Friday Report

Generative AI

Friday Report

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

From Washington, DC

  • Fierce Healthcare lets us know,
    • Bipartisan lawmakers have introduced a bill that aims to more closely align Medicare insurers’ prior authorization denials with medical need, as determined by board-certified specialist physicians.
    • The Reducing Medically Unnecessary Delays in Care Act of 2025 was introduced in the House Thursday by Rep. Mark Green, M.D., R-Tennessee, and referred to committee. It is a reintroduction of similar bills brought by the lawmaker in 2023 and 2022.
    • Green—along with Reps Greg Murphy, M.D., R-North Carolina, and Kim Schrier, M.D., D-Washington, who also backed the bill—said the legislation will help streamline necessary care and reduce administrative burden and burnout among providers.
  • Roll Call tells us,
    • “President Donald Trump on Friday threw his support behind the funding fix needed to allow the District of Columbia’s government to avoid $1.1 billion in budget cuts squeezed in the remaining half of the fiscal year, all but ensuring House passage of legislation the Senate passed two weeks ago.
    • “The full-year stopgap spending law, drafted by House Republicans, did not include the typical provision that would allow the D.C. government to tap into its fiscal 2025 budget for operating costs. This would force D.C. to go back to the previous year’s funding levels for the remainder of the fiscal year, which runs through Sept. 30, which local officials say would require steep cuts in critical services like law enforcement and education.”
  • STAT News reports,
    • “Peter Marks, the top Food and Drug Administration official who oversaw vaccines, gene therapies, and the blood supply, resigned Friday after being told by Trump administration officials he would be fired if he did not step down, according to people familiar with the situation.”
  • and
    • “President Trump has selected Sara Carter, a conservative journalist and Fox News contributor, as the nation’s next drug czar.” * * *
    • “If confirmed by the Senate, Carter would oversee the White House Office of National Drug Control Policy, an executive office housed across the street from the West Wing that makes policy recommendations and coordinates efforts between various federal agencies focused on substance use, both from a law enforcement and public health perspective.” 
  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today joined West Virginia Governor Patrick Morrisey for a press conference at the St. Joseph School in Martinsburg, WV, to celebrate the signing of new legislation banning seven types of harmful food dyes from school lunches beginning August 2025. Governor Morrisey announced at the event that he intends to request a waiver to restrict taxpayer funds from being used to purchase soda through the SNAP program.”

From the judicial front,

  • Healthcare Dive points out,
    • “The Department of Justice agrees that Claritev, formerly known as MultiPlan, conspired with health insurers to underpay doctors for medical care, according to a statement of interest filed by antitrust regulators on Wednesday in the consolidated lawsuit from providers against the cost management firm.
    • “Lawyers for the providers said the DOJ’s position affirms the validity of their case, while Claritev reiterated that it believes the lawsuits are without merit.
    • “The DOJ’s interest in the case signals antitrust regulators, including in the Trump administration, are still closely scrutinizing exchanges of potentially sensitive information between companies, along with their use of pricing algorithms.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “After much delay, Novartis has finally won a key FDA go-ahead for Pluvicto, opening up the radioligand therapy to a much broader prostate cancer population.
    • “The new approval, which triples Pluvicto’s eligible patient population, allows the radiopharmaceutical to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) before taxane-based chemotherapy, Novartis said Friday. Patients will have to have been treated with an androgen receptor pathway inhibitor (ARPI) to be considered.
    • “Pre-chemo mCRPC represents the most important indication in Novartis’ plan for Pluvicto to achieve more than $5 billion in peak sales. Initially cleared by the FDA in 2022 in the post-chemo setting, Pluvicto’s revenue is currently annualizing at about $1.5 billion based on its most recent quarterly number.”
  • and
    • Over the last three years, the FDA has approved six new hemophilia drugs, including three gene therapies.
    • Into this crowded treatment landscape comes another new medicine as the FDA has signed off on Sanofi’s Qfitlia (fitusiran), which sets itself apart as the only treatment for all types of hemophilia.
    • Not only is Qfitlia for those with hemophilia A and B, but unlike most treatments for the disorder, it also can be used by patients regardless of their inhibitor status.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.
    • “Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.” * * *
    • “This announcement follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.”
  • Per Managed Health Executive,
    • “Fresenius announced today [March 27, 2025] that the FDA has approved the biologics licensing applications (BLA) for denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), according to a news release. Prolia, the reference product for Conexxence, and Xgeva, the reference product for Bomyntra, were both developed by Amgen. As a result of a global settlement between Fresenius and Amgen, both biosimilars are expected to launch in the United States in mid 2025 and in the second half of 2025 in Europe.
    • “Bomyntra and Conexxence are the fourth pair of denosumab biosimilars. Other Prolia biosimilars include Jubbonti, Ospomyv and Stoboclo. Additional Xgeva biosimilars include Wyost, Xbryk and Osenvelt.
    • “Although the active drug ingredient in Conexxence and and Bomyntra is deosumab, they have different indications.
    • ‘Conexxence is approved for patients at high risk for fractures, including osteoporosis patients and patients undergoing cancer treatments that affect bone density. It comes as a 60 mg/mL single-dose prefilled injection to be administered every six months via subcutaneous injection. Adverse reactions varied by indication.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is declining nationally to low levels. 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 continues to decline; however, 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 American Hospital Association News adds,
    • “There are 483 confirmed cases of measles in 19 states across the country, according to the latest data from the Centers for Disease Control and Prevention. The agency said 93% of the cases are outbreak-associated. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • NBC News adds,
    • “We are experiencing an extremely concerning decline in measles vaccination in the very group most vulnerable to the disease,” said Benjamin Rader, a computational epidemiologist at Boston Children’s Hospital, an assistant professor at Harvard Medical School and the author of a recent study that looked at children’s vaccination rates.” * * *
    • “Rader said that the true MMR vaccination rate among young children can be misrepresented by publicly reported numbers, because MMR surveillance is drawn from older children who are already in kindergarten.
    • “Younger children under the age of 5 are not fully captured in surveillance data because they have not reached kindergarten age — although a 2021 estimate from the CDC notes a subset of younger children, namely those who received at least one MMR dose by 24 months, were 90.6% vaccinated for measles.
    • “In Rader’s study, published online in February in the American Journal of Public Health, his team surveyed approximately 20,000 parents of children under 5 from July 2023 through April 2024, finding only 71.8% reported that their children received at least 1 dose of MMR vaccine — much lower than CDC estimates.
    • “The researchers used a digital surveillance platform that the CDC has used to estimate things like at-home Covid testing, he said.  
    • “Rader downplayed the difference in numbers between his findings and the CDC data, emphasizing that, while accurate, the CDC data does not provide a complete picture — despite its best intentions.
    • “Dr. Scott Roberts, associate medical director of infection prevention at the Yale School of Medicine in New Haven, Connecticut, who was not part of the research, called the findings “worrisome.”   
  • Health Day relates,
    • “Tobacco control measures like anti-smoking campaigns and cigarette taxes have prevented nearly 4 million lung cancer deaths during the past five decades, a new American Cancer Society study estimates.
    • “More than 3.8 million lung cancer deaths were averted due to substantial reductions in smoking, gaining a little more than 76 million years of extra life among Americans, researchers say in CA: A Cancer Journal for Clinicians.
    • “The substantial estimated numbers of averted lung cancer deaths and person-years of life gained highlight the remarkable effect of progress against smoking on reducing premature mortality from lung cancer,” lead investigator Dr. Farhad Islami, the ACS’ senior scientific director for cancer disparity research, said in a news release. 
    • “In fact, the number of averted lung cancer deaths accounts for roughly one-half of all cancer deaths that were prevented in recent decades, researchers said.
    • “However,” Islami added, “Despite these findings, lung cancer is still the leading cause of cancer death in the United States, and smoking-attributable morbidity and mortality from other cancers or diseases remain high.”
  • Per Healio,
    • “There were 69 nonfatal fentanyl exposures in 2015 and 893 in 2023.
    • “Two-thirds of adolescents who were exposed to fentanyl used it intentionally.” * * *
    • “According to the researchers, nearly 39.4% of all overdoses and 65.7% of those among adolescents involved intentional misuse or abuse. In contrast, 81.7% of overdoses among younger children were reported to be unintentional.
    • “It was surprising that a large portion of adolescents used fentanyl intentionally,” Palamar said. “We often think of pediatric exposures to fentanyl as being unintentional.”

From the AI front,

  • Per an NSF news release,
    • “Powered exoskeletons that enable humans to move faster or lift heavy objects more easily have been envisioned for decades. In science fiction, advanced exoskeletons such as the power loader in the movie “Aliens” or Marvel Comics’ Iron Man’s suit provide the wearer with superhuman capabilities with nearly zero limitations.
    • “There are exoskeletons in use today, but current technology falls short of the vision laid out in science fiction, and widespread use of exoskeletons is hampered because to work properly, a suit must be tested and adapted to work with each user individually, a complicated and lengthy process.
    • “Now, engineering researchers supported by the U.S. National Science Foundation have made a breakthrough, creating a new method that takes advantage of artificial intelligence and computer simulations to improve the process of enabling users and exoskeletons to work together. This framework is compatible with a variety of assistive devices and could improve the lives of millions of able-bodied and mobility-impaired individuals.
    • “This marks a major advance in exoskeleton engineering by eliminating one of its biggest hurdles: individualized calibration,” said Alexander Leonessa, program director for the NSF Mind, Machine and Motor Nexus program. “Using AI and human-robot simulations, the team developed a scalable, adaptable system that assists a wide range of users without lengthy setup. It is a key step toward making exoskeletons practical, versatile and accessible for both industry and mobility-impaired individuals – smart, human-centered engineering at its best.”

From the U.S. healthcare business front,

  • FiercePharma reports,
    • “A rival bidder has emerged to acquire struggling gene therapy specialist bluebird bio.
    • Ayrmid has offered to buy bluebird for $4.5-apiece upfront, plus a one-time contingent value right (CVR) of $6.84 per share tied to a sales milestone, bluebird said Friday.
    • “The upfront tag is 50% higher than the $3-per-share selling price that bluebird has previously penned with Carlyle and SK Capital Partners. That private equity duo’s buyout offer also includes a $6.84-per-share CVR.
    • “For now, bluebird’s board has not changed its mind and the company remains bound by the original merger agreement. But it’s willing to look at the new unsolicited non-binding written proposal.
    • “Consistent with its fiduciary duties, the bluebird Board of Directors is carefully reviewing the Ayrmid proposal in consultation with its legal and financial advisors,” the Massachusetts biopharma said Friday.”
  • Beckers Hospital Review tells us,
    • “Insight Hospital and Medical Center Trumbull and Hillside Rehabilitation Hospital, both in Warren, Ohio, paused all inpatient, outpatient and emergency room services March 27 due to ongoing bankruptcy and financial disruptions from former owner Dallas-based Steward Health Care.
    • “Tom Connelly, local president of the American Federation of State, County and Municipal Employees, told NBC affiliate WFMJ March 28 that the hospitals also laid off the director of nursing, the assistant director of nursing, the administrative secretary and the human resources coordinator.
    • “A spokesperson for Insight Health refuted the claims to Becker’s and denied upper management layoffs.
    • “Existing patients at both Insight hospitals are being transferred, with appointments being canceled to protect patient safety, an Insight Health spokesperson said in a March 27 statement shared with Becker’s.
  • Beckers Payer Issues informs us,
    • “Enrollment in provider-sponsored Medicare Advantage plans declined by nearly 60,000 members for 2025, according to a report from Chartis. 
    • “The healthcare consulting firm published an analysis of CMS Medicare Advantage enrollment data March 25. 
    • “Overall, Medicare Advantage plans gained 1.3 million new enrollees, a smaller growth rate than the program has seen in previous years. 
    • “Kaiser Permanente saw the largest membership growth for 2025 among provider-sponsored plans, gaining 58,000 new members. Trinity Health and UPMC Health Plan each added 11,000 MA members.” 

