Midweek Update

OPM

Midweek Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • Per a House Oversight Committee press release,
    • “As part of the budget reconciliation process, the House Committee on Oversight and Government Reform held a markup today and passed budget legislation that advances President Trump’s agenda and saves American taxpayers over $50 billion. The Committee will now finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • Govexec provides details on the markup here.
  • Federal News Network tells us,
    • “Agencies are facing a roughly two-week deadline to show the Trump administration how they plan to implement coming changes for probationary employees.
    • “By May 16, agencies are expected to report their plans for adding a new “affirmative” certification requirement for probationary employees. Agencies are also expected to detail how they intend to train supervisors and HR practitioners on the coming changes, according to new guidance the Office of Personnel Management published Tuesday.
    • “The guidance outlines more detailed expectations for agencies to update how they manage probationary periods following President Donald Trump’s executive order last Thursday. That order called for the creation of “Civil Service Rule XI” and added a hurdle for probationary employees to clear before they become tenured employees. Agencies will now be required to review and actively sign off on probationary workers’ continued employment before they can reach a tenured employment status.”
  • Per Healthcare Dive,
    • “House Republicans are calling on the Center for Medicare and Medicaid Innovation to rethink its priorities under the Trump administration, including by improving transparency with providers and focusing on payment models that save the government money.
    • “In a letter sent this week by Republicans on the House Ways and Means Committee to CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton, lawmakers said they were “concerned” with the innovation center’s track record of creating models that often don’t improve care quality or reduce costs. 
    • “The legislators added that CMMI has also “promoted a political agenda ahead of its Congressionally mandated purpose,” like focusing on health equity instead of cost savings.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Nearly 12% of Americans still smoke cigarettes, the leading cause of preventable death nationwide. Yet there are only two medications authorized by the Food and Drug Administration to help them quit — the more effective of which, varenicline, can come with unsavory side effects like nausea that make people less likely to stick with treatment.
    • “A new pill with fewer side effects could soon be available from the Washington state-based biotech Achieve Life Sciences. The company plans to file for FDA approval of its drug, called cytisinicline, in June. 
    • “Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 and to launch in the U.S. by the end of that year. “This will be the first new drug for nicotine dependence in nearly 20 years,” he said.” 
  • Fierce Healthcare informs us,
    • “While Johnson & Johnson isn’t the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New Jersey drugmaker is confident that a broad label will land its product an enviable market position in the long run.
    • “The FDA on Wednesday approved J&J’s nipocalimab under the brand name Imaavy as a new treatment option for generalized myasthenia gravis (gMG). The green light, which J&J says covers the “broadest population of people living with gMG,” includes patients ages 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
    • “Anti-AChR and anti-MuSK antibody-positive people make up more than 90% of the total antibody-positive gMG population, J&J estimates. All told, the company figures gMG—which causes the communication between the body’s nerves and muscles to break down—affects around 700,000 people worldwide.”
  • Per MedTech Dive,
    • “Medtronic has won Food and Drug Administration approval for the Omniasecure defibrillation lead, the company said Friday.
    • “The lead connects to an implantable defibrillator and treats potentially life-threatening types of irregular heart rhythm. Medtronic said Omniasecure is the world’s smallest defibrillation lead.
    • “The approval limits the use of the lead to the right ventricle. Medtronic shared data on placing the lead in the left bundle branch last week but has yet to win FDA approval in that setting.
  • MedCity News lets us know,
    • “Patients with the most severe form of a certain inherited disease have skin that is susceptible to wounds, some that never fully heal. For years, the only treatment was supportive care, including laborious and frequent changes of wound dressings covering much of the body. Biotechnology research in this disease, epidermolysis bullosa (EB), has pursued therapeutic options. A personalized treatment that Abeona Therapeutics makes from a patient’s own skin cells is now approved by the FDA, marking the agency’s third approval in this rare disorder in the past two years.
    • “The regulatory decision announced Tuesday covers the treatment of wounds in adults and children who have recessive dystrophic epidermolysis bullosa (RDEB). The therapy, known in development as prademagene zamikeracel, or pz-cel for short, will be marketed under the brand name Zevaskyn. Cleveland-based Abeona expects Zevaskyn will become available in the third quarter of this year.
    • “We have heard from the RDEB community that there is a persistent, unmet need to meaningfully heal RDEB wounds, especially those that are chronic and prone to infection,” CEO Vishwas Seshdari said during a Tuesday morning conference call. “Through a single application, Zevaskyn can provide people with RDEB the opportunity for significant wound closure and pain reduction in even the most severe wounds.”

