Holiday Weekend Update

Congress

Holiday Weekend Update

David Ermer–Congress, Medical / Rx research, No Surprises Act, U.S. Healthcare–

“Simplicity is a virtue”

From Washington, DC,

  • Congress is taking a State / District work break this week following Memorial Day.
  • The Office of Management and Budget’s Office for Information and Regulatory Affairs has completed its review of the No Surprises Act Independent Dispute Resolution final rule, which indicates that this significant final rule will be published in the Federal Register this week.

From the judicial front,

  • USA Today, via Yahoo Finance, reports
    • “CVS sued Tennessee state officials on May 22 to block legislation the pharmacy giant said would force the closure of the chain’s 136 Tennessee pharmacy locations.
    • “CVS filed the U.S. District Court lawsuit in Nashville after Tennessee Gov. Bill Lee signed legislation to prohibit companies from owning both pharmacy benefit managers and retail pharmacies. The Tennessee legislation takes effect July 1, 2028.”

From the public health and medical /Rx research front,

  • STAT News reports,
    • “Eli Lilly said Monday that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol.
    • “Lilly acquired the therapy, VERVE-102, in its $1 billion buyout of Verve Therapeutics last year. Executives tout it as a potential treatment to broadly prevent heart disease, the world’s leading killer, as many patients struggle to stay on existing, more conventional medicines for reducing cholesterol levels.
    • “There were no treatment-related serious adverse events in the Phase 1 study — a notable finding, given that Verve had to shelve its first candidate due to safety concerns. 
    • “The data were simultaneously published in the New England Journal Medicine and presented at the European Atherosclerosis Society in Athens.
    • “Lilly now plans to begin a Phase 2 trial in an unspecified number of patients. It will likely need to then run Phase 3 trials in thousands of patients for the treatment to earn approval.” 
  • The Washington Post relates,
    • “Pancreatic cancer is an exquisitely cruel diagnosis, leaving only 13 percent of people alive after five years. But in the early 1980s, scientists discovered a weakness — a mutated protein called KRAS — that spurred the aggressive growth and spread an array of tumors. In pancreatic cancer, it would turn out to be a key driver of nearly every case. 
    • “There was just one problem. The KRAS protein they needed to block was flat and smooth, without the crevices and cracks, pockets and sockets that a drug needs to get a toehold.
    • “No longer.
    • “In the span of a few weeks, the conventional wisdom on pancreatic cancer and KRAS has been upended. In April, biotech company Revolution Medicines announced that its experimental pill, called daraxonrasib, had notched an unprecedented success — patients lived for 13 months, twice as long as those given regular chemotherapy. The full details will be presented next weekend at the American Society of Clinical Oncology meeting in Chicago, but federal regulators have already expanded access to the drug while it is being reviewed.
    • “It’s the start of a huge wave for this disease,” said Eileen O’Reilly, a gastrointestinal medical oncologist at Memorial Sloan Kettering Cancer Center. Following behind are other drugs that may work better and the potential to use the approach against lung and colorectal cancers.”
  • Medscape informs us,
    • “GLP-1 receptor agonists, like semaglutide, are gaining importance in liver disease treatment, notably for metabolic-associated steatohepatitis (MASH) and alcohol use disorder (AUD), offering benefits beyond weight loss, including potential hepatoprotection.
  • and
    • “CAR T-cell therapy, initially for cancer, shows promise in treating autoimmune diseases like multiple sclerosis. While offering hope, it poses risks and uncertainties, including potential long-term side effects and high costs, necessitating further research.”

From the U.S. healthcare business front.

  • Beckers Payer Issue points out,
    • ‘Point32Health reported an adjusted net income of $248 million in the first quarter, a sharp reversal from a $21 million adjusted net income a year prior.
    • “The insurer, parent company of Harvard Pilgrim Health Care and Tufts Health Plan, said the Q1 results included an operating income of $86 million, investment income of $6 million, and a gain from the sale of its Integra Partners subsidiary. Revenues were $2.4 billion and membership was nearly 2 million.
    • “In the first quarter of 2025, the company reported an operating loss of $39 million and investment income of $61 million, on revenues of $2.4 billion and membership of approximately 2 million.
    • “While we are optimistic for the remainder of the year, we recognize that medical and pharmaceutical cost trends remain volatile and will continue to present challenges,” CFO Michael Marrone said.’
  • Per a Health Care Cost Institute news release,
    • “Conventional wisdom and economic theory suggest that more competition means lower prices. In health care, there is longstanding evidence that geographic areas with less competition among hospitals are associated with higher negotiated commercial prices. Regulators and researchers use the Herfindahl-Hirschman Index (HHI) to measure market concentration at a geographic area. HHI can range from 0 (competitive market) to 10,000 (monopoly market). Hospital markets that are considered “highly concentrated,” (HHI greater than 2,500) generally means that there are a limited number of hospitals or health systems that dominate the market. There also is evidence in the economic literature that geographic areas that have a limited number of insurance companies are associated with lower negotiated commercial prices. These insurance markets are considered “highly concentrated.” 
    • “In this cross-sectional analysis of 2022 data, we examine the impact of competition on prices across the US.  Specifically, we compared a measure of hospital prices – the inpatient hospital price index from HCCI’s Health Cost Landscape – in areas with varying levels of hospital and insurance company concentration. We focused on inpatient hospital prices because they are most directly related to hospital and health insurance market dynamics.      
    • “We find that inpatient hospital prices are the highest in metro areas where hospital markets are very highly concentrated (least competitive) and insurance markets were moderately concentrated (the most competitive among the markets in the Landscape). Inpatient hospital prices in these metro areas were, on average, about 25% higher than the national median in 2022. Inpatient prices were lowest, in contrast, in metro areas where hospital markets were the least concentrated but the health insurer market was highly concentrated.  Among metro areas where health insurers are highly concentrated and hospitals are least concentrated, inpatient hospital prices were about 10% lower than the national median.”  
  • Kaufmann Hall lets us know,
    • “[H]ospitals across the country are facing difficulty placing patients into SNFs and other post-acute sites of care, delaying discharge of medically ready patients. Post-acute access constraints are structural and systemic and are reshaping hospital performance—including hospital margins, capacity, throughput, quality metrics, staff morale, and patient experience. Health systems that proactively redesign their post-acute strategy, particularly through aligned SNF and other post-acute partnerships, can materially improve performance across these dimensions and mitigate risk, while also equipping these facilities with the alignment and financial resources necessary to thrive.” * * *
    • “SNF bed supply fell 2.5% between 2019 and 2024, creating a sustained imbalance between supply and demand. As this imbalance persists, access challenges are likely to intensify rather than normalize. Hospitals in regions with SNF bed under capacity tend to experience greater mean length of stay, percentage of stays 28 days or more, and median distance traveled to admitting SNFs.” * * *
    • “Ultimately, improved SNF access is driven by alignment, incentives, and operating expertise—not [hospital] ownership alone. 
    • “Several health systems, such as Stanford Health Care, Scripps Health, and UC Davis Health, have also had success with the bed reservation / bed lease program as an aligned alternative for post-acute care access and patient throughput.”
  • Healthcare Dive tells us,
    • “Private equity-owned hospital operator Quorum Health plans to transition to nonprofit status this year through a deal with Healthside Partners.
    • “The definitive agreement announced Thursday is meant to help put Quorum, which has struggled to recover following its bankruptcy in 2020, on more stable financial footing through access to the tax and funding benefits nonprofit hospitals receive.
    • “The deal appears to be structured as straight asset transfer, wherein the nonprofit system Healthside will acquire Quorum’s assets without inheriting its liabilities and obligations. Quorum will remain a separate company that will then be dissolved, a spokesperson for the system said. The transition is expected to close this fall.”

Cybersecurity Saturday

David Ermer–Congress, Cybersecurity, Generative AI–

From the War with Iran front,

  • Cybersecurity Dive reports yesterday,
    • “Iranian government-backed hackers are using spear-phishing attacks and remote access Trojans (RATs) to spy on “high-value sectors” in the U.S. and the Middle East as part of Tehran’s response to the U.S.-Israeli war, according to Palo Alto Networks.
    • “The company’s Unit 42 researchers recently discovered six new RATs that an Iran-linked group the researchers call Screening Serpens has used for espionage purposes. The group “has increased its operations” since the war began, the researchers said, and malware metadata suggests that it has attacked “targets across the U.S., Israel and the [United Arab Emirates] as well as two additional Middle Eastern entities.”
    • “Screening Serpens — which other researchers call UNC1549, Smoke Sandstorm and Nimbus Manticore — has “consistently set its sights on high-value sectors,” Palo Alto Networks said, especially in the aerospace, defense and telecommunications industries.
    • “A defining characteristic of these recent campaigns is the deep personalization of the attackers’ lures,” researchers wrote. “By leveraging tailored social engineering tactics, including fake job requisitions and spoofed video conferencing meeting invitations, the attackers lure victims into initiating the infection chain, thereby exposing their organizations to further exploitation.”
  • Industrial Cyber adds,
    • “Ransomware groups are increasingly being used as proxy weapons in geopolitical cyber warfare, enabling nation-states to exert pressure on their adversaries while maintaining plausible deniability. What used to be financially motivated cybercrime and targeting can now influence operations and cause operational disruption. While the change has been incremental, it has been unmistakable. Criminal groups, ideological hacktivists, and state-aligned adversaries are converging and sharing environments, infrastructure, tactics, techniques, and procedures (TTPs), access brokers, and, at times, even strategic objectives.
    • “Operations linked to Iran demonstrate the sprawl between cybercrime, espionage and industrial sabotage as ever closer. A recent investigation exposed claims by pro-Iran hackers that they altered on-the-ground conditions to target critical wheat reserves, demonstrating how cyber activity can directly affect food security and industry. Once the contact is made, these adversaries can choose how and when to attack.”

From the Project Glasswing front,

  • Anthropic offers a look back at the project’s first month.
  • The Wall Street Journal adds,
    • “Anthropic is letting Mythos users [participating in Project Glasswing] share cybersecurity threats with others who may face similar vulnerabilities.
    • “Anthropic modified its previous stance amid concerns that limiting access to the information could hurt smaller companies.
    • “The new policy highlights challenges facing artificial-intelligence companies that are restricting access to their best models.’

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “Two cybersecurity-focused members of Congress agreed Thursday [May 21, 2026] that reductions to the Cybersecurity and Infrastructure Security Agency have done too much damage to an agency essential to defending civilian networks against foreign adversaries.
    • “Rep. Don Bacon, R-Neb., and Rep. James Walkinshaw, D-Va., spoke during a panel at the National Cyber Innovation Forum. Despite representing different parties, and serving on different congressional committees, the two lawmakers offered closely aligned assessments of CISA’s role and the consequences of recent cuts.” * * *
    • “In the model both lawmakers endorsed, they pushed for CISA to play more of a role after an intrusion, helping affected entities restore their networks while the FBI works to identify the source. Walkinshaw said advanced artificial intelligence expands the attack surface and makes that kind of centralized support more important.”
  • The Wall Street Journal relates,
    • “State cybersecurity officials urged the federal government on Thursday to roll back cuts to cybersecurity programs, arguing that deteriorating federal support weakens defenses just as artificial intelligence and nation-state belligerence are introducing significant new threats.
    • “Technology and cyber officials from New York, Florida and Tennessee told a House Homeland Security Committee hearing that states must now defend against advanced threats as federal backing diminishes.
    • “The witnesses cited the pending expiration of the State and Local Cybersecurity Grant Program, significant budget and workforce cuts to federal agencies and new limits on the information-sharing platforms that state governments rely on to track threats.”
  • Cyberscoop adds,
    • “Securing some of the open-source technology that serves as the backbone for all modern digital infrastructure is going to require some “hard decisions” amid a wave of malware attacks, the leader of the Cybersecurity and Infrastructure Security Agency said Thursday [May 21, 2026].
    • “The open-source community is one that I’m particularly worried about when we start to think about rapid escalation of vulnerability discovery,” acting director Nick Andersen said, referencing a cartoon about how key technologies that underpin the internet are often maintained by a single person.” * * *
    • “CISA has been working with industry and others “to modify our approach to vulnerability management, modify our approach to coordinated vulnerability disclosure, modify our approach to remediation, with the explicit understanding that we’re just not going to be able to keep up using traditional mechanisms,” Andersen said, speaking at the National Cyber Innovation Forum in Washington, D.C.
    • “The government and private sector can work together to identify the biggest threats and then give them the right level of attention, he said. On the federal government side, that means working to get a full picture of the extent of reliance on open-source technologies.” 
  • and
    • “President Donald Trump said he would postpone the release of an executive order that would set up a 90-day testing and vetting regime for frontier AI models, hours before the White House was set to publicly announce the signing. 
    • “Speaking to reporters in the Oval Office Thursday [May 21, 2026], Trump said he opted to delay the order “because I didn’t like certain aspects of it” and expressed concerns that it could harm U.S. AI industry competition with countries like China. 
  • Cyberscoop tells us,
    • “Authorities arrested and unsealed charges against a Canadian man accused of running Kimwolf, one of the most far-reaching DDoS botnets on record, the Justice Department said Thursday.
    • “Jacob Butler was arrested Wednesday [May 20, 2026] in Ottawa, Canada, and awaits extradition to the United States where he is charged with aiding and abetting computer intrusions and, if convicted, faces up to 10 years in prison.
    • “Investigators said the 23-year-old, also known as “Dort,” was a principal administrator of Kimwolf, a variant of the record-setting Aisuru DDoS botnet that spread like wildfire and eventually took over more than 2 million Android TV devices after its operators figured out how to abuse residential-proxy networks for local control.”
  • and
    • “European authorities took down a prominent virtual private network service and arrested the alleged administrator behind an operation that cybercriminals used to steal data, commit fraud and ransomware attacks, Europol said Thursday [May 21, 2026]. 
    • “First VPN, which was promoted on Russian-speaking cybercrime forums, gained popularity for providing services that allowed users to hide their infrastructure and identities. Officials said the service was entrenched in the cybercrime world and appeared in almost every major recent cybercrime investigation aided by Europol.
    • “For years, cybercriminals saw this VPN service as a gateway to anonymity,” Edvardas Šileris, head of Europol’s European Cybercrime Centre, said in a statement. 
    • “They believed it would keep them beyond the reach of law enforcement,” Šileris added. “This operation proves them wrong. Taking it offline removes a critical layer of protection that criminals depended on to operate, communicate and evade law enforcement.”
  • Security Week adds,
    • “Authorities in North America and Europe have participated in a law enforcement operation to disrupt First VPN, a popular cybercrime service used for ransomware and other attacks.
    • “According to the FBI, First VPN has been active since 2014, providing 32 exit nodes across 27 countries at the time of its disruption. The service, advertised on Russian-language dark web cybercrime forums, has been used by at least 25 ransomware groups for network reconnaissance and intrusions.”
    • “Bitdefender, which was involved in the takedown, pointed out that the 506 users are a subset of First VPN’s customer base, and investigators will determine which of them can be linked to criminal operations. 
    • “Some will be traced to known ransomware groups. Others will reveal fraud operations, data theft campaigns, or cybercrime-as-a-service infrastructure we didn’t know existed,” Bitdefender said.
    • “New anonymization services will appear. The economic demand hasn’t changed. But each takedown shortens the operational window of the next service and raises the barrier for actors who relied on turnkey solutions,” the cybersecurity firm added. “First VPN advertised itself as a service criminals could trust to keep them beyond law enforcement’s reach. The operation proved that claim wrong, and every actor evaluating the next anonymization service now knows the same risk exists.”

From the cybersecurity breaches and vulnerabilities front,

  • Health Exec reports,
    • “The largest public health system in the U.S. confirmed in a filing with the Department of Health and Human Services that a data breach on its network impacted 1.8 million patients, exposing their personal data to hackers.
    • “The data breach, which was said to have lasted for months, was revealed by NYC Health + Hospitals in March. At the time, the health system said it first discovered “suspicious activity” on its network in February, at which time it moved to “immediately” secure its systems from access by the unauthorized third-party.
    • “An investigation found cybercriminals had been inside its IT infrastructure since November 2025, stemming from a breach on an unnamed vendor the organization contracts with for services.”
  • Dark Reading relates,
    • “Defenders are dealing with an influx of vulnerabilities like never before, and patch prioritization has never been more critical, according to Verizon Business’s 2026 Data Breach Investigations Report (DBIR). This year’s report confirmed several ongoing trends on the vulnerability exploitation and around threat actors abusing AI, for example — but the 2026 DBIR more broadly promotes sticking to the cybersecurity fundamentals as the industry undergoes massive change.
    • “And indeed, defenders in the past year have been tasked with handling everything from self-replicating worms infesting software components to preparing for large language models (LLMs) that can supposedly discover critical zero-day vulnerabilities all on their own.
    • “Most striking in the DBIR might be the statistics that show vulnerability exploitation to be the most common initial access vector for breaches last year, up 31% from the previous year. Meanwhile, only 26% of critical vulnerabilities (defined as those in CISA’s Known Exploited Vulnerability catalog) were fully remediated by organizations in 2025, compared to 38% the previous year. Just over half (58%) were partially remediated last year, and 16% remained unaddressed.” * * *
    • “While organizations perhaps got worse at patching, Verizon also observed a dramatic increase in the number of vulnerability detections observed year over year, likely driven by AI-assisted bug hunting. “There were 68.7 million records in the 2022 dataset and 527.3 million in 2025 — almost eight times the volume,” the DBIR reads.”
  • The HIPAA Journal tells us,
    • “Verizon has published its 2026 Data Breach Investigations Report, which shows that the healthcare sector continues to be targeted by cybercriminal groups. The sector is having to contend with sustained multi-vector attacks, including ransomware, unpatched vulnerabilities, and human error. Regardless of the cause, the attacks are putting patient privacy, safety, and care at risk.
    • “Verizon tracked 1,492 healthcare incidents for its 2026 report, including 1,438 confirmed data disclosures, a majority of which were due to ransomware-driven system intrusions achieved through multiple attack vectors, including the exploitation of vulnerabilities (20%), phishing attacks (14%), stolen credentials (11%), and employee errors (11%). Threat actors are being given far too big a window of opportunity to exploit known vulnerabilities. Verizon found that in 2025, only 26% of critical vulnerabilities were fully remediated, with a median time for resolution stretching to 43 days. In healthcare, where complex legacy systems are the norm, the window of opportunity is greater, giving threat actors a wide attack window.
    • “While external actors accounted for the majority of incidents, insider breaches remain common in healthcare. Internal actors were behind 19% of breaches. As Verizon notes, human error continues to be a chronic source of breaches. The human element was involved in 54% of incidents, including misconfigurations, misdirected communications, the loss/theft of unencrypted devices, and poor cyber hygiene.
    • “The most common human-related cause of healthcare data incidents was misdelivery, which accounted for around 40% of incidents, followed by loss incidents at around 25%, and misconfigurations at around 20%. While greater investment in cybersecurity will help to address the 81% of breaches due to external actors, security awareness training plays an important part in preventing data breaches. Employees need to be made aware of security fundamentals and be taught the importance of practicing good cyber hygiene. Social engineering was the third main cause of healthcare breaches in 2025, the majority of which were due to phishing, followed by pretexting – these attack techniques need to be covered in depth in training courses.”
  • CISA added ten known exploited vulnerabilities (KVEs) to its catalog this week.
  • Cybersecurity Dive adds,
    • “The Cybersecurity and Infrastructure Security Agency is now letting security experts nominate vulnerabilities to the agency’s Known Exploited Vulnerabilities catalog.
    • “CISA on Thursday [May 21, 2026] published a form that technology vendors, independent researchers and anyone else can use to warn CISA that hackers are exploiting a vulnerability and it should be added to the KEV.
    • “This new reporting capability enhances CISA’s ability to identify, validate, and quickly share critical threat information,” Chris Butera, CISA’s acting executive assistant director for cybersecurity, said in a statement. “Early detection and coordinated vulnerability disclosure are among the most powerful tools we have to reduce risk at scale.”\
  • and
    • “Hackers stole data from thousands of GitHub repositories, the code-hosting giant said on Tuesday [May 19, 2026].
    • “While we currently have no evidence of impact to customer information stored outside of GitHub’s internal repositories (such as our customers’ enterprises, organizations, and repositories), we are closely monitoring our infrastructure for follow-on activity,” the company said in a post on X.
    • “On Wednesday [May 20, 2026], the company confirmed that attackers had compromised roughly 3,800 repositories after a GitHub employee used a malware-infected Visual Studio Code extension.
    • “We continue to analyze logs, validate secret rotation, and monitor for any follow-on activity,” GitHub said.”
  • Cyberscoop informs us,
    • “The FBI is warning organizations and defenders about Kali365, a growing phishing-as-a-service platform that retrieves Microsoft 365 access tokens, issuing a public service announcement Thursday [May 21, 2026]. 
    • “The toolkit bypasses multi-factor authentication and abuses OAuth device code authorizations via phishing lures impersonating common enterprise services. This technique grants cybercriminal-controlled applications access to Microsoft 365 accounts, opening victims up to a host of follow-on malicious activity, including data theft, fraud, extortion and ransomware attacks.
    • “Kali365 is one of many rapidly emerging device-code phishing tools, which are gaining popularity as a more effective means for cybercriminals to circumvent security controls while abusing legitimate Microsoft device authorization pages, according to researchers.
    • “Instead of gaining access to accounts via phishing kits that steal credentials and second-factor authentication codes, device-code phishing platforms connect a malicious app to a legitimate account with a single code. The process requires fewer steps and less interaction with the user, but victims do have to copy-and-paste a code generated by the Kali365 platform to grant access.”
  • Cyber Insider points out,
    • “Hidden audio commands can hijack AI voice assistants and transcription tools without users hearing anything unusual, according to new research set to be presented at the IEEE Symposium on Security and Privacy next week.
    • “The study shows that carefully crafted audio clips can elicit unauthorized actions from audio-language models (LALMs), including downloading files, sending emails, and performing web searches.
    • “The attack, dubbed “AudioHijack,” was developed by researchers from Zhejiang University, Nanyang Technological University, and the National University of Singapore. The team describes the attack as a form of “auditory prompt injection,” in which malicious instructions are embedded in ordinary audio using adversarial perturbations that remain nearly imperceptible to human listeners.
    • “Large audio-language models are increasingly powering voice assistants, meeting transcription services, customer support bots, and multimodal AI systems capable of both understanding and generating speech. Some platforms can also interact with external tools and services, allowing them to search the web, operate apps, or execute commands on behalf of users. According to the researchers, these capabilities significantly expand the attack surface.
    • “Attackers could potentially hide malicious prompts inside music, videos, voice notes, or even live conversations uploaded to AI services. The paper also describes scenarios in which hidden audio could be injected into Zoom meetings or multimedia content processed by AI assistants.”
  • The Hacker News notes,
    • “In February 2026, a phishing-as-a-service (PhaaS) platform called EvilTokens went live. Within five weeks, it had compromised more than 340 Microsoft 365 organizations across five countries. 
    • “The targets of the platform received a message asking them to enter a short code at microsoft.com/devicelogin and complete their normal MFA challenge, then walked away believing they had verified a routine sign-in. They had actually handed the operator a valid refresh token scoped to their mailbox, drive, calendar, and contacts, with the lifespan of a tenant policy rather than a session.
    • ‘The operator never needed a password, never tripped an MFA prompt, and never produced a sign-in event that looked like an intrusion. The attack succeeded because the OAuth consent screen has become an instinctive click, and the controls built to stop credential phishing do not look at the consent layer.
    • “Security researchers call the resulting condition consent phishing or OAuth grant abuse. The phishing click that mattered last decade handed over a password. The phishing click that matters now hands over a refresh token, and it sits structurally below the identity controls most organizations still treat as the perimeter.”

