Cybersecurity Dive

David Ermer

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

Cybersecurity Dive

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • NextGov/FCW lets us know,
    • “A cornerstone federal program that certifies the security architecture of private sector cloud services for government use is expected to announce a fundamental overhaul to its processes on Monday [March 24], according to multiple people familiar with the matter.
    • “The moves, in the long term, are expected to automate many of the certification process steps for the Federal Risk and Authorization Management Program, or FedRAMP, which is used to ensure cloud providers meet strict cybersecurity requirements before government agencies can use their services, according to the people, who were granted anonymity to be candid about the forthcoming changes.
    • “FedRAMP has been a mainstay in government procurement for the last decade but has faced repeated complaints about the slow pace of cloud service approvals. FedRAMP has different approval levels that vary based on the sensitivity of the data a cloud service can handle, with higher levels requiring stricter security controls and generally longer review processes.”
  • and
    • “Despite goals set last year by the National Institute of Standards and Technology to process a backlog of unanalyzed cybersecurity vulnerabilities, the agency said it’s not expecting a slowdown anytime soon.
    • “The National Vulnerability Database — NIST’s cornerstone repository for researchers who use its contents and measuring tools to assess the dangers of cyber exploits — has been backed up with unanalyzed vulnerabilities since February last year. The scientific standards agency was projected to clear the logjam this month based on rates observed this past summer, Nextgov/FCW previously reported.
    • “But NIST said Wednesday that vulnerability submissions increased 32% in 2024 and prior processing rates from spring and early summer last year are no longer sufficient to keep up with incoming submissions. The backlog is still growing as a result.
    • “We anticipate that the rate of submissions will continue to increase in 2025. The fact that vulnerabilities are increasing means that the NVD is more important than ever in protecting our nation’s infrastructure. However, it also points to increasing challenges ahead,” an agency spokesperson said. “To address these challenges, we are working to increase efficiency by improving our internal processes, and we are exploring the use of machine learning to automate certain processing tasks.”
  • Per a March 21, 2025, HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Health Fitness Corporation (Health Fitness), located in Illinois, that provides wellness plans to clients across the country, resolving a potential violation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.” * * *
    • “The settlement resolves OCR’s investigation of Health Fitness, which OCR initiated after receiving four reports from Health Fitness, over a three-month period (October 15, 2018, to January 25, 2019), of breaches of unsecured protected health information.  Health Fitness filed the breach reports on behalf of multiple covered entities as their business associate.  Health Fitness reported that beginning approximately in August 2015, ePHI became discoverable on the internet and was exposed to automated search devices (web crawlers) resulting from a software misconfiguration on the server housing the ePHI. Health Fitness discovered the breach on June 27, 2018.  Health Fitness initially reported that approximately 4,304 individuals were affected and later estimated that the number of individuals affected may be lower.  OCR’s investigation determined that Health Fitness had failed to conduct an accurate and thorough risk analysis, until January 19, 2024, to determine the potential risks and vulnerabilities to the ePHI held by Health Fitness.
    • “Under the terms of the resolution agreement, Health Fitness agreed to implement a corrective action plan that OCR will monitor for two years and paid $227,816 to OCR.” * * *
    • The resolution agreement and corrective action plan may be found at:  https://www.hhs.gov/sites/default/files/health-fitness-ra-cap.pdf [PDF, 202 KB].

From the cybersecurity breaches and vulnerabilities front,

  • Cyberscoop tells us,
    • “Cybercriminals used information-stealing malware to a devastating effect last year, capturing sensitive data that fueled ransomware, breaches and attacks targeting supply chains and critical infrastructure, according to a new report.
    • “Infostealers were used to steal 2.1 billion credentials last year, accounting for nearly two-thirds of 3.2 billion credentials stolen from all organizations, Flashpoint said in a report released Tuesday. By targeting identity and access, cybercriminals stole 33% more credentials in 2024 compared to the previous year. More than 200 million credentials were already stolen in the first two months of this year.
    • “Infostealers are proving to be incredibly versatile, contributing to account takeover, increasing data breach totals, acting as initial access vectors to ransomware, as well as assisting in exploitation via vulnerabilities,” Ian Gray, vice president of intelligence at Flashpoint, said in an email.”
  • Security Week informs us,
    • “Browser security cannot be ignored. It’s where people spend most of their working day, and it’s where attackers focus most of their attacks.
    • “Statistics come from Menlo Security’s analysis of 750,000 browser-based phishing attacks targeting more than 800 entities detected over the last 12 months. This analysis reveals a 140% increase in browser phishing, including a 130% increase in zero-hour phishing attacks (effectively, a zero-day attack applied to phishing).
    • “The reasons for the growth are multiple: our growing reliance on the browser for much of our daily work, the prevalence of zero-day vulnerabilities, the increasing sophistication of the cybercriminal underworld, and, worryingly, the growing influence of gen-AI. Gen-AI is particularly concerning, both for its use today and its potential use in the future.
    • “Threat actors have advanced in speed and skills. They are using the same tools and infrastructure as professional engineers,” comments Andrew Harding, VP of security strategy at Menlo Security. “We’re seeing a dangerous combination of zero-day attacks, advanced social engineering techniques, sophisticated phishing techniques, and readily available phishing-as-a-service kits, all designed to infiltrate systems and steal valuable data.”
    • “He adds, “This trend is only poised to escalate dramatically in 2025 as attackers adopt AI to increase both scale and effectiveness.”
  • Dark Reading adds,
    • “A nearly decade-long malware campaign known as “DollyWay World Domination” has compromised more than 20,000 WordPress websites over the past eight years.
    • “GoDaddy published a report this week claiming multiple threat campaigns tracked by various security researchers since 2016 are actually one larger operation perpetrated by VexTrio, a massive cybercrime network that leverages traffic distribution systems (TDSs) and lookalike domains to deliver malware and scams.
    • “GoDaddy’s Denis Sinegubko wrote in the company’s research blog that the operation is tracked as DollyWay World Domination due to a string of code found in variations of the DollyWay malware: “define(‘DOLLY_WAY’, ‘World Domination’);”.
  • and
    • “Mobile phone jailbreaks are thriving, exposing users to anywhere between three- and 3,000-times greater risk of cyber compromise.
    • “Organizations already face a significant risk in bring your own device (BYOD) attacks. More than 70% of infected devices are personal, and a good chunk of organizations have watched as malware entered their walls through unmanaged devices belonging to employees.
    • “The risk is supercharged, though, when those devices are cracked. New data from Zimperium shows that rooted and jailbroken Android phones and iPhones are 3.5 times more likely to be infected with malware and 250 times more likely to be totally compromised.
    • “What we’ve seen is that the amount of jailbreaks and roots has decreased slightly in recent years,” says Kern Smith, vice president of global solutions engineering at Zimperium. However, he warns, “The risk of those has increased significantly. These jailbreaks and roots expose these devices to a much, much higher risk profile. And mobile devices in general are being exposed to a much higher risk profile today. So it becomes a multiplier effect.”
  • Per Fedscoop,
    • “The Federal Bureau of Investigation has warned federal employees that cybercriminals are attempting to steal their login credentials in connection to a widely used government financial services platform, according to a notice viewed by FedScoop. 
    • “Hackers are targeting the Employee Personal Page, or MyEPP page, which is operated by the National Finance Center (NFC), a financial and human resources shared service within the Agriculture Department used by 661,000 employees across the federal government for payroll. The site, which is used to manage salary and benefits information, is typically accessed through an online account or with Login.gov credentials. 
    • “According to the FBI, cybercriminals hope to trick federal employees by running advertisements on search engines that impersonate the NFC website. If they click on the ad, employees are brought to a “sophisticated phishing website” that looks similar to the actual MyEPP page that aims to capture their login credentials when users enter them.”
  • Per Bleeping Computer,
    • “Veeam has patched a critical remote code execution vulnerability tracked as CVE-2025-23120 in its Backup & Replication software that impacts domain-joined installations.
    • “The flaw was disclosed yesterday and affects Veeam Backup & Replication version 12.3.0.310 and all earlier version 12 builds. The company fixed it in version 12.3.1 (build 12.3.1.1139), which was released yesterday.
    • “According to a technical writeup by watchTowr Labs, who discovered the bug, CVE-2025-23120 is a deserialization vulnerability in the Veeam.Backup.EsxManager.xmlFrameworkDs and Veeam.Backup.Core.BackupSummary .NET classes.”
  • Cybersecurity Dive tells us,
    • At least 11 state-sponsored threat groups since 2017 have been actively exploiting a Microsoft zero-day flaw allowing for abuse of Windows shortcut files to steal data and commit cyber espionage against organizations in various industries.
    • Researchers from Trend Micro’s Trend Zero Day Initiative (ZDI) have identified nearly 1,000 malicious .lnk files abusing the flaw, tracked as ZDI-CAN-25373, which allows attackers to execute hidden malicious commands on a victim’s machine by leveraging crafted shortcut files.
    • “By exploiting this vulnerability, an attacker can prepare a malicious .lnk file for delivery to a victim,” according to a Trend Micro blog post on Tuesday. “Upon examining the file using the Windows-provided user interface, the victim will not be able to tell that the file contains any malicious content.”
    • “The malicious files delivered by attackers include various payloads, including the Lumma infostealer and Remco’s remote access Trojan (RAT), that expose organizations to risks of data theft and cyber espionage.”
  • CISA added five known exploited vulnerabilities to its catalog this week.
    • March 18, 2025
      • CVE-2025-24472 Fortinet FortiOS and FortiProxy Authentication Bypass Vulnerability
      • CVE-2025-30066 tj-actions/changed-files GitHub Action Embedded Malicious Code Vulnerability
        • Dark Reading discusses the Fortinent KVE here, and Cybersecurity Dive discusses the Github KVE here.
    • March 19, 2025
      • CVE-2025-1316 Edimax IC-7100 IP Camera OS Command Injection Vulnerability
      • CVE-2024-48248 NAKIVO Backup and Replication Absolute Path Traversal Vulnerability
      • CVE-2017-12637 SAP NetWeaver Directory Traversal Vulnerability
        • Hacker News discusses the Edimax KVE here and the NAVIKO KVE here. Cybersecurity News discusses the SAP KVE here.
  • Cybersecurity Dive adds,
    • Johannes Ullrich of the SANS Internet Storm Center reported exploitation attempts this week against two critical Cisco vulnerabilities that were initially disclosed in September. CVE-2024-20439 is a static credential vulnerability in the Cisco Smart Licensing Utility, and CVE-2024-20440 is an information disclosure flaw in the utility. 
    • It’s unclear if the exploitation was successful, but Ullrich noted the static credential for CVE-2024-20439 was previously published by a security researcher and could be used to remotely access affected devices.
    • Ullrich told Cybersecurity Dive the exploitation attempts likely originate from a smaller botnet, with activity spiking over the last week.
  • Fierce Healthcare lets us know,
    • “A new report by Clearwater Security found that incident response and resilience was a major issue for private equity-owned healthcare companies, which need to improve consistency in cybersecurity governance in light of their high-growth business model.
    • “The assessment found systemic gaps in security preparedness, as healthcare organizations need more documented policies for cybersecurity practices from provider practices to digital health companies. Private equity firms need to consider the cybersecurity risk profiles of companies when deciding whether to acquire them or merge them with other businesses, Clearwater writes.
    • “Because private equity firms prioritize rapid growth of their portfolio companies, Clearwater found that health IT infrastructures and cybersecurity practices often fall behind. A cybersecurity incident can devalue a company overnight or rack up regulatory fines, a dangerous prospect for PE firms.
    • “The report looked at consumer health companies, healthcare data and analytics companies and physician practices owned by private equity firms. It also evaluated pharma, biosciences and dental services companies.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “A Medusa ransomware campaign is using a malicious driver to disrupt and even delete endpoint detection and response (EDR) products on targeted organization networks.
    • “According to new research from Elastic Security Labs, the malicious driver, dubbed ABYSSWORKER, is deployed along with a packer-as-a-service called HeartCrypt to deliver Medusa ransomware. Elastic noted the driver was first documented in a ConnectWise post in January involving a different campaign of IT support scams using Microsoft Teams.
    • “In the Medusa ransomware attacks, Elastic discovered the malicious driver imitates a legitimate CrowdStrike Falcon driver and is using digital certificates from other companies to masquerade as a legitimate program. 
    • “All samples are signed using likely stolen, revoked certificates from Chinese companies,” Cyril François, senior research engineer at Elastic Security Labs, wrote in the blog post. “These certificates are widely known and shared across different malware samples and campaigns but are not specific to this driver.”
  • Per Bleeping Computer,
    • “Two malicious VSCode Marketplace extensions were found deploying in-development ransomware, exposing critical gaps in Microsoft’s review process.
    • “The extensions, named “ahban.shiba” and “ahban.cychelloworld,” were downloaded seven and eight times, respectively, before they were eventually removed from the store.
    • “It is notable that the extensions were uploaded onto the VSCode Marketplace on October 27, 2024 (ahban.cychelloworld) and February 17, 2025 (ahban.shiba), bypassing safety review processes and remaining on Microsoft’s store for an extensive period of time.”
  • Per Trend Research,
    • “Trend Research uncovered new versions of the Albabat ransomware. The development of these versions signifies the ransomware operators’ potential expansion of their targets from Windows to Linux and macOS. Research also reveals the group’s use of GitHub to streamline operations.
    • “Enterprises should remain vigilant against ransomware threats like Albabat as a successful attack can incur reputational damage, operational disruption, and financial losses once threat actors get a hold of and ransom critical data.
    • “To mitigate Albabat ransomware, organizations should have strong access controls for sensitive data, update and patch systems regularly and have proper backups.”
  • Per TechSpot,
    • “Akira, one of the most dangerous ransomware strains floating around the internet, just met its match — an Indonesian programmer armed with cloud computing and sheer determination.
    • “As first reported by TechSpot, Yohanes Nugroho successfully cracked Akira, a multiplatform ransomware that has been wreaking havoc since 2023. Used by cyber criminals to target hundreds of businesses, government agencies, and industries, Akira has helped its developers earn millions.
    • “While this isn’t the first time someone has found a way to break Akira’s encryption, what makes this case remarkable is that Nugroho did it alone — and in just over 10 hours.”

