Midweek Report

NIH

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.”

Tuesday Report

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

From Washington, DC

Capitol Hill News

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

HHS News

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

FDA News

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–CDC, CMS, Congress, HSA, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • On Saturday, the House Appropriations Committee unveiled “The Full-Year Continuing Appropriations and Extensions Act, 2025.”
  • The Wall Street Journal adds,
    • “House lawmakers are expected to vote on the proposal, termed a continuing resolution or CR, as soon as Tuesday, with a majority needed to pass it. But even if House Republicans manage to stay united and pass the proposal over Democratic opposition, it will need at least 60 votes in the Senate, which has only 53 Republican lawmakers. 
    • “Funding for federal agencies runs out on Friday night. With no new legislation, many federal employees would be furloughed, while others would continue to report to work with no pay.” 
  • The Senate will be voting to confirm the President’s nominee for Secretary of Labor Lori Chavez-DeRemer Monday afternoon.
  • Committee meetings of note:
    • Committee: House Oversight and Government Reform
      Subcommittee: House Oversight and Government Reform Subcommittee on Government Operations
      Subject: “Shifting Gears: Moving from Recovery to Prevention of Improper Payments and Fraud”
      Date: 03/11/2025 (10:00 AM Local Time)(Add to My Calendar)
      Location: 2247 Rayburn House Office Building, Washington, D.C.
    • Committee: Senate Health, Education, Labor, and Pensions. Subject: Business meeting to consider the nominations of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health, and Martin Makary, of Virginia, to be Commissioner of Food and Drugs, both of the Department of Health and Human Services, and other pending calendar business
      Related Items: PN12-2, PN12-28
      Date: 03/13/2025 (9:30 AM Local Time)   (Add to My Calendar)
      Location: 562 Dirksen Senate Office Building, Washington, D.C.
    • Committee Senate Finance Committee Subject: Hearing to consider the nomination of Dr. Mehmet Oz to be CMS Administrator
      Witness: Dr. Mehmet Oz 
      Date: Friday, March 14, 2025, 10:00 AM Local Time)
      Location: 215 Dirksen Senate Office Building, Washington, DC
  • The AP explains “How a health savings account fits into your retirement strategy.”

From the public health front,

  • The Wall Street Journal explores how “One Couple in Their 90s Confronts a Stark Reality: Aging at Different Speeds; Lifelong partners grapple with how and whether to stay together when one can’t care for the other.”
  • The New York Times points out six sources of protein that are not meat and answers questions about fentanyl.
  • Beckers Hospital Review notes,
    • Researchers from the University of Texas Health Science Center at San Antonio have developed a drug that more than doubled median survival time and progression-free time for patients with glioblastoma during a clinical trial.
    • Patients who received the drug Rhenium Obisbemeda, or 186RNL, also experienced no dose-limiting toxic effects, according to a March 7 news release from UT Health San Antonio.
    • Glioblastoma is the most common form of brain tumor, with more than 90% of patients experiencing recurrence. If standard treatment fails, the median survival time is about eight months, the release said. \
    • “Glioblastoma has needed durable treatments that can directly target the tumor while sparing healthy tissue,” Andrew Brenner, MD, PhD, professor and chair of neuro-oncology research with Mays Cancer Center at UT Health San Antonio, said in the release. “This trial provides hope, with a second phase under way and planned for completion by the end of this year.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Higher volumes, more favorable reimbursement rates and more efficient labor spending helped Providence cut its 2024 operating losses nearly in half.
    • “On Thursday the nonprofit system reported a $644 million operating loss (-2.1% operating loss) across 2024, a stark improvement over the $1.17 billion operating loss (-4.1% operating margin) of the year prior. The 2024 tally includes $183 million in reconstruction costs “related to asset rationalization, employee reductions and other items,” according to its filing.
    • “Operating revenues across the system grew 7% year over year to $30.7 billion (5% when excluding a $426 million net gain in the first quarter), with management noting in its filing that the growth was spread across all of its operating categories.”
  • and
    • “Earlier this week, Eli Lilly partnered up with telehealth providers LifeMD and Teladoc Health to offer its lower cost, single-vial Zepbound (tirzepatide) to patients in the virtual care companies’ full-service weight loss management programs.
    • “The companies are directly contracting with Eli Lilly’s self-pay pharmacy, GiftHealth. The move could be a boon for telehealth weight loss programs, which have proved lucrative for virtual primary care companies. Many of the chronic condition management programs, including for weight loss, also offer remote monitoring, access to dietitians and health coaches, as well as the ability to be prescribed medication for weight loss, including older medications.
    • “The announcement follows Eli Lilly’s partnership with telehealth platform Ro three months ago. The pharmaceutical company launched its own direct-to-consumer telehealth offering for weight loss in January 2024. Now, it seems to be creating a marketplace of access.”
  • Beckers Payer Issues ranks Medicare insurers by the quality of their mobile applications.

