Friday Report

OPM

Friday Report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Cybersecurity Saturday

David Ermer–Cybersecurity, OPM–

From the cybersecurity policy and law enforcement front,

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

From the cybersecurity vulnerabilities and breaches front,

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

From the ransomware front,

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

From the cybersecurity defenses front,

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

Tuesday Report

David Ermer–Congress, COVID-19 testing, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC

Capitol Hill News

  • The Wall Street Journal reports,
    • The House [of Representatives] narrowly approved a Republican proposal to fund the government into the fall, as GOP lawmakers remained largely united following a last-minute push from the White House, overcoming Democratic opposition and setting up a fight in the Senate. 
    • Funding for the federal government expires this weekend. The GOP proposal would extend funding through Sept. 30 at fiscal 2024 spending levels, but it includes $13 billion in cuts in nondefense spending and $6 billion in increased military spending. It allocates additional money for border enforcement and forces Washington, D.C., to cut $1 billion from its budget. 
    • The measure passed 217-213, with Rep. Thomas Massie of Kentucky being the only Republican to vote against it. Democrats were largely united in opposition, with one Democrat, Rep. Jared Golden of Maine, voting yes. * * *
    • “The matter now heads to the Senate, where Republicans will need Democratic support to advance the bill. Senate Democrats were wrestling over the matter Tuesday. Some saw the funding deadline as their only leverage to push back against GOP efforts to dismantle federal programs, while others were wary of playing hardball and triggering a government shutdown. 
    • The House left town after Tuesday’s vote, effectively giving the Senate the option of approving or blocking the House measure—but not revising it.” 
  • Fierce Healthcare adds,
    • “Rep. Greg Murphy, M.D., R-N.C., posted on X Monday night that Johnson and Senate Majority Leader John Thune have agreed to include a doc pay fix in Congress’ budget reconciliation, which is expected to be finished in May to align with President Donald Trump’s first 100 days.
    • “A doc pay fix, which would counteract a 2.83% cut to Medicare physicians’ payment rates that went into effect Jan. 1, has been a central focus for provider lobbying groups as well as for physician members of the legislature. It was seen as the driving force behind passing an expanded healthcare package.
    • “The Energy and Commerce committee has an $880 billion deficit reduction target. E&C will identify those cuts from programs within its jurisdiction like Medicaid and other healthcare programs. It could identify some of those savings from items in the December healthcare package that did not make it into last year’s funding bill, such as PBM reform.”
  • Per Govexec,
    • “Also on Tuesday, Sen. Jerry Moran, R-Kan., who chairs the Senate Veterans Affairs Committee, announced during a hearing he will put forward legislation that will also seek to put some constraints on the Trump administration’s efforts to remake the Veterans Affairs Department’s workforce. He said VA must work closely with Congress and stakeholders such as veterans service organizations when seeking to make staffing cuts. The Republican chairman added he has voiced his reservations to VA Secretary Doug Collins.”

HHS News

  • The Washington Post reports,
    • Robert F. Kennedy Jr. is making one of his first official moves aimed at increasing oversight of the chemicals found in the nation’s food supply — a key component of his “Make America Healthy Again” agenda to root out chronic disease and childhood illness.
    • On Monday, Kennedy, who serves as the nation’s top health official, announced he was directing the Food and Drug Administration to “explore potential rulemaking” to tighten a decades-old loophole allowing food companies to put chemicals in their products without notifying the nation’s food regulators.
    • The practice Kennedy is targeting, known as “generally recognized as safe” (GRAS), can occur when companies self-certify the safety of a food additive. Companies aren’t required to tell the FDA when they include some chemicals and substances in their products, meaning there are probably hundreds of such ingredients added to the food supply without government oversight.
  • Per a March 10, 2025, CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address the troubling amount of improper enrollments impacting Affordable Care Act (ACA) Health Insurance Marketplaces across the country. CMS’ 2025 Marketplace Integrity and Affordability Proposed Rule includes proposals that take critical and necessary steps to protect people from being enrolled in Marketplace coverage without their knowledge or consent, promote stable and affordable health insurance markets, and ensure taxpayer dollars fund financial assistance only for the people the ACA set out to support.” * * *
    • “View the 2025 Marketplace Integrity and Affordability Proposed Rule (CMS-9884-P) here: https://www.cms.gov/files/document/MarketplacePIRule2025.pdf
    • “For additional information on the rule and its proposals, view the CMS fact sheet:  https://www.cms.gov/newsroom/fact-sheets/2025-marketplace-integrity-and-affordability-proposed-rule” 
  • Per Modern Healthcare,
    • “The U.S. Department of Health and Human Services increased its voluntary buyout offer for some employees for further layoffs this week as the agency faces pressure to reduce headcount, according to an email viewed by Bloomberg. 
    • “In addition to a $25,000 lump-sum buyout offer, some HHS workers would also receive around two months of paid administrative leave if they chose to accept the buyout. * * *
    • “The buyout offer was available to employees this week and expires Friday. The original buyout offer was extended to a “broad population of HHS employees,” according to an email. However, the Food and Drug Administration told staff Monday that employees responsible for reviewing drugs, medical devices and tobacco products aren’t eligible for the buyout program. 
    • “The HHS buyout offers are in addition to an early retirement program that relaxed service requirements for retirement.”
  • The U.S. Preventive Services Task Force issued a final recommendation on screening for food insecurity which received an inconclusive “I” grade.
    • “For children, adolescents, and adults:
      “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.”
  • Per Axios,
    • “The federal government’s free at-home COVID test distribution program has been suspended and is no longer accepting orders” as of March 9, 2025.
    • “For some previously distributed tests, expiration dates were extended to account for data that revealed a longer-than-expected shelf life.
    • “A full list of approved tests and their revised expiration dates is posted on the FDA website.”

FDA News

  • Per Cardiovascular Business,
    • “Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. 
    • “Loss of Pulse Detection asks the user if they are OK when it first detects the loss of pulse. If no response is provided, it triggers an audio alarm and countdown to when emergency services will be notified. If the countdown reaches zero, the alert is officially sent out.
    • “This feature is already available in 14 different countries. It will be made available in the United States for Google’s Pixel Watch 3 in the weeks ahead.”
  • Per Modern Healthcare,
    • “Siemens Healthineers has received clearance from the Food and Drug Administration for its Naeotom Alpha class of photon-counting computed tomography scanners.
    • “The company unveiled the two scanners in December, touting the Naeotom Alpha.Pro and Naeotom Alpha.Prime as more affordable options to its original Naeotom Alpha photon-counting CT, which received FDA clearance in September 2021.
    • “Photon-counting CT is a new technology that uses lower radiation doses than conventional CT and produces clearer images with fewer distortions.
    • “Siemens Healthineers’ photon-counting CTs are the only commercially available scanners of their kind available for clinical use but competitors are working to bring their versions to market.”

From the judicial front,

  • Govexec reports,
    • “A federal judge has ordered the acting head of the Office of Personnel Management to testify at a court hearing examining the legality of the Trump administration’s mass firings of federal employees, but the key workforce official has informed the court he will ignore the order. 
    • “Acting OPM Director Charles Ezell was slated to appear in a U.S. District Court in San Francisco on Thursday after Judge William Alsup ruled Monday on Monday that he must do so, but he will now face a to-be-determined sanction. The Trump administration had sought to block his testimony, saying it would raise constitutional concerns, but the judge rejected the argument. Ezell has already submitted written testimony, Alsup said, and now must be subject to cross examination. 
    • “After initial publication of this story, the Trump administration Tuesday evening informed the court Ezell would not testify and withdrew his written declaration suggesting he did not order the probationary firings across government. It called live testimony “not necessary” for Ezell or any other official. The plaintiffs in the case are seeking testimony from human resources personnel throughout government.” 