From the cybersecurity business and defense front,

  • NextGov/FCW reports,
    • “Google has moved to expand the security aspects of its cloud offering by agreeing to acquire Wiz in a $32 billion all-cash transaction, the global tech giant’s largest-ever.
    • “Wiz generates roughly $1 billion in annual revenue with FedRAMP-authorized cloud security products in areas such as prevention, active detection and response.
    • “Google sees the addition of Wiz as helping it support more agencies as they look to move their systems into multi-cloud and hybrid cloud environments.
    • “At the same time, software and (artificial intelligence) platforms are becoming deeply embedded across products and operations, bringing new and evolving risks for private enterprises, governments, and other public sector organizations,” Google Cloud CEO Thomas Kurian said in a release.”
  • Dark Reading explains why “Cyber Quality Is the Key to Security. The time to secure foundations, empower teams, and make cyber resilience the standard is now — because the cost of waiting is far greater than the investment in proactive security.”
  • TechTarget offers “13 API security best practices to protect your business. APIs are the backbone of most modern applications, and companies must build in API security from the start. Follow these guidelines to design, deploy and protect your APIs.”
  • Here are links to
    • Dark Reading’s CISO Corner
    • A HelpNetSecurity video about “Pay, fight, or stall? The dilemma of ransomware negotiations”
    • A Cyberscoop podcast in which its editor in chief “Greg Otto talks with FTI Consulting’s Allie Bohan exploring the challenges organizations face in maintaining effective communication during cyberattacks.”
    • The FEHBlog watched the seven-minute-long video and listed to the podcast while drafting this post and he found them worthwhile.

Friday Report

David Ermer–CDC, COVID-19, FDA, NIH, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “President Trump on Thursday issued a presidential memorandum aiming to expand the power of the Office of Personnel Management to fire federal employees, alarming experts and federal employee groups.
    • “The memo, quietly published Thursday night alongside an executive order mandating agencies share data, particularly with Elon Musk’s Department of Government Efficiency, delegates to OPM the authority to fire federal employees based on “post-appointment conduct.”
    • “A federal employee’s appointment occurs at the conclusion of their one-year probationary period, when their full civil service protections kick in. Prior to that point, the Office of Personnel Management has authority to determine whether a federal job applicant or new hire is “suitable” for federal employment, which generally refers to questions of their “character or conduct.”
    • “But once an employee’s probationary period has ended, the authority to discipline or remove an employee rests solely with agency that employs them. Indeed, even if an employee threatens national security, only his or her employing agency may take action to suspend or remove them.
    • “Trump’s memo expands who may remove employees for “conduct and character” reasons to include OPM and tasks the HR agency with writing the regulations governing the agency’s ostensibly new power. Agencies may make referrals to OPM for approval, or the OPM director may reach down and order individual agencies to discipline or fire workers.”
  • Fierce Healthcare informs us,
    • “Former Republican House Representative Michael Burgess, M.D., is a top choice for the White House’s second try at a Centers for Disease Control and Prevention (CDC) director nomination, according to a Reuters report citing three anonymous sources.
    • “One of the sources described Burgess to Reuters as the likely nominee but said that the decision is not yet final. The administration has not yet commented on its next choice for the role.
    • “Burgess, 74, practiced as an obstetrics and gynecology doctor before stepping into Capitol Hill in 2003. He chose not to seek reelection this past year.”
  • Healthcare Finance offers more details on the terrorist threat against hospitals.
    • On March 18, user @AXactual made a post on X with details related to the active planning of a coordinated, multi-city terrorist attack on United States health sector organizations, according to the joint threat bulletin.
    • The terrorist attack on hospitals would reportedly be by ISIS-K, a division of the jihadist group Islamic State, according to The HIPAA Journal. The post was added to the X account of American Kinetix, which claims to be a Christian company in the United States that consists of JSOC (Joint Special OperationsCommand), the CIA and combat veterans, The HIPAA Journal said.
    • American Kinetix said it had received reports of possible pre-attack surveillance at hospitals.” * * *
    • “The primary targets would be mid-tier cities with low-security facilities, the joint threat bulletin said. With the information claiming multiple simultaneous targets, attackers would likely select health sector facilities with visibly weak security and conduct prior planning coordination.” 
  • The American Hospital Association (AHA) News lets us know,
    • “The Drug Enforcement Administration and Department of Health and Human Services yesterday announced that the effective date for the final rule regarding telemedicine prescribing of buprenorphine will be further delayed from March 21 to Dec. 31. The original effective date was Feb. 18 before the first delay to March 21. As outlined in the Jan. 20 White House memorandum announcing the regulatory freeze, the agencies decided to delay the implementation of rules to review any questions of fact, law and policy.
    • “The waiver provisions outlined in the third extension of telemedicine flexibilities for prescribing controlled substances will remain in effect to waive in-person visit requirements through Dec. 31.
    • “Once implemented, the final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation.”
  • STAT News points out,
    • “The Food and Drug Administration cleared Alnylam Pharmaceuticals’ treatment for a progressive heart condition Thursday, setting it up to compete with therapies from BridgeBio and Pfizer.
    • “Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular-related death and hospitalizations. This indication was widely expected among investors and is similar to the indications given for competing therapies.
    • “The treatment, which will be sold under the brand name Amvuttra, was additionally approved to reduce urgent heart failure visits.”
  • BioPharma Dive adds,
    • “Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available for the condition, company executives said Thursday.
    • “The price of the drug, Amvuttra, was revealed on a Thursday evening conference call discussing the Food and Drug Administration’s decision to clear the treatment in people with transthyretin amyloidosis, or ATTR, cardiomyopathy. Alnylam already markets the medicine for people with a form of the condition that affects the nerves but has long looked to an approval in cardiomyopathy as the kind of revenue driver that can help it turn a consistent profit.
    • Alnylam will begin selling Amvuttra as two other treatments, Pfizer’s tafamidis and BridgeBio Pharma’s Attruby, are already accessible. Both tafamidis and Attruby are taken orally, while Amvuttra is injected. Although none of the drugs have been tested directly against another and cross-trial comparisons come with caveats, Amvuttra’s benefits also don’t appear to be clearly superior to its rivals.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for five consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for five consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota CIDRAP reports,
    • “The Texas Department of State Health Services (TDSHS) today reported 30 more cases in a measles outbreak in the western part of the state near the New Mexico border, as the New Mexico Department of health added 4 new cases to its total, pushing the outbreak total to 351.
    • “Meanwhile, as global cases surge, a handful of states reported new cases in people who had connections to international travel. In a weekly update today, the Centers for Disease Control and Prevention (CDC) said it has received reports of 378 cases this year, well past the 285 cases reported for all of 2024. 
    • “The cases are from 18 jurisdictions, and 90% are linked to three outbreaks. The CDC’s update includes the first cases of the year from Kansas, Ohio, and Michigan. Kansas last week reported its first measles infection since 2018, and media reports say at least six cases have been reported in the southwest part of the state in Grant and Stevens counties.”
  • The AP relates,
    • “A common blood test may miss ovarian cancer in some Black and Native American patients, delaying their treatment, a new study finds. It’s the latest example of medical tests that contribute to health care disparities.
    • “Researchers have been working to uncover these kinds of biases in medicine. Recently, the Trump administration’s crackdown on diversity, equity and inclusion has jeopardized such research as universities react to political pressure and federal agencies comb through grants looking for projects that violate the president’s orders.
    • “Native American women have the highest rate of ovarian cancer. Black women with ovarian cancer have lower rates of survival compared to white women. Finding ovarian cancer early can lead to better chances of survival.
    • ‘The new study, supported by grants from the National Cancer Institute and published Thursday in JAMA Network Open, looked at a test called CA-125. The test measures a tumor marker in the blood, and doctors use it to determine if a woman with a suspicious lump should be referred to a cancer specialist.” 
  • Per a National Cancer Institute news release,
    • “When people who smoke are screened for lung cancer, studies have suggested that the screening visit can be an opportune time for health care providers to offer them ways to stop smoking.
    • “Results from a large clinical trial now show that a comprehensive program that integrates intensive counseling and cessation medications may be a particularly effective way of accomplishing that goal.
    • “The study included more than 600 adults who were current smokers. By the end of the 3-month treatment period, nearly 40% of those randomly assigned to participate in an intensive cessation program had quit smoking and had not started up again. In contrast, about 25% of those referred to a tobacco use quitline hit that same benchmark.
    • “The results were published March 1 in JAMA Internal Medicine. 
    • “According to the study’s lead investigator, Paul Cinciripini, Ph.D., of the University of Texas MD Anderson Cancer Center, the findings confirm that when people who smoke are being screened for lung cancer, it “presents a critical opportunity” to support them in quitting. The type of support, however, appears to be particularly important, Dr. Cinciripini said.
    • “Another important takeaway is “the importance of having [dedicated cessation specialists] be a part of [cessation] treatment,” said Carolyn Reyes-Guzman, Ph.D., of NCI’s Tobacco Control Research Branch, which funded the study.” 
  • Per Healio,
    • “Risk for moderate to severe depressive symptoms during pregnancy varied widely across 20 different racial and ethnic groups, suggesting women from different cultural backgrounds view and report depression symptoms differently, data show.
    • “Our study found differences among racial and ethnic subgroups in several aspects of prenatal depression, including the likelihood of receiving a diagnosis and reporting symptoms when screened in prenatal care,” Kendria Kelly-Taylor, PhD, a research fellow with Kaiser Permanente Northern California Division of Research, told Healio. “We found most of the [racial] groups were less likely to have a diagnosis of prenatal care and more likely to report moderate-to-severe depressive symptoms when screened. Previous research provides some possible reasons for these findings, which include differences in how patients in various racial and ethnic subgroups experience symptoms, view their symptoms, and their comfort in discussing them with a clinician or having a diagnosis in their medical record.”
  • HealthDay reports,
    • “The total injury death rate in the United States increased from 2013 through 2021, then declined through 2023, according to a March data brief published by the National Center for Health Statistics.
    • “Sally C. Curtin, from the National Center for Health Statistics in Hyattsville, Maryland, presents trends in injury death rates overall and by three leading intents (unintentional, suicide, and homicide) for 2003 to 2023.
    • “Curtin found that the total age-adjusted injury death rate increased 21 percent from 2013 to 2019 (58.8 to 71.2 per 100,000 standard U.S. population) after a period of stability from 2003 to 2013; there was an additional 25 percent increase through 2021 (89.0), followed by a 4 percent decline through 2023 (85.3). From 2003 to 2019, there was a threefold increase in unintentional drug overdose death rates, followed by a 58 percent increase through 2022 and a 4 percent decline through 2023. From 2006 to 2018, there was an increase in firearm-involved suicide death rates, followed by a decline in 2019 and an increase through 2021; rates remained stable through 2023. The firearm-involved homicide death rate declined from 2003 to 2014, then increased through 2021, and declined through 2023.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Johnson & Johnson JNJ said it is increasing U.S investments to more than $55 billion over the next four years, boosting spending on manufacturing, R&D and technology in a move it says will create jobs and help speed up drug discovery and development.
    • “The healthcare conglomerate said Friday that the investment represents a 25% increase from the previous four-year period.
    • “Part of that will go toward four new manufacturing facilities in the U.S., and the expansion of existing sites, J&J said, adding that it is kick-starting the investment by breaking ground on a North Carolina biologics manufacturing facility on Friday.”
  • Beckers Hospital Review notes,
    • “East Ohio Regional Hospital, a 140-bed healthcare facility in Martins Ferry, has closed, local media outlets reported. 
    • “Signs posted at EORH entrances March 20 said “Hospital closed! Please go to the nearest hospital Trinity, Reynolds or Wheeling!” according to the outlets, including The Intelligencer and NBC and Fox affiliate WTOV.
    • “The closing is the latest chapter for the struggling hospital and comes as workers reported having not received their most recent paychecks. Employees were not paid as scheduled March 7 and said they remained unpaid as of March 20, according to The Intelligencer.”
  • Per Beckers Payer Issues,
    • The healthcare industry needs to have more conversations about patient experience, AI and preventive care, according to payer executives. 
    • Becker’s connected with 25 leaders to learn more about what they say is underdiscussed in healthcare. 
    • The leaders’ observations can be found in the article.

Thursday Report

David Ermer–ACA, CDC, FDA, Generative AI, Government Contracting, HSA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Mark Tegethoff on Unsplash

Happy first day of Spring!

