FEHBlog

Tuesday Report

David Ermer–CDC, Congress, Electronic health records, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–

From Washington, DC

Capitol Hill News

  • Roll Call lets us know,
    • “The Senate took its first procedural step Tuesday on a budget blueprint that would pave the way for a filibuster-proof border security, defense and energy package, a key part of President Donald Trump’s legislative agenda.
    • “Once GOP leaders were certain of a critical mass of senators returning to Washington in time, they teed up a vote on the motion to proceed to the fiscal 2025 budget resolution, which was agreed to on a mostly party-line, 50-47 vote. Only a simple majority is needed to proceed and to eventually adopt the framework on a final vote, but Republicans don’t expect any Democrats to help them advance it, making every GOP vote count.  
    • “Once a budget resolution is adopted in both chambers, key congressional committees can get to work on writing the actual reconciliation bill — which is immune to a filibuster, like the budget resolution — to implement their fiscal priorities.
    • “The initial Senate plan laid out in the fiscal 2025 resolution envisions spending boosts for defense and border security, domestic energy incentives and offsets to pay for the package. It doesn’t address the 2017 tax cuts expiring at the end of the year, instead promising to come back with a second budget reconciliation process later this year to deal with the tax pieces of the GOP agenda.”

White House News

  • Fierce Healthcare tells us,
    • “A new executive order signed by President Trump aims to expand access to in vitro fertilization (IVF) and make it more affordable.
    • “The order directs the Domestic Policy Council to make policy recommendations to protect IVF access and “aggressively” reduce the associated costs for treatment. The policies should focus on ensuring reliable access to IVF and addressing areas that exacerbate the out-of-pocket and health plan costs associated with the care.
    • “These are treatments that have become unaffordable for many Americans,” Will Scharf, the White House staff secretary, said at a press conference on Tuesday.”
  • Per MedPage Today,
    • “The Trump administration’s efforts to address the causes of chronic diseases will all be based on “unbiased science,” HHS Secretary Robert F. Kennedy Jr. said Tuesday.
    • “We will convene representatives of all viewpoints to study the causes for the drastic rise in chronic disease,” Kennedy said in a speech to HHS employees. “Some of the possible factors we will investigate were formally taboo or insufficiently scrutinized — the childhood vaccine schedule; electromagnetic radiation; glyphosate; other pesticides; ultra-processed foods … SSRIs [selective serotonin reuptake inhibitors] and other psychiatric drugs; PFAS [per- and polyfluoroalkyl substances]; PFOA [perfluorooctanoic acid]; microplastics — nothing is going to be off-limits.”
    • “Whatever belief or suspicion I have expressed in the past, I’m willing to subject them all to the scrutiny of unbiased science,” Kennedy said in the speech, a portion of which was posted on Xopens in a new tab or window. “That is going to be our template — unbiased science. That’s something that will make us all proud of this agency and of our role in restoring American health.”
    • “Let’s commission research that will satisfy all the stakeholders once and for all,” he continued. “Let’s use protocols that we all agree on in advance and not alter the outcomes of studies when they’re halfway through [because] they look inconvenient. Let’s all depoliticize these issues and reestablish a common ground for action and renew the search for existential truths with no political impediments and no preconceptions.”

Postal Service News,

  • Govexec informs us,
    • “Postmaster General Louis DeJoy will soon step down as head of the U.S. Postal Service, creating an opening for the agency’s governing board to fill as it is in the midst of implementing controversial and sweeping reforms to its operations. 
    • “DeJoy has requested the USPS board begin its process to find a successor just months after telling Congress he would remain in the post “until somebody hauls me out of here.” The postmaster general has faced significant criticism since his appointment to the role in 2020 for his efforts to slow down mail delivery, raise prices and consolidate mail processing while also winning some plaudits for creating a vision he said would eliminate the agency’s financial troubles. 
    • “Postmasters general serve no fixed terms and are chosen by the board. President Biden while in office faced some calls to fire DeJoy, a long-time Republican donor who came to USPS after running a successful private sector logistics company, though he could only be removed by the board or on his own volition. 
    • “DeJoy said “much critical work” remains to implement his vision for the agency, but he decided it was time to start the process of identifying a successor.”

Food and Drug Administration News

  • Fierce Pharma relates,
    • “Two years on, Bavarian Nordic’s $380 million vaccine M&A move appears to be paying off.
    • “The Danish company’s chikungunya vaccine, Vimkunya, has now crossed the FDA finish line, heating up the competition with Valneva by countering with a label that covers a broader population.
    • ‘The FDA approved Vimkunya’s use in people who are at least 12 years old, marking the first chikungunya vaccine that can be given to those younger than 18. With the nod, Bavarian Nordic also picked up a priority review voucher (PRV) under the FDA’s tropical disease PRV program; the company plans to monetize the PRV “when appropriate,” it said in a Friday press release.”

From the judicial front,

  • The AP, via Federal News Network, reports,
    • “A federal judge refused Tuesday to immediately block billionaire Elon Musk and the Department of Government Efficiency from accessing government data systems or participating in worker layoffs. 
    • “U.S. District Judge Tanya Chutkan found that there are legitimate questions about Musk’s authority but said there isn’t evidence of the kind of grave legal harm that would justify a temporary restraining order. 
    • “The decision came in a lawsuit filed by 14 Democratic states challenging DOGE’s authority to access sensitive government data. The attorneys general argued that Musk is wielding the kind of power that the Constitution says can only be held by those who are elected or confirmed by the Senate. 
    • “The Trump administration, for its part, has maintained that layoffs are coming from agency heads, and asserted that despite his public cheering of the effort Musk isn’t directly running DOGE’s day-to-day operations himself.” 
  • Per STAT News,
    • “California officials were dealt a setback by a federal judge who ruled that a controversial law banning so-called pay-to-delay deals between pharmaceutical companies is, in part, unconstitutional and so cannot be enforced against agreements that had no link to the state.
    • “In his ruling, U.S. District Court Judge Troy Nunley determined that the state law, which was enacted in 2019, violated the Dormant Commerce Clause of the U.S. Constitution because it would extend to pay-to-delay agreements that happened outside of California and, therefore, attempted to regulate interstate commerce.”

From the public health and medical research front,

  • The Wall Street Journal offers its perspective on bird flu. “With so much H5N1 virus circulating across the U.S., scientists worry we are a few mutations away from a potential human pandemic.”
  • Beckers Hospital Review discusses hospitalizations for measles outbreaks.
  • CNN reports,
    • “The best way to stay protected against measles is to get vaccinated, according to experts. The measles, mumps and rubella (MMR) vaccine is 93% effective against measles after one dose and 97% effective against measles after two, according to the CDC.
    • “Officials’ guidance says children should get two doses of the MMR vaccine: the first dose between 12 and 15 months and the second around age 4, before starting school.
    • “When people consider their choice about vaccinating their child, it isn’t just about their own individual child, but this is a public health issue. … If we just stop thinking about the health of the population, we are going to see more and more vaccine-preventable illness, outbreaks occur,” said Dr. Christina Johns, a pediatric emergency physician at PM Pediatrics.
    • “Older children or adults can also get vaccinated if they didn’t get the vaccine as a child, she says. However, people born before 1957 are likely to have been naturally infected and thus already have immunity, according to the CDC.
    • “CDC guidance also indicates that if someone is exposed to measles, getting the MMR vaccine within 72 hours could induce some protection or result in less serious illness.”
  • The National Cancer Institute blogs about “Many Men with Metastatic Prostate Cancer Are Not Getting the Recommended Treatments, Study Finds.”
  • Beckers Hospital Review tells us,
    • “Investments in primary care are declining and fewer clinicians are entering the field at a time when chronic disease rates are rising, according to a new report from researchers at the American Academy of Family Physicians. 
    • “The report, “The Health of US Primary Care: 2025 Scorecard Report — The Cost of Neglect,” points to underlying challenges contributing to a lack of access to primary care in the U.S., including insufficient funding and reimbursement rates. This marks the third edition of the scorecard report, led by researchers at the AAFP’s Robert Graham Center for Policy Studies in Primary Care. The report is co-funded by the Milbank Memorial Fund and The Physicians Foundation and is based on national and state-level data tracking primary care performance, workforce trends and reimbursement patterns.”
  • A National Institutes of Health online newsletter discusses “Dementia in the U.S. | Contact lenses slow myopia in kids | New malaria target.”
  • The HHS Inspector General released a report titled “Not All Medicare Enrollees Are Continuing Treatment for Opioid Use Disorder.”
  • Per BioPharma Dive,
    • “An experimental Duchenne muscular dystrophy gene therapy from Solid Biosciences showed potential in a small clinical trial, leading the biotechnology company to quickly raise funds on the findings.
    • “Three months after treatment with Solid’s therapy, SGT-003, the first three participants in an early-stage clinical trial produced higher-than-normal levels of a tiny protein linked to muscle function, Solid said Tuesday. No serious side effects were observed so far, the company added.
    • “Solid claims the results, while early, suggest SGT-003 could be more potent than Sarepta Therapeutics’ Elevidys, the only approved Duchenne gene therapy. The company intends to discuss an accelerated approval pathway with U.S. regulators later this year. Solid’s share price rose by as much as 79% Tuesday morning before settling back to trade up 40%. It announced a $200 million stock offering alongside the study results.”

From the U.S. healthcare business front,

  • CIGNA Healthcare announced,
    • “Specialty medications used to treat rare, chronic, and complex diseases are often administered via injection or infusion. While some patients need to receive these medications in a hospital setting, most patients can use options that are more affordable and more convenient. These include infusion centers not affiliated with hospitals, qualified physician’s offices, or administration in the patient’s home by a trained nurse. When appropriate, guiding patients to these non-hospital settings can make specialty treatment easier to access while reducing health care costs.
    • “Although some treating physicians have concerns about the quality and safety of alternative sites, new research published in the Journal of Clinical Pathways found that patients who received specialty medication treatments at non-hospital outpatient settings are less likely to experience adverse reactions or seek care at the emergency room than those treated at hospital outpatient settings. They are also less likely to be hospitalized within a week following treatment. These findings are based on a retrospective analysis of Cigna Healthcare claims data from more than 122,000 patients who received nearly 1 million injections or infusions of 72 specialty drugs between January 1, 2021, and October 31, 2023.
    • “This research clearly demonstrates that administering specialty medications in non-hospital settings is safe and effective,” said Dr. Jeff Langsam, national director of oncology and senior medical director of specialty pharmacy at Cigna Healthcare. “The convenience and comfort of these less intensive care settings also enhance the patient’s experience.”
  • Fierce Healthcare adds,
    • “CVS Health has named Ed DeVaney as president of its pharmacy benefit manager, CVS Caremark.
    • “DeVaney has served as interim president of Caremark since December 2024. The president’s role was vacated when David Joyner took over as CEO of CVS Health in October.
    • “CVS said that DeVaney joined the company in 2005 and held roles across Caremark and the company’s Aetna division. Prior to taking over as interim president, DeVaney was Caremark’s president of employer and health plans, where he led the team’s work to grow and retain its PBM customers.”
  • Beckers Health IT explains how artificial intelligence tools are being integrated into electronic health records.
  • Beckers Payer Issues discusses the healthcare stop loss market.

