Weekend update

David Ermer

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

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • Congress returns to Capitol Hill tomorrow following a two week long District / State work break.
  • Here is a link to this week’s calendar of Senate and House of Representatives committee business.
  • Roll Call offers an overview of this week’s activities.
    • “President Donald Trump is scheduled to meet at the White House Monday afternoon with Speaker Mike Johnson, beginning the first of several key legislative weeks for the president’s immigration, economic and tax policy agenda.”
  • Per a House Oversight Committee press release issued last Friday,
    • “House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) announced a markup will take place on Wednesday, April 30th at 10:00 a.m. ET to consider budget legislation to advance President Trump’s agenda to provide tax relief for American families and small businesses, rein in wasteful spending, and reduce the federal budget deficit for the American taxpayers. The House Oversight Committee’s budget reconciliation instructions require a net reduction in the federal deficit of no less than $50 billion and reforms to help balance the federal budget. Following the markup, the Committee will finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • The list of measures to be included in the markup includes
    • “SEC. 90006. FEHB PROTECTION –– Requires a comprehensive audit of employee dependents currently enrolled in FEHB plans—such as verifying marriage certificates and birth certificates—and requires any ineligible individual found to be receiving FEHB coverage be disenrolled. ($1.5 billion in net savings).”
  • This measure unfortunately overlooks the fact that OPM can but chooses not to use the HIPAA 820 electronic enrollment roster which would allow carriers to reconcile each enrollee with his / her premium payments. What is the sense of confirming family member eligibility if you don’t know whether the enrollee is paying the correct premium?
  • Federal News Network interviews Kevin Moss about what to expect from the FEHB / PSHB in 2026. What’s missing from OPM’s call letter and technical guidance? New cost containment measures.

From the public health and medical research front,

  • The New York Times reports,
    • “When a person develops solid tumors in the stomach or esophagus or rectum, oncologists know how to treat them. But the cures often come with severe effects on quality of life. That can include removal of the stomach or bladder, a permanent colostomy bag, radiation that makes patients infertile and lasting damage from chemotherapy.
    • “So a research group at Memorial Sloan Kettering Cancer Center, using a drug from the pharmaceutical company GSK, tried something different.
    • “The researchers started with a group of 103 people. The trial participants were among the 2 to 3 percent of cancer patients with tumors that should respond to immunotherapy, a drug that overcomes barriers that prevent the immune system from attacking cancers.
    • “But in clinical trials, immunotherapy is not supposed to replace the standard treatments. The researchers, led by Dr. Luis A. Diaz Jr. and Dr. Andrea Cercek, decided to give dostarlimab, an immunotherapy drug, on its own.” * * *
    • “In 49 of the patients, who had rectal cancer, the tumors disappeared and, after five years, have not recurred. Cancers also vanished for 35 of 54 patients who had other cancers, including in the stomach, esophagus, liver, endometrium, urinary tract and prostate.
    • “Out of all 103 patients, cancers recurred in only five. Three got additional doses of immunotherapy and one, whose tumor recurred in a lymph node, had the lymph node removed. Those four patients so far have no evidence of disease. The fifth patient had additional immunotherapy that made the tumor shrink.
    • “The investigators reported their results Sunday at the annual meeting of the American Association for Cancer Research and in a paper published in The New England Journal of Medicine.
    • “The results, said Dr. Bert Vogelstein, an oncologist at Johns Hopkins in Baltimore, are “groundbreaking.”
  • Medscape tells us,
    • “Malnutrition-related diabetes, distinct from both type 1 and type 2, has now been officially recognized and named “type 5 diabetes.”
    • “The vote to endorse the category took place on April 8, during the International Diabetes Federation’s (IDF’s) World Diabetes Congress, held in Bangkok, Thailand. In January 2025, a panel met in India to draft a consensus statement about the condition, due to be published soon, Meredith Hawkins, MD, professor of medicine at Albert Einstein College of Medicine, Bronx, New York, told Medscape Medical News.
    • “Malnutrition-related diabetes has historically been vastly underdiagnosed and poorly understood…The IDF’s recognition of it as ‘type 5 diabetes’ is an important step toward raising awareness of a health problem that is so devastating to so many people,” Hawkins said.”
  • The New York Times Well site provides a personalized protein target and protein counter. Check it out.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “The Cybersecurity and Infrastructure Security Agency will soon have a new second-in-command.
    • “Madhu Gottumukkala has been named deputy director. He comes over to CISA from his prior position in the South Dakota government, where Kristi Noem was most recently governor before taking over as secretary of the Department of Homeland Security. Gottumukkala had been commissioner of the Bureau of Information and Telecommunication (BIT) and state chief information officer.
    • “He’ll leave BIT on May 16. A CISA spokesperson confirmed that Gottumukkala would become deputy director of the agency.”
  • CISA gives us the results of the President’s Cup competition and also announced on April 23,
    • “The [Critical Vulnerabilities and Exposures] CVE Program is an invaluable public resource relied upon by network defenders and software developers alike. As the nation’s cyber defense agency, it is a foundational priority for CISA. Recent public reporting inaccurately implied the program was at risk due to a lack of funding. To set the record straight, there was no funding issue, but rather a contract administration issue that was resolved prior to a contract lapse. There has been no interruption to the CVE program and CISA is fully committed to sustaining and improving this critical cyber infrastructure. 
    • CISA is proud to be the sponsor for the CVE program, a role we have held for decades. During this time, the CVE Program has gone through many evolutions, and this opportunity is no exception. MITRE, CISA, and the CVE Board have transformed this program into a federated capability with 453 CVE Numbering Authorities (CNAs). This growth has enabled faster and more distributed CVE identification, providing valuable vulnerability information to the public and enabling defenders to take quick action to protect themselves. We have historically been and remain very open to reevaluating the strategy to support the continued efficacy and value of the program.  
    • We also recognize that significant work lies ahead. CISA, in coordination with MITRE and the CVE Board, is committed to actively seeking and incorporating community feedback into our stewardship of the CVE Program. We are committed to fostering inclusivity, active participation, and meaningful collaboration between the private sector and international governments to deliver the requisite stability and innovation to the CVE Program. And we are committed to achieving these goals together.
  • Bleeping Computer tells us,
    • “The FBI has asked the public for information on Chinese Salt Typhoon hackers behind widespread breaches of telecommunications providers in the United States and worldwide.
    • “In October, the FBI and CISA confirmed that the Chinese state hackers had breached multiple telecom providers (including AT&T, Verizon, Lumen, Charter Communications, Consolidated Communications, and Windstream) and many other telecom companies in dozens of countries.
    • “As revealed at the time, while they had access to the U.S. telecoms’ networks, the attackers also accessed the U.S. law enforcement’s wiretapping platform and gained access to the “private communications” of a “limited number” of U.S. government officials.”
  • The HHS Office for Civil Rights announced,
    • “Today [April 25], the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Comprehensive Neurology, PC (Comprehensive), a small New York neurology practice, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. The settlement resolves an OCR investigation of a [2020] ransomware attack against Comprehensive.” * * *
    • “Under the terms of the settlement, Comprehensive agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $25,000 to OCR.”
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-hipaa-racap-np.pdf, opens in a new tab [PDF, 245 KB]“
  • and
    • “Today [April 23], the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with PIH Health, Inc. (PIH), a California health care network, over potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The violations stem from a phishing attack that exposed unsecured electronic protected health information (ePHI), prompting concerns related to the Privacy, Security, and Breach Notification Rules under HIPAA.” * * *
    • “The settlement resolves an investigation that OCR conducted after receiving a breach report from PIH in January 2020. The breach report stated that in June 2019, a phishing attack compromised forty-five of its employees’ email accounts, resulting in the breach of 189,763 individuals’ unsecured ePHI. PIH reported that the ePHI disclosed in the phishing attack included affected individuals’ names, addresses, dates of birth, driver’s license numbers, Social Security numbers, diagnoses, lab results, medications, treatment and claims information, and financial information.”
    • “Under the terms of the resolution agreement, PIH has agreed to implement a corrective action plan that will be monitored by OCR for two years and paid a $600,000 settlement to OCR.” * * *
    • The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance enforcement/agreements/index.html.

Three important reports were released this week.

  • Per Cyberscoop,
    • “It looks like 2024 was a record year in cybercrime for all the wrong reasons, according to the FBI’s annual Internet Crime Complaint Center (IC3) report released Wednesday. 
    • “As cyber-enabled fraud and ransomware continue to harm individuals, businesses, and critical infrastructure, the report, now in its 25th year, provides crucial insight into evolving criminal tactics and their nationwide impact. The report is overflowing with key trends, case data, and other statistics from the FBI’s ongoing efforts to combat the cyberthreat landscape.”
  • and
    • “Cybercriminals and state-sponsored threat groups exploited vulnerabilities and initiated ransomware attacks with vigor last year, escalating the scope of their impact by hitting more victims and outmaneuvering defenses with speed.
    • “The rate of ransomware detected in data breaches jumped 37%, occurring in 44% of the 12,195 data breaches reviewed in Verizon’s 2025 Data Breach Investigations Report released Wednesday. Researchers observed the presence of ransomware in 32% of data breaches in last year’s report. 
    • “Verizon’s research underscores the twists and turns of cybercriminal activity and its wide-reaching impact on organizations. “We see less payment activity,” Alex Pinto, associate director of threat intelligence at Verizon Business, told CyberScoop, “but we don’t see it slowing down.”
  • Per Cybersecurity Dive,
    • “Threat actors motivated by financial gain continue to rise in prominence, representing 55% of all cyber actors during 2024, according to a report by Mandiant. The figures show a steady increase from 52% in 2023 and 48% in 2022. 
    • “Exploits remained the most common initial access vector for the fifth consecutive year, representing 33% of exploits overall, according to the Mandiant M-Trends 2025 report. However, stolen credentials become the second most common initial access point for the first time, indicating a rising trend. 
    • “Cyber threat groups are increasingly targeting unsecured data repositories as poor security hygiene continues to leave organizations at risk.”