From Washington, DC,

  • Per Becker’s Health IT,
    • The American Hospital Association and Health-ISAC are alerting hospitals to a social media post alleging plans for a coordinated, multi-city terrorist attack on healthcare facilities in the coming weeks.
    • The organizations said they are sharing the information as a precaution and remain in close contact with the FBI. They plan to provide updates as more details emerge, according to a March 20 news release.
    • The AHA and Health-ISAC said there is no information available to corroborate or discount the threat’s credibility.
    • “Generally, foreign terrorist groups do not publicize their upcoming attacks. However, this widely viewed post may encourage others to engage in malicious activity directed toward the health sector, so threats of this nature should be taken seriously,” the news release reads. “Security teams should review emergency management plans and spread awareness of the potential threat internally.”
  • Health Affairs Forefront offers reflections on the 15th anniversary of the Affordable Care Act, which will be marker on March 23, and an idea about how to add high deductible plans with health savings accounts to marketplace plans, which in the FEHBlog’s view is a great idea.
  • The American Hospital Association News tells us,
    • The Equal Employment Opportunity Commission and the Department of Justice yesterday announced the release of two documents warning against unlawful discrimination related to diversity, equity and inclusion in the workplace. A one-pager, “What To Do If You Experience Discrimination Related to DEI at Work,” and a Q&A, “What You Should Know About DEI-Related Discrimination at Work,” are based on Title VII, existing EEOC policy and Supreme Court precedent. 
    • “DEI is a broad term that is not defined in Title VII of the Civil Rights Act of 1964,” the agencies said. “In the past five years, DEI policies, programs, and practices have become increasingly prevalent in many of our nation’s largest and most prominent businesses, universities, and cultural institutions. The widespread adoption of DEI, however, does not change longstanding legal prohibitions against the use of race, sex, and other protected characteristics in employment.”
  • and
    • The Food and Drug Administration today issued an alert on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue.
  • Per an HHS news release,
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of chemical substances that may be present in food and that have the potential to cause harm.”
  • The President today signed an executive order implementing the following policy,
    • “The Federal Government spends approximately $490 billion per year on Federal contracts for common goods and services — the types of goods and services purchased by nearly every executive department and agency (agencies) — making it the largest buyer of goods and services in the world.  As a matter of sound management, these standardized procurement functions should be carried out in the most efficient and effective manner possible for the American taxpayer. The General Services Administration was established in 1949 through the Federal Property and Administrative Services Act, 40 U.S.C. 101 et seq., to provide “an economical and efficient system” for the core procurement services for agencies (40 U.S.C. 101).  It is time to return the General Services Administration to its original purpose, rather than continuing to have multiple agencies and agency subcomponents separately carry out these same functions in an uncoordinated and less economical fashion.”
  • Federal News Network discusses the EO here.
  • Bloomberg Law reports,
    • “The US Agriculture Department is preparing to spend as much as $100 million to combat bird flu by soliciting proposals for new poultry vaccines and virus detection methods.
    • “Officials plan to announce the funding opportunity for companies including vaccine manufacturers on Thursday, according to a USDA email obtained by Bloomberg Government and verified by two congressional staff granted anonymity to discuss the not-yet-public plan. 
    • “The solicitation announcement is expected to seek proposals that prevent, treat, or research bird flu infections, according to the Wednesday email signed by Tucker Stewart, the deputy assistant secretary for USDA’s Office of Congressional Relations.
    • “The money would be the agency’s latest step toward rolling out a $1 billion bird flu response plan that Agriculture Secretary Brooke Rollins announced in February. Rollins has downplayed the role vaccines will play in fighting the virus since announcing the strategy, citing high costs and low effectiveness rates.” 

From the public health and medical research front,

  • NBC News informs us,
    • “Prescriptions for ADHD medications have been spiking in recent years, with the sharpest increase among middle-aged and older women. They’re also the least likely to misuse the prescription stimulants, a new study found.
    • “The rise among women ages 35 to 64 has been substantial. At the end of 2022, 1.7 million women in this age group were prescribed stimulants such as Adderall and Ritalin for ADHD, compared to 1.2 million prescriptions in 2019.
    • “There’s been an overall jump in ADHD prescriptions since the pandemic and the rise of telehealth. The new analysis, published in JAMA Psychiatry by researchers at the National Institute on Drug Abuse, also looked into how the medications are being misused — that is, taking more of the drugs than prescribed, taking them at times that differed from what the doctor ordered or using medication from someone else’s prescription.” 
  • Cardiovascular Business points out,
    • “Using cannabis significantly raises a person’s myocardial infarction risk, even if they are young and otherwise quite healthy, according to the research team behind two new studies. The first is a retrospective analysis that was just published in JACC Advances, while the other is a meta-analysis being presented at ACC.25, the American College of Cardiology’s annual conference. 
    • “Asking about cannabis use should be part of clinicians’ workup to understand patients’ overall cardiovascular risk, similar to asking about smoking cigarettes,” Ibrahim Kamel, MD, clinical instructor at the Boston University Chobanian & Avedisian School of Medicine and the lead author of both studies, said in a statement. “At a policy level, a fair warning should be made so that the people who are consuming cannabis know that there are risks.”
    • “Kamel et al. performed a retrospective study of more than 4.6 million adults 50 years old or younger. All participants were free of significant cardiovascular comorbidities with no prior coronary artery disease. The average follow-up period was more than three years. Overall, the group found that cannabis use significantly increased a person’s risk of a myocardial infarction, ischemic stroke, heart failure and cardiovascular death.”
  • Per Healio,
    • “Markers of subclinical heart damage were observed among individuals who smoke cigarettes, even decades after quitting, according to a study published in the Journal of the American College of Cardiology.
    • “New data from the Cross-Cohort Collaboration-Tobacco Work Group showed that cigarette smoking was associated with elevated markers of inflammation, thrombosis and atherosclerosis, all of which decreased after cessation, except for coronary calcium, which remained elevated 30 years later.
    • “Understanding the mechanisms of smoking-related injury and the most sensitive biomarkers of subclinical harm is critical to clinical trial planning and tobacco regulatory policy, and might be important for planning studies and informing regulatory of new and emerging tobacco products as well,” Michael J. Blaha, MD, MPH, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Cardiovascular Disease at Johns Hopkins Medicine, told Healio. “The degree to which new and emerging tobacco products affect these same biomarkers will need to be explored.”
  • On the bright side, the Wall Street Journal illustrates how “Drug Overdoses Are on the Decline, in Charts. Fatalities from drugs including fentanyl are down from recent peaks.”
  • The AP reports,
    • “Nestle USA is recalling certain batches of its Lean Cuisine and Stouffer’s frozen meals for possible contamination with “wood-like material” after a report of potential choking. 
    • “The recall applies to limited quantities of meals with best-before dates between September 2025 and April 2026. They include Lean Cuisine Butternut Squash Ravioli, Lean Cuisine Spinach Artichoke Ravioli, Lean Cuisine Lemon Garlic Shrimp Stir Fry and Stouffer’s Party Size Chicken Lasagna. The products were distributed to major stores in the U.S. between September 2024 and this month. No products beyond those listed are affected. 
    • “Nestle officials said they are working with the U.S. Food and Drug Administration and the Agriculture Department and investigating the source of the wood-like material. The company said it launched the recall after consumers reported the problem, including at least one potential choking incident.”
  • Per Healio,
    • “Adults with insulin-treated type 2 diabetes had greater HbA1c reductions and larger improvement in time in range with use of an automated insulin delivery system compared with standard care, according to findings from a new trial.”
  • Per BioPharma Dive,
    • “On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene therapy Zolgensma.
    • “The drug, code-named OAV101, shares the same active ingredient as Zolgensma, which in 2019 gained U.S. approval for the treatment of a rare, muscle-wasting illness known as spinal muscular atrophy. Zolgensma, though, is injected into the veins, and is only cleared for use in patients under two years of age. Novartis has spent years trying to show OAV101, which is shot right into the spine, can be a safe and effective therapy for older kids.”

From the artificial intelligence front,

  • STAT News reports,
    • A panel of experts at a leading specialty society announced in a new clinical guideline that they have decided not to decide whether to recommend AI-assisted colonoscopies.
    • “After reviewing studies and using existing information to model outcomes, experts enlisted by the American Gastroenterological Association determined that using AI definitely increases adenoma detection rate (ADR), or colonoscopies that find polyps. But they figure, with low certainty, that using AI in screening only leads to 2 fewer colorectal cancer-related deaths per 10,000 people over 10 years. Citing a close call and fuzzy evidence, the panel decided not to issue a recommendation.”
  • MedTech Dive explains, “Quest, Google team on gen AI; GE Healthcare plans autonomous imaging; GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.” For details read the article.
  • RAND concludes “AI Models Are Skilled at Identifying Appropriate Responses to Suicidal Ideation, but Professionals Still Needed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “GE HealthCare launched its Invenia Automated Breast Ultrasound Premium system Thursday that features artificial intelligence tools.
    • “The system, which has premarket approval from the Food and Drug Administration, is designed to help better detect breast cancer in women with dense breasts.
    • “Detecting breast cancer in this patient population with mammography can be difficult for radiologists because both dense tissue and cancerous masses appear white in images, according to the American Cancer Society.
    • “Automated breast ultrasound produces clearer and more detailed images and has been shown in multiple studies to improve the sensitivity of detecting invasive cancer in dense breasts when used alongside mammography.”
  • and
    • “Post-acute care technology companies Medalogix and Forcura announced their merger Wednesday.
    • “The companies aim to create a platform for streamlining patient care transitions and better connect post-acute care providers to the broader healthcare system. Berkshire Partners, a Boston-based private equity firm, will be the majority owner of the combined company, which is not yet named, according to a news release. Chicago-based private equity firm The Vistria Group will be the largest minority shareholder, the release said.
    • “Financial terms of the deal were not disclosed.”
  • Per Fierce Pharma,
    • “Optum Rx is shifting its payment models to better meet the needs of pharmacies and consumers, the pharmacy benefit manager announced Thursday.
    • “The company said it will shift to a cost-based model, which will better align with “the costs pharmacies may face due to manufacturer pricing actions.” The PBM expects the change to be a positive one for the more than 24,000 independent and community pharmacies it works with, along with its members.
    • “Optum said it will begin to roll out the updated models now and intends to have a full implementation in place by January 2028.”
  • MedCity News lets us know,
    • “Evvy, a women’s health company, is now offering fertility insights through its vaginal microbiome test, the company announced on Tuesday.
    • “New York City-based Evvy is a direct-to-consumer company. Its vaginal microbiome test, starting at $129, checks for bacteria and fungi (or microbes) in people’s vaginas. After taking the test, people receive a report that explains the microbes found in the vagina and the health conditions related to those microbes. Based on the results, consumers receive a customized treatment plan and a one-on-one virtual session with a coach.
    • “Now, the test results include a section on fertility insights. Users of the test receive a “protective score,” which is a measure of protective bacteria like Lactobacillus. This is associated with improved fertility, lower inflammation and better pregnancy outcomes.”
  • Per BioPharma Dive,
    • “Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability to “reset” a patient’s immune system and ward off debilitating inflammatory diseases.
    • “The treatment, dubbed DR-0201, is known as a bispecific myeloid cell engager. It’s designed to engage specific immune cells that can prompt the body to deplete disease-causing B cells. It’s shown promise in preclinical and Phase 1 studies, Sanofi said. 
    • “As part of the deal announced Thursday, Sanofi agreed to pay as much as $1.3 billion more to privately held Dren Bio if DR-0201 succeeds in reaching certain development and launch goals. The French drugmaker expects to take over the DR-0201 program in the second quarter.”

Midweek Report

David Ermer–Congress, FDA, Medical / Rx research, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Govexec informs us,
    • “President Donald Trump on Friday repealed two late-issued Biden regulations and will likely revoke more in the coming weeks. 
    • “The Congressional Review Act enables Congress and the president, if they are in agreement, to overturn by simple majority regulations that were promulgated during the 60 Senate session days or 60 legislative House days before a session of Congress adjourns, whichever is earlier. In this case, Trump and congressional Republicans can use the CRA to override rules finalized on or after Aug. 16, 2024. 
    • “The resolutions, both of which Congress approved with some Democratic support, would:
    • S.J. Res 11, revoke a September Bureau of Ocean Energy Management rule that required oil and gas companies working on the Outer Continental Shelf to submit a report identifying potential archaeological resources on the sea floor that could be affected by such development. 
    • “H.J. Res 35, repeal a November EPA rule specifying requirements under the Methane Emissions Reduction Program, through which the agency charges oil and gas companies for methane and other greenhouse gas emissions if they surpass certain thresholds. 
    • Six other measures to block late Biden rules have been approved in either the House or Senate, including resolutions targeting EPA emission standards for rubber tire manufacturing (H.J. Res 61), IRS reporting requirements for digital asset sales (S.J. Res 3 / H.J. Res 25) and Energy Department conservation standards for consumer gas-fired instantaneous water heaters (H.J. Res 20). 
    • “In total, 57 CRA resolutions have been introduced, according to a tracker from the Center for Progressive Reform. The resolutions’ most frequent target is rules from the EPA.” 
  • Per MedTech Dive,
    • “Monogram Technologies received Food and Drug Administration 510(k) clearance for its mBôS TKA System for total knee replacements and will now work toward commercializing the system, the Austin, Texas-based company said Monday.
    • “Monogram aims initially to place the robot with surgeons who are key opinion leaders in strategic geographies as it establishes clinical experience and demonstrates the platform in real-world settings. It plans to integrate recent upgrades to the robot’s cutting system and other enhancements into the cleared mBôs device over the coming months.”

