Monday Report

Monday Report

Photo by Sven Read on Unsplash

From Washington, DC,

  • This afternoon, a cloture petition on the nomination of Russell Vought to be Director of the Office of Management and Budget was filed with the Senate. The next step will be a vote on the cloture motion which requires 51 votes.
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) and Finance Committee member Michael Bennet (D-Colorado), with Ranking Member Ron Wyden (D-Oregon) and Finance Committee member Tim Scott (R-South Carolina), reintroduced the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act that would ensure Medicare beneficiaries’ access to cutting-edge tests capable of detecting multiple types of cancer before symptoms appear.  Bipartisan companion legislation (H.R. 842) was also introduced in the U.S. House of Representatives.” * * *
    • Bill text can be found here
  • Nature adds,
    • “US Preventive Services Task Force (USPSTF) guidelines recommend single-cancer screening for select cancers (e.g., breast, cervical, colorectal, lung). Advances in genome sequencing and machine learning have facilitated the development of blood-based multi-cancer early detection (MCED) tests intended to complement single-cancer screening. MCED tests can interrogate circulating cell-free DNA to detect a shared cancer signal across multiple tumor types. We report real-world experience with an MCED test that detected cancer signals in three individuals subsequently diagnosed with cancers of the ovary, kidney, and head/neck that lack USPSTF-recommended screening. These cases illustrate the potential of MCED tests to detect early-stage cancers amenable to cure.”
  • The New York Times reports,
    • The U.S. Food and Drug Administration has given the green light to two biotechnology companies for clinical trials that will transplant organs from genetically modified pigs into people with kidney failure. If successful, these studies could lead to the broader use of cross-species transplantation, a dream of medical scientists for centuries.
    • One of the companies, United Therapeutics Corporation, will begin its trial with six patients, but that number could eventually rise to 50. The other, eGenesis, said it would begin with three patients and grow the study from there.
    • “We are entering a transformative era in organ transplantation,” said Mike Curtis, the president and chief executive of eGenesis.
  • The Government Accountability Office released a report on food safety.
    • “Millions of Americans get sick from foodborne illness every year. While many cases are mild, some cases can result in hospitalization, long-lasting complications, or even death.
    • “In this Q&A, we reported that the safety and quality of the U.S. food supply is governed by at least 30 federal laws, collectively administered by 15 federal agencies. Federal agencies have developed some agency-specific and joint goals related to reducing foodborne illness, but most of these goals have not been met.
    • “A national food safety strategy could help ensure agencies are working together in an effective and efficient manner to reduce foodborne illness.”
  • AHIP offers for public download a report on Medicare Advantage Demographics. “The most recent demographic data [released last Friday January 31] show that MA continued to be a vital source of coverage for low-income Medicare enrollees and diverse populations.”

From the public health and medical research front,

  • The New York Times considers whether the “Bird Flu Could Become Airborne? Scientists were slow to recognize that Covid spreads through the air. Some are now trying to get ahead of the bird flu.”
  • BioPharma Dive adds, “Drugmakers prep for bird flu outbreak, despite continued low risk. While the virus hasn’t made a sustained leap into humans, vaccines and treatments are being developed ahead of an outbreak.”
  • The American Medical Association lets us know what doctors wish their patients knew about Alzheimer’s Disease.
  • The Washington Post informs us,
    • “Those who go hungry or worry about getting food while pregnant are at higher risk of complications such as preeclampsia and gestational diabetes, a new analysis suggests.
    • “The paper, published in JAMA Network Open, used data from an online health survey of more than 19,300 pregnant Kaiser Permanente Northern California members between June 2020 and September 2022. Researchers did not find similar risks among those who received food assistance while pregnant.”
  • Per MedPage Today,
    • “Just over half of patients with overweight or obesity discontinued their GLP-1 receptor agonist within 1 year, with rates even higher among the subset without type 2 diabetes, according to a retrospective cohort study.
    • “Among over 125,000 patients, 53.6% discontinued their GLP-1 receptor agonist by 1 year, and these rates were significantly higher for patients without versus with type 2 diabetes (64.8% vs 46.5%), reported Ezekiel J. Emanuel, MD, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
    • “Regardless of diabetes status, every 1% of body weight loss was tied to a 3% lower risk of discontinuation, they wrote in JAMA Network Open.
    • “Of the 41,792 patients who stopped treatment and had a weight measurement at discontinuation available, 47.3% and 36.3% of those with and without type 2 diabetes, respectively, restarted their GLP-1 agent at 1 year, and 57.3% and 46.4% restarted within 2 years. For every 1% of body weight regained after discontinuing treatment, there was a 2% to 3% increased hazard of restarting treatment.
    • “The high discontinuation rate did not come as much of a surprise, as prior studies have reported GLP-1 receptor agonist discontinuation rates of up to 81%, Emanuel’s group wrote. They added that the links between weight loss and discontinuation and between weight regain and reinitiation “suggest that weight management is an important factor regardless of type 2 diabetes status.”
  • Per BioPharma Dive,
    • “Adding Pfizer’s cancer drug Braftovi to standard treatments helped people with a form of colorectal cancer live longer without their disease worsening than those who got the typical care alone in a Phase 3 trial, the company said Monday.
    • “The result confirms earlier research from the study, called Breakwater, which had shown that trial volunteers receiving Braftovi were significantly more likely to see their tumors shrink or disappear. Those data were used to support an accelerated U.S. clearance for Braftovi in colorectal cancer in December.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “Health supply chain costs and pharmaceutical expenses are projected to rise modestly between July 2025 and June 2026, according to new research from healthcare services company Vizient.
    • “Pharmacy spend will rise 3.8%, driven in part by increased demand for specialty medications. AbbVie’s autoimmune disease drug Humira will continue to be the most popular drug by total spend, however popular GLP-1s like Ozempic, Wegovy and Mounjaro are projected to enter the top-10 list of medications by total spend.
    • “Supply chain costs will rise by approximately 2% during the period, following higher prices for raw materials, increased freight and shipping costs and tariffs on medical-surgical products, according to the report.”
  • Fierce Healthcare adds,
    • “Moody’s Ratings is downgrading the insurance industry’s credit outlook to negative as elevated medical costs continue to batter payers.
    • “Moody’s analysts noted in a report that spending in the commercial market alone is set to increase by 8% this year, the fastest rate recorded in 13 years. Spending in the individual market, meanwhile, is set to climb by 7.5%, another increase that’s higher than in recent years.
    • “Factors driving these spending hikes include inflation, prescription drug spending and higher utilization of behavioral health. Based on those trends, Moody’s projects spending in Medicare Advantage (MA) will also increase by between 5% and 7%.
    • “We are changing our outlook on the health insurance sector to negative from stable,” the Moody’s analysts wrote. “Although we expect EBITDA growth to remain in the low single digits, insurers will continue to grapple with medical costs in excess of reimbursement rates for MA and Medicaid, while commercial coverage also faces continued high medical costs.
  • Per Healthcare Dive,
    • “Cigna has released a plan it says will make healthcare more affordable and accessible for its members — including tying executive compensation to customer satisfaction — as health insurers continue to reckon with discontent with their industry since the killing of a major insurance executive late last year.
    • Cigna plans to start linking bonus awards for high-level officers to the company’s net promoter score, a measure of customer loyalty and satisfaction, the Connecticut-based insurer said Monday.
    • “Cigna will also invest in more care advocates, pare back hurdles to receiving care and make it easier for doctors to update patients on the status of prior authorization requests. Cigna also plans to release an annual “customer transparency” report starting next year with information on its business practices, including data on prior authorization requests, appeals and denials.”
  • and
    • Bankrupt Prospect Medical Holdings said Friday it intends to sell Crozer Health, its four-hospital health system based in Pennsylvania, to an unnamed consortium of nonprofit healthcare operators.
    • Attorneys for Prospect said the proposed sale is the “only viable alternative to an immediate, forced shutdown of the Pennsylvania Hospitals” in documents filed in federal bankruptcy court on Friday.
    • Prospect will appear before the bankruptcy court on Thursday to seek approval for the transaction. As of Monday morning, the hospital operator had yet to file critical details about the sale to the court, including a proposed purchase price or the names of the possible buyers. However, a press release says the deal would include all Crozer hospitals, ambulatory surgery centers, clinics and physician offices.

Happy Groundhog Day

The Weather Channel reports, “Before a huge crowd filled with excitement and anticipation, and bundled up against temperatures in the 20s, t​he groundhog known as Punxsutawney Phil saw his shadow Sunday morning in central Pennsylvania. That means we could see six more weeks of winter, at least according to Groundhog Day lore.”

From Washington, DC

  • Capitol Hill News
  • The full Senate will begin to take up the nomination of Russell Vought to be Director of the Office of Management and Budget tomorrow afternoon.
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced [today] the Committee will mark up the nomination of Robert F. Kennedy Jr. to be Secretary of the U.S. Department of Health and Human Services (HHS) during an executive session on Tuesday, February 4, 2025, at 10:00AM ET.” 
  • On Wednesday February 5 at 10 am ET the House Oversight Committee will hold a hearing about
    “Rightsizing Government.”

OPM News

  • Federal News Network reports,
    • “The Office of Personnel Management’s blanket offer for federal employees to accept its “deferred resignation” offer is starting to narrow.
    • “Some agencies are notifying employees in certain critical positions that they are exempt from OPM’s offer. In other cases, agency leaders have told employees who already accepted the offer that they must keep working, regardless of what they have already been told by OPM.”
  • and
    • “The Office of Personnel Management is giving agencies the authority to offer early retirement to federal employees — in addition to the “deferred resignation” offer sent to most federal employees in a mass email earlier this week.
    • “OPM is approving VERA authority so eligible employees may receive VERA if they accept the deferred resignation officer,” OPM Acting Director Chuck Ezell wrote in an email obtained by Federal News Network. “If your full retirement eligibility data falls within the 2025 calendar year, the agency may extend your deferred resignation period to the date of your full retirement eligibility.”
    • “An OPM spokesperson confirmed to Federal News Network the VERA extends governmentwide.
    • “Federal and postal employees under the Civil Service Retirement System (CSRS) and Federal Employees Retirement System (FERS) are eligible for voluntary early retirement if they’re at least 50 years of age, with at least 20 years of service, or any age with at least 25 years of service.
    • “Voluntary Early Retirement Authority doesn’t always come with a financial incentive. But in cases agencies do offer money, the incentive is capped at $25,000.”