From the public health and medical research front,

  • Healio lets us know,
    • “The diabetes mortality rate in the U.S. dropped from 28.1 deaths per 100,000 people in 2000 to 19.1 deaths per 100,000 in 2019.
    • “Reductions in diabetes mortality were observed for all racial and ethnic groups.”
  • The Wall Street Journal reports,
    • “GLP-1s, including Ozempic, show promise in preventing age-related conditions like Alzheimer’s, osteoarthritis and certain cancers.
    • “GLP-1s work by suppressing appetite and reducing inflammation, potentially contributing to their preventive health benefits.
    • “While promising, more robust studies are needed to confirm the causal effects of GLP-1s on longevity and healthspan.”
  • The National Institutes of Health offers a research bulletin on the following topics: “Predicting preeclampsia | Liver gene editing | Mapping MS-like brain lesions.”
  • MedPage Today tells us five things that patients with low back pain need from their doctors and
    • “BMI was lower in kids whose mothers received a responsive parenting intervention in the INSIGHT randomized clinical trial.
    • “Across ages 3 to 9 years, children in a responsive parenting group had a lower mean BMI than those in a control group.
    • “The impact appeared significant only for girls.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of brensocatib (Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “The assessment will be publicly discussed during a meeting of the CTAF in September 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The National Cancer Institute informs us,
    • “For men with metastatic castration-resistant prostate cancer, an initial treatment that combines enzalutamide (Xtandi) and talazoparib (Talzenna)may help them live longer than just getting enzalutamide alone, according to updated results from a large clinical trial. Enzalutamide is a type of drug known as an androgen receptor antagonist and talazoparib is part of a group of drugs called PARP inhibitors.” * * *
    • “More information about the trial, which was funded by Pfizer, the maker of talazoparib, is available in this Cancer Currents story.”
  • Fierce Pharma adds,
    • “After Gilead Sciences’ lenacapavir made waves with stellar clinical results as a twice-yearly HIV prevention candidate, the drug has shown promise being dosed even further apart at only once a year.
    • “Two different once-yearly formulations of lenacapavir achieved blood concentrations that exceeded those associated with the strong HIV prevention efficacy that twice-yearly lenacapavir showed in phase 3 preexposure prophylaxis (PrEP) studies.
    • “The pharmacokinetic results came from a small phase 1 trial presented at the Conference on Retroviruses and Opportunistic Infections and simultaneously published in The Lancet.
    • “Based on the early-stage data, Gilead plans to start a phase 3 program for once-yearly lenacapavir in the second half of this year, with the potential for regulatory filings in 2027, Jared Baeten, M.D., Ph.D., Gilead’s vice president of HIV clinical development, told Fierce Pharma.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Hinge Health filed Monday for a proposed initial public offering.
    • “The virtual musculoskeletal health company, which contracts with employers, pharmacy benefit managers and large insurance companies to provide physical therapy and pain relief services, has been considered a potential IPO candidate since last year.”
  • and
    • “Tampa General Hospital and Mass General Brigham are teaming up to open a radiation oncology center in Florida.
    • “The 10,000-square-foot facility in Palm Beach Gardens will be co-branded and jointly owned. Tampa General will handle daily operations, while Mass General Brigham will provide oversight on quality and safety, according to a Tuesday news release.
    • “The center is scheduled to open in early 2026, the release said.”
  • Per Fierce Pharma,
    • “At its sprawling complex in Durham, N.C., Merck has opened a new $1 billion, 225,000-square-foot manufacturing plant slated to produce bulk substance for its megablockbuster HPV vaccine Gardasil.
    • “Merck built the new plant on the 262-acre campus it has occupied since 2004, where the pharma giant produces a variety of vaccines including shots to prevent chickenpox, measles and rubella.
    • “The complex manufactured more than 70 million doses last year, with the figure expected to increase this year, a Merck spokesperson said in an email. The campus now employs more than 1,000 people.”
  • Per STAT News,
    • “In the last two years, hundreds of businesses have cropped up to meet the surge in demand for the obesity and diabetes medications known as GLP-1s. The majority prescribe compounded copies of the drugs — a tenuous business strategy as shortages of the branded versions of the medications have come to an end. 
    • “Now, some businesses are setting their sights on another opportunity in compounding: hormones.
    • “Dozens of wellness and direct-to-consumer telehealth companies offering GLP-1s have begun marketing cash-pay hormone replacement therapy to women in perimenopause and menopause, and testosterone replacement therapy to men. Noom, best-known for its weight loss app and more recent GLP-1 offering, launched an HRT program for menopause in late February, and telehealth company Hims & Hers plans to roll out at-home testing over the next year to enable care for low testosterone, perimenopause, and menopause.
    • “Patients and physicians have long advocated for better access to hormone-based care. Men with low testosterone levels due to hypogonadism can face stigma as they seek care, and many women struggle to receive medically appropriate estrogen and progesterone to address serious hot flashes and help prevent osteoporosis. But clinicians and health policy researchers expressed concern that the emerging commodification of hormone replacement therapies — often marketed as a personalized fix for low energy, libido, and other age-related concerns — could lead to inappropriate prescriptions and put patients at risk.” 
  • Beckers Hospital Review points out,
    • “In August, Kaiser Permanente embarked on the largest rollout of generative AI in healthcare to date.
    • “The Oakland, Calif.-based health system offered Abridge, an ambient AI listening tool that drafts clinical notes for the EHR, to tens of thousands of providers.
    • “Becker’s caught up with Brian Hoberman, MD, executive vice president of IT and CIO at the Permanente Federation, at the HIMSS conference in Las Vegas to find out how the implementation is going.”
    • Here’s a link to that interview.
  • The Wall Street Journal adds,
    • “Last year, some cancer patients in Tennessee and Mississippi got a startling offer: Instead of videoconferencing with oncology specialists located hours away, they could see a hologram doctor, courtesy of the same special effects that have projected the Jonas Brothers and other celebrities at concerts and live events.
    • “The offer came from West Cancer Center & Research Institute, a health system that employs about 61 doctors and serves about 19,240 new patients a year across 12 locations in Tennessee, Mississippi and Arkansas. The system’s main clinic is in Germantown, Tenn., a suburb of Memphis.
    • “Its doctors typically spend hours on the road each week getting to the satellite clinics to see patients in more rural locations, while also relying heavily on videoconferencing for check-ins. Now, however, two of those clinics are replacing the video calls with life-size hologram-like displays, part of a cross-industry push to take videoconferencing to the next level.”

Tuesday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal offers a summary of seven takeaways from the President’s speech on Tuesday night.
  • Bloomberg Law tells us,
    • “A battle over legislation that would make it easier for Medicare cancer patients to get their drugs may reignite this week when a key Republican lawmaker is expected to reintroduce the proposal.
    • “The measure (H.R. 5526) was passed in the House in September 2024 but stalled in the Senate amid opposition from the pharmacy industry. Rep. Diana Harshbarger (R-Tenn.), a pharmacist, said in a statement to Bloomberg Law the legislation “is one of my top healthcare priorities, and I expect to reintroduce it this week.”
    • “This legislation had strong bipartisan support in Congress last year because it would greatly benefit the lives of countless seniors who need life-saving medications but might not be able to access them easily,” Harshbarger said. “I’m looking at all legislative opportunities to advance this bill and get it enacted into law.”
    • “The legislation, and S. 3458 introduced last Congress by former Sen. Kyrsten Sinema (I-Ariz.), would have amended the physician self-referral law and restored a Covid-19 pandemic-era waiver that allowed Medicare patients to receive their oral cancer medications through the mail, by courier, or via pick-up by family members.”
  • Wolters Kluwer lets us know,
    • “On March 2, 2025 the United States Department of the Treasury announced that with respect to the Corporate Transparency Act (CTA), it will not enforce any penalties or fines associated with the beneficial ownership information reporting (BOIR) rule under the current deadlines, and it will further not enforce any penalties or fines against United States citizens or domestic reporting companies or their beneficial owners after a forthcoming rule change takes effect. 
    • “The Treasury Department also announced that it will be issuing a proposed rulemaking that will narrow the scope of the BOI reporting rule to foreign reporting companies only. Treasury stated that it was taking this step “in the interest of supporting hard-working American taxpayers and small businesses and ensuring that the rule is appropriately tailored to advance the public interest.”
    • The Treasury Department’s press release can be read in full here: https://home.treasury.gov/news/press-releases/sb0038“
  • Federal News Network tells us,
    • “The Trump administration’s Office of Personnel Management has revised its guidance on probationary employees, now stating that OPM was not directing agencies to fire federal workers.
    • “An update to OPM’s Jan. 20 memo on Tuesday adds a paragraph clarifying that any decision to fire employees should be left to individual agencies.
    • “Please note that, by this memorandum, OPM is not directing agencies to take any specific performance-based actions regarding probationary employees,” the updated memo states. “Agencies have ultimate decision-making authority over, and responsibility for, such personnel actions.”
  • Kevin Moss, writing in Federal News Network, discusses how federal annuitants can control their FEHB premiums.
  • Per an FDA news release,
    • On Monday, the FDA approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Anticoagulants (blood thinners) are among the most commonly prescribed medications in the U.S., and Monday’s approval of the first generics of rivaroxaban, 2.5 mg, tablets will make a direct impact on American patients who rely on anticoagulant medications. Approving safe and effective generics to help provide patients more treatment options continues to be a priority for the FDA.

From the judicial front,

  • Per Fierce Healthcare,
    • “UnitedHealth Group notched a major court win in a legal challenge over its Medicare Advantage (MA) billing practices that is stretching into its second decade.
    • “The suit was first filed by a whistleblower in 2011, and the Department of Justice (DOJ) joined the case in 2017. The court-appointed special master released its report this week, in which, after reviewing the evidence, it determined “that the government is lacking any evidence in support of two essential elements of its False Claim Act and related common law claims.”
    • “The suit alleges that UnitedHealth conducted reviews of patients’ medical records that allowed it to identify underpayments while ignoring instances of overbilling. This would enable the company to juice its risk scores and thus its MA payouts.” * * *
    • “In the lawsuit, the feds argue that the billing practices allowed UHG to pocket $2.1 billion. The special master rebuffed an analysis from a government expert who identified 1.97 million codes among 28 million that were allegedly unsupported by the patients’ diagnoses.
    • “The special master noted in its report that the expert did not review medical charts before making this determination.” * * *
    • “The special master’s report recommends that the courts grant UHG a summary judgement and reject the DOJ’s request for partial summary adjudication.”

