Cybersecurity Saturday

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 Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Nextgov/FCW reports,
    • “Rep. Eric Swalwell, the House Homeland Security Committee’s leading Democratic voice on cybersecurity matters, suggested Wednesday that government contractors could be deployed to conduct offensive cybersecurity operations against foreign adversaries.
    • “Speaking at an Axonius event in Washington, D.C., the California congressman said the concept is worth exploring, in part, because “the federal government does not have the resources to protect every company that gets hit,” and that the moves could deter adversaries like Russia from targeting low-resourced critical infrastructure sectors.
    • “The remarks make Swalwell one of the first Democrats to publicly suggest that the private sector take a broader role in hacking back against foreign rivals. The dynamic has been floated in recent months largely by Republicans as a way to respond to headline-making Chinese intelligence intrusions into U.S. telecom systems and other infrastructure.”
  • Per a news release,
    • “Incident response is a critical part of cybersecurity risk management and should be integrated across organizational operations. The six Functions of the NIST Cybersecurity Framework (CSF) 2.0 all play vital roles in incident response.
    • “NIST has finalized Special Publication (SP) 800-61r3 (Revision 3), Incident Response Recommendations and Considerations for Cybersecurity Risk Management: A CSF 2.0 Community Profile, which describes how to incorporate incident response recommendations into cybersecurity risk management activities in alignment with CSF 2.0. This guidance will help organizations reduce the number and impact of incidents that occur and improve the efficiency and effectiveness of their incident detection, response, and recovery activities.
    • “SP 800-61r3 supersedes SP 800-61r2 (Revision 2), Computer Security Incident Handling Guide.
    • “Readers of SP 800-61r3 are encouraged to utilize the resources on NIST’s Incident Response project page in conjunction with this document to implement these recommendations and considerations.” 
  • The American Hospital Association News tells us,
    • “The House Energy and Commerce Oversight and Investigations Subcommittee April 1 discussed cybersecurity threats in legacy medical devices during a hearing. The subcommittee heard from experts on the dangers of outdated devices as the hardware can last several years longer than software.”

From the cyber vulnerabilities and breaches front,

  • The Cybersecurity and Infrastructure Security Agency added three known exploited vulnerabilities to its catalog this week.
  • Cybersecurity Dive reports on April 2,
    • A recent surge in login attempts targeting Palo Alto Networks’ PAN-OS GlobalProtect portals mainly located in the U.S. could be a precursor to a large-scale exploitation of unpatched or zero-day vulnerabilities, researchers have found. 
    • The threat activity means defenders with exposed Palo Alto Networks VPN systems should review March 2025 logs and consider engaging in detailed threat hunting to detect signs of compromise.
    • Over the last 30 days, nearly 24,000 unique IP addresses have attempted to access these portals, activity that suggests a coordinated effort to identify exposed or vulnerable systems for targeted abuse of flaws, according to a report released this week from security intelligence firm GreyNoise.
  • HelpNet Security points out “Attackers are targeting CrushFTP vulnerability with public PoC (CVE-2025-2825).”
    • “Exploitation attempts targeting the CVE-2025-2825 vulnerability on internet-facing CrushFTP instances are happening, the Shadowserver Foundation has shared on Monday, and the attackers have been leveraging publicly available PoC exploit code.”

From the ransomware front,

  • The Wall Street Journal reports,
    • “The Federal Trade Commission in March identified impostor scams—in which someone impersonates a loved one, colleague or government official—as the most-reported type last year, resulting in losses of nearly $3 billion. 
    • “Criminals increasingly use generative AI to mimic a loved one’s voice, making these kinds of scams more believable, the Federal Bureau of Investigation has warned. It takes just three seconds of audio to clone a voice with 85% accuracy, according to the security-software firm McAfee, whose survey of 7,000 people globally found that more than half regularly share voice content online.
    • “Criminals can also use AI to approximate the voice of someone of any age, gender or dialect. During a high-stress situation, a generic voice of a young woman could be confused for the voice of a daughter, according to cybersecurity experts.”
  • Per Cybersecurity Dive,
    • “The FBI, the Cybersecurity and Infrastructure Security Agency and a group of international partners on Thursday [April 3] warned that cyber threat groups are using a technique called “fast flux” to hide the locations of malicious servers, posing a significant threat to national security.
    • “Authorities warned that both criminal and state-linked threat groups have used fast flux to obfuscate the locations of these servers using fast-changing Domain Name System records. They also can create highly resilient command and control (C2) infrastructure to conceal their malicious operations, particularly in connection with botnets.
    • “Fast flux techniques are not only used for C2 communications but also in phishing campaigns to protect social engineering websites from being blocked or taken down, authorities said.” 
    • “Authorities did not specify whether there is an active campaign using fast flux or directly name any threat actor currently using the technique. However, they did reference past activity, noting that fast flux has been used in previous ransomware attacks linked to Hive and Nefilim. Additionally, a Russia-backed threat actor known as Gamaredon has also used fast flux to mask threat activities, according to the advisory.”
    • “Authorities did not specify whether there is an active campaign using fast flux or directly name any threat actor currently using the technique. However, they did reference past activity, noting that fast flux has been used in previous ransomware attacks linked to Hive and Nefilim. Additionally, a Russia-backed threat actor known as Gamaredon has also used fast flux to mask threat activities, according to the advisory.” 
  • Beckers Health IT informs us on March 31,
    • “The FBI is investigating a cyberattack on Oracle’s computer systems in which hackers stole patient data to extort multiple U.S. healthcare providers, Bloomberg reported March 28.
    • “Oracle notified some healthcare customers earlier this month that the breach occurred sometime after Jan. 22. According to a notice sent to clients and obtained by Bloomberg, hackers accessed company servers and copied patient data to an external location.
    • “A person familiar with the matter, who spoke on condition of anonymity, told the publication that cybercriminals attempted to demand ransom from affected medical providers. The total number of targeted providers and stolen patient records remains unknown.
    • “Oracle did not respond to Bloomberg’s request for comment. An FBI spokesperson also declined to comment.”
  • Per Bleeping Computer,
    • “​Port of Seattle, the U.S. government agency overseeing Seattle’s seaport and airport, is notifying roughly 90,000 individuals of a data breach after their personal information was stolen in an August 2024 ransomware attack.
    • “The agency disclosed the attack on August 24, saying the resulting IT outage disrupted multiple services and systems, including reservation check-in systems, passenger display boards, the Port of Seattle website, the flySEA app, and delayed flights at Seattle-Tacoma International Airport.
    • “Three weeks after the initial disclosure, the Port confirmed that the Rhysida ransomware operation was behind the August 2024 breach.
    • “After the incident, the Port also decided not to give in to the cybercriminals’ demands to pay for a decryptor even though they threatened to publish stolen data on their dark web leak site.
    • “We have refused to pay the ransom demanded, and as a result, the actor may respond by posting data they claim to have stolen on their darkweb site,” the Port of Seattle said on September 13, 2024.
    • “Our investigation of what data the actor took is ongoing, but it does appear that some Port data was obtained by the actor in mid-to-late August. Assessment of the data taken is complex and takes time.”
  • Forta discusses,
    • “HellCat [which] is the name of a relatively new ransomware-as-a-service (RaaS) group that first came to prominence in the second half of 2024. Like many other ransomware operations, HellCat breaks into organisations, steals sensitive files, and encrypts computer systems – demanding a ransom payment for a decryption key and to prevent the leaking of stolen files.”
  • GTSC brings us up to date on the Medusa ransomware gang.
    • The Medusa ransomware gang is a ransomware-as-a-service (RaaS) operation first identified in June 2021. Since then, it has targeted over 300 victims across various critical infrastructure sectors, including medical, education, legal, insurance, technology, and manufacturing. ​
  • Per SC Media,
    • “A threat actor using a combination of AI-powered vishing, the more conventional remote access tool Microsoft Quick Assist, and living-off-the-land techniques has demonstrated how a simple vishing attack can escalate into a full compromise.
    • “In an April 1 blog post, researchers from Ontinue reported that the techniques observed in this recent campaign align with those previously attributed to Storm-1811, a threat actor identified by Microsoft known for leveraging vishing, MS Quick Assist, and social engineering via MS Teams to gain network access.
    • “SC Media first reported on this group last May, in which it was reported the group abused Quick Assist to deploy the BlackBasta ransomware.”

