Weekend update

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Weekend update

David Ermer–Congress, Medical / Rx research, Mental health care, Rx coverage–

From Washington, DC,

  • The New York Times reports,
    • “President Trump on Saturday signed an executive order seeking to hasten research into the therapeutic benefits of LSD, Ecstasy, psilocybin and other mind-altering drugs by ordering federal agencies to ease restrictions that have long limited the ability of scientists to study them.
    • “The measure also provides $50 million for state-level research into ibogaine, a powerful psychedelic made from the root of a Central African shrub that has been drawing interest from researchers for its potential to treat opioid use disorder and other forms of substance abuse.
    • “The funding will most immediately benefit Texas, which has already committed $50 million to studying ibogaine but recently failed to secure matching funds from a private drug developer.
    • “I’m pleased to announce historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs,” Mr. Trump said from the Oval Office, where he was joined by a number of top cabinet officials and the podcaster Joe Rogan.”
  • Here is a link to the White House fact sheet on this executive order.

From the census front,

  • The New York Times informs us,
    • “Fertility in the United States has been declining since the Great Recession, and reached a new low last year, according to federal data released Thursday {april 9], causing some to fear a baby bust.
    • “But it’s not clear that will happen. Instead, there could be a lull, demographers say — a period of very low fertility that could eventually rebound.
    • “That’s because of a drastic shift among American women who are now of childbearing age: They are waiting longer to have babies. They’ve become much less likely to have them in their teens or 20s — and much more likely to in their 30s or 40s.
    • “Demographers have a name for this kind of lull in fertility: a “postponement transition.” It happened in the 1990s in Europe, then rebounded somewhat as the younger women who delayed pregnancy eventually had children. It also happened in the United States in the 1970s, as more women pursued college and careers after the women’s movement. These women didn’t end up having fewer children; they just had them later.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Doctors may be getting closer to having a potent weapon against a genetic driver of lung cancer that has long lacked any targeted treatment options.
    • “Researchers on Sunday presented early results of clinical trials of two experimental drugs targeting a gene called KRAS, one of the most common and challenging drivers of human cancers. Each drug takes aim at a different KRAS mutation that drives lung cancer, which kills more people worldwide each year than any other form of the disease.
    • “KRAS mutations act as an accelerator in cancer cells. Both drugs shrank tumors and slowed disease progression in patients with advanced cancer that had progressed despite standard chemotherapy and immunotherapy, raising hopes that doctors may be homing in on a new option for a form of cancer that has long resisted treatment. 
    • “I’ve never been this hopeful about KRAS mutations,” said Dr. Lei Deng, an oncologist at Fred Hutch Cancer Center in Seattle who wasn’t involved in either study. The research was presented at the American Association for Cancer Research annual meeting.”
  • Healio points out,
    • “Odds for developing Parkinson’s disease increased with newer groundwater and with carbonate aquifers, according to a poster presented at the American Academy of Neurology Annual Meeting. 
    • “Our previous studies have focused a lot on air pollution, but we know from prior research that contaminated drinking water can also impact health,” Brittany Krzyzanowski, PhD, who conducted the study at Barrow Neurological Institute, told Healio.
    • “There’s a wealth of underused data on drinking water sources, like aquifer type and groundwater characteristics, so we took the opportunity to explore how these factors might be linked to Parkinson’s disease,” said Kryzyzanowski, who is now with the Atria Research Institute.”

Froom the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY is in advanced talks to acquire Kelonia Therapeutics for more than $2 billion, according to people familiar with the matter.
    • “A deal could come as soon as Monday, assuming the talks don’t fall apart, the people said. The deal price could also include additional consideration if Kelonia reaches certain milestones, they said.
    • “Privately held Kelonia is developing a next-generation treatment for the blood cancer multiple myeloma. Buying it would position Eli Lilly to boost its position in the lucrative blood-cancer segment of the $240 billion global cancer-drug market.
    • Kelonia has raised just under $60 million to date, with its last public valuation being a little over $100 million as of April 2022, according to data from PitchBook.
    • “Kelonia is developing a next-generation so-called CAR-T therapy. CAR-T therapies deliver genes—or genetically altered cells—to help a patient’s immune system fight the cancer. 
    • “We have something that is truly transformative to the space,” Kelonia Chief Executive Kevin Friedman said in an interview in January at an industry conference.”
  • Fierce Healthcare tells us,
    • “More than 80% of primary care physicians are concerned about financial stability over the next several years, new research from Elation Health found.
    • “The health tech company surveyed 280 PCPs from Jan. 31 to Feb. 23 for its 2026 Primary Care Pulse Survey Report. Fifty-two percent of respondents were fully independent and 48% have some affiliation. 
    • “As financial pressures mount for PCP practices, 64% cite government and commercial payer reimbursement as their top concern. Staffing costs, workforce challenges, technology and IT costs and rising operational costs are also challenges for responding physicians. 
    • “Simultaneously, the report found 68% of respondents are actively developing plans to address concerns—ranging from increasing marketing to adopting new payment models. Sixty-seven percent of respondents plan to implement changes within the next two years while 27% report already implementing membership or cash-pay models and 18% report adopting value-based payment structures.” 

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iranian war front,

  • The New York Times reports on April 16,
    • “The exchange of bombs and missiles in the Middle East between Iran and its foes has been paused for more than a week now. Iran’s hackers, however, have remained active on the digital battlefield.
    • “Iran has continued its cyberspace operations since the cease-fire with the United States began on April 8, according to Western cybersecurity experts and former U.S. intelligence officials. In doing so, Tehran is trying to keep up pressure on the United States and Israel but also positioning itself to mount a bigger retaliation if peace talks do not resume.” * * *
    • “This is a time, more than ever, we should worry about Iran,” said Evan Peña, a co-founder of the cybersecurity firm Armadin. “In cyberwarfare there isn’t really a cease-fire.”
    • “Mr. Peña said that if the cease-fire or negotiations collapsed, Iran would want to be in a strong position to retaliate, potentially by attacking critical infrastructure in the United States. Tehran has done so in the past but generally with limited impact. More than a decade ago, Iranian hackers targeted a small dam in upstate New York, but by happenstance the dam’s sluice-gate controls had been taken offline for maintenance, much to the relief of U.S. investigators at the time.
    • “Iran, Mr. Peña said, is going to be more aggressive and devote more resources to trying to get access to American companies as the war rages on.” * * *
    • “Josh Zweig, the chief executive of Zip Security, which secures small and midsize enterprises, said Iran was specifically looking for less well-defended targets, like municipal-run water and energy facilities.
    • “He also said small firms that make investment decisions for wealthy individuals and families have been targeted.”

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “National Cyber Director Sean Cairncross expects more executive orders coming from the White House as part of implementing the national cybersecurity strategy, he said Wednesday [April 15].
    • “Staffers on Capitol Hill and others in the cyber world have been awaiting the implementation guidance the Trump administration had proclaimed would come to accompany the strategy  published last month.
    • “Asked at a Semafor event about whether that would include executive orders, Cairncross answered, “I think that that’s the case.”
    • “Cairncross touted American ingenuity for producing an artificial intelligence model like Anthropic’s Claude Mythos, rather than it developing under U.S. cyber rivals like China or Russia. He acknowledged reports about the administration holding meetings about the cyber risks and benefits of something like Mythos — “the model right now that everyone’s talking about” — adding that the administration is looking to balance the dangers and positive capabilities of AI in cyberspace.”
  • and
    • “The federal agency tasked with analyzing security vulnerabilities is overwhelmed as it and other authorities struggle to keep pace with a flood of defects that grows every year. The National Institute of Standards and Technology announced Wednesday that it has capitulated to that deluge and narrowed the priorities for its National Vulnerability Database.
    • “NIST said it will only prioritize analysis for CVEs that appear in the Cybersecurity and Infrastructure Security Agency’s known exploited vulnerabilities catalog, software used in the federal government and critical software defined under Executive Order 14028.
    • “The federal agency’s goal with the change is to achieve long-term sustainability and stabilize the NVD program, which has encountered previous challenges, notably a funding lapse in early 2024 that forced NIST to temporarily stop providing key metadata for many vulnerabilities in the database.” * * *
    • “NIST said CVEs that don’t fit its more narrow criteria will still be listed in the NVD, but they won’t be automatically enriched with additional details. 
    • “This will allow us to focus on CVEs with the greatest potential for widespread impact,” the agency said. “While CVEs that do not meet these criteria may have a significant impact on affected systems, they generally do not present the same level of systemic risk as those in the prioritized categories.”
  • Dark Reading adds,
    • [C]ybersecurity teams will need to move to make up for the loss of enrichment data, according to Shane Fry, chief technology officer at RunSafe Security. 
    • “Anthropic’s Mythos highlights why NIST is making this move in the first place,” Fry says. “They have already seen a surge in CVE submissions over the past year and have not been able to keep up. Mythos and other tools for AI-assisted vulnerability will only add to the volume of vulnerabilities disclosed. It’s a problem the industry has been aware of for some time.” 
    • “So without the ability to keep up with the sheer volume of CVEs cyber teams need to pivot, Fry adds. 
    • “The way forward will have to emphasize building defenses into software itself to prevent the exploit of bugs and zero-days even before patches are available or the vulnerability is disclosed,” he advises.” 
  • Federal News Network tells us,
    • “The [U.S.] Office of Personnel Management announced this week that it will be expanding its Tech Force hiring program to include opportunities for agencies to hire cybersecurity specialists. That’s on top of the program’s existing recruitment efforts for software engineers, data scientists and product managers.
    • “The newly added cybersecurity roles will focus on “protecting critical systems, strengthening federal cybersecurity capabilities and safeguarding the digital infrastructure relied on by millions of Americans,” OPM said in a press release.
    • “The federal government depends on strong cybersecurity to protect critical systems and maintain public trust,” OPM Director Scott Kupor said Monday. “Through Tech Force, we’re recruiting highly skilled cybersecurity professionals to take on real challenges and strengthen the government’s defenses where it matters most.”
  • Cyberscoop informs us,
    • “Authorities from 21 countries took down 53 domains and arrested four people allegedly involved in distributed denial-of-service operations used by more than 75,000 cybercriminals, Europol said Thursday. 
    • “The globally coordinated effort dubbed “Operation PowerOFF” disrupted booter services and seized and dismantled infrastructure, including servers and databases, that supported the DDoS-for-hire services, officials said.
    • “Law enforcement agencies obtained data on more than 3 million alleged criminal user accounts from the seized databases, and ultimately sent more than 75,000 emails and letters to participants, warning them to halt their activities.”
  • and
    • “Two New Jersey men were sentenced Wednesday for facilitating North Korea’s long-running scheme to plant operatives inside U.S. businesses as employees, generating more than $5 million in illicit revenue for the regime, the Justice Department said. 
    • “The U.S. nationals — Kejia Wang, also known as Tony Wang, and Zhenxing Wang, also known as Danny Wang — were part of a years-long conspiracy that placed operatives in jobs at more than 100 U.S. companies, including many Fortune 500 companies, based in 27 states and the District of Columbia. * * *
    • “Both men previously pleaded guilty to an assortment of crimes. Kejia Wang was sentenced to nine years in prison for conspiracy to commit wire and mail fraud, money laundering and identity theft. Zhenxing Wang was sentenced to 92 months in prison for conspiracy to commit wire and mail fraud and money laundering. 
    • “The pair were also ordered to forfeit a combined $600,000, of which two-thirds has already been paid, officials said.”

From the cybersecurity breaches and vulnerabilities front,

  • Health Exec reports,
    • “Healthcare IT infrastructure and electronic health record company CareCloud confirmed in a regulatory filing that it’s suffered a data breach, said to have impacted one of its six patient record stores, with hackers inside its network for “approximately eight hours.”
    • “The “cybersecurity incident” was disclosed in a filing with the U.S. Securities and Exchange Commission, and said the incident occurred on March 16. The company said that, while intruders did access patient medical records, it wasn’t clear if any data was stolen.
    • “An investigation into the data breach is still ongoing, and CareCloud said it’s working with a third-party cybersecurity organization to gather the details. After some downtime, CareCloud said it believes the invasion has been thwarted and that criminals no longer have a way inside its network.
    • “Systems were taken down and restored the same day. Details such as how the cyberattack was conducted and if any ransomware was deployed was not revealed. It’s also not clear if any notable cybercrime syndicate was behind the data breach, nor whether those responsible made any demands. 
    • “The filing with the SEC was released on March 24, and there hasn’t been any real update from the company since.”
  • The Cybersecurity and Infrastructure Security Agency added ten known exploited vulnerabilities (KVEs) to its catalog this week.
  • Cybersecurity Dive tells us,
    • “Hackers are attempting to exploit a high-severity flaw found in several end-of-life routers from TP-Link, according to a blog post published Friday [April 17] by Palo Alto Networks’ Unit 42. 
    • “Researchers warn the observed payloads share similarities to those found in malware used in Mirai-like botnets. Such activity would involve attempts to download the malware and execute on vulnerable devices, according to researchers. 
    • “The vulnerability was originally disclosed in June 2023, and proof of concept exploits appeared prior to the disclosure, wrote Unit 42 researchers. 
    • “The Cybersecurity and Infrastructure Security Agency previously added the command injection vulnerability, tracked as CVE-2023-33538, to its Known Exploited Vulnerabilities catalog in July 2025.” 

From the ransomware front,

  • The HIPAA Journal reports,
    • Brockton Hospital in Massachusetts is continuing [as of April 15] to grapple with a cybersecurity incident that took many of its electronic systems offline on April 6, 2026, and forced the hospital to divert ambulances to alternate facilities and cancel scheduled cancer treatments. An investigation into the cyberattack is ongoing, and the hospital is working with federal and state officials. While some systems have been brought back online, the hospital is continuing to use its downtime procedures, with staff members working off paper rather than computers. A Signature Healthcare spokesperson told Boston 25 News that the hospital would continue under downtime procedures for the next two weeks. * * *
    • “The Anubis ransomware-as-a-service group claimed responsibility for the attack. Anubis engages in double extortion, stealing data and encrypting files. A ransom must be paid to prevent the release of stolen data and obtain the keys to recover encrypted files. According to SuspectFile, which was contacted by a member of the Anubis group, files were encrypted in the attack. The Anubis spokesperson told SuspectFile that only non-critical systems were encrypted, and 2TB of data was stolen in the attack, including a large volume of patient data.
    • “Anubis is attempting to pressure Signature Healthcare into paying the ransom by adding the hospital to its data leak site, along with a countdown clock when the stolen data will be published. Signature Healthcare has yet to confirm the extent of data theft, which may not be known for some time. The priority continues to be patient care, remediating the attack, and bringing systems back online when it is safe to do so.”
  • Govtech relates,
    • “Ransomware continues to pose a serious threat to U.S. critical infrastructure, with more than 2,100 related incidents reported to federal authorities in 2025, according to the latest FBI Internet Crime Complaint Center (IC3) report.
    • “To put that number in perspective, IC3 reported roughly 1,100 data breach threats to critical infrastructure, which includes sectors such as health care, critical manufacturing, financial services, energy and agriculture, among others. Ransomware attacks directed at critical infrastructure are serious, possessing as they do the potential to disrupt operations, expose sensitive data and affect the delivery of public services.
    • “Those incidents have implications for state and local government organizations, which operate or support many of these systems. The nation’s critical infrastructure spans 16 sectors whose disruption would have a debilitating effect on the United States. Of these, the health-care and public health services sector reported the highest number of incidents, the report shows.”
  • SC Media adds,
    • “Analysis by Check Point researchers showed that out of the 672 ransomware attacks reported in March 2026, Qilin alone accounted for 20%, followed by Akira, which was responsible for 12% of the attacks, and Dragonforce RaaS, which was responsible for 8% of the incidents, reports Infosecurity News.”
  • and
    • “Suspected former Black Basta ransomware affiliates are ramping up targeting of senior-level executives with social-engineering attacks designed to deploy remote monitoring and management (RMM) software, ReliaQuest reported Tuesday.
    • “Black Basta, a previously notorious Russia-linked ransomware-as-a-service (RaaS), became defunct last year following leaked chats exposing its infrastructure and techniques. However, attacks leveraging the group’s distinct tactics, techniques and procedures (TTPs) have continued into 2026, with ReliaQuest noting an accelerating volume and increased targeting of company leadership.
    • “For example, Microsoft Teams-based phishing — a staple of Black Basta’s playbook — is becoming more prevalent, with 56% of all Teams phishing over the last year occurring within the last quarter, and nearly a third happening in March 2026 alone.”
  • Industrial Cyber notes,
    • “New data from Cyfirma disclosed that ransomware activity in March reflects a continuation of the sector’s shift toward structured, repeatable extortion models, where encryption is paired with data theft to maximize pressure on victims. The findings show that growing fragmentation of extortion groups suggests that smaller or emerging threat actor groups could adopt automation, AI-assisted reconnaissance, and data-driven victim profiling to scale operations efficiently. These campaigns rely heavily on coercive messaging, warning against third-party recovery attempts and reinforcing the risk of permanent data loss, underscoring how psychological pressure remains central to payment conversion strategies. 
    • “At the operational level, ransomware actors in March continue to refine rather than reinvent their tactics, prioritizing efficiency, scalability, and consistency across attacks. Cyfirma assesses that groups are likely to enhance encryption speed, standardize extortion workflows, and expand double extortion practices, while relying on common intrusion vectors such as phishing and exposed services. The broader trajectory points to incremental evolution within a mature ecosystem, where innovation is less about novel techniques and more about optimizing execution and monetization across a globally opportunistic threat landscape.” 
  • Security Boulevard informs us,
    • “Double extortion is bad enough—that’s the current tactic favored by ransomware groups—but the emerging quadruple extortion promises to further complicate mitigation and response by targeted organizations, prompting an escalation in extortion payments.  
    • “Yet that’s just one piece of evidence that ransomware continues to evolve despite high-profile takedowns by law enforcement—they just reincarnate or rebrand as new groups, new research by Akamai shows. Of course, the biggest game-changer is GenAI, as RasS operators like Black Basta and FunkSec press LLMs into service to generate code and greatly improve the social engineering techniques that give bad actors a foot in the door and to scale up attacks, opening the door for even less sophisticated actors to execute damaging attacks. 
    • “Ransomware groups continue to seek additional ways to generate profit, such as by pressuring victims and weaponizing compliance,”  researchers at Akamai note in their Ransomware Report 2025. 
    • “Noting that ransomware tactics have moved “away from traditional encryption-centric ransomware tactics towards more sophisticated and advanced extortion methods,” Nathaniel Jones, vice president, security and AI strategy and field CISO at Darktrace, says, “rather than relying solely on encrypting a target’s data for ransom, threat actors will increasingly employ double or even triple extortion strategies, encrypting sensitive data but also threatening to leak or sell stolen data unless their ransom demands are met.” 

