past two years. 
    • “The Wisconsin High Value Network looks to pool the expertise and scale of the independent rural hospitals, which have combined $880 million in net revenue, to improve care and lower costs. The Cibolo Health-backed network, announced Thursday, will give providers the data infrastructure and bargaining power to hone primary care services and expand alternative payment models, said David Hartberg, CEO of Vernon Health in Viroqua, Wisconsin, and board chair of the Wisconsin High Value Network.
    • “Cibolo, a rural hospital advisory firm, helped launch similar coalitions in North Dakota, Minnesota, Ohio, Montana and Nebraska. Cibolo will manage daily operations of the Wisconsin High Value Network.”
  • Per BioPharma Dive,
    • “Biogen is buying Alcyone Therapeutics after working with the company for more than two years on a better delivery system for neurological medicines built around antisense oligonucleotides.
    • “Under terms announced Thursday, Biogen will spend $85 million upfront to acquire the privately held company and promise additional payments to Alcyone investors if certain development and regulatory goals are reached. Biogen will gain all rights to ThecaFlex DRx, an implantable subcutaneous port and catheter device it’s been developing with Alcyone since 2023.
    • “The companies have two studies underway testing the system’s delivery of Biogen’s Spinraza drug for spinal muscular atrophy, Biogen said. Lowell, Massachusetts-based Alcyone has been developing ThecaFlex DRx since 2019 and manufactures the product locally.”
  • Per MedTech Dive,
    • “Siemens Healthineers and Stryker are partnering to develop a robotic system that can perform a range of elective and emergency neurovascular procedures, including treatment for strokes and aneurysms, the companies said Wednesday.
    • “The collaboration includes system design, access device and implant integration, imaging for robotic navigation and procedural workflow optimization. The project will combine Siemens Healthineers’ expertise in robotics and imaging with Stryker’s experience in neurovascular technologies.
    • “Carsten Bertram, head of advanced therapies at Siemens Healthineers, said the partnership will focus on creating an ecosystem of image guidance, robotics and devices to help physicians provide faster and more precise care to patients.”
  • Per Fierce Pharma,
    • “With both companies on an upward trajectory, argenx and its manufacturing partner Fujifilm Biotechnologies are taking a logical next step by expanding their collaboration.
    • “In addition to manufacturing drug substance for argenx’s autoimmune blockbuster Vyvgart at its facility in Hillerød, Denmark, Fujifilm will also make the product at its large-scale complex in Holly Springs, N.C. The CDMO will initiate production of Vyvgart at the plant in 2028.
    • “Fujifilm’s Holly Springs is slated to become operational this year and has already secured contracting work from several large drugmakers.” * * *
    • “Fujifilm began building the $2 billion Holly Springs campus in 2021, billing it then as the largest end-to-end biologics production plant in the world, with the expectation to employ roughly 725 at the facility.
    • “Then, in April of last year, Fujifilm upped its ante on the site, earmarking an additional $1.2 billion for its construction and increasing its expected headcount at the facility to 1,400 by 2031.” 

From the artificial intelligence front,

  • Beckers Payer Issues reports,
    • “Hawaii Medical Service Association and Blue Cross and Blue Shield of Kansas joined Blue Shield of California as co-founders of Stellarus, according to a Sept. 18 news release from the technology company. 
    • “Stellarus said it aims to help health plans of all sizes integrate AI and fresh technology to expedite prior authorization, reduce administrative costs and elevate member experience.
    • “Given Hawaii’s size and geographic position, we are better off if we enhance our ability to innovate and grow our technological capacities by investing in Stellarus with like-minded, mission-driven, not-for-profit health plans that are trying to accomplish the same things and solve the same problems,” said President and CEO of Hawaii Medical Service Association Mark Mugiishi, MD.” 
  • Beckers Hospital Review lets us know,
    • “Rochester, Minn.-based Mayo Clinic nurses and informatics teams have developed a [patent pending] in-house AI tool to help streamline clinical workflows.
    • “The tool, called the Nurse Virtual Assistant, integrates directly into Mayo’s EHR and provides a nurse-specific patient summary with links to resources including Lippincott guidelines, intravenous administration protocols and a clinical policy library, according to a Sept. 17 news release.
    • “Mayo Clinic said the tool is designed to reduce the time nurses spend navigating multiple systems, allowing them to focus more on patient care. It was tested and validated in a research study approved by Mayo’s institutional review board before being expanded to more than 9,600 nurses across inpatient and emergency department units.”
  • Per AHA News,
    • “The Joint Commission and the Coalition for Health AI released guidance Sept. 17 on the responsible use of artificial intelligence in health care, the first installment from their partnership that launched in June. The guidance includes recommendations on AI policies, local validation, monitoring and use for interpretation and integration into new or existing processes. CHAI and the Joint Commission plan to release further guidance and a playbook by year’s end.”

Midweek update

David Ermer–CDC, COVID-19 vaccine, FDA, HSA, Medical / Rx research, NCQA, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Roll Call lets us know,
    • “House Republican leaders overcame a key procedural hurdle Wednesday evening, paving the way for floor consideration of the short-term stopgap funding measure they will need to pass with GOP votes later this week due to near-uniform Democratic objections.
    • “The chamber adopted the rule for floor debate on the bill on a 216-210 party-line vote.” * * *
    • “If the GOP bill can get out of the House, [Senate Minority Leader Chuck] Schumer [(D NY)] did offer an exit strategy of sorts on Wednesday night, offering a chance to look at a future commitment to deal with the expiring exchange subsidies once the CR passes rather than insist on changes to the bill now before the Sept. 30 deadline.
    • “Well look, we have two weeks [until October 1, the beginning of the new federal fiscal year]. They should sit down and talk to us, and we maybe can get a good proposal,” Schumer said. “We’ll sit down and negotiate if they will sit down and negotiate. We don’t have a red line, but we know we have to help the American people.”
    • “Republican leaders argue the current income thresholds to qualify for the tax credits are too high, and GOP senators are discussing lowering those in any extension.”
  • The Wall Street Journal reports,
    • “The former director of the Centers for Disease Control and Prevention [Susan Monarez] said she was fired after refusing to compromise her scientific integrity, testifying that Robert F. Kennedy Jr. asked her to preapprove vaccine recommendations and remove career scientists.” * * *
    • “Republican senators largely defended Kennedy and sought to cast Monarez as either untrustworthy or disloyal. Some questioned her hiring of lawyers who have represented Hunter Biden and other officials targeted by Trump.” 
  • Here is a link to the Senate Health, Education, Labor and Pension Committee’s website on this hearing.
  • Roll Call tells us, “Senate Republicans took a final procedural step Wednesday to speed up consideration of President Donald Trump’s lower-level nominees, setting up the confirmation of dozens of appointees as early as this week.”
  • Modern Healthcare points out,
    • “The House passed the Lower Costs More Transparency Act of 2023 with a PBM provision in the last Congress. The Senate, however, only advanced PBM bills as far as committee consideration. At the end of 2024, a version of all those measures was added to a popular bipartisan package of healthcare legislation, in part because of the work of Rep. Buddy Carter (R-Ga.), a pharmacist who pushed the PBM provisions with House leaders. 
    • “The bill was on the verge of passing as part of the annual government funding bill when leaders pulled it from consideration because then-presidential adviser Elon Musk and President Donald Trump raised objections. PBM industry groups argued the provisions aimed at them were giveaways to drug companies, which they say are ultimately responsible for drug prices.
    • “In an interview [with Modern Healthcare], Carter said he expects PBM legislation to pass this year. 
  • The Plan Sponsor Council of America notes,
    • “The PSCA’s 2025 HSA Survey shows employees are increasing contributions to their health savings accounts, and more are investing those assets when given the opportunity, leading to an increase in average account balances for the third consecutive year.
    • “PSCA’s seventh annual HSA survey, sponsored by HSA Bank, was conducted in the summer of 2025 and reflects responses from nearly 600 employers with an HSA program. The survey tracks employee and employer HSA trends from 2024.
    • “The survey shows that 20 percent of participants now invest their HSA savings, up from 18 percent the prior year. Also, two-thirds of employers now offer investments, a 12 percent increase over a two-year period.”
  • Per MedTech Dive,
    • “The Food and Drug Administration posted two notices on Tuesday warning about unauthorized blood pressure and infant monitoring devices sold over the counter.
    • “Many devices for measuring blood pressure and monitoring infant vital signs are currently sold over the counter without FDA marketing authorization, the agency said. The FDA recommended looking for an authorized device.
    • “The regulator has sent warning letters in the past to companies for selling monitoring devices without authorization.” 
  • From Justice Department news releases,
    • “Today, the Antitrust Division of the Department of Justice announces its collaboration with the Federal Trade Commission (FTC) to identify over 125 anticompetitive regulations in response to the President’s Executive Order on Reducing Anti-Competitive Regulatory Barriers. Under the leadership of President Trump, the Antitrust Division, in close coordination with the FTC and federal agencies, conducted a comprehensive, government-wide effort to identify and reform anticompetitive regulations that distort markets and stifle competition.
    • “In America we believe in free markets, not central planning by government regulators or powerful monopolists,” said Assistant Attorney General Abigail Slater of the Justice Department’s Antitrust Division. “Lowering barriers to entry by removing anticompetitive regulations will free America’s innovators and entrepreneurs to do what they do best: drive America’s future success.”
  • and
    • “An indictment was unsealed Friday charging two Florida men for their roles in a scheme to submit approximately $34.8 million in false and fraudulent claims to Medicare for medically unnecessary products. As part of the scheme, the defendants and their co-conspirators targeted thousands of Medicare beneficiaries and, through deceptive telemarketing, persuaded them to accept medical equipment that they did not need, such as orthotic braces and continuous glucose monitors.” * * *
    • “According to court documents, Kenneth Charles Kessler III, 42, of Miami-Dade County, Florida, and Michael Andrew Gomez, 42, of Broward County, Florida, are charged in connection with their ownership and operation of seven durable medical equipment (DME) supply companies based in Florida. Kessler and Gomez are accused of paying illegal kickbacks and bribes to purported marketing companies that targeted thousands of Medicare beneficiaries with deceptive and aggressive telemarketing campaigns. The indictment alleges that these marketing companies obtained the beneficiaries’ personally identifiable information and arranged for purported telemedicine companies to generate doctors’ orders for unnecessary medical equipment. Kessler and Gomez allegedly used these doctors’ orders to submit false and fraudulent claims to Medicare through their network of DME companies.
    • “Kessler and Gomez are both charged with conspiracy to commit health care and wire fraud, two counts of health care fraud, conspiracy to defraud the United States and to offer and pay health care kickbacks, and two counts of offering and paying kickbacks in connection with a federal health care program. If convicted, Kessler and Gomez each face up to 65 years in prison. A federal judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.”

