Tuesday Report

Generative AI

Tuesday Report

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

From Washington, DC

  • Federal News Network interviews Bloomberg Government deputy news director Loren Duggan about what’s next for the Big Beautiful Bill Act.
  • Per a Senate press release,
    • Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) joined Sens. John Cornyn (R-Texas) and Amy Klobuchar (D-Minn.) to introduce the Don’t Sell My DNA Act to safeguard consumers’ sensitive genetic data during corporate bankruptcy proceedings.
    • The Don’t Sell My DNA Act strengthens consumer privacy protections by:
      • Modernizing the Bankruptcy Code to include genetic information in the definition of “personally identifiable information”;
      • Requiring written notice and affirmative consumer consent prior to the use, sale or lease of genetic information during bankruptcy proceedings; and
      • Requiring the trustee or debtor in possession of genetic information to permanently delete any data not subject to a sale or lease.
    • “Consumers should feel confident that any personal information shared with a public company isn’t up for grabs when that company files for bankruptcy,” Grassley said. “This bill would fill gaps in current law to help safeguard consumers’ genetic information and ensure Americans’ DNA isn’t treated like any other financial asset.”
  • The American Hospital Association lets us know,
    • Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women. 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) Innovation Center announced Monday it is extending three tracks within the Kidney Care Choices (KCC) Model through 2027.
    • “Starting in performance year 2026, the model’s financial methodology and participation options will be modified to “improve model sustainability,” the agency said. However, one KCC Model track will be shuttered a year early at the end of December.
    • “The KCC Model has 93 participants, and implementation first began in January 2022. The most recent participants were announced Jan. 15.”
  • The Equal Employment Opportunity Commission announced last week
    • The EEOC collects workforce data from employers with more than 100 employees (lower thresholds apply to federal contractors). Employers meeting the reporting thresholds have a legal obligation to provide the data; it is not voluntary.  * * *
    • The 2024 EEO-1 Component 1 data collection opened on Tuesday, May 20, 2025. The deadline to file the 2024 EEO-1 Component 1 report is Tuesday, June 24, 2025.
    • “As part of EEOC Acting Chair Lucas’ efforts to identify continued cost savings for the American public, there will be a shorter collection period during which filers may submit their 2024 reports. The collection period will not extend beyond the Tuesday, June 24, 2025 “Published Due Date” deadline. Additionally, beginning with the 2024 EEO-1 Component 1 data collection, all communications sent to filers will be electronic.” * * *
    • “Filers should visit the dedicated EEO-1 Component 1 website at www.eeocdata.org/eeo1
      to access the EEO-1 Component 1 Online Filing System (OFS), to find supplementary resource materials such as the 2024 EEO-1 Component 1 Instruction Booklet and 2024 EEO-1 Component 1 Data File Upload Specifications, and to get the latest updates. Filers needing additional assistance can access the Filer Support Team Message Center upon logging into the OFS.”

In Food and Drug Administration News,

  • The American Hospital Association News tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries, and one death associated with the issue.”
  • Per Fierce Pharma,
    • Despite facing ongoing legal pressure from its rival United Therapeutics, Liquidia has successfully landed a pair of long-awaited FDA approvals for its dry powder formulation of treprostinil.
    • The FDA has cleared treprostinil—also known by the trade name Yutrepia—to improve exercise ability in adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • and
    • The FDA has also approved Sanofi’s meningococcal vaccine MenQuadfi for use in infants as young as 6 weeks, multiple news outlets reported Tuesday. The shot was already cleared to protect against four prolific strains of meningococcal bacteria in individuals as young as 2 years and older.
    • The FDA based its decision on data from three phase 3 trials that found MenQuadfi worked as well as GSK’s rival meningococcal vaccine Menveo when given with other routine vaccines in children between the ages of 6 weeks to 19 months, Reuters pointed out. Sanofi’s trials enrolled more than 6,000 participants.
  • BioPharma Dive reports,
    • “A patient who received an experimental gene therapy developed by Rocket Pharmaceuticals has died following treatment, the company disclosed Tuesday.
    • “According to Rocket, the patient experienced what’s known as capillary leak syndrome, where plasma and proteins seep from blood vessels into surrounding tissue, and later died from an acute systemic infection.
    • “The Food and Drug Administration ordered the study’s halt Friday, while Rocket works with clinical trial monitors and other experts to investigate the cause. The company said it is focusing on a “novel immune suppression agent” it recently added to a pre-treatment preparatory regimen.”

From the judicial front,

  • The American Medical Association informs us,
    • “In a win for the nation’s youth—and all Americans’ health—the U.S. Supreme Court has ruled (PDF) that the Food and Drug Administration (FDA) did not act in an arbitrary and capricious manner when it told applicants that they could not put certain flavored e-cigarette liquids on the shelf.
    • “The unanimous decision overturned a 5th U.S. Circuit Court of Appeals ruling. Had that appellate-court ruling been allowed to stand, companies could have marketed products that clearly were designed to appeal to children, with names such as “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Pink Lemonade,” “Iced Pineapple Express” and “Killer Kustard Blueberry.”
    • “Justice Samuel A. Alito Jr., who wrote the opinion for the court, said the FDA did not act arbitrarily and capriciously when it denied the companies’ applications for premarket approval of the tobacco products. The companies challenged the agency’s decision arguing that, among other things, that the FDA didn’t give them fair notice about the evidentiary and comparative requirements used during the application stage and that the agency had changed its position on scientific evidence. 
    • “The high court remanded the case to the 5th Circuit to review other legal arguments, so this is not the end of the litigation, but it is a favorable step forward. The 5th Circuit’s decision was an outlier among the federal circuits that have considered similar cases.”
  • Per Govexec,
    • “At least one agency’s staff impacted by the mass dismissals of probationary workers can pursue their reinstatements as a class, the panel that hears federal employees’ challenges to firings has for the first time ruled, creating a new path for sweeping reversals of those terminations. 
    • “Hundreds of recently hired and subsequently fired employees at the Homeland Security Department will be part of a class action alleging their dismissals were unlawful after a Merit Systems Protection Board administrative judge granted the request. The DHS ruling was the first to come down after a consortium of lawyers filed similar challenges on behalf of fired probationary employees at 20 federal agencies. 
    • “I find that a class appeal is the fairest and most efficient way to adjudicate the appeal and that the putative class counsel and named appellants will adequately represent the interests of the parties,” said Sara Snyder, the chief administrative judge for MSPB’s western regional office.” 

From the public health and medical research front,

  • CBS News reports,
    • Cases of the new COVID-19 variant NB.1.8.1, linked to a large surge in China, have been detected in multiple locations across the United States, according to the Centers for Disease Control and Prevention. The earliest cases in the U.S. date back to late March and early April, and were detected through a screening program at airports for arriving international travelers.
    • “CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners,” a CDC spokesperson said in a statement last week.
    • The spokesperson said that, so far, too few U.S. sequences have been reported of NB.1.8.1 to be included in the agency’s variant estimates dashboard.
    • But hospitalizations abroad have raised questions about the new variant, its symptoms and more.
    • Answers to those questions may be found in the CBS News article.
  • ABC News adds,
    • “More than five years after the first cases of COVID-19 were detected in the United States, hundreds of people are still dying every week.
    • “Last month, an average of about 350 people died each week from COVID, according to data from the Centers for Disease Control and Prevention (CDC).” * * *
    • “The experts said there are a few reasons why people might still be dying from the virus, including low vaccination uptake, waning immunity and not enough people accessing treatments.” * * *
    • “CDC data shows that those aged 75 and older currently have the highest rate of COVID-19 deaths at 4.66 per 100,000.”
  • The American Medical Association let us know what doctors wish their patients knew about lung cancer screening.
  • The Washington Post relates,
    • “Engagement with digital technology was associated with a 58 percent reduced risk of cognitive impairment in people middle-aged and older, according to a study in the journal Nature Human Behavior.
    • “Researchers conducted a systematic review of 57 studies to see whether exposure to technology has helped or harmed cognition among the first generation of adults with prolonged exposure to digital devices such as smartphones, tablets and computers. The studies involved more than 411,000 adults with an average age of 69.
    • “The analysis revealed that technology could play a role in preserving brain function, not worsening it, said co-authors Jared Benge, a clinical neuropsychologist at the University of Texas at Austin’s Dell Medical School, and Michael Scullin, an associate professor of psychology and neuroscience at Baylor University.”
  • Per Medscape,
    • “Herpes simplex virus 1 (HSV-1) infection is associated with an increased risk of developing Alzheimer’s disease (AD), but treating the viral infection may offer protection, a new study found.
    • “In a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD.
    • “However, the authors and outside experts cautioned that no firm conclusions can be drawn from this observational study and called for more research.
    • “The study was published online on May 20 in BMJ Open. It was funded by Gilead Sciences, which is actively involved in the research and development of treatments for HSV.”
  • The Wall Street Journal points out,
    • Good posture improves circulation, respiration, digestion and bladder function. It also enhances cognitive ability and mood.
    • To improve posture, become aware of your body position, stand against a wall to align yourself, and perform dynamic stretching exercises.
    • Upright posture is associated with confidence, self-esteem, and reduced anxiety. Physical therapists can help develop personalized plans to improve posture.