From the U.S. healthcare business front,

  • Beckers Hospital Review offers executive insights on the impact that the President’s February 1, 2025, tariff program may have on healthcare.
  • Beckers also tells us,
    • “Healthgrades has recognized 250 U.S. hospitals as part of its 2025 America’s Best Hospitals Awards.
    • “The top 50 hospitals [which are listed in the article] represent the 1% of U.S. hospitals providing the highest level of quality care, according to a Jan. 28 news release. 
    • “Healthgrades evaluated the clinical performance of approximately 4,500 hospitals across more than 30 common procedures and conditions, the release said. Read more about the methodology here.”
  • Fierce Healthcare informs us,
    • “Medicare Advantage patients treated in value-based care models saw better outcomes than those treated in fee-for-service models, according to a new study.
    • “Researchers led by a team at Optum examined claims data on nearly 5.3 million person-years from 2016-19 across 20 different measurements and found that patients in accountable care models were 9% less likely to be admitted to the hospital and 9% less likely to visit the emergency department.
    • “The study found that value-based patients were also 22% less likely to be admitted to the hospital for concerns related to chronic conditions like chronic obstructive pulmonary disorder or asthma, including an 18% reduction in admissions related to hypertension.
    • “In addition, patients treated in the value-based models were 9% less likely to be admitted to the hospital from the emergency room, the study found.:

Cybersecurity Saturday

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “A bipartisan pair of House lawmakers are seeking to improve private-public coordination for financial institutions amid a surge of ransomware attacks on the sector.
    • “The Public and Private Sector Ransomware Response Coordination Act, introduced this week by Reps. Zach Nunn, R-Iowa, and Josh Gottheimer, D-N.J., would direct the Treasury secretary to deliver a report on existing collaboration between federal agencies and private financial companies, examining how those partnerships can be improved to better protect the industry from cyberattacks.
    • “The legislation from Nunn and Gottheimer, both members of the House Financial Services Committee, comes as global ransomware attacks jumped 67% from 2023 to 2024, according to the director of national intelligence. And according to Statista, approximately 65% of financial institutions globally reported experiencing a ransomware attack in 2024, up from 34% in 2021.”
  • Per a House of Representatives announcement,
    • On Wednesday, February 5, 2025, the Committee on Homeland Security will hold a hearing entitled, “Preparing the Pipeline: Examining the State of America’s Cyber Workforce.”
    • The Committee will meet at 10:00 a.m. EST in 310 Cannon House Office Building. Witnesses will be by invitation only.
    • This event will be streamed live at homeland.house.gov and on YouTube.
  • Cyberscoop adds
    • “The Federal Bureau of Investigation, along with several other international law enforcement departments, has seized control of several high-profile online platforms linked to cybercrime in a sweeping operation aimed at disrupting digital marketplaces for stolen credentials and hacking tools. The domains of forums Cracked[.]io and Nulled[.]to now redirect to FBI-controlled servers, signaling efforts to dismantle infrastructure that supports cybercriminal activity.
    • “As of Wednesday, visitors to the forums — long criticized as hubs for password theft, software piracy, and credential-stuffing attacks — encountered DNS error messages indicating federal intervention. Eagle-eyed cybersecurity researchers discovered Wednesday that the specialized servers that translate IP addresses into domain names redirected visitors to FBI-owned assets, effectively shutting down access. 
    • “Also seized were domains and services belonging to SellIX, which enabled users to create storefronts for illicit goods, and StarkRDP, a Windows remote desktop hosting service, which was allegedly leveraged by threat actors to anonymize attacks.
    • “According to the image on the Cracked and Nulled websites, law enforcement from Australia, France, Germany, Greece, Italy, Spain, and Romania were also involved. Europol also played a role, according to the image. 

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop lets us know,
    • Cryptojacking, the tactic of breaking into a device to steal computing resources and mine crypto, is a pervasive, frustrating and expensive problem. But attacks like these can also raise cybersecurity concerns, especially when they happen to the federal government. 
    • Last fall, the U.S. Agency for International Development learned it was hit by a cryptojacking incident, according to documents viewed by Scoop News Group. The agency was notified by Microsoft that a global administrator account located in a test environment had been breached through a password spray attack — a brute force attempt to enter a system by guessing a series of passwords. 
    • That account was then used to create another account — and both were then deployed to begin crypto-mining processes through USAID’s Azure resources. The result was around half a million dollars in cloud service charges to the agency.
    • Using government resources to break into an agency’s resources for the purpose of mining crypto might sound strange, but it happens. 
  • Per Cybersecurity Dive,
    • “The Food and Drug Administration has released a safety communication about the cybersecurity vulnerabilities of certain patient monitors from Contec and Epsimed.
    • “The notice, which the FDA published Thursday [January 30], describes three vulnerabilities that can allow people to gain access to remote monitoring technology and potentially manipulate the devices.
    • ‘The FDA is not aware of cybersecurity incidents, injuries or deaths linked to the vulnerabilities but is advising patients, healthcare providers and IT staff to take steps to mitigate the risks.”
  • and
    • “Threat actors are exploiting a zero-day vulnerability in Zyxel CPE Series devices months after the security flaw was originally reported to the company, researchers at GreyNoise disclosed in a blog post Tuesday.
    • “The critical command-injection vulnerability, tracked as CVE-2024-40891, allows an attacker to execute arbitrary commands on a CPE Series device, which can lead to exfiltration of data, infiltration of a computer network or total system compromise. 
    • “Due to GreyNoise’s first-hand, confirmed mass exploitation attempts for this vulnerability, we chose to disclose this to raise awareness among those who may be impacted,” a spokesperson for GreyNoise said via email. “All decisions to move forward were made in conjunction with VulnCheck and its policies.”
  • Dark Reading informs us,
    • “Researchers have discovered two new ways to manipulate GitHub’s artificial intelligence (AI) coding assistant, Copilot, enabling the ability to bypass security restrictions and subscription fees, train malicious models, and more.
    • “The first trick involves embedding chat interactions inside of Copilot code, taking advantage of the AI’s instinct to be helpful in order to get it to produce malicious outputs. The second method focuses on rerouting Copilot through a proxy server in order to communicate directly with the OpenAI models it integrates with.
    • “Researchers from Apex deem these issues vulnerabilities. GitHub disagrees, characterizing them as “off-topic chat responses,” and an “abuse issue,” respectively. In response to an inquiry from Dark Reading, GitHub wrote, “We continue to improve on safety measures in place to prevent harmful and offensive outputs as part of our responsible AI development. Furthermore, we continue to invest in opportunities to prevent abuse, such as the one described in Issue 2, to ensure the intended use of our products.”
  • The Cybersecurity and Infrastructure Security Agency added one known exploited vulnerability to its catalog this week.
  • The CIS Center for Internet Security adds,
    • “Multiple vulnerabilities have been discovered in Apple products, the most severe of which could allow for arbitrary code execution. Successful exploitation of the most severe of these vulnerabilities could allow for arbitrary code execution in the context of the logged-on user. Depending on the privileges associated with the user, an attacker could then install programs; view, change, or delete data; or create new accounts with full user rights. Users whose accounts are configured to have fewer user rights on the system could be less impacted than those who operate with administrative user rights.
    • “THREAT INTELLIGENCE:
      • Apple is aware of a report that CVE-2025-24085 may have been actively exploited against versions of iOS before iOS 17.2.”

From the ransomware front,

  • Forbes reports,
    • “With LockBit already stating that Feb. 3 will see it restart operations, the threat is about as real as it gets. So, what do you need to do?
    • “The primary mitigations are:
      • Install updates for operating systems, software and firmware as soon as they are released.
      • Require phishing-resistant, non SMS-based multi-factor authentication.
    • “In the face of these challenges, businesses, governments, and individuals must stay vigilant and proactive,” Matt Hull, global head of threat intelligence at NCC Group, warned, and that’s good advice that you would be well-advised to action immediately before the ransomware threat becomes a reality for you.”
  • Dark Reading points out,
    • “Two healthcare institutions, Frederick [Maryland] Health and New York Blood Center Enterprises (NYBCe), are grappling with disruptions from separate ransomware attacks they faced this past week.
    • “Frederick Health posted an update to its website on Jan. 27 noting that it “recently identified a ransomware event” and is working to contain it with third-party cybersecurity experts to get its systems back online.
    • “Though most of its facilities remain open and are still providing patient care, Frederick Health reported that its Village Laboratory is closed and that patients may experience some operational delays.
    • “New York Blood Center Enterprises, a nonprofit made up of a collection of independent blood centers, first identified suspicious activity affecting its IT systems on Jan. 26. On Jan. 29, it alerted the public that it took its systems offline in an effort to contain the threat, which was attributed to a ransomware attack. NYBCe is working to restore its systems; however, it remains unclear when it will be fully operational again. The organization expects processing times for blood donations at its centers and offsite blood drives may take longer than usual.”
  • Bleeping Computer adds,
    • “Community Health Center (CHC), a leading Connecticut healthcare provider, is notifying over 1 million patients of a data breach that impacted their personal and health data.
    • “The non-profit organization provides primary medical, dental, and mental health services to more than 145,000 active patients.
    • “CHC said in a Thursday filing with Maine’s attorney general that unknown attackers gained access to its network in mid-October 2024, a breach discovered more than two months later, on January 2, 2025.
    • “While the threat actors stole files containing patients’ personal and health information belonging to 1,060,936 individuals, the healthcare organization says they didn’t encrypt any compromised systems and that the security breach didn’t impact its operations.”
  • Hackers News explains how Interlock Ransomware infects healthcare organizations.

From the cybersecurity defenses front,

  • Cyberscoop informs us
    • “Imagine, for a moment, that your network is hit with ransomware.
    • “One of your employees clicked on a malicious link and now your network is compromised, data is encrypted and most of the organization’s systems are locked or offline.
    • “Then imagine if instead of assembling an incident response team, notifying the board and contacting law enforcement, the forensic sensors in your device’s firmware spring to life. They begin healing your network, restoring locked files, and communicating with other systems to collect forensic data.
    • “The firmware then analyzes the data to identify how the attackers entered and exploited system weaknesses, then blocks those vulnerabilities to prevent future breaches through the same entry points. 
    • “While it sounds like science fiction, researchers at one of the Pentagon’s top cyber innovation hubs are attempting to prove the idea is more than a pipe dream.
    • “Red-C, a new project being rolled out by the Defense Advanced Research Projects Agency, seeks to build new defenses into bus-based computer systems, which are firmware-level systems used in everything from personal computers to weapons systems to vehicles.”
  • Cybersecurity Dive tells us,
    • “Organizations that have consolidated security spending into integrated platforms have experienced improved cyber resilience and stronger operational efficiencies, according to a study released Tuesday by IBM and Palo Alto Networks
    • “Managing security stacks has been a struggle for organizations, which juggle an average of 83 different security tools from 29 different vendors, according to the study.
    • “More importantly, the “platformization” model reduces the time it takes to identify and mitigate security incidents by an average of 74 days and 84 days, respectively, the study found.”
  • Per Dark Reading,
    • “When automated pen-testing tools appeared a few years ago they prompted an interesting question: How close are they to replacing human pen testers? While the short answer was “not that close — yet,” they definitely had potential and were worth keeping an eye on.
    • “As I’ve just had the chance to review the latest iteration of these tools, it’s interesting to see how they’ve evolved and how close are they now are to replacing the human pen tester for offensive security work.” * * *
    • “Overall, it’s good to see these tools evolve. The rate of change is glacial, but they now understand cloud environments and can target Web applications, though they are still temperamental, costly, and miss a few things. One could argue humans are the same. For now, however, humans maintain the advantage — but they aren’t mutually exclusive. Just like crowdsourced security and traditional pen testing, automated pen testing is now another tool that can be layered onto your offensive security testing, where it can help you find the exploits that matter to your organization.”
  • Here is a link to Dark Reading’s CISO Corner/

Friday Report

From Washington, DC,

White House News

  • Per a White House fact sheet,
    • “ELIMINATING 10 REGULATIONS FOR EACH NEW REGULATION ISSUED: Today, President Donald J. Trump signed an Executive Order to unleash prosperity through deregulation. 
    • “The Order requires that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed.  
    • “The Director of the Office of Management and Budget will ensure standardized measurement and estimation of regulatory costs.
    • “It requires that for fiscal year 2025, the total incremental cost of all new regulations, including repealed regulations, be significantly less than zero.'”
  • FEHBlog observation – The White House needs to turn its attention to subregulatory guidance.

Capitol Hill news

  • Modern Healthcare reports,
    • “Doctors and some bipartisan allies on Capitol Hill advanced their campaign to boost Medicare physician reimbursements with the release of new legislation Friday.
    • “The Medicare Patient Access and Practice Stabilization Act of 2025 would give doctors a 6.6% rate increase through 2026 and be retroactive to the beginning of this year, when a 2.9% cut took effect.” * * *
    • “The next government funding bill, which must pass by March 14 to prevent a partial shutdown, is an obvious vehicle. Supporters would likely have a greater chance getting Medicare physician reimbursements into that legislation than into a broader bill with many billions in healthcare cuts that Trump and GOP leaders are drafting on a partisan track.”
  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Chuck Grassley (R-IA), a senior member and former chairman of the Senate Finance Committee, today sent a letter to the President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) urging them to embrace their bipartisan legislation, the Drug-price Transparency for Consumers (DTC) Act, to empower patients and providers and commit to voluntarily disclosing list prices in DTC advertisements. 
    • “The Senators wrote, “The United States is one of only two developed countries in the world that permits such pharmaceutical commercials. President Trump’s nominee for Health and Human Services Secretary has expressed interest in outright banning this practice. It would be wise for drug companies to adopt commonsense solutions to address the concerns that have been raised about DTC prescription drug advertising. As you are aware, the United States Senate previously voted unanimously to pass our measure to require that pharmaceutical companies disclose their list prices in DTC ads, and it is our hope that this policy will become law this Congress. This bipartisan legislation would ensure that when patients are bombarded with information about the newest wonder drug, the price is not kept secret. President Trump previously has issued regulations to advance this policy.” * * *
    • Full text of the letter is available here.