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call lets us know,
    • “Senate Majority Leader John Thune told GOP senators Wednesday that a compromise budget resolution could hit the floor for a “vote-a-rama” as soon as next week, which would allow the House to adopt it the following week before the two-week April recess.
    • “This accelerated time frame, if both chambers can adhere to it, would let Republicans hit the ground running after the recess to write the “big, beautiful” budget reconciliation bill that President Donald Trump wants.
    • “Speaker Mike Johnson, R-La., has set an informal deadline of Memorial Day to send the measure to Trump, including a massive tax cut package, more money for defense and border security, domestic energy incentives, a debt limit increase and trims to mandatory spending.
    • “As recently as Tuesday, Thune, R-S.D., had been telling colleagues that Senate consideration could slip to the week of April 7, which likely wouldn’t give the House time to act before the recess.
    • “But discussions made a big leap on Wednesday with a new strategy: provide a different, lower set of spending cut targets for Senate committees than their House counterparts. Under this scenario, the final budget resolution adopted by both chambers would “instruct” House and Senate committees differently.” * * *
    • “Both sets of instructions would be in the final budget resolution, and then the two chambers could hammer out differences later on what the actual reconciliation details look like.
    • “What needs to ultimately be reconciled is the final bill. The resolution’s looking different in two chambers, I don’t think anybody’s getting worked up about that,” Sen. Eric Schmitt, R-Mo., said Wednesday. “But eventually everybody does kind of need to unlock the process, which is what the resolution is for.”
    • “The working theory is that eventually what matters for “Byrd rule” enforcement in the Senate is whether that chamber’s reconciliation instructions are adhered to.”
  • and
    • “President Donald Trump on Thursday announced he would withdraw the nomination of New York Rep. Elise Stefanik to be U.S. ambassador to the United Nations, citing a need for Republicans to keep her seat amid narrow margins in the House. 
    • “With a very tight Majority, I don’t want to take a chance on anyone else running for Elise’s seat,” Trump posted on his Truth Social platform. “The people love Elise and, with her, we have nothing to worry about come Election Day. There are others that can do a good job at the United Nations.”
  • The American Hospital Association News tells us,
    • “The AHA March 27 voiced opposition to the Physician Led and Rural Access to Quality Care Act (H.R. 2191), a bill that would lift the ban on the establishment of physician-owned hospitals in certain rural areas and permit the unfettered expansion of POHs nationwide, regardless of location. In place since 2010, current law includes an exceptions process that allows existing POHs to expand if they accept Medicaid patients and are located in areas where beds are needed. 
    • “By performing the highest-paying procedures for the best-insured patients, physician-owners inflate health care costs and drain essential resources from community hospitals, which depend on a balance of services and patients to provide indispensable treatment, such as behavioral health and trauma care,” AHA wrote in comments to Rep. Morgan Griffith, R-Va., the bill’s author. “By increasing the presence of these self-referral arrangements, H.R. 2191 would only further destabilize community care.” 
  • Per a news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”
    • “The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.
    • “Secondly, it will streamline the functions of the Department. Currently, the 28 divisions of the HHS contain many redundant units. The restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to 5.
    • “Third, the overhaul will implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins. These priorities will be reflected in the reorganization of HHS.
    • “Finally, the restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact.” * * *
    • For more detailed information, please visit our fact sheet.
  • The HHS reorganization is worth a shot in view of the thirty yearlong federal budget outlook from the Congressional Budget Office.
  • Tammy Flanagan, writing in Govexec, offers federal retirement advice in these uncertain times.

From the public health and medical research front,

  • Medpage Today informs us,
  • and
    • “A flea-borne disease that was once largely eradicated from the U.S. may be making a resurgence, CDC researchers said during a clinician-focused call on Thursday.
    • “Murine typhus became so rare after public health efforts against it in the 1940s that it eventually stopped being a nationally notifiable disease.
    • “But now, cases are on the rise in two states that actively monitor the disease — Texas and California — and the illness may be going undiagnosed, experts said.”
  • Per a National Cancer Institute news release,
    • “Scientists have long been exploring ways to kill cancer cells by starving them of the nutrients they need to survive. A new study suggests that genetically modified fat cells could help researchers realize this goal.
    • “In the study, researchers genetically engineered white fat cells—the most common type of fat in the body—to aggressively consume nutrients such as glucose and fatty acids. When the engineered fat cells were implanted near tumors in mice, the tumors grew more slowly than tumors in mice without the engineered cells.
    • “The approach slowed the growth of cancer in mice even when the engineered fat cells were implanted far from a tumor, the researchers reported in Nature Biotechnology on February 4. 
    •  “We believe the engineered cells are outcompeting tumors for essential nutrients, suppressing the proliferation of cancer cells,” said study leader Nadav Ahituv, Ph.D., director of the University of California, San Francisco (UCSF) Institute for Human Genetics. “The findings suggest that engineered fat cells could be a new form of cellular therapy.”
  • Per Healio,
    • “Survivors [of metastatic breast cancer] who participated in [telephone-delivered] acceptance and commitment therapy reported less fatigue interference with functioning.
    • “Researchers are studying the approach for people with advanced gastrointestinal cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Nonprofit hospitals’ 2024 financial performances are beating the prior year’s tough numbers, though even the stronger organizations remain “well below pre-pandemic levels,” Fitch Ratings said.
    • “In a Thursday brief describing the financial profiles of its rated nonprofit hospitals, the agency attributed the year-to-year improvements to stronger revenues and volumes as well as slightly mitigated, but still pressured, labor spending.
    • “Fitch said the median operating margin among hospitals with early fiscal year ends (often June 30) was 1.2%, a flip from the prior year’s -0.5%. The agency said it expects the calendar year 2024 median margin for the remainder of its rated hospitals “will at least be in line” with the former group.”
    • “Persistent” labor pressures continue to push base salary and wage expenses upward by a median 6.9% among the rated hospitals, which Fitch said “would have been even higher without the sector’s ongoing efforts to recruit and retain talent, streamline operations and optimize supply chains.”
  • Beckers Hospital Review notes,
    • “Doylestown (Pa.) Health will officially join the University of Pennsylvania Health System on April 1, marking a significant expansion of Penn Medicine’s reach into Philadelphia’s northern suburbs. 
    • “The transaction follows regulatory reviews and approvals from the Pennsylvania Attorney General’s Office and the Federal Trade Commission.
    • “Under the new structure, Doylestown Health and its affiliates will be rebranded as Penn Medicine Doylestown Health. The integration combines one of the country’s leading academic health systems with a regional health system.” 
  • and
    • “Four blockbuster GLP-1 medications are expected to be among the 10 best-selling drugs in 2026, accounting for $66.8 billion in global sales, according to market research company Statista
    • “Statista predicts Ozempic will yield $22.3 billion in 2026, followed by Mounjaro with $19.8 billion, Wegovy with $13.4 billion and Zepbound with $11.3 billion.” 
  • Modern Healthcare reports,
    • “When Florida Blue wanted its call center employees to demonstrate greater emotional intelligence when dealing with customers, the nonprofit health insurance company enlisted a tutor incapable of emotion.
    • “A generative artificial intelligence, or genAI, chatbot instructs 30 Florida Blue customer service representatives on how to behave like human beings when interacting with other human beings. The chatbot guides workers on human behaviors, such as when to slow their speech, when to hasten a call to its conclusion and what to recommend to policyholders. The company plans to expand this pilot program to its entire 1,600-person call center team this year.
    • “A lot of the time, people carry emotion into calls with health insurers. When you’re upset, it just comes out. One of the prompts is to remind the advocate, ‘Hey, this member appears to be stressed. Make sure you’re pausing and listening to them,’” said Anne Hoverson, vice president of digital transformation at Florida Blue, a subsidiary of Guidewell.
    • “Insurance companies already used genAI for processing claims, predicting clinical needs and performing administrative functions, but this latest trend is different, said Josh Streets, a senior consultant at the International Customer Management Institute, which advises business on call centers.”
  • and
    • “GE HealthCare announced Thursday the commercial launch of Flyrcado, its PET imaging agent that assesses blood flow to the heart muscle, in select U.S. markets.
    • “The Centers for Medicare and Medicaid Services granted Flyrcado pass-through status starting April 1, allowing separate payments for the imaging agent and the PET/CT scan in hospital outpatient settings.
    • “In late September, the company announced that Flyrcado received Food and Drug Administration approval to detect coronary artery disease. It provides more accurate diagnostics than SPECT imaging, the current standard in cardiac nuclear medicine imaging, according to GE HealthCare.
    • “Since Flyrcado has a half-life of 109 minutes, which is significantly longer than other similar PET imaging agents, healthcare facilities don’t need to produce it on-site. Instead, it can be manufactured at off-site pharmacies and delivered as needed.”

Midweek Update

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, SCOTUS, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • It turns out that at yesterday’s markup meeting, the House Oversight and Government Reform Committee did clear HR 2193, the FEHB Protection Act of 2025, for floor consideration, along with the other bills considered during the markup.
  • The Senate confirmed James Bishop to be Deputy Director of the Office of Management and Budget by a 53-43 vote.
  • CMS today released a “Revised Final 2026 Actuarial Value (AV) Calculator Methodology.”
    • “The only changes that are being made to the Final 2026 AV Calculator as part of this Revised Final 2026 AV Calculator are the following:
      • “The de minimis range for bronze, silver, gold and platinum plans was expanded to +2
      • percentage points to -4 percentage points;
      • “The de minimis range for expanded bronze plans was expanded to +5 percentage points
      • to -4 percentage points;
      • “The de minimis range for income-based silver CSR plans was expanded to +1 percentage
      • points to -1 percentage points;
      • “The MOOP limit was updated to $10,600; and
      • “The AV Calculator version number was updated, and the AV Calculator label was
      • updated to “Revised Final 2026 AV Calculator”.
    • “These changes do not affect the AV calculation methodology. All AV calculations are the same
    • in both the Final 2026 AV Calculator and the Revised Final 2026 AV Calculator.”
  • The Congressional Research Service has summarized the federal requirements on private health insurance plans.
  • Per the American Hospital Association (“AHA”) News,
    • “The FBI March 26 advised that, after extensive investigation and intelligence review, they have not identified any specific credible threat targeted against hospitals in any U.S. city. The FBI advised if they receive credible threat information, they will immediately advise any identified potential targets and, if appropriate, alert the broader health care sector through the AHA, the Health-ISAC (Information Sharing and Analysis Center) and other appropriate channels. 
    • “On March 18, the AHA and Health-ISAC received multiple reports from the field regarding a public social media post alleging active planning of a coordinated, multi-city terrorist attack targeting hospitals in the coming weeks. 
    • “Out of an abundance of caution, the AHA and Health-ISAC notified the field of the potential threat, indicating that no further information was available to either corroborate the threat or dismiss it as not credible. The AHA and Health-ISAC today distributed an updated bulletin to members with the latest update from the FBI.” 

From the judicial front,

  • Bloomberg Law informs us,
    • “The US Supreme Court suggested [during an oral argument today] it’s likely to uphold a federal program that uses more than $8 billion in fees imposed on phone bills to subsidize the cost of telecom services for poor people, rural residents, schools and libraries.
    • “Hearing arguments in Washington on the decades-old Universal Service Fund, some conservative justices voiced concern that Congress had unconstitutionally handed off its taxing power to the Federal Communications Commission without imposing sufficient limits [also known as the non-delegation doctrine].”

In Food and Drug Administration news,

  • BioPharma Dive relates,
    • “The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease Prader-Willi syndrome, a long-awaited decision that follows an unorthodox pitch from the drug’s developer.
    • “The agency on cleared Vykat XR, from biotechnology company Soleno Therapeutics, for this hyperphagia that’s caused by Prader-Willi. Treatment has specifically been approved for adults and children at least four years of age. Soleno hasn’t yet disclosed the drug’s list price. 
    • “The approval is a milestone for research into a disease that’s proven difficult to target. Prader-Willi affects an estimated 10,000 to 20,000 people in the U.S. and causes multiple cognitive and behavioral symptoms.”
  • Per a National Cancer Institute (NCI) news release,
    • “The Food and Drug Administration (FDA) has given an accelerated approval to zenocutuzumab (Bizengri), making it the first drug that targets tumors with a very rare genetic alteration called an NRG1 fusion. Under the approval, zenocutuzumab can be used to treat people with pancreatic or non-small cell lung cancer (NSCLC) whose tumors have an NRG1 fusion and whose disease has gotten worse despite standard treatments.
    • “The approval was based on the results of a clinical trial in which one-third of patients treated with zenocutuzumab had sustained tumor shrinkage of at least 30% that lasted a median of 11 months. Most of the patients in the study had either NSCLC or pancreatic cancer.
    • “This is a patient population that has a very high unmet need,” said the study’s lead investigator, Alison Schram, M.D., of the Memorial Sloan Kettering Cancer Center. “This approval gives these patients, who have very few effective therapeutic options, a new treatment option.”
    • “Because it’s an accelerated approval, Partner Therapeutics, which licensed zenocutuzumab from Merus, must conduct additional studies to confirm that the drug helps patients clinically, which can include helping them live longer than with other treatments.’