From the cybersecurity defenses front,

  • The Wall Street Journal reports,
    • “The software bug was capable of crashing an operating system used by firewalls, servers and network appliances. It went undetected for over 27 years.
    • “Last month, it was caught by Mythos, the latest AI model from Anthropic that has spooked the White House, banking executives and cybersecurity professionals around the world.
    • Welcome to the bug armageddon. AI models like Mythos and others are finding bugs in older software at a rate never seen before.
    • “While most of the coding issues may be minor, their sheer volume has amplified the risk that smaller software developers will become overwhelmed with reports of bugs such as the one Mythos found. Thanks to AI, hackers will be able to leverage those bugs more quickly than ever before.
    • “The 1998 bug in the OpenBSD operating system was one of thousands Mythos found last month. Anthropic said last week that it is working with about 50 technology companies and organizations to find and fix bugs and currently has no plans to release Mythos to the general public.
    • “We need to know that we can release it safely, and it’s not exactly clear how we can do that with full confidence,” said Logan Graham, the head of Anthropic’s Frontier Red Team, which evaluates AI for risks.”
  • Security Week relates,
    • “To help security teams prepare for this future, the Cloud Security Alliance has developed and published The ‘AI Vulnerability Storm’: Building a ‘Mythos-ready’ Security Program. The report does not provide a solution, but it will help readers understand what is coming, and what they must do in preparation.
    • “Mythos will not fundamentally change the nature of cybersecurity. It primarily provides a step change in the pace of attacks, and the biggest single change will be the asymmetric advantage to the attacker increasing dramatically. Cybersecurity itself doesn’t change – it just needs to cope with a new ferocious pace. Best practice fundamentally remains the same, but its importance becomes more critical.
    • “Focus on the basics and harden your environment further,” say the CSA report authors. “Segmentation, egress filtering, multifactor authentication, and defense-in-depth/breadth all increase the difficulty for attackers.” Nothing there is new, but many firms have not done it adequately – and must rapidly start doing it effectively”
  • and
    • “OpenAI announced that it’s scaling its Trusted Access for Cyber program to thousands of verified defenders and hundreds of security teams. They will be given access to GPT-5.4-Cyber, a fine-tuned variant of GPT-5.4 that relaxes the usual guardrails for legitimate cybersecurity work. 
    • “GPT-5.4-Cyber also provides new capabilities such as binary reverse engineering, which enables users to analyze compiled executable software for vulnerabilities and malicious behavior.
    • “The new AI model is initially being offered on a limited, iterative basis to vetted security vendors, organizations, and researchers.
    • “Individual defenders who want to enroll into the Trusted Access for Cyber program and test GPT‑5.4‑Cyber can apply through chatgpt.com/cyber via an identity verification process, while enterprise teams must go through their OpenAI account representative.” 
  • Cyberscoop adds,
    • “A joint report from the Cloud Security Alliance (CSA), the SANS Institute and the Open Worldwide Application Security Project (OWASP) concludes that in the near term, organizations are “likely to be overwhelmed” by threat actors using AI to find and exploit vulnerabilities faster than defenders can patch them.
    • “While those organizations can use AI tools to speed up their own defenses, attackers “still face a heavier relative burden due to the inherent limitations of patching. This in turn leads to “asymmetric benefits” for attackers who can afford to adopt the technology without the same caution and bureaucracy as a multi-billion dollar business.
    • “The cost and capability floor to exploit discovery is dropping, the time between disclosure and weaponization is compressing toward zero, and capabilities that previously required nation-state resources are now becoming broadly accessible,” wrote Robert Lee, SANS Institute’s Chief AI Officer, Gadi Evron, CEO of Knostic and Rich Mogull, chief analyst at CSA, who served as the primary authors.”
  • TechTarget tells us, “How CIOs can beat AI challenges: A top researcher’s view.”
    • “CIOs are grappling with moving AI from the pilot stage to genuine implementation, and many are encountering organizational pitfalls that are stalling the delivery of real value.”
  • Healthexec informs us,
    • “Hospitals have always had to rely on multitudes of healthcare vendors to keep operations humming. In recent years the arrangement’s inherent management challenge has only grown more complex. 
    • “That’s largely because myriad AI technologies have changed daily life for provider organizations and industry partners alike. Arguably the biggest single difficulty to emerge from the transformation is the risk of cybersecurity breaches. 
    • “The Health Sector Coordinating Council (HSCC) is taking a crack at helping cybersecurity leaders, teams and stakeholders clear a path through the thicket. The assistance comes in the form of a 109-page document titled Third-Party AI Risk and Supply Chain Transparency Guide.
    • “The guidebook is authored by members of an HSCC working group focused on cybersecurity. The team’s guiding aim for the project was to “address the growing gaps in discovery and disclosure processes that make AI supply chain risk so difficult to manage.”
  • A NIST press release announced
    • “NIST SP 800-133 Rev. 3 (Initial Public Draft) Recommendation for Cryptographic Key Generation
    • “Proposed changes in this revision include the following:
      • “Asymmetric key-pair generation has been expanded to include methods for deriving randomness during key-pair generation.
      • “Key-pair generation now has options for derivation similar to symmetric keys and new methods for “seed expansion,” which allows for the limited use of SHAKE and deterministic random bit generators (DRBGs).
      • “Key-encapsulation mechanisms (KEMs) are discussed as a key-establishment option for symmetric key generation, and post-quantum cryptography (PQC) references have been added throughout (e.g., the new PQC signatures).
      • “Text has been reworded to address random number generation in alignment with SP 800-90C.
    • “Comments are especially requested regarding:
      • “Hardware security module (HSM) design — How do these requirements align with common practice and existing systems using a root seed/secret value?
      • “PQC implementations and protocol — How do these requirements fit with storing keys as seeds (e.g., for ML-KEM) and performing hybrid (i.e., combined classical and post-quantum) implementations?”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. sought to distance himself from U.S. measles outbreaks on Friday at a House Education and Workforce Committee hearing on the administration’s fiscal 2027 budget request.
    • “The hearing, part of Kennedy’s weeklong tour of Congress on the budget, was relatively light on spending discussions, as Democrats who have repeatedly requested such a hearing with Kennedy looked to pin him down on a range of issues. The hearing was often combative, with Democrats drawing attention to issues such as vaccines and Kennedy’s focus on school nutrition.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services today announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration. He most recently served as the U.S. Small Business Administration’s Chief Counsel for Advocacy.
    • “Mulligan will advise Health and Human Services Secretary Kennedy Robert F. Kennedy, Jr., and other agency leaders on policy development to continue to make health care more affordable for the American people. His portfolio will include cost-benefit analysis of regulation, econometric modeling, and program evaluation of major expenditures.”
  • Fierce Healthcare relates,
    • “Insurers hoping for a reprieve from an out-of-network billing system largely favoring healthcare providers will likely be left wanting as federal policymakers sit on their hands and one large payer’s bid to limit the claims faces an uphill battle, strategy firm Capstone concluded in a new report.” * * *
    • “Capstone expects any meaningful reversal of the IDR trend to most likely stem from direct action by payers. Chief among these is an administrative penalty Elevance Health implemented in 11 states for its Anthem BCBS commercial business. The policy levies a fee equal to 10% of the allowed amount on facility claims involving OON providers.
    • “The policy has faced substantial pushback from provider groups, though it still went into effect Jan. 1 in the 11 states with plans to expand similar fees in two more. Capstone noted that one of the initial states, Indiana, has already enacted legislation against the practice and that the broader policy is primed for legal challenges.
    • “However, if Elevance’s model is adopted more broadly, the OON ecosystem could shrink as facilities internalize the direct financial cost of hosting OON providers,” Capstone wrote. “In that scenario, provider groups would face pressure to either absorb the loss of facility relationships or accept often-lower in-network rates.” 
  • Bloomberg Law points out,
    • “The head of the Department of Labor’s employee benefits regulator defended how he’s changed the agency before lawmakers, saying he’s cut down on excessive litigation and enforcement.
    • “Daniel Aronowitz, leader of the Employee Benefit Security Administration, told members of a House Education and the Workforce subcommittee that the agency had reoriented its approach to follow the Employee Retirement Income Security Act, boasting that it was “the most pro-ERISA EBSA administration ever.” * * *
    • “The agency is revisiting a Biden-era [mental health] parity rule creating a comparative test to ensure employers are covering mental health equally with medical and surgical benefits. EBSA halted enforcement of the rule after The ERISA Industry Committee sued.
    • “Aronowitz noted that he didn’t believe the rule’s comparative analyses “got us anywhere. It just created cost and burden.”
    • “But he said EBSA is conducting investigations on medical necessity denials, exclusions for autism and opioid treatment, so-called “ghost networks” of unavailable doctors, and conflicts of interest.”
  • Thompson Reuters discusses this year’s obligation to provide notices of creditable coverage to Medicare Part D eligible individuals and to CMS.
    • “Sponsors of HRAs and other account-based plans, which are typically offered alongside major medical plans, will welcome the relief from providing burdensome and potentially confusing Part D creditable coverage notices. Sponsors of plans that remain subject to the disclosure requirements should use the 2027 parameters when determining whether their plans’ prescription drug coverage is creditable for that year.”
  • Healthcare Dive tells us,
    • “Employers, lawmakers, patient advocates, price transparency groups and more urged the Department of Labor to quickly finalize a rule that would force pharmacy benefit managers, shadowy middlemen in the drug supply chain, to share more pricing and compensation information.
    • “PBMs did not feel the same, according to industry comments on the proposed regulation.
    • “The rule has been caught up between two powerful industries — healthcare purchasers like employers and the PBMs they contract with to manage their drug benefits — since it was proposed in January, amid growing criticism of PBMs and a broader bet from the Trump administration that better price transparency will lower healthcare costs.”
  • and
    • “The CMS has proposed repealing the alternative pathway for new technology add-on payments, or NTAP, beginning in fiscal year 2028. The change is included as part of the 2027 Inpatient Prospective Payment Systems proposed rule. 
    • “Under the proposal, medical devices with breakthrough device designation would be required to meet the same eligibility criteria as other available technologies to receive the additional payments under the NTAP pathway.
    • “Industry trade group AdvaMed said the alternative pathway policy, implemented by the first Trump administration, has worked well. AdvaMed, in an emailed statement to MedTech Dive, said “it would be disappointing if this progress were rolled back.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has cleared an HPV self-collection kit and approved a related HPV assay for at-home use, enabling patients to obtain their own sample for cervical cancer screening.
    • “The Onclarity HPV Self-Collection Kit (Waters Corp.) is tested with the BD Onclarity HPV Assay (Waters Corp.), which now supports specimens collected both in clinic and at home. The assay detects all high-risk, carcinogenic genotypes and is the only FDA-approved HPV assay to identify “six individually and three groups of pooled results,” according to a manufacturer press release.
    • “The at-home, self-collection kit could help reduce barriers for unscreened or underscreened individuals, who comprise nearly 60% of cervical cancer cases.”
  • MedTech Dive relates
    • “Philips has received Food and Drug Administration clearance for an artificial intelligence-enabled CT system.
    • “The 510(k) clearance, which Philips disclosed Thursday, covers a Verida device that the company claims reduces image noise by 80% and reconstructs scans twice as fast as its predecessor.
    • “Jie Xue, chief business leader for precision diagnosis at Philips, recently said Verida’s throughput sets it apart from photon-counting CT technology. GE HealthCare and Siemens Healthineers sell photon-counting devices.”
  • CVS Health informs us,
    • “New treatments take years of research, clinical trials, and regulatory review before reaching patients. Several therapies approaching FDA decisions this spring could expand treatment options for people managing a range of conditions.
    • “CVS Caremark’s Clinical Pipeline Services team — made up of licensed clinical pharmacists and analysts — monitors new therapies moving through the drug pipeline and evaluates what those approvals could mean for members. The team’s latest Drugs to Watch report identifies several notable therapies with decisions expected between April and June 2026, including:
      • “A new oral option for patients with treatment-resistant hypertension
      • ​​​”A more convenient, at-home format for early Alzheimer’s disease treatment that avoids lengthy IV infusions​​​​​​​​​​
      • “The first FDA-approved treatment for a chronic ​​​​liver infection
      • “An additional non-nicotine option for adults looking to quit smoking.”

From the judicial front,

  • Bloomberg Law reports,
    • “A wave of hospital bankruptcies has brought in its wake high-stakes lawsuits aiming to boost creditor payouts by targeting health insurers over allegedly systemic claim denials.
    • “At least nine different health insurers in the past six months have been sued by bankruptcy estates or trustees appointed under bankruptcy plans for three major health-care businesses, according to court documents reviewed by Bloomberg Law. 
    • “Lawsuits against insurers for Steward Health Care System LLC, CarePoint Health Systems Inc., and Jackson Hospital & Clinic Inc. seek a combined $427.9 million and represent 32,000 patient claims across 32 hospitals and providers and six states.
    • “The litigation is ramping up as hospital bankruptcies accelerate amid disputes over private equity ownership, real estate investment trust structures, and federal cuts.” * * *
    • “A trustee for CarePoint, which operated three New Jersey safety-net hospitals before it filed for Chapter 11 in November 2024, sued Cigna Health & Life Insurance Co. in February. It argued Cigna underpaid its hospitals for various services by more than $114 million.
    • “Steward’s trustee filed at least seven lawsuits against insurers, including Blue Cross of Florida, CareSource Ohio, and Aetna Health, seeking to recover more than $63 million and alleging they withheld valid reimbursements.
    • “Jackson Hospital took a different approach, bringing a more than $250 million antitrust suit against Blue Cross and Blue Shield of Alabama in December. The insurer used market domination to allow for a pattern of baseless claim denials for emergency care, the suit said.”

From the public health and medical / Rx research front,

  • The Centers for DIsease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is low in most areas of the country.
    • “Influenza
      • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all HHS regions and influenza B activity continues to trend downward.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News reports,
    • “There are now 602 cases in the Utah measles outbreak, the state’s Department of Health and Human Services reported April 14. Of those, 405 cases have been diagnosed this year. The confirmed total of measles cases reported nationwide in 2026 has increased to 1,748, according to the latest data from the Centers for Disease Control and Prevention. There have been 19 reported outbreaks across 33 jurisdictions. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape adds,
    • Use of preexposure prophylaxis (PrEP) for HIV prevention in adolescents and young adults is “strikingly low,” though youth aged 13-24 years have nearly 1 in 5 new HIV infections in the US, according to a new study in JAMA Pediatrics. Use is particularly low in women and young people who live in the South and Midwest.
    • “Efforts to expand PrEP use among youths should address geographic disparities, legal and policy barriers, and clinician engagement to improve equitable access to HIV prevention,” the authors wrote, led by Nicholas Venturelli, MD, MPH, with Boston Children’s Hospital in Boston.
  • The University of Minnesota’s CIDAP relates,
    • “Historically, shigellosis cases in the United States have primarily been seen in young children in daycare settings and in people who’ve traveled to countries with poor sanitation. Infections with Shigella, a gut pathogen that causes diarrhea and vomiting, have also been fairly easy to treat.
    • “But the profile of who’s most at risk of shigellosis is changing, and the infections is becoming much harder to treat, according to a report published last week in Morbidity and Mortality Weekly Report, the flagship publication of the Centers for Disease Control and Prevention (CDC).
    • “In the report, researchers from the CDC and health departments across the country revealed that the vast majority of US Shigella infections from 2011 through 2023 were in adult men, a high proportion of whom (47%) had HIV. Analysis of nearly 17,000 Shigella isolates found that the proportion of isolates considered extensively drug-resistant (XDR) rose from 0% during 2011-2015 to 8.5% in 2023. 
    • “Approximately one-third of patients were hospitalized. And among patients with travel history, more than 80% reported no recent international travel.
    • “The report’s corresponding author said the findings reflect changes in epidemiology and resistance that are transforming Shigella from a primarily self-limiting infection that rarely required antibiotics into an emerging public health threat with limited treatment options. 
    • “Together, it’s a very concerning pattern of XDR Shigella strains that are being seen among vulnerable populations,” Naeemah Logan, MD, an epidemiologist with the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, told CIDRAP News.”
  • The AP informs us,
    • “The worrisome rise in colorectal cancer deaths in younger adults is concentrated in people with less education, suggesting socioeconomic factors could be driving the escalation, according to a new study.
    • “Celebrity deaths — including Chadwick Boseman in 2020 and James Van Der Beekearlier this year — have highlighted the increase in colorectal cancer deaths among younger adults, but the new paper was called the first to parse which people are most affected by the alarming rise. 
    • “The researchers found that over the last 30 years, the rise in colorectal cancer deaths in young adults occurred almost entirely among people without a four-year college degree.
    • “Of course, getting a college degree doesn’t protect you from getting colon cancer. Rather, experts say it’s a marker for other issues: People without degrees tend to earn less money, have poorer diets, exercise less and get less medical care.
    • “It’s not totally unexpected that the death risk is concentrated in the less advantaged, but the paper published Thursday in JAMA Oncology is the first national study to actually show the connection, said Dr. Paolo Boffetta, a researcher at Stony Brook Cancer Center in New York who wasn’t involved in the work.” 
  • The New York Times points out,
    • “Researchers at the University of Pittsburgh reported on Friday that they had trained the immune systems of a few patients to accept liver transplants without the drugs needed to avoid organ rejection.
    • “Three of eight patients have now been off the drugs for at least three years, perhaps an early step toward a new approach to transplantation that experts in the field have long hoped for. The study was published in Nature Communications.
    • “They’ve gone a long way toward proving a principle,” said Dr. William Jarnagan, chief of liver and transplant surgery at Memorial Sloan Kettering Cancer Center, who was not involved in the study.
    • “With further development, it could really be a game changer,” he added.
    • “Dr. Joohyun Kim, a liver transplant surgeon at Yale who was not involved with the study, said, “Even 10 years ago, people thought ‘tolerance induction’ was a dream.”
  • The Genetic Engineering and Biotechnology News adds,
    • “The American Association for Cancer Research (AACR) Annual Meeting kicks off this weekend in San Diego. A whirlwind of sessions, keynotes, fireside chats, posters, and exhibitors, the meeting is THE annual event for the cancer community.
    • “Before the conference, GEN spoke with AACR program chairs Paul S. Mischel, MD, Professor and Vice Chair for Research for the Department of Pathology at Stanford Medicine of Stanford University and Alice T. Shaw, MD, PhD, Chair of the Department of Medical Oncology and the Chief of Strategic Partnerships at Dana-Farber. In this interview, they share their perspectives on the event, what attendees should be looking out for, and what they, personally, are most looking forward to.”
  • and
    • “For pathogens like HIV, malaria, and rapidly evolving influenza strains, coaxing the immune system to produce the rare, highly potent antibodies needed for protection has long been a scientific bottleneck. Vaccines can train B cells to evolve such broadly neutralizing antibodies, but only under ideal conditions—and only in a small fraction of people. Even attempts to genetically edit mature B cells produced responses that faded as the cells died out.
    • “A team at The Rockefeller University has now taken a more upstream approach: programming hematopoietic stem and progenitor cells (HSPCs)—the source of all B lymphocytes—to carry permanent genetic instructions for therapeutic antibodies or other proteins. Because the immune system naturally amplifies rare, useful cells after vaccination, even a tiny number of edited stem cells can seed a durable, boostable immune response.
    • “The immune system is inefficient in that it produces a vast quantity of cells to protect itself,” said Harald Hartweger, a research assistant professor in Michel Nussenzweig’s Laboratory of Molecular Immunology. “We wanted to take advantage of the immune system’s ability to amplify useful, rare cells.”
    • “The study, published in Science and titled “B lymphocyte protein factories produced by hematopoietic stem cell gene editing,” demonstrates that CRISPR‑edited HSPCs can mature into B cells that express engineered antibodies upon vaccination. A standard vaccination then acts as the trigger: antigen exposure drives those edited B cells to expand, differentiate into plasma cells, and secrete high titers of the inserted antibody that last long-term.”

