FEHBlog

Weekend update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Senate maintains a daily Executive Calendar. There are now eight nominees whose names were reported to the Senate floor before Scott Kupor. According to the unanimous consent resolution page in the front of the calendar, the Senate will consider tomorrow the nominations of the earliest reported nominee David Fotouhi (March 13) and two nominees reported in May after Mr. Kupor (April 9). The FEHBlog think that this is the pattern that the Senate leadership is following, which means that the Senate is likely to take up Mr. Kupor’s nomination later this month. 
  • Roll Call summarizes expected Congressional activities for this week here.
    • As Senate committees continue to release their proposals for the House-passed reconciliation package this week, the House plans to vote on President Donald Trump’s proposals to rescind foreign aid and other spending, including for public broadcasting.
    • “The rescissions request sent to Congress by the Trump Administration takes the federal government in a new direction where we actually cut waste, fraud, and abuse and hold agencies accountable to the American people,” House Majority Leader Steve Scalise, R-La., said in a statement.
  • The Supreme Court will be issuing another batch of opinions this coming Thursday.
  • Last Thursday, HR Dive tells us,
    • “A federal appeals court’s “background circumstances” requirement for majority-group plaintiffs who seek to prove job discrimination cuts against both Title VII of the 1964 Civil Rights Act and U.S. Supreme Court precedent, Justice Ketanji Brown Jackson wrote for a unanimous SCOTUS on Thursday.
    • “The court reversed the 6th U.S. Circuit Court of Appeals’ decision in Ames v. Ohio Department of Youth Services, which had dismissed a heterosexual woman’s claim that she was unlawfully passed over for a promotion in favor of a lesbian woman and subsequently demoted, after which a gay man was hired to fill her original role. The plaintiff alleged that those decisions constituted illegal discrimination on the basis of her sexual orientation, which the Supreme Court has said is a form of sex-based discrimination under Title VII.
    • “The 6th Circuit held that the plaintiff could not show background circumstances to support her suspicion that her employer discriminated against her on the basis of her status as a member of a majority group.
    • “Justice Jackson, however, wrote that such requirements flout the Supreme Court’s case law, which “makes clear that the standard for proving disparate treatment under Title VII does not vary based on whether or not the plaintiff is a member of a majority group.”
    • “The court vacated and remanded the case to the 6th Circuit for further proceedings.”
  • Federal News Network interviews Tammy Flanagan about “what retiring feds need to know about their benefits in transition.”
    • “Timing is everything when thinking about when to drop your retirement paperwork. Understanding what happens to your leave balances, health insurance, and survivor benefits can inform that decision. Hear with more on those key considerations is the Founder and Principal Retirement specialist at Retire Federal, Tammy Flanagan.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “A new gene-tracking study in Nature shows that mpox spread among people in Nigeria for 8 years before it sparked a global outbreak in 2022.
    • “Using genomic tracing, researchers from Nigeria, the United States, Cameroon, Ethiopia, and Belgium estimate that the ancestor of the clade 2 mpox virus (mpxv) that ignited an international outbreak beginning in May 2022 first emerged in southern Nigeria in August 2014 and spread to 11 Nigerian states before human infections were detected in 2017. 
    • “In light of the findings, the authors write, “We need improved surveillance in the wildlife population in the forest systems to better understand the transmission and maintenance of MPXV in animal hosts,” as well as better human surveillance.
    • “We could have very easily prevented the 2022 multi-country outbreak if countries in Africa were given better access to therapeutics, vaccines, and surveillance technologies,” says first author Edyth Parker, PhD, MPhil, a researcher with the Institute of Genomics and Global Health and with the International Biosecurity and Biosafety Initiative for Science, in a Scripps Research news release. “In a vulnerably connected world, we cannot neglect epidemics until they get exported to the Global North.”
  • Medscape offers these reports from the recent American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • Changing the prescribing protocol for low-dose aspirin (LDA) for preeclampsia prevention from risk-based to universal significantly increased aspirin use in pregnant patients, based on new data presented at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • The use of LDA to reduce the risk for preeclampsia has been well established as an inexpensive and simple intervention, but it has remained underutilized nationwide, said lead author Meryl Y. Grimaldi, MD, of SBH Health System, New York City, in an interview.
    • “Many of the patients we care for at SBH Health are at high risk for preeclampsia, but we wanted to ensure that our eligible patients received the benefits of this intervention,” said Grimaldi, who presented the study at the meeting.
  • and
    • “Clinicians need to discuss and offer all patients a variety of pain management options for in-office gynecologic procedures ranging from intrauterine device (IUD) insertion to biopsies, according to new guidance published by the American College of Obstetricians and Gynecologists (ACOG). The guidelines, published on May 15, are the first formal ones from ACOG to not only acknowledge the range of pain experiences that can be associated with different procedures but also to explicitly lay out recommendations for the conversations providers should have with their patients about what pain management options are available.
    • “This guidance speaks to more than just Ob/Gyns,” Co-Author Genevieve Hofmann, DNP, women’s health nurse practitioner and assistant professor of Ob/Gyn at the University of Colorado School of Medicine in Aurora, Colorado, said during a discussion with the press on May 17 at American College of Obstetricians and Gynecologists (ACOG) Annual Meeting in Minneapolis. “It speaks to any physician who’s providing these types of services and certainly to advanced practice registered nurses who work in women’s health and provide these services.”
  • Medscape adds,
    • Regeneron said on Monday [June 2, 2025,] its experimental drug helped patients preserve up to 51% of lean mass and lose more fat when used in combination with Novo Nordisk’s popular obesity drug Wegovy in a mid-stage trial. 
    • In the 599-patient study, those on Wegovy alone lost about 7.9 pounds of muscle, while those on a combination of Regeneron’s trevogrumab and Wegovy lost up to 4.2 pounds. 
    • The combination helped patients shed up to 11.3% of their body weight compared with 10.4% for those on only Wegovy. 
    • The results mark an early win for Regeneron in the race against nearly a dozen companies to develop obesity treatments that preserve muscle, as they vie for a share of the potential $150 billion weight-loss drug market. 

From the U.S. healthcare business front,

  • Medical Economics “spoke with Mark McClellan, M.D., Ph.D., director, Duke-Margolis Institute for Health Policy, and a former administrator at CMS, about why value-based care hasn’t been adopted more quickly.” and let us know that “New Marit Health data from May, 2025, reveal that physicians feel most satisfied where compensation aligns with cost of living, practice expectations and quality of life. These 10 states show that perceived fairness matters just as much as raw earnings.”
  • The Wall Street Journal reports,
    • Unexpected healthcare costs can arise in retirement, such as uncovered drugs, isolation and concierge care.
    • Medicare Part D may not cover all drugs, potentially leading to high out-of-pocket expenses for uncovered medications.
    • Retirees may face unexpected travel costs for medical care based on retirement location or feel compelled to pay for concierge medical care.
  • All PSHB plans and Most FEHB plans offer Medicare Part D plans which are integrated with the regular plan formulary, thereby reducing one of the Journal’s identified risks.
  • Per BioPharma Dive,
    • “Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of the pharmaceutical industry’s largest licensing deals.
    • “One of those medicines, the antibody-drug conjugate Enhertu, again took the spotlight at the American Society of Clinical Oncology’s annual meeting here, showing potential to become part of standard therapy for the frontline treatment of advanced breast cancer. It did the same in 2022 and 2024.
    • “Okuzawa can point to Enhertu and four other antibody-drug conjugates Daiichi Sankyo’s developing with AstraZeneca and Merck & Co. as proof of the strength of its research laboratories. By 2030, the company plansto have these five “ADCs” approved across more than 30 tumor types, which would allow it to treat nearly 400,000 cancer patients each year.
    • “We’d like to become one of the most important players in oncology,” said Okuzawa, noting aspirations to crack the top 10 companies by cancer drug sales. “Our senior leaders are now talking about not only top 10, but maybe top 5. We’re very much confident in our ADCs.”
  • Per Fierce Healthcare,
    • Neuroscience technology company Brooklyn Health is using artificial intelligence to target a fundamental problem in neurology and psychiatry: the flawed approach to mental health outcomes measurement.
    • The startup aims to modernize mental health measurement and scoring in central nervous system (CNS) drug development, an area of CNS research that faces limitations in objectivity and standardization. 
    • “Clinical interviews, the standard for symptom assessment, are fundamentally unreliable and imprecise,” said Anzar Abbas, Ph.D., a neuroscientist and founder of Brooklyn Health, in an interview.
    • “Brooklyn’s platform uses AI and digital phenotyping methods it developed to evaluate the quality and scoring of clinical interviews in real time.” * * *
    • “Brooklyn’s current focus in on drug development and central nervous system clinical trials to improve outcome measurement, essentially, how well a drug is working. But the company has ambitions beyond clinical trials to support outcome measurement across all forms of behavioral health delivery, including in-clinic psychiatric care and virtual mental health platforms.” 
  • The Washington Post reports on a smartphone app Death Clock AI that predicts how many years a user has left before beginning to push daisies as they day.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Yesterday, the President issued a cybersecurity executive order. Here is a link to related fact sheet.
  • Federal News Network adds,
    • “President Donald Trump has signed a new cybersecurity executive order that continues many of the policies of his predecessors, while also marking out some key changes in the approach to software security, digital identity and more.
    • “The new executive order, “Sustaining Select Efforts to Strengthen the Nation’s Cybersecurity,” modifies many aspects of a cyber EO signed by President Joe Biden in January. It also makes changes to executive orders signed by President Barack Obama to focus federal cybersecurity law enforcement efforts on foreign nationals.
    • “But Trump’s new EO continues key aspects Biden directives, including an effort to strengthen the Cybersecurity and Infrastructure Security Agency’s role in defending civilian federal networks.” * * *
    • “The latest cybersecurity executive order also maintains federal efforts around post-quantum cryptography, Border Gateway Protocol, and advanced encryption.
    • “But it eliminates the January order’s directive for agencies to require federal software vendors to provide evidence of following secure development practices.
    • “Instead, Trump directs the National Institute of Standards and Technology to establish a new consortium with industry “that demonstrates the implementation of secure software development, security, and operations practices” based on NIST’s Secure Software Development Framework.”
  • Per Cybersecurity Dive,
    • “Trump’s elimination of Biden’s software security requirements for federal contractors represents a significant government reversal on cyber regulation. Following years of major cyberattacks linked to insecure software, the Biden administration sought to use federal procurement power to improve the software industry’s practices. That effort began with Biden’s 2021 cyber order and gained strength in 2024, and then Biden officials tried to add teeth to the initiative before leaving office in January. But as it eliminated that project on Friday, the Trump administration castigated Biden’s efforts as “imposing unproven and burdensome software accounting processes that prioritized compliance checklists over genuine security investments.”
    • “Trump’s order eliminates provisions from Biden’s directive that would have required federal contractors to submit “secure software development attestations,” along with technical data to back up those attestations. Also now eradicated are provisions that would have required the Cybersecurity and Infrastructure Security Agency to verify vendors’ attestations, required the Office of the National Cyber Director to publish the results of those reviews and encouraged ONCD to refer companies whose attestations fail a review to the Justice Department “for action as appropriate.”
  • Cyberscoop reports,
    • “Sean Cairncross laid out his vision to senators Thursday for the Office of the National Cyber Director if he is confirmed to lead it.
    • “A goal of mine is to make sure this office sits at the place that this committee and I believe Congress intended in the statute, and that is to lead cyber policy coordination across the federal government,” he told the Homeland Security and Governmental Affairs Committee at his confirmation hearing.
    • “In doing that, working with our interagency partners is vital,” he said. “We’ve been empowered to work with [the Office of Management and Budget] to ensure that budget alignment among the interagency aligns with administration policy, and I think those tools have to be leveraged, and relationships between us and the interagency — it’s making sure that it is monitored and enforced.”
  • Cybersecurity Dive adds,
    • “Two coalitions of cybersecurity companies, professional associations and experts have endorsed Sean Plankey and Sean Cairncross, President Donald Trump’s nominees to serve as director of the Cybersecurity and Infrastructure Security Agency and national cyber director, respectively.
    • “Plankey and Cairncross’s backers include executives at cybersecurity firms, former senior government officials from administrations of both parties and leaders of trade groups and think tanks.”
  • Per Bleeping Computer,
    • “The U.S. Department of State has announced a reward of up to $10 million for any information on government-sponsored hackers with ties to the RedLine infostealer malware operation and its suspected creator, Russian national Maxim Alexandrovich Rudometov.
    • “The same bounty covers leads on state hackers’ use of this malware in cyber operations targeting critical infrastructure organizations in the United States.
    • “This bounty is posted as part of the Department of State’s Rewards for Justice program established by the 1984 Act to Combat International Terrorism, which rewards informants for tips that help identify or locate foreign government threat actors behind cyberattacks against U.S. entities.”
  • Per Cyberscoop,
    • “Federal authorities on Thursday [June 5, 2025] said they seized $7.74 million from North Korean nationals as they attempted to launder cryptocurrency obtained by IT workers who gained illegal employment and funneled the wages to the North Korean regime.
    • “The allegedly illegally obtained funds were linked to Sim Hyon Sop, a representative of North Korean Foreign Trade Bank, and Kim Sang Man, CEO of Chinyong, an outfit associated with North Korea’s Ministry of Defense, the Justice Department said. Both North Korean nationals were added to the Treasury Department’s Office of Foreign Assets Control’s list of sanctioned individuals in 2023.
    • “The cryptocurrency seizure marks another action in a series of long-running law enforcement efforts to identify and prevent North Korean operatives from gaining employment at companies, evading U.S. sanctions, and sending payroll back to the North Korean government.”
  • Per Security Week,
    • “German authorities have named Russian national Vitaly Nikolaevich Kovalev as the founder and leader of the TrickBot cybercrime gang.”
    • “Established in 2016, the TrickBot group is believed to have infected millions of computers worldwide, exfiltrating sensitive information such as credentials, banking and credit card details, and personal information, while also enabling the deployment of other malware, such as ransomware.
    • “Authorities targeted TrickBot’s infrastructure in takedown attempts in 2020 and 2024 and announced charges and sanctions against over a dozen group members in 2023, including Kovalev, believed at the time to be a senior figure within the cybercrime ring.”