From the public health and medical research front,

  • The New York Times reports,
    • Measles cases in Kansas more than doubled in the last week, bringing the tally to 20, while another outbreak in Ohio has sickened 10 people, local public health officials reported on Wednesday.
    • There have been several large outbreaks in the United States this year, including one in West Texas that has spread to more than 320 people and hospitalized 40. Health officials have worried that the Texas outbreak may be seeding others.
    • More than 40 measles cases have been reported in New Mexico, and seven have been identified in Oklahoma. In both states, health officials said the infections were connected to the Texas outbreak.
    • In Kansas, the virus has mainly infected unvaccinated children in the southwest corner of the state. Genetic sequencing has suggested a link to the Texas and New Mexico outbreaks, state health officials told The New York Times on Wednesday.
  • Per the AHA News,
    • “A study published March 26 by the National Institutes of Health and the University of Oxford found that individuals who engaged in light and moderate-to-vigorous daily physical activity had a lower cancer risk than those with more a sedentary lifestyle. The study found that higher daily step counts, but not pace, was also associated with a lower cancer risk. In comparison to cancer risk for individuals taking 5,000 steps per day, risk was 11% lower for those taking 7,000 steps per day and 16% lower for those taking 9,000 steps per day. Risk reduction plateaued beyond 9,000 steps.”
  • This week’s Cancer Information Highlights from the NCI discuss “Quit Smoking | Metastatic Prostate Cancer | Kidney Cancer.”
  • The National Institute of Standards and Technology informs us,
    • “A rare but painful disorder can make it difficult for people to swallow food. The symptoms include weight loss and chest pain after eating. Scientists are working to better understand this condition, known as corkscrew esophagus, in hopes of finding more treatment or prevention options.
    • “We are working to contribute to that effort with an approach you may not associate with medical research. It involves math, physics and computer modeling.”
  • Medscape points out,
    • “In a recent final analysis of a phase 3 trial, the bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine [which are FDA approved] maintained high efficacy and a favorable safety profile against RSV-associated lower respiratory tract illness (RSV-LRTI) over two seasons in people aged ≥ 60 years.”
  • STAT News tells us, “Study suggests mRNA vaccine could make humans resistant to ticks that transmit Lyme bacteria. New tool shows how the human immune system responds to components of ‘tick cement.’”
    • “Ticks, once latched onto a fleshy target with their barbed, needle-like mouths, are ready for almost anything. They glue themselves to the skin using a complex, cement-like substance. And then, like a “little pharmacological company,” they dole out proteins to keep the blood flowing, make it relatively painless, and hamper any immune response that might reveal their parasitic presence, Yale University researcher Erol Fikrig says.
    • “It’s in those days of quiet blood-thirst that ticks pass along bacteria that causes conditions like Lyme disease, a growing problem driven in the U.S. by black-legged ticks (or Ixodes scapularis). Researchers have been trying for decades to understand just how the tiny tick is able to evade the human body’s defenses and pass along pathogens. 
    • “A new study by Fikrig and other researchers, published Wednesday in Science Translational Medicine, uses a powerful monitoring system to reveal how the human immune system is responsive to a litany of tick triggers — some of which might be leveraged to create a protective mRNA vaccine.” 
  • Per Fierce Pharma,
    • “Johnson & Johnson has produced the most convincing data to date that its combination of Rybrevant and Lazcluze could replace AstraZeneca’s Tagrisso as the new standard of care in first-line EGFR-mutated non-small cell lung cancer—proof it could extend patients’ lives.
    • “The Rybrevant-Lazcluze combo significantly reduced the risk of death by 25% versus Tagrisso in patients with newly diagnosed advanced EGFR-mutated NSCLC, according to data from the phase 3 Mariposa trial presented at the European Lung Cancer Congress (ELCC) 2025.
    • “While the median overall survival time was not yet reached for the combo, investigators expect that the J&J regimen could offer at least an extra year of life versus Tagrisso, on which patients have logged a median 36.7 months of survival.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Fewer physicians are considering leaving the profession in 2025 than in 2024, according to a new survey from the Harris Poll and electronic health record provider Athenahealth.
    • “Part of physicians’ improved job satisfaction was driven by increased adoption of artificial intelligence, the researchers said. Fewer physicians reported the technology was over-hyped this year, and they saw the most promise in transcription services and capabilities.
    • “Still, physicians shared concerns about the fate of the industry long-term and only 3 in 10 physicians were optimistic about the direction of U.S. healthcare generally. Respondents were most concerned about interoperability challenges, their organization’s financial health and meeting regulatory requirements.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.”
      • Key Clinical Findings
        • “For adults with advanced retinitis pigementosa and severe vision loss, ICER rated the current evidence on sonpiretigene isteparvovec as promising but inconclusive (“P/I”) due to concerns about durability of benefits and unknown short-term and long-term harms.
      • Key Cost-Effectiveness Findings
        • “Sonpiretigene isteparvovec has not yet been approved by the FDA for retinitis pigmentosa, and the manufacturers have not yet announced a US price for the therapy if approved. 
        • “ICER has calculated a health benefit price benchmark (HBPB) to be between $67,400 and $101,300 for treatment in one eye.”
  • The Brown & Brown consulting firm has posted an executive summary of its 2025 Employee Health and Benefits Strategy Survey.
  • Beckers Health IT survey notes,
    • “Amazon is testing a generative AI-powered health assistant, dubbed Health AI, on its website and mobile app, CNBC reported March 25.
    • “The chatbot is designed to answer health and wellness questions, suggest common care options for various medical needs, and recommend products. Some responses are marked with a “clinically verified” badge, indicating that the information has been reviewed by U.S.-based licensed clinicians, according to Amazon.
    • “In addition to providing health guidance, Health AI directs users to Amazon’s online pharmacy and clinical services from One Medical, the primary care provider Amazon acquired for $3.9 billion in 2022.”

Thursday Report

David Ermer–ACA, CDC, FDA, Generative AI, Government Contracting, HSA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Mark Tegethoff on Unsplash

Happy first day of Spring!

From Washington, DC,

  • Per Becker’s Health IT,
    • The American Hospital Association and Health-ISAC are alerting hospitals to a social media post alleging plans for a coordinated, multi-city terrorist attack on healthcare facilities in the coming weeks.
    • The organizations said they are sharing the information as a precaution and remain in close contact with the FBI. They plan to provide updates as more details emerge, according to a March 20 news release.
    • The AHA and Health-ISAC said there is no information available to corroborate or discount the threat’s credibility.
    • “Generally, foreign terrorist groups do not publicize their upcoming attacks. However, this widely viewed post may encourage others to engage in malicious activity directed toward the health sector, so threats of this nature should be taken seriously,” the news release reads. “Security teams should review emergency management plans and spread awareness of the potential threat internally.”
  • Health Affairs Forefront offers reflections on the 15th anniversary of the Affordable Care Act, which will be marker on March 23, and an idea about how to add high deductible plans with health savings accounts to marketplace plans, which in the FEHBlog’s view is a great idea.
  • The American Hospital Association News tells us,
    • The Equal Employment Opportunity Commission and the Department of Justice yesterday announced the release of two documents warning against unlawful discrimination related to diversity, equity and inclusion in the workplace. A one-pager, “What To Do If You Experience Discrimination Related to DEI at Work,” and a Q&A, “What You Should Know About DEI-Related Discrimination at Work,” are based on Title VII, existing EEOC policy and Supreme Court precedent. 
    • “DEI is a broad term that is not defined in Title VII of the Civil Rights Act of 1964,” the agencies said. “In the past five years, DEI policies, programs, and practices have become increasingly prevalent in many of our nation’s largest and most prominent businesses, universities, and cultural institutions. The widespread adoption of DEI, however, does not change longstanding legal prohibitions against the use of race, sex, and other protected characteristics in employment.”
  • and
    • The Food and Drug Administration today issued an alert on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue.
  • Per an HHS news release,
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of chemical substances that may be present in food and that have the potential to cause harm.”
  • The President today signed an executive order implementing the following policy,
    • “The Federal Government spends approximately $490 billion per year on Federal contracts for common goods and services — the types of goods and services purchased by nearly every executive department and agency (agencies) — making it the largest buyer of goods and services in the world.  As a matter of sound management, these standardized procurement functions should be carried out in the most efficient and effective manner possible for the American taxpayer. The General Services Administration was established in 1949 through the Federal Property and Administrative Services Act, 40 U.S.C. 101 et seq., to provide “an economical and efficient system” for the core procurement services for agencies (40 U.S.C. 101).  It is time to return the General Services Administration to its original purpose, rather than continuing to have multiple agencies and agency subcomponents separately carry out these same functions in an uncoordinated and less economical fashion.”
  • Federal News Network discusses the EO here.
  • Bloomberg Law reports,
    • “The US Agriculture Department is preparing to spend as much as $100 million to combat bird flu by soliciting proposals for new poultry vaccines and virus detection methods.
    • “Officials plan to announce the funding opportunity for companies including vaccine manufacturers on Thursday, according to a USDA email obtained by Bloomberg Government and verified by two congressional staff granted anonymity to discuss the not-yet-public plan. 
    • “The solicitation announcement is expected to seek proposals that prevent, treat, or research bird flu infections, according to the Wednesday email signed by Tucker Stewart, the deputy assistant secretary for USDA’s Office of Congressional Relations.
    • “The money would be the agency’s latest step toward rolling out a $1 billion bird flu response plan that Agriculture Secretary Brooke Rollins announced in February. Rollins has downplayed the role vaccines will play in fighting the virus since announcing the strategy, citing high costs and low effectiveness rates.” 

From the public health and medical research front,

  • NBC News informs us,
    • “Prescriptions for ADHD medications have been spiking in recent years, with the sharpest increase among middle-aged and older women. They’re also the least likely to misuse the prescription stimulants, a new study found.
    • “The rise among women ages 35 to 64 has been substantial. At the end of 2022, 1.7 million women in this age group were prescribed stimulants such as Adderall and Ritalin for ADHD, compared to 1.2 million prescriptions in 2019.
    • “There’s been an overall jump in ADHD prescriptions since the pandemic and the rise of telehealth. The new analysis, published in JAMA Psychiatry by researchers at the National Institute on Drug Abuse, also looked into how the medications are being misused — that is, taking more of the drugs than prescribed, taking them at times that differed from what the doctor ordered or using medication from someone else’s prescription.” 
  • Cardiovascular Business points out,
    • “Using cannabis significantly raises a person’s myocardial infarction risk, even if they are young and otherwise quite healthy, according to the research team behind two new studies. The first is a retrospective analysis that was just published in JACC Advances, while the other is a meta-analysis being presented at ACC.25, the American College of Cardiology’s annual conference. 
    • “Asking about cannabis use should be part of clinicians’ workup to understand patients’ overall cardiovascular risk, similar to asking about smoking cigarettes,” Ibrahim Kamel, MD, clinical instructor at the Boston University Chobanian & Avedisian School of Medicine and the lead author of both studies, said in a statement. “At a policy level, a fair warning should be made so that the people who are consuming cannabis know that there are risks.”
    • “Kamel et al. performed a retrospective study of more than 4.6 million adults 50 years old or younger. All participants were free of significant cardiovascular comorbidities with no prior coronary artery disease. The average follow-up period was more than three years. Overall, the group found that cannabis use significantly increased a person’s risk of a myocardial infarction, ischemic stroke, heart failure and cardiovascular death.”
  • Per Healio,
    • “Markers of subclinical heart damage were observed among individuals who smoke cigarettes, even decades after quitting, according to a study published in the Journal of the American College of Cardiology.
    • “New data from the Cross-Cohort Collaboration-Tobacco Work Group showed that cigarette smoking was associated with elevated markers of inflammation, thrombosis and atherosclerosis, all of which decreased after cessation, except for coronary calcium, which remained elevated 30 years later.
    • “Understanding the mechanisms of smoking-related injury and the most sensitive biomarkers of subclinical harm is critical to clinical trial planning and tobacco regulatory policy, and might be important for planning studies and informing regulatory of new and emerging tobacco products as well,” Michael J. Blaha, MD, MPH, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Cardiovascular Disease at Johns Hopkins Medicine, told Healio. “The degree to which new and emerging tobacco products affect these same biomarkers will need to be explored.”
  • On the bright side, the Wall Street Journal illustrates how “Drug Overdoses Are on the Decline, in Charts. Fatalities from drugs including fentanyl are down from recent peaks.”
  • The AP reports,
    • “Nestle USA is recalling certain batches of its Lean Cuisine and Stouffer’s frozen meals for possible contamination with “wood-like material” after a report of potential choking. 
    • “The recall applies to limited quantities of meals with best-before dates between September 2025 and April 2026. They include Lean Cuisine Butternut Squash Ravioli, Lean Cuisine Spinach Artichoke Ravioli, Lean Cuisine Lemon Garlic Shrimp Stir Fry and Stouffer’s Party Size Chicken Lasagna. The products were distributed to major stores in the U.S. between September 2024 and this month. No products beyond those listed are affected. 
    • “Nestle officials said they are working with the U.S. Food and Drug Administration and the Agriculture Department and investigating the source of the wood-like material. The company said it launched the recall after consumers reported the problem, including at least one potential choking incident.”
  • Per Healio,
    • “Adults with insulin-treated type 2 diabetes had greater HbA1c reductions and larger improvement in time in range with use of an automated insulin delivery system compared with standard care, according to findings from a new trial.”
  • Per BioPharma Dive,
    • “On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene therapy Zolgensma.
    • “The drug, code-named OAV101, shares the same active ingredient as Zolgensma, which in 2019 gained U.S. approval for the treatment of a rare, muscle-wasting illness known as spinal muscular atrophy. Zolgensma, though, is injected into the veins, and is only cleared for use in patients under two years of age. Novartis has spent years trying to show OAV101, which is shot right into the spine, can be a safe and effective therapy for older kids.”