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

  • Fierce Healthcare reports,
    • “The Purchaser Business Group on Health has released new data that highlights some of the key healthcare priorities of its jumbo employer members, with—perhaps unsurprisingly—the escalating affordability crisis as the biggest challenge.
    • “Rounding out the top three priorities are data analytics and transparency, as well as an interest in advanced primary care. PBGH based the findings of a survey of more than two dozens of its members, which represent some of the largest employers in the United States.
    • “Elizabeth Mitchell, president and CEO of PBGH, said in an interview that the escalating cost pressures have driven “a much more proactive approach from our members to address these concerns, which are simply not being addressed by the industry.”
    • “The urgency of that concern is absolutely growing,” Mitchell said. There is “also a heightened focus on transparency and understanding prices, and we are enabling that because they cannot just keep writing blank checks to the healthcare system when they have poor outcomes and just no demonstrable improvement in quality or value.”
  • Beckers Hospital Review informs us,
    • “Little Rock, Ark.-based Baptist Health reached a definitive agreement to acquire Magnolia (Ark.) Regional Medical Center.
    • “The deal, subject to customary regulatory approvals, is expected to be completed by July 12, according to an April 16 Baptist news release. On that date, the hospital will be rebranded as Baptist Health Medical Center-Magnolia.
    • “While it is an extremely challenging time to operate community hospitals, we have a proven track record of operating rural hospitals successfully in Arkansas,” Baptist President and CEO Troy Wells said in the release.”
  • and
    • “Mark Cuban has a pitch for hospitals: Manufacture drugs in their own parking lot.
    • “Mr. Cuban’s Cost Plus Drugs previously launched a Dallas-based manufacturing facility to address supply issues, starting with epinephrine and norepinephrine production. More recently, Mr. Cuban said his facility can also produce Pitocin, pediatric cancer drugs and sterile water — and that generic tablets can be cheaper when made in Dallas versus purchased from India.
    • “During Becker’s Spring 2026 Chief Pharmacy Officer Summit, Mr. Cuban explained how Cost Plus — which includes pharmacy, contracting, procurement and manufacturing businesses — is “modularizing” its manufacturing facilities.
    • “We’ve been able to take the manufacturing facility we have in Dallas and not only make it much smaller than what everybody else has done to that point, but we’ve been able to modularize them and put them in a pod that is effectively a tractor trailer,” Mr. Cuban said. “The trailers that go on the back that you see going down the road — we can manufacture sterile injectables in that tractor trailer.”
    • “Cost Plus is selling these manufacturing pods, which can be deployed anywhere from hospital sites to disaster zones to research facilities. He said rare disease therapies that historically cost upward of $500,000 and took six months to produce can now cost roughly $50,000 and possibly take less time.
    • “That, literally, over the long term, is going to be our biggest business and will save the most lives and money,” he said. “The more efficient we become at using robotics and AI, the less expensive we can manufacture drugs.” 
  • BioPharma Dive relates,
    • “Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine that’s being tested as a potential therapy for a few seizure disorders as well as Alzheimer’s disease.
    • “UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.
    • “The therapy, codenamed NRTX‑1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the “mesial temporal lobe” part of the brain.”
  • and
    • “Kailera Therapeutics, a high-profile drug startup aiming to compete with Novo Nordisk and Eli Lilly in obesity, said Thursday it banked $625 million in one of the sector’s largest-ever initial public offerings.
    • “The IPO haul far surpasses the $500 million it set out to raise in terms set earlier this week. Kailera sold more than 39 million shares at $16 apiece. It’ll begin trading on the Nasdaq stock exchange on Friday under the ticker symbol “KLRA.”
    • “Kailera’s offering is among the biggest, by total proceeds, raised by a venture-backed biopharmaceutical company, according to BioPharma Dive data. Its IPO eclipses Acelyrin’s $540 million stock sale in 2023, Sana Biotechnology’s $588 million issuance in 2021, and Moderna’s then-record $604 million pricing in 2018.”
  • MedTech Dive lets us know,
    • “GE HealthCare is expanding a mammography collaboration with RadNet subsidiary DeepHealth.
    • “The partnership brings more of DeepHealth’s artificial intelligence tools to GE HealthCare’s mammography machines, including a workflow for complex cases that may benefit from a secondary review.
    • “The companies announced the expanded initiative at the Society of Breast Imaging Annual Symposium on Thursday.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Roll Call reports,
    • “Senate Republicans plan to release a budget resolution next week that would kick-start the process for a reconciliation bill on immigration enforcement funding and help end a partial shutdown of the Department of Homeland Security, lawmakers said Thursday.
    • “The party is aiming to provide about $70 billion in funding for Immigration and Customs Enforcement and the Border Patrol to sustain them for at least the next three years, without placing any new guardrails on federal immigration agents sought by Democrats. The budget resolution would contain instructions to the Homeland Security and Governmental Affairs and Judiciary panels, which would be charged with writing the details of the upcoming reconciliation bill.
    • “Senate Majority Leader John Thune, R-S.D., said Thursday that the chamber is “hoping to get on a budget resolution by middle to end of next week.”
  • The American Hospital Association News relates,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. April 16 testified during two House hearings on the HHS fiscal year 2027 budget proposal, which requests $111.1 billion. He first appeared in a morning session held by the House Ways and Means Committee. In the afternoon, he testified during a hearing held by the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. Kennedy will appear in additional House and Senate hearings next week to testify on the budget proposal. 
    • “While the budget request is not binding, it serves as a preliminary framework for Congress and the administration as they determine federal funding levels and the scope of health care policy this year.”
  • The New York Times tells us,
    • “In a sharp break with his past rhetoric, Health Secretary Robert F. Kennedy Jr. offered a qualified embrace of the measles vaccine on Thursday, as President Trump named a new director of the Centers for Disease Control and Prevention whose views on vaccination are more conventional than Mr. Kennedy’s.
    • “In back-to-back hearings on Capitol Hill, Mr. Kennedy testified that the measles vaccine is safe and effective “for most people” and agreed it was safer than getting measles. Under questioning, he also allowed that the vaccine might have saved the lives of two unvaccinated children who died of measles in Texas earlier this year.
    • “His comments, while carefully couched, stand in stark contrast to his previous statements about vaccination. Coupled with Mr. Trump’s announcement of Dr. Erica Schwartz, a deputy surgeon general in his first administration, as his new pick for C.D.C. director, they provided the latest evidence yet that Mr. Kennedy is trying to publicly put his efforts to overhaul American vaccine policy behind him.”
  • The Washington Post adds,
    • “Kennedy highlighted efforts to phase out synthetic food dyes, overhaul dietary guidelines and strike deals with pharmaceutical companies. He said he planned to overhaul an influential task force focused on preventive screening recommendations. And he often appealed to his Make America Healthy Again base that doesn’t always fit within the Republican agenda, including saying he had “grave reservations” about a White House executive order boosting a commonly used weedkiller.
    • “Our children are the sickest generation in modern history — and decades of failed policy, captured agencies and profit-driven systems have caused it,” Kennedy said at Thursday morning’s hearing before the House Ways and Means Committee. “Parents across this country demanded change — and we are delivering it.”
  • The Wall Street Journal informs us,
    • ‘President Trump said Thursday he will nominate Dr. Erica Schwartz to direct the Centers for Disease Control and Prevention.
    • “The CDC has been without a permanent director since Susan Monarez wasousted last year after clashing with Health Secretary Robert F. Kennedy Jr.over vaccine policy.
    • “Schwartz served as deputy surgeon general, a nonpolitical role, in the first Trump administration. She has a medical degree from Brown University, as well as a master’s degree in public health and a law degree.” * * *
    • “Trump said he was also appointing three others to a team to help lead the CDC, including health executive Sean Slovenski; Commissioner of the Texas Department of State Health Services Dr. Jennifer Shuford; and Food and Drug Administration Principal Deputy Commissioner Dr. Sara Brenner.
    • “Kennedy voiced his support for the new team earlier Thursday in a hearing before a House subcommittee.”
  • The AHA News points out,
    • “The Centers for Medicare & Medicaid Services has released an updated request for applications for the Long-term Enhanced ACO Design Model, or LEAD. Applications are due May 17. The agency also announced that it will host an office hour April 21 at 1 p.m. ET for prospective applicants. CMS said it will address FAQs about eligibility, participation requirements, financial methodology, quality measures, and the application process and timeline. Participants can also submit questions in advance.”
  • Tammy Flanagan, writing in Govexec, discusses “when retirement calculations don’t move on the same timeline.”
    • “Retroactive pay changes and delayed annuity adjustments underscore how federal retirement processing often depends on timing, coordination, and most importantly, patience.”
  • Per an OPM news release,
    • “In a coordinated effort led by First Lady Melania Trump and the Administration for Children and Families (ACF), the Office of Personnel Management (OPM) today announced new actions to expand workplace flexibilities and support for foster and adoptive families across the federal workforce. 
    • “The initiative builds on Executive Order 14359, “Fostering the Future for American Children and Families,” and reflects a broader administration priority to help more children grow up in safe, stable, and loving homes.
    • “To advance these efforts, OPM is directing agencies to highlight key provisions in its Handbook on Leave and Workplace Flexibilities for Childbirth, Adoption, and Foster Care. Federal agencies are being mobilized to better connect employees with a wide range of workplace flexibility and benefits available when fostering or adopting a child. These include up to 12 weeks of paid parental leave, leave under the Family and Medical Leave Act, flexible work schedules, and other tools designed to help working families navigate major life transitions.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Eli Lilly’s new obesity pill Foundayo met the main goal of a heart safety trial in people with diabetes, putting people who take it at no greater risk of heart attacks and other cardiovascular events than people who received long-acting insulin, the company said Thursday.
    • “The Indianapolis-based drugmaker also said people who got Foundayo were at no greater risk of liver harm than those who got insulin, fulfilling a post-marketing requirement of the pill’s Food and Drug Administration approval for obesity. The trial additionally hinted that the pill might reduce the risk of death from any cause, although that finding would need to be confirmed in additional testing.
    • “Lilly said it will seek an approval for Foundayo in diabetes by the end of the second quarter and utilize a national priority review voucher that could lead to a speedy clearance. A regulatory OK in diabetes would open up a new front in a commercial war with Novo Nordisk, which has marketed a diabetes pill called Rybelsus since 2017.”
  • Cardiovascular Business relates,
    • “AOP Health, an Austrian pharmaceutical company, has secured U.S. Food and Drug Administration (FDA) approval for landiolol to be used for the treatment of supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, in pediatric patients.
    • “Landiolol, sold under the brand name Rapiblyk, is an adrenergic receptor blocker that acts fast. It is only meant be administered as an intravenous infusion in a hospital setting. 
    • “In 2024, the drug was approved for adults after the FDA reviewed data from multiple randomized trials. This update to cover patients of all ages was based on the LANDI-PED study, which included 60 pediatric patients presenting with SVT. Overall, treatment with landiolol was linked to a reduction in ventricular rate of more than 20%.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy (TRT) products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism (without a known cause).
    • “New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are eager to work with sponsors to further evaluate this potential new use while upholding our rigorous standards for safety and effectiveness.” 

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Rotavirus, a seasonal virus similar to influenza, has been rising across the U.S. since January. With infection rates higher now than this time last year, doctors have fresh concerns that declining vaccinations could lead to more severe illness and a higher surge in the coming years. 
    • “The virus — which is spread by hands touching an infected surface, then touching the mouth — used to be a major cause of severe illness among babies and young children in the U.S., responsible for more than 200,000 emergency room visits, up to 70,000 hospitalizations and dozens of deaths each year, according to the National Foundation for Infectious Diseases. That drastically changed after the first oral vaccine was approved 20 years ago.
    • “Data from WastewaterScan, an academic program through Stanford University in partnership with Emory University, shows the virus has been surging since January, with levels continuing to increase in certain parts of the U.S., including the West and the Midwest. * * *
    • “We’re seeing a lot of rotavirus in wastewater right now, definitely very high levels and that indicates to us that there are high levels of rotavirus infections in these communities,” said Dr. Marlene Wolfe, WastewaterScan’s program director and co-principal investigator.”
    • The Centers for Disease Control and Prevention estimates that 40,000 to 50,000 hospitalizations among infants and young children are prevented every year due to the vaccines, which are given starting at 2 months of age. 
    • “Despite the data, earlier this year, Health and Human Services Secretary Robert F. Kennedy Jr. announced changes to the childhood immunization schedule, which included removing the rotavirus vaccine and telling parents they should talk to their doctor before deciding to vaccinate. 
    • “The virus is still circulating,” Offit said. “So a choice not to get a vaccine is a very real choice to experience that infection.” While the schedule changes were put on hold by a federal judge last month, doctors worry that even attempted moves to change the guidelines likely planted seeds of doubt among some new parents, who may now hesitate to vaccinate for rotavirus.”
  • MedPage Today adds,
    • “Despite tetanus being preventable with vaccination, cases continue to occur in the U.S., with deaths mostly affecting older adults, the CDC reported.
    • “From 2009 through 2023, there were 402 tetanus cases reported to the CDC in 47 states and the District of Columbia, with 16 states reporting 37 tetanus-associated deaths, wrote Michelle Hughes, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in Morbidity and Mortality Weekly Report Surveillance Summaries.”
  • Beckers Hospital Review relates,
    • “New York City-based NYU Langone Health researchers found that nearly 7% of trauma admissions are associated with pedal-powered and electronic bikes or scooters.
    • “The study, published April 15 in Neurosurgery, analyzed 914 patients treated over five years at a New York City-based Bellevue Hospital Center. Researchers found that the share of trauma cases involving an electric mobility device grew from under 10% in 2018 to more than half in 2023.”
  • The New York Times tells us,
    • “Since the approval of new Alzheimer’s drugs in recent years, there has been a lingering question: While data indicated that they could modestly slow cognitive decline for some patients, would that effect be meaningful or too slight to make difference?
    • “A new review of research spanning a decade, published on Wednesday, concluded that the clinical benefit of these and similar drugs is negligible. But the way the review was conducted spurred heated criticism from many Alzheimer’s experts, including some who had been skeptical of some of them.”
  • STAT News points out,
    • “The scientists whose work spurred the development of powerful obesity drugs like Eli Lilly’s Zepbound are now raising a provocative hypothesis: Perhaps targeting the GLP-1 hormone is actually not necessary to achieve effective weight loss.
    • “A group of researchers led by Richard DiMarchi and Matthias Tschöp has created an experimental drug that activates receptors of the GIP and glucagon hormones. They propose — based on rodent and monkey studies — that this kind of molecule, when administered at high enough doses, may result in weight loss comparable to the weight loss seen with drugs that include GLP-1 as a target, and without the tolerability issues like nausea and vomiting that often come with the approved treatments, according to a peer-reviewed draft paper published this week.
    • “The research, funded by a biotech called BlueWater Biosciences, would still need to be confirmed in humans; oftentimes results seen in animals don’t translate in the clinic. But the proposed approach, outlined in the journal Molecular Metabolism by some of the most well-known scientists in the field, is likely to stir controversy, as it challenges a central notion underpinning not just the development of approved obesity products but also next-generation versions.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “The University of Southern California (USC) research team that identified the hormone-encoding gene GDF15 as a key driver of pregnancy sickness has identified nine additional genes linked to its most severe form, hyperemesis gravidarum (HG). Six of the identified genes had not been previously linked to the condition.
    • “The Keck School of Medicine of USC team and international collaborators conducted a genome-wide association study (GWAS), scanning the entire genome for differences between women who developed HG during pregnancy and those who did not. They analyzed data from more than 10,000 women with the condition and more than 450,000 controls across European, Asian, African, and Latino ancestries. Their findings offer new clues about the condition and new hope for those affected.
    • “Marlena Fejzo, PhD, a clinical assistant professor of population and public health sciences in the Center for Genetic Epidemiology at the Keck School of Medicine, led the present study and earlier research linking GDF15 to HG. Fejzo told GEN, “The study is much larger than previous studies and on a more diverse population allowing for identification of new genes associated with HG … The new genes give us new directions to explore for prediction, diagnosis, treatment, and response to therapies.”
  • and
    • “In a new study published in Nature titled, “Mapping convergent regulators of melanoma drug resistance by PerturbFate,” researchers from The Rockefeller University have developed a platform called PerturbFate that can systematically map how diverse disease-associated genetic variations reshape cells. By tracking gene regulation in single cells over time, the team identified regulatory nodes common to diverse variations. Using melanoma drug resistance as a proof-of-concept, results showed that these shared points of control offer a path toward combination therapies that can target disease across many genetic causes.”

