Friday Report

COVID-19

Friday Report

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

From Washington, DC

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

From the judicial front,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is declining nationally to low levels. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity continues to decline; however, CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The American Hospital Association News adds,
    • “There are 483 confirmed cases of measles in 19 states across the country, according to the latest data from the Centers for Disease Control and Prevention. The agency said 93% of the cases are outbreak-associated. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • NBC News adds,
    • “We are experiencing an extremely concerning decline in measles vaccination in the very group most vulnerable to the disease,” said Benjamin Rader, a computational epidemiologist at Boston Children’s Hospital, an assistant professor at Harvard Medical School and the author of a recent study that looked at children’s vaccination rates.” * * *
    • “Rader said that the true MMR vaccination rate among young children can be misrepresented by publicly reported numbers, because MMR surveillance is drawn from older children who are already in kindergarten.
    • “Younger children under the age of 5 are not fully captured in surveillance data because they have not reached kindergarten age — although a 2021 estimate from the CDC notes a subset of younger children, namely those who received at least one MMR dose by 24 months, were 90.6% vaccinated for measles.
    • “In Rader’s study, published online in February in the American Journal of Public Health, his team surveyed approximately 20,000 parents of children under 5 from July 2023 through April 2024, finding only 71.8% reported that their children received at least 1 dose of MMR vaccine — much lower than CDC estimates.
    • “The researchers used a digital surveillance platform that the CDC has used to estimate things like at-home Covid testing, he said.  
    • “Rader downplayed the difference in numbers between his findings and the CDC data, emphasizing that, while accurate, the CDC data does not provide a complete picture — despite its best intentions.
    • “Dr. Scott Roberts, associate medical director of infection prevention at the Yale School of Medicine in New Haven, Connecticut, who was not part of the research, called the findings “worrisome.”   
  • Health Day relates,
    • “Tobacco control measures like anti-smoking campaigns and cigarette taxes have prevented nearly 4 million lung cancer deaths during the past five decades, a new American Cancer Society study estimates.
    • “More than 3.8 million lung cancer deaths were averted due to substantial reductions in smoking, gaining a little more than 76 million years of extra life among Americans, researchers say in CA: A Cancer Journal for Clinicians.
    • “The substantial estimated numbers of averted lung cancer deaths and person-years of life gained highlight the remarkable effect of progress against smoking on reducing premature mortality from lung cancer,” lead investigator Dr. Farhad Islami, the ACS’ senior scientific director for cancer disparity research, said in a news release. 
    • “In fact, the number of averted lung cancer deaths accounts for roughly one-half of all cancer deaths that were prevented in recent decades, researchers said.
    • “However,” Islami added, “Despite these findings, lung cancer is still the leading cause of cancer death in the United States, and smoking-attributable morbidity and mortality from other cancers or diseases remain high.”
  • Per Healio,
    • “There were 69 nonfatal fentanyl exposures in 2015 and 893 in 2023.
    • “Two-thirds of adolescents who were exposed to fentanyl used it intentionally.” * * *
    • “According to the researchers, nearly 39.4% of all overdoses and 65.7% of those among adolescents involved intentional misuse or abuse. In contrast, 81.7% of overdoses among younger children were reported to be unintentional.
    • “It was surprising that a large portion of adolescents used fentanyl intentionally,” Palamar said. “We often think of pediatric exposures to fentanyl as being unintentional.”