From the cyber vulnerabilities and breaches front,

  • Healthcare Dive reports,
    • “A data breach at Yale New Haven Health has exposed the information of about 5.6 million people, according to a report submitted to federal regulators earlier this month.
    • “The Connecticut-based health system detected unusual activity on its IT systems in early March, Yale New Haven said in a press release. An investigation later found an unauthorized third party had gained access to its network and stole copies of some patient data. 
    • “The incident is the largest healthcare breach reported to federal regulators so far in 2025, according to a portal managed by the HHS’ Office of Civil Rights.”
  • and
    • “A data breach at Blue Shield of California exposed information from 4.7 million people, according to a notice filed with federal regulators earlier this month. 
    • “In February, the insurer learned that Google Analytics, a vendor Blue Shield employs to track use of its websites, was sharing member data with the advertising service Google Ads from April 2021 through January 2024, according to a breach notice. 
    • “Blue Shield can’t confirm whether any particular beneficiary’s information is affected due to “the complexity and scope of the disclosures,” so the insurer is notifying all members who could have accessed their information on affected websites during the nearly three-year period.” 
  • Cybersecurity Dive tells us,
    • “Conduent Inc. warned in an April 14 regulatory filing with the Securities and Exchange Commission that a “significant” number of people had their personal data stolen in a January cyberattack that affected a limited number of the company’s clients.
    • “The company, a major government payments technology vendor for social services and transit systems, was targeted in a Jan. 13 attack that disrupted certain operations. 
    • “The company warned it has incurred and accrued a material amount of nonrecurring expenses related to the breach. A spokesperson for the company did not have specific numbers yet, but a breach notification has already been posted by the California Attorney General’s office.”
  • andInfor
    • Threat groups from across the globe are increasingly weaponizing older vulnerabilities for exploitation, according to a report released Wednesday by GreyNoise Intelligence. 
    • More than half of these resurgent vulnerabilities affect edge technologies, the report shows. Nearly seven out of 10 of the most unpredictable vulnerabilities — known as Black Swan vulnerabilities — affect edge technologies.
    • Almost 40% of Black Swan vulnerabilities specifically affect VPNs and routers, according to the report.
  • Per Cyberscoop,
    • “Attackers exploited nearly a third of vulnerabilities within a day of CVE disclosure in the first quarter of 2025, VulnCheck said in a report released Thursday. The company, which focuses on vulnerability threat intelligence, identified 159 actively exploited vulnerabilities from 50 sources during the quarter.
    • “The time from CVE disclosure to evidence of exploitation in the first quarter was marginally faster than what VulnCheck observed during 2024, Patrick Garrity, security researcher at the company, said in the report. “This demonstrates the need for defenders to move fast on emerging threats while continuing to burn down their vulnerability debt,” Garrity wrote. 
    • “VulnCheck’s research reinforces multiple recent reports that warned about increased exploits in 2024. Mandiant said exploits were the most common initial infection vectorlast year, representing 1 of every 3 attacks. Verizon reported a 34% increase in exploited vulnerabilities, and IBM X-Force said exploitation of public-facing applications accounted for 30% of incident response cases last year.”
  • and
    • “Attackers are having a field day with software defects in security devices, according to a new report released Wednesday by Mandiant. 
    • “Exploits were the most common initial infection vector, representing 1 of every 3 attacks in 2024, and the four most frequently exploited vulnerabilities were all contained in edge devices, such as VPNs, firewalls and routers, Mandiant said in its M-Trends report released Wednesday.
    • “Exploitation of these vulnerabilities represented slightly less than half of all observed vulnerability exploitation,” said Kirstie Failey, principal threat analyst at Google Threat Intelligence Group, under which the Mandiant brand operates.
    • “Threat researchers and federal cyber authorities have been sounding the alarm about attacks targeting network edge devices for more than a year. Since 2024, security device exploits have resulted in attacks on government agencies and some of the most valuable publicly-traded companies in the world.”
  • Per Cybersecurity Dive,
    • “Security researchers warn that hackers are actively exploiting a critical unrestricted-file-upload vulnerability in SAP NetWeaver Visual Composer. 
    • “The vulnerability, tracked as CVE-2025-31324, could allow an unauthenticated user to upload malicious executable binaries. The vulnerability has a severity score of 10.  
    • “Researchers from Reliaquest disclosed the vulnerability to SAP after an investigation uncovered attackers uploading JSP webshells into publicly accessible directories.” 
  • FEHBlog note: CISA did not add a known exploited vulnerability to its catalog this week.

From the ransomware front,

  • Palo Alto Networks issued a report on extortion and ransomware trends in the first quarter of 2025.
  • Dark Reading reports,
    • “The ransomware-as-a-service model is perpetually troubling for dropping the barrier to entry for aspiring ransomware actors, and two threat actors are innovating in the space with additional affiliate models.
    • “Extended detection and response vendor Secureworks (owned by Sophos) published research today detailing expanded affiliate models belonging to ransomware-as-a-service (RaaS) gangs DragonForce and Anubis.
    • “As a model, ransomware-as-a-service (RaaS) has gained significant popularity in recent years. A threat actor typically sells or leases many of the tools a less experienced cybercriminal (or affiliate) would need to conduct a ransomware attack; the affiliate typically shares the proceeds from subsequent attacks with the operator.
    • “The RaaS model has significantly lowered the technical barriers for wannabe cybercriminals, and as such it has become a serious problem for organizations around the world.”
  • Infosecurity Magazine notes,
    • “A new ransomware strain known as ELENOR-corp, identified as version 7.5 of the Mimic ransomware, has been used in a series of targeted attacks on the healthcare sector.
    • “The campaign displays a range of advanced capabilities, including data exfiltration, persistent access and anti-forensic strategies designed to cripple recovery efforts and maximize damage.”

From the cybersecurity defenses front,

  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Patient safety, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Today, the Supreme Court held a conference of its justices at which the Court decided next steps with the Kennedy v. Braidwood Management case heard last Monday.
  • Bloomberg Law reports that following the conference,
    • “The Supreme Court ordered more briefing after arguments in a dispute over Obamacare’s preventative services mandate, which requires insurers to cover certain treatments like cancer screenings free of charge.
    • “In an order on Friday, the justices asked the parties to address whether the health secretary has the power to appoint the members of the US Preventive Services Task Force, which recommends services that should be covered under the Affordable Care Act. 
    • “The court wants to know “whether Congress has ‘by Law’ vested” the secretary with this authority.” * * *
    • “Additional briefs are due May 5. It’s rare but not unheard of for the court to request more briefing after a case has been argued.
    • “This occasionally occurs on issues that come up during argument if they weren’t initially briefed by the parties.”
    • FEHBlog note — That’s exactly what happened in the Braidwood Management case.
  • STAT News tells us,
    • “The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments.
    • “The announcement arrives two days after National Institutes of Health Director Jay Bhattacharya announced the intent to create such a registry at an all staff meeting, kicking off a firestorm of panic and confusion among autism self-advocates and the broader research community. Much of the fear centered around Bhattacharya’s remarks that the government would pull health data from private sources, such as electronic health records maintained by health care providers, pharmacy data, insurance claims and even wearables like smart watches and fitness trackers.”
  • Science Soft Healthcare predicts that “”By the end of 2026, 25–30% of all medical visits in the United States will be conducted via telemedicine. Although the adoption rate of telemedicine has been low in 2024, it will grow considerably with regulatory support from the US Congress.”
    • “In 2023, telemedicine usage in mental health was over three times higher than in other medical specialties, according to Epic Research. We believe that the resilient demand for telemedicine in mental health indicates that the technology is here to stay.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride Injection 500mg/100mL Infusion bags due to the products potentially containing inert polypropylene fibers. As of April 18, Amneal Pharmaceuticals said it received no reports of adverse events or injuries related to the recall. The recalled IV bags were distributed nationwide to wholesalers and distributors from April 23-Nov. 8, 2024.”

In other judicial news,

  • STAT News reports,
    • “Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy.
    • “A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
    • “Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA. For the two years when Ozempic and Wegovy were recently in shortage, compounders rushed to make copies to meet the enormous demand for weight loss treatments. But when semaglutide was ultimately taken off the FDA’s shortage list in February, the compounding trade group, called the Outsourcing Facilities Association, quickly sued the agency, arguing that there were still in actuality shortages of the branded treatments.”