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

  • Cardiovascular Business reports,
    • “XCath Robotics, a Houston-based medical robotics company, announced the successful completion of the world’s first telerobotic stroke operation of its kind. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the XCath Iris Surgical Robotic System to perform the historic procedure. While Pereira was in Santiago, Panama, the patient was approximately 120 miles away in Panama City.”
  • On a related note McKinsey & Co. interviews “Sam Hazen, CEO of HCA Healthcare, [who] reflects on the state of the industry and how emerging technologies and steadfast leadership can help meet patients where they are.”
  • Healthcare Dive relates,
    • “Walmart is expanding its digital health platform to include weight management services as the retail health giant looks to capitalize on consumer interest in GLP-1 weight loss drugs.
    • “The retailer’s digital health platform, called Better Care Services, can now connect patients to third-party weight management offerings from companies like Aaptiv and Curai Health. The providers can prescribe GLP-1s, while Walmart will handle prescription fulfillment, according to a Thursday press release.
    • “Walmart said the expansion should bridge the retailer’s pharmacy and digital health services, creating easier access to GLP-1s during a time of surging demand for the weight loss medications.”
  • Fierce Healthcare adds,
    • “More pharma companies are launching direct-to-consumer drug platforms and the rise of these self-pay services could improve access to medicines but also raise concerns about oversight and accountability.
    • “The Digital Medicine Society is leading a cross-sector effort, in partnership with pharma companies, virtual-first providers and digital pharmacies, to establish a scalable blueprint for direct-to-patient pharma models as the market continues to evolve.
    • “As Big Pharmas increasingly roll out platforms for direct-to-consumer drug sales, most offering steep discounts on popular medications, many patients are open to using the new services, Fierce Pharma Marketing reported. Three-quarters of U.S. consumers are “somewhat” or “very” likely to use DTC drug sale services, a survey found.” * * *
    • “The new initiative currently involves four leading pharma companies, with plans to add more. Founding partner companies involved in the initiative include Coalesce Health, DistributeRx, Fullspan Health, Health Advances, Phil, Inc., S3 Connected Health, Welldoc, Wheel and Ypsomed.”
  • and
    • “The American Psychological Association (APA)’s Labs division announced Tuesday the launch of a digital health resource guide for those seeking out mental health tools.
    • “The APA Labs Digital Badge Solutions Library is a searchable collection of resources and technologies that have earned the organization’s Digital Badge. Users can browse tools and applications related to behavioral health and wellness; clinical tools; family, pediatrics and monitoring and sleep, relaxation and mindfulness. 
    • “The library launched with “an initial cohort of early adopters” to meet independent evaluation demand, the announcement said. Six tools are currently in the library “with many more products in the evaluation pipeline,” APA Labs Managing Director Tanya Carlson told Fierce Healthcare in an emailed statement.”
  • Trilliant Health has posted its “2026 Behavioral Health Report.”
    • “An analysis of demand, supply and yield for behavioral health finds that the crisis has intensified in the years following the COVID-19 pandemic.”
  • AP lets us know,
    • ” A West Health–Gallup Center on Healthcare in America poll published Wednesday, conducted in late 2025 and backed up by at least three other recent surveys with similar findings, found that roughly one-quarter of U.S. adults had used an AI tool for health information or advice in the past 30 days.
    • “Dr. Karandeep Singh, chief health AI officer at the University of California San Diego Health, said AI tools, many of which now incorporate web search, are an upgraded version of Google health searches that Americans have been doing for decades.
    • “I almost view it like a better entry portal into web search,” he said. “Instead of someone having to comb through the top, you know, 10, 20, 30 links in a web search, they can now have an executive summary.”
  • Healthcare Dive adds,
    • “Abridge is expanding its clinical decision support tool through two partnerships with publishers of major medical journals, the AI scribe company announced Wednesday. 
    • “Under the deal, content from the New England Journal of Medicine and the JAMA Network will inform the AI’s responses when clinicians search for medical information and ask questions about patient care.
    • “The tool should allow clinicians to more easily access the latest medical research, Abridge said. “With the amount of complexity that exists in healthcare now, easy access to information for the right patient, the right moment, the right clinical conversation — it’s critical,” Matt Troup, clinical strategy principal at Abridge, said in an interview.”
  • Cardiovascular News notes,
    • “Stereotaxis, a St. Louis-based medtech company, has agreed to acquire Robocath, a major player in the field of robotic interventional cardiology technologies. 
    • “The deal includes an upfront payment of $20 million. Stereotaxis could pay up to an additional $25 million if certain regulatory and commercial milestones are met.
    • “Stereotaxis already specializes in robotic technologies used for a variety of minimally invasive endovascular procedures. Scooping up Robocath helps the company expand its offerings to include devices used for percutaneous coronary intervention (PCI) and other critical operations performed by interventional cardiologists in the cath lab. 
    • “Robocath is based in Rouen, France. The company’s flagship technology is the R-One+ system, a robotic system that helps cardiologists perform PCI, and work on a next-generation version of the R-One+ is already underway. Stereotaxis aims to ramp up work on that new technology once its acquisition is complete.” 

Midweek update

David Ermer–ACA, CMS, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor added another post to his excellent Secrets of OPM blog today. This one is titled “Simplicity is a Virtue.” In the FEHBlog’s opinion, OPM should focus on simplifying its administration of the FEHB and PSHB programs.
  • The FEHBlog noticed on the following rulemakings currently under Office of Management and Budget review:
  • The FEHBlog is concerned about the OPM rule because OPM has not implemented the HIPAA 820 electronic enrollment roster transaction that would allow carriers to reconcile individual enrollees with their premiums. What is the sense of having a pristine family member list without knowing whether the enrollee is paying the correct premium. The HIPAA 820 also would give carriers earlier notice about enrollees who have left federal employment and annuitants who have passed away.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. To further enhance nephrology care, HHS will also support data standardization and health information technology improvements across the kidney care ecosystem. The challenge will be run through the Kidney Innovation Accelerator (KidneyX).”
  • The Wall Street Journal reports,
    • “One in seven people who signed up for Affordable Care Act plans this year failed to pay after premium costs rose sharply, according to an analysis that provides the first comprehensive look at the impact of expiring federal subsidies. 
    • “Nationally, around 14% of those who enrolled in ACA plans this year didn’t pay their first monthly bill for January coverage. In some states, the share was a quarter or more, according to a new analysis from the actuarial firm Wakely Consulting Group, provided exclusively to The Wall Street Journal.
    • “It’s a big drop,” said Michelle Anderson, a Wakely consulting actuary. 
    • “Normally, the rate of falloff in ACA plan membership early in the year is in the midsingle-digit range.”

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The Food and Drug Administration is taking the first step toward potentially allowing compounding pharmacies to produce seven peptides that are currently restricted because of the agency’s previous warning over safety concerns.
    • “The agency’s expert advisory panel on pharmacy compounding is scheduled to discuss whether the peptides should be used in compounding for purposes for ulcerative colitis, wound healing, inflammatory conditions, obesity, insomnia and more, according to a Federal Register notice posted Wednesday announcing a late-July meeting.”

From the judicial front,

  • Bloomberg Law reports,
    • “A federal appeals court vacated an order rejecting a request to block a Maryland drug discount law, remanding the decision for review, in a victory for AbbVie Inc., Novartis AG, AstraZeneca Plc, and PhRMA.
    • “The US Court of Appeals for the Fourth Circuit ruled that a lower court “erred” when it denied the drugmakers’ motion for a preliminary injunction against Maryland’s H.B. 1056.
    • “The decision was driven by a recent order from the Fourth Circuit that upheld a block on West Virginia’s version of the contract pharmacy law, with the majority opinion stating that “West Virginia passed a materially similar statute, which this Court recently held is likely preempted”.

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Many scientists have contended that humans have evolved very little over the past 10,000 years.
    • A few hundred generations was just a blink of the evolutionary eye, it seemed. Besides, our cultural evolution — our technology, agriculture and the rest — must have overwhelmed our biological evolution by now.
    • “A vast study, published on Wednesday in the journal Nature, suggests the opposite. Examining DNA from 15,836 ancient human remains, scientists found 479 genetic variants that appeared to have been favored by natural selection in just the past 10,000 years.
    • “The researchers also concluded that thousands of additional genetic variants have probably experienced natural selection. Before the new study, scientists had identified only a few dozen variants.
    • “There are so many of them that it’s hard to wrap one’s mind around them,” said David Reich, a geneticist at Harvard Medical School and an author of the new study.” * * *
    • “Nandita Garud, a geneticist at the University of California, Los Angeles, who was not involved in the new study, said that unearthing natural selection over the past 10,000 years could do more than just illuminate our deep history.
    • “Scientists still don’t know much about how genetic variations influence our health. When they find a link between a genetic variant and a disease, Dr. Garud said, it will be important to see whether it has been favored by natural selection.
    • “That might give you a clue that this is important,” she said.”
  • The Wall Street Journal relates,
    • “Vertigo and dizziness, often caused by dislodged inner-ear crystals (BPPV), are common age-related problems increasing fall risk.
    • “Emergency-room visits for vertigo commonly result in unnecessary diagnostic tests and sedative medications, potentially worsening patient outcomes.
    • “Researchers are investigating links between BPPV and migraines, low vitamin D, and osteoporosis, while developing new rehabilitation treatments.”
  • Fierce Healthcare tells us,
    • “Behavioral health utilization increased substantially from 2018 to 2024, with anxiety disorder care fueling much of that growth, according to Trilliant Health. 
    • “The health data analytics and market research firm’s latest report outlines a 62.6% jump in behavioral health utilization, based on any visit associated with a behavioral health diagnosis code.
    • “Between 2008 and 2024, the prevalence of mental illness increased by almost 6 percentage points. About a quarter of adults had any mental illness in 2024, Trilliant found, though in adults 18-25 exhibit the highest prevalence both in terms of any mental illness (33%) and serious mental illness (16%). 
    • “Anxiety disorders accounted for the highest visit volume and experienced the fastest growth, up 89% from 2018 to 2024. Anxiety disorders in women aged 18-44 were also the highest utilization category in 2024. 
    • “It’s possible those figures are increasing because more screening is happening, acknowledged Trilliant Health Chief Research Officer Allison Oakes, Ph.D.”
  • Medscape adds,
    • “Utah’s pilot program using AI for psychiatric medication refills raises safety and compliance concerns. Critics argue it lacks transparency, proper research, and may violate FDA laws, emphasizing the need for licensed physician oversight.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Studying mice, researchers at Toronto’s Sinai Health have found that semaglutide—the active ingredient in popular weight loss drugs that mimic the gut hormone GLP-1—acts directly on a subset of liver cells to improve organ function, and does so independently of weight loss. The finding challenges long-held assumptions about how GLP-1 medicines work in the liver and could reshape how physicians treat metabolic liver disease.
    • “Headed by Daniel Drucker, MD, a senior investigator at the Lunenfeld-Tanenbaum Research Institute, the team reported on their findings in Cell Metabolism, in a paper titled “The weight-loss-independent hepatoprotective benefits of semaglutide are orchestrated by intrahepatic sinusoidal endothelial GLP-1 receptors.”\
  • Per Multiple Sclerosis News,
    • “People with diabetes are significantly more likely — with nearly 60% higher odds — to develop multiple sclerosis (MS) than those without the metabolic disease, which is marked by high blood sugar levels, according to a new systematic review and meta-analysis.
    • “A significant association was also observed specifically between type 2 diabetes, the most common form of the condition, and MS risk.
    • “The analysis did not, however, find clear evidence that MS increases the likelihood of developing diabetes.
    • “Current evidence indicates that [diabetes mellitus], specifically [type 2 diabetes], increases the risk of developing MS,” the researchers wrote. “However, a reverse association remains unconfirmed.”
  • Per MedPage Today,
    • “Primary care patients educated about Alzheimer’s disease blood-based biomarkers were generally willing to undergo tests and supported their use, survey data showed.
    • “After patients received a brief explanation of Alzheimer’s blood tests, 94.5% supported offering them to patients with memory complaints, and 85% said they were willing to complete a test if their clinician recommended it, reported Andrea Russell, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and co-authors.
    • “Patients endorsed Alzheimer’s blood tests when they informed medical care (94.2%), were covered by insurance (93.4%), if comprehensive education was received prior to testing (88.5%), and if testing was easy or convenient (88.1%), Russell and colleagues wrote in Alzheimer’s & Dementiaopens in a new tab or window.”
  • Healio adds,
    • “High vitamin D levels in mid-life were associated with lower levels of tau protein in the brain more than a decade later, suggesting a possible modifiable risk factor for Alzheimer’s disease, according to findings in Neurology Open Access.
    • “Previously, it was known that low circulating vitamin D in later life is associated with an increased risk of cognitive impairment and clinical dementia,” Martin D. Mulligan, MBBCh, BAO, a researcher at the University of Galway in Ireland, told Healio.
    • “Most prior studies evaluating the association between vitamin D and cognitive function typically measured circulating vitamin D in older adults,” he continued. What our study adds is a focus on early mid-life.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The increasing cost of medical care is driving more workers to forgo needed care or stop taking medications, ADP found in a recently released employee benefits survey. 
    • “Twenty-six percent of respondents said they’d skipped needed medical care for themselves or a family member due to out-of-pocket costs (compared to 21% in 2020), 22% have stopped taking or taken less medication (compared to 17% in 2020), and 15% declined vision or dental insurance so they could afford medical insurance. 
    • “The finding “points to the need for simpler plan design, clearer education and flexible options that reflect different budget preferences,” ADP observed. “Employers can play a stronger role in helping employees make cost-conscious choices without compromising care.”
  • Fierce Healthcare relates,
    • “Average physician pay rose about 3% between 2024 and 2025, from $374,000 to $386,000—outpacing the 2.7% U.S. core inflation rate that rounded out the year, a new annual report from Medscape found.
    • “Medscape’s 2026 Physician Compensation Report surveyed 5,916 physicians across more than 29 specialties. Total compensation numbers reflect base salary and incentive bonuses, plus other income sources like profit-sharing contributions, as reported by full-time physicians.
    • “Matthew Wells, Ph.D, a senior director at AGMA Consulting, called 2025 a “return to normalization” for physician compensation in the report and expects “consistency with increases” in the future. Driving factors cited by Wells include physician productivity in seeing more patients and improved technology-driven efficiency. 
    • “Fifty-three percent of all physicians report feeling fairly compensated, as opposed to last year’s report in which only 48% reported fair compensation—what the report notes was the “most dispirited response” it had seen in a decade of posing the question.” 
  • Beckers Hospital Review offers a non-exhaustive list of “32 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • and lets us know,
    • “The Illinois Health Facilities and Services Review Board approved Ontario, Calif.-based Prime Healthcare’s acquisition of Franciscan Health Olympia Fields (Ill.). 
    • “The 214-bed hospital is expected to transition to Prime on May 1, according to an April 14 news release shared with Becker’s. 
    • “Prime Healthcare entered an agreement in January to acquire the hospital and and Specialty Physicians of Illinois from Mishawaka, Ind.-based Franciscan Alliance. Prime said it plans to offer jobs to “substantially all employees” at Olympia Fields. 
    • “Olympia Fields is set to become Prime’s ninth Illinois hospital and 55th overall. In March 2025, the health system acquired eight Illinois facilities from St. Louis-based Ascension. Prime said that in the first year of ownership, it invested more than $104 million in the eight hospitals to enhance clinical care and operations, modernize infrastructure and expand service lines.” 
  • BioPharma Dive informs us,
    • “Beeline Medicines emerged from stealth Wednesday with plans to develop “precision therapies” for immune diseases, nearly a year after its backer Bain Capital teamed up with Bristol Myers Squibb to give five of the pharma’s experimental medicines a new home.
    • “Beeline’s pipeline is led by the licensed drug afimetoran, a daily oral treatment for systemic lupus erythematosus, a form of lupus, that targets a pair of receptor proteins which are responsible for regulating the immune system. At Bristol Myers, the drug had already been tested in a Phase 1b trial in a different form of lupus. A Phase 2 study is underway and is expected to be completed in the second half of this year, after which Beeline plans to launch “a pivotal development program.”
  • MedTech Dive adds,
    • “Avanos Medical has accepted a $1.27 billion go-private offer from American Industrial Partners, the company said Tuesday. 
    • “AIP agreed to pay a 72.1% premium to Avanos’ closing stock price on Monday. Avanos CEO Dave Pacitti told customers that AIP will back his company to strengthen its competitive position.  
    • “Avanos competes with businesses including Boston Scientific and Cook Medical for the specialty nutrition market, and rivals such as Medtronic and Stryker in the pain management space.”

