FEHBlog

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity and law enforcement front,

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

From the cybersecurity vulnerabilities and breaches front,

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

From the ransomware front,

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

From the cybersecurity defense front,

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

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “President Trump today released his discretionary spending budget blueprint for fiscal year 2026. The “skinny budget” request, which includes top line discretionary funding priorities, is not binding but can act as a starting point for Congress and the administration as they begin the appropriations process to fund the government. The administration later this month is expected to issue its full budget request, which will include its proposed changes to mandatory spending and tax policy.”  
  • Bloomberg Law adds,
    • “The president’s [skinny] budget calls for $557 billion in non-defense spending next year, which represents a cut of $163 billion from current levels. National security funding would increase to $1.01 trillion, a 13% increase from the previous year. Any final spending plan for regular agency budgets will need some Democratic support to pass the Senate, one of the few opportunities the minority party has to exert some leverage while Republicans have unified control over the federal government.”
  • Federal News Network informs us,
    • “Amid the Trump administration’s sweeping overhaul of the federal workforce, the Office of Personnel Management has shuttered an office that was central to developing leadership skills governmentwide.
    • “The Center for Leadership Development (CLD), an arm within OPM’s Human Resources Solutions (HRS) office, was bulldozed as part of an OPM reduction in force (RIF) in April. Federal News Network confirmed the elimination of the office with OPM, as well as two sources who provided further information on the condition of anonymity for fear of professional retribution.
    • “About 140 employees were working in the CLD office back in January, but those numbers had dwindled to about 80 employees over the last few months, according to an OPM employee familiar with the situation. Many CLD employees opted into the deferred resignation program (DRP) or voluntarily left their jobs. OPM notified the remaining employees on April 18 that their positions were being eliminated as part of the agency’s RIF.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Novo Nordisk NOVO.B said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on the market.
    • “The Bagsvaerd, Denmark, company said Friday that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.
    • “The FDA’s deadline to decide on the application will be in the fourth quarter, the company said.
    • “The application is based on results from a phase 3 randomized, controlled trial evaluating the efficacy and safety of the drug over 64 weeks, the company said.”
  • Per a National Cancer Institute news release,
    • “The Food and Drug Administration (FDA) has approved the combination of two immunotherapy drugs for the initial treatment of some people with advanced colorectal cancer. The approval is for the use of nivolumab (Opdivo) and ipilimumab (Yervoy) for people whose tumors are classified as MSI-H or dMMR.
    • “About 5% of people with advanced colorectal cancer have MSI-H or dMMR tumors, which means the tumors are unable to properly repair certain types of DNA damage that can occur during cell division. Several colorectal cancer experts said the approval should immediately make the combination the preferred initial, or first-line, treatment for people with advanced MSI-H or dMMR colorectal cancer. 
    • “The approval was based on updated findings from a large clinical trial, called CheckMate-8HW in which all participants had advanced colorectal cancer with MSI-H or dMMR tumors. Patients in the trial who were treated with the combination of nivolumab and ipilimumab lived substantially longer without their cancer getting worse, a measure known as progression-free survival, than patients treated with nivolumab alone.”
  • Modern Healthcare reports,
    • GE HealthCare said Friday it received Food and Drug Administration clearance for its artificial intelligence tool that uses deep learning to outline organs at risk in MRI images and help improve radiation therapy planning.
    • MR Contour DL can outline 37 organs and structures in the head-neck and pelvic areas. The process previously had to be done manually.
    • The AI model will be integrated into the company’s Intelligent RT radiation therapy workflow management solution, which provides clinicians with a real-time view of a patient’s radiation therapy treatment journey.
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • MedTech Dive adds,
    • “Intuitive Surgical received Food and Drug Administration clearance for its da Vinci Single Port surgical system for procedures performed through the anus.
    • “The clearance covers the use of the system for transanal local excision/resection, enabling physicians to reach lesions in the upper rectum without cutting the abdomen, according to the Thursday announcement. Conventional transabdominal rectal resection can require multiple incisions and the removal of the rectum. 
    • “Intuitive designed the single port device to navigate narrow body cavities. Physicians can control up to three multi-jointed instruments and a camera through a single entry point.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline 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 continues to decline in most areas of the country.
    • “Vaccination
      • “Vaccination coverage with influenza, COVID-19, and RSV vaccines remained low among U.S. adults and children during the 2024─25 respiratory virus illness season.”
  • Per the AHA News,
    • “The U.S. has had 935 confirmed cases of measles so far this year, according to the latest data from the Centers for Disease Control and Prevention. Cases have been reported by 29 states, with Texas reporting the most at 683 — a 20% increase from last week. There have been 12 outbreaks, and 93% of confirmed cases (869 of 935) are outbreak-associated. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
  • The University of Minnesota’s CIDRAP adds,
    • “The nation is now experiencing 12 [measles] outbreaks, one more than the previous week, and 93% of illnesses reported are connected to outbreaks.
    • “In related developments, CBS News reported yesterday that Health and Human Services Secretary Robert F. Kennedy Jr. would ask the CDC to develop new guidance for treating measles with drugs and vitamins. Today, the CDC posted new resources for public health departments and parents, along with a fact sheet for clinicians that covers two alternative treatments that Kennedy has pushed, including vitamin A, antibiotics, and inhaled steroids.”
  • and
    • “Twelve more US children have died of influenza, surpassing theprevious high for a flu season outside of a pandemic year, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.
    • “The pediatric deaths push the season total to 216, surpassing last season’s total of 207. Ten of the children died of influenza A, and two died from influenza B. Subtyping showed that eight of the influenza A deaths were caused by the H1N1 strain, and four were H3N2.”
  • CNN offers an interview with its wellness editor, who is an emergency medicine doctor, about whooping cough.
  • Per the University of Minnesota CIDRAP,
    • “A study published earlier this week in Nature Communications using claims data from the US Veterans Affairs (VA) Healthcare System finds protection from the 2024-25 Pfizer COVID-19 vaccine was 68%, 57%, and 56% against COVID-19–associated hospitalizations, emergency department and urgent care (ED/UC) visits, and outpatient visits, respectively.
    • “However, the authors caution that uptake of the vaccine was extremely low—only 3.7% through November 2024—and the study did not assess waning effectiveness.”
  • The New York Times reports,
    • The video is just under two and a half minutes long. A slim man with close-cropped hair walks into a room, pulls a long black mamba — whose venom can kill within an hour — from a crate and allows it to bite his left arm. Immediately after, he lets a taipan from Papua New Guinea bite his right arm. “Thanks for watching,” he calmly tells the camera, his left arm bleeding, and then exits.
    • Over nearly 18 years, the man, Tim Friede, 57, injected himself with more than 650 carefully calibrated, escalating doses of venom to build his immunity to 16 deadly snake species. He also allowed the snakes — mostly one at a time, but sometimes two, as in the video — to sink their sharp fangs into him about 200 times.
    • This bit of daredevilry (one name for it) may now help to solve a dire global health problem. More than 600 species of venomous snakes roam the earth, biting as many as 2.7 million people, killing about 120,000 people and maiming 400,000 others — numbers thought to be vast underestimates.
    • In Mr. Friede’s blood, scientists say they have identified antibodies that are capable of neutralizing the venom of multiple snake species, a step toward creating a universal antivenom, they reported on Friday in the journal Cell.
  • The AHA News notes, “Older adults may be in circumstances that exacerbate challenges to accessing behavioral health care and have complex needs that can complicate behavioral health treatment. This new infographic gives statistics about how behavioral health care needs change in an aging population.” 
  • Healio tells us,
    • “Once-weekly semaglutide 2.4 mg significantly reduced steatohepatitis and liver fibrosis symptoms among adults with metabolic dysfunction-associated steatohepatitis and moderate or advanced liver fibrosis, researchers reported.
    • “In findings from part one of the ESSENCE phase 3 trialpublished in The New England Journal of Medicine,semaglutide 2.4 mg (Wegovy, Novo Nordisk) conferred greater improvements in multiple liver endpoints compared with placebo. In addition to greater improvements in steatohepatitis and liver fibrosis, researchers also observed greater weight loss, reduced insulin resistance and improvement in noninvasive liver markers with the GLP-1 medication.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna is building on client demand for tools to support patients on GLP-1 weight loss drugs, announcing two new programs on Friday meant to improve clinical care around the dispensing of GLP-1s and provide home delivery of the medications.
    • “The programs come as payers that contract with Cigna’s massive pharmacy benefit manager Express Scripts for their drug benefits want to offer GLP-1s but are put off by the medications’ steep list prices and unpredictable long-term outcomes, according to Cigna.
    • “The programs were announced in tandem with Cigna’s first quarter results, which came in well above analysts’ expectations. Revenue of $65.5 billion was up more than 14% year over year, while net income of $1.3 billion compares to a loss of $277 million same time last year. Cigna raised its 2025 profit outlook following the results.”
  • and
    • “Amwell narrowed its losses on growing revenue in the first quarter as the telehealth vendor continued to roll out products as part of a contract with the Department of Defense.
    • “The company posted a net loss of $18.4 million, down from $73.4 million in the prior-year period. Amwell reported revenue of $66.8 million, compared with $59.5 million in the first quarter last year. 
    • “The telehealth firm has deployed scheduled virtual visits across the Military Health System, executives said in an earnings call Thursday. However, rollouts for its automated and digital behavioral health programs will take place in the third quarter instead of the second due to leadership changes at the Defense Health Agency, leaders said.”
  • Fierce Healthcare points out,
    • “UnitedHealth Group and Amedisys have found buyers for key divestitures aimed at getting their $3.3 billion merger over the finish line, according to new filings.
    • “In documents submitted to the Securities and Exchange Commission (SEC), Amedisys said April 30 the companies entered an agreement to sell off certain Amedisys home health and hospice centers, as well as some of UnitedHealth’s care centers, to BrightSpring Health Services and the Pennant Group.
    • “Completion of these sales is contingent on several factors, according to the filing, including the final closure of the UnitedHealth-Amedisys deal.
    • “Financial terms were not disclosed in Amedisys’ filing, but the Pennant Group noted in a separate SEC document that it would pay about $102.5 million for the assets it’s buying from Amedisys and UnitedHealth.”
  • Per Biopharma Dive,
    • “Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in sales in the first quarter, spotlighting rising revenue from the biotech’s portfolio of copycat biologics.
    • “During the company’s first quarter earnings call, commercial chief Murdo Gordon said Amgen’s biosimilar products recorded $735 million in sales, roughly 9% of the company’s revenues. Those sales climbed 35% compared to the same period last year, showing the business “continues to contribute meaningfully to our long-term growth,” CEO Robert Bradway said.
    • “Still, Amgen’s overall performance is uneven. While some products are thriving, like an Avastin lookalike that booked $179 million in sales, others, such as its Humira biosimilar are struggling. Amgen recently launched a biosimilar version of Regeneron’s eye drug Eylea and could begin marketing a copycat form of AstraZeneca’s rare disease treatment Soliris sometime before the middle of the summer.”
  • and
    • “Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first quarter, surpassing analyst estimates by more than $20 million. 
    • “More than 17,000 patients have now taken the drug, known as Rezdiffra, Madrigal said Thursday. It won Food and Drug Administration approval in March 2024, becoming the first medication cleared to treat metabolic dysfunction-associated steatohepatitis, or MASH.
    • “The company said it’s now looking toward a potential mid-year approval that would position Rezdiffra as the first available MASH treatment in Europe. CEO Bill Sibold said he’s looking to build on what he described as an “exceptional launch” in the U.S.”
  • Fierce Pharma adds
    • “AstraZeneca has taken a key step in advancing Breztri Aerosphere toward a potential label expansion and achieving its goal of annual sales of $3 billion to $5 billion for the 3-in-1 inhaler.
    • “Two phase 3 trials evaluating the effectiveness and safety of Breztri in a total of 4,434 patients with uncontrolled asthma have met their primary endpoints. The studies showed that Breztri delivered statistically significant and clinically meaningful improvements in lung function compared to dual-drug combinations of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) maintenance treatments, AZ said.
    • “Data from the KALOS and LOGOS studies will be shared with regulatory authorities and presented at an upcoming medical meeting, the company added.”