From the cybersecurity vulnerabilities and breaches front,

  • CISA added nine known exploited vulnerabilities to its catalog this week.
  • Bleeping Computer tells us,
    • “A threat actor has re-released data from a 2021 AT&T breach affecting 70 million customers, this time combining previously separate files to directly link Social Security numbers and birth dates to individual users.
    • “AT&T told BleepingComputer that they are investigating the data but also believe it originates from the known breach and was repackaged into a new leak.
    • “It is not uncommon for cybercriminals to repackage previously disclosed data for financial gain. We just learned about claims that AT&T data is being made available for sale on dark web forums, and we are conducting a full investigation,” AT&T told BleepingComputer.”
  • andD
    • “Cisco has released patches to address three vulnerabilities with public exploit code in its Identity Services Engine (ISE) and Customer Collaboration Platform (CCP) solutions.
    • “The most severe of the three is a critical static credential vulnerability tracked as CVE-2025-20286, found by GMO Cybersecurity’s Kentaro Kawane in Cisco ISE. This identity-based policy enforcement software provides endpoint access control and network device administration in enterprise environments.
    • “The vulnerability is due to improperly generated credentials when deploying Cisco ISE on cloud platforms, resulting in shared credentials across different deployments.”
  • Dark Reading informs us,
    • “ClickFix campaigns are gaining steam according to various security researchers, with recent campaigns spotted across the globe from a wide swath of cyberattackers. The increasingly popular tactic represents a significant new evolution for social engineering, researchers say — and enterprises need to take note.
    • “ClickFix activity has been snowballing: Darktrace said yesterday that it recently identified multiple ClickFix attacks across customer environments in Europe, the Middle East, and Africa (EMEA), and in the United States; while SlashNext, in a separate report, detailed an unusual version of the attack vector that impersonates Cloudflare Turnstile, which is the Web protection company’s CAPTCHA-like Turing test. Also, this week, Cofense outlined a campaign that spoofed Booking.com CAPTCHAs, targeting hotel chains with remote access Trojans (RATs) and infostealers.”
  • and
    • The Federal Burau of Investigation (FBI) warned that cybercriminals are compromising Internet of Things (IoT) devices connected to home networks through the BADBOX 2.0 botnet.
    • The BADBOX 2.0 botnet was discovered several months ago after the original BADBOX campaign was disrupted in 2024. Human Security’s Satori Threat Intelligence and Research team, alongside Google, Trend Micro, the Shadowserver Foundation, and others, were able to partially disrupt the “complex and expansive” BADBOX 2.0 operation, noting that it remains the largest botnet of infected connected TV (CTV) devices ever uncovered.
  • Per Cybersecurity Dive,
    • “A financially motivated hacker group has been targeting Salesforce instances for months in a campaign that uses voice phishing to engage in data theft and follow-on extortion attempts, according to Google Threat Intelligence Group. 
    • “The hackers, whom Google tracks as UNC6040, impersonated IT workers and tricked employees at often English-speaking branches of multinational companies into sharing sensitive credentials that were then used to access the organizations’ Salesforce data, Google said in a blog post published Wednesday.
    • “As part of the social engineering campaign, the hackers tricked workers at these companies into visiting the Salesforce-connected app setup page, at which point the attackers used an unauthorized, malicious version of the Salesforce Data Loader app to access and steal sensitive information from the customers’ Salesforce environments. 
    • “Beyond the immediate data thefts, the hackers were able to move laterally within target networks, accessing victims’ other cloud services and moving into internal corporate networks.”

From the ransomware front,

  • The American Hospital Association warns,
    • “The FBI, Cybersecurity and Infrastructure Security Agency and Australian Cyber Security Centre June 4 released an advisory on updated actions and tactics used by the Play ransomware group. The group, active since 2022, has impacted a wide range of businesses and critical infrastructure in North America, South America and Europe. As of May, the FBI was aware of about 900 victims allegedly exploited by the group’s efforts.
    • “The threat actors are presumed to be a closed group, designed to “guarantee the secrecy of deals,” according to a statement on the group’s data leak website. They employ a double-extortion model that encrypts systems after exfiltrating data. Their ransom notes do not include an initial ransom demand or payment instructions. Instead, victims are instructed to contact the threat actors via email.
    • “Play ransomware was among the most active cyberthreat groups in 2024,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “This report highlights their evolving tactics, and health care cybersecurity teams should be aware of the changes.  As threat actors shift tactics, it is critical that network defenders keep pace. The double-layered extortion model and encryption of systems, as well as theft of data, pose a serious potential risk to hospitals and the delivery of health care.”
  • Cybersecurity Dive adds,
    • “Since mid-January, multiple ransomware groups, including initial access brokers affiliated with Play, have targeted vulnerabilities in a remote support tool called SimpleHelp. Researchers disclosed those flaws in January.  
    • “The new advisory updates the government’s original December 2023 warning about the Play ransomware group, which is also known as PlayCrypt. The hackers have previously been blamed for attacks targeting ConnectWise ScreenConnect and Rackspace. 
    • “The recent attacks exploiting SimpleHelp involve three flaws discovered by security firm Horizon3.ai.”
  • Bleeping Computer lets us know,
    • “Healthcare giant Kettering Health, which manages 14 medical centers in Ohio, confirmed that the Interlock ransomware group breached its network and stole data in a May cyberattack.
    • “Kettering Health operates over 120 outpatient facilities and employs over 15,000 people, including over 1,800 physicians.
    • “The healthcare network noted in a Thursday statement that its network devices have been secured, and its team is now working on re-establishing communication channels with patients disrupted by the outage triggered by last month’s ransomware attack.”
  • Security Week adds,
    • “American media company Lee Enterprises revealed this week that the disruptive cyberattack it dealt with earlier this year resulted in a data breach impacting nearly 40,000 individuals.
    • “Lee Enterprises owns 350 weekly and specialty publications across 25 states, and dozens of them suffered disruptions in February as a result of a ransomware attack that involved the encryption of critical applications and the theft of files.
    • “The company informed the Maine Attorney General’s Office this week that it recently completed its investigation into the incident and determined that personal information was compromised.
    • “According to Lee Enterprises, the attackers may have obtained the information of 39,779 people, including their names and Social Security numbers.
    • “Affected individuals are being offered 12 months of free credit monitoring and identity protection services.”
  • Honeywell lets us know,
    • “In a growing wave of sophisticated cyber threats against the industrial sector, ransomware attacks jumped by 46% from Q4 2024 to Q1 2025, according to Honeywell’s new 2025 Cybersecurity Threat Report. The research also found that both malware and ransomware increased significantly in this period and included a 3,000% spike in the use of one trojan designed to steal credentials from industrial operators.”
    • “To learn more and download the full report, visit our website.”

From the cybersecurity business and defenses front,

  • Cybersecurity Dive reports,
    • “Microsoft and CrowdStrike will lead a cooperative effort to map out the overlapping web of hacker groups that their researchers have disclosed and named, the companies said on Monday. 
    • “Palo Alto Networks and Google and its Mandiant unit have also agreed to join the collaborative effort on streamlining threat group taxonomy.
    • “For years, the companies’ different naming conventions for various criminal and state-linked threat groups have created unnecessary confusion and delays in the sharing of threat intelligence.
    • “Microsoft and CrowdStrike released an initial version of their threat actor matrix on Monday, listing the groups they track and each one’s corresponding aliases from other researchers.
    • “Palo Alto Networks and Google and its Mandiant unit are joining the collaborative effort on streamlining threat group taxonomy.”
  • The Wall Street Journal reports,
    • “CrowdStrike swung to a loss in the fiscal first quarter and posted a lower-than-expected outlook, as the costs of its outage last summer continue to weigh on results.
    • “The cybersecurity company said Tuesday its revenue is still being hurt by an incentive program it launched last year to try to retain customers after a widespread software outage in July.
    • “CrowdStrike had implemented a customer-commitment program, which let customers try some products for free, and was weighing on its subscription revenue. The program wrapped up at the end of fiscal-year 2025, but its effects are lingering.”
  • Dark Reading tells us,
    • “F5 this week announced the acquisition of Fletch, a San Francisco-based startup with agent-based artificial intelligence (AI) technology that analyzes massive amounts of threat intelligence data and remediates the most severe vulnerabilities in real time.
    • “Terms of the deal were not disclosed, but most of Fletch’s 15 employees have joined F5, which was seeking the technology and expertise to bring agentic AI capabilities to the recently introduced F5 Application Delivery and Security Platform (ADSP).”
  • Help Net Security points out,
    • “Cybersecurity leaders and consultants identified AI-driven automation and cost optimization as top organizational priorities, according to Wipro. 
    • “30% of respondents are investing in AI automation to enhance their cybersecurity operations. AI-driven automation can help in detecting and responding to threatsmore quickly and accurately, thereby reducing the need for extensive manual intervention. 
    • ‘26% of respondents are focusing on tools rationalization. This approach involves evaluating and consolidating duplicate security tools across platforms to eliminate redundancies and improve efficiency while reducing costs. 
    • “Another significant area is security and risk management process optimization, with 23% of organizations targeting this for cost savings. Streamlining these processes can lead to more effective risk management and better allocation of resources. Apart from these priorities, 20% are focusing on simplifying operating models to achieve better visibility and faster response across reduced attack surfaces.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–AHRQ, CDC, Congress, COVID-19, Employee Wellness Programs, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News reports,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Andy Kim, D-N.J., June 5 reintroduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with continuing its efforts addressing sepsis care. The agency’s work would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, and developing and implementing a sepsis outcome measure.
    • “The bill would also require a report on a sepsis outcome measure and a congressional briefing on the CDC’s sepsis activities. Additionally, the legislation includes a voluntary recognition program for hospitals that maintain effective sepsis programs or improve their programs over time.”
  • and
    • “The House June 4 passed the AHA-supported SUPPORT Act (H.R. 2483) by a 366-57 vote. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder, including programs to support the behavioral health workforce.”
  • Federal News Network tells us,
    • “More federal employees filed retirement papers with the Office of Personnel Management in May than in the last three months. OPM said it received more than 15,000 claims last month, driving the backlog up over 21,000. The processing time for these retirement claims remain consistent at 49 days on average in May and 52 days on average for the entire 2025. The increase in applications comes as OPM is requiring agencies to send retirement paperwork only in digital formats by July 15. OPM launched two new tools this week to improve the retirement services process. One is a new platform for agency HR and payroll providers and another to modernize the Electronic Official Personnel Folder (eOPF) platform.”
  • CMS shared “Federal Independent Dispute Resolution (IDR) Technical Assistance for Certified IDR Entities and Disputing Parties –June 2025 — Topic: Errors Identified After Dispute Closure.”
  • BenefitFocus discusses “Health Care Transparency 2.0 – What Might We See in Forthcoming Transparency Regulations.”

From the Food and Drug Administration front,

  • Per BioPharma Dive, “FDA meeting gives window into gene therapy field’s angst. Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.”
  • Per MedTech Dive,
    • “Medtronic is recalling certain tracheostomy tubes because of the risk that the devices could dislodge, causing an emergency where the patient cannot breathe or their airway is blocked, according to a Thursday Class I recall notice from the Food and Drug Administration. 
    • “The company sent a notice to customers on Feb. 26 asking them to quarantine and return all unused tubes from the affected lot. The recall applies to the Shiley adult flexible tracheostomy tube with taperguard cuff reusable inner cannula.
    • “Medtronic began the recall after receiving reports from customers that the flange used to secure the device may become disconnected. Patient harm was reported in some cases, but no deaths have been reported to date, a company spokesperson wrote in an email Thursday.”
  • BioPharma Dive relates,
    • “Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug it’s developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Vera’s therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies’ Farzin Haque cautioned not to “overinterpret the data” and argued the two datasets “are not clinically or statistically different for commercial uptake.” The Food and Drug Administration could approve Otsuka’s drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter.”

From the judicial front,

  • Beckers Hospital Review informs us,
    • “The CEO of a healthcare software company was convicted by a federal jury for his role in operating a platform that generated fraudulent physicians’ orders to defraud Medicare and other payers out of more than $1 billion.
    • “Gary Cox, 79, of Maricopa County, Ariz., was the CEO of Power Mobility Doctor Rx (DMERx), an internet-based platform that generated fraudulent orders for unnecessary orthotic braces, pain creams and other items, according to a June 3 Justice Department news release.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity is low and emergency department visits and laboratory percent positivity are at very low levels.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The AHA News lets us know,
    • “There have been 1,168 confirmed cases of measles across 33 states as of June 6 this year, according to the latest data from the Centers for Disease Control and Prevention. This year’s figure is more than four times higher than the 2024 total of 285 cases. There have been 17 outbreaks this year, and 89% of confirmed cases (1,040 of 1,168) are outbreak-associated. The vaccination status of 95% of all cases is classified as “unvaccinated or unknown.” 
  • Of note, Health Day warns us,
    • “An afternoon snooze might seem appealing to middle-aged folks and seniors, but these naps could carry a high cost.
    • “People with certain types of napping patterns have a greater risk of an early death, researchers are slated to report at an upcoming meeting of the American Academy of Sleep Medicine (AASM).
    • “People who slept longer during the day, had irregular daytime sleep patterns, or slept more around midday and early afternoon were at greater risk, even after accounting for health and lifestyle factors,” lead researcher Chenlu Gao, a postdoctoral research fellow at Massachusetts General Hospital in Boston, said in a news release.
    • “The findings call into question the whole concept of the “power nap.”
  • HHS’s AHRQ posted a report about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • Per HR Dive,
    • “Work can either fuel employee well-being or become a source of strain for employees already stressed out by economic volatility and political tension, according to a May 12 survey of employee mental health by Inmar Intelligence.
    • “Of the 1,000 U.S. full- and part-time employees who responded to the May 12 survey, 34% said their job positively impacts their mental health, while 33% reported a negative impact, Inmar found.
    • “This near-even split reinforces the importance of thoughtful leadership and inclusive workplace design to support the full spectrum of employee needs,” the business technology firm stated in a May 29 post.”
  • Cardiovascular Business reports,
    • “Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first robotic explant of a transcatheter aortic valve replacement (TAVR) device and subsequent aortic valve replacement.
    • “The group already has plenty of experience breaking new ground in the field of robotic-assisted surgery. They developed a robotic aortic valve replacement (RAVR) technique that is now being used all over the world and performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure in 2024.
    • “This latest breakthrough started when Thelma Hyer, a 67-year-old female patient, presented with a failing TAVR valve in addition a leaky mitral valve. She had received her TAVR valve just four years prior, but premature structural valve degeneration had already made a full replacement necessary.
    • “Vinay Badhwar, MD, executive chair of the WVU Heart and Vascular Institute, initially recommended open-heart surgery to remove the failing TAVR valve and then replace her aortic and mitral valves. However, Hyer and her family had hesitations due to her history of scoliosis and arthritis. Badhwar then proposed using robotics as an alternative. 
    • “The technology had never been used in this exact way before, but Badhwar was confident in the abilities of both his team and the robotic surgery platform. The group developed a plan, talked it over with the patient, and went forward with the robotic procedure in late May. 
    • “The operation—including the TAVR explant and the replacement of both heart valves—appears to have been a success. Hyer was discharged after less than a full week of observation.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Omada Health shares jumped after the company made its public-market debut, propelled by Americans’ renewed focus on how weight affects physical health.
    • “Shares of the virtual healthcare platform climbed 35% to $25 on Friday, at one point hitting a high of $28, above the initial offering price of $19. The price gives it a market valuation of around $1.4 billion.
    • “The gains are a sign investors are willing to invest in newly public companies after a volatile stock market pushed some companies like payments platform Klarna to delay its IPO filing. Stablecoin issuer Circle opened on Thursday at $69, more than double its offering price, and was recently trading at $119.15. Hinge Health HNGE 0.83%increase; green up pointing triangle, another digital health company, opened in May at $39 after offering a $32 price.
    • “Omada is trading publicly after 14 years of providing support to patients with weight-related chronic illnesses. Leadership sees the current moment as the perfect time for an IPO, as GLP-1 drugs such as Ozempic, Wegovy and Mounjaro have sparked renewed focus on health problems that can stem from obesity, President Wei-Li Shao said.
    • “We’re entering this unique moment in time where there’s a convergence between what we’ve been working on for over a decade, and then also what society is increasingly caring about,” Shao said.”
  • Becker Hospital Review discusses ten key transactions that created Ascension 2.0.
    • “Over the last 16 months, St. Louis-based Ascension has sold or consolidated about 35 hospitals across the country as it revamps its hospital portfolio, operating model and overall financial performance.
    • “Despite reporting a $466 million operating loss (a -2.4% margin) for the nine months ending March 31, 2025, the Catholic nonprofit system has made notable strides in improving its liquidity position. That progress is largely attributed to the successful collection of accounts receivable that had temporarily spiked due to two major cybersecurity incidents — the May 2024 ransomware attack and the February 2024 Change Healthcare cyberattack.
    • “Since the fourth quarter of fiscal 2024 — the three months ending June 30, 2024 — Ascension has improved recurring operating performance by $1.4 billion, while increasing patient volumes and same-facility revenue.”
  • Beckers Health IT tells us,
    • “California-based Stanford Health Care is piloting an internally developed, AI-backed software designed to revolutionize clinician interaction with the EHR.
    • “Nigam Shah, MBBS, PhD, chief data science officer at Stanford Health Care, is leading the development team for ChatEHR, which allows clinicians to ask questions, request summaries and pull specific information from a patient’s medical record. ChatEHR is built directly into Stanford’s EHR to maximize clinical workflow.
    • “The pilot is available to a small cohort of 33 physicians, nurses and physician assistants. The technology is secure and designed for information gathering; not medical advice.
    • “ChatEHR, which has been in development since 2023, facilitates a more streamlined and efficient way for clinicians to interact with patient records.
    • “This is a unique instance of integrating [large language model] capabilities directly into clinicians’ practice and workflow,” said Michael Pfeffer, MD, chief information and digital officer at Stanford Health Care and School of Medicine, in a news release. “We’re thrilled to bring this to the workforce at Stanford Health Care.”
  • Drug Store News informs us,
    • “Walmart has become the first retailer to scale its drone delivery to five states with its recently announced service expansion in Atlanta, Charlotte, Houston, Orlando and Tampa. The new service will launch at 100 stores throughout Arkansas, Florida, Georgia, North Carolina and Texas, in addition to current operations in Northwest Arkansas and the Dallas-Fort Worth area.
    • “As we look ahead, drone delivery will remain a key part of our commitment to redefining retail,” said Greg Cathey, SVP, Walmart U.S. transformation and innovation. “We’re pushing the boundaries of convenience to better serve our customers, making shopping faster and easier than ever before.”
    • “Continued Cathey: “This expansion of our drone delivery service marks a significant milestone in that journey. As the first retailer to scale drone delivery, Walmart is once again demonstrating its commitment to leveraging technology to enhance our delivery offerings with a focus on speed.” 