From the U.S. healthcare business front,

  • Fair Health released today a claims-based analysis of GLP-1 drugs and obesity. Beckers Hospital Review summarizes this analysis here.
  • The Wall Street Journal considers the price outlook for GLP-1 drugs used to treat obesity.
  • Fierce Pharma tells us,
    • “After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. 
    • “The companies that took the biggest hits were in the United States, where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.
    • “Among the top 25 revenue companies in the industry in Q1, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).”
  • Per BioPharma Dive,
    • “Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have already caught the attention of other large pharmaceutical firms.
    • “Per an announcement Tuesday, Lilly plans to acquire SiteOne Therapeutics in an all-cash deal. The companies aren’t disclosing how much money is being exchanged upfront or when they expect the transaction to close. But, if SiteOne’s research programs hit certain regulatory and commercial goals, the amount paid to its shareholders could reach that 10-figure mark.”
  • and
    • “Biogen is partnering with RNA drug developer City Therapeutics to develop a better way of reaching an unspecified target that “mediates key central nervous system diseases.” Biogen will pay City, a startup that launched publicly late last year, $16 million in upfront fees and invest another $30 million in convertible notes that could later become a minority stake. “With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach,” Biogen research head Jane Grogan said in a statement.”
  • Per an Institute for Clinical and Economic Review news release,
    • “ICER today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of apitegromab(Scholar Rock Holdings), nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
  • Beckers Health IT discusses why Texas Health is taking a loss on its hospital at home program and summarizes Medscape’s list of telehealth friendly states which Utah leads.
  • Beckers Clinical Leadership identifies the 24 U.S. hospitals that have received the American Nurses Credentialling Center’s Magnet with Distinction award. “The Magnet with Distinction program was created as a special designation to celebrate hospitals and healthcare organizations that exceed scoring thresholds required to earn Magnet recognition.”
  • The Wall Street Journal reports,
    • “AI-powered ambient-listening technology is expanding in healthcare, documenting doctor-patient encounters.
    • “AI scribes save doctors time on documentation, reducing burnout and improving focus on patients, according to pilot programs.
    • “Concerns exist around patient privacy, data security and costs, but patient feedback has been largely positive.”
  • Fierce Healthcare offers insights into how Anthem Blue Cross is growing its behavioral health network in California.
    • “The insurer’s network is built on partnerships with multiple organizations, with recent additions including Headway, Rula and Octave. Through its relationship with these firms, the insurer is seeking to make it simpler for members to find providers that meet their unique needs.
    • “Through Headway, the insurer connects employers and plan members with personalized services. Rula, meanwhile, makes it easier for members to schedule an appointment with one of the more than 10,000 providers in its network.
    • “Octave, similarly, is built to make it simple for members to find a provider across multiple specialties, backgrounds and evidence-based approaches, according to the announcement.”
  • NIST explains for those interested how an MRI machine works.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop tells us,
    • “A bipartisan Senate duo is reintroducing legislation Thursday that would establish an executive branch panel to align conflicting cybersecurity regulations on the private sector.
    • “Michigan Sen. Gary Peters, the top Democrat on the Homeland Security and Governmental Affairs Committee, is bringing back the Streamlining Federal Cybersecurity Regulations Act with co-sponsor James Lankford, R-Okla.
    • “By reducing the number of duplicative or burdensome reporting requirements, we can give businesses the tools to better secure our critical infrastructure against the serious threat of cyberattacks,” Peters said about the reintroduction of the bill, which CyberScoop is first reporting. “This legislation ensures federal agencies can work collaboratively to create effective cybersecurity standards, enabling businesses to focus on safeguarding their systems rather than navigating a maze of conflicting requirements.”
  • and
    • “A bipartisan pair of senators is taking another shot at legislation that would require federal government contractors to follow National Institute of Standards and Technology guidelines on vulnerability disclosure policies.
    • “The Federal Contractor Cybersecurity Vulnerability Reduction Act from Sens. Mark Warner, D-Va., and James Lankford, R-Okla., advanced out of the chamber’s Homeland Security and Governmental Affairs Committee last November but never got a full floor vote.
    • “The companion bill from Reps. Nancy Mace, R-S.C., and Shontel Brown, D-Ohio, meanwhile, was reintroduced in January and passed the House in March.
    • “The re-do from Warner and Lankford would make sure government contractors have the same legal obligations that federal agencies do in abiding by NIST’s recommendations on vulnerability disclosure policies. With VDPs, organizations can receive unsolicited reports on software vulnerabilities and patch them before an attack occurs.” 
  • Per a Cybersecurity and Infrastructure Security Agency news release,
    • The Cybersecurity and Infrastructure Security Agency (CISA) is proud to announce the appointment of Madhu Gottumukkala as its new Deputy Director. In this role, he will help lead CISA’s mission to understand, manage, and reduce risk to the cyber and physical infrastructure that the American people rely on every day. 
    • Prior to his appointment as the CISA Deputy Director, Dr. Gottumukkala served as Commissioner and Chief Information Officer for South Dakota’s Bureau of Information and Technology, overseeing statewide technology and cybersecurity initiatives. He assumed this role after serving as South Dakota’s second-ever chief technology officer, focused on innovation through the adoption of emerging technologies, while increasing efficiency by replacing outdated legacy systems.
    • “I am honored to be appointed by Secretary Noem to serve as Deputy Director of CISA. As a former state and local leader, I have seen firsthand the exceptional work CISA does in advancing our nation’s cybersecurity and infrastructure resilience,” said Gottumukkala. “I look forward to building on that foundation by fostering collaboration and strengthening resilience across all levels of government and the private sector. Together, through trusted partnerships, transparency, and shared responsibility, we can better manage systemic risks and safeguard the critical functions that ensure our nation’s safety and prosperity.”
  • Cybersecurity Dive reports,
    • “Microsoft’s Digital Crimes Unit (DCU) on Wednesday [May 21] announced an international operation to disrupt Lumma Stealer, a variant of infostealing malware that is popular with criminal gangs and other threat actors worldwide. 
    • “Hackers have used Lumma to steal passwords, credit cards, bank account information and cryptocurrency wallets in major attack campaigns in recent years, Steven Masada, assistant general counsel at Microsoft’s DCU, said in a blog post.
    • “Between March 16 and May 16, Microsoft identified more than 394,000 Windows computers infected with Lumma. After obtaining a court order from the U.S. District Court for the Northern District of Georgia, Microsoft seized 2,300 domains that formed the backbone of Lumma’s infrastructure. The U.S. Department of Justice also seized Lumma’s central command structure and disrupted online marketplaces that sold Lumma.”
  • Here is a link to a related CISA advisory.

From the cybersecurity vulnerabilities and breaches front,

  • CISA added seven known exploited vulnerabilities to its catalog this week.
    • May 19, 2025
      • CVE-2025-4427 Ivanti Endpoint Manager Mobile (EPMM) Authentication Bypass Vulnerability
      • CVE-2025-4428 Ivanti Endpoint Manager Mobile (EPMM) Code Injection Vulnerability
      • CVE-2024-11182 MDaemon Email Server Cross-Site Scripting (XSS) Vulnerability
      • CVE-2025-27920 Srimax Output Messenger Directory Traversal Vulnerability
      • CVE-2024-27443 Synacor Zimbra Collaboration Suite (ZCS) Cross-Site Scripting (XSS) Vulnerability
      • CVE-2023-38950 ZKTeco BioTime Path Traversal Vulnerability
        • Ivanti discusses its KVEs here.
        • Cyber Press discusses the MDaemon KVE here.
        • TechTarget discusses the Srimax KVE here.
        • Syscan discusses the Synacor KVE here.
    • May 22, 2025
      • CVE-2025-4632 Samsung MagicINFO 9 Server Path Traversal Vulnerability
        • The Hacker News discusses this KVE here.
  • On May 21, released a joint cybersecurity advisory which
    • highlights a Russian state-sponsored cyber campaign targeting Western logistics entities and technology companies. This includes those involved in the coordination, transport, and delivery of foreign assistance to Ukraine. Since 2022, Western logistics entities and IT companies have faced an elevated risk of targeting by the Russian General Staff Main Intelligence Directorate (GRU) 85th Main Special Service Center (85th GTsSS), military unit 26165—tracked in the cybersecurity community under several names (see “Cybersecurity Industry Tracking”). The actors’ cyber espionage-oriented campaign, targeting technology companies and logistics entities, uses a mix of previously disclosed tactics, techniques, and procedures (TTPs). The authoring agencies expect similar targeting and TTP use to continue.
  • On May 22, CISA released an “Advisory Update on Cyber Threat Activity Targeting Commvault’s SaaS Cloud Application (Metallic).
  • Security Week relates “The developers of OpenPGP.js have released updates to patch a critical vulnerability that can be exploited to spoof message signature verification.”
    • “OpenPGP.js is an open-source JavaScript implementation of the OpenPGP email encryption library, enabling its use on any device. According to its developers, “The idea is to implement all the needed OpenPGP functionality in a JavaScript library that can be reused in other projects that provide browser extensions or server applications.”
    • “Its website shows that OpenPGP.js is used by projects such as FlowCrypt, Mymail-Crypt, UDC, Encrypt.to, PGP Anywhere, and Passbolt.”
  • Dark Reading points out “3 Severe Bugs Patched in Versa’s Concerto Orchestrator. Three zero-days could have allowed an attacker to completely compromise the Concerto application and the host system running it.”
  • Per SC Media,
    • “Stolen credentials were the root cause of more than 30% of data breaches last year, according to Verizon’s 2025 Data Breach Investigations Report. Attackers compromised more than 23 million unmanaged and user-controlled devices—including personal laptops and home systems used in remote work settings—to extract login information, often using session cookies to bypass multi-factor authentication and other access controls.
    • “Credentials don’t just manifest—you’re either phishing them, brute forcing them, or stealing them via malware,” said Philippe Langlois, lead data scientist at Verizon and co-author of the 2025 DBIR, speaking at last month’s RSAC 2025.
    • “Those numbers aren’t outliers—they’re symptoms of a deeper failure in enterprise cybersecurity. Identity systems, Langlois noted at RSAC 2025, are now routinely exploited as entry points with attackers relying less on technical exploits—like finding and exploiting software vulnerabilities—and more on credential-based access, where they simply log in using stolen usernames, passwords, or hijacked sessions.”

From the ransomware front,

  • Cybersecurity Dive lets us know,
    • “Kettering Health is facing a cyberattack that’s impacting patient care, the Ohio-based health system said on Tuesday [May 20].
    • “The provider was hit by a system-wide technology outage Tuesday morning due to unauthorized access to its network, Kettering said in a press release. 
    • “Elective inpatient and outpatient procedures at the health system’s facilities were canceled Tuesday. Kettering’s call center was also knocked offline and might have been occasionally inaccessible, the provider added.”
  • Security Week informs us,
    • “In a data breach notice published on its website, Marlboro-Chesterfield Pathology said it discovered unauthorized activity on some internal IT systems on January 16, 2025. An investigation revealed that the hackers had stolen some files.
    • “The compromised data includes personal information such as name, address, date of birth, medical treatment information, and health insurance information. The stolen information varies by individual. 
    • “MCP informed the US Department of Health and Human Services (HHS) this week that the incident impacted 235,911 individuals.”
  • Per Bleeping Computer,
    • “The FBI warned that an extortion gang known as the Silent Ransom Group has been targeting U.S. law firms over the last two years in callback phishing and social engineering attacks.
    • “Also known as Luna Moth, Chatty Spider, and UNC3753, this threat group has been active since 2022and was also behind BazarCall campaigns that provided initial access to corporate networks for Ryuk and Conti ransomware attacks.
    • “In March 2022, following Conti’s shutdown, the threat actors separated from the cybercrime syndicate and formed their own operation called Silent Ransom Group (SRG).
    • “In recent attacks, SRG impersonates the targets’ IT support in email, fake sites, and phone calls using social engineering tactics to gain access to the targets’ networks.
    • “This extortion group doesn’t encrypt the victims’ systems and is known for demanding ransoms not to leak sensitive information stolen from compromised devices online.”
  • Per Dark Reading,
    • “Yet another threat group has embraced the trend of combining email bombing with vishing to gain initial access to systems and deploy ransomware.
    • “This time the adversary employing the technique, first documented as a tactic of Black Basta ransomware group, is the recently emerged 3AM ransomware group, researchers at Sophos revealed in a recent blog post. Sophos spotted an attack in the first quarter this year by 3AM affiliates, which followed the familiar playbook and successfully stole data from the targeted system but did not complete the ransomware attack.”
  • Per Fortra’s Tripline,
    • “Health-ISAC recently released their 2025 Health Sector Cyber Threat Landscape Report, a comprehensive outline of the malicious activity aimed at healthcare in the previous year. Not surprisingly, ransomware was cited by security professionals in the industry as the number one threat of 2024 and the top area of concern coming into 2025 (followed by third-party breaches, supply chain attacks, and zero-day exploits). Some things never change.
    • “However, when it comes to ransomware, they do evolve. Take a look at [the Tripline article] some of the reasons ransomware maintains its top spot as the primary plague of healthcare organizations as we move into another threat-filled year.”