From the judicial front,

  • Federal News Network relates,
    • “The U.S. Supreme Court said Wednesday that federal employees who also are in the military reserve must be paid the equivalent of their civilian salaries when called to active duty during national emergencies.
    • “The 5-4 decision could affect hundreds of thousands of people, ensuring that they don’t suffer financially when they temporarily leave one form of government service for another.
    • “The justices ruled in an appeal filed by an air traffic controller who spent about five years on active duty in the Coast Guard at a pay rate lower than what he earns as a Federal Aviation Administration employee.”
  • Reuters reports,
    • “Genetic testing company 23andMe agreed on Tuesday to allow a court-appointed overseer to take charge of ensuring customers’ genetic data remains protected during the company’s bankruptcy, settling a dispute with several U.S. states.
    • “Those states had argued the company was not taking data security seriously enough.
    • “U.S. Bankruptcy Judge Brian Walsh approved the agreement at a court hearing in St. Louis, Missouri, ordering the appointment of a consumer protection ombudsman who will be empowered to review 23andMe’s handling of customers’ genetic information and its security policies.”

From the public health and medical research front,

  • CNBC reports,
    • “Aon researchers found that within two years, improved health outcomes for patients who were taking GLP-1 drugs lowers the growth rate of medical care costs. 
    • “Aon looked at medical claims data for 139,000 U.S.-based workers with employer health coverage who took GLP-1 medications between 2022 and 2024.
    • “Since 2023, GLP-1s have driven up employer spending on drugs at a faster pace than high-priced specialty drugs used to treat cancer and autoimmune conditions, according to an Evernorth study.”
  • Beckers Hospital Review considers what is driving increased use of GLP-1 drugs among children.
  • Per Cardiovascular Business,
    • “Drinking champagne may be associated with significant cardiovascular benefits, according to a new study published in the Canadian Journal of Cardiology.
    • “The study identified dozens of lifestyle changes that may help lower a person’s risk of sudden cardiac arrest (SCA). Some of the changes—eating more fruit, losing weight—were straightforward, but a few of the research team’s findings were unexpected. Drinking champagne and/or white wine, for example, was linked to a reduced SCA risk. The same was also true for spending more time at a computer—though that may tell us more about education levels than screen time.
    • “These findings all come from a new exposome-wide association study (EWAS) out of China. The study’s authors explored the UK Biobank study, focusing on data from more than 500,000 patients. They then looked for associations between SCA and 125 different modifiable lifestyle factors.
    • “To our knowledge, all previous studies on the risk factors of SCA were hypothesis-driven and focused on a limited number of candidate exposure factors grounded in previous knowledge or theoretical frameworks,” wrote first author Huihuan Luo, PhD, a researcher with Fudan University in Shanghai, China, and colleagues. “This might lead to publication bias distorting summary conclusions and might increase the likelihood of false positive findings resulting from inter-related exposures. More importantly, the hypothesis-driven approach might miss important exposures or relationships beyond the predefined hypothesis. To tackle these limitations, a hypothesis-free, data-driven EWAS has emerged as a robust analytical framework for simultaneously exploring hundreds of exposures. This data-driven approach does not rely on previous knowledge and facilitates the identification of novel or underexplored associations.” * * *
    • Click here for the full study.
  • Per Medscape,
    • “People with osteoarthritis are more likely to be diagnosed with other pain-related comorbidities such as fibromyalgia, chronic fatigue syndrome (CFS), gout, and irritable bowel syndrome and psychological comorbidities such as depression, according to observational data presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting.
    • “The study also found that all these five conditions were themselves associated with an increased risk for incident osteoarthritis, and in the case of fibromyalgia, there may be a causal association.
    • “Physiotherapist and epidemiologist Subhashisa Swain, MPH, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, Oxford, England, presented an analysis of data from the multicenter European Comorbidities in Osteoarthritis (ComOA) study, which is examining electronic health records to identify associations between 61 different comorbidities with osteoarthritis and the clusters and trajectories of those comorbidities and osteoarthritis.”
  • The New York Times offers guidance on hip exercises.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana beat earnings expectations for the first quarter and reaffirmed its 2025 guidance on Wednesday, after medical costs came in as predicted. It’s a positive development for the insurer, which has been rocked by higher spending in privatized Medicare plans and the safety-net Medicaid program.
    • “Humana attributed the results to higher Medicare and Medicaid premiums and membership growth in Medicare prescription drug plans and state contracts. Earnings were offset somewhat by an ongoing decline in Medicare Advantage membership after Humana culled underperforming plans to resuscitate margins this year.