From the judicial front,

  • Per FiercePharma,
    • “Previously at the epicenter of the U.S. opioid crisis, Purdue Pharma is looking to reenter the public lexicon as a new public benefit company. After a prior bankruptcy settlement was nixed by the Supreme Court, the drugmaker has come back with a new plan that would deliver more than $7.4 billion to its creditors.
    • “The company hopes to emerge from the Chapter 11 bankruptcy process it entered in 2019 with a new reorganization plan, filed Wednesday with the U.S. Bankruptcy Court for the Southern District of New York. The plan lays out more than $7.4 billion in payments to compensate opioid victims and “abate the opioid crisis,” Purdue said in a press release.
    • “That $7.4 billion sum includes available company cash and payments by the Sacklers, the billionaire family who helmed the company until 2019.” * * *
    • “The plan is subject to confirmation by the bankruptcy court, which is expected to hold a hearing in May. After a potential court approval, Purdue would solicit votes to finalize the plan.”

From the public health and medical research front,

  • STAT News reports,
    • “The expanding measles outbreak that has spread from West Texas into New Mexico and Oklahoma could take a year to contain, a public health leader in the area where the outbreak started warned on Tuesday.
    • “Katherine Wells, director of public health for the city of Lubbock, said the outbreak is still growing, with capacity to transmit both locally and further afield through spread to pockets of unvaccinated individuals. Though the response teams have been stressing the importance of vaccination, uptake of vaccines “has definitely been a struggle,” Wells said.”
    • “This is going to be a large outbreak. And we are still on the side where we are increasing the number of cases, both because we’re still seeing spread and also because we have increased testing capacity, so more people are getting tested,” Wells said during a press conference organized by the Big Cities Health Coalition, a forum for leaders of metropolitan health departments. 
    • “I’m really thinking this is going to be a year-long in order to get through this entire outbreak,” she said.”
  • AHA News relates,
    • The U.S. birth rate fell 2% in 2023 to about 3.6 million, according to final data released March 18 by the Centers for Disease Control and Prevention. The cesarean delivery rate increased 1% in 2023 to 32.3%. The preterm birth rate was 10.41%, essentially unchanged from 2022. Medicaid was the source of payment for 41.5% of births, a slight increase from 2022 (41.3%).
  • Health Day adds,
    • “Young American women are greeting the prospect of pregnancy with a decided “meh,” driving down U.S. fertility rates, a U.S. Centers for Disease Control and Prevention (CDC) study says.
    • “The actual number of U.S. births declined by 14% between 1990 and 2023, and the fertility rate went down by 23%, according to a paper in the CDC’s National Vital Statistics Reports.
    • “This drop in fertility occurred mainly among women younger than 30, statistics show.
    • “Women under 30 accounted for 7 in 10 births (70%) in 1990. But by 2023, this age group accounted for less than half of U.S. births (49%).
    • “The sharp drop in births among young women overwhelmed a slight increase in birth rates among women 30 and older, researchers reported.
    • “In summary, the decline in fertility rates over the past few decades results from declining rates among females younger than 30 that are offset somewhat by smaller increases in rates among older women,” the research team led by senior researcher Brady Hamilton of the CDC’s Division of Vital Statistics concluded.”
  • The Washington Post reports,
    • “Pollen seasons are not the same across the United States. Now, a report released Tuesday by the nonprofit Asthma and Allergy Foundation of America shows where allergy sufferers had it the worst last year.
    • “About a quarter of U.S. adults suffer from seasonal allergies — many experiencing itchy and watery eyes, a scratchy throat and an ever-running nose. Pollen exposure is now lasting longer and intensifying nationwide, data shows, as warmer temperatures take over more of the year. But for some areas, the changes are more dramatic.
    • “The report ranks the top 100 largest U.S. cities by how challenging they were for allergy sufferers to live in last year. These “allergy capitals” are based not only on pollen counts, but also on the use of over-the-counter medication and the number of allergy physicians in the area.”
  • MedPage Today points out,
    • “The simple addition of a deadline to a mailed invitation for fecal immunochemical test (FIT) colorectal cancer (CRC) screening resulted in improved return rates, the randomized TEMPO trial showed.
    • “Across eight study arms, the highest return rate was seen with a 2-week deadline without a problem-solving planning tool, with 68% of usable FIT kits returned by 3 months compared with 66% in the control group (no deadline and no planning tool), reported Kathryn Robb, PhD, of the University of Glasgow in Scotland, and colleagues in The Lancet.”
  • Per BioPharma Dive,
    • “Prime Medicine will test its gene editing technology as treatment for a rare liver and lung disorder, revealing on Tuesday plans for a research program in alpha-1 antitrypsin deficiency. 
    • “The company, which is developing “prime editing” as a way to flexibly edit genes without cutting through both strands of DNA, expects to ask regulators next year for permission to begin human testing of the new treatment. 
    • “The program in alpha-1 antitrypsin deficiency, or AATD, is the first new target Prime has picked since significantly paring back its research plans last September. As with other developers of genetic medicines, Prime has faced investor scrutiny on the pace and cost of its research.:

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Cigna has officially sealed the deal on the $3.3 billion sale of its Medicare business to Health Care Service Corporation.
    • “HCSC acquired Cigna’s Medicare Advantage, Part D, supplemental benefits and CareAllies units as part of the deal.
    • “While it will no longer operate the Medicare unit directly, Cigna said it will continue to provide pharmacy benefit management and other services through its Evernorth division, as part of an agreement with HCSC.”
  • Healthcare Dive lets us know,
    • “Optum Rx is moving to eliminate prior authorizations on dozens of drugs, the UnitedHealth-owned pharmacy benefit manager said Wednesday, paring back a key pain point for physicians and patients at a time of widespread discontent with middlemen in the healthcare industry.
    • “Starting May 1, Optum Rx will eliminate reauthorizations — when drugs already being used by a patient need to be reapproved by their plan — for roughly 80 drugs. The program will cut up to 25% of all reauthorizations, or 10% of prior authorizations overall, the PBM said.
    • ‘The drugs included treat high cholesterol, lung disease, multiple sclerosis, migraines and more. Optum Rx said it plans to apply the policy to additional drugs in the future.”
  • The Wall Street Journal reports,
    • “Today was supposed to mark the beginning of the end for cheaper, knockoff versions of hot weight-loss drugs. The Food and Drug Administration wants bulk production of the copycats to stop—starting Wednesday for pharmacy-prepared versions of Zepbound and later in the spring for knockoffs of Ozempic and Wegovy.
    • “But telehealth companies and pharmacies that have fueled wide use of copycats have other plans.
    • “Telehealth platform Hims & Hers Health says it will keep offering pharmacy-made, or compounded, versions of Ozempic and Wegovy tweaked to individual prescriptions. And some of the pharmacies making the GLP-1 drug copycats will continue, according to people familiar with the industry.
    • “The firms are seeking to take advantage of current law, which allows compounding pharmacies to make special, individualized versions of drugs that aren’t available commercially. Telehealth firms and pharmacies instead intend to sell versions of the obesity drugs tailored for specific patients whose doctors say they need a different dosage than one of the original drugs or a version with extra vitamins added. 
    • “A lot of these patients won’t be able to afford switching over to a brand-name medication,” said Dr. Taylor Kantor, a co-founder of Ivim Health, a telehealth platform offering obesity drugs. “We’re trying to make sure those patients aren’t left in the dust.”
  • MedTech Dive tells us,
    • Orthopedic device companies gathered last week in San Diego to demonstrate their latest innovations and discuss industry trends at the American Academy of Orthopaedic Surgeons’ annual meeting.
    • Robotic surgery systems remained a focus at the event, with Stryker showcasing the newest version of its Mako surgical robot and Johnson & Johnson displaying a feature that was cleared for its Velys robot last year, allowing it to be used for partial knee replacements. 
    • Company executives also discussed economic trends, expecting procedure volumes and hospital equipment purchases to remain steady despite financial pressures.
    • [The article includes] four takeaways from the event
  • Fierce Healthcare notes,
    • “Instacart is rolling out multiple features it says will make it easier for users to make healthy choices, headlined by its artificial-intelligence-powered Smart Shop.
    • “The tool seeks to make grocery shopping through the platform more “intuitive,” according to an announcement from the company, while leveraging AI and machine learning to personalize the experience. Users can select from 14 dietary preference options, including gluten-free, low-calorie or pescatarian, to tailor their shopping.
    • “For example, take an individual looking for foods low in carbohydrates. There are many food options that are naturally low-carb, which can make recommendations difficult. Through the AI tech, Smart Shop is able to filter these options and delineate the difference between items that are deliberately chosen to be low in carbs.”

Tuesday Report

David Ermer–Congress, FDA, SDOH, U.S. Healthcare–

From Washington, DC

  • Per HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS) announced today that Secretary Robert F. Kennedy, Jr. renewed the public health emergency declaration addressing our nation’s opioid crisis, which will allow sustained federal coordination efforts and preserve key flexibilities that enable HHS to continue leveraging expanded authorities to conduct certain activities in response to the opioid overdose crisis.
    • “Although overdose deaths are starting to decline, opioid-involved overdoses remain the leading cause of drug-related fatalities,” HHS Secretary Kennedy said. “This Administration is going to treat this urgent crisis in American health as the national security emergency that it is. Renewing the Opioid Public Health Emergency Declaration affirms the Administration’s commitment to addressing the opioid overdose crisis and is one of many critical steps we will take to Make America Healthy Again.”
  • and
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.
    • “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” said HHS Secretary Kennedy. “Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”
    • “The FDA is announcing a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation’s most vulnerable populations.”
  • STAT News reports,
    • “In a last-ditch effort to turn its fortunes around, Anson General [ located in Anson, a West-Central Texas town of roughly 2,300 people] applied to be a Rural Emergency Hospital, a new type of hospital Congress created in 2023 to keep rural hospitals afloat. The government pays these hospitals a fixed sum each month — over $3 million annually — instead of reimbursing them for the inpatient services they provide. Medicare also adds 5% to their payments for outpatient services. For Anson General, those monthly checks of roughly $270,000 have brought it back from the brink. 
    • “And yet, just 38 hospitals have taken up the new designation since 2023, fewer than researchers had predicted. Many of them are hospitals like Anson General, whose leaders felt they had no other choice. 
    • “It would seem to be a stopgap to the hospital closure crisis,” said Brock Slabach, chief operations officer of the National Rural Health Association. “In that sense, I think it’s fulfilling its mandate.” * * *
    • “Becoming a REH means giving up inpatient care. These hospitals still operate emergency rooms and treat patients on an observation basis, which can entail overnight stays, as well as provide outpatient care and operate labs.
    • “For most eligible hospitals, though, the cons outweigh the pros. The biggest downside, several hospital leaders said, is the fact that REHs can’t have swing beds. A swing bed is a hospital bed that can be used to provide both acute care and post-acute rehabilitation. They’re especially important in rural communities, which don’t always have nursing homes or rehabilitation facilities. In those areas, patients travel elsewhere for surgeries and return to swing beds in their local hospitals to recover and receive occupational or physical therapy. 
    • “U.S. Sens. Jerry Moran (R-Kan.), and Tina Smith, (D-Minn.), introduced a bill dubbed REH 2.0 that would make several tweaks to the designation, including allowing the hospitals to have swing beds, though it wouldn’t make them eligible for 340B discounts.” 
  • Reuters lets us know,
    •  The U.S. Food and Drug Administration (FDA) issued a warning on Friday, advising consumers against inhaling products containing nitrous oxide, commonly known as ‘laughing gas,’ due to potentially serious side effects, including death.
    • Nitrous oxide is an odorless, colorless gas that leads to euphoria, relaxation, and dissociation from reality when inhaled.” * * *
    • “It is available in compact, affordable cartridges that are easily accessible and sold under various brand names, including Galaxy Gas, Baking Bad, and Miami Magic.
    • “The FDA cautioned against the improper use of these products in any canister, tank, or charger size, as misuse could result in severe health issues, including blood clots, loss of consciousness, paralysis, psychiatric disorders, and even death.”