From the public health and medical research front,

  • Katelyn Jetelina, a/k/a Your Local Epidemiologist, remarks
    • “If you’re 65+ or moderately/severely immunocompromised, a spring Covid-19 vaccine is available. Last October, CDC recommended a second dose of the 2024-2025 Covid-19 vaccine for this spring. It’s a 6-month recommended interval, so the first people will be eligible this week.
    • “Are they still working? Yes. Data published last week showed Covid-19 vaccines provided 45% additional protection against hospitalizations this winter.”
  • The Wall Street Journal points out that the Health and Human Services Department under its new leadership is heightening its scrutiny of vaccines.
  • In this week’s online Research Matter, NIH discusses “Tracking diet from stool samples | Diabetes & antibiotic resistance | Cancer cell cooperation.”
  • Per an NIH news release,
    • An observational study supported by the National Institutes of Health (NIH) found that infants who had more diverse bacteria in their gut had lower childhood blood pressure, and this protective association was stronger if they were breastfed for at least six months. The findings published in the Journal of the American Heart Association.
    • For the research, investigators reviewed data from 526 children enrolled in a prospective study in Denmark. They looked for connections between infant gut bacteria, which can be influenced by nutrition and supports a variety of health functions, and childhood blood pressure. To assess this, they collected fecal samples to analyze bacteria in the infants’ intestines during their first week, month, and year of life. Three and six years later, they measured the children’s blood pressure.
    • The researchers found children with more diverse gut bacteria at one month had lower blood pressure six years later. They then assessed the influence of breastfeeding, which was measured in this study for durations of at least six months. They discovered that among children breastfed for at least six months, the blood-pressure lowering effect of having more diverse bacteria in their gut was even stronger. Specifically, those with a greater diversity of gut bacteria throughout the first month of life had systolic blood pressure that was about 2 mm Hg lower six years later if they were breastfed for at least six months.
  • The National Cancer Institute points out,
    • “A new study has identified a group of genetic changes that are likely involved in the development of cancer in children. According to the findings, genomic changes affecting large pieces of DNA, called structural variants, contribute to an estimated 1% to 6% of pediatric solid tumors.” * * *
    • “Overall, the researchers estimated that structural variants are involved in the development of 1% to 6% of neuroblastomas, Ewing sarcomas, and osteosarcomas. That is a rough estimate limited by the relatively small number of children in the study and the exclusion of certain types of structural variants due to technical limitations, the team noted.”
  • STAT News reports,
    • “It’s easy to think cervical cancer could be 100% preventable. Along with lung, breast, and colorectal cancer, it has screening tests to find precancerous changes that can be treated before full-blown cancer develops. Even more, there is a highly effective vaccine against HPV, the virus that causes most cervical cancer diagnoses.
    • “Still, those two forms of prevention are not enough if people aren’t getting them, a research letter published Monday in JAMA Network Open reports. The cross-sectional study found incidence and mortality rates have been climbing in rural counties in the United States since 2012, going in the wrong direction after declining since 2001. Cases were 25% higher and deaths were 42% higher in rural counties compared to urban counties through 2019. 
    • “Researchers said those jumps in incidence and mortality showing up in rural areas may be a result of lower screening, diagnosis, and treatment rates, all an offshoot of reduced options for care outside cities.
    • “There was also a trend toward higher incidence among Black women starting in 2017, but that rise was not statistically significant. Other research, from the American Cancer Society, has concluded the mortality rate for Black women is roughly 65% higher than the rate for white women.”
  • BioPharma Dive relates,
    • “Merck & Co.’s cancer immunotherapy Keytruda is one of the pharmaceutical industry’s biggest successes. The drug’s arrival in 2014 introduced a new way of treating cancer and, over time, it became standard therapy for a panoply of different tumors. Clinical achievements brought about commercial performance, making Keytruda the world’s best-selling medicine.
    • “After the repeated failure of past attempts to improve on Keytruda, a new class of drugs might finally offer a better backbone for immunotherapy’s next decade.
    • “Last September, biotechnology companies Summit Therapeutics and Akeso revealed clinical trial results showing one of these drugs significantly outperformed Keytruda. Called ivonescimab, it cut the risk of lung cancer progression in half compared to Keytruda in a Phase 3 study — a result so striking it sparked a wave of investment in oncology research practically overnight.
    • “This really was a ‘black swan’ event,” said Allen Yang, Summit’s chief medical officer. “It’s clearly what everybody’s been looking for.”

From the U.S. healthcare business front,

  • Fierce Healthcare shares news from this week’s HIMSS conference being held in Las Vegas.
  • Healthcare Dive adds,
    • “Lightning-fast evolution in artificial intelligence and growing adoption of the models is giving rise to concerns that AI could exacerbate existing divides between technological haves and have-nots in the healthcare industry.
    • “But all types of providers — regardless of location or finances — can adopt AI, experts said Monday at the HIMSS conference in Las Vegas.
    • “It’s just a question of knowing how.
    • “Rural hospitals, smaller systems and health clinics without a massive IT infrastructure should reach out to AI companies to discuss potential partnerships, said Graham Walker, co-director of advanced development at Kaiser Permanente’s medical group, during a panel.”
  • The Wall Street Journal reports,
    • “Walgreens Boots Alliance is closing in on a deal with private-equity firm Sycamore Partners that would take the struggling drugstore chain off the public market for around $10 billion, according to people familiar with the matter. 
    • “The sides are aiming to complete a deal as soon as Thursday, assuming a last-minute snag doesn’t delay the talks or end them entirely, the people said. 
    • “They have been discussing Sycamore paying between $11.30 a share and $11.40 a share in cash, the people said. The deal could also include contingent value rights that would increase the value if certain targets are later reached, they added. 
    • “Should Sycamore complete the deal for the whole company, it is expected to maintain the core U.S. retail business and sell off or take public the other parts of the company, the people said.”
  • Modern Healthcare informs us,
    • “CVS Health has dealt its Medicare Shared Savings Program accountable care organization business to Wellvana, the companies announced Tuesday.
    • “As part of the all-stock transaction, CVS Health took a minority stake in Wellvana, a privately held physician-enablement vendor. The companies did not disclose the terms of the deal and did not immediately respond to interview requests.”
  • Beckers Payer Issues lets us know,
    • “Blue Cross Blue Shield of Michigan reported a loss of $1.02 billion on enterprise revenue of $40.6 billion in 2024, driven by rising utilization of expensive medical services and costs for prescription and specialty drugs.
    • “The company reported an underwriting loss of $1.7 billion in 2024, resulting in a negative operating margin of -4.2%. These losses were partly offset by strong performance from the company’s investment portfolio. 
    • “In 2024, Blue Cross saw an increase of $3 billion for medical and pharmacy claims costs compared to 2023. There was an increase of $900 million in pharmacy claims costs, including $544 million for specialty drugs, of which $215 million was for new indications on autoimmune drugs. GLP-1 drugs alone produced $1.1 billion in claims in 2024, a 29% increase from 2023.
    • “Total membership stands at 5.1 million. There are 663,000 Medicare Advantage members, 286,000 Medicaid members, and 160,000 ACA members.”
  • Healthcare Dive tells us,
    • “Winston-Salem, North Carolina-based Novant Health and Durham, North Carolina-based Duke University Health System will partner to build an unspecified number of new campuses across North Carolina, according to a Monday press release.
    • “The partnership aims to increase patient access to primary care and advanced specialty treatment, as well as shorten wait times for care.
    • “Construction on the first sites will begin this summer, and facilities will open approximately 18 months after work begins, according to the news release.” 

Wednesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, OPM, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

Capitol Hill News

  • Modern Healthcare reports,
    • “Lawmakers who support tough rules on pharmacy benefit managers reaffirmed their ambitions to reanimate legislation that nearly passed Congress in December.
    • “The House Energy and Commerce Committee’s Health Subcommittee relaunched the push at a hearing Tuesday that featured declarations from majority Republicans and minority Democrats that they will tackle high pharmaceutical prices and limited competition in the PBM market through bills that have lingered for more than a year without final action.
    • “I can tell you it is a priority of mine to ensure these commonsense and bipartisan policies become law,” Energy and Commerce Committee Chair Brett Guthrie (R-Ky.) said at the hearing.”
  • Per a Senate news release,
    • “In a Wall Street Journal letter to the editor, Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.) welcomed Health and Human Services Secretary Robert F. Kennedy Jr.’s support for enhanced transparency regarding direct-to-consumer (DTC) prescription-drug advertisements. Grassley and Durbin are leading bipartisan legislation to require price disclosures in DTC commercials.”
  • STAT News informs us,
    • “Once again, House lawmakers have introduced a bill to alter a key provision of the Inflation Reduction Act in response to arguments that the federal law is discouraging investment in developing so-called small molecule medicines.
    • “The legislation, known as the Ensuring Pathways to Innovative Cures Act, would allow Medicare to begin negotiating with pharmaceutical companies over the prices of small molecule medicines 13 years after they reach the market. Currently, negotiations begin after nine years and the legislation — which was re-introduced by Rep. Greg Murphy (R-N.C.) — would shift the timetable so that it is the same as for large molecule medicines, also known as biologics.
    • “By making this change, the legislation would remove what the pharmaceutical industry and its investors claim is a disincentive for pursuing small molecule drugs, since these medicines would have less time on the market before Medicare would be able to negotiate set prices. This process means there will be small returns on investments for small molecule drugs, according to those who support the bill.”
  • The American Hospital Association News (AHA) tells us,
    • “Both chambers of Congress have reintroduced AHA-supported legislation, the Conrad State 30 and Physician Access Reauthorization Act (S. 709]/H.R. 1585), to reauthorize and expand the program that allows foreign-born medical graduates to practice medicine in rural and underserved areas. The bipartisan legislation extends the program for three years and would increase current state allocations from 30 to 35 physicians per year. It would also provide flexibility to expand the number of waivers in states where demand exceeds that limit.” 

White House News

  • The AHA News lets us know,
    • “The White House yesterday issued an executive order that directs the Departments of Health and Human Services, Labor, and Treasury to improve upon and increase enforcement of the hospital and insurer price transparency requirements in the Hospital Price Transparency and Transparency in Coverage regulations. Specifically, the White House instructs the departments to “rapidly implement and enforce” the regulations, including by taking actions in the next 90 days to increase enforcement and standardization and ensure that “actual prices,” rather than estimates are disclosed.”
  • Beckers Payer Issues offers six notes for payers on this Executive Order.
  • Per Govexec,
    • “The Trump administration has given federal agencies until March 13 to deliver their plans to dramatically slash their workforces through layoffs as the Trump administration moves to the second phase of its initiative to cut federal employees. 
    • “The plans will focus on the “maximum elimination” of functions not required by law, Office of Management and Budget director and Office of Personnel Management acting Director Charles Ezell said in new guidance on Wednesday, and include a resulting “significant reduction” in employees. As a starting point for the cuts, Vought and Ezell said, agencies should focus on employees whose jobs are not required in statute and who face furloughs in government shutdowns—typically around one-third of the federal workforce, or 700,000 employees. 
    • “Pursuant to the president’s direction, agencies should focus on the maximum elimination of functions that are not statutorily mandated while driving the highest-quality, most efficient delivery of their statutorily required functions,” Vought and Ezell said.”
  • The Washington Post reports,
    • “The Trump administration is giving federal agencies until mid-April to suggest relocations of bureaus and offices out of the D.C. region, a move that would have widespread impacts on the local economy.
    • “In a guidance issued Wednesday to the heads of all executive departments and agencies, the directors of the Office of Management and Budget and the Office of Personnel Management laid out steps for compliance with President Donald Trump’s order to eliminate “waste, bloat and insularity” in the government. Part of that is a directive to submit “any proposed relocations of agency bureaus and offices from Washington, D.C. and the National Capital Region to less-costly parts of the country” by April 14.” * * *
    • “Also on Wednesday, Trump issued an executive order giving agencies seven days to submit an inventory of their real property and 30 days to identify all leases that can be terminated. Within 60 days, the order stated, the General Services Administration — the government’s real estate arm — must come up with a plan to dispose all property deemed “no longer needed.”
  • Bloomberg Law informs us,
    • “US health officials are reevaluating a $590 million contract for bird flu shots that the Biden administration awarded to Moderna Inc., people familiar with the matter said.
    • “The review is part of a government push to examine spending on messenger RNA-based vaccines, the technology that powered Moderna’s Covid vaccine. The bird flu shot contract was awarded to Moderna in the Biden administration’s final days, sending the company’s stock up 13% in the two days following the Jan. 17 announcement.”

CMS News

  • Fierce Healthcare notes,
    • “Just over 34.4 million people were enrolled in Medicare Advantage (MA) plans as of Feb. 1, representing fairly slim growth across the program’s annual enrollment period.
    • “Enrollment grew by 3.8% from February 2024 to February 2025, according to anticipated data released this week from the Centers for Medicare & Medicaid Services. This would make for the lowest growth rate in more than a decade, according to researchers at KFF.
    • “The KFF analysts said enrollment in MA has more than doubled since 2010.”
  • and
    • “While lobbyists are supplicating President Donald Trump and the Republican-led Congress to continue their leadership on telehealth and extend expiring flexibilities—which Trump began during the COVID-19 pandemic—they no longer are asking for a concrete timeline.
    • “Three hundred and fifty organizations signed a letter to congressional leadership Monday urging lawmakers to extend expiring Medicare telehealth flexibilities and to restore telehealth access lost by commercially insured patients in December.
    • “The organizations told Congress that they prefer to make the telehealth flexibilities permanent. However, in a messaging shift, the groups said they “recognize this could be a multi-year process” and asked Congress to consider a “long-term” extension.”

Food and Drug Administration News

  • The New York Times relates,
    • “The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.
    • “The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.” * * *
    • “In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.
    • “Physicians have long complained that, as a result, clozapine is grossly underutilized.
    • “Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.
    • “I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “A child who tested positive for measles died in West Texas, the state health department said, marking the first death in an outbreak that has sickened nearly 140 people. 
    • “The Texas Department of State Health Services said a school-age child died after being hospitalized in Lubbock. The child wasn’t vaccinated, the state health department said.
    • “The child’s death marked the first measles-related death in the U.S. since 2015.” * * *
    • “The reality of this outbreak is pushing more people to get vaccinated, said Katherine Wells, director of public health in Lubbock. The public-health department has administered around 100 more measles vaccines over the past week or two than they do normally. More than half of those went to children receiving the vaccine for the first time. School nurses also checked students’ vaccine records and alerted parents if their sons or daughters hadn’t received their second dose yet, Wells said.
    • “The goal right now is to find pockets of unvaccinated people who have not yet been exposed and just get our vaccination rates up as high as possible,” Wells said. “That’s what’s going to slow this down.”
  • CBS News points out,
    • “This season’s influenza vaccine may have been a poor match to a strain of the flu virus that caused many infections this winter, early data released by the Centers for Disease Control and Prevention suggests.
    • “The CDC’s latest data come as much of the U.S. is finally seeing signs of a slowdown in influenza activity after waves of illness this past fall and winter that climbed to the worst rates recorded from hospitals and doctor’s offices since the 2009 swine flu pandemic.”
  • The National Cancer Institute tells us whether “AI Help Predict Which Cancer Patients Should Be Treated with Immunotherapy?” and offers Cancer Information Highlights about “Metastatic Prostate Cancer | Prenatal Blood Test | Nivolumab via Injection.”
  • Health Day adds,
    • “Frequent exercise can help colon cancer survivors live longer, perhaps even outlasting average folks, a new study suggests.
    • “Colon cancer patients who were very physically active had three-year survival rates that were slightly higher than the general population, researchers report in the journal Cancer.
    • “This new information can help patients with colon cancer understand how factors that they can control — their physical activity levels — can have a meaningful impact on their long-term prognosis,” lead researcher Justin Brown, director of the Cancer Metabolism Program with the Pennington Biomedical Research Center at Louisiana State University, said in a news release.”
  • Per Healio,
    • “Pregnant women with low vitamin D levels during the first trimester were four times more likely to give birth prematurely compared with women with adequate vitamin D levels, researchers wrote in The American Journal of Clinical Nutrition.
    • “Testing for vitamin D status is not currently part of standard prenatal care in the U.S.,” Alison D. Gernand, PhD, MPH, RD, associate professor of nutritional sciences at Pennsylvania State University, told Healio. “Clinical care providers should consider talking to pregnant patients about vitamin D during the first prenatal visit — asking whether they have vitamin D-rich foods in their diet and how much vitamin D is in the supplement they are taking.”
  • and
    • “Among populations with low adherence to colorectal cancer screening, annual fecal immunochemical testing was the cheapest and most effective noninvasive screening method, according to a study published in JAMA Network Open“
  • BioPharma Dive lets us know,
    • “AstraZeneca said Wednesday that its experimental drug camizestrant delayed tumor progression in a Phase 3 testing its use as a first-line treatment in people with a certain type of breast cancer. The drug, an oral, hormone receptor protein-degrading therapy known as a SERD, was tested alongside an approved CDK4/6 inhibitor in people whose HR-positive, HER2-negative tumors have an “emergent” ESR1 mutation. People in the study were receiving standard hormone therapy and a CDK4/6 drug and then either continued, or swapped out the hormone treatment for camizestrant, once a tumor scan showed signs of an ESR1 mutation. The result was a “highly statistically significant and clinically meaningful improvement” in progression-free survival for camizestrant recipients, AstraZeneca said. Menarini Group’s similar drug Orserdu is available in the second line setting, while others from Arvinas, Eli Lilly and Roche are in advanced testing.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmaker Eli Lilly plans to build four new manufacturing plants in the U.S., a $27 billion investment that the company expects will create 3,000 high-skilled jobs and employ 10,000 construction workers.
    • “Three of the new sites would produce active pharmaceutical ingredients for its drugs, and the fourth would produce sterile injectable medicines such as diabetes drug Mounjaro, Lilly said Wednesday. The company hasn’t picked the locations yet. It expects the plants to be making medicines within five years.
    • “The announcement, by one of the country’s biggest drugmakers, is the latest by a company outlining a major capital push in the U.S. while President Trump seeks to revive domestic manufacturing.
    • “It comes as Lilly and other pharmaceutical companies seek warm relations with the new administration and press it to pursue industry objectives, including the extension of corporate tax cuts enacted during the first Trump administration.
    • “We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Lilly Chief Executive David Ricks said in an interview.”
  • Per Modern Healthcare,
    • “Mobile medical units will deliver hospital-at-home care to patients in rural communities as part of a five-year pilot program aimed at expanding healthcare access in underserved areas.
    • “The Advanced Research Projects Agency for Health recently awarded an undisclosed amount of funding to Boston’s Mass General Brigham, University of Utah’s Huntsman Cancer Institute and Kentwood, Michigan-based Homeward Health to develop programs that will extend hospital-level care to patients in remote communities using mobile platforms.
    • “Health systems have used hospital-at-home as a way to ease overcrowding and free up beds. More than 380 hospitals have Medicare waivers allowing them to provide acute care to patients where they live at the same reimbursement rate as an inpatient stay. While the waiver is set to expire at the end of March, there has been bipartisan support to continue it and hospitals continue to launch in-home acute care programs.
    • “But the concept has not taken off in rural America, in part because the CMS waiver requires patients to live within 25 miles of a participating hospital. Staffing can also be a challenge, as well as patient buy-in.”
  • and
    • “Teladoc posted a net loss of just over $1 billion in 2024 related to ongoing struggles at its direct-to-consumer BetterHelp business that are expected to continue this year.
    • “The annual net loss of $1 billion, or $5.87 per share, reported Wednesday, compared with a 2023 loss of $220 million, or $1.34 per share. The company took a non-cash goodwill impairment charge of $790 million attributed to BetterHelp. Revenue tied to BetterHelp, which Teladoc acquired in June 2015 for $4 million, decreased 8% in 2024. Overall revenue declined 1%.
    • “Compared with a year ago, fourth-quarter revenue decreased 3% and its net loss was 68% worse.
    • “The outlook for this year isn’t encouraging. The company said it expects BetterHelp revenue to decline nearly 10%. Still, during an earnings call, CEO Chuck Divita was bullish on the direct-to-consumer segment and said Teladoc will pursue strategies to turn the company around.”
  • Tech Target discusses “How healthcare consumerism is driving provider revenue growth.”
    • “Sixty-five percent of healthcare executives are prioritizing growth strategies to increase revenue, according to the Deloitte Center for Health Solutions. And health system leaders expect consumers to play a major role in their organizations’ organic growth.
    • “The survey from Deloitte underscored a shift from merger and acquisition activity as a means of growing revenue to consumer attraction and retention. However, to attract new consumers and drive organic growth, over half of health system executives (and about half of health plan leaders) said they need to improve consumer engagement, trust and the overall patient experience.”