Tuesday report

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

From Washington, DC,

  • Fierce Healthcare reports,
    • “A prominent physician voice in the House of Representatives has introduced a new bill that would compel insurers to apply the cost for drugs purchased from direct-to-consumer platforms to deductibles and out-of-pocket maximums.
    • “North Carolina Republican Greg Murphy, M.D., on Tuesday unveiled the Every Dollar Counts Act, a bill that aims to lower patients’ out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise.
    • “Using these platforms, patients can often find prices that cost far less out-of-pocket, especially for branded drugs, per Murphy’s office.”
  • The American Hospital Association News adds,
    • “The AHA and dozens of other organizations April 14 sent a letter of support to Reps. Suzan DelBene, D-Wash., and Mike Kelly, R-Pa., for their introduction of the Chronic Care Management Improvement Act. The bill would waive beneficiary cost-sharing requirements for Medicare beneficiaries receiving chronic care management services. Beneficiaries are currently required to pay a 20% coinsurance fee to receive such services. “This cost-sharing requirement creates a barrier to care, as beneficiaries are being billed for services that do not always include interfacing with their provider, thus creating confusion for patients,” the organizations wrote. “Also, many of these beneficiaries consider any additional out-of-pocket expense for healthcare services untenable.”
  • CMS has posted MMSEA Section 111 GHP User Guide Version 7.8 – April 13, 2026 (PDF)
    • “The GHP User Guide * * * is your primary source for Section 111 GHP reporting requirements.”
  • OPM Director Scott Kupor has added a new post titled “Merit Matters” to his Secrets of OPM blog.
    • “If we want the best talent in the federal government – which I think we do – we should not refuse to hire college dropouts, unless dropping out of college is somehow representative of their ability to work successfully on behalf of the American people. And, if they are in fact world-class engineers, then we should pay them at the level at which they are performing versus force-fitting them into a lower pay level because they have no prior work experience.
    • “Once again, merit matters.”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Fox News’ Saturday in America with host Kayleigh McEnany to highlight the launch of EarlyCareers.gov, a new initiative to recruit more early career Americans into federal service and strengthen the government’s talent pipeline.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Even as Eli Lilly gets underway with its next major obesity launch in Foundayo, an FDA document related to the oral treatment shows lingering reservations about multiple “unexpected serious” risks potentially related to the drug.
    • “In the FDA’s approval letter (PDF) for GLP-1 pill Foundayo, the agency tasks Eli Lilly with obtaining more information about the med’s potential link to major adverse cardiovascular events and drug-induced liver injury. In addition, the agency wants to gain more info about delayed gastric emptying associated with the drug and its potential effects in lactating women.
    • “In its assessment of the medicine’s data, the FDA “determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events (MACE), drug-induced liver injury (DILI), and exposure to [Foundayo] during lactation,” the letter says.”
  • STAT News adds,
    • “In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
    • “FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
    • “In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, and this inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.”
  • MedTech Dive relates,
    • “Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected.
    • “Medline began the recall in February, and it was posted to the Food and Drug Administration’s website last week. The problem was the subject of a warning letter that Medline received in March, also recently posted to the FDA’s website.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. When finalized, this guidance will provide recommendations for standardized methods for comprehensively assessing the safety of genome editing therapies to bring effective treatments to patients sooner.
    • “Genome editing holds extraordinary promise for treating previously incurable genetic diseases, and today’s announcement represents the FDA’s forward approach to drive innovation and advance the development of genome editing therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance provides sponsors with clear, scientifically-grounded recommendations for evaluating off-target editing risks using state-of-the-art sequencing technologies. We are serious about moving this ball forward.”  
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research, supports the FDA’s framework for accelerating development of individualized therapies for ultra-rare diseases launched in February. The framework revolutionizes how the FDA engages with industry and promotes a path for transformative rare disease treatments.
    • “The “Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing” guidance provides specific recommendations on sequencing strategies, sample selection, analysis parameters, and reporting.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal [magistrate] judge has tossed an Elevance subsidiary’s lawsuit against billing intermediary HaloMD and several California-based providers alleging they’re abusing the out-of-network billing dispute process set up by the No Surprises Act.
    • “[Magistrate] Judge Karen Scott of the Central District of California dismissed the suit on Monday, finding that Anthem Blue Cross, Elevance’s California subsidiary, failed to prove that the companies were gaming the law’s independent dispute resolution, or IDR, in order to inflate their reimbursement.
    • “It’s a major win for HaloMD, which is facing similar lawsuits from Elevance in three other states and has found itself in hot water over its status as the No. 1 submitter of IDR disputes. The Texas-based company cheered the court’s decision, while Elevance said it plans to appeal.”
    • Yesterday, Anthem Blue Cross did appeal the court’s decision to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law reports,
    • “A Delaware judge threw out lawsuits seeking to link the heartburn drug Zantac to cancer, freeing makers of the product from facing trials in the state over the cases.
    • “Superior Court Judge Francis “Pete” Jones concluded Monday lawyers for ex-Zantac users couldn’t produce legitimate evidence backing up claims the over-the-counter product caused cancer. Zantac is currently made by French drugmaker Sanofi.” * * *
    • Because former Zantac owners GSK Plc, Pfizer Inc., Sanofi and Boehringer Ingelheim Pharmaceuticals already have settled thousands of Zantac suits over the last several years, it’s unclear how many Delaware cases will be dismissed by Jones’ order. GSK paid more than $2 billion in 2024 to resolve what it said was more than 90% of its pending cases.

From the public health and medical / Rx research front,

  • Fierce Healthcare reports,
    • “Seven in 10 U.S. adults gamble, according to a survey from the National Council on Problem Gambling (NCPG). Commercial gaming revenue broke records at $78.7 billion in 2025, with over $18 billion in tax revenue going into state and local coffers. All gaming segments, from casinos to sports betting to online games (iGaming), are growing. Throw in prediction markets, which allow users to speculate on the outcome of real-world events but are not legally considered gambling platforms, and the betting buffet becomes basically limitless. 
    • “This menu of options is creating an addiction crisis yet to be widely recognized by the public, policymakers and the healthcare sector, experts caution. Current national problem gambling prevalence is unknown due to a lack of research and funding dedicated to the issue. States that measure and publish their own prevalence rates see anywhere from 1% to 6%. Those most at risk include young adults, men and online gamblers. Gambling-related harms can be dire, from financial stress to co-occurring behavioral health conditions to suicide, which a fifth of individuals with gambling addiction attempt.
    • “To understand problem gambling, what’s driving it and efforts underway to address it, Fierce Healthcare talked to two dozen providers, researchers, advocates and regulators. This story is also based on a review of research, as well as exclusive data from Komodo Health analyzed on Fierce Healthcare’s behalf.
    • “It’s a small but mighty group of us that have been in this field, treating,” said Jody Bechtold, L.C.S.W., president of the International Problem Gambling and Gaming Certification Organization (IPGGC). “We call it the next opioid epidemic.” 
  • Healio tells us,
    • “The risk for subsequent fractures is similar for older adults, regardless of whether they had an initial major osteoporotic fracture or nonmajor osteoporotic fracture, researchers reported.
    • “In findings published in Journal of Bone and Mineral Research, researchers found that sustaining a major or nonmajor osteoporotic fracture raises the risk for subsequent fractures and mortality.”
  • Infectious Disease Advisor informs us,
    • “Rhinovirus and enterovirus are associated with severe clinical outcomes among hospitalized patients, including mechanical ventilation and death, highlighting the need for expanded respiratory virus surveillance among high-risk patient populations.”
  • MedPage Today points out,
    • “A dual deprescribing intervention for proton pump inhibitors (PPIs) targeting patients and their primary care doctors proved effective in reducing potentially inappropriate use, a cluster-randomized trial in France found.
    • “At 1 year, the combined approach — where patients got educational material about reducing PPI use mailed to them and their physicians received a letter detailing a deprescribing algorithm — resulted in twice as many patients cutting their PPI use in half (14.9%) versus usual care (7%) or physician-targeted intervention alone (7.7%, P<0.001 for both).
    • “The results underscore “the value of prioritizing patient-facing deprescribing strategies,” wrote researchers led by Jean-Pascal Fournier, MD, PhD, of Nantes Université in France, in JAMA Internal Medicineopens in a new tab or window. Furthermore, the interventions were not associated with a resurgence in gastroesophageal reflux disease (GERD) symptoms.
    • “PPIs in the U.S. are frequently prescribed for inappropriate indications and sometimes prescribed indefinitely, according to Fournier and colleagues.” * * * Potentially unnecessary PPI spending — reimbursements in 2015 hit $12 billion in the U.S.

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

  • Modern Healthcare reports,
    • “The Purchaser Business Group on Health, which represents large companies, launched a project to combine federally required data with claims data culled from its biggest members to provide insight into costs and quality in employer-sponsored health plans.
    • “This has the potential to supply employers with unprecedented access to healthcare pricing data that could help curb escalating employee health benefit costs, said Purchaser Business Group on Health President and CEO Elizabeth Mitchell.
    • “There is employer demand for this information that is unmet in the market,” Mitchell said during a Purchaser Business Group on Health webinar on healthcare transparency in February.
    • “The Purchaser Business Group on Health has found that normal market forces that should be expected to link prices to quality don’t function in healthcare. Prices often fluctuate wildly based more on the size and market power of health systems or insurers than on the quality of services rendered.
    • “For instance, its data reveal prices at hospitals in the same markets do not correlate with scores from the Leapfrog Group, which assesses hospital quality and safety. Often, low-rated hospitals charge more. Or the same hospital charges vastly different prices for the same procedures depending on the insurance plans, not any differences in the service.” 
  • and
    • “Health systems are increasing their investments in concierge medicine to meet patient demand and keep burned-out doctors practicing.
    • “Though typically a small percentage of a health system’s operations, concierge medicine — where patients pay thousands of dollars in membership fees for increased access to primary care physicians — helps diversify revenue and creates growth opportunities in new and existing markets.
    • “Still, it’s a controversial model that raises questions about equal access to care because it historically has appealed to wealthier, often older individuals looking for more personalized primary care. Health systems say patient demand has expanded beyond that demographic.”
  • Fierce Healthcare relates,
    • “Anthem and Mount Sinai have reached a new multi-year contract agreement, restoring coverage for thousands after the system went out-of-network last month.
    • “Anthem Blue Cross and Blue Shield of New York said in a statement Monday that the three-year deal returns Mount Sinai’s hospitals, physicians and other providers to its network. The health plan said that the contract “reflects both organizations’ commitment to delivering quality care while helping control healthcare costs for New York workers, families, employers and taxpayers.”
    • “The contract also includes updated reimbursement models that aim to reward quality and outcomes, while continuing to support accurate billing and payment.”
  • The Wall Street Journal lets us know ,
    • Healthcare giant Johnson & Johnson JNJ reported nearly 10% revenue growth for the latest quarter on strong cancer drug sales that offset a steep decline from one of its bestselling drugs, Stelara.
    • J&J said its first-quarter sales rose to $24.06 billion, topping the mean estimate of $23.62 billion from analysts surveyed by FactSet. Adjusted quarterly earnings also beat Wall Street expectations.
    • On the back of those results, the drug and medical-device maker boosted its full-year financial forecast. So far, disruptions from the war in Iran haven’t materially hurt J&J.
    • “There’s a lot of macro uncertainty out there,” J&J Chief Financial Officer Joseph Wolk said in an interview. “We think the fact that we’re not only maintaining but raising” the forecast is a sign of the company’s strength, he added.
    • J&J has been working to ensure consistent growth after losing patent protection for Stelara, a treatment for skin and digestive conditions. Competitors introduced lower-cost alternatives last year, leading to a 60% drop in first-quarter sales of the brand-name version of the drug.
    • Strong sales of J&J cancer medications like multiple-myeloma treatment Darzalex helped make up for those declines. The company’s cancer-drug sales rose more than 22% for the quarter. J&J is in a stronger position than some of its peers, which face even bigger patent cliffs in coming years.
  • BioPharma Dive tells us,
    • “Eli Lilly is again turning to dealmaking to boost its oncology portfolio, reaching a deal Tuesday to acquire a biotechnology company, CrossBridge Bio, that’s developing newer types of targeted cancer medicines.
    • “Lilly will pay up to $300 million in cash for CrossBridge, a Houston-based startup making antibody-drug conjugates for cancer. That total includes an unspecified upfront payout and subsequent payment tied to a development milestone, CrossBridge said in a statement.
    • “The deal hands Lilly technological capabilities that have become increasingly desirable to major pharmaceutical firms. Antibody-drug conjugates, or ADCs, are now a pillar of cancer care, a method of precisely delivering a toxic blow to malignant cells. Over 20 ADCs are currently available to treat tumors of the breast, lung, bladder and more. Many are working their way into earlier treatment lines, in some cases supplanting decades-old chemotherapy approaches.”
  • MobiHealth informs us,
    • “New York-based virtual women’s health provider Maven Clinic announced a strategic collaboration with care concierge company Wellthy to combine clinical care and caregiving support for employees.
    • “Maven Clinic is a digital reproductive health and family platform that offers fertility and family planning services, pregnancy and postpartum care, parenting and pediatric support, and menopause-related care.
    • ‘Wellthy offers a care concierge service that connects employees with care teams to help them navigate the healthcare system, including finding in-home support, understanding benefits, accessing legal resources and obtaining financial assistance.
    • “The company also offers Backup Care services to help employees find emergency care for family members, including daycares, on-site childcare facilities and other community-based programs.    
    • “The aim of Maven and Wellthy’s partnership is to help employees in the “sandwich generation, – those in the period of starting a family and caring for an older loved one – navigate the process from fertility, growing a family and overseeing eldercare.
    • “This partnership is about building a system that reflects how people live, with clinical care and caregiving support together in one place. When technology makes that support intuitive, you don’t just improve outcomes – you make it possible for people to ask for help in the first place,” Kate Ryder, founder and CEO of Maven Clinic, said in a statement.”
  • The Wall Street Journal informs us,
    • “Novo Nordisk NOVO.B said it would work with ChatGPT maker OpenAI on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as healthcare companies seek to harness the technology to get ahead of the competition.
    • “The Danish drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients.
    • “The group said the partnership would boost efficiency across manufacturing, distribution, the supply chain and corporate, with pilot programs initially launching in research and development, manufacturing and commercial operations ahead of a full AI integration by the end of the year.” * * *
    • “Drugmakers are turning to AI companies and their increasingly powerful models to improve operations and cut repetitive tasks for employees, giving them more time to focus on R&D in a bet that advancements in the technology will help them identify promising new drugs and treatments.”
  • Modern Healthcare adds,
    • “Health systems and payers are making big investments in artificial intelligence to improve their operations by reducing administrative burden, beefing up clinical prediction capabilities and increasing access to care. 
    • “A case in point: This year alone, UnitedHealth Group is investing $1.6 billion into its AI efforts. Companies also are realigning executive roles by adding chief AI officers or adding AI responsibilities to C-suite executives overseeing data and innovation.” * * *
    • “Mike Baker, chief operating officer, UnitedHealthcare
    • “UnitedHealth Group, our parent, has embedded the use of AI across our business to simplify healthcare and improve how people access care, information and support. UnitedHealth Group is investing $1.6 billion this year with the aim of making experiences more personalized, reducing administrative friction for clinicians, increasing transparency around cost and coverage, and supporting better care decisions.” 

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, HSA, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Washington Post lets us know,
    • “The White House will make the case Monday to Congress — and to voters — that it has developed a strategy to address frequent frustrations involving U.S. medical care, such as too few physicians and too much paperwork.
    • “The Trump administration casts its physician-focused agenda as a fix for a strained health care system — pointing to a $50 billion funding program for rural health it contends will boost the number of doctors in remote areas, efforts to reduce payment distortions that favor hospitals rather than doctors, and regulatory changes intended to speed insurance approvals for tests and follow-up care.
    • “Together, these reforms will enable faster, more affordable, and higher-quality physician services for Americans,” the White House writes in the Economic Report of the President [WhiteHouse.gov link], an annual document previewed with The Washington Post and set to be transmitted to Congress on Monday.
    • “The economic report, which does not offer new proposals, is best understood as a distillation of White House economists’ thinking ahead of this year’s midterm elections, in which voters’ frustrations regarding health care costs and access are set to play a central role. Past administrations have often used the report, which is written by the president’s Council of Economic Advisers, as a messaging document to rally support for their initiatives. This year’s report addresses health care affordability, a key focus for President Donald Trump and his advisers, and says it is working to “unleash” more competition in health care markets to lower costs and improve quality.”
  • Bloomberg Law informs us,
    • “Senate Republicans aren’t planning to include Medicare and Medicaid changes in the next partisan spending package—instead focusing it largely on ending the partial government shutdown.
    • “Top Republicans plan to use a bill that advances through the simple-majority budget reconciliation process to fund immigration enforcement and US Border Patrol and would not require Democrats’ support.
    • “Though some Republicans have been pushing for including Medicare and Medicaid policies in the package, the narrow focus does not leave room for other priorities, Senate Majority Leader John Thune (R-S.D.) said Monday. He said budget instructions will not be sent to the Senate Finance Committee.” * * *
    • “But he didn’t rule out returning to other health care policies. For instance, he mentioned a provision blocking federal Medicaid payments from going to Planned Parenthood, which was included in the 2025 tax-and-spending law and sunsets in July, as a possible candidate for inclusion.”
  • Beckers Hospital Review reports,
    • “CMS on April 10 proposed a 2.4% pay increase for hospitals under the fiscal 2027 Inpatient Prospective Payment System, but hospitals are concerned that the update does not keep pace with the mounting financial challenges.
    • “CMS has proposed another inadequate update to inpatient payment rates, another extremely high productivity cut, and reductions to disproportionate share payments — in the face of rising need for care and higher uninsured rates,” Ashley Thompson, the American Hospital Association’s vice president of public policy analysis and development, said in an April 10 statement. 
    • “Beth Feldpush, America’s Essential Hospitals’ senior vice president of policy and advocacy told Becker’s in an April 11 statement that the proposed DSH payment cuts “fails to acknowledge the growing number of uninsured individuals due to recent Congressional actions.” 
    • ‘Charlene McDonald, president and CEO of the Federation of American Hospitals, said in an April 10 statement that CMS’ proposal is a step in the right direction, but added it “does not negate the compounding effects of rising inflation, record levels of uncompensated care and a growing uninsured population.”
    • “National hospital group leaders also raised concerns about another aspect of the proposal: the introduction of the first mandatory nationwide episode-based payment model.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services picked 150 digital health companies and healthcare providers to participate in the launch of its tech-enabled chronic care model.
    • “The Center for Medicare and Medicaid Innovation (CMMI) announced in December the Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model as a 10-year payment program to encourage the use of technology to treat chronic diseases. CMS aims for the ACCESS Model to provide stable, recurring payments for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety. The model will help pay for telehealth software, wearables and wellness apps that address the conditions.
    • “The CMMI plans to use outcome-aligned payments to cover the cost of technology for Medicare providers if a patient with a qualifying chronic condition achieves clinically significant outcomes, such as lowering their blood pressure.” 
  • Citeline points out,
    • An April 1, 2026, proposal [Federal Register link] from the US Treasury Department would allow whistleblowers who alert the government to certain financial crimes to collect 10%-30% of any monetary penalties collected, creating a new risk for healthcare firms – especially those with overseas business partners. The public comment period ends on June 1, 2026.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For the first time, the FDA has approved generics for AstraZeneca’s Type 2 diabetes blockbuster Farxiga. The U.S. regulator has given thumbs up to 14 companies, including Teva, Sandoz and a host of Indian drugmakers including Aurobindo, Biocon, Cipla, Lupin and Zydus to produce 5 mg and 10 mg tablets of dapagliflozin.
    • “The treatment is indicated for glycemic control and to reduce the risk of hospitalization for heart failure for those with Type 2 diabetes who also have established cardiovascular disease or multiple cardiovascular risk factors.Farxiga generated sales of $8.5 billion last year, including $1.7 billion in the U.S.
    • “The FDA originally approved the SGLT2 inhibitor in 2014. Generic versions of Farxiga became available (PDF) in the U.K. and Japan in the second half of last year.”
  • and
    • “From a negative phase 3 readout and a seemingly tightening regulatory climate to a grueling three-month review extension, the path for Travere Therapeutics in its first-in-disease bid was anything but certain. Yet, the company has defied the odds, securing Filspari a landmark FDA approval in focal segmental glomerulosclerosis (FSGS) and delivering the first treatment for the rare kidney disease.
    • “Monday’s FDA approval makes Filspari the first therapy specifically indicated for FSGS, a condition that represents a $1 billion-plus sales opportunity, according to Leerink Partners analysts. The drug was originally approved in 2023 for the treatment of IgA nephropathy, another kidney disease.
    • “FSGS is estimated to affect more than 40,000 patients in the U.S. The disorder is characterized by scarring in the kidney’s filtering units as protein keeps leaking into the urine, often leading to further disease progression and kidney failure, sometimes quite rapidly.” 
  • Cardiovascular Business relates,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has received U.S. Food and Drug Administration (FDA) clearance for a new algorithm designed to detect signs of cardiac amyloidosis (CA). This represents Anumana’s second FDA clearance in just two weeks, highlighting the company’s growing impact in the world of cardiovascular care. 
    • “CA is a life-threatening condition that often leads to heart failure complications, but it remains critically underdiagnosed. Anumana sees this clearance as a way to help care teams identify CA early so patients can receive timely treatment.
    • “The newly cleared algorithm, which previously received the FDA’s breakthrough device designation, was designed to evaluate standard 12-lead electrocardiograms (ECGs) and flag patients at increased risk of CA. 
    • “Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” Maulik Nanavaty, CEO of Anumana, said in a prepared statement. “The more conditions we can identify from a single ECG, the more valuable the test becomes in clinical practice. That’s what Anumana is working toward with each new clearance as we continue to advance our rigorous clinical evidence approach.”

