FEHBlog

Weekend Update

David Ermer–Congress, COVID-19 vaccine, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC

  • The House Budget Committee will resume consideration of the budget reconciliation bill tonight at 10 pm ET.
  • The New York Times reports that “The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.”

From the public health and medical research front,

  • The New York Times further reports,
    • “Surgeons in Southern California have performed the first human bladder transplant, introducing a new, potentially life-changing procedure for people with debilitating bladder conditions.
    • “The operation was performed earlier this month by a pair of surgeons from the University of California, Los Angeles, and the University of Southern California on a 41-year-old man who had lost much of his bladder capacity from treatments for a rare form of bladder cancer.
    • “I was a ticking time bomb,” the patient, Oscar Larrainzar, said on Thursday during a follow-up appointment with his doctors. “But now I have hope.”
    • “The doctors plan to perform bladder transplants in four more patients as part of a clinical trial to get a sense of outcomes like bladder capacity and graft complications before pursuing a larger trial to expand its use.”
  • and
    • “Kristin Kramer woke up early on a Tuesday morning 10 years ago because one of her dogs needed to go out. Then, a couple of odd things happened.
    • “When she tried to call her other dog, “I couldn’t speak,” she said. As she walked downstairs to let them into the yard, “I noticed that my right hand wasn’t working.”
    • “But she went back to bed, “which was totally stupid,” said Ms. Kramer, now 54, an office manager in Muncie, Ind. “It didn’t register that something major was happening,” especially because, reawakening an hour later, “I was perfectly fine.”
    • “So she “just kind of blew it off” and went to work.
    • “It’s a common response to the neurological symptoms that signal a T.I.A., a transient ischemic attack or ministroke. At least 240,000 Americans experience one each year, with the incidence increasing sharply with age.” * * *
    • “Now, a large epidemiological study by researchers at the University of Alabama at Birmingham, published in JAMA Neurology, points to another reason to take T.I.A.s seriously: Over five years, study participants’ performance on cognitive tests after a T.I.A. drops as steeply as it does among victims of a full-on stroke.” * * *
    • “An accompanying editorial by Dr. Eric Smith, a neurologist at the University of Calgary, was pointedly headlined “Transient Ischemic Attack — Not So Transient After All!”
  • Medscape adds,
    • Is it time for universal screening for atrial fibrillation (AF), the most commonly treated type of arrhythmia that sets people up for strokes?
    • The question is important. While estimates of prevalence vary, a recent study found AF affects about 4% of the adult population or about 10 million in the United States. More than 795,000 people in the United States have a strokeeach year, and AF is blamed for 1 in 7.
    • For now, however, US organizations that issue guidelines and many leading cardiologists agree: It’s not yet warranted and may result in anticoagulation overtreatment, along with what they call the “nontrivial” risk for bleeding from that treatment.
    • However, it’s definitely a stay tuned situation, as researchers continue to investigate whether widespread screening can reduce the number of strokes in the broad population, others look at the role of “smart” technology, and still others focus on subsets of the population that might benefit most from routine screening.
  • The Washington Post points out,
    • “Eating an unhealthy diet is tied to an earlier first period, a new analysis suggests.
    • “The study linked a girl’s first menstrual period — a milestone known as menarche — to what she ate, showing ties between potentially inflammatory diets rich in processed and refined foods, red meat and beverages such as soda and an earlier onset of menstruation.
    • “Published in Human Reproduction, the study looked at 7,530 participants in the Growing Up Today Study, an ongoing study that evaluates factors thought to influence health across a lifetime. Participants enrolled in 1996 and 2004 and answered questionnaires about diet and activity, general health, family history, demographic factors and when they got their first period.
    • “Researchers assessed participants’ diets using two rubrics: the Alternative Healthy Eating Index, a score based on participants’ adherence to a healthy diet, and the Empirical Dietary Inflammatory Pattern, which identifies diets linked to inflammation. These potentially inflammatory diets are higher in processed foods, beverages like soda and juice, and red meat.
    • “Ninety-three percent of participants started their period during the study, at a median age of 13.1 years. But the age of menarche varied among participants with different diets. Overall, having a healthier diet predicted later menarche, and those who ate the healthiest diet were 8 percent less likely to get their first period in the next month. The association remained after researchers adjusted for body mass index, height and neighborhood socioeconomic status.”

From the U.S. healthcare business front,

  • The Wall Street Journal let us know,
    • “A government crackdown on cheaper copies of Ozempic and similar diabetes and weight-loss drugs was intended to shut the door on that booming market.
    • “It hasn’t exactly worked out that way. 
    • “Instead, some compounding pharmacies and telehealth companies that make the copies have found new ways in. They are making and selling dosages slightly different from the standard, FDA-approved amounts or including additives such as vitamins B3 and B12. Others have changed how the drug is taken, switching from injectables to under the tongue drops or pills.
    • “These providers are relying on a law that allows bespoke versions of drugs that are unavailable commercially. Though some patients report delays in receiving the compounded medications, many are still getting them—at least for now—said patients and industry professionals. 
  • MedTech Dive tells us,
    • “Siemens Healthineers said Wednesday it is investing $150 million to expand production in the U.S.
    • “Siemens is relocating manufacturing operations for its radiation oncology business Varian from Mexico to the U.S. The company said the change will add around 50 jobs in California.
    • “The company is also building a 60,000 square foot “Experience Center” in North Carolina, investing $141 million in a research and innovation district that it has been involved with since 2023.”

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.”

Thursday Report

David Ermer–AHRQ, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Healthcare Dive summarizes the healthcare-related provisions of the various House committee budget reconciliation recommendations that the House Budget Committee will take up tomorrow.
  • As promised, the Departments of Health and Human Services, Labor, and the Treasury released today a non-enforcement policy concerning the 2024 mental health parity amendments.
    • “The Departments have requested that the ERIC litigation be held in abeyance while the Departments reconsider the 2024 [Mental Health Parity] Final Rule, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation through notice and comment rulemaking.
    • The Departments will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months. This enforcement relief applies only with respect to those portions of the 2024 Final Rule that are new in relation to the 2013 final rule. The Departments note that MHPAEA’s statutory obligations, as amended by the CAA, 2021, continue to have effect. 
  • The Wall Street Journal reports,
    • “The Trump administration is planning to drop recommendations that pregnant women, teenagers and children get Covid-19 vaccines as a matter of routine, according to people familiar with the matter.
    • “The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., is expected to remove the Centers for Disease Control and Prevention’s recommendations for those groups around the same time it launches a new framework for approving vaccines, the people said.
    • “The exact timing of the announcement wasn’t clear, the people said, though it was expected in the coming days.”
  • Tammy Flanagan, writing in Govexec, discusses “Getting ready to retire. What you should do and how you should approach your retirement and health benefits planning before leaving federal service.”

From the FDA front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today is taking a major step to increase transparency and ensure the safety of chemicals in our food. The agency is launching a stronger, more systematic review process for food chemicals already on the market—especially those that concern consumers most.
    • “No parent should ever worry about what’s in their child’s food,” said HHS Secretary Robert F. Kennedy, Jr. “We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”
    • “Under the leadership of Secretary Kennedy and FDA Commissioner Martin A. Makary, M.D., M.P.H., the FDA will roll out several key actions over the coming months:
      • “A modernized, evidence-based prioritization scheme for reviewing existing chemicals. A draft will be released for public comment soon.
      • “A final, systematic post-market review process shaped by stakeholder input.
      • “An updated list of chemicals under review, including BHT, BHA, and ADA. The FDA will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide. FDA will continue to share information about the status of this work on its public website as part the agency’s push for greater transparency.”
  • Fierce Pharma adds,
    • “Six years after Merck bought out Peloton Therapeutics, the New Jersey drugmaker is not remaining stationary with the crown jewel of the deal.
    • “On Wednesday, the FDA approved a third indication for Welireg (belzutifan), signing off on the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor to treat patients with rare pheochromocytoma or paraganglioma (PPGL) tumors in the endocrine system.
    • “The approval covers patients 12 and older with locally advanced, unresectable or metastatic PPGL and makes Welireg the first oral treatment for advanced PPGL, per Merck.”
  • Per MedPage Today,
    • The FDA granted a first-ever approval for a first-line therapy for anal cancer to the PD-1 inhibitor retifanlimab (Zynyz), the agency announced Thursday.
    • The approval stipulates use in combination with carboplatin and paclitaxel in newly diagnosed locally advanced/metastatic squamous cell carcinoma of the anal canal (SCAC) or as monotherapy for patients whose disease progressed on platinum-based chemotherapy.
    • “Patients with inoperable, locally recurrent, or metastatic anal cancer have historically faced poor 5-year survival rates and limited treatment options,” said Marwan Fakih, MD, of City of Hope in Duarte, California, in a statement from drugmaker Incyte. “This approval marks an important advancement as it makes a new treatment approach available for this challenging disease.”