From the public health and medical research front,

  • The Centers 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 continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • “RSV
      • “RSV activity continues to decline in most areas of the country.
    • “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.
    • “Other Respiratory Illnesses
      • “Mycoplasma pneumoniae
        • Respiratory infections caused by the bacteria Mycoplasma pneumoniae have increased in some areas of the United States over the last few weeks as indicated by emergency department visits and test positivity. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
      • “Pertussis
        • “Reported cases of whooping cough (pertussis) continue to be elevated nationwide but preliminary case reports have been trending downward for the past several months. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.“
  • The University of Minnesota’s CIDRAP adds,
    • “Flu activity continues to ebb nationwide, with rates of influenza-like illness (ILI) dropping further last week, but flu-related deaths in children climbed to 204, up 6 from the previous week, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.”
  • The AHA News lets us know,
    • “There have been 884 confirmed cases of measles nationwide so far this year, with cases reported by 29 states, according to the latest data from the Centers for Disease Control and Prevention. There have been 11 outbreaks, and 93% of confirmed cases (820 of 884) are outbreak-associated. The vaccination status of 97% of all cases is classified as “unvaccinated or unknown.”
    • “The CDC April 24 released a report that said increasing national and local measles, mumps and rubella vaccination coverage is essential to preventing measles cases and outbreaks. The report also said that cases this year are the second highest in 25 years. A JAMA study also released April 24 found that measles could become endemic again within another 25 years if current childhood vaccination rates remain the same.”
  • The University of Minnesota’s CIDRAP drills down on these measles statistics.
  • Eating Well reports,
    • “A recall on a popular brand of apple juice sold in 28 states was just announced, according to the Food and Drug Administration. This is due to a potential contamination with patulin, a mycotoxin that can cause internal organ damage when consumed in excess. Approximately 173,616 bottles are affected by this recall.
    • “The product impacted is Martinelli Apple Juice sold in its signature clear, round glass bottles with a white metal screw top lid. The recalled 10-ounce apple juice bottles were sold in 4-packs, contain a UPC of “0 41244 04102 2” and have a best-by date of December 5, 2026. They were sold at retail locations in the following states: Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin.
    • “This recall was just classified as a Class II recall, meaning that drinking this apple juice can  “cause temporary or medically reversible adverse health consequences,” per the FDA.
  • Healio points out,
    • An estimated 24,499 people visited the ED for adverse events related to semaglutide in the 2 years after its approval for weight loss, according to a study published in Annals of Internal Medicine.
    • The most common symptoms included nausea, vomiting and diarrhea, which had been previously documented in clinical trials. However, researchers also discovered that 16% of ED visits involved hypoglycemia.
    • “What I see in clinical practice is that some patients end up in the ED due to these severe symptoms from semaglutide, and it is not recognized in the ED,” Pieter Cohen, MD, associate professor of medicine at Harvard Medical School and internist at Cambridge Health Alliance, told Healio. “It is really important to make sure we are asking our patients about the use of semaglutide when they have these symptoms, particularly since use is so prevalent these days.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Centene beat Wall Street expectations for earnings and revenue in the first quarter thanks to significant membership increases, especially in Affordable Care Act and Medicare prescription drug plans, according to results released Friday.
    • “Citing the strong enrollment, the St. Louis-based payer raised its revenue guidance and reiterated its earnings guidance for 2025.
    • “However, Centene signaled medical costs may also be increasing, raising the outlook for its full-year medical loss ratio — a marker of spending on patient care. Centene’s stock fell 7% in Friday morning trade following the results.”
  • Per BioPharma Dive,
    • “Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations.  
    • “Gilead’s oncology portfolio generated $758 million in sales over the first three months of the year, down about 4% compared to the same period in 2024. Slower-than-expected sales of Gilead’s breast cancer drug Trodelvy were the main culprit, though the company also blamed lower demand for a decline in cancer cell therapy revenue.
    • “Gilead’s HIV drug business, though, helped offset those losses, garnering $4.6 billion and climbing 6% year over year. The company expects further growth in the future, as by June 19 the Food and Drug Administration could significantly expand use of lenacapavir, a twice-yearly injectable medicine proven in testing to prevent HIV infections.
  • Beckers Payer Issues provides 101 things to know about Blue Cross Blue Shield.
  • Beckers Hospital Review offers a list of the 25 most expensive hospital drugs.
  • Fierce Healthcare tells us,
    • “HCA Healthcare reaffirmed its 2025 guidance following an opening quarter of solid care demand and better-than-expected earnings.
    • “The country’s largest for-profit health system announced Friday morning $1.61 billion of net income attributable to the company ($6.45 per diluted share) and revenues of $18.32 billion for the first quarter. Both are improvements over the prior year’s $1.59 billion ($5.93 per diluted share) and $17.34 billion.
    • “Adjusted EBITDA for the quarter was $3.73 billion, also up from $3.35 billion in the first quarter of 2024.”
  • Per Fierce Pharma,
    • “With the potential for pharmaceutical import tariffs spurring a rush of life sciences investments in the U.S., AbbVie is joining the trend with plans to spend billions in the country over the next decade.
    • “AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker’s CEO, Rob Michael, said on a call with analysts Friday.
    • “AbbVie’s executives did not go into the fine details of the domestic investment plan on the call, though the company’s CFO Scott Reents noted that a portion of the sum will be earmarked to build four new U.S. production facilities devoted to active pharmaceutical ingredients (API), drug product, peptides and devices.”
  • and
    • “After unveiling a new drug substance facility in North Carolina in December, Amgen is doubling down on expanding its U.S. production presence with plans for a major upgrade at its plant in central Ohio.
    • “The new project represents the latest in a string of pharma investments in the U.S. as the Trump administration threatens to clamp down on the industry with sector-specific import tariffs.
    • “Amgen is plugging $900 million into an expansion of its biomanufacturing facility in New Albany, Ohio, the company said Friday. The project is expected to bring the total number of Amgen jobs in the state to 750 and increase the company’s overall investment in Ohio to more than $1.4 billion.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, NIH, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.  
    • “Cassidy said the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.   
    • “In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.”  
  • The President signed an executive order strengthening probationary periods in the federal civil service. Here’s a link to a fact sheet.
  • Govexec tells us, “Ex-feds launch websites to help unemployed civil servants find new jobs. Many federal employees are looking for positions outside of government following reductions in force and the Trump administration’s push for workers to take separation incentives.”
  • Per a Drug Enforcement Administration news release,
    • DEA’s National Prescription Drug Take Back Day is your chance to rid your medicine cabinet of unneeded and unwanted medications. Start your spring cleaning this year on April 26 by visiting a collection site near you.
    • Mark your calendar for this upcoming event! Participating drop-off sites will be open from 10 a.m. to 2 p.m. (local time) on Saturday, April 26. Collection sites are located around the country and will be collecting:
      • Tablets
      • Capsules
      • Patches
      • Other solid forms of prescription drugs.
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan for evaluating a measure regarding “Vision in Children Ages 6 Months to 5 Years: Screening.” The public comment deadline is May 21, 2025.
  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.”

From the judicial front,

  • Professor Katie Keith wrote an article in Health Affairs Forefront about the Kennedy v. Braidwood Management oral argument presented to the Supreme Court last Monday.
  • Fierce Pharma informs us,
    • “Halozyme is not holding back against Merck & Co. in the companies’ injectable Keytruda patent dispute, having now escalated a verbal warning into a lawsuit.
    • “In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck’s popular cancer drug Keytruda infringes 15 of its patents.
    • “Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs.
    • “Halozyme is seeking an injunction to block Merck’s planned commercialization of subcutaneous (SC) Keytruda, which is under FDA review with a decision expected by Sept. 23. The San Diego drug delivery expert is also asking for monetary relief and “an enhancement of damages,” because the alleged infringement is said to be willful, according to its complaint.
    • “Even though SC Keytruda has not reached the market, Merck opened itself to patent litigation after publicly laying out its intention to launch the product this year pending FDA approval.”

In State government news,

  • Mercer offers a roundup of selected state healthcare developments in the first quarter of 2025.

From the public health and medical research front,

  • CNN reports,
    • “The United States has seen progress in reducing certain cancer risks, as overall smoking rates remain on a decline. But for other risk factors, such as those tied to cervical cancer, there is room for improvement, according to a new American Cancer Society report.
    • “The prevalence of people smoking fell from about 14% in 2019 to 11% in 2023, according to the report published Wednesday in the journal Cancer Epidemiology, Biomarkers & Prevention. Cigarette smoking is known to significantly increase the risk of developing cancer. It’s estimated to cause about 1 out of every 3 cancer deaths in the US. * * *
    • “The prevalence of people being up-to-date on recommended cervical cancer screenings has dropped from 74.8% in 2019 to 73.4% in 2021 among ages 21 to 65, the report found, leaving more women at risk of not detecting disease early. The reported noted that the decrease is alarming as HPV vaccination rates have remained “statistically unchanged” in recent years. In 2023, 61.4% of adolescents ages 13 to 17 were up-to-date for the HPV vaccination series, similar to 61.7% in 2021 and up from 54.2% in 2019.
    • “HPV or human papillomavirus is a group of more than 150 viruses that can cause certain types of cancer. Spread primarily through sexual contact, most cases of HPV clear on their own within two years, but when the infection does not go away, health problems like cancer may occur – which is why preventing these infections with vaccination has been key.”
  • The National Cancer Institute announced,
    • “Researchers have discovered what appears to be a critical biological driver of the most common form of ovarian cancer. The discovery, they believe, could spearhead the development of approaches for finding ovarian cancer at its earliest stages or preventing the disease from taking hold in the first place.
    • “Multiple studies have shown that high-grade serous ovarian cancer arises from precancerous growths called serous tubal intraepithelial carcinoma (STIC) lesions in the fallopian tubes. These lesions can eventually travel into the ovaries and transform into full-blown tumors.
    • “In this new study, Lan Coffman, M.D., Ph.D., of the University of Pittsburgh School of Medicine, and her colleagues showed that STIC lesions appear to arise and turn into tumors in the ovaries with the assistance of a type of stem cell that they called high-risk mesenchymal stem cells (MSCs).
    • “These high-risk MSCs—which have specific characteristics that appear to help their cancer-fueling capabilities—were abundant in the tissue, or stroma, immediately underneath STIC lesionsExit Disclaimer in fallopian tube tissue samples from women without cancer. They were also sometimes present in normal tissue. 
    • “When the researchers implanted high-risk MSCs along with healthy fallopian tube cells into mice, some developed ovarian cancer, including, in some cases, metastatic cancer, the researchers reported March 14 in Cancer Discovery.
    • “It’s not yet clear if high-risk MSCs are the primary instigator that causes healthy fallopian cells to transform into high-grade serous ovarian cancer, Dr. Coffman said, but the group’s findings support the idea that these cells are intimately involved. 
    • “What we believe we’re seeing is that [high-risk MSCs] are a supportive ‘soil’ for cancer initiation,” she said.”
  • Beckers Hospital Review adds,
    • “Some early-onset colorectal cancers may be caused by exposure to a bacterial toxin within the first 10 years of life, according to a study published April 23 in Nature.
    • “An international research team, led by Ludmil Alexandrov, PhD, from the University of California San Diego, analyzed 981 colorectal cancer genomes from patients across 11 countries for the study.” 
  • STAT News points out “Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe. Cellular debris lingering in the liver and and a penicillin relative are identified.”
  • The AHA News tells us,
    • “A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of an accident by 25%. The study analyzed public health and transportation data from seven states from 2020-2023. The results showed a significant association between acute COVID-19 infections and an increase in vehicle crashes.”
  • The Wall Street Journal reports,
    • A new study by French researchers found that some combinations of food additives were associated with a higher risk of Type 2 diabetes.
    • Researchers found that combinations of emulsifiers, colors and sweeteners increased the diabetes risk beyond what could be explained by individual substances alone.
    • Food-industry representatives defended combinations of what they said were safe ingredients, which they said are important for food safety and quality.
  • WTW notes, “Therapeutic alliance, the bond between client and therapist, is a game-changer in mental health programs. Employers must focus on measuring to predict better results and reduce dropout rates.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck’s first-quarter net income increased, driven by Keytruda sales, reaching $5.08 billion, or $2.01 a share, up from $4.76 billion year-over-year.
    • Despite sales of Keytruda rising 4% to $7.2 billion, Merck cut its 2025 adjusted earnings projection, citing tariffs and a license agreement.
    • Sales of HPV vaccine Gardasil fell 41% due to lower Chinese demand, while animal-health product sales rose 5% to $1.6 billion.
  • and
    • “Roche’s Q1 sales beat estimates due to demand for drugs like Ocrevus and Hemlibra.
    • “Roche is boosting its U.S. manufacturing to avoid potential tariffs, investing $50 billion over five years.
    • “Roche maintains its full-year guidance, anticipating mid-single-digit sales growth.”
  • Healthcare Dive adds,
    • “Molina beat analyst expectations for earnings and revenue in the first quarter, with a topline of $11.1 billion, up 12% year over year, and net income of $298 million, down 1% year over year, according to results released Wednesday.
    • “The California-based insurer said its medical costs increased moderately in the quarter, mostly due to utilization of long-term supports and services, expensive drugs and behavioral health, along with more spending on seasonal illnesses like the flu. However, costs were generally in line with what Molina had predicted, a bright spot after UnitedHealth, the largest private insurer in the U.S., reported an unexpected spike in spending earlier this month.
    • “Molina’s results can be viewed as “good enough,” TD Cowen analyst Ryan Langston wrote in a note on the insurer’s first quarter performance.”
  • Per BioPharma Dive,
    • Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty.
    • Sales climbed 9.7% to 9.9 billion euros, or $11.3 billion, in the period, beating the consensus analyst estimate of 9.6 billion euros. Earnings for the core business rose almost 16% to 1.79 euros a share, topping the consensus expectation of 1.70 euros a share.
    • The French drugmaker benefited from the launch of new drugs and the continuing growth of Dupixent, a blockbuster medicine used to treat conditions including asthma, eczema and chronic obstructive pulmonary disease. The drug’s sales jumped 20% to 3.5 billion euros in the quarter, Sanofi said Thursday.
  • Per MedTech Dive,
    • Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott. 
    • Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
    • The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
  • and
    • Edwards Lifesciences maintained full-year financial forecasts on Wednesday, projecting sales of its heart valves would offset hits from tariff and acquisition costs.
    • First-quarter sales of transcatheter aortic valve replacements, Edwards’ largest business, were better than the company expected, executives said on an earnings call.
    • Edwards’ TAVR sales were stifled last year by capacity constraints as heart teams performed more mitral and tricuspid valve procedures with the company’s newest devices. Hospitals are now addressing capacity issues by expanding capabilities for handling increased volumes, said Larry Wood, group president of TAVR and surgical structural heart. 
  • Modern Healthcare reports,
    • “Health systems have been shouldering the cost of mobile integrated healthcare programs for at-risk patients, but some insurers may be ready to start picking up the tab as providers prove they can save money.
    • “UMass Memorial Health, Geisinger, Prisma Health and others that operate these at-home care programs say the service saves millions of dollars by preventing emergency room visits and rehospitalizations of chronically ill patients. Government and private insurers have been covering little to none of the cost, but that could be changing as systems get information to prove the programs are effective.”
  • Mobihealth News informs us,
    • San Francisco-based Hinge Health, a digital musculoskeletal care platform, announced it is partnering with Cigna Healthcare to offer the health insurance company’s self-insured clients access to Hinge’s digital musculoskeletal (MSK) care platform. 
    • Hinge offers individuals with MSK conditions access to a multidisciplinary care team, including health coaches, orthopedic surgeons and physical therapists, as well as to digital tools like surgery decision support.
    • The company also provides a pelvic health program tailored for women and Enso, its FDA-cleared wearable that delivers electrical pulses to help alleviate everyday pain.
    • Cigna’s members who choose to enroll will have access to Hinge Health through Cigna’s condition-specific care program Pathwell Bone & Joint Solution.
    • Hinge touts that it is now an MSK provider for the five largest national health plans in the U.S. by self-insured lives. 
  • Per Fierce Healthcare,
    • “Health insurers can’t lose sight of improvements to the consumer experience as they find ways to reduce and manage rising costs, according to a new report from Forrester.
    • “The analysts offered one broad takeaway for payers: “Cut costs, not corners.” They noted that the industry is at a key crossroads where it’s critical to improve consumer experience and boost trust and consider those challenges as they build strategies around cost.
    • “Health insurers must improve CX, build consumer trust, and find innovative ways to create more sustainable cost structures and better economics for customers,” they wrote. “But the thirst for cost efficiency can’t cloud insurers’ strategic visions to create better health outcomes.”
  • Per Fierce Pharma,
    • “With the threat of Trump administration’s tariffs swirling and biopharma companies bracing for impact, many are announcing their intention to strengthen their presence in the U.S.
    • “The latest to hop on the invest-in-USA bandwagon is Thermo Fisher Scientific. The Massachusetts-based producer of medical instruments, diagnostics and pharmaceuticals will spend an additional $2 billion in the U.S. over the next four years “strengthening American innovation, manufacturing and economic competitiveness,” the company said in a release.
    • “Three-quarters of the pledge will bolster Thermo Fisher’s manufacturing operations, while the remaining $500 million will expand its R&D efforts.”