From the census front,

  • The Wall Street Journal reports,
    • “The first of the youth-obsessed baby boomers turn 80 this year, including President Trump, and they want to shake up old age.
    • “Having reached octogenarian levels, a generation that shaped much of our past is shaping the future of aging for themselves and those who follow. They want better healthcare and housing, cures for dementia and a say in when to die. New professions and products will appear. Their massive spending will shift and innovators will follow.
    • “They are reinventing old age,” says Joseph Coughlin, director of the Massachusetts Institute of Technology AgeLab. Unlike the patient Silent Generation, boomers had high expectations and used their sheer numbers as well as financial and political clout to make them happen, which isn’t necessarily a bad thing.
    • “If you don’t have expectations of getting better, then you simply become satisfied with what is,” says Coughlin.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Protein-hungry shoppers are buying more meat with their health top of mind. Health experts, however, wish they’d think beyond the butcher counter.” * * *
    • “Meat is indeed packed with protein, but it comes with some well-established health drawbacks.
    • “Saturated fat we’ve known about for decades,” said Dr. Sarah C. Hull, a cardiologist at Yale Medicine. It’s common in red meat and contributes to increasing LDL cholesterol levels, hardening the blood vessels and, in turn, raising the risk of heart attack or stroke.” * * *
    • “Hull said that many common plant-based proteins are particularly high in fiber, which 95% of Americans don’t get enough of, and they’re generally associated with better overall health outcomes than animal proteins. Her research suggests that increased consumption of certain plant-derived nutrients may help counter some negative effects of red meat and ultra-processed foods.”
  • Health Day relates,
    • “Influenza vaccination may offer cardiovascular protection even when it does not prevent infection, according to a study published online April 2 in Eurosurveillance.” * * *
    • “Hospital admissions for heart attack and stroke were more frequent in the first week after testing positive for influenza than during any other period in the year before and after their test,” the authors write. “This increased risk was about half as high among people who tested positive for influenza but had received the influenza vaccine that season.”
  • and
    • “Children with ADHD are more apt to have a bright future if they’re diagnosed in their early elementary years rather than as high schoolers, a new study says.
    • “Kids diagnosed with ADHD at an earlier age are more likely to have better grades and go on to college, researchers reported April 8 in JAMA Psychiatry. They’re also less likely to drop out of school.
    • “ADHD diagnosis during the first years of school was associated with better school performance, more academic track choices and lower probability of school dropout,” concluded the research team led by Lotta Volotinen, a doctoral researcher at the University of Helsinki in Finland.
    • “The findings support the recommendations for earlier diagnosis, and screening for ADHD before age 12 years should be considered,” the team wrote.”
  • The American Medical Association lets us know “what doctors wish patients knew about managing food allergies.”
    • Once a food allergy is diagnosed, learning how to avoid triggers, recognize warning signs and when to seek medical care are key. Two physicians share more.
  • Per Cardiology Advisor,
    • “Maternal stroke is associated with significantly higher rates of maternal mortality and severe delivery complications, including cardiac arrest and acute renal failure.”
  • Per Pulmonology Advisor,
    • “The increased risk for asthma attacks among those using marijuana was consistent regardless of whether individuals vaped or smoked cannabis or did both.”
  • Per an Oregon State University news release,
    • “Researchers at Oregon Health & Science University have uncovered a key reason why immunotherapy has largely failed in pancreatic cancer — and identified a promising strategy to overcome that resistance. 
    • “The study, published in the journal Immunity, shows that pancreatic tumors actively reshape their immune environment by co‑opting regulatory immune cells that normally shut down tumor-killing cells. By reprogramming those cells, the research reveals a potential pathway to make immunotherapy effective against one of the deadliest and most treatment‑resistant cancers. 
    • “Pancreatic cancer is incredibly resistant to most therapies,” said the study’s senior author, Katelyn Byrne, Ph.D., assistant professor of cell, developmental and cancer biology in the OHSU School of Medicine and member of the OHSU Brenden‑Colson Center for Pancreatic Care. “Even when we know the immune system is capable of long‑lasting protection, it’s been very difficult to get that response to work in this disease.” 
    • “In the new study, Byrne and team tested an experimental immunotherapy in mouse models known as agonistic CD40, which works differently from standard checkpoint inhibitors. Rather than targeting a single immune signal, the therapy broadly activates the immune response upstream. 
    • “Byrne said the researchers were surprised to find out that activating the immune system this way didn’t just stimulate tumor‑killing cells — it also reprogrammed regulatory T cells, converting them from immune suppressors into cells that support anti‑tumor activity. 
    • “We didn’t expect this,” Byrne said. “The therapy doesn’t directly target Tregs, but as a secondary effect of turning on the immune response, those Tregs changed their behavior. Cells that were shutting down the immune reaction suddenly started supporting tumor killing.” 
    • “The team’s findings help explain one reason why many immunotherapies haven’t worked in pancreatic cancer and point to a possible solution: Treatments may need to both turn on the immune system and overcome the tumor’s own ability to shut it down.” 
  • Per an NIH news release,
    • “A National Institutes of Health (NIH)-funded research team has discovered an enhanced CRISPR gene-editing system that could enable targeted delivery inside the human body — a key step toward broader clinical use. Researchers identified a naturally occurring enzyme, Al3Cas12f, that is small enough to fit into adeno-associated virus vectors, a leading targeted delivery method for gene therapies. They then engineered an enhanced version that dramatically improved gene-editing performance in human cells. 
    • “The advance addresses a major limitation in CRISPR technology. Commonly used gene-editing proteins are too large for targeted delivery systems, restricting clinical applications to cells modified outside the body, such as blood and bone marrow. 
    • “Smart delivery of gene editing systems is a powerful notion with broad clinical implications, and this basic science finding takes us a significant step toward that future,” said Erica Brown, Ph.D., acting director of NIH’s National Institute of General Medical Sciences (NIGMS).” 
  • BioPharma Dive adds,
    • “Revolution Medicines said Monday its experimental pancreatic cancer drug hit every goal at an early checkpoint in a Phase 3 trial, helping people who got it live nearly twice as long as those who got standard chemotherapy.
    • “Enrollees who got daraxonrasib lived a median of 13.2 months after treatment, compared with 6.7 months for those who got chemo, a finding that equates to a 60% reduction in the risk of death among those who got the experimental drug. Daraxonrasib achieved its other objectives at an interim look at the results, findings so striking that the company ended the trial early. Revolution enrolled people whose metastatic pancreatic cancer had returned after an earlier treatment.
    • “The Food and Drug Administration has already awarded daraxonrasib a “national priority” voucher that could help Revolution gain an approval within weeks of an official submission. Revolution shares rose nearly 40% in early trading, adding $7 billion to the company’s already hefty valuation.”
  • BioPharma Dive also informs us,
    • “An experimental therapy from Allogene helped eliminate signs of cancer better than standard treatment in a Phase 3 trial in first-line large B-cell lymphoma, results suggesting the biotechnology company may have found a role to use donor-derived cell therapy against the deadly blood cancer.  
    • “After 45 days of treatment, seven of the 12 patients given Allogene’s therapy in the study were negative for “minimal residual disease,” meaning that diagnostic tests could no longer detect signs of cancer. By comparison, only 2 of 12 placebo recipients hit that mark, a roughly 42-percentage-point difference that clears an important bar published literature has suggested is crucial for delaying a relapse. 
    • “The results come from an early “futility” analysis. Allogene is enrolling 220 people in the study and expects to report in 2027 results showing whether treatment staved off cancer’s return.
  • and
    • “In experimental drug from Spyre Therapeutics helped lower signs of disease activity and improve remission rates in a Phase 2 study of people with ulcerative colitis. 
    • After 12 weeks of treatment, patients who received “SPY001” in the trial had a statistically significant, 9.2-point reduction on a scoring system that assesses the severity of their disease, meeting the study’s primary objective. Notably, treatment was also associated with a 40% remission rate and a 51% improvement on endoscopic imaging. One severe adverse event was reported — chest pain in a 68-year-old male with a history of cardiovascular disease — but was deemed unrelated to treatment.
    • Spyre said the findings were “clinically meaningful” and support SPY001’s “best-in-class profile.” The drug is one of multiple therapies the company is evaluating in Phase 2 trials in inflammatory bowel disease. Proof-of-concept data for two other therapies in the trial are expected later this year. Data from a placebo-controlled portion of the study are on track for 2027.” 
  • Per Fierce Pharma,
    • “Eli Lilly has chalked up another victory in the chronic lymphocytic leukemia (CLL) space, as its BTK inhibitor Jaypirca delivered its fourth positive phase 3 readout in the blood cancer. 
    • “Monday, Lilly said its phase 3 Bruin CLL-322 trial in patients with previously treated CLL or small lymphocytic lymphoma (SLL) has met its primary endpoint. In an industry first, the study showed that adding Jaypirca to a fixed-duration regimen of venetoclax and rituximab significantly extended progression-free survival (PFS) compared with the standard combo alone. 
    • “As Lilly pointed out, Bruin CLL-322 is the first phase 3 in CLL to utilize and outperform a venetoclax-based regimen. Roche and AbbVie sell venetoclax, an oral BCL-2 inhibitor, under the brand name Venclexta.” 

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

  • Beckers Payer Issues reports,
    • “Houston-based Memorial Hermann Health System and BCBS Texas agreed on a contract April 11, bringing the health system back in network.
    • “The agreement ensures “access to quality care at cost-effective prices,” BCBS Texas said in an April 13 statement shared with Becker’s. It covers both commercial and Medicare Advantage members. The previous contract expired April 1, affecting commercial members. The health system had beenout of network for Medicare Advantage plans since Jan. 1.”
  • Fierce Healthcare offers a look at how Evernorth’s new Delaware specialty pharmacy facility highlights a broader care coordination approach.
  • Beckers Hospital Reports ranks 83 health systems by their most recent revenue.
    • “Revenue growth continued across the hospital industry in 2025, with many of the nation’s largest health systems posting mid- to high-single-digit gains fueled by stronger patient volumes, improved payment rates and the expansion of ambulatory and pharmacy operations. 
    • “But the gains were far from uniform. Some systems grew revenue by double digits through mergers, acquisitions and new payer arrangements, while others saw declines as they shed hospitals and restructured their portfolios.”
  • and tells us,
    • “The world’s two main GLP-1 drug manufacturers, Eli Lilly and Novo Nordisk, are taking different approaches with rolling out their recently approved GLP-1 pills for weight loss. 
    • “Two oral GLP-1s, two very different commercial strategies. Health systems operating metabolic programs or making formulary decisions need to understand both.
    • “While both companies offer their recently approved GLP-1 pills through pharmacies and direct-to-consumer platforms that circumvent pharmacy benefit managers, they are diverging in other routes. 
    • “Eli Lilly is betting on retail and digital access, as it’s offering its weight loss GLP-1 pill through GoodRx, telehealth firm Ro and same-day delivery with Amazon Pharmacy. 
    • “By contrast, Novo Nordisk launched a Wegovy subscription program through WeightWatchers, LifeMD, Ro and Hims & Hers — with which the drugmaker previously had a strained relationship. With the 12-month subscription plan, Novo Nordisk said patients can save up to $600 per year on the Wegovy pill.” 
  • and informs us,
    • “Large language models may help identify drug safety signals in clinical notes, though their performance remains below thresholds required for clinical decision support.
    • “Researchers evaluated three models — GPT-3.5, GPT-4 and GPT-4o — using clinical notes from 100 patients at Nashville, Tenn.-based Vanderbilt Health, 70 patients at the University of California—San Francisco and 272 patients from seven Roche-sponsored trials, according to an April 6 Vanderbilt news release.
    • “For detecting immune-related adverse events at the patient level, GPT-4o achieved F1 scores of 56%, 66% and 62% across the respective datasets. The F1 score reflects how well a model balances correctly identifying real safety issues while avoiding false alarms. At the individual note level, the model reached an average F1 score of 57% across 667 notes.
    • “An F1 score of 90% or more is considered excellent, while 80% or higher may support clinical decision-making.”
  • STAT News points out,
    • “Every day, more than 40 million people ask ChatGPT about health care, according to OpenAI. They’re asking questions about diet, exercise, insurance — and in some cases, serious symptoms that would typically get discussed on a 911 call or in a doctor’s office.
    • “For some health systems, that’s creating an imperative. A small number of hospitals are trying to recapture some of those clinical conversations from commercial large language models like ChatGPT, Claude, and Gemini. They’re implementing their own patient-facing chatbots, ones that draw directly from their existing medical records and can funnel patients toward care in their own system. 
    • “Hartford HealthCare this week will launch PatientGPT, a chatbot engineered by clinical AI company K Health, to its patients in Connecticut. Two health systems — California-based Sutter Health and Reid Health, serving Indiana and Ohio — have announced pilot versions of Emmie, the chatbot built by medical record mammoth Epic. The list is likely to grow rapidly.
    • “Health systems need to do this, either through a vendor or building it themselves,” said Mount Sinai chief AI officer Girish Nadkarni, the senior author of a recent study that found ChatGPT Health missed high-risk emergencies when used to triage patients.”
  • The Wall Street Journal cautions,
    • “The artificial intelligence gold rush is rapidly drying up the supply of computing power, leading to product issues and reliability problems.
    • “Anthropic experiences frequent outages and limits user token usage, while OpenAI scrapped its Sora app to free up compute.
    • “CoreWeave raised prices over 20% and extended contracts, as spot-market Nvidia GPU rental costs rose 48% in two months.” * * *
    • “All of it points to a classic problem that has popped up in technology booms throughout history, from the 19th-century railroad expansion to the telecom and internet explosion of the early 2000s. Demand is growing far faster than companies are able to access resources and build out infrastructure. Historically, price increases have been among the only ways to address a supply crunch, but such a move could be perilous for frontier AI companies, which are in a ferocious competition to gain users.”
  • Per MedTech Dive,
    • “Stryker said Monday that it has agreed to buy intravascular lithotripsy firm Amplitude Vascular Systems. The companies did not disclose the terms of the acquisition. 
    • “Intravascular lithotripsy is a procedure to treat artery disease. Boston-based Amplitude Vascular Systems, or AVS, uses pressure waves generated by carbon dioxide through a balloon catheter to break up calcified plaque.
    • “The acquisition is expected to bolster Stryker’s peripheral vascular portfolio once AVS’ device is cleared in key markets.”
  • and
    • “GE HealthCare has provided an update on the integration of its bkActiv intraoperative ultrasound technology with Medtronic’s Stealth AXiS surgical navigation system.
    • “The integrated product is now available commercially, GE HealthCare said Thursday. Medtronic said it had integrated bkActiv into Stealth AXiS when the surgical system received regulatory clearance last month.
    • “Integrating the technologies gives surgeons real-time ultrasound images, helping them to assess mid-procedure anatomy changes that could affect the preoperative plan.”