Thursday Report

David Ermer–ACA, AHRQ, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Senate has adjourned until next Monday with no sign of when the President’s nominee for OPM Director Scott Kupor will receive floor consideration. According to the Senate Executive Calendar, there are many nominees besides Mr. Kupor patiently waiting their turn.
  • Federal News Network offers an article about Wednesday’s House Oversight Committee markup and passage of its budget resolution.
  • Per a Senate press release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, applauded the U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) announcement of Generation Gold Standard, a new initiative to pursue a universal vaccine platform for viruses that are most likely to cause pandemics. HHS Secretary Kennedy and NIH Director Bhattacharya announced the initiative to protect people against multiple strains of widely contagious viruses through a beta-propiolactone (BPL)-inactivated, whole-virus platform.  
    • “Scientists have long considered universal vaccines as the Holy Grail solution to protect Americans from quickly mutating viruses,” said Dr. Cassidy. “I am glad that Secretary Kennedy and the Trump administration are prioritizing this important area of research so we can be better prepared to tackle tomorrow’s health threats.”
    • “According to HHS, the clinical trials for universal influenza vaccines are scheduled to begin in 2026, with Food and Drug Administration (FDA) approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029.”  
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services, through the Office of the Assistant Secretary for Health and Office of Population Affairs, released a comprehensive review, opens in a new tab of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria. This review, informed by an evidence-based medicine approach, reveals serious concerns about medical interventions, such as puberty blockers, cross-sex hormones, and surgeries, that attempt to transition children and adolescents away from their sex.
    • “The review highlights a growing body of evidence pointing to significant risks—including irreversible harms such as infertility—while finding very weak evidence of benefit. That weakness has been a consistent finding of systematic reviews of evidence around the world.
    • “The review also fills a gap in the medical literature and existing clinical practice reviews with regard to the ethical aspects of pediatric medical transition. HHS believes that medical ethics should be central in this debate.”
  • The Internal Revenue Service announced
    • SECTION 2. 2026 INFLATION ADJUSTED ITEMS
      • “.01 Health Savings Account Inflation Adjusted Items.
        • “(1) Annual contribution limitation. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(A) for an individual with self-only coverage under a high– deductible health plan is $4,400. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(B) for an individual with family coverage under a high deductible health plan is $8,750.
        • “(2) High deductible health plan. For calendar year 2026, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,700 for self-only coverage or $3,400 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,500 for self-only coverage or $17,000 for family coverage.”
  • OPM proposed a new rule
    • “The Office of Personnel Management (OPM) is proposing to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Currently, agencies are prohibited from establishing quotas or limits on the number or proportion of the various rating levels assigned, meaning that each senior executive potentially can receive any rating based on their performance, irrespective of how other senior executives perform within the agency. However, governmentwide SES ratings data have consistently shown that virtually all SES receive the highest rating levels (i.e., levels 4 and 5) despite documented reports of SES failings. Removing the prohibition on forced distribution would allow agencies to establish and enforce limits on the highest SES rating levels, thereby increasing rigor in the SES appraisal process and leading to a more normalized distribution of SES ratings across the Federal Government.”
    • The FEHBlog estimates that the public comment period will end on June 2, 2025.
  • Tammy Flanagan, writing in Govexec, provides “a crash course in retirement planning. Let’s revisit my tips and resources for transitioning from employee to annuitant.”
  • Fierce Healthcare lets us know,
    • The Centers for Medicare & Medicaid Services (CMS) has launched the Fraud Detection Operation Center (FDOC) to fight waste, fraud and abuse, the agency announced this week.
    • Listed on a new webpage are a list of “recent success stories.” They include taking action against improper enrollment in Affordable Care Act (ACA) plans, cracking down on false billing of wound care services and scrutinizing “problematic activities” regarding hospice claims.
    • The page also claims it stopped payments to a provider who died 20 years ago as well removed 18 providers convicted of a “serious crime” for not meeting adequate standards.” ***
    • “The FDOC leverages the Fraud Prevention System (FPS), a system developed, built and operated by federal contractor Peraton. The FPS uses artificial intelligence and machine learning models to flag potentially fraudulent behavior by providers, allowing investigators to more easily see whether a provider should be funneled to the government’s case management system.”

From the Food and Drug Administration front,

  • Fierce Pharma tells us,
    • “Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in “radical” changes to how it signs off on new vaccines.
    • “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN. 
    • “It isn’t immediately clear which “new” vaccines will be affected by the policy. Flu and COVID-19 vaccine shots are updated annually to match the latest strains and variants, so manufacturers do indeed roll out new shots based on their existing platforms. For novel vaccines against completely new viral targets, placebo testing is a regular part of the R&D and regulatory review process.” * * *
  • Per BioPharma Dive,
    • “The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership.
    • “Alongside first quarter earnings Thursday, the biotechnology company said a U.S. approval decision previously expected this year may now occur in 2026. Moderna filed for approval in 2024 based on a late-stage study showing the shot sparked immune responses against both viruses in adults 50 years of age or older. But the FDA has communicated that it will require Phase 3 flu efficacy data before issuing a clearance, Moderna said.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Department of Justice is accusing three of the largest health insurers in the U.S. of paying brokers kickbacks for enrolling seniors in their Medicare Advantage plans.
    • “CVS unit Aetna, Elevance and Humana paid brokers eHealth, GoHealth and SelectQuote hundreds of millions of dollars in return for signing people up for their MA coverage from 2016 to 2021 — regardless of the plans’ suitability for those members’ needs, according to the DOJ’s complaint filed Thursday.
    • “Spokespeople for Humana and CVS said the companies are reviewing the DOJ’s complaint and did not provide detailed comment for this story, though CVS said it disagrees with the allegations. Elevance did not respond to a request for comment.”

From the public health and medical research front,

  • CBS News reports,
    • “Diabetes deaths in the U.S. have fallen to some of the lowest rates in years, according to new preliminary figures published by the Centers for Disease Control and Prevention, reversing a surge in mortality that was seen during the COVID-19 pandemic.
    • “There were 26.4 deaths per 100,000 people from diabetes, according to early death certificate data for the third quarter of 2024 published this month by the CDC’s National Center for Health Statistics. 
    • “Death rates from diabetes peaked in 2021, according to CDC figures, at 31.1 deaths per 100,000 people for that year. Diabetes was the eighth leading cause of death in 2021. The CDC says the link between COVID-19 and diabetes may be to blame for that increase. 
    • “Data show an increase in mortality rates for all people during the COVID-19 pandemic, and research shows that people with underlying conditions, including diabetes, are more likely to become very sick from COVID-19 and have a higher risk of hospitalization and death,” Christopher Holliday, head of the CDC’s Division of Diabetes Translation, told CBS News in a statement.
    • “Holliday added that research shows the pandemic may also have made it harder for Americans to properly manage the disease, ranging from interruptions to physical activity to disruptions to routine medical care diagnosing and treating the disease.”
  • MedPage Today adds,
    • While the incidence of breast cancer in young women has been increasing over the last 20 years, breast cancer deaths in this age group fell significantly between 2010 and 2020, researchers found.
    • Among women ages 20 to 49, incidence-based mortality declined from 9.70 per 100,000 women in 2010 to 1.47 per 100,000 in 2020, reported Adetunji Toriola, MD, PhD, MPH, of the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, at the American Association for Cancer Research annual meeting in Chicago.” * * *
    • “While breast cancer mortality declined for each racial/ethnic group, rates differed substantially between groups.
    • “Black women had the highest incidence-based mortality in 2010 (16.56 per 100,000), and while that rate declined significantly over the next decade, these women still had the highest incidence-based mortality rate in 2020 (3.41 per 100,000).
    • “White women had the lowest incidence-based mortality in 2010 (9.18 per 100,000) and 2020 (1.16 per 100,000).
    • “Moreover, 5-year relative survival rates by race/ethnic group showed that rates exceeded 88.7% for most groups, except for Black women (82.4%). That discrepancy was similar for 10-year relative survival rates.
    • “There were significant declines in mortality among women aged 20 to 49 with breast cancer,” Toriola said during a press briefing. “However, there are still opportunities for improvements, especially in relation to eliminating disparities in survival.”
  • HCPLive informs us,
    • The burden of chronic kidney disease (CKD) attributable to physical inactivity increased significantly from 1990-2021, according to findings from a recent study
    • Leveraging data from the Global Burden of Disease (GBD) 2021, the study found that despite some regional declines in mortality rates, global CKD-related deaths and disability-adjusted life years (DALYs) have risen significantly, especially in low-sociodemographic index (SDI) regions, among older adults, and in females.1
    • “In recent years, low physical activity has become a major risk factor for noncommunicable diseases, contributing to the increased incidence of various chronic conditions, including diabetes, cardiovascular diseases, and CKD,” ZhenYi Zhao, of the School of Competitive Sports at Beijing Sport University in China, and colleagues wrote.
  • Per an NIH news release,
    • “The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy.”
  • The New York Times reports,
    • The happiness curve is collapsing.
    • For decades, research showed that the way people experienced happiness across their lifetimes looked like a U-shaped curve. Happiness tended to be high when they were young, then dipped in midlife, only to rise again as they grew old.
    • But recent surveys suggest that young adults aren’t as happy as they used to be, and that U-shaped curve is starting to flatten.
    • This pattern has shown up yet again in a new study, one of a collection of papers published on Wednesday in the journal Nature Mental Health. They are the first publications based on the inaugural wave of data from the Global Flourishing Study, a collaboration between researchers at Harvard and Baylor University.” * * *
    • “The study participants had relatively low measures of flourishing on average until age 50, the study found. This was the case in a number of countries, including the United Kingdom, Brazil and Australia. But the difference between the younger and older adults was largest in the United States, the researchers said.
    • “It is a pretty stark picture,” said Tyler J. VanderWeele, the lead author of the study and director of Harvard’s Human Flourishing Program. The findings raise an important question, he said: “Are we sufficiently investing in the well-being of youth?”
  • Healio relates,
    • “Individuals using e-cigarettes exclusively had a significantly elevated risk for COPD, whereas this was not found when assessing the risk for type 2 diabetes or heart failure, according to data published in Nicotine and Tobacco Research.
    • “For clinicians, these results offer helpful information about how e-cigarettes compare to regular cigarettes in terms of health risks,” John Erhabor, MD, MPH,research postdoctoral fellow at Johns Hopkins Medicine, told Healio. “While e-cigarettes may have fewer heart and metabolic risks than regular cigarettes, they are still tied to certain problems like COPD and possibly high blood pressure in some age groups.
    • “Doctors should take these differences into account when advising patients and make clear that switching completely from regular cigarettes to e-cigarettes may potentially lower health risks, but using both does not offer the same benefit,” Erhabor said.”
  • The American Medical Association News points out,
    • “The Health Resources and Services Administration announced its toll-free number (1-833-TLC-MAMA) and promotional toolkit are available in advance of Maternal Mental Health Awareness Week, May 5-11. Since its launch on Mother’s Day 2022, the hotline has received more than 54,173 calls and texts from individuals seeking help for themselves (73%) or on behalf of someone else (4%). The hotline is available in English and Spanish and offers interpreters in more than 60 languages.”
  • The U.S. Preventive Services Task Force released a final research plan for “Sexually Transmitted Infections: Behavioral Counseling.” The next step is a proposed recommendation.
  • STAT New warns,
    • The era of “tranq” may be ending.
    • “But tranq, as the powerful veterinary tranquilizer xylazine is known in the illicit drug supply, is being replaced at least in part by a dangerous new sedative: medetomidine. In the past year, the anesthetic has become an increasingly common element in the drug supply, with cities and states including Philadelphia, Pittsburgh, Chicago, and San Francisco reporting cases of medetomidine-involved overdoses.
    • “In Philadelphia in particular, reports of medetomidine have skyrocketed. When the city first began testing for the substance in May 2024, it found medetomidine in 29% of fentanyl samples analyzed, according to data from the city’s public health department. Six months later, medetomidine’s prevalence had increased threefold to 87% — while xylazine’s dropped from 100% early in the year to 42% in November.”
  • The CDC adds in a related report issued today,
    • Summary
    • What is already known about this topic?
      • Medetomidine is an increasingly common adulterant of illegally manufactured opioids.
    • What is added by this report?
      • During October 2024–March 2025, a total of 23 adult patients who used illegally manufactured opioids sought treatment within a health care system in Pittsburgh, Pennsylvania. All exhibited severe autonomic hyperactivity, and most required dexmedetomidine infusion and intensive care unit–level management. Medetomidine metabolites were detected in all 10 patients for whom retrospective analysis was performed, despite only two having detectable parent compound (medetomidine) on comprehensive urine drug screening.
    • What are the implications for public health practice?
      • Health care providers in regions where medetomidine has been detected in the drug supply should be prepared to manage a severe withdrawal syndrome among patients who use illegally manufactured opioids, even if drug testing for medetomidine is negative.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health’s insurance division Aetna will stop offering plans for individuals on the Affordable Care Act exchanges in 2026, after the company projected big losses in the business this year.
    • “The news was announced in tandem with CVS’ first quarter results, which exceeded investor expectations and represent a turnaround for CVS’ beleaguered insurance business, analysts said. The Rhode Island-based healthcare company reported net profit of $1.8 billion — up 60% year over year — on revenue of $94.6 billion.
    • “CVS’ pharmacy benefit manager Caremark also reached an agreement with Danish drugmaker Novo Nordisk to give its weight loss drug Wegovy preferred access on Caremark’s standard formulary, which covers tens of millions of Americans. The deal should increase access to Wegovy at the expense of other therapies, such as Eli Lilly’s Zepbound.”
  • Fierce Pharma notes,
    • “Moderna is extending its cost savings program into 2027 and targeting a cash breakeven point sometime in 2028 as the larger U.S. vaccine market faces new uncertainties under the Trump administration.
    • “Moderna aims to reduce its GAAP operating costs by 1.4 billion to $1.7 billion between 2025 and 2027, the company announced Wednesday. The Massachusetts biotech now targets $4.7 billion to $5 billion in GAAP costs in 2027, versus $7.2 billion last year.
    • “On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its cash operating costs from about $6.3 billion in 2024 to about $5.5 billion this year, and then further to $4.7 billion and $4.2 billion in the two subsequent years.
    • “Compared with cash operating costs, GAAP costs also include stock-based compensation for executives and asset value depreciation.”
  • The Leapfrog Group released its Spring 2025 hospital patient safety grades today.
  • Per MedTech Dive,
    • “GE Healthcare cut its 2025 adjusted earnings outlook to reflect an estimated 85-cent-per-share impact from tariffs, especially duties affecting trade with China, executives said on an earnings call Wednesday.
    • “CEO Peter Arduini said bilateral U.S. and China tariffs account for 75% of the total net impact.
    • “For the full year, GE Healthcare now expects adjusted earnings in a range of $3.90 to $4.10 per share, down from the prior estimate of $4.61 to $4.75.
    • “The revised outlook assumes that tariffs remain at the current elevated levels and that U.S. reciprocal tariffs on the rest of the world — announced April 2 — return to pre-pause rates on July 9. The forecast also assumes Mexico and Canada tariffs remain in place, with exemptions under the U.S.-Mexico-Canada Agreement continuing for all eligible imports.”
  • and
    • “Abbott has struck a deal to integrate data from its Libre continuous glucose monitors into Epic’s electronic health record systems in the U.S., the companies said Tuesday.
    • “The integration will connect Abbott’s data management software to Epic’s EHR systems. Linking the systems will allow clinicians to view glucose data captured by Libre devices within Epic. 
    • “The Epic integration could be the start of a broader Abbott initiative. Lisa Earnhardt, group president of medical devices for Abbott, said in a statement that the company aims to expand the integrated model to “other medical devices and connected care platforms in the future.”
  • Modern Healthcare reports,
    • “Medical weighing and measuring technology company seca launched the first compact, portable body composition scanner designed for primary care on Thursday.
    • “The mBCA Alpha scanner generates a detailed assessment of a patient’s body composition in 24 seconds, which includes percentages of fat, bone and muscle. Clinicians can use the information to spot early signs of excess body fat, age-related muscle decline and the impact medications like GLP-1s can have on the body, among other factors.
    • “Primary care physicians typically rely on weight and body mass indexing to determine a patient’s risk of chronic conditions such as obesity, diabetes, heart disease and metabolic syndrome. But body mass index doesn’t reflect muscle mass or fat distribution, which can vary significantly depending on age, gender and race, according to Nina Crowley, director of clinical education and partnerships at seca.
    • “The American Medical Association issued a policy update in June 2023 that called out body mass index as an imperfect way of measuring body fat in some populations and recommended it be used in conjunction with other screenings including body composition.
    • “Other imaging modalities like MRI and dual-energy X-ray absorptiometry can also provide information about a patient’s body composition, but Alpha can do it at a fraction of the cost, according to Crowley.”