From the ransomware front,

  • Sophos reports,
    • “SophosLabs analysts investigated WantToCry ransomware attacks that involved the threat actors abusing the Server Message Block (SMB) service for initial access and then exfiltrating files to attacker-controlled infrastructure for remote encryption. The detection surface is significantly reduced because WantToCry operates without local malware execution, and there is no post-compromise activity beyond exfiltrating files and rewriting them to disk.
    • “The WantToCry name appears to be a reference to the notorious WannaCry (also known as WCry) ransomware worm, which propagated via a vulnerability in SMB at the start of 2017. While WantToCry is not self-propagating and there is no evidence to suggest that the two operations are connected, organizations with internet-exposed SMB services are similarly at risk.” * * *
    • “As with all ransomware activity, prevention remains key to mitigating the threat of remote ransomware operations like WantToCry. Preventive measures include disabling the SMBv1 protocol across the organization, removing “guest” or anonymous SMB access, and blocking inbound SMB traffic (ports TCP/139 and TCP/445) at all internet-facing firewalls. Additionally, it is important to ensure that backups cannot be accessed via SMB protocols.
    • “Organizations should also implement network-level controls and file content monitoring to address this attack methodology effectively. A tool like Sophos CryptoGuard can identify, block, and roll back encryption activity performed via SMB protocols.
    • “WantToCry relies on weak authentication and internet exposure rather than on software vulnerabilities or malware delivery mechanisms. Extended detection and response (XDR) solutions can identify reconnaissance and brute-force attempts against SMB services, providing early warnings of potential WantToCry operations.”
  • Bleeping Computer relates,
    • “Threat actors brute-forced VPN credentials and bypassed multi-factor authentication (MFA) on SonicWall Gen6 SSL-VPN appliances to deploy tools used in ransomware attacks.
    • “During the intrusions, the hacker took between 30 and 60 minutes to log in, do network reconnaissance, test credential reuse on internal systems, and log out.
    • “SonicWall warned in a security advisory for CVE-2024-12802 that installing the firmware update alone on Gen6 devices does not fully mitigate the vulnerability, and a manual reconfiguration of the LDAP server is required. Failing to do so leaves open the possibility of bypassing MFA protection.”
  • The American Hospital Association lets us know,
    • “Microsoft announced May 19 that it disrupted operations of Fox Tempest, a threat actor operating as a malware-signing-as-a-service used by cybercriminals to deploy malicious code, including ransomware. Microsoft said Fox Tempest has enabled attacks on a range of sectors in the U.S. and internationally, including health care, education, government and financial services. The actor has been linked to other ransomware groups, including INC, Qilin and Akira. 
    • “One component of modern security is that software packages need to be digitally signed to prove their authenticity,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “Normally, these signatures can only be provided by trusted, verified sources. Fox Tempest provided these signatures to malware so that it appeared to be legitimate to security systems. This service enabled a number of ransomware actors to attack health care and other sectors. Microsoft has revoked over 1,000 certificates issued by Fox Tempest. Hospitals and health systems should ensure that certificate verification is enabled on their cybersecurity toolsets.” 
  • and
    • “Cyberattacks against hospitals, health systems and mission-critical health care third-party providers have surged in recent years. While these attacks often involve theft of patient data and medical research, the most concerning are high-impact ransomware attacks that continue to shut down critical medical systems, resulting in disruption and delays to health care delivery. There is no doubt that these types of disruptive attacks create a direct risk to patient and community safety. To be clear, these are not data-theft crimes, they are in fact “threat to life” crimes.
    • “The perpetrators of these foreign-based ransomware attacks are primarily, but not exclusively, Russian-speaking or based in Russia. Other adversarial nations that provide shelter for dangerous international criminals to launch cyberattacks against the U.S. are the usual suspects — Iran, China and North Korea.
    • “There have been thousands of ransomware and data theft attacks targeting U.S. health care over the last several years. In fact, the FBI reported that in 2025 alone, the health care sector suffered 460 ransomware attacks, far more than any other critical infrastructure sector. Since 2020, over 3,200 hacking incidents have been reported to the Department of Health and Human Services Office for Civil Rights, impacting 574 million individuals. Many incidents were actually encryption ransomware attacks accompanied by data theft — “the double extortion,” in which the perpetrators demand an additional ransom for both a decryption key to unlock systems and in exchange for not publishing stolen patient health records.
    • “The silver lining? We have a great deal of “battle experience” and tough lessons learned, which has helped us collaborate to harden systems and prepare for impact and recovery. We at the AHA, working with victims, the field and the federal government, have also been able to reliably identify strategic cyber risk related to third parties, patient safety and supply chain.
    • The top three risks are
      • Geopolitical tensions
      • Cyberattacks agains third parties, and
      • Autonomous Artificial Intelligence-generated and -facilitated Cyberattacks.

From the cybersecurity defenses front,

  • Cyberscooop reports,
    • “On Wednesday [May 20], Microsoft released two new red teaming tools — Rampartand Clarity — meant to help developers design more secure agentic software and assist incident responders in the face of ongoing breaches.
    • “Rampart is built on top of PyRIT, an existing open automation framework Microsoft developed for red teaming generative AI systems. But while PyRIT scans already-built systems for security flaws, Rampart is made to continuously test code for vulnerabilities during the development process, encoding both adversarial and benign testing scenarios into the software development pipeline to flag exploitable bugs and dependencies.
    • “Microsoft said Rampart was built to focus on cross-prompt injection attacks, where “an agent retrieves or processes potentially poisoned content from documents, emails, tickets, and other data sources that manipulate behavior indirectly.” It also confirms fixes or exploits work as intended through multiple rounds of testing, as opposed to tools that perform “single shot validation.”
    • “The second tool, Clarity, can be run as a desktop app, a web interface or directly embedded into a coding agent to provide real time security engineering guidance to developers at the outset of a project. It can categorize and track different business objectives related to the code and highlight downstream security implications along with more secure by design alternatives.”
  • Per Dark Reading,
    • “AI Agents Are Shifting Identity Security Budget Dynamics.”
    • “AI agent projects are proliferating throughout the enterprise, and those AI agent identities require management, security, and governance. New Omdia research shows the AI agent identity budget dynamics are very different than traditional IAM projects.”
  • Per Cyberscoop commentaries,
    • “The Canvas breach proved that prevention is no longer enough.
    • “Cybercriminals brought down the most widely used learning platform in North America. The Canvas breach is a blueprint for how SaaS attacks now work — and a warning about how unprepared most organizations still are.”
  • and
    • “The readiness paradox: Why a false sense of cyber confidence is becoming a liability
    • “As AI expands the attack surface and alert fatigue grows, cyber exposure management offers a clearer path to understanding where risk truly concentrates and how to reduce it before a crisis hits.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Patient safety, U.S. Healthcare, Uncategorized–

Simplificity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The House Appropriations Committee advanced a draft fiscal 2027 Legislative Branch spending bill on Wednesday that would slash the budget for the Government Accountability Office by nearly one-quarter and give a boost to Capitol Police.
    • “The party-line vote of 34-28 came after a contentious markup stretching late into the evening, as Democrats argued the GAO cut would undermine its mission.”
  • The Hill informs us,
    • “Federal Reserve Chair Kevin Warsh was sworn in Friday beside President Trump, kicking off his term as the new head of the central bank at a critical time for the U.S. economy.” * * *
    • “Warsh, 56, returns to the Fed board after serving as a member from 2006 to 2011. He was nominated to the Fed by former President George W. Bush, whom he served as a White House economic adviser before becoming the youngest Fed board member in history.
    • A graduate of Stanford University and Harvard Law School, Warsh also worked at Morgan Stanley and served in various academic and advisory roles outside of his government service. 
    • Warsh was most recently a fellow at Stanford’s Hoover Institution, an influential conservative think tank known for its close ties to prominent Republican policymakers.
  • Healthcare Dive relates,
    • “The HHS is continuing its crackdown on healthcare fraud, launching a program that will use artificial intelligence to examine audits from states and other federal grant recipients — and potentially affect Medicaid funds.
    • “The Office of the Assistant Secretary for Financial Resources will look across all states to analyze at least five years of audits that grantees file annually with the federal government, the department said Thursday. 
    • “The agency says past audits include internal control issues and “chronic” noncompliance. If recipients aren’t able to fix those problems, the HHS could temporarily withhold payments, hold back future funds, or suspend or terminate awards.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions. The FDA said that Abiomed identified an issue where if a patient is treated with a left ventricular Impella device and experiences an extended period longer than 80 minutes with no residual pulsatility, the Abiomed Automated Impella Controller may be forced to restart due to an internal software error.” 
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis (scarring), liver cancer, liver failure, and even death.
    • “Today’s approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” said Wendy Carter, D.O., Acting Director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.”

From the judicial front,

  • Bloomberg Law reports,
    • “The importance of the $885 million antitrust verdict this week against Takeda Pharmaceuticals Co. Ltd. had less to do with the nine-figure damages than ending private plaintiffs’ losing streak challenging deals delaying cheaper generics.
    • “The Boston federal jury’s finding that Takeda improperly paid a competitor to delay it from bringing a generic version of its Amitiza constipation medication to market marked the first time a private plaintiff won at trial in a reverse-payment case.
    • “Most challenges to deals between branded drug companies and generic makers either settle or are dismissed before reaching trial, with the more nuanced agreements sometimes making it to a jury. Three have been tried before a jury since the US Supreme Court put drugmakers on notice that the dealings could run afoul of antitrust laws. Until Monday, juries had rejected plaintiffs’ claims each time. 
    • “I expect the case to send ripples through legal departments — if not boardrooms — across the country,” said Robin Feldman, a law professor at the University of California in San Francisco who studies pharmaceutical regulation and intellectual property. She called the verdict a “groundbreaking decision.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country. Because of the later start, some areas of the country may continue to see higher levels of RSV through May. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is low in most areas of the country. Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “As the nation moves closer to topping last year’s measles total in just the first half of 2026, the Centers for Disease Control and Prevention (CDC) today confirmed 59 new cases in a nationwide outbreak that has now reached 1,952 infections. 
    • “All but nine cases are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.”
  • and
    • “Although an Ebola outbreak is growing rapidly in central Africa, experts say it doesn’t pose a public health threat to the United States.
    • “The outbreak, centered in the Democratic Republic of the Congo (DRC), has grown to nearly 750 suspected cases and more than 170 deaths, the World Health Organization (WHO) announced today. Although the risk from Ebola in the DRC is high, the risk of global spread is low, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said. 
    • “Many US infectious diseases experts agree.
    • “This is a horrible situation in affected areas of Africa,” said Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, which publishes CIDRAP News. “But for the world, it is not.”
    • “That’s because Ebola, which spreads through contact with bodily fluids, is far more difficult to spread than the airborne respiratory viruses that Americans have confronted in recent years, such as influenza, COVID-19, measles, and even the Andes strain of the hantavirus, which recently caused an outbreak on a cruise ship.”
  • BioPharma Dive points out,
    • “ASCO26: 5 data snapshots ahead of the year’s biggest cancer drug meeting.
    • “Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting gave a peek at anticipated datasets from Merck, BioNTech, Eli Lilly and Moderna.”
  • Per a National Institutes of Health news release,
    • “A team of researchers at the National Institutes of Health (NIH) have unveiled new details about the events GLP-1 receptor agonists trigger within neurons, which have been largely unexplored until now. A study in mice identified key intracellular signaling processes that are tied to the weight-loss effects of the GLP-1 drug semaglutide. The findings improve our understanding of how increasingly prevalent GLP-1s may influence human behavior and identify new opportunities to potentially enhance treatment.
    • “The weight-loss benefits of GLP-1s are well documented and scientists generally know the brain regions associated with these effects. However, several questions remain, such as why responses to medication differ between patients and why the effects for most eventually plateau.
    • “We know much less about the nuts and bolts of what goes on within the neurons that these medications target. By digging into these mechanisms, we’re beginning to answer some of these questions,” said co-corresponding author Andrew Lutas, Ph.D., an investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).”
  • CNN reports,
    • “Pregnant women are routinely advised to take prenatal vitamins for their health and their baby’s development. Now, a new study published Monday in JAMA Network Open concluded that children whose mothers received higher-dose vitamin D supplements during pregnancy performed better on certain memory tests at age 10.”
  • MedPage Today relates,
    • “Preserved global brain structure appeared to buffer cognitive decline in people with Alzheimer’s pathology.
    • “Younger-appearing brains had weaker links between pathology and poorer outcomes in multiple cognitive domains.
    • “Other measures of brain reserve or cognitive reserve showed no clear protective cognitive effect.”
  • Health Day tells us,
    • “Middle-aged people who have migraine with an aura could be more at risk for stroke.
    • “Those who had migraine with aura had a 73% increased risk of stroke
    • “Middle-aged men who suffered any kind of migraine had a more than 3.5-fold increased risk of stroke.”
  • and
    • “Use of calcium, vitamin D, or combined supplementation has little to no effect on the prevention of fractures and falls in adults, according to a review published online May 20 in The BMJ.
    • “Olivier Massé, Pharm.D., from CIUSSS du Nord-de-l’Île-de Montréal, and colleagues conducted a systematic review and meta-analysis to examine the effect of calcium, vitamin D, or combined supplementation on fractures and falls in adults. A total of 69 trials, with 153,902 participants, were included in the review.
    • “Most trial participants were community dwelling (87 percent) and not at high fracture or fall risk (73 percent). The researchers found that little to no effect was found from use of calcium supplements (risk ratio, 0.91), vitamin D supplements (risk ratio, 1.00), or combined supplementation (risk ratio, 0.91) for the primary outcome of any fracture. There was little to no effect on other fracture and fall outcomes seen for calcium, vitamin D, or combined supplementation, based mainly on moderate-to-high certainty of evidence. After extensive exploration of heterogeneity across multiple subgroup analyses, the findings remained robust.”
  • BioPharma Dive informs us,
    • “The outlook for an experimental Parkinson’s disease drug dimmed on Thursday with the announcement that it had failed a key clinical trial.
    • “Developed through a partnership Denali Therapeutics and Biogen, the drug is designed to inhibit an enzyme tied to one of the most common genetic drivers of Parkinson’s: a gene called LRRK2. When this gene mutates, it causes the waste disposal systems in cells to malfunction, leading to the buildup of toxic proteins that damage and destroy neurons.
    • “In 2022, Biogen and Denali kicked off what would ultimately become a nearly 650-person trial that pitted their drug against a placebo. The companies are now saying this mid-stage study showed the drug — codenamed BIIB122 — was not significantly better at slowing the disease progression, as measured by a well-known scale clinicians use to assess how Parkinson’s is affecting a patient’s movement and daily life.”

From the U.S. healthcare business and artificial intelligence front,

  • Per an EBRI news release,
    • “The Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey found that the majority of insured individuals still receive health insurance through their employer.
    • “Employment-based health coverage remained the dominant source of health insurance for privately insured adults, with six in 10 receiving coverage through their own job.” * * *
    • “Coverage patterns have been largely stable, with about one-third enrolled in individual-only coverage and most others covering a spouse or partner.”
  • Fierce Pharma relates,
    • “With both Novo Nordisk’s and Eli Lilly’s oral GLP-1s establishing their footing in the U.S. obesity market, the companies’ respective Wegovy pill and orforglipron tablet Foundayo are making their mark on prescription trends for a class previously confined primarily to injectables.
    • “Looking at the past four weeks, total U.S. GLP-1 prescriptions were up 3.6%, compared to 1.8% at the same time last year, analysts at Citi wrote in a Friday note to clients, citing script tracking data from IQVIA. The Citi team attributed that momentum to the ability of Novo’s and Lilly’s new oral launches to “broaden and reshape the market” for obesity incretin drugs.”
  • MedCity News considers whether “Mark Cuban’s Cost Plus Wellness Appeal to Employers?”
    • Employer advocates said Cost Plus Wellness could help spur more direct contracting and transparency in healthcare, though they questioned whether the model can scale and adequately measure provider quality and outcomes.
  • Beckers Hospital Review reports,
    • “Philadelphia-based Penn Medicine reported an operating income of $238.5 million (2.4% margin) for the nine months ended March 31, up 46.3% from $163 million (1.9% margin) in the same period last year, according to financial documents filed May 20.
    • “The results follow the April 1, 2025, acquisition of Doylestown (Pa.) Health. Doylestown Hospital, a 245-bed teaching hospital, became Penn Medicine’s seventh hospital and is now known as Penn Medicine Doylestown Health.”
  • STAT News tells us,
    • “Retro Biosciences, the longevity startup backed by OpenAI CEO Sam Altman, has raised more money at a $1.8 billion valuation, it announced Friday. 
    • “Retro has a big mission: Add 10 healthy years to the human lifespan. It is seeking to do that by using a variety of technologies, including in vivo gene therapies, cell replacement therapies, and other approaches to spur younger, healthier cells into aging tissues.
    • “The company is currently running its first clinical trial — testing a pill designed to enhance the body’s ability to better clear out protein aggregates in patients with Alzheimer’s disease. Retro CEO Joe Betts-LaCroix told the audience at STAT’s Breakthrough Summit West on Tuesday that the trial is going “super good” and that researchers haven’t seen any dose-limiting toxicities. He said he anticipates releasing some data from the trial around August.”  
  • Fierce Healthcare informs us,
    • “Innovaccer acquired CaduceusHealth to combine its AI platform with the company’s revenue cycle management services and staff to serve ambulatory care providers.
    • ‘Innovaccer, founded in 2014, built software solutions to unify enterprise data and applies AI to automate manual tasks and streamline workflows for payers and providers. Last year, it rolled out Flow Auth, an AI-powered prior authorization solution that is part of Flow by Innovaccer, an AI-powered revenue cycle suite designed to modernize financial operations for health systems. Other capabilities include Flow Capture, an autonomous medical coding solution and Flow Collect, an AI-powered denial management and revenue recovery tool.
    • “Innovaccer claims that it now serves over 200 health systems and payers, 95% of community pharmacies and 80 million patient lives across the United States. Flow is built on Gravity, Innovaccer’s healthcare AI infrastructure platform.”
  • and
    • “Eugene, Ore.-based Ksana Health is undertaking a multi-institutional research effort aimed at creating a new class of artificial intelligence to advance mental health and substance use disorder treatment and prevention.
    • “The software company was awarded a $17.9 million contract by the U.S. Department of Health and Human Services (HHS) to create a Large Health Behavior Model (LHBM). Its goal is to train AI models on smartphones and other wearables data, including sleep, mobility and language use linked to large scale electronic health records (EHRs).
    • “This initiative augments Ksana’s current efforts to shift behavioral healthcare from episodic, subjective assessment toward continuous, data-driven health promotion, reducing healthcare spending, improving quality of life, and reaching populations that currently lack access to effective behavioral health support,” said Tony Scripa, Ksana Health COO and project co-investigator, in a statement.”
  • and
    • “More than seven in 10 Medicare members report feeling confusion or uncertainty when navigating online health information, a new whitepaper from CVS Health found. 
    • “The research (PDF) drew insights from Medicare-eligible consumers through surveys, interviews and ethnographic studies. 
    • “Seventy-one percent of respondents report an eagerness to use more digital health care tools and 86% report an eagerness to use them. However, 58% of respondents report that low digital health literacy is negatively impacting their ability to manage their health. 
    • “We’re caring for the fastest-growing and most clinically complex population in the country, and what we found in the research challenges a common assumption—older adults actually are more open to engaging with technology than many think,” said Dr. Benjamin Kornitzer, M.D., Aetna senior vice president and CMO, in a statement. “It creates a real opportunity to meet them where they are and provide day-to-day support, whether it’s managing medications, following up after a visit, or staying on track with chronic conditions. Technology and engagement can help them live healthier, more independent lives.”
    • “As a result, CVS said it is applying insights from the research across its digital offerings, including clearer navigation, stronger accessibility features and added privacy and security transparency.” 

