Tuesday Report

Generative AI

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • Congress moved one step closer to reauthorizing a key cyber threat information-sharing law on Thursday during a hearing that highlighted both the act’s value and potential shortcomings.
    • The House Homeland Security Committee’s cyber subcommittee held the hearing [on May 15] to evaluate the private sector’s satisfaction with the 2015 Cybersecurity Information Sharing Act, which expires on Sept. 30. Witnesses from the tech industry praised the law for encouraging companies to share cyber threat indicators with each other and with federal agencies, but they also offered lawmakers suggestions for how to improve the program.”
  • Defensescoop tells us,
    • “The Department of Defense has expanded its number of cyber teams by 12, with two more slated to come online in the next few years, according to a spokesperson.
    • “The cyber mission force began building in 2012, and the initial 133 teams reached full operational capability in 2018. In DOD’s fiscal 2022 budget request, U.S. Cyber Command proposed and was eventually approved for a phased approach to add 14 additional cyber mission force teams beyond the original 133. That request and authorization in 2021 was the first substantial effort to grow that force since it was designed almost a decade ago, long before modern and advanced threats had surfaced.
    • “In 2021, the Secretary of Defense directed the creation of 14 New cyber teams by September 2028. Of the 14 teams, 12 have been established. These teams are spread across Army, Air Force, and Navy Commands,” a Cybercom spokesperson said.
    • “They declined to offer specifics regarding how many additional teams each service received or what types of teams those additional builds provided to each service — such as offensive, defensive or support teams — citing operational security.”
  • Per a May 15 HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Vision Upright MRI, a small California health care provider that conducts magnetic resonance imaging and related services, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Breach Notification and Security Rules. The settlement resolves an OCR investigation concerning the breach of an unsecured server containing the medical images of 21,778 individuals.” * * *
    • “Under the terms of the resolution agreement, Vision Upright MRI agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $5,000 to OCR.” 
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/hhs-ocr-hipaa-racap-vum/index.html“
  • Cyberscoop informs us,
    • “Federal authorities seized two domains and indicted four foreign individuals for alleged involvement in a long-running botnet service that infected older wireless internet routers, the Justice Department said Friday. 
    • “The malware created for the botnet allowed infected routers to be reconfigured, which granted unauthorized access to third parties and made the routers available for sale as proxy servers on Anyproxy.net and 5socks.net, according to law enforcement officials. Both domains, which were managed by a company headquartered in Virginia and hosted on servers worldwide, now render seizure notices under an effort the DOJ and FBI dubbed “Operation Moonlander.”
    • “The 5socks.net website claimed to be in operation for over 20 years and had more than 7,000 proxies for sale worldwide for a monthly subscription of $9.95 to $110 per month, according to prosecutors. The botnet’s overseas operations were also seized and disabled by law enforcement agencies in the Netherlands and Thailand.
    • “Authorities also indicted the botnet’s alleged administrators and charged them with conspiracy and damage to protected computers, for conspiring with others to maintain, operate and profit from the bot.”
  • and
    • Liridon Masurica, the alleged lead administrator of cybercrime marketplace BlackDB.cc, was extradited to the United States on Friday and faces charges that carry a maximum penalty of 55 years in federal prison, the Justice Department said Tuesday. 
    • Masurica, 33, who is also known as “@blackdb,” was arrested by authorities in Kosovo on Dec. 12. He made his initial appearance in federal court in Tampa, Fla., on Tuesday and was ordered detained pending a trial. 
    • Federal prosecutors charged Masurica with one count of conspiracy to commit access device fraud and five counts of fraudulent use of 15 or more unauthorized access devices.
    • Masurica, of Gjilan, Kosovo, is accused of running BlackDB.cc since 2018. The cybercriminal marketplace offered to sell compromised account and server credentials, credit card information and other personally identifiable information of individuals mostly located in the United States, the DOJ said.

From the cybersecurity breaches and vulnerabilities front,

  • Cyberscoop reports,
    • “Hundreds of victims are surfacing across the world from zero-day cyberattacks on Europe’s biggest software manufacturer and company, in a campaign that one leading cyber expert is comparing to the vast Chinese government-linked Salt Typhoon and Volt Typhoon breaches of critical infrastructure.
    • “The zero-days — vulnerabilities previously unknown to researchers or companies, but that malicious hackers have discovered — got patches this month and last month, but there are signs it could be getting worse before it gets better, according to Dave DeWalt, CEO of NightDragon, a venture capital and advisory firm. Ransomware gangs are now reported to be exploiting it, beyond the original Chinese government-connected attackers.
    • “The net of it is this is like the Typhoon size, so much like we saw [with] Volt Typhoonand then Salt Typhoon,” DeWalt told CyberScoop. “Once these exploits get into the wild, it’s a race to see who can get more access to it. So initially it looks like three Chinese actors all used it, and now we’re going to see more.”
    • “A number of companies have been tracking the vulnerability and its consequences, including one, Onapsis, that DeWalt’s company invests in, along with EclecticIQ, ReliaQuest and Google’s Mandiant.”
  • and
    • “Over the past few years, cybersecurity experts have increasingly said that nation-state operatives and cybercriminals often blur the boundaries between geopolitical and financial motivations. A new report released Wednesday shows how North Korea has flipped that idea on its head. 
    • “North Korea has silently forged a global cyber operation that experts now liken to a mafia syndicate, with tactics and organization far removed from other nation-state actors, according to a comprehensive new report released by DTEX Systems.
    • “The study — based on years of investigations, technical analysis, and work with other open-source intelligence analysts — pulls back the curtain on a highly adaptive regime that has built its cyber capabilities on a survivalist, profit-driven approach. It reveals a hierarchy blending criminality, espionage, and front-line IT work, coordinated by an authoritarian government that rewards loyalty and secrecy while punishing failure.” * * *
    • “You can read the full report on DTEX’s website.”
  • Cybersecurity Dive relates.
    • “The FBI is warning about a threat campaign in which malicious actors are impersonating senior U.S. officials using malicious text messages and AI-generated voice messages.
    • “The messages have been sent to current and former federal and state officials and others who may be contacts of those individuals, the bureau said in an alert released Thursday.
    • “The messages are designed to establish a rapport with individuals who might then turn over access to a personal account, according to the alert. These social engineering techniques could be used to reach additional contacts and gain access to additional information or funds.”
  • Bleeping Computer lets us know,
    • “A new tool called ‘Defendnot’ can disable Microsoft Defender on Windows devices by registering a fake antivirus product, even when no real AV is installed.
    • “The trick utilizes an undocumented Windows Security Center (WSC) API that antivirus software uses to tell Windows it is installed and is now managing the real-time protection for the device.
    • “When an antivirus program is registered, Windows automatically disables Microsoft Defender to avoid conflicts from running multiple security applications on the same device.
    • “The Defendnot tool, created by researcher es3n1n, abuses this API by registering a fake antivirus product that meets all of Windows’ validation checks. * * *
    • “While Defendnot is considered a research project, the tool demonstrates how trusted system features can be manipulated to turn off security features.
    • “Microsoft Defender is currently detecting and quarantining Defendnot as a ‘Win32/Sabsik.FL.!ml; detection.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added nine known exploited vulnerabilities to its catalog this week.
  • May 13, 2025
    • “CVE-2025-30400 Microsoft Windows DWM Core Library Use-After-Free Vulnerability
    • “CVE-2025-32701 Microsoft Windows Common Log File System (CLFS) Driver Use-After-Free Vulnerability
    • “CVE-2025-32706 Microsoft Windows Common Log File System (CLFS) Driver Heap-Based Buffer Overflow Vulnerability
    • “CVE-2025-30397 Microsoft Windows Scripting Engine Type Confusion Vulnerability
    • “CVE-2025-32709 Microsoft Windows Ancillary Function Driver for WinSock Use-After-Free Vulnerability”
      • Crowdstrike discusses these KVEs here.
      • Cyberscoop discusses Microsoft’s May 13 Patch Tuesday here.
      • See also Bleeping Computer article titled “Microsoft confirms May Windows 10 updates trigger BitLocker recovery”
  • May 14, 2025
    • “CVE-2025-32756 Fortinet Multiple Products Stack-Based Buffer Overflow Vulnerability”
      • Rapid 7 discusses this KVE here.
  • May 15, 2025
    • “CVE-2024-12987 DrayTek Vigor Routers OS Command Injection Vulnerability
      • This KVE is discussed here.
    • “CVE-2025-4664 Google Chromium Loader Insufficient Policy Enforcement Vulnerability
      • This KVE is discussed here.
    • “CVE-2025-42999 SAP NetWeaver Deserialization Vulnerability”
      • The KVE is discussed here.
  • Cyberscoop adds,
    • “Apple rolled out a series of substantial security updates Monday for its major software platforms, with advisories covering iOS, iPadOS, and two versions of macOS lines, addressing more than 30 vulnerabilities in total. 
    • “Among the numerous fixes, iOS 18.5 and iPadOS 18.5 introduce the first security update for Apple’s in-house C1 modem, featured in the newly released iPhone 16e. The patch addresses a baseband vulnerability (CVE-2025-31214) that, according to the company, could have allowed an attacker “in a privileged network position” to intercept network traffic. While the specific details remain undisclosed, the risk highlights concerns about how devices communicate on the hardware level, since baseband processors control things like data transmission, call processing, and other network functions.”
  • PC World reports
    • “Malware is a thing you just have to be aware of. But it’s pretty rare that it can actually damage your computer in a permanent sense — wipe the drive if you’re okay with losing local data, and you can generally get up and running in a day or two. But what if the microcode running on your CPU’s tiny integrated memory becomes infected? One security researcher says he’s done it.
    • “Christiaan Beek of Rapid7 says he has created a proof-of-concept ransomware that can hide inside a CPU’s microcode, building on previous work that emerged when Google required AMD processors to always return “4” when asked for a random number. He claims that modifying UEFI firmware can install an unsigned update to the processor, slipping past any kind of conventional antivirus or OS-based security.” * * *
    • “CPU-level ransomware has not been seen “in the wild,” and it seems likely that when and if it emerges, it’ll be a state-level actor that exploits it first. That means your typical user probably won’t be targeted, at least immediately. Still, maybe keep a remote backup of your important files, just in case.”

From the ransomware front,

  • Per a news release,
    • “Black Kite, the leader in third-party cyber risk intelligence, today announced its newest report, 2025 Ransomware Report: How Ransomware Wars Threaten Third-Party Cyber Ecosystems, which provides a deep analysis into evolving ransomware trends and threats. The report found that threats have escalated with more actors, less predictability, and deeper entanglement in supply chains, underscoring an urgent need for organizations to implement intelligence-driven defenses and proactive vendor monitoring.”
  • Beckers Hospital Review tells us,
    • “From October 2009 to October 2024, ransomware and hacking have increasingly driven healthcare data breaches, a May 14 study published in JAMA Network Open found. 
    • “The study examined ransomware attacks and other hacking incidents across all healthcare organizations covered by HIPAA from October 2009 through October 2024. It analyzed breaches affecting 500 or more patient records that were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights.”
  • Cybersecurity Dive reports,
    • “A cybercrime gang believed to be responsible for three attacks in the U.K. in recent weeks has turned its attention toward the U.S. and has been able to compromise multiple targets in the sector, according to researchers from Google Threat Intelligence Group and Google subsidiary Mandiant. 
    • “Researchers said the same threat actors linked to attacks against U.K. companies are now using well-crafted social engineering techniques against U.S. retail companies.  
    • “The threat group, tracked as UNC3944 or Scattered Spider, is widely considered the prime suspect in the attacks on British firms Harrods, Co-op and M&S, but Mandiant and Google have not formally attributed the intrusions to any specific actor. Researchers said, however, that the hackers behind the U.S. attacks share the same techniques and procedures as the intruders in the British incidents.”
  • Dark Reading adds,
    • “While dynamic DNS services have been around for many years, they’ve recently emerged as an integral tool in the arsenals of cybercriminal groups like Scattered Spider.
    • “Dynamic DNS (DDNS) services automatically update a domain name’s DNS records in real-time when the Internet service provider changes the IP address. Real-time updating for DNS records wasn’t needed in the early days of the Internet when static IP addresses were the norm.” * * *
    • “In a blog post last month, threat intelligence vendor Silent Push reported that despite some notable arrests of alleged members in 2024, Scattered Spider was actively engaged in new phishing campaigns targeting well-known enterprises. One of the key findings of the report was a shift in tactics from Scattered Spider members that featured the use of rentable subdomains from dynamic DNS providers like it.com Domains LLC.
    • “In an example of an observed attack, Scattered Spider actors established a new subdomain, klv1.it[.]com, designed to impersonate a similar domain, klv1.io, for Klaviyo, a Boston-based marketing automation company.
    • “Silent Push’s report noted that the malicious domain had just five detections on VirusTotal at the time of publication. The company also said the use of publicly rentable subdomains presents challenges for security researchers.”
  • Bleeping Computer points out,
    • “Ransomware gang members increasingly use a new malware called Skitnet (“Bossnet”) to perform stealthy post-exploitation activities on breached networks.
    • “The malware has been offered for sale on underground forums like RAMP since April 2024, but according to Prodaft researchers, it started gaining significant traction among ransomware gangs since early 2025.
    • ‘Prodaft told BleepingComputer they have observed multiple ransomware operations deploying Skitnet in real-world attacks, including BlackBasta in Microsoft Teams phishing attacks against the enterprise, and Cactus.”