From the cybersecurity business and defenses front,

  • Cybersecurity Dive reports,
    • “Shares of Palo Alto Networks fell Wednesday after the company reported better-than-expected earnings in the third fiscal quarter but disappointed some investors over its margins. 
    • “The company reported non-GAAP (generally accepted accounting principles) net income of 80 cents a share during the quarter that ended on April 30, up from 66 cents in the same quarter last year. Those earnings beat consensus estimates of 77 cents. 
    • “Revenue grew 15%, to $2.3 billion, in the quarter, compared with $2 billion in the same period last year.”
  • and
    • Companies designing AI systems should protect training data from tampering and strictly limit access to its underlying infrastructure, the U.S. and three allies said in a joint guidance document published on Thursday [May 22].
    • The AI security guidance addresses multiple topics, including protecting data throughout the AI systems’ life cycle, supply chain considerations and ways to mitigate possible attacks on large data sets.
    • The multilateral warning reflects concerns in the U.S. and allied nations about powerful AI models containing vulnerabilities that can ripple across critical infrastructure.
  • NIST discusses “Cybersecurity and AI: Integrating and Building on Existing NIST Guidelines.”
  • The Wall Street Journal explains “How to lock down your finances and online accounts after a data breach spreads your information to the secret corners of the internet.”
  • Here’s a link to Dark Reading’s CISO Corner.

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Joshua Hoehne on Unsplash

From Washington, DC,

  • Govexec tells us,
    • Rep. Gerry Connolly, D-Va., died Wednesday morning after a battle with esophageal cancer. He was 75 years old.
    • Connolly is leaving behind a legacy as a legislator who fought for the federal workforce, government contractors and the economic development of his home region of Northern Virginia.
    • In April, Connolly announced he would not seek re-election in 2026 and would step down from his post as the ranking member of the House Oversight Committee. He first announced his diagnosis in November, shortly after easily winning a ninth term to the House.
  • RIP, Congressman.
  • The Wall Street Journal reports,
    • “House Republicans made a series of last-minute changes to their sprawling tax-and-spending bill, searching for a path that could unite the party’s warring wings headed into a nail-biter floor vote expected early Thursday.
    • “New language to assuage conservatives would accelerate new Medicaid work requirements to December 2026 from 2029 and end certain tax credits for wind energy and solar energy by 2028 instead of a slower phaseout through 2031. The updates would also formally lock in a $40,000 cap on the state and local tax deduction starting this year, up from a $30,000 cap in the prior plan; that change was designed to satisfy Republicans from high-tax states such as New York and New Jersey. 
    • “Lawmakers from states such as Florida and Texas that haven’t expanded Medicaid under Obamacare would get a favorable change to a funding formula, and border states would get $12 billion for security costs incurred during the Biden administration. An indoor-tanning excise tax that was eliminated in the original bill text would be maintained and a nuclear-energy tax break would be expanded. Federal land swaps in Nevada and Utah would be eliminated. Gun-rights supporters won changes to the tax treatment of suppressors. 
    • “The revised legislation advanced in an initial vote in the early hours of Thursday morning, with all Republicans except one in favor, and all Democrats opposed.” * * *
    • “I believe we are going to land this airplane,” Johnson said during a hectic day of legislating that saw the House Rules Committee start a hearing at 1 a.m. and continue past sunset. He is trying to finish the bill in the House before Memorial Day; it would then go to the Senate, and Republicans are aiming to get it to Trump’s desk by July 4.” 
  • Per the New York Times,
    • “The House early Thursday narrowly passed a wide-ranging bill to deliver President Trump’s domestic agenda, after Speaker Mike Johnson put down several mini-rebellions in Republican ranks to muscle the legislation to its first major victory over unified Democratic opposition.
    • “The early morning vote was 215 to 214, mostly along party lines.”
  • Fierce Healthcare adds,
    • “We have a tiny sliver that really matters to employers and working families,” said James Gelfand, president and CEO of The ERISA Industry Committee, a group representing large employers. “But I can say those provisions are monumental to us.”
    • “There’s a laundry list of items Gelfand and others are happy the bill, in its current form, includes.
    • “Employer-offered worksite clinics with free or discounted primary care services would now be available to employees on high-deductible health plans (HDHPs), even if they already have an HSA.” * * *
    • “Other changes allow HSA funds to be spent on gym memberships, increases the HSA contribution limit for some individuals, classifies bronze and catastrophic plans as a HDHP that can pair with an HSA and permits one spouse to contribute to an HSA even if the other spouse has a flexible spending account.” * * *
    • “The bill [further codifies a rule from 2019 creating the [ICHRA] program and lets employees use pretax dollars through a cafeteria plan to pay for on-exchange marketplace premiums, explains the KFF.
  • and
    • “A bipartisan bill aiming to reform prior authorization has been reintroduced in the Senate.
    • “The Improving Seniors’ Timely Access to Care Act seeks to streamline the prior auth process in Medicare Advantage (MA), which would ease administrative burdens on providers and reduce delays in accessing care for patients.
    • “The bill is co-sponsored by Sens. Roger Marshall, R-Kan., and Mark Warner, D-Va., and is supported by dozens of senators on both sides of the aisle. A version of the legislation in the House is also backed by a bipartisan group.”
  • Per an CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced a significant expansion of its auditing efforts for Medicare Advantage (MA) plans. Beginning immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated audits and invest additional resources to expedite the completion of audits for payment years 2018 through 2024.”
  • The American Hospital Association News informs us,
    • “The Administration for Strategic Preparedness and Response today released a bulletin on workplace violence in health care that includes recommendations for strengthening security protocols, enhancing emergency preparedness, supporting workforce mental health and promoting information sharing.”

From the Food and Drug Administration front,

  • BioPharma Dive points out,
    • “After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older.
    • “The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase 3 trial of a standalone seasonal influenza vaccine it’s developing. Earlier this month, Moderna had told investors the FDA would require efficacy data from this trial before considering approval of the combo vaccine.
    • “Moderna’s confirmation comes one day after the FDA announced new rules for COVID vaccine approvals, for which it will now require placebo-controlled studies for any clearance in healthy adults under 65 years old.”
  • and
    • “Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer.
    • “Members of the Oncologic Drugs Advisory Committee voted 6-2 that the benefits of Darzalex’s use in high-risk smoldering multiple myeloma outweighed its risks. However, panelists wrestled with some controversial aspects of the Phase 3 trial J&J is using to ask for an expanded approval. Namely, FDA staff had flagged the trial’s inclusion of patients that could be classified as having a lower risk of progression, as well as an unclear survival benefit following disease progression.
    • “The FDA isn’t required to follow the advice of its outside expert panels but usually does.”
  • MedTech Dive adds,
    • “Teal Health published data Monday from a trial of its cervical cancer screening sample self-collection device in JAMA Network Open.
    • “The paper describes a trial of 599 people who both self-collected samples and underwent standard clinician collection. Self-collection correctly identified 95.2% of the positive samples.
    • “Teal won Food and Drug Administration approval for the self-collection device in early May, setting the company up to start shipping the product to customers in June.”
  • The New York Times provides helpful background information about the Alzheimer’s Disease blood test that the FDA approved for marketing last week.
    • “The test, manufactured by Fujirebio Diagnostics, is intended to be used only by specialists in Alzheimer’s, the F.D.A. said. Its mouthful of a name — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — describes what the test measures: levels of two proteins, amyloid and tau, that are hallmarks of Alzheimer’s disease.
    • “In people who develop Alzheimer’s, amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is much more closely correlated with cognitive decline.” * * *
    • “The F.D.A., and Alzheimer’s experts, emphasized that the blood test should be given only to people who are already experiencing cognitive decline and are ages 55 and older. Moreover, it should not be used on its own to diagnose or to rule out Alzheimer’s.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Biden’s cancer diagnosis has sparked a debate over prostate-cancer screening guidelines.
    • “Increased diagnoses of later-stage cancers are suspected to be linked to changing screening guidance.
    • “Some prostate-cancer specialists said that there has also been a shift in how they manage lower-risk prostate cancer.”
  • Per STAT News,
    • “In what researchers hope could be a case of 1 + 1 = 3, new research suggests that combining a model to predict 10-year cardiovascular risk with an imaging test of coronary arteries could be better than either method alone at identifying people in danger of their first heart attack.
    • “The model is PREVENT, which computes a risk score based on measures familiar from the primary care office: blood pressure, cholesterol levels, kidney function, age, and BMI, as well as questions about type 2 diabetes, smoking, and social determinants of health. The imaging test is a CT scan that detects calcium buildup in arteries leading to the heart. High amounts of calcium, alone and inside fatty plaques, can lead to blockages and heart attacks.” * * *
    • “It’s not always clear who should be screened for coronary calcium; thus, we decided to see if the PREVENT score could be used in this novel manner,” Morgan Grams of New York University’s Grossman School of Medicine told STAT. She is an author of the study published Wednesday in the Journal of the American Heart Association. “Once we determined that it could, we assessed whether the coronary calcium score could add information to PREVENT in the prediction of incident cardiovascular disease. It did.”
       
  • Per a National Institute of Health news release,
    • Research teams funded by the National Institutes of Health (NIH) have created a versatile set of gene delivery systems that can reach different neural cell types in the human brain and spinal cord with exceptional accuracy. These delivery systems are a significant step toward future precise gene therapy to the brain that could safely control errant brain activity with high precision. In contrast, current therapies for brain disorders mostly treat only symptoms.
    • The new delivery systems carry genetic material into the brain and spinal cord for targeted use by specific cell types. This platform has the potential to transform how scientists can study neural circuits. It provides researchers with gene delivery systems for various species used in research, without the need for genetically modified, or transgenic, animals. Examples include illuminating fine structures of brain cells with fluorescent proteins and activating or silencing circuits that control behavior and cognition.
    • “Imagine this new platform as a delivery truck dropping off specialized genetic packages in specific cell neighborhoods in the brain and spinal cord,” said John Ngai, Director of the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “With these delivery systems, we can now access and manipulate specific cells in the brain and spinal cord – access that was not possible before at this scale.”
  • Healio notes,
    • “Increased dietary fiber was associated with reduced likelihood of stroke, especially small-vessel stroke, in addition to reduced all-cause mortality and improved poststroke survival, researchers reported.
    • “Data on the link between daily dietary fiber intake and odds of stroke and adverse stroke outcomes were published in Stroke.”