Happy Presidents Day

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Mount Rushmore Photo by Laura Nyhuis on Unsplash

From Washington, DC

  • Milliman explains how to navigate the new mental health parity rules which are under a legal challenge before the U.S. District Court for the District of Columbia.
  • Per Fierce Pharma,
    • “Pfizer’s two-year run with the only 5-in-1 meningococcal vaccine on the U.S. market has come to an end. Now, GSK is ready to play catch-up after nabbing its own FDA approval. 
    • “The FDA approved the British drugmaker’s Penmenvy vaccine to protect people ages 10 to 25 against meningococcal serogroups A, B, C, W and Y (MenABCWY), which together cause the most invasive meningococcal disease (IMD) cases globally. The shot mixes the antigenic components of GSK’s established meningococcal vaccines Bexsero and Menveo, which target MenB and MenACWY, respectively, to offer broader coverage in fewer doses.”
  • MedPage Today adds,
    • “The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday [February 14].
    • “Like its reference counterpart, insulin aspart (Novolog), the biosimilar helps lower mealtime blood sugar spikes to improve glycemic control. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.
    • “For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement.

From the U.S. public health and medical research front,

  • Beckers Clinical Leadership identifies America’s priciest health conditions.
  • Medscape notes,
    • “The CDC recommends everyone age 6 months or older get a flu vaccine, although so far this year, fewer adults have gotten the shot, compared to last year. The adult flu vaccination rate this season is 44%, down from 48% last season. According to the National Foundation for Infectious Diseases, “as long as influenza (flu) viruses are circulating in your community, it’s not too late to get vaccinated against flu.”
  • The New York Times offers “New Insights into Older Hearts. Heart disease is more common in people over 65, but treatments are better than ever. That can complicate decision-making for older heart patients.”
  • Consumer Reports, writing in the Washington Post, explains “How to keep your eyes healthy and your vision sharp. Cataracts, dry eyes, glaucoma and other eye problems become more common with age. Knowing the early signs and acting fast can make a difference.”
  • Per Healio,
    • There is evidence that GLP-1s can ameliorate psychiatric and neurologic symptoms.
    • More clinical trials on the direct and indirect effects of GLP-1s and their mechanisms of action are needed.
  • and
    • “American Indian and Alaska Native women face substantially higher risk for heart disease, particularly during reproductive-age years.
    • “Generational trauma, violence and racism have compounded [pregnancy] risks.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health’s quarterly net patient revenue dipped for the first time in months.
    • “The health system saw net patient revenue of $8.9 billion in the second quarter of fiscal 2025, a 5% drop from the year-ago period, according to its earnings report released Friday. Net patient revenue, or revenue from providing healthcare services after contractual discounts, makes up most of providers’ total operating revenue and can have a big impact on the bottom line.
    • “The results were markedly different from last year, when CommonSpirit was one of several systems that saw big increases in net patient revenue due to higher utilization and improved payer rates.
  • Beckers Hospital Review shares more insights on CommonSpirit Health’s second quarter report.
  • Beckers Payer Issues discusses the adverse impact of the Inflation Reduction Act on payers.
  • Fierce Healthcare relates,
    • “As obesity rates rise across the U.S., a new study from UnitedHealthcare and the Health Action Council examines the financial costs that this growing “epidemic” may cause for employers.
    • “The report (PDF) notes that 75% of adults in U.S. are either overweight or obese, up from 50% in 1990. Obesity rates grew fastest among younger adults, according to the report.”The HAC represents about 230 self-funded employers, and, among its members, about a quarter (26%) have been diagnosed with obesity. The obese population accounts for 46% of the employers’ medical spend, according to the report.
    • “Per member per month costs for obese employees were more than double on average compared to those who were not obese, the study found. Per member per month costs for those with obesity averaged $973, compared to $421 for non-obese workers.”
  • and
    • “As both regulatory and market forces are pushing the industry toward more transparency in healthcare pricing, MultiPlan sees opportunities to be a bigger player in data and tech for providers, payers and employers.
    • “The data analytics company, which has been in the market for 45 years, launched a rebrand at the ViVE 2025 digital health conference on Monday.
    • “Rebranded Claritev, the company is focused on developing new products and technologies that provide data insights to a broader swath of the healthcare market. Providing “actionable insights” to healthcare organizations will be a key part of the company’s growth, Travis Dalton, chairman, CEO and president, told Fierce Healthcare in an interview in the lead-up to the ViVE 2025 event.”
  • MedTech Dive informs us,
    • “Medtronic has bought nano surface technology from Nanovis for use in its next-generation spine fusion implants.
    • “Nanovis, which disclosed the deal Tuesday [February 11], has developed nanotechnology to improve the speed and consistency of bone growth. The company has its own portfolio of spine devices.
    • “Medtronic will use the technology to develop PEEK interbody spine fusion devices that enhance implant fixation. The technology could help bone grow and fuse with the implant.”
  • The Wall Street Journal reports,
    • “If you need a prescription filled in the coming years, don’t be surprised if it flies in and lands in your backyard. 
    • “Hospitals and doctors are increasingly experimenting with the use of drones to deliver medications, lab tests and supplies to patients being treated at home. Some are testing whether drones can be used to deliver organs for transplant more quickly and cheaply. And in some cities, a 911 call today could set off a drone carrying a defibrillator, Narcan spray or tourniquet to the scene of an emergency ahead of the arrival of paramedics.” * * *
    • “One of the challenges in this space five to 10 years ago was that there wasn’t a really clear regulatory framework. Over the last 18 months this has solidified, especially in the U.S. There is now a clear path to scale,” says Adam Woodworth, chief executive officer of Wing, the drone-service unit of Google’s parent Alphabet GOOGL.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop lets us know,
    • “Cybercrimes could be punished more harshly under a new bill from a pair of senators that seeks to amend U.S. criminal code on computer fraud.
    • “The Cyber Conspiracy Modernization Act from Sens. Mike Rounds, R-S.D., and Kirsten Gillibrand, D-N.Y., would modify the Computer Fraud and Abuse Act (CFAA) to establish a specific penalty for conspiracy and boost penalties for violators. 
    • “As cyber technologies continue to rapidly evolve, we need more people working to secure cyberspace as well as harsher penalties for those perpetrating these crimes,” Rounds said in a statement. “As chairman of the Senate Armed Services Committee’s Subcommittee on Cybersecurity, I am committed to working on policies that strengthen the United States’ ability to respond quickly and decisively to cyberattacks which have been on the rise.”
    • “Under current law, the Department of Justice can only charge conspiracy to commit cybercrimes through a general statute unrelated to the CFAA. Individuals charged under the general conspiracy statute face a maximum five-year penalty.”
  • Cybersecurity Dive informs us,
    • “President Donald Trump plans to nominate Sean Cairncross, a former official at the Republican National Committee, as the next national cyber director, according to a list of planned nominees obtained by Cybersecurity Dive. 
    • “Those nominees are expected to be sent imminently to the Senate to be considered for the confirmation process. 
    • “Cairncross would be the first major nominee for a top cybersecurity role since the Trump administration took office. 
    • “He is founder and president of the Cairncross Group, a strategic consultancy based in Washington, D.C.
    • “Cairncross previously worked as CEO of the Millennium Challenge Corp., an independent government agency that works to reduce poverty by promoting economic growth across the globe.”
  • Federal News Network notes,
    • “A former cyber executive at the Department of Homeland Security and the Energy Department has joined the Cybersecurity and Infrastructure Security Agency.
    • “Karen Evans is now “senior advisor for cybersecurity” at CISA, an agency spokesman confirmed to Federal News Network today. Evans posted about joining CISA on LinkedIn last night.
    • “A CISA spokesman did not confirm whether Evans would be elevated to a permanent role at the agency. But multiple sources said Evans is likely to either be named as executive assistant director for cybersecurity at CISA or move on to a top position at DHS headquarters.
    • “During the first Trump administration, Evans was DHS CIO between June 2020 and January 2021. She also served as assistant secretary for cybersecurity, energy security and emergency response at the Energy Department between 2018 and 2020.”
  • NextGov/FCW offers background on OPM’s new Chief Information Officer, Greg Hogan.
  • Per a Justice Department news release,
    • The Justice Department today [February 10] unsealed criminal charges against Roman Berezhnoy, 33, and Egor Nikolaevich Glebov, 39, both Russian nationals, who allegedly operated a cybercrime group using the Phobos ransomware that victimized more than 1,000 public and private entities in the United States and around the world and received over $16 million in ransom payments. Berezhnoy and Glebov were arrested this week as part of a coordinated international disruption of their organization, which includes additional arrests and the technical disruption of the group’s computer infrastructure.
    • From May 2019, through at least October 2024, Berezhnoy, Glebov, and others allegedly caused victims to suffer losses resulting from the loss of access to their data in addition to the financial losses associated with the ransomware payments. The victims included a children’s hospital, health care providers, and educational institutions.

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports,
    • Microsoft threat researchers discovered a series of what they are calling “device code” phishing attacks that allowed a suspected Russia-aligned threat group to gain access to and steal data from critical infrastructure organizations, the company said in research released Thursday.
    • The group, which Microsoft tracks as Storm-2372, has targeted governments, IT services and organizations operating in the telecom, health, higher education and energy sectors across Europe, North America, Africa and the Middle East.
    • Microsoft observed attackers generating a legitimate device code sign-in request and then duping targeted users to input the code into a login page for productivity apps. By exploiting the device code authentication flow, Storm-2372 has gained access to targeted systems, captured authentication tokens and used those valid tokens to achieve lateral movement and steal data.
    • “They’ve been successful in these attacks, though Microsoft itself is not affected,” Sherrod DeGrippo, director of threat intelligence strategy at Microsoft, said in a video summarizing the report’s findings.
  • and
    • “Salt Typhoon, the Chinese nation-state threat group linked to a spree of attacks on U.S. and global telecom providers, remains active in its intrusion and has hit multiple additional networks worldwide, including two in the United States, Recorded Future said in a report released Thursday [February 13].
    • “Recorded Future’s Insikt Group observed seven compromised Cisco network devices communicating with Salt Typhoon infrastructure on five telecom networks between early December and late January. The compromised companies include an unnamed U.S. internet service provider and telecom company, a U.S.-based affiliate of a U.K. telecom provider, a large telecom provider in Thailand, an Italy-based ISP and a South Africa-based telecom provider.
    • “Salt Typhoon’s ongoing attack spree underscores the enduring challenge global cyber authorities and network defenders confront in trying to thwart the nation-state group’s activities. U.S. and White House officials in December warned they may never know if the group has been completely booted from networks.” 
  • Cybersecurity Dive relates,
    • “The FBI and Cybersecurity and Infrastructure Security Agency on Wednesday [February 12] warned Ransomware gangs are adapting to stronger enterprise defenses and increased law enforcement pressure with more sophisticated tactics, according to Huntress’ 2025 Cyber Threat Report.
    • In 75% of the ransomware incidents Huntress observed in 2024, threat actors used remote access Trojans (RATs), while 17.3% of attacks featured abused of remote monitoring and management products like ConnectWise ScreenConnect, TeamViewer and LogMeIn.
    • In an effort to evade EDR protections, threat actors are shifting to data theft and extortion attacks instead of deploying ransomware and increasingly relying on “living off the land” techniques with legitimate system administrator tools. that hackers are abusing buffer overflow vulnerabilities to launch malicious attacks against organizations. 
    • “Buffer overflow vulnerabilities occur when a hacker gains access or writes information outside of the memory buffer, according to the advisory from the FBI and CISA. 
    • “Buffer overflow vulnerabilities are prevalent issues in memory-safety software design that can lead to data corruption, program crashes, exposure of sensitive data and remote code execution.
  • Per Bleeping Computer,
    • “Attackers are now targeting an authentication bypass vulnerability affecting SonicWall firewalls shortly after the release of proof-of-concept (PoC) exploit code.
    • “This security flaw (CVE-2024-53704), tagged by CISA as critical severity and found in the SSLVPN authentication mechanism, impacts SonicOS versions 7.1.x (up to 7.1.1-7058), 7.1.2-7019, and 8.0.0-8035, used by multiple models of Gen 6 and Gen 7 firewalls and SOHO series devices.
    • “Successful exploitation enables remote attackers to hijack active SSL VPN sessions without authentication, which grants them unauthorized access to targets’ networks.
    • “SonicWall urged customers to immediately upgrade their firewalls’ SonicOS firmware to prevent exploitation in an email sent before disclosing the vulnerability publicly and releasing security updates on January 7.”
  • CISA added seven known exploited vulnerabilities to its catalog this week.
  • The DC Health Link cybersecurity breach lawsuit settlement is explained here.