From the public health and medical research front,

  • The Wall Street Journal tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. has made combating chronic diseasea rallying cry as he looks to overhaul the health department and “Make America Healthy Again.”
    • “So how healthy is America, historically? It isn’t that we used to be healthier, data show, but the biggest threats have changed.
    • “The deadliest scourges in the U.S. were once infectious, with influenza and tuberculosis topping the list at the start of the 20th century. Better sanitation and advances in antibiotics and vaccines muzzled them, transforming Americans’ well-being. Medical innovations and antismoking campaigns then spurred decades of progress against heart disease and cancer.
    • “But chronic diseases, persistent or long-lasting health conditions, are undermining that momentum, contributing to our stalled life expectancy over the past decade that trails behind that of other wealthy nations.
    • “Much of the gap in life expectancy is due to deaths among working-age adults, says Dr. Steven Woolf, a life-expectancy researcher at the Virginia Commonwealth University.
    • “Americans die earlier and are sicker than people in other high-income countries,” he said. “This has been true for a long time, and the trend is getting worse.”
  • Health Day informs us,
    • “More U.S. teenagers are getting weight-loss surgery, despite the discovery of new drugs like Ozempic/Wegovy that help people drop pounds surgery-free, a new study says.
    • “Weight loss surgeries for teens increased 15% between 2021 and 2023, researchers reported earlier this month in The Journal of Pediatrics.
    • “Further, much of the increase in weight-loss surgery is due to its increased popularity among Hispanic and Black teenagers, groups disproportionately affected by severe obesity compared to white teens, researchers said.
    • “The number of U.S. adolescents having access to this treatment that we know is safe and effective is the highest it’s ever been, and hopefully it’s the start of a positive weight loss journey that will get them to better health,” lead researcher Sarah Messiah, director of the Child and Adolescent Population Health Program at UT Southwestern Medical Center, said in a news release.”
  • Per Beckers Hospital Review,
    • “Adult patients taking Wegovy saw a reduced risk of experiencing a major adverse cardiovascular event within the first three months of treatment, according to a secondary analysis of the drug’s clinical trial data, presented May 12 at the European Congress on Obesity.”
  • Very good news from an NIH news release,
    • “A research team supported by the National Institutes of Health (NIH) has developed and safely delivered a personalized gene editing therapy to treat an infant with a life-threatening, incurable genetic disease. The infant, who was diagnosed with the rare condition carbamoyl phosphate synthetase 1 (CPS1) deficiency shortly after birth, has responded positively to the treatment. The process, from diagnosis to treatment, took only six months and marks the first time the technology has been successfully deployed to treat a human patient. The technology used in this study was developed using a platform that could be tweaked to treat a wide range of genetic disorders and opens the possibility of creating personalized treatments in other parts of the body.
    • “A team of researchers at the Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania (Penn) developed the customized therapy using the gene-editing platform CRISPR. They corrected a specific gene mutation in the baby’s liver cells that led to the disorder. CRISPR is an advanced gene editing technology that enables precise changes to DNA inside living cells. This is the first known case of a personalized CRISPR-based medicine administered to a single patient and was carefully designed to target non-reproductive cells so changes would only affect the patient.
    • “As a platform, gene editing — built on reusable components and rapid customization — promises a new era of precision medicine for hundreds of rare diseases, bringing life-changing therapies to patients when timing matters most: Early, fast, and tailored to the individual,” said Joni L. Rutter, Ph.D., director of NIH’s National Center for Advancing Translational Sciences (NCATS).”
  • BioPharma Dive adds,
    • “We are still in very early days,” said Rebecca Ahrens-Nicklas, an assistant professor of pediatrics at the University of Pennsylvania and study author. Doctors will monitor KJ’s progress and are considering other ways to evaluate the therapy’s effects without a biopsy.
    • “Yet the findings could carry important implications for drug research. There are more than 7,000 rare diseases, many of which are so uncommon they’re unlikely to be profitable for any companies that develop treatments for them. Gene editing could be a powerful solution, but an expensive development path and slim sales prospects make such medicines tough investment propositions. A large number of biotechnology firms pursuing gene editing are struggling to survive.” 
  • Here is a link to the All of Us Research Project’s Medical Minutes.
  • Per MedPage Today,
    • “First-line treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) significantly improved survival compared with lenvatinib (Lenvima) or sorafenib (Nexavar) for patients with unresectable hepatocellular carcinoma (HCC), the randomized phase III CheckMate 9DW trial showed.
    • “Of more than 600 patients, median overall survival (OS) was 23.7 months with the PD-1 inhibitor and CTLA-4 inhibitor combination versus 20.6 months with single-agent tyrosine kinase inhibitors (HR 0.79, 95% CI 0.65-0.96, P=0.018), reported Peter R. Galle, MD, of the University Medical Center in Mainz, Germany, and colleagues.
    • “Respective OS rates were 49% versus 39% at 24 months and 38% versus 24% at 36 months, they wrote in The Lancet.
    • “The overall survival rates “are the longest and highest reported for the approved systemic treatments in this setting,” wrote Galle and colleagues, adding that the results “support nivolumab plus ipilimumab as a first-line treatment” in unresectable HCC.
    • “Results of this trial led to the recent FDA approval of the combination as first-line treatment for adults with unresectable or metastatic HCC.”
  • Per Fierce Pharma,
    • “Merck’s Keytruda, with more than 40 approved indications, hasn’t yet been able to crack specifically into ovarian cancer. But with promising early results from a phase 3 study in certain patients, the checkpoint inhibitor may have found its place.
    • “At a pre-specified interim analysis of Merck’s phase 3 Keynote-B96 trial, which is testing Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer, the drug showed “statistically significant and clinically meaningful” improvements in progression-free survival regardless of patients’ PD-L1 status, Merck reported on Thursday.
    • “The trial compared the Keytruda regimen against placebo and chemotherapy, again with or without Avastin.”
  • HHS’s AHRQ released a systematic review finding
    • “No completed studies show if blood-based, multicancer screening tests help people compared with no screening or standard single-cancer screenings. We do not know if these tests save lives, reduce advanced cancers, or improve quality of life.
    • “We found 20 studies covering 109,177 people that tested how accurate 19 different multicancer screening tests were. Thirteen of these studies had serious flaws in how they were conducted.
    • “Accuracy varied widely based on:
      • “What the tests measured and how researchers analyzed it,
      • “How many and which types of cancers researchers tried to find,
      • “Which types of people were tested, and
      • “How the studies were designed.
    • “We graded the strength of evidence for accuracy as insufficient, meaning we cannot draw firm conclusions.
    • “We only found one study reporting on potential harms from multicancer screening tests. We graded the strength of evidence as insufficient for harms based on this single study.
    • “Studies that will be completed in the next 2 to 4 years may give more information about whether multicancer screening tests work and whether they have harms.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Higher patient volumes were not enough to keep CommonSpirit Health in the black during its latest quarter.
    • “Patient volumes soared across the country over the past couple of years due to a rebound in demand after the COVID-19 pandemic and overall population growth in fast-growing markets.
    • “The trend largely boosted net patient revenue and helped pad bottom lines for many health systems. Volume growth is one part of CommonSpirit’s strategy to improve operating performance.
    • “However, this year may bring a more complicated dynamic, given continued inflation, tariffs and federal funding uncertainty weighing on hospital finances.
    • “Chicago-based CommonSpirit recorded a $42 million net loss in its third quarter, compared with $282 million in net income a year ago, according to financial documents published Thursday. Results are not adjusted for the California provider fee program, which would add supplemental payments if approved by the Centers for Medicare and Medicaid Services.
    • “CommonSpirit said its financial results were impacted by expenses increasing at a faster rate than revenue, despite strong volumes, lower lengths of stay and higher productivity levels.”
  • Beckers Hospital Review lets us know,
    • “Texas Rural Hospital in Cleveland is set to reopen within the next week after it abruptly closed its doors the week of May 12 due to funding shortages, KIAH reported May 15. 
    • “The hospital’s lease agreement with Cleveland-based Emergency Hospital Systems, a community emergency hospital system, ended in March 2025. It then gained new ownership under HealCrest Network, a spokesperson for EHS said in a May 14 statement shared with Becker’s.
    • “Hospital employees told KIAH that they did not receive pay on May 9; however, the hospital said it plans to repay them in the coming days.”
  • and
    • [Another article shows] “the adjusted expenses per inpatient day in 2023 for nonprofit, for-profit, and government hospitals in every U.S. state, based on the latest estimates provided by Kaiser State Health Facts. 
    • “The figures are based on information from the 2023 American Hospital Association Annual Survey. They are an estimate of the expenses incurred in a day of inpatient care and have been adjusted upward to reflect an estimate of outpatient service volumes, according to the KFF. 
    • “The foundation notes the figures are “only an estimate of expenses incurred by the hospital” for one day of inpatient care and do not substitute actual charges or reimbursement for care provided.
    • “To see how expenses compare to one year prior, find 2022’s adjusted expenses per inpatient day here. 
      • National average
      • Nonprofit hospitals: $3,288
      • For-profit hospitals: $2,529
      • State/local government hospitals: $2,857
  • Per a press release,
    •  “Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (together, Blue cross) today reported a combined after-tax first quarter net income of $37 million on revenue of $2.6 billion (1.4% net margin). These results reflect an operating and other loss of $9.8 million (-0.4% operating margin) and investment income of $46.8 million.
    • “The big story is that spending on medical and pharmacy services for our members remains elevated, at near historic highs,” said Chief Financial Officer Ruby Kam. “Two notable callouts in the first quarter involve higher spending due to the difficult flu season as well as the continued impact of high-cost GLP-1 medications.” Kam said the company projects operating and net losses for full-year 2025 and has implemented a comprehensive plan to improve its financial results. Last year, the company posted the worst operating loss in its 87-year history.
    • “Blue Cross is the leading private health plan in Massachusetts with 3 million members.”
  • Fierce Healthcare points out,
    • “Earlier this month, pharmacy chain Rite Aid filed bankruptcy for the second time in less than two years, revealing that it would seek buyers for its retail locations.
    • “In the Pacific Northwest, it’s garnering interest from pharmacy rival CVS Health, according to a report in Bloomberg. Rite Aid CEO Matthew Schroeder told employees on Thursday that CVS had made a bid on a large number of stores in Washington, Oregon and Idaho along with patient prescription data, according to a recording reviewed by the outlet.
    • “If a deal were to go through, it would give CVS greater reach in a region where its presence is currently smaller, per the article.
    • “Schroeder said that Rite Aid has also received bids on some of its assets from multiple other pharmacy groups, including Walgreens, Albertsons, Kroger and Giant Eagle, Bloomberg reported.”
  • Per an Institute for Clinical and Economic Research news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatment for Retinitis Pigmentosa. Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of sonpiretigene isteparvovec compared to usual care.”