From the cybersecurity business and defenses front,

  • Cyberscoop reports,
    • “Proofpoint has entered into an agreement to acquire Hornetsecurity Group, a Germany-based provider of Microsoft 365 security services, in a deal reportedly valued at more than $1 billion.
    • “The acquisition, described as the largest in Proofpoint’s history, comes amid accelerating consolidation in the cybersecurity industry as companies seek to broaden their offerings to enterprise customers of all sizes. While Proofpoint did not disclose terms, CNBC reports the deal is “well over” $1 billion. 
    • “Hornetsecurity, headquartered in Hannover, Germany, serves more than 12,000 managed service providers (MSPs) and 125,000 small and mid-sized businesses (SMBs) primarily across Europe. According to a press release announcing the deal, Hornetsecurity brings in $160 million in annual recurring revenue, with growth exceeding 20% year over year. 
    • “For Proofpoint, the acquisition provides an entry point into the SMB market through Hornetsecurity’s established MSP network.'” * * *
    • “The transaction comes as Proofpoint, which was taken private by Thoma Bravo in 2021for $12.3 billion, is exploring an IPO, according to the CNBC report.” 
  • and
    • “Coinbase responded to a security incident with combative measures Thursday after the company said cybercriminals bribed some of the cryptocurrency exchange’s international support staff to steal data on customers. The unnamed threat group stole personally identifiable information and other sensitive data on less than 1% of Coinbase’s monthly users, the company said in a blog post.
    • “The cybercriminals contacted customers under the guise of an employee at Coinbase in an attempt to dupe people into relinquishing their cryptocurrency. “They then tried to extort Coinbase for $20 million to cover this up. We said no,” the company said.
    • Coinbase flipped the script as part of its response. “Instead of paying this $20 million ransom, we’re turning it around and we’re putting out a $20 million award for any information leading to the arrest and conviction of these attackers,” Coinbase CEO Brian Armstrong said in a video posted on X.
    • “For these would-be extortionists, or anyone seeking to harm Coinbase customers, know that we will prosecute you and bring you to justice,” he added.” 
  • Dark Reading shares insights on the recent RSAC conference and of course also offers its CISO Corner.

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican spending hawks blocked the party’s giant tax-and-spending bill on Friday, delivering President Trump a setback over disagreements on Medicaid, clean-energy tax breaks and budget deficits.
    • “The holdouts—Reps. Chip Roy of Texas, Ralph Norman of South Carolina, Josh Brecheen of Oklahoma and Andrew Clyde of Georgia—stopped the Budget Committee from advancing the legislation, which leaders hope to pass by the full House next week. The panel failed to move the bill on a 16-21 vote, with those four Republicans and Rep. Lloyd Smucker (R., Pa.) joining all Democrats in opposition. Smucker, who backs the measure, said he voted no for procedural reasons, so he can call for a revote later.
    • “Budget Committee Chairman Jodey Arrington (R., Texas) said lawmakers were close to agreements on making changes to win the necessary votes. The committee scheduled its session to resume at 10 p.m. Sunday.”
  • and
    • “The U.S. lost its last triple-A credit rating.
    • “Moody’s Ratings downgraded the U.S. government on Friday, citing large fiscal deficits and rising interest costs.
    • “Runaway budget deficits mean U.S. government borrowing will balloon at an accelerating rate, pushing interest rates up over the long term, Moody’s said. The firm said in a March report that fiscal weakness looked set to continue even under analysts’ best-case scenarios.”
  • Modern Healthcare adds,
    • “Long-sought legislation to monitor and restrict how pharmacy benefit mangers operate could finally pass — if Republicans can move their sweeping budget bill that includes a string of those provisions.
    • ‘New PBM measures are tucked into the bill advanced Wednesday by the House Energy and Commerce Committee, which aims to cut more than $880 billion in spending, including $625 billion from Medicaid. The restrictions have long been championed by Health Subcommittee Chair Buddy Carter (R-Ga.), who was a pharmacist before becoming a congressman.”
  • Per Govexec
    • “The Trump administration is abiding by a court order to pause layoffs across most federal agencies, but it is still finding ways to shrink the federal workforce through involuntary means. 
    • “The Housing and Urban Development Department has begun once again firing its probationary employees—those recently hired or promoted—through a process distinct and separate from a reduction in force. Other agencies, including the Labor Department and National Science Foundation, meanwhile, are walking back recent RIFs due to a court-issued temporary restraining order. 
    • “That order specifically prevented agencies from issuing layoffs or taking any action to implement their Agency RIF and Reorganization Plans, which were mandated by the Office of Management and Budget and the Office of Personnel Management earlier this year. Agencies that were on the cusp of implementing RIFs, such as the Interior Department, have put those plans on ice at least until the restraining order is set to expire after May 23.”
  • FedWeek called our attention to this OPM benefits administration letter about “Family Member Eligibility Verification Updates and Enrollment Processing.”
  • Fierce Pharma informs us,
    • “On the heels of a production-tinged executive order earlier this month, the Trump administration is doubling down on efforts to boost medicine manufacturing in the U.S.
    • “In a new public-private partnership spearheaded by the administration, the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) are linking up with several universities and companies in a bid to improve manufacturing for essential medicines using technologies such as artificial intelligence, machine learning and informatics.
    • “The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban’s Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release.”
  • STAT News reports,
    • “Optum, the health data and care provider division of UnitedHealth Group, is developing a way to calculate how sick Medicare patients are through artificial intelligence, instead of relying solely on diagnosis codes submitted by physicians.
    • “Ken Cohen, a physician and Optum’s executive director of translational research, said Thursday at a conference organized by America’s Physician Groups that he was working with the Duke-Margolis Institute for Health Policy on this “next generation” of Medicare risk coding using AI.”

From the FDA front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
    • “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
  • STAT News adds,
    • “Jason Karlawish, a professor of medicine at the University of Pennsylvania who specializes in Alzheimer’s research, said that “used right, this is a test that could really help to improve the diagnostic experience.”
    • “But with the availability of easier-to-use tests, there’s always the risk of “some frisky prescribing habits,” Karlawish said. Particularly in the field of Alzheimer’s, where just a small number of doctors are trained to treat the increasingly common condition, “the outcome can be inappropriate prescribing of the tests because a lot of people have a desire to get it, but not a lot of clinicians know how to properly use it.”
    • “The test should only be used to help diagnose people who have confirmed cognitive impairment, and there’s a risk some doctors may skip the step of confirming, as it’s “much easier to order a test than it is to talk to a patient,” Karlawish said. 
    • “Still, “in the history of Alzheimer’s disease, this is a big day,” he said. “The notion 10 years ago that there’d be a blood test that detects the pathologies of Alzheimer’s was a bit of a science fiction fantasy kind of story, and now here it is FDA-approved and ready for clinical practice.”
  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ (AMRX.O), opens new tab self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.
    • “The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday.”

From the judicial front,

  • The American Hospital Association News informs us,
    • “A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies. 
    • “Judge Dabney Friedrich issued the ruling in a case brought by a number of drug companies, finding that when the statute says that in implementing price reductions, “any rebate or discount” taken into account shall be “as provided by the Secretary,” it means that HHS has the authority to approve or reject the proposed rebate models. “Put another way, the statute contemplates that the Secretary may ‘have as a condition’ or ‘stipulate’ how any rebate or discount is accounted for in the price ultimately paid by covered entities.” * * *
    • “HHS recently announced that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May.”

From the public health and medical research front.

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low and declining.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The University of Minnesota CIDRAP notes,
    • “The US measles picture grew by 23 cases this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “A total of 1,024 confirmed measle cases have been reported from 31 jurisdictions, with 14 outbreaks (defined as 3 or more related cases). Ninety-two percent of confirmed cases are outbreak-associated.
    • “Of the cases, 96% have occurred in people who are either unvaccinated or have unknown vaccination status, and 128 (13%) of case-patients have been hospitalized, including 69 children under the age of 5. Three deaths have been confirmed to date, including two in unvaccinated school-aged children.” * * *
    • “The CDC notes on its measles outbreak page that one the reasons for more measles activity is because MMR coverage among kindergartners is now below 95%—the level needed to maintain elimination status. Two doses of the MMR vaccine are 97% effective at preventing measles, and one dose is about 93% effective.”
  • The American Journal of Managed Care lets us know,
    • “Higher dietary inflammatory index (DII) scores are significantly associated with an increased risk of Alzheimer disease–related death among American adults, according to a study published in Experimental Gerontology.
    • “Although the exact mechanisms of Alzheimer disease remain unknown, accumulating evidence suggests that chronic inflammation plays a key role in its pathogenesis and progression. In particular, past research shows that neuroinflammation accelerates neuronal damage, synaptic loss, and cognitive decline observed in patients with Alzheimer disease.
    • “Anti-inflammatory diets can alleviate neuroinflammation in patients with Alzheimer disease by reducing systemic inflammation through several immune pathways in the brain and indirectly through the gut microbiome and body circulation pathways. Therefore, the researchers emphasized that an anti-inflammatory diet may constitute a beneficial nutritional approach in Alzheimer disease management.”
  • The Wall Street Journal reports
    • “Electricity is gaining traction as a potential treatment for diseases like cancer and rheumatoid arthritis.
    • “Companies like Novocure and SetPoint Medical are developing devices that use electricity to treat diseases.
    • “Clinical trials show promise, with devices extending survival for some cancer patients and improving arthritis symptoms.”
  • STAT News adds,
    • “Leading oncologists said this week that artificial intelligence will one day be as integrated into cancer care as it is in smartphones and self-driving cars — and that this is a change we should welcome.
    • “Their comments, made at STAT’s Breakthrough Summit West on Wednesday, reflected an optimistic view for how the health care system can use AI across nearly all aspects of cancer care, from matching patients with clinical trials to predicting how they might fare on a given treatment. Some of this work is already happening. The panelists noted that AI has the potential to offer deep expertise across a growing number of precisely defined cancer indications, and that the technology can generate insights research focused on individual hypotheses might miss.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Cleveland Clinic reported an operating income of $52.8 million (1.3% margin) in the first quarter, up slightly from $50.2 million (1.3% margin) in the same period last year, according to financial documents published May 16.”
  • and
    • “Phoenix-based Banner Health reported an operating income of $142.4 million (3.6% margin) in the first quarter, up from an $89.3 million operating gain (2.4% margin) in the first quarter of 2024, according to financial documents published May 15.”
  • Healthcare Dive reports,
    • “Rite Aid is selling more than 1,000 pharmacies to rival drugstore operators as the beleaguered “pharmacy chain limps through bankruptcy processes for a second time.
    • Rite Aid said it was formally pursuing sales of “substantially all of its assets” earlier this month. Now, healthcare companies CVS Health and Walgreens, along with grocery stores Albertsons, Kroger and Giant Eagle, are among the buyers snapping up Rite Aid stores, the company said on Thursday.
    • “CVS is one of the biggest buyers, agreeing to acquire prescription files from 625 Rite Aid locations in 15 states in areas where it already has a presence, along with fully buying and operating 64 stores in Idaho, Oregon and Washington. The sales are subject to approval by a New Jersey bankruptcy court, which is scheduled to hold a hearing on May 21 regarding the transactions.”
  • Fierce Healthcare tells us,
    • “More than 6 in 10 survey respondents say they expect their healthcare organizations to see higher revenue from value-based care arrangements this year than in 2024, according to a joint report from the National Association of Accountable ACOs and health tech company Innovaccer.
    • “The report surveyed 168 executive and clinical leaders at health systems, accountable care organizations, specialty providers, federally qualified health centers and other delivery organizations.
    • “The findings indicate a growing reliance on VBC programs for some organizations. A significant segment, 30%, of organizations said a quarter of their revenue is tied to VBC contracts. More than 20% indicated at least half of their revenue is derived from fully capitated or downside risk contracts.
    • “Three-fourths of respondents believe further financial support would propel VBC adoption more.”
  • The Wall Street Journal reports,
    • “Novo Nordisk CEO Lars Fruergaard Jorgensen is stepping down after eight years in the role.
    • “The move follows market challenges, a share-price decline, and pressure from its controlling foundation.
    • “Former CEO Lars Rebien Sorensen will join the board amid concerns about losing ground to Eli Lilly.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity and law enforcement front,