Thursday report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

A commenter, Patrick Morselli, accurately observed in response to the OPM Director’s blog post that “Simplicity has a high cost in most organizations. Feels like the hardest work is undoing complexity other smart people left behind.”

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Republicans broke with President Trump over his administration’s plan to create a $1.8 billion settlement fund to pay people who claim political persecution, with widespread opposition forcing party leaders Thursday to abandon votes on immigration-enforcement funding and send lawmakers home early for their Memorial Day break.
    • “The “anti-weaponization” fund is a Trump priority, after he alleged for years that his supporters, including those prosecuted over the Jan. 6, 2021, attack at the Capitol, had been targeted unfairly by the Biden administration. But its creation has run into blowback in the Senate, and the immigration-enforcement bill gave senators leverage to dig in their heels.
    • “I don’t like the fund at all,” said Sen. John Curtis (R., Utah), who added he didn’t think any guardrails could fix it. Sen. Thom Tillis (R., N.C.), a frequent target of Trump criticism who is retiring, called it a “payout pot for punks.”
    • “With no resolution in sight, Senate Majority Leader John Thune (R., S.D.) sent senators home for their weeklong Memorial Day recess, putting the Republican-led Congress on course to miss Trump’s deadline to have the Immigration and Customs Enforcement and Border Patrol measure on his desk by June 1.”
  • Healthcare Dive relates,
    • “Lawmakers are mulling reform of how Medicare pays physicians, concerned that insufficient reimbursement in the federal insurance program is incentivizing consolidation and increasing healthcare costs.
    • “Physician pay has declined over the past two decades when accounting for inflation, spurring independent providers to be acquired by hospital systems rather than go it alone, provider witnesses told representatives during a House Energy and Commerce subcommittee hearing Wednesday. And representatives agreed that’s a concern.
    • “Making sure that independent physician practices stay open […] is one of the most critical ways we can ensure competition and drive down costs,” said Rep. Kim Schrier, D-Wash.”
  • The American Hospital Association adds,
    • “Rep. Randy Feenstra, R-Iowa, introduced the Rural Maternity Options for Medical Support Act on May 19. The bill would guarantee that beds used solely for labor and delivery are not counted toward the 25-bed limit for critical access hospitals. The bill is co-sponsored by Reps. Darin LaHood, R-Ill., Jill Tokuda, D-Hawaii, and Kim Schrier, D-Wash. 
    • “New and expecting moms deserve access to high-quality labor and delivery services,” said Lisa Kidder Hrobsky, AHA senior vice president for advocacy and political affairs. “The Rural Maternity Options for Medical Support Act of 2026 strengthens access to maternal health services for mothers in rural areas by ensuring that higher volume critical access hospitals have labor and delivery beds available, even if their other patient beds are full. The AHA appreciates Rep. Feenstra’s leadership to support critical access hospitals and families across the nation.” 
  • and
    • “The House Education and Workforce Committee May 21 unanimously passed the Transparency in Billing Act (H.R. 8684). The bill would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and it would impose civil monetary penalties on hospitals that violate the requirement. 
    • The AHA has previously opposed this policy, saying that hospitals are already transparent about the location of care delivery on their bills and that it would create a significant administrative burden to providers and the health care industry at large.” 
  • Fierce Healthcare tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. removed two key leaders of the U.S. Preventive Services Task Force (USPSTF), a key advisory panel that offers guidance on preventive services, according to media reports.
    • ‘Vice chairs John Wong, M.D. and Esa Davis, M.D. were dismissed from the task force in letters sent to them by Kennedy on May 11, The New York Times reported on Wednesday, citing copies of the letters obtained by reporters. STAT, CNN, Politico and The Hill also reported the terminations, citing the letters.” * * *
    • “The terminations leave the panel with just eight sitting members. Five other members saw their terms expire at the start of this year, and Kennedy did not replace them, and the previous chair, Michael Silverstein, departed on his own, STAT reported.”
  • Federal Network News informs us,
    • “Shane Stevens, the top official for the Office of Personnel Management’s healthcare and insurance arm, is stepping down from his role, Federal News Network has learned.
    • “Stevens, a political appointee, has been serving as associate director of healthcare and insurance at OPM since last summer. He announced in an email Thursday afternoon that he is voluntarily resigning, effective immediately.”
  • Best wishes, Mr. Stevens. Thanks for your service.
  • Tammy Flanagan, writing in Govexec, lets us know “what federal employees get wrong about divorce and retirement.”
    • “Errors involving survivor benefits, health coverage and court orders can create financial problems years after a marriage ends.”
  • FedWeek explains “Insuring Children at College and Federal Benefits Considerations (with a Checklist).”

From the Food and Drug Administration front,

  • Radiology Business reports,
    • “Medtronic is recalling more than 18,000 surgical devices due to a risk of contamination. The recall includes certain lots of the company’s Gundry and DLP retrograde cannulae, which are cardiopulmonary bypass vascular catheters used to perform open heart surgeries.
    • “This recall was put in place due to the potential of a sterile barrier breach. Only certain lots of these devices are included in the recall.
    • ‘The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall. This means the agency believes these devices could cause “temporary or medically reversible adverse health consequences.”
  • STAT News relates,
    • “Wearable maker Whoop has not resolved a dispute with the Food and Drug Administration over a blood pressure feature the company launched last year, according to a top health executive at the company. 
    • “FDA warned Whoop last July over the feature that gives users a daily estimate of their systolic and diastolic blood pressure, saying that it’s a medical device that requires agency review. Whoop argues that the feature is exempt from FDA review because it is intended for wellness purposes.” * * *
    • “The dispute between FDA and Whoop turned up the heat in a simmering debate about how the agency ought to oversee low-risk products. Proponents of deregulation argue that the time and expense required for FDA authorization impede innovation and that FDA review is unnecessary to ensure the safety of many products that potentially benefit consumers.”

From the judicial front,

  • Federal News Network reports,
    • “Some federal employees may now have an easier time qualifying for disability retirement benefits, following a recent precedential decision from the U.S. Court of Appeals for the Federal Circuit.”
    • “In April, the court ruled that federal employees’ disability retirement applications cannot be denied solely based on a lack of “objective” medical evidence. The ruling applies in cases where federal employees have already been removed from their jobs due to a “medical inability to perform.”
    • “Objective documentation, like lab tests or prescription lists, can support an argument but cannot be the sole basis for denying claims, the court said. “Subjective” medical evidence, like a diagnosis based on self-described symptoms, must also be considered. If employees’ disability retirement claims rely on subjective evidence, they won’t automatically be denied benefits.
    • “The decision last month overturned a 2024 ruling from the Merit Systems Protection Board, which had upheld the Office of Personnel Management’s denial of a disability retirement application from a former OPM employee in 2016.”
  • The New York Times relates,
    • “The Justice Department announced charges on Thursday against 15 people for attempting to defraud Minnesota Medicaid and other social service programs in the state of more than $90 million. 
    • “Top officials, including Robert F. Kennedy Jr., the health and human services secretary, and Mehmet Oz, head of the Centers for Medicare and Medicaid Services, appeared in Minneapolis to announce the charges. “The fraud here in Minnesota is shocking,” said Colin McDonald, an assistant attorney general overseeing the administration’s crackdown on fraud.
    • “Among the defendants are an owner and an employee of autism clinics, who are charged with submitting $46.6 million in fraudulent claims to Medicaid, the public health plan that covers low-income people. Additional defendants were charged with filing bogus claims to Medicaid for other services, including those that assist disabled people with obtaining housing and living independently.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The world’s most popular weight-loss and diabetes drugs are linked to a powerful new possible benefit: better outcomes for cancer patients. 
    • “A suite of four new studies suggest that people taking so-called GLP-1 drugs like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro saw reductions in tumor progression, lower overall chance of death and less risk of developing breast cancer.
    • “It’s really provocative that they showed, in several cancers, that people who took these drugs seem to have a lower risk of their cancer returning,” said Dr. Jennifer Ligibel, a breast oncologist at the Dana-Farber Cancer Institute who wasn’t involved in any of the studies.
    • “One study from researchers at the Cleveland Clinic Cancer Institute tracked more than 10,000 patients with early-stage cancers who started GLP-1 drugs after diagnosis and compared their disease progression to those on a different diabetes medication. Those on GLP-1s were less likely to see their cancer spread.
    • “In lung cancer patients, the rate of progression to advanced disease was cut roughly in half—10% in GLP-1 users versus 22% in the comparison group. Breast cancer patients showed a similar pattern, with progression rates of 10% versus 20%. Colorectal and liver cancers also showed statistically significant reductions.”
  • and
    • “An investigational drug developed by Eli Lilly LLY  delivered clinically meaningful weight loss in a trial, the company said as it looks to expand its obesity treatment portfolio amid soaring demand.
    • “Lilly said Thursday that retatrutide, designed to be taken once a week, met the primary endpoint in a phase 3 clinical trial, as well as key secondary endpoints.
    • “According to Ania Jastreboff, a Yale School of Medicine professor and lead investigator for the trial, every dose of retatrutide assessed resulted in clinically meaningful weight reduction for nearly all participants. On average, those with severe obesity on the highest dose lost 30% of their body weight over two years, Jastreboff added.
    • “The trial evaluated the therapy’s efficacy and safety on adults who are overweight and had other medical conditions such as type 2 diabetes, chronic pain and cardiovascular issues.
    • “More results will be shared later this year, Lilly added.”
  • Healio adds,
    • “Studies show that GLP-1 receptor agonists have significant potential for treating glaucoma, diabetic retinopathy and other eye diseases, but important nuances remain to be investigated, according to a review published in BMC Ophthalmology.
    • “Although GLP-1 RAs have revolutionized metabolic disease management, their potential therapeutic role in ocular diseases — particularly those driven by shared metabolic and inflammatory pathways — remains underexplored,” Yu Luo, of Beijing University of Chinese Medicine, and colleagues wrote. “Their multifaceted neuroprotective properties and anti-inflammatory mechanisms present a distinctive therapeutic opportunity for ophthalmic pathologies, potentially offering direct ocular benefits beyond systemic metabolic control.”
  • and
    • “Adults with obesity achieved greater long-term weight loss if they partook in a nutrition plan designed for rapid weight loss compared with one designed for gradual weight loss, according to trial data.
    • “Line Kristin Johnson, RD, PhD, senior researcher at Vestfold Hospital Trust in Norway, said there has been debate among researchers regarding whether rapid weight loss leads to worse long-term outcomes for people with obesity. In findings from a randomized pragmatic trial presented at the European Congress on Obesity, Johnson and colleagues found implementing a calorie-restricted eating pattern for rapid weight loss can induce a larger decrease in body weight at 1 year than a gradual weight-loss eating pattern.”
  • Endocrinology Advisor points out,
    • “Life-course body size progression, particularly transitioning from a thinner childhood body size to adult obesity, significantly increases risks for stroke, coronary artery disease, and heart failure.”
  • Healio also notes,
    • “Only a third of cancer survivors receive advice on weight control and improving their diet from health care professionals, and less than half are informed about the benefits of physical activity.
    • “Individuals who do receive advice on losing weight, salt and fat intake, and exercise are three to eight times more likely to engage in healthy behaviors than those who did not.
    • “We need more effort to deliver lifestyle behaviors to patients,” Chao Cao, PhD, MPH, instructor in the department of medical oncology at Dana-Farber Cancer Institute, told Healio.”
  • Fierce Pharma tells us,
    • “Phase 3 data for Merck & Co. and Kelun-Biotech’s antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) suggest the race is heating up to establish a new standard of care in first-line non-small cell lung cancer.
    • “According to an abstract released ahead of the ASCO 2026 annual meeting, combining the TROP2-directed ADC with Keytruda slashed the risk of disease progression or death by a major 65% compared with Keytruda alone in treatment-naïve, PD-L1-positive NSCLC. The p-value is below 0.0001, suggesting high statistical significance.
    • “Key overall survival results, which will underpin regulatory considerations in first-line NSCLC, were not mature at the Sept. 29, 2025, data cutoff, but a strong trend with a preliminary 45% improvement in favor of the combo arm was observed.” 
  • Per MedPage Today,
    • “Undetected attention deficit-hyperactivity disorder (ADHD) was not uncommon among adults hospitalized after traffic accidents, according to a cross-sectional study from the Dominican Republic.
    • ‘Among 95 adults admitted for traffic-related injuries without a prior diagnosis, more than a third (34.7%) screened positive on the Adult ADHD Self-Report Scale, reported Amanda Abreu, MD, of the Universidad Iberoamericana in Santo Domingo, Dominican Republic.
    • “High-risk driving behaviors — including violations, mistakes, and slips — were more common among adults who screened positive (66.6% vs 30.6%, P=0.0016), she reported at the American Psychiatric Association annual meeting.
    • “We’re not saying that ADHD alone caused the accidents, nor are they unsafe drivers, but these findings suggest that this is a really vulnerable population we should look into, and we should help protect,” Abreu said.”
  • and
    • “Low-risk pancreatic cystic lesions were found to be associated with a long-term risk of pancreatic cancer in a retrospective cohort study.
    • “The incidence rate of pancreatic cancer among patients with pancreatic cystic lesions was higher than that of the general population (1.89 vs 0.14 per 1,000 person-years).
    • ‘Over a quarter of patients were diagnosed with pancreatic cancer more than 5 years after detection of lesions, suggesting longer-term follow-up is needed to avoid missed diagnoses.”
  • Per the Wall Street Journal,
    • “New French research links natural food color additives to increased risks of Type 2 diabetes and cancer, similar to synthetic dyes.
    • “Beta-carotene, curcumin and anthocyanins used as color additives were linked to a higher risk of Type 2 diabetes. Beta-carotene used as a food coloring was also linked to breast cancer.
    • “The findings challenge the Trump administration’s push for natural dyes and food companies’ shift away from artificial colors.”
  • Per BioPharma Dive,
    • “BioMarin is looking to expand the use of its top-selling medicine, Voxzogo, with positive study results released Wednesday.
    • I’n 2021, Voxzogo became the first drug approved to improve growth in children with achondroplasia, the most common form of dwarfism. The new results pertain to a related condition called hypochondroplasia that generally presents in less severe ways and might not be noticed until later in a child’s life.
    • ‘In the Phase 3 trial, researchers found participants given Voxzogo were growing faster than those who received a placebo. After a year, the Voxzogo patients also had significant increases in standing height and arm span, a key finding that could help children function better in daily tasks and retain more independence.”

From the U.S. healthcare business and artificial intelligence front,

  • Managed Healthcare Executive reports,
    • ‘For the average person, healthcare costs rose 7.9% in 2026 to $8,460, which is the highest annual increase in more than a decade, according to the 2026 Milliman Medical Index
      (MMI). For a hypothetical family of four, healthcare costs reached $37,824, Milliman found. The Milliman Medical Index measures healthcare costs covered by a typical employer-sponsored health insurance plan.”
    • “The increase reflects structural forces that are not going away, Milliman Principal and Consulting Actuary Deana Bell said in a news release. “Outpatient costs have quadrupled for the MMI’s family of four since the MMI was first published in 2005, with much of the trend exacerbated by delivery system consolidation, specialty drug growth, and site-of-care shifts.”
  • Beckers Hospital Review relates,
    • “The National Council of State Boards of Nursing found the District of Columbia has the most licensed nurses per capita, while Utah is the state with the fewest for the second year in a row.
    • “The organization created a course of nursing licensure statistics in the U.S. and its territories. The data was compiled using the NCSBN’s database and Nursys, an electronic information system where regulatory bodies enter licensure data. All of the council’s 58 members shared licensure data, which amounted to 6,903,665 registered and practical nurses — up from 6,870,362 last year.
    • ‘According to the data, Wyoming and Vermont had the fewest licensed nurses in their states overall, at 9,620 and 13,528, respectively. Meanwhile, California and New York had the most licensed nurses at 708,141 and 610,207, respectively.” 
  • Healthcare Dive tells us,
    • “Nonprofit health system Providence is throwing in the towel on the majority of its health insurance businesses, citing the difficulty of running a regional health plan amid regulatory pressures and rising costs.
    • “Starting next year, Providence, which covers about 440,000 people in a handful of western states, will no longer offer Medicaid, Affordable Care Act or employer-sponsored plans, the Renton, Washington-based system announced on Wednesday.
    • ‘The decision comes as Providence attempts to shore up its financial footing and refocus on delivering care. Still, the company plans to maintain its Medicare Advantage operations through a partnership with a national carrier, according to the release.”
  • Modern Healthcare tells us,
    • “Sutter Health and Allina Health have moved a step closer to joining forces.
    • “Sacramento, California-based Sutter and Minneapolis-based Allina said Thursday they signed a definitive agreement to form a $26 billion combined system with 39 hospitals. The agreement follows a letter of intent announced in March. The proposal is on track to close by the end of the year pending customary regulatory approval, the organizations said in a news release.” 
  • BioPharma Dive informs us,
    • “Eli Lilly has snagged Engage Biologics, a biotechnology company that aims to deliver genetic medicines without viral payloads, in a deal worth up to $202 million.
    • “Lilly said Wednesday it has acquired the preclinical biotech in an all-cash deal, including an undisclosed upfront payment, with the possibility of future payouts based on research, development and commercialization milestones. The acquisition gives Lilly non-viral DNA delivery technology, dubbed the “Tethosome” platform.
    • “We believe that the combination of Engage’s platform with Lilly’s significant capabilities will meaningfully accelerate development of new genetic therapies,” Will Olsen, co-founder and CEO of Engage, said in a statement.”
  • Fierce Healthcare lets us know,
    • “Electronic medical record (EMR) company Canvas Medical launched Canvas Studio Thursday, a no-code interface that allows clinicians and other healthcare professionals to build custom EMR workflows.
    • “Canvas Medical CEO Adam Farren told Fierce Healthcare the company was “serving a market” for software developers to customize workflows for end users within its ONC-certified EHR platform. 
    • “What Studio does is replace the developer with an AI agent, so that the end user, the clinician or administrative staff user, can directly customize and extend Canvas themselves using the agent,” Farren said.”
  • and
    • “Employers are set to significantly increase their use of AI in health benefits, a new survey shows, even as they continue to face barriers to rolling out the tech.
    • “WTW polled 312 employers with about 4.6 million workers for the 2026 AI Use in Health and Benefits Survey, and found that 72% of those surveyed plan to embed AI into their benefits programs in the next two years. By comparison, only 20% said they are currently doing so.
    • “The employers cited several key areas where they see AI likely supporting benefits at work, such as improved communication, cited by 68%, and data insights and analytics, noted by 59%. In addition, 57% of those surveyed said AI would likely support greater personalization.
    • “Jeff Chandler, North America commercialization leader for Health & Benefits at WTW, said in a press release that these top priorities are all “areas where AI can materially improve how benefits teams make decisions and support employees.”