From the Covid vaccine front,

  • STAT News informs us,
    • “Amid growing concern about Americans’ access to vaccines, the country’s biggest health insurance association said its member plans will continue to cover all shots recommended by a federal advisory committee prior to any changes by its new slate of appointees.
    • “America’s Health Insurance Plans’ announcement comes just ahead of the first meeting of the Advisory Committee on Immunization Practices’ 12 members handpicked by Health and Human Services Secretary Robert F. Kennedy Jr. The selection of the five newest members was announced Monday, and their meeting is Thursday and Friday. Experts have speculated that, among other steps, the panel will drop the existing recommendation that newborns receive the hepatitis B vaccine, a move that could lead to a resurgence of the virus and, as a result, liver disease and cancer.” * * *
    • “AHIP said its plans will cover all vaccines recommended by ACIP as of Sept. 1, 2025, and that there would be no cost sharing for patients through the end of 2026. That includes updated Covid-19 and influenza vaccines. Health insurers are required to make vaccines free if they are recommended by ACIP and adopted by the Centers for Disease Control and Prevention, but AHIP’s pledge ensures coverage will continue even if the new members change the panel’s recommendations.” 
  • The Washington Post warns that ACIP could increase the age at which senior citizens can receive the Covid vaccine without cost sharing from 65 to 75.
    • “The people familiar with the deliberations cautioned that the situation is fluid and rapidly changing. The recommendations would also need to be approved by the acting director of the Centers for Disease Control and Prevention before taking effect, and it’s unclear how quickly that would happen.
    • “If a senior is concerned about losing access to a coronavirus vaccine, “they should absolutely try to get vaccinated as soon as possible,” said Caitlin Donovan, senior director at Patient Advocate Foundation. But even if more restrictive guidelines take effect, she noted most seniors have an underlying condition such as diabetes, heart issues or a history with smoking. * * *
    • “If you can’t find an appointment quickly, contact your primary care physician and discuss your options,” Donovan said. “They should be willing to write you a prescription after considering your risk levels.”
  • The New York Times adds,
    • “Four Democratic-controlled Western states on Wednesday issued their own recommendations on who should get three common seasonal vaccines, a sharp rejection of efforts by Health Secretary Robert F. Kennedy Jr. to upend vaccine policy at the federal level.
    • The so-called West Coast Health Alliance — which includes health officials in California, Oregon, Washington and Hawaii — recommended that every resident 6 months and older receive the flu vaccine this fall. They also recommended that broad swaths of the population receive a Covid-19 shot, including pregnant women and all children from 6 months to 2 years old, and that R.S.V. vaccines be given to infants under 8 months and adults over 75, as well as to others with certain risk factors.
    • “The detailed guidance generally mirrors clinical recommendations that have been made by the federal government and by national medical organizations such as the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Today in its weekly update, the Centers for Disease Control and Prevention (CDC) said there are 1,491 confirmed measles cases in the United States this year in 42 jurisdictions, an increase of 37 cases in the past week. 
    • “Eighty-six percent of cases have been linked to one of 38 reported outbreaks, and roughly 12% of all case-patients have required hospitalization. 
    • “Last year the country recorded only 285 measles cases, and 2025 has been the worst year for measles activity in the United States since the virus was officially declared to be eliminated in 2000.”
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) has launched an effort to advance research on whole-person health and create an integrated knowledge network of healthy physiological function. Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote health. For example, a multicomponent lifestyle intervention including healthy diet, physical activity and stress management may improve multiple and interconnected aspects of health including cardiovascular (e.g. blood pressure), metabolic (e.g. glucose metabolism) and musculoskeletal function (e.g. muscle strength).
    • “Biomedical research is largely organized around the study of specific organs and diseases. In contrast, we do much less research on health itself, which is an integrated process involving the whole person,” said Helene M. Langevin, M.D., director of NIH’s National Center for Complementary and Integrative Health, which leads the NIH-wide program.
    • “The five-year research initiative will proceed in several stages, drawing from existing scientific knowledge to develop a complete, working model of healthy human physiology. It will build on the NIH Human Reference Atlas and the Human BioMolecular Atlas Program (HuBMAP) to connect the complex anatomy and function of the body’s different organs and systems into a single “map.”
    • “Future stages of the project will link common clinical measures, such as blood pressure, blood glucose and cholesterol, to major physiological functions. This initiative will also populate the framework with existing human data and ultimately build and test an interactive model of whole-person health.
    • “By organizing healthy physiological function into a whole-body knowledge network, researchers will be able to explore scientific questions about health in a new way,” said Dr. Langevin. “With our ability to acquire new scientific data at an increasingly dizzying speed, the importance of integrating and connecting new data to what we already know is greater than ever. The Whole Person Reference Physiome will lay a foundation for understanding the factors that drive declines in health and mechanistic pathways to health restoration.”
  • and
    • “Research supported by the National Institutes of Health (NIH) shows that repeated head impacts from contact sports can cause early and lasting changes in the brains of young- to middle-aged athletes. The findings show that these changes may occur years before chronic traumatic encephalopathy (CTE) develops its hallmark disease features, which can now only be detected by examining brain tissue after death.
    • “This study underscores that many changes in the brain can occur after repetitive head impacts,” said Walter Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “These early brain changes might help diagnose and treat CTE earlier than is currently possible now.”
    • “Scientists at the Boston University CTE Center, the U.S. Department of Veterans Affairs Boston Healthcare System and collaborating institutions analyzed postmortem brain tissue from athletes under age 51. Most of them had played American football. The team examined brain tissue from these athletes, using cutting-edge tools that track gene activity and images in individual cells. Many of these tools were pioneered by the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. The researchers identified many additional changes in brains beyond the usual molecular signature known to scientists: buildup of a protein called tau in nerve cells next to small blood vessels deep in the brain’s folds.
    • “For example, the researchers found a striking 56% loss of a specific type of neurons in that particular brain area, which takes hard hits during impacts and also where the tau protein accumulates. This loss was evident even in athletes who had no tau buildup. It also tracked with the number of years of exposure to repetitive head impacts. The findings thus suggest that neuronal damage can occur much earlier than is visible by the currently known CTE disease marker tau. The team also observed that the brain’s immune cells, called microglia, became increasingly activated in proportion to the number of years the athletes had played contact sports.”
  • The American Journal of Managed Care informs us,
    • “Early-onset T2D is rising in the US, especially among underserved populations, with a worse cardiometabolic profile than later-onset cases.
    • “Financial hardships are more significant for younger adults, women, and minority groups with T2D, necessitating policies addressing medical and financial well-being.
    • NHANES data from 1999 to 2020 shows increased prevalence of early-onset T2D, highlighting the need for improved screening and diagnosis in younger adults.
    • ‘Study limitations include cross-sectional data, potential recall bias, and exclusion of institutionalized populations, affecting generalizability and causal inferences.’
  • Per Healio,
    • “Walking quickly for 15 minutes per day was associated with a significant reduction in all-cause mortality and CVD mortality, according to a cohort study published in American Journal of Preventive Medicine.
    • “Many studies have explored the health benefits provided by regular walking, including recent findings on the ideal step count and how walking can improve life expectancy for middle-aged adults.”
  • The Wall Street Journal reports,
    • “Eli Lilly’s diabetes pill, orforglipron, showed better blood sugar control than Novo Nordisk’s oral semaglutide in a Phase 3 trial.
    • “Orforglipron met primary and secondary goals across doses, with some participants reaching near-normal blood sugar levels.
    • “Lilly said the results, combined with the pill’s scalability, show its potential as a key Type 2 diabetes treatment.”
  • Per BioPharma Dive,
    • “Roivant and subsidiary company Priovant said Wednesday their inflammatory disease pill succeeded in a Phase 3 trial in the rare condition dermatomyositis, significantly reducing signs and symptoms of the disorder by more than placebo when used for one year.”
    • “Company executives said they plan to ask the Food and Drug Administration to approve the pill, called brepocitinib, in early 2026, based on trial results they called “the first ever positive registrational trial for a targeted therapy” in dermatomyositis.
    • “Brepocitinib is being developed by Priovant Therapeutics, which is part owned by Pfizer. The big drugmaker licensed the pill to Roivant in 2022 as part of a pipeline cull.”
  • and
    • AstraZeneca reported divergent outcomes from two late-stage studies on Wednesday. In one Phase 3 trial, a subcutaneous form of its marketed medicine Sophnelo helped lower signs of disease activity in people with the most common form of lupus. In the other, its drug Fasenra, used to treat asthma and a few other conditions, failed meaningfully lower the rate of moderate or severe chronic obstructive pulmonary disease attacks. The under-the-skin injection of Sophnelo is being reviewed by regulators. AstraZeneca will analyze the Fasenra data to “further understand the results,” the company said.
  • Per Fierce Pharma,
    • “SK Biopharmaceutical’s Xcopri (cenobamate) met the bar in a phase 3 trial that could support the company’s ambitions of building a blockbuster with an expansion into another seizures subtype.
    • “The South Korean pharma won FDA approval for Xcopri in 2019 as a treatment for partial-onset seizures, also known as focal seizures, in adults. Since then, with rapid global growth, SK has outlined blockbuster ambitions for the drug by 2029. 
    • “Now, with a positive phase 3 trial, another indication for primary generalized tonic-clonic (PGTC) seizures could be on the table.”
  • Beckers Hospital Review identifies “four new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports
    • “Baltimore-based Johns Hopkins Medicine has ended contract negotiations with UnitedHealthcare without a new deal, The Baltimore Banner reported Sept. 15. 
    • “Johns Hopkins went out of network with UnitedHealthcare on Aug. 25 after eight months of negotiations and several extensions of their existing agreement. 
    • “Health system leaders did not rule out an agreement in the future, but a spokesperson told The Banner they decided to make patients “aware of this stalemate now, to provide our patients and their employers the time they need to explore alternative insurance options during the upcoming open enrollment season.” 
    • “Both parties have said the impasse was not about money but other provisions in the contract, according to the report. Johns Hopkins said UnitedHealthcare was demanding overly burdensome prior authorization requirements. The payer said the system wanted to be able to exclude certain employer-sponsored plans.
    • “UnitedHealthcare Mid-Atlantic CEO Joseph Ochipinti told the news outlet the payer remains at the negotiation table. He said they expect “network providers to honor their commitment to care for the individuals and families who rely on them as in-network providers.”
  • and
    • lists the top NCQA rated commercial health plans in each state.
  • Per a Healthcare Cost Institute news release,
    • “Primary care offers patients a critical connection point to the health care system. With contact, continuity, comprehensiveness, and coordination as its base1, primary care has been shown to improve health outcomes and population health, reduce health disparities, and save health care dollars. Despite the virtues and benefits of primary care, it seems to be getting harder to access. In 2025, there were 7,901 primary care health professional shortage areas. A recent report found that primary care physicians per capita declined between 2012 and 2021, and fewer trainees chose to pursue primary care than specialty care over the same period.
    • “In response, a number of states are innovating to increase investment in primary care. By one estimate, nearly 20 states have taken action to improve primary care with initiatives ranging from defining and measuring primary care to setting specific primary care spending targets.
    • “This analysis assesses what portion of total health care spending is dedicated to primary care, in alignment with many of the primary care spending targets that are expressed as a percentage of total health care spending. We defined the percentage of primary care as the portion of ambulatory spending rendered by primary care providers (PCPs) relative to total medical and prescription spending among people with Employer-Sponsored Insurance (ESI) and Medicare Fee-for-Service (FFS) between 2018 and 2022. 
    • “The results presented below are based on a narrow definition of primary care provider based on provider specialty. We conducted the same analysis using an expanded list of specialties, (e.g., obstetrics and registered nurses and other allied practitioners). As expected, the share of primary care spending was higher using the broader definition. Otherwise, the patterns observed with the narrow definition also applied to the broader definition. The results of the analysis using both definitions are available in the downloadable data.
    • “Approximately 4% of spending went to primary care in 2022.”
  • Beckers Health IT lets us know,
    • “Epic’s revenue rose to $5.7 billion in 2024, a company spokesperson told Becker’s, as the EHR vendor continues to add health system customers.
    • “That number is up from $4.9 billion in 2023 and $1.2 billion in 2012. Epic has continued to consolidate its U.S. market share lead over the past few years, from 31% of acute care hospitals in 2021 to 42.3% in 2024, per KLAS Research. Its nearest competitor, Oracle Health, clocked in at 22.9%. Epic is the market share leader for all U.S. acute care hospital types except standalone facilities with 200 beds or fewer.”