Thursday Report

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Senate Republicans are considering cuts to Medicare spending to help pay for Donald Trump’s signature legislative package.
    • “The GOP lawmakers are proceeding cautiously as they expand their search for savings to a popular health insurance program nearly all Americans rely upon in retirement, presenting the move as an effort to root out waste, fraud and abuse. That includes cutting payments to health insurance companies that run private Medicare plans.”
  • The Wall Street Journal adds,
    • “Humana, the second-biggest Medicare insurer, has told congressional staffers that it will support moves that would curtail billing practices worth billions in extra payments to the industry, according to staffers and a document viewed by The Wall Street Journal.
    • “The stance by a leader in the Medicare Advantage business—in which insurers offer privately run Medicare plans—represents an important development in a growing debate over how the companies are paid in the $460 billion program.
    • “Insurers get paid more for covering sicker patients in Medicare Advantage, giving companies an incentive to record more diagnoses. Humana has told congressional staffers that it is willing to back new limits on lucrative payments insurers can gain from diagnoses recorded by nurse practitioners who visit millions of enrollees in their homes, according to a one-page policy overview shared with congressional staffers.
    • “After the Journal published this article Thursday morning, the biggest Medicare insurer, UnitedHealth Group, posted a statement saying that it too would support a new limit on the use of diagnoses from home visits.”
  • Healio points out,
    • HHS has ended a government-funded program that distributed free COVID-19 tests to community organizations, a department spokesperson confirmed to Healio.
    • “With COVID-19 behaving more like the seasonal flu — rising and falling through the year — and tests widely available at retail stores nationwide, continued federal distribution is a significant waste of taxpayers’ dollars,” the spokesperson said. “The COVID-19 pandemic is over.” * * *
    • “The program differed from the mail-based program that was started and stopped several times throughout the pandemic and provided U.S. residents the opportunity to get free COVID-19 tests delivered directly to their homes.”
    • “HHS is in the process of purchasing a supply of tests that can distinguish between COVID-19 and influenza to have on hand for emergencies.”
  • Tammy Flanagan, writing in Govexec, discusses “Should you stay, or should you go? 10 tips for navigating your federal retirement decision. What to consider—financially and emotionally—before leaving government service.”

From the public health and medical research front,

  • Chief Healthcare Executive tells us,
    • Two years ago, the American Diabetes Association and The Leapfrog Group announced that they were joining forces to recognize hospitals for providing excellent care to patients with diabetes.
    • Now, the groups are announcing honors for a second batch of recipients, and they’re recognizing more than twice as many hospitals.
    • The American Diabetes Association and the Leapfrog Group have announced 36 hospitals as 2025 Recognized Leaders in Caring for People Living with Diabetes. A year ago, the groups recognized 17 hospitals [which are listed in the article].
    • The organizations say they want to give public recognition to hospitals, but they are also highlighting the importance of providing proper care for patients with diabetes.
    • Nearly one-third of patients admitted to hospitals (30%) are diagnosed with diabetes. Some of those are patients that are being treated in the hospital for another illness or injury.
  • The New York Times reports,
    • “The technology that powered Covid vaccines may also lead scientists to a cure for H.I.V. Using mRNA, Australian researchers said they were able to trick the virus to come out of hiding, a crucial step in ridding the body of it entirely.
    • “The research, published last week in Nature Communications, is still preliminary, and so far, has been shown to be successful only in a lab. But it suggests that mRNA has potential far beyond its use in vaccines as a means to deliver therapies against stubborn adversaries.
    • “Short for messenger RNA, mRNA is a set of instructions for a gene. In the case of Covid vaccines, the instructions were for a piece of the coronavirus. In the new study, they are for molecules key to targeting H.I.V.
    • “Dr. Sharon Lewin, director of the Cumming Global Center for Pandemic Therapeutics in Melbourne, who led the study, called mRNA a “miraculous” tool “to deliver things that you want into places that were not possible before.”
  • STAT News adds,
    • “People with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness, a new observational study concludes, adding to a short list of concerns about eye health in people taking the powerful medications.
    • “The research, published Thursday in JAMA Ophthalmology, found that after one year, more than twice as many people on GLP-1 drugs developed neovascular age-related macular degeneration compared to similar people who were not taking the drugs. The risk was 0.2% in people taking GLP-1s and 0.1% in those who didn’t. Participants, drawn from health records of nearly 140,000 patients in Canada, were matched for socioeconomic status and a long list of conditions in addition to diabetes.” * * *
    • “Seeing such a clear signal in our study was striking,” co-author Reut Shor of the University of Toronto told STAT. “The absolute risk remains low, but the advanced form of AMD is a condition with serious implications for vision and quality of life. So a doubling of risk is clinically meaningful, particularly for vulnerable populations like older adults who may already be at elevated baseline risk.”
  • Per Health Day,
    • “A quality improvement strategy can improve electronic health record-based screening for depression and anxiety in people with epilepsy, according to a study published online April 16 in the Journal of Clinical and Translational Science.
    • “Heidi M. Munger Clary, M.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues developed an implementation strategy for anxiety and depression screening among people treated at an epilepsy center. Implementation outcomes were evaluated five months postimplementation compared to two three-month preimplementation time frames.”
  • and
    • Dietary patterns seem to be associated with depressive symptoms, according to a study published online June 3 in BMJ Nutrition, Prevention & Health.
    • Gabriella Menniti, M.D., from Unity Health Toronto, and colleagues conducted a cross-sectional study using National Health and Nutrition Examination Survey 2007 to 2018 data to examine the association between restrictive dietary patterns and depressive symptoms stratified by sex and body mass index.
  • Per MedPage Today,
    • High blood pressure (BP) awareness increasingly slipped under the radar since the COVID-19 pandemic, according to nationally representative health data.
    • Results from National Health and Nutrition Examination Survey (NHANES) cycles, spanning the years 2013 to 2023, showed no improvement in the proportion of adults having hypertension, diabetes, and high cholesterol who self-reported being unaware and never diagnosed. In fact, hypertension awareness stood out for trending significantly in the wrong direction:
      • Adults with hypertension not realizing it: 14.6% in 2013-2014 to 17.8% in 2021-2023
      • Adults with diabetes not realizing it: 27.5% to 28.9%
      • Adults with high total cholesterol not realizing it: 11.5% to 11.9%
    • “Given declining cardiometabolic health in young adults, it is concerning that approximately one in three with hypertension, two in five with diabetes, and one in four with a high cholesterol level are unaware of having these conditions. Policy efforts to address these gaps in awareness are needed to prevent future cardiovascular events,” wrote Rishi Wadhera, MD, MPP, MPhil, of Beth Israel Deaconess Medical Center and Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Cardiology“

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us,
    • “Nonprofit hospitals are seeing margins improve as patient demand for care soars, according to Kaufman Hall’s “National Hospital Flash Report” released June 5.
    • “Kaufman Hall, a Vizient company, analyzed data from 1,300 hospitals collected by Strata Decision Technology for its monthly report.
    • “Hospital performance from January to April outpaced the first four months of 2024, largely driven by patient volume and hospital efficiency,” said Erik Swanson, managing director and group leader, data and analytics, at Kaufman Hall. “Operating room minutes, ED visits and inpatient revenue are trending upward, demonstrating a strong demand for services. A decline in average length of stay indicates that hospitals are triaging, treating, and discharging patients effectively and appropriately.”
  • Modern Healthcare reports,
    • “Nineteen critical access hospitals in Nebraska have formed a clinically integrated network, the third coalition of its kind created over the past three months.
    • “The Nebraska High Value Network aims to give rural hospitals the scale to lower costs, invest in new technology, improve treatment and expand value-based contracts while remaining independent. The network, announced Thursday, follows similar alliances in Montana, Ohio, Minnesota and North Dakota.” * * *
    • “Cibolo Health, the rural health advisory firm that helped launch these hospital collaborations, will manage daily operations of the Nebraska High Value Network. The network will include clinical and business integration committees led by member hospital executives who will oversee quality and administrative initiatives.”
  • Beckers Clinical Leadership lets us know,
    • “The District of Columbia has the most physicians per 100,000 population, while Idaho has the fewest specialist physicians and Nevada has the fewest primary care physicians per 100,000, KFF data found.
    • “KFF used data from Redi-Data to find the number of MD and DO active state-licensed physicians as of April 2025. Becker’s used Census data from 2025 to find the population of each state.
    • “There are 535,542 primary care physicians and 570,655 specialist physicians in the U.S. this year.
    • “[The article includes a chart with] the number of primary care and specialist physicians per 100,000 people in each state and the District of Columbia.”
  • Per MedTech Dive,
    • “Johnson & Johnson CFO Joseph Wolk, at the Bernstein investor conference last week, tempered the company’s expectation that it would suffer a $400 million tariff impact this year.
    • “Wolk gave the update after the U.S. and China reached a temporary agreement to pause escalating tariff rates between the two countries for 90 days.
    • “Weeks before the pause, J&J had predicted on an April’s earnings call that it would incur tariff-related costs of about $400 million this year, primarily affecting its medtech business.
    • “But Wolk, at the Bernstein conference, suggested the forecasted tariff hit could change in the future.
    • “Just based on the retaliatory China tariffs that we had in our $400 million assessment, that probably cuts the $400 million down to $200 million,” Wolk said, responding to a question about the shifting tariffs landscape. That does not include any impact that could result from the Trump administration’s Section 232 investigations, he said. The Trump administration has launched special investigations into the pharmaceutical and semiconductor industries that could lead to tariffs.
    • “In addition, Wolk noted, tariffs between the U.S. and Europe remain in flux.” 

Midweek Report

David Ermer–Congress, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington, DC

  • The American Hospital Association News tells us,
    • “A Congressional Budget Office report released June 4 found that enactment of the fiscal year 2025 budget reconciliation bill, the One Big Beautiful Bill Act (H.R. 1), would lead to 10.9 million people becoming uninsured in 2034 due to significant changes to the Medicaid program and Affordable Care Act coverage. A follow-up letter from the CBO provides more detail on how these changes would impact the number of uninsured. The CBO also estimated that the bill would lower gross benchmark premiums for marketplace plans under the ACA by an average of 12.2%.”
  • Per a Senate news release,
    • On Wednesday, June 11, 2025, at 10:15 am the Senate Judiciary Committee will hold a hearing titled “23 and You, the Privacy and National Security Implications of the 23 and Me Bankruptcy.”
  • STAT News reports,
    • In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment.
    • “The dispute with Halozyme Therapeutics occurs as Merck plans to sell a new injectable version of Keytruda that the company is betting will sustain a medicine that has accounted for nearly half of its sales. Patent protection for the treatment, which is currently administered intravenously and generated $29.5 billion in revenue last year, lapses in 2028.
    • “At issue before the PTO are certain enzymes called Mdase that Halozyme developed to enable the administration of drugs by injection. Last November, Merck petitioned the PTO to reconsider seven patents that were awarded to Halozyme, arguing they were overly broad and should not have been granted. The filing came a few months after the PTO granted one patent in particular.
    • “Patent challenges are almost a daily feature of behind-the-scenes jockeying in the pharmaceutical industry, but the battle over Keytruda is more closely watched than most since the stakes are so high for Merck. In March, the company asked the Food and Drug Administration to approve the injectable version, which would cut treatment time in half, and a decision is expected in September.”
  • Per an HHS new release,
    • “The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announces the appointment of Paula M. Stannard as Director of the Office for Civil Rights. In this role, Director Stannard is the Department’s chief officer and adviser to Secretary Robert F. Kennedy, Jr. concerning the implementation, compliance, and enforcement of Federal health information privacy, security, and breach notification rules under the Health Insurance Portability and Accountability Act (HIPAA) as well as Federal civil rights, conscience, and religious freedom laws in HHS’ jurisdiction.
    • “I’m proud to welcome Paula back to HHS,” said Secretary Robert F. Kennedy, Jr. “She’s a proven public servant who delivered results during her time at HHS under both President Trump and President George W. Bush. Paula brings deep institutional knowledge, relentless focus, and an unwavering commitment to civil rights. Under her leadership, the Office for Civil Rights will drive forward President Trump’s bold civil rights agenda with clarity, energy, and purpose.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “Moderna Inc. has agreed to do a placebo-controlled trial of its new Covid vaccine that was recently approved by US regulators, Health and Human Services Secretary Robert F. Kennedy Jr. said Tuesday.
    • “In a post on X, Kennedy said he wanted to “address those of you who have anxieties” about the Food and Drug Administration’s limited approval of Moderna’s vaccine, which was cleared for a narrower segment of the population than prior shots. 
    • “Moderna declined to comment. As a condition for approving the new shot, the FDA required a future placebo-controlled study in adults ages 50 to 64 without high-risk conditions, according to agency documents.
    • “Kennedy said that “the FDA will monitor and collect data throughout the trial for every adverse outcome” and “scrutinize every aspect of the trial.”
  • Per a press release,
    • Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced today FDA clearance of its most significant technological advancement to date. The clearance includes an entirely new portable MRI scanner powered by the proprietary Optive AI™ software. This new system delivers the highest level of image quality, functionality, and usability to date, unlocking a new brain imaging paradigm for clinicians and their patients.
  • Per FiercePharma,
    • “Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
    • “The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC. The new nod allows Nubeqa to be used along with ADT by those who can’t tolerate chemo.
    • “The FDA endorsement was based on results of a phase 3 trial, ARANOTE, which showed that Nubeqa significantly extended the time before tumor progression or death in patients with mCSPC compared with ADT alone. In the study of 669 patients who were randomized 2 to 1 to receive 600 mg of Nubeqa plus ADT or placebo plus ADT, Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, allowing the trial to achieve its primary endpoint.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help speed the reviews of certain gene therapy applications it brings to the regulator in the future.
    • “The so-called platform technology designation issued to Sarepta is meant to streamline the development and evaluation process for gene therapies using a specific delivery tool, a viral vector dubbed rAAVrh74. That component is part of multiple Sarepta programs, among them the already approved Duchenne muscular dystrophy gene therapy Elevidys.
    • “According to Sarepta, the designation is one of the first given to a drug program since the initiative was launched by the FDA. It enables Sarepta to use evidence previously gathered from studies involving the vector in future applications, though differences in how some of its newer gene therapies are manufactured may limit its usefulness.”
  • Per MedTech Dive,
    • “Smiths Medical has recalled infusion pumps to update the instructions to address three problems that could lead to serious injury or death. The devices are staying on the market. 
    • “The Food and Drug Administration, which published Class I notices about the recalls Tuesday, said issues with some CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps could interrupt or delay treatment. Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.” 