Wednesday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • NBC News reports
    • “Two Key House committees advanced their portions of a sweeping package for President Donald Trump’s agenda on party-line votes Wednesday following marathon meetings. 
    • “The tax-writing Ways and Means Committee advanced its bill, which would permanently extend Trump’s 2017 cuts, Wednesday morning after a session that clocked in at more than 17 hours.
    • “Later Wednesday, the Energy and Commerce Committee passed its legislation, which includes steep Medicaid cuts, after meeting for more than 26 hours.”
    • “The House Agriculture Committee was still debating its part of the broader package which includes a $290 billion cut to Supplemental Nutrition Assistance Program (SNAP), late Wednesday afternoon. The panel began its markup around 7:30 p.m. Tuesday before breaking around midnight and reconvening Wednesday morning. 
    • “The Ways and Means and Energy and Commerce committees did not make substantive changes to the original plans offered by their chairs.” 
  • Following the creation of committee recommendations, the House Budget Committee will take responsibility for the budget reconciliation bill. Per a Budget Committee news release today,
    • “On Friday, May 16th, 2025, at 9:00 AM in 210 Cannon House Office Building, the House Committee on the Budget will hold a markup to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2025, H. Con. Res. 14. 
    • “Committee hearings and markups are available LIVE from our website or YouTube.”
  • The American Hospital Association News tells us,
    • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 14 testified on President Trump’s discretionary budget proposal for fiscal year 2026 in hearings before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies and the Senate Committee on Health, Education, Labor and Pensions. The proposal includes $93.8 billion for HHS, which is a 26.2% reduction from the FY 2025 enacted level.”
  • The Wall Street Journal offers its insights on these hearings here.
  • Federal News Network lets us know that OPM is proceeding with its retirement application processing improvements, notwithstanding the cancellation of the Workday contract.
  • Govexec takes on “Age gap retirement planning for federal employees: Avoiding the ‘Widow’s Penalty,’ Medicare planning and more. How to think about the best ways to utilize your retirement and health care benefits when you may be older, or younger, than your spouse.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is taking bold steps to modernize the nation’s digital health ecosystem with a focus on empowering Medicare beneficiaries through greater access to innovative health technologies. The agency, in partnership with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), is seeking public input on how best to advance a seamless, secure, and patient-centered digital health infrastructure. The goal is to unlock the power of modern technology to help seniors and their families take control of their health and well-being, manage chronic conditions, and access care more efficiently.” * * *
    • “The request for information (RFI) invites input from patients, caregivers, providers, payers, technology developers, and other stakeholders on how CMS and ASTP/ONC can: 
      • “Drive the development and adoption of digital health management and care navigation applications; 
      • “Strengthen interoperability and secure access to health data through open, standards-based technologies; 
      • “Identify barriers preventing the seamless exchange of health information across systems; and
      • Reduce administrative burden while accelerating progress toward value-based, patient-centered care.”
    • “The public comment period will be open through June 16. The RFI is available at https://public-inspection.federalregister.gov/2025-08701.pdf, and the public should submit all comments through the provided weblink.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The number of people who died of drug overdoses in the U.S. dropped dramatically in 2024, a promising sign amid a national fentanyl crisis that has fueled a surge in drug-related deaths in recent years.  
    • “Drug-overdose deaths dropped by 27% to around 80,000 deaths in 2024 from about 110,000 in 2023, according to preliminary data released by the Centers for Disease Control and Prevention on Wednesday. The deaths reported last year fell closer to levels not seen since before the Covid-19 pandemic, which exacerbated the country’s drug-overdose crisis and led to a surge in deaths.
    • “Yearly declines in new overdose deaths are rare and tend to be small, making 2024’s drop unprecedented in its scope. This is also only the fourth year in more than three decades in which the U.S. reported fewer drug fatalities, but also the second in a row after a modest reduction in 2023.” * * *
    • “Despite the drop in drug-overdose related deaths in 2024, the yearly tally is still much higher than those recorded less than a decade ago and before the opioid crisis took off in the 1990s. The U.S. recorded well over 100,000 deaths a year from 2021 to 2023, according to federal data.”
  • Reuters informs us,
    • “The Texas health department reported 717 cases of measles in the state on Tuesday, an increase of eight since its last update on Friday, as the U.S. battles one of the worst outbreaks of the childhood disease in the country.
    • “Cases in Gaines County, the epicenter of the outbreak, rose to 405 from 403 since the last update, according to the Texas Department of State Health Services.
    • “Texas had reported seven additional cases in the last update on Friday, which was the lowest increase since the outbreak began in February.
    • “New Mexico’s health department reported 71 cases, unchanged from its last update. Most of the state’s cases are from Lea County, adjacent to Gaines County in Texas.”
  • Per Becker’s Hospital Review,
    • “Seventy-six percent of oncologists reported seeing an increasing number of patients presenting with advanced-stage cancer. Of those, 75% attributed the increase to screening barriers, according to a survey published May 13 by the Harris Poll on behalf of Quest Diagnostics. 
    • “The Harris Poll surveyed 174 medical oncologists and 76 surgical oncologists on their experiences with advanced-stage cancer diagnoses and recurrence between Aug. 6 and Sept. 4.” * * *
    • “Read the full survey results here.” 
  • The National Cancer Institute (NCI) posted its latest edition of Cancer Currents, which is a research blog.
  • Per HCPLive,
    • “Findings from a recent study suggest iron deficiency anemia (IDA)independently and significantly increases the odds of ischemic stroke in young adults.
    • “IDA is the most common form of anemia globally. It results from iron deficiency, when there are insufficient iron stores to support the production of red blood cells. IDA disproportionately affects women due to regular iron losses through menstruation and increased iron demands during pregnancy. Maternal anemia can lead to the child exhibiting intellectual disability, autism spectrum disorder, and attention-deficit/hyperactivity disorder.
    • “Additionally, it is currently estimated that 10-15% of all strokes occur in adults aged 18-50, a group that also exhibits an increased prevalence of IDA. However, little data has been collected regarding the association between IDA and stroke in young adults.
    • “Although multiple studies have explored the association of IDA and thrombotic events in children, our study was the first to explore its role in ischemic stroke in a young adult population, that is, most susceptible to IDA,” wrote Jahnavi Gollamudi, MD, University of Cincinnati, and colleagues.
    • “Investigators classified patients into 2 groups: those with a first-time ischemic stroke diagnosis were defined as Group A, and those without a history of ischemic stroke were defined as Group B.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a series of changes in the architecture and cell composition of connective tissues of the breast, known as stromal tissue, that is associated with an increased risk of developing aggressive breast cancer among women with benign breast disease, and poorer rates of survival among women with invasive breast cancer. This process, which they call stromal disruption, could potentially be used as a biomarker to identify women with benign breast disease who are at high risk of developing aggressive breast cancers, as well as those with breast cancer who may be at increased risk of recurrence or death.
    • “Such insights could help inform the development of cancer prevention and treatment strategies that target the stromal microenvironment. In addition, stromal disruption is inexpensive to assess and could be widely adopted, particularly in low-resource settings where molecular analysis is impractical or very expensive.”
  • Per Fierce Pharma,
    • “After flexing its antibody-drug conjugate bona fides at last year’s American Society of Clinical Oncology (ASCO) conference, AbbVie is advancing its solid tumor ambitions with a new FDA green light.
    • “The FDA on Wednesday granted an accelerated approval to AbbVie’s c-Met-directed ADC Emrelis, also known as telisotuzumab vedotin, as a new treatment option for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who’ve previously received systemic therapy. The drug is cleared in patients whose tumors exhibit high overexpression of the c-Met protein.
    • “The c-Met protein is overexpressed in around 25% of patients with advanced epidermal growth factor receptor wild-type, non-squamous NSCLC, and roughly half of those patients have high c-Met overexpression, AbbVie explained in a press release.”
  • Per BioPharma Dive,
    • “A two-drug regimen involving an experimental cancer immunotherapy from iTeos Therapeutics and GSK didn’t significantly delay tumor progression in a Phase 2 trial, leading the companies to end development and terminate the collaboration they formed around the drug four years ago.
    • “When added to GSK’s drug Jemperli, the immunotherapy, known as belrestotug and aimed at a cellular target called TIGIT, didn’t meet preset criteria for progression-free survival compared to Jemperli alone in people with non-small cell lung cancer. The study showed a “trend below the meaningful threshold” for drug responses in study arms including people with head and neck cancer, the companies said Tuesday.
    • “Based on the results, iTeos and GSK are stopping all ongoing trials of belrestotug, including an ongoing Phase 3 study in lung cancer. iTeos is “taking immediate steps to preserve capital” as well as starting a strategic review.”

From the U.S. healthcare business front,

  • We start with global news from the Wall Street Journal,
    • “GSK will acquire a liver-disease treatment from Boston Pharmaceuticals for up to $2 billion as it seeks to boost its pipeline of new drugs.
    • “The British pharma giant said Wednesday that it will pay the U.S. biotech company $1.2 billion upfront, with a further $800 million in potential success-based milestone payments.
    • “The drug is currently in late-stage trials, with a potential market launch in 2029. It aims to treat a form of liver disease characterized by inflammation and damage caused by a build-up of fat. GSK said the drug is also being explored for use in alcohol-related liver disease, and that mid-stage data has shown potential to reverse liver fibrosis and halt disease progression.
    • “Unlike current daily tablet treatments, efimosfermin is designed to be administered as a monthly shot. GSK plans to develop it both as a monotherapy–which uses one type of treatment–and in combination with its own experimental liver-disease therapies.”
  • and
    • “Danish pharmaceutical company Novo Nordisk has signed a collaboration deal with U.S. biotech Septerna that will see the two companies develop pills to treat obesity, type 2 diabetes and other cardiometabolic diseases.
    • “Under the terms of the agreement, Septerna is eligible to receive around $2.2 billion from Novo Nordisk, including over $200 million in upfront and near-term milestone payments.
    • “The U.S. company will also receive research, development and commercial milestone payments, on top of tiered royalties on global net sales of marketed products. Novo Nordisk will cover all research-and-development costs.”
  • STAT News lets us know,
    • “The mood at the annual meeting of the American Society of Cell and Gene Therapy isn’t amazing. The biotech market has been bad for years. The FDA and NIH are shrouded in uncertainty. But many researchers tried to project confidence. Over the last four years, 16 gene and cell therapies have been approved, as one presenter noted Tuesday. Also, there was a purple-clad Mardi Gras-style stilt walker directing attendees into the main hall — so there’s that.”
  • Beckers Hospital Review points out that “A total of 66 hospitals [named in the article] received both Healthgrades’ Outstanding Patient Experience and Patient Safety Excellence awards.”
  • Per Beckers Payer Issues,
    • “Contract disputes between insurers and health systems are down in 2025 compared to the second half of 2024.
    • “According to data from FTI Consulting, there were 133 total disputes in 2024, compared to 86 in 2023 and 51 in 2022. In the first quarter of 2025, 26 total disputes have been recorded, compared to 50 in Q4 2024 and 37 in Q3 2024. Network breaks between Medicare Advantage plans and health systems tripled from 2022 to 2024.
    • “FTI has tracked media reports regarding negotiations over reimbursement rates between provider organizations and insurance companies during each quarter since early 2022.”
  • HR Dive notes,
    • “While 86% of employers think their benefits are modern, only 59% of workers agree,  according to the results of Prudential’s 2025 Benefits and Beyond study, released Monday. 
    • “Workers say their top challenges are saving for retirement (45%), cost of everyday goods (44%), cost of housing (29%) and making it paycheck to paycheck (26%); and 1 in 10 workers identified being able to survive paycheck to paycheck as their No. 1 worry, the study found. 
    • “The study’s findings are clear: When it comes to workplace benefits, there is a disconnect on what companies offer and what employees actually need — now and in the future,” the press release said.”