From the artificial intelligence front,

  • STAT News reports,
    • A panel of experts at a leading specialty society announced in a new clinical guideline that they have decided not to decide whether to recommend AI-assisted colonoscopies.
    • “After reviewing studies and using existing information to model outcomes, experts enlisted by the American Gastroenterological Association determined that using AI definitely increases adenoma detection rate (ADR), or colonoscopies that find polyps. But they figure, with low certainty, that using AI in screening only leads to 2 fewer colorectal cancer-related deaths per 10,000 people over 10 years. Citing a close call and fuzzy evidence, the panel decided not to issue a recommendation.”
  • MedTech Dive explains, “Quest, Google team on gen AI; GE Healthcare plans autonomous imaging; GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.” For details read the article.
  • RAND concludes “AI Models Are Skilled at Identifying Appropriate Responses to Suicidal Ideation, but Professionals Still Needed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “GE HealthCare launched its Invenia Automated Breast Ultrasound Premium system Thursday that features artificial intelligence tools.
    • “The system, which has premarket approval from the Food and Drug Administration, is designed to help better detect breast cancer in women with dense breasts.
    • “Detecting breast cancer in this patient population with mammography can be difficult for radiologists because both dense tissue and cancerous masses appear white in images, according to the American Cancer Society.
    • “Automated breast ultrasound produces clearer and more detailed images and has been shown in multiple studies to improve the sensitivity of detecting invasive cancer in dense breasts when used alongside mammography.”
  • and
    • “Post-acute care technology companies Medalogix and Forcura announced their merger Wednesday.
    • “The companies aim to create a platform for streamlining patient care transitions and better connect post-acute care providers to the broader healthcare system. Berkshire Partners, a Boston-based private equity firm, will be the majority owner of the combined company, which is not yet named, according to a news release. Chicago-based private equity firm The Vistria Group will be the largest minority shareholder, the release said.
    • “Financial terms of the deal were not disclosed.”
  • Per Fierce Pharma,
    • “Optum Rx is shifting its payment models to better meet the needs of pharmacies and consumers, the pharmacy benefit manager announced Thursday.
    • “The company said it will shift to a cost-based model, which will better align with “the costs pharmacies may face due to manufacturer pricing actions.” The PBM expects the change to be a positive one for the more than 24,000 independent and community pharmacies it works with, along with its members.
    • “Optum said it will begin to roll out the updated models now and intends to have a full implementation in place by January 2028.”
  • MedCity News lets us know,
    • “Evvy, a women’s health company, is now offering fertility insights through its vaginal microbiome test, the company announced on Tuesday.
    • “New York City-based Evvy is a direct-to-consumer company. Its vaginal microbiome test, starting at $129, checks for bacteria and fungi (or microbes) in people’s vaginas. After taking the test, people receive a report that explains the microbes found in the vagina and the health conditions related to those microbes. Based on the results, consumers receive a customized treatment plan and a one-on-one virtual session with a coach.
    • “Now, the test results include a section on fertility insights. Users of the test receive a “protective score,” which is a measure of protective bacteria like Lactobacillus. This is associated with improved fertility, lower inflammation and better pregnancy outcomes.”
  • Per BioPharma Dive,
    • “Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability to “reset” a patient’s immune system and ward off debilitating inflammatory diseases.
    • “The treatment, dubbed DR-0201, is known as a bispecific myeloid cell engager. It’s designed to engage specific immune cells that can prompt the body to deplete disease-causing B cells. It’s shown promise in preclinical and Phase 1 studies, Sanofi said. 
    • “As part of the deal announced Thursday, Sanofi agreed to pay as much as $1.3 billion more to privately held Dren Bio if DR-0201 succeeds in reaching certain development and launch goals. The French drugmaker expects to take over the DR-0201 program in the second quarter.”

Monday Report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg Law reports,
    • “Mehmet Oz, President Donald Trump’s nominee to lead the Centers for Medicare & Medicaid Services, used his Senate confirmation hearing Friday to tout the benefits of artificial intelligence to help streamline the prior approval process for Medicare managed care plans.
    • “But consumer policy watchers were immediately leery, noting the string of recent legal challenges stemming from AI-influenced coverage denials by Medicare Advantage plans.
    • “We are very concerned that increasing the use of AI will only make the prior authorization situation worse,” Alice Bers, litigation director at the Center for Medicare Advocacy, said in a statement.” * * *
    • “Sen. Tina Smith (D-Minn.) expressed similar concerns about lawsuits against MA insurers alleging use of AI to determine length of hospital stays and to deny claims. “This is a big concern,” Smith told Oz. “My view is that a human needs to have a final say in these decisions.”
    • “Oz said he agreed with Smith about the need for humans to make final coverage decisions. But Oz maintained that he thinks “AI can play a vital role in accelerating pre-authorization.”
    • “He also said the CMS should be using AI to identify insurers that are misusing the technology.”
  • Beckers Hospital Review adds,
    • “CMS will not change the Biden administration’s plan to negotiate prices for 15 previously named prescription drugs, and the agency’s next potential leader says he will defend the program in court.
    • “In January, CMS selected Ozempic, Rybelsus, Wegovy, Trelegy Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Breo Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, and Otezla to be included in the second round of negotiations aimed at reducing drug costs for Medicare beneficiaries. 
    • “On March 14, CMS said it had signed agreements with manufacturers, who will now participate in meetings and roundtables throughout 2025 to negotiate maximum fair prices for the 15 drugs, with final agreements due by Nov. 1.
    • “Mehmet Oz, MD, President Donald Trump’s pick for CMS administrator, told the Senate Finance Committee March 14 he would defend the negotiation program in court.
    • “It’s the law. I’m going to defend it and use it,” he said, adding that it is one of multiple approaches he would pursue to lower drug costs.
    • “The selected drugs account for approximately $41 billion in total spending under Medicare Part D between November 2023 and October 2024, or about 14% of Medicare Part D’s prescription drug costs, according to CMS. The negotiated prices for the drugs will take effect in 2027.”
  • HUB International tells us,
    • “Following on the enactment late last year of two bills to simplify employer reporting under the Affordable Care Act (“ACA”), the IRS has now released its first bit of guidance in the form of Notice 2025-15. The notice provides guidance on how employers can avoid providing individual Forms 1095-C to their employees. Perhaps unsurprisingly, it essentially piggybacks on existing guidance that applies to insurance carriers and other coverage providers.”
  • STAT News adds, “FTC highlights new concern over ‘pay-to-delay’ deals that determine when generics are sold. The agency noted restrictions on how many drugs a generic company may sell as part of a patent settlement.”
  • Per MedTech Dive,
    • “The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines.
    • “The letter said the disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
    • “The FDA linked to a letter B. Braun sent to customers in January. B. Braun said “additional supply and labor constraints over the holidays” had reduced production and it would run out of product on Jan. 20.”
  • Per Fierce Pharma,
    • “A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.
    • “The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls.” 

From the judicial front,

  • A panel of the U.S. Court of Appeals for the Ninth Circuit denied the Justice Department’s request for an immediate stay of the lower court’s decision to reinstate terminated probationary employees from six federal agencies. The panel set a briefing schedule on the Justice’s Department’s underlying motion to stay.
  • Bloomberg Law reports,
    • “Walmart Inc. is suing many of the nation’s largest pharmaceutical companies, alleging they colluded to inflate the price of hundreds of generic drugs and caused the retailer to pay more for the medications than it should have.
    • “Mylan Inc., Teva Pharmaceuticals USA Inc., and Glenmark Pharmaceuticals Inc. are among the defendant companies that exchanged drug price points and bid information as part of a conspiracy that specifically targeted Walmart, according to a nearly 700-page complaint filed Friday in the US District Court for the Eastern District of Pennsylvania.
    • “Walmart is one of the largest pharmacy providers in the US, purchasing hundreds of millions of dollars of prescription drugs every year. 
    • “The suit adds to similar cases against pharma companies brought by independent pharmacies, hospitals, and federal and state law enforcers.”
    • “The case is Walmart v. Actavis Elizabeth LLC, E.D. Pa., No. 2:25-cv-01383, 3/14/25″ 

From the public health and medical research front,

  • The Washington Post reports,
    • “By 2050, there will be an estimated 25.2 million people living with Parkinson’s disease worldwide, a 112 percent increase from 2021, according to a new study published in the journal BMJ.
    • “The World Health Organization estimated that 8.5 million people worldwide were living with Parkinson’s disease in 2019.
    • “Researchers used data from the 2021 Global Burden of Disease Study, pulling information from 195 countries and territories. They identified aging and population growth as the main contributors to the projected increase in Parkinson’s numbers, noting that growth rates would differ at regional and national levels.”
  • The American Medical Association lets us know what doctors wish their patients knew about pertussis.
  • MedPage Today tells us,
    • “A probiotic mixture reduced fever duration by 2 days versus placebo among children with upper respiratory tract infections.
    • “Probiotics have emerged as a new potential approach to managing infectious diseases.
    • “Adverse events were mild, and did not significantly differ between the two groups.
  • and fills us in on which adults need a measles booster in the U.S.
  • Beckers Hospital Review identifies the “10 most, least overweight and obese cities in the U.S.”
    • “McAllen, Texas, topped WalletHub’s 2025 ranking of the most overweight and obese cities in the U.S., published March 17, while Honolulu is the healthiest-weight city.”
  • Per a press release,
    • “The National Institute of Standards and Technology (NIST) has released a human stool reference material that will help scientists accurately measure the gut microbiome. The initiative aims to speed progress in a cutting-edge field of medical research targeting some of humanity’s most serious and intractable diseases.
    • “The human gut microbiome is a rich, teeming ecosystem of microorganisms and their byproducts that line the human gastrointestinal tract. Over the last decade, scientists have linked activity in the gut microbiome to obesity, diabetes, mental illness, cancer and other medical conditions. Researchers believe that a new class of drugs targeting the gut microbiome can treat many of these conditions.”
  • Per National Institutes of Health news releases,
    • “Surgical removal of enlarged tonsils and adenoids in children with mild sleep-disordered breathing (SDB) appears to significantly reduce the frequency of medical office visits and prescription medicine use in this group, according to a clinical study supported by the National Institutes of Health (NIH). The findings, published in JAMA Pediatrics, show that the surgery, called adenotonsillectomy, was tied to a 32% reduction in medical visits and a 48% reduction in prescription use among children with a mild form of the condition.”
  • and
    • In a preclinical study, rodents treated with uric acid showed improved long-term outcomes after acute ischemic stroke. The findings suggest that the treatment may work as an add-on therapy to standard stroke treatments in humans. The study was funded by the National Institutes of Health (NIH) and published in Stroke.
  • Consumer Reports, writing in the Washington Post, informs us about “Everything you need to know to keep your teeth healthy. Toothpaste matters, and you might want to consider adding a tongue scraper to your routine.”
  • Per BioPharma Dive,
    • “An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with several types of blood cancer by helping avert a potentially dangerous side effect. 
    • “According to clinical trial results announced by Orca on Monday, about three-quarters of people treated with the company’s T cell immunotherapy did not experience moderate-to-severe chronic graft-versus-host disease through one year, compared to only 38% of those given the standard transplant. 
    • “Graft-versus-host disease, or GvHD, is a serious complication of transplants involving cells sourced from matched donors. Orca aims to develop its therapy, which uses a purified mix of donor-derived T cells and stem cells, as a safer transplant alternative in cancers like acute myeloid leukemia.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Median hospital margins remained stable to kick off 2025, as many reported higher service volumes and expenses.
    • “Kaufman Hall’s “National Hospital Flash Report” revealed January median operating margins hit 4.4%, up from 3.7% in December and 0.6% last January. Without allocations, the median operating margin grew to 8%, a 12-month high. the averages are based on data from more than 1,300 hospitals and gathered by Strata Decision Technology. 
    • “January was a relatively stable month for hospitals, as more people received care due in part to seasonal challenges like flu and other respiratory diseases. Hospitals are also experiencing more rapid revenue growth from inpatient than outpatient services. Expenses are also rising, driven primarily by drug costs, though the rate of cost growth has slowed,” said Erik Swanson, managing director and group leader, data and analytics, of Kaufman Hall.”
  • Fierce Healthcare notes,
    • “Highmark Health reported $29.4 billion in revenue and $50 million in net income for 2024 as the organization continues to weather notable headwinds that have battered health insurers.
    • “Highmark also posted $209 million in operating losses, according to its earnings report released last week. The full year results “reflect the negative operating performance of Highmark Health Plans,” the company said in a press release, as the team faced cost pressures throughout the year.
    • “United Concordia Dental and HM Insurance Group, the company’s stop-loss division, were bright spots with steady performance. Highmark said that trend was backed by growing dental membership and a disciplined pricing approach.
    • “Its health system, Allegheny Health Network, also saw improvements as patient volumes increased across “all delivery areas.”
    • “While our consolidated revenue improved, we continue to face significant industry headwinds and medical cost trends, including high costs for prescription drugs, especially GLP-1s, the impact of Medicaid redeterminations and nationwide high utilization, especially within the Medicare Advantage portfolio,” said Carl Daley, chief financial officer and treasurer of Highmark Health.” 
  • Fierce Pharma points out “the top 10 drugs losing US exclusivity in 2025.”
    • “While each year features high-profile losses of exclusivity in the pharma industry, this year’s list is something of a doozy.”
  • The Wall Street Journal reports,
    • “Pfizer PFE had a problem. Doctors weren’t prescribing its migraine drug Nurtec because they assumed insurance coverage would be too much of a hassle.
    • “So last year the company created a phone line for doctors and patients to call Pfizer directly for help. Pfizer now credits that and other changes for a 31% increase in Nurtec’s U.S. sales last year.
    • “The beleaguered drugmaker’s shares still haven’t recovered from their post-Covid slump, and shareholders are wary. But sales of products such as Nurtec and the vaccine Abrysvo that the company has been counting on are rising, and an activist shareholder’s push has lost steam. 
    • “Pfizer did it by shaking up its U.S. sales strategy, shifting where it deploys its sales representatives, how they market to doctors and how the company helps patients pay for their prescriptions.”
  • Per Modern Healthcare,
    • “Scripps Health plans to build a $1.2 billion medical campus that will include a 200- to 250-bed hospital and outpatient facilities.
    • “The San Diego-based health system’s board last week approved the 13-acre development in San Marcos, California. The first phase of the project will feature space for specialty and primary care offices, ambulatory surgery, cancer care, imaging, lab and other services, and the second phase includes the hospital, according to a Monday news release.
    • “The outpatient center will be built in two to three years, and the hospital will take about six years, a spokesperson estimated.”
  • and
    • “Sharon Regional Medical Center is set to reopen Tuesday, about two months after the former Steward Health Care facility in Pennsylvania closed.
    • “On Friday, the Pennsylvania Department of Health approved Pasadena, California-based Tenor Health Foundation’s plans to reopen the 163-bed hospital. In January, Judge Christopher Lopez of the U.S. Bankruptcy Court for the Southern District of Texas in Houston signed off on the hospital management company’s takeover of the facility, which employed more than 800 workers“
  • From BioPharma Dive,
    • “AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.
    • “The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.”