  • Cyberscoop reports,
    • “Homeland Security Secretary Kristi Noem outlined her plans Tuesday to refocus the Cybersecurity and Infrastructure Security Agency (CISA) on protecting critical infrastructure from increasingly sophisticated threats — particularly from China — while distancing the agency from what she characterized as mission drift under previous leadership.
    • “Speaking at the 2025 RSAC Conference, Noem provided the most detailed vision yet of how the current administration is pushing CISA to a “back-to-basics” approach aimed at hardening defenses against adversaries who have demonstrated capabilities to infiltrate critical systems.”
  • and
    • “Threat intelligence sharing is flowing between the private sector and federal government and remains unimpeded thus far by job losses and budget cuts across federal agencies that support the cyber mission, according to executives at major security firms.
    • “Top brass at Amazon, CrowdStrike, Google and Palo Alto Networks said there’s been no change to interactions with the federal government since President Donald Trump was inaugurated earlier this year.
    • “Across multiple interviews and media briefings during the RSAC 2025 Conference this week, none of the leaders at these top cybersecurity companies conveyed any concern about or experience with communication breakdowns. Each of them dismissed the idea that collaboration has slowed down amid significant workforce reductions and strategic changes across the federal government.”
  • Earlier this week, the National Institute of Standards and Technology released its FY 2024 Cybersecurity & Privacy Program Annual Report.
  • Federal News Network tells us,
    • “While much of the cybersecurity community’s attention was out west at the annual RSA Conference, the Justice Department announced yet another settlement in its pursuit of contractors who falsely attest to meeting cybersecurity requirements.
    • “DoJ announced today that Raytheon Company, RTX Corporation and Nightwing Group have agreed to pay $8.3 million to settle allegations that Raytheon violated the False Claims Act by falling short of contractually mandated cybersecurity standards.
    • “RTX sold its cybersecurity, intelligence and services business to Nightwing in 2024. DoJ’s case centered on conduct between 2015 and 2021, prior to the acquisition.
    • “The case is another feather in the cap for DoJ’s Civil-Cyber Fraud Initiative. Started under the Biden administration, the goal of the initiative is to enforce cybersecurity requirements that many contractors had been ignoring through the False Claims Act.”
  • Per the Hacker News,
    • “The U.S. Department of Justice (DoJ) on Thursday announced charges against a 36-year-old Yemeni national for allegedly deploying the Black Kingdom ransomware against global targets, including businesses, schools, and hospitals in the United States.
    • “Rami Khaled Ahmed of Sana’a, Yemen, has been charged with one count of conspiracy, one count of intentional damage to a protected computer, and one count of threatening damage to a protected computer. Ahmed is assessed to be currently living in Yemen.
    • “From March 2021 to June 2023, Ahmed and others infected computer networks of several U.S.-based victims, including a medical billing services company in Encino, a ski resort in Oregon, a school district in Pennsylvania, and a health clinic in Wisconsin,” the DoJ said in a statement.”
  • Cyberscoop adds,
    • “Federal authorities extradited a Ukrainian citizen to the United States on Wednesday to face charges for participating in a series of ransomware cyberattacks on organizations based in the U.S. and multiple European countries. 
    • “Artem Stryzhak, 35, was arrested in Spain in June 2024 and was scheduled to appear for arraignment Thursday in the U.S. District Court for the Eastern District of New York. Stryzhak is accused of conspiracy to commit fraud and related activity, including extortion.
    • “Prosecutors accuse Stryzhak and his co-conspirators of using Nefilim ransomware to encrypt computer networks in the U.S., Canada, France, Germany, Australia, the Netherlands, Norway and Switzerland between late 2018 to late 2021.
    • “As alleged, the defendant was part of an international ransomware scheme in which he conspired to target high-revenue companies in the United States, steal data, and hold data hostage in exchange for payment. If victims did not pay, the criminals then leaked the data online,” John Durham, U.S. attorney for the Eastern District of New York, said in a statement.”

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive reports,
    • “Hackers are increasingly using AI in their attacks and defenders should follow suit, Check Point Software Technologies said in a report published Wednesday.
    • “The company’s AI security report, announced at the 2025 RSAC Conference in San Francisco, also found that one in 13 generative AI prompts contained potentially sensitive information, and one in every 80 prompts posed “a high risk of sensitive data leakage.”
    • “Unauthorized AI tools, data loss, and AI platform vulnerabilities topped the list of AI risks for enterprises, according to Check Point.”
  • and
    • “In a report published Tuesday, Google said it saw hackers exploit fewer zero-day vulnerabilities in the wild in 2024 than in 2023.
    • “The company attributed the decrease to improvements in secure software development practices.
    • “Still, Google said it is seeing a “slow but steady” increase in the rate of zero-day exploitation over time.”
  • CISA added eight known exploited vulnerabilities to its catalog this week.
  • “April 28, 2025
    • “CVE-2025-1976 Broadcom Brocade Fabric OS Code Injection Vulnerability
    • “CVE-2025-42599 Qualitia Active! Mail Stack-Based Buffer Overflow Vulnerability
    • “CVE-2025-3928 Commvault Web Server Unspecified Vulnerability”
    • Bleeping Computer discusses these KVEs here.
  • “April 29, 2025
    • “CVE-2025-31324 SAP NetWeaver Unrestricted File Upload Vulnerability”
    • Cybersecurity Dive discusses this KVE here.
  • “May 1, 2025
    • “CVE-2024-38475 Apache HTTP Server Improper Escaping of Output Vulnerability
    • “CVE-2023-44221 SonicWall SMA100 Appliances OS Command Injection Vulnerability
    • Cybersecurity News discusses the Apache KVE here.
    • Bleeping Computer discusses the SonicWall KVE here.
  • “May 2, 2025
    • “CVE-2025-34028 Commvault Command Center Path Traversal Vulnerability
    • “CVE-2024-58136 Yiiframework Yii Improper Protection of Alternate Path Vulnerability”
    • Security Affairs discusses these KVEs here.

From the ransomware front,

  • Techradar points out,
    • New research has revealed the scale of recent ransomware revolution, warning it remains a dominant threat to organizations worldwide.
    • A Veeam study, which gathered insights from 1,300 CISOs, IT leaders, and security professionals across the Americas, Europe, and Australia, found nearly three-quarters of businesses were impacted by ransomware over the past year.
    • Cybersecurity measures seem to be having some effect, with businesses facing ransomware incidents dropping slightly from 75% to 69% – and ransomware payments are also decreasing, as in 2024, 36% of affected businesses chose not to pay, and 60% of those who did paid less than half of the demanded ransom.
  • Dark Reading adds,
    • “Several high-profile retailers based in the UK have suffered cyberattacks in recent weeks, and all signs point to two possible threat actors being behind the campaign.
    • “The National Cyber Security Centre (NCSC), the UK’s primary cyber agency, said on May 1 that it was tracking a series of attacks impacting retailers. NCSC CEO Dr. Richard Horne said in an included statement that the agency was working with affected organizations and that “these incidents should act as a wake-up call to all organizations.”
    • “Co-Op, Marks & Spencer, and Harrods are among the retailers that have confirmed attacks in recent weeks. In an article published May 2, Bloomberg News reported a spokesperson for the DragonForce ransomware gang — a group that emerged as a ransomware-as-a-service (RaaS) player in 2023 — took credit for the attacks against all three retailers.
    • “Last month, researchers from Sophos’ Secureworks reported that DragonForce had an RaaS model where affiliates could create their own “brand,” using DragonForce’s ransomware or using their own tools for extortion attacks.”
  • and
    • “The notorious Scattered Spider threat group continues to attack high-value targets despite landing on the receiving end of multiple global law enforcement operations.
    • “Scattered Spider gained notoriety in recent years with high-profile breaches and ransomware attacks against large enterprises, including Las Vegas casino and hotel giants Caesars Entertainment and MGM Resorts in 2023. First emerging in 2022, the group’s members displayed a knack for social engineering schemes that allowed them to steal credentials from targeted organizations and gain privileged access into their networks. * * *
    • Bleeping Computer this week reported that the cyberattack against British retail giant Marks & Spencer was perpetrated by members of the group using DragonForce ransomware. Earlier this month, threat intelligence vendor Silent Push said it had observed significant threat activity, specifically phishing campaigns targeting well-known brands this year, from Chick-fil-A to Louis Vuitton.
  • and
    • “RansomHub, an aggressive ransomware-as-a-service (RaaS) operation that gained prominence over the past year in the wake of law enforcement actions against LockBit and ALPHV, appears to have abruptly gone dark earlier this month.
    • “In a new report this week that offers an in-depth look at RansomHub’s affiliate recruitment methods, negotiation tactics, and aggressive extortion strategies, researchers at Group-IB described the operation as inactive since April 1.
    • “Cybercriminals associated with the operation may have migrated to the Russian-language speaking Qilin RaaS operation and are continuing their attacks under that banner, Group-IB said. The security vendor did not offer any explanation for the rapidly growing RansomHub operation’s seemingly sudden and unexpected demise — if that is indeed what it is.”
  • TechTarget offers a “look at the [seven] distinct stages of the ransomware lifecycle to better understand how attackers strike — and how defenders might be better able to resist.

From the cybersecurity defense front,

  • Cyberscoop reports
    • “Leaders of various federal research agencies and departments outlined a vision Tuesday for the future of critical infrastructure security, emphasizing the promise of combining formal software development methods with large language models (LLMs). 
    • “Acting DARPA Director Rob McHenry told an audience at the RSAC 2025 Conference that such a combination could “virtually eliminate software vulnerabilities” across foundational system infrastructures, a departure from the traditionally accepted risks of software flaws.
    • “We’ve all been trained in a world where we have to accept that there are vulnerabilities in our software, and bad guys exploit those vulnerabilities,” he said. “We try to mitigate the damage and patch them, and we go round on this merry-go-round. That technologically does not need to be true anymore.”
    • “DARPA’s statements came in the context of the AI Cyber Challenge, a public-private collaboration involving industry leaders such as Google, Microsoft, Anthropic and OpenAI. The initiative tests whether advanced AI systems can identify and patch vulnerabilities in open-source software components vital to the electric grid, health care, and transportation.”
  • and
    • “Cryptography experts say the race to fend off future quantum-computer attacks has entered a decisive but measured phase, with companies quietly replacing the internet plumbing that the majority of the industry once considered unbreakable.
    • “Speaking at Cloudflare’s Trust Forward Summit on Wednesday, encryption leaders at IBM Research, Amazon Web Services and Cloudflare outlined how organizations are refitting cryptographic tools that safeguard online banking, medical data and government communications. The aim is to stay ahead of quantum machines that, once powerful enough, could decode the math protecting today’s digital traffic.
    • “Over the next five to 10 years you’re going to see a Cambrian explosion of different cryptographic systems,” said Wesley Evans, a product manager for Cloudflare’s research team, referring to an evolutionary period with a rapid diversification of animal life that occurred roughly 540 million years ago.” 
  • Dark Reading adds,
    • “Each year, top SANS faculty joins the RSAC conference to present what their community of practitioners and researchers see as the most pressing challenges facing the cybersecurity community for the year to come. This year’s list of top-five threats aren’t merely technical, and tackling them will demand coordinated leadership from the very top of the organization and beyond.
    • “The attack techniques outlined in the SANS RSAC 2025 keynote underscore a common theme: Cybersecurity is no longer confined to the security operations center — it’s a leadership issue that impacts every layer of the enterprise,” according to a SANS media statement. “The threats of tomorrow demand a strategic, integrated response rooted in visibility, agility, and cross-functional alignment.”
  • Bleeping Computer notes,
    • “Microsoft has announced that all new Microsoft accounts will be “passwordless by default” to secure them against password attacks such as phishing, brute force, and credential stuffing.
    • “The announcement comes after the company started rolling out updated sign-in and sign-up user experience (UX) flows for web and mobile apps in March, optimized for passwordless and passkey-first authentication.
    • “As part of this simplified UX, we’re changing the default behavior for new accounts. Brand new Microsoft accounts will now be ‘passwordless by default’,” said Joy Chik, Microsoft’s President for Identity & Network Access, and Vasu Jakkal, Corporate Vice President for Microsoft Security.”
  • Here is a link to Dark Reading’s CISO Corner.