    • “However, it’s still early in 2025, so Humana is remaining cautious when it comes to medical utilization, executives said. The payer’s outlook is also complicated by uncertainty stemming from its ongoing legal bid to improve MA quality ratings.”
  • The American Hospital Association News notes,
    • “The AHA April 30 released a report highlighting how hospitals and health systems continue to experience significant financial headwinds that can challenge their ability to provide care to their patients and communities. The report outlines the financial burden of heightened expenses hospitals have faced in recent years in caring for patients, as well as the increasing strain on the field.  
    • “It explains how hospitals have raised wages to recruit and retain staff amid workforce shortages and how Medicare and Medicaid continue to underpay hospitals for patient care as shortfalls worsen. Other findings include how practices of certain Medicare Advantage plans exacerbate hospitals’ financial burden, and that tariffs on medical imports could significantly raise costs for hospitals as nearly 70% of medical devices marketed in the U.S. are manufactured exclusively overseas. 
    • “This report should serve as an alarm bell that a perfect storm of rising costs, inadequate reimbursement, and certain corporate insurer practices are jeopardizing the ability of hospitals to deliver high-quality, timely care to their communities,” said AHA President and CEO Rick Pollack. “With so much at stake, policymakers must recommit to making preserving access to hospital care a national priority.” 
  • The Wall Street Journal reports,
    • “Trump’s executive order on drug prices is seen as a win for the pharmaceutical industry.
    • “Drugmakers spent millions lobbying against pharmacy-benefit managers (PBMs), blaming them for high drug prices.
    • “PhRMA funded various groups, including minority healthcare nonprofits, to criticize PBMs.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group announced Tuesday that Patrick Conway, M.D., would take the helm of its Optum division.
    • “Conway, an insurance industry and health policy veteran, was previously the CEO of Optum’s pharmacy benefit management unit, Optum Rx. He also held leadership roles at the company’s healthcare delivery arm, Optum Health.
    • “Conway will step in as CEO of Optum on May 6. His prior work includes serving as the director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services, which is responsible for developing critical payment models for government insurance programs.”
  • and
    • “Despite the poor financial performance of BetterHelp, whose revenue fell by 11% in Q1, Teladoc has grown its investment in virtual mental healthcare by acquiring UpLift in a $30 million all-cash transaction.
    • “The deal closed on April 30, the same day as Teladoc’s first quarter 2025 earnings call. The company fared worse than Wall Street expected in Q1, posting a net loss of $93 million, or $0.53 lost per share. Wall Street Analysts expected the company share price to decrease by $0.33.
    • “A significant upside to the acquisition is the new-found ability for BetterHelp customers to use insurance coverage for mental health services, a barrier that has kept some customers from signing up with the cash-pay mental health provider. UpLift will be included in the company’s BetterHelp reporting segment going forward, executives said.
    • “UpLift provides virtual mental health therapy, psychiatry and medication management services. It serves the health plan market and covers 100 million lives. It has a network of over 1,500 mental health providers.”
  • Per BioPharma Dive,
    • “Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA.
    • “Announced Wednesday, the acquisition will hand the Swiss pharmaceutical firm a drug prospect called farabursen, which recently completed a Phase 1b study in people with autosomal dominant polycystic kidney disease, or ADPKD.
    • “Per deal terms, Regulus shareholders will receive $7 in cash per share, a premium of more than 100% to the stock’s closing price Tuesday. Additionally, Novartis has committed to pay an additional $7 per share via a so-called contingent value right that’s linked to the achievement of an unspecified regulatory milestone.”
  • and
    • “Sales of BridgeBio’s new heart medicine Attruby blew past analyst expectations in the first quarter, as the company built by “science nerds” took on market behemoth Pfizer.
    • “Net product revenue reached $36.7 million in the period, surpassing the consensus analyst estimate of $12.6 million. The drug won Food and Drug Administration approval in November to treat a genetic condition known as transthyretin amyloidosis with cardiomyopathy.
    • “As of April 25, Attruby had 2,072 prescriptions written by 756 prescribers, BridgeBio said Tuesday after the market closed. That momentum built on encouraging numbers released in February and helped push the company’s shares up in early trading Wednesday.”
  • Per Beckers Hospital Review,
    • “Mark Cuban Cost Plus Drug Co. has secured another partnership targeting the specialty pharmaceutical market, according to an April 28 news release shared with Becker’s. 
    • “EverPharm, a specialty unit-dose medication company, is joining its portfolio with Cost Plus Drugs’ pricing model, which is the drug’s manufacturing cost plus a 15% markup and a $10 shipping and labor fee. On April 16, Cost Plus Drugs launched a similar partnership with Morris & Dickson, a full-line and specialty pharmaceutical distributor. 
    • “The partnership with EverPharm will roll out in phases, the release said, with an initial focus on offering key unit-dose medicines to pharmacies and healthcare providers through the Cost Plus Marketplace.” 