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Ransomware gangs are adapting to stronger enterprise defenses and increased law enforcement pressure with more sophisticated tactics, according to Huntress’ 2025 Cyber Threat Report.
    • “In 75% of the ransomware incidents Huntress observed in 2024, threat actors used remote access Trojans (RATs), while 17.3% of attacks featured abuses of remote monitoring and management products like ConnectWise ScreenConnect, TeamViewer and LogMeIn.
    • “In an effort to evade EDR protections, threat actors are shifting to data theft and extortion attacks instead of deploying ransomware and increasingly relying on “living off the land” techniques with legitimate system administrator tools.”
  • Dark Reading tells us,
    • “A recent RA World ransomware attack utilized a tool set that took researchers by surprise, given that it has been associated with China-based espionage actors in the past.
    • “According to Symantec, the attack occurred in late 2024. The tool set includes a legitimate Toshiba executable named toshdpdb.exe that deploys on a victim’s device. It then connects to a malicious dynamic link library (DLL) that deploys a payload containing a PlugX backdoor.
    • “The threat actors in this case used the tool kit to ultimately deploy RA World ransomware inside an unnamed Asian software and services company, demanding a ransom of $2 million. No initial infection vector was found. However, the attacker claimed they compromised the victim’s network by exploiting a Palo Alto PAN-OS vulnerability (CVE-2024-0012), according to Symantec.”
    • “The attacker then said administrative credentials were obtained from the company’s intranet before stealing Amazon S3 cloud credentials from its Veeam server, using them to steal data from its S3 buckets before encrypting computers,” added the researchers, who hypothesized that based on tactics, techniques, and procedures, the attacker could be China-linked Emperor Dragonfly, aka Bronze Starlight, a group that has been known to deploy ransomware to obscure intellectual property theft in the past.”
  • Reuters reports,
    • “The United States joined Australia and Britain in targeting Russia-based Zservers service provider for its role in supporting the Lockbit ransomware attacks, the U.S. Department of Treasury said on Tuesday [February 11], citing national security concerns.
    • “U.S. Treasury’s Office of Foreign Assets Control also designated two Russian nationals who they said were key administrators for Zservers, a bulletproof hosting services provider or BPH, it added.
    • “Ransomware actors and other cybercriminals rely on third-party network service providers like Zservers to enable their attacks on U.S. and international critical infrastructure,” wrote Bradley Smith, acting Under Secretary of the Treasury for Terrorism and Financial Intelligence.
    • “The action follows joint U.S., UK and Australia cyber sanctions last year targeting the Evil Corp ransomware group, Treasury added.”

From the cybersecurity defenses and business front,

  • Per Cyberscoop,
    • “Identity security giant CyberArk has acquired Boston-based Zilla Security, a cloud-native identity governance and administration startup, in a deal worth up to $175 million.
    • “The acquisition, announced Thursday [February 13], includes $165 million in cash and a $10 million earn-out contingent on performance milestones. Zilla’s co-founders, CEO Deepak Taneja and Nitin Sonawane, along with their team, will join CyberArk. Zilla’s flagship products — Zilla Comply and Zilla Provisioning — will be integrated into CyberArk’s Identity Security Platform as standalone offerings.
    • Founded in 1999, CyberArk has traditionally built its reputation on securing privileged access across enterprise systems. In recent years, the company has bolstered its portfolio through a series of acquisitions, the most significant being the $1.54 billion purchase of machine identity firm Venafi last year. Together with this latest move, CyberArk seeks to expand its reach into modern identity security — an area increasingly critical as organizations shift toward hybrid and cloud-based environments.
  • An ISACA expert discusses how to define a security incident.
    • “[W]hat is a good definition of a security incident? In my opinion, I believe the NIST definition from NISTIR 8183A Vol. 3 is an amazing definition for small and medium-sized organizations. It states, “An occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits or that constitutes a violation or imminent threat of violation of security policies, security procedures, or acceptable use policies.” The “or potentially” does a lot of heavy lifting here but is still a much better definition than those that allow people to more easily wiggle their way out of filling out a ticket for a potential incident. A common occurrence is cherry-picking more vague definitions that don’t have the built-in safeguards and controls around the definition such as the NIST SP 800-53 Rev. 5 for a non-federal system. 
    • “Besides the fact that leveraging this definition means that occurrences such as false positives and security investigations properly follow the ticketing process instead of being undocumented events, there are other helpful points to this definition. The terms “Confidentiality, Integrity and Availability” being in the definition ensures that incidents such as DDOS attacks are not reported as simply “outages” or “infrastructure changes.” The phrase “Constitutes a violation or imminent threat of violation of” expands the scope of what should be monitored and have alerts in place as well as points more eyes inward on internal incidents, which is a wonderful steppingstone toward zero trust.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–CMS, COVID-19, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Kaufmann Hall considers health policy in the second Trump administration.
  • Fierce Healthcare lets us know,
    • “The Department of Health and Human Services (HHS) is firing up to 5,200 probationary employees today, as part of an unprecedented cutting of jobs across the federal government.
    • “Of the impacted workers, 1,300 are employed by the Centers for Disease Control and Prevention (CDC) while a sizeable portion work for the National Institutes of Health (NIH). Employees were given four weeks paid administrative leave and notified on the morning of Feb. 14, as first reported by the Associated Press.” * * *
    • “The Department of Veterans Affairs announced layoffs Thursday affecting more than 1,000 federal workers, in a move the Trump administration said would save $98 million per year.”
  • The Wall Street Journal notes,
    • The Trump administration’s effort to slash the federal workforce is pushing employees into a challenging job market, where their age and lack of corporate experience can hold them back.
    • Federal workers are also facing an environment where hiring for white-collar jobs has slowed.
    • Despite the availability of state and local government jobs, many of these positions take place outside offices and aren’t a good match for federal workers’ experience.
  • The American Hospital Association News tells us,
    • “President Trump Feb. 13 signed a presidential memorandum ordering the development of a comprehensive plan for “restoring fairness in U.S. trade relationships and countering non-reciprocal trading arrangements.”
    • “The announcement directs the U.S. Trade Representative and the Secretary of Commerce, in consultation with the secretaries of a number of U.S. agencies, to develop plans for reciprocal tariffs on every country that taxes U.S. imports and submit a report to the president. In addition, within 180 days of the memo, the director of the Office of Management and Budget will assess all fiscal impacts on the federal government and the impacts of any information collection requests on the public and deliver an assessment in writing to the president.
    • “For more information, see the presidential memo and fact sheet.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
    • Influenza
    • RSV
      • “RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.”
    • Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • Beckers Clinical Leadership points out,
    • “A farmer in Mercer County, Ohio, has tested positive for H5N1 influenza, marking the state’s first human case of bird flu. 
    • “The worker had direct contact with deceased commercial poultry, according to a Feb. 12 news release from the Ohio Department of Health.”
  • Per Medscape,
    • “How long will vaccine protection last? A simple blood test may have the answer. Researchers at Stanford School of Medicine, Stanford, California, have identified a molecular signature in the blood that appears days after vaccination and predicts the durability of the immune response. Published in Nature Immunology in January, this discovery could transform vaccine development, testing, and personalization of vaccines. The study also offers insights into why some vaccines provide lifelong immunity while others lose effectiveness within months.”
  • Per Healio
    • “The percentage of U.S. adults with obesity did not significantly rise from 2013 to 2023, though a small uptick in the rate of obesity was seen for children and adolescents, according to data published in JAMA.
    • “From 2013 to August 2023, there were small increases in obesity in children and adolescents aged 2 to 19 years, driven by increases among males and children aged 2 to 5 years,” Samuel D. Emmerich, DVM, an epidemiologist at the CDC National Center for Health Statistics, told Healio. “In adults aged 20 years and older, severe obesity increased slightly, driven by increases among women and middle-aged adults. There were no significant changes in any other subgroups, in high weight-for-length or in high waist circumference.”
  • Per HCPLive,
    • “New research is shedding light on a heightened risk of colorectal cancer (CRC) in patients with both nonadvanced and advanced adenomas detected during colonoscopy, highlighting the importance of surveillance colonoscopy in this population and the need for more frequent screening among those with advanced adenomas.
    • “Leveraging data from the Minnesota Colon Cancer Control Study, the present analysis found individuals with adenomas at colonoscopy, regardless of whether or not they were advanced, were at a greater risk of developing CRC than those with no adenomas. Additionally, findings showed participants with advanced adenomas were at increased risk of both CRC mortality and all-cause mortality.
    • “Studies have reported the association of advanced adenomas with increased risk of CRC and CRC-related death over the following 5 to 15 years compared with having no advanced adenomas. The association of nonadvanced adenomas with CRC incidence and mortality after colonoscopy is less clear,” Aasma Shaukat, MD, MPH, a gastroenterologist and Robert M. and Mary H. Glickman Professor of Medicine at New York University Grossman School of Medicine, and colleagues wrote. “However, to our knowledge, no studies have evaluated the association of adenomas and advanced adenomas with all-cause mortality.”
  • Health Day adds,
    • “You may be less likely to develop an especially lethal form of colon cancer if you’re a longtime consumer of yogurt, new research finds.
    • “Folks who ate two or more servings of yogurt per week for years had 20% lower odds for an aggressive type of tumor typically found on the right side of the colon, researchers reported Feb. 12 in the journal Gut Microbes.
    • “The tumors’ tissues also tested positive for a bacterium commonly found in yogurt, called Bifidobacterium.
    • “It has long been believed that yogurt and other fermented milk products are beneficial for gastrointestinal health,” co-senior author Dr. Tomotaka Ugai, a pathologist at Mass General Brigham in Boston, noted. “Our new findings suggest that this protective effect may be specific for Bifidobacterium-positive tumors.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Johnson & Johnson’s halt of U.S. sales of a new heart-rhythm device due to safety concerns is hobbling a major strategic push by the company into one of the industry’s fastest-growing markets.
    • “The healthcare company paused use of the device, known as Varipulse, last month after receiving reports of neurovascular events in several patients. The company didn’t explain what the events were, but several strokes have been reported to a federal device-safety database, and doctors’ concerns are centered on strokes.
    • “J&J has been racing to catch up to competitors in the fast-growing market for medical devices treating irregular heart rhythms, and to revive the company’s medical-device business generally. 
    • “Rivals Boston Scientific and Medtronic have dominated the market for so-called pulsed-field ablation devices, which research firm Clarivate estimates will reach about $12 billion by 2032, from $1.6 billion last year. 
    • “More than 10 million Americans have the heart-rhythm disorder that the devices treat. 
    • “This is a huge hit for J&J,” said Dr. John Mandrola, an electrophysiologist at Baptist Health in Louisville, Ky., who treats patients with heart-rhythm problems. “The market’s so big, and this just sets them back.”
  • Beckers Payer Issues lists major health insurers by 2024 medical loss ratios.
  • Kaufmann Hall takes a look at “Navigating Health Systems Through a Decade of Change” via a conversation with Rich Liekweg, CEO of BJC Health System in Missouri, and Nick Barto, president of BJC Health System.