Tuesday Report

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “National Institutes of Health director Jay Bhattacharya on Monday asserted that the agency remains committed to research that advances the health of minorities — despite the Trump administration’s sharp focus on rolling back programs dealing with diversity, equity, and inclusion.
    • “Bhattacharya said that President Trump’s executive orders, which state that DEI programs are illegal and discriminatory and direct federal agencies to terminate any of their own such programs, are “misunderstood.”
    • “I don’t think that [the orders are] aimed at stopping fundamental research that advances the health and wellbeing of minority populations. I wouldn’t have accepted this job if that was the case,” he said. “I think that the health and wellbeing of minority populations, as well as every American, are a central focus of the NIH and will continue to be under my watch.”
  • The NIH’s understanding matches the FEHBlog’s reading of those DEI program executive orders, which are directed at workforces, not healthcare.
  • The Wall Street Journal adds,
    • “For months, investors have feared that Health and Human Services Secretary Robert F. Kennedy Jr. and his Make America Healthy Again movement would derail biomedical innovation. His ousting of Peter Marks—a senior official at the Food and Drug Administration and key proponent of faster drug approvals—sent biotech stocks tumbling last month and stoked concerns that the agency was being politicized and turned against science.
    • “A more nuanced narrative is now taking shape. 
    • “While heightened vaccine scrutiny and sweeping FDA staff cuts remain serious threats, recent signals have been more upbeat. In an interview late last week, newly appointed FDA Commissioner Marty Makary—a former Johns Hopkins surgeon—delivered a relatively bullish message for the biotech sector. Speaking with Megyn Kelly, Makary said he would speed up approvals for rare-disease treatments, cut reliance on animal testing by incorporating computational models and shorten the industry’s typical 10-year drug- development timeline.
    • “He also vowed to reduce pharmaceutical companies’ influence over the FDA approval process and end what he called the agency’s “cozy” relationship with the industry. Importantly, he emphasized a commitment to protecting innovation and maintaining a science-based approach to regulation.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again.
    • “The FDA is taking the following actions:
      • “Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
      • “Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
      • “Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
      • “Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
      • “Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
      • “Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.”
  • The U.S. Public Health Service Task Force posted the following draft grade B recommendation that applies to “Pregnant and postpartum women who are at increased risk of perinatal depression.”
    • “The USPSTF recommends that clinicians provide or refer those at increased risk of perinatal depression to counseling interventions during pregnancy and the postpartum period.”
    • The recommendation notes “When final, this recommendation will update the 2019 recommendation statement on interventions to prevent perinatal depression. The current draft recommendation is consistent with the 2019 recommendation; both are B recommendations”
    • The public comment period ends on May 19, 2025.

From the public health and medical research front,

  • The New York Times reports,
    • “The spread of measles in the Southwest now constitutes the largest single outbreak since the United States declared the disease eliminated in 2000, federal scientists told state officials in a meeting on Monday.
    • “The New York Times obtained a recording of the meeting. Until now, the Centers for Disease Control and Prevention had not publicly described the outbreak in such stark terms.
    • “More measles cases were reported mostly in Orthodox Jewish communities in New York City and New York State in 2019. But health officials regard those as separate outbreaks, because they were fueled by multiple introductions of the virus by international travelers.
    • “C.D.C. officials now view the spread of measles in Texas, Oklahoma and New Mexico as a single outbreak, Dr. Dan Filardo, who leads the agency’s task force for the measles response, told state health officials at the meeting.”
  • Medscape makes five long COVID predictions for 2025 and beyond.
  • The American Hospital Association News tells us,
    • “A study published April 17 by BMC Infectious Diseases found increased incidents of Acinetobacter baumanniiand carbapenem-resistant A. baumannii infections between 2018 to 2022. A. baumannii is a pathogen considered to be a major cause of health care-associated infections. The study found that A. baumannii cases per 100 hospitalization encounters grew from 1.15 in 2018 to 1.25 in 2021, before dropping to 1.11 in 2022. The CRAB incidence rate grew from 0.39 cases per 100 hospitalization encounters in 2018 to 0.53 cases in 2022. 
    • “Researchers said the pathogen’s ability to survive in hospitals and in patients not showing any symptoms for extended periods of time contributed to increased outbreaks.” 
  • MedPage Today points out,
    • “Cytisinicline increased biochemically confirmed abstinence [from smoking tobacco] nearly threefold versus placebo when taken for 6 weeks and more than fourfold when taken for 12 weeks.
    • “The drug was well tolerated with no treatment-related serious adverse events.
    • “The trial is expected to support filing with the FDA for a new drug indication as a tobacco-product cessation aid.”
  • Beckers Hospital Review notes,
    • “A recent study found that changing the default prescription length for statins to 90 days significantly increased the number of long-term prescriptions written, potentially improving patient adherence. 
    • “The intervention, which was implemented at the University of Pennsylvania’s health system in Philadelphia, set 90-day prescriptions as the default option in the electronic health record for statins. By the end of the study, the health system saw the proportion of 90-day prescriptions rise from 71% to 91%, according to an April 22 news release from Penn Medicine. 
    • “The study, published in JAMA Internal Medicine on April 7, found that the change designed as a “nudge” to guide doctors toward better prescribing behavior had helped to reduce the need for patients to visit the pharmacy multiple times a year. 
    • “The findings suggest that default settings in EHRs can be a tool in increasing medication adherence without additional effort from clinicians, the release said.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance posted mixed results for the first quarter but reaffirmed its 2025 earnings outlook, solidifying guidance it published early to pacify investors after UnitedHealth posted dismal results last week, leading to a selloff of health insurer stocks.
    • “UnitedHealth’s results were driven by unexpectedly high medical spending on Medicare Advantage members, a trend that Elevance on Tuesday said it had observed but wasn’t any more drastic than expected.
    • “Overall, Elevance beat Wall Street expectations in the quarter with revenue of $48.9 billion, up almost 15% year over year, in part due to the higher premiums it’s charging customers this year in a bid to resuscitate insurance margins. The insurer posted profit of $2.2 billion, down 3% year over year. Elevance’s stock was up slightly in morning trading following the results.”
  • Per MedCity News,
    • “With rising operational costs, major shifts in Medicaid, and other financial pressures bearing down on the healthcare system, forecasting revenue and allocating resources effectively has never been as important for health plans as it is today. And anticipating the future has probably never been so challenging.
    • “Health plans have been gradually deploying artificial intelligence programs and sophisticated analytics for years to make programs more effective while reducing costs and mitigating financial risk.
    • “But with today’s challenges, the gradual approach has become a luxury. According to McKinsey, health plans should pick up the pace.”
  • Modern Healthcare adds,
    • “Payers, providers and health technology companies may soon be asking accrediting organizations to sign off on their use of artificial intelligence.
    • “AI is being used across the industry but a lack of regulation at the state and federal levels is prompting industry stakeholders to create their own guidelines for safe and effective AI use. The next step might well see the issue addressed in accreditation programs.
    • “While the AI accreditation process could take years to develop, there is confidence that it will become commonplace. On top of the potential impact of AI on patient outcomes, there is a cost to develop and adopt products. This cost factor is driving the need for more transparency on model efficacy, said Dr. Lee Schwamm, chief digital health officer at New Haven, Connecticut-based Yale New Haven.”
  • The Wall Street Journal reports,
    • “Swiss pharmaceutical giant Roche ROG -0.31%decrease; red down pointing triangle
      plans to invest $50 billion in the U.S. over the next five years, the latest major spending commitment by a big drugmaker as the industry faces President Trump’s tariff threats.” * * *
    • “The investment by Roche will fund new research hubs and new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California, the company said Tuesday. The company said that investment would create 1,000 jobs at Roche and more than 11,000 elsewhere including nearly 6,500 construction jobs.
    • “The company currently has 15 R&D centers and 13 manufacturing sites in the U.S., employing more than 25,000 people.
    • “Roche said it would export more medicines from the U.S. than it imports once its new and expanded manufacturing site are in operation. The group’s diagnostics division currently already holds a surplus from the U.S., it said.”
  • MedCity News relates,
    • “Aeroflow Health, a health tech company, last week announced a new diabetes management program, which aims to improve adherence, outcomes and care coordination for health plan members.
    • “Asheville, North Carolina-based Aeroflow Health was founded in 2001 and offers an array of medical devices covered by insurance. The company has four lines: Aeroflow Breastpumps, Aeroflow Diabetes, Aeroflow Sleep and Aeroflow Urology. In addition to medical devices, it provides education and consultations. The company has partnerships with more than 1,000 insurance plans and serves more than 1.4 million patients annually.
    • “Through the new diabetes program, patients gain access to educational content on how to manage their condition, including medication adherence, lifestyle modifications and glucose monitoring strategies. They can also use a new AI-powered digital health tool that syncs with continuous glucose monitoring data. This allows patients to receive personalized insights on their health, AI-driven coaching and communication with their provider.”

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, SCOTUS–

From Washington, DC,

  • Congress remains on a District/State work break this week.
  • Tomorrow at 10 am ET. the U.S. Supreme Court will hear oral arguments in the Kennedy v. Braidwood Management, No. 24-316, case. Amy Howe provides background on the case here. The case considers the constitutional authority of the U.S. Preventive Services Task Force to make recommendations for no-cost coverage of preventive services under the Affordable Care Act.
  • MedPage Today points out,
    • “The need to revamp the Organ Procurement and Transplantation Network (OPTN) is dire. Nearly 25% of livers and 33% of kidneys collected for donation go unused. The average transplant wait time is 3-5 years, but it can stretch even longer in some parts of the country. Much of the network’s donation and recipient data collection is performed manually, prolonging pre-transplant procedures. All of this is unwelcome news for more than 100,000 people currently on the organ transplant waitlist. And many are running out of time.
    • “Despite these challenges, the U.S. organ transplant system still saves over 48,000 lives a year. And policymakers have been pushing to increase this numbers. The Health Resources and Services Administration (HRSA), the entity housed within HHS that oversees the transplant network, is tasked with modernizing the system and saving more lives. HRSA is working hard to close the gap between recipient identification, donor matching, and subsequent transplant surgeries.
    • “HRSA must continue to push modernization efforts aggressively, using operational and technology improvements and stakeholder collaboration to save more lives and increase public trust in the transplant system. Reform efforts should focus on three key areas: streamlining of responsibilities, technological upgrades, and transparency.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Consuming more than eight alcoholic drinks a week is associated with brain injuries linked to Alzheimer’s disease and cognitive decline, a recent study in the journal Neurology suggests.
    • “The analysis looked for links between heavy drinking and brain health. Researchers used autopsy data from the Biobank for Aging Studies at the University of São Paulo Medical School in Brazil collected between 2004 and 2024. The team analyzed data from 1,781 people ages 50 or older at death. The average age at death was 74.9. * * *
    • The analysis showed that heavy drinkers and former heavy drinkers, respectively, had 41 percent and 31 percent higher odds of neurofibrillary tangles — clumps of the protein tau that accumulate inside brain neurons and have been associated with Alzheimer’s disease.
    • “Moderate, heavy and former heavy drinkers also had a higher risk of hyaline arteriolosclerosis, which thickens the walls of small blood vessels in the brain, impeding blood flow and causing brain damage over time. Though 40 percent of those who never drank had vascular brain lesions, they were more common in moderate (44.6 percent), heavy (44.1 percent) and former heavy drinkers (50.2 percent), the study found.”
  • Per Medscape,
    • “An investigational drug, currently known as AZD0780, lowers low-density-lipoprotein cholesterol (LDL-C) to target levels in most patients whose cholesterol is still over target despite statin therapy, results from the phase 2b PURSUIT trial show.
    • “AZD0780 inhibits PCSK9, a protein that regulates cholesterol metabolism. Inhibition of this protein has proven useful in lowering LDL-C. Current drugs in this class include two monoclonal antibodies, alirocumab and evolocumab, and a small interfering RNA, inclisiran. However, unlike current PCSK9 inhibitors, which must be injected, AZD0780 is an oral therapy.
    • “We’ve had PCSK9 inhibitors on the market in the United States for 10 years,” said investigator Michael Koren, MD, a cardiologist and CEO of the ENCORE Research Group in Jacksonville, Florida. However, “people are still not getting to goal,” he explained during his presentation of the results at the American College of Cardiology Scientific Session 2025 in Chicago, which were published simultaneously in the Journal of the American College of Cardiology.”
  • The Wall Street Journal informs us about “How Your Midlife Eating Habits Can Help You Live Longer and Healthier.”
    • “If you reach 70 years old healthy and disease-free, you might have your diet to thank, new research suggests.
    • “The study, which analyzed the health data of more than 100,000 people over the course of 30 years, is the first of its kind to examine how dietary patterns affect not only lifespan but also how well people age. The upshot: A diet emphasizing vegetables, fruits, healthy fats and some animal products such as fish and dairy over the long term was the most likely to make a difference in aging in good health.
    • “Sticking to a balanced diet with a moderate amount of healthy animal protein, in fact, outperformed following a more plant-based diet, in terms of healthy aging. The researchers also found that eating more ultra processed foods was linked to worse physical and cognitive health in older age.
    • “The study, published in Nature Medicine and led by researchers at Harvard University, the University of Copenhagen and the University of Montreal, adds to the growing body of research on human health spans—the number of years we live in good health—and the factors that can extend those years.” 