From the public health and medical research front,

  • STAT News reports,
    • “KJ Muldoon, the first infant treated with a personalized gene-editing drug, has been discharged from the hospital for the first time in his life, the Children’s Hospital of Philadelphia announced Tuesday. After 307 days at CHOP, KJ was dressed in what early studies suggest are the world’s smallest and cutest graduation cap-and-gown before leaving.
    • “It’s a promising sign for KJ, his family, and the therapy researchers built in just 6 months. Born with an ultra-rare disease that prevented his liver from breaking down ammonia, he was rushed to CHOP, where specialists kept him under strict monitoring to prevent ammonia from flaring and doing long-term damage. Typically, he would receive a liver transplant. Instead, scientists across the country teamed to devise a gene-editing treatment.
    • “KJ received the first of three doses at six months old. He’s now 10 months old. The hope is that, while not cured, he has been left with a far more mild version of his disease. Meanwhile, researchers are working on ways to scale his treatment for thousands of others.”
  • and
    • “Circulating tumor DNA blood tests are rapidly gaining popularity among oncologists for their potential to detect cancer recurrence and treatment resistance earlier than traditional imaging. But despite their promise, data presented at the annual ASCO meeting this week suggest that the clinical value of ctDNA tests is still unproven.
    • “While some trials hint at benefits, others lack conclusive survival outcomes — which raises concern about whether early interventions based on ctDNA actually improve patients’ lives.
    • “We need evidence to know the true value of these tests,” University of Pennsylvania cancer researcher Angela DeMichelle told STAT’s Angus Chen. “They have incredible potential to help people, but if we don’t do the studies and don’t do them the right way, we can hurt people.”
  • The American Journal of Managed Care adds,
    • A blood-based circulating tumor DNA (ctDNA) test detected colorectal cancer (CRC) with 79.2% sensitivity and 91.5% specificity, according to a recent prospective study. These findings suggest the investigational test may be a viable noninvasive screening option, although its ability to detect advanced precancerous lesions remains limited.
    • The population-based, observational study is published in JAMA.
    • “This study was designed as a large, prospective diagnostic accuracy evaluation of a blood-based CRC screening test, with blinded comparison to colonoscopy in an average-risk screening population,” wrote the researchers of the study. “It enrolled a geographically and demographically diverse cohort across 201 sites, approximating the racial and ethnic distribution of the US.”
    • “CRC is the second leading cause of cancer-related deaths globally, with more than 1.9 million new cases and 930,000 deaths estimated in 2020 alone. Increased access to screening options—including stool-based tests, visual exams, and emerging blood-based tests—can help detect CRC at its most treatable stages and reduce both incidence and mortality.”
  • Per Reuters,
    • “American teens are increasingly turning to the weight-loss drug Wegovy as more families and their doctors gain confidence in its use for young people with obesity, new data shared with Reuters shows.
    • “The average rate of teens beginning treatment with the highly effective Novo Nordisk (NOVOb.CO), opens new tab drug grew 50% last year to 14.8 prescriptions per 100,000 adolescents, according to an analysis by health data firm Truveta.”
  • Per Healio,
    • “Enrollment in a patient-delivered intervention allowed adults with overweight or obesity to better maintain weight loss than those receiving standard of care, according to trial findings published in JAMA Internal Medicine.
    • “In the CHAMPS randomized controlled trial, adults with overweight or obesity who previously lost at least 5% of their body weight with lifestyle intervention were randomly assigned to a weight-loss maintenance intervention led by fellow patients who previously lost weight or to standard of care weight maintenance led by a physician. Adults participating in the patient-led intervention were more successful at maintaining their body weight.”
  • Medscape notes,
    • “As part of treating the overall well-being of your patients, it may be beneficial to recommend nutritional counseling. More insurance carriers are providing this service as a benefit.
    • “When patients have conditions such as type 2 diabetes, high blood pressure, heart disease or obesity, suggesting nutritional counseling could help your patients become more informed about making healthier choices. More health insurance plans cover nutritional counseling, although some may only provide coverage for specific conditions.
    • “Integrating nutritional counseling into routine clinical practice is essential and necessary to achieving optimal health outcomes,” said Scott Isaacs, MD, adjunct assistant professor of medicine, Emory University, and president of the American Association of Clinical Endocrinology, who is based in Atlanta. “By ensuring that nutritional counseling is accessible, personalized, and supported by insurance, we empower our patients to prevent disease, effectively manage chronic conditions, and improve both quality of live and longevity.”
  • The Wall Street Journal reports,
    • “New research is helping to answer an important question about ultra-processed foods: Which ones might be healthier? 
    • “One reason many ultra–processed foods often lead us to eat big meals and heavy snacks is because of their texture, which makes them go down easily and quickly, according to a new study presented this week at a conference in Orlando, Fla., of the American Society for Nutrition.
    • “But some diets filled with ultra-processed foods don’t cause us to eat as much. People in the study who had a diet of slower-to-eat ultra-processed foods such as crunchy breakfast cereal and multigrain buns consumed an average of 369 fewer calories a day than when they were eating quick-to-eat ultra-processed foods such as commercially made smoothies and soft breads.
    • “Meals that are equally satisfying were eaten in different ways purely as a function of the way they’re textured,” said Ciarán Forde, a professor at Wageningen University in the Netherlands, who led the study.”
  • Per an NIH press release,
    • Researchers at the National Institutes of Health (NIH) have identified which brain circuits are vital for visual acuity and how they are affected by damaged retinal cells. While vision restoration therapies, such as stem-cell and gene therapies, aim to replace or repair damaged cells in the eye, it is critical to understand how brain circuits involved in vision are affected by retinal cell loss. Study results suggest that targeting these circuits may be necessary to achieve optimal recovery of visual function, and have significant implications for the development of future vision restoration therapies that address visual pathways beyond the retina. The study published today in The Journal of Neuroscience.
    • “A huge amount of progress has been made in repairing the eye, however little attention has been paid to the functional consequences beyond the eye,” said the study’s lead investigator, Farran Briggs, Ph.D., senior investigator at NIH’s National Eye Institute (NEI). “Brain circuits downstream of damaged or dying retinal cells in the eye may also undergo some loss of function following changes to their retinal inputs.”

From the U.S. healthcare business front,

  • Beckers Health IT lets us know about six things concerning “CVS Health’s $20B bet on integrated, tech-enabled care,” and five details about Mark Cuban’s pharmacy network.
  • Modern Healthcare reports,
    • “Despite tight budgets and other operational challenges, health systems are increasingly investing in replacement hospitals and sustainability, while maintaining a strong focus on outpatient facilities in construction and design projects.
    • “More than 53% of the construction and design firms that responded to Modern Healthcare’s 2025 Construction and Design Survey said the industry is growing, even as it faces financial headwinds such as funding limitations, inflation and recent tariffs.”
  • Per BioPharma Dive,
    • “Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm Camurus that promises to produce longer-acting medications.
    • “Camurus’ FluidCrystal technology is designed to methodically release a therapeutic drug substance into the body over a period of days or months. After an injection, the solution interacts with bodily fluids to transform into a liquid crystalline gel. The gel holds the active ingredient and then slowly degrades, releasing medicine.
    • “The deal includes an unspecified upfront payment as part of an initial package that may be worth as much as $290 million, Camurus said Tuesday. That figure also includes payments for reaching certain development and regulatory milestones. Another $580 million could be available for meeting sales goals, along with mid-single digit royalties for successful products.”
  • BioPharma Dive summarizes its reporters’ takeaways from the ASCO conference which ended yesterday.
  • Fierce Healthcare relates,
    • “DispatchHealth and Medically Home closed their merger deal on Wednesday, combining the forces of at-home care and hospital-at-home leaders.   
    • “Operating under the DispatchHealth brand, the combined company will provide three core service lines. Its hospital-alternative care service, also called hospital at home, provides inpatient hospital-level care at home. The company also provides emergency-level care, when appropriate, to help patients avoid ED visits. 
    • “The merger was announced in mid-March. In the coming months, the company will integrate Medically Home’s technology platform and clinical command center for use nationwide, the company said.
    • “The two leadership teams have combined. Jennifer Webster will continue as the CEO of DispatchHealth. Graham Barnes, who took over as CEO of Medically Home in August 2024, is departing to pursue new opportunities. Pippa Shulman, D.O., has assumed the role of chief medical officer, according to a press release.”

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.
  • This afternoon, the House of Representatives passed by voice vote the Esophageal Cancer Awareness Act, HR 3490.
    • “This bill requires the Government Accountability Office to report to Congress on (1) the impact of esophageal cancer-related health care spending under the Federal Employees Health Benefits Program (FEHBP) for federal employees and retirees diagnosed with esophageal cancer, and (2) how often FEHBP participants with a high risk of esophageal cancer undergo screenings according to established guidelines.” 
    • The bill honors the late Rep. Gerald Connelly (D VA) who died from the disease. The bill now heads to Senate.
  • The New York Times reports,
    • “President Trump on Tuesday ratcheted up pressure on Senate Republicans to quickly embrace and pass legislation carrying his domestic agenda, intensifying a battle inside the G.O.P. about what should be in the measure and how much it should cost.”
  • Govexec adds,
    • “The Trump administration plans to send its first spending cuts request to Congress on Tuesday, asking lawmakers to swiftly eliminate $9.4 billion in funding for the Corporation for Public Broadcasting and various foreign aid programs.
    • “The request for what are called rescissions allows the White House budget office to legally freeze spending on those accounts for 45 days while the Republican-controlled Congress debates whether to approve the recommendation in full or in part, or to ignore it.
    • “The proposal calls on lawmakers to eliminate $1.1 billion from the Corporation for Public Broadcasting, which provides funding for National Public Radio and the Public Broadcasting Service. That means NPR and PBS would lose their already approved federal allocations, if the request is approved by Congress.”
  • Fierce Healthcare points out,
    • “The Centers for Medicare and Medicaid Services plans to undertake several new health tech initiatives, senior leaders announced today at a closed meeting with stakeholders. 
    • “The Department of Health and Human Services held a meeting today to discuss health tech policy and its recent request for information on health tech initiatives. CMS seems to be moving ahead with some of the initiatives it asked stakeholders to provide feedback on in its RFI — among them a national provider directory and modern identity verification for Medicare beneficiaries.
    • “This comes as the HHS’ health IT office announced a new leader this morning, Thomas Keane, M.D. Keane spoke at the meeting of stakeholders today at the Hubert H. Humphrey building in Washington, D.C.” 
  • Healthcare Dive adds,
    • Thomas Keane, a software engineer and interventional radiologist, began his role as national coordinator [for health information technology] Monday, the spokesperson said. He previously worked at the ASTP and served as a senior advisor to the deputy secretary of the HHS, according to his biography on the agency’s website. 
  • Healthcare Dive also relates,
    • “The Trump administration rescinded guidance on Tuesday directing hospitals to perform abortions during medical emergencies, even in states with restrictive abortion bans. 
    • “The Biden administration published the guidance in 2022, shortly after Roe v. Wade was overturned, asserting doctors were required to perform emergency care, even if that included abortions, under the Emergency Medical Treatment and Labor Act. * * *
    • “The CMS now says that guidance “does not reflect the policy of this Administration.” The new guidance is effective May 29, and furthers an executive order from President Donald Trump seeking to remove regulatory red tape, the CMS said.” * * *
    • “Texas and Idaho, which have some of the nation’s most restrictive abortion bans, have repeatedly argued that there is no conflict between EMTALA and their policies, because both states allow abortion when the mother’s life is at risk.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal district court judge on Tuesday denied motions to dismiss complaints in two lawsuits against data analytics firm MultiPlan — now operating as Claritev — and a number of insurers.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois denied Claritev’s motion to dismiss complaints in two lawsuits involving federal and state antitrust and consumer protection claims.” * * *
    • “Both lawsuits allege Claritev colluded with insurers to reduce pay for out-of-network providers, violating state and federal antitrust laws under the Sherman Act.
    • “We remain confident in the strength of our legal position and look forward to presenting the facts as the case moves forward,” Claritev said in a statement Tuesday. “These lawsuits will only serve to increase healthcare cost for employers and patients. We will vigorously defend ourselves through the legal process while remaining focused on delivering value to our customers and the broader healthcare ecosystem.”
  • Per Healthcare Dive,
    • “Centene is being sued for wrongful death after one of its members died after failing to get the mental healthcare he needed because of the insurer’s inadequate provider networks, according to the lawsuit filed by the member’s mother.
    • “The suit, filed late May in the Superior Court of Maricopa County in Arizona, accuses Centene’s subsidiary in the state, Health Net, of maintaining “ghost networks” — wherein insurers say providers are in network that aren’t, inflating the care options available under their plans to the detriment of actual access.
    • “As a result, Centene violated state and federal laws requiring network accuracy and adequacy, according to the suit, which also accuses the St. Louis-based payer of negligence and fraud. Centene did not respond to a request for comment.”
  • Per MedTech Dive,
    • “The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, according to two lab industry groups.
    • “The 60-day window for the FDA to appeal the ruling by the U.S. District Court for the Eastern District of Texas expired over the weekend. The Association for Molecular Pathology supported the FDA’s move not to appeal.
    • “This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statement.”