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • An OPM news release tells us,
    • U.S. Office of Personnel Management (OPM) Director Scott Kupor joined the Ruthless Podcast to discuss a number of wide-ranging topics including OPM’s ongoing efforts to bring top talent into the federal workforce and enhance operational efficiency across government.
    • WATCH HERE
  • The American Hospital Association News informs us,
    • “The House Appropriations Committee today released bill text for a continuing resolution to fund the government through Nov. 21. The bill also extends key health care programs set to expire Sept. 30 through the length of the CR. They include extending the Medicare-dependent Hospital and low-volume adjustment programs, telehealth and hospital at home flexibilities, delaying Medicaid Disproportionate Share Hospital cuts, and extending the Cybersecurity Information Sharing Act. The House is expected to vote on the measure this week. The Senate will follow in an attempt to avert a government shutdown by Sept. 30.”
  • Politico adds,
    • “A group of GOP senators are working on legislation to extend Affordable Care Act subsidies with policy changes designed to win over conservatives, according to four people granted anonymity to disclose private discussions.
    • “This group has gotten “technical assistance” from the Senate Finance Committee, which has jurisdiction over the subsidies, according to two of the sources. The Obamacare subsidies are set to expire at the end of this year.”
  • Per the AHA News,
    • “The House Ways and Means Oversight Subcommittee today hosted a hearing on tax-exempt hospitals. The AHA submitted a statement for the hearing, highlighting the amounts that tax-exempt hospitals spend annually on community benefits and where those funds are spent. The AHA also highlighted its analysis released Sept. 10 that found tax-exempt hospitals provided nearly $150 billion in total benefits to communities in 2022, marking a nearly 50% increase in community benefit spending from 2017. Additionally, the AHA explained why a flexible community benefit approach is best for communities as opposed to suggestions for a definition and evaluation from the Internal Revenue Service.” 
  • Per a Congressional news release,
    • Sens. Chuck Grassley (R-Iowa) and Ben Ray Luján (D-N.M.) reintroduced bipartisan legislation bolstering pharmacists’ ability to serve older Americans in communities that lack easy access to doctors or where pharmacists can provide certain basic medical services.
    • The Pharmacy and Medically Underserved Areas Enhancement Act encourages pharmacists to offer health care services (like health and wellness screenings), immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide them. Many states already allow pharmacists to provide these services. However, there is currently no way for pharmacists to receive Medicare reimbursement for providing them. * * *
    • “Grassley and Luján also requested feedback from stakeholders on pharmacists providing services for chronic care needs, given the unique pressing challenges of chronic care among seniors. Text of the request-for-information (RFI) can be found HERE.
    • “The full text of the legislation is available HERE.”
  • Healthcare Dive reports,
    • “Doctors — especially specialists — are pushing back against proposed changes to Medicare payment that would tamp down on reimbursement next year.
    • “Medicare’s proposed physician fee schedule for 2026 includes a base rate hike of 2.5%. But it also includes an efficiency adjustment that would reduce payment by 2.5% for thousands of procedures and changes to how regulators calculate practice expense that would lower reimbursement for services performed in facilities like hospitals.
    • “The reforms are meant to account for increased efficiency in procedures that doctors perform frequently, realign payment for primary and specialty care, and recognize larger indirect costs for doctors in office-based settings.
    • “Many physicians support those goals. But the policy changes themselves are a bad idea, doctors are warning the CMS.”
  • Fierce Healthcare points out,
    • “In its annual health plan ratings, the National Committee for Quality Assurance (NCQA) found that 11 out of 998 rated plans earning top marks, more than double last year’s total. 
    • “Of the 11 plans to achieve a 5-star rating, eight were commercial plans and three were Medicare plans. They included Blue Cross and Blue Shield of Massachusetts, UPMC Health Plan and several Kaiser Foundation Health Plans.  An additional 55 plans earned a 4.5-star rating. Most plans ranked between 3 and 4 stars, same as in 2024. The NCQA says its ratings help consumers and regulators assess the quality and effectiveness of health plans. 
    • “The report found year-over-year improvements in coordination and continuity of care in Medicare. The NCQA also identified progress across nearly all six diabetes-related measures. The Kidney Health Evaluation for Patients with Diabetes metric showed an average increase of over 5% across all product lines. 
    • “Additionally, the NCQA found improved adult and adolescent immunization rates. Though childhood immunization rates continued to decline, they did so at a slower pace than last year.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not require a product to be immediately removed from the market. However, there are specific recommendations all clinicians should follow. 
    • “The FDA first shared details with the public about these concerns in early August, noting that some of Boston Scientific’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) were associated with a potential risk of rising low-voltage shock impedance (LVSI). If this occurs, it can make the leads less effective over time. 
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” the agency said at the time.”
  • The AHA News adds,
    • “The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.” 
    • “In addition, the FDA issued an early alert for certain Medline convenience kits containing Medtronic DLP Left Heart Vent Catheters due to issues found with certain lots of cannula products where the catheter may not retain its shape. Medline sent a notice to affected customers that recommended they destroy any affected product after completing the list of recall actions.” 