Midweek update

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

Simplicity is a virtue.

Medium adds, “Simplicity, though not traditionally viewed as a virtue, is the greatest virtue of all because it makes practicing every other virtue that much easier.”

From Washington, DC,

  • Healthcare Dive reports,
    • “Senate Democrats are trying to roll back a pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare. 
    • “Sens. Ron Wyden, D-Ore., Maria Cantwell, D-Wash., Richard Blumenthal, D-Conn., and Kirsten Gillibrand, D-N.Y., introduced a resolution Wednesday that would invoke the Congressional Review Act — a legislative tool lawmakers can use to overturn agency actions — to end the WISeR model, which went into effect in six states this year. 
    • “Democrats have railed against the pilot for months, arguing the model delays or denies Medicare beneficiaries’ care. “Americans are sick and tired of abusive prior authorization tactics putting needed health care out of reach,” Wyden said in a statement. “The last thing seniors need is even more AI denying the care they need.”
  • The American Hospital Association relates,
    • “The AHA May 20 provided comments to the House Energy and Commerce Subcommittee on Health for a hearing on the physician fee schedule, the Medicare Access and CHIP Reauthorization Act and potential payment reform. The AHA highlighted responses to previous congressional requests for information on reform to MACRA and physician payments. They include asking Congress to provide conversion factor updates for the physician fee schedule that reflect changes in input costs and inflation, and to improve cost measures used in the Merit-based Incentive Payment System. The AHA also outlined policy considerations for alternative payment model design, advanced APM participation incentives and accountable care organizations.” 
  • STAT News tells us,
    • “Health secretary Robert F. Kennedy Jr. has elevated a senior health official to serve as an interim surgeon general until that position is filled by a Senate-confirmed nominee. 
    • “Stephanie Haridopolos, a family medicine physician who is currently a senior adviser and chief of staff for the Office of the U.S. Surgeon General, is now the office’s director of health communications, Kennedy told staff in an email sent late Tuesday. According to that email, Assistant Secretary for Health Brian Christine used his “delegation of authority powers” to allow Haridopolos to carry out the duties of surgeon general. 
    • “She will “promote [U.S. Surgeon General] public health actions, advisories, and guidance until our next Surgeon General is sworn into office,” Kennedy said.”
  • An HHS news release adds,
    • “The U.S. Department of Health and Human Services (HHS) Office of the Surgeon General today released the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents, which raises national awareness about the growing risks associated with excessive and harmful screen use among young people.
    • “Children and adolescents now spend as much or more time on screens as they do sleeping or in school. National estimates show that adolescents average seven to nine hours a day on entertainment screens, and most report using their devices right before bed. What they encounter online and the excessive, and sometimes compulsive, use of screens is increasingly linked to real-world harm.” * * *
    • The Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents is available at https://www.surgeongeneral.gov. Additional resources for families, schools, and communities are available here.
  • Govexec informs us,
    • “Federal employee morale dropped last year, as President Donald Trump downsized and otherwise overhauled the civil service, according to a new data analysis from Gallup. 
    • “[A]fter the reforms took effect, federal workers experienced declines in employee engagement and job satisfaction, alongside increases in burnout and job-search activity,” the researchers wrote. “These shifts were larger than those observed among comparable state and local government workers — and private sector counterparts — during the same period.”
    • “The analytics firm noted, however, that the data shows there was a “rebound” in some areas by the end of 2025.” 
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) proposed today a sweeping crackdown on state Medicaid payment practices that have driven payment rates well above Medicare levels, leading to excessive federal costs. The Medicaid Managed Care State Directed Payments (SDP) and Medicaid Fee-for-Service (FFS) Targeted Practitioner Payments Proposed Rule would set clear caps and better align Medicaid payments with Medicare standards. If finalized, the proposed rule would generate an estimated $775 billion in total savings over 10 years, including $510 billion in federal savings. Our goal: to refocus Medicaid dollars on individuals and families instead of inefficient payment schemes.
    • “The proposed rule would:
      • “Cap SDP provider payment rates at 100% of Medicare payment rates for expansion states and 110% of Medicare payment rates for non-expansion states (or 100% of the Medicaid state plan rate if a comparable Medicare rate is not available), consistent with section 71116 of the WFTC legislation and historical Medicaid FFS payment levels,
      • “Apply similar limits to certain targeted Medicaid fee-for-service payments, and
      • ‘Establish consistent national standards to improve transparency and accountability.
    • “CMS is seeking public comment on the proposed rule, including feedback on implementation. “To view the proposed rule on the Federal Register, visit: https://www.federalregister.gov/d/2026-10292. 
    • “To view the fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/medicaid-managed-care-state-directed-payments-medicaid-fee-service-targeted-medicaid-practitioner“

From the Food and Drug Administration front,

  • BioSpace reports,
    • “No child deaths were directly linked to COVID-19 vaccines, according to the FDA’s long-awaited analysis of adverse events.
    • “Late last year, former CBER director Vinay Prasad claimed in a leaked internal memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The FDA, after much blowback from the industry and independent experts, promised to disclose its analysis by the end of 2025, but the agency largely kept its specific findings under wraps.
    • “Those findings were made publicly available last week as part of a letter from Sen. Ron Johnson (R-WI) to health secretary Robert F. Kennedy, Jr., seeking for greater transparency around the safety of COVID-19 vaccines.”
  • Fierce Pharma relates,
    • “Patrick Soon-Shiong’s ImmunityBio has convinced the FDA to weigh its case for a potential expansion of its bladder cancer med Anktiva, citing “overlapping features” in the indication it’s targeting with the interleukin-15 agonist’s existing approval. 
    • “The FDA has now accepted ImmunityBio’s application for Anktiva plus the Bacillus Calmette-Guérin (BCG) vaccine in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA has set a target decision date of Jan. 6, 2027, ImmunityBio said in a May 19 release.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention yesterday issued an advisory on the Ebola disease outbreak in the Democratic Republic of the Congo and Uganda. The agency said the risk of spread to the U.S. is currently considered low. The notice includes recommendations for clinicians and guidance for U.S. travelers visiting DRC or Uganda. The World Health Organization declared a public health emergency of international concern May 17 due to the outbreak.” 
  • The Washington Post relates,
    • “Teens averaged over 50 minutes of smartphone use between the hours of 10 p.m. and 6 a.m. on school nights, researchers found, and nearly half of the teens used their phones between midnight and 4 a.m. The majority of that phone use was spent on social media apps like YouTube, Instagram or TikTok, the study found. Others were looking at streaming apps or playing games like Roblox or Clash Royale.
    • “The study, published Monday in the journal JAMA Pediatrics, followed the screen use of 657 adolescents, a cohort with an average age of 15. All are participants in the national Adolescent Brain Cognitive Development Study, which includes a racially and economically diverse sample of children and is the largest long-term study of brain development and child health in the United States. 
    • “Researchers drew data from an app installed on the teens’ phones that passively tracked their screen use patterns, said Jason Nagata, the lead author and an associate professor of pediatrics at the University of California at San Francisco. This is significant because “a lot of prior studies have relied on self-reporting of screen use,” he said, which isn’t as thorough or accurate.” * * *
    • “And the full impact on sleep likely goes beyond the minutes spent staring at a glowing screen, Nagata adds. Social media use in particular “is very emotionally activating,” he says. “There’s a lot of stimulation, and that can make it harder for teens in particular to wind down, even after you’ve turned the phone off.”
  • Genetic Engineering and BioTechnology News tells us,
    • “Researchers headed by a team at Icahn School of Medicine at Mount Sinai have discovered that many gut bacteria use a flexible survival strategy—known as epigenetic “bet-hedging”—to withstand disruptions such as antibiotics and diet changes.
    • “Studying infant and gut microbiomes, the investigators showed that microbes can switch between functional states, rather than relying solely on genetic mutations, to try to survive shifting conditions. While bet-hedging has been observed in disease-causing bacteria, this is the first study to show that it is widespread among the beneficial microbes that make up the healthy human gut.
    • “The findings shed light on a previously hidden layer of microbiome biology and may help explain why probiotics and fecal microbiota transplantation (FMT) produce inconsistent benefits across individuals.
    • “Gang Fang, PhD, professor of genetics and genomic sciences and director of the Center for Genomic AI and Microbiome Medicine at the Icahn School of Medicine at Mount Sinai, is senior and corresponding author of the team’s published paper in Cell Host & Microbe, titled “Epigenetic phase variation in the gut microbiome enhances bacterial adaptation
  • STAT News adds,
    • “While Tippi MacKenzie was a postdoctoral fellow in the early 2000s, she and her lab mates experimented with using the then-new technology of gene replacement therapy to try to treat inherited disorders in mice before they were born. Over and over it worked. They cured mice with hemophilia and mice with tyrosinemia. And the whole time, people kept telling her that gene therapy in human fetuses was just around the corner, just five years away. 
    • “It’s now been 25 years, and such a reality has yet to materialize. But after promising discussions with the Food and Drug Administration, MacKenzie is now closer than anyone’s ever been.
    • “Her team has submitted an investigational new drug (IND) application to the agency seeking approval for a small trial that aims to treat five fetal patients with a rare lysosomal storage disorder. The agency told them they could bypass animal testing, because the safety profile of the vector they plan to use already has been so well characterized by other academics and companies developing gene therapies for kids and adults.
    • “Thinking back on it, of course, you can’t really do in utero gene therapy until the field of adult and pediatric gene therapy has been well established,” MacKenzie said Tuesday at STAT’s Breakthrough Summit West. “So we basically had to wait for everything to catch up.”
  • Per a National Institute of Standards and Technology news release,
    • “My Research Is Working Toward a Pain-Free Mammogram Alternative.”\
      • “A woman in the U.S. has a one in eight chance of developing breast cancer. That’s a scary number, but the good news is that more women are being diagnosed early and surviving than ever before. 
      • “We have a long way to go before low-field MRI becomes a common alternative to mammograms. But my fellow researchers and I will continue to work to make this happen, because all patients deserve a highly accurate and pain-free approach to screening for breast cancer.” 
  • Medscape informs us,
    • “Digital tools can enhance GLP-1 therapy for obesity and diabetes by bridging gaps in patient education and follow-up. However, clinicians must focus on meaningful outcomes and personalized guidance to ensure effective use and adherence.”
  • MedPage Today points out,
    • “Antibiotics are sometimes prescribed for lower back pain when more conventional therapies don’t work, based on some studies showing bacteria in affected spinal discs.
    • “In this randomized trial, no benefit from amoxicillin-clavulanate could be discerned for patients with refractory low back pain and herniated discs at 1 year.
    • “The authors recommended that antibiotics no longer be prescribed for this indication.”
  • Per Healio,
    • “Data collected from a number of clinical trials found that despite recent “buzz,” there is no significant link between GLP-1 receptor agonists and the progression of diabetic retinopathy, according to a speaker.
    • “These medications have been labeled not to be good for patients who have preexisting diabetic retinopathy, but I don’t think that is fair,” Majda Hadziahmetovic, MD, associate professor of ophthalmology at Duke University, said during a virtual presentation at Real World Ophthalmology.“Those conclusions actually came from two main clinical trials, and both of those clinical trials were cardiovascular outcome trials. Diabetic retinopathy and retinal health were just the side effects that they were not looking at very carefully.”
  • and
    • “Self-collection may be as effective as clinician-collected HPV tests and improve screening rates.
    • “But its implementation requires OB/GYNs to first transition [from pap smears] to primary high-risk HPV screening.”
  • Infectious Disease Advisor adds,
    • “Screening recommendations for HCV [hepatitis C] have expanded in recent years to include universal screening among adults, with an emphasis on reflexive testing strategies in which a positive HCV antibody (Ab) result automatically triggers confirmatory RNA testing. This approach is intended to reduce delays in diagnosis and improve identification of patients eligible for treatment. To evaluate how these recommendations have influenced testing practices, researchers conducted a retrospective analysis of HCV testing patterns from 2018 to 2024 within a large US commercial laboratory network.” * * *
    • “Increased adoption of reflexive HCV testing, alongside laboratory stewardship initiatives and updated screening recommendations, has contributed to more complete and timely diagnostic evaluation of HCV infection.”
  • Per MedTech Dive,
    • “Medtronic on Wednesday said two analyses of its Symplicity Spyral renal denervation system, presented as abstracts at the EuroPCR meeting in Paris, showed the procedure significantly reduced blood pressure in patients over three years.
    • “Outcomes after renal denervation for 787 patients who had prior cardiovascular events were evaluated in one study, while the second followed 903 people with severe hypertension.
    • “The analyses, from the global SYMPLICITY registry, add to a growing body of evidence supporting renal denervation, Medtronic said.”

From the U.S. healthcare business and artificial intelligence front,

  • 401k Specialist reports,
    • “While some workers believe they’ll be employed past retirement age, the truth is that some may be forced into an early retirement.  
    • “Findings from the 2026 Annual Retirement Study from the Allianz Center for the Future of Retirement show that over half of Americans (53%) currently have a target age they plan to retire at.
    • “However, the reality is that many depart the workforce earlier than initially expected. While the findings report that 53% of Americans retired on their own schedule, 42% had to retire earlier than planned. In fact, only 5% of retirees surveyed reported leaving their role later than anticipated.
    • “The findings emulate recent research from the Society of Actuaries, which showed that 59% of its respondents retired earlier, and only 6% left the workforce later than planned.
    • “When asked why they exited the workforce earlier, Allianz found that most reasons were beyond the retiree’s control. Common causes included health issues that prevented job performance (30%) and unexpected job loss (21%), while others realized they were financially ready earlier than expected (21%).
    • “Finances, as expected, play a major role when deciding when to retire. Retirees must consider day-to-day costs and inflation numbers, along with necessary expenses like medical expenditures as they age.
  • Fierce Healthcare relates,
    • “Patient collections are playing a bigger and bigger role in health systems’ total revenues, bringing a new focus on the difficulties organizations face in securing timely, or any, payments for their services, a new survey report warns. 
    • ‘The poll of 205 healthcare revenue heads, conducted by healthcare fintech vendor PayZen and the Healthcare Financial Management Association, found that 22% of respondents named patient balances as their top priority, roughly double the 11% rate reported a year prior. Patient balances were a “nearly universal” presence among the respondents’ concerns, also up from the 73% rate of a year prior. 
    • “Commercial revenue remained the respondents’ overall top priority, though the portion who indicated so dipped from last year’s 75% to 62%. Government program revenue also inched upward from 13% to 16%, naming it their top revenue concern.” 
  • and
    • “Maven, a virtual provider for women’s and family health, has launched its direct-to-consumer products featuring a virtual care clinic, a GLP-1 offering and a hormone therapy offering.
    • “They are available through cash-pay for now. The goal is to close gaps between prescriptions and follow-ups that GLP-1s and hormone therapies require. 
    • “In terms of pricing, the GLP-1s start at $150 a month. For the hormone product, there is a $150 1-time fee, which includes two virtual visits, in addition to medication costs. Specialty care visits in the virtual clinic are currently pay-per-visit, though insurance coverage for those is the eventual goal.”
  • BioPharma Dive tells us,
    • “Privately held Mentari Therapeutics plans to hit the public markets through a reverse merger with InMed Pharmaceuticals, creating a combined company focused on antibody drugs that can prevent migraines.
    • “The deal, announced Tuesday, has already received approval from the boards of both parties and is expected to close in the back half of this year. Terms hold that InMed shareholders would own roughly 1.5% of the combined company, which is slated to have a pro forma equity value of about $421 million. Baked into that value is a concurrent private placement that will result in gross proceeds of approximately $290 million.”
  • MedTech Dive informs us,
    • “Medtronic said Wednesday it has agreed to buy SPR Therapeutics, a company making a device that uses peripheral nerve stimulation to treat chronic pain.
    • “Under the terms of the deal, Medtronic would pay $650 million in cash to buy all outstanding equity in SPR Therapeutics. The purchase would add to Medtronic’s neuromodulation business, allowing the company to provide more pain relief options earlier in people’s care.
    • “The deal is Medtronic’s third major acquisition announced so far this year. In March, Medtronic agreed to buy neurovascular technology company Scientia Vascular for $550 million, and in February, the company announced plans to buy CathWorks, which makes tools to help detect coronary artery disease, for up to $585 million. Medtronic closed the CathWorks acquisition in April.”
  • Per Healthcare Dive,
    • Aetna’s chief digital and technology officer on how the insurer is using AI for patient engagement
    • Nathan Frank discusses how the insurer is using AI to engage members, how the company thinks about risks, and the importance of monitoring the tools and soliciting feedback.
  • Per Fierce BioTech,
    • “The big new thing in medtech for 2026 is AI-powered apps and chatbots designed to help patients navigate their laboratory test results. Now, testing giant Labcorp is getting in on the act. 
    • “The company is launching “MyLabcorp,” a mobile app that brings together lab results with AI-enabled features and clinical guideline-based content.
    • “The idea is that this can be viewed on a user’s phone via the app, giving users “additional context about their health and support more informed conversations with healthcare providers,” according to a May 20 statement.” 
  • Per Fierce Healthcare,
    • “Doximity plans to accelerate its spending on artificial intelligence this year as it aims to become a leading AI platform for doctors.
    • “The health tech company plans to up its R&D and compute spend along with more investments in brand marketing and its AI-enabled peer review capabilities, executives said during the company’s recent earnings call for its fiscal 2026 fourth quarter and full year results. The company’s 2027 fiscal year began April 1.
    • “The company plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask (formerly DoxGPT).” 

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–

A few years ago, the FEHBlog stopped including pictures because they disrupted the blog’s flow. It occurred to the FEHBlog that it could not hurt the flow to add a slogan which the FEHBlog appropriately am borrowing from the OPM Director Scott Kupor:

“Simplicity is a virtue.”

The FEHBlog chose this slogan to remind us that we should aim to simplify the healthcare system in our country, including the beloved FEHB and PSHB programs.