Midweek Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • Per a House Oversight Committee press release,
    • “As part of the budget reconciliation process, the House Committee on Oversight and Government Reform held a markup today and passed budget legislation that advances President Trump’s agenda and saves American taxpayers over $50 billion. The Committee will now finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • Govexec provides details on the markup here.
  • Federal News Network tells us,
    • “Agencies are facing a roughly two-week deadline to show the Trump administration how they plan to implement coming changes for probationary employees.
    • “By May 16, agencies are expected to report their plans for adding a new “affirmative” certification requirement for probationary employees. Agencies are also expected to detail how they intend to train supervisors and HR practitioners on the coming changes, according to new guidance the Office of Personnel Management published Tuesday.
    • “The guidance outlines more detailed expectations for agencies to update how they manage probationary periods following President Donald Trump’s executive order last Thursday. That order called for the creation of “Civil Service Rule XI” and added a hurdle for probationary employees to clear before they become tenured employees. Agencies will now be required to review and actively sign off on probationary workers’ continued employment before they can reach a tenured employment status.”
  • Per Healthcare Dive,
    • “House Republicans are calling on the Center for Medicare and Medicaid Innovation to rethink its priorities under the Trump administration, including by improving transparency with providers and focusing on payment models that save the government money.
    • “In a letter sent this week by Republicans on the House Ways and Means Committee to CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton, lawmakers said they were “concerned” with the innovation center’s track record of creating models that often don’t improve care quality or reduce costs. 
    • “The legislators added that CMMI has also “promoted a political agenda ahead of its Congressionally mandated purpose,” like focusing on health equity instead of cost savings.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Nearly 12% of Americans still smoke cigarettes, the leading cause of preventable death nationwide. Yet there are only two medications authorized by the Food and Drug Administration to help them quit — the more effective of which, varenicline, can come with unsavory side effects like nausea that make people less likely to stick with treatment.
    • “A new pill with fewer side effects could soon be available from the Washington state-based biotech Achieve Life Sciences. The company plans to file for FDA approval of its drug, called cytisinicline, in June. 
    • “Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 and to launch in the U.S. by the end of that year. “This will be the first new drug for nicotine dependence in nearly 20 years,” he said.” 
  • Fierce Healthcare informs us,
    • “While Johnson & Johnson isn’t the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New Jersey drugmaker is confident that a broad label will land its product an enviable market position in the long run.
    • “The FDA on Wednesday approved J&J’s nipocalimab under the brand name Imaavy as a new treatment option for generalized myasthenia gravis (gMG). The green light, which J&J says covers the “broadest population of people living with gMG,” includes patients ages 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
    • “Anti-AChR and anti-MuSK antibody-positive people make up more than 90% of the total antibody-positive gMG population, J&J estimates. All told, the company figures gMG—which causes the communication between the body’s nerves and muscles to break down—affects around 700,000 people worldwide.”
  • Per MedTech Dive,
    • “Medtronic has won Food and Drug Administration approval for the Omniasecure defibrillation lead, the company said Friday.
    • “The lead connects to an implantable defibrillator and treats potentially life-threatening types of irregular heart rhythm. Medtronic said Omniasecure is the world’s smallest defibrillation lead.
    • “The approval limits the use of the lead to the right ventricle. Medtronic shared data on placing the lead in the left bundle branch last week but has yet to win FDA approval in that setting.
  • MedCity News lets us know,
    • “Patients with the most severe form of a certain inherited disease have skin that is susceptible to wounds, some that never fully heal. For years, the only treatment was supportive care, including laborious and frequent changes of wound dressings covering much of the body. Biotechnology research in this disease, epidermolysis bullosa (EB), has pursued therapeutic options. A personalized treatment that Abeona Therapeutics makes from a patient’s own skin cells is now approved by the FDA, marking the agency’s third approval in this rare disorder in the past two years.
    • “The regulatory decision announced Tuesday covers the treatment of wounds in adults and children who have recessive dystrophic epidermolysis bullosa (RDEB). The therapy, known in development as prademagene zamikeracel, or pz-cel for short, will be marketed under the brand name Zevaskyn. Cleveland-based Abeona expects Zevaskyn will become available in the third quarter of this year.
    • “We have heard from the RDEB community that there is a persistent, unmet need to meaningfully heal RDEB wounds, especially those that are chronic and prone to infection,” CEO Vishwas Seshdari said during a Tuesday morning conference call. “Through a single application, Zevaskyn can provide people with RDEB the opportunity for significant wound closure and pain reduction in even the most severe wounds.”

From the judicial front,

  • Federal News Network relates,
    • “The U.S. Supreme Court said Wednesday that federal employees who also are in the military reserve must be paid the equivalent of their civilian salaries when called to active duty during national emergencies.
    • “The 5-4 decision could affect hundreds of thousands of people, ensuring that they don’t suffer financially when they temporarily leave one form of government service for another.
    • “The justices ruled in an appeal filed by an air traffic controller who spent about five years on active duty in the Coast Guard at a pay rate lower than what he earns as a Federal Aviation Administration employee.”
  • Reuters reports,
    • “Genetic testing company 23andMe agreed on Tuesday to allow a court-appointed overseer to take charge of ensuring customers’ genetic data remains protected during the company’s bankruptcy, settling a dispute with several U.S. states.
    • “Those states had argued the company was not taking data security seriously enough.
    • “U.S. Bankruptcy Judge Brian Walsh approved the agreement at a court hearing in St. Louis, Missouri, ordering the appointment of a consumer protection ombudsman who will be empowered to review 23andMe’s handling of customers’ genetic information and its security policies.”