Weekend Update

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

From Washington, DC

  • Per a Senate news release,
    • “The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing Thursday [April 16 at 10 AM] on how Congress can lower the cost of prescription drugs for American families by increasing competition among generic and biosimilar manufacturers. U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, is spearheading President Trump’s mission to make health care affordable.”
  • Hopefully, Congress will resolve the Department of Homeland Security shutdown this week. Federal News Network adds,
    • “Homeland Security Secretary Markwayne Mullin is recalling all furloughed Department of Homeland Security staff to report to their next scheduled shift, despite the ongoing partial government shutdown.
    • “In an official message sent to DHS employees late Friday afternoon, staff were told that “all DHS employees, excepted and non-excepted/non-exempt” are to be returned “to a work and paid status, effective on your next regularly scheduled duty day.”
  • Here’s a link to Roll Call’s projected activities on Capitol Hill this week.

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • About one in five males older than 15 years is infected with a high-risk HPV type.
    • Among males ages 9 to 26 years, those who received the 9-valent HPV vaccine had a lower risk of a composite of HPV-related cancers compared with those who were unvaccinated.
    • These results indicate that HPV vaccination should be sex-neutral, researchers said.
  • The New York Times asks whether you are confused about the new cholesterol guidelines? If so, here’s what to hnow.
    • “New recommendations suggest that some people should start trying to lower their cholesterol as early as age 30.”
  • and
    • lets us know about “D.W.I.s, relationship problems, accusations of secret drinking: Auto-brewery syndrome can wreak havoc on people’s lives and reputations.”
      • “The Mystifying Syndrome That Makes People Spontaneously Drunk.”
  • NPR Shots informs us
    • “Forty percent of Americans have their daily lives interrupted by uncomfortable bowel symptoms, according to the American Gastroenterological Association. That’s a lot of troubled guts.
    • “But Dr. Trisha Pasricha says at the other end of the spectrum, there are people who experience “poophoria.” That’s Pasricha’s term for a state of being where doing your business is painless and worry-free. “ I just want you to poop quickly, effortlessly, and then go live your best life,” she says.”
    • The article provides the Doctor’s advice.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The Affordable Care Act of 2010’s medical loss ratio provision, which requires insurers to spend 80-85% of premium dollars on medical care, likely accelerated revenue diversification through venture capital arms, said Rachel Sachs, a law professor and co-director at The Cordell Institute at Washington University School of Law. Insurers are incentivized to find other profit generators that are not capped by federal legislation.
    • “Acquiring a stake in a company can lead to long-term financial gain if they exit their position or acquire the business. Cigna, for example, purchased telehealth provider MDLive in 2021 after Cigna Ventures invested in its Series E round in 2018.
    • “An insurer also may see value in the emerging company’s product and encourage the parent company to deploy it.” * * *
  • Fierce Pharma relates,
    • “Novartis is launching a three-front push to close healthcare gaps in heart disease and cancer, expanding initiatives to roughly triple its footprint by 2030. 
    • “The three initiatives include the new Inclusive Health Accelerators (IHA) program. Launched in five U.S. cities this week, IHAs are designed to support early detection of prostate and breast cancer and address care gaps in underserved populations. Novartis will use the community-driven IHA model to support access to education, free screenings, diagnosis and follow‑up care.
    • ‘Basel-based Novartis will collaborate with local groups in New York, Los Angeles, Detroit, Houston and Baltimore to deliver the services. The initiative builds on existing U.S. partnerships, such as the Health Assessments and Rapid Transformation program that Novartis launched last year.”
  • and
    • “As geopolitics bring reshoring interest to a fever pitch, the United States Pharmacopeia (USP) is adding to the impetus for local drug production with a warning that homes in on the pharmaceutical building blocks known as key starting materials. 
    • “In its new supply chain vulnerabilities update (PDF), USP, a nonprofit that helps set quality standards for medicines, highlighted 100 acute and chronic medications that, while not necessarily all in current shortage, are at risk of supply gaps and other disruptions. This is due to bottlenecks in their production chains, especially in the upstream phase focused on activities like sourcing raw materials, according to USP. 
    • “Looking at the broad trends, some 30% of the drugs on USP’s updated list are currently in shortage, per the U.S. FDA. Many of the therapeutics that have made it into the lineup are deemed essential by the World Health Organization or FDA, including multiple hospital drugs, chemotherapies, steroids and anesthetics, as well as drugs for chronic conditions like ADHD, diabetes and cardiac diseases, among many others.
    • “Notably, 63% of the medicines identified for their supply chain vulnerabilities are injectables, which USP chalked up to the “inherent manufacturing complexity” of that dosage form. Oral solid meds like tablets and capsules represented the second-biggest group of vulnerable drugs, making up 22% of the list, according to USP. 
    • “In perhaps the biggest flag from the updated list, USP noted that nearly half (48%) of the drugs included have at least one of their key starting materials (KSMs) solely manufactured in one country, which the organization deemed a “potential point of failure.” 
  • BioPharma Dive informs us,
    • “Chinese biotechnology company Oricell Therapeutics said Friday it banked more than $110 million in a “pre-IPO” venture funding that will help it advance a portfolio of cell therapies for tough-to-treat solid tumors. 
    • “Oricell’s lead program is being tested against advanced hepatocellular carcinoma, an aggressive liver cancer that most frequently occurs in people with chronic organ damage. That therapy, Ori-C101, has already completed early testing in humans and demonstrated what the company claims to be a “best-in-class efficacy and safety profile.” 
  • The Wall Street Journal adds,
    • “Finding innovative ways to treat cancer is Pfizer’s biggest priority so to boost cutting-edge technologies, Pfizer executives went to Shenyang, China. There, last summer, Pfizer paid $1.25 billion to China’s 3SBio for rights to a cancer drug candidate.
    • “Not long ago, China was a backwater for drug research. Its companies made pharmaceutical ingredients or lower-cost generic drugs. Its patients offered an opportunity for big drugmakers to sell medicines developed in the West. 
    • “Now it’s a major player in biotechnology. Researchers and startups in China are racing to develop hot new medicines for cancer, weight-loss and other diseases. Many are on the cutting edge of molecular biology. 
    • “China is rallying their innovation to degrees that we haven’t seen before,” Pfizer Chief Executive Albert Bourla said. 
    • “Looking to tap in to the innovation, big drugmakers and investors are spending billions to lock up rights to promising Chinese-originated drug candidates like 3SBio’s.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iranian War front,

  • Dark Reading reports,
    • With the US and Iran having reached a fragile ceasefire this week, security researchers and executives are left wondering whether there will be a commensurate pause in the cyberwarfare that has ramped up around the war.
    • The day after the temporary truce was announced, Iran’s most high-profile false-flag hacktivist operation, Handala, offered that it would participate in a temporary pause in hostilities. But even if one takes that group at its word, history suggests that ceasefires rarely stop or slow cyberactivity surrounding kinetic wars. In fact, in the absence of more effective ways of fighting, cyberattacks tend to flare significantly.
    • “Historical data and recent intelligence analysis indicate that a military ceasefire rarely equates to a ‘digital stand-down,'” warns Austin Warnick, director of Flashpoint’s National Security Intelligence Team. Instead, he tells Dark Reading, “Cyber operations often remain steady or even flare up as an asymmetric pressure valve while kinetic hostilities are paused.”
  • Cyberscoop adds,
    • “The fallout and potential exposure from Iran’s state-backed targeting of U.S. critical infrastructure extends to more than 5,200 internet-connected devices, researchers at Censys said in a threat intelligence brief Wednesday [April 8]. 
    • “Of the programmable logic controllers manufactured by Rockwell Automation/Allen-Bradley that Censys identified as potentially exposed to Iranian government attackers, nearly 3,900, or about 3 out of every 4, are based in the United States. 
    • “The cybersecurity firm identified the devices based on details multiple federal agencies shared in a joint alert Tuesday, and published additional indicators of compromise, including operator IPs and other threat hunting queries.
    • “Federal authorities earlier this week warned that Iranian government attackers have exploited devices that control industrial automation processes and disrupted multiple sectors during the past month. Some victims also experienced financial losses as a result of the attacks, officials said.” 
  • MedTech Dive tells us,
    • “Stryker is now fully operational after a[n Iranian] cyberattack took down its manufacturing, ordering and shipping operations.
    • “The medtech company’s global manufacturing and commercial, ordering and distribution systems have been fully restored, according to a Thursday [April 9] filing with the Securities and Exchange Commission.
    • “Stryker said that the attack had a material impact on its operations, which will affect the company’s financial results for the first quarter of 2026. However, Stryker does not expect a material impact on its full-year guidance of 8% to 9.5% organic sales growth and adjusted earnings per share of $14.90 to $15.10.
    • “The company did not detail the expected financial impact on the first quarter.”

From the cybersecurity policy and law enforcement front,

  • The Wall Street Journal reports,
    • “Top White House officials are racing to address potential cybersecurity threats posed by the latest artificial-intelligence models, highlighting how AI’s perils are becoming a top priority for the Trump administration.
    • “National Cyber Director Sean Cairncross is leading the administration’s response, convening officials across agencies to identify security weaknesses in critical infrastructure and bolster government systems that could be exploited by AI, people familiar with the matter said. The administration is working with the private sector to make sure Americans are safe when new models are released, White House officials said.
    • “In recent days, the administration has held discussions featuring Vice President JD Vance and Treasury Secretary Scott Bessent with leading tech and financial executives about coordinating the private sector’s response to potential cyberattacks and preparing online systems, the people said. 
    • “The moves come during an intensifying race among the top AI companies to release more powerful models that could cause widespread online disruptions if put to work by bad actors. 
    • Anthropic said this week its new AI model Mythos was so good at finding and exploiting software bugs that the company has no plans to release it to the general public. Instead, Anthropic has made a preview version of the model available to roughly 50 companies and organizations that run critical infrastructure, including leading tech companies such as Apple, Amazon.com and Google. The aim is to find and fix bugs in hardware and software before the model is publicly released. 
    • ​​”The company has also held discussions with government officials about the model’s cyber capabilities. 
    • “OpenAI and other model developers are also expected to release powerful tools in the weeks ahead.” 
  • and
    • “Over the past six months, cybersecurity researchers have become increasingly worried that AI systems are not only becoming better at finding bugs, but that they are also shrinking the window of time between when a bug is disclosed and when it can be exploited with working attack software.
    • “Late last year, researchers at Stanford University found that AI software was almost as good as humans at finding and exploiting bugs on a real-world network. 
    • “And earlier this year Anthropic’s Claude Opus 4.6 model found more high-severity bugs in the Firefox browser in two weeks than the rest of the world typically reports in two months. 
    • When measuring dollar cost to find a bug, Mythos is about 10 times as efficient as previous AI models, Graham said.  Details of Mythos’s capabilities were previously reported by Fortune.”
  • HIPAA Journal lets us know,
    • “To help HIPAA-regulated entities manage risks and vulnerabilities, OCR has recorded a risk management video. In the video, Nicholas Heesters, OCR’s Senior Advisor for Cybersecurity, explains the HIPAA risk management requirements and provides examples of potential risk management violations identified during OCR’s investigations of data breaches.
    • “In December 2025, OCR requested questions from HIPAA-regulated entities on risk management,and has provided answers to a selection of those questions in the video. The video also shares important resources to help HIPAA-regulated entities comply with this important HIPAA Security Rule requirement. You can view the video on OCR’s YouTube channel.”
  • Cybersecurity Dive relates,
    • “The Justice Department on Tuesday [April 7] announced that it had stopped Russia’s military intelligence agency from using hacked U.S. routers to maliciously redirect internet traffic and steal data from victims that include governments and critical infrastructure operators.
    • “Operatives of the Russian GRU have spent several years breaking into TP-Link small office and home office (SOHO) routers around the world and reconfiguring them to send DNS requests through Kremlin-controlled servers, which allowed Moscow to collect internet traffic and even passwords, emails and other sensitive information from victim networks. In response, the FBI launched “Operation Masquerade,” sending commands to hacked routers that collected forensic data and reset their DNS settings to erase Russia’s foothold in the devices.
    • “DOJ announced the operation hours after Microsoft revealed Russia’s abuse of SOHO routers. “For nation-state actors like Forest Blizzard,” Microsoft said, “DNS hijacking enables persistent, passive visibility and reconnaissance at scale.”

From the cybersecurity breaches and vulnerabilities front,

  • Bleeping Computer reports,
    • “Bitcoin Depot, which operates one of the largest Bitcoin ATM networks, says attackers stole $3.665 million worth of Bitcoin from its crypto wallets after breaching its systems last month.
    • “The company manages more than 25,000 Bitcoin ATMs and BDCheckout locations worldwide and reported revenue of $615 million in 2025.
    • “As revealed in a filing with the U.S. Securities and Exchange Commission, the company discovered the attack on March 23 after detecting suspicious activity on some of its IT systems.”
    • “While it took immediate measures to contain the breach, the attackers had time to steal credentials to digital asset settlement accounts and transfer over 50 Bitcoin from Bitcoin Depot’s wallets before their access was blocked.”
  • Dark Reading discusses how “Russia’s ‘Fancy Bear’ APT Continues Its Global Onslaught.”
    • “Victims don’t need to match the cyber espionage group’s technical sophistication, experts say. But patching and some form of zero trust are now non-negotiable.”
  • The Cybersecurity and Infrastructure Security Agency added two known exploited vulnerabilities to its catalog this week.
  • Bleeping Computer advises,
    • “Analysis of CISA’s Known Exploited Vulnerabilities over the past four years shows critical vulnerabilities still open at Day 7 worsened from 56% to 63% despite teams closing 6.5x more tickets. Staffing cannot solve this.
    • “Of the 52 tracked weaponized vulnerabilities in our study, 88% were patched more slowly than they were exploited — half were weaponized before any patch existed.
    • “The problem is not speed. It is the operational model itself.
    • “Cumulative exposure, not CVE counts, is the true risk metric that security teams now need to measure. While dashboards reward the sprint to get patches implemented, breaches exploit the tail. AI is not another attack surface — instead, the transition period where AI-powered attackers face human defenders is the industry’s most dangerous window.
    • “In response, defenders have to implement their own autonomous, closed-loop risk operations.”
  • and tells us,
    • “Attackers have been exploiting a zero-day vulnerability in Adobe Reader using maliciously crafted PDF documents since at least December.
    • “The attacks have been discovered by security researcher Haifei Li (the founder of the sandbox-based exploit-detection platform EXPMON), who warned on Tuesday that the attackers are using what he described as a “highly sophisticated, fingerprinting-style PDF exploit” to target an undisclosed Adobe Reader security flaw.
    • “Li also said that these attacks have been targeting Adobe users for at least 4 months, stealing data from compromised systems using privileged util.readFileIntoStream and RSS.addFeed Acrobat APIs, and deploying additional exploits.
    • “This ‘fingerprinting’ exploit has been confirmed to leverage a zero-day/unpatched vulnerability that works on the latest version of Adobe Reader without requiring any user interaction beyond opening a PDF file,” Li warned.
    • “Even more concerning, this exploit allows the threat actor to not only collect/steal local information but also potentially launch subsequent RCE/SBX attacks, which could lead to full control of the victim’s system.”
  • Cybersecurity Dive informs us,
    • “A cyber threat actor is using the React2Shell vulnerability as the basis for a widespread credential-harvesting campaign that has compromised everything from AI tool API keys to cloud platform passwords.
    • “After identifying internet-facing React Server Components instances that are vulnerable to React2Shell, the hackers upload a malicious payload to the server — without the need for authentication — that lets them execute arbitrary code on the target server, researchers at Cisco’s Talos threat intelligence group said in a recent report.
    • “The payload contains a “multi-phase credential harvesting tool that harvests credentials, SSH keys, cloud tokens, and environment secrets at scale,” Cisco researchers wrote.
    • “The entire process after target identification is automated. “No further manual interaction is required to extract and exfiltrate credentials harvested from the system,” Cisco said.”

From the ransomware front,

  • The American Hospital Association reports,
    • “Health care and public health was the top sector targeted for cyberthreats in 2025, according to the FBI’s latest annual report on internet crimes. There were 460 ransomware attacks and 182 data breaches, totaling 642 cyber events. Financial services was the next highest sector at 447 total events. 
    • “This report quantifies what we already knew anecdotally about the health care sector being the most targeted by ransomware attacks,” said John Riggi, AHA national advisor for cybersecurity and risk. “The vast majority are perpetrated by foreign ransomware gangs, primarily Russian-speaking groups, which specifically target health care hoping for a big payout. They know these attacks cause disruptions and delays to digitally dependent health care delivery, posing a risk to patient and community safety, thereby increasing the exigency and pressure for a potentially large ransom payment. These despicable acts are in fact threat-to-life crimes and remind us to do what we can on defense and prepare for clinical continuity not if, but when, an attack strikes.” 
  • Dark Reading relates,
    • “Storm-1175 actors are running up-tempo campaigns to deliver Medusa ransomware, putting pressure on organizations to patch critical vulnerabilities faster. 
    • “In a blog post on Monday, Microsoft Threat Intelligence detailed how Storm-1175, a financially motivated cybercrime group, is conducting “high velocity ransomware campaigns” that typically exploit known vulnerabilities in the sweet spot for threat actors: the time between a vulnerability’s initial disclosure and the widespread adoption of the patch. Microsoft also tied the exploitation of several zero-day vulnerabilities to the group.”
    • “Storm-1175’s playbook appears to be predicated on speed. Attackers move quickly from vulnerability exploitation to data exfiltration and, finally, delivery of Medusa ransomware, “often within a few days and, in some cases, within 24 hours,” according to Microsoft.
    • “The threat actor’s high operational tempo and proficiency in identifying exposed perimeter assets have proven successful, with recent intrusions heavily impacting healthcare organizations, as well as those in the education, professional services, and finance sectors in Australia, United Kingdom, and United States,” the blog post stated.”
  • SC Media informs us,
    • “In March, more than a dozen CISOs and other security managers gathered online to discuss how best to handle ransomware in today’s AI-powered environments.
    • “Because the CyberRisk Collaborative roundtable discussion, sponsored by Akamai, followed the Chatham House rule, we can’t tell you who said what. But the latest CRC report, “Redefining Ransomware Containment,” summarizes what was said.
    • “The group’s main message: Ransomware is no longer just a cybersecurity issue, but a full-scale business-resilience challenge.
    • “Organizations should focus on ransomware recovery, the participants agreed. While rapid containment remains critical, stopping an attack is only part of the solution. True success against ransomware includes maintaining business operations, minimizing disruption, and lining up technical response with organizational priorities.
    • “Containment speed is important, but even a quickly halted attack can lead to substantial financial loss or reputational damage. Organizations must take a view of incident success that includes recovery timelines and customer impact alongside traditional security metrics. That’s because a ransomware incident affects the entire enterprise, not just IT systems.
    • “Because business continuity is the true benchmark of resilience, CISOs and other security managers in the roundtable discussion stressed that customers and stakeholders often care less about how quickly an attack is contained and more about whether services remain available.
    • “The CISOs said that as a result, leading organizations are folding ransomware response into broader business-continuity and disaster-recovery plans. That way, critical operations can keep going even during an active incident, and downstream impacts on customers, partners, and markets will be lessened.”