Midweek Report

David Ermer–CDC, COVID-19 vaccine, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare–

From Washington, DC,

  • Federal News Network interviews Stephanie Kostro, executive vice president for policy at the Professional Services Council about the re-write of the Federal Acquisition Regulation that the President announced in an April 16, 2025, Executive Order.
  • Federal News Network adds,
    • “After laying off employees as part of its reduction in force (RIF), the Office of Personnel Management is now circulating a handful of job announcements to impacted employees that are nearly identical to their previous roles — only in a different OPM component.
    • “In an internal email obtained by Federal News Network, OPM notified the impacted staff members on Monday of five vacancies in OPM’s Human Resources Solutions (HRS) office, which manages the software for USA Jobs, USA Staffing and other federal HR products and services.”
  • Fierce Healthcare tells us,
    • “The National Institutes of Health (NIH) will begin work on a comprehensive federal database of patient records to study autism and chronic disease, Director Jay Bhattacharya, M.D., Ph.D., announced Monday. 
    • “The commitment gives legs to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s calls to find the root cause of childhood autism, which he calls an epidemic. The NIH appears poised to put federal resources to work to create a central, shareable resource for the researchers that undertake RFK Jr.’s call to action.”

From the judicial front,

  • Healthcare Dive informs us,
    • “U.S. Bankruptcy Judge Stacey Jernigan approved Prospect Medical Holdings’ plan to begin winding down operations at Crozer Health on Tuesday, after lawyers for the health system said an 18 months-long effort to find new buyers for the facilities was unsuccessful.
    • “Emergency departments at Crozer-Chester Medical Center and Taylor Hospital, both in Delaware County, Pennsylvania, are set to stop receiving patients by ambulance this week. They’ll continue to accept walk-in patients for up to a week after, according to the hospitals’ closure plan, which attorneys characterized as evolving.
    • “The closure plan faced significant pushback from county officials, nurses and nonprofits who warn that closing the facilities will force residents to travel farther for care and could risk lives.”
  • STAT News reports,
    • “Amid ongoing battles over alternate supplies of blockbuster weight loss drugs, Eli Lilly filed new lawsuits against four telehealth firms and their affiliates but is using a new line of attack — the drugmaker accused two of the companies of engaging in the corporate practice of medicine.
    • “To date, Lilly and its rival, Novo Nordisk, have filed dozens of suits against numerous companies involved in compounding versions of semaglutide and tirzepatide, the obesity and diabetes drugs known as GLP-1s. For the past three years, telehealth firms, compounding pharmacies, and med spas have partnered to manufacture, prescribe and distribute copies of the drugs while shortages existed. Those lawsuits alleged trademark infringement, false claims and unfair competition, but have so far yielded varying outcomes.
    • “This time, Lilly has alleged two companies, Mochi Health and Fella Health, engaged in the corporate practice of medicine, which refers to controlling and influencing prescribing decisions of health care providers. They purportedly did so with the help of affiliated medical groups and compounding pharmacies, according to separate lawsuits filed on Wednesday in the U.S. District Court for the Northern District of California.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • “U.S. births grew 1% in 2024 to 3.6 million, according to preliminary data from the Centers for Disease Control and Prevention. The cesarean delivery rate slightly increased to 32.4% in 2024, from 32.3% in 2023. The 2024 preterm birth rate was 10.41%, unchanged from 2023.”
  • and
    • “There have been 8,064 reported cases of whooping cough in the U.S. so far this year, according to the latest data from the Centers for Disease Control and Prevention. There were 3,835 cases at the same time in 2024.”
  • Per today’s American Medical Association’s Morning Rounds,
    • “The New York Times (4/22, Gross) reports that “neuroscientists have learned that estrogen is vital to healthy brain development but that it also contributes to conditions including multiple sclerosis and Alzheimer’s. Changes in estrogen levels – either from the menstrual cycle or external sources – can exacerbate migraines, seizures and other common neurological symptoms.” In the brain, “estrogen can bind directly to receptors within neurons and other cells, setting off a cascade of actions. It can also be broken down into metabolites, called neurosteroids, which exert their own far-reaching effects.” Researchers also know that estrogen “can modulate neuron firing, reduce inflammation, increase neuroplasticity, help turn glucose into energy, prevent plaque from building up and improve blood flow in the brain.” A recent review published in Brain Medicine suggests there are a “huge number of neurological diseases that can be affected by sex hormone fluctuations.”
  • The Wall Street Journal reports,
    • “Mounting evidence suggests that vaccination against the varicella zoster virus—which causes chickenpox in children and triggers shingles in adults—also protects the brain.  
    • “Several recent studies suggest that the vaccines reduce the risk of dementia in older adults, but key questions remain, including How the vaccines might work to stop or delay the condition, and whether the benefit is limited to people of a certain age. 
    • “The vaccines studied, Zostavax and Shingrix, both appeared to offer protection. 
    • “The latest study found that among 70- and 80-year-olds in Australia, people who were eligible to get the Zostavax shot were 1.8 percentage points less likely to get a dementia diagnosis in the next 7.4 years than those who were ineligible. The study was published in the journal JAMA Wednesday.”
  • Per a National Cancer Institute (NCI) news release,
    • “New immune-based treatments for kidney and pancreatic cancer have shown promising results in two small clinical trials. In both trials, the treatments appeared to prevent cancer from returning in patients who had successful surgery to remove their tumors.
    • “The treatments are called therapeutic cancer vaccines because they help the immune system eliminate an existing cancer. 
    • “In both trials, the treatments were made specifically for each patient based on intensive genetic analyses of their tumor samples collected during surgery. The analyses allowed the research teams to identify mutated proteins, known as neoantigens, on each patient’s cancer cells. These rogue proteins can act like an activated security alarm to the immune system, alerting it that the cancer cells are threats that should be killed. 
    • “For different reasons, however, this alarm system fails. The neoantigen-based treatments are designed to step into this breach, reinforcing to the immune system that any cells displaying these mutated proteins must be eliminated.
    • “In both studies, patients received multiple doses of their personalized treatments in the months following surgery. Giving the therapy after surgery is intended to kill any remaining cancer cells elsewhere in the body and potentially establish a small band of immune cells that can recognize and kill any cancer cells that pop up in the future.”
  • The NCI’s Cancer Information Highlights consider “Physical Activity | Dormant Cancer Cells | Young People with Advanced Cancer.”
  • Per STAT News,
    • “The young people who wanted to quit e-cigarettes didn’t necessarily think they were addicted. But they did think nicotine cravings were a problem. When they enrolled in a Massachusetts General Hospital trial, they told researchers they couldn’t study in the library or work at their desks for long before getting the urge to vape. “They really didn’t like that loss of control,” said Eden Evins, director of the Center for Addiction Medicine at Mass General.
    • “Using the oral pill varenicline in combination with behavioral counseling is the most effective way for young people to get that control back, according to the results of the study co-authored by Evins, published Wednesday in the Journal of the American Medical Association. Of participants ages 16 to 25, half of those who took varenicline for 12 weeks were able to abstain from e-cigarettes for the last month of that period, compared to 14% of the placebo group. After a total of six months, 28% of people in the varenicline group were still vape-free, compared to 7% of the placebo group.” 
  • Per Fierce Pharma,
    • “Akeso and Summit Therapeutics’ giant-killing, PD-1xVEGF bispecific antibody ivonescimab has posted another phase 3 trial win in lung cancer, this time as part of a chemotherapy combination. 
    • “An independent data monitoring committee has determined that the HARMONi-6 trial for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC) has met its primary endpoint of progression-free survival (PFS), Akeso said Tuesday.
    • “At the first pre-specified interim analysis of the 532-patient Chinese study, ivonescimab plus chemotherapy “decisively beat” BeiGene’s PD-1 inhibitor Tevimbra plus chemotherapy, Akeso said. The results—which will be presented at a medical conference later this year—were “statistically significant and clinically meaningful,” the Chinese company added.”
  • and
    • “Schizophrenia drug Cobenfy, a key component in Bristol Myers Squibb’s plan to navigate a transition period of major loss of exclusivity, has hit a phase 3 setback.
    • “Cobenfy as an adjunctive treatment to atypical antipsychotics failed to show superior efficacy versus placebo with atypicals when used in patients with inadequately controlled schizophrenia, according to results from the phase 3 Arise trial, Bristol Myers said Tuesday.
    • “The trial logged a numerical improvement, with adjunctive Cobenfy showing a 2-point reduction compared with placebo on the primary endpoint of reduction in the Positive and Negative Syndrome Scale (PANSS) total score at week 6. However, the number didn’t reach statistical significance. PANSS is a clinician-administered tool used to assess schizophrenia symptoms.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Healthcare spending continues to plague employers — but most aren’t yet taking sizable steps to curb costs.
    • “Nearly 85% of employers say surging healthcare prices are their biggest benefits challenge, according to a survey of about 1,800 plan sponsors nationwide published Wednesday from insurance brokerage and consulting company Lockton.
    • “Employers are bracing for healthcare costs to balloon 6%-8% this year, especially as workers seek more expensive specialty care.”
  • Becker Payer Issues adds,
    • “There may be a link between rising insurance premiums and increased utilization of services, particularly across the Medicare Advantage space.
    • “In its first quarter earnings report, UnitedHealth Group reduced its year-end earnings outlook amid rising use of physician and outpatient services among its Medicare Advantage membership and “unanticipated changes in the profile of Optum Health members.”
    • “One key insight that emerged from the company was a major rise in elective care activity, which was linked directly to the higher premiums faced by some of UnitedHealth’s group MA members. The company reported that among some public sector retiree groups, premiums had increased dramatically (in some cases by as much as $150 a month) from $50 to $200. Instead of disengaging from using their benefits, these members appear to have engaged more than usual.
    • “We’re seeing a significant and disproportionate increase in utilization largely within our public sector group retiree business. This population experienced the greatest year-over-year premium increases,” UnitedHealthcare CEO Tim Noel told investors. “We did assume that we would see some care activity level increases in this population, but we’re seeing far surpasses what we would have recently anticipated. And in that population as well, we are seeing more preventative care, more annual wellness visits, more in-home clinical assessments. The driver there is also really the follow-on care that results from that.”
  • Fierce Healthcare relates,
    • “Community Health Systems’ narrow first-quarter net loss landed right in line with Wall Street’s expectations, though the public for-profit hospital operator increased its net operating revenue on solid demand, according to financial results released Wednesday after market close.
    • “Even though healthcare providers are navigating significant change as our operating environment continues to evolve, we remain confident that our strategies are strengthening our operations and positioning the company for long-term success,” CEO Tim Hingtgen said in the results announcement.
    • “Net loss attributable to the company was $13 million (-$.10 per diluted share), an improvement over the $41 million loss (-$0.32) of the prior year’s first quarter—though the losses were narrower for both periods after adjustments (for impairment and loss on sale of business and related costs).
    • “Net operating revenues landed at $3.16 billion, just above expectations and a 0.6% year-over-year increase. On a same-store basis taking CHS’ recent divestitures into account, net operating revenues rose by 3.1%. Both of those came alongside a 1% decrease in total admissions and a 2.3% dip in adjusted admissions, but respective same store increases of 4% and 2.6%.”
  • MedTech Dive notes,
    • “Boston Scientific CEO Mike Mahoney told investors Wednesday the company expects an impact of about $200 million this year due to the Trump administration’s tariff policies, becoming the latest medtech company to forecast an impact of hundreds of millions of dollars.
    • “However, Boston Scientific, like others that have reported, still expects to perform well in 2025. Mahoney said Boston Scientific is “very bullish” on the year, and the firm raised its 2025 guidance from a growth range of 12.5%-14.5% on a reported basis to 15%-17%, even with the $200 million charge.”
  • Per KFF,
    • “The growing role of Medicare Advantage has been a defining feature of Medicare in recent years, with Medicare Advantage plans now covering more than half of all eligible Medicare beneficiaries. While most Medicare Advantage enrollees (and most people with Medicare overall) live in urban areas, as of 2024, most Medicare beneficiaries who live in the nation’s most rural counties are enrolled in traditional Medicare, not Medicare Advantage. This means that reliance on Medicare’s stand-alone prescription drug plans (PDPs) for coverage of the Medicare Part D prescription drug benefit is likely to be greater among Medicare beneficiaries living in the most rural parts of the country.”
  • MedPage Today lets us know,
    • “Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the FDA, the company said Wednesday.
    • “The news sent company shares soaring more than 21% in morning trading and appeared to resolve concerns that Trump administration officials might be holding up a decision on the shot.
    • “Novavax makes the nation’s only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups.”