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Last week, the President issued another Executive Order on deregulation. The EO begins
    • “Deregulation is a critical priority for my Administration.  We will foster prosperity by freeing Americans from the heavy burden of Federal regulations accumulated over decades.”
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services May 13 announced a 60-day public comment period opened for stakeholders regarding its request for information to remove outdated or unnecessary regulations. The request stems from an executive order issued in January requiring HHS to implement a “10-to-1” rule, eliminating at least 10 existing regulations for every new regulation introduced. Comments on the RFI can be submitted at regulations.gov/deregulation.”
  • When will OPM make a similar deregulation announcement?
  • The Congressional Research Service released a report on the House Oversight and Government Reform Committee’s budget reconciliation measures. The Congressional Budget Office posted its own report on those recommendations.
    • “In CBO’s estimation, the reconciliation recommendations of the House Committee on Oversight and Government Reform would, on net, decrease deficits by $51.0 billion over the 2025‑2034 period. The estimated budgetary effects of the legislation are shown in Table 1. The costs of the legislation mainly fall within budget functions 550 (health), 600 (income security), 800 (general government), and 950 (undistributed offsetting receipts).”
  • Modern Healthcare reports,
    • “Doctors that treat Medicare beneficiaries would receive a pay boost under the sweeping tax-and-spending cuts legislation House Republicans unveiled Monday.
    • “Medicare reimbursements to physicians declined 2.9% this year, provoking outcries from medical societies that complain doctor pay has failed to keep up with cost increases. The GOP measure would raise rates next year and remake the Medicare Physician Fee Schedule to link future updates to the Medicare Economic Index, which generally rises faster than overall inflation.
    • “In 2026, the legislation would hike Medicare physician payments by an estimated 2.25%. That projection is based on how the bill would modify the “conversion factor” that determines Medicare fees for physician services. Next year, that formula would be boosted by 75% of growth in the Medicare Economic Index. In later years, it would fall to 10% of medical inflation.
    • “The physician pay increase comes with a downside for some providers, however. While the measure would raise rates, it would curtail financial incentives under alternative payment models.”
  • Bloomberg Law reports,
    • “House Republicans revived a set of policies that would change how prescription drug middlemen do business, as President Donald Trump again denounced the industry, sending shares of some of the companies down Monday.
    • “The budget proposal from the House Committee on Energy and Commerce includes a set of reforms that Congress considered last year but ultimately didn’t pass. It would remove one method that the companies, which negotiate with drugmakers and pharmacies on behalf of employers, health insurers and government programs, use to boost profits.
    • “The revival of the modest reforms in the House budget plan adds to pressure on the companies, which are already facing intense scrutiny in Washington. Trump complained about the companies known as pharmacy benefit managers during a press conference Monday touting his executive order intended to help lower the prices Americans pay for drugs.”
  • The Senate Judiciary Committee held a hearing today on the allegedly adverse impact of prescription benefit manager practices on rural pharmacies.
  • Beckers Hospital Review looks into a Republican budget reconciliation proposal in Congress to “place a 10-year moratorium on state and local governments regulating AI. The provision would prevent any laws targeting AI models, systems or automated decision tools during that time.”
  • The AHA News informs us,
    • “The Centers for Medicare & Medicaid Services May 13 launched a new strategy focused on three pillars: promoting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition. To support the new strategic plan, CMS Administrator Mehmet Oz, M.D., and Innovation Center Director Abe Sutton hosted a public webinar highlighting the Innovation Center’s commitment to take learnings from historical investments in value-based care to the “Make America Healthy Again” initiative. They also highlighted the need for models to demonstrate cost savings and improved outcomes in accordance with statutory requirements. The agency posted FAQs regarding the new strategic direction on a new homepage.”
  • and
    • “The Centers for Medicare & Medicaid Services May 12 issued a proposed regulation that would change how states may structure provider taxes for purposes of generating revenue for their Medicaid programs. CMS states that these changes are intended to prevent states from adopting provider taxes that are not “generally redistributive” and therefore may be in violation of the statute. While CMS notes that they have particular concerns about certain Medicaid managed care organization taxes, these policies, if adopted, would apply to all provider taxes. The public has 60 days to comment.”
  • Beckers Hospital Review offers eight things to know about this proposed regulation.
  • The U.S. Preventive Services Task Force confirmed today the continuing validity of its Grade A recommendation of “early, universal screening for syphilis infection during pregnancy [for asymptomatic women]; if an individual is not screened early in pregnancy, the USPSTF recommends screening at the first available opportunity.” * * * “To achieve the benefit of screening, it is important that screening occur as early in pregnancy as possible and that everyone with abnormal syphilis test results receive timely, evidence-based evaluation and treatment.”

From the judicial front,

  • STAT News reports,
    • “The now 13-year-long legal saga over who invented CRISPR took yet another unexpected turn on Monday, in a ruling that could not only change U.S. ownership of patent rights to the groundbreaking gene-editing technology but more broadly redefine how the law determines when an invention has been made. 
    • “The U.S. Court of Appeals for the Federal Circuit sided with the University of California and the University of Vienna in their bid to revive a fight over foundational CRISPR-Cas9 patents that the schools say should go to their Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier. In 2022, the U.S. Patent and Trademark Office determined that a group of scientists led by Feng Zhang of the Broad Institute of Harvard and the Massachusetts Institute of Technology had conceived of uses of the technology in humans before Doudna and Charpentier.” 

From the public health and medical research front,

  • From HHS news releases,
    • “The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA. Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.
    • “The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said FDA Commissioner Marty Makary, M.D., M.P.H. “I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed–a groundbreaking initiative to ensure the safety, reliability, and nutritional adequacy of infant formula for American families. The FDA issued a Request for Information (RFI) to begin the nutrient review process required by law for infant formula. Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.
    • “Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” said HHS Secretary Robert F. Kennedy, Jr. “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen. You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.”
    • “Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.
    • “Commenters will have 120 days to submit responses. Further information on how to submit a comment can be found here.”
  • This week’s issue of NIH Research Matters covers the following topics — “Measuring tinnitus | Fat metabolism & pancreatic cancer | Senescent cell subtypes.”
  • The Washington Post reports,
    • “More U.S. high-schoolers used nicotine pouches — smokeless nicotine powder products — last year than the year before, according to new research published in JAMA Network Open.
    • “The researchers, who used data from a nationally representative survey of 10,146 youths in 2023 and 2024, said 5.4 percent of 10th- and 12th-graders reported having used nicotine pouches, up from 3 percent the year before. The 10th- and 12th-graders’ use of pouches in the 12 months and 30 days before the surveys also increased year to year. Males were also more likely to use pouches than females.
    • “Looking at race and ethnicity data, use was highest among White, non-Hispanic 10th- and 12th-grade teens — 9 percent had used a nicotine pouch at some point. Teens in rural areas were also more likely to use the products than urban or suburban youths: In 2024, 11.2 percent of rural youths vs. 5.9 percent of suburban and 3 percent of urban youths said they’d used a pouch.”
  • Per Healio,
    • “Social determinants of health at the community level, such as median income and walkability, have a larger influence on hip replacement outcomes than an individual patient’s race, according to data.
    • “The study was inspired by “persistent disparities observed in total hip arthroplasty outcomes, often attributed to individual factors such as race,” study author Bella Mehta, MD, MBBS, MS, a rheumatologist at Hospital for Special Surgery, told Healio.”
  • Per MedPage Today,
    • “Treating early Alzheimer’s disease patients with lecanemab (Leqembi) was feasible and most patients tolerated the drug well, a retrospective study at one specialty memory clinic showed.
    • “Infusion-related reactions occurred in 37% of 234 Alzheimer’s patients treated with lecanemab and typically were mild, according to Suzanne Schindler, MD, PhD, of Washington University School of Medicine in St. Louis, and co-authors.
    • “Amyloid-related imaging abnormalities (ARIA) emerged in 42 of 194 people (22%) who received at least four lecanemab infusions and had at least one MRI, the researchers reported in JAMA Neurology.
    • “Overall, 29 people (15%) had ARIA with brain edema or effusion (ARIA-E) — with or without ARIA with brain hemorrhage or hemosiderin deposition (ARIA-H), including microhemorrhages and superficial siderosis — and 13 people had isolated ARIA-H (6.7%).
    • “Most ARIA cases were asymptomatic (74%) and radiographically mild (62%). Eleven patients (5.7%) developed symptomatic ARIA; two (1.0%) were patients with clinically severe ARIA symptoms. No patients developed a macrohemorrhage or died.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Andrew Witty is stepping down as chief executive officer of UnitedHealth, citing personal reasons, the healthcare giant announced Tuesday.
    • “Witty, who has run UnitedHealth since 2021, is departing following a sharp downturn in the company’s financial performance from higher medical spending and unfavorable policy changes. He will be replaced effective immediately by Stephen Hemsley, the chairman of UnitedHealth’s board and its CEO from 2006 to 2017.
    • “UnitedHealth also suspended its 2025 guidance on Tuesday, pointing to the ongoing increase in medical care activity.”
  • The Wall Street Journal adds,
    • “In a call with analysts Tuesday, the company said it was seeing medical costs continue to accelerate beyond the trends it flagged last month and signs that the issue was spreading beyond enrollees in its Medicare plans. 
    • “To all stakeholders, including employees and shareholders, I’m deeply disappointed in and apologize for the performance setbacks we have encountered from both external and internal challenges,” Hemsley said. “This company has both the opportunities and capabilities to deliver exceptional services and outcomes for customers, consumers and care providers, and to continue to reliably generate the earnings growth that align with our 13% to 16% long term growth range.”
    • “The company said it expects to return to growth in 2026.”
  • Beckers Payer Issues offers us five things to know about Mr. Hemsley.
  • Beckers Payer Issues also discusses recent developments in the GLP-1 drug market.

Monday Report

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • Roll Calls offers a summary of this week’s activities on Capitol Hill.
  • The Senate Majority Leader filed cloture today on Eric Ueland who is the President’s nominee for OMB Deputy Director. Mr. Ueland shared the stage with Mr. Kupor, the President’s nominee for OPM Director, at their Senate Homeland Security Committee confirmation hearing on April 3.
  • The American Hospital Association News tells us,
    • “The White House May 12 released an executive order to reduce prescription drug costs by allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in other countries. The order directs the Secretary of Health and Human Services to propose rules that impose most favored nation pricing and take other measures to reduce prescription drug costs.’ 
  • BioPharma Dive adds,
    • “In a press briefing on Monday, White House officials revealed key details in the order. HHS will communicate the most-favored-nation prices to drugmakers and establish a mechanism for selling them directly to consumers at that price. If companies don’t use those prices, a new figure would be set through negotiation or federal regulation.
    • “The White House will also ask the Food and Drug Administration to expand reimportation from countries with lower drug costs, officials said, though those requests would occur at a time of heightened tensions regarding global trade.
    • “The Department of Commerce and U.S. Trade Representative will additionally be instructed to take action against countries that keep their drug prices low, the officials added.”
  • The Wall Street Journal reports, “The pharmaceutical industry’s reaction to President Trump’s executive order on drug prices? It could have been worse.”
  • Per Fierce Healthcare,
    • “The Trump administration has issued new draft guidance for the third cycle of Medicare drug price negotiations.
    • “The proposals seek to boost transparency in the program and put a focus on negotiating for the drugs that come at the highest cost to Medicare. The agency is also aiming to avoid negative impacts from the negotiated prices on U.S.-based pharmaceutical innovation, according to an announcement.
    • “Under the guidance, drugs administered under Medicare Part B would be potentially included for the first time. The agency is looking for feedback in comments on how to manage access to the maximum fair price negotiated for Part B drugs.
    • “The guidance also outlines that CMS may choose to renegotiate the price for certain drugs already set for 2026 or 2027.”
  • Modern Healthcare tells us,
    • “A record 24.3 million people signed up for health insurance on federal and state-based marketplaces during the exchange open enrollment period for 2025.
    • “Fueled by enhanced subsidies enacted in 2021 and extended in 2022, the number blew past the record set a year ago by nearly 2.9 million — a 13% increase, the Centers for Medicare and Medicaid Services reported Monday. The more sizable tax credits will expire at the end of this year, barring a congressional renewal.”
  • The AHA New informs us,
    • “The AHA May 12 responded to the Office of Management and Budget’s April 11 request for information on regulatory relief, making 100 suggestions to the Trump administration to help reduce burden on hospitals and health systems. “The Trump administration has rightly pointed out that the health status of too many Americans does not reflect the greatness or wealth of our nation,” said AHA President and CEO Rick Pollack. “Excessive regulatory and administrative burdens are a key contributor, as they add unnecessary cost to the health care system, reduce patient access to care and stifle innovation.”  
    • “The AHA’s recommendations fall under four categories: billing, payment and other administrative requirements; quality and patient safety; telehealth; and workforce.”