Tuesday Report

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

From Washington, DC,

  • By a 217 – 215 vote, the House of Representatives tonight passed the White House’s “big, beautiful [reconciliation] bill” — H. Con. Res. 14 — “Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), Chairman of the Senate Judiciary Committee and a former Chairman of the Senate Finance Committee, sent a letter to UnitedHealth Group Chief Executive Officer Andrew Witty demanding detailed information on the company’s Medicare billing practices.”
  • Govexec tells us,
    • “The Trump administration is reshaping the top ranks of federal agencies by making more employees politically appointed and ensuring those who remain in career roles are evaluated based on how well they implement the president’s agenda. 
    • “The Office of Personnel Management on Monday called on all agencies to redesignate some of their Senior Executive Service employees as political appointees, rather than reserving them for career staff. On Tuesday, it announced a new performance appraisal system for career executives, which will now give the most significant weight to how well the top-level supervisors carry out the president’s policies.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is giving an ultimatum to remote and teleworking employees who are more than 50 miles away from their official duty stations.
    • “OPM is directing employees in this scenario to either report to their current duty station, agree to a “management-directed reassignment” and relocate to office space in another geographic region, or accept termination from their jobs.
    • “According to presentation slides shared with Federal News Network, these are the options employees more than 50 miles of their OPM facility will receive in a “Management Direct Reassignment” memo on Wednesday.
    • “OPM is giving employees until Friday, March 7 to respond.”
  • and
    • “Social Security beneficiaries impacted by the Windfall Elimination Provision and the Government Pension Offset may begin receiving their one-time retroactive payments as soon as this week.
    • “The Social Security Administration has significantly shortened its timeline to start distributing benefit payments to public sector workers whose Social Security benefits have been impacted by WEP and GPO. SSA said it began distributing the one-time retroactive payments this week, and most payments will process incrementally over the next month.
    • “The agency said in a press release Tuesday that most beneficiaries should receive their one-time retroactive payments by the end of March. The retroactive payments are backdated to January 2024.”
  • The American Hospital Association News continues to fill us in on its rural healthcare leadership conference.
  • Per Fierce Healthcare,
    • “The federal government under the Trump administration has turned its focus to cutting costs, and a new report from the Blue Cross Blue Shield Association highlights policy efforts it says could save nearly $1 trillion in healthcare costs over the next decade.
    • “The road map includes 10 policy proposals for stakeholders to consider, and BCBSA said these changes could drive federal savings of $524 billion, lower private insurance premiums by $389 billion and save patients $180 billion out-of-pocket.
    • “The largest potential area for savings, according to the analysis, is to adopt site-neutral payments in Medicare, which the paper estimates would save $484 billion over 10 years. The report also suggests that mandating a different provider identifier for off-campus facilities than what’s required for on-campus facilities could save an additional $11 billion.”

From the judicial front,

  • Fierce Pharma informs us,
    • “Compounding pharmacies aren’t surrendering their ability to create cheaper knockoff versions of Eli Lilly and Novo Nordisk’s weight loss drugs without a fight.
    • “In response to the FDA declaring on Friday that the shortage for Novo’s blockbuster GLP-1 treatments Ozempic, approved for diabetes and Wegovy, which has a license in obesity, was over and that compounders would have to stop producing them in the next 60 to 90 days, an organization which backs the pharmacies has filed a lawsuit (PDF) in U.S. District Court in Fort Worth, Texas.
    • “The complaint alleges that the U.S. regulator is “dismissing evidence that the shortage persists,” in removing the drugs from its shortage list “without notice-and-comment rulemaking.”
    • “It is the second lawsuit filed in the same court from the Outsourcing Facilities Association (OFA) and Texas-based FarmaKeio Superior Custom Compounding.
    • “In October, in a complaint that is still pending, they sued the FDA after it removed Lilly’s tirzepatide—the main ingredient in its diabetes and obesity blockbusters Mounjaro and Zepbound—from its shortage list.”