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy weight-loss drug helps patients stop thinking about food, according to a new study.
    • “According to results of the study, which were presented at a medical conference in Austria, patients taking Wegovy for weight-loss experienced a substantial drop in so-called “food noise”—unwanted and intrusive thoughts about food—alongside improvements in their mental well-being and lifestyle.
    • “Novo Nordisk said the number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy, while 64% of respondents reported improved mental health and 80% reported healthier habits while taking the drug.
    • “It is very encouraging to see these new data from people using Wegovy that, in addition to weight-loss, Wegovy may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives,” said Filip Knop, incoming chief medical officer at Novo Nordisk.
    • “The U.S.-based Inform study released Tuesday surveyed 550 people taking Wegovy for weight-loss to assess the impact of the drug on mental well-being and eating habits relating to food noise.”
  • MedPage Today adds,
    • “A higher 7.2 mg dose of semaglutide led to significantly greater weight loss compared with placebo in adults with obesity, with or without type 2 diabetes.
    • “Participants across two randomized trials also had improvements in cardiovascular risk factors.
    • “Secondary and exploratory analyses suggested that the 7.2 mg dose led to a greater change in body weight versus the currently approved highest dose of 2.4 mg.”
  • Per a National Institutes of Health news release,
    • ‘The National Institutes of Health (NIH) has launched effort aimed at reducing the rate of preventable stillbirths in the United States. Investigators will develop tools, devices and other technologies that have the potential to affect diagnosis and prevention efforts relevant to stillbirth, which occurs in 1 in 160 deliveries in the U.S. About 23,600 stillbirths at 20 weeks or greater gestation are reported annually.
    • “More than 60% of stillbirth cases remain unexplained even after exclusion of common causes, such as congenital abnormalities, genetic factors, and obstetric complications. NIH will fund the Stillbirth Research Consortium for more than $37 million over five years, pending the availability of funds, with $750,000 in co-funding from the Department of Health and Human Services.
    • “This consortium will provide an integrated, collaborative program to support cutting edge research to identify the root causes of stillbirth and inform evidence-based strategies to address stillbirth risks,” said Alison Cernich, Ph.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Too many families needlessly face the grief of stillbirth.”
    • “People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. The rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. About 40% of stillbirths that occur during labor and birth are considered potentially preventable.” 
  • Genetic Engineering and Biotechnology News reports,
    • “A novel strategy developed by scientists at Rice University allows scientists to zoom in on tiny segments of proteins inside living cells, revealing localized environmental changes that could indicate the earliest stages of diseases such as Alzheimer’s, Parkinson’s, and cancer. The study results could offer promise for drug screening that targets protein aggregation diseases.
    • “The research team engineered a fluorescent probe known as AnapTh into precise subdomains of proteins, creating a tool that monitors microenvironmental shifts in real time. Unlike conventional techniques that provide only broad signals, this approach reveals how distinct regions of the same protein behave differently during the aggregation process. The work, led by Han Xiao, PhD, professor of chemistry and director of Rice’s SynthX Center, enhances the basic understanding of disease mechanisms and lays the groundwork for identifying drug targets and screening potential therapeutics at an earlier stage.
    • “We essentially built a molecular magnifying glass,” Xiao said. “This allows us to visualize subtle environmental changes that previously went unnoticed, and those early changes often hold the key to understanding protein-related diseases.” Xiao and colleagues reported on their findings in Nature Chemical Biology, in a paper titled, “Real-time imaging of protein microenvironment changes in cells with rotor-based fluorescent amino acids,” in which they concluded: “These results demonstrate that the technology reported in this paper provides a versatile tool for exploring microenvironment changes of protein substructures at high spatial resolution, enabling direct visualization of the local environment around specific amino acid residues.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY unveiled plans to build a $5 billion manufacturing facility in Virginia as part of the drugmaker’s pledge to bolster its domestic medicine production with four new pharmaceutical manufacturing sites.
    • “Eli Lilly said the new plant, located just west of Richmond in Goochland County, will be the first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.
    • “The Indianapolis company said the site also will boost its domestic manufacturing of antibody-drug conjugates.
    • “Eli Lilly said the new plant will create more than 650 new company jobs, along with 1,800 construction jobs.
    • “Eli Lilly in February said it would invest $27 billion to build four new pharmaceutical manufacturing sites in the U.S., more than doubling its U.S. capital expansion commitments since 2020 to more than $50 billion.”
  • and
    • “So far this year, more than a dozen drugmakers [, including Lilly,] have pledged to spend more than $350 billion collectively by the end of this decade on manufacturing, research and development and other functions in the U.S., a Wall Street Journal tally of company announcements showed.
    • “The vast majority of our products going into the U.S. are manufactured in the U.S.,” GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. “This of course adds to it, and it’s about the new pipeline that’s going through.”
  • Modern Healthcare informs us,
    • “Health systems are revamping pediatric care to fight emergency department overcrowding before Medicaid funding cuts further endanger access. 
    • “Many emergency rooms are full, leading to care delays and provider burnout. Hospital operators have responded by tasking social workers with triage duties and setting up virtual consultations with specialists. They are also consolidating emergency services and asking data analytics companies to better track and predict capacity and utilization trends, health system executives said. 
    • “Health systems have crafted many of these strategies around pediatric patients, who may bear the brunt of the Medicaid cuts authorized by the “One Big Beautiful Bill,” among other federal policy changes, experts said.
    • “The population that will get hit the hardest in emergency medicine will be pediatrics,” said Dr. Ken Heinrich, chief medical officer of emergency medicine at staffing company SCP Health. 
    • “Providers are facing a surge in pediatric mental health issues, fueling care backlogs across hospital emergency departments. Providers have enlisted social workers and adjusted their emergency department layouts to meet that demand.”
  • and
    • “Labcorp has completed its acquisition of BioReference Health’s oncology diagnostic testing assets for up to $225 million. 
    • “The independent laboratory company paid $192.5 million at closing and and could pay up to $32.5 million more in an earn-out tied to the assets’ performance, according to a Monday news release.
    • “Labcorp previously acquired select clinical, reproductive and women’s health diagnostic assets from BioReference last September for more than $237 million.”
  • MedCity News notes,
    • “Berry Street, a nutrition therapy company, has launched its GLP-1 Nutrition Pathway Program, which is meant to provide nutrition support for those starting, taking and getting off of GLP-1s.
    • “The New York City-based company works with health plans and connects patients in need of nutrition support to a network of registered dietitians. It provides personalized treatment plans for patients struggling with weight management, diabetes, heart health, kidney disease and numerous other conditions.”
  • Per a UHC press release,
    • “Building on our March announcement committing to modernize pharmacy payment models, Optum Rx has increased reimbursement minimums for brand drugs for approximately 2,300 independent pharmacies – those not affiliated with a pharmacy services administrative organization (PSAO), chain or other entity – across the country. This move, which went into effect on September 1, 2025, will support the long-term sustainability of pharmacies, which play a critical role in patient care. 
    • “This is the latest announcement from Optum Rx, which continues to expand on initiatives to transform how pharmacies are reimbursed for drugs. Optum Rx first launched improved reimbursement earlier this year, with Epic Pharmacy Network, a PSAO representing more than 1,000 independent pharmacies, being the first PSAO to partner with us.”
  • BioPharma Dive lets us know,
    • “Novartis is broadening its bet on drugs that can destroy disease-causing proteins, agreeing Monday to a new deal with biotechnology company Monte Rosa Therapeutics.
    • “Through the collaboration, the companies will work to develop multiple novel protein “degrading” drugs for immune conditions. Monte Rosa will conduct discovery and early testing before Novartis takes over development for programs it chooses to license. The biotech will get $120 million in upfront cash per deal terms. It could also receive as much as $5.7 billion overall should various development and sales milestones be met, plus royalties on sales of any eventual products.”
    • Monte Rosa is among the many companies pursuing “molecular glue” drugs, which force together a target protein with an enzyme that flags it for destruction by the cell’s waste disposal system. The approach is seen as a way to access tough-to-reach drug targets, and is one of several strategies biotechs are using to degrade harmful proteins, rather than bind and block them as traditional drugs do.
  • Per Beckers Hospital Review,
    • “Amazon has added Fay, a dietitian platform, as the first nutrition care service available through its Health Benefits Connector.
    • “The collaboration allows eligible Amazon customers to discover and enroll in Fay’s insurance-covered nutrition services while browsing for wellness and health benefits, according to a Sept. 16 news release.
    • “Fay connects individuals with registered dietitians based on their goals, health history and insurance eligibility. Services include counseling, preventive care and coaching, which the company said are often available at no cost to patients.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Healthcare accreditation body URAC is rolling out the nation’s first accreditation program for users and developers of healthcare artificial intelligence. 
    • “The first-in-the-nation program will evaluate risk management, business management and performance monitoring with specific modules for users and developers. URAC accredits organizations ranging from small pharmacies to multistate payer organizations. 
    • The organization, which has been accrediting healthcare organizations for decades, hopes the URAC gold star will help promote trust in AI.
    • “We think that this is a great opportunity to give people that seal of approval, that gold star, that someone independent has gone in behind the scenes and audited to make sure that this is trustworthy,” Shawn Griffin, M.D., CEO and president of URAC, said in an interview.”
  • and
    • “Aegis Ventures’ digital consortium gained three new members as health systems look to collaborate to develop and scale artificial-intelligence-powered health tech solutions and tackle common pain points.
    • “Yale New Haven Health System, Keck Medicine of USC and Hartford HealthCare joined the collaborative, expanding its reach to 14 regional health systems. The consortium, which includes Northwell Health, UPMC, Stanford Health Care and Vanderbilt Health, will codevelop, invest in and deploy health tech solutions alongside Aegis Ventures. 
    • “The partnerships with the three new health systems will accelerate the consortium’s pipeline of companies with two startups set to launch this fall, according to John Beadle, co-founder and managing partner of Aegis Ventures.
    • “Next year, I think we could be more aggressive, just given that the model of the blueprint worked well. We have the right set of partners, the right team, the resources are in place to do it, but I think we’re most focused on seeing this year out really strong,” Beadle said.”
  • and
    • “Healthcare technology and AI company Innovaccer has acquired Story Health, a digital specialty care platform with health system inroads.
    • “Financial terms of the deal, announced Tuesday, were not disclosed. Innovaccer said the deal adds to its scalable Healthcare Intelligence Cloud offering, which in recent months was bolstered by the company’s other strategic acquisitions.
    • “Healthcare doesn’t change through dashboards alone,” Abhinav Shashank, co-founder and CEO of Innovaccer, said in the announcement. “It changes when data and AI power completely new clinical models. Story Health has proven that in specialty care; and we’re excited to bring this technology and clinical expertise to our health system customers nationwide.”
    • “Cupertino, California-based Story Health, a Fierce 15 2024 honoree, launched in late 2020 and has raised about $27 million in funding from backers such as Northpond Ventures, B Capital Group, LRVHealth, Define Ventures and General Catalyst. Its approach combines virtual coaching, biometric monitoring and care team alerts to support patients with chronic conditions between clinical visits.”

Monday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, Mental health care, Obesity, U.S. Healthcare–

From Washington, DC

  • Federal News Network tells us,
    • “Less than two months away from this fall’s Open Season, Democrats in Congress are raising concerns that the Office of Personnel Management may not be fully prepared to administer the major health insurance program for millions of Postal Service employees and annuitants.
    • “Top Democrats from several congressional committees sent a letter Friday to OPM Director Scott Kupor to push for answers about key issues recently identified in the new Postal Service Health Benefits program. The letter comes a few months after the agency’s inspector general office found “critical” staffing vacancies and funding issues in the PSHB’s central enrollment platform, which all program participants must use to enroll or make changes to their insurance options.
    • “Given the potential for severe consequences among PSHB enrollees, the Postal Service, and carriers, we urge that OPM immediately address the critical issues identified in OPM OIG’s flash report,” the lawmakers said in Friday’s letter, signed by the top Democrats on the Senate Homeland Security and Governmental Affairs Committee and the House Oversight and Government Reform Committee as well as both congressional appropriations committees.” ***
    • “The concerns in Congress come just ahead of OPM’s anticipated announcement of the 2026 premium rates for both the PSHB and FEHB programs by the end of September. It also comes a couple months ahead of this year’s Open Season, when millions of federal employees and annuitants will be able to update their health enrollment options ahead of plan year 2026. This year’s Open Season will run from Nov. 10 to Dec. 8 for the 2026 plan year.
    • “The lawmakers gave OPM until the end of the week to explain in more detail when it will staff up to the 11 employees it determined it needs to run the platform. They’re also pushing OPM for answers on its contingency plan if the data platform fails, and how it will ensure the PSHB is appropriately funded for the upcoming budget cycle.”
  • Healthcare Dive informs us that “a key CDC panel meets this week [September 18 and 19] to discuss vaccines. Here’s what to know. Advisers hand-picked by HHS Secretary Robert F. Kennedy Jr. are set to vote on guidelines for measles, hepatitis B and COVID vaccines.”
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of five new members to the CDC Advisory Committee on Immunization Practices (ACIP). [The appointees are named in the release.] These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, evidence-based science, and diverse expertise in guiding the nation’s immunization policies. In June, Secretary Kennedy reconstituted ACIP to restore public trust in vaccines.
  • and
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Sept. 15 announced that states can now apply for funding from the Rural Health Transformation Program created under the One Big Beautiful Bill Act. The program will fund $50 billion to rural providers from fiscal year 2026 to FY 2030. CMS said the funds would support goals of promoting preventative health and addressing root causes of diseases, improving efficiency and sustainability, strengthening workforce recruitment and retention, initiating innovative care models, and fostering the use of innovative technology for efficient care delivery, data security and access to digital health tools.  
    • “CMS said half of the funds would be distributed evenly to states with an approved application, while the other half would be awarded to states based on individual state metrics and applications that “reflect the greatest potential for and scale of impact” on rural communities. States have until Nov. 5 to apply, and CMS will announce the recipients by Dec. 31.”
  • Per MedPage Today,
    • Reaction is generally positive to a federal initiative aimed at increasing electronic health record (EHR) interoperability and giving patients and providers quicker access to information about visits.
    • The voluntary initiative, announced on July 30, would require all participating EHR companies to connect directly to national data-sharing networks approved by the Centers for Medicare & Medicaid Services (CMS), the American Medical Association (AMA) noted in a Sept. 5 statement. “These systems must now deliver real-time, full patient information, including clinical notes, images, and medication lists that physicians actually use in care, rather than the basic data fields that are now available.
    • “EHR companies that have agreed to participate in the initiative include Epic, Amazon, eClinicalWorks, Oracle Health, and TruBridge.”
  • Deloitte points out in a white paper,
    • “Strategic investments in disease prevention, early detection, and other proactive measures could save the US health care system up to $2.2 trillion a year by 2040—more than $7,000 per person—according to new research from Deloitte’s actuarial and health care teams. These investments could also help save Medicare more than $500 billion a year on medical and prescription drug claims, strengthen the program’s long-term financial outlook, and expand the number of years beneficiaries live in good health. Deloitte analysis suggests that lowering Medicare spending in this way could delay potential insolvency and ease the need for benefit reductions or tax increases to maintain the program as it currently exists.”
  • Per Fierce Pharma,
    • “Forty-two years after approving the potent diuretic Bumex (bumetanide) as both an oral and infused treatment for edema, the FDA has endorsed a new version of the drug to be delivered as a nasal spray.
    • “The U.S. regulator has signed off on Corstasis Therapeutics’ Enbumyst to relieve the edema associated with congestive heart failure (CHF), chronic kidney disease (CKD) and liver disease. Edema is the accumulation of fluid in the body’s tissues that causes swelling.
    • “It is the first FDA nod for Nevada-based Corstasis, which develops outpatient therapies for the treatment of fluid overload in patients with cardiorenal and hepatic diseases. Edema is the leading cause of hospitalization and readmission for patients with CHF, CKD and cirrhosis of the liver, accounting for more than 1 million visits annually, Corstasis explained.”