Friday Report

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

From Washington, DC

  • Govexec tells us,
    • “Lawmakers are pursuing two different paths to keep the government funded past March 14, though the Republican majority in both chambers is hoping to pass a measure to keep agencies funded at their current levels through September. 
    • “The year-long continuing resolution would allow for only a small number of changes to existing spending levels, which are currently at the same total that agencies received in fiscal 2024. Democratic appropriators are hoping to instead buy more time with a short-term stopgap bill that would allow negotiators to come to a bipartisan agreement on full-year fiscal 2025 funding measures.
    • “House Speaker Mike Johnson, R-La., has said he will release the text of a continuing resolution to cover the remainder of fiscal 2025 in the coming days and put it to a vote on the House floor early next week. Johnson will face a narrow margin to pass the measure, particularly as the most conservative members of his caucus rarely vote for CRs of any duration. House Democrats have indicated they will not support the measure. 
    • “President Trump is pushing for the year-long stopgap option and the White House has lobbied Republicans to support that bill. 
    • “Despite Johnson’s plans, top appropriators from both parties in the House and Senate have continued to meet and are closing in on a deal to set the top-line funding levels for regular appropriations bills, according to a source familiar with the talks. They are hoping to finalize that agreement in the coming days to demonstrate that a full-year CR is not the only viable option to avert a shutdown.”
  • Medical Economics lets us know,
    • “The Medicare Payment Advisory Commission (MedPAC) is inching closer to a recommendation on revising how doctors get paid through the Medicare Physician Fee Schedule.
    • “On March 6, MedPAC opened its latest two-day meeting with almost 90 minutes of discussion of the best ways to balance beneficiary access and costs, physician pay, taxpayer resources, and overall costs to the U.S. Department of Health and Human Services (HHS).
    • “While the members had suggestions about the nuances of physician pay and the language to describe it, there was general agreement on two draft recommendations to Congress:
      • Congress should replace the current law updates to the physician fee schedule with an annual update based on a portion of the growth in the Medicare Economic Index (MEI). An example could be: MEI minus 1 percentage point.
      • Congress should direct the HHS secretary to improve the accuracy of relative payment rates for clinician services by updated costs data regularly, and ensuring the methodology used to determine payment rates for different services reflects the settings in which clinicians practice medicine.
    • “Depending on commissioner feedback, MedPAC could vote on the recommendations in April to be included in its June 2025 report to Congress.”
  • Per MedTech Dive,
    • “The Federal Trade Commission has challenged a private equity firm’s attempt to buy Surmodics for approximately $627 million, the regulator said Thursday.
    • “Surmodics provides outsourced hydrophilic coatings for devices. GTCR, the private equity group that is attempting to buy Surmodics, owns a majority stake in another coating company, Biocoat.
    • “The FTC said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition between Biocoat and Surmodics.”