OPM News

  • OPM issued an addendum (FEHBlog Dropbox link) to its 2026 FEHB / PSHB call letter today which implements two of the President’s executive orders.
  • Federal News Network reports,
    • “Trump administration officials are taking major steps to cut down the size of the workforce and federal programs at the Office of Personnel Management.
    • “During an internal meeting Friday morning, Trump administration officials directed OPM senior career staff to begin making plans to cut the agency’s workforce and programs by 70%. Multiple sources with direct knowledge of the meeting confirmed the details of the meeting to Federal News Network.
    • “Sources who provided information to Federal News Network on the condition of anonymity said the political leadership at the agency also directed OPM leaders to stop work on anything that is not statutorily required.
    • “Trump administration officials told agency office leaders and associate directors at OPM to prepare briefs over the weekend detailing all of their work and programs that are statutorily required. By Monday, all OPM offices are expected to give political leaders organizational staffing charts with plans for an initial 30% reduction for both federal employees and contractors.”

Postal Service news

  • Federal News Network tells us
    • “The Postal Service’s regulator warns the next phase of a 10-year reform plan would slow mail delivery for a “significant portion of the nation,” but wouldn’t save USPS enough money to justify the changes.
    • “The Postal Regulatory Commission, in an advisory opinion on key parts of the USPS “Delivering for America” plan, found upcoming changes meant to cut billions of dollars each year wouldn’t do much to help the agency regain its long-term financial footing — but would lead to “disproportionate” cuts in service across rural communities.
    • “A PRC official told Federal News Network that nearly 40% of single-piece first-class mail — including letters and postcards — would see a service downgrade under these changes — and that the impact would be even greater in rural areas.
    • “The Commission urges the Postal Service to reconsider whether the speculative, meager gains from this proposal outweigh the certain downgrade in service for a significant portion of the nation,” the PRC wrote Friday.”

FDA News

  • MedPage Today informs us,
    • “The FDA approved an oral combination of meloxicam and rizatriptan (Symbravo) to treat adults with acute migraine with or without aura, Axsome Therapeutics announcedopens in a new tab or window.
    • “Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT 1B/1D agonist (triptan). The newly approved drug uses a proprietary technology called MoSEIC to increase meloxicam’s solubility and speed of absorption after the drug is taken orally while maintaining its extended plasma half-life.
    • “A significant proportion of migraine patients experience inadequate efficacy with currently available acute treatments, leading to even greater suffering, and an increased risk of worsening of migraine pain and attack frequency,” said Richard Lipton, MD, of Albert Einstein College of Medicine in New York City, in a statement. “Results of multiple clinical trials demonstrate that Symbravo can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in many areas of the country.
    • “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 was similar to last week. 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 many 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.
  • News supplementing the CDC report
    • Health Day notes,
      • “People still see COVID-19 as an ongoing public health threat, even though the pandemic officially ended in 2023, according to a new HealthDay/Harris Poll.
      • “Nearly 3 in 4 people (72%) agree COVID is still a serious public health issue, including more than a third (35%) who strongly agree, the poll found.
      • “COVID has settled into the sort of ongoing health threat already posed by the seasonal flu, which had its turn as a pandemic back in 1918, Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said.
      • “You’ll get hundreds of thousands of people hospitalized with influenza every year,” Offit told HealthDay TV. “You’ll get tens of thousands of people who die every year from influenza. I think that’s what COVID is now. I think this virus will be with us for decades, if not longer.”
    • The University of Minnesota’s CIDRAP lets us know
      • “The nation’s flu activity continued a steady rise last week, with 44 states at the high or very high level and that national test positivity just shy of 30%, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
      • “Outpatient visits for flulike illness have been above the national baseline for 9 weeks in a row. Of samples that tested positive for flu at public health labs, nearly all were influenza A, and subtyped influenza A samples were about evenly split between the H3N2 and 2009 H1N1 strains.
      • “On the CDC’s flu activity map, most of the country is awash in shades of red that reflect high or very high activity. However, some states are shaded purple, the highest level on the activity scale. They include Southeastern states such as Louisiana, South Carolina, and Tennessee, but also several in the Northeast, including Massachusetts, New Jersey, New York, and New Hampshire.
      • “The CDC reported 16 more pediatric flu deaths, which push the season’s total to 47. The deaths occurred between the middle of December and the week ending January 25. All involved influenza A, and, of 13 subtyped samples, 7 were H1N1 and 6 were H3N2. 
      • “For deaths overall, the level remained steady, with flu making up 1.6% of all deaths last week.
      • “Emergency department (ED) visits for flu are at the very high level and are increasing in all age-groups, making up 7% of all ED visits, the CDC said in its weekly respiratory virus snapshot. Meanwhile, hospitalizations for flu remain elevated and are likewise on the rise for all age-groups.”
  • Per STAT News,
    • “Researchers confirmed that antidepressants lead to a significant reduction in generalized anxiety
    • “The long-awaited update, published by the Cochrane Database of Systematic Reviews, considered by some to be the gold-standard of evidence-based health care, considered evidence from 37 unique randomized control trials with 12,226 participants and found that these drugs are effective compared to a placebo.
    • “The drugs’ long-term impacts are muddier, said Prof. Peter Tyrer, an emeritus psychiatry professor at Imperial College London who was not involved in the study. Some patients have difficulties stopping antidepressants because of withdrawal problems. 
    • “The main reason why antidepressants were preferred to benzodiazepines (drugs that are equally effective in treating generalised anxiety) was the dependence risk, we just seem to have shifted the problem of adverse effects from one class of drugs to another,” Tyrer said. 
  • and
    • “To create one of the most advanced immunotherapies in cancer, CAR-T cell therapies, scientists engineer immune T cells to carry a synthetic protein on their surfaces. This protein, called the chimeric antigen receptor or CAR, is what gives these engineered cells such potency against certain cancers and allows them to recognize and destroy malignant cells. In a new study, scientists have found that CAR-T cells are able to donate this synthetic protein to normal T cells, essentially arming other cells in the immune system with advanced technology to kill cancer.
    • “While this finding is fascinating scientists and cancer researchers, it’s not yet clear how sharing CARs between T cells might impact CAR-T therapy efficacy or influence the design of future synthetic receptors, experts told STAT. However, the work does reveal new biology around how T cells share proteins with one another and gives bioengineers some insights into how to manipulate that process.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Aetna, Blue Shield of California and Centene’s Health Net have launched a shared, value-based payment model for reimbursing primary care physicians in California.
    • “The project, led by the California Quality Collaborative and the Integrated Healthcare Association, involves 11 providers across the state, covering about 17,000 patients. The single payment model went live on Jan. 1 and aims to address primary care reimbursement challenges, improve health equity, and boost health outcomes. The model focuses on small, independent practices and could eventually expand beyond California, according to a Jan. 30 news release.
    • “Instead of each health plan using its own payment system, the three insurers use a single, shared system that rewards physicians for providing high-quality care, especially among underserved populations. The CQC will help practices implement the new system, improve care coordination, and integrate mental and physical health services. A platform called Cozeva will provide data to help physicians track their performance and close care gaps.
    • “Participating providers are here. A full model guide is available here.
  • Kauffman Hall offers an infographic about the state of rural healthcare.
  • BioPharma Dive considers the following — “After decades of research, Vertex Pharmaceuticals has an approved pain medicine. Can one of the most powerful biotechs contend with a healthcare system that’s long favored opioids?” The FEHBlog hopes so.
  • Per Fierce Pharma,
    • “One of the most important launches for Novartis in recent years is off with a bang.
    • “Following a broad FDA approval for the adjuvant treatment of HR-positive, HER2-negative early breast cancer in September, Novartis’ Kisqali grew U.S. sales by 65% year over year—or nearly 25% sequentially—to $549 million in the fourth quarter of 2024.
    • “A Novartis presentation released on Friday shows that Kisqali’s new patient starts jumped from an average of around 1,500 per month before the approval to about 2,200 in both October and November. Data for December were not yet available.”
  • and
    • “Two years after AbbVie’s loss of market exclusivity for Humira, those “How it Started and How it’s Going” memes are looking better each quarter for the Illinois drugmaker.
    • “On Friday, when AbbVie reported its quarterly earnings, the pharma giant jacked up its 2027 projected sales of Humira follow-ons Skyrizi and Rinvoq to a combined $31 billion. It is a $4 billion increase on the company’s previous guidance for the immunology duo.
    • “Chief commercial officer Jeff Stewart explained that the projection increase has come because of growing “share capture.” Skyrizi now holds 40% of the total prescription share of the biologics psoriasis market, he said.
    • “Of the $4 billion adjustment to the 2027 projection, $2 billion has been added to Skyrizi’s estimate in inflammatory bowel disease (IBD) and $500 million has been added to Rinvoq’s in the same indication.  
    • “Across the board, we’re seeing tremendous performance, particularly in IBD,” Stewart explained.”

Thursday Report

Photo by Josh Mills on Unsplash

From Washington, DC

Capitol Hills News

  • Modern Healthcare reports,
    • “Robert F. Kennedy Jr.’s chances of confirmation as Health and Human Services secretary appeared to hinge Thursday on convincing a handful of Senate Republicans that he would adhere to accepted science when it comes to vaccines. * * *
    • “Three key Republicans pressed the prominent vaccine critic to moderate his past positions and unequivocally endorse vaccinations, starting with HELP Committee Chair Dr. Bill Cassidy (R-La.). Cassidy likewise challenged Kennedy during the Senate Finance Committee’s confirmation hearing Wednesday.
    • “Cassidy declined to declare support for President Donald Trump’s nominee to be the nation’s highest-ranking health official during the hearing or when questioned afterward. GOP Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska) also have not declared support for Kennedy.” * * *
    • “Kennedy could lose up to three Republicans and still be confirmed. The nominee needs 51 votes, and Republicans have a 53-47 advantage over Democrats in the Senate. If necessary, Vice President JD Vance would break a 50-50 tie in his constitutional capacity as president of the Senate.
    • “If Cassidy, Collins, Murkowski and McConnell all vote nay, Kennedy would be one vote short, assuming every Democrat opposes him. Yet a few Democrats have not declared their positions on the nominee, such as Sens. Cory Booker (N.J.) and John Fetterman (Pa.).
    • “The Finance Committee will vote whether to recommend confirmation to the Senate, while the HELP Committee will not. The Finance Committee vote has not been scheduled but may come as soon as next week. Cassidy sits on the Finance Committee, while Collins, Murkowski and McConnell do not.”
  • Roll Call tells us,
    • “Senate Budget Committee Republicans approved Russ Vought’s nomination to serve as President Donald Trump’s budget director on Thursday, overcoming the absence of Democrats on the panel who boycotted the markup.
    • “The 11-0 party-line vote clears the way for Vought’s nomination to go to the full Senate. The Senate Homeland Security and Governmental Affairs Committee, which shares jurisdiction over the Office of Management and Budget, approved Vought’s selection in a party-line vote last week.
    • “Thanks to Democrats’ boycott, Republicans had to wait for all 11 GOP panel members to trickle in from their other obligations due to rules requiring a quorum of committee members before taking a vote.”