From the AI front,

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

From the U.S. healthcare business front,

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

Weekend update

David Ermer–CDC, Congress, COVID treatment, FDA, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call adds,
    • Both the House and Senate come back from recess this week to begin a busy three-week period that’s expected to focus on Republicans’ budget reconciliation agenda, including extending and expanding tax cuts and tightening immigration policy.
    • The top items on the House agenda this week, meanwhile, will include more measures to overturn Biden administration rules. And the Senate will continue to vote on more of President Donald Trump’s nominations. The headliners this week are the nominees to lead the National Institutes of Health and the Food and Drug Administration.
    • With a stopgap spending law now in effect through Sept. 30, the Republican majorities in both the House and Senate can fully turn their attention to their budget reconciliation agenda.
    • This work period on Capitol has just three weeks, followed by the traditional two-week recess that coincides with Easter and Passover. By then, House and Senate Republicans will want to make progress on resolving differences on how to execute the process that allows them to pass legislation without the risk of filibusters in the Senate.
  • Roll Call also gives us the 119th Congress in numbers, mid-March edition.
  • On Tuesday morning at 10 am, the House Oversight and Government Reform Committee will mark up the following batch of bills,
    • H.R. 1295, the Reorganizing Government Act of 2025; 2) H.R. 1210, the Protecting Taxpayers’ Wallet Act; 3) H.R. ___, the Preserving Presidential Management Authority Act; 4) H.R. 2174, the Paycheck Protection Act; 5) H.R. 2193, the FEHB Protection Act of 2025; 6) H.R. ___, the Federal Accountability Committee for Transparency (FACT) Act; 7) H.R. 2056, District of Columbia Federal Immigration Compliance Act; 8) H. Res. 187, Of inquiry requesting the President to transmit certain information to the House of Representatives referring to the termination, removal, placement on administrative leave, moved to another department of Federal employees and Inspectors General of agencies; 9) H. Res. 186, Of inquiry requesting the President to transmit certain documents to the House of Representatives relating to the conflicts of interest of Elon Musk and related information.
  • Healthcare Dive tells us,
    • “A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and Human Services confirmed.
    • “The Advisory Committee on Immunization Practices, or ACIP, had originally been scheduled to meet Feb. 26 to Feb. 28, but was unexpectedly delayed soon after Robert F. Kennedy Jr., a longtime critic of U.S. vaccination policies, took office as health secretary. At that time, an HHS spokesperson said the rescheduling was to allow extra time for public comment.” * * *
    • “ACIP, which includes outside vaccine experts as well as federal health officials, will now convene on April 15 and April 16, Andrew Nixon, HHS’ director of communications, wrote in an email to BioPharma Dive.” 
    • “A notice posted Friday ahead of publication Monday in the federal register indicated that advisers will discuss the current measles outbreak, as well as vaccines for COVID-19, human papillomavirus, monkeypox, respiratory syncytial virus and other pathogens.”
  • The New York Times reports,
    • “Robert F. Kennedy Jr., the nation’s health secretary, on Saturday instructed leaders of the nonprofit he founded to take down a web page that mimicked the design of the Centers for Disease Control and Prevention’s site but laid out a case that vaccines cause autism.
    • “The page had been published on a site apparently registered to the nonprofit, the anti-vaccine group Children’s Health Defense. Mr. Kennedy’s action came after The New York Times inquired about the page and after news of it ricocheted across social media.
    • “The page was taken offline Saturday evening.” 
  • Pharmacy Practice News informs us,
    • “The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video.
    • “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.”
    • “These activities can result in “a thousand fraudulent prescriptions using an unsuspecting doctor’s DEA number within a 14-hour time frame,” Ms. Hager said.”