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) threw a wrench into a Republican plan to avert a government shutdown this weekend, saying there wasn’t enough Democratic support to advance the measure funding federal agencies through Sept. 30.
    • “Republicans “do not have the votes in the Senate,” to move the resolution forward, Schumer said on the Senate floor, indicating that his party was prepared to block it. He blamed Republicans, saying they “chose a partisan path” in their bill without any input from congressional Democrats.  
    • “As an alternative, Schumer floated a shorter-term plan that would fund the government for a month. “I hope my Republican colleagues will join us to avoid a shutdown on Friday,” he said.
    • “Government funding will lapse at 12:01 a.m. Saturday if Congress doesn’t act. The GOP-led House left town after it approved Republicans’ resolution on Tuesday, effectively giving the Senate no time to revise the bill—but to simply pass it or reject it.”
  • The Hill adds,
    • Some Democrats floated the idea that an amendment vote on the 30-day CR, which would fail, could be won in exchange for the requisite number of votes to advance the GOP bill. Some Republicans could support it, according to Sen. Tim Kaine (D-Va.), but not enough that it would be adopted. 
    • “It remains unclear whether Republicans would go along with that though. Senate Majority Leader John Thune (R-S.D.) did not fully shoot down the idea. 
    • “I think there would have to be some understanding,” he told The Hill on Wednesday evening. “We’ll see. I’m not sure exactly what their demand is — if they just need a vote on that, and if in exchange for that they’ll give us the votes to fund the government.”
    • “Thune added that discussions are “going on right now” on a path forward, but he also panned the idea of a full shift to a 30-day CR in order to finish 2025 appropriations bills.”
  • The Wall Street Journal further tells us,
    • “The Centers for Medicare and Medicaid Services plans to terminate four demonstration projects at the end of 2025, closing out models affecting primary care, kidney care and healthcare payments in the state of Maryland.
    • “The agency will also make changes to other projects, including dropping a planned initiative that would offer certain generic drugs to Medicare enrollees for $2. CMS said its planned terminations would save nearly $750 million, and an agency official said the projects would affect millions of patients.”
  • Per Modern Healthcare,
    • “Johnson & Johnson MedTech said Wednesday its Monarch Quest robotic platform received clearance from the Food and Drug Administration.
    • “Robotic-assisted bronchoscopy is a minimally invasive technique that allows surgeons to reach airways and suspicious lung nodules.”

From the public health and medical research front,

  • The New York Times reports,
    • “Measles continues to spread in West Texas and New Mexico, with more than 250 people infected — many unvaccinated school-age children. Two cases in Oklahoma, for which state officials have not provided a location, have also been linked to these outbreaks. Twelve other states have reported isolated measles cases, typically linked to international travel.”
  • The American Medical Association lets us know what doctors wish patients knew about measles.
  • STAT News reminds us,
    • “The 2020s have inarguably been Covid-19’s decade. 
    • “Since the coronavirus outbreak was acknowledged as a pandemic exactly five years ago, the pandemic has killed well over 1 million Americans, derailed the global economy, and sparked political upheaval that continues today. It also yielded what many hail as the greatest scientific accomplishment in human history: the development of effective vaccines in under a year. 
    • “Yet in dominating the early 2020s, Covid-19 also distracted from what is arguably a more significant public health emergency. Even at the height of the pandemic, more young Americans died of drug overdose than Covid. And in the last year, the overall death toll from the country’s drug crisis has exceeded the Covid-19 pandemic as the deadliest health event this generation.”
  • MedPage Today notes,
    • “Using only targeted models of syphilis screening in the emergency department (ED) would miss large proportions of active syphilis cases as well as new HIV diagnoses and acute HIV cases, according to new research.
    • “Only screening patients for syphilis who came to the ED for gonorrhea and chlamydia testing would have missed 76.4% of positive syphilis screens as well as 68.7% of new HIV diagnoses, reported Kimberly Stanford, MD, MPH, of the University of Chicago Medical Center.”
  • Healio informs us,
    • “An increase in depressive symptoms was observed among U.S. teenagers without, rather than with, behavioral risk factors, underscoring the need for greater screening in this population, data show. 
    • “Over the last decade, national survey data has revealed a sharp rise in depressive symptoms among U.S. adolescents,” Tanner J. Bommersbach, MD, MPH, child and adolescent psychiatrist and assistant professor at the University of Wisconsin School of Medicine and Public Health, told Healio regarding the research presented in The Lancet Regional Health Americas. “Yet, surprisingly little is known about what is driving this increase and which adolescents are most affected.”
  • Consumer Reports, writing in the Washington Post, explains what to do about ear pain.
  • Per a National Institutes of Health press release,
    • “The antiviral drug tecovirimat used without other antivirals did not reduce the time to clinical resolution of clade II mpox lesions or improve pain control among adults in an international clinical trial sponsored by the National Institutes of Health (NIH). The trial enrollment was stopped in late 2024 when an interim analysis showed that tecovirimat monotherapy was ineffective in the study population. Detailed results were presented at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.
    • “This study brought us a step forward in better understanding mpox disease and potential treatment strategies,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial. “We are grateful to the study team and participants for their contributions to groundbreaking research on a disease that we still do not know enough about.”
  • The National Cancer Institute’s Cancer Information Highlights cover the following topics this week: “AI and Immunotherapy | Breast Reconstruction | Multiple Myeloma Research.”
  • Food Safety Magazine alerts us,
    • “The U.S. Centers for Disease Control and Prevention (CDC) has released a summary analyzing the causes of foodborne illness outbreaks that occurred between 2014 and 2022. Data included in the analysis was drawn from the Foodborne Disease Outbreak Surveillance System (FDOSS), via the National Outbreak Reporting System (NORS).
    • “According to CDC, approximately 800 foodborne illness outbreaks occur in the U.S. each year, causing an estimated 15,000 illnesses, 800 hospitalizations, and 20 deaths, annually.
    • “An overall trend revealed in the FDOSS data for 2014–2022 included that many foodborne illness outbreaks occur because of contamination of food by an animal or environmental source before arriving at the point of final preparation. Additionally, most viral outbreaks are caused by contamination from ill food workers. The data showed that common contributing factors to bacterial outbreaks are 1) allowing foods to remain out of temperature control for a prolonged period, and 2) inadequate time and temperature control during cooking.”
  • The American Hospital Association News relates,
    • “The AHA and Press Ganey March 12 released a new report showing hospital and health system patients reporting improvements in overall care experience and perception of safety alongside gains in key safety outcomes. It also shows that the health care workforce has had a rebound in their reported experience, resilience and perceptions of safety culture.
    • “The insights report, “Improvement in Safety Culture Linked to Better Patient and Staff Outcomes,” highlights how hospitals that foster a strong culture of safety also report a better experience for patients and the health care workforce.
    • “Key report findings include: 
      • “13 million patients surveyed after hospital stays report improvements in their overall care experience and perception of safety.
      • “Surveys of 1.7 million members of the health care workforce show a rebound in their reported experience, resilience and perceptions of safety culture, following the enormous strain of the COVID-19 pandemic.
      • “Improvements in key safety outcomes like falls and infections across more than 25,000 units in 2,430 hospitals.”
  • Per MedTech Dive,
    • “Capstan Medical says it has notched a first in the treatment of structural heart disease, employing a robot to implant two people with mitral valve replacement devices.
    • “Current treatment options for heart valve disease exclude too many patients who are not good candidates for existing procedures, said Capstan CEO Maggie Nixon, and the company hopes its approach will provide them with a new alternative.
    • “The Santa Cruz, California-based startup is developing a valve implant, catheter and robotic delivery platform to expand structural heart intervention to a broader group of people.
    • “There need to be more percutaneous, minimally invasive options to help treat valve disease,” Nixon said in an interview.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Blue Shield of California President and CEO Lois Quam is out at the company two months after taking the helm.
    • “The company declined to explain the circumstances of Quam’s immediate departure.
    • “Chief Financial Officer Mike Stuart will serve as interim president and CEO until the board names a permanent successor, the company said in a news release Tuesday. Stuart has worked at the nonprofit insurer for more than a decade, the company said.
    • “Quam joined the company as president in August after having served as CEO of Pathfinder, a nonprofit global health organization. She was named CEO in early January as part of a corporate restructuring and was touted as its first female CEO.”
  • Fierce Healthcare reports,
    • “Health technology company Innovaccer launched a new platform that seeks to make it easier for insurers to manage risk adjustment and quality improvements.
    • “On Wednesday, Innovaccer unveiled the 360-Degree Gap Closure Solution, which assist payers in improving coding accuracy and patient outcomes. The tool comes at a time when the industry is under significant scrutiny from regulators over coding practices.
    • “The platform enables better engagement across different care settings, greater automation and data governance, Innovaccer said. Health plans can deploy one-click campaigns that address care gaps in a way that reaches provider offices, pharmacies and home healthcare.”
  • Per BioPharma Dive,
    • “Roche has raised its bet on obesity, agreeing to pay Zealand Pharma $1.65 billion to license an experimental shot the Danish company put into a Phase 2b trial in December, Zealand said Wednesday.
    • “Per deal terms, Roche will pay $1.4 billion immediately and $250 million in anniversary payments to license petrelintide. With further milestone payments, Zealand could receive up to $5.3 billion. Roche and Zealand will co-commercialize the shot in the U.S. and Europe, and share in any profits and losses.
    • “The deal gives Roche access to a type of experimental drug known as an amylin analog, a class the Swiss pharmaceutical company didn’t obtain when it acquired Carmot Therapeutics 15 months ago. Roche plans on testing petrelintide with one of those drugs, for which Zealand could reimburse Roche $350 million.”
  • Per MedTech Dive,
    • “Labcorp will pay up to $225 million to acquire the oncology diagnostics businesses of BioReference Health, a subsidiary of Opko Health, to expand its portfolio of tests used in cancer care.
    • “The deal, announced Tuesday, includes $192.5 million to be paid at closing and a payment of up to $32.5 million based on performance. 
    • “The assets, including certain customer accounts, generate about $85 million to $100 million in annual revenue, according to the announcement. Labcorp expects the acquisition to be accretive to earnings in the first year after closing.”
  • Healthcare Dive relates,
    • “Hospital operator Landmark Holdings of Florida filed for Chapter 11 bankruptcy protections on March 9, becoming the latest in a growing number of embattled providers to restructure amid financial headwinds. 
    • “In first day court filings, Landmark, which owns or operates six long-term acute care hospitals across three states, said rising labor and pharmaceutical costs, as well as stagnating Medicare reimbursements, had dinged Landmark’s profitability and threatened the provider’s ability to make timely loan repayments.”
    • “Still, Landmark told the court it expects to have enough cash on hand to keep its hospitals open through the bankruptcy process.:
  • STAT News lets us know,
    • While there are no official statistics on the number of end-of-life doulas in the United States as this emerging field is still largely unregulated, Fortune reports that the National End-of-Life Doula Alliance (NEDA) has significantly grown its membership, especially after the pandemic. In 2024, NEDA had over 1,500 registered members, compared to about 250 in 2019. 
    • “The term “end-of-life-doula” was first formally used in the early aughts. In 2001, the Jewish Board of Family and Children’s Services launched the “Doula to Accompany and Comfort Program,” a pilot program that trained volunteers to aid and support people who would otherwise die alone. 
    • “Sometimes known as “death doulas,” [these] professionals * * *help people navigate what can be a confusing and overwhelming time.”

Weekend Update

David Ermer–CDC, Congress, Generative AI, U.S. Healthcare–

From Washington, DC

  • Roll Call updates on this week’s activities on Capitol Hill/

From the public health front,

  • The Wall Street Journal reports,
    • “Measles outbreaks across Texas and New Mexico have sickened nearly 100 people, with more cases expected, according to state health officials.
    • “The disease has spread through the South Plains region of Texas since late January, the Texas Department of State Health Services said Friday. Ninety cases have been identified to date in the state. Five patients were vaccinated, and the rest were unvaccinated or their status was unknown, the agency reported. 
    • “Due to the highly contagious nature of this disease, additional cases are likely to occur in the outbreak area and the surrounding communities,” the agency said. 
    • “The disease has been found across several counties in Texas, but the largest cluster of patients, 51, has been in Gaines County on the western border, according to health department data.  
    • “The New Mexico Department of Health has reported a measles outbreak that has infected nine people in Lea County, which borders Gaines County in Texas. The agency has begun contact tracing among those who developed symptoms to try to minimize the spread and has offered free vaccinations. 
    • “Among the 90 known cases in Texas, 77 were among people under 17 years old. Sixteen patients had to be hospitalized, the state said. 
    • “Last year, the Centers for Disease Control and Prevention reported 285 cases of measles nationwide, across 33 states that included Texas and New Mexico. The CDC counted 16 outbreaks, defined as three or more related cases, that accounted for about 198 out of the 285 people who fell ill. By comparison, in 2023, four outbreaks were reported among 59 individual illnesses.”
  • The New York Times lets us know six things E.R. doctors wish you’d avoid.
  • The Washington Post informs us,
    • “Forty-four percent of rural Medicare patients must drive an hour or more for surgery, a recent analysis in JAMA finds. The study shows that patients in rural areas typically drive 55 minutes to a hospital — far longer than their counterparts in more populous areas.
    • “The research used beneficiary data from Medicare to identify patients 65 to 99 years old who had any of a list of common surgeries between 2010 and 2020. The study looked at about 12.3 million surgery admissions overall, 2.6 million of which were in rural areas.
    • “The number of rural Medicare beneficiaries who traveled more than 60 minutes for their procedure rose from 36.8 percent in 2010 to 44.1 percent in 2020, with the median travel time climbing from 47 minutes to 55 minutes. Among nonrural Medicare beneficiaries, travel times were lower, with a median of 20 minutes’ travel in 2010 vs. 23 minutes in 2020.
    • “Travel times depended on the risk involved in surgery; median times for low-risk procedures such as appendectomies and hernia repair were lower than for higher-risk surgeries like aortic valve repair or a liver resection.”
  • The Wall Street Journal discusses the growing lack of public trust in the medical profession. It strikes the FEHBlog that health insurers can contribute toward restoring that trust by encouraging the use of primary care physicians and reducing prior authorization requirements.