From the public health and medical/Rx research front,

  • The American Medical Association lets us know what doctors wish their patients knew about healthy aging.
  • Per Health Day,
    • “A new type of noninvasive brain stimulation may help people with moderate to severe depression feel better faster than standard treatments, researchers in a new report say.
    • “The method, called high-definition transcranial direct current stimulation (HD-tDCS), uses small electrodes on the scalp to deliver mild electrical currents to specific parts of the brain involved in mood regulation.
    • “In the trial conducted by UCLA researchers, 71 adults with major depression were randomly assigned to receive either active HD-tDCS or a sham treatment for 20 minutes a day over 12 working days. 
    • “The group receiving real treatment showed a greater drop in their depression scores than the control group, according to findings published Sept. 11 in JAMA Network Open.”
  • and
    • “Women who overcome cervical cancer might have another potentially life-threatening health crisis on their horizon, researchers say.
    • “Cervical cancer survivors have nearly double the risk of developing anal cancers compared to the general population, researchers reported Sept. 11 in JAMA Network Open.
    • “And their risk increases as they grow older, and as time passes since their cervical cancer treatment, results show.
    • “Both types of cancer are linked to infection with human papillomavirus (HPV), researchers noted. The virus is mainly spread during intimate contact.
    • “We’ve known for a long time that both cervical and anal cancers are caused by HPV, the human papillomavirus,” senior researcher Ashish Deshmukh said in a news release. He’s the co-director of the Cancer Prevention and Control Research Program at the Medical University of South Carolina Hollings Cancer Center in Charleston.
    • “But what hasn’t been well-understood is how that shared risk might connect the two diseases over a woman’s lifetime,” Deshmukh said.”
  • Per Healio,
    • “A telephone-based weight-loss intervention helped women with breast cancer and obesity lose almost 5% of their baseline body weight, according to results of a randomized phase 3 trial.
    • “Participants lost significant weight regardless of race, ethnicity, menopause status, income and more.
    • “The data are the first from the Breast Cancer Weight Loss (BWEL) trial, which is evaluating whether weight loss can reduce recurrence, development of new cancers and mortality.”
  • Beckers Hospital Review calls attention to “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”
  • Per BioPharma Dive,
    • “An experimental drug from biotechnology company aTyr Pharma missed its main goal in a Phase 3 trial, failing to help people with an inflammatory lung condition called pulmonary sarcoidosis significantly cut down on their use of steroids after nearly a year of treatment.
    • “The drug, called efzofitimod, is aTyr’s only clinical-stage prospect, and the company believed it might help reduce the inflammation and accompanying steroid use in people with pulmonary sarcoidosis. ATyr is also testing the drug in a Phase 2 trial in systemic sclerosis-related interstitial lung disease.” 

From the U.S. healthcare business front,

  • Willis Tower Watson explains how “alternative plan designs help employers offer affordable, high-value care; guiding members to better providers with transparent costs. Success depends on clear goals, smart design & strong analytics.”
  • The Employee Benefits Research Institute reports,
    • “The 2025 EBRI Employee Mental Health Survey, based on a survey of 3,103 employees in March and April 2025, explored workers’ experiences with both physical and mental health care to better understand their behaviors and attitudes toward health care generally and mental health care more specifically. The survey also explored access to care and patterns of health care use. For this report, all employees who reported that they or a covered family member used mental health care services are referred to as respondents reporting a mental health condition. Of note, a number of respondents who reported utilizing mental health services did not report a mental health condition. This is consistent with the well-documented underreporting of mental health conditions.”
  • Healthleaders Media considers why patients are filing more complaints against hospitals, thereby illustrating oversight gaps and trust issues that demand CEO attention.
  • MedCity News discusses what’s next for Walgreens following its private equity sale.
  • Per MedTech Dive,
    • “Intuitive Surgical unveiled new software capabilities for the da Vinci 5 robot that give surgeons more information, such as a replay of key moments in a procedure. Surgeons can review the video as the procedure is ongoing without removing their head from the console.
    • “Another new feature is a gauge displaying measurements of the force applied to the patient’s tissue by instruments. Intuitive’s force feedback technology already allows surgeons to sense the instrument pressure applied to tissue.
    • “The updates, which received 510(k) clearance from the Food and Drug Administration, are the first in a planned series of new system capabilities designed to improve patient outcomes and surgeon and hospital efficiency, the company said Friday.”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for the Centers for Medicare & Medicaid Services (CMS) for treating Crohn’s disease and ulcerative colitis. ICER will evaluate Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.). This report will be submitted to CMS as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028.  
    • “While the final list of drugs subject to negotiation will not be released until February 2026, ICER is developing this report with the expectation that Entyvio® will be subject to negotiation next year.  
    • “Building on our two previous reports, ICER’s expertise in comparative clinical effectiveness and value will continue to help inform the important conversations around Medicare drug price negotiation,” said ICER’s President and CEO Sarah K. Emond, MPP. “While we know CMS may consider many different factors and inputs during negotiations, we believe ICER’s approach to applying the guidance in a consistent framework.”

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports that the Democrat “Party wants expanded Obamacare subsidies restored in any deal to keep government funded past Sept. 30.”
    • “Democrats are more confident in their negotiating stance compared with March, when a similar attempt to play hardball fizzled. While today’s talks pit them against Republican leaders who want a two-month spending deal with no big additions, they are finding support among rank-and-file GOP lawmakers fearing political backlash if their voters are hit by higher health-insurance bills next year.
    • “Republicans have to come to meet with us in a true bipartisan negotiation to satisfy the American people’s needs on healthcare, or they won’t get our votes, plain and simple,” Senate Minority Leader Chuck Schumer (D., N.Y.) said Thursday.
    • “Senate Majority Leader John Thune (R., S.D.) said he was open to discussions about extending the subsidies, but not as a condition of a short-term spending bill he has proposed to keep the government open into November. Such an extension would give Congress more time to iron out full-year spending deals.
    • “The fight centers on the extension of expiring Affordable Care Act tax credits. The subsidies, which expanded the payments offered under the existing ACA, or Obamacare, were first passed in 2021 by Democrats as a temporary measure tied to a Covid-19 aid law. Republicans didn’t renew them in their sprawling tax-and-spending legislation President Trump signed in July, meaning they will expire at the end of this year.”
  • According to the legislative calendars for the House of Representatives and the Senate, next week is scheduled for a District / State work break which means that we have seven legislative days before the end of federal government’s fiscal year. Fortunately, with respect to prospects for a government shutdown, there is no national election this year so Congress will be in session for the fourth quarter rather than on the campaign trail.
  • The New York Times reports,
    • “The Food and Drug Administration has warned Hims & Hers, a major telehealth purveyor of widely popular obesity drugs, to stop “false or misleading” marketing, according to a copy of a letter sent to the company and obtained by The New York Times.
    • “The F.D.A.’s letter was one of about 100 warning letters sent to drug advertisers this week. The agency commissioner, Dr. Marty Makary, said on Tuesday that the letters were being sent to traditional pharmaceutical companies as well as to online pharmacies.
    • “The letter, sent on Tuesday to Hims & Hers, warned the company to halt the use of marketing language that falsely implies that one of its products is approved by the F.D.A. The agency has not yet publicly released the letter.
    • “Hims & Hers has capitalized on a huge demand for weight-loss drugs like Novo Nordisk’s drug Wegovy, offering low-cost, copycat versions made through a process of mixing drug ingredients known as compounding. In the past few years, telemedicine companies like Hims & Hers have emerged as an aggressive new type of drug advertiser.”

From the judicial front,

  • Federal News Network reports,
    • “A federal judge in San Francisco found the Office of Personnel Management unlawfully directed agencies to fire probationary federal employees en masse.
    • “U.S District Court Judge William Alsup ruled late Friday that OPM “exceeded its own powers,” and “directed agencies to fire under false pretense,” telling probationary employees that they were being terminated for poor performance.
    • “The ruling doesn’t reinstate any of the 25,000 probationary federal employees fired around mid-February, but it does direct many agencies to update their personnel records to specify that these employees were not fired for poor performance or misconduct. Agencies must also send letters to impacted employees starting they were not fired for performance.
    • “The ruling, in a lawsuit led by federal employee unions, applies to the departments of Commerce, Defense, Health and Human Services, Labor, Treasury, Transportation and Agriculture. OPM, NASA, the State Department and the Office of Management and Budget are exempt from the ruling.”