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “Sanofi will acquire Vigil Neuroscience for $470M, potentially reaching $600M with milestone payments.
    • “The deal centers on neurology, adding VG-3927, an Alzheimer’s treatment, to Sanofi’s pipeline.
    • “Vigil’s VGL101 molecule will return to Amgen before the Sanofi acquisition closes in Q3.”
  • Fierce Healthcare reports,
    • “Digital physical therapy company Hinge Health priced its IPO at $32 per share on Wednesday, at the top of the company’s expected price range.
    • “The company said it raised $437 million by selling 13,666,000 million shares of its Class A common stock, according to a press release issued Wednesday. Hinge Health said it sold 8.5 million shares and 5.1 million shares are being sold by existing shareholders.
    • “Hinge Health will begin trading tomorrow morning on the New York Stock Exchange under the ticker symbol “HNGE.” The offering is expected to close May 23.”
  • Fierce Pharma relates,
    • “Cigna’s Evernorth is rolling out a new pharmacy benefit management program that caps members’ monthly cost for key GLP-1 drugs.
    • “Evernorth said in an announcement that through its Express Scripts arm it negotiated directly with the manufacturers for Wegovy and Zepbound—Novo Nordisk and Eli Lilly, respectively—to cap patients’ monthly costs at $200. The company said this could save as much as $3,600 per year compared to savings patients receive through direct-to-consumer discount programs.
    • “Evernorth added that the costs will contribute toward a patient’s deductible as well.
  • CNBC adds, “Evernorth’s new weight loss pricing program will begin in the second half of the year, as employers begin to make decisions about coverage for next year’s plans.”
  • Per STAT News,
    • “Five years after launching, a unique nonprofit drug company has published data showing that consumers and health plans saved considerable money on a generic cancer medicine thanks to its “transparent” pricing model. And it maintains that the findings validate plans to distribute and — eventually — manufacture still more copycat medicines for the U.S. market.
    • “The company — CivicaScript — was created as a vehicle to combat stubbornly high drug prices even after dominant brand-name medicines lost patent protection and generic competitors entered the market. Backed mostly by 18 Blue Cross Blue Shield plans, the nonprofit made its first drug available — a generic version of the Zytiga prostate cancer treatment — in August 2022.
    • “The initial wholesale price was $160, plus an $11 dispensing fee paid to pharmacies, but uptake was slow until it was accepted by pharmacy benefit managers and other health plans. But eventually, the gambit worked: Between September 2023 and December 2023, patients saved 64% and payers saved 92% by purchasing the generic distributed by CivicaScript, according to a new analysis.”
  • Beckers Payer Issues offers the view of eleven payer “leaders to learn what’s overhyped in healthcare.” 

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • Congress moved one step closer to reauthorizing a key cyber threat information-sharing law on Thursday during a hearing that highlighted both the act’s value and potential shortcomings.
    • The House Homeland Security Committee’s cyber subcommittee held the hearing [on May 15] to evaluate the private sector’s satisfaction with the 2015 Cybersecurity Information Sharing Act, which expires on Sept. 30. Witnesses from the tech industry praised the law for encouraging companies to share cyber threat indicators with each other and with federal agencies, but they also offered lawmakers suggestions for how to improve the program.”
  • Defensescoop tells us,
    • “The Department of Defense has expanded its number of cyber teams by 12, with two more slated to come online in the next few years, according to a spokesperson.
    • “The cyber mission force began building in 2012, and the initial 133 teams reached full operational capability in 2018. In DOD’s fiscal 2022 budget request, U.S. Cyber Command proposed and was eventually approved for a phased approach to add 14 additional cyber mission force teams beyond the original 133. That request and authorization in 2021 was the first substantial effort to grow that force since it was designed almost a decade ago, long before modern and advanced threats had surfaced.
    • “In 2021, the Secretary of Defense directed the creation of 14 New cyber teams by September 2028. Of the 14 teams, 12 have been established. These teams are spread across Army, Air Force, and Navy Commands,” a Cybercom spokesperson said.
    • “They declined to offer specifics regarding how many additional teams each service received or what types of teams those additional builds provided to each service — such as offensive, defensive or support teams — citing operational security.”
  • Per a May 15 HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Vision Upright MRI, a small California health care provider that conducts magnetic resonance imaging and related services, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Breach Notification and Security Rules. The settlement resolves an OCR investigation concerning the breach of an unsecured server containing the medical images of 21,778 individuals.” * * *
    • “Under the terms of the resolution agreement, Vision Upright MRI agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $5,000 to OCR.” 
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/hhs-ocr-hipaa-racap-vum/index.html“
  • Cyberscoop informs us,
    • “Federal authorities seized two domains and indicted four foreign individuals for alleged involvement in a long-running botnet service that infected older wireless internet routers, the Justice Department said Friday. 
    • “The malware created for the botnet allowed infected routers to be reconfigured, which granted unauthorized access to third parties and made the routers available for sale as proxy servers on Anyproxy.net and 5socks.net, according to law enforcement officials. Both domains, which were managed by a company headquartered in Virginia and hosted on servers worldwide, now render seizure notices under an effort the DOJ and FBI dubbed “Operation Moonlander.”
    • “The 5socks.net website claimed to be in operation for over 20 years and had more than 7,000 proxies for sale worldwide for a monthly subscription of $9.95 to $110 per month, according to prosecutors. The botnet’s overseas operations were also seized and disabled by law enforcement agencies in the Netherlands and Thailand.
    • “Authorities also indicted the botnet’s alleged administrators and charged them with conspiracy and damage to protected computers, for conspiring with others to maintain, operate and profit from the bot.”
  • and
    • Liridon Masurica, the alleged lead administrator of cybercrime marketplace BlackDB.cc, was extradited to the United States on Friday and faces charges that carry a maximum penalty of 55 years in federal prison, the Justice Department said Tuesday. 
    • Masurica, 33, who is also known as “@blackdb,” was arrested by authorities in Kosovo on Dec. 12. He made his initial appearance in federal court in Tampa, Fla., on Tuesday and was ordered detained pending a trial. 
    • Federal prosecutors charged Masurica with one count of conspiracy to commit access device fraud and five counts of fraudulent use of 15 or more unauthorized access devices.
    • Masurica, of Gjilan, Kosovo, is accused of running BlackDB.cc since 2018. The cybercriminal marketplace offered to sell compromised account and server credentials, credit card information and other personally identifiable information of individuals mostly located in the United States, the DOJ said.

From the cybersecurity breaches and vulnerabilities front,

  • Cyberscoop reports,
    • “Hundreds of victims are surfacing across the world from zero-day cyberattacks on Europe’s biggest software manufacturer and company, in a campaign that one leading cyber expert is comparing to the vast Chinese government-linked Salt Typhoon and Volt Typhoon breaches of critical infrastructure.
    • “The zero-days — vulnerabilities previously unknown to researchers or companies, but that malicious hackers have discovered — got patches this month and last month, but there are signs it could be getting worse before it gets better, according to Dave DeWalt, CEO of NightDragon, a venture capital and advisory firm. Ransomware gangs are now reported to be exploiting it, beyond the original Chinese government-connected attackers.
    • “The net of it is this is like the Typhoon size, so much like we saw [with] Volt Typhoonand then Salt Typhoon,” DeWalt told CyberScoop. “Once these exploits get into the wild, it’s a race to see who can get more access to it. So initially it looks like three Chinese actors all used it, and now we’re going to see more.”
    • “A number of companies have been tracking the vulnerability and its consequences, including one, Onapsis, that DeWalt’s company invests in, along with EclecticIQ, ReliaQuest and Google’s Mandiant.”
  • and
    • “Over the past few years, cybersecurity experts have increasingly said that nation-state operatives and cybercriminals often blur the boundaries between geopolitical and financial motivations. A new report released Wednesday shows how North Korea has flipped that idea on its head. 
    • “North Korea has silently forged a global cyber operation that experts now liken to a mafia syndicate, with tactics and organization far removed from other nation-state actors, according to a comprehensive new report released by DTEX Systems.
    • “The study — based on years of investigations, technical analysis, and work with other open-source intelligence analysts — pulls back the curtain on a highly adaptive regime that has built its cyber capabilities on a survivalist, profit-driven approach. It reveals a hierarchy blending criminality, espionage, and front-line IT work, coordinated by an authoritarian government that rewards loyalty and secrecy while punishing failure.” * * *
    • “You can read the full report on DTEX’s website.”
  • Cybersecurity Dive relates.
    • “The FBI is warning about a threat campaign in which malicious actors are impersonating senior U.S. officials using malicious text messages and AI-generated voice messages.
    • “The messages have been sent to current and former federal and state officials and others who may be contacts of those individuals, the bureau said in an alert released Thursday.
    • “The messages are designed to establish a rapport with individuals who might then turn over access to a personal account, according to the alert. These social engineering techniques could be used to reach additional contacts and gain access to additional information or funds.”
  • Bleeping Computer lets us know,
    • “A new tool called ‘Defendnot’ can disable Microsoft Defender on Windows devices by registering a fake antivirus product, even when no real AV is installed.
    • “The trick utilizes an undocumented Windows Security Center (WSC) API that antivirus software uses to tell Windows it is installed and is now managing the real-time protection for the device.
    • “When an antivirus program is registered, Windows automatically disables Microsoft Defender to avoid conflicts from running multiple security applications on the same device.
    • “The Defendnot tool, created by researcher es3n1n, abuses this API by registering a fake antivirus product that meets all of Windows’ validation checks. * * *
    • “While Defendnot is considered a research project, the tool demonstrates how trusted system features can be manipulated to turn off security features.
    • “Microsoft Defender is currently detecting and quarantining Defendnot as a ‘Win32/Sabsik.FL.!ml; detection.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added nine known exploited vulnerabilities to its catalog this week.
  • May 13, 2025
    • “CVE-2025-30400 Microsoft Windows DWM Core Library Use-After-Free Vulnerability
    • “CVE-2025-32701 Microsoft Windows Common Log File System (CLFS) Driver Use-After-Free Vulnerability
    • “CVE-2025-32706 Microsoft Windows Common Log File System (CLFS) Driver Heap-Based Buffer Overflow Vulnerability
    • “CVE-2025-30397 Microsoft Windows Scripting Engine Type Confusion Vulnerability
    • “CVE-2025-32709 Microsoft Windows Ancillary Function Driver for WinSock Use-After-Free Vulnerability”
      • Crowdstrike discusses these KVEs here.
      • Cyberscoop discusses Microsoft’s May 13 Patch Tuesday here.
      • See also Bleeping Computer article titled “Microsoft confirms May Windows 10 updates trigger BitLocker recovery”
  • May 14, 2025
    • “CVE-2025-32756 Fortinet Multiple Products Stack-Based Buffer Overflow Vulnerability”
      • Rapid 7 discusses this KVE here.
  • May 15, 2025
    • “CVE-2024-12987 DrayTek Vigor Routers OS Command Injection Vulnerability
      • This KVE is discussed here.
    • “CVE-2025-4664 Google Chromium Loader Insufficient Policy Enforcement Vulnerability
      • This KVE is discussed here.
    • “CVE-2025-42999 SAP NetWeaver Deserialization Vulnerability”
      • The KVE is discussed here.
  • Cyberscoop adds,
    • “Apple rolled out a series of substantial security updates Monday for its major software platforms, with advisories covering iOS, iPadOS, and two versions of macOS lines, addressing more than 30 vulnerabilities in total. 
    • “Among the numerous fixes, iOS 18.5 and iPadOS 18.5 introduce the first security update for Apple’s in-house C1 modem, featured in the newly released iPhone 16e. The patch addresses a baseband vulnerability (CVE-2025-31214) that, according to the company, could have allowed an attacker “in a privileged network position” to intercept network traffic. While the specific details remain undisclosed, the risk highlights concerns about how devices communicate on the hardware level, since baseband processors control things like data transmission, call processing, and other network functions.”
  • PC World reports
    • “Malware is a thing you just have to be aware of. But it’s pretty rare that it can actually damage your computer in a permanent sense — wipe the drive if you’re okay with losing local data, and you can generally get up and running in a day or two. But what if the microcode running on your CPU’s tiny integrated memory becomes infected? One security researcher says he’s done it.
    • “Christiaan Beek of Rapid7 says he has created a proof-of-concept ransomware that can hide inside a CPU’s microcode, building on previous work that emerged when Google required AMD processors to always return “4” when asked for a random number. He claims that modifying UEFI firmware can install an unsigned update to the processor, slipping past any kind of conventional antivirus or OS-based security.” * * *
    • “CPU-level ransomware has not been seen “in the wild,” and it seems likely that when and if it emerges, it’ll be a state-level actor that exploits it first. That means your typical user probably won’t be targeted, at least immediately. Still, maybe keep a remote backup of your important files, just in case.”