From the public health and medical research front,

  • CNBC reports,
    • “Aon researchers found that within two years, improved health outcomes for patients who were taking GLP-1 drugs lowers the growth rate of medical care costs. 
    • “Aon looked at medical claims data for 139,000 U.S.-based workers with employer health coverage who took GLP-1 medications between 2022 and 2024.
    • “Since 2023, GLP-1s have driven up employer spending on drugs at a faster pace than high-priced specialty drugs used to treat cancer and autoimmune conditions, according to an Evernorth study.”
  • Beckers Hospital Review considers what is driving increased use of GLP-1 drugs among children.
  • Per Cardiovascular Business,
    • “Drinking champagne may be associated with significant cardiovascular benefits, according to a new study published in the Canadian Journal of Cardiology.
    • “The study identified dozens of lifestyle changes that may help lower a person’s risk of sudden cardiac arrest (SCA). Some of the changes—eating more fruit, losing weight—were straightforward, but a few of the research team’s findings were unexpected. Drinking champagne and/or white wine, for example, was linked to a reduced SCA risk. The same was also true for spending more time at a computer—though that may tell us more about education levels than screen time.
    • “These findings all come from a new exposome-wide association study (EWAS) out of China. The study’s authors explored the UK Biobank study, focusing on data from more than 500,000 patients. They then looked for associations between SCA and 125 different modifiable lifestyle factors.
    • “To our knowledge, all previous studies on the risk factors of SCA were hypothesis-driven and focused on a limited number of candidate exposure factors grounded in previous knowledge or theoretical frameworks,” wrote first author Huihuan Luo, PhD, a researcher with Fudan University in Shanghai, China, and colleagues. “This might lead to publication bias distorting summary conclusions and might increase the likelihood of false positive findings resulting from inter-related exposures. More importantly, the hypothesis-driven approach might miss important exposures or relationships beyond the predefined hypothesis. To tackle these limitations, a hypothesis-free, data-driven EWAS has emerged as a robust analytical framework for simultaneously exploring hundreds of exposures. This data-driven approach does not rely on previous knowledge and facilitates the identification of novel or underexplored associations.” * * *
    • Click here for the full study.
  • Per Medscape,
    • “People with osteoarthritis are more likely to be diagnosed with other pain-related comorbidities such as fibromyalgia, chronic fatigue syndrome (CFS), gout, and irritable bowel syndrome and psychological comorbidities such as depression, according to observational data presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting.
    • “The study also found that all these five conditions were themselves associated with an increased risk for incident osteoarthritis, and in the case of fibromyalgia, there may be a causal association.
    • “Physiotherapist and epidemiologist Subhashisa Swain, MPH, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, Oxford, England, presented an analysis of data from the multicenter European Comorbidities in Osteoarthritis (ComOA) study, which is examining electronic health records to identify associations between 61 different comorbidities with osteoarthritis and the clusters and trajectories of those comorbidities and osteoarthritis.”
  • The New York Times offers guidance on hip exercises.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana beat earnings expectations for the first quarter and reaffirmed its 2025 guidance on Wednesday, after medical costs came in as predicted. It’s a positive development for the insurer, which has been rocked by higher spending in privatized Medicare plans and the safety-net Medicaid program.
    • “Humana attributed the results to higher Medicare and Medicaid premiums and membership growth in Medicare prescription drug plans and state contracts. Earnings were offset somewhat by an ongoing decline in Medicare Advantage membership after Humana culled underperforming plans to resuscitate margins this year.
    • “However, it’s still early in 2025, so Humana is remaining cautious when it comes to medical utilization, executives said. The payer’s outlook is also complicated by uncertainty stemming from its ongoing legal bid to improve MA quality ratings.”
  • The American Hospital Association News notes,
    • “The AHA April 30 released a report highlighting how hospitals and health systems continue to experience significant financial headwinds that can challenge their ability to provide care to their patients and communities. The report outlines the financial burden of heightened expenses hospitals have faced in recent years in caring for patients, as well as the increasing strain on the field.  
    • “It explains how hospitals have raised wages to recruit and retain staff amid workforce shortages and how Medicare and Medicaid continue to underpay hospitals for patient care as shortfalls worsen. Other findings include how practices of certain Medicare Advantage plans exacerbate hospitals’ financial burden, and that tariffs on medical imports could significantly raise costs for hospitals as nearly 70% of medical devices marketed in the U.S. are manufactured exclusively overseas. 
    • “This report should serve as an alarm bell that a perfect storm of rising costs, inadequate reimbursement, and certain corporate insurer practices are jeopardizing the ability of hospitals to deliver high-quality, timely care to their communities,” said AHA President and CEO Rick Pollack. “With so much at stake, policymakers must recommit to making preserving access to hospital care a national priority.” 
  • The Wall Street Journal reports,
    • “Trump’s executive order on drug prices is seen as a win for the pharmaceutical industry.
    • “Drugmakers spent millions lobbying against pharmacy-benefit managers (PBMs), blaming them for high drug prices.
    • “PhRMA funded various groups, including minority healthcare nonprofits, to criticize PBMs.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group announced Tuesday that Patrick Conway, M.D., would take the helm of its Optum division.
    • “Conway, an insurance industry and health policy veteran, was previously the CEO of Optum’s pharmacy benefit management unit, Optum Rx. He also held leadership roles at the company’s healthcare delivery arm, Optum Health.
    • “Conway will step in as CEO of Optum on May 6. His prior work includes serving as the director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services, which is responsible for developing critical payment models for government insurance programs.”
  • and
    • “Despite the poor financial performance of BetterHelp, whose revenue fell by 11% in Q1, Teladoc has grown its investment in virtual mental healthcare by acquiring UpLift in a $30 million all-cash transaction.
    • “The deal closed on April 30, the same day as Teladoc’s first quarter 2025 earnings call. The company fared worse than Wall Street expected in Q1, posting a net loss of $93 million, or $0.53 lost per share. Wall Street Analysts expected the company share price to decrease by $0.33.
    • “A significant upside to the acquisition is the new-found ability for BetterHelp customers to use insurance coverage for mental health services, a barrier that has kept some customers from signing up with the cash-pay mental health provider. UpLift will be included in the company’s BetterHelp reporting segment going forward, executives said.
    • “UpLift provides virtual mental health therapy, psychiatry and medication management services. It serves the health plan market and covers 100 million lives. It has a network of over 1,500 mental health providers.”
  • Per BioPharma Dive,
    • “Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA.
    • “Announced Wednesday, the acquisition will hand the Swiss pharmaceutical firm a drug prospect called farabursen, which recently completed a Phase 1b study in people with autosomal dominant polycystic kidney disease, or ADPKD.
    • “Per deal terms, Regulus shareholders will receive $7 in cash per share, a premium of more than 100% to the stock’s closing price Tuesday. Additionally, Novartis has committed to pay an additional $7 per share via a so-called contingent value right that’s linked to the achievement of an unspecified regulatory milestone.”
  • and
    • “Sales of BridgeBio’s new heart medicine Attruby blew past analyst expectations in the first quarter, as the company built by “science nerds” took on market behemoth Pfizer.
    • “Net product revenue reached $36.7 million in the period, surpassing the consensus analyst estimate of $12.6 million. The drug won Food and Drug Administration approval in November to treat a genetic condition known as transthyretin amyloidosis with cardiomyopathy.
    • “As of April 25, Attruby had 2,072 prescriptions written by 756 prescribers, BridgeBio said Tuesday after the market closed. That momentum built on encouraging numbers released in February and helped push the company’s shares up in early trading Wednesday.”
  • Per Beckers Hospital Review,
    • “Mark Cuban Cost Plus Drug Co. has secured another partnership targeting the specialty pharmaceutical market, according to an April 28 news release shared with Becker’s. 
    • “EverPharm, a specialty unit-dose medication company, is joining its portfolio with Cost Plus Drugs’ pricing model, which is the drug’s manufacturing cost plus a 15% markup and a $10 shipping and labor fee. On April 16, Cost Plus Drugs launched a similar partnership with Morris & Dickson, a full-line and specialty pharmaceutical distributor. 
    • “The partnership with EverPharm will roll out in phases, the release said, with an initial focus on offering key unit-dose medicines to pharmacies and healthcare providers through the Cost Plus Marketplace.” 

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, NIH, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • The International Foundation of Employee Benefit Plans let us know,
    • Over a dozen bills that would amend the Internal Revenue Code of 1986 to expand health savings accounts (HSAs) have been introduced in Congress this year, according to the International Foundation’s [article]. If enacted, the bills aim to change the disadvantages of HSAs and/or high-deductible health plans (HDHPs) that make them inaccessible or undesirable to some people. If enacted, some bills would allow more people to own HSAs, contribute more annually, and use HSA dollars for more items and services. Other bills would change HDHPs to allow more than preventive services, such as chronic disease treatments, to be covered before the deductible.
  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, May 6, 2025, at 10:00 AM to consider James O’Neill to be Deputy Secretary of the Department of Health and Human Services (HHS) and Gary Andres to be an Assistant Secretary of HHS.”  
  • Beckers Payer Issues offers five notes on the Trump Administration’s approach to Medicare Advantage so far.
  • Modern Healthcare adds,
    • “Leaders at the Centers for Medicare and Medicaid Services are exploring proposals to limit health insurers’ use of tactics that can delay medical care, people familiar with the discussions said. 
    • “The aim of the proposals would be to cut the number of medical procedures subject to “prior authorization,” meaning ones in which doctors have to fill out additional paperwork for ultimate approval. CMS is exploring making policies more uniform across different health insurance plans. 
    • “Another goal is automating coverage determinations so patients can get decisions faster, said the people, who weren’t authorized to speak publicly on the matter. The discussions are in preliminary stages, and the agency’s direction could change.”
  • Modern Healthcare also shares some health insurer associations’ deregulatory ideas offered to the Trump Administration.
    • “The Coalition Against Surprise Medical Billing, which includes the health insurance trade group AHIP and the Blue Cross Blue Shield Association, wants CMS to make the No Surprises Act out-of-network billing dispute resolution process more favorable to their members, it wrote the White House, HHS, the Treasury Department and the Labor Department last Tuesday.
    • “The Alliance of Community Health Plans, which represents insurers affiliated with nonprofit health systems, wants CMS to nix a variety of quality and performance reporting requirements, including for defunct programs such as the Medicare Advantage Value-Based Insurance Design model, which CMS shut down last year.
    • “The association also wants CMS to ease rules regarding beneficiary communications, such as requiring them to opt into digital communications. These mandates are the “epitome of administrative burdens,” Alliance of Community Health Plans President and CEO Ceci Connelly wrote to CMS April 9.”
  • MedPage Today’s editor in chief interviews the new FDA Commissioner Marty Makary, MD, here.

From the judicial front,

  • STAT News reports,
    • “The Supreme Court on Tuesday rejected hospitals’ argument that the federal government doesn’t pay them enough for treating low-income patients [by a 7-2 majority].
    • “The seven-justice majority instead sided with the Department of Health and Human Services’ interpretation of the law concerning disproportionate share hospital, or DSH, payments, which compensate hospitals for treating low-income patients. More than 200 hospitals brought the case, Advocate Christ Medical Center v. Kennedy, arguing the federal agency’s misreading of the law causes it to underpay them by well over $1 billion each year.” 

From the public health and medical research front,

  • The National Institutes of Health (NIH) announced,
    • adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using cutting-edge alternative nonanimal research models aligns with the U.S. Food and Drug Administration’s (FDA) recent initiative to reduce testing in animals. While traditional animal models continue to be vital to advancing scientific knowledge, using new and emerging technologies can offer unique strengths that, when utilized correctly or in combination, can expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions.
    • “For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” said NIH Director Dr. Jay Bhattacharya. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”
  • The current issue of NIH Research Matters covers the following topics: “Restoring speech after paralysis | CT scans and cancer risks | Visual information processing in the brain.”
  • Health Day tells us,
    • “A Kaiser Permanente colon cancer screening initiative put a huge dent in cancer cases and deaths over two decades, a new study says.
    • “The systematic outreach program doubled colon cancer screening rates, researchers are scheduled to report at the upcoming Digestive Disease Week meeting in San Diego.
    • “As a result, cancer cases were cut by a third and colon cancer deaths by half, researchers report.
    • “In addition, racial disparities in colon cancer outcomes nearly vanished as a result of the initiative, researchers said.
    • “By offering an effective screening approach equally to everyone, we were able to eliminate much of the disparity,” said lead investigator Dr. Douglas Corley, chief research officer with the Kaiser Permanente Division of Research in Northern California.
    • “Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients,” he said in a news release. “Now, those differences are nearly gone.”
  • MedPage Today informs us,
    • “The addition of the pregnancy checkbox on death certificates in 2003 was responsible for most of the spike in maternal deaths since 2000.
    • “However, in 2021, adjusted maternal death rates peaked at 18.86 per 100,000 live births, in line with the COVID pandemic.
    • “Of note, both infant and fetal death rates per 1,000 live births declined across the study period.” * * *
    • “Our work is the first to quantitatively separate out the effect of change in data collection from actual trends in maternal mortality,” co-author Robin Park, MSc, also of the University of Oxford, told MedPage Today. “Adjusting for the change in data collection, we find that the rate of maternal mortality has been relatively constant since 2000.”
    • “Park noted that while the checkbox doesn’t change the definition of maternal death, “anecdotal evidence suggests that it makes coders more likely to add a maternal or pregnancy-related cause of death,” and thus it’s been difficult for researchers to “parse out the true trends from changes in data collection.”
  • Per MedTech Dive,
    • “Since its U.S. debut more than a year ago, pulsed field ablation continues to gain converts at a fast pace, with devices from Boston Scientific and Medtronic leading the way.
    • “The procedure is becoming physicians’ preferred ablation method for treating atrial fibrillation, an irregular rhythm that can lead to complications such as blood clots, stroke and heart failure. PFA delivers electrical pulses to targeted areas of the heart causing abnormal rhythms, offering a potentially safer approach than older treatments that use heat or extreme cold to ablate the tissue.
    • “In connection with the Heart Rhythm Society’s 2025 meeting in San Diego, which wrapped this weekend, Boston Scientific, Medtronic, Abbott and Johnson & Johnson all unveiled data supporting their devices.
    • “Truist analysts, in a note to clients Sunday, said physicians they spoke with at the event reported that the more efficient PFA procedures were allowing their institutions to perform at least 20% to 30% more cases.”

From the U.S. healthcare business front,

  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of tirzepatide (Zepbound®, Eli Lilly & Co.) and semaglutide (Wegovy®, Novo Nordisk) for the treatment of obesity. ICER will also assess how these treatments affect additional obesity-related outcomes.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“
  • The Wall Street Journal reports,
    • “AstraZeneca’s core EPS rose to $2.49, revenue increased 10% to $13.59B, but shares fell over 4% amid legal challenges in China.
    • “The company reaffirmed its 2025 targets after oncology revenue grew 13% to $5.64B, driven by Tagrisso and Imfinzi.
    • “China revenue rose 3%, but the company faces potential fines in the country over alleged illegal drug imports.”
  • and
    • “Hims & Hers partners with Novo Nordisk to offer Wegovy for weight loss, with subscriptions starting at $599 a month.
    • “The collaboration includes clinical support and nutrition guidance via Hims & Hers’ platform and NovoCare Pharmacy.
    • “Novo and Lilly are partnering with telehealth providers amid competition in the weight-loss drug market.”
  • and
    • “Merck is investing $1 billion in a Delaware plant to expand its U.S. manufacturing, amid potential tariff concerns.
    • “The plant will produce biologic drugs and a new, easier-to-use version of Keytruda, the company’s blockbuster cancer drug.
    • “The facility is Merck’s first in-house U.S. site for Keytruda, ensuring domestic supply and creating at least 500 on-site jobs.”
  • Per Healthcare Dive,
    • “Universal Health Services reported earnings for the first quarter on Monday evening that came in below Wall Street’s expectations for revenue. The for-profit’s behavioral health business also underperformed compared to its acute care service line.
    • “Behavioral health adjusted admissions declined by 1.6% compared to the prior year, while acute care admissions grew by 2.4%. Executives blamed the leap year in 2024 and atypical winter weather in some markets for depressed patient days, noting adolescent behavioral care utilization rates were particularly impacted by weather-related school closures. 
    • “CEO Marc Miller told investors during a Tuesday morning earnings call that UHS could get its behavioral health unit back on track to grow patient day revenue by 2.5% to 3% by the end of the year. However, the executive declined to specify when investors could expect to see improvement and dodged questions about whether volumes are expected to improve in the second quarter or the back half of the year.”
  • Per Fierce Healthcare,
    • “Though it opted to stick with annual guidance numbers given in February, Tenet Healthcare’s “outstanding” first-quarter performance has the company pushing ahead on growth initiatives in the face of financial headwinds and policy uncertainties.
    • “Tuesday morning, the hospital and ambulatory surgical center operator shared a $406 million net income attributable to the company ($4.27 per diluted share) for the first three months of the year. Net operating revenues decreased year over year from $5.4 billion to $5.2 billion, largely reflecting hospital divestitures during the prior year.
    • “Its adjusted EBITDA of $1.16 billion was up 14% over the same period a year prior and “well above the high end of our guidance range,” Chief Financial Officer Sun Park said Tuesday.
    • “Tenet CEO Saum Sutaria, M.D., told analysts that the earnings growth stems from divesting low-margin facilities and recent years’ focus on operating discipline. It’s set the stage for Tenet to continue focusing on labor structure and supply standardization, to increase its operating leverage and to build out its portfolio of well-performing assets.”
  • and
    • “Telehealth company LifeMD bought assets from Optimal Human Health MD to accelerate its push into the women’s health market.
    • “The acquisition establishes a scalable clinical and operational foundation for a comprehensive virtual health program, set to launch this summer, focused on hormone health, bone density, metabolism and long-term wellness. LifeMD’s virtual women’s health platform will target areas such as menopause and osteoporosis.
    • “The company did not disclose financial details of the acquisition.”
  • Modern Healthcare reports,
    • “Dr. Shawn Griffin, president and CEO of URAC, has had a front row seat to AI’s evolution in healthcare and he’s worried there are not enough guardrails.
    • “There is an urgent need for standards to be developed and quickly, given the change in presidential administrations, said Griffin, who six years ago became the first physician to lead the nonprofit accreditation organization for hospitals, health plans, telehealth providers, pharmacies and other healthcare players.”
    • “Looking at the way that AI was coming into healthcare, we recognized that there was a need for some sort of verifiable standards to be implemented to protect patients and to look out for their best interests in this area that’s moving so fast,” Griffin said. “It’s been on our radar screen for a few years.”
    • In the fall, URAC plans to launch a healthcare AI accreditation program, making it one of several organizations initiating these specific types of accreditation programs.