From the public health and medical research front,

  • The New York Times reports, “Dementia May Not Always Be the Threat It Is Now. Here’s Why. The number of cases will increase, but the rates seem to be declining with every birth cohort that reaches advanced ages, researchers said.”
    • Eric Stallard, an actuary and co-director of the Biodemography of Aging Research Unit at Duke University, read the [recent dementia] study and thought the team “seemed very competent at their analysis” of individual risk.
    • But when it came to the projection that cases would double, which assumed that the incidence of dementia would remain stable over the next 40 years, “I don’t believe it,” Mr. Stallard said.
    • “The notion that the number of people with dementia will double over the next 25, 30 or 35 years due to the aging of baby boomers is widespread, it’s pervasive — and it’s wrong,” he added.
    • “He and two other Duke researchers recently published a commentary in JAMA pointing out that the age-specific prevalence of dementia in this country had steadily declined for 40 years.
    • “If your risks are lower than your parents’ risks and this trend continues, you won’t see the doubling or tripling of dementia that’s been projected,” said Dr. Murali Doraiswamy, director of the Neurocognitive Disorders Program at Duke and a co-author of the JAMA article.
    • “To be clear, experts agree that the number of people with dementia will climb in coming decades, simply because the disorder rises so steeply with age and the number of older adults in the United States will increase.
    • “But Mr. Stallard estimates that the increase will be more like 10 to 25 percent by 2050. “It will still be a significant challenge for the health system in the U.S.,” he said.”
  • The University of Minnesota CIDRAP lets us know,
    • Another study is raising questions about whether compliance with a federally mandated hospital protocol aimed at improving sepsis care and management is associated with better outcomes.
    • The study, published this week in JAMA Network Open, found that sepsis patients who received care that was noncompliant with the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) tended to be older, have more comorbidities, and have more complex clinical presentation than those who received compliant care. When those factors were accounted for, SEP-1 compliance was no longer associated with improved mortality.
    • The study comes on the heels of a systematic review and meta-analysis, published last month in the Annals of Internal Medicine, that found no evidence that SEP-1 compliance was associated with improved mortality.
  • and
    • “People who started taking the antiviral drug ensitrelvir within 72 hours after a household member tested positive for COVID-19 were significantly less likely to be infected, according to results from an international phase 3 clinical trial presented last week at the Conference on Retroviruses and Opportunistic Infections in San Francisco.
    • “Made by Japanese pharmaceutical firm Shionogi, ensitrelvir is approved in Japan for the treatment of mild to moderate COVID-19.  * * *
    • “In addition to vaccination, post-exposure prophylaxis with timely use of an oral antiviral would be a valuable way to help prevent COVID-19 illness in people who have been exposed, especially people at high risk for severe disease,” Frederick Hayden, MD, a University of Virginia School of Medicine professor emeritus who helped design the trial and presented the findings, said in a university news release.
    • “This is the first clinical trial of an oral antiviral drug to show significant protection against COVID-19 [infection],” he added. “If approved by the [US] Food and Drug Administration for this purpose, it would be an important addition to current preventive strategies.”
  • A Wall Street Journal reporter tells us “A Year After I Stopped Taking a [GLP-1} Weight-Loss Drug, I’ve Lost 20 More Pounds. I’m one of the millions of people trying to keep the weight off without taking expensive drugs like Mounjaro or Ozempic for life. It wasn’t easy, but I found ways.”
    • “My first mistake in stopping the medicine [after reaching his target weight in five months] was that I didn’t wean myself off it more slowly. I stopped cold turkey, and my hunger pangs and food noise came back with a vengeance. Some doctors and researchers have begun to recommend stopping more gradually, as well as taking appetite suppressants like phentermine to ease the transition. This has helped reduce weight regain in some patients.
    • “My second mistake was not having a structured nutrition plan at the ready. The medicine had helped winnow my bad habits down to a number I could actually manage, from perhaps 25 or 30 entrenched eating behaviors (really!) down to more like five or six (I still can’t shake my addiction to impulsive runs to the 7-Eleven, for example). But even a few bad habits—when they meet with what feels like insatiable hunger—can do a lot of damage.
    • “After a few months, I found a highly structured nutrition program, one with expert coaching that focused on a low-carb diet. While the transition was difficult, it eventually helped me bring my cravings under control. 
    • “Virta Health, a startup I turned to for a few months, has users test their blood daily. The results, which measure glucose levels and another indicator of dietary compliance, are beamed through an app to a nutrition coach. Being aware that someone was watching—and would know if I had cheated—was immensely helpful as I sought to improve my nutrition and manage hunger.
    • “Without wading into the nutrition wars over the keto or Atkins or Mediterranean diet or any other, I’ve found that I have generally been far less hungry when I’ve eaten more protein, fiber and healthy fats. Meanwhile, drastically limiting carbohydrates has had another benefit: forcing me to eat more vegetables. Gobs and gobs of them.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The Longevity Business Is Booming—and Its Scientists Are Clashing. The antiaging movement has raced ahead amid fierce debates; critics of a grandfather of the field, Leonard Guarente, include former protégés and rivals.”
  • and
    • “Doctors Are Just as Frustrated as You by Our Messed-Up Healthcare System. Trust between doctors and patients is fraying, but there are ways to mend it.”
      • “One of doctors’ biggest gripes: largely corporate institutions that effectively set patient quotas and require extensive documentation. One physician said he and other doctors are allowed 15 minutes with patients; exceeding that leads to poor performance reviews and “being out of compliance.”
      • “These doctors think patients lose trust because they don’t understand who or what is in control. “Physicians have lost autonomy,” says Dr. Corinne Rao, an internal medicine physician and hospitalist. “Their decisions are subject to the financial interests of their employer.” 
      • “Doctors also say that trust—and respect—go both ways. “It’s like a marriage,” says Dr.  James Schouten, a family physician. Each side has to give 100%. Implying that a loss of trust is entirely the doctor’s fault, he says, suggests the patient has no role in establishing or maintaining trust.
      • “They do, he and others say.”