From the ransomware front,

  • Per a news release,
    • “Black Kite, the leader in third-party cyber risk intelligence, today announced its newest report, 2025 Ransomware Report: How Ransomware Wars Threaten Third-Party Cyber Ecosystems, which provides a deep analysis into evolving ransomware trends and threats. The report found that threats have escalated with more actors, less predictability, and deeper entanglement in supply chains, underscoring an urgent need for organizations to implement intelligence-driven defenses and proactive vendor monitoring.”
  • Beckers Hospital Review tells us,
    • “From October 2009 to October 2024, ransomware and hacking have increasingly driven healthcare data breaches, a May 14 study published in JAMA Network Open found. 
    • “The study examined ransomware attacks and other hacking incidents across all healthcare organizations covered by HIPAA from October 2009 through October 2024. It analyzed breaches affecting 500 or more patient records that were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights.”
  • Cybersecurity Dive reports,
    • “A cybercrime gang believed to be responsible for three attacks in the U.K. in recent weeks has turned its attention toward the U.S. and has been able to compromise multiple targets in the sector, according to researchers from Google Threat Intelligence Group and Google subsidiary Mandiant. 
    • “Researchers said the same threat actors linked to attacks against U.K. companies are now using well-crafted social engineering techniques against U.S. retail companies.  
    • “The threat group, tracked as UNC3944 or Scattered Spider, is widely considered the prime suspect in the attacks on British firms Harrods, Co-op and M&S, but Mandiant and Google have not formally attributed the intrusions to any specific actor. Researchers said, however, that the hackers behind the U.S. attacks share the same techniques and procedures as the intruders in the British incidents.”
  • Dark Reading adds,
    • “While dynamic DNS services have been around for many years, they’ve recently emerged as an integral tool in the arsenals of cybercriminal groups like Scattered Spider.
    • “Dynamic DNS (DDNS) services automatically update a domain name’s DNS records in real-time when the Internet service provider changes the IP address. Real-time updating for DNS records wasn’t needed in the early days of the Internet when static IP addresses were the norm.” * * *
    • “In a blog post last month, threat intelligence vendor Silent Push reported that despite some notable arrests of alleged members in 2024, Scattered Spider was actively engaged in new phishing campaigns targeting well-known enterprises. One of the key findings of the report was a shift in tactics from Scattered Spider members that featured the use of rentable subdomains from dynamic DNS providers like it.com Domains LLC.
    • “In an example of an observed attack, Scattered Spider actors established a new subdomain, klv1.it[.]com, designed to impersonate a similar domain, klv1.io, for Klaviyo, a Boston-based marketing automation company.
    • “Silent Push’s report noted that the malicious domain had just five detections on VirusTotal at the time of publication. The company also said the use of publicly rentable subdomains presents challenges for security researchers.”
  • Bleeping Computer points out,
    • “Ransomware gang members increasingly use a new malware called Skitnet (“Bossnet”) to perform stealthy post-exploitation activities on breached networks.
    • “The malware has been offered for sale on underground forums like RAMP since April 2024, but according to Prodaft researchers, it started gaining significant traction among ransomware gangs since early 2025.
    • ‘Prodaft told BleepingComputer they have observed multiple ransomware operations deploying Skitnet in real-world attacks, including BlackBasta in Microsoft Teams phishing attacks against the enterprise, and Cactus.”

From the cybersecurity business and defenses front,

  • Cyberscoop reports,
    • “Proofpoint has entered into an agreement to acquire Hornetsecurity Group, a Germany-based provider of Microsoft 365 security services, in a deal reportedly valued at more than $1 billion.
    • “The acquisition, described as the largest in Proofpoint’s history, comes amid accelerating consolidation in the cybersecurity industry as companies seek to broaden their offerings to enterprise customers of all sizes. While Proofpoint did not disclose terms, CNBC reports the deal is “well over” $1 billion. 
    • “Hornetsecurity, headquartered in Hannover, Germany, serves more than 12,000 managed service providers (MSPs) and 125,000 small and mid-sized businesses (SMBs) primarily across Europe. According to a press release announcing the deal, Hornetsecurity brings in $160 million in annual recurring revenue, with growth exceeding 20% year over year. 
    • “For Proofpoint, the acquisition provides an entry point into the SMB market through Hornetsecurity’s established MSP network.'” * * *
    • “The transaction comes as Proofpoint, which was taken private by Thoma Bravo in 2021for $12.3 billion, is exploring an IPO, according to the CNBC report.” 
  • and
    • “Coinbase responded to a security incident with combative measures Thursday after the company said cybercriminals bribed some of the cryptocurrency exchange’s international support staff to steal data on customers. The unnamed threat group stole personally identifiable information and other sensitive data on less than 1% of Coinbase’s monthly users, the company said in a blog post.
    • “The cybercriminals contacted customers under the guise of an employee at Coinbase in an attempt to dupe people into relinquishing their cryptocurrency. “They then tried to extort Coinbase for $20 million to cover this up. We said no,” the company said.
    • Coinbase flipped the script as part of its response. “Instead of paying this $20 million ransom, we’re turning it around and we’re putting out a $20 million award for any information leading to the arrest and conviction of these attackers,” Coinbase CEO Brian Armstrong said in a video posted on X.
    • “For these would-be extortionists, or anyone seeking to harm Coinbase customers, know that we will prosecute you and bring you to justice,” he added.” 
  • Dark Reading shares insights on the recent RSAC conference and of course also offers its CISO Corner.

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican spending hawks blocked the party’s giant tax-and-spending bill on Friday, delivering President Trump a setback over disagreements on Medicaid, clean-energy tax breaks and budget deficits.
    • “The holdouts—Reps. Chip Roy of Texas, Ralph Norman of South Carolina, Josh Brecheen of Oklahoma and Andrew Clyde of Georgia—stopped the Budget Committee from advancing the legislation, which leaders hope to pass by the full House next week. The panel failed to move the bill on a 16-21 vote, with those four Republicans and Rep. Lloyd Smucker (R., Pa.) joining all Democrats in opposition. Smucker, who backs the measure, said he voted no for procedural reasons, so he can call for a revote later.
    • “Budget Committee Chairman Jodey Arrington (R., Texas) said lawmakers were close to agreements on making changes to win the necessary votes. The committee scheduled its session to resume at 10 p.m. Sunday.”
  • and
    • “The U.S. lost its last triple-A credit rating.
    • “Moody’s Ratings downgraded the U.S. government on Friday, citing large fiscal deficits and rising interest costs.
    • “Runaway budget deficits mean U.S. government borrowing will balloon at an accelerating rate, pushing interest rates up over the long term, Moody’s said. The firm said in a March report that fiscal weakness looked set to continue even under analysts’ best-case scenarios.”
  • Modern Healthcare adds,
    • “Long-sought legislation to monitor and restrict how pharmacy benefit mangers operate could finally pass — if Republicans can move their sweeping budget bill that includes a string of those provisions.
    • ‘New PBM measures are tucked into the bill advanced Wednesday by the House Energy and Commerce Committee, which aims to cut more than $880 billion in spending, including $625 billion from Medicaid. The restrictions have long been championed by Health Subcommittee Chair Buddy Carter (R-Ga.), who was a pharmacist before becoming a congressman.”
  • Per Govexec
    • “The Trump administration is abiding by a court order to pause layoffs across most federal agencies, but it is still finding ways to shrink the federal workforce through involuntary means. 
    • “The Housing and Urban Development Department has begun once again firing its probationary employees—those recently hired or promoted—through a process distinct and separate from a reduction in force. Other agencies, including the Labor Department and National Science Foundation, meanwhile, are walking back recent RIFs due to a court-issued temporary restraining order. 
    • “That order specifically prevented agencies from issuing layoffs or taking any action to implement their Agency RIF and Reorganization Plans, which were mandated by the Office of Management and Budget and the Office of Personnel Management earlier this year. Agencies that were on the cusp of implementing RIFs, such as the Interior Department, have put those plans on ice at least until the restraining order is set to expire after May 23.”
  • FedWeek called our attention to this OPM benefits administration letter about “Family Member Eligibility Verification Updates and Enrollment Processing.”
  • Fierce Pharma informs us,
    • “On the heels of a production-tinged executive order earlier this month, the Trump administration is doubling down on efforts to boost medicine manufacturing in the U.S.
    • “In a new public-private partnership spearheaded by the administration, the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) are linking up with several universities and companies in a bid to improve manufacturing for essential medicines using technologies such as artificial intelligence, machine learning and informatics.
    • “The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban’s Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release.”
  • STAT News reports,
    • “Optum, the health data and care provider division of UnitedHealth Group, is developing a way to calculate how sick Medicare patients are through artificial intelligence, instead of relying solely on diagnosis codes submitted by physicians.
    • “Ken Cohen, a physician and Optum’s executive director of translational research, said Thursday at a conference organized by America’s Physician Groups that he was working with the Duke-Margolis Institute for Health Policy on this “next generation” of Medicare risk coding using AI.”

From the FDA front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
    • “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
  • STAT News adds,
    • “Jason Karlawish, a professor of medicine at the University of Pennsylvania who specializes in Alzheimer’s research, said that “used right, this is a test that could really help to improve the diagnostic experience.”
    • “But with the availability of easier-to-use tests, there’s always the risk of “some frisky prescribing habits,” Karlawish said. Particularly in the field of Alzheimer’s, where just a small number of doctors are trained to treat the increasingly common condition, “the outcome can be inappropriate prescribing of the tests because a lot of people have a desire to get it, but not a lot of clinicians know how to properly use it.”
    • “The test should only be used to help diagnose people who have confirmed cognitive impairment, and there’s a risk some doctors may skip the step of confirming, as it’s “much easier to order a test than it is to talk to a patient,” Karlawish said. 
    • “Still, “in the history of Alzheimer’s disease, this is a big day,” he said. “The notion 10 years ago that there’d be a blood test that detects the pathologies of Alzheimer’s was a bit of a science fiction fantasy kind of story, and now here it is FDA-approved and ready for clinical practice.”
  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ (AMRX.O), opens new tab self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.
    • “The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday.”

From the judicial front,

  • The American Hospital Association News informs us,
    • “A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies. 
    • “Judge Dabney Friedrich issued the ruling in a case brought by a number of drug companies, finding that when the statute says that in implementing price reductions, “any rebate or discount” taken into account shall be “as provided by the Secretary,” it means that HHS has the authority to approve or reject the proposed rebate models. “Put another way, the statute contemplates that the Secretary may ‘have as a condition’ or ‘stipulate’ how any rebate or discount is accounted for in the price ultimately paid by covered entities.” * * *
    • “HHS recently announced that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May.”

From the public health and medical research front.