News from the American Society of Clinical Oncology’s conference

  • The New York Times reports,
    • “A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year.
    • “They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice.
    • “They all got immunotherapy, in a study that was a last-ditch effort.
    • “A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease.
    • “These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words “potential cure.”
    • “The new study, reported Tuesday at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech.”
  • Per Fierce Pharma,
    • “Though they are both multiple myeloma drugs with the same mechanism of action, Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s powerhouse Darzalex, largely because it reached the market five years later.
    • “But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody.
    • “Tuesday, at the American Society of Clinical Oncology annual meeting in Chicago, Sanofi presented data from two trials that showed Sarclisa administered subcutaneously (SC) from an investigational on-body injector (OBI) reduced treatment time and produced similar efficacy and safety compared to intravenous (IV) infusion.”
  • Per BioPharma Dive,
    • “An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company.
    • “The study, known as Oasis-4, is the fourth successful trial test of Bayer’s drug, called elinzanetant. Detailed data presented at the American Society of Clinical Oncology’s annual meeting Monday showed treatment reduced vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer.”
  • and
    • “A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial.
    • “Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncology’s meeting in Chicago. They could potentially expand the number of people able to receive J&J’s Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga.”
  • The Wall Street Journal reports,
    • “Roche said Tecentriq combined with lurbinectedin shows significant survival benefits for patients with extensive-stage small cell lung cancer.
    • “The Swiss pharmaceutical company said Tuesday that late-stage trials showed the combination led to a 46% reduction in the risk of the disease progressing or death, and 27% reduction in the risk of death.
    • “The combination can be used a as a first-line maintenance treatment for people with the cancer following induction therapy with carboplatin, etoposide and Tecentriq, it said.
    • “The safety profile of the combination was consistent with the known safety profiles of Tecentriq and lurbinectedin, Roche said.”

In other medical research and public health news,

  • Cigna, writing in LinkedIn, explains why early detection is so important to fighting breast cancer.
  • The latest issue of the National Institutes of Health’s Research Matter covers “Customized gene therapy | Parents with substance use disorders | Ultra-processed food consumption.”
  • The New York Times discusses “Anorexia in Middle Age and Beyond. A growing number of older women are seeking treatment for eating disorders. Many have struggled without help for decades.”
  • MedCity News informs us,
    • “The World Health Organization estimates that about 10% of women and girls of reproductive age around the world — roughly 190 million people — suffer from chronic pain as a result of endometriosis. 
    • “Take this estimate with a grain of salt, though — it’s likely too low. The average diagnostic delay for endometriosis patients is eight years, driven in large part by the fact that the standard method used to diagnose the disease is an invasive surgical procedure.”
    • Boston-based biotech startup Heranova Lifesciences is working to address this problem by developing a non-invasive blood-based test. Just this spring, the company announced the LDT validation and U.S. launch of this product, which is called HerResolve. * * *
    • “The gold standard that doctors use to diagnose endometriosis is laparoscopy followed by histological confirmation. With this method, doctors put patients under anesthesia and perform a laparoscopy to look at the tissue and lesions growing outside the uterus — then, the doctor takes a tissue sample to confirm the diagnosis under a microscope.
    • “This method of testing is invasive — and not very quick. Heranova’s test seeks to address these issues by using machine learning to analyze a panel of biomarkers in a patient’s blood sample to determine whether or not they have endometriosis. 
    • “The test’s accuracy is on par with laparoscopy followed by histopathology, said Farideh Bischoff, Heranova’s chief medical officer.”
  • Per Health Day,
    • “Clinicians consider administration of human papillomavirus (HPV) vaccine as feasible at age 9 to 10 years, and parents appear to be receptive to discussing vaccination at this age, according to a study published online June 2 in Pediatrics.
    • “Caroline K. Tietbohl, Ph.D., from the University of Colorado and Children’s Hospital Colorado in Aurora, and colleagues conducted an explanatory sequential mixed-methods study as part of an ongoing randomized trial that compared initiation at ages 9 to 10 years (intervention) versus 11 to 12 years (control) across 17 practices in Colorado (nine intervention) and 16 practices in California (eight intervention). At one month after study initiation, practice clinicians were surveyed, and semi structured interviews were conducted at three months after study initiation.” * * *
    • “The results of our prospective trial will determine if initiating vaccination earlier increases vaccination completion rates, especially by age 13 years,” the authors write.
  • The Wall Street Journal reports,
    • People are more likely to get cancer as they age. Dr. Miriam Merad has an unconventional idea of how that might be reversed: using allergy drugs and other seemingly unlikely medications to damp a condition known as “inflammaging.”
    • The immunologist and oncologist has spent years examining malignant tumors to learn why people over age 50 account for nine in 10 cancer diagnoses in the U.S. She and her research team at the Icahn School of Medicine at Mount Sinai in New York City have homed in on an answer: the aging immune system. Their studies of individual immune cells in human lung tumors, as well as in old mice, have revealed how chronic, or pathogenic, inflammation in older people—dubbed inflammaging—interferes with the immune system and fuels cancer growth.
    • Merad and other researchers are testing whether existing anti-inflammatory medications usually used to fight rheumatoid arthritis or allergy conditions like asthma or eczema can slow cancer in older patients. They are also searching for new drugs. “Aging is something that we think we can transform,” says Merad, director of the Marc and Jennifer Lipschultz Precision Immunology Institute at Mount Sinai.”

From the U.S. healthcare business front,

  • Becker Payer Issues lets us know,
    • “Following a tumultuous period for UnitedHealth Group, new CEO and board chair Stephen Hemsley addressed investors on June 2, acknowledging the company’s recent shortcomings and detailing his plan to restore the high performance that investors and customers expect moving forward.
    • “Mr. Hemsley expressed a deep commitment to regaining trust through increased transparency, improved pricing strategies, and a renewed focus on internal operations, particularly at Optum Health and UnitedHealthcare. 
    • “We are well aware we have not fulfilled your expectations or our own,” he said. “We apologize for that performance and we are humbly determined to earn back your trust and your confidence.”
    • The article also provides eight notes on Mr. Hemsley’s talk.
  • STAT News adds,
    • UnitedHealth Group’s new CEO told investors that the company is reevaluating how it tallies Medicare Advantage patients’ diagnoses for reimbursement purposes, an issue currently under investigation by the Justice Department. 
    • Stephen Hemsley’s remarks during the company’s annual shareholder meeting on Monday signal a noteworthy shift: UnitedHealth is now publicly acknowledging potential issues with how it assesses the health of its Medicare Advantage members.” * * *
    • “Our management team has been working with urgency through a comprehensive and methodical review of our operations from end to end,” Hemsley said. “Digging into every part of the organization to evaluate how we have been performing and to improve that performance.”
  • Fierce Pharma notes,
    • “Medicare Part D beneficiaries can now tap into Amazon Pharmacy’s PillPack for pre-sorted medication packets, the retail giant announced on Tuesday.
    • “PillPack sorts a patient’s medications into personalized, tear-away packets that are labeled by date and time, which can make it easier to follow prescribed regimens. The expansion brings this service to more than 50 million Part D enrollees who take daily medications, Amazon said.
    • “Once eligible customers sign up for packets through PillPack, Amazon Pharmacy will coordinate needed refills to ensure prescriptions arrive on time.
    • “In addition to growing its reach in the Part D market, Amazon announced that it will roll out new services to support caregivers in managing medications for a family member or loved one.”
  • Modern Healthcare reports,
    • “Pyx Health, a digital mental health platform, on Tuesday announced its acquisition of FarmboxRx, a company that provides fresh produce food boxes to Medicare and Medicaid members.”
  • Beckers Hospital Review informs us that “Hospitals [are] push[ing] back on low Leapfrog grades.”
  • Per Fierce Healthcare,
    • “In January, H1 picked up provider data management software company Ribbon Health to broaden its reach into the health plan, provider system and digital health sectors.
    • “Five months later, the healthcare tech company has acquired Veda Data Solutions to build out its provider data and automation solutions for payers.
    • “Financial terms of the deal were not disclosed.
    • “Founded 10 years ago, Veda fixes bad provider data for healthcare organizations. Inaccurate and out-of-date health plan provider directories continue to be a thorny problem in healthcare and can make it difficult for patients to find a clinician when they need care.”

Monday Report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “The White House is not requesting an increase in pay for federal employees in fiscal 2026. President Donald Trump released more details of his budget request for next year late Friday afternoon. The appendix section of the budget proposals also includes provisions to continue the pay freeze for certain non-career Senior Executive Service members and political appointees. In all, the new budget document details more specific discretionary spending requests for each agency. Unlike the “skinny” budget released in early May, the administration did include funding requests for the Office of Personnel Management, the Education Department and independent agencies like the Consumer Financial Protection Bureau.”
  • Healthcare Dive adds,
    • “The White House released a more detailed budget proposal on Friday that yields more information on how the Trump administration is aiming to reshape the HHS next year, including drastic cuts to the National Institutes of Health.
    • “The updated proposal doubles down on plans to slash the NIH’s budget nearly in half, consolidate the HHS’ 28 operating divisions into 15, eliminate dozens of federal healthcare and social welfare programs and terminate more than 5,000 contracts.
    • “The Trump administration argues the changes are necessary to streamline HHS functions and eliminate priorities around diversity, equity and inclusion panned by conservatives.
    • ‘The administration can’t fully implement the budget without the support of Congress. Lawmakers usually make changes to the executive branch’s spending wish list in appropriations legislation.
  • Beckers Hospital Review points out,
    • “HHS has proposed oversight of the 340B drug pricing program to the Centers for Medicare & Medicaid Services as part of a broader reorganization. 
    • “The move, initially referenced in a preliminary memo from White House officials in April, would place the 340B program under CMS’s Program Management authority, allowing the agency to use its in-house drug pricing expertise and streamline oversight, according to HHS’s Budget in Brief. 
    • “Funding for 340B oversight would be maintained at $12 million to “provide oversight and auditing of covered entities and drug manufacturers, support operational improvements, and increase operational efficiencies,” the document said. 
    • “The 340B drug pricing program requires drug manufacturers to offer discounts on outpatient prescription drugs to eligible safety-net hospitals. CMS Program Management is a key part of the federal health infrastructure, overseeing the administration of Medicare, Medicaid, the Children’s Health Insurance Program and the Federal Exchange.” 
  • Per Federal News Network,
    • “The Trump administration is proposing changes that would make it easier to fire federal employees accused of misconduct in a matter of days, because they no longer meet “suitability and fitness” standards required to join the federal workforce.
    • “The Office of Personnel Management, in a proposed rule it will publish Tuesday in the Federal Register, plans to expand suitability adjudications normally reserved for federal job applicants to include current employees.
    • “The proposed rule, once finalized, would allow the Trump administration to fast-track the firing of federal employees, on the grounds that they no longer meet suitability standards for federal employment.
    • “OPM’s proposed rule states agencies must remove federal employees within five workdays, if it decides they no longer meet the suitability standard.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH), which serves as a bridge to transplant for patients with end-stage heart failure.
    • “BiVacor’s TAH is based on rotary blood pump technology and approximately the size of an adult’s fist. It has no valves or flexing ventricle chambers, and its only moving part is a magnetically suspended double-sided centrifugal pump impeller.
    • “The FDA’s decision signals just how much potential the agency sees in this technology. The breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. Its representatives work directly with the manufacturer, for example, and submissions are prioritized.
    • “This is more than a regulatory milestone,” Daniel Timms, PhD, founder and chief technology officer of BiVacor, said in a statement. “It’s a validation of a concept we’ve spent decades proving that a fully implantable, TAH isn’t just possible, it’s necessary. Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The breakthrough device designation puts us on a faster track to deliver exactly that.”
  • MedPage Today notes,
    • “The FDA granted de novo authorization to the first artificial intelligence (AI) program to support breast cancer risk prediction from screening mammograms.
    • “The program, called Clairity Breast, analyzes mammograms for subtle features that correlate with future breast cancer risk, according to a news release from Clairity. The analysis results in a 5-year risk score validated from analysis of more than 77,000 mammograms from multiple hospital-based and free-standing mammography facilities.
    • “The system can be applied immediately to clinical practice, Larry Norton, MD, a breast cancer specialist at Memorial Sloan Kettering Cancer Center in New York City, told MedPage Today.
    • “We’re very excited about it,” said Norton, who also is founding scientific director of the Breast Cancer Research Foundation, which supported development of Clairity Breast. “We were confident that it’s going to turn out to be something that’s going to help people, something that we think really has great science behind it.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Court of Appeals for the Fifth Circuit granted a Texas doctor group’s request Friday to rehear its challenge to a Biden administration rule governing the arbitration process for surprise medical bill disputes.
    • “The No Surprises Act protects patients from most unexpected out-of-network bills by requiring insurers and medical providers to undergo an arbitration process for payment disputes. But the process is the subject of countless legal battles, and the Texas Medical Association has successfully challenged multiple provisions of the implementation regulations.
    • “A three-judge panel previously upheld several portions of the rule (RIN: 1210-AC17) in a mixed decision regarding the qualifying payment amount—a key factor arbitrators use to settle disagreements. The Texas Medical Association had asked the full panel to reconsider the decision upholding the exclusion of bonuses as well as the inclusion of “ghost rates,” or contracted rates for services that a doctor hasn’t actually provided.”