From the judicial front,

  • On May 9 (although the FEHBlog did not find it until today), the Justice Department asked the U.S. District Court of the District of Columbia to hold the ERISA Industry Committee’s lawsuit challenging the legality of the 2024 federal mental health parity amendments in abeyance while the governing agencies decide whether to modify or rescind the amendments. Here is a Dropbox link to the motion. The government’s motion states in short:
    • “The Departments have informed undersigned counsel that they intend to reconsider the 2024 Rule at issue in this litigation, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation.” * * *
    • “The 2024 Rule has two applicability dates: plan years beginning on or after January 1, 2025, and plan years (in the individual market, policy years) beginning on or after January 1, 2026. On April 25, 2025, the Departments informed undersigned counsel that they intend to (1) issue a non-enforcement policy in the near future covering the portions of the 2024 Rule that are applicable for plan years beginning on or after January 1, 2025, and January 1, 2026, and (2) reexamine the Departments’ current MHPAEA enforcement program more broadly. To confer with Plaintiff about the requested stay, Defendants provided Plaintiff with a copy of the non-enforcement policy that they expect to publicly release memorializing their intention not to enforce the portions of the 2024 Rule that are applicable for plan years beginning on or after January 1, 2025, and January 1, 2026.” 
  • Today, the presiding Judge Timothy J. Kelly granted the motion and ordered the parties to file status reports every 90 days beginning August 7, 2025.

From the public health and medical research front,

  • STAT News lets us know,
    • “Health secretary Robert F. Kennedy Jr. and his lieutenants have sent multiple signals in recent weeks that they envisage a world in which far fewer people are urged to get Covid-19 shots each fall. They aren’t the first ones to suggest it.
    • “The Advisory Committee on Immunization Practices — the expert panel that has, until now, guided the nation’s vaccine policies — is already talking about changing policy in ways that would have this exact effect. A presentation from the group’s meeting last month suggests that, if they’re allowed to meet this summer, they’ll recommend annual shots for adults 65 and older, some younger adults with medical conditions that increase their risk of severe illness from Covid infection, including pregnant people, possibly health care workers, and some very young children. Read more from STAT’s Helen Branswell.”
  • MedPage Today points out,
    • [T]he mumps vaccine’s less-than-stellar performance is no secret. Infectious disease experts readily acknowledge that the mumps portion of the vaccine isn’t as good as the measles or rubella portions.
    • “We eliminated measles by 2000 and rubella by 2005, but we’ve never eliminated mumps,” Paul Offit, MD, of the Children’s Hospital of Philadelphia, told MedPage Today. “So it’s true that it’s not as good of a vaccine as those two.”
    • “Indeed, mumps cases occur every year, and there have been several “outbreak” years in the last two decades — but the CDC isn’t hiding that. It reports mumps cases on its website.
    • “And it doesn’t mean the baby should be thrown out with the bath water. In fact, the mumps vaccine “has dramatically reduced the incidence of mumps by about 99%,” since it was introduced in 1967, Offit said, highlighting the accompanying drop in incidence of acquired deafness.
    • “Mumps was the most common cause of acquired deafness in the U.S.,” Offit said. “Now, homes for the deaf have closed.”
    • “Mumps cases fell from more than 150,000 in 1968 to 357 in 2024, according to CDC data.”
  • and
  • Per BioPharma Dive,
    • “Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use of Valneva’s chikungunya vaccine in people at least 60 years of age.
    • “The recommendation announced Monday comes days after the European Medicines Agency temporarily suspended use of the vaccine, known as Ixchiq, in those over 65 pending an investigation. A committee advising the CDC previously suggested a precaution for use in a similar age group.
    • “The FDA and CDC have upheld recommendations for use in adults between 18 and 60 years of age, while the EMA still endorses the shot for individuals between 12 and 64.”
  • The American Medical Association lets us know what doctors wish their patient knew about cancer screenings and prevention.
  • Consumer Reports, writing in the Washington Post, discusses, “how to ease IBS symptoms. Irritable bowel syndrome affects 10 to 15 percent of U.S. adults. Dietary and other changes can help.”
  • Per Fierce Pharma,
    • “The HER2-targeted antibody-drug conjugate that Pfizer gained from its Seagen buyout has delivered positive results in a pivotal study among Chinese patients with newly diagnosed bladder cancer, a readout that bodes well for the New York pharma’s own global phase 3 trial.
    • “A combination of the HER2 agent, called disitamab vedotin, and Junshi Biosciences’ PD-1 inhibitor toripalimab outperformed chemotherapy at both delaying tumor progression and extending patients’ lives as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma, RemeGen said Monday.
    • “The results came from an interim analysis of a Chinese phase 3 trial coded RC48-C016, which has now met its two primary endpoints of progression-free survival and overall survival, according to RemeGen. The company said the improvements were statistically significant and clinically meaningful.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente logged a 2.9% operating margin and 16.1% year-over-year jump in first-quarter operating revenues on the back of recent health system acquisitions through its Risant Health subsidiary, the Oakland, California-based integrated health system announced Friday.
    • “Year-over-year overall performance reflected a continued focus on affordability for members and customers and the addition of Risant Health revenues,” the system said.
    • “The topline results shared ahead of Kaiser’s required filings outline more than $31. 8 billion of operating revenues and $30.9 billion of operating expenses, both well above the $27.4 billion and $26.5 billion of Q1 2024.
    • “These translated to an operating income of $932 million for the quarter ended March 31, 2025, a slight decline from the prior year’s $935 million and 3.4% operating margin.”
  • Per Beckers Payer Issues,
    • On average, insurers pay 4.7% higher commercial prices to hospitals that are a part of their Medicare Advantage networks compared to those not in network, according to a study published May 8 in Health Services Research.
    • The study analyzed 5,654 insurer-hospital contracts across seven large insurers that offer both commercial (employer-sponsored and ACA) and MA health plans. The researchers used data from Turquoise Health, the American Hospital Association, and Clarivate, focusing on five commonly used services. 
    • “We compared inpatient negotiated commercial prices between insurers at the same hospital that do not include the hospital in their MA network and those that do,” the researchers wrote. “We used Poisson regression with hospital fixed effects, adjusting for insurer fixed effects and insurer-market covariates.” * * *
    • “We find suggestive evidence consistent with this ‘price-shifting’ hypothesis, where prices in the commercial market may be adjusted to secure agreement over MA networks. We find that insurers pay higher commercial prices to hospitals that are in their MA networks,” the researchers concluded.”
  • MedTech Dive notes,
    • “Roche Diagnostics will build a $550 million expansion to produce continuous glucose monitors at an Indianapolis facility. Roche will use the site to make its Accu-Chek Smartguide devices, which launched last year in Europe as the company’s first CGM.
    • “Our goal is to initiate production within three years, followed by preparing for future generations of that CGM solution,” Richeal Cline, head of global operations for Roche Diagnostics, said in a Monday press conference. 
    • “The Indianapolis site is Roche Diagnostics’ North American headquarters. It houses research and development, laboratories, manufacturing and other functions, and produces Roche’s Accu-Chek diabetes test strips. The facility is one of two global distribution hubs for the company.
    • “Roche will refurbish an existing building for the manufacturing space and may construct new buildings to meet future demand, Cline said.”
  • Beckers Hospital Review tells us,
    • “Walgreens is expanding its use of robotic micro fulfillment centers to handle prescription volume as part of a renewed push to streamline pharmacy operations and address staffing challenges, CNBC reported May 11.
    • “The company told the news outlet it plans to have its 11 automated facilities serve more than 5,000 stores by the end of 2025, up from 4,800 in February. 
    • ‘The centers, first introduced in 2021, use robots and conveyor systems to fill maintenance prescriptions for chronic conditions such as diabetes and high blood pressure. However, Walgreens had paused the expansion in 2023 to address performance issues and gather feedback from its stores. 
    • “The new expansion is aimed at reducing routine tasks for in-store pharmacy staff to free them up for more clinical work like vaccinations and health screenings, the report said.” 