From the public health and medical research front,

  • Health Day tells us,
    • “Nearly 1 in 3 children live with a chronic condition that could significantly affect their health for the rest of their lives, a new study says.
    • “Chronic illnesses affected more than 30% of children ages 5 to 17 by 2018, up from around 23% in 1999, researchers report in the journal Academic Pediatrics.
    • “This adds up to about 130,000 more children each year being diagnosed with a chronic illness.
    • “This increase has been driven by diagnoses of ADHD/ADD, autism, asthma, prediabetes and mood disorders like depression or anxiety, lead researcher Lauren Wisk, an assistant professor of medicine at the David Geffen School of Medicine at UCLA, said in a news release.”
  • Health Leaders offers “Social Determinant of Health Considerations for CMOs.”
  • Healio relates,
    • “Women with chronic pelvic pain disorders who engaged in moderate to vigorous physical activity had improved mental health scores vs. those who did not, according to study results published in the Journal of Pain Research.
    • “Moderate to vigorous intensity physical activity could be a beneficial way for patients who have a chronic pelvic pain disorder to manage their overall mental health,” Ipek Ensari, PhD, assistant professor in the department of artificial intelligence and human health at the Icahn School of Medicine at Mount Sinai, told Healio. “This seems to be a consistent effect, because even after we adjusted for things like physical pain, physical function and pre-existing psychiatric diagnoses, we still saw this positive significant association between physical activity, behavior and their mental health and well-being at each week as we looked at the results.”
  • Sadly, BioPharma Dive reports,
    • A young man with Duchenne muscular dystrophy has died following treatment with Sarepta Therapeutics’ gene therapy Elevidys, the company said Tuesday.
    • In a short statement, Sarepta said the patient suffered acute liver failure after receiving Elevidys, the only approved gene therapy for the disease. Liver damage is a known risk of treatment with Elevidys as well as other gene therapies that are built around a type of modified virus. The death is the first reported among the more than 800 people in clinical testing and commercially who been treated with the therapy, however.
    • “According to Sarepta, testing showed the patient had a recent infection with cytomegalovirus, a common virus that for most people doesn’t cause symptoms but can lead to serious health issues in those with weakened immune systems. A treating physician cited the infection as a “possible contributing factor” to the death, as cytomegalovirus can infect and damage the liver, leading to hepatitis.
    • “The company reported the death to study investigators, physicians and health authorities. It plans to update Elevidys’ prescribing information to “appropriately represent the event.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “DispatchHealth Tuesday announced a definitive agreement to acquire Medically Home, which would create one of the nation’s largest providers of home-based healthcare services.
    • “The combined company would offer an array of home-based medical services, including urgent care, acute-level care and skilled nursing to patients in 50 metropolitan markets across 23 states and the District of Columbia, with approximately 2,200 employees.
    • “Neither company would disclose financial terms of the deal, which is expected to close by the middle of the year, pending regulatory approval.”
  • and
    • “Patina Health rolled out a new program Tuesday that will provide expanded home-based care to Medicare Advantage members.
    • “The Bala Cynwyd, Pennsylvania-based company said Patina Total Health will provide health assessments, medication management, primary care, urgent care and behavioral health services to older adults in their homes through in-person and telehealth visits. Patina Health is launching the new initiative later this week with a national insurer in Charlotte, North Carolina, the company said in a news release. The company did not disclose the name of the insurer but hopes to ultimately work with multiple Medicare Advantage plans.”
  • and
    • “GE HealthCare announced on Tuesday that it is partnering with Nvidia to work on autonomous X-ray and ultrasound scanners that will leverage artificial intelligence-enabled software to capture and analyze medical images.
    • “The company is developing the technology to help ease the burden of rising patient volumes and staff shortages on healthcare professionals, Roland Rott, president and CEO of imaging at GE HealthCare, said in a news release.”
  • Per Fierce Healthcare,
    • Food delivery and engagement company FarmboxRx will launch Drivers Health, a social determinants of health (SDOH) product line for health plans to better serve their members.
    • FarmboxRx combines food as medicine with health literacy to drive member behavioral change, most notably for members living in food deserts. Drivers Health, starting in June, will act as a care management intervention to connect members to underutilized benefits through food deliveries, founder and CEO Ashley Tyrner-Dolce said in an interview with Fierce Healthcare.
    • “We’ve always had health literacy in the box,” she said. “What Drivers Health is built around is connecting to that care … where we take on that care management piece for the health plan through our member contact center.”
    • “Drivers Health will be an additional product line offered to plans with Medicare, Medicaid and duals members. Many people make difficult financial decisions, having to choose between paying a bill, buying food or refilling a medication. Yet members often don’t realize the full scope of benefits available to them unless there is adequate outreach, said Tyrner-Dolce. These benefits can include transportation, utility or mail-order pharmacy perks.”

Monday Report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg Law reports,
    • “Mehmet Oz, President Donald Trump’s nominee to lead the Centers for Medicare & Medicaid Services, used his Senate confirmation hearing Friday to tout the benefits of artificial intelligence to help streamline the prior approval process for Medicare managed care plans.
    • “But consumer policy watchers were immediately leery, noting the string of recent legal challenges stemming from AI-influenced coverage denials by Medicare Advantage plans.
    • “We are very concerned that increasing the use of AI will only make the prior authorization situation worse,” Alice Bers, litigation director at the Center for Medicare Advocacy, said in a statement.” * * *
    • “Sen. Tina Smith (D-Minn.) expressed similar concerns about lawsuits against MA insurers alleging use of AI to determine length of hospital stays and to deny claims. “This is a big concern,” Smith told Oz. “My view is that a human needs to have a final say in these decisions.”
    • “Oz said he agreed with Smith about the need for humans to make final coverage decisions. But Oz maintained that he thinks “AI can play a vital role in accelerating pre-authorization.”
    • “He also said the CMS should be using AI to identify insurers that are misusing the technology.”
  • Beckers Hospital Review adds,
    • “CMS will not change the Biden administration’s plan to negotiate prices for 15 previously named prescription drugs, and the agency’s next potential leader says he will defend the program in court.
    • “In January, CMS selected Ozempic, Rybelsus, Wegovy, Trelegy Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Breo Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, and Otezla to be included in the second round of negotiations aimed at reducing drug costs for Medicare beneficiaries. 
    • “On March 14, CMS said it had signed agreements with manufacturers, who will now participate in meetings and roundtables throughout 2025 to negotiate maximum fair prices for the 15 drugs, with final agreements due by Nov. 1.
    • “Mehmet Oz, MD, President Donald Trump’s pick for CMS administrator, told the Senate Finance Committee March 14 he would defend the negotiation program in court.
    • “It’s the law. I’m going to defend it and use it,” he said, adding that it is one of multiple approaches he would pursue to lower drug costs.
    • “The selected drugs account for approximately $41 billion in total spending under Medicare Part D between November 2023 and October 2024, or about 14% of Medicare Part D’s prescription drug costs, according to CMS. The negotiated prices for the drugs will take effect in 2027.”
  • HUB International tells us,
    • “Following on the enactment late last year of two bills to simplify employer reporting under the Affordable Care Act (“ACA”), the IRS has now released its first bit of guidance in the form of Notice 2025-15. The notice provides guidance on how employers can avoid providing individual Forms 1095-C to their employees. Perhaps unsurprisingly, it essentially piggybacks on existing guidance that applies to insurance carriers and other coverage providers.”
  • STAT News adds, “FTC highlights new concern over ‘pay-to-delay’ deals that determine when generics are sold. The agency noted restrictions on how many drugs a generic company may sell as part of a patent settlement.”
  • Per MedTech Dive,
    • “The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines.
    • “The letter said the disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
    • “The FDA linked to a letter B. Braun sent to customers in January. B. Braun said “additional supply and labor constraints over the holidays” had reduced production and it would run out of product on Jan. 20.”
  • Per Fierce Pharma,
    • “A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.
    • “The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls.” 

From the judicial front,

  • A panel of the U.S. Court of Appeals for the Ninth Circuit denied the Justice Department’s request for an immediate stay of the lower court’s decision to reinstate terminated probationary employees from six federal agencies. The panel set a briefing schedule on the Justice’s Department’s underlying motion to stay.
  • Bloomberg Law reports,
    • “Walmart Inc. is suing many of the nation’s largest pharmaceutical companies, alleging they colluded to inflate the price of hundreds of generic drugs and caused the retailer to pay more for the medications than it should have.
    • “Mylan Inc., Teva Pharmaceuticals USA Inc., and Glenmark Pharmaceuticals Inc. are among the defendant companies that exchanged drug price points and bid information as part of a conspiracy that specifically targeted Walmart, according to a nearly 700-page complaint filed Friday in the US District Court for the Eastern District of Pennsylvania.
    • “Walmart is one of the largest pharmacy providers in the US, purchasing hundreds of millions of dollars of prescription drugs every year. 
    • “The suit adds to similar cases against pharma companies brought by independent pharmacies, hospitals, and federal and state law enforcers.”
    • “The case is Walmart v. Actavis Elizabeth LLC, E.D. Pa., No. 2:25-cv-01383, 3/14/25″ 

From the public health and medical research front,

  • The Washington Post reports,
    • “By 2050, there will be an estimated 25.2 million people living with Parkinson’s disease worldwide, a 112 percent increase from 2021, according to a new study published in the journal BMJ.
    • “The World Health Organization estimated that 8.5 million people worldwide were living with Parkinson’s disease in 2019.
    • “Researchers used data from the 2021 Global Burden of Disease Study, pulling information from 195 countries and territories. They identified aging and population growth as the main contributors to the projected increase in Parkinson’s numbers, noting that growth rates would differ at regional and national levels.”
  • The American Medical Association lets us know what doctors wish their patients knew about pertussis.
  • MedPage Today tells us,
    • “A probiotic mixture reduced fever duration by 2 days versus placebo among children with upper respiratory tract infections.
    • “Probiotics have emerged as a new potential approach to managing infectious diseases.
    • “Adverse events were mild, and did not significantly differ between the two groups.
  • and fills us in on which adults need a measles booster in the U.S.
  • Beckers Hospital Review identifies the “10 most, least overweight and obese cities in the U.S.”
    • “McAllen, Texas, topped WalletHub’s 2025 ranking of the most overweight and obese cities in the U.S., published March 17, while Honolulu is the healthiest-weight city.”
  • Per a press release,
    • “The National Institute of Standards and Technology (NIST) has released a human stool reference material that will help scientists accurately measure the gut microbiome. The initiative aims to speed progress in a cutting-edge field of medical research targeting some of humanity’s most serious and intractable diseases.
    • “The human gut microbiome is a rich, teeming ecosystem of microorganisms and their byproducts that line the human gastrointestinal tract. Over the last decade, scientists have linked activity in the gut microbiome to obesity, diabetes, mental illness, cancer and other medical conditions. Researchers believe that a new class of drugs targeting the gut microbiome can treat many of these conditions.”
  • Per National Institutes of Health news releases,
    • “Surgical removal of enlarged tonsils and adenoids in children with mild sleep-disordered breathing (SDB) appears to significantly reduce the frequency of medical office visits and prescription medicine use in this group, according to a clinical study supported by the National Institutes of Health (NIH). The findings, published in JAMA Pediatrics, show that the surgery, called adenotonsillectomy, was tied to a 32% reduction in medical visits and a 48% reduction in prescription use among children with a mild form of the condition.”
  • and
    • In a preclinical study, rodents treated with uric acid showed improved long-term outcomes after acute ischemic stroke. The findings suggest that the treatment may work as an add-on therapy to standard stroke treatments in humans. The study was funded by the National Institutes of Health (NIH) and published in Stroke.
  • Consumer Reports, writing in the Washington Post, informs us about “Everything you need to know to keep your teeth healthy. Toothpaste matters, and you might want to consider adding a tongue scraper to your routine.”
  • Per BioPharma Dive,
    • “An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with several types of blood cancer by helping avert a potentially dangerous side effect. 
    • “According to clinical trial results announced by Orca on Monday, about three-quarters of people treated with the company’s T cell immunotherapy did not experience moderate-to-severe chronic graft-versus-host disease through one year, compared to only 38% of those given the standard transplant. 
    • “Graft-versus-host disease, or GvHD, is a serious complication of transplants involving cells sourced from matched donors. Orca aims to develop its therapy, which uses a purified mix of donor-derived T cells and stem cells, as a safer transplant alternative in cancers like acute myeloid leukemia.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Median hospital margins remained stable to kick off 2025, as many reported higher service volumes and expenses.
    • “Kaufman Hall’s “National Hospital Flash Report” revealed January median operating margins hit 4.4%, up from 3.7% in December and 0.6% last January. Without allocations, the median operating margin grew to 8%, a 12-month high. the averages are based on data from more than 1,300 hospitals and gathered by Strata Decision Technology. 
    • “January was a relatively stable month for hospitals, as more people received care due in part to seasonal challenges like flu and other respiratory diseases. Hospitals are also experiencing more rapid revenue growth from inpatient than outpatient services. Expenses are also rising, driven primarily by drug costs, though the rate of cost growth has slowed,” said Erik Swanson, managing director and group leader, data and analytics, of Kaufman Hall.”
  • Fierce Healthcare notes,
    • “Highmark Health reported $29.4 billion in revenue and $50 million in net income for 2024 as the organization continues to weather notable headwinds that have battered health insurers.
    • “Highmark also posted $209 million in operating losses, according to its earnings report released last week. The full year results “reflect the negative operating performance of Highmark Health Plans,” the company said in a press release, as the team faced cost pressures throughout the year.
    • “United Concordia Dental and HM Insurance Group, the company’s stop-loss division, were bright spots with steady performance. Highmark said that trend was backed by growing dental membership and a disciplined pricing approach.
    • “Its health system, Allegheny Health Network, also saw improvements as patient volumes increased across “all delivery areas.”
    • “While our consolidated revenue improved, we continue to face significant industry headwinds and medical cost trends, including high costs for prescription drugs, especially GLP-1s, the impact of Medicaid redeterminations and nationwide high utilization, especially within the Medicare Advantage portfolio,” said Carl Daley, chief financial officer and treasurer of Highmark Health.” 
  • Fierce Pharma points out “the top 10 drugs losing US exclusivity in 2025.”
    • “While each year features high-profile losses of exclusivity in the pharma industry, this year’s list is something of a doozy.”
  • The Wall Street Journal reports,
    • “Pfizer PFE had a problem. Doctors weren’t prescribing its migraine drug Nurtec because they assumed insurance coverage would be too much of a hassle.
    • “So last year the company created a phone line for doctors and patients to call Pfizer directly for help. Pfizer now credits that and other changes for a 31% increase in Nurtec’s U.S. sales last year.
    • “The beleaguered drugmaker’s shares still haven’t recovered from their post-Covid slump, and shareholders are wary. But sales of products such as Nurtec and the vaccine Abrysvo that the company has been counting on are rising, and an activist shareholder’s push has lost steam. 
    • “Pfizer did it by shaking up its U.S. sales strategy, shifting where it deploys its sales representatives, how they market to doctors and how the company helps patients pay for their prescriptions.”
  • Per Modern Healthcare,
    • “Scripps Health plans to build a $1.2 billion medical campus that will include a 200- to 250-bed hospital and outpatient facilities.
    • “The San Diego-based health system’s board last week approved the 13-acre development in San Marcos, California. The first phase of the project will feature space for specialty and primary care offices, ambulatory surgery, cancer care, imaging, lab and other services, and the second phase includes the hospital, according to a Monday news release.
    • “The outpatient center will be built in two to three years, and the hospital will take about six years, a spokesperson estimated.”
  • and
    • “Sharon Regional Medical Center is set to reopen Tuesday, about two months after the former Steward Health Care facility in Pennsylvania closed.
    • “On Friday, the Pennsylvania Department of Health approved Pasadena, California-based Tenor Health Foundation’s plans to reopen the 163-bed hospital. In January, Judge Christopher Lopez of the U.S. Bankruptcy Court for the Southern District of Texas in Houston signed off on the hospital management company’s takeover of the facility, which employed more than 800 workers“
  • From BioPharma Dive,
    • “AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.
    • “The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.”