From the public health and medical research front,

  • Healthcare Finance reports,
    • “Fewer clinicians are entering into the primary care field, and investments in primary care are on the downswing, finds a new report from the American Academy of Family Physicians and Milbank Memorial Fund.
    • “According to the findings, years of neglect and chronic underinvestment by the healthcare system have left U.S. primary care in a position where it’s increasingly unable to meet patients’ needs, particularly in rural and other underserved communities.
    • “The combination of worsening primary care access and sicker patients has created a cycle whereby patients use more expensive services like emergency rooms, which raises healthcare costs and premiums, further reducing affordability and access, the report said. And overall healthcare spending continues to rise faster than economic indicators, with the primary care infrastructure only receiving a small fraction of that money.” * * *
    • “People are shifting away from traditional primary care providers, with about three in 10 forgoing primary care altogether between 2016 and 2022, according to FAIR Health’s 2023 analysis of private claims data.
    • “That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians.” * * *
    • “People are increasingly turning to telehealth for their primary care needs. At 94%, the vast majority of patients are satisfied with their experience pursuing virtual primary care, and nearly four in five (79%) say it has allowed them to take charge of their health, according to a November 2022 survey released by Elevance Health.”
  • Per Healio,
    • “Obesity trends have stayed stable in the last couple years, whereas severe obesity has trended downward, a recently published report suggested.
    • “However, the percentage of people with a healthy weight has also decreased in the decade-plus”
    • “What stands out most is that younger adults experienced the greatest increase in BMI, while older adults saw a leveling off and even a decline in recent years,” Kristen Bartelt, RN, a research clinician with Epic Research, told Healio. “This shift suggests that different age groups may be experiencing unique influences when it comes to weight and health.”
  • MedPage Today adds,
    • “Higher adherence to the Mediterranean diet was associated with a 6% lower risk of obesity-related cancer over 15 years.
    • “Risks for colorectal, liver, and kidney cancers were significantly reduced in people with medium or high adherence to the top-ranked diet.
    • “Obesity-related cancer risk reduction was even greater among current and former smokers.”
  • What’s more, Rheumatology Advisor notes,
    • “Dietary predictors linked to reduced mortality among patients with rheumatoid arthritis included high intake of protein and fiber, along with reduced consumption of refined grains”
  • The NIH Research Matters bulletin covers “Boosting peanut tolerance | Artificial sense of touch | Scratching and skin inflammation”
  • BioPharma Dive lets us know,
    • “Ten of 11 children born profoundly deaf experienced some degree of hearing improvement after receiving an experimental gene therapy developed by Regeneron Pharmaceuticals.
    • “A few of the children can now hear sound at near-normal levels, like conversational speech. One, who was 10 months old when treated and has been followed for more than a year, correctly identified spoken words, like “mommy,” “cookies” and “airplane,” without visual cues in a formal test.
    • “The findings, disclosed by the company Monday alongside a presentation at a medical meeting, are a notable achievement in the development of gene therapies for congenital deafness. Other companies and groups, including Eli Lilly, France’s Sensorion and researchers at Fudan University in Shanghai, are working on similar treatments as Regeneron.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Health insurers wrapped up 2024 in rough shape, recording falling profits from insurance businesses and releasing guidance suggesting that medical costs could continue climbing this year.
    • “In the fourth quarter, payers continued to slog through elevated medical spending in Medicare and Medicaid. Higher costs popped up in once-safe commercially insured populations, too, suggesting American workers are sicker than before.
    • “All told, major publicly traded insurers’ medical loss ratios, key metrics of spending on patient care, rose an average of 2.8 percentage points from the fourth quarter of 2023 to the fourth quarter of 2024.” * * *
    • “Insurers are attempting to resuscitate their profits this year, including by shedding unprofitable MA members. During fourth-quarter calls, major Medicare insurers said they’ve successfully lost members that were dragging down their margins — and shunted other beneficiaries into plan designs that give more control over spending.”
  • The Wall Street Journal reports
    • “Eli Lilly LLY is expanding its offerings of its hit weight-loss drug Zepbound for people who want to pay cash instead of using their health plans and reducing prices for certain dosages.
    • “The pharmaceutical company said it would start selling higher dosages of its Zepbound drug, known as tirzepatide, through Lilly Direct, its direct-to-consumer business. The new dosages – in 7.5 and 10 milligram single-dose vials – will cost patients $599 per month and $699 per month, respectively.
    • “The price for both dosages goes down to $499 per month if patients refill their prescriptions within 45 days, as part of a type of customer loyalty program.
    • “The company also cut the per-month price of the lower dosages by about $50. The 2.5-mg vials will cost $349, down from $399; the 5-mg vials will be $499, down from $549.
    • “Lilly Direct allows patients to bypass insurers and traditional pharmacies. Lilly said it had received requests from many patients to offer the higher doses.
    • “We can’t wait until the complex healthcare system is offering access to anti-obesity medications like all other chronic diseases,” said Patrik Jonsson, president of Lilly’s cardiometabolic health unit. “But in the meantime, this is a response to patients’ requests.”
  • Fierce Pharma adds,
    • “Looking to avoid a repeat of the shortages that plagued Mounjaro and Zepbound during their initial rollouts, Eli Lilly is building supply of its oral GLP-1 contender orforglipron well before the drug’s expected approval in 2026.
    • “As of Dec. 31, Lilly had amassed pre-launch inventory worth $548.1 million that was “primarily related to orforglipron,” the company said in its annual report issued last week.
    • “When we believe that future commercialization is probable and the future economic benefit is expected to be realized, we capitalize prelaunch inventory prior to regulatory approval,” the company explained in its securities filing.”
  • MedCity News explains why “‘The Hardest Thing Is Separating the Wheat from the Chaff’: 5 Leaders on the State of Healthcare AI. Healthcare AI is developing at a rapid rate, and the industry’s attitude on how to best regulate and deploy this technology is evolving every day, according to leaders attending this year’s ViVE conference.”
  • Per MedTech Dive,
    • “Quest Diagnostics has struck a deal to buy kidney disease laboratory testing service assets from Fresenius Medical Care, the companies said Monday.
    • “The acquisition will add dialysis-related water testing to Quest’s portfolio. Quest will perform the tests and other end-stage kidney disease laboratory services for Fresenius Medical Care’s dialysis centers in the U.S.
    • “Quest, which has not disclosed the value of takeover, completed eight buyouts last year, but CEO Jim Davis recently told investors the company would “moderate” its dealmaking pace in 2025.” 
  • and
    • “Thermo Fisher Scientific agreed to pay about $4.1 billion in cash to acquire Solventum’s purification and filtration business.
    • “The technologies, used in the production of biologics and medical devices and for industrial applications, generated about $1 billion in revenue last year. The business employs about 2,500 people globally and will become part of Thermo Fisher’s life sciences solutions segment.
    • “The Solventum unit is highly complementary to Thermo Fisher’s bioproduction business that offers cell culture media and single-use technologies, Thermo Fisher CEO Marc Casper said in the Tuesday announcement.”

Monday Report

David Ermer–Congress, COVID treatment, FDA, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reminds us,
    • “The calendar will officially turn to March this week, putting Congress in the same month as the looming March 14 government shutdown deadline. Despite that date fast-approaching, however, lawmakers in both parties have still not struck a deal to keep the lights on in Washington past the middle of next month — raising the possibility of a shutdown.”
  • Federal News Network notes,
  • HUB International discusses the Labor Department and CMS 2023 Mental Health Parity Compliance reports.
    • While not an exclusive or comprehensive list of all possible violations, the [article’s] list provides some guidance on the types of issues the Departments view as violations (particularly on the NQTL side). Employers should review their plan designs for any potential MHPAEA violations based on the [article’s] enforcement data and work with their providers to rectify any noncompliant design elements.
  • The Labor Department’s Inspector General released a report on Mental Health Parity Enforcement encouraging more resources be given to the enforcers. The FEHBlog believes that this additional cost can be avoided by simplifying the Mental Health Parity rule.
  • The HHS Inspector General reports “Medicare Part D Spending for 10 Selected Diabetes Drugs [including GLP-1 drugs] Totaled $35.8 Billion in 2023, an Increase of 364 Percent From 2019.”
  • MedPage Today tells us,
    • “The FDA approved adaptive deep brain stimulation (DBS) technology (BrainSense adaptive DBS and BrainSense electrode identifier) for people with Parkinson’s disease, Medtronic announced Monday.
    • “Like other DBS devices, the newly approved technology uses a surgically implanted neurostimulator to transmit electrical signals. The adaptive feature adjusts therapy based on a patient’s neural activity in real time, reducing the need to manually adjust stimulation.
    • “Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson’s disease,” said Helen Bronte-Stewart MD, MSE, of Stanford University School of Medicine in California, in a statement. “The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs.”