Monday Report

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Five months after announcing his esophageal cancer diagnosis, Virginia Rep. Gerald E. Connolly said Monday that he won’t seek a 10th term and also plans to step down as the top Democrat on the House Oversight and Government Reform Committee.
    • “The sun is setting on my time in public service,’’ Connolly, 75, said in a message to his constituents in Virginia’s 11th District. “With no rancor and a full heart, I move into this final chapter full of pride in what we’ve accomplished together over 30 years.” * * *
    • “Until his permanent successor on the committee is chosen, Connolly has asked Massachusetts Rep. Stephen F. Lynch to cover for him as the panel’s top Democrat, Politico reported Monday.”
    • Best wishes, Congressman.
  • STAT News tells us,
    • “In keeping with the Trump administration’s quest to slash spending at the federal health department, it’s hired a famously thrifty technology entrepreneur to lead Medicare. 
    • “As the CEO of health IT company Collective Medical, Chris Klomp flew bargain-priced Frontier Airlines and once boasted about sleeping in rental cars and crummy motels on business trips. The office snacks were from Costco. The penny-pinching didn’t stop after the bootstrapped company raised nearly $50 million from blue chip investors like Kleiner Perkins. One morning, Klomp arrived at the company’s headquarters just outside Salt Lake City, his 1960’s teal Ford pickup loaded full of printer paper that was on sale at Staples.” * * *
    • “Under Klomp’s watch, crucial decisions will be made about the direction of Medicare. They include whether to rein in abusive coding and denials practices by private Medicare Advantage plans that cover a majority of enrollees, whether to reform how Medicare pays doctors and hospitals, and whether it will pay for a new breed of obesity medications. Because of Medicare’s reach, other insurers often follow its lead on payments and other policies, putting Klomp in a position to significantly influence the entire American health care system.”
  • Healio adds,
    • “Medicare Part D coverage of obesity medications could lead to a large increase in health care costs due to the prices of the drugs, according to data from a microsimulation model published in JAMA Health Forum.
    • “As Healio previously reported, CMS decided to not move forward with a previously proposed rule to have Medicare begin covering obesity medications in the 2026 calendar year, though the agency said it could reconsider the proposal in future rulemaking.
    • “If Medicare were to cover obesity medications, however, there could be huge financial implications, according to David D. Kim, PhD, assistant professor of medicine and public health sciences at University of Chicago. 
    • “Our finding is that obesity drugs [would be] a pretty substantial cost, [about] $47 billion over the next 10 years,” Kim told Healio. “These are important numbers, because a lot of people say that GLP-1s will save a lot of money in health care because obesity is a risk factor for many other conditions. … Our paper highlighted that in some sense, GLP-1s do save money, but not enough to offset the high prices of the medication.”
  • BioPharma Dive lets us know,
    • “Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable pending an agreement with the Food and Drug Administration on a postmarketing clinical trial.
    • “Last week, Novavax revealed the agency had requested what’s known as a postmarketing commitment to further study the shot in clinical tests. On Friday, The Wall Street Journal reported the FDA had asked Novavax to conduct an additional randomized clinical trial, which would be a costly and time-consuming additional step for the company.
    • “A spokesperson for Novavax, contacted by BioPharma Dive Friday, said the company “cannot comment on the details of the request” while engaging with the FDA. It’s unclear when exactly the agency wants Novavax to complete the study.”

From the judicial front,

  • Modern Healthcare reports,
    • “Elevance Health is facing a second lawsuit accusing it of maintaining inaccurate provider directories, also known as “ghost networks.”
    • The plaintiffs are three people covered under New York state employee health benefits who allege that Elevance Health division Carelon Behavioral Health misrepresented providers as in-network, causing them financial harm. The attorneys are seeking class-action status.” * * *
    • Pollock Cohen and Walden Macht Haran & Williams filed the lawsuit against Elevance Health subsidiary Anthem Blue and Cross Blue Shield of New York in the U.S. District Court for the Southern District of New York.
    • “The Elevance Health plaintiffs allege Carelon Behavioral Health, which administers mental health benefits to state and municipal employees enrolled in the New York State Health Insurance Program’s Empire Plan, misled policyholders seeking mental healthcare.”

From the public health and medical research front,

  • STAT News reports,
    • “A clinical trial run by the National Cancer Institute seems to confirm that a single dose of the vaccine used to prevent infection with the human papilloma virus is just as effective as two — and, therefore, also helps to prevent cancer.
    • “The result could transform efforts to reach the three-quarters of children globally who should receive the vaccines but don’t. The shots prevent cervical cancer and also anal, penile, and some head-and-neck cancers. Worldwide, 350,000 women die from cervical cancer, the most common HPV cancer.
    • “I think we can all agree that one dose and two doses of … these fantastic vaccines work really well,” said Aimée R. Kreimer, the NCI investigator who presented the new data here Monday at the annual meeting of the American Association for Cancer Research. “We’re really excited about these results.”
    • “In developed countries, including the U.S., two doses of the vaccines are currently recommended. But in the clinical trial, whether one dose or two doses were used, the results were equivalent, according to the study of 20,000 girls between ages 12 and 16 in Costa Rica who were followed for 4 1/2 years. In all cases, the estimated efficacy of the vaccines was upwards of 97%.”
  • Per MedPage Today,
    • “Another benefit of GLP-1 receptor agonist (RA) use may be protection from persistent atrial fibrillation (Afib or AF) after ablation, according to a large Veterans Affairs database.
    • “New initiators of these drugs in 2015-2022 — specifically people with type 2 diabetes (T2D), obesity, and active Afib — showed significant improvement in their time to first hospitalization for Afib, Afib-related procedures (cardioversion/ablation), or all-cause mortality over a median 3 years of follow-up (HR 0.87, 95% CI 0.68-0.96) when compared against controls getting a DPP-4 inhibitor (DPP4i) or sulfonylurea.
    • “Accounting for mortality as competing risk, the Afib burden trended numerically in favor of the GLP-1 RA group (HR 0.85, 95% CI 0.61-1.03), noted Varun Sundaram, MD, PhD, MSc, of Case Western Reserve University in Cleveland, in his presentation of the TRANSFORM-AF study at the Heart Rhythm Society annual meeting.
    • “This is an exciting study for people with AF, T2D, and obesity along with the clinicians treating them. This retrospective study suggests there is a cardioprotective effect of GLP-1RA compared to DPP4i in hard AF endpoints,” commented James Lo, MD, PhD, of Weill Cornell Medicine/New York-Presbyterian Hospital in New York City.
  • Medical News Today warns us,
    • “A multi-decade study finds that the damage done by smoking, heavy drinking, and being physically inactive begins at a far younger age than previously understood.
    • “Although the unwanted health consequences of these habits over the long term are well-known, the research offers evidence that their negative impact, though not as severe, actually occurs over the short term.
    • “Participants in the study were assessed for depression, sense of well-being, metabolic risk, and sense of healthfulness, all of which suffered as a result of smoking, drinking, and being inactive.
    • “While it is no surprise that a lifetime of smoking, heavy drinking, and physical inactivity is a recipe for ill health later in life. 
    • “Now, a new study finds that these habits can result in health issues as young as the age of 36, including their influence on mental health.
    • “The findings of the study were recently published in the Annals of Medicine.”
  • Health Day adds,
    • “Risk factors for dementia could start taking their toll as early as a person’s 20s and 30s, a new study says.
    • “Younger adults who carry known risks for dementia performed worse on memory and thinking tests between ages 24 and 44, researchers report in the May issue of the journal The Lancet: Regional Health Americas.
    • “The findings lay the groundwork for early detection of Alzheimer’s disease and dementia, researchers say.
    • “This is the first study to look at risk factors of dementia and Alzheimer’s disease in a large group of generally healthy younger adults, researchers say.
    • “Previously, research on Alzheimer’s disease risk factors has focused on individuals aged 50 and older,” lead researcher Allison Aiello, a professor of epidemiology at the Columbia University Aging Center, said in a news release.
    • “These new results show that well-established risk factors and blood biomarkers for dementia appear to start affecting cognitive function even before middle age, Aiello said.
    • “These risk factors include education level, gender, blood pressure, cholesterol, exercise and body mass index, a measure of body fat based on height and weight, results show. All these are measured using a Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score.”
  • The American Medical Association tells us what doctors wish their patients knew about insomnia.
  • Benefits Pro relates,
    • “According to researchers, the survey reveals a possible cognitive dissonance: Americans know they should schedule a preventive care screening or wellness visit, but their behavior often suggests otherwise. For 65% of Americans, experiencing a health scare is what made them realize they need to be more proactive about their health. Attitudes about preventive care are often counterintuitive, however, as many of those who believe they will be diagnosed with cancer are more likely to delay screenings (62% vs. 42%).
    • “Many avoid going to the doctor instead of doing what they can to avoid a health scare or detect a problem early,” Tom Morey, Aflac’s senior vice president and chief actuary, said in a statement while also noting his own health crisis that kept him away from work for nearly two years and in and out hospitals for 18 months. “It starts with making preventive care a priority and taking steps toward establishing a trusted relationship with a primary care doctor. Personally, this helped me to feel more confident, more in control of my health, and more empowered to deal with an illness that, otherwise, may have gone undetected.”
  • Health Day also informs us,
    • “Breast cancer patients fare better if they continue to exercise during their treatment, and a new program can help women get the activity they need to boost their odds, researchers say.
    • “The Comprehensive Oncology Rehabilitation and Exercise (CORE) program assesses women’s physical activity needs based on the stage to which their cancer has progressed, researchers reported today in the journal Cancer.
    • “More than 3 in 5 patients (62%) completed their referral to an exercise program designed to meet their specific needs, researchers said.
    • “CORE may serve as a model workflow algorithm aimed to integrate both exercise and rehabilitation services from time of diagnosis and beyond,” senior researcher Adriana Coletta, an investigator at the University of Utah’s Huntsman Cancer Institute, said in a news release.”
  • Consumer Reports, writing in the Washington Post, points out,
    • “You often hear that fish is brain food. True, but so are eggs, pork loin and Brussels sprouts. That’s because they’re rich in choline, a nutrient related to B vitamins.
    • “Choline is critically important for a variety of body and brain functions,” says Ramon Velazquez, an assistant professor at the Arizona State University-Banner Neurodegenerative Disease Research Center in Tempe. It’s part of all cell membranes, and in recent years there’s been increasing evidence linking it to better cognitive function and even a lower risk of Alzheimer’s disease. But about 90 percent of people don’t get enough of it.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Most Blue Cross and Blue Shield companies lost money last year as rising Medicaid and Medicare costs squeezed their bottom lines.
    • “The vast majority of 31 Blues companies reported weaker operating margins as membership declined and medical and pharmaceutical costs rose, according to an analysis of state financial filings that Mark Farrah Associates performed for Modern Healthcare.
    • “Across the Blues, operating margin fell 3.2 percentage points from a 0.3% gain in 2023 to a 2.9% loss in 2024. Just eight Blues companies reported positive operating margins last year.
    • “That contrasts with the annual margin growth enjoyed by national, publicly traded insurers. For-profit insurers average operating margin rose 1.6 percentage points to 2.4% in 2024, according to the health data analytics firm.”
  • Beckers Payer Issues tells us fifty things to know about UnitedHealth Group.
  • Fierce Healthcare relates,
    • “While health plans are not likely to feel the most acute effects from the Trump administration’s tariffs, they face downhill impacts from market volatility and rising costs, according to a new analysis from Fitch Ratings.
    • “The report examines the way tariffs could affect multiple types of insurance and estimates that health insurers in particular face moderate exposure to the slower economic growth and financial performance that are more indirect results of the tariffs.
    • “Health plans benefit in this particular case from the vast majority of their operations being domestic. However, while that suggests the impacts will be fairly limited in the short term, the effects would ramp up should the tariffs remain in place for an extended period, or if they evolve to be more restrictive.
    • “As an example, tariffs on pharmaceutical products would also likely lead to short-term cost pressures on insurers, according to Fitch.”
  • FiercePharma notes,
    • “Ending a 20-year-plus drought, Merck & Co.’s Keytruda demonstrated that its use around surgery can reduce the risk of certain head and neck cancers from returning.
    • “Continuous use of Keytruda—both before and after surgery—reduced the risk of recurrence or death by 27% in patients with stage 3 or 4a, resected, locally advanced head and neck squamous cell carcinoma (HNSCC), according to results from the phase 3 Keynote-689 trial presented at the American Association for Cancer Research Annual Meeting 2025.
    • “In the study, Keytruda was added to postoperative radiotherapy with or without chemo. Investigators compared the perioperative Keytruda regimen with the sans-Keytruda standard treatment.
    • “Keynote-689 marks the first positive trial in more than two decades in resected locally advanced HNSCC, making Keytruda the first PD-1 inhibitor to mount such a benefit.”
  • Per BioPharma Dive,
    • “Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months of negotiations over an acquisition.
    • “The German pharmaceutical firm will pay $47 per SpringWorks share, a small premium to the stock’s closing price Friday but 17% higher than the $40.28 it closed at on Feb. 7, the last trading day before reports emerged of the companies’ discussions.
    • “SpringWorks has developed two drugs that are approved in the U.S. to treat rare tumors. Ogsiveo is cleared for adults with desmoid tumors, while Gomekli won the Food and Drug Administration’s OK in February for adults and children with neurofibromatosis type 1 who experience symptoms from a type of benign tumor.”
  • Per MedTech Dive,
    • “Medtronic has filed for Food and Drug Administration approval of its Hugo soft tissue robotic surgery system with a urologic indication, marking a major step in its bid to compete with Intuitive Surgical. The company said Saturday that it made the submission in the first quarter of 2025. 
    • “Medtronic also completed enrollment in hernia and benign gynecology studies and received approval to start a trial in oncologic gynecology procedures. The studies will support submissions for additional U.S. indications for the robot.
    • “Data from the company’s investigational device exemption study for the Hugo robot in urologic surgery, presented at the American Urological Association annual meeting, met the primary goals for safety and effectiveness, according to Medtronic.”