Tuesday Report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Report

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

From Washington, DC

  • The Associated Press, Roll Call, Fierce Healthcare, and the FEHBlog agree based on today’s oral argument that the U.S. Supreme Court will not affirm the U.S. Court of Appeals for the Fifth Circuit’s holding that the members of the U.S. Preventive Services Task Force are principal officers of the United States who must be nominated by the President and confirmed by the Senate. The Supreme Court will issue its decision in June or early July.
  • STAT News reports,
    • “Hospitals, health insurers, and insurance agents are asking President Trump to pump the brakes on a regulation that would lead to potentially millions of people losing their health insurance.
    • “That’s not to say the health care industry disagrees with all of Trump’s proposals, which would make it more difficult for people to get health coverage through the Affordable Care Act’s marketplaces. But at a minimum, lobbyists are urging the White House not to enforce any new rules until 2027 at the earliest, according to a review of public letters that were due this month.” * * *
    • “One particular proposal puts insurers and providers at odds. In 2021, the Biden administration created monthly “special enrollment periods” that allow anyone who makes between 138% and 150% of the poverty line to enroll in an ACA plan. Usually, outside of losing a job or other special circumstances, people can only sign up for an ACA policy during the annual open enrollment window. The idea is to discourage people from getting insurance only when they get sick or injured.
    • The Trump administration wants to eliminate those monthly special enrollment periods immediately. Big insurers such as Centene and UnitedHealthcare, health insurance lobbying groups like America’s Health Insurance Plans and the Blue Cross Blue Shield Association, and broker groups like the National Association of Benefits and Insurance Professionals support that move. They contend some people, and brokers, are taking advantage of the continuous enrollment opportunities.
    • “Excessive [special enrollment periods] are administratively burdensome and create challenges for health plans to distribute enrollee risk,” Ceci Connolly, the CEO of the Alliance of Community Health Plans, told federal officials.” 
    • “Hospitals pushed back on the idea that people are abusing the process. They also have a lot to lose from Trump’s proposals. ACA plans pay more than Medicare and Medicaid plans, and if millions of people switch to Medicaid or become uninsured, hospitals risk losing tens of billions of dollars in revenue.”
  • Bloomberg Law tells us,
    • “With mass reductions in force across the federal government on the horizon, the AFL-CIO, federal workers’ unions, and advocacy groups have mobilized a network of more than 1,000 volunteer attorneys to provide legal services to laid off federal employees.
    • “Leaders behind the new Federal Workers Legal Defense Network launched last week say they saw a need for more federal-sector labor law resources based on the sheer number of federal workers being let go and the Trump administration’s response to lawsuits seeking to restore these jobs. More than 100,000 federal workers have left or been fired from the federal government so far.”
  • Per a Justice Department news release,
    • “The Justice Department, together with the Drug Enforcement Administration (DEA) and Department of Health and Human Services Office of Inspector General (HHS-OIG), today announced a $300 million settlement with Walgreens Boots Alliance, Walgreen Co., and various subsidiaries (collectively, Walgreens) to resolve allegations that the national chain pharmacy illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA) and then sought payment for many of those invalid prescriptions by Medicare and other federal health care programs in violation of the False Claims Act (FCA). The settlement amount is based on Walgreens’s ability to pay. Walgreens will owe the United States an additional $50 million if the company is sold, merged, or transferred prior to fiscal year 2032.” * * *
    • “In addition to the monetary payments announced today, Walgreens has entered into agreements with DEA and HHS-OIG to address its future obligations in dispensing controlled substances. Walgreens and DEA entered into a memorandum of agreement that requires the company to implement and maintain certain compliance measures for the next seven years.” * * *
    • “The civil settlement resolves four cases brought under the qui tam, or whistleblower provisions of the FCA by former Walgreens employees. The FCA authorizes whistleblowers to sue on behalf of the United States and receive a share of any recovery. It also permits the United States to intervene and take over such lawsuits, as it did here. The relators will receive a 17.25% share of the government’s FCA recovery in this matter.”
  • Fierce Healthcare adds,
    • ‘In a statement, Walgreens’ spokesperson Fraser Engerman said, “We strongly disagree with the government’s legal theory and admit no liability. Our pharmacists are dedicated healthcare professionals who care deeply about patient safety and continue to play a critical role in providing education and resources to help combat opioid misuse and abuse across our country.
    • “This resolution allows us to close all opioid related litigation with federal, state, and local governments and provides us with favorable terms from a cashflow perspective while we focus on our turnaround strategy that will benefit our team members, patients, customers, and shareholders,” Engerman said.”
  • The American Hospital Association (AHA) News relates,
    • “The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi. 
    • “BD identified an increase in material fatigue leaks associated with certain PowerPICC Intravascular Catheters. The FDA sent a letter to affected consumers recommending unused catheters be removed from where they are used or sold, and in-use catheters have updated instructions.
    • “Conavi reported an incident where the sheath of its Novasight Hybrid catheter detached during use. Conavi sent all affected providers a recall notice recommending they return the product to the company.”
  • MedTech Dive informs us,
    • “Medtronic has received Food and Drug Administration approval for a version of its latest glucose sensor that can pair with the company’s insulin pumps.
    • “The device, called Simplera Sync, can be used with Medtronic’s MiniMed 780G insulin pumps as part of an automated insulin delivery system, the company said Friday.
    • “Medtronic is planning a limited launch of the sensor starting this fall. CEO Geoff Martha told investors in February that the company expects Simplera Sync, and a new glucose monitor being developed with Abbott, to grow the company’s U.S. diabetes business.”
  • and
    • “Precision Neuroscience received 510(k) clearance for an electrode array that can be implanted for up to 30 days to map brain activity, the company announced Thursday. 
    • “The clearance is a milestone for the New York-based startup, which plans to use the electrode array as part of a brain-computer interface that is currently in development.
    • “Precision Neuroscience said the decision was the first time a company developing a next-generation wireless BCI has received FDA clearance, as it competes with rivals including Elon Musk’s Neuralink and Synchron, whose backers include Jeff Bezos and Bill Gates.”