From the cybersecurity defenses front,

  • Cyberscoop reports,
    • “Businesses don’t always get what they pay for in cybersecurity. Some of the most expensive cloud network firewall vendors are among the worst performers against exploits and evasions, according to the most comprehensive, independent testing CyberRatings.org has conducted to date.
    • “Cisco, by far the most expensive cloud network firewall offering across the top 10 vendors on price per megabits per second, ranked seventh with an overall security effectiveness score of 53.5%, according to CyberRatings.org research released Wednesday. 
    • “The trio of big cloud providers — Amazon Web Services, Microsoft Azure and Google Cloud Platform — fared even worse, each landing at the bottom of the pack with a 0% security effectiveness score. 
    • “We’ve been told to use cloud-native technologies, that they’re better suited than using bolt-ons. Well, that’s clearly not the case here,” CyberRatings.org CEO Vikram Phatak told CyberScoop.”
  • Dark Reading explains “How an Interdiction Mindset Can Help Win War on Cyberattacks. The US military and law enforcement learned to outthink insurgents. It’s time for cybersecurity to learn to outsmart and outmaneuver threat actors with the same framework.”
  • In email news
    • Bleeping Computer lets us know “Google rolls out easy end-to-end encryption for Gmail business users.”
    • Dark Reading informs us “Microsoft Boosts Email Sender Rules for Outlook. Beginning on May 5, the tech giant will enforce new email authentication protocols for Outlook users who send large volumes of email.”
  • Per a NIST news release, here are “7 Tips to Keep Your Smart Home Safer and More Private, From a NIST Cybersecurity Researcher.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Senate over the weekend is expected to cast a final vote on its revised budget resolution for fiscal year 2025. Senate Republicans April 3 voted to proceed on the resolution which kicked off debate. Today the Senate was slated to debate and process a number of amendments before holding a final vote on the resolution. The budget resolution is expected to pass and move to the House for consideration next week.” 
  • Per a CMS fact sheet,
    • The Centers for Medicare & Medicaid Services (CMS) issued a final rule on April 4, 2025, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) programs. The Contract Year (CY) 2026 MA and Part D final rule implements changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the MA and Part D programs. 
    • CMS is not finalizing certain provisions from the proposed rule at this time. CMS may address these proposals in future rulemaking, as appropriate. CMS is also announcing that it is not finalizing three provisions from the proposed rule (Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies, Procedures and Ensuring Equitable Access to Medicare Advantage Services—Guardrails for Artificial Intelligence, and Part D Coverage of Anti-Obesity Medications (AOMs) and Application to the Medicaid Program). 
    • This fact sheet discusses the major provisions of the CY 2026 MA and the Part D final rule. The final rule can be downloaded here: https://www.federalregister.gov/public-inspection/2025-06008/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare. 
  • The Wall Street Journal emphasizes,
    • “The Trump administration said Friday that Medicare and Medicaid won’t expand coverage of popular anti-obesity drugs, rejecting a proposal issued late last year by the Biden administration.
    • “The decision deals a blow, at least for now, to Americans who are covered by the government health-insurance programs and wanted their help paying for the popular but pricey drugs. 
    • “Yet the administration left open the possibility of revisiting the decision later.
    • “Expanding coverage of the obesity medications “is not appropriate at this time,” a Centers for Medicare and Medicaid Services spokeswoman said.
    • “She said CMS may reconsider the policy after more review of the drugs’ “potential benefits” and “relevant costs,” including costs to state Medicaid agencies.”
  • For perspective, STAT News pointed out last September
    • A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.
  • Per a House Budget Committee news release,
    • “House Budget Committee Chairman Jodey Arrington (R-Texas) today appointed Budget Committee Member Rep. Blake Moore (R-Utah) to chair the Committee’s Health Care Task Force. 
    • “The Task Force will build on its work from the 118th Congress by examining opportunities to modernize and personalize the health care system and support policies to fuel innovation and increase patient access to quality and affordable care. One of the initial areas of focus for the Budget Health Care Task Force will be examining the budgetary effects of chronic disease and opportunities to Make America Healthy Again.” 
  • Per an HHS news release,
    • “HHS Secretary Robert F. Kennedy, Jr. will embark [next Monday through Wednesday] on a multi-state tour to celebrate MAHA initiatives in the Southwest. He will meet with elected officials, tribal leaders, nutrition experts, and charter school visionaries as he works to fulfill President Trump’s promise to Make America Healthy Again.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • COVID-19
      • “COVID-19 activity is declining nationally to low levels. 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
    • 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 AHA News tells us,
    • “There are 607 confirmed cases of measles across the U.S., according to the latest data released April 4 by the Centers for Disease Control and Prevention. The majority of cases are in Texas, as an outbreak in the state has grown to 481 cases, according to the Texas Department of State Health Services.  
    • “Cases have been reported by 21 states, with 93% being outbreak-associated, according to the CDC. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.” 
  • Per Health Day,
    • “Strokes caused by an artery tear are landing five times as many Americans in the hospital these days, a new study says.
    • “Cervical artery dissection involves a small tear in the inner lining of an artery in the neck that supplies blood to the brain.
    • “Blood can clot at the site of the tear. If the clot breaks loose, it can travel to the brain and cause a stroke.
    • “Hospitalizations for this sort of stroke have increased nearly fivefold during the past 15 years, according to findings published April 2 in the journal Neurology.
    • “Cervical artery dissection is an important cause of stroke, especially in people under 50, so it is crucial to detect it right away,” senior researcher Dr. Shadi Yaghi, a vascular neurologist at Brown University in Providence, R.I., said in a news release.
    • “Strokes that are not fatal can lead to long-term disability, poor mental health and reduced quality of life,” he said. “Our research found a dramatic increase in the number of hospitalizations for cervical artery dissection, with rates rising steadily year over year.” 
    • “These sort of tears in the cervical artery are most often caused by a motor vehicle crash or other accident that causes neck strain, researchers said. However, activities as simple as heavy lifting has been known to cause a cervical artery tear in some people.”
  • The New York Times shares “10 Small Things Neurologists Wish You’d Do for Your Brain. Easy everyday habits can help keep you sharp. And it’s never too late to start them.”
  • Per MedTech Dive,
    • “Boston Scientific’s pulsed field ablation catheter, Farapulse, was noninferior to Medtronic’s Arctic Front cryoballoon in a randomized trial, researchers found in a study published in The New England Journal of Medicine.
    • “The study, which was published Monday and funded by a Swiss hospital, randomized 210 patients with symptomatic paroxysmal atrial fibrillation to undergo PFA or cryoablation. Atrial tachyarrhythmia, a heart rhythm disorder where the atria beat too fast, recurred in 39 patients in the PFA cohort and 53 people in the cryoablation group.
    • “Medtronic reported declines in its cryoablation business last year but said the losses were offset by growth of its PulseSelect single-shot catheter, which competes with Farapulse for the growing PFA market.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “Rural areas are quickly losing independent physicians and medical practices amid the corporatization of healthcare, a new report finds.
    • “The report was commissioned by the Physicians Advocacy Institute (PAI), a nonprofit advocacy organization focused on fair and transparent payment policies. The research, conducted by Avalere Health, used the IQVIA OneKey database, which contains physician and practice location information on health system ownership.
    • “The number of independent doctors in rural areas fell 43% from January 2019 to January 2024, with rural areas losing 5% of all practicing physicians. Meanwhile, people in rural areas had access to 11% fewer medical practices as of January 2024.
    • “Nearly 9,500 doctors left independent practice in rural areas, predominantly in the Midwest and Northeast. States like Indiana, Massachusetts, New Jersey and Ohio lost more than 50% of independent docs.
    • “This decline in rural healthcare providers has been primarily driven by a drop in independent docs and practices as well as the acquisition of these practices by hospitals and corporate entities, the report said.” 
  • Beckers Hospital Review lets us know,
    • “South Bend, Ind.-based Beacon Health System has signed a definitive agreement to acquire Ascension Michigan’s southwest region, which includes four hospitals, 35 outpatient clinics and an ambulatory surgery center.
    • “The hospitals include:
      • “Ascension Borgess Hospital (Kalamazoo)
      • “Ascension Borgess Allegan Hospital
      • “Ascension Borgess-Lee Hospital (Dowagiac)
      • “Ascension Borgess-Pipp Hospital (Plainwell)
    • “Expanding our reach deeper into southwest Michigan broadens access to high-quality, affordable care for communities served by Ascension, extends our service area and provides growth opportunity to further strengthen the health system,” Beacon Health CEO Kreg Gruber said in an April 3 news release. “This acquisition will create a bright future for these communities by ensuring access to quality healthcare services for generations.”
  • Per Fierce Pharma,
    • “With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth out of another drug from its $27.8 billion Horizon Therapeutics buy. 
    • “Uplizna is the first drug to win an FDA approval for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can present in multiple organs and cause fibrosis and permanent organ damage, with or without symptoms.
    • “The CD19-targeted therapy made strides in treating the disease in its phase 3 MITIGATE trial. In the study, Uplizna demonstrated an 87% reduction in the risk of IgG4-RD flares over placebo during the 52-week placebo-controlled period, with 10.3% of those on Uplizna experiencing a flare-up compared to 59.7% of those taking placebo.
    • “With the approval, patients and physicians now have a “proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use,” Amgen’s executive vice president of R&D Jay Bradner, M.D., said in a company release. “This approval underscores Amgen’s ongoing commitment and leadership in developing innovative treatments targeting CD19+ B-cells across multiple therapeutic areas.”
    • “Now, the road ahead for Amgen’s success in IgG4-RD lays in raising awareness of the rare disease, which was only recently established with an International Classification of Diseases code in 2023. About 20,000 people are estimated to have the disease in the U.S., but the exact number is hard to pinpoint due to limited data, according to Amgen.”
  • and
    • “As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud.
    • “GSK and Pfizer have moved to scrap a patent lawsuit around their respective RSV vaccines, according to a filing in the U.S. District Court in Delaware.
    • “The settlement comes after a U.K. high court in November sided with Pfizer, ruling that two GSK RSV vaccine patents were invalid.”

From the artificial intelligence front,

  • Beckers Payer Issues discusses how health plans can use “AI to Drive Patient Outcomes & Health Plan ROI.”
  • Modern Healthcare adds,
    • “Artificial intelligence and other cutting-edge innovations could radically reshape how care is delivered, but tapping technology’s full potential and getting a return on investments is far off, according to industry executives.
    • “We need enduring, ambitious vision,” said Dr. Vivek Garg, chief medical officer at Humana’s CenterWell healthcare services division, during Modern Healthcare’s 2030 Playbook conference in Nashville Wednesday. “You’re going to need the leadership and the board to make trade-offs and to make investments. …They’ve got to do it because they know what they stand for, and they want to see what they can become and how much further they can go in their vision.” * * *
    • “More collaboration between payers and providers is imperative, said Mike Bennett, chief strategy and transformation officer at Highmark Health.
    • “If we both don’t start working together and using the tools we both have, we’re going to end up leaving [our populations] behind,” Bennett said. “AI doesn’t care whether you’re a payer or provider.”

Thursday Report

David Ermer–CMS, Congress, Medical / Rx research, OPM, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The FEHBlog watched today’s confirmation hearing for the President’s nominee for OPM Director, Scott Kupor. Clearly, Mr. Kupor is on a glide path to Senate confirmation. The next step toward that goal will occur at a business meeting of the Senate Homeland Security and Government Affairs Committee on Wednesday April 9 at 10 am.
  • The American Hospital Association News tells us,
    • “The Senate April 3 by a vote of 53-45 confirmed Mehmet Oz as the new administrator for the Centers for Medicare & Medicaid Services.” 
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. said he would reinstate some programs and federal workers cut earlier this week as part of his sweeping reorganization of the department.
    • “Some programs that were cut, they’re being reinstated,” Kennedy said Thursday. “Personnel that should not have been cut were cut. We’re reinstating them.”
  • Per Senate news releases,
  • and
    • “Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) led a markup on six bipartisan Grassley-backed bills to boost competition in the pharmaceutical industry and improve access to more affordable prescription drugs. All six bills advanced in committee by voice vote.” Five of the six bills target pharma, while the sixth bill requests an FTC study of consolidation in the PBM industry.
  • Healthcare Dive reports,
    • “AdvaMed, one of the medical device industry’s largest trade groups, reiterated its opposition to broad-based tariffs Wednesday, saying the actions would hurt innovation, cost jobs and increase healthcare costs, after the Trump administration announced new duties on most U.S. trading partners.
    • “The medtech industry should be exempted from these tariffs,” CEO Scott Whitaker said in a statement.” * * *
    • “Meanwhile, providers have been bracing for the impact of tariffs after the American Hospital Association, alongside the Healthcare Distribution Alliance, also failed to secure carve-outs for critical medical supplies, despite months of lobbying.”
  • Stars and Stripes informs us,
    • “The Department of Defense has scheduled “listening sessions” at three U.S. military bases in Japan next week to collect feedback on a pilot program designed to connect DOD civilians with Japanese health care providers.  Anyone who has used the program — the Health Insurance Enhancement for DOD Civilian Employees in Japan — is encouraged to participate at sessions at Misawa Air Base, Camp Foster and Yokosuka Naval Base, according to a March 28 email distributed by the Defense Health Agency’s National Capital Region.”
  • The Government Accountability Office released a report about DOD’s Actions to Address Challenges with Accessing Health Care in Japan and Guam.
    • The Department of Defense relies on its civilian employees and contractors in Japan and Guam to provide services such as engineering, food service, and teaching. They may receive health care at military facilities but only on a space-available basis—after active-duty service members and their families.
    • Accessing health care through local providers can be difficult. For example, in Japan, they face language barriers and must pay for care up front. DOD started a program intended to help them find providers and pay bills. In Guam, DOD has a working group to address issues that may arise from planned growth of the civilian population on Guam.

From the judicial front,

  • Modern Healthcare reports,
    • “Federal Trade Commission Chair Andrew Ferguson said he will get involved in the agency’s [internal] legal action against the leading pharmacy benefit managers.
    • “In a post shared Thursday on the social media platform X, Ferguson said he no longer is recusing himself from the matter.” * * *
    • “Ferguson, a critic of PBMs, recused himself due to his prior role in advising Virginia’s attorney general on the decision to file an amicus brief in a class-action lawsuit against PBMs, he wrote Thursday in a statement shared on the social media platform. He said his stance had changed to “ensure that the case can continue.”
    • “He said he consulted with the agency’s ethics attorneys when making the decision to involve himself.
    • “The FTC did not immediately respond to questions about next steps. In the Tuesday order pausing the case, FTC General Counsel Lucas Croslow said the pause would remain in effect for at least 105 days, and an evidentiary hearing date would be scheduled 225 days after the stay is lifted.”
  • Fierce Healthcare relates,
    • “The Department of Justice is urging the courts to reject a legal expert’s report that puts its longstanding challenge to UnitedHealthcare’s Medicare Advantage billing practices in jeopardy.
    • “In a memorandum issued this week, DOJ argues that the court-appointed special master’s report, which was released in March, erred in determining that the agency had not presented enough evidence to support the main claims in the case. 
    • “In addition, DOJ alleges that the special master is also pushing to make California’s Central District Court “the first and only court in the nation to read a new requirement into the reverse False Claims Act.” In the report, it interprets a key phrase in the FCA as requiring “proof of an affirmative act of deception,” which DOJ says is “inconsistent with the text, structure and purpose of the FCA.” * * *
    • “In a statement, UnitedHealth emphasized that its “business practices have always been transparent, lawful and approved by our regulator, CMS.”
    • “After more than a decade of DOJ’s wasteful and expensive challenge to our Medicare Advantage business, the Special Master concluded there was no evidence to support the DOJ’s claims we were overpaid or that we did anything wrong,” the company said.
    • “A judge will now be tasked with ruling on whether the case will move forward.”

From the public health and medical research front,

  • Cardiovascular Business offers key takeaways from the 2025 conference of the American Association of Cardiologists.
  • Per an NIH news release,
    • “An artificial intelligence (AI)-driven screening tool, developed by a National Institutes of Health (NIH)-funded research team, successfully identified hospitalized adults at risk for opioid use disorder and recommended referral to inpatient addiction specialists. The AI-based method was just as effective as a health provider-only approach in initiating addiction specialist consultations and recommending monitoring of opioid withdrawal. Compared to patients who received provider-initiated consultations, patients with AI screening had 47% lower odds of being readmitted to the hospital within 30 days after their initial discharge. This reduction in readmissions translated to a total of nearly $109,000 in estimated healthcare savings during the study period.
    • “The study, published in Nature Medicine, reports the results of a completed clinical trial, demonstrating AI’s potential to affect patient outcomes in real-world healthcare settings. The study suggests investment in AI may be a promising strategy specifically for healthcare systems seeking to increase access to addiction treatment while improving efficiencies and saving costs.
    • “Addiction care remains heavily underprioritized and can be easily overlooked, especially in overwhelmed hospital settings where it can be challenging to incorporate resource-intensive procedures such as screening,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “AI has the potential to strengthen implementation of addiction treatment while optimizing hospital workflow and reducing healthcare costs.”
  • Per Cardiovascular Business,
    • “New research shows early-pregnancy blood pressure trajectories are strongly associated with new-onset hypertension years after pregnancy. This may help better stratify risk for targeted surveillance and early interventions, and improve the prediction of cardiovascular disease risk in women later in life. The study was published in the American Heart Association Journal Hypertension this week.[1]
    • “Blood pressure patterns observed in the first half of pregnancy, even among women without hypertensive disorders of pregnancy (HDP), can identify women at greater risk of developing hypertension up to 14 years after giving birth. The new findings are from a large observational study supported by the National Institutes of Health (NIH). Among groups of women who did not develop HDP, those with higher-risk blood pressure patterns, including elevated-stable patterns during early pregnancy, were still 11 times more likely to develop hypertension years later than those women with less risky blood pressure patterns.”  
  • Per HCP Live,
    • “Bariatric surgery improves survival and is cost-effective for patients with obesity and cirrhosis, compared to lifestyle modifications alone.
    • “Sleeve gastrectomy and Roux-en-Y gastric bypass show increased expected survival and quality of life benefits, despite higher initial costs.
    • “The study emphasizes the need for greater awareness and uptake of bariatric surgery, given its long-term health improvements and potential reductions in obesity-related comorbidities.”
  • Fierce Pharma tells us,
    • “The interim results of a phase 3 trial of Merck’s pulmonary arterial hypertension (PAH) treatment Winrevair were so conclusive that the company not only halted the study for efficacy but did the same two months later in another trial of the first-in-class activin signaling inhibitor.
    • “Merck has revealed data from the study, providing further evidence of the value of Winrevair, which has been approved in more than 40 countries, including in the U.S. a year ago. 
    • “The Zenith trial included 172 patients at the highest risk of mortality—those in the World Health Organization Functional Class (FC) III or IV—and achieved its primary endpoint of time to clinical worsening to first morbidity or mortality event.”
  • Medscape reports,
    • “A low-density lipoprotein cholesterol (LDL-C) level below 70 mg/dL was associated with a 26% reduced risk of all-cause dementia and a 28% lower risk of Alzheimer’s disease-related dementia (ADRD), with statin use further decreasing that risk, a new study suggests.
    • “While earlier research had suggested lower LDL levels may offer a protective advantage against dementia, these findings provide a specific target number, which investigators said could prove helpful in clinical practice. 
    • “These findings emphasize the importance of targeted LDL-C management as part of dementia prevention strategies, with potential integration into clinical guidelines,” lead investigator Yerim Kim, MD, PhD, Department of Neurology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea, and colleagues wrote.”