Weekend Update

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

From Washington, DC,

  • The Senate Executive Calendar informs us that Majority Leader Thune is bringing to the Senate floor nominations that received Committee approval in the same week as OPM Director nominee Scott Kupor (Calendar No. 81).
  • The Wall Street Journal reports,
    • “House Republicans are releasing their plan to cut Medicaid spending, with the program’s defenders in the GOP appearing to win the intraparty clash over how aggressively to change the system that provides health insurance to more than 70 million low-income and disabled people. 
    • “A section-by-section summary of the bill text, which was viewed by The Wall Street Journal, includes some of the changes Republicans have weighed for Medicaid, including work requirements and more frequent eligibility checks. But it doesn’t lower the minimum share the federal government contributes to Medicaid in each state, cap per-person federal spending in the program or other steps some spending hawks sought.” * * *
    • “The bill would require Medicaid recipients to work, volunteer or attend school for 80 hours a month. The requirement would apply to most able-bodied adults through age 64 without dependents and includes exceptions for pregnant women, people with substance-use disorders and others.”
  • Fierce Healthcare tells us,
    • “Senators Shelley Moore Capito, R-W.Va., and Jeanne Shaheen, D-N.H., reintroduced the Access to Prescription Digital Therapeutics (PDT) Act on Thursday to expand access to software-based treatments.
    • “Advocates will bring new economic data from Germany to make the case to Congress, Centers for Medicare & Medicaid Services (CMS) Director Mehmet Oz, M.D., and Department of Health and Human Services Secretary Robert F. Kennedy Jr. to create pathways for coverage of the technologies. 
    • “By leaning into the Make America Healthy Again (MAHA) crowd in Washington, advocates at the American Telemedicine Association’s (ATA’s) lobbying arm think they have an unprecedented chance to pass the bill. 
    • “The Access to PDT Act would create a reimbursement pathway for software that treats medical conditions, like Cognoa’s early autism diagnosis product and Freespira’s panic attack disorder treatment. The category has broadly struggled with uptake because the Medicare program does not have the authority to cover the technologies under its existing benefit categories.”
  • Bloomberg Law reports,
    • “President Donald Trump said he plans to sign an executive order to cut prescription drug prices by mandating that the US pays the same price for drugs as whichever country pays the lowest price in the world.
    • “He said in a social media post that that he would sign the order at 9 am Monday, Washington time. He predicted pharmaceutical prices could drop 30% to 80%. 
    • “Trump’s Truth Social post didn’t detail how the order would work. He also didn’t specify potential limits on the policy, such as if it would apply only to government programs like Medicare or Medicaid, or if the White House sees a way to apply this more broadly.”
    • If true, this would be a policy mistake in the FEHBlog’s opinion. Government price controls usually backfire.
  • Federal News Network reports,
    • “The Office of Personnel Management appears to be walking back the surprise sole-source contract award it made just a week ago for HR information technology services.
    • “On Friday, OPM posted a one-sentence notice on SAM.gov saying that the justification and approval it issued a week earlier, explaining its no-bid award to Workday, was being “canceled in its entirety.”
    • “Spokespeople for OPM and Workday did not immediately respond to inquiries from Federal News Network, and the reasons for canceling the justification document were not immediately clear. Also unclear was whether the government was canceling the $342,200 award entirely, or merely the approval document that allowed the contract to go forward without a competitive bidding process. However, federal contracting experts said the agency would not be able to proceed with the award without a documented justification and approval.”
  • Medical Economic informs us,
    • “Osteoboost Health Inc. announced Wednesday the nationwide release of Osteoboost, the first and only FDA-cleared prescription medical device for low bone density, offering new hope for the more than 50 million Americans affected by osteopenia and osteoporosis.
    • “The wearable device delivers targeted vibration therapy to the spine and hips—areas most vulnerable to osteoporotic fractures. Cleared through the FDA’s De Novo pathway and designated a Breakthrough Device, Osteoboost represents a major innovation in preventative care for bone health.
    • “The longevity conversation is everywhere, but people rarely mention bone health even though it is fundamental to aging with confidence,” said Laura Yecies, CEO of Osteoboost Health. “Osteoboost empowers people to lead longer, stronger, and more active lives.”
    • “Designed for at-home use, the belt-like device requires 30 minutes a day of therapy and can be worn while performing everyday tasks such as walking or cooking.”

From the judicial front,

  • Govexec relates,
    • “Federal agencies cannot take any action to implement its widespread layoff plans across government after a federal judge ruled the Trump administration has likely acted unlawfully in ordering the staffing reductions. 
    • “The pause came in the form of a temporary restraining order and will last at least 14 days, Judge Susan Illston for the U.S. Court for the Northern District of California ruled Friday evening, meaning agencies cannot issue any reduction-in-force notices through May 23. The order came as several agencies, such as the Interior Department, Agriculture and others, were expected to begin implementing large-scale layoffs in the coming days. 
    • “The order prevents agencies from implementing their Agency RIF and Reorganization Plans, previously mandated by the Office of Personnel Management and Office of Management and Budget, and President Trump’s executive order that precipitated them. It applies to OMB and OPM, as well as the departments of Agriculture Commerce, Energy, Health and Human Services, Housing and Urban Development, Interior, Labor, State, Treasury, Transportation and Veterans Affairs. It also applies to AmeriCorps, the Environmental Protection Agency, the General Services Administration, the National Labor Relations Board, the National Science Foundation, the Small Business Administration and the Social Security Administration.”
  • Here is a Dropbox link to the Judge’s opinion, which the Justice Department has appealed to the U.S. Court of Appeals for the Ninth Circuit.

From the public health and medical research front,

  • The New York Times fills us in on the hepatitis A outbreak in Los Angele County, California.
    • “The first signs of the infection can look a lot like a classic stomach bug: fever, fatigue, nausea and a loss of appetite, followed by vomiting and diarrhea. Over time, people who become infected can also experience yellowed skin and eyes, dark urine and pale stools.
    • “One of the challenges to halting a hepatitis A outbreak is that contact tracing can be nearly impossible. The infection can incubate for up to seven weeks before symptoms appear, and a person carrying the virus can spread it for up to two weeks before they feel ill.
    • “In addition, a significant proportion of people who become infected don’t experience major symptoms, said Dr. Edward Jones-Lopez, an infectious disease specialist with Keck Medicine of the University of Southern California, so they do not visit their doctor, who in turn does not run a blood test and report the case.”
  • Per Medscape,
    • “Many of the US children not vaccinated with the measles-mumps-rubella (MMR) vaccine in the past decade were also missing other routine vaccinations after 12 months of age, according to data presented at Pediatric Academic Societies (PAS) 2025 Meeting.
    • “Efforts to increase MMR vaccination should include outreach to families whose children fall behind on vaccines or may have lost contact with primary care,” Sophia R. Newcomer, PhD, MPH, of the University of Montana in Missoula, Montana, and colleagues reported in a poster.
    • “The findings have particular significance in the midst of the current measles outbreaks, which have resulted in three deaths, including two children, in 2025. The Centers for Disease Control and Prevention (CDC) reported 884 total cases in 2025 as of April 25, most of which (93%) are associated with the 11 outbreaks in the country. The cases have spread to 29 states excluding Washington, DC, with 11% of cases involving hospitalization. Most of the cases were in children younger than 5 years (30%) or aged 5-19 years (38%), and 97% of the children were unvaccinated or their vaccination status was unknown.”
  • The Washington Post discusses new alternatives to knee replacement surgery. “Physicians caution that the treatments aren’t permanent fixes, but they may work well for some.”
  • Cardiovascular Business points out,
    • “Tirzepatide is associated with a much lower all-cause mortality rate than semaglutide when patients present with type 2 diabetes, chronic kidney disease (CKD) and heart failure, according to new data presented at SCAI 2025 Scientific Sessions, the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).
    • “Tirzepatide and semaglutide are both popular diabetes drugs being used more and more for weight loss and other benefits.
    • “Tirzepatide is a popular dual GIP/GLP-receptor agonist sold by Eli Lilly and Company under the brand names Zepbound and Mounjaro. It has previously been linked to improved outcomes in patients with sleep apnea and heart failure with preserved ejection fraction. 
    • “Semaglutide, meanwhile, is a GLP-1 receptor agonist sold by Novo Nordisk under the brand names Wegovy and Ozempic. It has been associated with a long list of health benefits, including several associated with improvements in cardiovascular symptoms in patients with and without diabetes.” * * *
    • Tirzepatide is associated with a much lower all-cause mortality rate than semaglutide when patients present with type 2 diabetes, chronic kidney disease (CKD) and heart failure, according to new data presented at SCAI 2025 Scientific Sessions, the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).” * * *
    • “Lead author Adbul Wali Khan, MD, a resident at the University of Missouri Kansas City, presented the group’s findings. Overall, semaglutide was linked to a higher one-year risk of all-cause mortality, acute myocardial infarction, ischemic stroke and hospital readmission than tirzepatide. The rates of hemorrhagic stroke, atrial fibrillation, atrial flutter and cardiac arrest were comparable between the two drugs.
    • “Semaglutide did appear to perform better than tirzepatide in one important way; HbA1c levels were less likely to be under 7% for patients treated with tirzepatide than those treated with semaglutide.” 
  • Medscape considers whether new approaches can turn the tide against U.S. pain problems.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Omada Health, a virtual chronic care provider, filed to go public Friday, marking the second digital health company making plans for an initial public offering in 2025.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering.
    • “It intends to list on the Nasdaq Global Market under the ticker symbol “OMDA.”
  • Per Healthcare Dive,
    • “New Insulet CEO Ashley McEvoy set out her priorities for the diabetes technology company on Thursday. 
    • “Insulet is already a standout success story,” McEvoy told investors during her first call after taking on the role, adding that the firm is one of the fastest-growing businesses in medtech. “Now is the time to envision what it will take to expand from a medtech platform with emerging global strength to a durable world leader in diabetes management.” 
    • “McEvoy was named chief executive in late April, with the goal of helping the insulin pump maker prepare for its next phase of growth. Previously, she led Johnson & Johnson’s medtech business unit and has more than 15 years of leadership experience in the medical device sector. 
    • “McEvoy said Insulet sits at the intersection of consumer health and medtech.
    • “I have a deep appreciation for the consumer’s increasing role in healthcare decisions and understanding that is especially relevant to a wearable technology like Omnipod,” McEvoy said.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Per a Senate news release,
    • “U.S. Senators Mike Rounds (R-S.D.), Chairman of the Senate Armed Services Committee’s Subcommittee on Cybersecurity, and Gary Peters (D-Mich.) introduced a bipartisan bill to extend the Cybersecurity Information Sharing Act (CISA) of 2015 for an additional ten years.
    • CISA, signed into law in 2015, incentivizes companies to voluntarily share cybersecurity threat indicators, such as software vulnerabilities, malware or malicious IP addresses, with the Department of Homeland Security (DHS). This protects Americans’ personal information and makes certain that both the federal government and companies can take collaborative steps to prevent data breaches or attacks from cybercriminals and foreign adversaries.
    • “The Cybersecurity Information Sharing Act of 2015 has been instrumental in strengthening our nation’s cyber defenses by enabling critical information sharing between the private sector and government,” said Rounds. “Allowing this legislation to lapse would significantly weaken our cybersecurity ecosystem, removing vital liability protections and hampering defensive operations across both the defense industrial base and critical infrastructure sectors.”
    • “As cybersecurity threats grow increasingly sophisticated, information sharing is not just valuable—it remains essential for our national security,” said Peters. “For the past ten years, these critical protections have helped to address rapidly evolving cybersecurity threats, and this bipartisan bill will renew them so we can continue this collaborative partnership between the private sector and government to bolster our nation’s cybersecurity defenses against a wide range of adversaries.”
    • Click HERE to read full text of the bill.
  • Cyberscoop reports,
    • “A bipartisan Senate bill would formally ban the use of DeepSeek by federal contractors, part of a larger effort to keep the Chinese-made large language model out of government systems and networks, where lawmakers fear it could pose cybersecurity and national security concerns.
    • “The bill, introduced by Sens. Bill Cassidy, R-La., and Jacky Rosen, D-Nev., would bar federal contractors from using the model to carry out any activity related to a federal contract. It also blocks contractors from using any successor model developed by High Flyer, the Chinese quantitative firm that made DeepSeek.
    • “Cassidy and Rosen cited the potential that the use of DeepSeek — which acknowledges that it sends user data back to China — to carry out contract work may put sensitive federal data in the hands of the Chinese government.
    • “AI is a powerful tool which can be used to enhance things like medicine and education,” Cassidy said in a statement. “But in the wrong hands, it can be weaponized. By feeding sensitive data into systems like DeepSeek, we give China another weapon.” 
  • and
    • “Authorities in Poland have arrested four people accused of administrating and selling access to distributed denial of service (DDoS) services, according to a press release from Europol.  
    • “The suspects are believed to have operated six so-called “stresser” or “booter” services that enabled customers across the world to launch thousands of attacks on targets ranging from government offices to businesses and schools. From 2022 to 2025, the platforms — identified as Cfxapi, Cfxsecurity, neostress, jetstress, quickdown, and zapcut — allegedly allowed users to bombard websites and servers with high volumes of junk traffic, often rendering them inaccessible. 
    • “The services, which offered easy-to-navigate interfaces, required minimal user knowledge: attackers could select a target, choose the attack specifications, and pay as little as 10 euros for each disruption, according to Europol.
    • “The arrests in Poland were part of a coordinated law enforcement response spanning four countries and supported by Europol. In addition to the Central Cybercrime Bureau in Poland, the investigation was supported by German Federal Criminal Police Office, the Prosecutor General’s Office in Frankfurt, the Dutch National Police, and multiple U.S. agencies, including the Department of Justice, FBI, Homeland Security Investigations (HSI), and Defense Criminal Investigative Service (DCIS).” 