From the public health and medical research front,

  • The AHA News lets us know,
    • “Overall cancer death rates declined steadily among both men and women from 2018 through 2022, according to the National Institutes of Health’s latest annual report. Cancer death rates decreased an average of 1.7% per year for men and 1.3% per year for women. Progress in reducing cancer deaths overall is mostly due to declines in both incidence and death rates for lung cancer and other smoking-related cancers, but cancers associated with obesity have been increasing, researchers noted.”
  • STAT News points out,
    • “High blood pressure earned its reputation as the silent killer by causing heart attacks, heart failure, and strokes.
    • “It’s also been a suspect in dementia. Some studies have hinted at a correlation between lower blood pressure and fewer dementia cases, but they were too small and too short to lend statistical significance to the link. It’s also been noted that people with untreated high blood pressure carry a 42% higher risk of developing dementia. 
    • “Now a new study published Monday in Nature Medicine reports that intensive blood pressure control lowered the risk of dementia by 15% and cognitive impairment by 16%. The large, cluster-randomized trial in rural China once again illuminated the role of “village doctors,” the local term for community health workers, who outdid usual care.
    • “This is an incredibly important study,” Dan Jones, a past president of the American Heart Association, told STAT. He was not involved in the new research. “Here’s something tangible that now we can tell our patients. This is so important for motivating people to control their blood pressure and treating it intensively as well.”  
  • BioPharma Dive notes,
    • “A two-drug regimen involving AstraZeneca and Daiichi Sankyo’s Enhertu topped standard therapy in a large study in HER2-positive breast cancer, the companies said Monday.
    • “In a Phase 3 trial, a combination of Enhertu and the targeted therapy pertuzumab held tumors in check longer than THP, a regimen of chemotherapy and precision medicines that’s commonly used as an initial treatment for metastatic breast tumors expressing the HER2 protein. The companies didn’t provide specifics, but said the regimen displayed a “highly statistically significant and clinically meaningful effect” on so-called progression-free survival in the study, with benefits across all patient subgroups.
    • “Additionally, while it is too early to tell whether Enhertu and pertuzumab are extending lives, “an early trend” favors their impact on survival, the companies said. Investigators and patients also remain blinded to a different arm of the trial comparing Enhertu alone to THP. That part of the study will continue to a final analysis.
    • “Safety was consistent with what’s been observed in use of each individual therapy, the companies said. AstraZeneca and Daiichi will present the findings at a future medical meeting and share the results with regulators.”
  • Fierce Pharma adds,
    • “In the first phase 3 trial to show the superiority of a TROP2-targeted antibody-drug conjugate and an immunotherapy agent in first-line triple-negative breast cancer (TNBC), Gilead Sciences’ Trodelvy has notched a much-needed win.
    • “Trodelvy’s combination with Merck & Co.’s Keytruda was better than Keytruda and chemotherapy at prolonging the time before cancer returns or death in patients with previously untreated metastatic TNBC whose tumors express PD-L1, Gilead announced Monday.
    • ‘The readout came from the phase 3 Ascent-04, or Keynote-D19, trial, which sets PD-L1 positivity cutoff at a combined positive score of at least 10, the same population that got Keytruda-chemo its FDA nod in this setting in 2020.”
  • Per Infectious Disease Advisor,
    • “Neurologic manifestations of syphilis increased across demographic groups and among those with HIV infection from 2019 to 2022, suggesting the need to evaluate all patients with syphilis for evidence of neurologic signs and symptoms.”
  • The American Medical Association lets us know “what doctors wish patients knew about becoming a living kidney donor.”
  • Consumer Reports, writing in the Washington Post, shares “tools and tips to help make life easier when your eyes don’t work as well anymore.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Prospect Medical Holdings-owned Crozer Health plans to start closing facilities following a lengthy, but unsuccessful, battle to secure a buyer.
    • “Prospect Medical filed a motion Monday asking the U.S. Bankruptcy Court for the Northern District of Texas for an emergency hearing to approve an expedited closure for Upland, Pennsylvania-based Crozer’s hospitals and outpatient facilities.
    • “Crozer plans Wednesday to start diverting emergency cases to other facilities and to stop elective inpatient admissions, in addition to trauma, surgical, OB-GYN, burn, behavioral health, oncology and outpatient services. Next Monday, Crozer plans to close all ambulatory services, according to court documents.
  • Beckers Hospital Review adds,
    • “Mid Coast Medical Center Trinity (Texas) will close April 25, after months of attempting to secure facility long-term sustainability and financial stability. 
    • “El Campo, Texas-based Mid Coast Health System, which manages and operates the facility, pointed to “significant financial challenges experienced by hundreds of rural hospitals” that have been made worse by “delays in establishing Medicare and Medicaid billing with commercial health insurance” for the closure, according to an April 18 news release on the hospital’s Facebook page. 
    • “The health system also pointed to increased accounts payable for supplies and services, lower-than-expected revenue from collections owed on patient copays and insufficient local tax revenue for operational shortfalls.” 
  • The Washington Post reports,
    • “Americans spent an estimated $71.7 billion on GLP-1 drugs including Ozempic and Wegovy in 2023, a 500 percent increase from their spending on such drugs five years earlier, according to a research letter published in JAMA Network Open.”
  • Per BioPharma Dive,
    • Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed to BioPharma Dive. 
    • Novo first reported in 2023 that the drug, an oral form of semaglutide, succeeded in a Phase 3 trial, helping people on the highest dose lose about 15% of their body weight after 64 weeks. However, the Danish drugmaker didn’t seek approval immediately afterwards, instead focusing attention on other medicines that might improve upon the injectable drug it sells as Wegovy for obesity and Ozempic for diabetes. 
    • The approval filing comes as a race with rival Eli Lilly to develop a weight loss pill has intensified. Lilly last week said its oral GLP-1 pill succeeded in a large trial in diabetes. That drug, orforglipron, could be submitted to regulators if an ongoing study in obesity also meets its objectives. 
  • ABC News explains how pharmacies are speeding up home delivery of prescription drugs.
  • Per Modern Healthcare,
    • “Labcorp has completed its acquisition of North Mississippi Health Services’ ambulatory outreach laboratory business. 
    • “Tupelo-based North Mississippi will still operate its hospital and clinic labs, according to a Monday news release. Under the purchase agreement, Labcorp plans to open three patient service centers by mid-year in Tupelo, West Point and Amory, Mississippi. It also will become a referral laboratory for the health system’s hospitals and clinics. Financial terms were not disclosed.” 
  • Per Beckers Hospital Review,
    • Inadequate coordination of patient discharges was named among the top 10 threats to patient safety in 2025, according to a recent report from ECRI and the Institute for Safe Medication Practices. Gaps in communication, follow-up and medication management continue to put patients at risk after they leave the hospital.
    • To strengthen discharge processes and ensure safer transitions of care, hospitals are deploying more proactive, interdisciplinary approaches — from virtual medication reconciliation to integrated navigation platforms and social determinants of health screening.
    • Becker’s recently asked three hospital and health system leaders to share one key strategy their organization is implementing to improve discharge coordination and reduce safety risks.
    • Their responses are featured [in the article.]
  • and
    • “The American College of Obstetricians and Gynecologists is recommending “a paradigm shift” to prenatal care, opting for a more personalized and tailored approach to improve access and outcomes.” 
    • The article shares five things to know about this change.
  • Healthcare Dive reminds us,
    • “The healthcare industry is awash in consumer financing options, for everything from plastic surgery to teeth whitening to a Botox top-up and your dog’s mangled paw. 
    • “Dermatologists, vets and dentists – the domain of many elective procedures — are primary customers of medical financing. 
    • “Less common is low-cost financing for insured people facing an unexpected medical emergency or a $1,000 insurance deductible.
    • “As the U.S. health system has pushed more treatment costs onto patients through higher-cost deductible plans – and overall healthcare inflation – more people have fallen into arrears on medical bills, said Brandon Pace, chief legal officer at PayZen, a San Francisco startup that’s seeking to expand the buy now, pay later installment model into the medical field.”

Weekend Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity renewals, policy and law enforcement front,