From the U.S. healthcare business front,

  • Fierce Healthcare takes a five year look back at the COVID 19 pandemic and how it impacted healthcare.
  • Beckers Payer Issues offer thoughts about “From volume to value: The shift in healthcare that’s helping put patients first.”
  • Plan Adviser lets us know,
    • “Research and investment provider Devenir LLC reported that health savings account balances rose 19% in 2024 from 2023 levels, reaching almost $147 billion. The number of accounts grew 5% last year, according to the firm’s year-end survey.
    • “The sustained growth in both assets and participation demonstrates a growing awareness among consumers and employers of HSAs’ long-term value in managing healthcare costs,” said Jon Robb, a Devenir senior vice president of research and technology, in a statement.”
  • Per Beckers Hospital Review
    • “California has the highest hourly mean wage for registered nurses in the U.S., and Oregon has the highest hourly mean wage for RNs after adjusted for cost of living, according to data published April 2 by the Bureau of Labor Statistics.
    • “[In the article you will find] the mean hourly and annual wages for nurses in 49 states and Washington, D.C., adjusted for cost of living. Becker’s calculated these figures using May 2024 salary data from BLS and 2024 cost of living index data from the World Population Review.” 
  • and
    • “Heritage Valley Kennedy Hospital in Kennedy Township, Pa., will close on June 30 due to declining patient volume and reduced insurance reimbursements, according to an April 2 news release shared with Becker’s.
    • “Following the closure, emergency care, outpatient surgery, and diagnostic services will shift to Heritage Valley’s Sewickley and Beaver locations, according to the report. Some services, including a walk-in clinic, X-rays and physical rehabilitation, will remain available at the adjacent medical office building.
    • “Heritage Valley said it is in talks with Encompass Rehabilitation about its leased 12-bed unit at Kennedy Hospital and is exploring partnerships to sustain behavioral health services in the area.”

Happy National Employee Benefits Day!

David Ermer–ACA, CDC, Congress, FDA, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

“National Employee Benefits Day is celebrated each year in April. The day recognizes trustees, administrators, benefits practitioners and professional advisors for their dedication to providing quality benefits and the important role they play in their colleagues’ well-being.”

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Republicans rallied behind a fiscal framework that allows more than $5 trillion in tax cuts over a decade, taking a crucial step toward turning President Trump’s agenda—tax cuts, border security and national defense—into law. 
    • “But the GOP budget resolution released Wednesday won’t be the final word along the complicated path to a major tax and spending bill. The plan employs a controversial accounting maneuver, postpones decisions about spending cuts and conflicts with a competing House plan. 
    • “The Senate is likely to vote on its budget later this week, but key House members are already objecting, warning that the Senate’s approach doesn’t guarantee the deep spending cuts they see as necessary.”
  • Modern Healthcare adds,
    • “The Senate Budget Committee unveiled a budget resolution Wednesday that could pave the way to less draconian cuts in health programs than House lawmakers previously proposed.
    • “The Senate proposal includes the House’s earlier recommendations that could lead to billions in health program cuts — but it also includes instructions for the Senate to go a different route while renewing tax cuts passed during President Donald Trump’s first term. The upper chamber’s resolution would delay sorting out differences with the House.
    • “The Senate’s budget resolution and negotiations with the lower chamber could provide for greater flexibility around healthcare cuts, which moderate Republicans in the House said they would not support if they were too steep. It also means the healthcare sector will have to wait to see what healthcare cuts — or spending — could be on tap until the Senate has done its work.”
  • Per a news release, “Today, Health, Employment, Labor, and Pensions Subcommittee of the House Education and Labor Committee held a hearing titled “A Healthy Workforce: Expanding Access and Affordability in Employer-Sponsored Health Care.”
  • Modern Healthcare points out,
    • “The Health and Human Services Department is restructuring agencies that enforce regulation, handle claims disputes, and investigate potential civil rights violations as part of a department-wide reorganization.
    • “A new assistant secretary for enforcement will oversee three parts of HHS — the Departmental Appeals Board, the Office of Medicare Hearings and Appeals and the Office of Civil Rights — as part of a sweeping overhaul announced last week. The new role raises questions about how HHS plans to handle billions of dollars in claims disputes and appeals resolutions, as well as how the offices will operate within the new structure. Healthcare attorneys are also watching for how HHS handles the operational elements of the reorganization, including staffing decisions and the chain of command at the affected offices.”
  • Fierce Healthcare lets us know,
    • “President Donald Trump made good on his threat of announcing new and steeper tariffs during a Wednesday afternoon White House event, setting the stage for higher prices and supply chain uncertainty for numerous industries including healthcare.
    • “The tariffs, set to go into effect at midnight, are the largest trade policy shift for the U.S. in decades and an end to the so-called free-trade era. They include a minimum 10% tariff that affects “all countries,” according to the White House. 
    • “Additionally, a slew of higher, individualized reciprocal tariffs will go into effect for dozens of countries with which the U.S. has a large trade deficit, the White House said. These are broadly designed to be around half of those imposed by most trade partners, including longtime allies.
    • “A 39% European Union tariff rate, for instance, will be matched by a 20% rate, the president explained. A 67% tariff imposed by China will see a reciprocal 34% tariff from the U.S.
    • “Pharmaceuticals are among a select list of goods that will not be subject to the higher reciprocal tariffs, according to a fact sheet released shortly after the signing ceremony and affirmed in the signed executive order. 
    • “The president also signed an order to close the “de minimis loophole,” a trade policy signed into law by Congress that allows shipments valued at less than $800 to be duty-free, for Chinese imports.”
  • Healthcare Dive points out,
    • “Enrollment in the Affordable Care Act marketplaces reached a new high in 2025, boosted by growth in states won by President Donald Trump in last year’s election, according to a research brief by KFF. 
    • “Sign-ups in the insurance marketplaces have more than doubled over the past five years, increasing from 11.4 million in 2020 to 24.3 million in 2025, the health policy research firm said Wednesday. 
    • “Much of the growth is linked to more generous federal financial assistance for the health plans first made available in 2021, according to KFF. But those enhanced premium subsidies are set to expire at the end of the year absent congressional action.”
  • The Wall Street Journal relates,
    • “Federal drug regulators have missed the deadline for making a key decision regarding a Covid-19 vaccine from Novavax, days after the Food and Drug Administration’s vaccine chief was pushed out.
    • “The agency was set to give full approval to Novavax’s shot, but senior leaders at the agency are now sitting on the decision and have said the Novavax application needed more data and was unlikely to be approved soon, people familiar with the matter said. 
    • ‘The FDA has allowed emergency use of Novavax’s Covid-19 vaccine. It set an April 1 deadline for a decision on whether to grant a normal, full approval, the people said.
    • “The decision would have cleared the vaccine’s continuing use though the pandemic emergency has passed. The FDA gave full approval to Covid-19 shots from Pfizer and its partner BioNTech and from Moderna in 2021 and 2022, respectively.
    • “Novavax said it is “continuing to communicate with the FDA and dialogue to ensure they have all the information required to complete our” application. 
    • “A Health and Human Services Department spokesman declined to comment. The FDA didn’t immediately respond to requests for comment.”

From the judicial front,

  • Bloomberg Law reports,
    • “Portions of a Tennessee law aimed at increasing pharmacy access are preempted by the federal employee benefits statute and can’t be enforced against certain self-funded employer health plans, a federal judge ruled.
    • “The law’s “any-willing-provider” requirement—which limits a plan’s ability to exclude pharmacies from its network—has an “impermissible connection” with benefit plans governed by the Employee Retirement Income Security Act, Judge Charles E. Atchley Jr. said Monday for the US District Court for the Eastern District of Tennessee. That’s because it dictates the scope of provider networks eliminates plans’ “discretion to shape benefits as they see fit,” he said.
    • “ERISA also preempts the Tennessee law’s prohibition on using financial incentives to promote or discourage use of a particular pharmacy, Atchley said, explaining that the law prevents ERISA-governed plans from “designing and providing benefits in a way that the plan determines best serves participants.”
    • “The decision is a victory for commercial bakery McKee Foods Corp., which initially filed suit to counter a campaign by defendant Thrifty Med Plus Pharmacy to be reinstated in the pharmacy network for McKee’s employee health plan.” * * *
    • “The case is McKee Foods Corp. v. BFP Inc., E.D. Tenn., No. 1:21-cv-00279, 3/31/25.”
  • The Wall Street Journal reports,
    • “The Federal Trade Commission’s [internal] lawsuit against three large pharmacy-benefit managers over insulin prices is on hold after President Trump fired two of the agency’s commissioners. 
    • “The FTC this week halted a lawsuit against the country’s largest drug middlemen, which negotiate drug prices for employers and insurers. The FTC said it needs to pause the litigation because its two remaining commissioners, both Republicans, are recused from the case, leaving none to oversee it.
    • “The antitrust enforcer in September 2024 sued Cigna’s Express Scripts, UnitedHealth Group’s Optum Rx and CVS Health’s CVS Caremark, accusing the firms of inflating the price of insulin. The lawsuit said firms profited by pocketing the discounts they had negotiated for the higher-priced insulin products they steered their customers to buy.
    • The FTC said in a court filing that the companies had agreed to put the case on hold for at least 105 days.”