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • Congress returns to Capitol Hill tomorrow following a two week long District / State work break.
  • Here is a link to this week’s calendar of Senate and House of Representatives committee business.
  • Roll Call offers an overview of this week’s activities.
    • “President Donald Trump is scheduled to meet at the White House Monday afternoon with Speaker Mike Johnson, beginning the first of several key legislative weeks for the president’s immigration, economic and tax policy agenda.”
  • Per a House Oversight Committee press release issued last Friday,
    • “House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) announced a markup will take place on Wednesday, April 30th at 10:00 a.m. ET to consider budget legislation to advance President Trump’s agenda to provide tax relief for American families and small businesses, rein in wasteful spending, and reduce the federal budget deficit for the American taxpayers. The House Oversight Committee’s budget reconciliation instructions require a net reduction in the federal deficit of no less than $50 billion and reforms to help balance the federal budget. Following the markup, the Committee will finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • The list of measures to be included in the markup includes
    • “SEC. 90006. FEHB PROTECTION –– Requires a comprehensive audit of employee dependents currently enrolled in FEHB plans—such as verifying marriage certificates and birth certificates—and requires any ineligible individual found to be receiving FEHB coverage be disenrolled. ($1.5 billion in net savings).”
  • This measure unfortunately overlooks the fact that OPM can but chooses not to use the HIPAA 820 electronic enrollment roster which would allow carriers to reconcile each enrollee with his / her premium payments. What is the sense of confirming family member eligibility if you don’t know whether the enrollee is paying the correct premium?
  • Federal News Network interviews Kevin Moss about what to expect from the FEHB / PSHB in 2026. What’s missing from OPM’s call letter and technical guidance? New cost containment measures.

From the public health and medical research front,

  • The New York Times reports,
    • “When a person develops solid tumors in the stomach or esophagus or rectum, oncologists know how to treat them. But the cures often come with severe effects on quality of life. That can include removal of the stomach or bladder, a permanent colostomy bag, radiation that makes patients infertile and lasting damage from chemotherapy.
    • “So a research group at Memorial Sloan Kettering Cancer Center, using a drug from the pharmaceutical company GSK, tried something different.
    • “The researchers started with a group of 103 people. The trial participants were among the 2 to 3 percent of cancer patients with tumors that should respond to immunotherapy, a drug that overcomes barriers that prevent the immune system from attacking cancers.
    • “But in clinical trials, immunotherapy is not supposed to replace the standard treatments. The researchers, led by Dr. Luis A. Diaz Jr. and Dr. Andrea Cercek, decided to give dostarlimab, an immunotherapy drug, on its own.” * * *
    • “In 49 of the patients, who had rectal cancer, the tumors disappeared and, after five years, have not recurred. Cancers also vanished for 35 of 54 patients who had other cancers, including in the stomach, esophagus, liver, endometrium, urinary tract and prostate.
    • “Out of all 103 patients, cancers recurred in only five. Three got additional doses of immunotherapy and one, whose tumor recurred in a lymph node, had the lymph node removed. Those four patients so far have no evidence of disease. The fifth patient had additional immunotherapy that made the tumor shrink.
    • “The investigators reported their results Sunday at the annual meeting of the American Association for Cancer Research and in a paper published in The New England Journal of Medicine.
    • “The results, said Dr. Bert Vogelstein, an oncologist at Johns Hopkins in Baltimore, are “groundbreaking.”
  • Medscape tells us,
    • “Malnutrition-related diabetes, distinct from both type 1 and type 2, has now been officially recognized and named “type 5 diabetes.”
    • “The vote to endorse the category took place on April 8, during the International Diabetes Federation’s (IDF’s) World Diabetes Congress, held in Bangkok, Thailand. In January 2025, a panel met in India to draft a consensus statement about the condition, due to be published soon, Meredith Hawkins, MD, professor of medicine at Albert Einstein College of Medicine, Bronx, New York, told Medscape Medical News.
    • “Malnutrition-related diabetes has historically been vastly underdiagnosed and poorly understood…The IDF’s recognition of it as ‘type 5 diabetes’ is an important step toward raising awareness of a health problem that is so devastating to so many people,” Hawkins said.”
  • The New York Times Well site provides a personalized protein target and protein counter. Check it out.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “The Cybersecurity and Infrastructure Security Agency will soon have a new second-in-command.
    • “Madhu Gottumukkala has been named deputy director. He comes over to CISA from his prior position in the South Dakota government, where Kristi Noem was most recently governor before taking over as secretary of the Department of Homeland Security. Gottumukkala had been commissioner of the Bureau of Information and Telecommunication (BIT) and state chief information officer.
    • “He’ll leave BIT on May 16. A CISA spokesperson confirmed that Gottumukkala would become deputy director of the agency.”
  • CISA gives us the results of the President’s Cup competition and also announced on April 23,
    • “The [Critical Vulnerabilities and Exposures] CVE Program is an invaluable public resource relied upon by network defenders and software developers alike. As the nation’s cyber defense agency, it is a foundational priority for CISA. Recent public reporting inaccurately implied the program was at risk due to a lack of funding. To set the record straight, there was no funding issue, but rather a contract administration issue that was resolved prior to a contract lapse. There has been no interruption to the CVE program and CISA is fully committed to sustaining and improving this critical cyber infrastructure. 
    • CISA is proud to be the sponsor for the CVE program, a role we have held for decades. During this time, the CVE Program has gone through many evolutions, and this opportunity is no exception. MITRE, CISA, and the CVE Board have transformed this program into a federated capability with 453 CVE Numbering Authorities (CNAs). This growth has enabled faster and more distributed CVE identification, providing valuable vulnerability information to the public and enabling defenders to take quick action to protect themselves. We have historically been and remain very open to reevaluating the strategy to support the continued efficacy and value of the program.  
    • We also recognize that significant work lies ahead. CISA, in coordination with MITRE and the CVE Board, is committed to actively seeking and incorporating community feedback into our stewardship of the CVE Program. We are committed to fostering inclusivity, active participation, and meaningful collaboration between the private sector and international governments to deliver the requisite stability and innovation to the CVE Program. And we are committed to achieving these goals together.
  • Bleeping Computer tells us,
    • “The FBI has asked the public for information on Chinese Salt Typhoon hackers behind widespread breaches of telecommunications providers in the United States and worldwide.
    • “In October, the FBI and CISA confirmed that the Chinese state hackers had breached multiple telecom providers (including AT&T, Verizon, Lumen, Charter Communications, Consolidated Communications, and Windstream) and many other telecom companies in dozens of countries.
    • “As revealed at the time, while they had access to the U.S. telecoms’ networks, the attackers also accessed the U.S. law enforcement’s wiretapping platform and gained access to the “private communications” of a “limited number” of U.S. government officials.”
  • The HHS Office for Civil Rights announced,
    • “Today [April 25], the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Comprehensive Neurology, PC (Comprehensive), a small New York neurology practice, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. The settlement resolves an OCR investigation of a [2020] ransomware attack against Comprehensive.” * * *
    • “Under the terms of the settlement, Comprehensive agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $25,000 to OCR.”
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-hipaa-racap-np.pdf, opens in a new tab [PDF, 245 KB]“
  • and
    • “Today [April 23], the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with PIH Health, Inc. (PIH), a California health care network, over potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The violations stem from a phishing attack that exposed unsecured electronic protected health information (ePHI), prompting concerns related to the Privacy, Security, and Breach Notification Rules under HIPAA.” * * *
    • “The settlement resolves an investigation that OCR conducted after receiving a breach report from PIH in January 2020. The breach report stated that in June 2019, a phishing attack compromised forty-five of its employees’ email accounts, resulting in the breach of 189,763 individuals’ unsecured ePHI. PIH reported that the ePHI disclosed in the phishing attack included affected individuals’ names, addresses, dates of birth, driver’s license numbers, Social Security numbers, diagnoses, lab results, medications, treatment and claims information, and financial information.”
    • “Under the terms of the resolution agreement, PIH has agreed to implement a corrective action plan that will be monitored by OCR for two years and paid a $600,000 settlement to OCR.” * * *
    • The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance enforcement/agreements/index.html.

Three important reports were released this week.

  • Per Cyberscoop,
    • “It looks like 2024 was a record year in cybercrime for all the wrong reasons, according to the FBI’s annual Internet Crime Complaint Center (IC3) report released Wednesday. 
    • “As cyber-enabled fraud and ransomware continue to harm individuals, businesses, and critical infrastructure, the report, now in its 25th year, provides crucial insight into evolving criminal tactics and their nationwide impact. The report is overflowing with key trends, case data, and other statistics from the FBI’s ongoing efforts to combat the cyberthreat landscape.”
  • and
    • “Cybercriminals and state-sponsored threat groups exploited vulnerabilities and initiated ransomware attacks with vigor last year, escalating the scope of their impact by hitting more victims and outmaneuvering defenses with speed.
    • “The rate of ransomware detected in data breaches jumped 37%, occurring in 44% of the 12,195 data breaches reviewed in Verizon’s 2025 Data Breach Investigations Report released Wednesday. Researchers observed the presence of ransomware in 32% of data breaches in last year’s report. 
    • “Verizon’s research underscores the twists and turns of cybercriminal activity and its wide-reaching impact on organizations. “We see less payment activity,” Alex Pinto, associate director of threat intelligence at Verizon Business, told CyberScoop, “but we don’t see it slowing down.”
  • Per Cybersecurity Dive,
    • “Threat actors motivated by financial gain continue to rise in prominence, representing 55% of all cyber actors during 2024, according to a report by Mandiant. The figures show a steady increase from 52% in 2023 and 48% in 2022. 
    • “Exploits remained the most common initial access vector for the fifth consecutive year, representing 33% of exploits overall, according to the Mandiant M-Trends 2025 report. However, stolen credentials become the second most common initial access point for the first time, indicating a rising trend. 
    • “Cyber threat groups are increasingly targeting unsecured data repositories as poor security hygiene continues to leave organizations at risk.”