Weekend Update

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

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump signed the wrapup spending bill for fiscal 2025 on Saturday, heading off a partial government shutdown that would have begun to be felt on Monday when federal agencies are scheduled to open for business.
    • “The six-month stopgap measure, which funds government programs through Sept. 30, cleared the Senate on Friday after enough Democrats crossed the aisle to vote to end debate, defying intense pressure from the left wing of their party. The deadline for Trump’s signature was technically midnight, but shutdown procedures don’t typically begin until the workweek starts.”
  • Here’s a link to the American Medical Association’s view of last week’s MedPAC report to Congress.
    • “Endorsing a stabilizing approach to Medicare reform, the Medicare Payment Advisory Commission (MedPAC) recommended today that Congress link next year’s physician payment update to the growth in the cost of providing care.
    • “The recommendation comes just as Congress failed this week to prevent this year’s 2.8 percent cut, marking the fifth consecutive year of cuts. 
    • “With exquisite timing, MedPAC has highlighted how Congress can strengthen Medicare policy. With uncertainty surrounding the continuing resolution, the report offers a roadmap to Congress on how to address the cuts,” said American Medical Association President Bruce A. Scott, M.D. “The AMA appreciates commissioners and staff for listening to physicians around the country.”

From the judicial front,

  • Bloomberg Law reported last Friday night,
    • “The Trump administration filed an emergency motion Friday asking a federal appeals court to immediately pause an order from a San Francisco judge requiring six cabinet agencies to rehire thousands of terminated employees.
    • “The petition asks the US Court of Appeals for the Ninth Circuit, the largest appeals court in the country, to issue an order on Friday temporarily blocking a preliminary injunction from Judge William Alsup while the case proceeds through the appeals process.
    • “The judge, who sits on the US District Court for the Northern District of California, on Thursday ordered the departments of Defense, Veterans Affairs, Energy, Interior, Agriculture, and Treasury to rehire the probationary employees who were laid off in early February at the direction of the Office of Personnel Management.
    • “The government also filed a notice of appeal on Friday to the Fourth Circuit in a second case that reinstated probationary workers. A Maryland federal judge on Thursday ruled in that case that 18 different federal agencies must rehire the workers.”
  • Govexec adds in a report posted last night,
    • “The Trump administration appears to be preparing to comply with multiple court orders to quickly place tens of thousands of federal workers fired during their probationary periods, according to officials at three agencies briefed on the plans. 
    • “The recently hired, or in some cases recently promoted or transferred, employees will not immediately go back to their jobs but instead be placed on paid administrative leave. The employees are impacted by two separate court rulings issued on Thursday, which could lead to different outcomes for different workers.”

From the public health and medical research front,

  • The Washington Post reports,
    • “How old are your organs? The answer might not match your chronological age — and a new analysis finds that an organ’s biological age might predict a person’s risk of diseases such as cancer, dementia and heart disease.
    • “The research, published in the Lancet Digital Health, analyzed data from Whitehall II, a long-running British study of aging that has followed over 10,000 British adults for more than 35 years. Between 1997 and 1999, the Whitehall study took blood plasma samples from participants when they were 45 to 69 years old.
    • “The current study analyzed those blood samples as well as follow-up data for 6,235 Whitehall participants, who were by then ages 65 to 89. The researchers used the analysis to help measure the gap between a person’s age and the biological age of nine of their organs: heart, blood vessels, liver, immune system, pancreas, kidneys, lungs, intestines and brain. Then they looked at follow-up data that showed the kinds of diseases participants developed as they aged over the next two decades.
    • The organs aged at different rates in different people and even within the body, the researchers write — and those with “fast-aging” organs had an increased risk of 30 of the 45 age-related diseases studied.” * * *
    • “The researchers say the study shows the promise of an organ-specific blood test, which is simpler than past methods.”
  • The Post also offers “The good news about anxiety. In the right amount, anxiety can heighten focus and detail orientation. It also spurs creativity and motivates us to problem-solve.”
  • The Wall Street Journal delves into “Generation Xanax: The Dark Side of America’s Wonder Drug. Amid rising concerns about benzodiazepines, some patients who try to quit are suffering extreme anxiety, memory loss and intense physical pain.”
  • Medscape tells us,
    • “Glucagon-like peptide 1 receptor agonists (GLP-1RA) are linked to a 54% lower risk for developing hematologic cancers than insulin in patients with type 2 diabetes (T2D). The medication shows particular effectiveness in reducing risk for myelodysplastic syndromes and myeloproliferative neoplasms vs metformin.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “A new breed of drug middlemen are pushing an unusual cost-saving strategy that lets their employer clients tap a federal program meant for hospitals that serve the poor.
    • “The government program, known as 340B, allows hospitals that care for many uninsured and low-income patients to purchase outpatient medicines at steep discounts. Hospitals can pocket the savings, but they can also choose to pass the discounts on to patients at their pharmacies.
    • Companies such as Rescription, MakoRx and Liviniti are selling pharmacy-benefit plans that save employers money by funneling workers to those 340B hospital pharmacies instead of traditional drugstores. The workers get the discounted 340B price under these plans. Hospitals participate because it expands their customer base and they receive fees for dispensing prescriptions, the companies say.
    • “The companies count some of the participating hospitals among their clients, providing benefits for hospital workers. They say they are hoping to change the business of pharmacy-benefit managers, or PBMs, which traditionally negotiate prices for their clients with drugmakers and demand rebates to cut net costs.”

Cybersecurity Saturday

David Ermer–Cybersecurity, OPM–

From the cybersecurity policy and law enforcement front,

  • Federal News Network lets us know,
    • “A former Energy Department and National Security Council official has been tapped to lead the Cybersecurity and Infrastructure Security Agency [CISA].
    • “President Donald Trump today [March 11, 2025,] formally nominated Sean Plankey to serve as director of CISA. Plankey’s name was included among a slew of nominations sent to the Senate.
    • “During Trump’s first term, Plankey served as principal deputy assistant secretary for Energy’s Office of Cybersecurity, Energy Security and Emergency Response, known as “CESER,” which leads cyber preparedness in the energy sector. He also served on Trump’s National Security Council as director for maritime and Pacific cybersecurity policy.”
  • Per a March 12, 2025, CISA news release,
    • CISA’s Red Team is among the best in the world and remains laser focused on helping our federal and critical infrastructure partners identify and mitigate their most significant vulnerabilities and weaknesses. This has not changed.
    • Contrary to inaccurate reporting, CISA has not “laid off” our Red Team. CISA has taken action to terminate contracts where the agency has been able to find efficiencies and eliminate duplication of effort. As good stewards of the taxpayer dollar and in accordance with good fiscal governance practices, CISA regularly reviews contracts across the agency to ensure that we have the capabilities that we need and that we are allocating resources in ways that make the most impact. This was a contract action that did not impact the employment status of CISA personnel.  
    • CISA’s Red Teams continue their work without interruption. The team works directly with network defenders, system administrators, and other technical staff to address strengths and weaknesses across critical infrastructure networks and systems. They continue to assist organizations in refining their detection, response, and hunt capabilities to protect the nation’s critical infrastructure from a range of threats.
  • Dark Reading offers context for this release.
  • The National Institute of Standards and Technology announced on March 12, 2025,
    • “The comment period for [draft] NIST Special Publication 1308, NIST Cybersecurity Framework 2.0: Cybersecurity, Enterprise Risk Management, and Workforce Management Quick Start Guide is open through April 25, 2025, at 11:59 PM.”
  • Fedscoop tells us,
    • “Ethan Klein, an emerging technology policy adviser during the first Trump administration, has been nominated to be the White House’s chief technology officer, the Office of Science and Technology Policy confirmed Tuesday. 
    • “After serving in the first Trump White House, Klein completed a PhD in nuclear science and engineering at MIT, where he worked to develop nuclear tech for arms control and nonproliferation with funds from a fellowship through the National Nuclear Security Administration.” 
  • and
    • An Office of Personnel Management watchdog investigation into cybersecurity risks on government networks and the potential exposure of sensitive information will include an examination of DOGE access to those systems.
    • OPM’s Office of Inspector General said in a letter to Democrats on the House Oversight Committee that it would incorporate “parts” of the lawmakers’ February request to probe DOGE’s unauthorized accessing of IT networks and Americans’ data into “existing work.” The watchdog also said it had “initiated a new engagement on specific emerging risks at OPM that are related to issues raised” in Democrats’ letter.
  • Dark Reading relates,
    • “A dual Russian-Israeli citizen working as one of LockBit ransomware group’s lead developers has been extradited from Israel to the US. Rostislav Panev, 51, was arrested in 2023 and had his first US court appearance on March 14.
    • “According to the complaint against him, Panev was a developer for LockBit ransomware group from 2019 to at least February 2024. The ransomware group attacked more than 2,500 victims in 120 countries, 1,800 of them in the US. Victims ranged from individuals to small businesses and even multinational corporations that included nonprofit organizations, educational institutions, hospitals, and critical infrastructure. In targeting them, LockBit was able to garner at least $500 million in ransom payments and cause billions of dollars in losses.”

From the cybersecurity vulnerabilities and breaches front,

  • Security Week reports on March 10, 2025,
    • “More than 560,000 people were impacted across four data breaches disclosed last week to authorities by the healthcare organizations Hillcrest Convalescent Center, Gastroenterology Associates of Central Florida, Community Care Alliance, and Sunflower Medical Group.”
  • CISA added thirteen known exploited vulnerabilities to its catalog this week:
    • March 10, 2025
      • CVE-2025-25181 Advantive VeraCore SQL Injection Vulnerability
      • CVE-2024-57968 Advantive VeraCore Unrestricted File Upload Vulnerability
      • CVE-2024-13159 Ivanti Endpoint Manager (EPM) Absolute Path Traversal Vulnerability
      • CVE-2024-13160 Ivanti Endpoint Manager (EPM) Absolute Path Traversal Vulnerability
      • CVE-2024-13161 Ivanti Endpoint Manager (EPM) Absolute Path Traversal Vulnerability
        • NIST discusses the Advantive CVEs here and here
        • Cybersecurity Dive discusses the Ivanti CVEs here.
    • March 11, 2025
      • CVE-2025-24983 Microsoft Windows Win32k Use-After-Free Vulnerability
      • CVE-2025-24984 Microsoft Windows NTFS Information Disclosure Vulnerability
      • CVE-2025-24985 Microsoft Windows Fast FAT File System Driver Integer Overflow Vulnerability
      • CVE-2025-24991 Microsoft Windows NTFS Out-Of-Bounds Read Vulnerability
      • CVE-2025-24993 Microsoft Windows NTFS Heap-Based Buffer Overflow Vulnerability
      • CVE-2025-26633 Microsoft Windows Management Console (MMC) Improper Neutralization Vulnerability
        • Cyberscoop discusses these CVEs here.
    • March 13, 2025
      • CVE-2025-24201 Apple Multiple Products WebKit Out-of-Bounds Write Vulnerability
      • CVE-2025-21590 Juniper Junos OS Improper Isolation or Compartmentalization Vulnerability
        • Cyberscoop discusses the Apple CVE here.
        • Cybersecurity Dive discusses the Juniper CVE here.

From the ransomware front,

  • Cybersecurity Dive reports,
    • “The Medusa ransomware gang has infected more than 300 organizations in critical infrastructure sectors such as the medical, manufacturing and technology industries.
    • That’s according to a joint cybersecurity advisory published Wednesday by CISA, the FBI and the Multi-State Information Sharing and Analysis Center (MS-ISAC). The agencies noted that Medusa — which is not connected to MedusaLocker ransomware — has been active since 2021 and initially began as a closed ransomware operation.
    • “While Medusa has since progressed to using an affiliate model, important operations such as ransom negotiation are still centrally controlled by the developers,” the [March 12, 2025,} advisory said. “Both Medusa developers and affiliates — referred to as ‘Medusa actors’ in this advisory — employ a double extortion model, where they encrypt victim data and threaten to publicly release exfiltrated data if a ransom is not paid.”
  • and
    • “A newly discovered ransomware strain, tracked as SuperBlack, has been used in a series of attacks targeting critical vulnerabilities in Fortinet since late January, according to a report by Forescout Research-Vedere Labs.
    • “The attacks involved exploitation of two vulnerabilities, CVE-2024-55591 and CVE-2025-24472, which can allow unauthenticated attackers to gain super admin privileges on FortiOS firewalls. 
    • “Researchers link the attacks to a threat actor — tracked as Mora_001 — that has operational overlaps with LockBit ransomware operations.
       