From the judicial front,

  • The Hill informs us,
    • “A federal judge has effectively ended the ability of compounding pharmacies to make their own copies of Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro. 
    • “In a sealed decision filed late Wednesday, Judge Mark Pittman of the Northern District of Texas declined to issue an injunction to stop the Food and Drug Administration (FDA) from declaring there was no longer a shortage of the medicines’ active ingredient, tirzepatide.” * * *
    • “Eli Lilly in a statement said the decision “marks the end of the road for mass compounding of risky, unapproved knockoffs that threaten the health and safety of Americans.” 
    • “Any company that continues mass compounding tirzepatide “is breaking the law, and we will work with regulators and law enforcement to stop it,” a company spokesperson said.  
    • “A similar OFA lawsuit against the FDA for removing from the shortage list semaglutide, the active ingredient in Ozempic, is pending.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The Washington Post reports,
    • “An unvaccinated New Mexico adult who tested positive for measles has died, the second death in a growing outbreak centered along the Texas-New Mexico border, officials said Thursday.
    • “The individual did not seek medical care before death, New Mexico health department officials said. The official cause of death is under investigation by New Mexico’s Office of the Medical Investigator. However, the state health department scientific laboratory has confirmed the presence of the measles virus in the person, the state health department said.
    • “The person was a resident of Lea County, where at least 10 cases of measles have been reported. Lea County is just over the border from Gaines County, Texas, where the outbreak is centered.
    • “Six of the Lea County cases are among adults, and four are in children. Seven of the 10 were unvaccinated, and three have unknown vaccination histories.”
  • The American Hospital Association News relates,
    • “Cigarette smoking by adults has dropped to its lowest level in 60 years, the Centers for Disease Control and Prevention reported today. Despite that, tobacco is the leading cause of preventable death in the U.S., the agency said. 
    • “From 2017-2023, an approximate 6.8 million decrease in adults who exclusively smoke cigarettes was offset by a 7.2 million increase in adults who exclusively smoke e-cigarettes. Cigarette smoking overall by U.S. adults decreased from 42.4% in 1965 to 11.6% in 2022.”
  • Per Aunt Minnie,
    • “Breast and colorectal cancer screening in 2023 rebounded from declines during the COVID-19 pandemic and surpassed pre-pandemic screening estimates, according to findings published March 5 in JAMA.
    • “Yet researchers led by Jessica Star from the American Cancer Society in Atlanta, GA, also found that cervical cancer screening numbers are still below pre-pandemic estimates, and that improvements in cancer screening rates were mostly seen in individuals with higher socioeconomic status.
    • “Improving patient communication around cancer screening and providing patient navigators to assist with the structural and cost barriers to screening are two ways health systems can help with successful screening rebounds,” Star told AuntMinnie.com.”
  • Medscape assesses Alzheimer’s Disease diagnosis and care.
  • The National Cancer Institute lets us know,
    • “How doctors treat a form of liver cancer called intermediate-stage hepatocellular carcinoma (HCC) is likely to change, based on updated findings from two large clinical trials. Both trials tested a procedure called TACE in combination with immunotherapy drugs and treatments called angiogenesis inhibitors. TACE, or transarterial chemoembolization, involves using a catheter to deliver chemotherapy directly to the liver.”
  • Per Healio,
    • “After rising over a 35-year period, thyroid cancer incidence in the U.S. plateaued from 2010 to 2019, according to findings published in The Lancet Diabetes & Endocrinology.
    • “In a retrospective analysis of data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) and National Center for Health Statistics databases, researchers found no changes in metastasis or mortality rates for adults diagnosed with thyroid cancer from 1975 to 2019, despite a rising incidence rate during that time. These findings reveal thyroid cancer may have been over-diagnosed in more recent years, according to Zachary Zumsteg, MD, associate professor of radiation oncology and biomedical sciences, and radiation oncology director of the head and neck oncology disease research group at Cedars-Sinai. However, Zumsteg noted the plateau of thyroid cancer incidence in the past 10 years of the study may be indicative of a change in diagnostic practices.”
  • Per BioPharma Dive,
    • Johnson & Johnson is terminating some research for an experimental drug that the company previously predicted could be a multibillion-dollar product.
    • In a statement released Thursday afternoon, J&J said it will stop developing the drug, called aticaprant, as an add-on therapy for patients with major depressive disorder. Over the past few years, a series of large, late-stage clinical trials tested aticaprant in adults who have hard-to-treat MDD and moderate-to-severe cases of a defining symptom of the disorder, anhedonia, which presents as a loss of interest or an inability to experience joy.
    • “While the drug continues to look safe and well-tolerated, the program has shown “insufficient efficacy in the target patient population,” according to J&J. Aticaprant may still have potential, however, so the company plans to “explore future development opportunities” in other “areas of high unmet need.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Not much has gone right for Walgreens Boots Alliance in the past decade. 
    • “Customers bought more and more household items online at sites such as Amazon.com, instead of Walgreens’s more than 8,000 stores across the U.S. The pharmacy chain inked deals with other drug suppliers and doctors’ offices, but stood pat while rivals, including CVS and Express Scripts, merged with big health insurers, gaining control of the medical-reimbursement purse strings that were squeezing pharmacies.
    • “Walgreens cash flow sagged, its debt piled up and shares sank. And on Thursday, Walgreens was sold to private-equity firm Sycamore for $10 billion, down a staggering 91% from its $106 billion peak in 2015.
    • “The storied pharmacy chain—which became a ubiquitous seller of everything from diabetes injections to nail files as retailers consolidated across the U.S.—fell after it neglected to keep up with customer preference to buy online and failed to navigate the fierce competition and intense cost pressures of healthcare.
    • “It could shrink more after its sale. Sycamore, a New York-based firm that specializes in retail and consumer investments and, more recently, is better known for smaller deals, is expected to sell off pieces of the business or work with partners to turn it around, The Wall Street Journal reported.
    • “Globally, the transaction ranks as one of the largest leveraged buyouts in the past decade.”
  • The Journal also tells us about “The Walgreens Billionaire Watching His Empire Come Apart
  • From Monaco, Stefano Pessina built a retailer valued at about $100 billion. It agreed to be taken private this week for roughly $10 billion.”
  • BioPharma Dive points out,
    • “Optum Rx, a pharmacy benefit manager owned by one of the country’s largest insurance companies, UnitedHealth Group, has added a new, much-anticipated pain drug to some of its commercial formularies.
    • “Sold as Journavx, the drug received U.S. approval in late January as a treatment for the short-lived “acute” pain typically felt after an operation or accident. Journavx works differently than other available medications, and its developer, the biotechnology juggernaut Vertex Pharmaceuticals, has positioned it as an important, non-opioid option for pain management.”
  • Beckers Hospital Review lists 18 health systems with strong finances.