Thursday Report

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

From Washington, DC,

Capitol Hill News

  • Roll Call reports,
    • “House GOP leaders cleared an important hurdle Thursday morning after cutting a deal with Freedom Caucus holdouts on a budget resolution amendment that would lock in a mechanism to enact deeper spending cuts in exchange for bigger tax cuts.
    • “The agreement paved the way for Budget Committee approval later in the day Thursday of the fiscal 2025 blueprint needed to unlock their “big, beautiful” reconciliation bill. House Republicans want to use the filibuster-proof process to enact large pieces of their legislative agenda, including extensions of the expiring 2017 tax cuts, domestic energy production incentives, immigration enforcement and defense spending.”
  • The American Hospital Association (AHA) News lets us know, “The Senate Feb. 13 by a vote of 52-48 confirmed Robert F. Kennedy Jr. as the new secretary of the Department of Health and Human Services.” 
  • An HHS news release adds
    • “Robert F. Kennedy, Jr. today was sworn in as the 26th Secretary of the U.S. Department of Health and Human Services (HHS) in the Oval Office by Associate Justice of the Supreme Court Neil Gorsuch.
    • “Immediately following the ceremony, President Trump with Secretary Kennedy by his side, signed the “Establishing the President’s Make America Healthy Again Commission” Executive Order to investigate and address the root causes of America’s escalating health crisis, with a focus on childhood chronic disease.”
  • The Journal of Accountancy informs us,
    • “A bill to extend the deadline for an estimated 32 million small businesses to report their beneficial ownership information (BOI) as mandated by the Corporate Transparency Act (CTA) passed the U.S. House unanimously.
    • “The House passed H.R. 736, Protect Small Businesses From Excessive Paperwork Act of 2025, 408–0, on Monday. The bill, which goes to the Senate next, extends the deadline for filing BOI reports to Jan. 1, 2026. The deadline for most reports previously was Jan. 1, 2025, but the reporting requirements have been caught up in numerous court cases and are now on hold.
    • “A companion bill was introduced Tuesday in the Senate by Tim Scott, R-S.C., the chairman of the Senate Banking Committee.
    • “This is a simple solution that we’ve worked on together, and it’s one of the most pressing concerns small businesses face,” Rep. Zach Nunn, R-Iowa, who sponsored the bill, said on the House floor before the vote. “So, whether you’re a Democrat or a Republican, we all have small businesses and a hometown responsibility to fight for them today.”
    • “Both bills affect only reporting companies existing before Jan. 1, 2024. Companies formed after that date are not affected.
    • “Melanie Lauridsen, the AICPA’s vice president–Tax Policy & Advocacy, said in a LinkedIn post that the proposed deadline extension is “hopeful information” – despite the possibility of court rulings changing reporting requirements at any moment.”

White House news

  • The AHA News tells us,
    • “President Trump Feb. 13 signed an executive order establishing the Make America Healthy Again Commission, to be chaired by Department of Health and Human Services Secretary Robert F. Kennedy Jr. The commission is tasked with “investigating and addressing the root causes of America’s escalating health crisis, with an initial focus on childhood chronic diseases.” 
    • “The commission has four main policy directives to reverse chronic disease:  
      • “Empower Americans through transparency and open-source data and avoid conflicts of interest in all federally funded health research. 
      • “Prioritize gold-standard research on why Americans are getting sick in all health-related research funded by the federal government. 
      • “Work with farmers to ensure that U.S. food is healthy, abundant and affordable. 
      • “Ensure expanded treatment options and health coverage flexibility for beneficial lifestyle changes and disease prevention. 
    • “Within 100 days, the White House said the commission will produce an assessment that summarizes what is known and what questions remain regarding the childhood chronic disease crisis, and within 180 days, the commission will produce a strategy, based on the findings of the assessment, to improve the health of America’s children.”
  • For those interested, here is a link to the new DOGE website.
  • The Washington Post reports,
    • “The Trump administration on Thursday moved swiftly to fire thousands of workers and directed agency heads to terminate most trial and probationary staff — a move that could affect as many as 200,000 employees, according to four people familiar with internal conversations who, like others interviewed for this report, spoke on the condition of anonymity because they are not authorized to speak publicly.
    • “It was not immediately clear how many of those hired by the federal government within the last two years would be affected. One person familiar with the matter said some employees, such as those working on public safety and law enforcement issues, would be spared, and agency heads could exempt others.”
  • Govexec adds,
    • “Recent hires at the Office of Personnel Management were terminated on Thursday afternoon, according to three people familiar with the matter and internal communications obtained by Government Executive.
    • “The firings come as agencies across government are purging employees in their probationary status from their rolls and the Trump administration is deploying a bevy of tools to slash their workforces. 
    • “On President Trump’s first day in office, OPM instructed agencies across government to collect names of probationary employees. Those workers typically were hired within the last one-to-two years, depending on their hiring mechanism. Agencies have since gathered lists of those employees and delivered them to OPM, and some subsequently sent notices to staff reminding them of their status and their vulnerability to rapid firings. 
    • “Recent hires in probationary status do not maintain the same protections against firings as do most other federal workers, though they can still appeal to the Merit Systems Protection Board if they allege the firings took place for partisan political reasons.”

From the judicial front,

  • The Associated Press via MedPage Today relates,
    • “A federal judge on Thursday temporarily blocked President Donald Trump’s recent executive order aimed at restricting gender-affirming healthcare for transgender people under age 19.
    • “The judge’s ruling came after a lawsuit was filed earlier this month on behalf of families with transgender or nonbinary children who allege their healthcare has already been compromised by the president’s order. A national group for family of LGBTQ+ people and a doctors organization are also plaintiffs in the court challenge, one of many lawsuits opposing a slew of executive orders Trump has issued as he seeks to reverse the policies of former President Joe Biden.
    • “Judge Brendan Hurson, who was nominated by Biden, granted the plaintiffs’ request for a temporary restraining order following a hearing in federal court in Baltimore. The ruling, in effect for 14 days, essentially puts Trump’s directive on hold while the case proceeds. The restraining order could also be extended.”

From the public health and medical research front,

  • The New York Times reports,
    • “Three dairy veterinarians, including one who worked only in states with no known bird flu outbreaks in cows, had recent, undetected bird flu infections, according to a new study from the Centers for Disease Control and Prevention. The results are based on antibody testing of 150 veterinarians working in 46 U.S. states.
    • “The findings were not entirely surprising, experts said, but did suggest that the virus, known as H5N1, could be infecting cows and people in more states than have been officially reported.
    • “We do not know the extent of this outbreak in the U.S.,” said Seema Lakdawala, a virologist at Emory University. “There are clearly infections happening that we’re missing.”
    • “Since the bird flu outbreak in dairy cows was first reported last March, the virus has been confirmed in more than 950 herds in 16 states. It has also been detected in 68 people, 41 of whom had contact with sick cows. Most people have had mild symptoms.”
  • The American Medical Association lets us know “What doctors wish patients knew about UTI prevention.”
  • The National Cancer Institute released Cancer Information Highlights about “Fructose Fuels Cancer Growth | Lung Cancer Stigma | Multiple Myeloma.”
  • The National Institutes of Health posted “Research in Context: Detecting Cancer.”
  • Per MedPage Today,
    • “The blood test achieved high accuracy, with 98% specificity and 73% sensitivity for detecting pancreatic cancer.
    • “When combined with CA 19-9 biomarker testing, the sensitivity increased to 85% while maintaining high specificity.
    • “The test successfully differentiated between cancer and non-cancer pancreatic conditions using protease activity detection.”
    • “Integrating an early test for pancreatic cancer into clinical practice will be difficult, Suneel Kamath, MD, of the Cleveland Clinic, continued. Although incidence and mortality continue to increase, the cancer is much less common than breast, colon, and lung cancers. In addition to targeting high-risk populations, another possible strategy would be a one-time screening at a certain age.
    • “Early-stage pancreatic cancer still carries a poor survival rate of just 44% at 5 years,” he told MedPage Today. “The majority of people with stage I or II pancreatic cancer will die of their cancer in the first 5 years after diagnosis. For breast, colorectal, and prostate cancers, those rates are over 90%, often over 95%, so we will not screen our way into curing pancreatic cancer. We will have to find better ways to treat it once it has occurred too because early detection alone is not enough.”
  • and
    • Epidural steroid shots for back pain had mixed results, an AAN review showed.
    • The treatment demonstrated promising short-term benefits for radiculopathy patients.
    • In other situations, benefits were unclear or limited.

From the U.S. healthcare business front,

  • Beckers Payer Issues offers more observations on how “CVS is working ‘tirelessly’ to improve Aetna.”
  • Healthcare Dive points out,
    • “Tenet Healthcare brought in profits of $3.2 billion in 2024, up from $611 million in 2023, on strong same-store revenue, growth in high-acuity care and effective cost management strategies, health system executives said during an investor call Wednesday.
    • “The earnings performance was stronger than expected based on Tenet’s full year guidance, which the company updated midway through the year.
    • “Still, Tenet faced challenges during the fourth quarter and underperformed on operating revenue compared to Wall Street’s expectations. Analysts also pressed executives during the call about the health system’s plans to weather possible regulatory changes in Washington moving forward, including proposed cuts to the Medicaid program.”
  • Per Fierce Pharma,
    • “As Alnylam Pharmaceuticals approaches its highly anticipated March 23 FDA decision date for a potential expansion of Amvuttra to treat patients in an increasingly competitive indication—transthyretin amyloid cardiomyopathy (ATTR-CM)—the company is emphasizing market dynamics.
    • “The category is rapidly growing and it’s been largely underserved,” Tolga Tanguler, Alnylam’s chief commercial officer said during a conference call Thursday.” This will be a market-growth story.”
    • “After Alnylam divulged last month at the J.P. Morgan Healthcare Conference that it expects Onpattro and Amvuttra to generate between $1.6 billion and $1.7 billion in 2025, there was little suspense left in Thursday’s fourth-quarter earnings presentation about the company’s expectation for its potential launch into the new indication.”
    • “The projection compares to the ATTR franchise’s combined 2024 sales of $1.23 billion, including $970 million for Amvuttra, which nearly achieved blockbuster status in just its second full year on the market.”