From Washington, DC,

  • Roll Call reports,
    • “The Homeland Security Department would get a new influx of funding to investigate child exploitation cases, including to identify victims of sexual abuse material online, under the GOP budget reconciliation bill. 
    • “The $108.5 million added in a substitute amendment Tuesday would support hiring additional investigators and forensic analysts within the department. The roughly $72 billion immigration enforcement package advanced out of the Senate Homeland Security and Governmental Affairs Committee on an 8-5 vote.
    • “Sen. Josh Hawley, R-Mo., pushed to include the funds in reconciliation, which he said would allow DHS to add 200 new positions to “rescue children who have been captured by sex trafficking, including a new program for local, state and federal law enforcement to coordinate their efforts.”
  • The Hill relates,
    • “The Department of Health and Human Services (HHS) on Monday withdrew its amended charter for a highly influential vaccine advisory committee that would have loosened eligibility requirements, citing administrative errors.
    • “In a notice set to be officially published in the Federal Register, HHS formally withdrew its proposed amendment to the charter for the Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention.”
  • Here’s a link to the White House’s fact sheet on yesterday’s expansion of TrumpRx to include 600 generic drugs.
  • Fierce Healthcare tells us,
    • “A new analysis from the Office of Inspector General found a similar net cost for drugs through vertically-integrated Part D plans compared to other plans.
    • “Vertically-integrated firms accounted for 35% of contracts Part D in 2023, according to OIG’s report. Eleven of the 300 organizations offering Part D coverage that year were considered vertically integrated, meaning they also owned a pharmacy benefit manager.
    • “While net drug costs were on par between the two types of organizations, the study found that vertically integrated firms came to those prices through different means than other organizations. In most cases, vertically integrated Part D plans paid pharmacies more initially but then clawed back more through fees and rebates to reach a net price.
    • “Other Part D plans, meanwhile, generally paid less upfront but also got less back from pharmacies later on.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a $7.5 million investment to expand Americans’ access to high-quality protein, strengthen nutrition security, and reduce food waste nationwide. Through a new agreement with HATCH for Hunger, HHS will support a national initiative to redirect surplus protein to families in need, improve health outcomes, and help reduce the burden of chronic disease. This effort aligns with the Dietary Guidelines for Americans (DGAs), which emphasize the importance of protein-rich foods like meats, eggs, and dairy as part of a healthy diet.
    • “The U.S. Department of Agriculture (USDA) also announced its intent to fund a competitive grant program to strengthen cold chain infrastructure for emergency food assistance operations, including faith-based partners who serve communities in need. USDA will provide up to $7.5 million to help eligible nonprofit organizations safely distribute nutrient-dense proteins such as meat, eggs, seafood, and dairy to Americans in need. Additional information will be forthcoming from the Department.”
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services has released its fiscal year 2025 Program for Evaluating Payment Patterns Electronic Reports, or PEPPERs, for critical access hospitals. The reports help hospitals review their billing data to ensure accurate claims. They can be used to identify billing patterns that may need improvement, locate areas that may need audits or additional monitoring, find diagnosis-related groups that may be under- or over-coded, and track areas where patient stays are becoming longer. The reports can be accessed by authorized officials, access managers and users with the staff end user business function through CMS’ PEPPER Portal. CMS also has a guide and FAQ available for users on accessing the PEPPER. Additionally, CMS said it will host a webinar this summer for CAHs and short-term acute care hospitals.”
  • Modern Healthcare adds,
    • “The Health and Human Services Department Office of Inspector General is auditing every Medicaid Fraud Control Unit as it questions their efficacy.
    • “Medicaid fraud units recovered about $2 billion in fiscal 2025, but data show state to state variation in the level of convictions and recoupments.
    • “Providers should watch for tougher state enforcement as HHS scrutinizes state Medicaid fraud units.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has granted Coya 302 a fast-track designation for ALS, according to a press release from Coya Therapeutics.” * * *
    • “Coya 302 combines a low dose of IL-2 with CTLA-4 immunoglobulin in a subcutaneous form.
    • “The therapy enhances regulatory T-cell function while suppressing pro-inflammatory monocytes and macrophages.”
  • and
    • “The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.
    • “Golimumab-sldi (Immgolis, Accord BioPharma) has been approved as a biosimilar to golimumab (Simponi, Johnson & Johnson) for adults with moderately to severely active ulcerative colitis. It is administered via subcutaneous injection in a single-dose prefilled syringe.”
  • and
    • “The FDA has proposed to withdraw its approval of avacopan for ANCA-associated vasculitis, alleging that employees of the original manufacturer, ChemoCentryx, manipulated data in the sole trial used to assess the drug’s efficacy. 
    • “In a letter to Amgen, which acquired avacopan (Tavneos) in its 2022 purchase of ChemoCentryx, Tracy Beth Høeg, MD, PhD, acting director of the FDA Center for Drug Evaluation and Research (CDER), also asserted that the original new drug application filed by ChemoCentryx contained false statements regarding the trial, known as the ADVOCATE study. The allegations follow post-marketing data released by the FDA in March identifying 76 cases of drug-induced liver injury with possible or probable causal links to avacopan, including seven cases of vanishing bile duct syndrome (VBDS). Of the 76 cases, eight were fatal.”

From the judicial front,

  • Bloomberg Law reports,
    • “At least two lawsuits alleging doctors are abusing arbitration for surprise medical bills are headed to the appeals circuit, escalating yet another issue under the No Surprises Act and creating more pressure on Congress and the Trump administration to revisit the system.” * * *
    • “Last month, Anthem Blue Cross Life and Health Insurance Co. appealed a US District Court’s ruling in California that rejected its ability to sue billing vendor HaloMD and doctor group Sound Physicians over ineligible claims, even though Anthem alerted the arbitrator to the issue. A federal court in Florida in April also ruledagainst Aetna because it didn’t alert the arbitrator that claims submitted by Radiology Partners were ineligible.
    • “The cases are now at the US Court of Appeals for the Ninth and Eleventh circuits, respectively.”
  • STAT News adds,
    • “A new dashboard produced by Turquoise Health, a company that specializes in price transparency data, illustrates just how lucrative the process has become for clinicians. The tool, which is free to use, compares the median in-network rates that health insurers and providers negotiate to the amounts out-of-network providers are being awarded for the same services under federal arbitration. The former comes from federal Transparency in Coverage files, and the latter from the Centers for Medicare and Medicaid Services. 
    • “It also shows the qualifying payment amounts (QPAs) for those services, which is calculated by the insurers and is supposed to represent the median in-network amount for the same service in that area. 
    • “The numbers are striking. Providers took home $9.8 billion in total awards across 5.3 million independent dispute resolution (IDR) decisions between 2023 and the first half of 2025. About 12% of that amount, or $1.2 billion, was fees paid to the arbiters. IDR awards were about nine times the QPA for the same service in the same area, although, as with the lumbar laminectomy, some ran much, much higher. 
    • “This just seems like an area where the costs are rampant and way over where they should be — certainly higher than CMS intended when they set all this stuff up,” said Leland Robbins, Turquoise Health’s senior director of data products.”
  • Per a Justice Department news release,
    • “A jury in the Central District of California convicted a California doctor yesterday in a $45 million scheme to defraud Medicare by submitting claims for Botox injections that were never provided and medically unnecessary, and for obstructing the investigation by manipulating and altering medical records in an attempt to mislead criminal investigators. The investigation was initiated as a result of a referral from the Health Care Fraud Section’s Data Analytics Team, after its analysis showed that the defendant was paid more by Medicare for Botox injections than any other doctor in the United States.
    • “Violetta Mailyan falsely diagnosed patients, fraudulently billed for Botox injections while she was actually on lavish vacations, and tried to trick federal agents with fake records,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “The Fraud Division’s data-driven approach will shine a light on fraud schemes across the country, ensuring that no doctor can engage in these types of brazen schemes to rob Medicare.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “The idea of drinking during pregnancy sounds like a generational punchline: Someone’s grandmother drank beer to fatten her fetus, another had a nightly martini to get a healthy amount of sleep — presumably unthinkable behavior in today’s America. 
    • “Yet after precipitous declines in the last 50 years, rates of alcohol use in pregnancy in the U.S. started climbing upward a decade ago. More than 1 in 8 pregnant adults reported drinking in the past month, according to STAT’s analysis of 2024 government data, making alcohol use a more common national phenomenon than gestational diabetes. Of those who drank, a quarter reported having four or more drinks in one sitting — binge drinking — in the prior month. 
    • “While rates of alcohol use in pregnancy are lower in the U.S. than those of several peer nations, the effects are all around Americans. Alcohol is the key driver of what are, by some estimates, the nation’s top neurodevelopmental conditions: fetal alcohol spectrum disorders, or FASDs.
    • “The exact prevalence of FASDs is difficult to measure, but the most recent federally funded community studies have found as many as 1 in 20 school-aged children may have a disorder caused by prenatal alcohol exposure. By comparison, about 1 in 31 American children has autism, per recent estimates from the Centers for Disease Control and Prevention.
    • “Not all fetuses exposed to alcohol have birth defects or go on to develop intellectual disabilities, researchers say. But every person born with an FASD was harmed by alcohol specifically. They worry this point is being glossed over as Americans question the conventional medical advice of avoiding all alcohol while pregnant.”
  • The latest post of the National Institutes of Health’s Research Matters covers the following topics:
    • Team-based care improves blood pressure control
      • “Researchers found that a multifaceted intervention was better than a standard approach at reducing high blood pressure among low-income patients.
      • “Similar multifaceted, team-based strategies could be implemented widely to benefit underserved populations.”
    • Effects of early exposure to toxic metals
      • “Scientists found that toxic metal exposures during specific time windows increased the risk of brain and mental health symptoms a decade later.
      • “These results support the need for preventing excessive early life metal exposures and associated harms.”
    • Scientists spur growth of implanted liver tissue
      • “Researchers developed a way to control the growth of lab-grown liver tissue after it was implanted into mice.
      • “The technique could one day lead to alternative treatments for people who need organ transplants.”
  • Health Day relates,
    • “Long-term exposure to smog might increase the risk of Lewy body dementia, the brain disease that CNN founder Ted Turner battled for several years before his recent death, a new study says.
    • “Even small increases in particle pollution and nitrogen dioxide are linked to increased risk of Lewy body dementia (LBD) and Parkinson’s disease-related dementia, researchers reported May 14 in JAMA Network Open.
    • “People’s risk of LBD nearly quadrupled for every incremental increase in exposure to particle pollution, researchers found.
    • “Similarly, risk for Parkinson’s-related dementia more than doubled for every such increase in particle pollution exposure, the study found.
    • “While this research does not establish causation, it does show a clear association between air pollution exposure and increased risk of these dementias,” said researcher Dr. Gregory Pontone, chief of the Aging, Behavioral and Cognitive Neurology Division at the University of Florida in Gainesville.”
  • and
    • “New-onset atrial fibrillation (AF) may accelerate kidney function decline, according to a study published online May 14 in JAMA Network Open.
    • “Yuichiro Mori, M.D., from Kyoto University in Japan, and colleagues conducted a retrospective cohort study to examine the association of new-onset AF with subsequent kidney function decline in working-age adults. Participants included screening attendees aged 35 to 59 years in sinus rhythm without previous AF, cardiovascular comorbidities, or end-stage kidney disease. A total of 23,510 adults who developed new-onset AF during the annual screening interval were matched in a 1:5 ratio to 117,550 individuals who did not develop new-onset AF.”
    • * * * “This finding suggests the importance of cardiovascular-kidney-metabolic perspectives in AF management,” the authors write. “Further investigation is needed on the cumulative impact of AF on chronic kidney disease progression and on the effectiveness of AF treatments for improving kidney outcomes.”
  • The Washington Post informs us,
    • “Modern psychiatry has long struggled with one brutal fact: the people most at risk of suicide often cannot wait weeks for therapy or antidepressants to work. Now, a new study suggests researchers may have found the first drug regimen capable of rapid and sustaining relief from suicidal thoughts across a broad group of patients.
    • “Suicide remains one of the nation’s most urgent public health crises, with roughly 13 million Americans seriously considering it each year and about 50,000 dying by suicide annually.
    • “A study to be presented Tuesday at the American Psychiatric Association’s annual meeting found that a surprising combination of drugs — a single ketamine infusion followed by low-dose buprenorphine — significantly sustained reductions in suicidal ideation in adults with major depressive disorder.
    • “This is really a breakthrough study that provides hope and immediate clinical applications,” said Ned Kalin, editor-in-chief of the journal that will publish the paper and chair of the Department of Psychiatry at the University of Wisconsin School of Medicine and Public Health.
    • “But outside experts who were not involved in the study urged caution.
    • “Bertha Madras, a professor of psychobiology at Harvard Medical School, said that while the findings are intriguing, doctors should be careful not to move too quickly.”
  • Genetic Engineering and Biotechnology News points out,
    • “A University of Bath-led research effort received £500,000 to develop an organ-on-chip device that replicates connections between the brain, gut, and pancreas. The GlucoBrain project is designed to allow researchers to track how signals move between the organs and uncover why diabetes may lead to changes in memory and cognition.
    • “Collaborators include investigators from the University of Oxford and Johns Hopkins. Their findings could pave the way for new treatments to improve the lives of millions of people affected by diabetes, dementia, or both, notes the team.
    • ‘Diabetes and Alzheimer’s disease are two of the world’s most pressing health problems, especially in aging societies. While diabetes is widely known to affect the heart, kidneys, and eyes, growing evidence suggests it is also linked with problems in memory, learning, and brain function. However, the biological mechanisms behind this link remain poorly understood.
    • “Our gut, pancreas, and brain are constantly communicating via a network of signals, helping us regulate hunger and blood sugar,”  says Despina Moschou, PhD, project lead. “But we still don’t fully understand how these signals interact at a cellular level and why glucose levels are linked to cognitive decline. “By creating a connected system on a chip, we can study in real time how signals travel between organs, how diabetes may impair brain function, and how new drugs could help.”
  • MedPage notes,
    • “Men treated with GLP-1 receptor agonists had significant increases in testosterone levels, according to findings from a retrospective analysis.
    • “Among men who received semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro, Zepbound), median total testosterone increased from 320 to 419 ng/dL and median free testosterone increased from 9.0 to 10.4 ng/dL (P<0.001 for both), reported Andrés Heriberto Guillén-Lozoya, MD, of the Mayo Clinic in Rochester, Minnesota, at the American Urological Associationopens in a new tab or window annual meeting.
    • “After adjusting for age and body mass index (BMI), total testosterone increased by a median of 97.6 ng/dL, while free testosterone increased by 1.3 ng/dL (P<0.001 for both).
    • “Meanwhile, median BMI decreased from 33.6 to 30.4 (P<0.001).”
  • Per BioPharma Dive,
    • “A drug prospect from Relay Therapeutics has shown signs in a mid-stage clinical trial that it may be able to treat a cluster of conditions associated with the development of abnormal blood vessels.
    • “In 20 people with these “vascular anomalies,” a 12-week regimen of Relay’s therapy, zovegalisib, was associated with a 60% response rate across all doses tested, the company said Tuesday. Nearly all patients experienced an improvement in symptoms, and responses were observed in people with different disease subtypes and “PIK3CA” mutations driving their condition.
    • “Investigators did have to dial back dosing in 23% of people getting one of the doses Relay will take into further testing. But the company also said no patients discontinued treatment, most common adverse events were “low-grade, manageable, and reversible” and the drug appeared safe enough to envision the kind of “chronic use” that’d be necessary for these conditions. Company shares climbed by about 10% in early Tuesday trading.”
  • Per Fierce Pharma,
    • “Two months after UCB revealed the success of Bimzelx in a head-to-head trial against AbbVie’s Skyrizi in patients with psoriatic arthritis (PsA), the Belgian drugmaker has unveiled the detailed results.
    • ‘In the phase 3b study that included 553 patients, 49% of those on Bimzelx achieved reduced disease activity versus 38% of those on Skyrizi at week 16. The result was deemed to be statistically significant, UCB said.
    • “The disease activity primary endpoint was measured by ACR50, which is a composite efficacy measurement, specified by the American College of Rheumatology, which indicates 50% or greater improvement from baseline in tender or swollen joint counts in addition to 50% improvement in three of five other disease markers.”
  • Per MedTech Dive,
    • “Boston Scientific said Tuesday a pivotal study of its coronary intravascular lithotripsy catheter to treat severely calcified coronary artery disease met its primary safety and effectiveness endpoints.
    • “The data, presented at the EuroPCR 2026 conference in Paris, showed a 93.3% rate of freedom from major adverse cardiac events at 30 days, exceeding the primary safety goal of 86.2%. The device demonstrated 93.7% procedural success, defined as stent delivery with residual stenosis of less than 50% and no major adverse events during the hospital stay, exceeding the 85.8% goal.
    • “Boston Scientific said the study results will support its regulatory submission for the Seismiq 4CE catheter to address severe calcium during the lesion preparation phase of percutaneous coronary interventions to open blocked arteries.”

From the U.S. healthcare business and artificial intelligence front,

  • Corporate Insight discusses “How Leading Health Plans Are Rethinking the Claims Experience.”
    • “For years, the claims experience has been one of the most friction-heavy touchpoints in healthcare. Members struggle to understand their Explanation of Benefits, navigate claim submission processes and track reimbursement status—often ending up on the phone with member services when the digital channel fails them. Corporate Insight’s April 2026 Health Plan Monitor Update noted two major plans addressing this from different angles: Aetna through contextual cost explanation at the point of confusion, and UnitedHealthcare through a structured, self-service submission overhaul.
    • “The two approaches are complementary. One tackles post-service, helping members understand a claim after it has been processed. The other addresses submission, reducing friction when members initiate a claim. Together, they reflect a maturing view of what claims look like in the digital experience.”
  • MedCity News calls attention to
    • “What Seasonal Pressures Continue to Teach Us About the Fragility of the US Surgical System
    • “When demand fluctuates, even slightly, the margin for error becomes clear – highlighting the urgent need for greater efficiency to meet rising procedural demand.”
  • Modern Healthcare adds,
    • “Health systems are improving the profitability of their operating rooms through efficiency upgrades.
    • “Trinity Health, WellSpan and UCI Health are among many health systems redesigning spaces and using data to maximize the OR’s potential.
    • “Declining reimbursement will require health systems to become more efficient, executives said.”
  • STAT News relates,
    • “Here’s one more sign of Eli Lilly’s dominance in the drug industry: It took both top spots in a prominent ranking of pharmaceutical innovators and investors.
    • “The index, produced by U.K.-based IDEA Pharma, ranks drug company laboratories on two different sets of criteria: innovation, which takes into account revenue from new products, new drug approvals, and major drug development events; and invention, which looks at the number of drugs a company has in development, its clinical trials, and its R&D investment, among other factors. IDEA is part of SAI MedPartners, a larger consultancy.”
    • “This is the first time that one company — in this case, Lilly — has ranked No. 1 in both categories.”
       
  • Beckers Health IT adds,
    • “Several startups with a footprint in healthcare [listed in the article] made CNBC’s annual Disruptor 50 rankings May 19, with one AI giant surpassing a rival in 2026.
    • “Anthropic passed OpenAI to rank No. 1 on this year’s list, with both companies having recently unveiled healthcare AI offerings. An advisory board weighs the criteria for the rankings, which are based on detailed quantitative and qualitative information submitted by nominated companies.”
  • Fierce Healthcare lets us know,
    • “Online health and wellness company Hims & Hers posted a $92 million loss in the first quarter as it shifts its business from selling compounded weight loss drugs to branded GLP-1 medications.
    • “During the same period a year ago, Hims & Hers posted a profit of $49.5 million.
    • “The company brought in revenue of $608 million in Q1, up 4% year-over-year. The company’s stock was down about 15% in mid-day trading on Tuesday following the unexpected Q1 loss. Revenue also missed Wall Street analysts’ expectations. Hims & Hers reported a loss of 40 cents per share in Q1 2026 compared to the Zacks Consensus Estimate of EPS of a profit of 4 cents. Revenue also missed the Zacks Consensus Estimate by 1.9%.”
  • and
    • “Nourish, a virtual nutrition-focused metabolic provider, has raised $100 million in a series C round. 
    • “The round was led by Menlo Ventures, with participation from Thrive Capital, Index Ventures, J.P. Morgan Growth Equity Partners, Maverick Ventures, Y Combinator and more. The capital will be used to grow Nourish’s provider workforce, accelerate its investment in AI and deepen partnerships with payers and health systems.
    • “The company is pivoting from being a dietitian-only nutrition platform to a more comprehensive metabolic health clinic by hiring physicians. Nourish patients are typically paired with a registered dietitian, but now lab testing, GLP-1 prescriptions and other virtual care are also becoming available. There is currently a waitlist to see Nourish physicians, though the goal is to rapidly expand by the end of this year to meet the “overwhelming demand,” per executives.”
  • and
    • “Healthcare AI company Commure has banked $70 million in fresh funding, reaching a $7 billion valuation.
    • “General Catalyst led the funding round, which also included participation from Sequoia Capital, Morgan Stanley, and Kirkland & Ellis, according to an announcement. Commure said that it will use the funds to scale its platform and continue building out its technology.
    • “The company offers AI tools and agents that embed in the workflow of health systems and providers. Its tech is largely focused on simplifying administrative work, which Commure said consumes about $1 trillion each year across the country.
    • “Its revenue cycle management tool and advanced clinical workflow tool are deployed across more than 500 organizations that include more than 3,000 sites of care, Commure said in the announcement. Among those are more than 130 of the largest health systems in the country, such as Tenet Healthcare and HCA Healthcare.”
  • MedCity News points out,
    • “John Ayers believes most healthcare AI hype has not yet translated into meaningful patient impact — though he thinks that may soon change. This belief drove Ayers and a team of researchers to create ChatCPR, an AI agent launched this week that coaches users through CPR in real time.
    • ‘Ayers, head of AI at the University of California San Diego’s Altman Clinical and Translational Research Institute, is the lead author of a widely discussed 2023 JAMAstudy that found AI chatbots’ responses to patient messages are often more accurate and empathic than those written by human doctors.” * * *
    • “So, the researchers built ChatCPR to handle more advanced, guideline-critical details. A study published Monday in JAMA not only introduced the tool but also showed that it outperformed 911 dispatchers in guiding bystanders through CPR when tested against recordings from real 911 calls.
    • “The research team rolled out ChatCPR this week as an open-source public resource rather than a commercial product. They are making the training materials, guidelines, prompts and architecture publicly available so that the right companies and emergency-response organizations can build on it, improve it and deploy it broadly, Ayers said.
    • “In his eyes, the key challenge in healthcare AI is implementation — not necessarily having the most advanced model. This is why the team intentionally built ChatCPR on a relatively small, lower-performing language model and still achieved strong results through careful design and domain-specific training. 
    • “Ayers said this means the tool could eventually run directly on smartphones without requiring internet connectivity.”
  • The Wall Street Journal adds,
    • “Yes, AI Can Make Mistakes. AI Can Find Them, Too.
    • “Since chatbots hallucinate their own facts, it’s useful (and easy) to have a second, nitpicking AI that can audit the results for errors.”