  • and
    • “About six of every 10 ransomware claims in 2024 involved the compromise of a perimeter security device such as a virtual private network or firewall, according to the Coalition Cyber Threat Index report released Tuesday [March 11, 2025]. In two of every 10 cases, remote desktop protocols were exploited for initial access. 
    • “Stolen credentials served as the initial access vectors in almost half of the cases, while software vulnerabilities were exploited in about three of every 10 cases. 
    • “Two thirds of businesses had at least one internet-exposed web login panel at the time they applied for cyber insurance policies, according to the report. The cyber insurance provider said it detected more than 5 million exposed remote management solutions and tens of thousands of exposed login panels.”
  • Dark Reading points out,
    • “A recent analysis of a year’s worth of chat logs from the infamous Black Basta ransomware group revealed that its members used nearly 3,000 unique credentials to attempt to compromise a variety of corporate networks.
    • “The top five uses of the credentials? Targeting remote-desktop software and virtual private networks (VPNs), according to threat intelligence firm KELA, which published its analysis of the chat logs last week.
    • “From Microsoft’s Remote Desktop Web Access to Palo Alto’s Global Protect and from Cisco’s VPN services to general remote login portals, stealing credentials to target remote access is perhaps the most popular technique used by ransomware groups. Once compromised, such services can be used as gateways to the corporate networks and quickly lead to data exfiltration and eventual ransomware deployment, says Irina Nesterovsky, chief research officer for KELA.
    • “Obtaining such credentials and successfully accessing those platforms — either due to lack of MFA or bypassing it — allows the actors a foothold into an organization’s network, which they can then further expand using different tools and reconnaissance,” she says. “KELA observed the Black Basta ransomware actors discussing the sourcing of specifically login credentials to VPN and remote access portals in the context of a ransomware operation — it is very clear what such credentials are abused for.”
  • Bleeping Computer adds,
    • “The Black Basta ransomware operation created an automated brute-forcing framework dubbed ‘BRUTED’ to breach edge networking devices like firewalls and VPNs.
    • “The framework has enabled BlackBasta to streamline initial network access and scale ransomware attacks on vulnerable internet-exposed endpoints.
    • “The discovery of BRUTED comes from EclecticIQ researcher Arda Büyükkaya following an in-depth examination of the ransomware gang’s leaked internal chat logs.”
  • Per Security Affairs,
    • “Microsoft observed a North Korea-linked APT group, tracked as Moonstone Sleet, deploying Qilin ransomware in limited attacks since February 2025. The APT group uses Qilin ransomware after previously using custom ransomware.
    • “Moonstone Sleet has previously exclusively deployed their own custom ransomware in their attacks, and this represents the first instance they are deploying ransomware developed by a RaaS operator.” Microsoft wrote on X.
    • “In May 2024, Microsoft observed the North Korea-linked group “Moonstone Sleet” (Previously tracked as Storm-1789) using known and novel techniques like fake companies, trojanized tools, a malicious game, and custom ransomware for financial gain and espionage.
    • Storm-1789, initially linked to other North Korean threat groups, has since adopted unique tactics, tools, and attack infrastructure.
    • “Moonstone Sleet threat actors target financial and cyberespionage victims using trojanized software, custom malware, malicious games, and fake companies like StarGlow Ventures and C.C. Waterfall to engage victims on LinkedIn, freelancing sites, Telegram, and email.”

From the cybersecurity defenses front,

  • Dark Reading explains why “Healthcare organizations must enhance their cybersecurity arsenal. Doing so can help them prevent financial, compliance, and reputational damage.
  • Here’s a link to Dark Reading’s CISO Corner.

Happy Pi Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “The Senate March 14 approved by a vote of 54-46, a continuing resolution to fund the government through Sept. 30. The House passed, by a vote of 217-213, the bill earlier in the week. President Trump is expected to sign the measure.
    • “The bill extends certain key health care provisions that were set to expire at the end of March, including eliminating Medicaid disproportionate share hospital cuts, and extending the enhanced low-volume adjustment and Medicare-dependent hospital programs; key telehealth waivers; the hospital-at-home program; the Work Geographic Index Floor program; and add-on payments for ambulance services.”
  • Upshot — No government shutdown.
  • Fierce Healthcare adds,
    • “A last-ditch effort to pass a bipartisan healthcare package pushed aside at the end of 2024 that includes telehealth extensions and pharmacy benefit manager reform, reverses doc pay cuts and addresses the opioid crisis has failed.
    • “That legislation was brought to the floor by Senators Ron Wyden, D-Oregon and Bernie Sanders, I-Vermont, March 14 ahead of a key procedural vote [on the continuing resolution]. The senators’ bill required unanimous consent, or it would not advance. Sen. Rick Scott, R-Florida, quickly rejected the bill.”
  • Per a Senate news release,
    • “Today, the Senate overwhelmingly voted to pass the Halt All Lethal Trafficking of (HALT) Fentanyl Act. The bipartisan legislation, led by Judiciary Chairman Chuck Grassley (R-Iowa), Health, Education, Labor and Pensions Chairman Bill Cassidy, M.D. (R-La.) and Sen. Martin Heinrich (D-N.M.), would permanently classify fentanyl-related substances before their temporary Schedule I status expires on March 31, 2025. 
    • “Last month, the HALT Fentanyl Act was passed out of the Senate Judiciary Committee by a bipartisan vote of 16-5. Attorney General Pam Bondi has endorsed the legislation. President Trump’s Office of Management and Budget has confirmed that, if Congress passes the bill in its current form, the president will sign it. The legislation now heads to the House of Representatives.
    • “The HALT Fentanyl Act is a critical step towards ending the crisis that’s killing hundreds of thousands of precious American lives. I thank my Senate colleagues for passing this bill with broad, overwhelming support. I urge my House colleagues to swiftly pass the Senate version of this battle-tested, bipartisan bill to save lives, advance research and support our brave men and women in blue,” Grassley said.: * * *
    • “Download bill text HERE and a fact sheet HERE.”
  • The AHA News tells us,
    • “The Senate Finance Committee March 14 held a confirmation hearing on Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services. Oz, a doctor and former television show host, indicated that some of his priorities in the position, if confirmed, would be to reduce health care spending by improving poor health, increasing use of technology, incentivizing providers, and stopping wasteful spending, fraud and abuse. The committee will soon schedule a vote on whether to advance his nomination to the full Senate.”
  • The Wall Street Journal adds,
    • “Mehmet Oz, the Trump administration’s nominee to lead the Medicare agency, said some actions by private insurers in the Medicare Advantage program amounted to fraud and cheating, and he intended to go after them as head of the Centers for Medicare and Medicaid Services. 
    • “His comments, during his Senate confirmation hearing on Friday, were focused on industry practices that can boost insurers’ Medicare Advantage payments by documenting more diagnoses in their patients. Medicare Advantage insurers get higher payouts when patients have certain conditions. 
    • “There’s a new sheriff in town,” said Oz, a heart surgeon known for his long-running television show. He criticized “upcoding” in Medicare Advantage and said, “I pledge if confirmed I will go after it.”
  • Per Senate news releases,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, laid out his health care priorities during a hearing to consider Dr. Mehmet Oz’s nomination to be Administrator of the Centers for Medicare and Medicaid Services (CMS). Oz committed to supporting Grassley’s efforts to lower prescription drug costs, strengthen rural health care, help kids with exceptional medical needs, preserve transitional health plans and improve the agency’s responsiveness to Congress.”
  • and
    • “At a U.S. Senate Finance Committee hearing to consider the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator, Chairman Mike Crapo (R-Idaho) highlighted Dr. Oz’s wealth of firsthand experience as an accomplished physician and his clear vision for creating a healthier nation.  Crapo and Dr. Oz discussed how he would address the nation’s chronic disease epidemic, as well as how he might approach reforming payment programs to improve efficiency.
    • “Crapo concluded the hearing with, “There is no doubt you are qualified to serve as the next Administrator of [CMS], and I look forward to voting in favor of your nomination and am urging all of my colleagues to do the same.”
  • The AHA News informs us,
    • “The Medicare Payment Advisory Commission March 13 released its March report to Congress that includes recommendations for hospital and other Medicare payment systems for fiscal year 2026. Among the recommendations, MedPAC urged Congress to update the base payment rate for hospitals by current law plus 1%.  
    • “An update above current law is necessary given the combination of providers’ continued financial pressures, and almost two decades of sustained and substantial negative Medicare margins,” AHA wrote in a January letter to MedPAC. “Simply put, even after the recommended payment update, Medicare’s payments to hospitals would remain inadequate.” 
  • Per a Food and Drug Administration news release,
    • “Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.
    • “The new study, published in the peer-reviewed scientific journal American Journal of Preventive Medicine, found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.”

From the judicial front,

  • Politico reports,
    • “A federal appeals court has given President Donald Trump’s administration the go-ahead to enforce a pair of controversial executive orders that seek to root out diversity, equity and inclusion efforts in federal agencies and government contractors.
    • “The three-member appeals panel — including two judges appointed by Democratic presidents — lifted a lower court’s injunction that had put the policy on hold last month.
    • The ruling Friday from the panel of the Richmond, Virginia-based 4th Circuit Court of Appeals is not a final decision on the legality of Trump’s anti-DEI policy. It merely allows the government to administer the policy while litigation continues.
    • “In separate opinions explaining their votes, the three judges suggested the Trump administration should be allowed to demonstrate that it will abide by anti-discrimination laws and respect First Amendment rights as it implements the executive orders, which Trump issued on the first two days of his new term.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota’s CIDRAP reports,
    • “The measles outbreak in Texas has risen by 36 cases, pushing the US case count for the year past the number for all of 2024.
    • “The outbreak of the highly contagious virus, which began in late January and is centered in the western part of the state, now stands at 259 cases, according to the latest update from the Texas Department of State Health Services (DSHS). Of those patients, 257 are either unvaccinated or have unknown vaccination status, and 201 are children ages 17 or younger. Thirty-four patients have been hospitalized, with one death in an unvaccinated child who had no known underlying conditions.
    • “Eleven counties to date have reported cases, but two thirds of the cases (174; 67%) are in Gaines County, which has one of the highest rates of school-aged children in Texas who have opted out of at least one vaccine. The county is home to a large Mennonite community with low vaccination rates.
    • “DSHS officials said they have determined that three of the case-patients previously listed as vaccinated were not vaccinated. Two had received their measles, mumps, and rubella (MMR) vaccine doses 1 to 2 days before their symptoms started and after they had been exposed to the virus. The third had a vaccine reaction that mimicked a measles infection and has been removed from the case count.”
  • The University of Minnesota CIDRAP also notes,
    • “The US Food and Drug Administration (FDA) yesterday announced the strains it recommends manufacturers include in seasonal flu vaccines for the 2025-26 flu season, and [as usual] they mirror recommendations announced by the World Health Organization (WHO) last month.” 
  • Gallup reports,
    • “Americans’ assessments of their mental and physical health are the least positive they have been in Gallup’s 24-year trend, reflecting a decadelong decline that began around 2013 and accelerated sharply with the onset of the COVID-19 pandemic in 2020.
    • “Three in four U.S. adults in Gallup’s latest annual reading rate their mental health (75%) and, separately, their physical health (76%) as either “excellent” or “good.” This contrasts with a record-high 89% rating their mental health positively as recently as 2012, and a high of 82% for physical health in 2003.
    • “As fewer Americans have rated their mental and physical health positively, most of the change has been in the percentages rating each aspect “excellent” — shrinking to 31% for mental health and 24% for physical health.”
  • The National Science Foundation points out,
    • “A team of researchers led by the recipient of a U.S. National Science Foundation Faculty Early Career Development grant has developed a new storage method for protein-based drugs that could potentially eliminate the need for refrigeration of important medicines. Using an oil-based solution and a molecule acting as a coating to enclose the proteins in these drugs, researchers demonstrated a technique to prevent the proteins from degrading rapidly — a protection that traditionally requires refrigeration.
    • “The research is led by Scott Medina at Pennsylvania State University and published in Nature Communications. It demonstrates a possible practical application to eliminate the need to refrigerate hundreds of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
    • “The work could eventually reduce the cost of refrigerating such drugs throughout the supply chain and enable greater use of protein-based therapies where constant refrigeration isn’t possible, including military environments. 
    • “Over 80% of biologic drugs and 90% of vaccines require temperature-controlled conditions. This approach could revolutionize their storage and distribution, making them more accessible and affordable for everyone,” says Medina.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have determined that dermatitis resulting from topical steroid withdrawal (TSW) is distinct from eczema and is caused by an excess of an essential chemical compound in the body. Scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) identified treatments that could be studied in clinical trials for the condition based on their potential to lower levels of the chemical compound—called nicotinamide adenine dinucleotide (NAD+), a form of vitamin B3. The findings were published today in the Journal of Investigative Dermatology.
    • “Dermatitis is characterized by inflammation, itching, or burning sensations on the skin, and can result from various conditions including TSW and eczema. Eczema, also known as atopic dermatitis, is a common cause of dermatitis and affects 10 to 30% of children and 2 to 10% of adults each year in the United States. Topical steroids—specifically glucocorticoids or topical corticosteroids—have long been used as a first-line treatment for dermatitis caused by eczema because the drugs are safe, effective, easy to apply, and considered well-tolerated.” * * *
    • “The scientists provisionally established criteria that can be used by health care providers to identify TSW in people. People who have stopped topical steroid treatment and meet the criteria may be diagnosed by practitioners as having TSW. The researchers suggest that patients identified as having TSW could be treated using the proposed mitochondrial complex I-blocking drugs.
    • “The results of this study may help practitioners identify TSW in patients and work towards developing safe and effective treatments. According to the researchers, more research is needed to determine whether all patients with TSW have an excess of NAD+, or if there are other features that define TSW. Additionally, the diagnostic criteria will help health care providers and researchers to better understand the prevalence of TSW and evaluate the effects of using topical steroids.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.
    • “But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?
    • “The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.
    • “To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)”
  • Per STAT News,
    • “Biotech company Altimmune announced in an investor call yesterday that it will study its obesity drug, which targets receptors of the GLP-1 and glucagon hormones, in alcohol use disorder, as mounting evidence supports the potential of GLP-1 drugs to help with addiction.
    • “Altimmune executives think that their molecule, called pemvidutide, could be particularly helpful for liver conditions, since there are glucagon receptors located in the liver. The company has already been studying the drug in weight loss and in the liver disease MASH, and are now expanding into alcohol-related conditions.
    • “The company plans to start a study in alcohol use disorder in the second quarter of this year, and another study in alcohol-related liver disease in the third quarter.
    • “Eli Lilly has also started studying mazdutide, a GLP-1/glucagon drug it’s developing with Chinese biotech Innovent, in alcohol use disorder. Lilly CEO Dave Ricks has said the company also plans to test obesity drugs in other areas of addiction, like nicotine and drug use disorders.
    • “Novo Nordisk is running a study of its obesity drugs in alcohol-related liver disease but has not yet started any trials in addiction.”
  • Per Beckers Hospital CFO Report,
    • As healthcare organizations continue to navigate shifting financial and operational landscapes, new data from Kaufman Hall and Strata highlights significant trends in physician productivity, compensation, and costs.
    • In the fourth quarter, median work relative value units per full-time physician varied across specialties, with medical specialties leading at 7,139 wRVUs. Physician compensation followed a similar pattern, with surgical specialists earning the highest median paid compensation at $491,000 per FTE.
    • Despite an encouraging increase in net revenue per physician, rising expenses remain a challenge. These figures underscore the mounting financial pressures and workforce challenges facing healthcare organizations. For executives, balancing rising costs, evolving productivity demands, and compensation structures will be critical in sustaining financial stability and operational efficiency.
  • Beckers Hospital Review points out ten drugs poised to be top sellers next year.