From the public health and medical/Rx research front,

  • The Wall Street Journal explains how to start ditching ultraprocessed foods.
    • “When choosing ready-to-eat snacks and meals, check the label and aim for products that clock in at less than 1.5 calories per gram, says Kevin Hall, a former scientist at the National Institutes of Health who led the agency’s research on ultraprocessed foods before he left in the spring. Ultraprocessed foods are often energy-dense, containing more calories per gram than less-processed foods. 
    • “The particular combinations of fat, sugar, sodium and carbs that ultraprocessed foods often contain aren’t generally found in nature. Researchers call these combinations “hyperpalatable,” and they exert a strong effect on our brain’s reward system, which makes us crave them, says Tera Fazzino, associate director of the Cofrin Logan Center for Addiction Research and Treatment at the University of Kansas.”
  • Medscape considers whether oral GLP-1s can transform the obesity treatment landscape?
    • “Experts agreed that there’s room for a wide variety of obesity medications.
    • “Patients could also consider bariatric surgery, said Karan Chhabra, MD, assistant professor in the Department of Surgery and the Department of Population Health at the NYU Grossman School of Medicine in New York City. He is the coauthor of a study recently presented at the American Society for Metabolic and Bariatric Surgery’s 2025 Annual Scientific Meeting that showed that patients who underwent bariatric surgery experienced significantly more weight loss after 2 years than patients who received weekly injections of semaglutide or tirzepatide.
    • “Expanded access to GLP-1s for chronic weight management could help many people, but only time will tell what the specific impact of oral GLP-1 medications will be [e.g., will oral GLP-1 drugs carry a materially lower price?].”
  • The New York Times Well newsletter offers “five simple steps to calm yourself down. These techniques can help you handle the ups and downs of daily life.”
    • “There are lots of ways to deal with the ups and downs of daily life, Marc Brackett, the founding director of the Yale Center for Emotional Intelligence, told me. He’s developed a framework called RULER — recognize, understand, label, express and regulate — and it’s used in over 5,000 schools nationwide.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Imaging company Siemens Healthineers and minimally invasive medical device maker Cook Medical announced a partnership Saturday to offer one of the first turnkey interventional MRI suite solutions.
    • “The solution comprises Siemens Healthineers’ MRI technologies and services like its interventional planning software along with Cook Medical‘s medical devices designed for MRI, including catheters, guidewires and sheaths. Both companies will provide specialized training and ongoing clinical support.
    • “Currently, hospitals that seek to build an interventional MRI suite have to buy the equipment separately and create their own suite.
    • “Interventional MRI provides real-time imaging during minimally invasive procedures including those in oncology for soft tissue tumors, pediatric cases and structural heart conditions. Compared with interventional fluoroscopy and interventional CT, the technology offers superior image quality for soft tissues and eliminates radiation exposure.”
  • and
    • “B. Braun announced Friday it has acquired digital robotic-assisted 3D surgical microscopy company True Digital Surgery for an undisclosed amount.
    • “Previously, B. Braun, a Germany-based global medical device company, held a minority stake in the firm and partnered on developing the Aesculap Aeos robotic digital microscope. The acquisition will allow B. Braun to leverage the firm’s expertise to further advance the microscope’s development.
    • “B. Braun’s surgical division Aesculap launched the microscope in the U.S. in September 2020. It provides surgeons with 3D digital visualization while performing complex ophthalmology, neurosurgery, ENT and spinal surgeries.”
  • BioPharma Dive informs us,
    • “Takeda on Thursday said Rhonda Pacheco will become head of its U.S. business unit on Sept. 29. Pacheco has been at Eli Lilly for more than a decade and, since 2023, has been the group vice president of the pharmaceutical company’s cardiometabolic health unit, where she oversaw the lucrative launches of Lilly’s GLP-1 drugs. At Takeda, she’ll succeed Julie Kim, who was selected this year to take over for retiring CEO Christophe Weber in June 2026 and will serve as “interim” head of the company’s global portfolio ahead of the transition.”
  • Health Exec points out,
    • “Non-profit health system Mayo Clinic said on Monday that it’s planning to close six clinics in Minnesota, its home state, in an effort to remedy staffing shortages. 
    • “Specifically, the clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter and Wells will all be shutting their doors forever. In addition, its hospital in Albert Lea will end elective surgeries in some specialties, including gynecology and orthopedics. However, a spokesperson for Mayo Clinic told HealthExec future procedures will be moving to nearby patient care centers. The hospital is still operating as normal, and its emergency room remains open. 
    • ‘Mayo Clinic said the changes will go into effect Dec. 10. It’s launched a resource webpage to answer common questions patients may have, as it says it’s working to transition all of them to new locations. Patients will “receive a letter and portal message explaining the changes” and presenting them with options, the online FAQ confirms. In some cases, that means shifting in-person visits over to telehealth.” 
  • Per HR Dive,
    • “Pay raise budgets for next year are predicted to mirror 2025’s increases, according to a Sept. 3 report from The Conference Board. On average, companies said they plan to up their salary budgets by 3.4% in 2026.   
    • “Actual increases this year were on average 3.4%, lower than the 4% predicted in last year’s survey but still higher than the 3% average seen prior to 2020, The Conference Board said.
    • “Today’s labor market is one of recalibration, not retreat,” Mitchell Barnes, an economist at The Conference Board, said in a news release. “Companies are rebalancing their workforce and labor strategies,” slowing headcount growth and investing in training, Barnes noted.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Nextgov/FCW reports,
    • “A top Cybersecurity and Infrastructure Security Agency official said the agency is prepared to accept any extension Congress authorizes for a fundamental cybersecurity threat intelligence-sharing law, which is set to expire Sept. 30 unless renewed by lawmakers.
    • “We’ll take whatever the Congress decides to authorize us, wherever they see fit within their purview, to authorize and to give us our authorities to be able to use,” Nick Andersen, CISA’s executive assistant director for cybersecurity, told reporters Thursday [September 11] on the sidelines of the Billington Cyber Summit.
    • “The Cybersecurity Information Sharing Act of 2015 lets private sector providers freely transmit cyber threat information to government partners with key liability protections in place, shielding firms from lawsuits and regulatory penalties when sharing threat data with the government.
    • “So at this point, I think my primary concern is if it lapses,” Andersen added. “Give us 30 days for the Congress to do what they need to do. Give us two years. Give us ten years. Give us 50. Whatever you take, we’ll take it. Obviously, we love stability for the organization and stability for our partners to understand how we’re going to protect and exchange information. But really, that’s up to Congress.”
  • Cyberscoop tells us,
    • “The Cybersecurity and Infrastructure Agency is delaying finalization of a rule until May of next year that will require critical infrastructure owners and operators to swiftly report major cyber incidents to the federal government, according to a recent regulatory notice.
    • “Under the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) of 2022, CISA was supposed to produce a final rule enacting the law by October of this year. But last week, the Office of Management and Budget’s Office of Information and Regulatory Affairs published an update that moved the final rule’s arrival to May 2026.
    • “A CISA official told CyberScoop that the move would give the agency time to consider streamlining and reducing the burden on industry of a previously proposed version of the rule, citing public comments in response to that version, as well as harmonizing the law with other agencies’ cyber regulations.”
  • Cybersecurity Dive lets know,
    • “National Cyber Director Sean Cairncross said [on September 9] the Trump administration plans a whole-of-nation approach in order to combat the threat of malicious cyberattacks from the U.S.’s top geopolitical rivals. 
    • “Cairncross delivered the opening keynote at the Billington Cybersecurity Summit, saying the administration will push forward an aggressive new posture to counter the risks presented by authoritarian regimes like China.” * * *
    • “The Billington keynote marks the first major public remarks by Cairncross since he won Senate confirmation to lead the Office of the National Cyber Director in August.” 
  • FedScoop informs us,
    • “The U.S. government’s acting chief information security officer outlined his three priorities for federal cyber officials over the next year at a cybersecurity event in Washington on Tuesday [September 9], emphasizing the need for collaboration across the government.  
    • “During a fireside chat at the Billington Cybersecurity Summit, acting cyber chief Michael Duffy said focusing enterprise cyber defense, increasing operational resilience, and securing a modern U.S. government are the areas he’s outlined as priorities for the next year in conversations with the federal cyber leaders on the CISO Council. 
    • “He also previewed an upcoming tabletop exercise the CISO Council will be doing in the next month to address operational resilience.” 
  • Cybersecurity Dive points out,
    • “The Cybersecurity and Infrastructure Security Agency said it remains firmly committed to supporting and further enhancing the Common Vulnerabilities and Exposures program, which is a critical program for identifying and mitigating software flaws that can expose computer systems to exploitation. 
    • “Nick Andersen, the new executive assistant director for cybersecurity at CISA, expressed staunch support for the CVE program during a discussion on Thursday at the Billington Cybersecurity Summit in Washington, D.C. 
    • “CISA on Wednesday [September 10] released a road map that outlined its priorities for the CVE program, with the full intention to further develop the program and create a plan for robust funding and wider participation. 
    • Andersen told reporters after the presentation that it’s “exceedingly important” for CISA to be able to grow and expand the program.
    • “The feedback that we’ve gotten consistently is people are looking for somebody to call objective balls and strikes out there,” Andersen said. 
  • Per Federal News Network,
    • “The Pentagon will soon issue more details on its much-hyped effort to “blow up” the Risk Management Framework used to accredit software.
    • “Katie Arrington, who is performing the duties of the Defense Department chief information officer, said DoD will unveil the “10 commandments” of the “new RMF” in the next couple of weeks. DoD’s work to revamp how it accredits software has been a top discussion point in federal technology circles in recent months.
    • “It’s the 10 tenants of the new RMF,” Arrington said at the Billington Cyber Summit on Thursday.
  • Cyberscoop notes,
    • “The Department of Justice unsealed an indictment against a Ukrainian national alleged to be central to a ransomware campaign affecting hundreds of companies worldwide. 
    • “Volodymyr Viktorovych Tymoshchuk, known online as “deadforz,” “Boba,” “msfv,” and “farnetwork,” is accused of developing and deploying ransomware variants Nefilim, LockerGoga, and MegaCortex, all of which have been used in attacks on prominent organizations in the United States, Europe, and elsewhere since at least 2018.
    • “According to the indictment, filed in the Eastern District of New York, Tymoshchuk and his alleged co-conspirators are believed to have extorted more than 250 companies across the U.S. and hundreds more globally, generating tens of millions of dollars in damages. Victims suffered not just the loss of data and disabling of business operations, but high mitigation and recovery costs. * * *
    • “Additionally, the State Department announced rewards totaling up to $10 million for information leading to the arrest or conviction of Tymoshchuk, with a separate reward of up to $1 million for information on other key leaders of the groups deploying the ransomware variants.”

From the cybersecurity vulnerabilities and breaches front,

  • CISA added one known exploited vulnerability to its catalog this week.
  • Cybersecurity Dive reports,
    • “A sophisticated phishing-as-a-service operation has been targeting Google and Microsoft accounts and can bypass traditional defense mechanisms, including multifactor authentication, researchers at Okta Threat Intelligence warned in a blog post on Thursday, 
    • “The phishing operation, dubbed VoidProxy, uses adversary-in-the-middle techniques to bypass normal authentication flow. 
    • “Researchers first learned of attacks linked to the operation in January, but Dark Web advertisements for VoidProxy appear to have begun as early as August 2024, according to Okta researchers. The attacks are ongoing, and Okta said they have targeted valuable accounts.”  * * *
    • “Google agrees with recommendations in the Okta report that users should adopt passkeys as a strong method to protect against phishing, the spokesperson added.
    • “Microsoft declined to comment, however a spokesperson provided a link with general mitigation guidance.”
  • Dark Reading adds,
    • “A recent phishing campaign that used the Salty2FA phishing kit demonstrates how the cybercriminal enterprise continues to evolve to the point where adversarial tools are nearly on par with enterprise-grade software, experts said.
    • “Researchers from Ontinue tracked a campaign using the phishing kit that shows various technical innovations in which cybercriminals are approaching phishing infrastructure “with the same methodical planning that enterprises use for their own systems,” Rhys Downing, an Ontinue threat researcher, wrote in a blog post published Tuesday.”
  • CSO tells us,
    • “Attackers are increasingly exploiting generative AI by embedding malicious prompts in macros and exposing hidden data through parsers.
    • “The switch in adversarial tactics — noted in a recent State of File Security study from OPSWAT — calls for enterprises to extend the same type of protection they already apply to software development pipelines into AI environments, according to experts in AI security polled by CSO.
    • “Broadly speaking, this threat vector — ‘malicious prompts embedded in macros’ — is yet another prompt injection method,” Roberto Enea, lead data scientist at cybersecurity services firm Fortra, told CSO. “In this specific case, the injection is done inside document macros or VBA [Visual Basic for Applications] scripts and is aimed at AI systems that analyze files.”
    • “Enea added: “Typically, the end goal is to mislead the AI system into classifying malware as safe.”
  • Per InfoSecurity Magazine,
    • “People are often described as one of the biggest security threats to any organization. At first glance, it would be hard to argue with such a sweeping statement.
    • “Whether the result of malice or negligence, the ‘human element’ featured in around 60% of data breaches over the past year, according to Verizon. A recent spate of attacks targeting corporate Salesforce instances highlights the evolving nature of the social engineering threat – and just what’s at stake.
    • “The challenge for CISOs is that insider risk is not just about negligence. Those intent on wrongdoing are usually harder to spot and exact a much heavier toll on their employer. To coincide with International Insider Threat Awareness Month, we take a look at what CISOs can do to push back the tide.”
    • Check it out.