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medicare, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Roll Call offers an overview of this week’s anticipated activities on Capitol Hill.
  • STAT News reports,
    • “Bill Cassidy, a key Republican health care leader in the Senate, will lose his seat, as Louisiana’s Senate primary heads for a runoff between state treasurer John Fleming and Rep. Julia Letlow, who won President Trump’s endorsement.” * * *
    • “Cassidy’s defeat is a win for President Trump and his allies, who have criticized the senator for voting in 2021 to convict the president for inciting the January 6 insurrection.” * * *
    • “Cassidy will likely remain chair of his committee until his term ends at the start of next year, potentially setting up roadblocks for Kennedy as he attempts to fill several vacancies across his department. That includes a new Food and Drug Administration commissioner, and nominees for surgeon general and Centers for Disease Control and Prevention director.”
  • Federal News Network points out four benefits bills in Congress for federal employees, retirees to watch. “Potential adjustments to short-term disability insurance and credit protection for feds during government shutdowns are on the table through new legislation.
  • Per a May 15, 2026, Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) issued a sweeping rule to strengthen oversight of the Affordable Care Act (ACA) Exchanges for plan year 2027 by lowering user fees, tightening eligibility verification, and giving states greater authority over plan oversight.
    • The final rule, “Notice of Benefit and Payment Parameters for 2027; Basic Health Program” (the 2027 Payment Notice final rule) reduces federal Exchange user fees to help lower premiums, establishes new safeguards to prevent improper enrollments, ensures subsidies go only to eligible individuals, increases consumer choice, affordability, access and protections, and expands state flexibility to manage Exchange operations.
    • “The rule strengthens program integrity, expands consumer protections, promotes plan innovation and consumer choice, and restores greater authority to states. 
    • “American taxpayers deserve to know their dollars are going only to people who truly qualify,” said CMS Administrator Dr. Mehmet Oz. “This rule strengthens eligibility checks, cracks down on abuse, and gives insurers more flexibility to offer affordable, consumer-focused coverage options.”
  • Here is a link to the CMS fact sheet on this final rule.
  • Kevin Moss writes in Govexec,
    • “CMS is launching the Medicare GLP-1 Bridge program, which will extend coverage of certain GLP-1 medications for weight loss to eligible Medicare beneficiaries, regardless of whether they have an underlying medical condition” effective July 1, 2026. 
    • “For [FEHB and PSHB} annuitants enrolled in Part D, this program could expand your options. Here’s [in the article] what it covers, who qualifies, and what it means for you.”
  • The U.S. Supreme Court will be releasing opinions at 10 am every Thursday morning until the end of next month.

From the public health and medical / Rx research front

  • The Wall Street Journal considers whether “the Weight-Loss Drug Revolution Causing a Frailty Epidemic? As millions flock to GLP-1s, doctors warn the drugs can cause rapid and significant muscle loss” and assesses “What Science Tells Us About the Risks of Hantavirus. Rare virus has high fatality rate and can spread through the air, research shows, though it is easier to contain than Covid-19.”
  • Health Day reports,
    • “A major women’s health condition is getting a new name—and experts say it could change how millions are diagnosed and treated worldwide.
    • “Polycystic ovary syndrome, or PCOS, will now be known as polyendocrine metabolic ovarian syndrome, or PMOS.
    • “The condition affects more than 170 million women worldwide and is linked to hormone imbalances, weight and metabolic issues, mental health symptoms, skin changes and fertility challenges.
    • “Experts said the old name was misleading because the condition is not actually defined by ovarian cysts.
    • “What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” said Helena Teede, director of the Monash Center for Health Research & Implementation in Australia and an endocrinologist at Monash Health.”
  • BioPharma Dive relates,
    • “A year after Vertex’s big launch, pain drug research faces a pivotal moment.
    • “Journavx started to revive area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?”

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Nurse practitioners and physician assistants are increasingly filling healthcare gaps, with NP ranks growing 60% to 461,000 between 2019 and 2025.
    • “Doctors’ groups express concern that non-MD providers practicing without physician oversight may pose risks to patients.
    • “A 2023 study found that allowing nurse practitioners to work without physician supervision reduced deaths that could have been prevented through healthcare by 2%”
  • Fierce Healthcare relates,
    • “Even without counting the multi-billion hit tied to the early termination of a major joint venture and outsourcing arrangement, CommonSpirit Health’s operations took a bruising during the three months ended March 31.
    • “The major Catholic nonprofit system reported Friday a $578 million operating loss (-5.8% operating margin) during the third quarter of its fiscal year. That’s after two key adjustments: normalization for delayed income received through California’s provider fee program; and removing the nearly $2.5 billion of “special charges” the system recorded on paper for the quarter that include contract termination and intangible asset impairment stemming from its breakup with Tenet Healthcare’s revenue cycle services business. 
    • “For comparison, CommonSpirit had logged an $85 million operating loss (-0.9% operating margin) a year prior with the California provider fee program adjustment. Across the first nine months of the fiscal year, the system is looking at a $743 million operating loss (-2.4% operating margin) for 2026 and a $282 million operating loss (-1.0% operating margin) in 2025, with the same adjustments.” 
  • Health Exec tells us,
    • “The days when most doctors worked in independent practice settings are fading from memory like old photoprints in a musty scrapbook.
    • “Taking their place is an era dominated by physician employment. And the employers are not only hospitals but also a “vast array of corporate entities with various financial incentives for employing physicians.”
    • “The quote is from the authors of a new report compiled by Avalere Health for the Physicians Advocacy Institute, also known as PAI.
    • “The shift towards corporatization of physician practice, the PAI analysts add, has “significant implications for costs, patient care and the future practice of medicine.”
    • “The report looks at trends in practice acquisitions as well as physician employment over the eight-year stretch from January 2018 to January 2026.”
  • MedCity News informs us,
    • “Anomaly Insights, an AI-powered payer intelligence company, announcedWednesday that it raised $17 million in funding.
    • “The company’s platform analyzes healthcare transactions to identify payer behavior patterns, policy changes and adjudication deviations. It helps predict at-risk payments so providers can proactively ensure claims are paid accurately. It also detects new denial patterns and identifies revenue opportunities. Currently, Anomaly is being used across more than 20 health systems.
    • “Specifically, the company seeks to solve the issue of “not knowing whether a healthcare encounter will be paid for or not before it happens,” said Mike Desjadon, CEO of Anomaly.”

Cybersecurity Saturday

David Ermer–Congress, Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • Cyberscoop reports,
    • “The House Homeland Security Committee is digging into Anthropic’s AI model Mythos in a series of briefings and hearings, as questions proliferate on whether and how the federal government will make use of the technology touted for its ability to autonomously uncover cyber vulnerabilities.
    • “Wednesday [May 13] brought a closed-door briefing for the House Homeland Security Committee from Anthropic. The chairman of the panel’s cybersecurity subcommittee said he is planning to hold a hearing on the topic. And committee Democrats are requesting a classified briefing with Anthropic.
    • “A committee aide who attended the briefing said it included a live demonstration of Mythos, “allowing members to see firsthand how advanced AI can identify and reason through software vulnerabilities. What we saw reinforced the urgency of ensuring that federal agencies, including our civilian cyber defenders, can responsibly access and deploy the most advanced U.S. models to find and patch vulnerabilities before foreign adversaries or criminal actors exploit them.” * * *
    • “There’s a divide on which federal agencies are using Mythos thus far. For example: CISA reportedly isn’t, but the National Security Agency is.” 
  • GovCon Wire adds,
    • “Anthropic’s Project Glasswing and Claude Mythos announcement may have sparked concerns across the cybersecurity community, but Pentagon technology leaders say the emergence of Mythos-style AI models could ultimately strengthen U.S. cyber defense capabilities rather than weaken them.
    • “Katherine Sutton, DOW [Department of War] assistant secretary for cyber policy, emphasized that the focus should not solely remain on the offensive risks associated with advanced cyber AI, according to Breaking Defense. 
    • “I hear a lot of people talking about challenges and threats when they talk about Mythos,” Sutton said. “[But] there’s huge opportunity in these models. One of the foundational things that they’re going to enable is the development of secure code.”
  • Cyberscoop points out,
    • “Two of the most advanced artificial intelligence models — Anthropic’s Claude Mythos Preview and OpenAI’s GPT-5.5 — have significantly surpassed the already-accelerating pace at which AI systems are completing autonomous cybersecurity tasks, according to separate findings published Wednesday by the United Kingdom’s AI Security Institute (AISI) and Palo Alto Networks.
    • “The AISI, which conducts pre-deployment evaluations of frontier AI models on behalf of the British government, said both Claude Mythos Preview and GPT-5.5 have substantially exceeded the doubling trend the institute had been tracking since late 2024. Whether the results represent an isolated capability jump or the start of a new, faster trajectory remains unclear.”
  • Cybersecurity Dive relates,
    • “In February, a coalition that includes corporate titans JPMorgan Chase, Mastercard, AT&T and Berkshire Hathaway Energy launched the Alliance for Critical Infrastructure (ACI), vowing to take the lead in helping infrastructure sectors work more closely together to understand and mitigate the shared cybersecurity risks they face. Reading between the lines, the message was clear: The critical infrastructure community, increasingly alarmed at the Trump administration’s retreat from decades-long partnerships, is trying to fill the growing void of coordination and leadership.” * * *
    • “Government budget cuts and personnel losses have made it much harderfor agencies to support and advise infrastructure operators, and the White House has encouraged states to take over historically federal responsibilities for protecting local utilities. Amid those changes, infrastructure firms like the ones that founded the ACI say the private sector must step up.
    • “Ben Flatgard, the ACI’s chairman, noted that the private sector manages the vast majority of U.S. infrastructure. “We can’t outsource that responsibility or the risk management practices that come along with it,” he said in an interview with Cybersecurity Dive. “We need to own the solution for that as well.”
    • “Many experts say that while the government must retain a leadership role in protecting critical infrastructure, it’s a good sign that private companies want to assume more of the burden.”
  • Per a Cybersecurity and Infrastructure Security Agency (CISA) news release,
    • “CISA and the Group of Seven (G7) international partners—Germany, Canada, France, Italy, Japan, the United Kingdom, and the European Union—have released joint guidance, Software Bill of Materials for AI – Minimum Elements, to help public and private sector stakeholders improve transparency in their artificial intelligence (AI) systems and supply chains.
    • “A software bill of materials (SBOM) acts as an “ingredients list” for software that better positions organizations to understand their supply chains and make risk-informed decisions about how to protect their critical systems. The guidance builds on CISA’s previous work with federal and international partners to establish a shared vision for a software bill of materials and provides recommendations on minimum elements that should be included in an SBOM for AI. Because AI systems are software systems, these recommendations should be considered in addition to the general minimum elements for an SBOM. 
    • “While not exhaustive or mandatory, the supplemental minimal elements outlined in this guidance reflect the consensus of G7 experts and will expand over time to keep pace with the rapid advancement of AI technology.” 

From the cybersecurity breaches and vulnerabilities front,

  • Cybersecurity Dive lets us know,
    • “Seven out of every 10 organizations suffered at least one identity-related breach over the past year, according to a report released Tuesday [May 12] by Sophos. Organizations, on average, reported three separate identity-related incidents during that time.
    • ‘Two-thirds of ransomware victims said the cyberattack stemmed from an identity-related incident, said Sophos. The report is based on a survey of 5,000 IT and cybersecurity leaders across 17 countries. 
    • “The mean recovery cost was $1.64 million, read the report, and the median cost was $750,000. Seven of every 10 respondents reported recovery costs of more than $250,000.”
  • Bleeping Computer adds,
    • “Initial access broker KongTuke has moved to Microsoft Teams for social engineering attacks, taking as little as five minutes to gain persistent access to corporate networks.
    • “The threat actor tricks users into pasting a PowerShell command that ultimately delivers the ModeloRAT, which has been previously seen in ClickFix attacks [1, 2].
    • “Initial access brokers (IAB) like KongTuke typically sell company network access to ransomware operators, who use it to deploy file-theft and data-encrypting malware.
    • “Cybercriminals have increasingly adopted Microsoft Teams in attacks, reaching out to company employees and pretending to be IT and help-desk staff.”
  • CISA added two known exploited vulnerabilities (KVEs) to its catalog this week.
  • Security Week reports,
    • ‘For the first time, Google has identified a zero-day exploit believed to have been developed using artificial intelligence.
    • “The company published a new report on Monday [May 11]. summarizing its observations on the use of AI in the cyber threat landscape, drawing on data collected recently by Gemini, Google Threat Intelligence Group (GTIG), and Mandiant. 
    • One of the most notable findings is that a prominent cybercrime group leveraged AI to develop a zero-day exploit designed to bypass two-factor authentication (2FA) on an open source web-based system administration tool. The exploit was implemented in a Python script.
    • The hacker group and the targeted tool have not been named, but Google said it worked with the impacted vendor to prevent mass exploitation, which appeared to be the threat actor’s plan.
    • “Although we do not believe Gemini was used, based on the structure and content of these exploits, we have high confidence that the actor likely leveraged an AI model to support the discovery and weaponization of this vulnerability,” Google explained.
  • Fand
    • “Linux distributions are informing users about a new kernel vulnerability that can be exploited by a local attacker to escalate privileges to root.
    • “Dubbed Fragnesia and officially tracked as CVE-2026-46300, the issue resides in the kernel’s XFRM ESP-in-TCP subsystem, allowing an unprivileged attacker to gain root permissions by overwriting sensitive system files. 
    • “A majority of Linux distributions are affected, and they have started releasing patches.
    • “A proof-of-concept (PoC) exploit is available, but there is no evidence that Fragnesia has been exploited in the wild.
    • “Similar to Dirty Frag, Fragnesia exploits a vulnerability in the XFRM ESP-in-TCP subsystem to achieve a memory write primitive in the kernel,” Microsoft’s threat intelligence team said.” 
  • The Wall Street Journal relates.
    • “Security researchers say they have discovered a new way of circumventing Apple’s AAPL 1.07%increase; green up pointing triangle state-of-the art security technology, using techniques they discovered while testing an early version of Anthropic’s M”ythos AI software in April.
    • “:The researchers with Calif, a Palo Alto-based security research company, say the software they wrote links together two bugs and a handful of techniques to corrupt the Mac’s memory and then gain access to parts of the device that should be inaccessible.
    • “It is what’s known as a privilege escalation exploit, and if it were chained together with other attacks it could be used by a hacker to seize control of the computer.
    • “The technique is noteworthy because Apple has put so much effort into locking down MacOS, said Michał Zalewski, a security researcher who formerly worked at Google and who reviewed the Calif research but wasn’t involved in the testing. 
    • “Apple, which is deploying and testing frontier AI models to test and patch vulnerabilities, is reviewing the Calif report to validate its findings. “Security is our top priority, and we take reports of potential vulnerabilities very seriously,” a company spokeswoman said.”

From the ransomware front,

  • Cyberscoop reports,
    • “Instructure, the company behind Canvas, said it reached an agreement with the cybercriminals who threatened to leak a trove of sensitive data they claim was stolen during a prolonged cyberattack on the widely used education tech platform.
    • “Pressure was mounting on the company as widespread outages left schools, students and teachers temporarily unable to access critical data late last week when the company took Canvas offline after the attackers defaced the platform’s login page. By Friday, the company said Canvas — a central hub for K-12 and university coursework, exams, grades and communication — was back online and fully operational. 
    • “ShinyHunters, a decentralized crew of prolific cybercriminals that researchers affiliate with The Com, claimed responsibility for the attack on its data leak site and was attempting to extort the company for an unknown ransom amount. 
    • “Instructure didn’t outright say it paid a ransom, but insisted the agreement provided all necessary assurances. “The data was returned to us. We received digital confirmation of data destruction (shred logs),” the company said in an update Monday [May 11]. * * *
    • “The House Homeland Security Committee on Monday published a letter to [Instructure CEO Steve] Daly seeking a briefing with him or a senior leader at Instructure by May 21. 
  • and
    • “Foxconn, one of the world’s largest manufacturers of electronics sold by major tech vendors, is recovering from a cyberattack that disrupted some of the company’s factories in North America.
    • :Nitrogen, a ransomware group that’s known for targeting organizations in the manufacturing, construction and technology sectors, claimed responsibility for the attack on its data leak site and said it stole 8 terabytes of data spanning more than 11 million files. 
    • “The threat group posted screenshots of some of the allegedly stolen data and claimed it compromised “confidential instructions, projects and drawings from Intel, Apple, Google, Dell, Nvidia and many other projects.” 
    • “Foxconn is famously known as the primary assembler of Apple iPhones. Apple and the other companies allegedly impacted by the attack did not respond to a request for comment.” ***
    • “Nitrogen was first observed in 2023, using ALPHV, one of the most prevalent ransomware variants at that time, Cynthia Kaiser, senior vice president at Halcyon’s Ransomware Research Center, told CyberScoop. The group started using stolen code from Conti, another formerly prolific ransomware variant, in 2024 to build its own custom attack tools to hit Windows and VMware server environments, she added.”
  • Cybersecurity Dive relates,
    • “West Pharmaceutical Services on Wednesday [May 13] said it has contained a ransomware attack it suffered earlier this month and is restarting critical systems, including manufacturing, receiving and shipping, at certain locations, according to an update on its website. 
    • “The Exton, Pa.-based company, one of the world’s leading makers of drug-delivery devices and solutions, confirmed that data was stolen and encrypted in the attack, in a Monday filing with the Securities and Exchange Commission.” * * *
    • “Palo Alto Networks Unit 42, handled incident response to the attack, according to an assurance letter shared by the pharmaceutical services company. The letter confirms that the ransomware attack was contained and any malicious binaries and unauthorized persistence mechanisms were neutralized.” 
  • The HIPAA Journal adds,
    • Ransomware groups have claimed responsibility for attacks on Advanced Family Surgery Center in Tennessee, Orem Eye Clinic in Utah, and Belmont Aesthetic & Reconstructive Plastic Surgery in Virginia/Washington D.C.
  • Dark Reading notes,
    • “A new threat campaign is using RubyGems as a dead drop to store exfiltrated data, but the attacker’s long-term plans are less clear. 
    • “Software development security vendor Socket published research concerning a campaign dubbed “GemStuffer,” where an attacker abused the RubyGemspackage registry “as a data transport mechanism rather than a conventional malware distribution channel,” according to a blog post. RubyGems is a package manager for the Ruby programming language, and acts as a way for developers to distribute Ruby programs or libraries, which are referred to as “gems.”
  • Checkpoint Research posted its first quarter 2026 ransomware report.
    • Key Findings
      • Consolidation after peak fragmentation: The top 10 ransomware groups accounted for 71% of all Q1 2026 victims, a sharp reversal from the fragmentation seen in Q3 2025. The ransomware ecosystem is once again consolidating around fewer, more dominant operators.
      • Volume stabilization at historically high levels: There were 2,122 victims posted on data leak sites (DLS), making this period the second-highest Q1 on record. The long growth trend is stabilizing.
      • Qilin’s sustained dominance: Qilin maintained its position as the most prominent ransomware operation for the third consecutive quarter, posting 338 victims.
      • The Gentlemen is the breakout story of Q1 2026 reaching the third place on the global ransomware list, increasing their victim count from 40 victims in Q4 2025 to 166 in Q1 2026.
      • LockBit 5.0 comeback confirmed: LockBit posted 163 victims in Q1 2026, climbing to fourth place.
  • Dark Reading adds,
    • “Tables Turn on ‘The Gentlemen’ RaaS Gang With Data Leak
    • “An OPSEC failure provides a window into what helped the ransomware group rise: a generous affiliate model, opportunistic TTPs, and an effective organizational structure.”
  • CSO discusses the economics of Ransomware 3.0.
    • “The uncomfortable truth your board needs to hear is this: The question is no longer whether your organisation will face a sophisticated threat actor. For any organisation of meaningful size, operating in a connected supply chain, with digital customer relationships, the question is how well-prepared you are when it happens. The economics of ransomware as a criminal enterprise have never been stronger. Attack-as-a-service platforms have lowered the barrier to entry. Ransom payment data is analysed and used to calibrate future demands. These groups study your financial filings.
    • “Investing in incident response capability — in people, process and technology — is not a cost centre decision. It’s the only bet that pays off in both the prevention scenario and the response scenario. Insurance pays out after the damage is done. A mature response architecture reduces the damage itself.
    • “The organisations that navigated the Cl0p MOVEit campaign of 2023 with the least disruption weren’t the ones with the biggest insurance policies. They were the ones who had mapped their data flows, limited unnecessary MOVEit exposure and had a response team that could move within hours rather than days.”