From the public health and medical research front,

  • CBS News reports,
    • “The Centers for Disease Control and Prevention has updated its warning about the risk of contracting measles while traveling, after the agency tallied dozens of cases so far this year in travelers who were infectious while flying on airplanes within the U.S.
    • “Travelers can catch measles in many travel settings including travel hubs like airports and train stations, on public transportation like airplanes and trains, at tourist attractions, and at large, crowded events,” the agency now says, in an update published Wednesday.”
  • Per HCPLive,
    • “Cardiac deaths have risen since 2020, with more occurring at home, indicating a potential gap in care for heart disease patients during the pandemic.
    • “Hospital data showed a 20–34% reduction in acute myocardial infarction hospitalizations, while at-home cardiac deaths increased, suggesting changes in care-seeking behavior.”
  • MedPage Today informs us,
    • “Measles, mumps, and rubella (MMR) vaccination rates in children declined in some counties across the U.S. during the COVID-19 pandemic, researchers found.
    • “Across 2,066 counties in 33 states with both pre- and post-pandemic vaccination data, the county-level mean MMR vaccination rate decreased from 93.92% to 91.26%, according to Lauren Gardner, PhD, of Johns Hopkins University in Baltimore, and colleagues.
    • “A decline in coverage was reported in 78% of counties during this time, and only four states — California, Connecticut, Maine, and New York — had an increase in median county-level vaccination rates, they reported in a JAMA research letter.”
  • The American Medical Association tells us what doctors wish their patients knew about e-cigarettes.
  • Consumer Reports, writing in the Washington Post, discusses “What to know about nerve pain and tingling hands and feet. Tingling or painful sensations in your hands and/or feet are the main symptoms of neuropathy.”
  • The Wall Street Journal reports,
    • “Novartis said Pluvicto demonstrated positive results in patients with PSMA-positive metastatic hormone-sensitive prostate cancer.
    • “The Swiss pharmaceutical company on Monday said Pluvicto showed statistically significant and clinically meaningful benefits—including combined with hormone therapy versus hormone therapy alone—with positive trend in overall survival.
    • “The results are from a prespecified interim analysis of a Phase 3 trial, it said.
    • “Pluvicto is already approved for metastatic castration-resistant prostate cancer and now shows potential in patients in an earlier disease setting, it said.
    • “The company will present results at an upcoming medical meeting and based on FDA feedback, will submit for regulatory review in the second half of the year, it said.
    • “Pluvicto is a radioactive medication used to treat some types of prostate cancer.”
  • Per BioPharma Dive,
    • “An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future. 
    • “According to Vera, the drug, called atacicept, met its main goal in a Phase 3 trial in IgA nephropathy, a chronic condition that can lead to kidney failure. After 36 weeks of treatment, atacicept was associated with a 42% reduction versus a placebo — and a 46% decline from the study’s start — in the amount of protein in participants’ urine, an important marker of kidney health. 
    • “Without providing specifics, Vera said atacicept’s other efficacy results were “consistent with or better than” what was observed in mid-stage testing and had a safety profile “comparable to placebo.” The company will share the data with the Food and Drug Administration in the coming weeks and intends to file an accelerated approval request in the fourth quarter.”
  • Per Fierce Pharma,
    • “Amgen has detailed a positive phase 3 readout for its T-cell engager Imdelltra in previously treated small cell lung cancer (SCLC).
    • “The DLL3xCD3 bispecific has shown that it can help patients live longer, has a more tolerable safety profile and improves certain cancer-related symptoms compared with chemotherapy in second-line SCLC, according to results from the phase 3 DeLLphi-304 trial. The data will be presented June 2 at the 2025 American Society of Clinical Oncology annual meeting and simultaneously published in The New England Journal of Medicine.
    • “The drug significantly reduced the risk of death by 40% versus chemo in SCLC patients who had tried one line of platinum-based chemotherapy. Patients in the Imdelltra arm lived a median 13.6 months, compared with 8.3 months for chemo.
    • “All patient subgroups appeared to have benefited, regardless of their prior PD-1/L1 exposure, presence of brain metastases or liver metastases, and the type of prior chemotherapy. Among those who had tried a PD-1/L1 inhibitor, Imdelltra’s death risk reduction was 39%. In PD-1/L1-naïve patients, the number was 35%.
    • “These data underscore Imdelltra’s potential to transform patient outcomes and the small cell lung cancer treatment paradigm,” Amgen’s R&D chief, Jay Bradner, M.D., said in a statement.
    • “Findings from the DeLLphi-304 trial could help convert Imdelltra’s accelerated approval earned last year into a full approval.”

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “UnitedHealth Group shareholders signed off on the planned compensation package for newly-reinstated CEO Stephen Hemsley.
    • “Hemsley, who returned to the CEO role last month, will earn a $1 million base salary each year. He will also receive a one-time $60 million equity award in nonqualified stock options.”
  • The Wall Street Journal reports,
    • “BioNTech & Bristol Myers will jointly develop BioNTech’s BNT327 cancer-drug candidate.
    • “Bristol Myers will make a $1.5B upfront payment to BioNTech, with $2B in payments through 2028.
    • “BNT327 is being evaluated in Phase 3 trials as a first-line treatment in lung cancer.”
  • Per Fierce Pharma,
    • “In late April, when Sanofi revealed that it was selling a controlling stake in its consumer health business Opella for 10 billion euros ($11.4 billion), chief financial officer Francois Roger said that the French drugmaker would “explore external growth opportunities for bolt-on acquisitions.”
    • “Just five weeks later, Sanofi has made a deal few would describe as “bolt-on,” as it has bought out Massachusetts-based Blueprint Medicines for up to $9.5 billion.
    • “With the deal, Sanofi gains Blueprint’s portfolio of rare immunological disease treatments, including systemic mastocytosis (SM) pill Ayvakit, which generated sales of $479 million last year and has peak sales potential of $2 billion, the 14-year-old company projected last year.
    • “Blueprint also brings a next-generation SM candidate in elenestinib, a KIT D816V inhibitor which is the subject of a phase 2/3 study, and an early-stage KIT inhibitor BLU-808. KIT plays a central role in mast cell activation, Sanofi said, which is implicated in a broad range of inflammatory diseases.”
  • STAT News lets us know,
    • “Atai Life Sciences, among the most prominent biotechs focused on psychedelic medicines, said Monday it will merge with private psychedelic startup Beckley Psytech, pending results of a trial for a drug based on the practice of “smoking toad.”
    • “The new company will be known as Atai Beckley, with Beckley Psytech shareholders receiving 31% of shares in the entity.  The deal, which values Beckley at $370 million, comes as the Trump administration has expressed support for the field.” 
  • Beckers Hospital Review informs us,
    • “St. Louis-based Ascension is reportedly in talks to acquire ambulatory surgery center company AmSurg for about $3.9 billion, according to Bloomberg.
    • “AmSurg split from Envision Healthcare when the company emerged from bankruptcy in 2023. It is now backed by Pacific Investment Management Co., King Street Capital Management and Partners Group.
    • “A potential acquisition would significantly expand Ascension’s footprint in the ASC space, aligning with the broader trend toward lower-cost, outpatient care settings. AmSurg has a network of more than 250 surgery centers across 34 states and supports nearly 2,000 physicians, according to its website.”
  • and
    • “Blythe, Calif.-based Palo Verde Hospital is at risk of shutting down due to financial challenges over resignations and months of litigation, The Desert Sun reported May 30. Becker’s reached out to the hospital, which remains open as of June 2. 
    • “Congressman Raul Ruiz, MD, raised concern for the 51-bed hospital in a May 28 letter, obtained by the Sun, to California Gov. Gavin Newsom, asking the state for $4 million in emergency funding, otherwise the hospital could shutter “as soon as tomorrow.”
  • Beckers Hospital Review also collected eight GLP-1 updates for your information.
  • Per Healthcare IT News,
    • “The Clinic by Cleveland Clinic, an initiative with telemedicine technology and services company Amwell, has been getting life-changing results from leading-edge virtual care. 
    • “The Clinic has been providing virtual second opinions by the many top specialists at the renowned healthcare organization. The platform connects patients to more than 3,500 specialists across Cleveland Clinic without the need for the patients to travel to a major medical center.
    • “Misdiagnoses contribute to more than 800,000 deaths or disabilities each year in the U.S., Johns Hopkins has found, costing the healthcare system hundreds of billions, beyond the human cost. 
    • “Data from the Clinic by Cleveland Clinic shows that in 67% of cases patients receive a new diagnosis or treatment recommendation after seeking a second opinion.”
  • Per Fierce Healthcare,
    • “Electronic health records giant Epic announced Monday that more than 1,000 hospital customers and 22,000 clinics using its EHR are now live on a government-backed data exchange, as the company doubles down on a commitment it made last year.
    • “Epic said in an announcement that it marks a significant milestone in “making health information seamlessly and securely available wherever care happens.”
    • “In March, Epic reported that more than 2,000 hospital customers and more than 50,000 Epic clinics were either live or preparing to go live on the federal Trusted Exchange Framework and Common Agreement (TEFCA) framework for nationwide health data exchange, according to Becker’s Health IT.
    • “The company’s goal is to have all its customers live on TEFCA by the end of the year, Epic said in August. The health IT company now commands 42.3% of the hospital EHR market, up from 39.1% a year prior, so shifting all its hospital customers to TEFCA would represent a significant share of U.S. hospitals.”
  • and
    • “Digital health company Scripta Insights is joining forces with RxSaveCard with the goal of making it easier for employers to manage drug costs and meet their fiduciary duties.
    • “RxSaveCard offers a proprietary cost management and payment solution for pharmacy benefits, and those tools will be integrated into Scripta’s AI-powered Rx Navigation platform.
    • “For members, the integration is designed so they can better find savings for a variety of drugs, including high-cost specialty products.
    • “The platform is designed to identify lower-cost options both in the member’s prescription drug coverage or through cash-pay, according to an announcement from the companies.”

Weekend update

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

From Washington, DC

  • Roll Call tells us what actions the Houses of Congress are expected to take this week.
  • The Supreme Court begins the last month of its October 2024 term this week. The Court plans to release new opinions on Thursday. SCOTUSblog keeps track of the Court’s decisions here.
  • The Trump Administration released its detailed FY 2026 budget proposal last Friday. The proposal includes the three traditional FEHB / PSHB appropriations provisions
    • The contraceptive coverage mandate (Sec. 721)
    • The abortion coverage restriction / Hyde amendment (Secs. 611, 612)
    • The prohibition on application of full Cost Accounting Standard coverage to FEHB carriers (Sec. 609)
  • The proposal adds the following new provision (Sec. 743)
    • “None of the funds made available by this Act or any other Act may be provided for insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.”
  • Govexec adds,
    • The proposal [Sec. 743] comes just a week after House Republicans made a late change to their budget reconciliation package, which initially would have barred Medicaid or CHIP funds going toward pediatric gender affirming care, to ban federal funds going to those treatments for adults as well.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out new guidelines for COVID shot approvals.
    • The new vaccine, which Moderna will sell as mNexspike, is cleared for healthy adults 65 years and older and for individuals aged between 12 years and 64 years with one or more underlying “risk factors,” the company said Saturday.

From the judicial front,

  • Govexec tells us,
    • “An appeals court has allowed a pause on all layoffs at most major federal agencies to remain in place, rejecting the Trump administration’s bid to block a lower court’s injunction and likely sending the matter to the Supreme Court for final adjudication. 
    • “A ruling preventing most reductions in force and agency reorganizations from taking place will continue indefinitely after the U.S. Court of Appeals for the Ninth Circuit ruled—in a 2-1 decision—in favor of the unions, municipalities and advocacy groups that sued over the workforce reduction plans. The Trump administration brought the case on an emergency basis, seeking a stay of a district court ruling that had found President Trump likely acted outside his legal and constitutional powers.”
    • Here’s a link to the Court’s opinion.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When facing down a cancer diagnosis, patients often ask: What can I do to help my own odds? 
    • “The answer, data increasingly shows, is to go back to the basics: exercise and a good diet. 
    • “A structured exercise program with a trainer helped colorectal cancer patients lower their risks of death and cancer recurrence after treatment, according to a study released Sunday at the American Society of Clinical Oncology’s annual conference in Chicago and published in the New England Journal of Medicine. 
    • “The study spanned more than a decade and is the first to answer conclusively in a controlled trial whether physical activity can improve cancer-related survival, the study’s authors said. Patients in the program had a 37% lower risk of death after eight years, compared with patients who only received educational information on exercise.”
  • The New York Times informs us,
    • “Breast cancer patients whose tumors have spread to other parts of their bodies live from scan to scan. Is their treatment working? Or will they learn their cancer is growing again?
    • “But a new study sponsored by the drug company AstraZeneca showed that there is an alternative: Instead of waiting for a scan to show that a cancer is growing, it’s possible to find early signs that the cancer is resisting the drugs that were controlling it.
    • “To do that, researchers used a blood test to find mutations in cancer cells that let the tumors defy standard treatments. Early detection allowed patients to be switched to a different drug that overcomes the mutated cancer. The result was to keep the cancers in check longer and allow patients to have more than an extra year without deteriorating quality of life.
    • “The study was reported Sunday at the annual meeting of the American Society of Clinical Oncology (ASCO) and published in The New England Journal of Medicine.”
  • Also from ASCO, Biopharma Dive relates,
    • “AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly prescribed, two-drug regimen involving chemotherapy.
    • “The finding, detailed Saturday at the American Society of Clinical Oncology’s annual meeting, gives physicians a clearer choice for when patients’ disease progresses after initial treatment.
    • “Data from the trial should also shore up AstraZeneca and Daiichi’s market position. Enhertu already won Food and Drug Administration approval for gastric cancer that’s positive for a protein called HER2 following first-line treatment with Herceptin, an older HER2-targeting medicine.”
  • The Washington Post lets us know about “four ways women are physically stronger than men. Strength is associated with brute force, but female bodies excel in resilience and other key areas.”
  • The New York Times Well suggests ten workouts that you can take on vacation.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Could you use some discreet help with birth control from a $14.99-a-month period-tracking app?
    • “How about a hands-free, wearable breast pump, for $549; a $299 wristband to soothe hot flashes; or an extra-slim, temperature-neutral, LED-lit speculum to bring to gynecologists’ appointments — part of a $125 kit including “comfy socks”?
    • “These products and more are part of a fast-growing industry known as “femtech” — high-tech solutions for women’s health needs — whose many female founders say they’re tackling age-old inequities.
    • “Investors have jumped in, growing the market from $40.2 billion in 2020 to a projected $75 billion this year. And that’s just for starters: A “ghost market” of strategies to address “profoundly underserved women’s health needs” could reap up to $360 billion, a venture capital firm reported in March.
    • “Many areas of women’s health — like menstrual pain, endometriosis, polycystic ovarian syndrome, preeclampsia, and menopause — have been overlooked for so long by traditional medicine that women have had to take these problems into their own hands and innovate,” said Elizabeth Gazda, CEO of Embr Labs, which makes the wristband to treat hot flashes. “And because these innovations are occurring at a time of expanding technological ability, with cloud computing and ubiquitous smartphone adoption, women’s health is now leapfrogging men’s health.”
  • In the same vein, Fortune Well interviews Midi Health’s CEO Joanne Strober.
    • The menopause care company, launched in 2021, has helped 200,000 women get support and care to manage menopause and is the fastest-growing virtual health care company for women in midlife. But CEO Joanna Strober admits that many women left their appointments wanting more guidance: How much fiber should I be eating? What’s the proper combination of melatonin and magnesium to improve sleep? How do I prevent cognitive decline?
    • Now, Strober hopes to give them an answer—and appeal to younger women. 
    • In an exclusive interview with Fortune, Strober shared the expansion plans for Midi Health with the launch of AgeWell, which she calls a “longevity roadmap grounded in women’s hormonal health” to improve women’s “strength” and “vitality.” 