  • Federal News Network reported on Tuesday,
    • “The Cybersecurity and Infrastructure Security Agency [CISA] has inked a last-minute funding extension for a key cyber vulnerability management program.
    • CISA’s contract with MITRE to manage the Common Vulnerabilities and Exposures, or CVE, program was set to expire on Wednesday. But after an outcry from the cybersecurity community, CISA executed an 11-month option period for MITRE’s contract on Tuesday night.
    • “The CVE program is invaluable to the cyber community and a priority of CISA,” a CISA spokesperson said on Wednesday. “Last night, CISA executed the option period on the contract to ensure there will be no lapse in critical CVE services. We appreciate our partners’ and stakeholders’ patience.”
    • The CVE program is a public database of known security vulnerabilities in software and hardware. It’s relied on by organizations across the world to manage cyber vulnerabilities in products and services. CISA’s “Known Exploited Vulnerabilities” database, for instance, relies on CVEs to prioritize how quickly federal agencies must patch bugs on the list.
  • Cybersecurity Dive adds,
    • “Two federal lawmakers today introduced a bipartisan bill that preserves key regulation that facilitates the sharing of cyber-threat data between private companies and the federal government. 
    • “The Cybersecurity Information Sharing Extension Act, introduced by U.S. Sens. Gary Peters (D-MI) and Mike Rounds (R-SD), would extend provisions of the Cybersecurity Information Sharing Act of 2015, which is due to expire in September. The law encourages businesses to share information about ongoing cybersecurity threats with the federal government and is one of few legislative actions that has actually had an impact on real-world cybersecurity, security experts said.
    • “Specifically, the Cybersecurity Information Sharing Act of 2015 gives incentives to companies to voluntarily share cybersecurity threat indicators, such as software vulnerabilities, malware or malicious IP addresses, with the Department of Homeland Security (DHS). It does this by providing legal protections for companies that do so by providing federal antitrust exemptions and precluding them from being held accountable for state and federal disclosure laws.”
  • CISA announced,
    • “Cyber threats across the globe have put into focus our country’s need for cyber talent. CISA leads and hosts the President’s Cup Cybersecurity Competition to identify, recognize, and reward the best cyber talent across the federal workforce. Participants are challenged to outthink and outwit their competitors in a series of tests designed to expand cyber skills that are based on real-world situations.  For President’s Cup 6, participants will compete in a maximum velocity metaverse full of mayhem and taking place in a world light years ahead of our own.  
    • “Want to see what it’s like to participate in the President’s Cup? Federal employees can visit the President’s Cup Practice Area to take on challenges from previous competitions and receive a certificate of completion. Anyone can visit the President’s Cup GitHub page to find descriptions, solution guides, virtual machine builds and other artifacts from challenges featured in previous President’s Cup competitions. ” 
  • The National Institute of Standards and Technology (NIST) let us know,
    • “A draft update to the NIST Privacy Framework will enable organizations to use it seamlessly with the agency’s Cybersecurity Framework, which received its own update last year. 
    • “Targeted changes to content and structure respond to stakeholder needs and make the document easier to use.”
    • “NIST is accepting public comments on the draft via privacyframework@nist.gov until June 13, 2025. A template for submitting comments can be found at the NIST Privacy Framework website. Following the comment period, NIST will consider additional changes and release a final version later this calendar year.”
  • The HHS Office for Civil Rights announced on April 17,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Guam Memorial Hospital Authority (GMHA), a public hospital on the U.S. Territory, island of Guam, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, following the receipt of two complaints alleging that the electronic protected health information (ePHI) of GMHA patients was impermissibly disclosed.” * * *
    • “Ransomware and hacking are the primary cyber-threats to electronic protected health information within the health care industry. Failure to conduct a HIPAA risk analysis puts this information at risk and vulnerable to future ransomware attacks and other cyber-threats,” said OCR Acting Director Anthony Archeval.
    • “Under the terms of the resolution agreement, GMHA agreed to implement a corrective action plan that will be monitored by OCR for three years, and paid OCR $25,000.” * * *
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-hipaa-recap-gmha.pdf, opens in a new tab [PDF, 228 KB]“
  • Per Bleeping Computer,
    • “The FBI warns that scammers impersonating FBI Internet Crime Complaint Center (IC3) employees offer to “help” fraud victims recover money lost to other scammers.
    • “Over the last two years, between December 2023 and February 2025, the FBI said it has received over 100 reports of fraudsters using this tactic.
    • “Complainants report initial contact from the scammers can vary. Some individuals received an email or a phone call, while others were approached via social media or forums,” the law enforcement agency warned in a Friday public service announcement.”

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports,
    • “A House panel has concluded that the U.S. government should double down on export controls and other tools to slow down the progress of Chinese AI companies like DeepSeek, while also preparing for a future where those efforts fail.
    • “In a report released Wednesday, the House Select Committee on the Chinese Communist Party further fleshes out the financial and technological resources that went into building DeepSeek’s R1 reasoning model, as well as its potential risks to U.S. economic and national security.
    • “The authors conclude that the DeepSeek website and app “acts as a direct channel for foreign intelligence gathering on Americans’ private data.”
  • Dark Reading adds,
    • “One of China’s major state-funded espionage groups has created or otherwise upgraded various malware programs, signaling a notable arsenal refresh that defenders need to be aware of.
    • “Mustang Panda (aka Bronze President, Stately Taurus, and TA416) is an advanced persistent threat (APT) believed to be sponsored by the People’s Republic of China (PRC). It has long been known for spying on targets of interest to the PRC, including: military and government organizations, nongovernmental organizations (NGOs), think tanks, minority groups, and corporations in major industries, primarily around East and Southeast Asia but also in the West.
    • “Recently, the group attacked an organization based in Myanmar. In the process, researchers from Zscaler uncovered four previously unknown attack tools the group is now using. They include two keyloggers, a tool for facilitating lateral movement, and a driver used to evade endpoint detection and response (EDR) software. Besides that, the group has also upgraded its signature backdoor, “Toneshell.”
  • Per Cybersecurity Dive,
    • “Lemonade Inc. has begun sending notification letters to about 190,000 people after their driver’s license numbers were transmitted unencrypted, according to regulatory filings by the company. 
    • “The company said a technical issue in its online application process for car insurance led to the exposure of data in an application programming interface call to a third-party data provider, according to an April 9 filing with the Securities and Exchange Commission. 
    • “As part of the online application process, certain information is sent between a server and a user’s browser, according to the filing. This includes data used to generate an insurance quote.  
    • “Lemonade said it learned of the issue on March 14 and said the exposures likely lasted from April 2023 through March 2024, according to a notice filed with the California Attorney General’s office.”
  • and
    • “Hertz Corp. confirmed a threat actor gained access to sensitive personal data in a breach linked to vulnerabilities in Cleo file-transfer software, according to a filing Friday with the Maine Attorney General’s office. 
    • “Hertz said it learned on Feb. 10 that an unauthorized third party obtained the data in connection with an attack spree that took place between October and December 2024. Hertz completed an analysis of the stolen data on April 2. 
    • “Importantly, to date, our investigation has found no evidence that Hertz’s own network was affected by this event,” a Hertz spokesperson said via email. 
  • CISA added four known exploited vulnerabilities to its catalog this week.
  • April 16, 2025
    • CVE-2021-20035 SonicWall SMA100 Appliances OS Command Injection Vulnerability
      • Cybersecurity Dive discusses this KVE here.
  • April 17, 2025
    • CVE-2025-31200 Apple Multiple Products Memory Corruption Vulnerability
    • CVE-2025-31201 Apple Multiple Products Arbitrary Read and Write Vulnerability
    • CVE-2025-24054 Microsoft Windows NTLM Hash Disclosure Spoofing Vulnerability
      • Dark Reading discusses the Apple KVEs here.
      • Hacker News discusses the Microsoft KVE here.
  • Cybersecurity Dive adds,
    • “Huntress on Monday published research that showed exploitation of CVE-2025-30406, a deserialization vulnerability in Gladinet’s CentreStack enterprise file-sharing platform for managed service providers (MSPs). The cybersecurity vendor said seven organizations were compromised via the zero-day flaw, which involves a hardcoded cryptographic key that can be used to gain remote code execution.
    • “Huntress warned that Gladinet’s Triofox product also relies on a hardcoded key and is vulnerable to CVE-2025-30406. Triofox is an on-premises file-sharing server designed for larger enterprises, according to Gladinet.
    • “CISA added CVE-2025-30406 to its known exploited vulnerabilities catalog on April 9. Gladinet first disclosed the flaw on April 3 and warned that exploitation had already been observed in the wild.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “DaVita has been hit by a ransomware attack that’s affecting operations, the kidney care provider said Monday. 
    • “The dialysis company discovered the attack, which encrypted parts of its network, on Saturday, according to a securities filing. Davita then activated its response plans and isolated affected systems.
    • “The company did not disclose how its operations are being affected or how long the disruption will last, but said patient care is continuing.” 
  • and
    • “Ahold Delhaize confirmed Thursday that certain files from its U.S. operations were stolen in a November cyberattack after a threat group claimed credit for the incident.
    • “The threat group, tracked as Inc Ransom, claimed in a Wednesday post on its leak site to have up to 6 TB of sensitive data from the Netherlands-based supermarket operator’s U.S. division and threatened to release the information if its demands are not met, according to researchers at Arctic Wolf. The attackers have not said what those demands are.
    • “Since the incident was detected, our teams have been working diligently to determine what information may have been affected,” Ahold Delhaize USA said in a statement.”
  • Per Security Week,
    • “The Oregon Department of Environmental Quality (DEQ) is the regulatory agency in charge of the quality of air, land and water in the state. The organization revealed on April 9 that it had launched an investigation into a cyberattack that forced it to shut down networks as part of containment efforts.
    • “The DEQ has been issuing updates every day since, and several of the updates pointed out that the agency had found no evidence of a data breach. 
    • “The incident disrupted email and help desk services, as well as vehicle inspection stations. The agency said its environmental data management system is hosted on a separate server and has not been impacted.
    • “After the regulator’s repeated denials about suffering a data breach, the notorious Rhysida ransomware group took credit for the attack on Monday, claiming to have stolen 2.5 Tb of files, including employee data.” 
  • Bleeping Computer points out,
    • “The Interlock ransomware gang now uses ClickFix attacks that impersonate IT tools to breach corporate networks and deploy file-encrypting malware on devices.
    • “ClickFix is a social engineering tactic where victims are tricked into executing dangerous PowerShell commands on their systems to supposedly fix an error or verify themselves, resulting in the installation of malware.
    • “Though this isn’t the first time ClickFix has been linked to ransomware infections, confirmation about Interlock shows an increasing trend in these types of threat actors utilizing the tactic.
    • “Interlock is a ransomware operation launched in late September 2024, targeting FreeBSD servers and Windows systems.
    • “Interlock is not believed to operate as a ransomware-as-a-service model. Still, it maintains a data leak portal on the dark web to increase pressure on victims, demanding payments ranging from hundreds of thousands of dollars to millions.”
  • The Register adds,
    • “Ransomware operators jack up their ransom demands by a factor of 2.8x if they detect a victim has cyber-insurance, a study highlighted by the Netherlands government has confirmed.
    • “For his PhD thesis [PDF], defended in January, Dutch cop Tom Meurs looked at 453 ransomware attacks between 2019 and 2021. He found one of the first actions intruders take is to search for documents with the keywords “insurance” and “policy.” If the crooks find evidence that the target has a relevant policy, the ransom more than doubles on average.
    • “In double-extortion attacks, where intruders threaten to publish data stolen from the victim unless the ransom is paid, those with insurance on average are quoted 5.5x more than those who don’t.” * * *
    • “According to the research, firms with a proper backup system were 27x less likely to pay criminals off, for the simple reason that they usually don’t need to. Even then, surprisingly, some do.
    • “In roughly 5 out of 100 cases in which a payment is made, victims do have the option to recover in a way other than paying, but they still choose to pay – for example to recover faster or to prevent reputational damage,” he said.
    • “In the remaining 95 cases, there is no other option to recover. In those cases, their entire IT infrastructure is broken and can no longer be repaired, making paying the ransom the only option to avoid bankruptcy.”