Thursday Report

David Ermer–CDC, Congress, FDA, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats took the threat of a government shutdown off the table, following a grueling intraparty fight in which lawmakers struggled with how best to resist President Trump’s fast-paced efforts to slim down federal agencies.
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) said he would vote to advance a Republican measure, set for Friday morning, to fund the government through September. Earlier, in a closed-door lunch, he also said that enough Democrats would join him to help the Republicans clear the chamber’s critical 60-vote hurdle, people familiar with the matter said.
    • “I will vote to keep the government open and not shut it down,” Schumer said on the Senate floor, characterizing Democrats’ alternatives as a Hobson’s choice with no good option. He said that in a shutdown, Trump could decide “to cherry pick which parts of the government to reopen in a protracted shutdown.”
  • The American Hospital Association News tells us,
    • “The White House March 13 withdrew the nomination of former Republican congressman Dave Weldon for director of the Centers for Disease Control and Prevention.
    • “Meanwhile, the Senate Committee on Health, Education, Labor and Pensions advanced the nominations of Jay Bhattacharya for director of the National Institutes of Health and Marty Makary for commissioner of the Food and Drug Administration. Both nominees will next be considered by a full Senate vote.”
  • Federal News Network informs us,
    • “The Postal Service is letting a team from the Department of Government Efficiency take a closer look at its reform plans.
    • “Postmaster General Louis DeJoy, in a letter sent to congressional leaders Thursday, said he signed an agreement last night with DOGE representatives and the General Services Administration to “assist us in identifying and achieving further efficiencies.”
    • “DeJoy told lawmakers that USPS is heading in the right direction under his 10-year Deliverying for America reform plan and that DOGE’s work is “aligned with our efforts.”
    • “While we have accomplished a great deal, there is much more to be done. We are happy to have others to assist us in our worthwhile cause,” DeJoy wrote.”

From the judicial front,

  • The Wall Street Journal relates,
    • “A federal judge has ordered six federal agencies to reinstate thousands of probationary employees who were fired last month, dealing a blow to the Trump administration’s efforts to rapidly scale back the size of the federal workforce.
    • “The Trump administration has encountered a number of legal challenges in its push to slash the government’s size and spending, including a lawsuit from a coalition of 20 states over plans to eliminate nearly half of the staff of the Education Department.
    • “The Education Department, with around 4,500 employees as of last year, is the smallest cabinet-level agency. Polls show most Americans oppose eliminating the department.”
  • FEHBlog note — The Justice Department has noticed an appeal of the reinstatement order to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law adds,
    • “A US judge in Maryland directed 18 agencies to temporarily rehire thousands of terminated employees, dealing another judicial defeat to Trump administration efforts to shrink the federal sector.
    • “The government gave no advance notice before firing newer workers, known as probationary employees, and conducted no individual assessments to justify their discharge based on performance, Judge James Bredar of the US District Court for the District of Maryland said Thursday in granting a temporary restraining order. 
    • “Bredar, an Obama appointee, found the terminations were unlawful workforce reductions that negatively impacted 19 states and the District of Columbia, which sued to challenge the firings.
    • “The ruling will apply for 14 days to workers at agencies including the Labor, Health and Human Services, Education, and Energy departments; the Environmental Protection Agency; the Consumer Financial Protection Bureau; and the US Agency for International Development. 
    • “It comes after a separate federal judge in California ordered six federal agencies to rehire probationary employees they fired since Feb. 13. Both decisions add to mounting setbacks for President Donald Trump and billionaire Elon Musk, who have attempted to cull the federal workforce in the name of efficiency.”

From the public health and medical research front,

  • Cardiovascular Business points out,
    • “U.S. patients are significantly less likely to die from heart failure-related cardiac arrest now than they were 25 years ago, according to new data published in the American Journal of Cardiology. However, the authors noted, certain disparities still exist, suggesting cardiologists and other healthcare providers have much more work to do. 
    • “Heart failure currently affects over 64 million adults worldwide, with about 6 million impacted in the United States, a number expected to rise to 8 million by 2030, wrote corresponding author Sivaram Neppala, MD, an assistant professor with the cardiology division at The University of Texas Health Sciences Center, and colleagues. “Patients diagnosed with heart failure face a significantly higher risk of cardiac arrest, contributing to 30-50% of mortality cases within this population. Those with systolic dysfunction are six to nine times more likely to experience sudden cardiac death. Cardiac arrest and heart failure can lead to irregular heart rhythms and myocardial fibrosis, increasing the risk of ventricular arrhythmias and highlighting the need for urgent care.”
    • “Neppala et al. explored U.S. Centers for Disease Control and Prevention data from 1999 to 2023, tracking changes in the overall age-adjusted mortality rate (AAMR) for cardiac arrest in patients with heart failure. All patients included in their analysis were 25 years old or older.
    • “Overall, the researchers found that the AAMR for heart failure-related cardiac arrest dropped from 25.3 per 100,000 adults in 1999 to 20.6 in 2023. The reduction was the most pronounced from 1999 to 2011, with an annual percentage change of -2.95%, but then remained largely unchanged from 2011 to 2018. The overall AAMR then increased from 2018 to 2021—a time when the COVID-19 pandemic was at its most severe—before dropping yet again from 2021 to 2023. 
    • “The subsequent decline from 2021 to 2023 (APC: -4.05%) indicates recovery and improved access to healthcare, highlighting the pandemic’s effects on cardiovascular outcomes and the necessity for resilient healthcare systems,” the authors wrote.”
  • STAT News discusses the importance of improving the availability of HIV self-testing.
    • “In May 2024, the Massachusetts Department of Public Health released a troubling report on a cluster of HIV infections, with more than 200 new cases since 2018 attributable to injection drug use in the Boston region. These findings have national implications: Similar HIV outbreaks have been described nationwide during the overdose crisis, including in West Virginia, Indiana, and Ohio. The increase in HIV cases amid the U.S. drug overdose crisis underscores the urgent need for a comprehensive response tailored to the unique challenges faced by people who use drugs. The importance of such efforts cannot be understated. In fact, in Massachusetts, 14% of new HIV diagnoses every year are attributed to injection drug use — nearly twice the national average.
    • “One potential solution is HIV self-testing, which would allow for rapid identification and treatment. Identifying HIV cases is the first step in addressing clusters, and quickly learning one’s status allows people to rapidly seek both treatment and prevention. Unlike traditional laboratory-based testing, which may take several days for results delivery, HIV self-testing relies on saliva and provides results in 20 minutes. The test is easily performed outside of a clinical setting by swabbing gums and collecting a sample of saliva. HIV self-testing has been available since 2012 and is recommended by the Centers for Disease Control and Prevention for accurate HIV diagnosis. It’s even part of the Department of Health and Human Services’ plan for Ending the HIV Epidemic (EHE) by 2030.
    • “But HIV self-testing remains underutilized among not only the general public, but especially people who use drugs. As the nation emerges from the Covid-19 pandemic, during which self-testing for infectious diseases became commonplace, increasing HIV self-testing among people who use drugs may limit the spread of a virus that, while manageable with medication, can lead to significant health risks if left untreated.”
  • MedPage Today lets us know,
    • “Better midlife diet was tied to better brain connectivity and white matter integrity later in life.
    • “Lower waist-to-hip ratio was associated with better memory and executive function at 70.
    • “Diet improvements over time were linked with better white matter integrity in several brain regions.”
  • The National Cancer Institute aggregated its latest research news while the National Institute of Diabetes and Digestive and Kidney Diseases reflects on its 75th anniversary.
  • Per Beckers Hospital Review,
    • “A recently approved drug for acute ischemic stroke works as well as the treatment used in most U.S. hospitals and may offer advantages for some patients, according to a study led by a researcher from Dallas-based UT Southwestern Medical Center. 
    • “The study, published March 12 in JAMA Network Open, compared the newly approved tenecteplase in a single quick injection to alteplase, the stroke treatment that has been used for decades and requires an hourlong infusion. “

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna is revamping its C-suite and consolidating oversight of its two main businesses — insurance and health services operations — under one executive, the company announced Thursday.
    • “Brian Evanko, currently chief financial officer and the head of Cigna’s health insurance division Cigna Healthcare, will serve as Cigna’s chief operating officer, managing both Cigna Healthcare and health services division Evernorth. Ann Dennison, who was deputy CFO under Evanko, will step up as enterprise CFO. The changes are effective at the end of this month.
    • “Meanwhile, Eric Palmer, the current CEO of Evernorth, is departing the company at the end of April, an apparent victim of the restructuring. A spokesperson for Cigna did not respond to a request for comment on the reason behind Palmer’s departure.”
  • Modern Healthcare notes,
    • “Highmark Health’s insurance business challenges weighed on the organization’s overall financial performance in 2024, the company reported Thursday.
    • “The nonprofit Blue Cross Blue Shield licensee saw its net income plummet 90.6% to $50 million while revenue rose nearly 9% to $29.4 billion. The company also reported operating losses of $209 million, compared with an operating gain of $338 million in 2023.
    • “Our entire industry faces strong financial headwinds. That underscores the need for a more economically sustainable approach that delivers better health experiences and outcomes,” Highmark Health President and CEO David Holmberg said on a telephone briefing announcing the financial results.”
  • Per BioPharma Dive,
    • “Mallinckrodt and Endo Pharmaceuticals, which have struggled through bankruptcies related to opioid litigation, said Thursday that they will merge in a cash and stock transaction that will leave a combined company valued at $6.7 billion.
    • “Shareholders of Mallinckrodt will end up with 50.1% of the combined company and current Mallinckrodt CEO Siggi Olafsson will take the top job at the new entity as well. Per deal terms, Endo shareholders will receive Mallinckrodt stock and a share of $80 million in cash.
    • “After the merger, a business made up of Endo’s sterile injectables and both companies’ generic pharmaceuticals will be separated out. The companies haven’t yet decided what that separation will look like, Olafsson told analysts and investors on a conference call. The board will “make the best decision going forward” after the combination of the businesses, he said.”
  • Per MedTech Dive,
    • “Vivani Medical said Wednesday it plans to spin off its neurostimulation business to form an independent, publicly traded company. 
    • “Formerly Second Sight Medical Products, the independent company will trade as Cortigent and advance brain implants to help people recover body functions such as vision and movement.
    • “Vivani, which is focused on GLP-1 implants, acquired the neurostimulation technology through a merger in 2022 and first filed paperwork to list Cortigent as an independent company in 2023.”