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

Cybersecurity policy and law enforcement,

  • Helpnet Security tells us,
    • “NIST has introduced a new way to estimate which software vulnerabilities have likely been exploited, and it’s calling on the cybersecurity community to help improve and validate the method.
    • “The new metric, “Likely Exploited Vulnerabilities” (LEV), aims to close a key gap in vulnerability management: identifying which of the thousands of reported flaws each year are actually being used in real-world attacks.
    • “Organizations typically rely on two main tools for this: the Exploit Prediction Scoring System (EPSS), which estimates the chance of future exploitation, and Known Exploited Vulnerability (KEV) lists like the one maintained by CISA. But both have limits. EPSS is predictive and doesn’t account for past exploitation, while KEV lists are confirmed cases but often incomplete.
    • “LEV aims to bridge that gap by calculating the probability that a vulnerability has been exploited in the past, based on historical EPSS data. It’s a statistical estimate, not a confirmation, which is why the whitepaper emphasizes that LEV is meant to augment, not replace, existing methods.” * * *
    • The researchers outline four key ways LEV could be used:
      • 1. Estimate how many vulnerabilities have been exploited.
      • 2. Check how complete KEV lists are.
      • 3. Identify high-risk vulnerabilities missing from those lists.
      • 4. Fix blind spots in EPSS, which sometimes underestimates risk for already-exploited bugs.
  • Next Thursday, the Senate Homeland Security and Governmental Affairs Committee will hold a confirmation hearing for the following Department of Homeland Security nominees.
    • Sean Cairncross, of Minnesota, to be National Cyber Director, Robert Law, of the District of Columbia, to be Under Secretary for Strategy, Policy, and Plans, James Percival, of Florida, to be General Counsel, Sean Plankey, of Pennsylvania, to be Director of the Cybersecurity and Infrastructure Security Agency, and Kevin Rhodes, of Florida, to be Administrator for Federal Procurement Policy.
  • Federal News Network reports yesterday,
    • “The Trump administration is proposing to cut more than 1,000 positions at the Cybersecurity and Infrastructure Security Agency.
    • “Under the 2026 budget request, CISA would go from approximately 3,732 funded positions today to 2,649 positions next year. The staff reductions are detailed in CISA’s fiscal 2026 budget justification, posted today. They present the most detailed view yet of the Trump administration’s proposal to cut CISA’s budget by nearly $500 million.
    • “The proposed cuts still have to be approved by Congress as part of the 2026 appropriations process. But they come as hundreds of CISA employees have already left under the Trump administration. Meanwhile, more staff could depart through deferred resignations or early retirements offered to DHS staff in April.
    • “The proposed cuts are spread across CISA’s various divisions. CISA’s cybersecurity division would go from 1,267 positions to 1,063 jobs. CISA’s infrastructure security division would go from about 343 positions to 325 jobs.”
  • Dark Reading informs us,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) and Australian Cyber Security Centre (ACSC) released new guidance this week on procuring, implementing, and maintaining security information and event management (SIEM) and security orchestration, automation, and response (SOAR) platforms.
    • “SIEM and SOAR help organizations collect and analyze data from firewalls, endpoints, and applications to better detect and respond to cybersecurity incidents. However, many organizations encounter significant implementation and deployment challenges, including significant costs and ongoing maintenance requirements. The guidance noted these are not “set it and forget it” tools.
    • “These platforms are becoming more essential as organizations store and manage an influx of data that is highly attractive to attackers, particularly personally identifiable information and personal health information. Additionally, increasing infrastructure complexity is creating gaps in visibility and making threat detection more difficult. There are more endpoints to secure, more applications, more third-party vendors, and more remote workers for attackers to exploit.”  
  • Per HHS Office for Civil Rights news releases,
  • and
    • “Today [May 30, 2025], the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced a settlement with Comstar, LLC (“Comstar”), a Massachusetts company that provides billing, collection, and related services to non-profit and municipal emergency ambulance services, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. The settlement resolves an OCR investigation concerning a ransomware breach that affected 585,621 individuals.”
    • “Under the terms of the settlement, Comstar agreed to implement a corrective action plan that OCR will monitor for two years, and paid OCR $75,000.”
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/hhs-hipaa-agreement-comstar/index.html.”
       
  • Cybersecurity Dive points out,
    • “U.S. authorities on Thursday [May 28, 2025] charged 16 defendants in a massive global operation to disrupt the Russia-based cybercrime group behind the DanaBot malware. 
    • “DanaBot infected more than 300,000 computers around the world, facilitating fraud and ransomware and resulting in more than $50 million in damage, according to federal prosecutors. The U.S. coordinated with multiple foreign governments and private cybersecurity firms to dismantle the botnet operators’ infrastructure.
    • “The Department of Justice charged Aleksandr Stepanov, 39, a.k.a. “JimmBee,” with conspiracy, conspiracy to commit wire and bank fraud and additional charges. Artem Aleksandrovich Kalinkin, 34, a.k.a. “Onix,” was charged with conspiracy to gain unauthorized access to a computer to gain information and to defraud, among additional charges. 
  • Bleeping Computer lets us know,
    • The Federal Criminal Police Office of Germany (Bundeskriminalamt or BKA) claims that Stern, the leader of the Trickbot and Conti cybercrime gangs, is a 36-year-old Russian named Vitaly Nikolaevich Kovalev.
    • “The subject is suspected of having been the founder of the ‘Trickbot’ group, also known as ‘Wizard Spider,'” BKA said last week [English PDF], after another round of seizures and charges part of Operation Endgame, a joint global law enforcement action targeting malware infrastructure and the threat actors behind it.
    • “The group used the Trickbot malware as well as other malware variants such as Bazarloader, SystemBC, IcedID, Ryuk, Conti and Diavol.
    • “Kovalev is now also wanted in Germany, according to a recently issued Interpol red notice saying he was charged with being the ringleader of an unnamed criminal organization.”
  • and
    • “An international law enforcement operation has taken down AVCheck, a service used by cybercriminals to test whether their malware is detected by commercial antivirus software before deploying it in the wild.
    • “The service’s official domain at avcheck.net now displays a seizure banner with the crests of the U.S. Department of Justice, the FBI, the U.S. Secret Service, and the Dutch police (Politie).
    • “According to an announcement on the Politie website, AVCheck was one of the largest counter antivirus (CAV) services internationally, which helped cybercriminals assess the stealthiness and evasion of their malware.
    • “Taking the AVCheck service offline marks an important step in tackling organized cybercrime,” stated Politie’s Matthijs Jaspers.
    • “With this [action], we disrupt cybercriminals as early as possible in their operations and prevent victims.”
  • USA Today reports,
    • “An Iranian national pleaded guilty for his role in an international ransomware scheme that targeted the computer networks of Baltimore and other U.S. cities, disrupting services and causing tens of millions of dollars in losses, federal authorities said.
    • “Sina Gholinejad, 37, pleaded guilty May 27 to one count of computer fraud and abuse and one count of conspiracy to commit wire fraud, the Justice Department said in a news release. Gholinejad was arrested Jan. 10 at Raleigh-Durham International Airport in North Carolina, federal court records show.
    • “He faces a maximum penalty of 30 years in prison and is set to be sentenced in August, the Justice Department announced.”

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive informs us,
    • “A previously unknown team of Russian government-backed hackers is targeting critical infrastructure organizations in multiple sectors to collect intelligence for Moscow, Microsoft and the Dutch government said in separate reports published Tuesday.
    • “The group, which Microsoft calls Void Blizzard and the Dutch intelligence services call Laundry Bear, has been using stolen credentials and automated bulk-email collection from cloud services to scoop up data on NATO member states and Ukraine.
    • “Void Blizzard’s cyberespionage operations tend to be highly targeted at specific organizations of interest to the Russian government, including in government, defense, transportation, media, non-governmental organizations (NGOs), and healthcare sectors primarily in Europe and North America,” Microsoft said in a blog post.”
  • and
    • “A “highly targeted” spearphishing campaign is attempting to ensnare financial executives at banks, investment firms, energy utilities and insurance companies around the world, Trellix said in a report published Wednesday.
    • “The malicious emails are rigged with installers that allow the hackers to remotely access victim computers.
    • “With this amount of access to legitimate accounts, attackers could steal files or initiate fraudulent money transfers, potentially without raising red flags.”
  • and
    • “ConnectWise is investigating suspicious activity — likely associated with a nation-state actor — affecting a limited number of customers that use ScreenConnect. 
    • “In a post on its website, ConnectWise said it has notified all affected customers, alerted law enforcement to the attack and retained Mandiant to help with its investigation. 
    • “A company spokesperson added that ConnectWise issued a patch for ScreenConnect, implemented enhanced monitoring and hardening measures across its environment.” 
  • and
    • “More than 9,000 ASUS routers have been compromised in a months-long hacking campaign that researchers from GreyNoise warn may be a prelude to the creation of a botnet.
    • “Hackers are breaching routers through brute-force login attempts and authentication bypasses that rely on a command injection vulnerability, tracked as CVE-2023-39780, to execute system commands, GreyNoise researchers said in a blog post on Wednesday.
    • “GreyNoise first detected suspicious activity in March, when it flagged three suspicious HTTP POST requests made to ASUS routers, according to Matthew Remacle, senior researcher at GreyNoise.
    • “ASUS released a patch for the vulnerability in a recent firmware update, but the initial bypass attempts have not received CVEs, according to GreyNoise. In addition, researchers say, if a router was compromised before the firmware was updated, a backdoor will still remain on the devices unless secure shell protocol access is explicitly disabled.” 
  • Per Cyberscoop,
    • “As the internet fills up with clips from AI-video generators, hacking groups are seeding the online landscape with malware-laced programs and fake websites hoping to cash in on the trend.
    • “Tracked by researchers at Mandiant and Google Cloud, the campaign is being carried out by a group identified as “UNC6032.” Since mid-2024, they have spread thousands of advertisements, fake websites and social media posts promising victims access to popular prompt-to-video AI generation tools like Luma AI, Canva Dream Lab and Kling AI.
    • “Those promises lead to phishing pages and malware, with the group deploying infostealers and backdoors on victim devices. Compromised parties saw their login credentials, cookies, credit card data and in some cases Facebook information stolen, and the scheme appears to be impacting a wide range of industries and geographic areas.”
  • CISA did not add any known exploited vulnerabilities to its catalog this week.

From the ransomware front,

  • Dark Reading tells us,
    • “Extortionist-cum-information broker “Everest Group” has pulled off a swath of attacks against large organizations in the Middle East, Africa, Europe, and North America, and is now extorting victims over records stolen from their human resources departments.
    • “This May, the long-overlooked threat actor advertised nine new cyberattacks. Victims ranged from healthcare organizations to construction and facilities management companies. But its biggest win came against Coca-Cola, from which it stole records associated with hundreds of employees, including their personally identifying information (PII) like names and addresses, salary records, and scans of passports and visas.
    • “In each of these leaks, researchers from VenariX found files relating to SAP SuccessFactors, SAP’s cloud-based HR management platform. The researchers believe the attacks to be legitimate and estimate that initial access in each case likely occurred through a third-party SAP service provider called “INK IT Solutions.”
  • The Hacker News notes,
    • “The threat actors behind the DragonForce ransomware gained access to an unnamed Managed Service Provider’s (MSP) SimpleHelp remote monitoring and management (RMM) tool and then leveraged it to exfiltrate data and drop the locker on multiple endpoints.
    • “It’s believed that the attackers exploited a trio of security flaws in SimpleHelp (CVE-2024-57727, CVE-2024-57728, and CVE-2024-57726) that were disclosed in January 2025 to access the MSP’s SimpleHelp deployment, according to an analysis from Sophos.
    • “The cybersecurity company said it was alerted to the incident following a suspicious installation of a SimpleHelp installer file, pushed via a legitimate SimpleHelp RMM instance that’s hosted and operated by the MSP for their customers.”
    • The threat actors have also been found to leverage their access through the MSP’s RMM instance to collect information from different customer environments about device names and configuration, users, and network connections.
  • Fortra tells us what we need to know about Interlock ransomware.
  • Per Bleeping Computer,
    • “Threat actors linked to lesser-known ransomware and malware projects now use AI tools as lures to infect unsuspecting victims with malicious payloads.
    • “This development follows a trend that has been growing since last year, starting with advanced threat actors using deepfake content generators to infect victims with malware.
    • “These lures have become widely adopted by info-stealer malware operators and ransomware operations attempting to breach corporate networks.
    • “Cisco Talos researchers have discovered that the same technique is now followed by smaller ransomware teams known as CyberLock, Lucky_Gh0$t, and a new malware named Numero.
    • “The malicious payloads are promoted via SEO poisoning and malvertising to rank them high in search engine results for specific terms.”
  • Per CFO Dive,
    • “About one in four companies targeted in a ransomware incident in the last year did not get all their data back after paying the attacker, cybersecurity firm Delinea said in a report released Wednesday.
    • “Delinea also found that most ransomware today includes data-theft extortion, with 85% of victims saying they were threatened with having their data published or sold.
    • “Paying the ransom doesn’t always bring the desired results,” Delinea said in the report.”

From the cybersecurity business and defenses front,

  • Dark Reading notes,
    • “Tenable Security has announced plans to acquire Apex, an Israel-based startup specializing in security solutions driven by artificial intelligence (AI). Apex will be integrated into Tenable One, Tenable’s software-as-a-service-based exposure management platform.
    • “Founded in 2023, Apex helps organizations discover ungoverned AI. Co-founders Matan Derman (CEO) and Tomer Avni (chief product officer) developed a platform designed to surface all AI activities, including shadow apps, AI-generated code, and fake identities. The boutique company of roughly 20 employees competes with Prompt Security, Lasso Security, and Aim Security.”
  • Per Cyberscoop,
    • “Zscaler announced Tuesday its intention to acquire Red Canary, a company known for Managed Detection and Response (MDR) services, to boost its ability to integrate artificial intelligence, automation and human expertise into its security offerings. 
    • “The acquisition is positioned around the convergence of Zscaler’s data-driven, AI-centric cloud security and Red Canary’s decade of operational expertise in MDR. Zscaler’s executive leadership emphasizes the blending of large-scale data intelligence and automated, agentic Security Operations Centers (SOCs) with the capabilities of ThreatLabz, its security research division.
    • “The proposed acquisition of Red Canary is a natural expansion of our capabilities into managed detection and response and threat intelligence to accelerate our vision of AI-powered SOC of the future,” Jay Chaudhry, CEO and founder of Zscaler, said in a press release. “By integrating Red Canary with Zscaler, we will deliver to our customers the power of a fully integrated Zero Trust platform and AI-powered security operations.”
  • Dark Reading lets us know,
    • “Chief information security officers (CISOs) are being paid better than ever, more likely to be an executive — or report directly to an executive — and have expanding responsibilities. Yet tight security budgets continue to be a major challenge.
    • “Overall, the top cybersecurity professional is doing well at large companies and has proven their value but continually has to work to link security to business opportunities rather than costs, according to two surveys published this week.
    • “The average CISO at large US companies — those with revenue of $1 billion or more — has a current compensation of $532,000, including base salary, bonuses, and equity benefits, according to survey data published by cybersecurity consultancy IANS Research on May 29. Increasing responsibilities come with the high salaries, with CISOs now often charged with assessing business risk, product security, and digital strategy.
  • Per Dark Reading explains why “A Defense-in-Depth Approach for the Modern Era By integrating intelligent network policies, zero-trust principles, and AI-driven insights, enterprises can create a robust defense against the next generation of cyber threats.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NCQA, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash
  • The University of Minnesota’s CIDRAP tells us,
    • “The Centers for Disease Control and Prevention (CDC) yesterday updated its childhood immunization schedule with a revised recommendation on COVID-19 vaccines for healthy children.
    • “The changes partly reflect a new position on COVID vaccine recommendations for healthy children announced earlier in the week by Department of Health and Human Services Secretary Robert F. Kennedy Jr., though they do not go as far as Kennedy had suggested.
    • “The CDC childhood immunization schedule now says that healthy children ages 6 months to 17 years, when the parent expresses a desire for their child to vaccinated, “may receive COVID-19 vaccination, informed by the clinical judgement of a healthcare provider and personal preference and circumstances.” Previously, the agency had recommended COVID-19 vaccines for healthy children ages 6 months and older, based on the recommendation of the CDC’s Advisory Committee on Immunization Practices.” * * *
    • “[A]ccording to the CDC, shared clinical decision-making recommendations on the immunization schedule are required to be covered by private insurers [with no cost sharing when provided in-network] under the Affordable Care Act.
    • “The CDC is still recommending COVID vaccination for children ages 6 months to 17 years who are moderately or severely immunocompromised.”
  • Govexec informs us,
    • “The White House on Friday told the government’s top watchdog it will only cooperate when doing so does not impede its ability to carry out President Trump’s agenda, reigniting a feud that traces back to the president’s first term in office. 
    • “The letter, from Office of Management and Budget General Counsel Mark Paoletta to the Government Accountability Office, follows the watchdog last week finding the Trump administration violated federal spending laws by withholding money appropriated by Congress. Paoletta denied that the administration has flouted the Impoundment Control Act, the law that prohibits the executive branch from withholding congressionally appropriated funds for policy reasons. 
    • “The OMB official criticized GAO for asking too many questions of the White House, including the dozens of probes the watchdog has opened into potential illegal impoundments. Paoletta noted that GAO has around 50 “open engagements” with the budget office. 
    • “Not only does GAO exceed its statutory authority when it unhelpfully injects itself into an agency’s implementation of a program, GAO also hampers the Executive Branch’s ability to carry out its statutory mandates,” Paoletta said in the letter, which was first reported by The Washington Post. He added the legislative branch agency often attempts to substitute its “policy views for those of the president.” 
  • The American Medical Association News lets us know,
    • “The Government Accountability Office May 29 released a report recommending the Centers for Medicare & Medicaid Services target behavioral health services when auditing Medicare Advantage plans’ use of prior authorization. CMS said it currently does not target behavioral health services because they make up a small percentage of MA services, the report said.     
    • “The report describes selected MA organizations’ prior authorization requirements and use of internal coverage criteria for prior authorization decisions on behavioral health services. It also examines CMS’ oversight of the use of internal coverage criteria, among other issues. GAO said that CMS “would take the recommendation under advisement in the future.” 