Wednesday Report

David Ermer–Congress, COVID-19 vaccine, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The New York Times lets us know,
    • “Dr. Jay Bhattacharya, Donald J. Trump’s nominee to lead the National Institutes of Health, told senators at his confirmation hearing on Wednesday that studies had not shown a link between vaccines and autism, even as he urged more research on the question.” * * *
    • “Dr. Bhattacharya [,a Stanford University health economist,] burst into the news at the height of the pandemic in October 2020, when he co-wrote an anti-lockdown treatise, the Great Barrington Declaration, that argued for “focused protection” — a strategy that would focus on protecting the elderly and vulnerable while letting the virus spread among younger, healthier people.
    • ‘The nation’s medical leadership, including Dr. Francis S. Collins and Dr. Anthony S. Fauci, then director of the National Institute of Allergy and Infectious Diseases, denounced the plan. Referring to Dr. Bhattacharya and his co-authors as “fringe epidemiologists,” Dr. Collins wrote in an email that “there needs to be a quick and devastating takedown of its premises.”
    • ‘Dr. Collins, who later stepped down as the N.I.H. director to pursue his laboratory research, retired last week in anticipation of Dr. Bhattacharya’s arrival. At Wednesday’s hearing, Senator Pete Ricketts, Republican of Nebraska, introduced Dr. Bhattacharya by praising him for having “great intellectual honesty and courage” to offer an alternative approach to handling the pandemic.”
  • The Wall Street Journal reports
    • “Rep. Sylvester Turner, a Texas Democrat who was just sworn into the House in January, died on Tuesday night.” * * *
    • “Turner’s sudden death will also have an immediate consequence in the political body in which he had served: House Republicans now have slightly more cushion as Democrats await a special election to fill the seat. With his death, the majority now stands at 218-214.
    • “The House GOP majority math is so slim that the confirmation of Rep. Elise Stefanik (R., N.Y.) to serve as U.S. Ambassador to the United Nations has been held up as Republicans wait to fill the seats of former Reps. Matt Gaetz (R., Fla.) and Mike Waltz (R., Fla.). The special elections for both Florida seats are set to take place on April 1. Stefanik has continued to serve in the House for now.” * * *
    • “It wasn’t immediately clear when Texas Gov. Greg Abbott will call a special election for Turner’s seat.” 
  • MedTech Dive informs us,
    • “Philips stopped selling an implant used to repair damaged arteries after reports of 20 injuries and some devices needing to be removed.
    • “The Food and Drug Administration said in a Monday recall notice that all customers should stop using Philips’ Tack Endovascular System immediately. The agency classified the recall as Class I, the highest risk category.
    • “Philips is not aware of serious harm or death accompanying the use of the device, a company spokesperson wrote in an email. The FDA said no deaths were reported.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Justice Department under President Donald Trump is defending the federal government’s position in several Medicare Advantage lawsuits challenging policies that originated during President Joe Biden’s term.
    • “Given Trump’s overall repudiation of the Biden years and Republicans’ generally favorable disposition toward Medicare Advantage and preference for light regulation, Wall Street expected the new administration to take it easier on health insurance companies. So far, in court at least, that’s not what’s happening.
    • “Since Trump returned to the White House in January, the Justice Department has filed briefs supporting the Biden administration’s defenses against companies such as Humana and eHealth in Medicare Advantage cases regarding the Star Ratings quality assessment program, marketing rules and the risk-adjustment system.”
  • and
    • “A health system at the center of a legal dispute over emergency abortions notified a federal court Tuesday that the Justice Department is dropping its challenge to Idaho’s anti-abortion laws.
    • “President Joe Biden’s administration contended that hospitals in states with restrictive abortion laws nevertheless are required to provide the procedure in emergencies to preserve the life and health of pregnant patients under the Emergency Medical Treatment and Active Labor Act of 1986, known as EMTALA. President Donald Trump, who opposes abortion rights, was expected to change course and now has, according to Boise, Idaho-based St. Luke’s Health System.
    • “St. Luke’s submitted a brief to the U.S. District Court for the District of Idaho on Tuesday saying its attorneys received an email on Monday from an unnamed federal official informing them that the Justice Department intends to withdraw its case against the Idaho laws.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “Over half of adults and a third of kids and teens around the world will have overweight or obesity by 2050, according to two reports using data on 204 countries and territories.