From the cyber vulnerabilities and breaches front,

  • Healthcare Dive reports,
    • “A data breach at Yale New Haven Health has exposed the information of about 5.6 million people, according to a report submitted to federal regulators earlier this month.
    • “The Connecticut-based health system detected unusual activity on its IT systems in early March, Yale New Haven said in a press release. An investigation later found an unauthorized third party had gained access to its network and stole copies of some patient data. 
    • “The incident is the largest healthcare breach reported to federal regulators so far in 2025, according to a portal managed by the HHS’ Office of Civil Rights.”
  • and
    • “A data breach at Blue Shield of California exposed information from 4.7 million people, according to a notice filed with federal regulators earlier this month. 
    • “In February, the insurer learned that Google Analytics, a vendor Blue Shield employs to track use of its websites, was sharing member data with the advertising service Google Ads from April 2021 through January 2024, according to a breach notice. 
    • “Blue Shield can’t confirm whether any particular beneficiary’s information is affected due to “the complexity and scope of the disclosures,” so the insurer is notifying all members who could have accessed their information on affected websites during the nearly three-year period.” 
  • Cybersecurity Dive tells us,
    • “Conduent Inc. warned in an April 14 regulatory filing with the Securities and Exchange Commission that a “significant” number of people had their personal data stolen in a January cyberattack that affected a limited number of the company’s clients.
    • “The company, a major government payments technology vendor for social services and transit systems, was targeted in a Jan. 13 attack that disrupted certain operations. 
    • “The company warned it has incurred and accrued a material amount of nonrecurring expenses related to the breach. A spokesperson for the company did not have specific numbers yet, but a breach notification has already been posted by the California Attorney General’s office.”
  • andInfor
    • Threat groups from across the globe are increasingly weaponizing older vulnerabilities for exploitation, according to a report released Wednesday by GreyNoise Intelligence. 
    • More than half of these resurgent vulnerabilities affect edge technologies, the report shows. Nearly seven out of 10 of the most unpredictable vulnerabilities — known as Black Swan vulnerabilities — affect edge technologies.
    • Almost 40% of Black Swan vulnerabilities specifically affect VPNs and routers, according to the report.
  • Per Cyberscoop,
    • “Attackers exploited nearly a third of vulnerabilities within a day of CVE disclosure in the first quarter of 2025, VulnCheck said in a report released Thursday. The company, which focuses on vulnerability threat intelligence, identified 159 actively exploited vulnerabilities from 50 sources during the quarter.
    • “The time from CVE disclosure to evidence of exploitation in the first quarter was marginally faster than what VulnCheck observed during 2024, Patrick Garrity, security researcher at the company, said in the report. “This demonstrates the need for defenders to move fast on emerging threats while continuing to burn down their vulnerability debt,” Garrity wrote. 
    • “VulnCheck’s research reinforces multiple recent reports that warned about increased exploits in 2024. Mandiant said exploits were the most common initial infection vectorlast year, representing 1 of every 3 attacks. Verizon reported a 34% increase in exploited vulnerabilities, and IBM X-Force said exploitation of public-facing applications accounted for 30% of incident response cases last year.”
  • and
    • “Attackers are having a field day with software defects in security devices, according to a new report released Wednesday by Mandiant. 
    • “Exploits were the most common initial infection vector, representing 1 of every 3 attacks in 2024, and the four most frequently exploited vulnerabilities were all contained in edge devices, such as VPNs, firewalls and routers, Mandiant said in its M-Trends report released Wednesday.
    • “Exploitation of these vulnerabilities represented slightly less than half of all observed vulnerability exploitation,” said Kirstie Failey, principal threat analyst at Google Threat Intelligence Group, under which the Mandiant brand operates.
    • “Threat researchers and federal cyber authorities have been sounding the alarm about attacks targeting network edge devices for more than a year. Since 2024, security device exploits have resulted in attacks on government agencies and some of the most valuable publicly-traded companies in the world.”
  • Per Cybersecurity Dive,
    • “Security researchers warn that hackers are actively exploiting a critical unrestricted-file-upload vulnerability in SAP NetWeaver Visual Composer. 
    • “The vulnerability, tracked as CVE-2025-31324, could allow an unauthenticated user to upload malicious executable binaries. The vulnerability has a severity score of 10.  
    • “Researchers from Reliaquest disclosed the vulnerability to SAP after an investigation uncovered attackers uploading JSP webshells into publicly accessible directories.” 
  • FEHBlog note: CISA did not add a known exploited vulnerability to its catalog this week.

From the ransomware front,

  • Palo Alto Networks issued a report on extortion and ransomware trends in the first quarter of 2025.
  • Dark Reading reports,
    • “The ransomware-as-a-service model is perpetually troubling for dropping the barrier to entry for aspiring ransomware actors, and two threat actors are innovating in the space with additional affiliate models.
    • “Extended detection and response vendor Secureworks (owned by Sophos) published research today detailing expanded affiliate models belonging to ransomware-as-a-service (RaaS) gangs DragonForce and Anubis.
    • “As a model, ransomware-as-a-service (RaaS) has gained significant popularity in recent years. A threat actor typically sells or leases many of the tools a less experienced cybercriminal (or affiliate) would need to conduct a ransomware attack; the affiliate typically shares the proceeds from subsequent attacks with the operator.
    • “The RaaS model has significantly lowered the technical barriers for wannabe cybercriminals, and as such it has become a serious problem for organizations around the world.”
  • Infosecurity Magazine notes,
    • “A new ransomware strain known as ELENOR-corp, identified as version 7.5 of the Mimic ransomware, has been used in a series of targeted attacks on the healthcare sector.
    • “The campaign displays a range of advanced capabilities, including data exfiltration, persistent access and anti-forensic strategies designed to cripple recovery efforts and maximize damage.”

From the cybersecurity defenses front,

  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

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

From Washington, DC,

  • Today, the Supreme Court held a conference of its justices at which the Court decided next steps with the Kennedy v. Braidwood Management case heard last Monday.
  • Bloomberg Law reports that following the conference,
    • “The Supreme Court ordered more briefing after arguments in a dispute over Obamacare’s preventative services mandate, which requires insurers to cover certain treatments like cancer screenings free of charge.
    • “In an order on Friday, the justices asked the parties to address whether the health secretary has the power to appoint the members of the US Preventive Services Task Force, which recommends services that should be covered under the Affordable Care Act. 
    • “The court wants to know “whether Congress has ‘by Law’ vested” the secretary with this authority.” * * *
    • “Additional briefs are due May 5. It’s rare but not unheard of for the court to request more briefing after a case has been argued.
    • “This occasionally occurs on issues that come up during argument if they weren’t initially briefed by the parties.”
    • FEHBlog note — That’s exactly what happened in the Braidwood Management case.
  • STAT News tells us,
    • “The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments.
    • “The announcement arrives two days after National Institutes of Health Director Jay Bhattacharya announced the intent to create such a registry at an all staff meeting, kicking off a firestorm of panic and confusion among autism self-advocates and the broader research community. Much of the fear centered around Bhattacharya’s remarks that the government would pull health data from private sources, such as electronic health records maintained by health care providers, pharmacy data, insurance claims and even wearables like smart watches and fitness trackers.”
  • Science Soft Healthcare predicts that “”By the end of 2026, 25–30% of all medical visits in the United States will be conducted via telemedicine. Although the adoption rate of telemedicine has been low in 2024, it will grow considerably with regulatory support from the US Congress.”
    • “In 2023, telemedicine usage in mental health was over three times higher than in other medical specialties, according to Epic Research. We believe that the resilient demand for telemedicine in mental health indicates that the technology is here to stay.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride Injection 500mg/100mL Infusion bags due to the products potentially containing inert polypropylene fibers. As of April 18, Amneal Pharmaceuticals said it received no reports of adverse events or injuries related to the recall. The recalled IV bags were distributed nationwide to wholesalers and distributors from April 23-Nov. 8, 2024.”

In other judicial news,

  • STAT News reports,
    • “Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy.
    • “A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
    • “Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA. For the two years when Ozempic and Wegovy were recently in shortage, compounders rushed to make copies to meet the enormous demand for weight loss treatments. But when semaglutide was ultimately taken off the FDA’s shortage list in February, the compounding trade group, called the Outsourcing Facilities Association, quickly sued the agency, arguing that there were still in actuality shortages of the branded treatments.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today:
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline 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 continues to decline in most areas of the country.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults.
    • “Other Respiratory Illnesses
      • “Mycoplasma pneumoniae
        • Respiratory infections caused by the bacteria Mycoplasma pneumoniae have increased in some areas of the United States over the last few weeks as indicated by emergency department visits and test positivity. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
      • “Pertussis
        • “Reported cases of whooping cough (pertussis) continue to be elevated nationwide but preliminary case reports have been trending downward for the past several months. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.“
  • The University of Minnesota’s CIDRAP adds,
    • “Flu activity continues to ebb nationwide, with rates of influenza-like illness (ILI) dropping further last week, but flu-related deaths in children climbed to 204, up 6 from the previous week, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.”
  • The AHA News lets us know,
    • “There have been 884 confirmed cases of measles nationwide so far this year, with cases reported by 29 states, according to the latest data from the Centers for Disease Control and Prevention. There have been 11 outbreaks, and 93% of confirmed cases (820 of 884) are outbreak-associated. The vaccination status of 97% of all cases is classified as “unvaccinated or unknown.”
    • “The CDC April 24 released a report that said increasing national and local measles, mumps and rubella vaccination coverage is essential to preventing measles cases and outbreaks. The report also said that cases this year are the second highest in 25 years. A JAMA study also released April 24 found that measles could become endemic again within another 25 years if current childhood vaccination rates remain the same.”
  • The University of Minnesota’s CIDRAP drills down on these measles statistics.
  • Eating Well reports,
    • “A recall on a popular brand of apple juice sold in 28 states was just announced, according to the Food and Drug Administration. This is due to a potential contamination with patulin, a mycotoxin that can cause internal organ damage when consumed in excess. Approximately 173,616 bottles are affected by this recall.
    • “The product impacted is Martinelli Apple Juice sold in its signature clear, round glass bottles with a white metal screw top lid. The recalled 10-ounce apple juice bottles were sold in 4-packs, contain a UPC of “0 41244 04102 2” and have a best-by date of December 5, 2026. They were sold at retail locations in the following states: Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin.
    • “This recall was just classified as a Class II recall, meaning that drinking this apple juice can  “cause temporary or medically reversible adverse health consequences,” per the FDA.
  • Healio points out,
    • An estimated 24,499 people visited the ED for adverse events related to semaglutide in the 2 years after its approval for weight loss, according to a study published in Annals of Internal Medicine.
    • The most common symptoms included nausea, vomiting and diarrhea, which had been previously documented in clinical trials. However, researchers also discovered that 16% of ED visits involved hypoglycemia.
    • “What I see in clinical practice is that some patients end up in the ED due to these severe symptoms from semaglutide, and it is not recognized in the ED,” Pieter Cohen, MD, associate professor of medicine at Harvard Medical School and internist at Cambridge Health Alliance, told Healio. “It is really important to make sure we are asking our patients about the use of semaglutide when they have these symptoms, particularly since use is so prevalent these days.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Centene beat Wall Street expectations for earnings and revenue in the first quarter thanks to significant membership increases, especially in Affordable Care Act and Medicare prescription drug plans, according to results released Friday.
    • “Citing the strong enrollment, the St. Louis-based payer raised its revenue guidance and reiterated its earnings guidance for 2025.
    • “However, Centene signaled medical costs may also be increasing, raising the outlook for its full-year medical loss ratio — a marker of spending on patient care. Centene’s stock fell 7% in Friday morning trade following the results.”
  • Per BioPharma Dive,
    • “Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations.  
    • “Gilead’s oncology portfolio generated $758 million in sales over the first three months of the year, down about 4% compared to the same period in 2024. Slower-than-expected sales of Gilead’s breast cancer drug Trodelvy were the main culprit, though the company also blamed lower demand for a decline in cancer cell therapy revenue.
    • “Gilead’s HIV drug business, though, helped offset those losses, garnering $4.6 billion and climbing 6% year over year. The company expects further growth in the future, as by June 19 the Food and Drug Administration could significantly expand use of lenacapavir, a twice-yearly injectable medicine proven in testing to prevent HIV infections.
  • Beckers Payer Issues provides 101 things to know about Blue Cross Blue Shield.
  • Beckers Hospital Review offers a list of the 25 most expensive hospital drugs.
  • Fierce Healthcare tells us,
    • “HCA Healthcare reaffirmed its 2025 guidance following an opening quarter of solid care demand and better-than-expected earnings.
    • “The country’s largest for-profit health system announced Friday morning $1.61 billion of net income attributable to the company ($6.45 per diluted share) and revenues of $18.32 billion for the first quarter. Both are improvements over the prior year’s $1.59 billion ($5.93 per diluted share) and $17.34 billion.
    • “Adjusted EBITDA for the quarter was $3.73 billion, also up from $3.35 billion in the first quarter of 2024.”
  • Per Fierce Pharma,
    • “With the potential for pharmaceutical import tariffs spurring a rush of life sciences investments in the U.S., AbbVie is joining the trend with plans to spend billions in the country over the next decade.
    • “AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker’s CEO, Rob Michael, said on a call with analysts Friday.
    • “AbbVie’s executives did not go into the fine details of the domestic investment plan on the call, though the company’s CFO Scott Reents noted that a portion of the sum will be earmarked to build four new U.S. production facilities devoted to active pharmaceutical ingredients (API), drug product, peptides and devices.”
  • and
    • “After unveiling a new drug substance facility in North Carolina in December, Amgen is doubling down on expanding its U.S. production presence with plans for a major upgrade at its plant in central Ohio.
    • “The new project represents the latest in a string of pharma investments in the U.S. as the Trump administration threatens to clamp down on the industry with sector-specific import tariffs.
    • “Amgen is plugging $900 million into an expansion of its biomanufacturing facility in New Albany, Ohio, the company said Friday. The project is expected to bring the total number of Amgen jobs in the state to 750 and increase the company’s overall investment in Ohio to more than $1.4 billion.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, NIH, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.  
    • “Cassidy said the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.   
    • “In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.”  
  • The President signed an executive order strengthening probationary periods in the federal civil service. Here’s a link to a fact sheet.
  • Govexec tells us, “Ex-feds launch websites to help unemployed civil servants find new jobs. Many federal employees are looking for positions outside of government following reductions in force and the Trump administration’s push for workers to take separation incentives.”
  • Per a Drug Enforcement Administration news release,
    • DEA’s National Prescription Drug Take Back Day is your chance to rid your medicine cabinet of unneeded and unwanted medications. Start your spring cleaning this year on April 26 by visiting a collection site near you.
    • Mark your calendar for this upcoming event! Participating drop-off sites will be open from 10 a.m. to 2 p.m. (local time) on Saturday, April 26. Collection sites are located around the country and will be collecting:
      • Tablets
      • Capsules
      • Patches
      • Other solid forms of prescription drugs.
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan for evaluating a measure regarding “Vision in Children Ages 6 Months to 5 Years: Screening.” The public comment deadline is May 21, 2025.
  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.”