Happy Lincoln’s Birthday

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–

Our greatest President

From Washington, DC

Capitol Hill News

  • The American Hospital Association (AHA) News tells us,
    • House Republicans Jan. 12 released a budget resolution for fiscal year 2025 focusing on the Trump administration’s agenda on border security, defense, energy and taxes. The budget resolution, which acts as an outline for the reconciliation process, calls for increasing the debt ceiling by $4 trillion and allows for $4.5 trillion in spending for tax cuts. It also would allocate $200 billion for border and defense spending. The resolution instructs seven committees to come up with no less than $1.502 trillion in mandatory cuts over ten years. 
    • Notably, for health care, the bill instructs the House Energy and Commerce Committee to cut mandatory spending by no less than $880 billion. The committee has primary jurisdiction over a number of health care programs, including Medicaid, and some proposals have been circulating that would enact significant cuts to Medicaid. The House is expected to mark up its budget resolution tomorrow. 
  • Politico adds,
    • “Senate Republicans easily pushed their budget resolution out of committee on Wednesday — the first step toward being able to enact President Donald Trump’s massive domestic policy agenda.
    • “The Senate Budget Committee voted 11-10, along party lines, to approve the fiscal framework meant to tee up a package of energy, border security and defense policy through the partisan budget reconciliation process. Across the Capitol, House GOP leaders struggled at the same time to rally their own around a far more expansive plan that would pave the way for legislation that would bundle those same policies alongside trillions of dollars in tax cuts.”
  • The Senate Invoked, 53-47: Motion to invoke cloture on Executive Calendar #17 Robert F. Kennedy, Jr. to be Secretary of HHS. The Senate is expected to confirm Mr. Kennedy’s nomination as HHS Secretary Thursday morning.
  • Fierce Healthcare lays out the “top policy issues for hospitals, payers, docs and tech” on Capitol Hill this year.

White House news

  • Here is a link to the President’s February 11 executive order captioned “IMPLEMENTING THE PRESIDENT’S “DEPARTMENT OF GOVERNMENT EFFICIENCY” WORKFORCE OPTIMIZATION INITIATIVE,” which was mentioned in Tuesday’s report.
  • The American Society of Pension Professionals and Actuaries lets us know,
    • “Daniel Aronowitz has been officially nominated by the White House to become next Assistant Secretary of Labor for the Employee Benefits Security Administration (EBSA). He is the President of Euclid Fiduciary (now Encore Fiduciary), a fiduciary liability insurance underwriting company for employee benefit plans.
    • “His experience in the professional liability industry includes expertise as a coverage lawyer and underwriter.”
  • The AHA News informs us, “Tom Engels is the new administrator for the Health Resources and Services Administration, according to its website. Engels previously held the same position in the first Trump administration from 2019 to 2021.”
  • Federal News Network updates us on federal agency efforts to bring their workforces back to office.

Judicial front

  • Federal News Network reports,
    • “The Trump administration is free to continue implementing its controversial deferred resignation program after a federal court in Massachusetts dissolved a restraining order that had delayed the program’s deadline by several days.
    • “In a written opinion Wednesday afternoon, Judge George O’Toole said he had determined that the three federal unions that had challenged the program lacked the standing they’d need in order to meet the legal standard for a temporary restraining order.” * * *
    • “Wednesday’s ruling does not completely end the legal challenge — it only affects the unions’ requests for a temporary pause in the deferred resignation program while their claims work their way through the litigation process. However, in denying a temporary restraining order and preliminary injunction, O’Toole said he had determined the unions were unlikely to succeed on the merits of their case.
    • “OPM is pleased the court has rejected a desperate effort to strike down the deferred resignation program. As of 7 p.m. tonight, the program is now closed,” said McLaurine Pinover, a spokeswoman for the office. “There is no longer any doubt: the deferred resignation program was both legal and a valuable option for federal employees. This program was carefully designed, thoroughly vetted, and provides generous benefits so federal workers can plan for their futures.”
    • In fact, the Fork in the Road program closed at 7:20 pm ET Wednesday night per its website.

FDA News

  • Fierce Pharma notes,
    • “More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green light to treat large B-cell lymphoma (LBCL).
    • “The CD30-directed antibody-drug conjugate has been approved in combination with lenalidomide and rituximab for certain LBCL patients, the FDA said Wednesday. Eligible patients must have tried at least two prior lines of systemic therapy and be ineligible for an autologous hematopoietic stem cell transplant or a CAR-T therapy.
    • “Adcetris won the approval after showing it helped patients with heavily pretreated LBCL live longer in a phase 3 trial.”

From the public health and medical research front,

  • CBS News reports,
    • “For the first time since the beginning of the pandemic, more people in the U.S. died of influenza than from COVID-19 in the week ending on Jan. 25, according to weekly figures published by the Centers for Disease Control and Prevention.
    • “For the week ending on Jan. 25, nearly 1.7% of all deaths nationwide were attributed to the flu, compared to roughly 1.5% being the result of COVID-19, according to CDC data. Rates of influenza hospitalizations are more than three times higher than COVID-19 hospitalizations amid this season’s record wave of flu infections.”
  • and
    • “The U.S. confirmed at least a dozen deaths from whooping cough last year, according to preliminary figures released this week by the Centers for Disease Control and Prevention. That marks the most fatalities from the bacterial infection since a 2017 surge of the illness, which is also known as pertussis.
    • “Over the last month, pertussis infections have been rising again. While cases reported to the CDC by health departments dipped over the winter holidays, weekly infections have accelerated for a month straight since then.”
  • The New York Times adds,
    • “A worsening measles outbreak has taken root in Texas, sickening two dozen and hospitalizing nine on the western edge of the state, where childhood vaccination rates have dwindled in recent years.
    • “As of Tuesday, 22 children and two adults had been infected, all of whom were unvaccinated, local health officials said. * * *
    • “The Texas outbreak has so far been limited to residents of Gaines County, which borders New Mexico and has roughly 20,000 residents. Last year 82 percent of kindergarten students received the measles, mumps and rubella vaccine, according to state data. That figure is roughly 10 percentage points lower than the average vaccination rate in Texas public schools and far below the federal target of 95 percent for measles vaccination.”
  • Nature points out that “Dozens of new obesity drugs are coming; these are the ones to watch. Next-generation obesity drugs will work differently from Ozempic and Wegovy — aiming to deliver greater weight loss with fewer side effects.”
  • BioPharma Dive, on the other hand, lets us know “A small semaglutide trial suggests the medicine’s suppression of appetite may extend to alcohol, but larger trials are needed to establish a conclusive benefit.”
  • Per Fierce Healthcare,
    • “More than five years ago, Apple launched three medical studies to test how well its Apple Watch can track a person’s mobility and cardiovascular health, changes in hearing and women’s health and fertility.
    • “The tech company is now broadening its health research ambitions to use its devices, including iPhones, Apple Watch and AirPods along with third-party devices, for a longitudinal, virtual study to monitor changes in participants’ health, spanning a wide range of health and disease areas.
    • “Apple wants to tap into the devices and apps that individuals use every day to evaluate the connections between physical and mental health as well as social determinants, such as whether someone lives alone or with family, and how all these aspects of health factor into a person’s overall well-being.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS Health’s profits were nearly cut in half last year as the healthcare giant wrestled with elevated medical costs in its Aetna insurance business. 
    • “The company reported net income of $4.6 billion in 2024, compared with $8.4 billion in the prior year, according to earnings results released Wednesday. 
    • “But CVS showed signs of financial improvement in the fourth quarter, beating Wall Street expectations on earnings and revenue.” 
  • Bloomberg explains,
    • “In the insurance unit, CVS spent 94.8% of premium revenue on medical care in the quarter, less than analysts expected. Investors prefer a lower number. However, CVS said in a separate filing that high use of medical services will continue to pressure the business. 
    • “The company pointed in particular to high costs in its business that manages care for patients on Medicaid, the US health program for the poor. States have been cutting Medicaid rolls since the pandemic, often culling healthier patients in the program while sicker patients remain.” 
  • Fierce Healthcare adds,
    • “CVS Health CEO David Joyner went on the defense of the pharmacy benefit management industry on the company’s Q4 earnings call Wednesday morning.” * * *
    • “One of the most powerful forces helping to offset rising healthcare costs is PBMs like Caremark,” Joyner said. “These entities remain the only part of the drug supply chain and entirely focused on lowering costs, but have erroneously been subject to deceptive rhetoric and misinformation.”
    • “Joyner noted that branded pharmaceutical manufacturers “added $21 billion of annual gross drug spend through their price actions” in January. Drugs where PBMs lack tools to negotiate prices have seen prices rise more than twice as fast as other products, he said.
    • “In addition, Joyner said that “multiple well-known economists” have projected that PBMs create $100 billion in net value each year for the healthcare system.”
  • Per the AHA News,
    • The Council for Affordable Quality Healthcare Feb. 11 released a report  highlighting how the health care industry can save $20 billion by transitioning from manual to electronic workflows.  
    • In addition, it found that the industry could save $515 million annually on electronic prior authorizations and save providers and staff 14 minutes per transaction.
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys outlined plans to divest a significant number of home health and hospice locations as they seek to close their $3.3 billion merger.
    • “In a court filing issued late last week, UHG said it intends to pursue a divestiture plan that would sell off “at minimum” 128 combined home health and hospice facilities. The company said in the filing that once the divestitures are completed it will operate only 10% of home health services in the U.S. and 4% of hospice services.
    • “UnitedHealth argued that leaves plenty of competition in this space, as it will still be up against 11,000 home health agencies and more than 5,000 hospice agencies across the U.S.
    • ‘The Department of Justice sued to block the deal in mid-November, arguing that it would hamper competition across multiple home health markets.”
  • Per JAMA Open,
    • “Question How have the proportion and absolute number of psychiatrists providing professional services to traditional Medicare enrollees changed as the field has grown?
    • “Findings In this cross-sectional study using data from 2014 to 2022, the nationwide proportion of psychiatrists billing Medicare Part B declined from 44% in 2014 to 33% in 2022. The number of psychiatrists billing Medicare Part B declined by 3772 during a time when the total number of active psychiatrists increased by 6076.
    • “Meaning These findings suggest that during a time of psychiatrist workforce growth, the proportion and number of psychiatrists accepting Medicare Part B decreased, further suggesting potential decreases in access to psychiatrist-led care for older adults and individuals with disabilities.”

Tuesday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

Capitol Hill news

  • Roll Call reports,
    • “House Republicans are plowing ahead with a budget resolution markup on Thursday before the chamber’s scheduled one-week recess begins the following day. 
    • “The blueprint wasn’t finalized yet and leadership also has some work to do in preparation for the floor, with key holdouts looking for assurances on things like spending cuts and raising the statutory debt ceiling. 
    • “But Speaker Mike Johnson, R-La., said after the GOP conference’s weekly meeting Tuesday that the “intention” was to mark up the blueprint in committee on Thursday after hammering out the details Tuesday. “We’ll be rolling out the details of that probably by tonight,” Johnson said. “We are right on the schedule that we need to be on.”
    • “The Budget panel has a 24-hour notice rule for posting text before bringing the resolution up for a committee vote.
    • “By the end of the day, we’ll be able to have the final pieces to put the budget resolution along with the reconciliation instructions in play, because we have to communicate that in some detail when we mark it up,” House Budget Chairman Jodey C. Arrington, R-Texas, said Tuesday after the conference meeting.”
  • The House Budget Committee has scheduled “a markup for the Concurrent Resolution on the Budget for Fiscal Year 2025 which will be held on February 13, 2025, at 10 am.