From the cybersecurity breaches and vulnerabilities front,

  • Bleeping Computer tells us,
    • “Ascension, one of the largest private healthcare systems in the United States, has revealed that the personal and healthcare information of over 430,000 patients was exposed in a data breach disclosed last month.
    • “As Ascension revealed in breach notification letters sent to affected individuals in April, their information was stolen in a data theft attack that impacted a former business partner in December.
    • “Depending on the impacted patient, the attackers could access personal health information related to inpatient visits, including the physician’s name, admission and discharge dates, diagnosis and billing codes, medical record number, and insurance company name. They could also gain access to personal information, including name, address, phone number(s), email address, date of birth, race, gender, and Social Security numbers (SSNs).” * * *
    • “Our investigation determined on January 21, 2025, that Ascension inadvertently disclosed information to a former business partner, and some of this information was likely stolen from them due to a vulnerability in third-party software used by the former business partner.” * * *
    • “Although Ascension didn’t share any details regarding the breach affecting its former business partner, the timeline of the breach implies that the attack was part of widespread Clop ransomware data theft attacks that exploited a zero-day flaw in Cleo secure file transfer software.
    • “Last year, Ascension notified almost 5.6 million patients and employees that their personal, financial, insurance, and health information had been stolen in a May 2024 Black Basta ransomware attack.”
  • and
    • “Cisco has fixed a maximum severity flaw in IOS XE Software for Wireless LAN Controllers by a hard-coded JSON Web Token (JWT) that allows an unauthenticated remote attacker to take over devices.
    • “This token is meant to authenticate requests to a feature called ‘Out-of-Band AP Image Download.’ Since it’s hard-coded, anyone can impersonate an authorized user without credentials.
    • “The vulnerability is tracked as CVE-2025-20188 and has a maximum 10.0 CVSS score, allowing threat actors to fully compromise devices according to the vendor.”
  • Cybersecurity Dive informs us,
    • “A second wave of cyberattacks is targeting a critical vulnerability in SAP NetWeaver Visual Composer, according to researchers.
    • “Following the initial round of threat activity disclosed in April, opportunistic threat actors are leveraging webshells that were previously established through exploitation of CVE-2025-31324. The vulnerability, with a CVSS score of 10, allows unauthenticated attackers to upload arbitrary files and take full control of a system, according to researchers at Onapsis.
    • “Onapsis and Mandiant are tracking hundreds of confirmed compromises worldwide, with the cases spanning across multiple industries, including utilities, manufacturing, oil and gas and other critical infrastructure sectors. 
    • “The Cybersecurity and Infrastructure Security Agency (CISA) added the vulnerability to its known exploited vulnerabilities catalog in late April.” 
  • Cyberscoop adds,
    • “Vulnerabilities are proliferating in SonicWall devices and software this year, putting the vendor’s customers at risk of intrusion via secure access gateways and firewalls.
    • “The year started off on a sour note for the California-based company when it released security advisories for nine vulnerabilities on Jan. 7. The total number of vulnerabilities publicly disclosed by the company so far in 2025 has grown to 20. 
    • “SonicWall vulnerabilities are also making a consistent appearance on the Cybersecurity and Infrastructure Security Agency’s known exploited vulnerabilities (KEV) catalog. Cyber authorities confirm that attackers exploited four vulnerabilities in SonicWall products so far this year, and 14 total since late 2021.
    • “Eight of those vulnerabilities have been exploited in ransomware campaigns, according to CISA.”
  • Bleeping Computer adds,
    • “SonicWall has urged its customers to patch three security vulnerabilities affecting its Secure Mobile Access (SMA) appliances, one of them tagged as exploited in attacks.
    • “Discovered and reported by Rapid7 cybersecurity researcher Ryan Emmons, the three security flaws (CVE-2025-32819, CVE-2025-32820, and CVE-2025-32821) can be chained by attackers to gain remote code execution as root and compromise vulnerable instances.
    • “The vulnerabilities impact SMA 200, SMA 210, SMA 400, SMA 410, and SMA 500v devices and are patched in firmware version 10.2.1.15-81sv and higher.”
  • CISA added four known exploited vulnerabilities to its catalog this week.
  • May 5, 2025
    • CVE-2025-3248 Langflow Missing Authentication Vulnerability
    • Dark Reading discusses this KVE here.
  • May 6, 2025
    • CVE-2025-27363 FreeType Out-of-Bounds Write Vulnerability
    • Hacker News discusses this KVE here.
  • May 7, 2025
    • CVE-2024-6047 GeoVision Devices OS Command Injection Vulnerability
    • CVE-2024-11120 GeoVision Devices OS Command Injection Vulnerability
    • SC Media discusses these KVEs here.

From the ransomware front,

  • Dark Reading reports,
    • “Email-based attacks continued to cost enterprises big bucks in 2024, according to new cyber-insurance claims data.
    • “Cyber-insurance carrier Coalition published its “2025 Cyber Claims Report” on May 7, showing that business email compromise (BEC) attacks and fund transfer fraud (FTF) accounted for 60% of all the company’s claims last year. BEC attacks were particularly problematic for customers, according to Coalition; claims severity for such threats increased 23%, with incident’s costing organizations, on average, $35,000.
    • “That dollar figure is a far cry from the average loss for ransomware attacks in 2024, which Coalition said was $292,000. However, the claims report, which features data from customers in the US, the UK, Canada, and Australia, offered some encouraging data points, including a 7% drop in ransomware claims severity and a 3% decline in claims frequency.
    • “Additionally, Coalition found that FTF claims severity fell dramatically by 46%, to an average loss of $185,000, while claims frequency dropped 2%. Overall, the cyber-insurance carrier said it observed “remarkable year-over-year (YoY) stability” for claims, despite an intensifying threat landscape where financially motivated attackers continue to develop novel techniques and exploit new vulnerabilities.”
  • The Hacker News relates,
    • “Threat actors with ties to the Qilin ransomware family have leveraged malware known as SmokeLoader along with a previously undocumented .NET compiled loader codenamed NETXLOADER as part of a campaign observed in November 2024.
    • “NETXLOADER is a new .NET-based loader that plays a critical role in cyber attacks,” Trend Micro researchers Jacob Santos, Raymart Yambot, John Rainier Navato, Sarah Pearl Camiling, and Neljorn Nathaniel Aguas said in a Wednesday analysis.
    • “While hidden, it stealthily deploys additional malicious payloads, such as Agenda ransomware and SmokeLoader. Protected by .NET Reactor 6, NETXLOADER is difficult to analyze.”
    • “Qilin, also called Agenda, has been an active ransomware threat since it surfaced in the threat landscape in July 2022. Last year, cybersecurity company Halcyon discovered an improved version of the ransomware that it named Qilin.B.”
  • Per Bleeping Computer,
    • “The Play ransomware gang has exploited a high-severity Windows Common Log File System flaw in zero-day attacks to gain SYSTEM privileges and deploy malware on compromised systems.
    • “The vulnerability, tracked as CVE-2025-29824, was tagged by Microsoft as exploited in a limited number of attacks and patched during last month’s Patch Tuesday.
    • “The targets include organizations in the information technology (IT) and real estate sectors of the United States, the financial sector in Venezuela, a Spanish software company, and the retail sector in Saudi Arabia,” Microsoft said in April.”
  • The Wall Street Journal reports,
    • “The hacking group that once shut down half the Las Vegas Strip has returned and is causing turmoil at U.K. retailers.
    • “The hackers call themselves Star Fraud but are more widely known as Scattered Spider, a collective of largely young men and teenagers that have wreaked havoc across industries in recent years.
    • “U.K. retailers Harrods, Marks & Spencer MKS -1.05%decrease; red down pointing triangle and Co-op have all reported cyber intrusions in the past two weeks. Scattered Spider hasn’t been publicly named as the culprit of the hacks, but is suspected in at least some of them, according to people familiar with the investigation.
    • “The attacks bear all the hallmarks of Scattered Spider attacks, disrupting online sales and certain payments and leading to the theft of customer data. The stores have remained open.
    • “The group’s hackers “typically work their way through a sector, so other retailers should take the opportunity to harden their defenses,” said John Hultquist, chief analyst with Google’s Mandiant cybersecurity investigations group.” 
  • Per Cyberscoop,
    • “Five months after education software vendor PowerSchool paid an unnamed threat actor a ransom in exchange for the deletion of sensitive stolen data, some of the company’s customers are now receiving extortion demands. 
    • “A threat actor, who may or not be the same criminal group behind the attack, has contacted four school district customers of PowerSchool in the past few days, CyberScoop has learned, threatening to leak data if they don’t pay. 
    • “The downstream extortion attacks highlight the ongoing risk organizations confront when a vendor is hit by a cyberattack, exposing not just their data but also that of others in their supply chain. The follow-on extortion attempts also underscore that paying ransoms for data does not guarantee stolen data won’t be leaked.”
  • Dark Reading reports,
    • “The notorious ransomware gang LockBit appeared to suffer another setback this week after its network was compromised by an unknown adversary.
    • “On May 7, a range of security researchers observed that LockBit’s Dark Web leak site had been altered. Instead of listing victim organizations, the site now features a simple message: “Don’t do crime CRIME IS BAD xoxo from Prague,” along with a link to a zip archive.
    • “The archive, according to analysis from Qualys yesterday, among others, includes a SQL database file from LockBit’s affiliate panel. Coalition researchers, meanwhile, noted the file includes extensive internal data from the ransomware-as-a-service operation, including nearly 60,000 Bitcoin addresses and more than 4,000 chats with victim organizations from between Dec. 19, 2024, and April 29, 2025.
    • “The file also contains information on more than 70 LockBit administrators and affiliates, researchers noted, including plaintext passwords, as well individual builds and configurations of the LockBit ransomware code. However, the leaked data did not include decryptors or private keys.”