Friday Report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Happy Pi Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “The Senate March 14 approved by a vote of 54-46, a continuing resolution to fund the government through Sept. 30. The House passed, by a vote of 217-213, the bill earlier in the week. President Trump is expected to sign the measure.
    • “The bill extends certain key health care provisions that were set to expire at the end of March, including eliminating Medicaid disproportionate share hospital cuts, and extending the enhanced low-volume adjustment and Medicare-dependent hospital programs; key telehealth waivers; the hospital-at-home program; the Work Geographic Index Floor program; and add-on payments for ambulance services.”
  • Upshot — No government shutdown.
  • Fierce Healthcare adds,
    • “A last-ditch effort to pass a bipartisan healthcare package pushed aside at the end of 2024 that includes telehealth extensions and pharmacy benefit manager reform, reverses doc pay cuts and addresses the opioid crisis has failed.
    • “That legislation was brought to the floor by Senators Ron Wyden, D-Oregon and Bernie Sanders, I-Vermont, March 14 ahead of a key procedural vote [on the continuing resolution]. The senators’ bill required unanimous consent, or it would not advance. Sen. Rick Scott, R-Florida, quickly rejected the bill.”
  • Per a Senate news release,
    • “Today, the Senate overwhelmingly voted to pass the Halt All Lethal Trafficking of (HALT) Fentanyl Act. The bipartisan legislation, led by Judiciary Chairman Chuck Grassley (R-Iowa), Health, Education, Labor and Pensions Chairman Bill Cassidy, M.D. (R-La.) and Sen. Martin Heinrich (D-N.M.), would permanently classify fentanyl-related substances before their temporary Schedule I status expires on March 31, 2025. 
    • “Last month, the HALT Fentanyl Act was passed out of the Senate Judiciary Committee by a bipartisan vote of 16-5. Attorney General Pam Bondi has endorsed the legislation. President Trump’s Office of Management and Budget has confirmed that, if Congress passes the bill in its current form, the president will sign it. The legislation now heads to the House of Representatives.
    • “The HALT Fentanyl Act is a critical step towards ending the crisis that’s killing hundreds of thousands of precious American lives. I thank my Senate colleagues for passing this bill with broad, overwhelming support. I urge my House colleagues to swiftly pass the Senate version of this battle-tested, bipartisan bill to save lives, advance research and support our brave men and women in blue,” Grassley said.: * * *
    • “Download bill text HERE and a fact sheet HERE.”
  • The AHA News tells us,
    • “The Senate Finance Committee March 14 held a confirmation hearing on Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services. Oz, a doctor and former television show host, indicated that some of his priorities in the position, if confirmed, would be to reduce health care spending by improving poor health, increasing use of technology, incentivizing providers, and stopping wasteful spending, fraud and abuse. The committee will soon schedule a vote on whether to advance his nomination to the full Senate.”
  • The Wall Street Journal adds,
    • “Mehmet Oz, the Trump administration’s nominee to lead the Medicare agency, said some actions by private insurers in the Medicare Advantage program amounted to fraud and cheating, and he intended to go after them as head of the Centers for Medicare and Medicaid Services. 
    • “His comments, during his Senate confirmation hearing on Friday, were focused on industry practices that can boost insurers’ Medicare Advantage payments by documenting more diagnoses in their patients. Medicare Advantage insurers get higher payouts when patients have certain conditions. 
    • “There’s a new sheriff in town,” said Oz, a heart surgeon known for his long-running television show. He criticized “upcoding” in Medicare Advantage and said, “I pledge if confirmed I will go after it.”
  • Per Senate news releases,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, laid out his health care priorities during a hearing to consider Dr. Mehmet Oz’s nomination to be Administrator of the Centers for Medicare and Medicaid Services (CMS). Oz committed to supporting Grassley’s efforts to lower prescription drug costs, strengthen rural health care, help kids with exceptional medical needs, preserve transitional health plans and improve the agency’s responsiveness to Congress.”
  • and
    • “At a U.S. Senate Finance Committee hearing to consider the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator, Chairman Mike Crapo (R-Idaho) highlighted Dr. Oz’s wealth of firsthand experience as an accomplished physician and his clear vision for creating a healthier nation.  Crapo and Dr. Oz discussed how he would address the nation’s chronic disease epidemic, as well as how he might approach reforming payment programs to improve efficiency.
    • “Crapo concluded the hearing with, “There is no doubt you are qualified to serve as the next Administrator of [CMS], and I look forward to voting in favor of your nomination and am urging all of my colleagues to do the same.”
  • The AHA News informs us,
    • “The Medicare Payment Advisory Commission March 13 released its March report to Congress that includes recommendations for hospital and other Medicare payment systems for fiscal year 2026. Among the recommendations, MedPAC urged Congress to update the base payment rate for hospitals by current law plus 1%.  
    • “An update above current law is necessary given the combination of providers’ continued financial pressures, and almost two decades of sustained and substantial negative Medicare margins,” AHA wrote in a January letter to MedPAC. “Simply put, even after the recommended payment update, Medicare’s payments to hospitals would remain inadequate.” 
  • Per a Food and Drug Administration news release,
    • “Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.
    • “The new study, published in the peer-reviewed scientific journal American Journal of Preventive Medicine, found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.”