Weekend update

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

From Washington, DC

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

From the public health and medical research front,

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

Thursday Report

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

From Washington, DC

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

From the judicial front,

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

In State government news,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

From Washington, DC,

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

In Food and Drug Administration news,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–
Texas Blue bonnets

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump’s “one big, beautiful bill” is headed for one big, ugly negotiation. 
    • “Congressional Republicans last week approved the fiscal blueprint that lets them pack disparate items from Trump’s wish list into a single bill that won’t need Democratic votes. GOP lawmakers expect the giant legislation to extend expiring tax cuts, implement Trump’s new tax-cut promises, increase the debt limit, cut spending and boost border security and national defense. 
    • “The one-bill strategy bets that Republicans lock arms with Trump and plunge ahead, unwilling to defy the president on an up-or-down vote on his agenda. Packaging everything together could give each party faction victories to highlight, even if they must accept pieces they detest. 
    • “The next few months will bring a blur of policies, numbers and congressional procedures that will make Republicans confront internal fractures over tax rates, incentives, Medicaid and budget deficits. The unity they have displayed so far will be tested, particularly in the House, where Speaker Mike Johnson (R., La.) has guided a fractious majority through tight votes by reassuring lawmakers they can fight over details later.”
  • Federal News Network lets us know,
    • “Although the details of House Republicans’ narrowly approved budget framework are still up in the air, some initial proposals show the possibility of changes to federal benefits, mainly in retirement and health care.
    • “As part of the GOP budget resolution, the House Oversight and Government Reform Committee is looking at cuts of at least $50 billion from its mandatory spending, according to the framework that lawmakers approved in a vote of 216-214 on Thursday. That level of spending cuts would almost certainly dig into federal benefits, the National Active and Retired Federal Employees Association (NARFE) said.
    • “Given the only major mandatory spending under the committee’s jurisdiction is federal retirement and health benefits, cuts of such a magnitude would necessarily come from cuts to federal retirement and health benefits,” NARFE wrote in a letter to Congress last week.” * * *
    • “A spokesperson for Oversight Committee Republicans declined to comment on where the proposed spending cuts would most likely move forward. But many proposals are already circulating, including several possibilities that could bring changes to federal employees’ retirement benefits, health insurance and more.”
  • Govexec adds,
    • “President Trump appears set to propose freeze civilian federal employees’ pay next year, according to draft budget documents.
    • “The news came in the form of a passback, which is effectively the Office of Management and Budget’s response to agencies’ individual budget submissions. A report by the Congressional Research Service says agencies can appeal certain programmatic decisions to OMB, the documents are, for all intents and purposes, the office’s final decision.
    • “A copy of one agency’s passback, obtained by Government Executive, said the document’s funding levels “reflect a pay freeze for civilian employees in calendar year 2026.”