OPM News

  • Federal News Network informs us,
    • “The Office of Personnel Management is sharing initial details with internal employees on what the federal return-to-office mandate will look like for OPM’s own staff members.
    • “Starting March 3, OPM employees are expected to report to work on-site full-time, OPM Acting Director Charles Ezell told employees Wednesday evening in an all-staff email, obtained by Federal News Network.
    • “Ezell described his email as a “preview” of the agency’s return-to-office plans, adding that OPM will host a town hall next week to share more details with employees.
    • “As with any operational change, we know we will encounter challenges, but I am confident that you will bring the same diligence and innovation to this process as you have countless other efforts we have undertaken at OPM,” Ezell wrote in the email to OPM employees.
    • “Ezell’s email comes in response to a Jan. 23 memo outlining how agencies are expected to respond to President Donald Trump’s directive to end remote work in the federal workforce. The OPM guidance clarified that the mandate applies to both teleworkers and remote workers, but that there are exemptions for employees with disabilities, qualifying medical conditions or other “compelling reasons.”
    • “Emerging return-to-office plans may vary by agency, but agencies in the executive branch are expected to similarly issue implementation plans to return their employees to the office full-time.”
  • Tammy Flanagan, writing in Govexec, offers advice figuring out the Fork in the Road program.

FDA News,

  • BioPharma Dive reports,
    • “The movement to steer pain treatment away from opioids notched a major victory Thursday, as the Food and Drug Administration approved a new, highly anticipated drug from Vertex Pharmaceuticals.
    • “The culmination of decades of work, Vertex’s Journavx is now cleared to treat the short-lived “acute” pain usually felt after an accident or a surgery. Vertex hopes to eventually get the drug approved for chronic pain as well, though clinical trials testing it in that setting have produced mixed results.
    • “Acute pain is often treated with a combination of acetaminophen, anti-inflammatory agents like ibuprofen and, if necessary, opioids, which pose an addiction risk because they act directly on the brain and stimulate pleasure centers. Despite the dangers, insurance companies, pharmacy managers and drugmakers like Purdue Pharma for years pushed for the use of opioids in pursuit of immense profits. The resulting overdose crisis has killed hundreds of thousands of people in the U.S. alone.”

Miscellany

  • Beckers Payer Issues points out,
    • “An organization representing Medicare Advantage insurers is asking CMS to pause any policy changes to the program not required by law in 2026. 
    • “In a Jan. 28 press release, the Better Medicare Alliance, a pro-MA group backed by several major insurers, urged the agency to prioritize “stability” in its 2026 proposed rule. 
    • “In November, the Biden administration pitched several major regulatory changes for 2026, including requiring Medicare to cover GLP-1 drugs for individuals with obesity.” 

From the public health and medical research front,

  • MedPage Today lets us know,
    • An online dementia prevention program improved cognition in a trial of 6,100 older adults.
    • Scores in complex attention, executive function, and memory improved.
    • Women versus men and people ages 55-65 versus 66-77 benefited more from the program.
  • Per Fortune Well,
    • “The myth that cannabis is harmless because it’s natural has been further debunked—by scientists in a pot-friendly state. New research from the University of Colorado Anschutz Medical Campus shows that heavy lifetime cannabis use may harm working memory in young adults.
    • “In what the university calls the largest study of its kind, researchers used brain imaging technology to explore the effects of recent and lifetime cannabis use on brain function among more than 1,000 people ages 22 to 36. During a task assessing working memory—the short-term storage of information that can be applied to activities such as reasoning and problem-solving—the majority of recent (68%) and heavy lifetime (63%) cannabis users showed reduced brain activity. The findings were published Jan. 28 in the journal JAMA Network Open.”
  • and
    • “How many times a day do you touch your phone? It’s pretty easy to lose count, as it seems like our cell phones never leave our side—even when we use the bathroom. You might want to rethink your toilet doom scrolling, though, as your phone can be one of the worst breeding grounds for fecal bacteria and other viruses.
    • “Several studies of health care workers show the high level of bacterial and microorganism growth on their mobile phones—but it’s not just in clinical settings that bacteria thrives on smartphones. A 2017 study of high school students’ phones found the presence of over 17,000 bacterial gene copies per phone—the more gene copies, the greater potential for faster bacteria growth.
    • “Most jarringly, researchers at the University of Arizona found that cell phones carry 10 times more bacteria than a toilet seat, including E.coliSalmonella, norovirus, staph, and gonorrhea. That can add up to a lot of bacterial exposure, as a Reviews.org survey reports that Americans check their phones a whopping 205 times a day.
    • “People’s phones are out when urinating and defecating, exposing the phones to bacteria,” says Dr. Suraj Saggar, chief of infectious disease at Holy Name Medical Center in New Jersey. “Then put it into a pocket or purse that is dark, allowing bacteria to grow.”
    • “[In the article], experts tell Fortune how worried you should be about potential pathogens on your phone and the best way to keep it clean.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Cigna closed out 2024 on shaky footing, posting fourth-quarter results below Wall Street’s expectations due to a rise in medical costs. Meanwhile, top executives pledged changes to medical and pharmacy plans amid widespread discontent with health insurance companies.
    • On Thursday, the Connecticut-based company reported revenue of $65.7 billion, up 29% year over year, and income of $1.4 billion, up 38% year over year. However, adjusted income from operations, which Cigna believes is a better metric of how the company performs, fell 8% year over year to $1.8 billion, well below analyst forecasts.
    • Cigna CEO David Cordani told investors Thursday morning the company will work to make receiving medical and pharmacy care cheaper and easier for its customers, amid criticism that insurers and pharmacy benefit managers are profiteering at the expense of the American consumer.”
  • Bloomberg Law adds,
    • “Cigna’s health benefits division spent 87.9% of premium revenue on medical expenses in the fourth quarter, more than analysts were expecting from that key measure. Management blamed it on “stop loss” plans, which employers use to guard against costly medical claims.
    • “Cigna’s management said the problem was increased use of cancer drugs like Keytruda, which is priced at around $200,000 a year, and multiple sclerosis treatment Ocrevus, listed at around $80,000 annually. Expensive hospital stays for cancer and heart surgeries also drove up medical spending, management said.”
  • Per Fierce Healthcare,
    • “Cigna executives said that the company is on track to close the sale of its Medicare Advantage business in the first quarter of 2025, in line with its expectations.
    • “The insurer announced plans to sell off its MA plans to Health Care Service Corporation in January 2024 in a deal valued at $3.7 billion. Chief Financial Officer Brian Evanko said that all federal antitrust approvals have been received, as have all but one state approval.”
  • MedTech Dive reports,
    • “Zimmer Biomet has agreed to buy Paragon 28, an orthopedics company focused on foot and ankle implants, for an equity value of approximately $1.1 billion.
    • “Zimmer will purchase all outstanding shares of Paragon 28 for $13 per share, according to the Tuesday announcement. The amount is a slight premium over Paragon’s Tuesday closing price of $12; however, its shares fell below $5 as recently as October. The deal is expected to close in the first half of 2025.
    • “Needham analysts, in a Wednesday note to investors, wrote they have viewed Paragon as a potential acquisition target for a long time and were “surprised by the small premium that [Zimmer] is paying.” The analysts expect Zimmer to pull off more acquisitions, potentially outside of orthopedics.”

Midweek Update

From Washington, DC,

  • Per a CMS press release issued today,
    • “Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program on January 17, 2025. As the second cycle begins under the Trump Administration, CMS is committed to incorporating lessons learned to date from the program and to considering opportunities to bring greater transparency in the Negotiation Program. CMS intends to provide opportunities for stakeholders to provide specific ideas to improve the Negotiation Program, consistent with the goals of achieving greater value for beneficiaries and taxpayers and continuing to foster innovation.”
  • The American Hospital Association (AHA) News tells us,
    • The AHA Jan. 28 voiced support for bipartisan legislation to reauthorize for five years the Dr. Lorna Breen Health Care Provider Protection Act, which provides grants to help health care organizations offer behavioral health services for front-line health care workers. Introduced yesterday by Sens. Tim Kaine, D-Va., Roger Marshall, R-Kan., Jack Reed, D-R.I., and Todd Young, R-Ind., the bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. 
  • Federal News Network informs us,
    • “A significant majority of federal employees who took a Federal News Network survey say they don’t plan on accepting the Office of Personnel Management’s offer to resign and go on paid administrative leave.
    • “In a survey of 4,619 federal employees, more than three-quarters of respondents said they don’t intend to accept the deal OPM sent to most civil federal workers in a mass email Tuesday afternoon.” * * *
    • “More than 500 respondents — about 11% of those who took the poll — said they intend to accept the deal.
    • “Among those who expect to accept the offer, 54% said they already had plans to retire from federal service soon or leave for a job outside the federal workforce.” * * *
    • “About 70% of respondents said they don’t have enough information from OPM to make their decision either way. Many said OPM hasn’t provided enough details on what accepting the deal would mean for their health and life insurance plans, or whether it would impact their pensions.”
  • ICD10 Monitor relates,
    • “The Centers for Medicare & Medicaid Services (CMS) have issued the display copy of the Final Rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage, or MA, and the Prescription Drug Plans) established by the Patient Protection and Affordable Care Act.
    • “The Final Rule became effective as of Jan. 1, 2025. The 60-day Refund Rule is included as part of the 3,000+-page 2025 Physician Fee Schedule Final Rule. 
    • “The federal Overpayment Statute requires any person who receives or retains Medicare or Medicaid funds to which they are entitled to report and return any overpayment to the appropriate government official or contractor within 60 days after “identification” of the overpayment, per Section 1128J(d) of the Social Security Act, 42 U.S.C. § 1320a-7k(d).
    • “Failure to report and return an “identified” overpayment in a timely manner could create a false claim situation subject to the False Claims Act (FCA). The False Claims Act, among other things, addresses individuals who knowingly conceal or avoid an obligation to pay or refund money to the federal government.”