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low and declining.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The University of Minnesota CIDRAP notes,
    • “The US measles picture grew by 23 cases this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “A total of 1,024 confirmed measle cases have been reported from 31 jurisdictions, with 14 outbreaks (defined as 3 or more related cases). Ninety-two percent of confirmed cases are outbreak-associated.
    • “Of the cases, 96% have occurred in people who are either unvaccinated or have unknown vaccination status, and 128 (13%) of case-patients have been hospitalized, including 69 children under the age of 5. Three deaths have been confirmed to date, including two in unvaccinated school-aged children.” * * *
    • “The CDC notes on its measles outbreak page that one the reasons for more measles activity is because MMR coverage among kindergartners is now below 95%—the level needed to maintain elimination status. Two doses of the MMR vaccine are 97% effective at preventing measles, and one dose is about 93% effective.”
  • The American Journal of Managed Care lets us know,
    • “Higher dietary inflammatory index (DII) scores are significantly associated with an increased risk of Alzheimer disease–related death among American adults, according to a study published in Experimental Gerontology.
    • “Although the exact mechanisms of Alzheimer disease remain unknown, accumulating evidence suggests that chronic inflammation plays a key role in its pathogenesis and progression. In particular, past research shows that neuroinflammation accelerates neuronal damage, synaptic loss, and cognitive decline observed in patients with Alzheimer disease.
    • “Anti-inflammatory diets can alleviate neuroinflammation in patients with Alzheimer disease by reducing systemic inflammation through several immune pathways in the brain and indirectly through the gut microbiome and body circulation pathways. Therefore, the researchers emphasized that an anti-inflammatory diet may constitute a beneficial nutritional approach in Alzheimer disease management.”
  • The Wall Street Journal reports
    • “Electricity is gaining traction as a potential treatment for diseases like cancer and rheumatoid arthritis.
    • “Companies like Novocure and SetPoint Medical are developing devices that use electricity to treat diseases.
    • “Clinical trials show promise, with devices extending survival for some cancer patients and improving arthritis symptoms.”
  • STAT News adds,
    • “Leading oncologists said this week that artificial intelligence will one day be as integrated into cancer care as it is in smartphones and self-driving cars — and that this is a change we should welcome.
    • “Their comments, made at STAT’s Breakthrough Summit West on Wednesday, reflected an optimistic view for how the health care system can use AI across nearly all aspects of cancer care, from matching patients with clinical trials to predicting how they might fare on a given treatment. Some of this work is already happening. The panelists noted that AI has the potential to offer deep expertise across a growing number of precisely defined cancer indications, and that the technology can generate insights research focused on individual hypotheses might miss.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Cleveland Clinic reported an operating income of $52.8 million (1.3% margin) in the first quarter, up slightly from $50.2 million (1.3% margin) in the same period last year, according to financial documents published May 16.”
  • and
    • “Phoenix-based Banner Health reported an operating income of $142.4 million (3.6% margin) in the first quarter, up from an $89.3 million operating gain (2.4% margin) in the first quarter of 2024, according to financial documents published May 15.”
  • Healthcare Dive reports,
    • “Rite Aid is selling more than 1,000 pharmacies to rival drugstore operators as the beleaguered “pharmacy chain limps through bankruptcy processes for a second time.
    • Rite Aid said it was formally pursuing sales of “substantially all of its assets” earlier this month. Now, healthcare companies CVS Health and Walgreens, along with grocery stores Albertsons, Kroger and Giant Eagle, are among the buyers snapping up Rite Aid stores, the company said on Thursday.
    • “CVS is one of the biggest buyers, agreeing to acquire prescription files from 625 Rite Aid locations in 15 states in areas where it already has a presence, along with fully buying and operating 64 stores in Idaho, Oregon and Washington. The sales are subject to approval by a New Jersey bankruptcy court, which is scheduled to hold a hearing on May 21 regarding the transactions.”
  • Fierce Healthcare tells us,
    • “More than 6 in 10 survey respondents say they expect their healthcare organizations to see higher revenue from value-based care arrangements this year than in 2024, according to a joint report from the National Association of Accountable ACOs and health tech company Innovaccer.
    • “The report surveyed 168 executive and clinical leaders at health systems, accountable care organizations, specialty providers, federally qualified health centers and other delivery organizations.
    • “The findings indicate a growing reliance on VBC programs for some organizations. A significant segment, 30%, of organizations said a quarter of their revenue is tied to VBC contracts. More than 20% indicated at least half of their revenue is derived from fully capitated or downside risk contracts.
    • “Three-fourths of respondents believe further financial support would propel VBC adoption more.”
  • The Wall Street Journal reports,
    • “Novo Nordisk CEO Lars Fruergaard Jorgensen is stepping down after eight years in the role.
    • “The move follows market challenges, a share-price decline, and pressure from its controlling foundation.
    • “Former CEO Lars Rebien Sorensen will join the board amid concerns about losing ground to Eli Lilly.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity and law enforcement front,

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

From the cybersecurity vulnerabilities and breaches front,

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

From the ransomware front,

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

From the cybersecurity defense front,

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

Tuesday Report

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “National Institutes of Health director Jay Bhattacharya on Monday asserted that the agency remains committed to research that advances the health of minorities — despite the Trump administration’s sharp focus on rolling back programs dealing with diversity, equity, and inclusion.
    • “Bhattacharya said that President Trump’s executive orders, which state that DEI programs are illegal and discriminatory and direct federal agencies to terminate any of their own such programs, are “misunderstood.”
    • “I don’t think that [the orders are] aimed at stopping fundamental research that advances the health and wellbeing of minority populations. I wouldn’t have accepted this job if that was the case,” he said. “I think that the health and wellbeing of minority populations, as well as every American, are a central focus of the NIH and will continue to be under my watch.”
  • The NIH’s understanding matches the FEHBlog’s reading of those DEI program executive orders, which are directed at workforces, not healthcare.
  • The Wall Street Journal adds,
    • “For months, investors have feared that Health and Human Services Secretary Robert F. Kennedy Jr. and his Make America Healthy Again movement would derail biomedical innovation. His ousting of Peter Marks—a senior official at the Food and Drug Administration and key proponent of faster drug approvals—sent biotech stocks tumbling last month and stoked concerns that the agency was being politicized and turned against science.
    • “A more nuanced narrative is now taking shape. 
    • “While heightened vaccine scrutiny and sweeping FDA staff cuts remain serious threats, recent signals have been more upbeat. In an interview late last week, newly appointed FDA Commissioner Marty Makary—a former Johns Hopkins surgeon—delivered a relatively bullish message for the biotech sector. Speaking with Megyn Kelly, Makary said he would speed up approvals for rare-disease treatments, cut reliance on animal testing by incorporating computational models and shorten the industry’s typical 10-year drug- development timeline.
    • “He also vowed to reduce pharmaceutical companies’ influence over the FDA approval process and end what he called the agency’s “cozy” relationship with the industry. Importantly, he emphasized a commitment to protecting innovation and maintaining a science-based approach to regulation.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again.
    • “The FDA is taking the following actions:
      • “Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
      • “Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
      • “Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
      • “Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
      • “Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
      • “Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.”
  • The U.S. Public Health Service Task Force posted the following draft grade B recommendation that applies to “Pregnant and postpartum women who are at increased risk of perinatal depression.”
    • “The USPSTF recommends that clinicians provide or refer those at increased risk of perinatal depression to counseling interventions during pregnancy and the postpartum period.”
    • The recommendation notes “When final, this recommendation will update the 2019 recommendation statement on interventions to prevent perinatal depression. The current draft recommendation is consistent with the 2019 recommendation; both are B recommendations”
    • The public comment period ends on May 19, 2025.

From the public health and medical research front,

  • The New York Times reports,
    • “The spread of measles in the Southwest now constitutes the largest single outbreak since the United States declared the disease eliminated in 2000, federal scientists told state officials in a meeting on Monday.
    • “The New York Times obtained a recording of the meeting. Until now, the Centers for Disease Control and Prevention had not publicly described the outbreak in such stark terms.
    • “More measles cases were reported mostly in Orthodox Jewish communities in New York City and New York State in 2019. But health officials regard those as separate outbreaks, because they were fueled by multiple introductions of the virus by international travelers.
    • “C.D.C. officials now view the spread of measles in Texas, Oklahoma and New Mexico as a single outbreak, Dr. Dan Filardo, who leads the agency’s task force for the measles response, told state health officials at the meeting.”
  • Medscape makes five long COVID predictions for 2025 and beyond.
  • The American Hospital Association News tells us,
    • “A study published April 17 by BMC Infectious Diseases found increased incidents of Acinetobacter baumanniiand carbapenem-resistant A. baumannii infections between 2018 to 2022. A. baumannii is a pathogen considered to be a major cause of health care-associated infections. The study found that A. baumannii cases per 100 hospitalization encounters grew from 1.15 in 2018 to 1.25 in 2021, before dropping to 1.11 in 2022. The CRAB incidence rate grew from 0.39 cases per 100 hospitalization encounters in 2018 to 0.53 cases in 2022. 
    • “Researchers said the pathogen’s ability to survive in hospitals and in patients not showing any symptoms for extended periods of time contributed to increased outbreaks.” 
  • MedPage Today points out,
    • “Cytisinicline increased biochemically confirmed abstinence [from smoking tobacco] nearly threefold versus placebo when taken for 6 weeks and more than fourfold when taken for 12 weeks.
    • “The drug was well tolerated with no treatment-related serious adverse events.
    • “The trial is expected to support filing with the FDA for a new drug indication as a tobacco-product cessation aid.”
  • Beckers Hospital Review notes,
    • “A recent study found that changing the default prescription length for statins to 90 days significantly increased the number of long-term prescriptions written, potentially improving patient adherence. 
    • “The intervention, which was implemented at the University of Pennsylvania’s health system in Philadelphia, set 90-day prescriptions as the default option in the electronic health record for statins. By the end of the study, the health system saw the proportion of 90-day prescriptions rise from 71% to 91%, according to an April 22 news release from Penn Medicine. 
    • “The study, published in JAMA Internal Medicine on April 7, found that the change designed as a “nudge” to guide doctors toward better prescribing behavior had helped to reduce the need for patients to visit the pharmacy multiple times a year. 
    • “The findings suggest that default settings in EHRs can be a tool in increasing medication adherence without additional effort from clinicians, the release said.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance posted mixed results for the first quarter but reaffirmed its 2025 earnings outlook, solidifying guidance it published early to pacify investors after UnitedHealth posted dismal results last week, leading to a selloff of health insurer stocks.
    • “UnitedHealth’s results were driven by unexpectedly high medical spending on Medicare Advantage members, a trend that Elevance on Tuesday said it had observed but wasn’t any more drastic than expected.
    • “Overall, Elevance beat Wall Street expectations in the quarter with revenue of $48.9 billion, up almost 15% year over year, in part due to the higher premiums it’s charging customers this year in a bid to resuscitate insurance margins. The insurer posted profit of $2.2 billion, down 3% year over year. Elevance’s stock was up slightly in morning trading following the results.”
  • Per MedCity News,
    • “With rising operational costs, major shifts in Medicaid, and other financial pressures bearing down on the healthcare system, forecasting revenue and allocating resources effectively has never been as important for health plans as it is today. And anticipating the future has probably never been so challenging.
    • “Health plans have been gradually deploying artificial intelligence programs and sophisticated analytics for years to make programs more effective while reducing costs and mitigating financial risk.
    • “But with today’s challenges, the gradual approach has become a luxury. According to McKinsey, health plans should pick up the pace.”
  • Modern Healthcare adds,
    • “Payers, providers and health technology companies may soon be asking accrediting organizations to sign off on their use of artificial intelligence.
    • “AI is being used across the industry but a lack of regulation at the state and federal levels is prompting industry stakeholders to create their own guidelines for safe and effective AI use. The next step might well see the issue addressed in accreditation programs.
    • “While the AI accreditation process could take years to develop, there is confidence that it will become commonplace. On top of the potential impact of AI on patient outcomes, there is a cost to develop and adopt products. This cost factor is driving the need for more transparency on model efficacy, said Dr. Lee Schwamm, chief digital health officer at New Haven, Connecticut-based Yale New Haven.”
  • The Wall Street Journal reports,
    • “Swiss pharmaceutical giant Roche ROG -0.31%decrease; red down pointing triangle
      plans to invest $50 billion in the U.S. over the next five years, the latest major spending commitment by a big drugmaker as the industry faces President Trump’s tariff threats.” * * *
    • “The investment by Roche will fund new research hubs and new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California, the company said Tuesday. The company said that investment would create 1,000 jobs at Roche and more than 11,000 elsewhere including nearly 6,500 construction jobs.
    • “The company currently has 15 R&D centers and 13 manufacturing sites in the U.S., employing more than 25,000 people.
    • “Roche said it would export more medicines from the U.S. than it imports once its new and expanded manufacturing site are in operation. The group’s diagnostics division currently already holds a surplus from the U.S., it said.”
  • MedCity News relates,
    • “Aeroflow Health, a health tech company, last week announced a new diabetes management program, which aims to improve adherence, outcomes and care coordination for health plan members.
    • “Asheville, North Carolina-based Aeroflow Health was founded in 2001 and offers an array of medical devices covered by insurance. The company has four lines: Aeroflow Breastpumps, Aeroflow Diabetes, Aeroflow Sleep and Aeroflow Urology. In addition to medical devices, it provides education and consultations. The company has partnerships with more than 1,000 insurance plans and serves more than 1.4 million patients annually.
    • “Through the new diabetes program, patients gain access to educational content on how to manage their condition, including medication adherence, lifestyle modifications and glucose monitoring strategies. They can also use a new AI-powered digital health tool that syncs with continuous glucose monitoring data. This allows patients to receive personalized insights on their health, AI-driven coaching and communication with their provider.”