From the U.S. healthcare business front,

  • The Washington Post explains why GLP-1 weight loss drugs also are reshaping the economy.
  • Per Healthcare Dive,
    • “Orlando Health will close Rockledge Hospital and four outpatient facilities in Brevard, Florida on April 22, just months after buying the 298-bed facility from bankrupt Steward Health Care. 
    • “The health system blamed the closure on Steward, saying in a statement that “years of neglect” had left the Rockledge’s electrical, plumbing and heating, ventilation and air conditioning systems failing. 
    • “Orlando plans to demolish Rockledge and replace it with a new facility, as it would cost more to renovate and repair Rockledge than to build a hospital from the ground up, the system said.”
  • Per BioPharma Dive,
    • “Bluebird bio, a pioneering gene therapy developer that in recent years has struggled to stay afloat, has agreed to be acquired and taken private in a deal with investment firms Carlyle Group and SK Capital.
    • “Under an agreement announced Friday, Bluebird will sell to the two firms for $3 per share upfront. Bluebird shareholders could receive an additional $6.84 per share via a so-called contingent value right, should its currently marketed gene therapies reach $600 million in net yearly sales by the end of 2027.
    • “The deal values Bluebird at just over $29 million upfront, and potentially about $96 million if the CVR is redeemed.”
  • Per Modern Healthcare,
    • “Hartford HealthCare, which operates seven hospitals and a network of physicians, behavioral health services and other providers in Connecticut, is partnering with the artificial intelligence-driven virtual health provider K Health to improve access to primary care. On April 1, the organizations will launch HHC 24/7, a virtual health platform powered by K Health, designed to make “comprehensive, personalized primary care available anytime and anywhere.” The service will be fully integrated with Hartford HealthCare. Terms of the partnership were not disclosed.”

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, SCOTUS, Telehealth, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

From Washington, DC

  • Govexec tells us,
    • “A 50-page document, compiled by GOP members of the House Budget Committee and first reported by Politico, outlines a list of provisions that could be included in the [budget reconciliation] package, which would not be subject to the Senate’s 60-vote filibuster threshold, includes a litany of proposals increasing federal workers’ contribution to their retirement and health care benefits, in exchange for worse payouts.” * * *
    • “On health care benefits, the House GOP proposes replacing the current system, by which the federal government pays for a percentage of health care premiums through the Federal Employees Health Benefits Program and the new Postal Service Health Benefits program, with a “voucher model.”
    • “Under this option, the FEHB and PSHB programs would be reformed by replacing the current premium-sharing structure with a voucher, which would not be subject to income and payroll taxes,” the document states.
    • “And the document calls for enactment of a bill introduced last year to require the Office of Personnel Management to audit FEHBP for improper enrollments. But OPM has said that under the current “decentralized” nature of the program, the agency does not have the capabilities to conduct such an audit.
    • “Prior to the presidential transition, then-President Biden’s OPM sent Congress a legislative proposal, drawn on lessons learned in launching the PSHB program this year, to revamp how it administers FEHBP so that it can conduct better oversight.”
    • FEHBlog observation — Better oversight starts with giving FEHBP and FEDVIP carriers the HIPAA 820 enrollment roster transactions that would allow them to reconcile individual enrollees with premiums paid.
  • MedPage reports,
    • “Legislation providing more scrutiny for pharmacy benefit managers (PBMs) that failed to make it through Congress in the waning days of 2024 seems to still be viable for passage this year, according to a House staff member.
    • “I think there’s plenty of political will there; that’s what I’ve seen from members,” Preston Bell, a professional staff member on the House Ways & Means Committee, said Thursday at an event sponsored by the American Enterprise Institute (AEI) on the future of the Medicare prescription drug benefit. “I do think there are disparate ideas across Congress as to how much intervention within the PBM market is appropriate. What you’ve seen come through Congress in the [massive continuing resolution] package [released and rejected in December 2024] is probably the litmus test, or maximum, of what is feasible for that type of reform.”
  • Healthcare Dive informs us,
    • “Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator’s leadership biography page. * * *
    • “Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary as FDA commissioner, but he has not yet been confirmed by the Senate. Confirmation hearings for Robert F. Kennedy Jr., who, as Trump’s pick to run the Department of Health and Human Services, would be Makary’s boss, are scheduled for Jan. 29 and Jan. 30.
    • “Brenner worked in the FDA’s medical devices branch, most recently as chief medical officer for in vitro diagnostics and associate director for medical affairs. A preventive medicine physician, Brenner has been at the agency since 2019, according to her LinkedIn page, and helped coordinate diagnostic standards and policy as part of HHS’ COVID-19 response. 
    • “Brenner was previously a senior policy advisor at the White House Office of Science and Technology Policy under the first Trump administration.”
  • The Hill lets us know,
    • “The Food and Drug Administration (FDA) has withdrawn a rule that would have banned menthol cigarettes and flavored cigars, putting a formal end to a policy that had been indefinitely delayed under the Biden administration. 
    • “A regulatory filing showed the rule had been “withdrawn” on Jan. 21, President Trump’s second day in office. The move is a significant blow to public health groups who said banning menthol had the potential to save hundreds of thousands of lives, particularly among Black smokers.”
  • The IRS released its 2024 tax return edition of Publication 969 which concerns health savings accounts and other tax favored health plans.

From the judicial front,

  • Bloomberg Law reports,
    • “A former Johnson & Johnson executive’s allegations that the drug company overpaid for prescription drug benefits are “speculative and hypothetical,” and injuries she did suffer cannot be resolved by the court, a New Jersey federal judge ruled.
    • “The decision Friday dismissed most of Ann Lewandowski’s high-profile class action that argued the pharmaceutical giant violated its fiduciary duties under the Employee Retirement Income Security Act by not negotiating better drug prices with its pharmacy benefit manager, Express Scripts, or switching to a different PBM. 
    • “The lawsuit is one of several recent [actually it was the first] attempts to hold employers responsible through ERISA for monitoring and reducing health-care costs. The claims against J&J reveal that not even large drug companies are immune to complaints over high drug prices.
    • “Judge Zahid N. Quraishi in the US District Court for the District of New Jersey concluded that Lewandowski lacked standing to sue in dismissing two of her three claims. Lewandowski’s argument that J&J’s plan forced her to pay higher premiums and cost her higher wages was speculative “at best,” he said.
    • “And while Lewandowski did show that her copays for some drugs exceeded prices offered by other health plans, the court could not fulfill a key requirement for standing by making her whole, the judge said. Any amount refunded to her would have to go through the health plan for money it spent after she hit her out-of-pocket limit, Quraishi said.
    • “In straightforward terms, a favorable decision would not be able to compensate Plaintiff for the money she already paid,” he wrote.
    • “The judge did find that Lewandowski has standing to pursue her claim against J&J for not providing more information she requested around the plan’s drug prices, including the contract with Express Scripts, which was not a party to the suit. Quraishi invited Lewandowski to amend her complaint.”
  • The Wall Street Journal points out,
    • “Enforcement of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership, remains on hold despite a U.S. Supreme Court ruling in favor of the Treasury Department. 
    • “The Supreme Court on Thursday overturned a lower court order that was blocking enforcement of the CTA. However, a separate national injunction issued earlier this month by a federal judge apparently remains in place and continues to block the law’s implementation.
    • “The Treasury’s Financial Crimes Enforcement Network, which is overseeing the law’s implementation, issued an alert Friday confirming compliance with the CTA isn’t mandatory while the injunction remains in force.” 
  • Fierce Healthcare relates,
    • “The Centers for Medicare & Medicaid Services has changed course on plans to appeal a court ruling that determined it must recalculate UnitedHealthcare’s Medicare Advantage star ratings.
    • “The agency submitted a filing in Texas district court earlier this week saying it intended to file an appeal to the Fifth Circuit Court. In new court documents filed Friday, CMS has withdrawn its notice of appeal.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • Seasonal influenza activity remains elevated across the country and is increasing in most areas. COVID-19 activity is elevated in many areas of the country. RSV activity has peaked in many areas of the country.
    • COVID-19
      • COVID-19 activity is elevated in many areas of the country, though wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity has declined in the last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
      • Seasonal influenza activity remains elevated across the country and is increasing in many areas.
    • RSV
      • RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • Vaccination
      • Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • BioPharma Dive relates,
    • “An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development.  
    • ‘Novo said Friday it is planning “further clinical development” of the drug, called amycretin, but didn’t specify the design of additional trials or when they might begin. Amycretin affects the same two targets as a Novo drug called cagrisema that recently missed expectations in a Phase 3 trial but does so in a single molecule rather than a two-drug combination.”
       
  • Per Healio,
    • “Integrating lifestyle care into low back pain management resulted in greater improvements in disability, weight loss and physical quality of life vs. just guideline-recommended care, a randomized study showed.
    • “The findings, published in JAMA Network Open, “could influence future updates to back pain guidelines,” Emma Mudd, PhD, senior research officer at the University of Sydney in Australia and the analysis’ lead author, said in a press release. “Patients valued the holistic support, and the outcomes speak for themselves.”
  • Earlier this week, the CVS Health Foundation announced $4 million in grants related to its health aging initiative.