From the public health and medical research front,

  • The AHA News informs us,
    • “A National Institutes of Health study published today found that blood pressure patterns observed during the first half of pregnancy can determine a woman’s risk of developing hypertension up to 14 years after giving birth. The study found that women showing certain blood pressure patterns during the first 20 weeks of pregnancy were more likely to develop hypertension years later. Researchers identified six risk groups of blood pressure trajectory that ranged from ultra-low to elevated-stable patterns. Women with elevated-stable patterns were at the highest risk.” 
  • Per Beckers Hospital Review,
    • “Lung cancer screening more than tripled after the U.S. Preventive Services Task Force expanded screening eligibility in 2021, according to a March 20 research letter published in JAMA Oncology.” * * *
    • “Read the full analysis here.” 
  • Nevertheless, MedPage Today cautions,
    • “Among eligible populations, screening for breast and colorectal cancers was nearly four times more common than for lung cancer.
    • “Among those who never had lung cancer screening, roughly 60% had undergone screening for breast and colorectal cancers.
    • “The findings suggest individuals eligible for low-dose CT screening may be receptive to efforts aimed at increasing uptake.”
  • Per Medscape,
    • “Two recent studies have added to the growing body of research suggesting consuming more dairy reduces a person’s risk of getting colorectal cancer.
    • “A prospective cohort study in Nature Communications published in January looked at the incidence of colorectal cancer (CRC) in more than 540,000 UK women over 16 years and found a 14% reduced risk for the cancer for every 200 g of dairy milk consumed per day. It also found an 8% reduced risk per 50 g of yogurt per day.
    • “The other study, from GutMicrobes, also published in January, looked specifically at yogurt intake with a focus on Bifidobacterium, a bacteria commonly found in yogurt. The researchers found that people who had at least two servings per week of yogurt had a 20% lower risk for Bifidobacterium-positive tumors than those who had less than one serving per month of yogurt, “suggesting the antitumor effect of yogurt intake on the specific tumor subgroup.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Jobs in the health insurance industry fell last year, something that hasn’t happened since 2009 and bucked an uptick in overall employment.
    • “It is a turning point for the industry, after years of profit growth and strategic expansions into pharmacy and provider businesses that increased headcount. Some of the largest publicly traded insurers reported steep workforce declines, according to a Modern Healthcare analysis of regulatory filings.
    • “Elevance Health, Humana, UnitedHealth Group and Centene cut their workforces, with the biggest reductions coming from the latter two companies. CVS Health and Molina Healthcare kept their workforce steady. Cigna grew its headcount nearly 1.4%.
    • “Across the seven companies, employment dipped 4.6% in 2024. Moreover, when not accounting for UnitedHealth Group, which reported a major reduction overseas, staffing among the other six still slipped 1.4%. National employment across all industries grew 1.2% last year, according to the Bureau of Labor Statistics.
    • “It was such a growth story for many years, and that’s tapered a little bit,” said Judy Busby, senior vice president and managing director of insurance staffing company The Jacobson Group.”
  • Per Beckers Hospital Review,
    • “Nonradiologists interpreted 43.6% of office-based imaging studies in 2022, according to a study published April 2 in the American Journal of Roentgenology. 
    • “Researchers from the Harvey L. Neiman Health Policy Institute analyzed more than 1.6 million Medicare physician office-based imaging claims ordered by nonradiologists. They found that just 36.4% of the studies were interpreted by a radiologist.” * * *
    • “For imaging type, nonradiologists interpreted 52% of ultrasound images, 5.3% of CT scans and 6.1% of MRIs. Smaller practices — those with one to nine providers — had a higher rate of self-interpretation than practices with 500 or more physicians.”Our results raise potential implications for quality of patient care,” Vijay Rao, MD, senior vice president of enterprise radiology at Philadelphia-based Jefferson Health and one of the study’s authors, said in a news release. “The large differences between radiologists and nonradiologists in interpretation training could lead to differences in diagnostic accuracy.”
  • Per MedTech Dive,
    • “Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark Bio, an alliance of academic institutions, hospitals and biotech companies founded in 2021 to help turn research ideas into broadly available genetic medicines.
    • “Landmark will continue to operate as a distinct entity, based in Watertown, Massachusetts. The acquisition by Artis BioSolutions will allow Landmark to scale up operations and “bring breakthrough therapies to more patients” Landmark CEO Ran Zheng said in a statement.
    • “Artis BioSolutions, backed by the venture capital firm Oak HC/FT, is now well positioned as a contract development and manufacturing organization for advanced therapies, the company said Wednesday. Artis BioSolutions said it can help customers speed up timelines, lower manufacturing costs and improve both product quality and supply chain management.”
  • The Wall Street Journal reports,
    • “Hims & Hers’s addition of obesity drug Zepbound won’t do much to bolster its weight-loss business, analysts say.
    • “Hims & Hers has been selling a compound GLP-1 for around $165 a month but will now offer the brand-name Zepbound for around $1,900 a month. Investors worry patients won’t make that price leap and that Hims, which has built its business on affordable healthcare, will struggle to meet its revenue goal.
    • “It’s probably unlikely that a compounded GLP-1 customer at Hims that’s paying $165 per month is going to transition to paying $1,900 per month for the fully branded,” Needham analyst Ryan MacDonald said. “There’s a question about how achievable the weight-loss revenue guidance is for 2025.”

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Trump administration began broad staff cuts at the Health and Human Services Department, locking some workers out of federal buildings and reassigning others to new agencies including the Indian Health Service.
    • “Emails notifying employees of cuts and reassignments flooded inboxes on Monday night and Tuesday morning. The move is part of Health and Human Services Secretary Robert F. Kennedy Jr.’s strategy to shrink and reshape the nation’s health agencies.
    • “The cuts extend far and wide, from the Food and Drug Administration and the National Institutes of Health to the Centers for Disease Control and Prevention. 
    • “On the social-media platform X, Kennedy said what the government had been doing wasn’t working: “We must shift course. HHS needs to be recalibrated to emphasize prevention, not just sick care. These changes will not affect Medicare, Medicaid, or other essential health services.” 
    • “An HHS spokesman said the cuts wouldn’t affect drug or food reviewers or inspectors. “This critical work continues,” he said.”
  • Per a Senate committee press release,
    • “Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Bernie Sanders (I-VT), ranking member of the HELP Committee, sent a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., inviting him to participate in a[n April 10, 2025,] HELP Committee hearing on the reorganization of HHS.”
  • Federal News Network adds,
    • “The departments of Agriculture, Defense, Energy, Transportation and Housing and Urban Development, as well as the Small Business Administration and the General Services Administration, have all restarted their deferred resignation programs, Federal News Network has confirmed.
    • “The “fork in the road” relaunch at those seven agencies comes at the same time many agencies are beginning to take on plans for conducting reductions in force (RIFs).”
  • Fierce Healthcare discusses what’s going on with Dr. Mezmet Oz’s efforts to be confirmed as CMS Director.
  • Healthcare Dive reports,
    • “Sens. Chuck Grassley, R-Iowa, and Ron Wyden, D-Ore., sent letters to HHS officials last week demanding the CMS and the Health Resources and Services Administration look into the growing problem of “line skipping” in organ donation, after media reports suggested patients were being passed over in the organ donation process in favor of less sick recipients.
    • “Reports from The New York Times, cited by the senators, found line skipping occurred in nearly 20% of transplants from deceased donors last year. For comparison, patients received out of order organ donations in about 2% of such donations in 2016, the letter said.
    • “The senators have charged the CMS and HRSA, which oversee organ procurement organizations, with explaining their process for monitoring organ distribution, and asked officials to provide transparency into any complaints the agencies might have received about line skipping since 2019.”
  • Per a Justice Department news release,
    • Today, Attorney General Pamela Bondi released the following statement:
      • “Luigi Mangione’s murder of Brian Thompson — an innocent man and father of two young children — was a premeditated, cold-blooded assassination that shocked America. After careful consideration, I have directed federal prosecutors to seek the death penalty in this case as we carry out President Trump’s agenda to stop violent crime and Make America Safe Again.”
      • “As alleged, Luigi Mangione stalked and murdered UnitedHealthcare executive Brian Thompson on Dec. 4, 2024. The murder was an act of political violence. Mangione’s actions involved substantial planning and premeditation and because the murder took place in public with bystanders nearby, may have posed grave risk of death to additional persons.   
      • “Following federal murder charges handed down on Dec. 19, 2024, Attorney General Bondi has now directed Acting U.S. Attorney Matthew Podolsky to seek the death penalty in this case.
      • “This is in line with Attorney General Bondi’s Day One Memo as Attorney General entitled Reviving The Federal Death Penalty And Lifting The Moratorium On Federal Executions.”

From the patient safety front,

  • The American Hospital Association News lets us know,
    • “As part of the AHA’s Patient Safety Initiative, a dedicated webpage features case studies showing how hospitals and health systems across the nation are implementing effective and innovative programs to create a culture of safety, improve staff well-being and connect with their communities. READ NOW.”

From the public health and medical research front,

  • Cardiovascular Business reports, “Embracing a healthy plant-based diet can help patients with obesity, diabetes and heart disease live longer, according to new research presented during ACC.25, the annual conference of the American College of Cardiology (ACC).”
  • Per MedPage Today,
    • “A diet involving fasting on three nonconsecutive days per week yielded a 6.37 lbs greater weight loss after a year than a daily caloric deficit.
    • “Both groups aimed for a total weekly energy deficit of 34%.
    • “Weight-loss differences were likely due to greater adherence to the intermittent fasting diet.”
  • This week’s issue of NIH Research Matters discusses “Diet and healthy aging | Peptide eye drops | Bacteria use antimicrobial agent.”
  • The Washington Post takes “a closer look at vitamin D’s role in gut health. Health-care providers often recommend meeting your vitamin D requirements through food rather than sun exposure.”
  • Per an NIH news release,
    • “A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness in patients with metastatic gastrointestinal cancers, according to results of a clinical trial led by researchers at the National Institutes of Health (NIH). The findings, published April 1, 2025 in Nature Medicine, offer hope that this therapy could be used to treat a variety of solid tumors, which has so far eluded researchers developing cell-based therapies.”
  • Health Day informs us,
    • “Surgery might not be needed in breast cancer patients whose tumors are wiped out by chemotherapy and radiation therapy
    • “31 women who had surgery after successful chemo and radiation treatment remained cancer-free five years later
    • “As many as 60% of early-stage breast cancers are completely eliminated by chemo and radiation prior to surgery, researchers noted.”
  • Consumer Reports, writing in the Washington Post, discusses “How to keep your memory sharp as you age. Simple habits can reduce your risk of memory loss and dementia — and slow cognitive decline.”
  • Per MedPage Today,
    • “A new blood-based test reflected Alzheimer’s tau tangle pathology.
    • “The assay measured a new plasma tau species known as endogenously cleaved MTBR-tau243.
    • “The test distinguished various stages of Alzheimer’s and separated it from non-Alzheimer’s tauopathies.” * * *
    • “This blood test clearly identifies Alzheimer’s tau tangles, which is our best biomarker measure of Alzheimer’s symptoms and dementia,” [Dr. Randall] Bateman said in a statement. The test also provides a good indication about whether a patient’s symptoms are due to Alzheimer’s or another disorder, he noted.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Hims & Hers is expanding its weight-loss offering on its telehealth platform with the addition of Eli Lilly’s LLY  Zepbound prescription and generic liraglutide.” * * *
    • “The telehealth-consultation platform on Tuesday said its aim is to bring customers more treatment options that best suit their needs.
    • “We’ve now expanded that choice even further by adding access to generic liraglutide and branded tirzepatide through our platform,” the company said.
    • “Hims & Hers’ platform already offers weight-loss brands including Novo Nordisk’s NOVO.B Ozempic and Wegovy.
    • The company said it plans to continue expanding its weight loss offering to deliver a more personalized experience to its customer base.
  • Per Beckers Hospital Review,
    • “Eli Lilly is broadening its direct-to-consumer approach by partnering with a digital health company, Noom, which is focused on weight management. 
    • “The collaboration connects Noom users with Eli Lilly’s pharmacy provider, GiftHealth, to facilitate access to Zepbound single-dose vials for individuals with a prescription, according to a March 31 Noom news release. 
    • “The integration also allows users to track prescription fill statuses and shipping dates within an app. Eli Lilly’s decision to offer Zepbound in a single-dose vial format for cash-paying patients is part of a broader effort to increase access to the weight loss drug.”
  • and
    • “Durham, N.C.-based Duke University Health System has completed its $284 million acquisition of Lake Norman Regional Medical Center and related businesses in Mooresville, N.C., from subsidiaries of Franklin, Tenn.-based Community Health Systems.
    • “Duke finalized the acquisition April 1. The 123-bed acute care hospital will be renamed Duke Health Lake Norman Hospital, according to a Duke Health news release.
    • “This is an exciting day for Duke Health and the Lake Norman team,” DUHS CEO Craig Albanese, MD, said in the release. “We have a bright future ahead and look forward to bringing the excellence and innovation of Duke Health to enhance the care offered at Duke Health Lake Norman Hospital and clinics.” 
  • Modern Healthcare relates,
    • “Novant Health, with MedQuest Associates, has signed an agreement to acquire 18 OrthoCarolina imaging centers in the Carolinas.  
    • “The deal, which closed March 31, involves 13 locations in the Charlotte region in North Carolina, three locations in the Winston-Salem region in North Carolina and two locations in South Carolina. MedQuest, which is owned by Novant, will manage day-to-day operations at the sites, according to a Tuesday news release.
    • “Financial details of the deal were not disclosed. 
    • “Winston-Salem-based Novant operates more than 900 care locations in the Carolinas, including 19 hospitals, about 750 physician clinics and other outpatient facilities. MedQuest operates more than 50 outpatient centers and mobile radiology units.”

Monday Report

David Ermer–FDA, Medical / Rx research, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The American Hospital Association (AHA) News tells us,
    • “The Department of Justice March 27 announced it is launching an Anticompetitive Regulations Task Force to advocate for “the elimination of anticompetitive state and federal laws and regulations that undermine free market competition.” The DOJ said its Antitrust Division is seeking public comments until May 26 on laws and regulations considered to be the most significant barriers to competition in markets such as health care, housing, transportation, food and agriculture, and energy.”

From the judicial front,

  • STAT News lets us know,
    • “A federal judge in Texas squashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds. 
    • “The Court VACATES and SETS ASIDE, in its entirety, the FDA’s Final Rule titled Medical Devices; Laboratory Developed Tests,” the ruling reads. “The Court remands this matter to the Secretary of Health and Human Services for further consideration.” * * *
    • “Laboratory scientists develop all kinds of tests, including ones looking for rare diseases or cancer, or examining prenatal genetics. Labs argue that their tests are not medical devices, but rather “professional health care services” that should not be subject to regulation. 
    • “Before President Trump took office, experts speculated that his administration might try to roll back the rule anyway given Trump’s deregulatory bent. But the U.S. Department of Justice attorney assigned to the Texas case robustly defended the LDT rule, indicating that the Trump administration was willing to stand by it. 
    • “The judge’s decision may have implications for FDA’s broader authority when it comes to regulating medical devices. The government may appeal the case to the U.S. Court of Appeals for the Fifth Circuit.” 
  • Bloomberg Law tells us,
    • “A federal judge rejected Johnson & Johnson’s third attempt to use bankruptcy to set up a multi-billion-dollar trust fund to pay women who claim they got cancer using baby powder and other products allegedly tainted with a toxic substance.
    • “The decision ends the controversial proposal which would have forced a settlement of almost all its talc-related cancer lawsuits. US Bankruptcy Judge Christopher Lopez dismissed the bankruptcy of a small J&J unit called Red River Talc following a two-week trial in Houston in which holdout cancer victims claimed a vote of victims was flawed.
    • “Lopez agreed and dismissed the case.
    • “The bankruptcy case is Red River Talc LLC , Bankr. S.D. Tex., No. 24-90505, 3/31/25.”