From the public health and medical research front,

  • STAT News reports,
    • In July 2022, 988 launched as the number anyone across the country could dial in a mental health crisis. It’s one entryway to a sprawling system of mental health care options, but new research shows that since then, critical crisis services have not become more available — a key objective of the nationwide rollout, designed to strengthen an underfunded, patchwork system that left many people alone in times of crisis. 
    • While calls to the national hotline have continued to increase, fewer psychiatric facilities are offering emergency psychiatric walk-in services, mobile crisis response units, and suicide prevention services, according to a study published Wednesday in JAMA Psychiatry.
    • “988 isn’t going to reach its full potential until there’s a full system of crisis services in every single community,” said Hannah Wesolowski, chief advocacy officer at the National Alliance on Mental Illness.”
  • and
    • From plant-based chocolate milk to fizzy reduced-sugar drinks courtesy of Michelle Obama, the beverage market is always introducing new offerings to appeal to kids. But new dietary recommendations from several major health organizations say that children should really stick with drinking water and plain pasteurized milk.
    • The recommendations for children ages 5-18, released Wednesday, come from the Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association. 
    • Their advice is in keeping with broader draft dietary guidelines created by an advisory committee to the U.S. government at the end of last year, which also said water should be the main thing that people of all ages drink. But the report is notable in carving out specific stances on the wide range of beverage options marketed to families, including plant-based milk and drinks containing non-sugar sweeteners. 
  • Per MedPage Today,
    • Fluctuating cholesterol levels were tied to higher dementia risks in a large study of older adults.
    • Relationships were seen for variability in both total cholesterol and LDL-C levels.
    • Links with dementia were independent of baseline values or whether trends were up or down.
  • Per Healio,
    • The addition of high-dose IV vitamin C to standard chemotherapy nearly doubled overall survival for patients with advanced pancreatic cancer, according to results of a randomized phase 2 trial.
    • Vitamin C also delayed the impact of adverse events and improved quality of life.
  • Per Medscape,
    • “Low-dose aspirin reduced colorectal cancer (CRC) recurrence rates by more than half in patients with tumors harboring mutations in the PI3K signaling pathway, according to findings from the phase 3 ALASCCA trial.
    • “These results stress “the importance of upfront genomic testing” in patients with CRC, said Anna Martling, MD, PhD, from Karolinska Institutet, Stockholm, Sweden, who reported the findings at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2025 in San Francisco.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “A big-business coalition is using hospital, insurer and employer healthcare cost information to help companies negotiate the price of services and coverage for employees.
    • “The Purchaser Business Group on Health will combine healthcare price transparency data and other information from providers and insurers with claims data from five large employers to analyze the cost and quality of care across 10 markets, the group said in a Wednesday news release.
    • “We are developing a new level of transparency and analysis that does not currently exist for the commercial market,” PBGH Chief Operating Officer Won Andersen said in the news release. “The project represents a pivotal step toward enhancing transparency and accountability in healthcare spending and purchasing.”
  • Beckers Payer Issues lets us know,
    • “Express Scripts, The Cigna Group’s pharmaceutical benefit manager, will implement new policies designed to prevent members from paying the full list price for drugs. 
    • “Most Express Scripts patients spend less than $100 out-of-pocket for their prescriptions each year, but some patients in high-deductible plans may pay the full list price for medications, according to a Jan. 29 news release. 
    • “Evernorth, Cigna’s health services arm, which manages Express Scripts, will shift its standard offerings to protect patients from paying the list price for medications. The company will also implement better predictability in drug pricing for patients, especially those in high deductible plans, according to the release.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical continues to build out its health system partnerships to expand its network of primary care clinics.
    • “Montefiore Health System is now partnering with the company to open up access to primary and specialty care in New York’s Westchester County and surrounding areas.
    • “Amazon, which bought primary care company One Medical in a $3.9 billion deal in 2023, will open its first primary care offices in Westchester County in affiliation with Montefiore next year, the companies announced Wednesday.
    • “The primary care office will offer same and next-day appointment availability, on-site lab services and wraparound virtual care support for members, Amazon said.
    • “This new relationship will enable patients to have increased access to seamless coordinated care through Amazon One Medical’s innovative care model and Montefiore’s high-quality network of specialists, hospitals, and facilities.
    • ‘Montefiore and Amazon One Medical will determine where to open new facilities over the next several years, executives said.”
  • The Wall Street Journal observes,
    • If obesity is a chronic disease, like kidney or heart conditions, demand for GLP-1 drugs shouldn’t ebb and flow with the seasons. But the weight-loss market is far from typical.
    • After analyzing data going back to 2016, one analyst thinks he has identified a seasonal pattern in demand for drugs such as Eli Lilly’s LLY Zepbound and Novo Nordisk’s NOVO.B Wegovy: The drugs have stellar growth in initial sign-ups in the first half of the year followed by slower gains in the second half. 
    • This pattern resembles the cyclical nature of gym memberships rather than the steady trajectory of most pharmaceutical markets, and for good reason: At the start of the year, people often make resolutions to lose weight, exercise or start new diets. It stands to reason that some of these resolutions might also lead to increased demand for weight-loss prescriptions such as GLP-1 drugs.
    • If the logic is even half-right, it could help explain Eli Lilly’s back-to-back misses [in the second half of 2024] that have confounded Wall Street.
  • MedTech Dive offers “four robotic surgery trends to watch in 2025. Intuitive Surgical will face competition this year from Medtronic and smaller companies like CMR Surgical and Moon Surgical coming to the U.S. market with robotic surgery systems.”

Tuesday Report

OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • The Washington Post reports,
    • “The White House’s Office of Personnel Management sent an email blast Tuesday to civilian government employees offering them an easy way to quit with pay through Sept. 30, the most sweeping effort yet by the new Trump administration to shrink the ranks of the federal workforce.
    • “The email instructed employees to reply to the message saying they want to resign if they would like to take the offer, which would provide the incentive for workers who accept by Feb. 6, said an Office of Personnel Management spokesperson. Not all employees will be eligible, according to the spokesperson, who said some of the exemptions will be up to agency heads. Additional carveouts exist for immigration officers, some people in national security-focused roles, the Postal Service and the armed forces, the spokesperson said.”
  • Here is a link to OPM’s FAQs on its “Fork in the Road” program.
  • Federal News Network adds,
    • “Federal employees have filed a lawsuit against the Trump administration’s Office of Personnel Management, after the agency created and began testing an email system meant to deliver mass communications directly to federal employees’ inboxes.
    • “The lawsuit from two anonymous federal employees in the executive branch alleges OPM violated the 2002 E-Government Act by not releasing details of how the communication system will manage federal employees’ personal information stored in the system.
    • “Kel McClanahan, executive director of the National Security Counselors law firm, filed the pro bono lawsuit on behalf of the plaintiffs, alleging that the email system poses security risks for federal employees’ personal information.”
  • and
    • “President Donald Trump’s pick to oversee much of the federal government’s real estate portfolio is looking to significantly downsize the amount of office space that agencies occupy.
    • “Michael Peters, commissioner of Public Buildings Service within the General Services Administration, said the agency is looking at cutting up to half its total real estate portfolio over the coming years.
    • “I’m just getting ramped up, but I think our initial review says that number could be up to a 50% reduction on our square footage across the portfolio. We’re not going to do that in six months, but we’re going to try to do this as rapidly as we can,” Peters said Tuesday.
    • “Peters said a “disproportionate amount of that space” would come from the Washington, D.C. metro area — and will include GSA moving out of its own 1800 F Street headquarters.”
  • The President issued an executive order today announcing, “the policy of the United States that it will not fund, sponsor, promote, assist, or support the so-called “transition” of a child [including teenagers under age 19] from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”
    • With respect to the FEHB Program
      • “The Director of the Office of Personnel Management, as appropriate and consistent with applicable law, shall:
        • “(a)  include provisions in the Federal Employee Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs call letter for the 2026 Plan Year specifying that eligible carriers will exclude coverage for pediatric transgender surgeries or hormone treatments; and
        • “(b)  negotiate to obtain appropriate corresponding reductions in FEHB and PSHB p
          premiums.”
  • STAT News informs us,
    • “The Center for Medicare and Medicaid Innovation is continuing plans to implement a pilot project testing new ways for state Medicaid programs to pay for multimillion-dollar cell and gene therapies.
    • “The pilot was started during the Biden administration, following an executive order from former President Biden that directed the center to come up with new ideas to lower drug prices. President Trump rescinded that executive order on Inauguration Day, which initially left the future of the pilot unclear. 
    • “President Trump’s Executive Order never rescinded the work that was underway by the CMS Innovation Center on drug models,” a Department of Health and Human Services spokesperson said in an email to STAT.
    • “The pilot addresses an existential issue for state Medicaid programs: how to pay for cell and gene therapies that are highly effective, but expensive, on fixed budgets. 
    • “Two drug manufacturers that make treatments for sickle cell disease are participating: Bluebird Bio, which makes Lyfgenia, and Vertex Pharmaceuticals, which makes Casgevy. Lyfgenia’s list price is $3.1 million, and Casgevy’s list price is $2.2 million.” 
  • The Wall Street Journal lets us know,
    • Novo Nordisk said the Food and Drug Administration approved the diabetes-drug Ozempic to be used to help kidney-disease patients.
    • “Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type 2 diabetes and chronic kidney disease, the company said Tuesday.
    • “The approval makes Ozempic the most broadly indicated GLP-1 drug on the market, the Bagsvaerd, Denmark, company said. The FDA approved semaglutide for weight loss under the brand name Wegovy in 2021.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Monday expanded use of AstraZeneca and Daiichi Sankyo’s Enhertu, allowing the drug to be given earlier and more broadly in people with an aggressive form of breast cancer.
    • Since 2022, Enhertu has been approved in the U.S. to treat advanced breast tumors expressing “low,” but still detectable, levels of the HER2 protein. With its new decision, the agency widened Enhertu’s availability to include treatment of tumors with “ultralow” HER2 expression. HER2 protein levels must be determined by an FDA-approved test, AstraZeneca and Daiichi said in a statement.”

From the public health and medical research front,

  • The Washington Post reports,
    • “A new strain of avian influenza has been identified for the first time in the United States, raising concerns that the virus is transforming in a way that could eventually cause wider outbreaks among humans.
    • “U.S. officials disclosed the discovery of the virulent H5N9 strain at a California duck farm in a report in recent days to the World Organization for Animal Health, which maintains a database of animal disease threats.
    • “That disclosure comes as the United States confronts a growing outbreak of another bird flu strain, H5N1, that is spreading in poultry farms across the nation and has infected dairy cows for the first time. Human cases have been sporadic and confined mostly to dairy workers exposed to sick animals.
    • “The H5N9 strain itself does not pose a grave threat to humans, officials and experts said.”
  • The American Hospital Association News tells us,
    • “Dementia cases in the U.S. are expected to double by 2060, reaching 1 million new cases per year, according to a study released Jan. 13 by NYU Langone Health. The study found that the risk of developing dementia any time after age 55 is 42%, more than double the risk reported in prior studies. The study authors attributed previous underestimates of dementia risk to unreliable documentation in health records and on death certificates, minimal surveillance of early-stage dementia cases and underreporting of cases by race.” 
  • The New York Times relates,
    • “Rates of sudden unexpected infant death in the United States increased by nearly 12 percent from 2020 to 2022, according to new research published on Monday in the journal JAMA Pediatrics.
    • “Though the study offered some good news — overall infant mortality rates dropped by 24 percent from 1999 to 2022 — it also raised questions about why more babies appear to be dying during sleep, and why rates of sleep-related death remain notably higher among Black, Native American and Pacific Islander babies than among white and Asian infants.
    • “Dr. Elizabeth Wolf, an associate professor of pediatrics with Children’s Hospital of Richmond at Virginia Commonwealth University who was among the new study’s authors, called the findings “pretty alarming.”
    • “The death of an infant from SIDS or SUID is unbelievably horrific,” Dr. Wolf continued, using two acronyms that describe sleep-related deaths among infants. “And we as a public health community need to do everything we can to try and reduce the risk factors as much as possible.”
  • Cardiovascular Business relates,
    • “Cannabis use is on the rise throughout the United States, but it is not as harmless as some people may believe. In fact, according to a new in-depth analysis in Nature Reviews Cardiology, regular cannabis use increases a person’s risk of multiple adverse cardiovascular outcomes, including myocardial infarction, arrhythmias and cardiomyopathy.[1]
    • “The study’s authors, a group of researchers with the Stanford Cardiovascular Institute, explored a wide variety of topics, including ongoing policy trends related to cannabis and the science behind why it appears to make such a significant impact on the cardiovascular system. The group also emphasized that it will be important to learn more about the long-term impact of cannabis use as time goes on. 
    • “Cannabis is emerging as a risk factor for adverse cardiovascular health,” wrote first author Mark Chandy, MD, PhD, who is now an assistant professor at Western University in Ontario, Canada, and colleagues. “With changing public perceptions and an overall decline in tobacco use, cannabis is poised to replace tobacco as a legal drug of choice. Previous restrictions are ending with the widespread decriminalization and legalization of cannabis, boosting use of the drug. A public perception that cannabis is harmless and therapeutically beneficial persists, despite mounting evidence from preclinical and clinical studies showing that cannabis use can harm the cardiovascular system and pose other serious health problems, not unlike tobacco.”
  • Per Beckers Hospital Review,
    • “Cedars-Sinai experts are advocating for patients to have access to GLP-1 medications such as semaglutide as a key component to caring for and preventing cardiovascular disease. 
    • “Physicians are now able to improve multiple “downstream” conditions, such as heart disease, by prescribing one medication “upstream,” according to a Jan. 10 news release from Los Angeles-based Cedars Sinai. 
    • “Amanda Velazquez, MD, director of obesity medicine at the health system, said in the release that semaglutide has enabled patients with high blood pressure to reduce their antihypertensive medications.
    • “Martha Gulati, MD, director of preventive cardiology and the Anita Dann Friedman Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai, said although semaglutide has been associated with blood pressure and cholesterol level improvements, it does not replace statins. 
    • ‘Dr. Gulati also said the effectiveness of the drug class raises the important question: “Do we want patients to get CVD and only then treat them? Or should we treat them earlier so we can prevent CVD events?”
  • The Wall Street Journal discusses “The Scientific Fight Over Whether Aging Is a Disease.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers raised the list prices of more than 800 prescription drugs for blood pressure, cancer and other conditions by a median 4% at the start of this year.
    • “The modest size of the annual increases could help companies avoid criticism of gouging from President Trump while seeking his administration’s support for such priorities as taking aim at the rebates given to middlemen and altering a federal program providing discounts to certain hospitals. Last year’s median price increase was 4.5%.”
  • Fierce Healthcare points out,
    • “The National Community Pharmacists Association (NPCA) is warning the feds that independent pharmacists are likely to face significant financial hardship due to Medicare drug price negotiations.
    • “In comments submitted on the latest Medicare advance notice, the organization says it conducted a survey of 8,000 pharmacy owners and managers about the drug price negotiation program and found that 93.2% have either decided not to stock drugs under negotiation or are considering not stocking these products.
    • “The survey found that 32.8% of independent pharmacists have already made the decision to not stock one or more of the 10 drugs in the first round of negotiations. In addition, 60.4% of those surveyed said they are considering similar steps.
    • “The NCPA said this is because they’re concerned about “financial losses” through the program.
    • “That will be devastating to the program,” said NCPA CEO B. Douglas Hoey in a press release. “Patients who need these prescriptions will be unable to get them, because their pharmacies cannot participate in the program.'”
  • Per Beckers Hospital Review,
    • “In less than a year, Mark Cuban’s Cost Plus Marketplace has expanded its portfolio to more than 6,000 medicines. 
    • ‘Mark Cuban Cost Plus Drug Co. launched the Marketplace in February 2024, which at the time had more than 4,000 medicines in short supply to directly sell to healthcare facilities. 
    • ‘Since then, customers have realized savings between 40% and 60% compared to traditional wholesalers, according to Chief Commercial Officer Alan Bowe. 
    • “The Marketplace now sells to thousands of hospitals, clinics, ambulatory surgery centers, long-term care sites, dialysis centers and retail pharmacies in all 50 states, Mr. Bowe told Becker’s Jan. 23.”
  • Beckers also brings us up to date on current drug shortages.
  • Fierce Healthcare lets us know,
    • CVS Health is rolling out a new customer app that aims to make it simpler and more convenient for users to manage health benefits, pharmacy benefits and prescriptions.
    • Within the application, users can monitor prescriptions for themselves as well as family members across CVS’ pharmacies, Caremark mail orders and CVS Specialty. This includes “full transparency” into the status of a prescription order and the cost, CVS said.
    • In addition, users can schedule key immunizations for their entire family, and access spending and benefits details from both Aetna and Caremark through the app.
  • Beckers explains the new normal in hospital capacity and announces
    • “UNC Health and Duke University Health System, based in Chapel Hill, N.C., and Durham, N.C., respectively, are uniting to build a comprehensive healthcare campus, featuring the state’s first freestanding children’s hospital.
    • “The two institutions filed legal documents Jan. 28 with the state to establish a nonprofit entity, North Carolina Children’s, according to a joint news release. 
    • NC Children’s will feature a 500-bed children’s hospital on a 100-plus-acre campus at a yet-to-be-identified site in the Research Triangle region.
    • “The new campus will also include a children’s behavioral health center, outpatient clinics, research and teaching facilities, hospitality houses (e.g., Ronald McDonald House) and mixed-use infrastructure to accommodate hotels, restaurants and retail stores, according to the release.”