From the U.S. healthcare business front,

  • Beckers Hospital Review notes,
    • “Mayo Clinic’s chief executive said at the World Economic Forum’s annual meeting in Davos, Switzerland, that he is fully committed to the adoption of artificial intelligence in healthcare, the Rochester (Minn.) Post Bulletin reported.
    • “I personally would not want to have my healthcare, in some specialties, without AI because I firmly believe I will get a better outcome,” said Gianrico Farrugia, MD, president and CEO of the Rochester-based health system, according to the newspaper’s coverage of the event Jan. 22.
    • “Mayo Clinic has been at the forefront of developing and deploying healthcare AI, with 320 algorithms in use, the news outlet reported.”
  • Beckers Payer Issues adds,
    • Insurers do not have to own every part of the healthcare system to improve connection, according to Jim Boyman, vice president of GuideWell Health. 
    • GuideWell is the parent company of Florida Blue. In December, the company launched an initiative to manage cancer care for Florida Blue ACA members. Through a partnership with Cerritos, Calif.-based The Oncology Institute and primary care organization Sanitas, Florida Blue members diagnosed with cancer will be connected with an oncology team to manage a personalized treatment plan. 
    • “Everyone talks about how fragmented healthcare is,” Mr. Boyman told Becker’s. “This shows how you don’t necessarily have to own all parts of the system to reduce that fragmentation. You can use technology and relationships to collaborate and overcome fragmentation through programs like this.” 
  • Fierce BioTech reports,
    • “Neomorph is building out its supply of Big Pharma partnerships, this time stamping down an option-to-license pact with AbbVie that centers around the biotech’s molecular glue platform.
    • “AbbVie will pay the San Diego biotech an undisclosed upfront sum and offer up to $1.64 billion in option fees and milestones, plus royalties, according to a Jan. 23 release.
    • “The new partners will look to develop molecular glue degraders—a novel class of small molecules designed to selectively degrade proteins that drive disease—for multiple targets across oncology and immunology.
    • “Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward,” Steven Elmore, Ph.D., AbbVie’s vice president of small molecule therapeutics and platform technologies, said in the release. “We are excited to collaborate with Neomorph to develop novel molecular glue degraders that could pave the way for new, effective therapies in the treatment of immune disorders and cancer.”
    • “Neomorph emerged in 2020 and quickly garnered a neuro deal worth up to $1.45 billion in biobucks with Biogen, plus a partnership with Novo Nordisk that offers up to $1.46 billion.” 
  • Per Fierce Healthcare,
    • “Self-funded employer health plan Centivo is announcing Centivo Care, a tech-forward virtual primary care platform integrated with behavioral health specialists.
    • “Centivo’s virtual offerings, which will be available in states where the company operates, are increasingly desired by its clients’ members, said Wayne Jenkins, M.D., chief medical officer for Centivo and president of Centivo Care, in an interview with Fierce Healthcare.
    • “He said at first, just 5% to 10% of people preferred the virtual option, but now it’s closer to 20%. For some employers, they see an even higher adoption rate. One of its clients, JetBlue Airlines, sees high utilization since their employees travel so often and can more easily text with a physician or schedule a video call than attend an appointment in person.
    • “Centivo Care is one of few primary care practices to earn a Patient-Centered Medical Home accreditation from the National Committee for Quality Assurance, the company said in a news release. These virtual appointments are free, and members receive personalized care plans, after-visit summaries, preventive care reminders and more.”
  • Per Beckers Hospital Review,
    • Telehealth utilization grew across most U.S. regions in October 2024, with the Midwest as the sole exception, according to FAIR Health’s monthly telehealth regional tracker.
    • Nationally, telehealth claim lines increased from 4.80% of medical claim lines in September to 4.89% in October, marking a 2% rise. Regional increases varied, with the West seeing the largest growth at 2.8%, while the Midwest experienced a 3.7% decrease.
    • Here are four things to know about telehealth utilization, according to FAIR Health’s tracker:
      • Psychiatric nurses moved up to the second-most common telehealth specialty nationally in October, overtaking family practice, which fell to fourth place.
      • Mental health conditions remained the leading telehealth diagnostic category nationally and regionally. 
      • The tracker revealed modest differences in telehealth costs compared to office visits. For instance, the median cost for a nutritional therapy reassessment was typically $1 to $2 lower via telehealth than in-office, except in the West, where telehealth costs were slightly higher.
      • Telehealth usage was highest among patients aged 31–40, followed by those aged 19–30, a pattern consistent across all regions.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Federal News Network tells us,
    • “President-elect Donald Trump’s pick to lead the Department of Homeland Security is signaling potential changes at the Cybersecurity and Infrastructure Security Agency.
    • “South Dakota Gov. Kristi Noem, nominated by Trump to serve as homeland security secretary, testified before the Senate Homeland Security and Governmental Affairs Committee on Friday. She fielded a range of questions, largely on border security and immigration enforcement.
    • “On the cybersecurity front, Noem in her opening statement said she would prioritize a “comprehensive, whole-of-government approach to cybersecurity,” without offering further specifics.
    • “I fully acknowledge that people in Washington, DC do not have all of the answers, and therefore I will leverage private, public partnerships,” Noem added as part of her opening statement. “I will advance cutting edge state of the art technologies to protect our nation’s digital landscape.”
  • Cybersecurity Dive lets us know,
    • “The White House rolled out a highly anticipated executive order on Thursday [January 16, 2025] to combat a rising level of sophisticated attacks targeting U.S. government agencies, critical infrastructure providers and high-profile individuals by state-linked threat groups and other malign actors. 
    • “The executive order will give the U.S. more authority to level sanctions against malicious actors that have disrupted hospitals and other critical providers. 
    • “Federal authorities also plan to leverage the government’s $100 billion in annual IT spending to make sure technology companies develop more secure software.” * * *
    • To help increase security in the public and private sector, the executive order aims to: 
      • Give the U.S. more authority to level sanctions against hackers that have critical providers, including hospitals. 
      • Require software vendors doing business with the federal government to prove they are using secure development practices. The federal government plans to validate that evidence and publish the information to help private sector buyers make informed decisions on secure software. 
      • The National Institute for Standards and Technology will develop guidance on how to deploy software updates in a secure and reliable manner. 
      • The General Services Administration will develop guidance on how cloud customers can securely use these products.  
      • Identify minimum cybersecurity standards for companies working with the federal government. Bureaucracy and cybersecurity requirements for using federal information systems will be streamlined for three years. 
      • Federal authorities will begin research into AI-based tools to search for software vulnerabilities, manage patching and detect threats. A public-private partnership will be developed to use AI to protect critical infrastructure in the energy sector. 
      • The U.S. will only buy internet-connected devices that meet Cyber Trust Mark standards starting in 2027.   
  • Cyberscoop adds,
    • “A sweeping executive order on cybersecurity released Thursday won largely positive reviews, with the main question being its timing — and what will come of it with the executive branch set to be handed over from president to president.”
  • NextGov/FCW informs us,
    • The Office of Personnel Management did not take long nor have to look too far to find its next chief information officer.
    • Melvin Brown II, who previously served as OPM’s deputy chief information officer, was named OPM’s chief information officer this week, according to a LinkedIn post he published Sunday January 12, 2025.
  • Cyberscoop relates,
    • “The Department of the Treasury has sanctioned a Chinese national and a cybersecurity company based in Sichuan, China, for taking part in the Salt Typhoon hacking campaign that has swept up data from at least nine U.S. telecommunications companies.
    • “The department’s Office of Foreign Assets Control (OFAC) named Yin Kecheng of Shanghai and the Sichuan Juxinhe Network Technology Co. Ltd., as entities that had “direct involvement” in the Salt Typhoon campaign. Kecheng is described as an affiliate of the Chinese Ministry of State Security with over a decade of hacking experience.
    • “Kecheng is also alleged to have been involved in a recent hack of the Treasury Department.”
  • Per HHS news releases,
    • “[On January 14, 2025,] the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Solara Medical Supplies, LLC (Solara), a supplier and direct-to-patient distributor of continuous glucose monitors, insulin pumps, and other supplies to patients with diabetes, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule and Breach Notification Rule following a [2019] breach of electronic protected health information (ePHI) caused by a phishing incident.” * * *
    • “In November 2019, OCR received a breach report concerning a phishing attack in which an unauthorized third party gained access to eight of Solara’s employees’ email accounts between April and June 2019, resulting in the breach of 114,007 individuals’ ePHI. In January 2020, OCR received notification of a second breach, when Solara reported that it had sent 1,531 breach notification letters to the wrong mailing addresses. OCR’s investigation determined that Solara failed to conduct a compliant risk analysis to identify the potential risks and vulnerabilities to ePHI in Solara’s systems; failed to implement security measures sufficient to reduce the risks and vulnerabilities to ePHI to a reasonable and appropriate level; and failed to provide timely breach notification to individuals, HHS, and the media.
    • “Under the terms of the resolution agreement, Solara agreed to implement a corrective action plan that will be monitored by OCR for two years and pay $3,000,000 to OCR.” * * *
    • “The resolution agreement and corrective action plan may be found here.”
  • and
    • “[On January 15, 2025,] the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Northeast Surgical Group, P.C. (NESG), a provider of surgical services in Michigan, for a potential violation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.” * * *
    • “In March 2023, OCR received a breach report concerning a ransomware incident that had affected NESG’s information system. NESG concluded that the protected health information of 15,298 patients had been encrypted and exfiltrated from its network. OCR’s investigation determined that NESG had failed to conduct a compliant risk analysis to determine the potential risks and vulnerabilities to ePHI in NESG’s systems.
    • “Under the terms of the resolution agreement, NESG agreed to implement a corrective action plan that OCR will monitor for two years and paid $10,000 to OCR.: * * *
    • “The resolution agreement and corrective action plan may be found here.”

From the cybersecurity vulnerabilities and breaches front,

  • Per Cybersecurity Dive,
    • “The Cybersecurity and Infrastructure Security Agency spotted Salt Typhoon on federal networks before defenders discovered the China-sponsored threat group intruded into U.S. telecom systems, Director Jen Easterly said Wednesday.
    • “CISA’s sleuthing “enabled law enforcement to unravel and ask for process on virtual private servers,” Easterly said during an onstage interview at the Foundation for Defense of Democracies. Details gathered from that investigation and response allowed CISA to discover Salt Typhoon and its activities, Easterly said.” * * *
    • “CISA’s observations didn’t prevent Salt Typhoon from attacking the telecom networks en masse, but Easterly presented the agency’s threat hunting and intelligence gathering capabilities as an example of intra-government and public-private collaboration improvements made under her stewardship of the agency.
    • “Easterly is scheduled to step down as CISA director when the President-elect Donald Trump takes office next week.”
  • and
    • Threat hunters are scrambling to determine the scope of damage and potential impact from a critical zero-day vulnerability that impacts a trio of Ivanti products, including Ivanti Connect Secure VPN appliances.
    • Shadowserver scans identified more than 900 unpatched Ivanti Connect Secure instances on Sunday [January 12, 2025] and said the devices are likely vulnerable to exploitation. The amount of unpatched and vulnerable instances found by Shadowserver scans is down from more than 2,000 on Thursday [January 9, 2025].
    • The nonprofit, which analyzes and shares malicious activity with more than 200 national computer security incident response teams covering 175 countries, was asked not to disclose how it knows these instances are unpatched, but has yet to receive any false positive feedback, Shadowserver CEO Piotr Kijewski told Cybersecurity Dive via email on Friday.
    • Researchers are especially concerned about widespread exploitation of the zero-day because of previous cyberattacks linked to software defects in Ivanti products.
  • CISA added seven more known exploited vulnerabilities to its catalog this week.
  • More details from
  • Cybersecurity Dive
    • “The Cybersecurity and Infrastructure Security Agency added a command injection vulnerability in BeyondTrust Remote Support and Privileged Access Products to its catalog of known exploited vulnerabilities on Monday [January 13, 2025]. 
    • “The medium-severity flaw, listed as CVE-2024-12686, allows an attacker with administrative privileges to inject commands into a computer network and run as if they are a site user. The vulnerability has a CVSS score of 6.6. 
    • “The CVE is the second vulnerability disclosed by BeyondTrust during its investigation into an attack spree in December. The attacker reset the passwords of numerous accounts after compromising a Remote Support SaaS API key. A limited number of RemoteSupport SaaS customers were impacted by the attacks.” 
  • CSO Online
    • Fortinet has confirmed the existence of a critical authentication bypass vulnerability in specific versions of FortiOS firewalls and FortiProxy secure web gateways. The flaw has been exploited in the wild since early December in what appears to be an indiscriminate and widespread campaign, according to cybersecurity firm Arctic Wolf.
    • The fix for this zero-day is part of a bigger patch cycle by Fortinet, which released updates for 29 vulnerabilities across multiple products, 14 of which impact FortiOS, the operating system used in Fortinet’s FortiGate firewalls. Some of the flaws impact multiple products that share the same code, which is the case for the zero-day now tracked as CVE-2024-55591.
    • Although Fortinet does not credit Arctic Wolf with discovering the vulnerability, the indicators of compromise listed in the advisory match the analysis of the attack campaign Arctic Wolf warned about in December and documented in more detail on Friday.
  • Security Week
    • “The software giant [Microsoft] on Tuesday called urgent attention to three separate flaws in the Windows Hyper-V NT Kernel Integration Virtualization Service Provider (VSP) and warned that malicious attackers are already launching privilege escalation exploits.
    • “An attacker who successfully exploited this vulnerability could gain SYSTEM privileges,” Microsoft said in a series of barebones advisories.
    • “As is customary, the company did not release technical details or IOCs (indicators of compromise) to help defenders hunt for signs of compromise.
    • “The three exploited zero-days — CVE-2025-21334, CVE-2025-21333 and CVE-2025-21335 — affect the Windows Hyper-V NT Kernel Integration Virtualization Service Provider (VSP) that handles efficient resource management and communication between the host system and guest virtual machines (VMs).” 
  • and
    • Threat actors are exploiting a critical-severity remote code execution (RCE) vulnerability in Aviatrix Controller to deploy malware, cybersecurity firm Wiz reports.
    • The issue, tracked as CVE-2024-50603 (CVSS score of 10/10), exists because user-supplied input is not properly neutralized, allowing unauthenticated, remote attackers to inject arbitrary code that is executed with high privileges on the Aviatrix cloud networking platform.
    • The solution is designed to help organizations manage and secure their cloud infrastructure across multiple providers from a single place.
    • Impacting certain endpoints within the Aviatrix Controller’s API, which is implemented in PHP, the vulnerability was patched in December, but technical information on it was only published last week.

From the ransomware front,

  • Cybersecurity Dive reports on January 17, 2025,
    • Blue Yonder said it is investigating a threat after Clop listed the supply chain management company among nearly 60 companies the ransomware group claims it hacked. The attacks were linked to exploited vulnerabilities in Cleo file-transfer software, according to researchers from Zscaler and Huntress. 
    • A spokesperson for Blue Yonder on Friday confirmed the company uses Cleo to manage certain file transfers. Once the zero-day was confirmed, Blue Yonder said it immediately took steps to mitigate the threat.
    • “Like many Cleo Harmony customers across the globe, we are currently investigating any potential impact of this matter on our business and we continue to update our customers as we have additional information,” the spokesperson told Cybersecurity Dive via email.”
  • CISO Online alerts us on January 13, 2025,
    • CISOs are being warned to make sure employees take extra steps to protect their AWS access keys after word that a threat actor is using stolen login passwords for ransomware attacks.
    • The target is Amazon S3 buckets and the attack uses AWS’ own encryption to make data virtually unrecoverable without paying the attackers for a decryption key, said a report by researchers at Halcyon Tech.
    • “Unlike traditional ransomware that encrypts files locally or in transit, this attack integrates directly with AWS’s secure encryption infrastructure,” the report notes. “Once encrypted, recovery is impossible without the attacker’s key.” * * *
    • “There are, however, a few things AWS customers’ IT administrators can do:
      • “use the Condition element in IAM (identity and access management) policies to prevent the application of SSE-C to S3 buckets. Policies can be configured to restrict this feature to only authorized data and users;
      • “enable detailed logging for S3 operations to detect unusual activity, such as bulk encryption or lifecycle policy changes;
      • “regularly review permissions for all AWS keys to ensure they have the minimum required access;
      • ‘disable unused keys and rotate active ones frequently.
    • “In a statement accompanying the Halcyon report, AWS referred customers to this web page with information for administrators on how to deal with suspected unauthorized activity on their accounts.”
  • Per Industrial Cyber,
    • “The U.S. National Institute of Science and Technology (NIST) through its National Cybersecurity Center of Excellence (NCCoE) division published Monday draft Ransomware Community Profile reflects changes made to the Cybersecurity Framework (CSF) from CSF 1.1 to CSF 2.0 which identifies security objectives that support managing, detecting, responding to, and recovering from ransomware events. The NIST IR 8374 Rev. 1 (draft) comes as the agency is currently considering a more comprehensive revision to the profile to reflect recent ransomware policy developments and incorporate the results of collaborative activities in the ransomware prevention and response space. 
    • “NIST is seeking feedback by March 14, 2025, on the revised draft of the risk management framework, which will guide the future of its ransomware prevention guidance. General comments on the draft are also encouraged. The agency is also looking for input on which elements of the Ransomware Community Profile have been beneficial. Suggestions for improvements to the Community Profile are also welcome.”