In Food and Drug Administration news,

  • Per Healio,
    • “The FDA approved Tryptyr to treat the signs and symptoms of dry eye disease, according to a press release from Alcon.” * * *
    • “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine, said in the release. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.” * * *
    • “Alcon expects a third quarter launch for Tryptyr in the U.S.”
  • Per HCPLive,
    • “The US Food and Drug Administration (FDA) has approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency.1
    • “Announced by Eton Pharmaceuticals on May 28, 2025, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have difficulty swallowing pills or special administration needs.” * * *
    • “Adrenal insufficiency is a rare, serious condition characterized by decreased production of aldosterone and cortisol due to reduced adrenal gland function. It can present acutely in an adrenal crisis or chronically, and if not recognized, can lead to very high morbidity and mortality.2 In the release, Eton Pharmaceuticals estimated that more than 5,000 adrenal insufficiency patients are present in the US between the ages of 5 and 17.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity, emergency department visits, and laboratory percent positivity are at very low levels.
      • Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The University of Minnesota’s CIDRAP adds,
    • “The US Centers for Disease Control and Prevention (CDC) in its weekly update today reported 42 measles cases, some tied to a large outbreak centered in West Texas and others linked to instances of community transmission or travel to other states or countries, lifting the nation’s total to 1,088 infections.
    • “Two more states reported their first cases this week, Iowa and Nebraska, putting the number of affected jurisdictions at 33. The number of outbreaks remained at 14, and 90% of cases are linked to outbreaks.” * * *
    • “The Texas Department of State Health Services (TDSHS) today reported 9 more cases in the West Texas outbreak, putting the total since January at 738. Though 35 counties have reported cases linked to the outbreak, only 7 still have ongoing transmission. 
    • “Like other states, Texas also continues to record measles cases from various sources that apparently aren’t linked to the larger outbreak, and today officials reported 8 more such infections, lifting that total to 32. 
    • “A few other states have reported cases linked to West Texas activity, but no new illnesses were reported in New Mexico or Oklahoma. On May 28, Kansas reported a total of 64 cases from 11 counties, 59 of them linked to an outbreak in the southwestern part of the state.’
  • CBS News reports,
    • “Hormel Foods Corporation is recalling over 256,000 pounds of canned beef stew nationwide due to potential contamination with wood fragments, according to federal health officials.
    • “In a recall notice posted Wednesday [May 28], the U.S. Department of Agriculture’s Food Safety and Inspection Service said the 20-oz. metal cans containing “Dinty Moore Beef Stew” were shipped to retail locations nationwide.
    • “The recalled products have a “FEB 2028” best by date, lot code “T02045” and establishment number “EST 199G” printed on the can. 
    • “The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product,” the notice read. 
    • “So far, there have been no confirmed reports of injury.”
  • The American Medical Association lets us know “what doctors wish patients knew about improving eye health.”
  • Health Day points out,
    • “Among U.S. youth, overdose deaths attributable to synthetic opioids alone are increasingly predominant, according to a study published online May 20 in Pediatrics.
    • “Megan Miller, M.P.H., from the New York University Grossman School of Medicine in New York City, and colleagues examined trends in overdose deaths involving combinations of synthetic opioids with benzodiazepine, cocaine, heroin, prescription opioids, and other stimulants. Findings were based on U.S. youth aged 15 to 24 years from 2018 to 2022 using the National Vital Statistics System multiple cause of death datasets.
    • “The researchers found that between 2018 and 2022, overdose death counts increased from 4,652 to 6,723 (10.85 to 15.16 per 100,000), with a slight decrease between 2021 and 2022. Deaths involving synthetic opioids only showed the largest increases (1.8 to 4.8 deaths per 100,000). Regardless of race, ethnicity, or sex, fatal synthetic opioid-only overdose rates were higher than polydrug overdose rates involving synthetic opioids since 2020. In 2022, rates of synthetic-only overdose deaths were 2.49- and 2.15-times higher among male versus female youth and among those aged 20 to 24 versus 15 to 19 years, respectively.”
  • and
    • “Heart disease, strokes and diabetes contribute to many dementia cases in the United States, but the risk is not equal everywhere, a new study says.
    • “Overall, more than a third (37%) of U.S. dementia cases are linked to eight conditions: diabetes, heart failure, atrial fibrillation, coronary artery disease, heart attack, stroke, high blood pressure and high cholesterol, researchers found.
    • “The South has the strongest link between these diseases and dementia, researchers reported recently in the journal Alzheimer’s & Dementia.
    • “A substantial number of dementia cases could be eliminated by mitigating modifiable cardiometabolic risk factors, especially in U.S. counties with a high risk of dementia attributed to these risk factors,” senior researcher Dr. Brad Racette said in a news release. He’s chair of neurology at Barrow Neurological Institute in Phoenix.”
  • Per a National Institutes of Health news release,
    • “A research team funded by the National Institutes of Health (NIH) has identified a diagnostic aid that has the potential to accurately predict the recurrence of diabetic foot ulcers that appear to be fully healed. By measuring the skin’s barrier function through a process known as trans-epidermal water loss, or TEWL, scientists were able to determine which wounds were more likely to reopen. TEWL measurements are a major factor in burn care, where deep layers of the skin are often damaged. The findings suggest that full restoration of skin barrier function should be incorporated into existing wound treatment standards to ensure complete wound closure and to better identify patients at risk of wound recurrence.
    • “This study is an important initial step to give clinicians treating diabetic foot ulcers a reliable diagnostic aid for the first time to assess an individual’s risk of ulcer recurrence,” said Teresa Jones, M.D. program director for the Division of Diabetes, Endocrinology, & Metabolic Diseases at NIH’s National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). “Foot ulcers are such a confounding issue with diabetes and being able to determine which wounds are at highest risk for recurrence could save many lives and limbs.”  
  • NCQA, writing in LinkedIn, tells us,
    • The use of peer support is a growing trend for populations affected by mental health and substance use disorders. Peers—both paid and volunteer—have many of the same lived experiences as the people they serve, and can help them navigate the health care system, access treatment and overcome barriers to recovery.
    • Peers are another avenue of support in the behavioral care system—their shared experience related to mental health, addiction and recovery helps them build trust relationships. Many studies show the benefits of peer support: decreased days in inpatient care, increased engagement in outpatient treatment, reduced readmission rates and lower relapse rates.
    • “There’s a stigma associated with receiving mental health and substance use treatment,” says Chrissy Craig, MSPH, NCQA’s Senior Health Care Analyst. “Because of their lived experience, peers can connect with people who may not be ready to engage in traditional treatment approaches. They can build trust and encourage individuals to get the help they need.”
    • Recognizing the importance of peer support, NCQA has added it as an option for follow-up care in four HEDIS® measures:
      • Follow-Up After Emergency Department Visit for Substance Use (FUA).
      • Follow-Up After Hospitalization for Mental Illness (FUH).
      • Follow-Up After Emergency Department Visit for Mental Illness (FUM).
      • Follow-Up After High-Intensity Care for Substance Use Disorder (FUI) (MY 2026).
  • Per Health Leaders Media,
    • “An AI tool that can detect inflammation in the coronary artery could help clinicians diagnose heart disease much earlier, even decades before the patient shows any outward signs of distress.
    • “CaRi-Heart Technology, developed by Connecticut-based Caristo Diagnostics, was recently given its own Category III CPT code by the American Medical Association’s CPT Editorial Panel, an important step in the path to adoption after FDA approval and, just as important, payer reimbursement. The technology has also shown promising results in trials conducted in 2024 at five National Health Service hospitals in the UK, where reports indicate more than half of patients analyzed by the AI tool had their treatments changed.
    • “To clinicians, the tool could be a critical step forward in the diagnosis and treatment of heart disease, the leading cause of death in the country.”
  • The Wall Street Journal reports,
    • “Sanofi and Regeneron’s respiratory drug, itepekimab, showed mixed results in late-stage trials for COPD.
    • “One trial saw a statistically significant 27% reduction, while the other missed its primary goal with only a 2% reduction.
    • “Sanofi shares fell 7% and Regeneron shares dropped 12% after the results; future steps will be discussed with regulators.”
  • Per BioPharma Dive,
    • “A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S.
    • “When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn’t meet the threshold for statistical significance, Summit said in a statement Friday.
    • “Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is “necessary” to support a submission.”

Fromm the U.S. healthcare business front,

  • The actuarial consulting firm, Milliman, announced on May 27,
    • the release of the 2025 Milliman Medical Index (MMI), which measures healthcare costs for Americans covered by a typical employer-sponsored health insurance plan. Healthcare costs for the average person increased 6.7% in 2025, with pharmacy costs increasing by 9.7% and outpatient facility care costs rising 8.5%. Healthcare costs for a hypothetical family of four rose to $35,119.
    • “Pharmaceutical costs have been a leading driver of healthcare spending in recent years,” says Milliman Principal and Consulting Actuary Dave Liner. “This year, outpatient facility services and pharmacy costs together accounted for nearly 70% of the total cost increase. Much of the outpatient growth is linked to high-cost drugs administered in outpatient settings.”
    • In recognition of the MMI’s 20th anniversary, this edition includes a look back at how healthcare costs have evolved in the last 20 years. “Since we began publishing the MMI 20 years ago, healthcare costs for American families have nearly tripled,” says Milliman Principal and Consulting Actuary Deana Bell. “Annual growth has averaged 6.1%, far outpacing any other household expense. No other cost category has risen as steeply or as consistently over the past two decades. Outpatient facility care saw the largest increase of any category, rising 286% since 2005, reflecting the growing complexity of procedures now handled outside of inpatient settings.”
    • Read this year’s MMI.
  • An essayist writing in the Wall Street Journal, opines “America’s hospital-bed shortage is about to become a crisis. As new construction declines and occupancy rates soar, experts warn that hospitals may soon cease to function properly because of overcrowding.”
  • Modern Healthcare reports,
    • “Health systems, accountable care organizations and others are bringing extra staff and tracking technology into post-acute care to reduce hospital readmissions.
    • “Health systems, such as OSF Healthcare, and accountable care organizations, such as Provider Partners Connect Care are using remote patient monitoring equipment, electronic medical records software and additional staff to ensure patients don’t have a set-back that will send them back to the hospital. Readmissions add costs that ripple through the healthcare system and the Centers for Medicare and Medicaid Services penalizes hospitals and nursing homes for higher-than-predicted readmissions within 30 days of a hospital discharge.”
  • and
    • “UnityPoint Health, based in West Des Moines, Iowa, and MercyOne Siouxland Medical Center in Sioux City, Iowa, have signed a letter of intent for UnityPoint to acquire the medical center. The proposed agreement includes the hospital, its associated facilities, physician practices and home care services. The acquisition is expected to be finalized this summer, pending customary closing conditions.”
  • and
    • MDaudit, a cloud-based continuous risk monitoring platform that helps healthcare organizations reduce billing vulnerabilities and increase revenue, has entered into a definitive merger agreement to acquire Streamline Health Solutions, a provider of tools that help healthcare providers improve financial performance. The all-cash transaction is valued at approximately $37.4 million, including debt. The deal is expected to close in the third quarter.
  • Per Fierce Healthcare,
    • Women’s healthcare company Wisp has launched a diagnostics arm to offer low-cost testing at home for sexual and reproductive health, the company announced May 28. 
    • Wisp is an online platform that prescribes medication for a range of women’s health needs such as oral contraception, yeast infections, fertility, emergency contraception and some medication abortion. Women can pick up their prescriptions at the pharmacy on the same day as their request, following approval by a provider. Wisp also ships medications in discreet packaging. 
    • Wisp will now offer at-home tests for common sexually transmitted infections and free telehealth consultations for positive results, according to a release by the company. Patients will send completed urine tests or swabs to a partnered CLIA/CAP accredited laboratory and receive results in three to five business days. 
    • “The new model expands on Wisp’s direct-to-consumer telehealth platform and eliminates the need for patients to visit an in-person clinic to complete diagnostic testing. Patients can collect samples at home with tests sent in discreet packaging to maintain privacy in their healthcare and receive services entirely from home.”
  • and
    • “Talkspace inked a partnership with Amazon Pharmacy to streamline psychiatric medication fulfillment and home delivery for its members.
    • “It marks the first time a virtual behavioral health solution has integrated with Amazon Pharmacy, the companies said.
    • “Psychiatric patients of Talkspace can now have their medications fulfilled through Amazon Pharmacy and delivered to their homes for seamless medication management. Talkspace and Amazon Pharmacy tout the partnership will improve medication adherence for Talkspace members.” 
  • Per Healthcare Dive,
    • Best Buy reported $109 million in charges primarily linked to restructuring at the electronics retailer’s health unit in its first quarter, the company said in earnings released Thursday. 
    • The company began restructuring its health business after it recorded a non-cash goodwill impairment charge of $475 million in its fourth quarter ended Feb. 1, linked to a downward revision in the long-term financial projections for its health segment. 
    • The retailer partners with healthcare organizations to provide in-home health services, but the business has taken “longer to develop than we initially thought,” as providers grapple with financial challenges and the future of the federal government’s hospital at home waiver seems uncertain, Best Buy CEO Corie Barry said during a call with investors Thursday.