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, SCOTUS–

From Washington, DC,

  • Congress remains on a District/State work break this week.
  • Tomorrow at 10 am ET. the U.S. Supreme Court will hear oral arguments in the Kennedy v. Braidwood Management, No. 24-316, case. Amy Howe provides background on the case here. The case considers the constitutional authority of the U.S. Preventive Services Task Force to make recommendations for no-cost coverage of preventive services under the Affordable Care Act.
  • MedPage Today points out,
    • “The need to revamp the Organ Procurement and Transplantation Network (OPTN) is dire. Nearly 25% of livers and 33% of kidneys collected for donation go unused. The average transplant wait time is 3-5 years, but it can stretch even longer in some parts of the country. Much of the network’s donation and recipient data collection is performed manually, prolonging pre-transplant procedures. All of this is unwelcome news for more than 100,000 people currently on the organ transplant waitlist. And many are running out of time.
    • “Despite these challenges, the U.S. organ transplant system still saves over 48,000 lives a year. And policymakers have been pushing to increase this numbers. The Health Resources and Services Administration (HRSA), the entity housed within HHS that oversees the transplant network, is tasked with modernizing the system and saving more lives. HRSA is working hard to close the gap between recipient identification, donor matching, and subsequent transplant surgeries.
    • “HRSA must continue to push modernization efforts aggressively, using operational and technology improvements and stakeholder collaboration to save more lives and increase public trust in the transplant system. Reform efforts should focus on three key areas: streamlining of responsibilities, technological upgrades, and transparency.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Consuming more than eight alcoholic drinks a week is associated with brain injuries linked to Alzheimer’s disease and cognitive decline, a recent study in the journal Neurology suggests.
    • “The analysis looked for links between heavy drinking and brain health. Researchers used autopsy data from the Biobank for Aging Studies at the University of São Paulo Medical School in Brazil collected between 2004 and 2024. The team analyzed data from 1,781 people ages 50 or older at death. The average age at death was 74.9. * * *
    • The analysis showed that heavy drinkers and former heavy drinkers, respectively, had 41 percent and 31 percent higher odds of neurofibrillary tangles — clumps of the protein tau that accumulate inside brain neurons and have been associated with Alzheimer’s disease.
    • “Moderate, heavy and former heavy drinkers also had a higher risk of hyaline arteriolosclerosis, which thickens the walls of small blood vessels in the brain, impeding blood flow and causing brain damage over time. Though 40 percent of those who never drank had vascular brain lesions, they were more common in moderate (44.6 percent), heavy (44.1 percent) and former heavy drinkers (50.2 percent), the study found.”
  • Per Medscape,
    • “An investigational drug, currently known as AZD0780, lowers low-density-lipoprotein cholesterol (LDL-C) to target levels in most patients whose cholesterol is still over target despite statin therapy, results from the phase 2b PURSUIT trial show.
    • “AZD0780 inhibits PCSK9, a protein that regulates cholesterol metabolism. Inhibition of this protein has proven useful in lowering LDL-C. Current drugs in this class include two monoclonal antibodies, alirocumab and evolocumab, and a small interfering RNA, inclisiran. However, unlike current PCSK9 inhibitors, which must be injected, AZD0780 is an oral therapy.
    • “We’ve had PCSK9 inhibitors on the market in the United States for 10 years,” said investigator Michael Koren, MD, a cardiologist and CEO of the ENCORE Research Group in Jacksonville, Florida. However, “people are still not getting to goal,” he explained during his presentation of the results at the American College of Cardiology Scientific Session 2025 in Chicago, which were published simultaneously in the Journal of the American College of Cardiology.”
  • The Wall Street Journal informs us about “How Your Midlife Eating Habits Can Help You Live Longer and Healthier.”
    • “If you reach 70 years old healthy and disease-free, you might have your diet to thank, new research suggests.
    • “The study, which analyzed the health data of more than 100,000 people over the course of 30 years, is the first of its kind to examine how dietary patterns affect not only lifespan but also how well people age. The upshot: A diet emphasizing vegetables, fruits, healthy fats and some animal products such as fish and dairy over the long term was the most likely to make a difference in aging in good health.
    • “Sticking to a balanced diet with a moderate amount of healthy animal protein, in fact, outperformed following a more plant-based diet, in terms of healthy aging. The researchers also found that eating more ultra processed foods was linked to worse physical and cognitive health in older age.
    • “The study, published in Nature Medicine and led by researchers at Harvard University, the University of Copenhagen and the University of Montreal, adds to the growing body of research on human health spans—the number of years we live in good health—and the factors that can extend those years.” 

From the U.S. healthcare business front,

  • Tech Target identifies “13 AI healthcare companies to watch in 2025. These AI healthcare companies are using generative AI to enhance efficiency, improve patient care and innovate diagnostics. We also explore types of AI in the healthcare space.”
  • Per a press release,
    • “At HIMSS25, Performant Healthcare, Inc. (Nasdaq: PHLT), a leader in technology-enabled payment integrity, eligibility and related analytics services, conducted a targeted survey of nearly 150 healthcare technology leaders to better understand the key drivers behind healthcare technology decision-making. The findings point to a healthcare landscape increasingly shaped by innovation, efficiency and the imperative to deliver better outcomes for patients.
    • “This press release features multimedia. View the full release here
  • Per a press release,
    • U.S. Business Action to End HIV has been named one of Modern Healthcare’s 2025 Innovator Awards recipients.
    • Modern Healthcare’s Innovators program recognizes leaders and organizations driving innovation that improves care and achieves measurable results.
    • U.S. Business Action to End HIV is reimagining the role of businesses in ending HIV. The Coalition empowers companies to reduce stigma, increase access to care, support community organizations, and advocate for policy change.
  • Fierce Healthcare tells us,
    • “Despite growing awareness around fertility challenges, 77% of women have hidden or downplayed their fertility treatment at work. 
    • “So finds the latest survey from Maven Clinic, a virtual women’s and family health provider. The survey reached more than 1,000 U.S. women who have gone through the fertility journey. The fertility journey comes with many challenges, from financial to emotional. These are often hidden from public view, Maven executives argue.
    • “Financial cost remains one of the biggest barriers to fertility care, with 75% of people experiencing financial strain when navigating fertility. Nearly half of survey respondents felt unprepared for the cost, particularly around medications or hormonal treatments, genetic testing and diagnostic testing.
    • “Most respondents (83%) had to cut back on expenses, and more than half had to use their savings meant for other life goals to afford fertility care. A third of the people said they took on debt, while 59% took on extra work.
    • “At the same time, people going through the fertility journey must deal with the emotional toll it can take. Most (91%) said fertility challenges impact their mental health, the survey found. And 78% reported limiting social interactions, like weddings and family gatherings, due to the emotional stress.” 

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law reports,
    • “President Donald Trump wants Congress to change a policy that gives certain drugs longer protection from drug price negotiations in Medicare, a fix that could address one of the drug industry’s top complaints with the Biden-era law.
    • “Trump directed his health secretary to work with lawmakers to end the differential treatment for small molecule drugs, typically pills, that face Medicare price negotiations sooner that more complex biologic medications.
    • “The directive came in an executive order Trump signed at the White House Tuesday. The order was light on specifics and included a grab-bag of other health policy goals.”
  • Modern Healthcare adds
    • “A bipartisan group of state attorneys general wants Congress to pass legislation that would break up healthcare conglomerates such as UnitedHealth Group, CVS Health and Cigna.
    • “Under the auspices of the National Association of Attorneys General, more than three dozen officials wrote congressional leaders on Monday asking them to ban companies from owning both pharmacy benefit managers and pharmacies, citing anticompetitive effects of consolidation in the healthcare system.”
    • Here is a link to that letter.
  • Fierce Pharma tells us,
    • “A two-day meeting of the Advisory Committee on Immunization Practices (ACIP), which was originally scheduled for February but was postponed by new HHS Secretary Robert F. Kennedy Jr., is underway today [April 15] in Atlanta and will conclude with panel votes on several vaccines on Wednesday afternoon.
    • “The independent advisers, who meet three times a year to inform vaccine policies in the U.S., today will discuss (PDF) the effectiveness of vaccines that defend against COVID-19, Mpox, chikungunya, HPV, cytomegalovirus (CMV) and the flu.
    • “The last item on Tuesday’s agenda will be an update on the U.S. measles outbreak. On Friday, the Centers for Disease Control and Prevention (CDC) reported 712 cases in more than 20 states, with the most concentrated spread underway in West Texas.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a member of the Senate Agriculture Committee and a lifelong family farmer, joined Sens. Pete Ricketts (R-Neb.) and Deb Fischer (R-Neb.), along with Reps. Randy Feenstra (R-Iowa) and Mark Alford (R-Mo.), in a letter urging the Make America Healthy Again (MAHA) Commission to use sound science and risk-based analysis in its policy decisions, particularly on crop protection tools and food-grade ingredients.
    • The letter was sent to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, Department of Agriculture (USDA) Secretary Brooke Rollins and Environmental Protection Agency (EPA) Administrator Lee Zeldin.
      • “We write to express our strong appreciation for your leadership and interest in working with each of you to ensure America has the healthiest people in the world. In recent decades, chronic illness rates have risen. This warrants our careful scrutiny to support better health outcomes. It is essential that policies supported by sound science and risk-based analyses are used to accomplish this goal,” the lawmakers wrote.
      • “We have concerns that environmentalists are advancing harmful health, economic, or food security policies under the guise of human health. Despite insinuations to the contrary, regular testing by FDA and USDA finds that more than 99% of all pesticide residues meet extremely conservative limits established by EPA according to the best available science,” they continued.”
    • Here’s a link to the letter.