Monday Report

Photo by Sven Read on Unsplash

From Washington, DC,

  • Nextgov/FCW reports,
    • “Billionaire Elon Musk paid a visit to the Office of Personnel Management’s building on Friday, people familiar have confirmed to Nextgov/FCW.” * * *
    • “Amanda Scales, a former employee of Musk’s artificial intelligence company xAI, is OPM’s new chief of staff.” 
  • Fedscoop informs us,
    • “The Trump administration is giving agency leaders two weeks to submit plans for how they intend to comply with the presidential directive to return all eligible employees to full-time, in-person work, the latest salvo in the restructuring of the federal workforce.  
    • “In a memo sent to agency heads Monday, the acting directors of the Office of Personnel Management and the Office of Management and Budget set a Feb. 7 deadline for return-to-work implementation plans, which will be reviewed and approved by OPM and OMB.”
  • The Senate confirmed Scott Bessent to be Secretary of the Treasury today by a 68-29 vote. The Secretary of the Treasury along with the Secretary of Health and Human Services and the Secretary of Labor, are Affordable Care Act regulators.
  • Roll Call adds,
    • “Bessent, 62, will become the nation’s first openly gay Treasury secretary and the highest-ranking LGBTQ government official in the country’s history.” * * *
    • “He brings a wealth of private-sector experience in the economy and markets to his new role, as well as a concern for the needs of working Americans,” Senate Majority Leader John Thune, R-S.D., said on the floor Monday before the vote.
    • “Senate Finance Chairman Michael D. Crapo, R-Idaho, during the confirmation process similarly praised Bessent’s character, demeanor and experience, while defending him from Democratic attacks about the nominee’s handling of his taxes.”
  • Roll Call also tells us,
    • “The Senate keeps processing President Donald Trump’s nominees this week, but much of the congressional attention will be on South Florida, where House Republicans are gathering for their annual issues and strategy conference.
    • “The conference is taking place at Trump National Doral in Miami, the president’s own private golf club, and Trump is expected to address the assembled lawmakers Monday evening.
    • “Punchbowl News reported over the weekend that Vice President JD Vance is expected to join the retreat as a headliner on Tuesday.
    • “Much of the discussion will focus on trying to plot the way forward for a filibuster-proof budget reconciliation package — especially to try to implement Trump’s immigration and tax policy agenda.”
  • The acting HHS Secretary Dorothy Fink announced,
    • “For nearly 50 years, the Hyde Amendment has protected taxpayer funds administered by the Department from paying for elective abortion. Pursuant to the President’s Executive Order of Jan. 24 (Enforcing the Hyde Amendment) and guidance from Office of Management and Budget, the Department will reevaluate all programs, regulations, and guidance to ensure Federal taxpayer dollars are not being used to pay for or promote elective abortion, consistent with the Hyde Amendment. This review will be conducted consistent with guidance issued by the Office of Management and Budget.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved monthly maintenance dosing of Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
    • “After taking Leqembi every two weeks for 18 months, patients can now transition to a monthly dose that the companies say is supported by modeling of data from Phase 2 and Phase 3 testing. Leqembi works by removing toxic aggregates of a protein from the brain.”

From the public health and medical research front,

  • STAT News reports
    • “In 2022, about 40% of deaths in the U.S. were caused by cardiovascular heart disease, including heart disease and stroke, which kill more people in the U.S. than the next two biggest killers — all forms of cancer and accidental deaths — combined. That’s according to an annual update from the American Heart Association on heart disease and stroke statistics, published today in Circulation
    • “Cardiovascular disease is “common, catastrophic, and costly,” an accompanying editorial notes. Despite its dominance, the overall number of deaths is leveling out after the pandemic shot numbers upwards. Yet contributing risk factors like high blood pressure and obesity continue to rise. 
    • Here are some more interesting findings:
      • The percentage of high schoolers who are physically active for over an hour every day decreased from almost 29% to just under 24% between 2011 to 2021.
      • Nearly 47% of all Americans have high blood pressure. In 2022, the prevalence was worst in Mississippi at about 40% and best in Colorado, at just under 25%. 
      • The rate of gestational diabetes in the U.S. increased 38% from 2016 to 2021, to 8.3% of pregnancies.
  • and
    • “Almost a century after people living in certain neighborhoods around Seattle and Tacoma, Washington were systemically denied financial services — a discriminatory, racist practice known as redlining — young cancer patients in those areas are dying at higher rates than those who live in unaffected areas. 
    • “An association between historic redlining and survival of adult-onset cancers has already been shown, but the data on adolescent and young-adult cancers come from a study published today in CANCER. Researchers analyzed data from 2000 to 2019 in those Washington cities on more than 4,300 patients aged 40 or younger, along with homeowners’ loan data and recent census tracts. They found that five years and 10 years after diagnosis, fewer people in previously redlined neighborhoods were still alive than those unaffected. (That’s about 85% vs. 90% five years out and 81% vs. 88% after ten years.)
    • “The disparity in deaths remained even after adjusting for factors like poverty. It emphasizes the importance of contextualizing today’s health disparities, the authors write, as well as the impact discrimination can have generations down the line.”
  • The New York Times suggests “‘A Dangerous Virus’: Bird Flu Enters a New Phase. A pandemic is not inevitable, scientists say. But the outbreak has passed worrisome milestones in recent weeks, including cattle that may have been reinfected.”
  • KAKE News from Wichita, Kansas, reports,
    • “State public health officials are calling an ongoing tuberculosis outbreak in northeast Kansas “unprecedented.” 
    • “The Kansas Department of Health and Environment [KDHE] reports 66 active cases of tuberculosis and 79 infections in the Kansas City Metro area in 2024. As of this month, the number of active cases rose to 67.
    • “In a Senate Committee on Public Health and Welfare meeting on Tuesday, Deputy Secretary of KDHE Ashley Goss said the department is working collaboratively with the Centers for Disease Control and Prevention.
    • “Some of you are aware we have mobilized staff and resources addressing an unprecedented tuberculosis outbreak in one of our counties,” Goss said. “We are working collaboratively with the CDC on that. The CDC remains on the ground with us to support.” * * *
    • “According to the KDHE website, there are currently 60 active cases of TB in Wyandotte County and seven in Johnson County. 
    • “Despite this, the KDHE says the cases are “very low risk” to the general public, including surrounding counties. 
    • “We are trending in the right direction right now, more to come on that,” Goss said in the meeting. “Hopefully we can get it wound down quickly.” 
  • The American Medical Association lets us know what doctors wish their patients knew about contagious norovirus.
  • Per Healio
    • “The vast majority of people in a study with long COVID had experienced multiple SARS-CoV-2 infections over the course of a 4-year period, researchers reported.
    • “While it is possible that the causes of long COVID could be many and variable depending on the patient population studied, with this cohort the evidence is clear that by having COVID numerous times, patients became more at-risk for developing long COVID,” Sean Clouston, PhD, professor in Stony Brook University’s Renaissance School of Medicine, said in a press release.”
  • and
    • “An investigational blood-based test identified nearly 80% of individuals who had colorectal cancer, according to results of a large prospective trial presented at ASCO Gastrointestinal Cancers Symposium. 
    • “The test also had a specificity greater than 90% for advanced colorectal neoplasia (ACN) and negative-predictive value for ACN.
    • “This new blood test may provide a convenient, effective option for colorectal cancer screening in the intended-use population, and perhaps help us boost adherence to screening,” Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman professor of medicine at NYU Grossman School of Medicine, said during a press briefing.
  • Per BioPharma Dive,
    • “Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people with cirrhosis due to metabolic dysfunction-associated steatohepatitis, a common disease that was formerly known as NASH.
    • Announced Monday by Akero, the study results exceeded investor expectations, more than doubling the value of shares in the biotechnology company. They also helped to push up the stock of 89bio, a competitor developing a similar type of drug to Akero’s.
    • “While the Food and Drug Administration last year approved the first treatment for MASH, its use is limited to people whose livers aren’t yet cirrhotic. According to Akero, its drug is the first compound to show a significant reversal of cirrhosis due to MASH in clinical testing.”
  • The Wall Street Journal reports,
    • “Late-stage trial data for Roche’s drug against muscle-wasting Elevidys showed positive results after two years of treatment for male patients aged 4 or older with Duchenne muscular dystrophy.
    • “The data read-out reduced difficulties in standing, walking and running that were statistically significant, which increased between one year and two years after treatment, the company said. The safety profile was in line with the drug’s profile and no new safety signals were identified, it said.
    • “The treatment is on market for people living with Duchenne aged four years old and over regardless of their ambulatory status in the U.S., United Arab Emirates, Qatar, Kuwait, Bahrain and Oman. It is approved for the treatment of ambulatory individuals aged four through seven years in Brazil and Israel.
    • “Duchenne muscular dystrophy is a genetic disorder characterized by the progressive loss of muscle.”
  • STAT News relates,
    • “Right now, patients with obesity and cirrhosis have few treatments for their progressive liver disease, but a new study offers one available option: bariatric surgery. Weight loss operations significantly cut the long-term risk of developing serious liver complications when compared to standard nonsurgical therapy.
    • “The 62 patients with obesity and cirrhosis in the clinical trial who underwent bariatric surgery — either gastric bypass or gastric sleeve procedures — later had a 72% lower risk of developing more serious liver disease compared to the 106 patients who didn’t have surgery. After 15 years, 20.9% in the surgical group but 46.4% in the nonsurgical group developed one of the major complications of liver disease, including liver cancer and death. 
    • “We showed, regardless of the stage of disease, if we help people to lose weight, we can improve their outcomes. That can provide hope for patients and medical providers,” said Ali Aminian, director of the Bariatric and Metabolic Institute at the Cleveland Clinic and co-author of the study published Monday in Nature Medicine.  “We can change the trajectory of the disease.”
  • Per Beckers Hospital Review,
    • “An Alabama woman who received a gene-edited pig kidney transplant at NYU Langone in November is recovering well more than 60 days after the procedure. 
    • “On Nov. 25, a team of clinicians at the New York City-based health system successfully transplanted UKidney, a 10-gene-edited pig kidney into Towana Looney, 53. Ms. Looney was on a transplant waiting list for nearly eight years before physicians determined the probability of a safe human transplant was slim. 
    • “Now, Ms. Looney is the longest-living recipient of the four Americans who have received a gene-edited pig organ, having surpassed the two-month mark. 
    • “If you saw her on the street, you would have no idea that she’s the only person in the world walking around with a pig organ inside them that’s functioning,” Robert Montgomery, MD, PhD, director of NYU Langone’s Transplant Institute, told the Associated Press in a Jan. 25 report at NBC News. 
    • “Unlike previous xenotransplant patients, Ms. Looney was in better overall health at the time of her transplant, leaving experts optimistic about the potential for broader success in the emerging field of xenotransplantation. Earlier cases involved individuals who were critically ill when they underwent the experimental procedures.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Cleveland Clinic served the largest number of patients in its history in 2024 with more than 15 million patient encounters worldwide, generating nearly $16 billion in revenue and ending the year with a 1.7% operating margin.  
    • “The year-end findings come from the annual State of the Clinic address made by CEO and President Tom Mihaljevic, M.D., on Jan. 27. 
    • “Years have passed since the COVID-19 pandemic and healthcare has not recovered. Today, about 40% of U.S. hospitals continue to lose money,” Dr. Mihaljevic said. “In the past, we could predict Cleveland Clinic’s financial health based on our productivity and expense management, but even that has changed.”
    • ‘Dr. Mihaljevic noted that despite the handling of more than 15 million patient encounters, the health system’s 1.7% operating margin fell short of its anticipated 2.7%. He attributed this shortfall to new financial pressures, including unexpected increase in charity care totaling $370 million, surging cost of malpractice insurance and rising costs of drugs due to smaller discounts on medications.”
  • Per Healthcare Dive,
    • “HCA Healthcare reported fourth quarter earnings on Friday that narrowly beat analysts’ expectations following back-to-back hurricanes this fall.
    • “The Nashville-based provider posted $18.3 billion in revenue for quarter, up 6% year over year. However, profit dipped compared to the same period last year, falling from $1.6 billion to $1.4 billion.
    • “Still, several analysts noted HCA’s financial guidance for 2025 is slightly more conservative than expected, raising concerns that Trump administration funding cuts to Medicaid and the Affordable Care Act could impact hospitals’ bottom lines.”
  • Modern Healthcare reports,
    • “Shares of Walgreens Boots Alliance tumbled today following a CNBC report that the Deerfield-based pharmacy chain was unlikely to sell itself to a private-equity firm.
    • “CNBC’s David Faber said on air this morning that sources say the possible deal in which Walgreens would sell itself to New York-based Sycamore Partners is “mostly dead.”
  • Fierce Pharma identifies the ten most anticipated drug launches of 2025.
  • McKinsey & Co. point out “Most top pharma companies derive more than 60 percent of their revenue from therapies for diseases that affect women uniquely, differently, or disproportionately, putting them in a prime position to close the sex- and gender-based health gap.”