From the ransomware front,

  • Per Security Week,
    • “Ransomware remains the primary digital threat to business. Phishing, often the initial point of failure, further expands into voice triggered transfer fraud.
    • “An analysis of risk based on cyberinsurance claims history provides an accurate overview of the true risk of cybercrime. It doesn’t provide a full global picture of risk since it can only be drawn from known cyberinsurance claims. Resilience is a cyberinsurance provider with a deep knowledge of cybersecurity.
    • “There are three major takeaways from the 2025 Midyear Cyber Risk Report produced by Resilience: vendor-related risk is down but still significant; ransomware remains the main threat; and phishing has leapt to clear prominence as the most common point of failure (aided in scale and sophistication by AI).
    • “The report notes a reduction in vendor-related risk (down from 22% of incurred losses in 2024 to 15% in H1 2025), but stresses that the downstream loss to affected companies remains high. “While incidents dropped in frequency, clients who experienced business interruption from a vendor-related incident had significant losses that rivaled losses from companies directly affected by ransomware.” This is an unseen risk that can only be addressed by continuously monitoring the vendors’ security posture.”
  • Per Check Point Research,
    • “First observed on September 5, Yurei is a newly emerged ransomware group that targeted a Sri Lankan food manufacturing company as its first leaked victim. The group follows a double-extortion model: they encrypt the victim’s files and exfiltrate sensitive data and then demand a ransom payment to decrypt and refrain from publishing the stolen information.
    • “Check Point Research (CPR) determined that Yurei’s ransomware is derived with only minor modifications from Prince-Ransomware, an open-source ransomware family written in Go. This highlights how open-source malware significantly lowers the barrier to entry for cybercriminals, enabling even less-skilled threat actors to launch ransomware operations.
    • “Yurei’s ransomware contains a flaw that may allow partial recovery through Shadow Copies, but the group primarily relies on data-theft-based extortion. As they stated on their blog, the fear and implications of data leakage are their main pressure point to get victims to pay the ransom.
    • “Since the first victim was listed on September 5, the number of victims has risen to three so far, pointing to a fast-growing operation.
    • “The investigation revealed hints that the threat actor’s origins may be in Morocco.”
  • Per Cyberscoop,
    • “Researchers and authorities are warning that Akira ransomware attacks involving exploits of a year-old vulnerability affecting SonicWall firewalls are on the rise. 
    • “A burst of about 40 attacks linked to CVE-2024-40766 hit SonicWall firewalls between mid-July and early August. Researchers have since observed another wave of ransomware attacks linked to active exploits of the defect, which affects the secure sockets layer (SSL) VPN protocol in multiple versions of SonicWall firewalls, and configuration errors. 
    • “Rapid7 has responded to a “double-digit number of attacks” related to the vulnerability and a series of misconfigurations in victim environments, the company said, expanding on a blog it published earlier this week.
    • “The Australian Cyber Security Centre also issued an advisory Wednesday noting that it, too, is responding to a recent increase in active exploitation of the defect. “We are aware of the Akira ransomware targeting vulnerable Australian organizations through SonicWall SSL VPNs,” the agency said.”
  • Per PC World,
    • “It’s a story almost as old as time: malware is wreaking havoc on Android devices again. Usually, Android malware aims to steal sensitive data and passwords in order to gain access to online accounts. Less commonly, it installs ransomware to extort large sums of money from users.
    • “A particularly dangerous malware variant that combines both techniques has now been discovered by security experts at ThreatFabric. Known as RatOn, the Trojan infiltrates an Android phone, accesses data, empties bank accounts, then locks the device to blackmail the owner.” * * *
    • “In the case of RatOn, the Trojan likely lands on Android devices through fake apps. Users are redirected to pages that imitate the Google Play Store, where attackers offer applications disguised as common social media apps like TikTok—except it’s malware.: * * *
    • To protect yourself, you should always check whether an app comes from a trustworthy provider. You should also always activate Google Play Protect in the Google Play Store so that apps are scanned for viruses and malware before they’re installed on your device.
  • Bleeping Computer warns,
    • “A recently discovered ransomware strain called HybridPetya can bypass the UEFI Secure Boot feature to install a malicious application on the EFI System Partition.
    • “HybridPetya appears inspired by the destructive Petya/NotPetya malware that encrypted computers and prevented Windows from booting in attacks in 2016 and 2017 but did not provide a recovery option.
    • “Researchers at cybersecurity company ESET found a sample of HybridPetya on VirusTotal. They note that this may be a research project, a proof-of-concept, or an early version of a cybercrime tool still under limited testing.
  • Cyberscoop adds,
    • “Researchers at New York University have taken credit for creating a piece of malware found by third-party researchers that uses prompt injection to manipulate a large language model into assisting with a ransomware attack.
    • “Last month, researchers at ESET claimed to have discovered the first piece of “AI-powered ransomware” in the wild, flagging code found on VirusTotal. The code, written in Golang and given the moniker “PromptLock,” also included instructions for an open weight version of OpenAI’s ChatGPT to carry out a series of tasks — such as inspecting file systems, exfiltrating data and writing ransom notes.
    • “ESET researchers told CyberScoop at the time that the code appeared to be unfinished or a proof of concept. Other than knowing it was uploaded by a user in the United States, the company had no further information about the malware’s origin. 
    • “Now, researchers at NYU’s Tandon School of Engineering have confirmed that they created the code as part of a project meant to illustrate the potential harms of AI-powered malware.”
    • In a corresponding academic paper, the researchers call the project “Ransomware 3.0” and describe it as a new attack method. This technique “exploits large language models (LLMs) to autonomously plan, adapt, and execute the ransomware attack lifecycle.”

From the cybersecurity business and defenses front,

  • Cyberscoop informs us,
    • “Major cyber intrusions by the Chinese hacking groups known as Salt Typhoon and Volt Typhoon have forced the FBI to change its methods of hunting sophisticated threats, a top FBI cyber official said Wednesday.
    • “U.S. officials, allied governments and threat researchers have identified Salt Typhoon as the group behind the massive telecommunications hack revealed last fall but that could have been ongoing for years. Investigators have pointed at Volt Typhoon as a group that has infiltrated critical infrastructure to cause disruptions in the United States if China invades Taiwan and Americans intervene.
    • “Those hacks were stealthier than in the past, and more patient, said Jason Bilnoski, deputy assistant director of the FBI’s cyber division. The Typhoons have focused on persistent access and gotten better at hiding their infiltration by using “living off the land” techniques that involve using legitimate tools within systems to camouflage their efforts, he said. That in turn has complicated FBI efforts to share indicators of compromise (IOCs).
    • “We’re having to now hunt as if they’re already on the network, and we’re hunting in ways we hadn’t before,” he said at the Billington Cybersecurity Summit. “They’re not dropping tools and malware that we used to see, and perhaps there’s not a lot of IOCs that we’d be able to share in certain situations.”
  • The Wall Street Journal reports,
    • “Japanese industrial giant Mitsubishi Electric said Tuesday that it intends to acquire U.S. cybersecurity company Nozomi Networks in a deal valued at about $1 billion.
    • “Nozomi will become a wholly owned subsidiary of Mitsubishi Electric under the terms of the deal and operate independently. The transaction value includes $883 million in cash as well as previous equity.
    • “Nozomi raised $100 million in a 2024 Series E funding round that included several heavyweights in operational technology, such as Mitsubishi Electric and Schneider Electric. Previous investors included Honeywell; the U.S. Central Intelligence Agency’s venture arm, In-Q-Tel; and Johnson Controls. 
    • “Nozomi Chief Executive Edgard Capdevielle said the company will continue to provide services to those prior investors and other companies after the acquisition, which is expected to close in the fourth quarter. 
    • “The fact that we’re now a wholly owned subsidiary of Mitsubishi does not change the fact that we will continue to be vendor-agnostic,” he said.”
  • Dark Reading adds,
    • “F5, a software company that improves application speed and security, today announced its plans to acquire CalypsoAI, a provider of adaptive artificial intelligence (AI) security capabilities. CalypsoAI’s technology will be integrated into the F5 Application Delivery and Security Platform (ADSP), F5 said.
    • Founded in 2018, CalypsoAI focuses on real-time protection against threats targeting AI applications and models, such as prompt injection and jailbreaking. The platform brings threat defense, red teaming at scale, and data security to businesses preparing to launch or adopt generative and agentic AI. CalypsoAI came in second place at RSAC Conference’s Innovation Sandbox earlier this year as a company that protects models and agents with prompt firewalls.
    • “By integrating CalypsoAI features into ADSP, F5 hopes to build modern firewalls and point solutions that can secure AI models, agents, and data flows. Traditional options “can’t keep up,” said François Locoh-Donou, president and CEO of F5, in a statement.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Congress, COVID-19, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog was pleased to see that OPM Director Scott Kupor added his regular Friday post to his OPM blog today after adding an insightful special post yesterday about the combined federal campaign. This Friday’s post concerns artificial intelligence.
  • MedTech Dive reports,
    • “A bipartisan bill introduced in Congress this week aims to more accurately determine Medicare reimbursement for laboratories by tying payment rates for diagnostic tests to a not-for-profit commercial claims database.
    • “The legislation would reform the 2014 Protecting Access to Medicare Act, also known as PAMA, which the lab industry for years has argued created a process that sets reimbursement rates artificially low.
    • “Called the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, the new bill would “dramatically improve” the data used to set rates for lab tests, the American Clinical Laboratory Association said Thursday.”
  • OPM released on the Federal Register’s Public Inspection List a final rule titled “Assuring Responsive and Accountable Federal Executive Management. Here’s the summary of the rule,
    • “The Office of Personnel Management (OPM) is issuing this final rule to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Governmentwide SES ratings data have consistently shown that most SES receive the highest rating levels (i.e., Levels 4 and 5) despite documented reports of SES failings. Allowing agencies to limit the highest SES rating levels will increase rigor in SES appraisal and lead to a more normalized distribution of SES ratings across the Federal Government.
    • The rule will be published in the Federal Register on September 15.
  • Per an HHS news release.
    • “The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will hold a meeting on Thursday and Friday, September 18-19, 2025, in Atlanta, GA. * * *
    • “The meeting will be available to the public via live webcast. The link will be available Thursday morning on the ACIP website. 
    • “The September 18-19 meeting draft agenda will be available on the ACIP website.” 
  • The Groom Law Group lets us know,
    • “The HIPAA Security Rule requires covered entities, such as group health plans and health insurance issuers, as well as business associates, to perform a written “security risk assessment” of the potential risks and vulnerabilities to protected health information (“PHI”) maintained on their systems and applications. 
    • Yesterday [September 10], the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) released an updated version of the Security Risk Assessment Tool (“SRA Tool”), which is an easy-to-use interactive application that covered entities and business associates can use to create the required security risk assessment.  The SRA Tool guides users through the required security risk assessment process using a series of multiple-choice questions, providing references and guidance along the way.  The updated SRA Tool offers new features, including a glossary, tips, and a remediation report.  
    • The OCR and Assistant Secretary for Technology Policy will host live webinars with training sessions on September 15 at 12:00 p.m. ET and September 16 at 3:00 p.m. ET.  You can register for the training sessions here.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA is signaling fresh control over the promotion of copycat drugs under President Donald Trump’s executive order to rein in pharmaceutical advertising, staking a position in a regulatory gray area around so-called compounded products.
    • “On Tuesday, Trump’s executive order called for “action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising.” 
    • “The Food and Drug Administration then sent hundreds of letters to drug companies warning of deceptive promotions, which included notices to online telehealth companies that market the compounded products, a spokesperson for the US Department of Health and Human Services said in an email. 
    • “The FDA is clearly looking to take a more aggressive stance with deceptive advertising practices, and that will include non-traditional targets,” said Melissa Wong, a life sciences attorney at Holland & Knight.”
  • STAT News tells us,
    • “Mark your calendars — the Food and Drug Administration will soon convene experts to discuss challenges around regulating mental health products that use artificial intelligence. The announcement arrives as a growing number of companies release chatbots powered by large language models with unpredictable output.
    • “Notice of the Nov. 6 meeting of the Digital Health Advisory Committee, published Thursday in the Federal Register, says newly released mental health products using AI pose “novel risks and, as mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges.” 
    • “The agency has yet to provide clear guidance on how it plans to regulate these devices or what developers must do to show they are safe and effective. But it’s clear the risks are real, as I detailed in my story last week about ChatGPT and other generative AI tools driving users into delusional spirals. Read more from STAT’s Mario Aguilar.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to download report listings or data sets, with reports being updated daily to include the most recent submissions.
    • “Today’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency. It follows the agency’s recent announcement on real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.” * * *
    • Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event. Additionally, the FAERS data is not an indicator of the safety profile of the cosmetic product. To learn more, read the frequently asked questions.
  • On a related note, the Wall Street Journal discusses health concerns raised about gel manicures.