From the cybersecurity defenses front,

  • CISA announced,
    • “The Cybersecurity and Infrastructure Security Agency (CISA), Federal Bureau of Investigation (FBI), Environmental Protection Agency (EPA), and Department of Energy (DOE)—hereafter referred to as “the authoring organizations”—are aware of cyber incidents affecting the operational technology (OT) and industrial control systems (ICS) of critical infrastructure entities in the United States. The authoring organizations urge critical infrastructure entities to review and act now to improve their cybersecurity posture against cyber threat activities specifically and intentionally targeting internet connected OT and ICS.”
    • Mitigations and resources are included in the announcement.
  • Bank Info Security lets us know that “Despite the rise of artificial intelligence and automation, human ingenuity remains a critical asset in defending against cyberthreats, said Kara Sprague, CEO at HackerOne.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

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

From Washington, DC,

  • Govexec reports,
    • “The U.S. Postal Service confirmed on Friday it will name David Steiner, a long-time CEO of Waste Management and FedEx board member, to become the nation’s 76th postmaster general, handing the reins to the executive while the mailing agency continues to reel financially and is in the midst of major political and operational disruption. 
    • “Steiner will succeed former Postmaster General Louis DeJoy, who resigned amid pressure in March, and Doug Tulino, who is currently the acting USPS chief. The Postal Service’s board of governors hired an outside firm to conduct a search to replace DeJoy and made the selection as required by law, though The Washington Post, which first reported Steiner’s selection, said President Trump and his administration pushed for the hire. 
    • “Still, the postal board threw its full weight behind Steiner. 
    • “Dave is the right person to lead the Postal Service at this time to ensure this magnificent and historic organization thrives into the future,” said Amber McReynolds, the board’s chair and a President Biden appointee. “Dave is a highly regarded leader and executive with tremendous vision, experience and skill that can be applied to the long-term mission and business needs of the Postal Service. 
    • “Steiner, who is expected to take over his new role in July, called it an “incredible honor” to be named as postmaster general. While Trump has floated the possibility of removing the Postal Service’s independent status, Steiner committed to it. He also vowed to work closely with postal unions, industry associations, customers and policymakers.”
       
  • The FEHBlog took a peek at reginfo.gov this morning, and he noticed the following:
    • “Department of Labor
      “AGENCY: DOL-EBSA RIN: 1210-AC30 Status: Pending Review
      “TITLE:Transparency in Coverage
      “STAGE: Prerule Economically Significant: No
      “RECEIVED DATE: 05/02/2025 LEGAL DEADLINE: None”
    • The FEHBlog expects that this prerule ties in with paragraph 12 of the President’s April 15, 2025, executive order on drug costs:
      • “Sec. 12. Improving Transparency into Pharmacy Benefit Manager Fee Disclosure. Within 180 days of the date of this order, the Secretary of Labor shall propose regulations pursuant to section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974 to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers.”
    • Evidently, you can request an EO 12886 meeting at this pre-rule stage. https://www.reginfo.gov/public/do/eoDetails?rrid=937013
  • On Monday, May 12, the Trump Administration must answer ERIC’s challenge to the legality of the 2024 mental health parity rule changes.  The FEHBlog reviewed the PACER docket sheet this morning, and the government has not asked for more time to answer beyond May 12. The Administration could resolve the case by withdrawing the rule making.
  • Per Radiology Business,
    • “Sen. Roger Marshall, MD, R-Kan., introduced legislation on Wednesday to boost Medicare payments for radiologists and other physicians. 
    • “The lawmaker is proposing the ‘‘Medicare Patient Access and Practice Stabilization Act of 2025.’’ This comes after Rep. Greg Murphy, MD, R-N.C., in January introduced the same bill in the U.S. House, which has now gathered 167 co-sponsors. 
    • “Marshall—who practiced as an OB-GYN specialist for 25 years before joining Congress—had not issued a statement about the proposal as of late Thursday. His office did not immediately respond to a Radiology Business request for comment.
    • “Anders Gilberg, senior VP of government affairs for the Medical Group Management Association, touted the bill on social media May 7. He said the initial proposal is to increase Medicare physician reimbursement by 8.51% starting on June 1.”

In Food and Drug Administration news,

  • MedCity News reports,
    • “On Friday, a San Francisco-based startup received FDA approval for the first-ever at-home cervical cancer test.
    • “The company, named Teal Health, was founded in 2020 and has raised $23 million. The startup has developed an at-home cervical cancer screening kit, which seeks to give patients an alternative to the in-office pap smear. 
    • “Many women don’t get a pap smear, which is the standard screening method for cervical cancer — CDC guidelines say that women should be tested regularly from ages 21-65, yet only 1 in 4 women of screening age get screened. Not only do many women struggle to find access to this exam, but many patients find the pap test to be uncomfortable and invasive.”
    • The article explains the at-home testing process.
    • “The startup is preparing to launch in California first, and it is already in network with Aetna, Cigna, UnitedHealthcare and Anthem Blue Cross Blue Shield, [CEO and founder Kara] Egan stated.
    • “We’re also in conversations with several large national payers to get this covered nationally. For us, the goal is to make sure it’s affordable for women,” she declared.
    • “She said Teal plans to start shipping tests to patients’ homes sometime next month.”
  • Per a National Institutes of Health news release,
    • “Today, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a new, joint innovative research initiative that will serve as a key element in fulfilling U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s commitment to Make America Healthy Again. With diet-related chronic diseases continually rising, it is imperative that the FDA and NIH work in lockstep to invest in gold standard science, prioritize a better understanding of the root causes to end the diet-related chronic disease crisis and safeguard the health of America’s children.
    • “Under the new Nutrition Regulatory Science Program, the FDA and NIH will implement and accelerate a comprehensive nutrition research agenda that will provide critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier. The initiative will aim to answer questions such as:
      • “How and why can ultra-processed foods harm people’s health?
      • “How might certain food additives affect metabolic health and possibly contribute to chronic disease?
      • “What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?
    • “Answering these questions and many others will enable effective policy development and help promote the radical transparency Americans deserve about the foods they are eating and how those foods can impact their health.”
  • To that end, an HHS news release announced that the FDA “granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.”
  • STAT News tells us,
    • “The FDA has granted accelerated approval to Verastem’s combination treatment for ovarian cancer. It licensed and has paired two drugs — avutometinib, an MEK inhibitor first developed by Roche subsidiary Chugai Pharmaceutical, with defactinib, an adhesion kinase blocker developed by Pfizer. The approval is for adults with a recurrent KRAS-mutated form of the disease who have already received systemic therapy.
    • “The approval of the treatment, called Avmapki Fakzynja, is based on a study of 57 pre-treated patients who showed a 44% overall response rate, with responses lasting up to 31 months. The company is also testing this combination in Phase 1/2 trial in patients with front-line metastatic pancreatic cancer.”

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.
    • “Vaccination
      • “New research finding: In the first RSV season with widespread availability of RSV prevention products (maternal vaccine and nirsevimab), RSV-associated hospitalization rates among infants were lower than in prepandemic seasons. A report released in the May 8, 2025, MMWR demonstrated that in 2024–25, RSV hospitalization rates were 45-52% lower in infants younger than 3 months old and 28-43% lower in infants younger than 8 months old compared to 2018-2020 seasons before product introduction.”
  • The University of Minnesota’s CIDRAP adds,
    • “A 2024-25 flu season that has been classified as high severity has now reached low transmission levels, but 10 new flu-related deaths in children bring the season’s total to 226, the most since 2009-10, when 288 pediatric deaths were recorded, according to the latest FluView update today from the Centers for Disease Control and Prevention (CDC).”
  • and
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 66 more measles cases, pushing the national total to 1,001 and in just over 4 months keeps the nation on track to pass the 2019 total, which marked the nation’s worst year since the disease was declared to be eliminated in 2000.
    • “The steady rise in cases is fueled by multiple outbreaks, with two more reported this week. The CDC is tracking 14 outbreaks that are responsible for 93% of cases.
    • “The Texas Department of State Health Services (TDSHS) today reported 7 more cases since its last update on May 6, lifting the state’s total to 709 confirmed patients, of whom 679 (96%) were unvaccinated or had an unknown vaccination status. The number of affected counties remained at 29, and most cases are in Gaines County, the outbreak’s epicenter.
    • “Five more hospitalizations were reported, putting that total at 92. The number of deaths remained at two.”
  • BioPharma Dive informs us,
    • “Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year.
    • “The drug is a reformulated version of an old medication, meloxicam, designed to more quickly treat the sharp, “acute” pain felt after an injury or operation.”

From the U.S. business healthcare front,

  • Fierce Healthcare reports,
    • “The American Medical Association (AMA) has announced John Whyte, M.D., as its new CEO and executive vice president, effective July 1.
    • “Whyte, a practitioner and author with experience at government agencies and private sector medical media outlets, will be taking over for James Madara, M.D. The outbound executive had shared plans to end his 14-year run last June.
    • “Unlike the physician association’s president and president-elect titles, which are voted on by membership for single-year terms, the CEO position is appointed by the AMA’s board of trustees for an open-ended tenure. They are tasked with overseeing the organization’s day-to-day operations.”
  • and
    • “Artificial intelligence assistants could ease the transition to value-based care for primary care practices, a new report by Phyx Primary Care found. 
    • “VBC can be administratively burdensome due to its enhanced reporting requirements. Primary care practices report that the transition to VBC is often long and results in a mix of VBC and fee-for-service billing practices. 
    • “In a study of 120 physicians who had used an AI scribe for 30 days or more, providers reported a 40% reduction in clinical review time for complex patients and a 32% decrease in physician burnout. The study was conducted by Phyx Primary Care, a nonprofit innovation lab that evaluates emerging technologies and evolving payment models.” 
  • Healthcare Dive relates,
    • “HCA Healthcare, Tenet Healthcare, Universal Health Services and Community Health Systems all posted financial results that beat Wall Street expectations for the first quarter of 2025. 
    • “Still, the health systems are maintaining their full-year outlooks as they exit the first quarter, despite most systems growing their revenue.” 
  • Per a press release,
    • Blue Cross Blue Shield of Massachusetts (“Blue Cross”) today announced a new virtual-first primary care option designed to support members’ health when and where they need it. CloseKnit, which provides virtual and in-person access to primary care, is now available to most Blue Cross members. This comes at a critical time as Massachusetts continues to face a primary care physician shortage.
    • As part of their agreement, CloseKnit is participating in Blue Cross’ value-based payment program and provides members with convenient and timely access to primary care.
    • Here is a link to CloseKnit’s website.