White House news

  • The Washington Post reports,
    • “President Donald Trump on Tuesday signed an executive order that calls on federal agencies to work with the U.S. DOGE Service in a bid to cut their existing workforce and limit future hiring. Ahead of the signing, Trump was joined in the Oval Office by Elon Musk, his billionaire ally who is overseeing DOGE, an agency that Trump has empowered to find government efficiencies.”
  • The Office of Personnel Management has updated its Fork in the Road website for the legal developments that occurred yesterday

Medical Coding news

  • The ICD10 Monitor alerts us that 50 new ICD 10 PCS codes will become effective on April 1. 2025.
  • Per a recent government bulletin,
    • The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (hereafter ASTP) Standards Bulletin 2025-1 (SB25-1) describes the development of the Draft United States Core Data for Interoperability Version 6 (Draft USCDI v6), which ASTP released on January 14, 2025. 
    • The USCDI sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide interoperable health information exchange and is a standard stewarded and adopted by ASTP on behalf of the U.S. Department of Health and Human Services (HHS). ASTP publishes new versions of USCDI annually, with a draft version released in January and a final version released in July to keep pace with clinical, technology, and policy changes that influence the use of clinical and related terminology. Draft USCDI v6 includes new data elements that seek to advance interoperability for patient care.
    • SB25-1 describes ASTP’s continued expansion of USCDI, following the same prioritization approach applied to USCDI Version 5. SB25-1 also reflects ASTP’s consideration of submissions for new data elements, comments on previously submitted data elements, and the evolving maturity of data elements through the USCDI+ Program.

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “COVID-19 vaccination averted more than 5,000 US in-hospital deaths, 13,000 intensive care unit (ICU) admissions, and 68,000 hospitalizations in 7 months in 2023-2024, researchers from the US Centers for Disease Control and Prevention (CDC) estimated late last week in Vaccine, although with considerable uncertainty.
    • “The investigators estimated COVID-related deaths, ICU admissions, and hospitalizations prevented by vaccination from October 1, 2023, to April 21, 2024, using a novel multiplier model that used causal inference, conditional probabilities of hospitalization, and correlations between data elements in simulations.
    • “The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has used estimates of the potential benefits and risks to inform vaccine policy decisions, and burden averted estimates can be used to evaluate vaccine policy,” the study authors wrote.”
  • STAT News lets us know,
    • “We’ve talked a lot about how hospitals have been recording a lot more patient visits throughout 2024. One major component of that: There’s been a lot more little bundles of joy lately.
    • “Analysts at investment bank Leerink Partners looked at birth data across four states (Arizona, Colorado, Florida, and North Carolina) and found births in December were up almost 4% year over year. 
    • “There’s an especially interesting trend in Florida: 53% of all births are covered by commercial health insurance (either from the parents’ workplace or the Affordable Care Act exchanges). 
    • “Usually, Medicaid covers the majority of births, but this reversal is “a reflection of redeterminations,” in which states kicked people off Medicaid if they no longer met eligibility requirements that were loosened during the pandemic, Leerink analysts wrote to investors.”
  • The Washington Post reports,
    • “California-based Tri-Union Seafoods has issued a voluntary recall of canned tuna sold at Trader Joe’s, Safeway, Harris Teeter, Walmart, Costco and other major grocery stores in dozens of states.
    • “The recall centers on concerns that a manufacturing defect in the cans may cause “a potentially fatal form of food poisoning,” the company said in a statement Friday.
    • “Tri-Union Seafoods said the defect, located on the cans’ pull-tab lid, may compromise the integrity of the product seal, especially over time, causing it to leak or become contaminated with the clostridium botulinum bacterium, which causes botulism.
    • “While Tri-Union Seafoods has said no illnesses linked to the recalled products have been reported, the company warned consumers not to use the product, “even if it does not look or smell spoiled.” The manufacturing company asked consumers to instead return the recalled tuna for a full refund, throw it away or contact Tri-Union directly for a retrieval kit and a coupon for a replacement product.” * * *
    • “Tri-Union Seafoods issued the recall notice Friday on all tuna products sold under the Genova, Van Camp’s, H-E-B and Trader Joe’s brand names.” * * *
    • “Tri-Union’s statement includes UPCs, can codes and best-by dates you can check to determine if your tuna is affected by the recall. Consumers can contact Tri-Union Seafoods at support@thaiunionhelp.zendesk.comor 833-374-0171 to request a replacement product.”
  • The Wall Street Journal lets us know,
    • “We all know cigarettes cause cancer. The memo on booze hasn’t reached everyone.
    • “Doctors say many people are surprised to learn alcohol raises the risk of certain cancers, such as liver, colorectal and breast cancer. And cancer patients say they aren’t always aware of the increased risk until after they have been diagnosed.
    • “As awareness increases—the former U.S. surgeon general recently called for adding warning labels on alcoholic beverages—more people are rethinking their drinking habits. On social-media sites like Reddit, cancer patients talk about replacing alcohol with cannabis, although this, too, has health issues. Others opt for mocktails or nothing at all.”
  • Per Beckers Hospital Review,
    • “A phase 3 trial found that a combination of a Pfizer and Astellas drug, enfortumab vedotin, and Merck’s drug, pembrolizumab, has significantly improved survival rates for patients with advanced bladder cancer. 
    • “The latest results from the trial, which focused on patients with untreated, locally advanced or metastatic urothelial cancer, showed that the combination therapy reduced the risk of death by 49% compared to traditional chemotherapy.” 
  • Healio tells us,
    • “Women prescribed a GLP-1 receptor agonist up to 2 years before conception were less likely to develop hypertensive disorders of pregnancy, gestational diabetes, have a preterm birth or cesarean delivery, researchers reported.
    • “Relatively little is known how preconception GLP-1 receptor agonist use may impact pregnancy outcomes,” Christopher T. Nau, MD, assistant professor in the department of reproductive biology at Case Western Reserve University School of Medicine and the division of maternal fetal medicine at University Hospitals Cleveland Medical Center, told Healio. “This study suggests that [GLP-1s] may have potential to be a powerful tool to optimize preconception health.”
    • “The findings were published in the American Journal of Obstetrics and Gynecology.”
  • MedPage Today notes,
    • “[A] Plasma p-tau217 [blood test] successfully identified Alzheimer’s pathology in several neurodegenerative syndromes.
    • “This included disorders not typically associated with Alzheimer’s disease, like frontotemporal dementia.
    • “Alzheimer’s pathology in syndromes related to frontotemporal lobar degeneration correlated with worse cognitive performance.”
  • Per an NIH news release,
    • “National Institutes of Health (NIH) scientists and their colleagues report that a single dose of a broadly neutralizing antibody (bnAb) administered prior to virus exposure protects macaques from severe H5N1 avian influenza. Highly pathogenic avian influenza (HPAI) H5N1 viruses have sporadically spilled over from birds into many other animals, including humans and dairy cows, in recent years. Although it has not yet acquired the capacity to spread readily between people, H5N1 has pandemic potential, which has spurred efforts to develop effective treatments and other countermeasures.
    • “The investigators studied a bnAb called MEDI8852, which was discovered and developed by Medimmune, now part of AstraZeneca. MEDI8852 targets a portion of a key flu protein that is less prone to change than other parts of the virus and thus is capable of conferring protection against a wide range of flu viruses. In the new study, a group of macaques received an injection of MEDI8852 and were exposed to aerosolized HPAI H5N1 virus three days later. All the pre-treated animals survived and experienced no or very limited signs of disease. In contrast, a group of control macaques developed severe or fatal illness within a short time after virus exposure.
    • “Of note, the scientists determined that MEDI8852 remained in the body for a prolonged time after the injection. According to scientists, protection from severe disease would extend to weeks beyond antibody infusion, providing a realistic preventative window in the face of an H5N1 outbreak.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana brought in profit of $1.2 billion in 2024, down more than half from $2.5 billion in 2023 due to significantly higher spending on its members’ care in Medicare and Medicaid, according to financial results released Tuesday.
    • “Still, Humana’s performance in the fourth quarter capping off the year was better than expected given ongoing cost pressures in the government programs, analysts said.
    • “Humana said it expects to lose 550,000 members in privatized Medicare Advantage plans this year — roughly one-tenth of its individual MA footprint — from cutting unprofitable plans to improve margins. The size of the membership loss is notably larger than Humana’s prior expectations.”
  • STAT News adds,
    • “The most important number in health insurance, at least to Wall Street and the companies themselves, is the medical loss ratio.” * * *
    • Here’s how fourth-quarter MLRs have looked for insurers so far, and how they compared to Wall Street’s consensus estimates: Molina Healthcare (90.2% actual vs. 88.7% consensus), Oscar Health (88.1% actual vs. 86.9% consensus), Cigna (87.9% actual vs. 84.7% consensus), UnitedHealth (87.6% actual vs. 86.5% consensus).
    • “Centene (89.6% actual vs. 90% consensus) and Elevance Health (92.4% actual vs. 92.6% consensus) each barely had lower fourth-quarter MLRs than expected.”
  • Per BioPharma Dive,
    • “Novartis is wagering more than $3 billion that a startup it helped launch six years ago has developed a better blood thinner than what’s now available.
    • “The Swiss drugmaker on Tuesday announced a deal to acquire Anthos Therapeutics, a Boston-based startup it formed with Blackstone Life Sciences in 2019. Novartis will pay $925 million upfront,and could pay up to $2.15 billion more should the drug at the center of the deal hit certain regulatory and sales milestones. The deal should close in the first half of 2025.
    • “Through the acquisition, Novartis will regain a blood-thinning drug, called abelacimab, that’s currently in late-stage testing. Novartis originally discovered the compound, but in 2019 licensed it to Anthos, a startup Blackstone Life Sciences launched with $250 million. That deal gave Novartis a minority stake in Anthos, which went on to advance the drug into Phase 3 testing.
  • Fierce Pharma notes,
    • “Some two years into Leqembi’s launch, Eisai continues to go all-in on its Alzheimer’s disease-fighting antibody, which the company believes could be finally nearing a “growth expansion phase” despite slow sales so far in the U.S.
    • “All told, Leqembi brought home around 13.3 billion Japanese yen ($87 million) in the third quarter of Eisai’s 2024 fiscal year, which will wrap up on March 31. In the U.S. specifically, Leqembi grew roughly 30% quarter-over-quarter to 7.7 billion yen (nearly $51 million), Eisai said in a recent earnings presentation (PDF).
    • “Cumulatively, the antibody has generated total sales of 29.6 billion yen (about $194 million) over the last nine months of 2024, putting Leqembi on track to reach a 12-month sales target of 42.5 billion yen ($279 million), Eisai’s chairman and CEO, Tatsuyuki Yasuno, said in an interview with Fierce Pharma.”
  • Per Beckers Hospital Review,
    • “Warner Robbins and Perry, Ga.-based Houston Healthcare’s bid to join Emory Healthcare was approved by both boards, according to a Feb. 10 news release.
    • “Both boards finalized the terms of a definitive agreement outlining the specific details and provisions of Houston Healthcare to integrate into Atlanta-based Emory. The two organizations have been working on an agreement since August 2024, when they signed a nonbinding letter of intent to combine.
    • “Emory and Houston Healthcare are now focused on finalizing the regulatory reviews and approvals before closing the transaction in the “coming months,” according to the statement.”