From the judicial front,

  • Per Govexec,
    • “An independent federal oversight agency has deemed at least some of President Trump’s mass firings of probationary period employees unlawful, creating a pathway for those employees to regain their jobs. 
    • “The Office of Special Counsel, the agency responsible for investigating illegal actions taken against federal employees, issued its decision for six employees, each at different agencies. While the decision was technically limited in scope, it could have immediate impact on all terminated staff at those six agencies and could set a wide-ranging precedent across government. It has not been made public and was provided to Government Executive by a source within the government. OSC, which did not provide the document to Government Executive, verified its authenticity. 
    • “OSC has turned the case over to the quasi-judicial Merit Systems Protection Board for enforcement of its findings and is so far requesting a 45-day stay on the firing decisions. The agency said it will use that time to further investigate the dismissals and determine the best way to mitigate the consequences from the apparent unlawful actions. 
    • “MSPB has three business days to issue a decision on the stay request. If it does not act by that deadline, the stay will go into effect.”
  • It’s worth adding that the Scotusblog explains
    • “The Supreme Court on Friday [February 21] left in place for now an order by a federal judge in Washington, D.C., that instructed President Donald Trump to temporarily reinstate the head of an independent federal agency [the Office of Special Counsel] tasked with protecting whistleblowers from retaliation. The justices did not act on a request from the Trump administration to block the order by U.S. District Judge Amy Berman Jackson, which had restored Hampton Dellinger as head of the Office of Special Counsel for 14 days, beginning on Feb. 12. Instead, the justices explained in a brief order, they put the government’s request on hold until Jackson’s order expires on Feb. 26.”
  • Per Healthcare Dive,
    • “Express Scripts, Caremark and Optum Rx are turning to an appeals court to try to reverse a legal setback in their ongoing feud with the Federal Trade Commission.
    • “The PBMs said on Friday they will ask the 8th Circuit Court of Appeals to halt the agency’s suit against them for allegedly inflating the cost of insulin, three days after a Missouri district judge ruled the FTC’s case could move forward.
    • “The PBMs — known as the “Big Three” for their outsized control of the U.S. prescription drug market — also asked the district judge again for an injunction halting the FTC’s suit pending their appeal. Express Scripts, Caremark and Optum Rx intend to ask the 8th Circuit for an injunction in one week unless the district court complies.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Cardiovascular disease remains the leading cause of death in the United States and accounted for 941,652 deaths in 2022, according to a report published by the American Heart Association.
    • “In the United States in 2022, heart disease and stroke killed more people than all forms of cancer and accidental deaths. Coronary heart disease was the leading cause of death attributable to cardiovascular disease (39.5 percent), followed by stroke (17.6 percent), other cardiovascular diseases (17 percent), hypertensive diseases (14 percent), heart failure (9.3 percent) and diseases of the arteries (2.6 percent), the AHA said. More people died of cardiovascular causes in 2022 than 2021, when there were 931,578 cardiovascular deaths, according to the report.
    • “The report also notes that between 2017 and 2020, nearly half of U.S. adults (48.6 percent) had some form of cardiovascular disease. According to the AHA, 59 percent of non-Hispanic Black women and 58.9 percent of non-Hispanic Black men had cardiovascular disease.
    • “Advances in clinical diagnosis and treatment have lessened the burden of heart disease over time, but more needs to be done to treat major risk factors, including obesity, high blood pressure and diabetes, said Keith Churchwell, a physician and clinical professor of medicine at the Yale School of Medicine who serves as volunteer president of the American Heart Association.”
  • The American Medical Association lets us know “what doctors wish patients knew about cancer screening and prevention.”
  • Healio informs us,
    • “Paxlovid may not decrease the risk for hospitalization or death in older adults vaccinated against COVID-19 as much as previously thought, according to research published in JAMA.
    • “Since the strongest predictor of severe COVID-19 is advanced age, it has been crucial to obtain evidence on whether the results of the Pfizer trials” — which showed Paxlovid reduced COVID-19 hospitalizations and deaths in unvaccinated adults — “generalized to older and vaccinated populations,” John Mafi, MD, MPH, associate professor-in-residence of medicine at the David Geffen School of Medicine at UCLA, said in a press release.
    • “At best, Mafi and colleagues wrote, Paxlovid could reduce COVID-19-related hospitalization by 1.3 percentage points, or 4 times less than the 5.5 percentage-point risk reduction reported in Pfizer’s original trial among unvaccinated adults.
    • “Our study effectively rules out the notion that Paxlovid causes large reductions in hospitalization in vaccinated older adults,” Mafi said. “While we cannot rule out a small reduction in COVID-19 hospitalization, our results indicate that, at best, Paxlovid’s potential effect on COVID-19 hospitalization among vaccinated older adults is four times weaker than the effect originally reported in Pfizer’s 2022 clinical trial.”
  • Consumer Reports< writing in the Washington Post, explores “How to keep your bones strong. Worried about osteoporosis? Here are the tests, moves, meds and foods you need to know about.”
  • The Wall Street Journal reports,
    • Frozen shakes served in hospitals and nursing homes have been recalled after being linked to a deadly outbreak of listeria, resulting in 12 deaths and sickening at least 38 people in 21 states.
    • The shakes, sold under the brands Lyons ReadyCare and Sysco Imperial, were made in the same facility in Fort Wayne, Ind., and have been recalled by both companies.
    • Listeria can cause serious illness, especially in newborns, older people, and those with weakened immune systems, and can survive on surfaces for long periods.
  • and
    • “Red-light therapy, a treatment involving exposure to low levels of red or near-infrared light, is gaining popularity for its purported benefits in weight loss, antiaging and mood balance.
    • “While some research shows promise in areas like dermatology and mood disorders, more evidence is needed to confirm its broader health benefits.
    • “Consumers should be cautious when purchasing red-light therapy devices, as there are no established standards for wavelength, intensity and length of treatment, and some products may not be effective or safe.”

From the U.S. healthcare business front,

  • The American Hospital Association News fills us in on its ongoing rural healthcare leadership conference.
  • Per BioPharma Dive,
    • “Summit Therapeutics and Pfizer on Monday said they will test an experimental Summit immunotherapy with Pfizer’s antibody drug conjugates in trials evaluating two of the sector’s most closely watched types of cancer medicines.
    • “Pfizer will oversee the clinical trials, which will involve Summit’s ivonescimab and multiple different Pfizer ADCs against certain solid tumors. The two companies will retain commercialization rights to their respective products, Summit said.
    • “According to Summit, the deal “will allow us to quickly advance beyond our promising late-stage development plan,” which already includes multiple studies in lung cancer. The companies didn’t provide specifics, but said the trials will begin in the middle of the year and aim to find “potentially landscape-changing combinations.”
  • Beckers Payer Issues relates,
    • Bon Secours Mercy Health and Cigna Healthcare will be out of network across eight Virginia hospitals [listed in the article] on April 1.
    • Almost all of Cigna’s business with Bon Secours is through employer-sponsored plans that are self-funded. If Bon Secours Mercy Health leaves our network, OAP and PPO members will be affected.
  • Beckers Hospital Review discusses “the twofold challenge of an older population — and how systems are adapting.”
    • “In less than a decade, older Americans are projected to outnumber children for the first time in U.S. history, sparking conversations about the need for age-friendly healthcare. 
    • “At the same time, declining birth rates and longer life expectancies — half of babies born in 2020 are expected to live past 100 years — pose potential workforce challenges.
    • “Becker’s connected with four health system leaders [in this article] to explore the challenges this demographic shift presents and how they are preparing to address it.”

Friday Report

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

Happy Washington’s Birthday (one day early)

First in war, first in peace, first in the hearts of his country

From Washington, DC,

  • “The American Medical Association News reports,
    • “The U.S. Senate voted 52-48, after a 10-hour “vote-a-rama” session, to adopt a budget resolution for fiscal year 2025 focusing on the border, military and energy. The bill would authorize roughly $340 billion in spending and be fully offset by corresponding spending cuts. The budget resolution is a blueprint for one of two budget reconciliation bills the Senate hopes to enact this year, with the second focusing on extending tax cuts and cutting spending.
    • “Meanwhile, the House of Representatives next week plans to vote on its own budget resolution focusing on the Trump administration’s agenda on border security, defense, energy and taxes. The budget resolution calls for $2 trillion in spending cuts that could potentially impact Medicaid and other key health care programs. The proposal also allows for up to $4.5 trillion in spending for tax cuts. President Trump this week expressed his preference for the House’s one-bill approach.” * * *
    • “Both chambers must pass a common budget resolution to move forward with the reconciliation process.”
  • MSN lets us know,
    • “President Donald Trump warned drugmakers in a private meeting [yesterday] that tariffs are coming and said companies should hustle to move overseas manufacturing to the US, according to two people familiar with the conversation.
    • “Trump also didn’t commit to pushing Congress to water down a drug pricing program enacted under President Joe Biden that the pharmaceutical industry has been seeking relief from. 
    • “The president’s tone suggests the pharmaceutical industry’s bid to win an ally in the White House might be more difficult than executives had hoped. Despite his pro-business leanings, Trump had a rocky relationship with drug companies in his first term, at one point accusing them of “getting away with murder” on the price of medicines.” 
  • The Wall Street Journal informs us,
    • The U.S. Food and Drug Administration declared that the shortage of Novo Nordisk’s weight-loss medications Wegovy and Ozempic has been resolved, according to its website.
    • The FDA announcement confirms that the U.S. supply of both prescription-only drugs now meets or exceeds the current and projected demand in the country, Danish pharmaceutical company Novo Nordisk said Friday.
    • The popularity of Novo Nordisk’s blockbuster GLP-1 drugs had forced the FDA to include Wegovy and Ozempic in its official shortage list, despite the company’s efforts to ramp up production.
    • Ozempic, which treats diabetes, and Wegovy, sold for obesity, have spent over two years on the FDA’s list. During that time, compounding pharmacies–those which produce custom medications–were legally entitled to produce copies of both semaglutide drugs, which were also cheaper than Novo Nordisk’s versions.
    • The regulator’s decision to take them off of the shortage list means that compounding pharmacies will need to stop making and selling knock offs.
  • Modern Healthcare adds
    • “The Food and Drug Administration issued a notice on Friday classifying its recall of the Boston Scientific Accolade pacemaker devices as the most serious type of recall.
    • “To date, 832 injuries and two deaths tied to the devices have been reported. The recall affects about 13% of Accolade devices manufactured before September 2018.
    • “The pacemakers treat slow heart rhythms by pacing the upper and lower chambers of the heart and adjusting the pacing rate to meet the body’s needs. Due to a manufacturing issue with the battery cathode, the pacemakers might enter safety mode under certain conditions, and as a result may not properly regulate the heart’s rhythm and rate, according to the FDA.”
  • Govexec tells us,
    • “The Office of Personnel Management is laying off its entire procurement team as the federal government’s human resources agency continues to reduce its footprint.
    • “Employees were informed Friday that their positions were being “abolished” and they would be separated from federal service in 60 days. The decision is separate from the ostensibly for-cause firings that OPM kicked off internally earlier this month and have subsequently swept up agencies throughout the government. 
    • “The employees impacted by Friday’s moves received reduction-in-force notices from acting OPM Director Charles Ezell, who said he was issuing the layoffs due to three separate executive orders issued by President Trump.” 
  • The IRS issued guidance about “Health Coverage Reporting Required by Sections 6055 and 6056,” the IRS 1095-B and 1095-C forms following up on a statutory change that occurred last December.