From the U.S. healthcare business front,

  • Tech Target identifies “13 AI healthcare companies to watch in 2025. These AI healthcare companies are using generative AI to enhance efficiency, improve patient care and innovate diagnostics. We also explore types of AI in the healthcare space.”
  • Per a press release,
    • “At HIMSS25, Performant Healthcare, Inc. (Nasdaq: PHLT), a leader in technology-enabled payment integrity, eligibility and related analytics services, conducted a targeted survey of nearly 150 healthcare technology leaders to better understand the key drivers behind healthcare technology decision-making. The findings point to a healthcare landscape increasingly shaped by innovation, efficiency and the imperative to deliver better outcomes for patients.
    • “This press release features multimedia. View the full release here
  • Per a press release,
    • U.S. Business Action to End HIV has been named one of Modern Healthcare’s 2025 Innovator Awards recipients.
    • Modern Healthcare’s Innovators program recognizes leaders and organizations driving innovation that improves care and achieves measurable results.
    • U.S. Business Action to End HIV is reimagining the role of businesses in ending HIV. The Coalition empowers companies to reduce stigma, increase access to care, support community organizations, and advocate for policy change.
  • Fierce Healthcare tells us,
    • “Despite growing awareness around fertility challenges, 77% of women have hidden or downplayed their fertility treatment at work. 
    • “So finds the latest survey from Maven Clinic, a virtual women’s and family health provider. The survey reached more than 1,000 U.S. women who have gone through the fertility journey. The fertility journey comes with many challenges, from financial to emotional. These are often hidden from public view, Maven executives argue.
    • “Financial cost remains one of the biggest barriers to fertility care, with 75% of people experiencing financial strain when navigating fertility. Nearly half of survey respondents felt unprepared for the cost, particularly around medications or hormonal treatments, genetic testing and diagnostic testing.
    • “Most respondents (83%) had to cut back on expenses, and more than half had to use their savings meant for other life goals to afford fertility care. A third of the people said they took on debt, while 59% took on extra work.
    • “At the same time, people going through the fertility journey must deal with the emotional toll it can take. Most (91%) said fertility challenges impact their mental health, the survey found. And 78% reported limiting social interactions, like weddings and family gatherings, due to the emotional stress.” 

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law reports,
    • “President Donald Trump wants Congress to change a policy that gives certain drugs longer protection from drug price negotiations in Medicare, a fix that could address one of the drug industry’s top complaints with the Biden-era law.
    • “Trump directed his health secretary to work with lawmakers to end the differential treatment for small molecule drugs, typically pills, that face Medicare price negotiations sooner that more complex biologic medications.
    • “The directive came in an executive order Trump signed at the White House Tuesday. The order was light on specifics and included a grab-bag of other health policy goals.”
  • Modern Healthcare adds
    • “A bipartisan group of state attorneys general wants Congress to pass legislation that would break up healthcare conglomerates such as UnitedHealth Group, CVS Health and Cigna.
    • “Under the auspices of the National Association of Attorneys General, more than three dozen officials wrote congressional leaders on Monday asking them to ban companies from owning both pharmacy benefit managers and pharmacies, citing anticompetitive effects of consolidation in the healthcare system.”
    • Here is a link to that letter.
  • Fierce Pharma tells us,
    • “A two-day meeting of the Advisory Committee on Immunization Practices (ACIP), which was originally scheduled for February but was postponed by new HHS Secretary Robert F. Kennedy Jr., is underway today [April 15] in Atlanta and will conclude with panel votes on several vaccines on Wednesday afternoon.
    • “The independent advisers, who meet three times a year to inform vaccine policies in the U.S., today will discuss (PDF) the effectiveness of vaccines that defend against COVID-19, Mpox, chikungunya, HPV, cytomegalovirus (CMV) and the flu.
    • “The last item on Tuesday’s agenda will be an update on the U.S. measles outbreak. On Friday, the Centers for Disease Control and Prevention (CDC) reported 712 cases in more than 20 states, with the most concentrated spread underway in West Texas.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a member of the Senate Agriculture Committee and a lifelong family farmer, joined Sens. Pete Ricketts (R-Neb.) and Deb Fischer (R-Neb.), along with Reps. Randy Feenstra (R-Iowa) and Mark Alford (R-Mo.), in a letter urging the Make America Healthy Again (MAHA) Commission to use sound science and risk-based analysis in its policy decisions, particularly on crop protection tools and food-grade ingredients.
    • The letter was sent to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, Department of Agriculture (USDA) Secretary Brooke Rollins and Environmental Protection Agency (EPA) Administrator Lee Zeldin.
      • “We write to express our strong appreciation for your leadership and interest in working with each of you to ensure America has the healthiest people in the world. In recent decades, chronic illness rates have risen. This warrants our careful scrutiny to support better health outcomes. It is essential that policies supported by sound science and risk-based analyses are used to accomplish this goal,” the lawmakers wrote.
      • “We have concerns that environmentalists are advancing harmful health, economic, or food security policies under the guise of human health. Despite insinuations to the contrary, regular testing by FDA and USDA finds that more than 99% of all pesticide residues meet extremely conservative limits established by EPA according to the best available science,” they continued.”
    • Here’s a link to the letter.

From the judicial front,

  • Bloomberg Law tells us,
    • “The Central States, Southeast and Southwest Areas Health and Welfare Fund and participant Charles A. Whobrey sued Arkansas Insurance Commissioner Alan McClain April 11, arguing a law requiring health plans to report pharmacy cost data and pay pharmacies a minimum amount violates the Employee Retirement Income Security Act. 
    • “The multiemployer benefit plan serves 500,000 people via local chapters of the International Brotherhood of Teamsters.
    • “It’s the latest in a broader legal fight over states’ attempts to regulate pharmacy benefit managers, which oversee the prescription drug benefit for health plans. The US Supreme Court is weighing whether to accept a case challenging an Oklahoma law regulating pharmacy benefit managers after determining that ERISA did not preempt a separate Arkansas PBM law in 2020.” * * *
    • “The case is Central States, Southeast and Southwest Areas Health and Welfare Fund et al v. McClain, in his official capacity as Insurance Commissioner of Arkansas et al., N.D. Ill., No. 1:25-cv-03938, complaint filed 4/11/25.”

From the public health and medical research front,

  • The National Academy of Sciences announced,
    • “Bird flu has infected livestock, wildlife, pets, and humans. Most people have general questions about the looming threat of this highly pathogenic virus, and we have answers. Join @NASEM Health and Medicine Division and @NASEM Earth & Life Sciences on April 29, 2025, for the first public webinar of a special series addressing H5N1 avian influenza. Learn how we got here, who’s at risk, and what’s at stake. Can’t make the date/time? All registrants will receive a link to the recording. Register here: https://tinyurl.com/bdhrywv2
  • The New York Times reports,
    • “The number of children living with autism in the U.S. is growing.
    • “About 1 in 31 children aged eight years old in 2022 had autism—an increase from previous years, according to a report from the Centers for Disease Control and Prevention published Tuesday. 
    • “Increased awareness and screening of the disorder partly explains its rise over time. Health and Human Services Secretary Robert F. Kennedy Jr. has said he is assembling a team of researchers to focus on the root causes of the increase and expects to begin to have answers by September. 
    • “The autism epidemic has now reached a scale unprecedented in human history because it affects the young,” he said Tuesday. “Autism is preventable and it is unforgivable that we have not yet identified the underlying causes. We should have had these answers 20 years ago.”
    • “The idea that vaccines cause autism, which Kennedy has pushed, has long been debunked by scientists, after multiple studies have failed to find a link.”
  • The Rand Organization informs us,
    • “Specialized hospital services that aid people with opioid use disorder regardless of why they are admitted can boost the number of patients who begin treatment with FDA-approved medication for opioid use disorder and increase the likelihood they remain engaged in that care once discharged, according to a new study.
    • “Reporting results from the first parallel assignment randomized clinical trial of a hospital-based addiction consultation service for people with opioid use disorder, researchers found that people who received treatment from a specialized addiction consultation service were about twice as likely to begin medication treatment for opioid use disorder as patients who received the normal course of care.
    • “In addition, those who received care from the special program were significantly more likely to link to care for opioid use disorder once they were discharged.
    • “Researchers say the study contributes to growing evidence that an inpatient addiction consultation service can have a positive effect on treatment initiation and linkage to post-discharge care. The findings are published in the journal JAMA Internal Medicine.”
  • AHRQ offers advice on “Implementing [US Preventive Services Task Force] Recommended Mental Health and Substance Use Screening and Counseling Interventions in Primary Care Settings for Children and Adolescents.”
  • Per Medscape,
    • “New data confirmed the safety and efficacy of AXS-05, a combination of dextromethorphan and bupropion, for the treatment of agitation associated with Alzheimer’s disease (AD).
    • “In the phase 3 ACCORD-2 study, AXS-05 (Axsome Therapeutics) met the primary and key secondary endpoints by statistically significantly delaying and preventing AD agitation relapse compared with placebo and was generally well tolerated.
    • “Overall, the data “build on the previous positive phase 2/3 studies and support the use of AXS-05 as a safe and effective treatment for Alzheimer’s disease agitation,” George Grossberg, MD, Saint Louis University School of Medicine, St. Louis, said at a press briefing announcing the results.
    • “Grossberg presented the late-breaking findings from ACCORD-2 on April 7 at the American Academy of Neurology (AAN) 2025 Annual Meeting.”
  • Per a National Cancer Institute news release,
    • “Many adolescents and young adults (AYAs) with advanced cancer don’t have discussions with their clinicians about how they want to approach palliative care until the final weeks of life, a study of medical records of nearly 2,000 young patients showed.
    • “The researchers also found that, as of more than 2 months before their deaths, few AYAs in the study had documented goals for care of any kind in their medical records, including things such as how aggressive they would like to be with their cancer treatments.
    • “The findings come from an NCI-funded study that analyzed how documented discussions between AYA patients with advanced cancer and their providers about the goals of care change over the patients’ last few months of life.  The study results were published December 19 in JAMA Network Open.”
  • Per an NIH news release,
    • “New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy exists for this rare inherited disease, which starts affecting vision from childhood. A report on the studies, conducted at the National Institutes of Health (NIH), published today in eLife.
    • “The discovery of reserpine’s effectiveness may greatly speed therapeutics for retinitis pigmentosa and many other inherited retinal dystrophies, which can be caused by one of more than a thousand possible mutations affecting more than 100 genes. Reserpine’s neuroprotective effect is independent of any specific underlying gene mutation,” said the study’s lead investigator, Anand Swaroop, Ph.D., senior investigator at NIH’s National Eye Institute.”
  • STAT News reports,
    • “U.S. researchers will soon test whether livers from a gene-edited pig could treat people with sudden liver failure — by temporarily filtering their blood so their own organ can rest and maybe heal.
    • “The first-of-its-kind clinical trial has been cleared by the Food and Drug Administration, according to pig producer eGenesis, which announced the step Tuesday with its partner OrganOx.” * * *
    • “The new study, which is expected to get underway later this spring, is a twist on the quest for animal-to-human organ transplants. Researchers won’t transplant the pig liver but instead will attach it externally to study participants.
    • “The liver is the only organ that can regenerate, but the question is whether having the pig’s liver filter the patient’s blood for several days could give it that chance.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS’ payment increase of 5.03% in 2026 “will likely significantly support the recovery” of Medicare Advantage plans as they continue to face rising medical costs, according to Fitch Ratings.
    • “Increased government scrutiny, reduced base payments and rising utilization in the last couple of years has put pressure on the program, leading plans to reduce benefits or pull back from unprofitable markets. CMS’ rate hike will increase payments to MA plans by more than $25 billion in 2026.
    • “While the higher 2026 payment rates do not resolve all the challenges facing MA insurers, they help relieve some pressures from increased healthcare utilization in the program,” Fitch analysts wrote April 14. “Depending on the insurer, the higher rates could enable a mix of enhancement of benefits in certain geographies, mitigation of Star Ratings pressure, or partial margin recovery.”
    • “Fitch expects MA to remain a key focus for insurers, and a clearer picture on the success of course correction measures will become available in the next few weeks as Q1 earnings reports are released.”
  • Per Fierce Pharma,
    • “Even as tariffs start to take a toll on Johnson & Johnson’s medtech business—with the threat of pharmaceutical duties not far behind—the New Jersey drug giant is confident it can weather any upcoming trade war turbulence. In fact, the company is boosting its sales guidance for the year following the close of a new neuroscience acquisition.
    • “J&J now expects to generate total operational sales of $91.6 billion to $92.4 billion in 2025, representing a $700 million increase over the forecast it initially unveiled in January, the company said in a Tuesday earnings release (PDF).
    • “J&J’s finance chief, Joseph Wolk, attributed the bump to J&J’s recent acquisition of neuroscience player Intra-Cellular Therapies for $14.6 billion. The deal, which closed earlier this month, allowed J&J to get its hands on the approved schizophrenia and bipolar disorder med Caplyta.”
  • Per Beckers Hospital Review,
    • “At the end of 2023, more than one-third of new prescriptions to treat Type 2 diabetes were GLP-1s, such as Mounjaro and Ozempic, among others, according to a study published April 15 in Annals of Internal Medicine. 
    • “Researchers at Mass General Brigham, based in Somerville, Mass., reviewed claims data from January 2021 to December 2023 to evaluate utilization trends among diabetes medications. 
    • “The drugs included glucagon-like peptide-1 receptor agonists (Ozempic), glucose-dependent insulinotropic polypeptide receptors (Mounjaro), glucose-lowering medications (metformin and insulin) and weight-lowering medications (phentermine). 
    • “Over those three years, use of Mounjaro, Ozempic and sodium-glucose cotransporter-2 inhibitors increased among adults with Type 2 diabetes. Use of other glucose-lowering drugs, including metformin, rapidly declined.
  • and
    • “Houston-based Texas Children’s has experienced “astounding” results from AI projects in recent months, its IT leader told Becker’s.
    • “Myra Davis, executive vice president and chief information and innovation officer of Texas Children’s, was recently recognized for her work when she was nominated for an ORBIE award for the nation’s top healthcare CIO.
    • “Becker’s caught up with Ms. Davis to discuss her most innovative IT projects — and what comes next.”
  • The New York Times reports,
    • “The quest to create an A.I. therapist has not been without setbacks or, as researchers at Dartmouth thoughtfully describe them, “dramatic failures.”
    • “Their first chatbot therapist wallowed in despair and expressed its own suicidal thoughts. A second model seemed to amplify all the worst tropes of psychotherapy, invariably blaming the user’s problems on her parents.
    • “Finally, the researchers came up with Therabot, an A.I. chatbot they believe could help address an intractable problem: There are too many people who need therapy for anxiety, depression and other mental health problems, and not nearly enough providers.
    • “Fewer than a third of Americans live in communities where there are enough mental health providers to meet the local demand. According to one study, most people with mental health disorders go untreated or receive inadequate treatment.
    • “So the team at Dartmouth College embarked on the first clinical trial of a generative A.I. therapist. The results, published in the New England Journal of Medicine-AI, were encouraging.
    • “Chatting with Therabot, the team’s A.I. therapist, for eight weeks meaningfully reduced psychological symptoms among users with depression, anxiety or an eating disorder.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a progressive heart condition, closing off an opportunity to expand use of a medicine it sees as a future blockbuster.
    • “According to Bristol Myers, Camzyos missed the dual main goals of a study focused on the non-obstructive form of “HCM,” or hypertrophic cardiomyopathy. It failed to meaningfully improve peak oxygen consumption as well as scores on an assessment of heart health. The company didn’t provide study details, but said more information will be shared “with the scientific community in the future.”
    • “Camzyos was acquired through the $13 billion buyout of MyoKardia in 2020 and two years later became the first drug cleared for use in the “obstructive” and more common form of the disease. Biotechnology companies Cytokinetics and Edgewise Therapeutics are developing similar medicines that are both in the advanced stages of clinical testing. Cytokinetics’ drug, aficamten, could be approved in the U.S. later this year.”