From the cybersecurity defenses front,

  • Cybersecurity Dive reports,
    • “OpenAI on Monday [May 11] launched a new cybersecurity initiative called Daybreak, which uses its large language models, Codex’s agentic capabilities and security partners to root out risk and call defense into action. The rollout is OpenAI’s answer to Anthropic’s Mythos model which debuted to limited preview last month and has highlighted weak security spots in software across various industries. 
    • “Like with Anthropic’s Project Glasswing, which sought tech vendors to support Mythos, OpenAI will work with industry and government partners to deploy cyber-capable models that are meant to build autonomous cyber defense capabilities into software from the start. Cloudflare, Cisco, CrowdStrike, Oracle and Zscaler are among a group of companies already using the technology, OpenAI said. Unlike Mythos, Daybreak is publicly available, and companies can request an assessment of their security risks.
    • “As AI providers compete for their share of the enterprise market with cybersecurity tools, tech leaders should experiment with all of their options, said Jeff Pollard, VP, principal analyst at Forrester, in an email to CIO Dive. “Take someone with responsibility for innovation in tech and cybersecurity and have them play with these capabilities to see what they offer,” he said.”
  • and
    • “Organizations are allocating more money for security against physical threats but the money is coming with more board oversight, and confusion remains over who has the lead role in physical security and how to blend physical security with cybersecurity, an EY survey finds. 
    • “Almost 80% of organizations say they increased the allocation for physical security over their last budget cycle, in some cases by as much as 50%, according to the EY Forensic & Integrity Pulse, based on responses from 250 executives and board members to a March survey.  
    • “Leaders are beginning to recognize gaps in crisis management and physical security preparedness as threats and risk evolve,” EY says in the report, released May 5.”
  • Dark Reading adds,
    • “AI Drives Cybersecurity Investments, Widening ‘Valley of Death’
    • “In a role reversal, investment dollars in security startups exceeded the value of mergers and acquisitions in 1Q26 by more than $1 billion, a rare occurrence.”
  • Security Week notes,
    • “Mythos Proves Potent in Vulnerability Discovery, Less Convincing Elsewhere
    • “Independent benchmarking finds Mythos highly effective for source code audits, reverse engineering, and native-code analysis, though its exploit validation and reasoning capabilities remain inconsistent.”
  • TechTarget explains how to implement zero trust for AI.
  • CSO informs us,
    • “Penetration tests of AI-based systems are revealing a greater percentage of high-risk flaws than those discovered in legacy systems.
    • “Security consultancy Cobalt’s annual State of Pentesting Report reveals that 32% of all AI and large language model (LLM) findings are rated as high risk — nearly 2.5 times the rate (13%) of severe flaws found in enterprise security tests more generally.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

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

From Washington, DC

  • Roll Call informs us,
    • “Republican leaders in Congress scored some victories this week in nominations and appropriations but struck out on easily advancing their partisan “reconciliation 2.0” proposal to fund immigration enforcement.
    • “The bill faces a hurdle in the form of the Senate Parliamentarian, who on Thursday evening advised that several provisions violate the Senate’s restrictive Byrd rule — and more could be coming. 
    • “This throws an obstacle in the way of the GOP’s efforts to provide some $72 billion in funding for immigration enforcement by President Donald Trump’s June 1 deadline, as Republicans will have to rewrite parts of the package to pass it with the filibuster-proof budget reconciliation process, requiring a simple-majority vote to pass, instead of the 60-vote threshold required for regular legislation.
    • “Republicans are expected to try to rewrite the legislation to remedy the violations or, if that’s not possible, remove the offending provisions ahead of a Homeland Security Committee markup of the title next week. 
    • “Senate Parliamentarian Elizabeth MacDonough was expected to hold a second “Byrd bath” Friday to hear arguments from Democratic and Republican Senate staff about the Judiciary Committee’s portion of the bill, including Secret Service money for security upgrades tied to Trump’s White House ballroom project.” 
  • Mercer Consulting reports,
    • “With the midterm congressional elections approaching and healthcare affordability top of mind for voters, lawmakers are actively considering new healthcare transparency reforms, including requirements for providers to show plainly what patients will have to pay and new billing standards for hospitals.
    • “Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy, R-LA, highlighted such price transparency legislation — Patients Deserve Price Tags Act (S 2355/HR 5582) — during a field hearing in Louisiana during last week’s congressional recess. Cassidy’s interest could signal that the legislation, which has may cosponsors from both parties, could soon see action at the Committee. 
    • “The bill would codify and expand current hospital price transparency rules that were established in the first Trump administration by extending requirements to clinical diagnostic laboratories, imaging centers, and ambulatory surgical centers. It would also make the prices that hospitals post clearer by requiring actual dollar-and-cents amounts, not estimates, as well as sharply increase financial penalties for hospitals and insurers that fail to disclose their negotiated rates. In addition, group health plans and insurers would have to give patients upfront, personalized cost estimates through an online self-service tool, as well as paper or phone options, before care is provided. The bill also ensures group health plans have access to claims data and prohibits third-party administrators from restricting that access.
    • “While several plan sponsor trade groups publicly support the legislation, they are working with lawmakers to make certain provisions more workable and better aligned with the PBM-focused transparency rules enacted in the Consolidated Appropriations Act, 2026 and proposed by the Department of Labor.”
  • AHIP lets us know “What They Are Saying: Broad Range of Experts Agree on a Root Cause of Healthcare Cost Crisis.”
    • “The evidence continues to underscore that making healthcare more affordable requires policymakers to address the root causes of high costs head-on through common-sense solutions like cracking down on anti-competitive hospital mergers and implementing site-neutral payment reforms.
    • “To learn more about how rising hospital costs are driving premiums higher and what policymakers can do to address it, visit AHIP.org/CostConnection.”
  • Fierce Healthcare relates,
    • “A bipartisan group of lawmakers in both chambers of Congress has reintroduced a bill aimed at barring companies from owning both a pharmacy benefit manager and retail pharmacies.
    • “The bill, called the Patients Before Monopolies (PBM) Act, would force conglomerates that include a PBM to divest pharmacies that they own. The legislation has existed in some form since 2024, and since its first introduction, Arkansas has implemented a similar legislation at the state level.
    • “Last month, Tennessee legislators also passed a bill that would prevent PBMs from owning pharmacies, which the governor is expected to sign into law.”
  • Mercer adds,
    • “Several developments in 2026 signal that the Trump administration is committed to improving behavioral health benefits for group health plan participants and beneficiaries — but the administration intends to put its own stamp on enforcement of the Mental Health Parity and Addiction Equity Act and propose new rules interpreting the landmark law.”
  • Per an HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $255 million to Vibrant Emotional Health (Vibrant) to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded network administrator. The 988 Lifeline has received more than 25 million contacts via call, text, chat, and ASL videophone since its launch.”
  • Modern Healthcare notes,
    • “The Centers for Medicare and Medicaid Service solicited the healthcare industry on ways it can identify and prevent fraud.
    • “The anti-fraud push drew cautious support, with providers and insurers seeking clear guardrails.
    • “Providers and insurers urged CMS to target high-risk services and avoid sweeping actions that would hamper care.” * * *
    • “New policies should focus on high-risk activities and not burden the ”vast majority of healthcare providers that are honorable in pursuing a mission to provide high-quality healthcare,” wrote the American Health Care Association/National Center for Assisted Living, which represents long-term care providers.
    • “The agency should also be careful not to add administrative burden since hospitals “already operate under extensive oversight requirements,” the American Hospital Association wrote.”
  • Beckers Payer Issues explains the federal crackdown on healthcare fraud, waste and abuse.
  • Newfront brings us up to date on the 2026 PCORI fee, which applies to FEHB and PSHB plan carriers.
    • “IRS Notice 2025-61 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.84 per covered individual for health plan years ending on or after October 1, 2025 and before October 1, 2026, including 2025 calendar plan years. This represents a 37-cent increase from last year’s $3.47 PCORI fee.
    • “Action Item: The annual PCORI fee must be reported and paid to the IRS by July 31, 2026, via the second quarter Form 720 (Rev. June 2026).”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission plans to end employee demographic data reporting, according to a proposal sent to the White House on Thursday.
    • “The agency wants to get rid of EEO-1, EEO-2, EEO-3, EEO-4 and EEO-5 reporting requirements. EEOC also wants to axe reporting requirements related to Title VII of the Civil Rights Act, the Americans with Disabilities Act, the Genetic Information Nondiscrimination Act and the Pregnant Workers Fairness Act.
    • “EEO-1 reporting has been a cornerstone of HR duties, required by firms with 100 or more employees and federal contractors with 50 or more employees that meet certain requirements. EEOC and analysts have used it to assess demographic data nationally, and — while the process is sometimes viewed as burdensome — employers have reportedly used the collected data for self-assessments regarding nondiscrimination and diversity.”
  • The Census Bureau notes,
    • “Since 2020, city centers of many major U.S. metro areas have had sluggish population gains, with some places even declining. But where growth did occur, it was mostly on the outer edges of these metro areas — with some exceptions.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With the ink barely dry on outgoing commissioner Marty Makary’s resignation, another top regulator may be heading for the exit at the FDA. 
    • “Tracy Beth Høeg, M.D., Ph.D.—who was named acting director of the agency’s Center for Drug Evaluation and Research (CDER) following the departure of veteran oncologist Richard Pazdur, M.D., last December—is now expected to depart in Makary’s footsteps, Reuters reported Friday, citing three sources familiar with internal plans at the regulator.” * * *
    • “Reuters clarified in its report that the CDER chief’s departure is likely, but that the decision has not yet been finalized.” 
  • and
    • “With the help of DNA testing company Natera and its personalized molecular residual disease (MRD) blood test Signatera, Roche’s PD-L1 inhibitor Tecentriq has chalked up its eleventh U.S. indication in the form of a new bladder cancer approval.
    • “Tecentriq and subcutaneous Tecentriq Hybreza can now be used as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) following a cystectomy, as identified by Signatera.” 
       
  • Biopharma Dive relates,
    • “The Food and Drug Administration has placed a clinical hold on Aardvark Therapeutics’ drug for Prader-Willi Syndrome, escalating a trial stoppage that began when signs of potential heart problems were detected in a study of healthy volunteers. 
    • “Aardvark said Thursday it will “unblind,” or reveal which enrollees in a late-stage trial received ARD-101, in order to help investigators and regulators determine whether the drug is safe and effective enough to continue testing in humans.
    • “The company has dosed 68 people in the placebo-controlled Phase 3 trial and another 19 in an open-label extension study, both which were intended to measure whether ARD-101 can address the “hyperphagia,” or insatiable hunger, distinctive to Prader-Willi. The cardiovascular concerns emerged from a safety trial in healthy people who’d received much higher doses than what was administered in the other studies.” 
  • Cardiovascular Business tells us,
    • “Stryker Sustainability Solutions, an Arizona-based division of Stryker focused on reprocessing single-use medical devices, has recalled certain lots of several reprocessed electrophysiology (EP) catheters. The recall, which covers more than 8,000 devices overall, was initiated after the company identified incomplete seals due to a process control issue.
    • “According to the U.S. Food and Drug Administration (FDA), this is a Class II recall. This means the agency believes the devices “may cause temporary or medically reversible adverse health consequences.”
  • The Wall Street Journal points out,
    • “Twenty people in Japan who took Amgen’s rare-disease drug Tavneos have died, and at least 22 developed a potentially fatal liver injury, according to Kissei Pharmaceutical, which sells the medicine in the country.
    • “Kissei told doctors Friday to stop prescribing the drug to new patients.
    • “The Japanese drugmaker said the 20 deaths occurred in people who had suffered a serious liver “impairment” and attributed 13 of the deaths to a condition, called vanishing bile duct syndrome, marked by the destruction of the ducts that carry bile out of the liver.
    • “Kissei said causal links to Tavneos hadn’t been confirmed in all 20 deaths.” * * *
    • “The medicine went on sale in Japan in 2022, according to Kissei. Also that year, Amgen bought the drug’s developer, ChemoCentryx, for $3.7 billion.
    • “In January, the FDA asked Amgen to voluntarily pull the drug from the U.S. market, but Thousand Oaks, Calif.-based Amgen refused.
    • “Then in March, the FDA said it had identified 76 global cases of serious liver injury linked to Tavneos, including eight deaths. Most were reported in Japan. Of the 76 global cases the FDA identified, seven involved the syndrome, and three of those patients died.
    • “In late April, the FDA moved to formally begin withdrawal proceedings.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 15, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue into May for some regions.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 51 new measles cases in a nationwide outbreak that has now reached 1,893 infections. All but nine cases are locally acquired, with the rest related to international travel.
    • “The agency reported two new outbreaks, for a total of 27. Last year the nation saw 48 outbreaks and 2,288 cases for the entire year. The United States could top that total in the coming months.
    • “Of this year’s cases, 21% involve children younger than 5 years, and 76% involve kids and young adults up to 19 years. Among all 2026 patients, 92% have been unvaccinated or have an unknown vaccine status. Six percent of patients this year have been hospitalized, compared with 11% last year.”
  • The American Hospital Association News relates,
    • “A Centers for Disease Control and Prevention report released May 14 found that U.S.-reported dengue cases in 2024 increased 359% above the annual average from 2010-2023. Dengue is a mosquito-borne viral disease that can cause mild to severe illness and death. There were 3,798 cases reported to the CDC in 2024, compared to the average of 828 from 2010-2023. The report found that 97.2% of cases in 2024 were travel-associated and that 2.8% were acquired locally. Individuals age 50-59 accounted for 21.8% of cases, and 57.5% of cases occurred in Hispanic or Latino individuals. In addition, 36.1% of patients were hospitalized and a total of six patients died. Most travel-linked cases were acquired in the Caribbean (34.1%), North America (24.3%) and Central America (15.6%).” 
  • Health Day informs us,
    • People who have survived a heart attack appear to have a higher risk of brain decline into dementia, a new study says.
    • On average, heart attack survivors have a yearly 5% increased risk of developing cognitive impairment, researchers reported today in the journal Stroke.
    • “Having had a heart attack in the past may speed up the decline in memory and thinking over time,” said lead researcher Dr. Mohamed Ridha, an assistant professor of neurology at Ohio State University in Columbus.
    • “Given the rising burden of dementia and cognitive decline among Americans, it is important to understand how cardiovascular disease affects their brain health,” Ridha said in a news release. “This knowledge can help heart attack survivors take steps to improve their brain health as they age.”
  • and
    • “Offering sigmoidoscopy screening reduces colorectal cancer (CRC) incidence in men and women — with a greater reduction among men — and reduces CRC mortality in men, according to a study published online May 12 in the Annals of Internal Medicine.
    • “Edoardo Botteri, Ph.D., from the Norwegian Institute of Public Health in Oslo, and colleagues report on the benefits of sigmoidoscopy after 23 years in a randomized controlled trial involving persons aged 50 to 64 years. A total of 100,210 persons were randomly assigned to screening with once-only sigmoidoscopy with or without one fecal immunochemical test or to no screening. The intention-to-screen analyses included 98,654 persons: 20,552 in the screening group and 78,102 in the no-screening group.
    • “The researchers found that the 23-year cumulative risk for CRC was 4.3 and 6.0 percent in the screening and no-screening groups, respectively, among men. The corresponding risks were 4.2 and 4.7 percent among women. In men, the 23-year cumulative risk for CRC death was 1.4 and 2.2 percent in the screening and no-screening groups, respectively, while in women, the corresponding risks were 1.3 and 1.4 percent. The strongest effect was seen for rectosigmoid cancer. Screening benefits were not changed with the addition of fecal blood testing.”
  • Healio adds,
    • “The survival benefit conferred by lung cancer screening in real-world settings may be smaller than observed in the pivotal trial on which national screening guidelines are based, study results suggest.
    • “Veterans receiving primary care in the VA health system exhibited a threefold higher risk for all-cause mortality than participants in the randomized National Lung Screening Trial (NLST) who had similar age and tobacco history.
    • “This is one of the first times we have been able to directly compare people who were enrolled in the trial with people in a real-world cohort who are eligible for screening,” Alison S. Rustagi, MD, PhD, assistant professor in University of California San Francisco’s department of medicine, told Healio. “It is not often that we see hazard ratios on the order of 3 in observational analyses. This shows a profound difference between these two populations.”
  • Per Medscape.
    • “Orforglipron, an oral GLP-1 receptor agonist, helps maintain weight loss after injectable therapies like tirzepatide and semaglutide, offering a practical continuation option for patients. Cardiometabolic benefits are largely preserved despite some weight regain.”
  • Per an National Institutes of Health news release,
    • “A group of pediatric eye disease researchers supported by the National Institutes of Health (NIH) has launched an open-access tool designed to help manage pediatric cases of amblyopia, a condition in which the brain fails to properly develop normal vision in one or both eyes early in life. It is the leading cause of preventable single-eye (monocular) vision loss, affecting three of every 100 children in the nation. The tool is aimed at expanding access to evidence-based amblyopia clinical-decision-making expertise amidst a shortage of pediatric eye care specialists in the United States.
    • “This online tool quickly distills the relevant literature into individualized treatment advice for busy clinicians anywhere with internet access. Those without internet access can utilize the article figures as clinical reference sheets,” said article lead author, Allison Summers, O.D., associate professor, Oregon Health & Science University, Portland.” * * *
    • “Known as the Amblyopia Navigator Decision-Support Instrument (ANDI), the tool is designed to guide any eye doctor through the diagnosis of amblyopia. Once amblyopia is diagnosed, ANDI helps to guide the eye care clinician without specialty training in pediatric eye care through management options. The tool helps the eye doctor determine the best glasses prescription for the patient based on a few clinical findings. The tool also helps the doctor determine how long to monitor whether glasses alone are improving vision, which can work for up to a third of children without any further treatment.
    • “If glasses are not enough, ANDI walks the eye doctor through next steps: patching the stronger eye for a couple of hours a day, using atropine eye drops to temporarily blur the stronger eye, or considering newer digital treatments delivered through specially designed games or videos. If a child stops making progress, the tool advises whether to increase the intensity of treatment, switch approaches, reassess the glasses prescription, or refer to a specialist. It provides steps for follow-up visits and what signs of recurrence to watch for after treatment ends. The tool can be used at an initial visit, or any follow-up visit in their amblyopia care journey.
    • “ANDI was developed by PEDIG, an NIH-funded research network with over 400 investigators, and it draws on evidence from 147 published studies. To access ANDI, go to https://public.jaeb.org/pedig.”