From the cybersecurity defenses front,

  • The Wall Street Journal reports,
    • “Artificial intelligence giant Anthropic unveiled a partnership with cybersecurity companies Tuesday [April 7] that raises more questions about how parts of the security industry may be disrupted by the emerging technology.
    • The company said its new Project Glasswing initiative allows select companies access to its Claude Mythos2 Preview frontier model, specifically for defensive cybersecurity work. Participants include CrowdStrike, Palo Alto Networks, Microsoft, Apple, Amazon’s AWS cloud business, JPMorgan Chase, Google, Broadcom, Nvidia and the Linux Foundation.
    • “Anthropic said its new model already has found thousands of high-severity vulnerabilities, including some in every major operating system and web browser.
    • “AI models have reached a level of coding capability where they can surpass all but the most skilled humans at finding and exploiting software vulnerabilities,” Anthropic said of Project Glasswing.
    • “The project shows how AI is beginning to reshape parts of the cybersecurity industry, with investors trying to anticipate which areas are built to last and which are ripe to be disrupted by automation. Cyber shares rose as some investors were encouraged by the companies’ inclusion in the Anthropic project, but uncertainty remains about how AI’s impact on the industry will play out.”
  • Forrester identifies ten consequences of Project Glasswing nobody’s writing about yet.
  • SC Media offers five ways to mitigate the risks of “cracked” software.
    • “The human element remains one of the top threat vectors within organizations. Well-intentioned employees trying to get their work done quickly and efficiently can sometimes unknowingly introduce new security risks in doing so.
    • “For instance, an employee needs a PDF editor or design tool, but can’t find an IT-approved option or doesn’t want to wait for access. So they download a free or “cracked” version from the web. It feels harmless. In reality, it creates a direct path into the organization’s IT environment.” * * *
    • “Security teams can reduce this risk, but it takes a shift in focus from policy to control. Taking the following five steps won’t eliminate shadow IT, but they will make it much harder for a quick download to turn into a serious incident:
      • “Block unauthorized executables at runtime: Stop unknown binaries from running, even if a user downloads them manually.
      • “Restrict local admin rights: Limit who can install or modify software so a single download can’t change the system.
      • “Apply a zero-trust approach to application control:  Allow only approved applications to run, block everything else.
      • “Use advanced endpoint protection to monitor for behavioral indicators, not just signatures:Look for patterns like manual installs, archive extraction, and unusual execution paths.
      • “Reinforce acceptable use policies and user awareness: Make expectations clear and explain the risks.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network offers an interview with Tammy Flanagan about how “health‑coverage decisions in retirement can shape when and how federal retirees tap their money.”
  • Govexec reports,
    • “The percentage of federal employees who are classified as “thriving” decreased by 10 points between 2024 and 2025, according to a recent report from Gallup, which sheds light on how civil servants are reacting to cuts and other reforms that President Donald Trump has made to agencies since the start of his second term. 
    • “By taking the average of responses from quarterly surveys conducted respectively in both years, the analytics firm found that the percentage of “thriving” feds dropped from 58% in 2024 to 48% in 2025.” * * *
    • “While the “thriving” rate for federal employees held steady at around 60% from 2022 to 2024, the latest data puts them on par with the average for U.S. workers in general, which also stood at 48% in 2025. That broader group, however, saw a smaller decline, going from 51% in 2024.”
  • OPM has brought the Director’s Secrets of OPM blog posts up to date on the agency’s website, which may be more easily accessible than Substack.
  • Per a CMS email,
  • This reporting requirement applies to FEHB and PSHB plans.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services April 9 held a demonstration showcasing the first series of products intended to push the health care industry toward a more connected ecosystem. The event highlighted tools and applications from more than 50 companies supporting the Medicare App Library that was initially announced in February. Tools intended to promote digital data access and eliminate manual check-in forms were featured, along with personalized health apps providing tailored guidance for nutrition, wellness and chronic disease management.” 
  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services has proposed a 2.4% payment rate bump for inpatient services for fiscal year 2027 as well as the first mandatory, nationwide test of an episode-based payment model. 
    • “The plans were outlined Friday in the annual release of CMS’ Inpatient Prospective Payment Systems (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System proposed rule. 
    • “Other planned changes, according to a fact sheet from the agency and the proposed rule’s summary, include various measure additions or modifications to measures in the Hospital Inpatient Quality Reporting Program; adjustments to the Transforming Episode Accountability Model (TEAM) alternative payment model controversially finalized in last year’s rule; and changes to graduate medical education payments to implement discrimination requirements aligned with the administration’s view of diversity, equity and inclusion practices.” 
  • A CMS news release adds,
    • “Medicare beneficiaries undergoing knee, hip, and ankle replacements, among the most frequent surgeries for people with Medicare, could soon experience more coordinated care and lower costs under a new Centers for Medicare & Medicaid Services (CMS) proposal. CMS is looking to implement these improvements by expanding the Comprehensive Care for Joint Replacement (CJR) Model nationwide through the Fiscal Year (FY) 2027 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule.
    • “Every year, Medicare funds thousands of knee, hip, and ankle replacements that help seniors keep up with their speedy little grandkids,” said CMS Administrator Dr. Mehmet Oz. “This proposed expansion of our successful joint replacement pilot program would better align financial incentives with improved health outcomes—protecting taxpayer dollars while ensuring patients get the care they need before, during, and after surgery.” * * *
    • “To learn more about the CJR-X Model, including independent evaluation reports, visit: https://www.cms.gov/priorities/innovation/innovation-models/cjr-x“
    • “The FY 2027 IPPS and LTCH PPS proposed rule can viewed on the Federal Register at: https://www.federalregister.gov/public-inspection/current. 
    • “For a fact sheet on FY 2027 IPPS and LTCH PPS proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/fy-2027-hospital-inpatient-prospective-payment-system-ipps-long-term-care-hospital-prospective.”
  • Fierce Healthcare relates,
    • “The Trump administration has issued a proposed rule that aims to significantly overhaul prior authorization for pharmaceuticals.
    • “Through the Interoperability Standards and Prior Authorization for Drugs rule, the Centers for Medicare & Medicaid Services said it would establish deadlines for payers in government insurance plans, setting the timeline at 24 hours for urgent requests and 72 hours for standard determinations.
    • “In addition, the rule would require insurers to publicly report certain metrics around prior authorization, including approval and denial rates; outcomes for appeals; and decision timeframes, according to an announcement from the agency.”
    • “The rule also builds on a 2024 regulation that took aim at prior authorization for non-drug services as well as payers’ 2025 pledge to significantly overhaul their approach to prior auth, an agreement brokered in part by CMS officials.” * * *
    • “CMS would also push to adopt Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models, making it easier for real-time electronic workflows to thrive.”
  • and
    • “Despite encountering a legal roadblock last month in his effort to rework the U.S. vaccine infrastructure, HHS secretary Robert F. Kennedy Jr. is continuing to reshape the Centers for Disease Control and Prevention’s vaccine advisory panel in a way that’s setting off alarm bells for some experts.
    • “In the new charter for the Advisory Committee on Immunization Practices (ACIP), the focus of the group—which helps advise the CDC on vaccine schedules and recommendations—seems to be shifting more toward concerns around vaccine safety and side effects. 
    • “In particular, the panel will now work on identifying “gaps in vaccine safety research, including adverse effects following vaccination.” The language is new in the updated charter and will likely appease the vaccine skeptic crowd, which has long used the potential for vaccine injuries and erroneous links to the development of neurological disorders like autism to further their cause.
    • “The group will also now specifically be tasked with reviewing new vaccine platforms such as mRNA shots, which have become a frequent bugbear in anti-vaccine rhetoric following the COVID-19 pandemic.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has, for the second time, turned back a medicine for a tough-to-treat skin cancer in a decision that marks a major setback for the therapy and its developer, biotechnology company Replimune.
    • “The agency on Friday rejected the treatment, vusolimogene oderparepvec or “RP1,” which had been under review for people whose advanced melanoma progresses despite treatment with a widely used cancer immunotherapy. In a letter made public Friday, the agency claimed that the review team, as well as multiple agency leaders and subject matter experts, determined the data are “insufficient to conclude substantial evidence of effectiveness.”
    • “The decision comes eight months after U.S. regulators spurned RP1, arguing that the company’s findings couldn’t be “adequately interpreted.” Replimune claimed to have been blindsided by the rejection and afterwards provided the FDA with additional information and analyses to boost its case. The agency, though, argued in its letter that its feedback to Replimune has remained consistent through years of communications and that its issues weren’t addressed.”
  • The Wall Street Journal relates,
    • “GSK withdrew its application for a drug touted last year by President Trump as a potential treatment for autism symptoms, just months after the company submitted it at the request of health officials.
    • “The U.K. drugmaker asked the Food and Drug Administration to pull its application for the drug leucovorin calcium because it doesn’t market the medicine, according to a regulatory filing posted Thursday. 
    • “The FDA had just approved leucovorin last month. Generic forms of the medicine will still be available. * * *
    • “GSK hadn’t sold the drug since 1999. At the request of the Food and Drug Administration, GSK said in September it would submit its application for patients with cerebral folate transport deficiency—a rare genetic condition with similarities to autism—in a move that allowed the agency to update the label for the drug and its generic counterparts. 
    • “FDA officials last month announced they had approved the drug for that condition based on a review of existing studies, but said in a call with reporters that they hadn’t found enough evidence to merit OK’ing the drug’s use to treat autism more broadly.
    • “Senior FDA officials said they examined scientific studies to see whether they could approve leucovorin to treat autism, but didn’t come up with enough strong scientific evidence to do so.
    • “A spokesman for HHS said GSK’s withdrawal on Thursday doesn’t affect generic versions of the drug, which already have updated labels for the genetic condition.”
  • Cardiovascular Business tells us,
    • :The U.S. Food and Drug Administration (FDA) is warning the public that certain sizing catheters from Indiana-based Cook Medical should no longer be used due to an increased risk of cracking or breaking.
    • “The agency’s warning covers specific lots of Cook Medical’s Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters. These devices are used for a variety of angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. They are made in a variety of sizes and multiple configurations.
    • “Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation and vessel injury,” according to the FDA. “In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death.”
    • “At this time, the FDA noted, no serious injuries or deaths have been linked to this issue. The agency is still reviewing the situation.
    • “The FDA’s early alert can be read in full here. It also includes a full list of all affected product lots.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “Even as the US respiratory illness season continues to ebb, it remains deadly, with the Centers for Disease Control and Prevention (CDC) documenting 12 more pediatric deaths in its FluView update today. 
    • “So far this season, 139 children have died from the virus, and about 85% with a known vaccination status were unvaccinated. While the CDC has classified this flu season as moderate for adults, it’s been high-severity for children.
    • “For comparison, in the previous three flu seasons the CDC logged 187, 210, and 296 flu-related deaths for the complete season. The 289 pediatric deaths in 2024-25 was the most since the 2009-10 H1N1 flu pandemic.
    • “Only four jurisdictions were reporting moderate flu activity last week, and none saw high activity. Flu accounted for 8.2% of viral respiratory diseases, down from 9.8% the previous week. A total of 2,589 people were hospitalized, compared with 3,050 the week before. The proportion of outpatient visits for flu declined to 2.4% from 2.6% the previous week.” * * *
    • “The level of acute respiratory illness causing people to seek medical attention is very low. Rates of respiratory syncytial virus (RSV) remain elevated, but the virus is past peak in many areas of the country, the CDC said in its weekly respiratory virus activity update today.
    • “COVID-19 levels are low in most parts of the country, and viral wastewater concentrations are low for RSV and very low for COVID-19 and influenza A.” 
  • The American Hospital Association adds,
    • “The Utah measles outbreak has increased to 583 cases, the state’s Department of Health and Human Services reported April 7. Of those, 386 cases have been diagnosed this year. Nationwide, there have been 1,714 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 94% of cases are outbreak-associated and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • Harvard Professor of Pediatrics Dr. David S. Ludwig opines in STAT News
    • “Targeting ultra-processed foods would make packaged foods less tasty and appealing, but no less fattening.
    • “Ironically, many products now emblematic of ultra-processed foods were developed in response to calls from nutrition scientists and government to replace dietary fat with carbohydrates, a misguided campaign that did more harm than good. We can’t afford another sweeping restructuring of the food supply based on imprecise interventions and uncertain science.
    • “Instead, focusing on processed carbohydrates offers a more precise and pragmatic solution, one that could invite collaboration with, rather than opposition from, the food industry.
    • “Delicious, calorie-rich food — whether home-prepared or packaged — isn’t the problem. What matters is how long we stay satisfied (satiety) relative to calories consumed. A 100-calorie snack or a sugary beverage isn’t better for our waistline than 200 calories from nuts if the lower-calorie option leaves us hungry and craving more soon after.
    • “By targeting the dietary drivers of weight gain, rather than misleading notions about food palatability and pleasure, we can have our (low-carb) cake and eat it, too.”
  • STAT News also tells us,
    • “With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavoredvapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem. 
    • “Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations. 
    • “The GAO report was focused on actions that involved the DOJ, so those tallies do not take into account enforcement actions like the seizure of more than 6 million illegal products by the Food and Drug Administration and U.S. Customs and Border Protection between 2024 and 2025. To put those seizures in context, a large seizure of $76 million worth of products in 2024 — 3 million vapes — equated to about 4% of China’s e-cigarette exports to the U.S. in a single month, said Steven Xu, an adjunct assistant professor at the University of Waterloo who studies e-cigarettes.
    • “Sen. Dick Durbin (D-Ill.), who requested the report, said it shows that much more work needs to be done to combat the public health threat posed by illegal vapes.”
  • Health Day informs us,
    • “Standard cognitive tests may fail to capture early brain changes in women 
    • “Women’s brains often show a steeper and more widespread decline than men’s when moving from mild impairment to Alzheimer’s
    • “Sex-specific standards may be needed to interpret brain scans and screening results accurately.”
  • and
    • “Cardiovascular health may impact fracture risk in women after menopause, according to a study published online March 27 in The Lancet Regional Health-Americas.” * * *
    • “Many of the same factors that protect your heart — regular physical activity, a balanced diet rich in calcium and vitamin D, not smoking and managing conditions like diabetes and high blood pressure — also help protect your bones,” Hossain said in a statement. “If you’ve been told you have intermediate or high cardiovascular risk, particularly if you are a postmenopausal woman, it may be worthwhile to talk to your doctor about bone health screening, given the many effective treatments available that reduce fracture risk.”

From the U.S. healthcare business front,

  • Beckers Payer Issues shares a boatload of Blue Cross Blue Shield updates.
  • Healthcare Dive reports,
    • “Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.
    • “But demand for treatments still far outpaces the science, as persistent structural barriers confound the women’s health space. 
    • “People have taken up the charge and are trying to make an impact in a specific area,” said Kim Dalla Torre, an EY Global and Americas Health leader.” * * *
    • “More also needs to be done to raise women’s awareness that menopausal symptoms shouldn’t be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms don’t reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.” 
       
  • Cigna, writing in LinkedIn, tells us,
    • “Mental fitness is essential for stress management, resilience, and workplace productivity, helping employees achieve work/life harmony.
    • “When organizations truly care about mental fitness, employees feel more supported and valued—which leads to higher engagement, fewer days missed from work, and meaningful reductions in healthcare costs for everyone.
    • “By thoughtfully weaving together mental and physical wellness programs, organizations can nurture a more vibrant and supportive workforce—leading to lasting success, greater employee retention, and the ability to attract exceptional talent.”
  • Healthcare Innovation points out,
    • “Sentara Health’s navigators are trained professionals with expertise in behavioral health, community resources, and motivational interviewing, working closely with ED teams and patients.
    • “The program started with pilot phases at select hospitals, expanding to 10 sites over a year, with ongoing data collection to measure impact and guide future improvements.
    • “Early results indicate significant reductions in readmission rates, demonstrating the program’s effectiveness in connecting patients to appropriate community-based care.”
  • Radiology Business informs us,
    • “In a bid to offer more services outside of Manhattan, Weill Cornell Medicine is planning to build a $57 million new radiology clinic in Brooklyn.
    • “The New York City academic system officially applied for the necessary state Department of Health approvals on Monday. Located in South Brooklyn’s Bay Ridge neighborhood on 86th Street, the clinic is expected to include three MRI machines, a CT scanner and ultrasound and mammography offerings, Crain’s New York Business reported. 
    • “The outpatient radiology clinic will be housed inside the NewYork-Presbyterian Bay Ridge Primary Multispecialty center and marks a significant expansion for the hospital system outside of Manhattan.
    • “While it’s premature to talk about the services of this location, we are always striving to meet the healthcare needs of New Yorkers in their own neighborhood,” Robert J. Min, MD, radiology chair and president and CEO of the Weill Cornell Physician Organization, told Radiology Business by email April 9. “We are still in the planning stages and will share details in the coming months.”
    • “Weill Cornell hopes the new center will help alleviate demand for radiology services in Brooklyn and the surrounding communities, according to the state application. The project is part of a bigger push by Weill Cornell and NewYork Presbyterian to expand their outpatient footprint across the city, local news outlet Hoodline reported Thursday.”