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–

From Washington, DC

  • NBC News reports,
    • “Speaker Mike Johnson, R-La., is facing a growing rebellion from conservative hard-liners in the House as Republicans seek to take up a budget blueprint that was recently adopted by the Senate to pass President Donald Trump’s agenda.
    • “House GOP leaders are eyeing a vote this week on the measure, which would unlock the path for committees to craft a massive bill to cut taxes, boost immigration enforcement and defense spending and lift the debt limit without Democratic votes.
    • “But a slew of House conservatives have blasted the Senate’s version for requiring just $4 billion in spending cuts. The House’s version, by contrast, called for $1.5 trillion to $2 trillion in spending cuts while largely steering clear of specifics.”
  • CBS News informs us,
    • “The Centers for Disease Control and Prevention has begun redeploying staff to respond to the deadly outbreak of measles in Texas, a spokesperson said Monday, a week after steep layoffs at the agency impacted its response to the spread of the virus. 
    • “A team of three deployed yesterday to meet with county and state officials to assess the immediate needs to respond to this outbreak. The team is meeting with officials again today,” CDC spokesperson Jason McDonald said in an email. 
    • “Health and Human Services Secretary Robert F. Kennedy Jr. first said Sunday that the CDC would be redeploying to Texas at its governor’s request, after another unvaccinated child died in the measles outbreak. An 8-year-old girl was the second fatality there this year.
    • “Once the assessment is complete, more CDC staff will be sent to Texas per Sec. Kennedy’s order and the governor’s request. The first teams deployed to Texas arrived on March and returned to CDC on April 1,” McDonald said.”
  • Per MedPage Today,
    • The U.S. Preventive Services Task Force (USPSTF) still recommends primary care behavioral counseling for breastfeeding, mostly in line with its 2016 guidelines.
    • In the updated recommendation statement published in JAMA, USPSTF wrote that “providing interventions or referrals, during pregnancy and after birth, to support breastfeeding” received a B grade, indicating moderate certainty these interventions will have moderate net benefit.

From the judicial front,

  • The Wall Street Journal tells us,
    • “The Supreme Court lifted a lower-court order that directed the Trump administration to reinstate about 16,000 federal employees it fired, handing the White House the third victory in a row as it seeks the justices’ emergency action to stop district judges from slowing its policies. 
    • “The justices on Tuesday said that environmental groups and other nonprofit organizations who say they were harmed by the reduction in public services caused by the layoffs didn’t have legal standing to bring suit. 
    • “The brief order was unsigned, as is typical when the court acts on emergency requests. Two liberal justices, Sonia Sotomayor and Ketanji Brown Jackson, said they voted to deny the Trump administration’s request.” * * *
    • “The Supreme Court on Tuesday agreed with the Trump administration that the nonprofits lacked legal standing to bring the case. The court added, though, that the order didn’t address other plaintiffs in the suit, including several labor unions and the state of Washington. Alsup’s injunction wasn’t based on their claims, although those parties may face other questions regarding their standing to bring suit.
    • “Tuesday’s order doesn’t resolve broader legal disputes over the administration’s mass layoffs of federal employees.”
  • Bloomberg Law relates,
    • “A string of lawsuits targeting the use of artificial intelligence and algorithms in claims denials is raising risks for private health insurers and employers, even as the litigation encounters early obstacles.
    • “A California federal judge’s recent decision to partially allow a case to proceed over Cigna Corp.’s alleged use of algorithms to improperly deny benefits signals that automation tools come with legal hazards.” * * *
    • “To the extent that these tools are being used to block or deny coverage across the board for medically necessary services and to a large number of beneficiaries—if that is the case and that’s how these have been used, that could expose insurers to significant risk,” said David Greenberg, partner at ArentFox Schiff LLP.
    • “Courts have allowed several lawsuits to proceed, but plaintiffs still face significant challenges in making their cases. In some instances, the insurance companies denied that the plaintiffs’ medical claims were even handled by an algorithm. Proving otherwise can be difficult.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • The Centers for Disease Control and Prevention April 8 sent an alert to health care providers on measles prevention and treatment. The agency said that risk remains low for most individuals across the U.S. and that the measles, mumps and rubella vaccine is the best way to protect against the disease. 
  • and
    • “The incidence of invasive group A strep infections increased from 3.6 to 8.2 cases per 100,000 people from 2013 to 2022, according to a study authored by the Centers for Disease Control and Prevention published April 7 by JAMA. The authors concluded that accelerated efforts to prevent and control these infections are needed, especially among groups at highest risk of infection, which includes individuals 65 years or older, American Indian or Alaska Native persons, residents of long-term care facilities, people experiencing homelessness, and people who inject drugs.” 
  • Per Medscape,
    • “Around 38 million people in the United States — or slightly over 11% of the population — have diabetes, according to the National Diabetes Statistics Report. Experts only expect that number to increase, and research suggests that the burden will be especially significant in low to low-middle socioeconomic areas.
    • “Consider the Mississippi Delta, a swath of fertile land in the floodplain of the Mississippi River. It has a rich and diverse cultural heritage, with a minority-majority population, along with significant economic challenges and a persistently high poverty rate. The region also has one of the highest diabetes rates in the country, which has put the healthcare community on alert.
    • “We are more intensely screening almost everybody,” said Brent Smith, MD, a family physician in Greenville, Mississippi, and a member of the board of directors of the American Academy of Family Physicians.”
  • AP reports,
    • “Health care systems can reduce suicides through patient screening, safety planning and mental health counseling, a new study suggests, an important finding as the U.S. confronts it 11th leading cause of death.
    • “The “Zero Suicide Model” was developed in 2001 at Detroit-based Henry Ford Health, where the focus on people considering suicide included collaborating with patients to reduce their access to lethal means such as firearms and then following up with treatment.
    • “The approach made a difference, and for all of 2009, the health system saw no suicides among patients. The researchers then studied what happened when a different health system, Kaiser Permanente, adopted the program in four locations from 2012 through 2019.
    • “Suicides and suicide attempts fell in three of the locations, while the fourth maintained a low rate of suicides and attempts. Suicide attempts were tracked in electronic health records and insurance claims data. Suicides were measured using government death records.”‘
  • The Washington Post notes,
    • “Those who exercised the most had a 26 percent lower cancer risk than those who exercised the least in an analysis of biomedical data, according to research published in the British Journal of Sports Medicine.
    • “The article drew upon data from UK Biobank, a longitudinal study that enrolled 500,000 adults in Britain between 2006 and 2010. After enrolling, more than 106,000 adults were invited to participate in the sub-study on physical activity. The final sample, stratified into five groups, or quintiles, of physical activity levels, included about 85,000 participants with a median age of 63 years.” * * *
    • “The research identified an inverse relationship between overall daily physical activity and cancer risk, indicating that even modest increases in activity levels were sufficient to significantly reduce the risk of the 13 cancers. Individuals in the second-highest quintile of physical activity had a 16 percent lower risk compared with those in the lowest quintile. Higher levels of activity had a more protective effect.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Monday it has enrolled the first patient in a pivotal study of a device for clearing “difficult-to-cross” coronary arteries.
    • “Like other products made by J&J’s Shockwave Medical, the Javelin intravascular lithotripsy catheter uses sound pressure waves to break up calcium deposits that are blocking blood flow. 
    • “The device is differentiated from other Shockwave products, and rival catheters from Abbott and Boston Scientific, because it emits waves from its tip. Other devices send waves from a balloon catheter that must cross the blocked part of the artery to be effective.” * * *