From the judicial front,

  • Professor Katie Keith wrote an article in Health Affairs Forefront about the Kennedy v. Braidwood Management oral argument presented to the Supreme Court last Monday.
  • Fierce Pharma informs us,
    • “Halozyme is not holding back against Merck & Co. in the companies’ injectable Keytruda patent dispute, having now escalated a verbal warning into a lawsuit.
    • “In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck’s popular cancer drug Keytruda infringes 15 of its patents.
    • “Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs.
    • “Halozyme is seeking an injunction to block Merck’s planned commercialization of subcutaneous (SC) Keytruda, which is under FDA review with a decision expected by Sept. 23. The San Diego drug delivery expert is also asking for monetary relief and “an enhancement of damages,” because the alleged infringement is said to be willful, according to its complaint.
    • “Even though SC Keytruda has not reached the market, Merck opened itself to patent litigation after publicly laying out its intention to launch the product this year pending FDA approval.”

In State government news,

  • Mercer offers a roundup of selected state healthcare developments in the first quarter of 2025.

From the public health and medical research front,

  • CNN reports,
    • “The United States has seen progress in reducing certain cancer risks, as overall smoking rates remain on a decline. But for other risk factors, such as those tied to cervical cancer, there is room for improvement, according to a new American Cancer Society report.
    • “The prevalence of people smoking fell from about 14% in 2019 to 11% in 2023, according to the report published Wednesday in the journal Cancer Epidemiology, Biomarkers & Prevention. Cigarette smoking is known to significantly increase the risk of developing cancer. It’s estimated to cause about 1 out of every 3 cancer deaths in the US. * * *
    • “The prevalence of people being up-to-date on recommended cervical cancer screenings has dropped from 74.8% in 2019 to 73.4% in 2021 among ages 21 to 65, the report found, leaving more women at risk of not detecting disease early. The reported noted that the decrease is alarming as HPV vaccination rates have remained “statistically unchanged” in recent years. In 2023, 61.4% of adolescents ages 13 to 17 were up-to-date for the HPV vaccination series, similar to 61.7% in 2021 and up from 54.2% in 2019.
    • “HPV or human papillomavirus is a group of more than 150 viruses that can cause certain types of cancer. Spread primarily through sexual contact, most cases of HPV clear on their own within two years, but when the infection does not go away, health problems like cancer may occur – which is why preventing these infections with vaccination has been key.”
  • The National Cancer Institute announced,
    • “Researchers have discovered what appears to be a critical biological driver of the most common form of ovarian cancer. The discovery, they believe, could spearhead the development of approaches for finding ovarian cancer at its earliest stages or preventing the disease from taking hold in the first place.
    • “Multiple studies have shown that high-grade serous ovarian cancer arises from precancerous growths called serous tubal intraepithelial carcinoma (STIC) lesions in the fallopian tubes. These lesions can eventually travel into the ovaries and transform into full-blown tumors.
    • “In this new study, Lan Coffman, M.D., Ph.D., of the University of Pittsburgh School of Medicine, and her colleagues showed that STIC lesions appear to arise and turn into tumors in the ovaries with the assistance of a type of stem cell that they called high-risk mesenchymal stem cells (MSCs).
    • “These high-risk MSCs—which have specific characteristics that appear to help their cancer-fueling capabilities—were abundant in the tissue, or stroma, immediately underneath STIC lesionsExit Disclaimer in fallopian tube tissue samples from women without cancer. They were also sometimes present in normal tissue. 
    • “When the researchers implanted high-risk MSCs along with healthy fallopian tube cells into mice, some developed ovarian cancer, including, in some cases, metastatic cancer, the researchers reported March 14 in Cancer Discovery.
    • “It’s not yet clear if high-risk MSCs are the primary instigator that causes healthy fallopian cells to transform into high-grade serous ovarian cancer, Dr. Coffman said, but the group’s findings support the idea that these cells are intimately involved. 
    • “What we believe we’re seeing is that [high-risk MSCs] are a supportive ‘soil’ for cancer initiation,” she said.”
  • Beckers Hospital Review adds,
    • “Some early-onset colorectal cancers may be caused by exposure to a bacterial toxin within the first 10 years of life, according to a study published April 23 in Nature.
    • “An international research team, led by Ludmil Alexandrov, PhD, from the University of California San Diego, analyzed 981 colorectal cancer genomes from patients across 11 countries for the study.” 
  • STAT News points out “Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe. Cellular debris lingering in the liver and and a penicillin relative are identified.”
  • The AHA News tells us,
    • “A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of an accident by 25%. The study analyzed public health and transportation data from seven states from 2020-2023. The results showed a significant association between acute COVID-19 infections and an increase in vehicle crashes.”
  • The Wall Street Journal reports,
    • A new study by French researchers found that some combinations of food additives were associated with a higher risk of Type 2 diabetes.
    • Researchers found that combinations of emulsifiers, colors and sweeteners increased the diabetes risk beyond what could be explained by individual substances alone.
    • Food-industry representatives defended combinations of what they said were safe ingredients, which they said are important for food safety and quality.
  • WTW notes, “Therapeutic alliance, the bond between client and therapist, is a game-changer in mental health programs. Employers must focus on measuring to predict better results and reduce dropout rates.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck’s first-quarter net income increased, driven by Keytruda sales, reaching $5.08 billion, or $2.01 a share, up from $4.76 billion year-over-year.
    • Despite sales of Keytruda rising 4% to $7.2 billion, Merck cut its 2025 adjusted earnings projection, citing tariffs and a license agreement.
    • Sales of HPV vaccine Gardasil fell 41% due to lower Chinese demand, while animal-health product sales rose 5% to $1.6 billion.
  • and
    • “Roche’s Q1 sales beat estimates due to demand for drugs like Ocrevus and Hemlibra.
    • “Roche is boosting its U.S. manufacturing to avoid potential tariffs, investing $50 billion over five years.
    • “Roche maintains its full-year guidance, anticipating mid-single-digit sales growth.”
  • Healthcare Dive adds,
    • “Molina beat analyst expectations for earnings and revenue in the first quarter, with a topline of $11.1 billion, up 12% year over year, and net income of $298 million, down 1% year over year, according to results released Wednesday.
    • “The California-based insurer said its medical costs increased moderately in the quarter, mostly due to utilization of long-term supports and services, expensive drugs and behavioral health, along with more spending on seasonal illnesses like the flu. However, costs were generally in line with what Molina had predicted, a bright spot after UnitedHealth, the largest private insurer in the U.S., reported an unexpected spike in spending earlier this month.
    • “Molina’s results can be viewed as “good enough,” TD Cowen analyst Ryan Langston wrote in a note on the insurer’s first quarter performance.”
  • Per BioPharma Dive,
    • Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty.
    • Sales climbed 9.7% to 9.9 billion euros, or $11.3 billion, in the period, beating the consensus analyst estimate of 9.6 billion euros. Earnings for the core business rose almost 16% to 1.79 euros a share, topping the consensus expectation of 1.70 euros a share.
    • The French drugmaker benefited from the launch of new drugs and the continuing growth of Dupixent, a blockbuster medicine used to treat conditions including asthma, eczema and chronic obstructive pulmonary disease. The drug’s sales jumped 20% to 3.5 billion euros in the quarter, Sanofi said Thursday.
  • Per MedTech Dive,
    • Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott. 
    • Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
    • The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
  • and
    • Edwards Lifesciences maintained full-year financial forecasts on Wednesday, projecting sales of its heart valves would offset hits from tariff and acquisition costs.
    • First-quarter sales of transcatheter aortic valve replacements, Edwards’ largest business, were better than the company expected, executives said on an earnings call.
    • Edwards’ TAVR sales were stifled last year by capacity constraints as heart teams performed more mitral and tricuspid valve procedures with the company’s newest devices. Hospitals are now addressing capacity issues by expanding capabilities for handling increased volumes, said Larry Wood, group president of TAVR and surgical structural heart. 
  • Modern Healthcare reports,
    • “Health systems have been shouldering the cost of mobile integrated healthcare programs for at-risk patients, but some insurers may be ready to start picking up the tab as providers prove they can save money.
    • “UMass Memorial Health, Geisinger, Prisma Health and others that operate these at-home care programs say the service saves millions of dollars by preventing emergency room visits and rehospitalizations of chronically ill patients. Government and private insurers have been covering little to none of the cost, but that could be changing as systems get information to prove the programs are effective.”
  • Mobihealth News informs us,
    • San Francisco-based Hinge Health, a digital musculoskeletal care platform, announced it is partnering with Cigna Healthcare to offer the health insurance company’s self-insured clients access to Hinge’s digital musculoskeletal (MSK) care platform. 
    • Hinge offers individuals with MSK conditions access to a multidisciplinary care team, including health coaches, orthopedic surgeons and physical therapists, as well as to digital tools like surgery decision support.
    • The company also provides a pelvic health program tailored for women and Enso, its FDA-cleared wearable that delivers electrical pulses to help alleviate everyday pain.
    • Cigna’s members who choose to enroll will have access to Hinge Health through Cigna’s condition-specific care program Pathwell Bone & Joint Solution.
    • Hinge touts that it is now an MSK provider for the five largest national health plans in the U.S. by self-insured lives. 
  • Per Fierce Healthcare,
    • “Health insurers can’t lose sight of improvements to the consumer experience as they find ways to reduce and manage rising costs, according to a new report from Forrester.
    • “The analysts offered one broad takeaway for payers: “Cut costs, not corners.” They noted that the industry is at a key crossroads where it’s critical to improve consumer experience and boost trust and consider those challenges as they build strategies around cost.
    • “Health insurers must improve CX, build consumer trust, and find innovative ways to create more sustainable cost structures and better economics for customers,” they wrote. “But the thirst for cost efficiency can’t cloud insurers’ strategic visions to create better health outcomes.”
  • Per Fierce Pharma,
    • “With the threat of Trump administration’s tariffs swirling and biopharma companies bracing for impact, many are announcing their intention to strengthen their presence in the U.S.
    • “The latest to hop on the invest-in-USA bandwagon is Thermo Fisher Scientific. The Massachusetts-based producer of medical instruments, diagnostics and pharmaceuticals will spend an additional $2 billion in the U.S. over the next four years “strengthening American innovation, manufacturing and economic competitiveness,” the company said in a release.
    • “Three-quarters of the pledge will bolster Thermo Fisher’s manufacturing operations, while the remaining $500 million will expand its R&D efforts.”