From the patient protection front,

  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Medtronic Aortic Root Cannulas due to a risk of unexpected loose material in the male luer used in the cannula. The loose material could become dislodged and cause serious injuries or death. The FDA said there have been no reports of injuries or death from the issue.”
  • Per MedTech Dive,
    • “Bausch + Lomb has recalled intraocular lenses in response to a growing number of reports that some patients are experiencing inflammatory reactions in their eyes, the company said Thursday.
    • “The company has seen a rise in reports of toxic anterior segment syndrome in recipients of its Envista Envy IOLs in the past few weeks, according to a letter to customers. In recent days, Bausch + Lomb received reports of TASS linked to Envista Aspire and Envista monofocal lenses.
    • “Bausch + Lomb is recalling all Envy and Aspire IOLs and certain lots of Envista monofocal lenses. J.P. Morgan analysts estimated 1% of total company sales could be at risk, but their counterparts at Evercore ISI outlined a scenario in which the issue could be resolved in the next six months.”

From the public health and medical research front,

  • The American Medical Association tells us ten things doctors wish women know about managing their health.
  • STAT News relates “Down to their heart cells, women and men have cardiovascular differences that matter. Men and women’s heart cells even prefer different kinds of fuel, new research shows.”
    • “Heart disease has long been the leading killer of adults, but beyond that stark fact, men and women diverge.
    • “From differences at the cellular level of the heart to circulatory structure to symptoms of distress and treatment, researchers are finding new manifestations of gender differences in cardiovascular disease. 
    • “Heart attacks look different in women than in stereotypically chest-clutching men, sending more diffuse pain shooting through the jaw, neck, arm, back, stomach, and more, all in ways that don’t scream “call 911.” Even where in the body a heart attack blocks blood flow is different: Microvessels in women get jammed, but it’s the larger arteries in men that starve the heart of oxygen. 
    • “The number and function of muscle cells in the heart differ, too. Women’s hearts have more cardiomyocytes than men, and their fuel tends to be more fatty acids as opposed to the sugars that male muscle cells prefer to burn, new research reveals. 
    • “All these differences have implications for diagnosis and treatment of cardiovascular disease.”
  • The AHA News informs us,
    • “A study published March 31 by the National Institutes of Health found that adults living in rural areas have worse cardiovascular health than those in urban communities due to social factors such as income, education, having enough food and owning a home. The agency found that those living in rural rather than urban areas were more likely to have heart disease (7% vs. 4%), high blood pressure (37% vs. 31%), high cholesterol (29% vs. 27%), obesity (41% vs. 30%) and diabetes (11% vs. 10%).”
  • The Wall Street Journal considers “If Vaccines Don’t Cause Autism, What Does? .”The risk of autism develops before we are even born.”
    • “Part of the frustration with autism risk is there isn’t much we can do to control it. Staying healthy during pregnancy, however, can help minimize risk.
    • “Janine LaSalle, a professor of microbiology and immunity at University of California, Davis, says there is evidence suggesting that maternal health risks—such as obesity, weight gained during pregnancy and gestational diabetes—can increase the risk of having a child with autism. 
    • “Another protective action pregnant moms can consider is taking a prenatal vitamin with folic acid and iron supplementation. This is especially important in the first month of pregnancy and so should be started when a woman is trying to conceive, says LaSalle. 
    • “If there was a single smoking gun it would have been found by now,” says LaSalle. “It really is the complexity of the formation of the human brain, and there’s just so many things that can influence it.”
  • MedPage Today notes,
    • “A patient navigation program significantly increased follow-up colonoscopy among those with an abnormal fecal immunochemical test (FIT) result.
    • “Ninety-four percent of patients who received navigation completed colonoscopy at 1 year versus 14% of those who received usual care.
    • “The trial was conducted at a community health center, suggesting results are applicable to real-world clinical settings.”
  • Beckers Clinical Leadership reflects on “Bariatric surgery’s next act: What 3 leaders expect.”
  • Per Beckers Hospital Review,
    • “Novo Nordisk’s diabetes pill Rybelsus, an oral semaglutide, reduced the risk of major heart-related events by 14% in adults with Type 2 diabetes and cardiovascular disease or chronic kidney disease, according to results from a stage 3 trial. 
    • “The findings, presented at the American College of Cardiology’s Annual Scientific Session in Chicago and published March 29 in the New England Journal of Medicine, showed that patients taking Rybelsus had a lower incidence of heart attacks, strokes and cardiovascular deaths compared to those taking the placebo. 
    • “Novo Nordisk has applied for regulatory approval to expand the Rybelsus label to include cardiovascular risk reduction, according to a March 29 news release from the company. The FDA and European Medicines Agency are reviewing the application with a decision anticipated in 2025.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Patient preferences for where to seek care have shifted in the post-pandemic era.
    • “The use of retail clinics and urgent care centers declined from 2022 to 2023, while emergency department use increased. Telehealth use also declined in that period, though it was still well above levels prior to the COVID-19 pandemic, according to a report from FAIR Health, a healthcare data company.
    • “To see where patients are going, FAIR Health analyzed its database of more than 50 billion claims records, which are provided by payers and administrators that handle claims for commercial plans. The report bases “use” on percentages of total medical claim lines, or the individual procedures listed on claims.
    • “FAIR Health Chief Operating Officer Thomas Swift said care sites are trying to find a new normal, and some of the changes in preferences may be part of the readjustment period.”
      • Retail clinic use is down.
      • Urgent care use also is down.
      • Emergency rooms are seeing growing demand.
      • Urgent care, medical offices have the highest prices.
      • Telehealth demand remains above pre-pandemic levels.
  • The Harvard Gazette adds,
    • “A new paper, published in JAMA Network Open, finds a surprising number of Americans traveling out-of-state for cancer care.
    • “The study, co-authored by Center for Geographic Analysis research associate Lingbo Liu, focuses on older adults whose treatment is covered by traditional Medicare, with the most striking results concerning rural Americans. Rural cancer patients in the study’s sample were about twice as likely as city-dwellers to cross state lines for surgical treatments. Rural residents were also three times more likely to leave the state for radiation and four times more likely for chemotherapy.
    • “These findings have important implications for healthcare fragmentation, or receiving services at more than one institution. Fragmentation, which is common with cancer care, is associated with communication gaps and decreased patient satisfaction. But telehealth has the potential to ease these concerns.
    • “When telehealth is used,” Liu offered, “it’s most likely to improve cancer care equity in rural areas and for the diverse populations within those areas.” 
  • Modern Healthcare tells us about microhospitals.
    • “What is a microhospital?
      • “A microhospital is a fully licensed, small-scale hospital that operates 24/7 and typically houses eight to 15 inpatient beds, in addition to emergency bays. There is no standard size for microhospitals, but they tend to be less than 50,000 square feet.
    • “What types of services do microhospitals provide?
      • “Microhospitals, also called neighborhood hospitals, can provide acute care, emergency services, surgeries, imaging and lab work to treat less complex conditions, such as broken bones or heart attacks. Higher-acuity trauma patients would be sent to a larger facility.
      • “Services at microhospitals fall between urgent care or ambulatory surgery centers and full-size traditional hospitals, said Joe Kight, head of healthcare for U.S. Bank’s institutional client group. The facilities are generally reimbursed for services at the same rate as a regular hospital.
    • “Who is investing in microhospitals?
      • “Many health systems, including Baylor Scott & White, Intermountain Health and CommonSpirit Health, have invested in microhospitals.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Journavx™, Vertex Pharmaceuticals) for the treatment of acute pain.”
    • “ICER’s report on this therapy was the subject of the February 2025 public meeting of the Midwest CEPAC, one of ICER’s three independent evidence appraisal committees. 
    • Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
    • “It has been a long time since we have had a new class of drugs for acute pain,” said ICER’s Chief Medical Officer David Rind, MD. “Suzetrigine has a different mechanism of action from prior oral therapies, and this creates options for treatment alone or in combination with existing medications. The overall value of this new drug is linked to the risk of a one-week course of opioids leading to opioid use disorder. If the risk is not zero and suzetrigine proves to be safe, we believe that suzetrigine will likely be a cost-effective, and perhaps a cost-saving, alternative from a long-term perspective. However, we note the skepticism about the evidence base from members of the Midwest CEPAC. Longer term data will help define the appropriate role of suzetrigine in practice, but a pain medicine with a new mechanism of action will create options for patients and clinicians.”
  • Per Fierce Pharma,
    • “Cigna’s Evernorth unit is expanding coverage for Neuronetics’ therapy for depression to adolescents.
    • “Neuronetics announced that Evernorth will offer coverage for its NeuroStar Transcranial Magnetic Stimulation (TMS) therapy to patients aged 15 and older who have major depressive disorder. The treatment uses magnetic pulses on different parts of the brain, offering an option for severe depression that does not have the same side effects as medication-based therapies.
    • “Per its website, more than 195,000 people have been treated with NeuroStar TMS, with 83% seeing significant improvement in their depression and 62% reporting full readmission.”
  • Beckers Hospital Review points out,
    • “Cigna’s Express Scripts has emerged as the largest pharmacy benefit manager in the U.S. by market share, overtaking long-time leader CVS Caremark, according to a March 31 report from the Drug Channels Institute.
    • “In 2024, Express Scripts handled 30% of all prescription claims, up significantly from 23% in 2023. Meanwhile, CVS Health’s CVS Caremark saw its share decline from 34% to 27% over the same period. Express Scripts’ growth was largely driven by a major contract win to manage pharmacy benefits for 20 million Centene members, previously served by CVS Caremark.
    • “Together with UnitedHealth Group’s Optum Rx, which processed 23% of claims, the three largest PBMs accounted for 80% of the total U.S. prescription claims market in 2024 — a one percentage point increase from 2023.”

Weekend Update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, OPM, Telehealth–
Texas bluebonnets now blooming in central Texas

From Washington, DC,

  • On April 3, 2025, at 10 am, ET, the Senate Homeland Security and Governmental Affairs Committee will hold a confirmation hearing for Scott Kupor, the President’s nominee for the position of OPM Director. The FEHBlog looks forward to Mr. Kupor’s confirmation.
  • Fierce Healthcare reports,
    • “Over three dozen healthcare associations and organizations penned a letter this week calling on House and Senate leaders for action on a bill bolstering foreign-born physician recruitment to underserved regions.
    • “The letters—which include the American Medical Association, the American Hospital Association and the Association of American Medical Colleges as signatories—speak to the Conrad 30 Waiver Program and its role in alleviating the nation’s worsening clinical workforce shortage.
    • “It allows foreign students who come to the U.S. for medical training immediately begin practicing in the U.S. by foregoing visa requirements that would force them to return to their home country for at least two years. In exchange, program participants are required to work full-time for at least three years in a medically underserved community.” * * *
    • “A pair of bills introduced in the House and Senate late last month and referred to their respective judiciary committees would reauthorize and “make necessary updates to strengthen the program,” the groups said.”
  • CMS is holding a virtual town hall meeting on April 30, 2025, from 10 am to 3 pm ET “for clinicians and researchers as well as other interested parties, such as patient advocacy organizations, patients, and caregivers, to share input relevant to the clinical considerations related to drugs selected for the second cycle of negotiations [under the Inflation Reduction Act].”

From the judicial front,

  • Govexec reports,
    • “President Trump can once again fire a key appointee who hears appeals of firings and suspensions of federal employees, putting the board on which she sits at risk of losing its functionality as the administration is pushing out large swaths of the federal workforce. 
    • “Cathy Harris, a Democrat nominated to the Merit Systems Protection Board by President Biden, was fired by Trump last month but quickly won reinstatement from a district judge. On Friday, a panel on the U.S. Court of Appeals for the D.C. Circuit in a 2-1 decision paused the lower court’s decision and said Trump could fire Harris. 
    • “The decision also applied to Gwynne Wilcox, a member of the National Labor Relations Board who Trump had fired, and a district court also reinstated. 
    • “If Harris is removed, MSPB would be left without a quorum. From 2017 to 2022, the board also lacked a quorum, which created a 3,500-case backlog that was only just recently eliminated. Due to an interim final rule established that same year, MSPB can conduct some actions without a quorum, though it cannot issue final decisions appealed to its central board.
    • “Zac Kurz, an MSPB spokesman, confirmed Friday evening that that the central board no longer has a quorum. While regional administrative judges can still issue initial rulings, the central board can no longer hear appeals of those rulings.”  