Weekend Update

From Washington, DC

  • The President’s nominee for Secretary of Health and Human Services, Robert F. Kennedy, Jr., will attend a Senate Finance Committee confirmation hearing on Wednesday and Senate Health, Education, Labor and Pensions Committee confirmation hearing on Thursday.
  • The Wall Street Journal reports,
    • “The Central Intelligence Agency has now concluded that the deadly Covid-19 pandemic most likely arose from a laboratory leak, lending credibility to a view that has been the focus of sharp debate among scientists and politicians for years.
    • “In doing so, the CIA has now joined the Federal Bureau of Investigation and the Energy Department in identifying a laboratory mishap in Wuhan, China, as the probable source of the Covid virus. It has killed more than 1.2 million Americans and over seven million people worldwide. 
    • CIA assesses with low confidence that a research-related origin of the COVID-19 pandemic is more likely than a natural origin based on the available body of reporting,” an agency spokesman said in a statement released Saturday. 
    • “The spokesman added that the judgment was “low confidence” and that the CIA would continue to evaluate “any available credible new intelligence reporting or open-source information that could change CIA’s assessment.” 
    • “The agency had previously taken the stance that it didn’t have enough information to assess whether the virus had leapt from an animal to a human or arose from a laboratory mishap. 

From the public health and medical research front,

  • The Washington Post notes
    • “Ever since the novel coronavirus reached the United States five years ago, it has unleashed punishing winter waves of illness.
    • “But the usual covid uptick is much more muted this winter and appears to have peaked. The virus is less rampant in wastewater compared with winters past. Hospitalization rates have gone down.
    • “Instead, an unusual medley of ailments emerged this season — walking pneumonia, RSV, norovirus and bird flu — along with the more familiar foe: influenza, which is garnering more attention than covid this time around because the hospitalization rate is three times as high.”
  • The University of Minnesota’s CIDRAP points out,
    • “The estimated effectiveness of the respiratory syncytial virus (RSV) among older US veterans in the 2023-2024 respiratory virus season against infection, emergency department/urgent care (ED/UC) visits, and hospitalization was 78%, 79%, and 80%, respectively.
    • “The findings, published this week in The Lancet Infectious Diseases, come from a target trial emulation study led by researchers at the Veterans Affairs Portland Health Care System in Oregon. The observational study was designed to fill in knowledge gaps remaining after clinical trials (e.g., vaccine effectiveness (VE) in people with weakened immune systems, effects on healthcare use for infection).”
  • and
    • “In the largest trial of its kind, patients receiving oral versus intravenous (IV) antibiotics for fracture-related infections (FRIs) had similar reoperation and reinfection rates, US researchers reported this week in JAMA Surgery. 
    • “But the primary and secondary analyses of trial results came to different conclusions regarding noninferiority, leaving some uncertainty about the findings.”
  • Per Fierce Pharma,
    • “Old drugs from Bristol Myers Squibb and Pfizer have delivered what the companies and researchers believe could establish them as new standard treatments for certain colorectal cancer patients.
    • “In Bristol Myers’ case, the company’s dual immunotherapy of Opdivo and Yervoy showed it could work better than Opdivo alone in patients with certain metastatic colorectal cancer. The combo lowered the risk of disease progression or death by 38% in patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, according to data from the phase 3 CheckMate-8HW trial to be presented at the ASCO Gastrointestinal Cancers Symposium.
    • “The study randomized 707 patients across various lines of treatment, with 55% of participants in the Opdivo-Yervoy arm and 52% of the Opdivo monotherapy arm entering in the first-line setting.”
  • The Wall Street Journal discusses new approaches to treating minor injuries like sprains. “Updated methods for treating sprains, strains and bruises now focus on boosting your body’s natural healing process.”

From the U.S. healthcare business front,

  • Beckers Hospital Review shares 109 statistics on hospital margins, revenues, which are bumpy by region.”
  • Kauffman Hall offers an infographic on hospital and health system M&A trends in 2024.
  • Per HR Dive,
    • CFOs expect their companies to see a 7.3% rise in salaries and wages paid in the next 12 months, according to a Q4 Deloitte survey, which polled 200 finance chiefs at companies with a minimum of $1 billion in revenue shortly after the U.S. election in November. The pay projection was nearly double the 3.65% rise anticipated in Q3, according to the findings of the Big Four firm’s previous quarter’s report. 

Cybersecurity Saturday

From the cybersecurity personnel front

  • Saturday morning, two term South Dakota Governor Kristi Noem received Senate confirmation of the President’s nomination of her to be Secretary of Homeland Security, which is the home of the Cybersecurity and Infrastructure Security Administration (CISA). The Senate vote was 59-34 in her favor.
  • Federal News Network reports in a January 24, article,
    • Greg Barbaccia seems to be the new federal chief information officer. Barbaccia updated his LinkedIn page just recently.
    • He replaces Clare Martorana, who was the federal CIO for the last three-plus years.
    • Emails to OMB and the White House seeking confirmation and comment was not immediately returned.
    • Barbaccia is a former Army intelligence sergeant and intelligence community analyst from 2003 to 2009. Since then, he’s worked in the private sector.
  • FedScoop lets us know in a January 22, 2025, article,
    • The Office of Personnel Management again has a new chief information officer. 
    • Greg Hogan will serve as CIO, an agency spokesperson confirmed to FedScoop on Wednesday [January 22]. His appointment comes roughly a week after Melvin Brown II took over that role following former CIO Guy Cavallo’s retirement from federal service. 