From the judicial front,

  • Politico reports.
    • “A federal judge blocked President Donald Trump’s bid to deprive federal funding from programs that incorporate “diversity, equity and inclusion” initiatives.
    • “U.S. District Judge Adam Abelson ruled that Trump’s policy likely violates the First Amendment because it penalizes private organizations based on their viewpoints. And the judge said the policy is written so vaguely that it chills the free speech of federal contractors concerned they will be punished if they don’t eliminate programs meant to encourage a diverse workforce.
  • Per Govexec,
    • “A federal judge in Washington, D.C., on Friday ended a weekslong-halt on the Trump administration’s plan to put the vast majority of employees at the U.S. Agency for International Development on administrative leave, denying unions’ request to issue a preliminary injunction in the case.
    • “The American Foreign Service Association and the American Federation of Government Employees sued to block the apparent effort to decimate the agency and reposition it under the auspices of the State Department. More than 2,000 employees were briefly placed on paid administrative leave before the court’s initial intervention earlier this month, and another 2,000 workers mostly stationed overseas also are on the at-least-temporary chopping block.
    • “U.S. District Judge Carl Nichols, a Trump appointee, had devoted most of his attention during hearings to concerns regarding the continued safety of those overseas workers stationed in high-risk regions. But recent filings from Peter Marocco, the agency’s day-to-day chief under Acting Administrator and Secretary of State Marco Rubio, stating that overseas employees will continue to have access to security-related systems like the SAFE Alert system and the SCRY Panic smartphone app, assuaged the judge’s fears.”
  • Beckers Hospital Review relates,
    • “The Trump administration plans to defend the ACA requirement that requires insurers to fully cover certain preventive services for their members. 
    • “On Feb. 18, the Justice Department filed a brief with the Supreme Court, arguing in favor of maintaining the Biden administration’s stance regarding the landmark case that centers on whether employers can exclude covered services on religious grounds. Specifically, the case addresses the authority of the U.S. Preventive Services Task Force (USPSTF) in mandating coverage for preventive services, including medications such as PrEP for HIV prevention.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in most 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 is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
    • “Additional Respiratory Illnesses
      • “Pertussis
        • “Reported cases of whooping cough (pertussis) continue to be elevated nationwide. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.
      • “Mycoplasma pneumoniae
        • “Respiratory infections caused by the bacteria Mycoplasma pneumoniae have declined from their peak in late 2024 but remain high nationwide, especially in young children. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
      • “Group A Strep
        • “Respiratory infections caused by group A Streptococcus bacterium, such as strep throat and scarlet fever, are elevated nationwide. This is typical for this time of year. Healthcare providers can do a quick test to see if someone has strep throat or scarlet fever and if treatment with antibiotics can help. Learn more: About Strep Throat | Group A Strep | CDC.
    • Season Outlook
      • “The CDC has determined that the highest hospital demand for COVID-19, flu, and RSV to date this season occurred during the week ending February 1, 2025, and it was lower than the peak demand from last season. However, influenza activity remains high in most areas.
      • “The peak hospital demand due to COVID-19 during this fall and winter respiratory season was lower than all previous seasons, and nearly 50% lower than the peak demand last season.
      • “CDC does not anticipate producing additional respiratory disease outlook updates during the remainder of the 2024-2025 season. Read the entire 2024-2025 Respiratory Season Outlook – February Update (2/19/2025)”
  • Per Medscape, “A weekly alcohol intake exceeding the limits recommended by US guidelines was associated with an increased risk for coronary heart disease (CHD) among young and middle-aged men and women. Women had a higher risk for CHD than men, especially when heavy episodic drinking was involved.”
  • ABC News reports,
    • “Rates of drug overdose deaths decreased in the United States for the first time since the COVID-19 pandemic began, according to new federal data published early Thursday.
    • “The rate of overdose deaths fell from 32.6 deaths per 100,000 people in 2022 to 31.3 per 100,000 people in 2023, a 4% decrease, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
    • “Dr. Aitzaz Munir, an assistant professor of psychiatry at Rutgers New Jersey Medical School and associate program director for the Rutgers Addiction Medicine Fellowship Program, told ABC News the drop in the overdose death rate was “surprising” to him but a positive sign.”
  • The National Cancer Institute lets us know,
    • “Women who are pregnant routinely undergo prenatal blood testing to screen their fetuses for chromosomal disorders such as Down syndrome. However, in rare cases, this noninvasive prenatal testing (NIPT) will result in an abnormal or inconclusive finding that isn’t related to the fetus but rather, to the mother’s DNA. 
    • “The results of a study of more than 100 women with unusual NIPT findings but a normally developing fetus now show that such findings can have serious implications for the mother. Nearly half of the women in the study turned out to have cancer Exit Disclaimer, the researchers reported December 5 in the New England Journal of Medicine.
    • “Most of these cancers were only detected through whole-body magnetic resonance imaging (MRI), which is not yet routinely used by doctors to follow up on abnormal NIPT results. In contrast, standard diagnostic tests, such as physical exams and blood work, missed many of the cancers.
    • “These cancers tend to be truly hidden,” said co-lead investigator Amy Turriff, M.S., of the National Human Genome Research Institute. “Our study found that whole-body imaging is critical to sufficiently evaluate women who receive these [abnormal] results for cancer.”
    • “I hope [these findings] will increase awareness of these types of results and what should be done to triage these patients to the appropriate levels of care,” said Neeta Vora, M.D., of the University of North Carolina School of Medicine, who studies prenatal genetic testing and maternal cancers but was not involved in the study.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies the most common reasons for hospitalizations.
    • “Maternal and neonatal stays accounted for 22% of hospitalizations in 2021, a recent KFF report found.
    • “The report is based on data from the American Hospital Association annual survey, the American Medical Association physician practice benchmark survey, the Census Bureau delineation files and population estimates, the healthcare cost and utilization project national inpatient samples, RAND hospital data and other sources.
    • “Maternal stays accounted for 1 in 10 hospitalizations and neonatal stays accounted for the same; hospital stays for mothers and newborns were recorded separately. Medicaid covered about 41% of births nationally.
    • “Other hospitalizations were categorized as medical (50%), surgical (18%), injury (5%), and mental health and substance abuse (5%) discharges.”
  • Per AIS Health,
    • “When it comes to how the country’s three dominant PBMs cover the blockbuster drug Humira (adalimumab) and its many biosimilars, one year has made a major difference.  
    • “As of 2025, AbbVie’s Humira either “has or will vanish from PBMs’ standard formularies,” Drug Channels CEO Adam Fein, Ph.D., wrote in his annual post analyzing which drugs were excluded on the standard commercial formularies offered by The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx, as of January 2025.”
  • Kauffman Hall offers an infographic about “The State of Trust in Public Health in AmericaMedCity”
  • MedCity News shares seven announcements from the VIVE Conference, a few of which already were included in the FEHBlog.
  • Per Fierce Pharma,
    • “Pfizer is pulling further away from the gene therapy field with its decision to discontinue hemophilia product Beqvez.
    • “The New York pharma is ending global development and commercialization of Beqvez less than a year after an FDA approval for the gene therapy to treat hemophilia B. The one-time treatment carried a list price of $3.5 million per person.
    • “Several reasons led to the discontinuation, including limited interest from patients and doctors toward hemophilia gene therapies to date, a Pfizer spokesperson told Fierce Pharma in a statement.
    • “No patients seem to have received commercial Beqvez since its FDA nod in April 2024. The Pfizer spokesperson said the company will communicate the news to patients and providers that are in the treatment qualification process, adding that the company remains committed to supporting those who received the med in any clinical trial.
    • “Following Beqvez’s exit from the market, Pfizer has no commercial or clinical-stage gene therapies left in the works, according to its website. The spokesperson confirmed that the company doesn’t have any active gene therapy programs at the moment.”

Thursday Report

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

From Washington, DC,

Capitol Hill News

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

White House news

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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