From the U.S. healthcare business and artificial intelligence front,

  • Mercer consulting offers “bold strategies” for payers to better control high cost members.
    • “While stop-loss coverage can help mitigate risk, many employers are finding it’s no longer enough. Unsurprisingly, “more focused management of high-cost claimants” is the top priority of large US health plan sponsors in their strategic planning for the next few years. In this post, we’ll discuss four areas where focused efforts can help employers rein in costs.”
      • Understand your data: Analyzing claims to gain clarity. 
      • Strategic oversight of medical specialty pharmacy and gene/cell therapies. 
      • Take a peekaboo view into neonatal intensive care unit management. 
      • Outlier inpatient stays.
  • Fierce Healthcare reports,
    • “CVS’ Omnicare unit has secured court approval to sell its business to virtual care company GenieRx Holdings, the healthcare giant announced Thursday.
    • “GenieRx, which offers an array of virtual health and medication services, is a joint partnership between Milrose Capital, a private equity firm, and Integro Asset Management, a healthcare-focused investment firm. Per court documents, the deal includes $250 million in cash as well as certain other liabilities, such as payroll expenses.
    • “In the announcement, CVS said that in combining with GenieRx, Omnicare will “have the opportunity to strengthen its service.” It will also continue to support it current clients in the lead up to closure, which is expected later this year, pending needed regulatory approvals.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.
    • Patients discontinue therapy early
    • Care models incompatible with sustained support
    • Costs and side effects deter patients.
  • Fierce Pharma tells us,
    • Total prescriptions for Eli Lilly’s Foundayo reached 10,248 for the week that ended May 8, up from 7,335 the prior week, according to IQVIA data cited by Citi. While still on the rise, Foundayo’s growth pace continued to lag behind that of Novo Nordisk’s Wegovy pill during the same stage of their launch. 
    • Wegovy’s total scripts rose by 1.3% week over week to nearly 446,000, as its share in the obesity GLP-1 market climbed 0.1 percentage point to 40.5%, according to Citi.
    • However, Wegovy’s growth apparently didn’t come from its oral formulation. Wegovy pill scripts landed at about 137,000 for the week, down from roughly 143,000 the prior week, marking the first time that the pill’s scripts have fallen since the oral launch in early January.
    • Scripts from the Wegovy pill made up 31% of total Wegovy scripts for the period, down 2 percentage points from the previous week. Still, Citi analysts argued that this roughly one-third of share “suggests preferences for oral formulations.”
    • Even as Wegovy gained ground, Lilly’s Zepbound remained the obesity market leader, with 59.5% share, as its nearly 656,000 scripts marked 0.8% growth week over week. 
  • Beckers Payer Issues offers payer perspectives on artificial intelligence tools.
    • “Using AI solutions to augment the work done by humans is an attractive solution for many payers.
    • “Getting started with these technologies, however, can feel daunting.
    • “To learn more about what it takes for payers to successfully incorporate AI and support more members, Becker’s Healthcare recently spoke with Chris Caramanico, CEO of Elligint Health, Amy Qureshi, RN, executive vice president of product strategy at Elligint Health, and Steven Tolle, chairman of the board at Elligint Health. Mr Tolle has significant experience developing and implementing AI from his time at IBM, Merge and IgniteData and addition serves as Chief of AI Strategy at Elligint Health.”
  • Fierce Healthcare adds,
    • Nearly 80% of payers now prefer implementing vendor-built artificial intelligence tools rather than developing internal capabilities, a new survey from Innovaccer found.
    • The survey draws insights from 63 health insurer organization leaders, including regional health plans to national carriers, the healthcare technology and AI company said in a press release. Respondents were polled in mid-December 2025 to mid-January, and include senior and C-suite executives.
    • Innovaccer CEO and co-founder Abhinav Shashank told Fierce Healthcare that the shift to outsourced solutions reflects the focus of how to “truly operationalize AI.” 
    • “What we are seeing is an emergence of how do you have platforms that companies can effectively offer that allow for more agentic orchestration,” Shashank said. “Because the reality of it is the technology is going to be a massive addition to how payers operate.” 
  • NBC News relates,
    • “Over the past two years, medical providers across America have quietly embraced a new AI tool called OpenEvidence to help them make clinical decisions, brush up on medical knowledge and even prepare for their licensing exams. The service, a sort of chatbot for doctors, was used by about 65% of U.S. doctors across almost 27 million clinical encounters in April alone, the company told NBC News.
    • “Everyone is using it,” said Dr. Anupam Jena, an internal medicine physician at Massachusetts General Hospital in Boston and a professor of healthcare policy at Harvard. “Its growth really has been exponential.”
    • “NBC News spoke with over two dozen doctors, hospital administrators, medical students and healthcare researchers from Hawaii to Maine to explore the rise of OpenEvidence. Each individual said they either used it regularly themselves or knew someone who did.
    • “Almost two-thirds of physicians — or roughly 650,000 doctors — in the U.S. actively use OpenEvidence, while another 1.2 million use it internationally, OpenEvidence representatives said. With its quick and tailored replies, OpenEvidence has become an AI-era equivalent of consulting a colleague for their expert opinion, though the software can also write patient discharge notes and provide custom study tools for doctors’ medical exams.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “If and when the next government shutdown rolls around, the laundry list of consequences will now include a pay freeze for U.S. senators.
    • “On a voice vote, the Senate passed a resolution from Sen. John Kennedy, R-La., that requires the Senate secretary to withhold compensation for the duration of a shutdown.
    • “The change in Senate rules is set to take effect on the date of the 2026 midterm elections to comply with the 27th Amendment to the Constitution, which prohibits a change in congressional salaries from being enacted until after an intervening election.
    • “The speedy passage, which followed a 99-0 procedural vote Wednesday, underscored a growing frustration among lawmakers with the frequency of partial shutdowns.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services has released details on downloading its upcoming fiscal year 2025 Program for Evaluating Payment Patterns Electronic Report, or PEPPER, for critical access hospitals. The report, set to release this month, summarizes provider-specific Medicare data statistics for areas often associated with improper Medicare payments due to billing, diagnosis related group coding and/or admission necessity issues. CMS said the report would be available through its PEPPER Portal to authorized officials, access managers and users with the staff end user business function in the CMS Identity and Access Management System. A guide and FAQ on accessing the PEPPER are also available for users.”
  • Tammy Flanagan, writing in Govexec, advises federal and postal employees that “Waiting to retire could be worth thousands of dollars.”
    • “Before you rush out the door, consider how a few more years of service can permanently boost your FERS annuity and Social Security benefits.”
  • Fierce Healthcare informs us,
    • “A new ad campaign takes aim at the “misaligned incentives” in the No Surprises Act arbitration process, arguing they “create a ‘fox guarding the hen house’ dynamic.”
    • “The seven-figure campaign from the Coalition Against Surprise Medical Billing, called “Judge Fox,” features a court battle between a pair of chickens and a pair of foxes. The chickens confer and say that a “reasonable judge” would not allow these foxes to freely set prices for medical bills.
    • “Then the judge also turns out to be a fox, meant to illustrate that private equity firms that own providers that purportedly flood the dispute resolution system may also operate the independent entities meant to mitigate these disputes.
    • “The coalition said in a press release that the campaign comes “amid mounting evidence that some private equity-backed providers and IDR middlemen are relentlessly abusing the IDR process to maximize their own profits at Americans’ expense.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “A lawyer is leading the FDA for the first time, after President Donald Trump‘s selection Tuesday of Kyle Diamantas to serve as acting commissioner after Marty Makary resigned.
    • “The promotion of Diamantas to acting FDA commissioner also marks the second time in history someone leading the agency’s food oversight has been put in charge, a move that comes as the Trump administration advances a range of food policy changes aligned with the “Make America Healthy Again” movement.”
  • Fierce Pharma relates,
    • “BeOne Medicines has entered the BCL-2 arena, securing an FDA green light for Beqalzi that carves out a unique piece of territory ahead of a potential broader clash with market leader Venclexta.
    • “The FDA has granted an accelerated approval to BeOne’s Beqalzi (sonrotoclax) for the treatment of patients with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy, including a BTK inhibitor, the company said Wednesday.
    • “The go-ahead makes Beqalzi the first BCL-2 inhibitor specifically approved for MCL in the U.S., as AbbVie and Roche’s first-to-market Venclexta has only been used off-label for this type of blood cancer.”
  • and
    • “Taiho Pharmaceutical nabbed an expanded FDA approval for its Inqovi, which can now be taken alongside AbbVie and Roche’s Venclexa (venetoclax) to treat newly diagnosed acute myeloid leukemia in patients who are 75 and older and ineligible for intensive induction therapy. 
    • “The therapy is the first all-oral combination treatment regimen cleared for this specific patient population and represents an alternative to standard-of-care parenteral hypomethylating agent-based regimens, which require frequent visits to the clinic. With a more convenient offering that can potentially reduce the overall treatment burden associated with receiving the standard-of-care at hospitals or infusion centers, Taiho figures that its approach can make a “meaningful impact for patients and caregivers,” chief medical officer Harold Keer, M.D., Ph.D. pointed out in a company release.” 
  • BioPharma Dive tells us,
    • “An experimental Duchenne muscular dystrophy gene therapy from Regenxbio has met its main objective in a pivotal trial, positioning the company to seek an accelerated regulatory clearance in the U.S.
    • “Three months after treatment with Regenxbio’s therapy, RGX-202, 28 of the 30 study participants receiving muscle biopsies produced at least 10% of normal levels of a diminutive protein, “microdystrophin,” believed to help Duchenne patients. That result hit the trial’s main goal and passed a key threshold needed to support an approval. Nine volunteers with at least one year of follow-up also demonstrated statistically significant improvements, from the study’s start, on multiple tests of motor function.
    • “Regenxbio did report two serious adverse events among treatment recipients — one case of heart inflammation and another of asymptomatic liver injury. Both were “easily managed and resolved within weeks” without further incident, and the average levels of liver inflammation markers in those who got RGX-202 didn’t surpass the “upper limit of normal.” Still, company shares fell by more than 35% as the safety findings “muddy the update,” wrote Leerink Partners’ analyst Mani Foroohar.”

From the judicial front,

  • Per Justice Department news releases,
    • “A federal jury in the Southern District of Florida convicted the founder and owner of HealthSplash yesterday for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.” * * *
    • “According to court documents and evidence presented at trial, Brett Blackman, 42, of Johnson County, Kansas, and his co-conspirators aggressively targeted hundreds of thousands of Medicare beneficiaries to get them to accept medically unnecessary orthotic braces and other items. They then arranged for purported telemedicine doctors to sign bogus prescription orders for these items, so that their co-conspirators could bill Medicare for them. All told, Blackman and his co-conspirators billed Medicare and other federal health care benefit programs over $1 billion for this unnecessary equipment.
    • “Blackman owned, controlled, and was the CEO of HealthSplash, which acquired Power Mobility Doctor Rx, LLC (DMERx) in September 2017. DMERx was an internet-based platform that generated false and fraudulent doctors’ orders for durable medical equipment (DME) and prescriptions for other items. As part of the scheme, Blackman and his co-conspirators connected pharmacies, DME suppliers, and marketers with telemedicine companies that would accept illegal kickbacks and bribes in exchange for signed doctors’ orders created using the DMERx platform. Blackman and his co-conspirators took a cut for themselves in exchange for the referrals.”
  • and
    • “Takeda Pharmaceuticals, U.S.A. Inc. has agreed to pay $13,670,921 to resolve allegations that it knowingly caused the submission of false claims to Medicare and other federal health care programs by paying kickbacks to healthcare providers to induce prescriptions of Trintellix, an antidepressant medication that Takeda marketed and sold to treat major depressive disorder.”
    • “The Department of Justice is committed to vigorously pursuing violations of the False Claims Act arising from illegal kickbacks,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “Such conduct can erode the trust that patients place in their healthcare providers and lead to higher drug costs for American taxpayers.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Health officials in the United States and around the world are assessing and managing potential exposures linked to the hantavirus outbreak on an expedition ship. Some of the American passengers on the ship are quarantining in Nebraska and Georgia. Others returned home earlier.” * * *
    • “David Fitter, the Centers for Disease Control and Prevention official leading the response, told reporters Thursday during a media briefingthat 41 people across the U.S. are under monitoring, but there are no cases.
    • “The people being monitored for symptoms fall into three groups. The first are the 18 passengers who were recently flown back to the United States from the Canary Islands and are being monitored in special facilities in Nebraska and Georgia. The second group comprises passengers who had already left the ship and returned home before the outbreak was identified. 
    • “In the third group are people who may have been exposed during flights with a known and symptomatic patient. That patient was the wife of the Dutch man, the first known patient to became sick, who died April 11 on board the ship. She left the ship and flew to Johannesburg, where she died on April 26.”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has isolated and mapped in detail the first comprehensive group of human antibodies targeting the measles virus. The findings reveal previously unknown details about how the human immune system fights measles and identify specific antibodies capable of reducing the virus to undetectable levels in an animal model. The research could serve as the foundation for development of a measles treatment.
    • “Measles cases have recently increased in the United States and worldwide. More than 470,000 measles cases were reported globally in 2024, and at least 72 outbreaks have been recorded in the United States since January 2025. While effective prevention in the form of vaccination is available, no safe and effective therapies have received regulatory approval in the United States. This leaves people who cannot safely receive the vaccine – the immunocompromised, pregnant women, and infants too young to be vaccinated – with a lack of medical options.
    • “With measles cases increasing, we urgently need effective therapeutics to protect the most vulnerable,” said Jeffrey K. Taubenberger, M.D., Ph.D., acting director of NIH’s National Institute of Allergy and Infectious Diseases. “This research gives us a clear picture for the first time of the most promising targets for antibody-based medicines that could protect or treat people for whom measles vaccination is not an option.”
  • Medscape tells us,
    • “Two new studies have identified risk factors that may be associated with the increasing incidence of colorectal cancer (CRC) among younger Americans.
    • “The majority of cases are sporadic, suggesting modifiable, nongenetic factors may play an important role,” said Mohamed Eldesouki, MD, internal medicine resident at New York Medical College at Saint Michael’s Medical Center in Newark, New Jersey, at Digestive Disease Week (DDW) 2026.
    • “In the first study, Eldesouki and colleagues identified a distinct phenotype, based on multiple factors, associated with an elevated risk in people aged 18-49 years. In addition, they found that inflammatory bowel disease, family history of CRC, severe obesity, and obesity were independent predictors that increased the risk for early-onset vs late-onset CRC more than twofold.
    • In the second study, a history of oral antibiotic exposure was associated with an increased risk for colorectal adenomas, especially among people with a greater or longer history of using these agents.”
  • Med Page Today informs us,
    • “Dementia with Lewy bodies — a disease characterized by faster progression and greater functional decline than Alzheimer’s disease — was confirmed as a predominantly late-onset dementia with incidence rising sharply with age, a systematic review and meta-analysis showed.
    • “Across 12 population-based studies, the pooled incidence was 46.85 per 100,000 person-years (95% CI 23.78-92.30) for people ages 65 and older, and the pooled prevalence was 352.26 per 100,000 population (95% CI 112.25-1,099.79), reported Daniele Urso, MD, MPH, of the University of Bari Aldo Moro in Italy, and co-authors in JAMANeurologyopens in a new tab or window.
    • “In people younger than 65, the pooled incidence was 0.34 per 100,000 person-years (95% CI 0.14-0.83) and the prevalence was 2.52 per 100,000 population (95% CI 1.43-4.44).”
  • Health Day points out,
    • “Women entering menopause are twice as likely to have lower heart health scores than those still having regular periods, a new study says.
    • “Perimenopausal women are more likely to have high cholesterol and blood sugar levels, researchers reported today in the Journal of the American Heart Association.
    • “These problems likely are fueled by varying estrogen levels, which can negatively affect cholesterol, insulin resistance, blood pressure and weight, researchers said.
    • “But diet also plays a powerful role, with women’s healthy nutrition scores declining as they begin and then enter menopause, the study found.
    • “Mid-life women should think of the perimenopausal period as a ‘window of opportunity.’ They should be proactive and not wait until they reach menopause to start checking their blood pressure, cholesterol and blood sugar levels,” said senior researcher Dr. Garima Arora, an professor of medicine at the University of Alabama at Birmingham.”
  • and
    • “Abdominal obesity (AO) is associated with a higher prevalence and greater severity of menopausal symptoms, according to a study published online May 5 in Menopause.” * * *
    • “Educating women early about healthy lifestyle interventions to prevent midlife weight gain is key to improving mental and physical well-being during a tumultuous time frame,” Monica Christmas, M.D., associate medical director for The Menopause Society, said in a statement.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Companies such as UnitedHealth Group, CVS Health, Cigna and Centene recorded strong first quarters.
    • “Earnings reports suggest chronically high medical costs may be subsiding.
    • “Insurers outperformed Wall Street expectations and upgraded earnings guidances, driving share prices higher.
    • “Seasonal factors, a shift toward higher-deductible plans and incomplete claims data cloud insights into cost trends.”
  • and
    • “UnitedHealth Group division Optum Rx has rolled out a new pharmacy benefit manager model the company describes as transparent.
    • “Optum Rx, first in PBM market share, will phase out practices tying revenue to drug prices and shift toward fees.
    • “The company is attempting to respond to criticisms from its customers, the public and policymakers about how PBMs operate.
    • “Chief rivals CVS Caremark and Express Scripts previously announced similar changes.”
    • * * * “The fact that we’re having this discussion shows progress,” said Robert Andrews, CEO of the Health Transformation Alliance, a coalition of large employers that lobbies Congress.”
  • The Wall Street Journal relates,
    • “Much of the public debate over cancer blood tests has focused on early detection products like the Galleri test from a company called Grail, which promises to screen healthy people for more than 50 types of cancer. 
    • “While these tests capture headlines and Super Bowl ads, the more proven opportunity for investors has been in a less glamorous market: checking for cancer recurrence.
    • For a patient who has just had a tumor surgically removed, the critical question is whether every cancer cell is gone. Many oncologists now use blood tests to answer that question months before a traditional scan could. 
    • “Natera NTRA, based in Austin, Texas, holds a near-monopoly in this market, known as minimal residual disease (MRD) testing. Its stock has roughly quadrupled over three years. The company is now valued at about $31 billion, making it the dominant player in what may be a new era of blood-based cancer testing. It has even surpassed Illumina, the sequencing giant on whose technology much of the industry depends. Revenue has grown from roughly $1 billion in 2023 to $2.3 billion last year and is projected by analysts on FactSet to reach $2.77 billion this year.”
  • and
    • “Merck KGaA lifted its full-year sales and earnings guidance, causing its shares to rise 8.2% in European midday trading.
    • “The company now forecasts net sales of 20.4 billion to 21.4 billion euros and organic sales growth of up to 3%.
    • “Merck cited strong momentum in its life-sciences unit and greater resilience in its healthcare division for the improved outlook.”
  • and
    • “State laws restricting private-equity involvement in the medical sector have taken their first scalps, as authorities signal an aggressive approach to enforcement.
    • “Last year, lawmakers in California and Oregon passed measures to prevent corporate healthcare investors from encroaching on medical care, part of a broad backlash against private equity’s role in the sector.
    • “The new laws started to bite last week. In California, Attorney General Rob Bonta unveiled the first settlement for violating the new law, penalizing Aspen Dental Management, which is backed by asset managers Leonard Green & Partners and Ares Management.
    • “Just a day earlier, Oregon hospital operator PeaceHealth scrapped plans to bring in an out-of-state medical-staffing company after a federal judge said the move looked like an end-run around the state’s strictest-in-the-nation ban on corporate medicine.”
  • Beckers Hospital Review tells us,
    • “Becker’s has compiled a list of the hospitals with a CMS 5-star rating for cleanliness.
    • “CMS’ Patient survey (HCAHPS)-Hospital database listed hospital ratings based on the Hospital Consumer Assessment of Healthcare Providers and Systems surveys. This is a national, standardized survey of hospital patients about their experience during a recent inpatient hospital stay. The surveys were completed between July 1, 2024, and June 30, 2025. The data was updated May 13. 
    • “In 2025, 374 hospitals had a five-star cleanliness rating and Wisconsin had the most highly rated hospitals for cleanliness at 30.
    • “This year, 22 more hospitals made it to 5-star ratings, and Texas had the hospitals recognized for cleanliness with 36.”
    • The article includes the list.
  • and
    • Americans are unlikely to see generic versions of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — until at least the end of 2031, according to a May 13 NBC News report.
    • Novo Nordisk first applied for a U.S. patent on semaglutide in 2006. While standard drug patents last 20 years, patent extensions and secondary patents have delayed generic competition in the U.S., experts told NBC News.
  • and
    • “Lentocilin, a penicillin G benzathine product, is back in stock and available to hospitals, clinics and pharmacies nationwide on Cost Plus Drugs’ marketplace.
    • “The restock comes as healthcare organizations continue managing supply disruptions affecting penicillin G benzathine products across the market, according to a May 11 company news release.
    • “Penicillin G benzathine is the only recommended treatment for syphilis during pregnancy and for preventing congenital syphilis — a condition whose national diagnosis rate has risen 203% over five years, according to an alert from the New Mexico Department of Health. The branded equivalent, Bicillin L-A, has been in shortage since 2023 and was further disrupted by a Pfizer recall in July 2025 due to particulates in prefilled syringes.” 
  • MedTech Dive points out,
    • “Johnson & Johnson has launched a new iteration of its Shockwave coronary intravascular lithotripsy catheter that is designed to make it easier for physicians to treat complex calcified lesions and restore blood flow in the arteries.
    • “Called Shockwave C2 Aero, the improvements in the fifth-generation platform are intended to allow clinicians to use the catheter in a broader range of cases. 
    • “The device is available in the U.S. and Japan and will be introduced in Europe and Canada in the coming months, J&J said Tuesday.”
  • Beckers Payer Issues discusses “How AI is turning UnitedHealth, CVS and Elevance into software companies.”