    • “If enacted, it would mark the first year that federal workers have not received a pay increase since 2013, the last of three years of pay freezes amid sequestration. President Trump previously proposed pay freezes in the first three of his annual budget submissions, but Congress ultimately overruled him each time, with raises in the range of 1.4% to 2.6%.
    • “In 2020, he proposed a 1% across-the-board pay increase for feds as part of his budgetary request but reneged on that pledge and supported efforts to freeze their pay later in funding negotiations. Congress ultimately adopted the 1% increase that year.”
  • The American Hospital Association points out a bevy of proposed Medicare regulations.
    • “The Centers for Medicare & Medicaid Services April 11 issued a  proposed rule that would increase Medicare inpatient prospective payment system rates by a net 2.4% in fiscal year 2026, compared with FY 2025, for hospitals that are meaningful users of electronic health records and submit quality measure data. 
    • “This 2.4% payment update reflects a hospital market basket increase of 3.2% as well as a productivity cut of 0.8%. This update also reflects CMS’ proposal to rebase and revise the market basket to a 2023 base year. In addition, the rule includes a proposed $1.5 billion increase in disproportionate share hospital payments and a proposed $234 million increase in new medical technology payments. Overall, it would increase hospital payments by $4 billion in FY 2026 as compared to FY 2025.  
    • “In addition, CMS has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.”
  • and
    • “The Centers for Medicare & Medicaid Services April 11 proposed increasing the long-term care hospital standard rate payments by 2.2% in fiscal year 2026 relative to FY 2025. This includes a 3.4% market basket update reduced by a 0.8 percentage point productivity adjustment. In addition, it includes a reduction of 0.3 percentage points due to CMS’ proposal to raise the fixed-loss amount for high-cost outlier payments to $91,247. The agency also has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.”
  • and
    • “The Centers for Medicare & Medicaid Services April 11 issued a proposed rule for the inpatient psychiatric facility prospective payment system for fiscal year 2026.  
    • “CMS proposes to increase IPF payments by a net 2.4%, equivalent to $70 million, in FY 2026. The payment update reflects a proposed market-basket update of 3.2% minus a productivity adjustment of 0.8 percentage points. CMS also proposes to update the outlier threshold so that estimated outlier payments remain at 2.0% of total payments. In addition, the agency would increase the adjustment factors for IPFs with teaching status and rural location and recognize increases to IPF teaching caps as required by law.”
  • and
    • The Centers for Medicare & Medicaid Services April 11 issued a proposed rule for the skilled nursing facility prospective payment system for fiscal year 2026. The proposal would increase aggregate payments by 2.8%, which reflects a 3.0% market basket update, a 0.8 percentage point cut for productivity, and an increase of 0.6 percentage points for the market basket forecast error for FY 2024. CMS also is proposing changes to some ICD-10 code mappings for payment classifications. In addition, it has included in the rule its previously published request for information seeking input on opportunities to streamline regulations and reduce burdens on providers.  
  • CMS adds
    • On April 11, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that proposes updates to Medicare payment policies and rates for hospices under the Fiscal Year (FY) 2026 Hospice Wage Index and Payment Rate Updated Proposed Rule (CMS-1835-P). CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for hospices annually. 
  • The public comment deadline for all five proposed rules is June 10, 2025. FEHB carriers certainly would appreciate receiving