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “Hospital average operating margins dropped from 3.4% in January to 2.5% in February, but are still above 2024 averages, according to Kaufman Hall’s “National Hospital Flash Report.”
    • “Kaufman Hall, a Vizient company, gathered financial performance data from 1,300 hospitals. The average operating margin dropped 11% month over month but grew 5% year over year. The average operating EBITDA margin decreased 7% month over month but grew 1% year over year.
    • “Net operating revenue per calendar day increased 8% year over year, driven by an 11% jump in inpatient revenue. Outpatient revenue grew just 8% compared to February 2024.
    • “Expenses were also on the rise, with total expenses also up 8% year over year driven by a 10% growth in supply expenses per calendar day. Drug expenses and non-labor expenses both jumped 9% while labor expenses grew 6% year over year. Purchased services expenses also increased 13% from February 2024.
    • “Patient volume held steady, as discharges per calendar day were up 6% year over year in February. Observation days dropped 9% and the average length of stay was flat compared to the same period last year. Emergency department visits increased 4%.”
  • Modern Healthcare adds,
    • “Health systems announced five hospital merger and acquisition proposals in the first three months of the year, the lowest quarterly amount in more than a decade.
    • “Providers were reluctant to wade into hospital transactions amid the uncertainty surrounding tariffs, federal funding concerns, state and federal regulatory changes and economic volatility, according to a new report from consultancy Kaufman Hall. Four of the five proposed hospital deals involved financially distressed facilities, the report found.”
  • Specifically, Fierce Healthcare reports,
    • “Northwell Health and Nuvance Health’s 28-hospital merger has cleared its final regulatory hurdle and is expected to close within the next 30 days.
    • “Tuesday, Connecticut’s Office of Health Strategy announced it had reached an agreement with the two health systems after just over two months of negotiations over their Certificate of Need application. The pair’s merger, announced 14 months ago, had received a similar all-clear from New York’s Public Health and Health Planning Council last September as well as sign-offs from each state’s attorneys general during the summer.
    • “Alongside price constraints tied in part to state and regional cost growth benchmark, Northwell—the acquirer—will invest at least $1 billion into Nuvance’s Connecticut and New York hospitals and refrain from any real estate sale leasebacks over a five-year period.”
  • Fierce Healthcare also lets us know,
    • “Rural hospital leaders are questioning whether they can continue to afford to do business with Medicare Advantage (MA) companies, and some say the only way to maintain services and protect patients is to end their contracts with the private insurers.
    • “MA plans pay hospitals lower rates than traditional Medicare, said Jason Merkley, CEO of the Brookings Health System in South Dakota. Merkley worried the losses would spark staff layoffs and cuts to patient services. So, last year, Brookings Health dropped all four contracts it had with major MA companies.
    • “I’ve had lots of discussions with CEOs and executive teams across the country in regard to that,” said Merkley, whose health system operates a hospital and clinics in the small city of Brookings and surrounding rural areas.
    • “Merkley and other rural hospital operators in recent years have enumerated a long list of concerns about the publicly funded, privately run health plans. In addition to the reimbursement issue, their complaints include payment delays and a resistance to authorizing patient care.
    • “But rural hospitals abandoning their MA contracts can leave local patients without nearby in-network providers or force them to scramble to switch coverage.”
  • Per Healthcare Dive,
    • “CVS Health named a new CFO Tuesday as the healthcare giant continues to shake up its leadership team. 
    • “Brian Newman, most recently CFO of shipping and logistics firm UPS, will start at CVS on April 21. Tom Cowhey, who took on the permanent CFO position at CVS early last year, will become a strategic advisor to CEO David Joyner, effective May 12. 
    • “In addition to the leadership change, CVS said it expects financial results for 2025 to meet or exceed its previously issued guidance. In February, the company reported expected adjusted earnings for the year between $5.75 and $6 a share.” 
  • Per Beckers Hospital Review,
    • “Walgreens Boots Alliance reported a $5.6 billion operating loss in its fiscal second quarter, an improvement from the $13.2 billion loss in the same period last year as the troubled retailer continues to prepare for a private equity buyout. 
    • “Operating losses included a $3 billion impairment charge tied to its Village MD business, according to an April 8 company news release. 
    • “Despite ongoing challenges, Walgreens reported better than expected results in sales, with sales rising 4% to $38.59 billion. In addition, pharmacy sales rose 12% while retail sales fell by 3%. 
    • “The company announced last month that it would be acquired by Sycamore Partners in a deal valued at $10 billion. Walgreens also recently suspended its quarterly dividend part of a broader cost cutting effort.”
  • Per Fierce Pharma,
    • “While much of the recent GLP-1 saga has been written in the U.S., Novo Nordisk continues to expand its semaglutide empire across the globe and make inroads into large markets like Brazil.
    • “Now, in a bid to boost its production capacity in Latin America’s most populous country, Novo is plugging 6.4 billion Brazilian reais (roughly $1.09 billion) into an expansion of its manufacturing plant in the Brazilian city of Montes Claros.
    • “The investment, which marks one of the largest ever for pharmaceuticals in Brazil, will “significantly” bolster the facility’s capacity to crank out a variety of injectables, including GLP-1 medicines like Ozempic and Wegovy, Novo said in a Portuguese-language press release.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Powerful Medical, a New York-based artificial intelligence (AI) company, has received the FDA’s breakthrough device designation for its AI model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
    • “The company’s PMcardio STEMI AI ECG model, nicknamed “Queen of Hearts,” identifies STEMI and STEMI-equivalent patterns in a patient’s ECG. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center and founder of Dr. Smith’s ECG Blog.
    • “For the last 20 years, life-saving treatment exists for heart attack patients, yet far too many still don’t receive the urgent care they need due to delays in diagnosis and inefficient triage,” said Robert Herman, MD, PhD, chief medical officer of Powerful Medical, said in a statement. “By equipping physicians and allied providers with an AI-powered tool for accurate and immediate STEMI detection, available around the clock, we can bridge this gap, ensure timely treatment, and improve patient outcomes, often preventing avoidable deaths.”
  • and
    • “Artificial intelligence (AI)-assisted mammography may be able to predict a woman’s risk of developing cardiovascular disease, according to new data being presented at ACC.25, the American College of Cardiology’s annual conference.
    • “Breast artery calcifications are already visible when radiologists review mammograms, but nothing typically happens with those findings. Researchers aimed to see if AI could do some of the heavy lifting and help translate those findings into an easy-to-understand cardiovascular risk score.
    • “The group trained an advanced AI model to segment calcified vessels in mammography images and produce a risk score that calculates the patient’s risk of developing heart disease. To help make the new-look algorithm as accurate as possible, they developed it using mammography images and electronic health record data from more than 56,000 patients. The patients were all treated from 2013 to 2020 within the Emory Healthcare health system, and at least five years of follow-up data were available for each of them.
    • “Advances in deep learning and AI have made it much more feasible to extract and use more information from images to inform opportunistic screening,” lead author Theo Dapamede, MD, PhD, a postdoctoral fellow at Emory University in Atlanta, said in a statement.”
  • Per Beckers Clinical Leadership,
    • “An AI tool that analyzes nurses’ notes for subtle clinical changes helped reduce patient risk of death by 35.6%, length of stay by 11.2% and sepsis risk by 7.5%, according to research published April 2 in Nature. 
    • “In a yearlong, multisite study, researchers assessed the tool across 74 clinical units in two health systems. Among 60,893 hospital encounters, about half involved the early warning system and the other half did not. 
    • “The system, dubbed COmmnuticating Narrative Concerns Entered by RNs (CONCERN), is a machine learning algorithm that uses real-time nursing surveillance notes and data patterns to detect all-cause deterioration risks. 
    • ‘Other EWSs often “rely on late and noisy physiologic indicators of deterioration” such as lab results and vital signs, according to the researchers. In contrast, this tool leverages nurses’ “subtle, yet observable, clinical changes that may not be captured in physiological data or well displayed in EHRs,” including small changes in mental status from baseline or slower recovery of arterial blood pressure after turning a patient.” 

Weekend Update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, Mental health care, Obesity, U.S. Healthcare–
Texas bluebonnets

From Washington, DC,

  • Roll Call reports,
    • “The Senate adopted a fiscal 2025 budget blueprint early Saturday mostly along party lines after a debate that began the night before, teeing up the House for a climactic final vote next week.
    • “Republicans beat back numerous amendments en route to adopting the measure on a 51-48 vote. 
    • “Rand Paul, R-Ky., voted “no” as he’s long promised due to the resolution’s allowance for raising the statutory debt limit by up to $5 trillion.
    • “Maine’s Susan Collins was the other GOP “no” vote, having earlier expressed concerns about potential Medicaid cuts later in the reconciliation process but not saying how she’ll vote. Collins is up for reelection in 2026 in a Democratic-leaning state.
    • “No Democrats voted for it.:
  • and
    • ​”Speaker Mike Johnson and his GOP leadership team on Saturday sought to tamp down a brewing revolt on the budget resolution that emerged even before the Senate adopted the plan in the wee hours and gained steam later in the morning.
    • “Johnson and the rest of the top four House Republican leaders sent a letter to the rank and file ahead of next week’s House vote on the Senate-revised budget blueprint assuring them that they will not accept watered-down spending cuts in the eventual filibuster-proof reconciliation bill the process is intended to unlock.
    • “We have and will continue to make it clear in all discussions with the Senate and the White House that —in order to secure House passage — the final reconciliation bill must include historic spending reductions while protecting essential programs,” the letter says.
    • “The leadership comments come after key figures in the conference, including House Budget Chairman Jodey C. Arrington, R-Texas; Freedom Caucus Chairman Andy Harris, R-Md., and Rep. Chip Roy, R-Texas, the Freedom Caucus policy chair, all expressed opposition to the Senate budget plan.” * * *
    • “The House GOP leadership letter Saturday * * * [laid] out a process they say will lead to a pre-negotiated settlement between the two chambers. 
    • “The reconciliation bill “must be drafted using a collaborative process that results in a single product that both chambers can pass, and President [Donald] Trump can sign into law,” the leadership wrote. “We have made it clear the House will NOT accept nor participate in an ‘us versus them’ process resulting in a take it or leave it proposition from the Senate.”
    • “The letter goes on to say that immediately after adopting the budget, House and Senate committees “will begin preparing together their respective titles of the reconciliation bill to be marked up in the next work period.”
    • ‘The process House GOP leaders laid out appears to follow what Democrats and then-President Joe Biden employed during the 117th Congress when they enacted two reconciliation bills. Both of those packages went through committee markups in the House, but not in the Senate; but senators were able to make their voices heard through amendment “vote-a-ramas” in that chamber.”
  • On April 9, 2025, at 10 am, the Senate Homeland Security and Governmental Affairs Committee will hold a “business meeting to consider the nominations of Scott Kupor, of California, to be Director of the Office of Personnel Management for a term of four years, and Eric Matthew Ueland, of Virginia, to be Deputy Director for Management, Office of Management and Budget.”
  • Federal News Network offers an interview with Kevin Moss about “the benefits and caveats to having both Medicare and FEHB. While enrolling in Medicare with FEHB coverage may seem like duplicating benefits, it can provide cost savings.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • A second child who was diagnosed with measles has died in Texas, marking another death in a growing measles outbreak that has so far sickened hundreds of people, hospitalized dozens and spread to nearby states. 
    • The school-age child was being treated for measles-related complications at UMC Health System in Lubbock, Texas, said the health system’s spokesman, Aaron Davis. The child, who died Thursday, wasn’t vaccinated, didn’t have any known underlying health conditions and died of “measles pulmonary failure,” according to the Texas Department of State Health Services.
    • “This unfortunate event underscores the importance of vaccination,” Davis said. * * *
    • “Health and Human Services Secretary Robert F. Kennedy Jr. traveled to Gaines County, Texas, the center of the measles outbreak, to console the two families who have lost children, he said in a post on X.” 
  • STAT News adds,
    • “Health secretary Robert F. Kennedy Jr. said Sunday that “the most effective way to prevent the spread of measles is the MMR vaccine,” his most direct statement yet on the issue, following the death of a second child of the condition in the outbreak in West Texas.” 
  • The Washington Post informs us,
    • Brandy Ellis [, a 49-year-old insurance compliance consultant] calls herself a cyborg.
    • Two small electrodes — thin metal wires — implanted deep inside her brain lead under her skin to a battery pack in her chest. Pulsing about 130 times a second, the deep brain stimulation (DBS) device, a kind of pacemaker, energizes an area that scientists say is key in regulating moods. * * *
    • “DBS is one of several emerging, high-tech therapeutic approaches — a.k.a. electroceuticals — that proponents say are extending psychiatry’s ability to help millions of patients. Increasingly over the past 20 years, testimonials to the potential of treatments that modulate brain functioning, such as DBS, transcranial magnetic stimulation, vagus nerve stimulation and, most recently, focused ultrasound, have been fueling new hope, despite considerable expense and hardship for patients, and mixed evidence of their effectiveness.
    • “Emory University neurologist and psychiatrist Patricio Riva Posse, one of Ellis’s therapists, describes the new trends — combined with ever more sophisticated brain-scanning technologies and new optimism about psychedelic drugs such as ketamine and psilocybin — as explosive progress.”
  • Per Medscape,
    • This patient case [discussed in the article] is a prime example of how, in some instances, losing weight with glucagon-like peptide 1 (GLP-1) agonists can impact muscle mass. To combat this health risk, more clinicians are now emphasizing on fat loss vs weight loss in patients taking GLP-1s. Weight loss refers to the overall decrease in weight from the body, which can include fat, muscle, and water, whereas fat loss refers only to the reduction of fat from the body.