From the public health and medical research front,

  • The New York Times reports,
    • “As many as one in five people — an estimated 64 million in the United States — have elevated levels of a tiny particle in their blood. It can greatly increase the risk of heart attacks and strokes.
    • “But few know about it, and almost no doctors test for it, because there was not much to be done. Diet does not help. Neither does exercise. There have been no drugs.
    • “But in the near future, that may change.
    • “On Sunday [today], cardiologists announced that an experimental drug made by Eli Lilly, lepodisiran, could lower levels of the particle, Lp(a), by 94 percent with a single injection. The effects lasted for six months and there were no significant side effects.
    • “But it is not yet confirmed that reducing Lp(a) levels also reduces the risk of heart attacks and strokes. That awaits large clinical trials that are now underway.
    • “The Lilly research was presented Sunday at the annual meeting of the American College of Cardiology and simultaneously published in the New England Journal of Medicine. At least four other companies are also testing innovative drugs that block the body’s production of Lp(a), a mix of lipids and a protein.
    • “Dr. David Maron, a preventive cardiologist at Stanford not involved in the Lilly research, said the evidence of profound and long-lasting reduction in lipoprotein levels with lepodisiran was “thrilling.”
    • “Dr. Martha Gulati, a preventive cardiologist at Cedars-Sinai Medical Center also not involved in the trial, said the study was “really elegant.”
  • and
    • “Many people use a smartwatch to monitor their cardiovascular health, often by counting the number of steps they take over the course of their day or recording their average daily heart rate. Now, researchers are proposing an enhanced metric, which combines the two using basic math: Divide your average daily heart rate by your daily average number of steps.
    • “The resulting ratio — the daily heart rate per step, or DHRPS — provides insight into how efficiently the heart is working, according to a study conducted by researchers at the Feinberg School of Medicine at Northwestern University and published today in the Journal of the American Heart Association.
    • “The study found that people whose hearts work less efficiently, by this metric, were more prone to various diseases, including Type II diabetes, hypertension, heart failure, stroke, coronary atherosclerosis and myocardial infarction.
    • “It’s a measure of inefficiency,” said Zhanlin Chen, a third-year medical student at the Feinberg School of Medicine at Northwestern University and lead author of the new study; his coauthors included several Feinberg faculty physicians. “It looks at how badly your heart is doing,” he added. “You’re just going to have to do a tiny bit of math.”
  • NPR Shots tells us,
    • “As a measles outbreak in West Texas and New Mexico continues to grow, and other states report outbreaks of their own, some pediatricians across the U.S. say they are seeing a new trend among concerned parents: vaccine enthusiasm.
    • “Our call center was inundated with calls about the MMR [measles, mumps, rubella] vaccine,” says Dr. Shannon Fox-Levine, a pediatrician in Broward County, Fla. She says parents are asking if their child is up to date on their vaccinations. Or “should they get another vaccine? Should they get an extra one? Can they get it early?” * * *
    • “Interest in vaccinations has ramped up ahead of the spring break travel season, says Dr. Susan Sirota, a primary care pediatrician in the Chicago area.
    • “We have many patients calling us because they are traveling to either Texas or places near Texas, or states where they suspect that vaccination rates are lower than we have in Illinois,” Sirota says. “Many families are requesting early MMR [vaccines].” 
  • MedPage Today lets us know, “Transcatheter aortic valve replacement (TAVR) continued to hold its own against surgery for younger patients at low surgical risk, with the Evolut Low Risk trial now halfway to its goal of 10-year follow-up.”
  • Per Medscape,
    • “GSK said on Tuesday that it is studying a group of more than a million older adults in the UK to examine whether its best-selling shingles vaccine lowers the risk of dementia.
    • “The British drugmaker is using the health data of some 1.4 million people, aged 65 to 66, some of whom received its Shingrix shot and some who did not. 
    • “GSK’s chief scientific officer Tony Wood said the data, from the state-run National Health Service’s (NHS) large database, is a unique set of information because due to a tweak in the UK’s shingles immunization program there is effectively a naturally randomized trial already taking place.”
  • and
    • “High-dose oral cholecalciferol (vitamin D3) supplementation significantly reduced disease activity in patients with clinically isolated syndrome (CIS) suggestive of multiple sclerosis (MS) in the randomized, controlled D-Lay MS trial.
    • “Combined with data from previous studies on vitamin D as an add-on therapy, the results of the D-Lay MS trial, which show a stronger effect of vitamin D in patients with vitamin D deficiency compared to others, strongly suggest that patients with vitamin D deficiency should be supplemented, regardless of whether they are already under disease-modifying therapy,” Eric Thouvenot, MD, PhD, University Hospital of Nimes, Neurology Department, Nîmes, France, told Medscape Medical News.
    • “The study was published online on March 10 in JAMA.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health Care Service Corp. was limited to selling Blue Cross and Blue Shield policies, including Medicare Advantage plans, in Illinois, Montana, New Mexico, Oklahoma and Texas before the deal.
    • “After the Cigna acquisition, Health Care Service Corp. has a much bigger footprint and can offer Medicare Advantage in 25 more states and the District of Columbia, Part D nationally, and Medigap in 48 states and the District of Columbia. The insurer now counts 830,000 Medicare Advantage members, about four times as many as prior to the Cigna purchase.” * * *
    • “Moving up a weight class means facing dominant for-profit Medicare Advantage carriers such as UnitedHealth Group subsidiary UnitedHealthcare, Humana and CVS Health subsidiary Aetna head on. Those three insurers collectively cover 57% of Medicare Advantage enrollees, according to an analysis of Centers for Medicare and Medicaid Services data the investment bank Stephens published in February.”
  • Beckers Payer Issues adds,
    • “Moody’s has downgraded Health Care Service Corporation’s insurance financial strength rating to A3 from A2 following the company’s acquisition of Cigna’s Medicare business on March 19.
    • “Moody’s cited likely challenges with the integration of the MA business into the company’s primarily commercial insurance operations, along with ongoing headwinds within the MA industry more broadly.  
    • “Another concern is the limited experience the company has with making and integrating major acquisitions in the recent past,” analysts wrote. “The company expects to invest an estimated $1 billion over the next two years into updating systems and for working capital to ensure its success, but this may prove to be insufficient.”
  • Kauffman Hall explains how health systems can create a sustainable approach to corporate shared services.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • The American Hospital Association tells us,
    • The Trump Administration March 28 announced that it renewed for one year the public emergency for ongoing malicious cyber-enabled activities against the U.S. The national emergency was first issued in April 2015.”
  • Cyberscoop tells us,
    • “Many cyber experts are panning a new Trump administration executive order that would shift more responsibilities for responding to cyberattacks to state and local governments, saying it will leave states holding the bag for a job they aren’t best equipped to handle.
    • “The executive order, issued last week, is entitled “Achieving Efficiency Through State and Local Preparedness.” Its stated purpose is to improve defenses against cyberattacks and other risks, but many expect it will do the opposite.
    • “Federal policy must rightly recognize that preparedness is most effectively owned and managed at the State, local, and even individual levels, supported by a competent, accessible, and efficient Federal Government,” it reads. “Citizens are the immediate beneficiaries of sound local decisions and investments designed to address risks, including cyber attacks, wildfires, hurricanes, and space weather.”
    • “A number of cyber experts said it was a misguided document, sometimes in harsh terms, especially as it pertains to where they believe responsibilities should be assigned.”
  • Indiana University Professor Scott Shackleford, writing in the Wall Street Journal, offers ideas five federal cybersecurity reforms:
    • “The U.S. is spending more than ever on cybersecurity yet cyberattacks continue to proliferate.
    • “According to McKinsey, global losses to cyberattacks could exceed $10.5 trillion this year, a 300% increase from 2015 and an amount larger than the economies of Germany and Japan combined.
    • “I believe a new approach is needed—one in which the federal government plays a more assertive role.
    • “For at least two decades, U.S. cybersecurity policy has been stuck in a pattern of incremental tweaks focused on the same basic ideas—encouraging voluntary industry cooperation, offering information-sharing partnerships and establishing new bureaucratic offices. It isn’t working. We need bold changes, the most important of which is treating cybersecurity as a public good akin to national security and public safety.” 
  • FCW/NextGov informs us,
    • “The General Services Administration launched FedRAMP 20x Monday, an effort it is pursuing with industry to use more automation and cut red tape around the government’s cloud security assessment and authorization program. 
    • “The Federal Risk and Authorization Management Program, or FedRAMP, is used to ensure services offered by cloud providers meet certain cybersecurity requirements before government agencies can use them.
    • “Our partnership with the commercial cloud industry needs serious improvement. Strengthening this relationship will help us fulfill our commitment to cutting waste and adopting the best available technologies to modernize the government’s aging IT infrastructure,” Stephen Ehikian, acting administrator of the General Services Administration, which runs FedRAMP, said in a statement. “FedRAMP 20x will give agencies access to the latest technology now — not months or years down the road.”
  • Security Boulevard summarizes public comments on the proposed HIPAA Security Rule amendments and discusses next steps. The public comment deadline was March 7.
  • Bleeping Computer points out,
    • “The U.S. Department of Justice (DOJ) has seized over $8.2 million worth of USDT (Tether) cryptocurrency that was stolen via ‘romance baiting’ scams.
    • “Previously referred to as ‘pig butchering,’ in this type of financial fraud victims are manipulated into making investments on fraudulent websites/apps that showcase massive returns.”