    • “If observed trends over the past 30 years continue, the total number of adultsopens in a new tab or window ages 25 and older living with overweight (body mass index [BMI] 25 to <30) or obesity (BMI ≥30) will reach 3.8 billion by 2050 — more than half of the likely global adult population at that time.
    • “Meanwhile, 356 million young people ages 5 to 14 years and 390 million young people ages 15 to 24 years are projected to have overweight or obesity by 2050, reported the Global Burden of Disease (GBD) Study 2021 Adult and Adolescent BMI Collaborators in The Lancet.
    • “This polycrisis will cause more avertable adverse health outcomes in the coming decades than any other modifiable risk at an individual level,” the researchers wrote. “Urgent, bold, and comprehensive initiatives are imperative to enable multisectoral collaboration and propel structural reforms to address drivers of overweight and obesity at individual and population levels. Although new-generation antiobesity medications appear promising, tactful, whole-system, public health strategies will continue to be crucial to achieving widespread and sustainable impact.”
  • Per an NIH press release,
    • A research team funded by the National Institutes of Health (NIH) has developed a medication that shows promise in treating acute and chronic pain. The drug, known as VIP36, targets the body’s cannabinoid receptor type 1 (CB1). It was found to be effective in three different animal models for pain and does not appear to cause the harmful side effects that have frustrated other efforts to target CB1. These results enhance understanding of how to design safer and more effective drugs targeting cannabinoid receptors and are an important step towards developing novel, non-addictive treatments for pain.
  • Cardiovascular Business reports,
    • Transcatheter aortic valve replacement (TAVR) is associated with better in-hospital outcomes than surgical aortic valve replacement (SAVR), according to a new analysis published in The Annals of Thoracic Surgery.[1] However, researchers noted, SAVR was linked to superior long-term outcomes, including a lower stroke risk, for both low- and intermediate-risk patients.
    • The newly published study included data from nearly 160,000 patients 65 to 85 years old who underwent aortic valve replacement from 2018 to 2022. All data came from the U.S. Centers for Medicare and Medicaid Services database. While 124,897 patients underwent TAVR, another 34,215 underwent first-time SAVR. The median follow-up period was 2.7 years.
    • Using Society of Thoracic Surgeons mortality risk scores as their primary guide, researchers determined if each study participant was a low-, intermediate- or high-risk patient. The low-risk group was represented by more than 36,000 TAVR patients and more than 1,400 SAVR patients. The intermediate-risk group, meanwhile, was represented by more than 44,000 TAVR patients and more than 9,000 SAVR patients. The high-risk group was represented by 44,000 TAVR patients and nearly 10,000 SAVR patients. 
    • In all three risk groups, TAVR patients were older and more likely to present with a history of heart failure or coronary artery disease than SAVR patients
  • MedPage Today relates,
    • Patients using GLP-1 drugs had no difference in the odds of postoperative aspiration pneumonia versus non-users.
    • There was also no significant difference in the odds of acute respiratory failure.
    • Findings support guidance recommending that a GLP-1 agent hiatus is not necessary before surgery.
  • Per Healio,
    • “Children were around half as likely to develop one or more long COVID symptoms if they were vaccinated.
    • “Vaccinated children were 75% less likely to experience long COVID symptoms that affected daily function.”
  • Per Health Day,
    • “Physical activity can improve the mental well-being of women living with chronic pelvic pain disorders like endometriosis and uterine fibroids, a new study says.
    • “Activities like brisk walking or aerobic exercise caused measurable improvements in women with pelvic pain, researchers reported in the Journal of Pain Research.
    • “Chronic pelvic pain disorders are incredibly complex and burdensome for those affected, yet we still have very few effective treatment strategies,” said senior researcher Ipek Ensari, an assistant professor of artificial intelligence and human health at the Icahn School of Medicine at Mount Sinai in New York City.
    • “Our research suggests that physical activity could be an important tool for improving mental health in these patients, offering them a proactive way to enhance their well-being,” Ensari added in a news release.” * * *
    • “We were particularly intrigued to find that the positive effects of exercise seem to lag by a few days, meaning the mental health benefits may build up gradually,” Ensari said. “This insight is vital for both patients and health care providers, as it underscores the importance of consistency in physical activity.”
    • “As women’s mental health improved, they also experienced improvements in physical function and reductions in pain, results show.”