From the cybersecurity vulnerabilities and breaches front,

  • On January 16, 2025, HHS’s Health Sector Cybersecurity Coordination Center issued its report on December 2024 vulnerabilities of concern to the health sector.
  • MedCity News points out that “Cybersecurity Threats Continue to Rise for Healthcare Organizations, Research Shows. The vast majority of healthcare organizations have spotted a cyberattack and suffered financial consequences as a result in the past 12 months, according to new research. A separate report also found that overall cyberattacks on healthcare organizations have risen by 32% year-over-year.”
  • Cybersecurity Dive tells us,
    • “Conduent, a New Jersey-based government contractor that provides technology platforms to multiple social service agencies and transit systems across the U.S., confirmed Wednesday it was impacted by a cyberattack.
    • “The incident first became public after Wisconsin officials reported delays in child support payments. Wisconsin was one of four states impacted by the outage.
    • “A spokesperson for Conduent confirmed the disruption was due to a cyber incident, but did not elaborate on the details. Conduent did not provide any details about how the incident was initially discovered or a specific timeline about the response.”
  • and
    • “BeyondTrust determined 17 customers were impacted in a December attack spree related to the compromise of a Remote Support SaaS API key. 
    • “The attack, attributed to a state-linked threat actor, included the compromise of several offices of the U.S. Treasury Department, where hackers gained access to unclassified data. 
    • “BeyondTrust said it worked with its affected customers to support their respective investigations by providing them with artifacts, logs, indicators of compromise and other information.
  • and
    • “Hewlett Packard Enterprise said it is investigating claims a threat group gained access to a trove of sensitive company data. 
    • “The threat group, IntelBroker, posted a claim on BreachForums that it had access to a large trove of HPE data, according to researchers from Arctic Wolf. 
    • “The allegedly stolen data includes private GitHub repositories, Docker builds, source code and other information, according to the posting. 
    • “Upon learning of the claim Thursday [January 23], the company immediately activated cyber response protocols, disabled related credentials and launched an investigation to determine whether the claims were valid, a spokesperson said Tuesday via email. 
    • “There is no operational impact to our business at this time, nor evidence that customer information is involved,” the spokesperson said.”
  • The American Hospital Association informs us
    • “The Cybersecurity and Infrastructure Security Agency and FBI Jan. 22 released an advisory explaining how cyberthreat actors “chained” vulnerabilities — deploying multiple vulnerabilities in rapid succession — during attacks on certain versions of Ivanti Cloud Service Appliances in September. Threat actors used an administrative bypass, structured query language and remote code execution vulnerabilities during the attack. The agencies said the actors gained initial access, obtained credentials and implanted webshells on victim networks.
    • “These attacks serve as another reminder of the importance of patch management in defending networks,” said Scott Gee, AHA deputy national advisor of cybersecurity and risk. “Think of this as a thief using bolt cutters to get through a perimeter fence, using a pry bar to force the door to the building open, and then using a hammer to break the glass protecting the jewels they came to steal. The good news for network defenders in this instance regarding Ivanti is that each of these tools can be detected.”
    • “CISA and the FBI strongly encouraged network administrators to upgrade to the latest supported version of Ivanti CSA.
    • “Any hospitals still using outdated versions of Ivanti CSA should update their systems immediately,” Gee said. “If unable to remove the outdated version, network security teams should implement detections based on the indicators of compromise in the advisory and understand the risk posed by this vulnerable technology.”
  • Cyberscoop notes,
    • “Researchers at Black Lotus Labs have uncovered an operation where a back door is dropped onto enterprise-grade Juniper Networks routers and listens for specific network signals, known as “magic packets,” to execute malicious commands. 
    • “The campaign, which researchers at the cybersecurity wing of Lumen Technologies refer to as “J-Magic,” was active between mid-2023 and mid-2024. The malware uses a custom variant of the open-source backdoor ‘cd00r,’ which operates invisibly to lay the groundwork for a reverse shell attack. The malware scans for five different predefined parameters before activating. If any of these parameters or “magic packets” are received, the malware sends a confirmation request. Once confirmed, J-Magic establishes a reverse shell on the local file system, allowing operators to control the device, steal data, or deploy further malware.
    • “Although the specific method of transmission into these routers remains unclear, many targeted devices are configured as virtual private network (VPN) gateways. Lumen’s analysis found that approximately half of the routers affected during the campaign functioned as VPN gateways.  
    • “The strategic focus of J-Magic on routers underscores a level of stealth, given that routers are rarely monitored with security software. The malware specifically targets JunoOS, Juniper’s FreeBSD-based operating system.” 
  • Per Dark Reading,
    • Cisco has released a patch for a critical vulnerability found in its Cisco Meeting Management feature that could allow a remote, authenticated attacker to elevate themselves to administrator privileges on an affected device.
    • “Cisco Meeting Management is a management tool for Cisco’s on-premises meeting platform, Cisco Meeting Server. The management system allows users to monitor and manage meetings that are running on the platform through two user roles: the first is for administrators with full rein over the platform; and the second is for “video operators,” who only have access to the meetings and overview pages.
    • “The vulnerability, tracked as CVE-2025-20156 (CVSS score of 9.9), is located in the REST API and exists because “proper authorization” is not enforced on REST API users. Should an attacker send specially crafted API requests to a specific endpoint, they could exploit the vulnerability and allow an attacker to gain administrator-level control over edge nodes managed by Cisco Meeting Management.
    • “This poses a risk to businesses, as a threat actor with video operator access on the platform could exploit this vulnerability to give themselves administrator privileges, allowing them the ability to change configurations, add users, and more, according to the advisory.”
  • Per Bleeping Computer,
    • “SonicWall is warning about a pre-authentication deserialization vulnerability in SonicWall SMA1000 Appliance Management Console (AMC) and Central Management Console (CMC), with reports that it has been exploited as a zero-day in attacks.
    • “The flaw, tracked as CVE-2025-23006 and rated critical (CVSS v3 score: 9.8), could allow remote unauthenticated attackers to execute arbitrary OS commands under specific conditions.
    • “The vulnerability affects all firmware versions of the SMA100 appliance up to 12.4.3-02804 (platform-hotfix). * * *
    • “We strongly advise users of the SMA1000 product to upgrade to the hotfix release version to address the vulnerability.”
    • “Microsoft’s Threat Intelligence Center discovered the flaw, so more details about the exploitation activity and when it started might be shared by Microsoft at a later date.”
  • The Hacker News adds,
    • “The U.S. Cybersecurity and Infrastructure Security Agency (CISA) on Thursday placed a now-patched security flaw impacting the popular jQuery JavaScript library to its Known Exploited Vulnerabilities (KEV) catalog, based on evidence of active exploitation.
    • “The medium-severity vulnerability is CVE-2020-11023 (CVSS score: 6.1/6.9), a nearly five-year-old cross-site scripting (XSS) bug that could be exploited to achieve arbitrary code execution.
    • “Passing HTML containing <option> elements from untrusted sources – even after sanitizing them – to one of jQuery’s DOM manipulation methods (i.e. .html(), .append(), and others) may execute untrusted code,” according to a GitHub advisory released for the flaw.
  • Plus we learn friom Cyberscoop,
    • A critical security flaw has been identified and potentially exploited in SonicWall’s Secure Mobile Access (SMA) 1000 series appliances, sparking significant concern among cybersecurity experts and users worldwide. 
    • The vulnerability, registered as CVE-2025-23006, allows remote, unauthenticated attackers to execute arbitrary operating system commands under certain conditions. The issue specifically impacts the Appliance Management Console (AMC) and Central Management Console (CMC) used widely in enterprise and government networks for administrative functions.
    • SonicWall issued a warning Wednesday [January 22, 2025] saying the flaw has a severity rating of 9.8 out of 10 by the Common Vulnerability Scoring System (CVSS) and may have been exploited by malicious actors. Microsoft’s Threat Intelligence Center is credited with uncovering the flaw, although it remains unclear when the exploitation might have commenced. Despite this, SonicWall’s advisory urges all SMA1000 users to upgrade immediately to the patched software version to prevent potential security breaches.
    • SonicWall’s products provide secure remote access for a wide swath of organizations, often serving managed security service providers (MSSPs), enterprises, and government agencies.
  • Bleeping Computer relates,
    • “The FBI warned today [January 23] that North Korean IT workers are abusing their access to steal source code and extort U.S. companies that have been tricked into hiring them.
    • “The security service alerted public and private sector organizations in the United States and worldwide that North Korea’s IT army will facilitate cyber-criminal activities and demand ransoms not to leak online exfiltrated sensitive data stolen from their employers’ networks.
    • “North Korean IT workers have copied company code repositories, such as GitHub, to their own user profiles and personal cloud accounts. While not uncommon among software developers, this activity represents a large-scale risk of theft of company code,” the FBI said.

From the ransomware front,

  • Cyberscoop reports,
    • “Researchers at cybersecurity firm Sophos are tracking multiple clusters of hacking activity leveraging Microsoft 365 instances, Microsoft Teams and email bombing tactics to deliver ransomware.
    • “In new research released Tuesday [January 21], the company said it had identified at least two distinct clusters of hacking activity using the tactics to infect targets between November and December 2024.
    • “First, several individuals at an organization are inundated with emails — up to 3,000 in 45 minutes in some cases. The sheer volume of spam is designed to overwhelm the target’s inbox and “create a sense of urgency” that may push them to reach out to IT for assistance, the researchers said.
    • “Then, using an external account, the hackers will message one of the targets over Microsoft Teams, posing as the organization’s IT support or a “Help Desk Manager.” Under the guise of assistance, the actors push the victim to permit a remote screen control session through Teams or Microsoft Quick Assist, which is then used to create command shells, access an external Sharepoint file and deploy malware on the victim’s device.
    • “With a command-and-control channel established, the attackers then use the target’s credentials to disable multifactor authentication and antivirus protections, connect to other hosts on the network and move laterally to compromise other systems.”
  • Cybersecurity News lets us know,
    • “New ransomware strains are quietly infiltrating VMware ESXi hosts by setting up SSH tunnels and concealing malicious traffic within legitimate activity.
    • “This stealth tactic allows attackers to access critical virtual machine environments without triggering many of the standard alarms or detection systems that monitor more conventional network paths.
    • “Because ESXi appliances often remain unmonitored, cybercriminals have seized the opportunity to hide in plain sight, exfiltrate data, and lock down virtual machines with minimal interference.
    • “Virtualized infrastructures are attractive targets for ransomware actors due to the high value of virtual machines and the rapid damage attackers can inflict if they seize control.
    • “Instead of compromising each guest system individually, criminals can focus on the ESXi host itself, enabling them to encrypt all virtual disks in one coordinated attack.”
  • Per the SentinelOne blog,
    • “The previous six months have seen heightened activity around new and emerging ransomware operations. Across the tail-end of 2024 and into 2025, we have seen the rise of groups such as FunkSec, Nitrogen and Termite. In addition, we have seen the return of Cl0p and a new version of LockBit (aka LockBit 4.0).
    • “Within this period of accelerated activity, the Ransomware-as-a-Service offerings HellCat and Morpheus have gained additional momentum and notoriety. Operators behind HellCat, in particular, have been vocal in their efforts to establish the RaaS as a ‘reputable’ brand and service within the crimeware economy.
    • “As a result of this recent activity, we analyzed payloads from both HellCat and Morpheus ransomware operations. In this post, we discuss how affiliates across both operations are compiling payloads that contain almost identical code. We take a high-level look at two samples in particular and examine their characteristics and behavior.” Check it out.

From the cybersecurity defenses front,

  • CISA advises,
    • “If you’re an IT defender or a vulnerability management pro, CISA’s Vulnrichment project can make your life easier. It enriches basic CVE data with actionable insights like Stakeholder-Specific Vulnerability Categorization (SSVC) decision points, Common Weakness Enumeration (CWE) IDs, and Common Vulnerability Scoring System (CVSS), all bundled into the CVE records you’re already pulling. Think of it as a turbocharged upgrade to the CVE data you’re already consuming. Best part? You don’t need to set up anything new—this enriched data is automatically baked into the CVE feeds you’re already using.
    • You’re soaking in it! Today, all Vulnrichment data ends up in the Authorized Data Publisher (ADP) container for individual CVEs, so if you’re pulling CVE data from https://cve.org via the API, or from GitHub at https://github.com/CVEProject/cvelistV5 ,  you’re already collecting Vulnrichment data. It’s just a matter of parsing it out.”
  • Check out Dark Reading for an article about MITRE’s Latest ATT&CK Simulations Tackle Cloud Defenses. The MITRE framework’s applied exercise provides defenders with critical feedback about how to detect and defend against common, but sophisticated, attacks.”
  • Security Week discusses attack surface management.
    • “The attack surface of an organization represents all of the assets (physical, virtual or human) that a malicious actor can potentially use to breach an organization,” says Alex Hoff, co-founder and chief strategy officer at Auvik Networks.
    • “Traditionally,” continues Raj Samani, SVP and chief scientist at Rapid7, “the focus of attack surface management has been on securing the broader attack surface – but the emphasis is now on preventing the exploitation of assets within increasingly complex environments.”
    • “While we have traditionally considered the Attack Surface to be a part of the overall IT infrastructure that can be treated and managed discretely, our view now is that the AS includes anything and everything a threat actor can target for exploitation.” 
  • Per Beckers Health IT,
    • “Global IT spending is expected to grow 9.8% in 2025, to $5.6 trillion, with much of that increase going to price hikes, according to Gartner.
    • “And while CIOs’ expectations for generative AI are on the wane — what the IT consultant called a “trough of disillusionment” — their spending on the technology will continue to rise, Gartner predicted. Those hardware upgrades will drive double-digit growth in data center systems, devices and software this year.”
  • Here is a link to Dark Reading’s CISO Corner.