From the cybersecurity vulnerabilities and breaches front,

  • Security Week lets us know,
    • “The National Institute of Standards and Technology (NIST) is still struggling to clear the growing backlog of CVEs in the official national vulnerability database and the problem will only get worse this year.
    • “That’s the gist of a fresh NIST update with an admission that the current pace of processing vulnerabilities is simply not enough to keep up with the surge in submissions.
    • “According to the update, while the National Vulnerability Database (NVD) is processing incoming CVEs at the same rate as before the slowdown in spring and early summer 2024, a 32 percent jump in submissions last year means that the backlog continues to grow.
    • “We anticipate that the rate of submissions will continue to increase in 2025,” the institute said, noting that it is exploring the use of AI and machine learning to automate certain processing tasks.”
  • The Cybersecurity and Infrastructure Security Agency added five known vulnerabilities to it catalog this week.
  • March 24, 2025
    • CVE-2025-30154 review dog action-setup GitHub Action Embedded Malicious Code Vulnerability
  • March 26, 2025
    • CVE-2019-9874 Sitecore CMS and Experience Platform (XP) Deserialization Vulnerability
    • CVE-2019-9875 Sitecore CMS and Experience Platform (XP) Deserialization Vulnerability
      • Security Affairs discusses the March 24 and 26 KVEs here.
  • March 27, 2025
    • CVE-2025-2783 Google Chromium Mojo Sandbox Escape Vulnerability
      • Bleeping Computer discusses a fix to this KVE here.
  • Cybersecurity Dive reports yesterday,
    • “Information security firms are taking measures to protect customers and their own networks as they wait for official guidance following claims of a massive attack against Oracle Cloud. 
    • “A threat actor last week claimed to have stolen 6 million data records, including user credentials, from Oracle Cloud, which could affect more than 140,000 customers. After initially releasing strong denials, Oracle has been silent this week, while security researchers have compiled evidence backing claims of an actual attack.” * * *
    • “Orca Security said it was initially skeptical of the reported breach and has not seen any confirmation that the hacker obtained user credentials. However, the firm did not consider Oracle’s initial denials to be fully transparent.
    • “We still believe that the risk outweighs our skepticism and that organizations should take immediate action to rotate credentials and otherwise protect their Oracle Cloud tenants as appropriate,” Neil Carpenter, field CTO at Orca Security, said via email.” 
  • and
    • “Researchers warn that three older vulnerabilities in DrayTek routers have been actively exploited in recent weeks, which coincides with widespread reports of devices automatically rebooting in recent days, according to GreyNoise Intelligence.  
    • “Researchers said exploitation activity has been observed against three vulnerabilities, tracked as CVE-2020-8515, CVE-2021-20123 and CVE-2021-20124. 
    • “GreyNoise researchers said they cannot directly link the exploitation to the reboots. However, in a post on X Wednesday morning, DrayTek said the reboots appear to be linked to vulnerabilities disclosed in early March.”
  • and
    • “A prolific Russian threat actor is exploiting a zero-day flaw in the Microsoft Management Console (MMC) framework to execute malicious code on targeted systems in an ongoing cyberattack campaign that puts unpatched systems at risk.
    • “The attacks, by a group that Trend Micro tracks as Water Gamayun, uses the CVE-2025-26633 vulnerability, also known as MSC Evil Twin, to manipulate .msc files and the MCC console’s Multilingual User Interface Path (MUIPath). From there the attacker, better known as EncryptHub, downloads and executes malicious payloads, maintains persistence and steals sensitive data from infected systems.
    • Microsoft patched MSC Evil Twin as part of its March Patch Tuesday raft of fixes on March 11. The flaw was still a zero-day when EncryptHub exploited it by executing malicious .msc files through a legitimate one, according to Trend Micro. The flaw allows an attacker to bypass a security feature in the MMC after convincing a victim to click on a malicious link or open a malicious file. The weakness stems from the console’s failure to properly sanitize user input.
  • Dark Reading reports,
    • “The rate of severe cloud security incidents affecting customers of Palo Alto Networks rose more than threefold over the course of 2024.
    • “By comparing the beginning and end of 2024, Palo Alto tracked a 388% increase in cloud security alerts affecting organizations. The overwhelming majority of that rise can be attributed to neither threats of a low severity (up 10% through the year) nor even medium-severity (up 21%), but high-severity incidents, which rose by a full 235%.
    • “The implication here is that malicious actors are not only attacking the cloud more often but also doing it more effectively.”
  • and
    • “Bypassing multifactor authentication isn’t hard, if you’re willing to get a little evil.
    • “Sophos researchers this week detailed how Evilginx, a malicious version of the widely used open source NGINX Web server, can be used in adversary-in-the-middle (AitM) attacks to steal credentials and authentication tokens. Perhaps more importantly, the hacking tool can beat MFA protection.
    • “Evilginx has been around for many years as an AitM framework for capturing user credentials, but security researchers have recently deployed the tool for more complex attacks. For example, Accenture security research Yehuda Smirnov last year developed a technique to beat Microsoft’s Windows Hello for Business by downgrading the authentication via an Evilginx attack.
    • “Smirnov demonstrated the technique at Black Hat USA 2024, and Microsoft issued a fix to prevent the attack. However, Sophos researchers say Evilginx can still be used to sweep up credentials and bypass MFA.”
  • Per Bleeping Computer,
    • “A newly discovered phishing-as-a-service (PhaaS) operation that researchers call Morphing Meerkat, has been using the DNS over HTTPS (DoH) protocol to evade detection.
    • “The platform also leverages DNS email exchange (MX) records to identify victims’ email providers and to dynamically serve spoofed login pages for more than 114 brands.
    • “Morphing Meerkat has been active since at least 2020 and it was discovered by security researchers at Infoblox. Although the activity has been partially documented, it went mostly under the radar for years.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Ransomware actors are increasingly abusing vulnerable drivers to craft tools known as “EDR killers,” which can disrupt and even delete extended detection and response products in enterprise networks, according to an ESET report published Wednesday.
    • “Threat actors abuse vulnerable drivers because they have kernel access to operating systems, which enables attackers to kill processes for security products like EDR before they can detect malicious activity.
    • “ESET researchers analyzed a custom tool called “EDRKillShifter,” which was developed and maintained by the notorious RansomHub ransomware gang and is now available on the dark web. The researchers observed an increase in the use of EDRKillShifter among other ransomware-as-a-service gangs such as Play, Medusa and BianLian.”
  • Beckers Health IT warns,
    • “The FBI and other federal authorities are warning healthcare organizations to safeguard against a ransomware group targeting the industry.
    • “The Medusa ransomware-as-a-service variant has been used to hack more than 300 victims from a variety of industries, including healthcare, most commonly through phishing campaigns and unpatched software vulnerabilities, according to a March cybersecurity advisory from the FBI, Cybersecurity and Infrastructure Security Agency, and Multi-State Information Sharing and Analysis Center.
    • “Medusa threat actors employ a “double extortion” model, where they both encrypt victims’ data and threaten to publicly release stolen information if their demands aren’t met, per the notice. They typically send ransom notes within 48 hours of an attack, offering to extend the deadline to pay by $10,000 a day.
    • “Healthcare organizations can protect against the threat by taking such steps as implementing a recovery plan, requiring multifactor authentication, and ensuring all operating systems, firmware and software are up to date, the agencies said.”
  • Per the Silicon Alley,
    • A new report out today from cybersecurity company SquareX Inc. is warning of a dangerous new evolution in ransomware: browser-native attacks that bypass traditional defenses and put millions of users at risk.
    • “Browser-based ransomware differs from traditional ransomware that relies on downloaded files to infect systems in that the ransomware operates entirely within the browser and requires no download. Instead, the attack targets the victim’s digital identity, taking advantage of the shift toward cloud-based enterprise storage and the fact that browser-based authentication has become the primary gateway to accessing these resources.
    • “In a case study published by SquareX last week, the attacks leverage AI agents to automate the majority of the attack sequence, requiring minimal social engineering and interference from the attacker.”
  • The Hacker News tells us,
    • “In what’s an instance of hacking the hackers, threat hunters have managed to infiltrate the online infrastructure associated with a ransomware group called BlackLock, uncovering crucial information about their modus operandi in the process. 
    • “Resecurity said it identified a security vulnerability in the data leak site (DLS) operated by the e-crime group that made it possible to extract configuration files, credentials, as well as the history of commands executed on the server.
    • ‘The flaw concerns a “certain misconfiguration in the Data Leak Site (DLS) of BlackLock Ransomware, leading to clearnet IP addresses disclosure related to their network infrastructure behind TOR hidden services (hosting them) and additional service information,” the company said.”
  • Security Week lets us know
    • “Ransomware Shifts Tactics as Payouts Drop: Critical Infrastructure in the Crosshairs
      Threats themselves change very little, but the tactics used are continually revised to maximize the criminals’ return on investment and effort.”

From the cybersecurity defenses front,

  • Cyberscoop reminds us,
    • “Despite glitches and possible funding potholes along the road, experts have nothing but praise and optimism for the CVE program’s future. “It’s not perfect by any means, but it has stood the test of time,” Art Manion, a longtime CVE expert and deputy director of ANALYGENCE Labs, speaking in his personal capacity, told CyberScoop. “A world without CVE in it would get pretty ugly.”
    • “MITRE’S Summers says, “It’s been 25 years of this program, and I don’t know if it’s possible to name another such public-private partnership program that has lasted that long and has continued to be so impactful in an ongoing way. I’m excited about the opportunity to continue evolving in ways that bring value to the community.”
    • “Empirical Security’s Roytman echoes the enthusiasm of his peers when he says, “The fact that we’ve gotten together as an industry and have this public good, and vendors build whole products off of it is wonderful and excellent and should continue to improve.”
  • Dark Reading offers “5 Considerations for a Data Loss Prevention Rollout; Strong DLP can be a game-changer — but it can also become a slow-moving, overcomplicated mess if not executed properly,” while SC Media provides “5 steps to protect against macOS security gaps.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Fierce Healthcare lets us know,
    • Bipartisan lawmakers have introduced a bill that aims to more closely align Medicare insurers’ prior authorization denials with medical need, as determined by board-certified specialist physicians.
    • The Reducing Medically Unnecessary Delays in Care Act of 2025 was introduced in the House Thursday by Rep. Mark Green, M.D., R-Tennessee, and referred to committee. It is a reintroduction of similar bills brought by the lawmaker in 2023 and 2022.
    • Green—along with Reps Greg Murphy, M.D., R-North Carolina, and Kim Schrier, M.D., D-Washington, who also backed the bill—said the legislation will help streamline necessary care and reduce administrative burden and burnout among providers.
  • Roll Call tells us,
    • “President Donald Trump on Friday threw his support behind the funding fix needed to allow the District of Columbia’s government to avoid $1.1 billion in budget cuts squeezed in the remaining half of the fiscal year, all but ensuring House passage of legislation the Senate passed two weeks ago.
    • “The full-year stopgap spending law, drafted by House Republicans, did not include the typical provision that would allow the D.C. government to tap into its fiscal 2025 budget for operating costs. This would force D.C. to go back to the previous year’s funding levels for the remainder of the fiscal year, which runs through Sept. 30, which local officials say would require steep cuts in critical services like law enforcement and education.”
  • STAT News reports,
    • “Peter Marks, the top Food and Drug Administration official who oversaw vaccines, gene therapies, and the blood supply, resigned Friday after being told by Trump administration officials he would be fired if he did not step down, according to people familiar with the situation.”
  • and
    • “President Trump has selected Sara Carter, a conservative journalist and Fox News contributor, as the nation’s next drug czar.” * * *
    • “If confirmed by the Senate, Carter would oversee the White House Office of National Drug Control Policy, an executive office housed across the street from the West Wing that makes policy recommendations and coordinates efforts between various federal agencies focused on substance use, both from a law enforcement and public health perspective.” 
  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today joined West Virginia Governor Patrick Morrisey for a press conference at the St. Joseph School in Martinsburg, WV, to celebrate the signing of new legislation banning seven types of harmful food dyes from school lunches beginning August 2025. Governor Morrisey announced at the event that he intends to request a waiver to restrict taxpayer funds from being used to purchase soda through the SNAP program.”

From the judicial front,

  • Healthcare Dive points out,
    • “The Department of Justice agrees that Claritev, formerly known as MultiPlan, conspired with health insurers to underpay doctors for medical care, according to a statement of interest filed by antitrust regulators on Wednesday in the consolidated lawsuit from providers against the cost management firm.
    • “Lawyers for the providers said the DOJ’s position affirms the validity of their case, while Claritev reiterated that it believes the lawsuits are without merit.
    • “The DOJ’s interest in the case signals antitrust regulators, including in the Trump administration, are still closely scrutinizing exchanges of potentially sensitive information between companies, along with their use of pricing algorithms.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “After much delay, Novartis has finally won a key FDA go-ahead for Pluvicto, opening up the radioligand therapy to a much broader prostate cancer population.
    • “The new approval, which triples Pluvicto’s eligible patient population, allows the radiopharmaceutical to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) before taxane-based chemotherapy, Novartis said Friday. Patients will have to have been treated with an androgen receptor pathway inhibitor (ARPI) to be considered.
    • “Pre-chemo mCRPC represents the most important indication in Novartis’ plan for Pluvicto to achieve more than $5 billion in peak sales. Initially cleared by the FDA in 2022 in the post-chemo setting, Pluvicto’s revenue is currently annualizing at about $1.5 billion based on its most recent quarterly number.”
  • and
    • Over the last three years, the FDA has approved six new hemophilia drugs, including three gene therapies.
    • Into this crowded treatment landscape comes another new medicine as the FDA has signed off on Sanofi’s Qfitlia (fitusiran), which sets itself apart as the only treatment for all types of hemophilia.
    • Not only is Qfitlia for those with hemophilia A and B, but unlike most treatments for the disorder, it also can be used by patients regardless of their inhibitor status.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.
    • “Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.” * * *
    • “This announcement follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.”
  • Per Managed Health Executive,
    • “Fresenius announced today [March 27, 2025] that the FDA has approved the biologics licensing applications (BLA) for denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), according to a news release. Prolia, the reference product for Conexxence, and Xgeva, the reference product for Bomyntra, were both developed by Amgen. As a result of a global settlement between Fresenius and Amgen, both biosimilars are expected to launch in the United States in mid 2025 and in the second half of 2025 in Europe.
    • “Bomyntra and Conexxence are the fourth pair of denosumab biosimilars. Other Prolia biosimilars include Jubbonti, Ospomyv and Stoboclo. Additional Xgeva biosimilars include Wyost, Xbryk and Osenvelt.
    • “Although the active drug ingredient in Conexxence and and Bomyntra is deosumab, they have different indications.
    • ‘Conexxence is approved for patients at high risk for fractures, including osteoporosis patients and patients undergoing cancer treatments that affect bone density. It comes as a 60 mg/mL single-dose prefilled injection to be administered every six months via subcutaneous injection. Adverse reactions varied by indication.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is declining nationally to low levels. 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 continues to decline; however, 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 American Hospital Association News adds,
    • “There are 483 confirmed cases of measles in 19 states across the country, according to the latest data from the Centers for Disease Control and Prevention. The agency said 93% of the cases are outbreak-associated. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • NBC News adds,
    • “We are experiencing an extremely concerning decline in measles vaccination in the very group most vulnerable to the disease,” said Benjamin Rader, a computational epidemiologist at Boston Children’s Hospital, an assistant professor at Harvard Medical School and the author of a recent study that looked at children’s vaccination rates.” * * *
    • “Rader said that the true MMR vaccination rate among young children can be misrepresented by publicly reported numbers, because MMR surveillance is drawn from older children who are already in kindergarten.
    • “Younger children under the age of 5 are not fully captured in surveillance data because they have not reached kindergarten age — although a 2021 estimate from the CDC notes a subset of younger children, namely those who received at least one MMR dose by 24 months, were 90.6% vaccinated for measles.
    • “In Rader’s study, published online in February in the American Journal of Public Health, his team surveyed approximately 20,000 parents of children under 5 from July 2023 through April 2024, finding only 71.8% reported that their children received at least 1 dose of MMR vaccine — much lower than CDC estimates.
    • “The researchers used a digital surveillance platform that the CDC has used to estimate things like at-home Covid testing, he said.  
    • “Rader downplayed the difference in numbers between his findings and the CDC data, emphasizing that, while accurate, the CDC data does not provide a complete picture — despite its best intentions.
    • “Dr. Scott Roberts, associate medical director of infection prevention at the Yale School of Medicine in New Haven, Connecticut, who was not part of the research, called the findings “worrisome.”   
  • Health Day relates,
    • “Tobacco control measures like anti-smoking campaigns and cigarette taxes have prevented nearly 4 million lung cancer deaths during the past five decades, a new American Cancer Society study estimates.
    • “More than 3.8 million lung cancer deaths were averted due to substantial reductions in smoking, gaining a little more than 76 million years of extra life among Americans, researchers say in CA: A Cancer Journal for Clinicians.
    • “The substantial estimated numbers of averted lung cancer deaths and person-years of life gained highlight the remarkable effect of progress against smoking on reducing premature mortality from lung cancer,” lead investigator Dr. Farhad Islami, the ACS’ senior scientific director for cancer disparity research, said in a news release. 
    • “In fact, the number of averted lung cancer deaths accounts for roughly one-half of all cancer deaths that were prevented in recent decades, researchers said.
    • “However,” Islami added, “Despite these findings, lung cancer is still the leading cause of cancer death in the United States, and smoking-attributable morbidity and mortality from other cancers or diseases remain high.”
  • Per Healio,
    • “There were 69 nonfatal fentanyl exposures in 2015 and 893 in 2023.
    • “Two-thirds of adolescents who were exposed to fentanyl used it intentionally.” * * *
    • “According to the researchers, nearly 39.4% of all overdoses and 65.7% of those among adolescents involved intentional misuse or abuse. In contrast, 81.7% of overdoses among younger children were reported to be unintentional.
    • “It was surprising that a large portion of adolescents used fentanyl intentionally,” Palamar said. “We often think of pediatric exposures to fentanyl as being unintentional.”