From the public health and medical research front,

  • The New York Times offers “Five Science-Backed Longevity ‘Hacks’ That Don’t Cost a Fortune.” Check it out.
  • Per Kaufmann Hall,
    • This week’s graphic highlights data from a recent study published by The Lancet on cancer incidence trends in the United States between 2000 and 2019 among those born between 1920 and 1990. Of the 34 types of cancer studied, 17 were found to have an increased incidence among those from the Generation X and Millennial cohorts. Compared to individuals in the 1955 cohort, incidence of small intestinal, thyroid, kidney and renal pelvic, and pancreatic cancers among those in the 1990 cohort was about three times higher. The incidence of those in the Generation X cohorts was also higher among these four cancers compared to the 1955 cohort’s rate. More adults are also getting diagnosed with cancer at younger ages
  • The Wall Street Journal considers “The Latest in Hernia Repair: New Techniques, New Research. As the population ages, the incidence of hernias is increasing. How do you know when surgery is needed?”
  • The Guardian reports,
    • “People who use the drug Mounjaro are able to sustain weight loss for three years, data from a trial suggests.
    • “Mounjaro, nicknamed the “King Kong” of weight loss drugs, contains tirzepatide and is self-administered in once-a-week injections.
    • “It works by mimicking two hormones called GLP-1 and GIP, resulting in appetite suppression, increased production of insulin, greater insulin sensitivity and a reduction in the rate at which food is emptied from the stomach. The medication is available for weight loss to some people on the NHS and it can also be bought privately with a prescription.”
  • Per Medscape,
    • Now that the US Food and Drug Administration has removed both tirzepatide and semaglutide from its Drug Shortages List, the widespread compounding of these drugs is ending. Tirzepatide’s deadline has already passed, while physicians and pharmacies have until April 22 for semaglutide. An estimated 2 million Americans have been using these more affordable copycats every month.
    • Even with direct-to-consumer discounts, monthly doses of brand-name versions cost hundreds more than compounded ones, putting them beyond the reach of many people. This means a significant number of compounded glucagon-like peptide 1 (GLP-1) users will be forced to go cold turkey — but studies consistently show weight regain when patients stop taking them abruptly. [The article suggests] how can you help your patients?
  • Per NPR Shots,
    • “Scientists have re-created a pain pathway in the brain by growing four key clusters of human nerve cells in a dish.
    • “This laboratory model could be used to help explain certain pain syndromes and offer a new way to test potential analgesic drugs, a Stanford team reports in the journal Nature.
    • “It’s exciting,” says Dr. Stephen Waxman, a professor at Yale School of Medicine who was not involved in the research.”

From the U.S. healthcare business front,

  • The KFF Peterson Health System Tracker assesses how cost affects access to healthcare and examines challenges with effective price transparency analyses.
  • Beckers Hospital Review tells us,
    • Physicians are seeing slower pay growth in the last year amid economic uncertainty, according to Medscape’s “Physician Compensation Report 2025.”
    • The company surveyed 7,322 physicians across 29 specialties from Oct. 3, 2024 to Jan. 15, 2025, and found compensation increased around 3.6% on average for physicians, which was the lowest growth rate since 2011 when Medscape first began reporting compensation.
    • Pay gains were around 1.4% for primary care physicians, hitting $281,000 last year, and 1% for specialists, hitting $398,000. Pay growth was the lowest since 2021 at the height of the pandemic. The pay figures cover base salary, incentive bonus and other income including profit-sharing.
    • “Specialists’ compensation was squeezed by payer reimbursement cuts, and we saw fewer specialties reporting pay increases than in several years,” the report states. “Nor was it a banner year for primary care physicians. With a lot of uncertainty in the political and regulatory arenas, and the post-COVID salary spending seemingly done, it seems like a good time for physicians to be careful with their expenses.”
  • and
    • “U.S. Bankruptcy Court Judge Kate Stickles has approved N.J.-based Hudson Regional Hospital to take over operational control of three Jersey City, N.J.-based CarePoint Health hospitals, allowing the system to exit bankruptcy.
    • “Hudson Regional now owns and operates Bayonne (N.J.) Medical Center and operates both Jersey City-based Christ Hospital and Hoboken (N.J.) University Medical Center, under the approved management agreement. Each hospital is now operated by an affiliated property owner, according to an April 11 news release shared with Becker’s.” 

Thursday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.