From the cybersecurity defense front,

  • Here are CISA news releases from the last week of the Biden administration:
    • “The Cybersecurity and Infrastructure Security Agency (CISA) published today [January 14, 2025] the Joint Cyber Defense Collaborative (JCDC) Artificial Intelligence (AI) Cybersecurity Collaboration Playbook. Developed alongside federal, international, and private-sector partners through JCDC, this playbook provides the AI community—including AI providers, developers, and adopters—with essential guidance on how to voluntarily share actionable incident information and it describes how proactive information sharing can enhance operational collaboration and improve resilience of AI systems.” 
    • “The Cybersecurity and Infrastructure Security Agency (CISA), in close coordination with the Office of Management and Budget (OMB), Office of the National Cyber Director (ONCD) and Microsoft, announces today [January 15, 2025] the release of Microsoft Expanded Cloud Log Implementation Playbook. This guidance helps public and private sector organizations using Microsoft Purview Audit (Standard) to operationalize newly available cloud logs to be an actionable part of their enterprise cybersecurity operations.”
    • CISA Director Jen Easterly’s final CISA blog post concerns “Strengthening America’s Resilience Against the PRC Cyber Threats.”
  • Here is a link to Dark Reading’s CISO Corner.

Midweek Report

David Ermer–CDC, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Per HHS press releases,
  • and
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today released updated National Behavioral Health Crisis Care Guidance (National Guidance), comprised of three documents: 2025 National Guidelines for a Behavioral Health Coordinated System of Crisis Care; Model Definitions for Behavioral Health Emergency, Crisis, and Crisis-Related Services; and a draft Mobile Crisis Team Services: An Implementation Toolkit, which is being released today for public comment. The updated National Guidance now reflects the national transition to the 988 Suicide & Crisis Lifeline in 2022 and other progress and emerging needs related to behavioral health crisis care and provides a framework for transforming behavioral health crisis care systems in communities throughout the United States, at a time when the U.S. continues to face record high rates of suicide and overdose.”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with South Broward Hospital District d/b/a Memorial Healthcare System (Memorial Healthcare System), a Florida health system, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The settlement resolves litigation resulting from an investigation about a complaint alleging a lack of timely access to an individual’s protected health information (PHI). The HIPAA Right of Access provisions require that individuals or their personal representatives receive timely access to their health information for a reasonable cost. OCR’s investigation determined that Memorial Healthcare System failed to provide timely access within 30 calendar days. Memorial Healthcare System has agreed to pay $60,000. The agreement marks OCR’s 52nd Right of Access enforcement action.”
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services and Drug Enforcement Administration published a series of rules Jan. 15 related to telemedicine prescribing of controlled substances, including a special registration proposed rule and a final rule on telemedicine prescribing of buprenorphine. 
    • “The proposed rule for special registration outlines three types of registration to waive in-person visit requirements prior to virtual prescribing of controlled substances and a state registration for every state in which a patient is treated by the special registrant. Providers would need to apply for the special registrations. The DEA also proposes that providers be required to review nationwide prescription drug monitoring programs after three years. Comments on the proposed rule are due March 15. 
    • “The DEA’s 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. Practitioners can then prescribe additional medication via other telemedicine encounters (real-time, two-way audio-visual) or after an in-person encounter. The agency finalized a stipulation that providers will need to complete a review of the PDMP for the state where the patient is located. Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD.”
  • and
    • “The Centers for Medicare & Medicaid Services announced Jan. 15 that 53.4% of people with Traditional Medicare are in an accountable care relationship with a provider, a 4.3% increase from last year. The agency said it is the largest increase since it began tracking accountable care relationships. 
    • “For 2025, CMS approved 228 applications for the Medicare Shared Savings Program, bringing the total number of accountable care organizations participating in MSSP to 476. Approved applicants included 55 new ACOs and 173 renewing or reentering ACOs, the most in the program’s history.  
    • “CMS said there was also a 16% increase from last year in federally qualified health centers, rural health clinics and critical access hospitals participating in the MSSP. In addition, 103 ACOs are continuing participation in CMS’ ACO Realizing Equity, Access, and Community Health Model, and 78 kidney contracting entities and 15 CMS Kidney Care First Practices are continuing participation in the Kidney Care Choices Model.”  
  • The Census Bureau has partnered with the Department of Defense to track how veterans fare in labor market when they return to civilian life. Check out their report.

From the Food and Drug Administration front,

  • The Wall Street Journal reports
    • “Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely active Crohn’s disease, an inflammatory bowel disease that causes chronic abdominal pain.
    • “The treatment, developed by the pharmaceutical company under the brand name Omvoh, is now approved to treat two types of inflammatory bowel disease in the U.S., the Indianapolis company said Wednesday. The drug was previously approved to treat ulcerative colitis in adults in October 2023.
    • “Omvoh’s approval as a treatment for Crohn’s disease was based on results from a study in which 53% of patients treated with the drug achieved clinical remission, and 46% of patients had visible healing of the intestinal lining, at one year.”
  • and
    • The Food and Drug Administration is banning the use of Red No. 3, an artificial dye linked to cancer in animals, from food and ingested drugs.
    • The move will impact thousands of food products on the market in the U.S., including Betty Crocker’s loaded mashed potatoes and MorningStar Farms plant-based bacon strips. It is even in products that aren’t red, such as Brach’s candy corn. 
    • Food manufacturers will have until early 2027 to reformulate products that use Red 3. Consumer advocates pushed the agency to revoke authorization for the additive after two studies linked it to cancer in male laboratory rats. 
  • Roll Call adds,
    • “The Food and Drug Administration unveiled a proposal on Wednesday to limit the amount of nicotine allowed in cigarettes and some other combustible tobacco products, a final step for the agency before the Trump administration takes over next week.
    • The FDA first announced it would pursue regulatory changes to maximum nicotine levels in combustible smoking products in 2022 in an effort to reduce the public health effects related to addiction and minimize youth uptake.
    • “The agency is seeking public comment on the rule, but the proposal’s fate is unclear given the coming change in administration.”
  • STAT News described the last two FDA steps along with Tuesday’s proposal putting nutrition labels on the front of food packages as springing into Making America Healthy Again.

From the judicial front,

  • Beckers Payer Issues lets us know that insurer lawsuits over Medicare Advantage Star ratings are piling up.
  • STAT News relates,
    • “After years of sparring, the Biden administration and Gilead Sciences have settled a contentious lawsuit over patents for a pair of HIV prevention pills in a case that raised questions about the extent to which government-funded research should lead to affordably priced medicines.
    • “At issue was a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The Centers for Disease Control and Prevention, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company had refused to reach a licensing agreement despite several attempts to strike a deal.
    • “Gilead, however, maintained it had invented the pills and that the concept of using Truvada to prevent HIV was well-known by the time the CDC tried to obtain its patents. The company also insisted it negotiated in good faith with the government. After a May 2023 trial, a jury sided with Gilead, finding it did not infringe on patents held by the CDC and, moreover, that those patents were invalid. The Biden administration, which sought $1 billion in royalties, subsequently appealed the decision.
    • “In a statement, the company said Wednesday that it will receive a license to “certain” current and future patents concerning HIV prevention that “will protect Gilead’s freedom to operate for years to come.” Any additional terms were not disclosed, although a Gilead spokeswoman wrote to say the settlement does not contain any payments from Gilead or the federal government.”

From the public health and medical research front,

  • The Hill reports,
    • “Respiratory illnesses are spreading throughout the U.S., causing multiple states to see a spike in hospital visits. The latest data shows another virus, known as HMPV, has also been spiking in some parts of the country. 
    • “The Centers for Disease Control and Prevention previously confirmed it was monitoring a spike in cases of HMPV, or human metapneumovirus, in China’s northern provinces. The agency noted the cases of the virus, which is not new, were not a “cause for concern in the U.S.” and that rates of infection nationwide are at typical “pre-pandemic” levels.
    • “HMPV is considered relatively common, with most infected before age 5, according to Dr. Eileen Schneider, an epidemiologist with the CDC. It often circulates during flu season and causes symptoms similar to the common cold, including coughing, wheezing, congestion and shortness of breath.” * * *
    • “Across Iowa, Kansas, Missouri and Nebraska, more than 5.8% of tests submitted for HMPV tested positive through the first week of the year, data shows. That’s more than double the positivity rate across the next-highest region — Alaska, Washington, Oregon and Idaho — which sits at around 2.7%.” * * *
    • “HMPV is typically diagnosed based on symptoms, the Cleveland Clinic explains, and not testing, unless you have serious symptoms.
    • “There are no vaccines or treatment therapies for HMPV, which makes preventing the spread of HMPV especially important. Health experts recommend washing your hands often and avoiding contact with those who are infected with HMPV if possible.”
  • Becker Hospital Review tells us,
    • “The latest data from the American Society of Health-System Pharmacists reports that the active number of drug shortages in the U.S. has decreased to 271, down from a high of 323 in the first quarter of 2024. However, despite this decline, ongoing challenges continue to burden healthcare providers.” 
  • and
    • “Eli Lilly expects its experimental weight loss pill, orforglipron, to receive approval as early as next year, CEO David Ricks told Bloomberg Jan. 13.
    • “The company is preparing to release key late-stage trial data on the drug by mid-2025. The weight loss pill aims to compete with popular injectable treatments like Eli Lilly’s own Zepbound and Novo Nordisk’s Wegovy, which currently dominate the space. 
    • “If approved, orforglipron would offer a pill alternative to the current injectables, making it easier for patients to use while also addressing manufacturing challenges. 
    • “In mid-stage trials, the drug helped patients lose up to 14.7% of body weight, compared to just 2.3% for those who took a placebo.”
  • The National Cancer Institute points out,
    • “For people with a history of smoking, a diagnosis of lung cancer can cause feelings of guilt and shame due to the stigma that’s often associated with the disease. This stigma can hinder open communication between patients and health care providers and hinder patients’ use of tobacco cessation counseling. Researchers at Memorial Sloan Kettering Cancer Center have developed a training program to help health care providers reduce lung cancer–related stigma. In this interview, the trial’s leaders, Smita Banerjee, Ph.D., a behavioral scientist, and Jamie Ostroff, Ph.D., a psychologist, discuss the impact of stigma on people with lung cancer and an NCI-supported clinical trial that’s evaluating the training program.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports “As deadly fires continue to rage in Los Angeles, healthcare companies far and wide are stepping up to serve those affected. At least 24 people have died from the fires, and dozens remain missing.” Bravo.  
  • STAT News notes,
    • “When Eli Lilly last year started offering lower-priced vials of its blockbuster obesity drug Zepbound, which were previously sold in injectable pens, it framed the move as a way to expand patient access. But some experts weren’t convinced, noting that Lilly was only offering the lowest doses in vials, and the new prices, $399 or $549 a month, are still prohibitive for many patients.
    • “CEO Dave Ricks said Lilly is now considering expanding the vial offering. “We’d like to lower the entry cost, and we’d like to have more doses available. That’s not something we’re announcing today, but we see that as an option,” he said Tuesday at a taping of ”The Readout LOUD,” STAT’s biotech podcast.”
  • Kaufmann Hall shares its “Winter 2025 Kaufman Hall Report: Highlights from the 2024 Healthcare Leadership Conference.”
  • Per Healthcare Dive,
    • “Teladoc Health is joining an Amazon marketplace that aims to connect consumers with health benefits programs, the telehealth vendor said Monday.
    • “Now, eligible users can find and enroll in Teladoc’s diabetes, hypertension, pre-diabetes and weight management programs through Amazon’s Benefits Connector.
    • “The program could help drive enrollment in Teladoc’s chronic care offerings, executives said at the J.P. Morgan Healthcare Conference in San Francisco on Monday. “I wouldn’t count on it bringing revenue for us very quickly, but it is certainly something that we will continue to pursue in terms of growing our chronic care program,” Teladoc CFO Mala Murthy said.”
  • Medical Economics explains why 2024 was a ‘blockbuster year’ for concierge medicine.
  • Fierce Pharma offers news from the third day of JP Morgan healthcare conference.
  • Healthcare Dive discusses top healthcare technology trends in 2025. The shape of AI regulation will be uncertain under the Trump administration this year, while healthcare companies will continue bolstering cyber defenses to withstand increasing attacks, experts say.