From the AI front,

  • Per an NSF news release,
    • “Powered exoskeletons that enable humans to move faster or lift heavy objects more easily have been envisioned for decades. In science fiction, advanced exoskeletons such as the power loader in the movie “Aliens” or Marvel Comics’ Iron Man’s suit provide the wearer with superhuman capabilities with nearly zero limitations.
    • “There are exoskeletons in use today, but current technology falls short of the vision laid out in science fiction, and widespread use of exoskeletons is hampered because to work properly, a suit must be tested and adapted to work with each user individually, a complicated and lengthy process.
    • “Now, engineering researchers supported by the U.S. National Science Foundation have made a breakthrough, creating a new method that takes advantage of artificial intelligence and computer simulations to improve the process of enabling users and exoskeletons to work together. This framework is compatible with a variety of assistive devices and could improve the lives of millions of able-bodied and mobility-impaired individuals.
    • “This marks a major advance in exoskeleton engineering by eliminating one of its biggest hurdles: individualized calibration,” said Alexander Leonessa, program director for the NSF Mind, Machine and Motor Nexus program. “Using AI and human-robot simulations, the team developed a scalable, adaptable system that assists a wide range of users without lengthy setup. It is a key step toward making exoskeletons practical, versatile and accessible for both industry and mobility-impaired individuals – smart, human-centered engineering at its best.”

From the U.S. healthcare business front,

  • FiercePharma reports,
    • “A rival bidder has emerged to acquire struggling gene therapy specialist bluebird bio.
    • Ayrmid has offered to buy bluebird for $4.5-apiece upfront, plus a one-time contingent value right (CVR) of $6.84 per share tied to a sales milestone, bluebird said Friday.
    • “The upfront tag is 50% higher than the $3-per-share selling price that bluebird has previously penned with Carlyle and SK Capital Partners. That private equity duo’s buyout offer also includes a $6.84-per-share CVR.
    • “For now, bluebird’s board has not changed its mind and the company remains bound by the original merger agreement. But it’s willing to look at the new unsolicited non-binding written proposal.
    • “Consistent with its fiduciary duties, the bluebird Board of Directors is carefully reviewing the Ayrmid proposal in consultation with its legal and financial advisors,” the Massachusetts biopharma said Friday.”
  • Beckers Hospital Review tells us,
    • “Insight Hospital and Medical Center Trumbull and Hillside Rehabilitation Hospital, both in Warren, Ohio, paused all inpatient, outpatient and emergency room services March 27 due to ongoing bankruptcy and financial disruptions from former owner Dallas-based Steward Health Care.
    • “Tom Connelly, local president of the American Federation of State, County and Municipal Employees, told NBC affiliate WFMJ March 28 that the hospitals also laid off the director of nursing, the assistant director of nursing, the administrative secretary and the human resources coordinator.
    • “A spokesperson for Insight Health refuted the claims to Becker’s and denied upper management layoffs.
    • “Existing patients at both Insight hospitals are being transferred, with appointments being canceled to protect patient safety, an Insight Health spokesperson said in a March 27 statement shared with Becker’s.
  • Beckers Payer Issues informs us,
    • “Enrollment in provider-sponsored Medicare Advantage plans declined by nearly 60,000 members for 2025, according to a report from Chartis. 
    • “The healthcare consulting firm published an analysis of CMS Medicare Advantage enrollment data March 25. 
    • “Overall, Medicare Advantage plans gained 1.3 million new enrollees, a smaller growth rate than the program has seen in previous years. 
    • “Kaiser Permanente saw the largest membership growth for 2025 among provider-sponsored plans, gaining 58,000 new members. Trinity Health and UPMC Health Plan each added 11,000 MA members.” 

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call lets us know,
    • “Senate Majority Leader John Thune told GOP senators Wednesday that a compromise budget resolution could hit the floor for a “vote-a-rama” as soon as next week, which would allow the House to adopt it the following week before the two-week April recess.
    • “This accelerated time frame, if both chambers can adhere to it, would let Republicans hit the ground running after the recess to write the “big, beautiful” budget reconciliation bill that President Donald Trump wants.
    • “Speaker Mike Johnson, R-La., has set an informal deadline of Memorial Day to send the measure to Trump, including a massive tax cut package, more money for defense and border security, domestic energy incentives, a debt limit increase and trims to mandatory spending.
    • “As recently as Tuesday, Thune, R-S.D., had been telling colleagues that Senate consideration could slip to the week of April 7, which likely wouldn’t give the House time to act before the recess.
    • “But discussions made a big leap on Wednesday with a new strategy: provide a different, lower set of spending cut targets for Senate committees than their House counterparts. Under this scenario, the final budget resolution adopted by both chambers would “instruct” House and Senate committees differently.” * * *
    • “Both sets of instructions would be in the final budget resolution, and then the two chambers could hammer out differences later on what the actual reconciliation details look like.
    • “What needs to ultimately be reconciled is the final bill. The resolution’s looking different in two chambers, I don’t think anybody’s getting worked up about that,” Sen. Eric Schmitt, R-Mo., said Wednesday. “But eventually everybody does kind of need to unlock the process, which is what the resolution is for.”
    • “The working theory is that eventually what matters for “Byrd rule” enforcement in the Senate is whether that chamber’s reconciliation instructions are adhered to.”
  • and
    • “President Donald Trump on Thursday announced he would withdraw the nomination of New York Rep. Elise Stefanik to be U.S. ambassador to the United Nations, citing a need for Republicans to keep her seat amid narrow margins in the House. 
    • “With a very tight Majority, I don’t want to take a chance on anyone else running for Elise’s seat,” Trump posted on his Truth Social platform. “The people love Elise and, with her, we have nothing to worry about come Election Day. There are others that can do a good job at the United Nations.”
  • The American Hospital Association News tells us,
    • “The AHA March 27 voiced opposition to the Physician Led and Rural Access to Quality Care Act (H.R. 2191), a bill that would lift the ban on the establishment of physician-owned hospitals in certain rural areas and permit the unfettered expansion of POHs nationwide, regardless of location. In place since 2010, current law includes an exceptions process that allows existing POHs to expand if they accept Medicaid patients and are located in areas where beds are needed. 
    • “By performing the highest-paying procedures for the best-insured patients, physician-owners inflate health care costs and drain essential resources from community hospitals, which depend on a balance of services and patients to provide indispensable treatment, such as behavioral health and trauma care,” AHA wrote in comments to Rep. Morgan Griffith, R-Va., the bill’s author. “By increasing the presence of these self-referral arrangements, H.R. 2191 would only further destabilize community care.” 
  • Per a news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”
    • “The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.
    • “Secondly, it will streamline the functions of the Department. Currently, the 28 divisions of the HHS contain many redundant units. The restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to 5.
    • “Third, the overhaul will implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins. These priorities will be reflected in the reorganization of HHS.
    • “Finally, the restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact.” * * *
    • For more detailed information, please visit our fact sheet.
  • The HHS reorganization is worth a shot in view of the thirty yearlong federal budget outlook from the Congressional Budget Office.
  • Tammy Flanagan, writing in Govexec, offers federal retirement advice in these uncertain times.

From the public health and medical research front,

  • Medpage Today informs us,
  • and
    • “A flea-borne disease that was once largely eradicated from the U.S. may be making a resurgence, CDC researchers said during a clinician-focused call on Thursday.
    • “Murine typhus became so rare after public health efforts against it in the 1940s that it eventually stopped being a nationally notifiable disease.
    • “But now, cases are on the rise in two states that actively monitor the disease — Texas and California — and the illness may be going undiagnosed, experts said.”
  • Per a National Cancer Institute news release,
    • “Scientists have long been exploring ways to kill cancer cells by starving them of the nutrients they need to survive. A new study suggests that genetically modified fat cells could help researchers realize this goal.
    • “In the study, researchers genetically engineered white fat cells—the most common type of fat in the body—to aggressively consume nutrients such as glucose and fatty acids. When the engineered fat cells were implanted near tumors in mice, the tumors grew more slowly than tumors in mice without the engineered cells.
    • “The approach slowed the growth of cancer in mice even when the engineered fat cells were implanted far from a tumor, the researchers reported in Nature Biotechnology on February 4. 
    •  “We believe the engineered cells are outcompeting tumors for essential nutrients, suppressing the proliferation of cancer cells,” said study leader Nadav Ahituv, Ph.D., director of the University of California, San Francisco (UCSF) Institute for Human Genetics. “The findings suggest that engineered fat cells could be a new form of cellular therapy.”
  • Per Healio,
    • “Survivors [of metastatic breast cancer] who participated in [telephone-delivered] acceptance and commitment therapy reported less fatigue interference with functioning.
    • “Researchers are studying the approach for people with advanced gastrointestinal cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Nonprofit hospitals’ 2024 financial performances are beating the prior year’s tough numbers, though even the stronger organizations remain “well below pre-pandemic levels,” Fitch Ratings said.
    • “In a Thursday brief describing the financial profiles of its rated nonprofit hospitals, the agency attributed the year-to-year improvements to stronger revenues and volumes as well as slightly mitigated, but still pressured, labor spending.
    • “Fitch said the median operating margin among hospitals with early fiscal year ends (often June 30) was 1.2%, a flip from the prior year’s -0.5%. The agency said it expects the calendar year 2024 median margin for the remainder of its rated hospitals “will at least be in line” with the former group.”
    • “Persistent” labor pressures continue to push base salary and wage expenses upward by a median 6.9% among the rated hospitals, which Fitch said “would have been even higher without the sector’s ongoing efforts to recruit and retain talent, streamline operations and optimize supply chains.”
  • Beckers Hospital Review notes,
    • “Doylestown (Pa.) Health will officially join the University of Pennsylvania Health System on April 1, marking a significant expansion of Penn Medicine’s reach into Philadelphia’s northern suburbs. 
    • “The transaction follows regulatory reviews and approvals from the Pennsylvania Attorney General’s Office and the Federal Trade Commission.
    • “Under the new structure, Doylestown Health and its affiliates will be rebranded as Penn Medicine Doylestown Health. The integration combines one of the country’s leading academic health systems with a regional health system.” 
  • and
    • “Four blockbuster GLP-1 medications are expected to be among the 10 best-selling drugs in 2026, accounting for $66.8 billion in global sales, according to market research company Statista
    • “Statista predicts Ozempic will yield $22.3 billion in 2026, followed by Mounjaro with $19.8 billion, Wegovy with $13.4 billion and Zepbound with $11.3 billion.” 
  • Modern Healthcare reports,
    • “When Florida Blue wanted its call center employees to demonstrate greater emotional intelligence when dealing with customers, the nonprofit health insurance company enlisted a tutor incapable of emotion.
    • “A generative artificial intelligence, or genAI, chatbot instructs 30 Florida Blue customer service representatives on how to behave like human beings when interacting with other human beings. The chatbot guides workers on human behaviors, such as when to slow their speech, when to hasten a call to its conclusion and what to recommend to policyholders. The company plans to expand this pilot program to its entire 1,600-person call center team this year.
    • “A lot of the time, people carry emotion into calls with health insurers. When you’re upset, it just comes out. One of the prompts is to remind the advocate, ‘Hey, this member appears to be stressed. Make sure you’re pausing and listening to them,’” said Anne Hoverson, vice president of digital transformation at Florida Blue, a subsidiary of Guidewell.
    • “Insurance companies already used genAI for processing claims, predicting clinical needs and performing administrative functions, but this latest trend is different, said Josh Streets, a senior consultant at the International Customer Management Institute, which advises business on call centers.”
  • and
    • “GE HealthCare announced Thursday the commercial launch of Flyrcado, its PET imaging agent that assesses blood flow to the heart muscle, in select U.S. markets.
    • “The Centers for Medicare and Medicaid Services granted Flyrcado pass-through status starting April 1, allowing separate payments for the imaging agent and the PET/CT scan in hospital outpatient settings.
    • “In late September, the company announced that Flyrcado received Food and Drug Administration approval to detect coronary artery disease. It provides more accurate diagnostics than SPECT imaging, the current standard in cardiac nuclear medicine imaging, according to GE HealthCare.
    • “Since Flyrcado has a half-life of 109 minutes, which is significantly longer than other similar PET imaging agents, healthcare facilities don’t need to produce it on-site. Instead, it can be manufactured at off-site pharmacies and delivered as needed.”