From the U.S. healthcare business front,

  • BioPharma Dive provides us with an “M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals. Big-ticket biotech buyouts have become scarce in recent months. U.S. policy upheaval threatens to keep it that way.”
  • Here is a link to Optum Rx’s Winter 2025 report on notable new drugs.
  • Per MedTech Dive,
    • “Eargo and Hearx have merged to create the over-the-counter hearing aid company LXE Hearing, the companies said Monday.
    • “Hearx, the maker of Lexie hearing aids, and Eargo competed for the OTC hearing aid market that the Food and Drug Administration created through the publication of a final rule in 2022. 
    • “Patient Square Capital, which took Eargo private in 2024, has invested $100 million in the combined company. LXE said the investment reflects confidence in the direct-to-patient hearing market.”
  • HR Dive relates,
    • “The U.S. Equal Employment Opportunity Commission has reached a settlement in two pregnancy discrimination cases and filed a new lawsuit on a third, the agency announced Thursday in a series of media releases.
    • “In the first settlement, an assisted living facility paid $20,000 to resolve allegations that it refused to schedule and then fired a temporary worker upon learning she was pregnant. In the second, a plant nursery paid $40,000 to resolve allegations it did not allow a worker to return after maternity leave. EEOC’s newly filed lawsuit alleged an employer refused to allow a worker with a high-risk pregnancy to work remotely to limit her exposure to COVID-19.  
    • “The actions highlight the agency’s continued interest in enforcing the relatively new Pregnant Workers Fairness Act. However, Acting Chair Andrea Lucas has expressed her opposition to aspects of the agency’s final rule, which was passed in April 2024.”

From the artificial intelligence front,

  • The Washington Post reports,
    • “In 2017, Ezekiel Emanuel, a well-known oncologist and health policy commentator, said radiologists would soon be out of work thanks to machine learning.
    • “That hasn’t happened, but although artificial intelligence isn’t replacing radiologists, it has significantly changed their field.
    • “More than three-quarters of the AI software cleared by the Food and Drug Administration for medical use is designed to support radiology practice, says Curtis Langlotz, a radiology professor at Stanford University and president of the Radiological Society of North America’s board of directors.
    • “Radiology is leading the way in the development and implementation of AI in clinical practice,” he adds. But AI isn’t reducing the need for human input.
    • “AI is not a better kind of intelligence, it’s just a different kind of intelligence,” Langlotz says. “A human plus a machine is better than either one alone. I would say that has been true since I began studying AI in the 1980s, and it continues to be true today.”

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Senate over the weekend is expected to cast a final vote on its revised budget resolution for fiscal year 2025. Senate Republicans April 3 voted to proceed on the resolution which kicked off debate. Today the Senate was slated to debate and process a number of amendments before holding a final vote on the resolution. The budget resolution is expected to pass and move to the House for consideration next week.” 
  • Per a CMS fact sheet,
    • The Centers for Medicare & Medicaid Services (CMS) issued a final rule on April 4, 2025, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) programs. The Contract Year (CY) 2026 MA and Part D final rule implements changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the MA and Part D programs. 
    • CMS is not finalizing certain provisions from the proposed rule at this time. CMS may address these proposals in future rulemaking, as appropriate. CMS is also announcing that it is not finalizing three provisions from the proposed rule (Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies, Procedures and Ensuring Equitable Access to Medicare Advantage Services—Guardrails for Artificial Intelligence, and Part D Coverage of Anti-Obesity Medications (AOMs) and Application to the Medicaid Program). 
    • This fact sheet discusses the major provisions of the CY 2026 MA and the Part D final rule. The final rule can be downloaded here: https://www.federalregister.gov/public-inspection/2025-06008/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare. 
  • The Wall Street Journal emphasizes,
    • “The Trump administration said Friday that Medicare and Medicaid won’t expand coverage of popular anti-obesity drugs, rejecting a proposal issued late last year by the Biden administration.
    • “The decision deals a blow, at least for now, to Americans who are covered by the government health-insurance programs and wanted their help paying for the popular but pricey drugs. 
    • “Yet the administration left open the possibility of revisiting the decision later.
    • “Expanding coverage of the obesity medications “is not appropriate at this time,” a Centers for Medicare and Medicaid Services spokeswoman said.
    • “She said CMS may reconsider the policy after more review of the drugs’ “potential benefits” and “relevant costs,” including costs to state Medicaid agencies.”
  • For perspective, STAT News pointed out last September
    • A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.
  • Per a House Budget Committee news release,
    • “House Budget Committee Chairman Jodey Arrington (R-Texas) today appointed Budget Committee Member Rep. Blake Moore (R-Utah) to chair the Committee’s Health Care Task Force. 
    • “The Task Force will build on its work from the 118th Congress by examining opportunities to modernize and personalize the health care system and support policies to fuel innovation and increase patient access to quality and affordable care. One of the initial areas of focus for the Budget Health Care Task Force will be examining the budgetary effects of chronic disease and opportunities to Make America Healthy Again.” 
  • Per an HHS news release,
    • “HHS Secretary Robert F. Kennedy, Jr. will embark [next Monday through Wednesday] on a multi-state tour to celebrate MAHA initiatives in the Southwest. He will meet with elected officials, tribal leaders, nutrition experts, and charter school visionaries as he works to fulfill President Trump’s promise to Make America Healthy Again.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • COVID-19
      • “COVID-19 activity is declining nationally to low levels. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
    • RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The AHA News tells us,
    • “There are 607 confirmed cases of measles across the U.S., according to the latest data released April 4 by the Centers for Disease Control and Prevention. The majority of cases are in Texas, as an outbreak in the state has grown to 481 cases, according to the Texas Department of State Health Services.  
    • “Cases have been reported by 21 states, with 93% being outbreak-associated, according to the CDC. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.” 
  • Per Health Day,
    • “Strokes caused by an artery tear are landing five times as many Americans in the hospital these days, a new study says.
    • “Cervical artery dissection involves a small tear in the inner lining of an artery in the neck that supplies blood to the brain.
    • “Blood can clot at the site of the tear. If the clot breaks loose, it can travel to the brain and cause a stroke.
    • “Hospitalizations for this sort of stroke have increased nearly fivefold during the past 15 years, according to findings published April 2 in the journal Neurology.
    • “Cervical artery dissection is an important cause of stroke, especially in people under 50, so it is crucial to detect it right away,” senior researcher Dr. Shadi Yaghi, a vascular neurologist at Brown University in Providence, R.I., said in a news release.
    • “Strokes that are not fatal can lead to long-term disability, poor mental health and reduced quality of life,” he said. “Our research found a dramatic increase in the number of hospitalizations for cervical artery dissection, with rates rising steadily year over year.” 
    • “These sort of tears in the cervical artery are most often caused by a motor vehicle crash or other accident that causes neck strain, researchers said. However, activities as simple as heavy lifting has been known to cause a cervical artery tear in some people.”
  • The New York Times shares “10 Small Things Neurologists Wish You’d Do for Your Brain. Easy everyday habits can help keep you sharp. And it’s never too late to start them.”
  • Per MedTech Dive,
    • “Boston Scientific’s pulsed field ablation catheter, Farapulse, was noninferior to Medtronic’s Arctic Front cryoballoon in a randomized trial, researchers found in a study published in The New England Journal of Medicine.
    • “The study, which was published Monday and funded by a Swiss hospital, randomized 210 patients with symptomatic paroxysmal atrial fibrillation to undergo PFA or cryoablation. Atrial tachyarrhythmia, a heart rhythm disorder where the atria beat too fast, recurred in 39 patients in the PFA cohort and 53 people in the cryoablation group.
    • “Medtronic reported declines in its cryoablation business last year but said the losses were offset by growth of its PulseSelect single-shot catheter, which competes with Farapulse for the growing PFA market.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “Rural areas are quickly losing independent physicians and medical practices amid the corporatization of healthcare, a new report finds.
    • “The report was commissioned by the Physicians Advocacy Institute (PAI), a nonprofit advocacy organization focused on fair and transparent payment policies. The research, conducted by Avalere Health, used the IQVIA OneKey database, which contains physician and practice location information on health system ownership.
    • “The number of independent doctors in rural areas fell 43% from January 2019 to January 2024, with rural areas losing 5% of all practicing physicians. Meanwhile, people in rural areas had access to 11% fewer medical practices as of January 2024.
    • “Nearly 9,500 doctors left independent practice in rural areas, predominantly in the Midwest and Northeast. States like Indiana, Massachusetts, New Jersey and Ohio lost more than 50% of independent docs.
    • “This decline in rural healthcare providers has been primarily driven by a drop in independent docs and practices as well as the acquisition of these practices by hospitals and corporate entities, the report said.” 
  • Beckers Hospital Review lets us know,
    • “South Bend, Ind.-based Beacon Health System has signed a definitive agreement to acquire Ascension Michigan’s southwest region, which includes four hospitals, 35 outpatient clinics and an ambulatory surgery center.
    • “The hospitals include:
      • “Ascension Borgess Hospital (Kalamazoo)
      • “Ascension Borgess Allegan Hospital
      • “Ascension Borgess-Lee Hospital (Dowagiac)
      • “Ascension Borgess-Pipp Hospital (Plainwell)
    • “Expanding our reach deeper into southwest Michigan broadens access to high-quality, affordable care for communities served by Ascension, extends our service area and provides growth opportunity to further strengthen the health system,” Beacon Health CEO Kreg Gruber said in an April 3 news release. “This acquisition will create a bright future for these communities by ensuring access to quality healthcare services for generations.”
  • Per Fierce Pharma,
    • “With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth out of another drug from its $27.8 billion Horizon Therapeutics buy. 
    • “Uplizna is the first drug to win an FDA approval for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can present in multiple organs and cause fibrosis and permanent organ damage, with or without symptoms.
    • “The CD19-targeted therapy made strides in treating the disease in its phase 3 MITIGATE trial. In the study, Uplizna demonstrated an 87% reduction in the risk of IgG4-RD flares over placebo during the 52-week placebo-controlled period, with 10.3% of those on Uplizna experiencing a flare-up compared to 59.7% of those taking placebo.
    • “With the approval, patients and physicians now have a “proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use,” Amgen’s executive vice president of R&D Jay Bradner, M.D., said in a company release. “This approval underscores Amgen’s ongoing commitment and leadership in developing innovative treatments targeting CD19+ B-cells across multiple therapeutic areas.”
    • “Now, the road ahead for Amgen’s success in IgG4-RD lays in raising awareness of the rare disease, which was only recently established with an International Classification of Diseases code in 2023. About 20,000 people are estimated to have the disease in the U.S., but the exact number is hard to pinpoint due to limited data, according to Amgen.”
  • and
    • “As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud.
    • “GSK and Pfizer have moved to scrap a patent lawsuit around their respective RSV vaccines, according to a filing in the U.S. District Court in Delaware.
    • “The settlement comes after a U.K. high court in November sided with Pfizer, ruling that two GSK RSV vaccine patents were invalid.”

From the artificial intelligence front,

  • Beckers Payer Issues discusses how health plans can use “AI to Drive Patient Outcomes & Health Plan ROI.”
  • Modern Healthcare adds,
    • “Artificial intelligence and other cutting-edge innovations could radically reshape how care is delivered, but tapping technology’s full potential and getting a return on investments is far off, according to industry executives.
    • “We need enduring, ambitious vision,” said Dr. Vivek Garg, chief medical officer at Humana’s CenterWell healthcare services division, during Modern Healthcare’s 2030 Playbook conference in Nashville Wednesday. “You’re going to need the leadership and the board to make trade-offs and to make investments. …They’ve got to do it because they know what they stand for, and they want to see what they can become and how much further they can go in their vision.” * * *
    • “More collaboration between payers and providers is imperative, said Mike Bennett, chief strategy and transformation officer at Highmark Health.
    • “If we both don’t start working together and using the tools we both have, we’re going to end up leaving [our populations] behind,” Bennett said. “AI doesn’t care whether you’re a payer or provider.”