Monday Report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, NIH, Obesity, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

White House News

  • Regulatory Focus considers how this Executive Order may impact the Food and Drug Administration.
  • The Regulatory Focus article notes that the Trump administration is in the process of updating the December 13, 2024, semi-annual regulatory agenda published by the Biden Administration.

Judicial News

  • Federal News Network reports,
    • President Donald Trump’s plan to downsize the federal workforce remains on hold after a courtroom hearing on Monday afternoon.
    • It’s the latest example of how the Republican president’s ambitious plans have become ensnared in the judicial system.
    • U.S. District Judge George O’Toole Jr. had paused the deferred resignation program, commonly described as a buyout, last week.
    • On Monday, he said the stay would remain in place until he issues a ruling. It’s unclear when that could happen.
    • Trump wants to use financial incentives to encourage government employees to quit. According to the White House, 65,000 workers had taken the government up on its offer as of Friday.

FDA News

  • Per MedTech Dive,
    • “The Food and Drug Administration published an early alert on Thursday about a BD device linked to 30 serious injuries and four deaths.
    • “The FDA issued the alert one day after BD wrote to customers to recommend actions to mitigate the risks posed by a system used to break up and remove clots from arteries. 
    • “Stress, wear, high temperatures, friction or localized pressure can cause part of BD’s Rotarex device to break, the FDA said, and result in vessel injuries and severe bleeding.”
  • Reuters informs us,
    •  “AbbVie (ABBV.N) said on Friday that the U.S. Food and Drug Administration approved its drug for complicated intra-abdominal infections, including those caused by drug-resistant bacteria.
    • “AbbVie and co-developer Pfizer’s (PFE.N), opens new tab drug, Emblaveo, is approved in combination with an antibiotic medication for patients 18 years and older with such infections.
    • “Deaths from antibiotic-resistant bacteria, also known as superbugs, have been on the rise globally, and health regulators have called for the development of newer treatments as resistance to older antibiotics grows.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “At least 24 million people have had seasonal flu this season, according to estimates  from the Centers for Disease Control and Prevention. Nearly 49,000 patients were admitted to hospitals with the flu for the week ending Feb. 1. Emergency department visits due to the flu remain classified as “very high” and “increasing,” the agency said. ED visits for COVID-19 are “low” and “decreasing,” while visits for respiratory syncytial virus are “moderate” and “decreasing.” Overall respiratory illness activity causing people to seek health care is “very high.” 
  • The Washington Post reports,
    • “A Nevada dairy worker was infected with a version of bird flu that is known to have killed one person in the United States and severely sickened a teen in Canada, state and federal health authorities said Monday.
    • “This version of the virus was detected for the first time in dairy farms last month in Nevada. The Central Nevada Health District said Monday that an adult was exposed to infected dairy cattle while working at a farm in the northwestern part of the state. The Centers for Disease Control and Prevention said its genetic analysis confirmed that the virus in the Nevada person is the same as was detected in the Nevada dairy cows.
    • “The Nevada worker had conjunctivitis, commonly known as pink eye, but no other reported symptoms. The worker is recovering, the district said, and close contacts and other workers exposed at the farm are being contacted and monitored for symptoms. They are being offered personal protective equipment, testing and antiviral medication, the district said. No additional cases have been confirmed.”
  • Cardiovascular Business lets us know,
    • “The virus responsible for COVID-19 is associated with several long-term heart risks, according to a new analysis published in Radiology.[1] This appears to be true regardless of the patient’s age or health at the time of infection.
    • “COVID-19, caused by SARS-CoV-2, is initially characterized by acute lung injury and respiratory failure,” senior author Junbo Ge, MD, director of the cardiology department at Zhongshan Hospital in Shanghai, China, said in a statement. “However, emerging evidence indicates COVID-19 also involves an extreme inflammatory response that can affect the cardiovascular system.”
    • “Ge et al. examined coronary CT angiography (CCTA) data from more than 800 patients with a mean age of nearly 64 years old. More than 67% of patients were men. While 41% of patients underwent CCTA prior to the COVID-19 pandemic, the remaining patients underwent CCTA during the pandemic. One in four of patients imaged during the pandemic presented with an active SARS-CoV-2 infection. All patients underwent baseline and follow-up measurements over time, allowing researchers to follow different trends over time.
    • “Overall, after reviewing more than 2,500 coronary artery lesions, the group determined that plaque volumes grew much faster in SARS-CoV-2 patients. High-risk plaques (20.1% vs. 15.8%), coronary inflammation (27% vs. 19.9%) and target lesion failure were also significantly more common in patients infected with SARS-CoV-2”
  • Per Beckers Hospital Review,
    • “Patients aren’t the only ones turning to obesity drugs to manage health. More physicians are using GLP-1s too, The New York Times reported Feb. 10.
    • “While there are no studies documenting the number of physicians taking GLP-1s, a number of physicians told the Times that they’ve noticed many colleagues growing thinner and sharing similar eating habits.
    • “Physicians “are a good litmus test for drugs that are highly effective,” Robert Califf, MD, the former FDA chief, told the Times.” 
  • Per National Institutes of Health press releases,
    • “Eating gradually increasing doses of store-bought, home-measured peanut butter for about 18 months enabled 100% of children with peanut allergy who initially could tolerate the equivalent of at least half a peanut to consume three tablespoons of peanut butter without an allergic reaction, researchers report. This easy-to-implement treatment strategy could potentially fulfill an unmet need for about half of children with peanut allergy, who already can tolerate the equivalent of at least half a peanut, considered a high threshold. The findings come from a trial sponsored and funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and published today in the journal NEJM Evidence.
    • “Children with high-threshold peanut allergy couldn’t participate in previous food allergy treatment trials, leaving them without opportunities to explore treatment options,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “Today’s report focuses on this population and shows that a very safe and accessible form of therapy could be liberating for many of these children and their families.”
  • and
    • “Influenza A virus particles strategically adapt their shape—to become either spheres or larger filaments—to favor their ability to infect cells depending on environmental conditions, according to a new study from National Institutes of Health (NIH) scientists. This previously unrecognized response could help explain how influenza A and other viruses persist in populations, evade immune responses, and acquire adaptive mutations, the researchers explain in a new study published in Nature Microbiology.”

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • “Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent settlement with Teva Pharmaceuticals that will keep a generic copy of Axsome’s top drug at bay in the U.S. until at least 2038.
    • “Axsome had sued Teva for patent infringement when the generic drugmaker filed for approval of a knock-off version of Auvelity, a medicine for major depressive disorder that last year earned Axsome some $290 million in net sales.
    • “Per the settlement struck by the two companies, Teva will gain a license to sell generic Auvelity on or after March 31, 2039, should Axsome gain regulatory exclusivity for pediatric use of the drug. If Axsome doesn’t, Teva can enter the U.S. market with its copy on Sept. 30, 2038.”
  • Fierce Pharma adds,
    • “Incyte’s ruxolitinib franchise, made up of blockbuster JAK inhibitor Jakafi and its topical counterpart Opzelura, have been the company’s driving focus for years. Now, with Jakafi approaching a 2028 patent cliff, Opzelura is gaining momentum as several expansion opportunities take shape.
    • “The 2021-approved Opzelura grew sales by 50% during 2024, reaching $508 million on the back of its two approved indications in atopic dermatitis and vitiligo. Included in the fourth quarter’s $162 million revenue haul is $24 million from sales outside of the U.S., where Opzelura’s European launch is seeing positive momentum, Incyte said on its earnings presentation Monday. 
    • “Opzelura remains the only marketed topical JAK inhibitor, although Leo Pharma’s delgocitinib is vying for a nod in chronic hand eczema. Besides studies in prurigo nodularis and mild to moderate hidradenitis suppurativa, Incyte’s next move for Opzelura is an expected approval in pediatric atopic dermatitis in the second half of this year.”
  • Beckers Hospital Review relates
    • “As of September, there were 284,626 licensed nurse practitioners practicing in the U.S., though NP availability per capita varies significantly across states.
    • “The total number of practicing NPs has remained relatively unchanged since January 2024, according to KFF data. 
    • “To compare NP availability across states, Becker’s analyzed KFF data on the number of practicing NPs alongside U.S. Census Bureau population estimates to calculate the number of NPs per 100,000 residents in each state.”
    • FEHBlog note — The article provides lists the states from highest to lowest NP availability per capita. Tennessee is on top.

Happy Super Bowl Sunday

David Ermer–Congress, Obesity, U.S. Healthcare–
Photo by Dave Adamson on Unsplash
  • The Wall Street Journal reports,
    • “Cardiologists advise having a game plan for the Super Bowl. Don’t overdo it on the nachos, sideline some of the salty snacks, and punt on more than a couple of beers. “You’re entitled to live life,” said Dr. Brett Sealove, chief of cardiology at Hackensack Meridian Jersey Shore University Medical Center in Neptune, N.J. “You just shouldn’t have a thousand wings, a bag of chips and go outside and smoke a pack of cigarettes.” 
    • “Burn off stress hormones by moving around for
      five or 10 minutes during breaks in the game, said O’Keefe. “Shoot a few baskets, take the dog for a walk around the block,” he said.” 

From Washington, D.C.,

  • Committee hearings worth noting:
    • House Ways and Means Subcommittee on Health
      Feb. 11, 2025, 2:00 PM ET | 1100 Longworth House Office Bldg, Washington, D.C.
      Hearing: Modernizing American Health Care: Creating Healthy Options and Better Incentives
      Witnesses: Brooks Tingle, Dr. Jay Carlson, Marcie Strouse, Leslie Dach.
      Meeting Details
    • Senate Committee on Health, Education, Labor, and Pensions
    • Feb. 12, 2025. 10:00 AM ET – Senate | G50 Dirksen Senate Office Building, Washington, D.C.
    • Meeting: Hearings to examine the nomination of Lori Chavez-DeRemer, of Oregon, to be Secretary of Labor.
    • Related Items: PN11-4
    • Meeting Details
  • Roll Call adds,
    • “Speaker Mike Johnson said Sunday that tentative plans for a House Budget Committee markup this week may now be postponed as Republican lawmakers continue to struggle to reach an agreement on the framework for a massive reconciliation package containing much of President Donald Trump’s legislative agenda.
    • “House leaders had been hoping to work through the weekend to reach agreement on a budget resolution that would allow for a markup as early as Tuesday. But Johnson said on “Fox News Sunday” that more time is needed.
    • “We were going to do a Budget Committee markup next week,” the Louisiana Republican said Sunday morning at Caesars Superdome in New Orleans, where he was preparing to watch the Super Bowl with President Donald Trump. “We might push it a little bit further because the details really matter. Remember that I have the smallest margin in history, about a two-vote margin currently, so I’ve got to make sure everyone agrees before we bring the project forward, that final product. And we’ve got a few more boxes to check, but we’re getting very, very close.”