From the judicial front,

  • Bloomberg Law tells us,
    • “The Central States, Southeast and Southwest Areas Health and Welfare Fund and participant Charles A. Whobrey sued Arkansas Insurance Commissioner Alan McClain April 11, arguing a law requiring health plans to report pharmacy cost data and pay pharmacies a minimum amount violates the Employee Retirement Income Security Act. 
    • “The multiemployer benefit plan serves 500,000 people via local chapters of the International Brotherhood of Teamsters.
    • “It’s the latest in a broader legal fight over states’ attempts to regulate pharmacy benefit managers, which oversee the prescription drug benefit for health plans. The US Supreme Court is weighing whether to accept a case challenging an Oklahoma law regulating pharmacy benefit managers after determining that ERISA did not preempt a separate Arkansas PBM law in 2020.” * * *
    • “The case is Central States, Southeast and Southwest Areas Health and Welfare Fund et al v. McClain, in his official capacity as Insurance Commissioner of Arkansas et al., N.D. Ill., No. 1:25-cv-03938, complaint filed 4/11/25.”

From the public health and medical research front,

  • The National Academy of Sciences announced,
    • “Bird flu has infected livestock, wildlife, pets, and humans. Most people have general questions about the looming threat of this highly pathogenic virus, and we have answers. Join @NASEM Health and Medicine Division and @NASEM Earth & Life Sciences on April 29, 2025, for the first public webinar of a special series addressing H5N1 avian influenza. Learn how we got here, who’s at risk, and what’s at stake. Can’t make the date/time? All registrants will receive a link to the recording. Register here: https://tinyurl.com/bdhrywv2
  • The New York Times reports,
    • “The number of children living with autism in the U.S. is growing.
    • “About 1 in 31 children aged eight years old in 2022 had autism—an increase from previous years, according to a report from the Centers for Disease Control and Prevention published Tuesday. 
    • “Increased awareness and screening of the disorder partly explains its rise over time. Health and Human Services Secretary Robert F. Kennedy Jr. has said he is assembling a team of researchers to focus on the root causes of the increase and expects to begin to have answers by September. 
    • “The autism epidemic has now reached a scale unprecedented in human history because it affects the young,” he said Tuesday. “Autism is preventable and it is unforgivable that we have not yet identified the underlying causes. We should have had these answers 20 years ago.”
    • “The idea that vaccines cause autism, which Kennedy has pushed, has long been debunked by scientists, after multiple studies have failed to find a link.”
  • The Rand Organization informs us,
    • “Specialized hospital services that aid people with opioid use disorder regardless of why they are admitted can boost the number of patients who begin treatment with FDA-approved medication for opioid use disorder and increase the likelihood they remain engaged in that care once discharged, according to a new study.
    • “Reporting results from the first parallel assignment randomized clinical trial of a hospital-based addiction consultation service for people with opioid use disorder, researchers found that people who received treatment from a specialized addiction consultation service were about twice as likely to begin medication treatment for opioid use disorder as patients who received the normal course of care.
    • “In addition, those who received care from the special program were significantly more likely to link to care for opioid use disorder once they were discharged.
    • “Researchers say the study contributes to growing evidence that an inpatient addiction consultation service can have a positive effect on treatment initiation and linkage to post-discharge care. The findings are published in the journal JAMA Internal Medicine.”
  • AHRQ offers advice on “Implementing [US Preventive Services Task Force] Recommended Mental Health and Substance Use Screening and Counseling Interventions in Primary Care Settings for Children and Adolescents.”
  • Per Medscape,
    • “New data confirmed the safety and efficacy of AXS-05, a combination of dextromethorphan and bupropion, for the treatment of agitation associated with Alzheimer’s disease (AD).
    • “In the phase 3 ACCORD-2 study, AXS-05 (Axsome Therapeutics) met the primary and key secondary endpoints by statistically significantly delaying and preventing AD agitation relapse compared with placebo and was generally well tolerated.
    • “Overall, the data “build on the previous positive phase 2/3 studies and support the use of AXS-05 as a safe and effective treatment for Alzheimer’s disease agitation,” George Grossberg, MD, Saint Louis University School of Medicine, St. Louis, said at a press briefing announcing the results.
    • “Grossberg presented the late-breaking findings from ACCORD-2 on April 7 at the American Academy of Neurology (AAN) 2025 Annual Meeting.”
  • Per a National Cancer Institute news release,
    • “Many adolescents and young adults (AYAs) with advanced cancer don’t have discussions with their clinicians about how they want to approach palliative care until the final weeks of life, a study of medical records of nearly 2,000 young patients showed.
    • “The researchers also found that, as of more than 2 months before their deaths, few AYAs in the study had documented goals for care of any kind in their medical records, including things such as how aggressive they would like to be with their cancer treatments.
    • “The findings come from an NCI-funded study that analyzed how documented discussions between AYA patients with advanced cancer and their providers about the goals of care change over the patients’ last few months of life.  The study results were published December 19 in JAMA Network Open.”
  • Per an NIH news release,
    • “New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy exists for this rare inherited disease, which starts affecting vision from childhood. A report on the studies, conducted at the National Institutes of Health (NIH), published today in eLife.
    • “The discovery of reserpine’s effectiveness may greatly speed therapeutics for retinitis pigmentosa and many other inherited retinal dystrophies, which can be caused by one of more than a thousand possible mutations affecting more than 100 genes. Reserpine’s neuroprotective effect is independent of any specific underlying gene mutation,” said the study’s lead investigator, Anand Swaroop, Ph.D., senior investigator at NIH’s National Eye Institute.”
  • STAT News reports,
    • “U.S. researchers will soon test whether livers from a gene-edited pig could treat people with sudden liver failure — by temporarily filtering their blood so their own organ can rest and maybe heal.
    • “The first-of-its-kind clinical trial has been cleared by the Food and Drug Administration, according to pig producer eGenesis, which announced the step Tuesday with its partner OrganOx.” * * *
    • “The new study, which is expected to get underway later this spring, is a twist on the quest for animal-to-human organ transplants. Researchers won’t transplant the pig liver but instead will attach it externally to study participants.
    • “The liver is the only organ that can regenerate, but the question is whether having the pig’s liver filter the patient’s blood for several days could give it that chance.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS’ payment increase of 5.03% in 2026 “will likely significantly support the recovery” of Medicare Advantage plans as they continue to face rising medical costs, according to Fitch Ratings.
    • “Increased government scrutiny, reduced base payments and rising utilization in the last couple of years has put pressure on the program, leading plans to reduce benefits or pull back from unprofitable markets. CMS’ rate hike will increase payments to MA plans by more than $25 billion in 2026.
    • “While the higher 2026 payment rates do not resolve all the challenges facing MA insurers, they help relieve some pressures from increased healthcare utilization in the program,” Fitch analysts wrote April 14. “Depending on the insurer, the higher rates could enable a mix of enhancement of benefits in certain geographies, mitigation of Star Ratings pressure, or partial margin recovery.”
    • “Fitch expects MA to remain a key focus for insurers, and a clearer picture on the success of course correction measures will become available in the next few weeks as Q1 earnings reports are released.”
  • Per Fierce Pharma,
    • “Even as tariffs start to take a toll on Johnson & Johnson’s medtech business—with the threat of pharmaceutical duties not far behind—the New Jersey drug giant is confident it can weather any upcoming trade war turbulence. In fact, the company is boosting its sales guidance for the year following the close of a new neuroscience acquisition.
    • “J&J now expects to generate total operational sales of $91.6 billion to $92.4 billion in 2025, representing a $700 million increase over the forecast it initially unveiled in January, the company said in a Tuesday earnings release (PDF).
    • “J&J’s finance chief, Joseph Wolk, attributed the bump to J&J’s recent acquisition of neuroscience player Intra-Cellular Therapies for $14.6 billion. The deal, which closed earlier this month, allowed J&J to get its hands on the approved schizophrenia and bipolar disorder med Caplyta.”
  • Per Beckers Hospital Review,
    • “At the end of 2023, more than one-third of new prescriptions to treat Type 2 diabetes were GLP-1s, such as Mounjaro and Ozempic, among others, according to a study published April 15 in Annals of Internal Medicine. 
    • “Researchers at Mass General Brigham, based in Somerville, Mass., reviewed claims data from January 2021 to December 2023 to evaluate utilization trends among diabetes medications. 
    • “The drugs included glucagon-like peptide-1 receptor agonists (Ozempic), glucose-dependent insulinotropic polypeptide receptors (Mounjaro), glucose-lowering medications (metformin and insulin) and weight-lowering medications (phentermine). 
    • “Over those three years, use of Mounjaro, Ozempic and sodium-glucose cotransporter-2 inhibitors increased among adults with Type 2 diabetes. Use of other glucose-lowering drugs, including metformin, rapidly declined.
  • and
    • “Houston-based Texas Children’s has experienced “astounding” results from AI projects in recent months, its IT leader told Becker’s.
    • “Myra Davis, executive vice president and chief information and innovation officer of Texas Children’s, was recently recognized for her work when she was nominated for an ORBIE award for the nation’s top healthcare CIO.
    • “Becker’s caught up with Ms. Davis to discuss her most innovative IT projects — and what comes next.”
  • The New York Times reports,
    • “The quest to create an A.I. therapist has not been without setbacks or, as researchers at Dartmouth thoughtfully describe them, “dramatic failures.”
    • “Their first chatbot therapist wallowed in despair and expressed its own suicidal thoughts. A second model seemed to amplify all the worst tropes of psychotherapy, invariably blaming the user’s problems on her parents.
    • “Finally, the researchers came up with Therabot, an A.I. chatbot they believe could help address an intractable problem: There are too many people who need therapy for anxiety, depression and other mental health problems, and not nearly enough providers.
    • “Fewer than a third of Americans live in communities where there are enough mental health providers to meet the local demand. According to one study, most people with mental health disorders go untreated or receive inadequate treatment.
    • “So the team at Dartmouth College embarked on the first clinical trial of a generative A.I. therapist. The results, published in the New England Journal of Medicine-AI, were encouraging.
    • “Chatting with Therabot, the team’s A.I. therapist, for eight weeks meaningfully reduced psychological symptoms among users with depression, anxiety or an eating disorder.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a progressive heart condition, closing off an opportunity to expand use of a medicine it sees as a future blockbuster.
    • “According to Bristol Myers, Camzyos missed the dual main goals of a study focused on the non-obstructive form of “HCM,” or hypertrophic cardiomyopathy. It failed to meaningfully improve peak oxygen consumption as well as scores on an assessment of heart health. The company didn’t provide study details, but said more information will be shared “with the scientific community in the future.”
    • “Camzyos was acquired through the $13 billion buyout of MyoKardia in 2020 and two years later became the first drug cleared for use in the “obstructive” and more common form of the disease. Biotechnology companies Cytokinetics and Edgewise Therapeutics are developing similar medicines that are both in the advanced stages of clinical testing. Cytokinetics’ drug, aficamten, could be approved in the U.S. later this year.”