From the judicial front,

  • Fierce Pharma notes,
    • “It was another swing and a miss for the biopharma industry on Thursday, when a federal appeals court in Philadelphia unanimously rejected (PDF) a challenge by Novartis on the legality of the Inflation Reduction Act (IRA) Medicare price negotiation program.
    • “It was the second time this month that the U.S. Court of Appeals for the Third Circuit swatted away an IRA challenge from Big Pharma. Last week, the same three-judge panel turned back (PDF) an appeal from Bristol Myers Squibb and Johnson & Johnson, although that decision was split.
    • “Judge Thomas Hardiman, a George W. Bush appointee, registered a dissenting opinion in the appeal brought by BMS and J&J. The other judges on the panel are Joseph Biden appointee Arianna Freeman and Donald Trump appointee Peter Phipps.”
  • Beckers Payer Issues points out,
    • “The U.S. Bankruptcy Court for the Middle District of Florida has approved a bid from Humana’s CenterWell to acquire the assets of The Villages Health, the health system serving The Villages retirement community in Florida.
    • “TVH filed for Chapter 11 bankruptcy in July. The court’s Sept. 9 decision allows the organizations to move forward with the transaction, which is expected to close in the fourth quarter, pending regulatory approvals, according to a Sept. 9 news release.
    • “The deal will bring TVH’s eight primary care centers and two specialty care centers serving more than 55,000 patients under CenterWell. CenterWell operates as a payor-agnostic provider, so TVH patients will be able to continue using their current insurance plans after the transition.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. “Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in children 5-17 years old and adults 65 years and older. Hospitalizations numbers are elevated in adults 65 years and older.”
    • “Influenza
    • “RSV
      • “RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection of infants in the 2025–26 respiratory virus season.
      • “Recommendations for use of 2025-2026 seasonal influenza vaccine have also been published in CDC’s MMWR.”
  • The American Hospital News informs us,
    • “The flu hospitalization rate during the 2024-25 flu season was the highest since 2010-11, according to a report published Sept. 12 by the Centers for Disease Control and Prevention. For all age groups, flu hospitalization rates were 1.8 to 2.8 times higher than median historical rates. Like previous seasons, most hospitalized patients (89%) had one or more underlying medical conditions, nearly 17% were admitted to an intensive care unit, 6% received assistance from a mechanical ventilator and 3% died while in the hospital.
    • “Additionally, the CDC said 32% of hospitalized patients received a flu vaccine and nearly 85% received antiviral treatment. Children and adolescents aged 5-17 received the lowest proportion of antiviral treatment at approximately 62%. The CDC recommended that all individuals older than six months receive a flu vaccine annually.”
  • The New York Times adds that a “Rare but Serious Complication Shows Flu’s Potential Harm, Acute necrotizing encephalopathy, or A.N.E., can result from influenza or other infections, including Covid-19.”
  • Health Day notes that “Comorbidities are seen less often in severe respiratory syncytial virus (RSV) infection in infants younger than 3 months compared with older children, according to a study published online Sept. 9 in The Lancet Regional Health: Europe.”
  • Per the University of Minnesota’s CIDRAP,
    • “The Los Angeles County Department of Public Health (LADPH) yesterday urged residents to make sure family members are protected from measles following the death of a school-age child who was infected with the virus during infancy and developed a rare complication from the disease called subacute sclerosing panencephalitis (SSPE). Health officials said SSPE is typically fatal in people who were infected with measles during early life.” * * *
    • “In related news, the Georgia Department of Public Health today announced another measles case, which involves an unvaccinated Fulton County resident who has no known history of international travel. The patient is no longer infectious but may have exposed others from September 2 to September 11. 
    • “Some of the exposure locations include Georgia State University, a restaurant on multiple days, and soccer games and practices.”
  • Per a National Institutes of Health press release,
    • “According to a study funded by the National Institutes of Health (NIH), older Americans with chronic low back pain who received acupuncture had greater improvement in physical function and reduced pain than those who received usual medical care only, generally prescribed medications or physical therapy. Chronic low back pain is the leading cause of disability worldwide and affects over one-third of older adults in the United States. Treatment options range from pain-relieving drugs to complementary therapies, including acupuncture. There is an urgent need for safe, effective, and non-addictive pain management approaches.
    • “Of the different treatments we have for chronic low back pain, most have a somewhat modest effect. They often reduce pain by about a third at best and can help people function better,” said lead author Lynn L. DeBar, Ph.D., Kaiser Permanente distinguished investigator. “Our clinical results suggests that acupuncture is working as well as many things that are more familiar to people. We found that the size of this effect, while modest, was positive and sustained.”
  • The Washington Post relates,
    • “Exercising muscles pumps out substances that can suppress the growth of breast cancer cells, according to an important new study of exercise and cancer.
    • “The study, published last month, involved 32 women who’d survived breast cancer. After a single session of interval training or weightlifting, their blood contained higher levels of certain molecules, and those factors helped put the brakes on laboratory-grown breast cancer cells.
    • “Our work shows that exercise can directly influence cancer biology, suppressing tumor growth through powerful molecular signals,” said Robert Newton, the deputy director of the Exercise Medicine Research Institute at Edith Cowan University in Perth, Australia, and senior author of the new study.”
  • Per the AHA News,
    • “A Gallup report published Sept. 9 found that nearly 48 million Americans currently have or are being treated for depression. The total, which equals 18.3% of the population, has significantly increased since 2019 (12.5%). The rate increased to 13.8% in 2020 — the onset of the COVID-19 pandemic — and continued to sharply increase. Adults who report having been diagnosed with depression in their lifetime are at 28.5%, nearing the record high of 29% recorded in the first quarter of 2023. The report said that reduced stigma in seeking mental health treatment may partly explain rising depression diagnoses, as 70% of Americans now prefer that their doctor ask about both physical and mental health concerns.”
  • BioPharma Dive lets us know that “signs point to potential benefits of GLP-1s in oncology. Early academic research suggests various ways weight loss drugs could have an impact in cancer care.”

From the U.S. healthcare business front,

  • The Employee Benefits Reseach Institute informs us,
    • “There were 13.1 million individuals with health care claims having employment-based benefits in 2022. However, the use of health care services is far from evenly distributed across the population. In fact, a small portion of the population accounts for a disproportionately large share of health care spending. These “high users” often have significant and complex medical needs and usually require ongoing or intensive care for one or more medical conditions. This Fast Fact is the second in a series of EBRI Fast Facts related to the concentration of health care spending and examines health care spending among individuals in employment-based health plans with the top medical conditions.”
  • Willis Towers Watson calls attention to the fact that “high-cost claims are rising fast, driven by complex conditions and specialty drugs. Employers must shift to data-driven, clinically focused strategies to manage risk and improve outcomes.”
  • Milliman explains “how to build a long-range GLP-1 forecast with the goal of estimating when could commercial health plans see a plateau?”
    • “In recent years, new treatment options for type-2 diabetes and obesity have resulted in substantial changes in clinical guidelines and prescribing patterns. Commercial payers have experienced a recent surge in the utilization of glucagon-like-peptide-1 (GLP-1) medications. Also, approved indications are expanding, including those for sleep apnea and cardiovascular conditions. This white paper provides a framework for building a long-range forecast and can help employers covering these drugs understand how trends associated with these drugs may change over time.”
  • Per Health Affairs Forefront,
    • “Industry and HHS should collaborate to develop a voluntary standardized identifier for provider networks that is consistent across all segments of the health insurance markets. To accomplish this, we propose convening a working group within an accredited standards body or industry collaboration to define the details of the standard and oversee implementation.
    • “This article examines how the lack of standardized identifiers for provider networks creates many frustrations for consumers and other health care stakeholders. It also reviews the role that standardized identifiers and standards bodies play in developing seamless consumer experiences in other industries and the roles they could play in health care in assisting consumers and other stakeholders.”
  • Beckers Hospital Review warns,
    • “Seven-hundred and fifty-nine rural U.S. hospitals are at risk of closure due to financial problems, with about 40% of those hospitals at immediate risk of closure.
    • “The counts are drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through August 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure.”