From the U.S. healthcare business front,

  • Fierce Healthcare brings us the latest on the HIMMS conference ongoing in Las Vegas.
  • Beckers Hospital Review notes,
    • “Rochester, Minn.-based Mayo Clinic reported an operating income of $1.3 billion (6.5% operating margin) in 2024, up from an operating income of $1.1 billion (6% margin) in 2023, according to its March 5 financial report.
    • “The health system recorded revenue of $19.8 billion in the 12 months ended Dec. 31, up from $17.9 billion in the same period last year. Mayo Clinic reported medical service revenue of $16.6 billion in 2024, up from $15 billion in 2023. 
    • “Operating expenses totaled $18.5 billion in 2024, up from $16.9 billion in 2023. Salaries and benefits totaled $10.5 billion, up from $9.7 billion in 2023. Supply and service expenses totaled $6.7 billion, up from $6 billion in the prior year. 
    • “Mayo Clinic’s success in 2024 reflects the innovative spirit of our exceptional staff and their dedication to meeting our patients’ changing needs,” Mayo Clinic President and CEO Gianrico Farrugia, MD, said. 
  • STAT News reports
    • “Novo Nordisk will start selling its obesity drug Wegovy directly to patients at a reduced price, following a similar move from Eli Lilly as the two drugmakers compete for market share and try to draw patients away from compounding pharmacies that have been making cheaper copies of weight loss drugs.
    • “Wegovy normally carries a list price of about $1,350 a month, but Novo will sell the treatment through its new direct-to-consumer offering called NovoCare Pharmacy at $499 a month for all doses to cash-paying patients, meaning patients who are paying on their own without insurance.
    • “Orders will be fulfilled by CenterWell Pharmacy, a subsidiary of Humana that offers home delivery services.”
  • Per Healthcare Dive,
    • Bankrupt Prospect Medical Holdings may need to find another buyer for its Connecticut hospital portfolio, after Yale New Haven Health, which originally signed an agreement to acquire the three facilities in 2022, called the deal “impossible” in a statement to Healthcare Dive.
    • A spokesperson for Yale New Haven said the deal was unworkable due to Prospect’s failure to pay vendors on time, disinvestment in the facilities and record of mismanagement. 
    • Connecticut Gov. Ned Lamont said in a press conference on Monday that Prospect has found possible buyers located in Connecticut and out of state that could be named in the coming weeks, according to a report from the Register Citizen.
  • Per BioPharma Dive,
    • “Jazz Pharmaceuticals is expanding its foothold in cancer drug research, announcing Wednesday it will pay $935 million to buy Chimerix and an experimental medicine under Food and Drug Administration review for treatment of a form of the brain cancer glioma.
    • “Per deal terms, Chimerix investors will receive $8.55 a share, a 72% premium on Tuesday’s closing price. Jazz expects the deal to close in the second quarter of 2025. The deal is all in cash, which Jazz will draw from holdings and investments that amounted to $3 billion at the end of 2024.
    • “If approved, Chimerix’s drug would join five other marketed cancer medicines in Jazz’s portfolio, potentially helping the Dublin-based company diversify revenue away from its biggest seller, the sleep drug Xywav.
    • “Called ONC201 or dordaviprone, the drug has been submitted for accelerated FDA approval in people who have gliomas with a mutation called H3 27M. A small 2014 study suggests that such mutations are common in people under the age of 50 who are diagnosed with glioma.”

Tuesday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Wednesday Report

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

From Washington, DC,

Capitol Hill News

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

White House News

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

CMS News

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

Food and Drug Administration News

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

Happy Washington’s Birthday (one day early)

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

From Washington, DC

Capitol Hill News

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

White House News

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

Postal Service News,

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

Food and Drug Administration News

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

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

From Washington, DC,

Capitol Hill News

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

White House news

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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