From the public health and medical research front,

  • The Wall Street Journal delves into bird flu.
    • “Bird flu’s risk for the general public is still low, with no signs of person-to-person transmission, researchers said. People are still safe to eat cooked eggs and poultry and drink pasteurized milk, they said, since heating milk and other animal products to high temperatures kills the virus. The chance of infected poultry or eggs entering the commercial market is also low, health officials said.  
    • “But health officials and researchers do advise people to be cautious: Avoid interacting with wild birds or sick animals, don’t consume raw milk or cheese, and properly cook and handle poultry. 
    • “Pasteurization is a tried and true intervention that we have to make sure our milk supply is safe,” said Dr. Manisha Juthani, commissioner of the Connecticut Department of Public Health. “Raw milk is most definitely a risk for not just H5N1 but many other things.”
    • “People with exposure to infected animals are at greater risk, especially if they aren’t using protective equipment. Dozens of farmworkers have been infected, and at least one person was infected after contact with wild birds and a noncommercial backyard flock.” 
  • The New York Times reports,
    • “Surgeons in Boston successfully transplanted the kidney of a genetically modified pig into a 66-year-old man with kidney failure last month, Massachusetts General Hospital announced on Friday.
    • “It was the fourth pig kidney transplant in the United States, and the first of three that will be done at Mass General as part of a new clinical trial sanctioned by the Food and Drug Administration. Two of the previous patients died shortly after the procedure, including one who was critically ill before the transplant.
    • ‘More than 100,000 people in the country are on waiting lists for transplant organs, mostly kidneys, but there is an acute shortage of human donor organs. Many people will die while waiting.
    • “To help alleviate the shortage, several biotech companies are editing the genes of pigs so that their organs will not be easily rejected by the human body.
    • “The new clinical trial, which is using organs produced by the biotech company eGenesis, is one of two studies of genetically engineered animal organs that got a green light from regulators earlier this week. The other, sponsored by United Therapeutics Corporation, will begin later this year with six patients, but that number could eventually rise to 50.
    • “The latest transplant recipient, Tim Andrews of Concord, N.H., had his surgery in late January and was well enough to be discharged a week later.”
  • Medscape discusses current considerations for prescribing GLP-1 drugs to patients.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Cyberscoop lets us know,
    • “Bipartisan legislation to close a loophole in federal cybersecurity standards by requiring vulnerability disclosure policies for government contractors is getting another shot at passage in this Congress.
    • “The Federal Contractor Cybersecurity Vulnerability Reduction Act, a bicameral, bipartisan bill that stalled out last year in the Senate, was reintroduced Friday [January 31] in the House by Reps. Nancy Mace, R-S.C., and Shontel Brown, D-Ohio. 
    • “The bill, whose 2024 companion in the upper chamber came from Sens. Mark Warner, D-Va., and James Lankford, R-Okla., calls on the Office of Management and Budget and the Defense Department to update federal acquisition policies to require all federal contractors to institute vulnerability disclosure policies (VDPs).
    • “This is a matter of national security,” Mace said in a press release. “Federal contractors handle some of the most sensitive information and critical infrastructure in the country. Without basic vulnerability disclosure policies, we are leaving a gaping hole in our cybersecurity defenses. This bipartisan bill ensures contractors uphold the same cybersecurity standards as federal agencies, reducing risks before they turn into catastrophic breaches.”
  • The Wall Street Journal reports,
    • “Lawmakers announced Thursday they planned to introduce a bill to ban DeepSeek’s chatbot application from government-owned devices, over new security concerns that the app could provide user information to the Chinese government. 
    • “The legislation written by Reps. Darin LaHood, an Illinois Republican, and Josh Gottheimer, a New Jersey Democrat, is echoing a strategy that Congress used to ban Chinese-controlled TikTok from government devices, which marked the beginning of the effort to block the company from operating in the U.S. 
    • “This should be a no-brainer in terms of actions we should take immediately to prevent our enemy from getting information from our government,” Gottheimer said.  
  • SC Media tells us,
    • “A U.S. cybersecurity agency issued a fresh set of guidance for organizations regarding best practices in securing their networks and data storage.
    • “The U.S. Cyber Security and Infrastructure Security Agency (CISA) posted a set of guidelines aimed at helping companies better secure the commonly used devices that sit at the edges of most networks.
    • “This set of guidance, led by international cybersecurity authorities, is intended to help organizations protect their network edge devices and appliances, such as firewalls, routers, virtual private networks (VPN) gateways, Internet of Things (IoT) devices, internet-facing servers, and internet-facing operational technology (OT) systems,” CISA explained.
    • “It’s thought that American organizations will be motivated in the new year to brush up on security and install updates for commonly exploited security vulnerabilities in their edge devices.”

From the cybersecurity vulnerabilities and breaches front,

  • CISA added eleven known exploited vulnerabilities to its catalog this week.
  • Supplemental Information on the additional KEVs.
    • Bleeping Computer provides background on the February 4 additions.
    • This Linux Security article explains the February 5 addition.
    • ACA Global explains the 7-Zip (a file compression) tool addition on February 6.
    • WNE Security explains the Dante Discovery addition also on February 6.
    • Bleeping Computer discusses the Microsoft Outlook addition also on February 6.
    • Hacker News delves into the Trimble Cityworks addition on February 7.
  • Cybersecurity Dive points out,
    • “Microsoft has identified more than 3,000 publicly exposed ASP.NET machine keys that could be used by threat actors in code injection attacks against enterprise servers.
    • “In a blog post Thursday, Microsoft Threat Intelligence said it observed “limited activity” in December, in which a threat actor used a publicly available ASP.NET machine key to inject malicious code and deploy the Godzilla post-exploitation framework. While Microsoft said the threat actor is “unattributed,” the U.S. government previously has tied the Godzilla framework, which creates malicious web shells that can be used as backdoors, to Chinese state-sponsored threat actor.
    • “In the course of investigating, remediating, and building protections against this activity, we observed an insecure practice whereby developers have incorporated various publicly disclosed ASP.NET machine keys from publicly accessible resources, such as code documentation and repositories, which threat actors have used to perform malicious actions on target servers,” Microsoft said in the blog post.”
  • and
    • “Security researchers warned about a surge in web login brute force attacks against edge devices from a suspected botnet since mid-to-late January, according to a post on X from the Shadowserver Foundation. 
    • “The threat activity targeted devices from several major vendors, including Palo Alto Networks, SonicWall and Ivanti, with more than 2.8 million source IPs per day, according to Shadowserver. The observed threat activity goes well beyond scanning and involves actual login attempts, researchers said.
    • “We do not know who is being targeted in particular, we can only observe attacks against our own honeypots,” Piotr Kijewski, CEO of Shadowserver, said via email.
  • Dark Reading reports
    • More than two weeks after China’s DeepSeek garnered worldwide attention with its low-cost AI model, threat actors have been busy capitalizing on the news by setting up phishing sites impersonating the company.
    • The fraudulent sites aim to deceive users into downloading malicious software or providing credentials and other sensitive information. Researchers at Israel-based Memcyco spotted at least 16 such sites actively impersonating DeepSeek earlier this week and believe the activity represents a coordinated attack campaign among threat actors.
  • Per SC Media,
    • “Infostealers were identified as the largest group of new macOS malware, having increased by 101% in the last two quarters of 2024, according to the Palo Alto Networks Unit42 research group.
    • “The Unit42 research team pointed to three prevalent macOS infostealers in the wild: Poseidon, Atomic and Cthulhu.
    • “While infostealers are often seen as limited in capability compared with trojans, the researchers said in a Feb. 4 blog post that by exfiltrating sensitive credentials, financial records and intellectual property, infostealers often lead to data breaches, financial losses and reputational damage.
    • “Most infostealers are indiscriminate, aiming to maximize data collection for impact and monetization,” wrote the researchers. “This broad range of information stealing capabilities exposes organizations to significant risks, including data leaks and providing initial access for further attacks, such as ransomware deployment.”

From the ransomware front,

  • Cyberscoop informs us,
    • “Ransomware payments saw a dramatic 35% drop last year compared to 2023, even as the overall frequency of ransomware attacks increased, according to a new report released by blockchain analysis firm Chainalysis. 
    • “The considerable decline in extortion payments is somewhat surprising, given that other cybersecurity firms have claimed that 2024 saw the most ransomware activity to date. Chainalysis itself warned in its mid-year report that 2024’s activity was on pace to reach new heights, but attacks in the second half of the year tailed off.
    • “The total amount in payments that Chainalysis tracked in 2024 was $812.55 million, down from 2023’s mark of $1.25 billion.
    • “Despite its small half-over-half (HoH) increase, we expected 2024 to surpass 2023’s totals by the end of the year,” the company wrote on its website. “Fortunately, however, payment activity slowed after July 2024 by approximately 34.9%. This slowdown is similar to the HoH decline in ransom payments since 2021 and the overall decline during H2 2024 in some types of crypto-related crime, such as stolen funds. Notably, the decline this year is more pronounced than in the last three years.”
    • “The disruption of major ransomware groups, such as LockBit and ALPHV/BlackCat, were key to the reduction in ransomware payments. Operations spearheaded by agencies like the United Kingdom’s National Crime Agency (NCA) and the Federal Bureau of Investigation (FBI) caused significant declines in LockBit activity, while ALPHV/BlackCat essentially rug-pulled its affiliates and disappeared after its attack on Change Healthcare. 
    • “As the industry has seen in past years, ransomware groups often fill the market after the heads of the pack have been dismantled by law enforcement. However, when LockBit and BlackCat disappeared, a well-known ransomware group did not immediately take the mantle. Instead, smaller groups took advantage of the situation, focusing on small to medium-sized targets and asking for small ransoms, according to Chainalysis’ report. 
    • “Additionally, the company says more organizations have become stronger against attacks, with many choosing not to pay a ransom and instead using better cybersecurity practices and backups to recover from these incidents.”
  • Per Bleeping Computer
    • “The North Korean hacking group known as Kimsuky was observed in recent attacks using a custom-built RDP Wrapper and proxy tools to directly access infected machines.
    • “This is a sign of shifting tactics for Kimsuky, according to AhnLab SEcurity Intelligence Center (ASEC), who discovered the campaign.
    • “ASEC says the North Korean hackers now use a diverse set of customized remote access tools instead of relying solely on noisy backdoors like PebbleDash, which is still used.”

From the cybersecurity defenses and business / history front

  • ISACA has released its 2025 State of Privacy Report.
  • Here’s a link to Dark Reading’s CISO Corner.
  • Cybersecurity Dive relates,
    • “Thoma Bravo-backed cybersecurity firm Sophos completed its acquisition of Secureworks Monday in an all-cash transaction valued at $859 million. 
    • “Sophos said the purchase of Secureworks positions Sophos as the largest pure-play provider of managed detection and response services, with a customer base of 28,000 organizations worldwide.
    • “The agreement also expands Sophos’s threat intelligence capabilities operating under the Sophos X-Ops name, with the addition of the Secureworks Counter Threat Unit and other security operations and advisory services.”
  • and
    • “SolarWinds Corp. has agreed to a $4.4 billion deal with Turn/River Capital whereby the private equity firm buys the software firm in an all-cash transaction at $18.50 per share. 
    • “The observability and IT management software provider will become a privately held company and no longer trade on the New York Stock Exchange. 
    • “We have built a great track record of helping customers accelerate business transformations through simple, powerful, secure solutions designed for hybrid and multicloud environments,” Sudhakar Ramakrishna, president and CEO of SolarWinds said in a statement. 
    • “The Austin, Texas-based firm took center stage in one of the most consequential cyberattack campaigns in history when state-linked hackers infected its Orion platform. The attack, disclosed in late 2020, led to massive reforms in how the industry developed software and attempted to secure IT systems against increasingly sophisticated state actors.”