From the cybersecurity defenses front,

  • The American Hospital Association News tells us,
    • “The Cybersecurity and Infrastructure Security Agency April 17 released guidance to reduce risks associated with a reported breach of Oracle cloud services. CISA said the scope and impact of the breach is unconfirmed and that credentials may be exposed that could be reused across unaffiliated systems or embedded. The guidance lists recommendations for organizations and individual users to mitigate the risk of potential compromise. 
    • “This alert not only contains practical guidance to mitigate the potential breach related to Oracle but also provides valuable guidance and best practices for general cloud security,” said John Riggi, AHA national advisor for cybersecurity and risk. “Generally speaking, we continue to see that most of the cyber risk exposure that hospitals and health systems face originates from insecure third-party technologies, service providers and the supply chain. It is vitally important for mission-critical third parties to share timely threat intelligence and adversary tactics with the federal government and affected clients. This is necessary to prevent potential cyberattacks, which could compromise sensitive data and risk patient safety.” 
  • Dark Reading asks “Are We Prioritizing the Wrong Security Metrics? True security isn’t about meeting deadlines — it’s about mitigating risk in a way that aligns with business objectives while protecting against real-world threats.”
  • Cyberscoop considers whether “Ivanti is the problem or a symptom of a systemic issue with network devices? Exploited vulnerabilities have turned up in Ivanti products 16 times since 2024. That’s more than any other vendor in the network edge device space.”
  • Bleeping Computer suggests “7 Steps to Take After a Credential-Based cyberattack.”
    • “When credentials fall into the wrong hands and hackers breach your systems, every minute counts — but having a well-rehearsed incident response plan will allow you to minimize damage and recovery time.”
  • Here is a link to Dark Reading’s CISO corner.

Friday Report

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

From Washington, DC,

  • Federal News Network tells us,
    • “Agencies will not be able to fill or create any federal jobs for another three months, after President Donald Trump extended the current federal hiring freeze until July 15.
    • “But even after the hiring freeze lifts later this summer, agencies will still be limited in how many new employees they can hire, and how many new positions they can create. The White House said it will cap agencies to one new hire for every four federal employees who leave the civil service.”
    • Here’s a fact sheet on the hiring freeze extension.
  • Fierce Healthcare adds,
    • “President Donald Trump and the Office of Personnel Management (OPM) are moving forward with “Schedule F,” a policy to make it easier to remove workers from federal agencies like the Department of Health and Human Services (HHS), Fierce Healthcare has confirmed.
    • “Implementing Schedule F will deprive 50,000 federal employees of civil service protections by classifying them as “at-will” workers. Once a final rule is issued, another executive order will be released to directly move positions under the final rule’s authority.
    • “The OPM’s proposed rule will give authority to the government to cut workers over performance that does not align with the administration’s priorities without procedural delays.”
    • The proposed rule appeared in the Federal Register’s public inspection list today. The proposed rule will be published in the Federal Register on April 23, 2025.

In Food and Drug Administration news,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced Thursday.
    • “Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.
    • “These representatives don’t vote on questions put to the committee. They are meant to share the perspective of their industry broadly, rather than of the specific company that employs them. There are also usually patient or consumer representatives on the panels.
    • “Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.”
  • Per Fierce Pharma,
    • “On its way to generating sales of $14 billion in just its seventh full year on the market, Sanofi and Regeneron’s Dupixent has experienced few setbacks. One came in 2023, however, when the FDA rejected the immunosuppressant as a treatment for chronic spontaneous urticaria (CSU), asking for more data.
    • “Eighteen months later—and backed by more conclusive results—the companies have convinced the U.S. regulator to sign off on Dupixent for the difficult-to-treat skin condition. With the nod, Dupixent becomes the first new medicine for CSU in more than a decade. 
    • “The approval clears Dupixent to be used by those age 12 and older who remain symptomatic despite using histamine-1 (H1) antihistamines. It’s a population of more than 300,000 among the roughly 3 million in the U.S. who have CSU, the companies said in a release.”
  • Per Medscape,
    • “The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class prescription digital therapeutic for the preventive treatment of episodic migraine in adults, its development company announced in a statement.
    • “The mobile smartphone app uses biological, psychologic, and behavioral approaches to target pain processing and includes such tools as an eDiary tracker and short daily lessons. It is intended for use alongside other acute and preventive treatments for migraine. 
    • “The marketing authorization, which was reviewed through the FDA’s de novo pathway for medical devices, is based on results from two recent clinical trials: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. As reported by Medscape Medical News, the findings were presented at the recent American Academy of Neurology (AAN) 2025 Annual Meeting.”

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 continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • RSV
      • “RSV activity continues to decline in most areas of the country.
    • 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.”
  • The University of Minnesota CIDRAP adds,
    • “The CDC confirmed 10 new pediatric flu deaths, bringing the season’s total to 198. This compares with 207 deaths last flu season. Nine of the new deaths were from influenza A and 1 from influenza B. Of the 8 influenza A cases for which scientists performed subtyping, 5 were caused by the H1N1 strain, and 3 were H3N2.”
  • The American Hospital Association (AHA) News tells us,
    • “The Centers for Disease Control and Prevention April 18 announced there have been 800 reported cases of measles across the country this year. Twenty-four states have reported cases and there have been 10 outbreaks. Most cases (94%) have been outbreak-associated. 
    • “Texas, which has the largest outbreak of any state, April reported a total of 597 cases. Michigan also reported an outbreak yesterday — the state’s first since 2019 — with three cases. CDC data shows that 11% of all cases have been hospitalized. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
  • The New York Times adds,
    • “As the United States struggles to contain a resurgence of measles that has swept through swaths of the Southwest, neighboring countries are responding to their own outbreaks.
    • “Canada has reported more than 730 cases this year, making this one of the worst measles outbreaks in the country since it declared the virus “eliminated” in 1998. Mexico has seen at least 360 measles cases and one death, most of them in the northern state of Chihuahua, according to Mexican health authorities.
    • “Many of the communities grappling with measles have large Mennonite populations that public health officials have linked to outbreaks. The multinational resurgence has concerned epidemiologists, who fear that simultaneous outbreaks near the U.S. border will make it more difficult to contain the virus.
    • “It’s just a line on the map that separates them — we share air, we share space,” said Lisa Lee, an epidemiologist at Virginia Tech.”
  • Medscape lets us know,
    • “Five classic risk factors for cardiovascular disease — high blood pressure, high cholesterol, obesity, diabetes, and smoking — at age 50 can reduce life expectancy by more than 10 years. This is the conclusion of an international study led by German researchers and presented at the 2025 American College of Cardiology Scientific Session.
    • “These five factors account for approximately 50% of the global burden of cardiovascular diseases. Our central question was how many additional years of life are possible if these factors are absent or modified in middle age,” said Christina Magnussen, MD, PhD, deputy director of the Department of Cardiology at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany, during her presentation in Chicago.
    • “The findings, also published in The New England Journal of Medicine, show that lifestyle changes and risk management in middle age can make a significant difference. Lowering blood pressure and quitting smoking had the most significant impacts.”
  • Diagnostic Imaging points out,
    • “Emerging research suggests that prior mammography screening within five years of breast cancer diagnosis for seniors significantly reduces the risks of later-stage diagnosis and breast cancer-specific mortality.
    • “For the study, recently published in JAMA Network Open, researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database for 13,028 women who had screening mammography-detected breast cancer. Over 77 percent of the cohort had at least one mammography screening in a five-year period prior to diagnosis and over 69 percent were in their 70s, according to the study. The researchers also noted that over 29 percent were diagnosed with later-stage (T2+ or N1+) disease.
    • “Multivariable analysis revealed that women having at least one mammography screening in the five years prior to diagnosis had a 54 percent lower risk of a later-stage presentation at diagnosis. The study authors found that these women also had a 36 percent lower risk of breast cancer-specific death.”
  • Per HealthDay,
    • “People might think they can reduce their risk of cancer by occasionally swapping their cigarettes for a vape pen — but they would be wrong, a new study says.
    • “So-called “dual users” — folks who both smoke and vape – are exposed to the same levels of nicotine and cancer-causing toxins as those who only smoke cigarettes, researchers reported in the journal Nicotine and Tobacco Research.”
  • Per the AHA News,
    • “A study published April 17 by JAMA Otolaryngology Head and Neck Surgery found that up to 32% of dementia cases from 2011-2019 could be attributed to hearing loss confirmed through testing. Self-reported hearing loss was not associated with higher dementia risk.”

From the U.S. healthcare business front,

  • CBS News reports,
    • “Blue Cross Blue Shield of Massachusetts says it will soon stop covering popular drugs for weight loss, like Ozempic and Wegovy.
    • “The medications have skyrocketed in price and popularity, but they’re now being blamed for crippling budgets in the public and private sector. As one of the fastest growing classes of medications, GLP-1 weight-loss drugs were originally brought on the market to treat diabetes. But their secondary use as a way for users to suppress diets and slim down sent sales through the roof. 
    • “Blue Cross announced Thursday that starting on January 1, 2026, standard coverage plans will not cover GLP-1s for weight loss. The company will continue to cover patients who are using the drugs for diabetes treatment. 
    • “Studies suggest nearly 1 in 8 people have used GLP-1s as the drugs become more common. That’s given drug companies the reason to increase prices.” 
  • FEHB premiums continue to reverberate from OPM’s sudden decision in January 2023 to require all FEHB plans to cover GLP-1 drugs for obesity. Traditionally, OPM announces a mandate in the call letter for benefit proposals and allows the carrier to raise its premiums in advance of the mandate. OPM should stick with tradition and in any event curb its mandate habit. The FEHBlog wonders whether Lilly’s GLP-1 pill will reduce overall costs on obesity drugs.
  • Modern Healthcare relates,
    • Hospitals are zeroing in on alternative care models to improve the nursing work experience and patient outcomes while lowering costs.
    • Eight in 10 nurse leaders are piloting new care models in their organizations, ranging from virtual nursing to home health, according to a recent study by healthcare solutions company Wolters Kluwer.
  • Per an ICER news release,
    • “This week, ICER released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions. The report will be open to public comment until May 13th. Click here for information on submitting a public comment.“
  • Per Beckers Hospital Review,
    • “Several large health systems reported operating losses in 2024, underscoring ongoing financial strain despite rising patient volumes and revenue growth. While inpatient revenue is climbing, expense pressures, cybersecurity disruptions and shifting care dynamics continue to weigh on margins — leaving even some of the nation’s largest systems in the red.
    • “In February, average hospital operating margins fell to 2.5%, down from 3.4% in January, according to Kaufman Hall’s latest “National Hospital Flash Report.” Despite the dip, margins remained above 2024’s year-to-date average, suggesting that while performance has improved compared to recent years, financial stability remains fragile.
    • “In the early months of 2025, volumes remain strong across the board,” Erik Swanson, managing director and data and analytics group leader at Kaufman Hall, said in an April 8 report.  “Emergency visits are rising, which is leading to challenges with ED boarding for many organizations. Data also show that inpatient revenue is growing while outpatient revenue has slowed, which points to the rapid growth in outpatient care in the last few years reaching its peak.”
    • The article describes the results for 11 health systems.