From the judicial front,

  • Politico reports,
    • “A federal appeals court has given President Donald Trump’s administration the go-ahead to enforce a pair of controversial executive orders that seek to root out diversity, equity and inclusion efforts in federal agencies and government contractors.
    • “The three-member appeals panel — including two judges appointed by Democratic presidents — lifted a lower court’s injunction that had put the policy on hold last month.
    • The ruling Friday from the panel of the Richmond, Virginia-based 4th Circuit Court of Appeals is not a final decision on the legality of Trump’s anti-DEI policy. It merely allows the government to administer the policy while litigation continues.
    • “In separate opinions explaining their votes, the three judges suggested the Trump administration should be allowed to demonstrate that it will abide by anti-discrimination laws and respect First Amendment rights as it implements the executive orders, which Trump issued on the first two days of his new term.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota’s CIDRAP reports,
    • “The measles outbreak in Texas has risen by 36 cases, pushing the US case count for the year past the number for all of 2024.
    • “The outbreak of the highly contagious virus, which began in late January and is centered in the western part of the state, now stands at 259 cases, according to the latest update from the Texas Department of State Health Services (DSHS). Of those patients, 257 are either unvaccinated or have unknown vaccination status, and 201 are children ages 17 or younger. Thirty-four patients have been hospitalized, with one death in an unvaccinated child who had no known underlying conditions.
    • “Eleven counties to date have reported cases, but two thirds of the cases (174; 67%) are in Gaines County, which has one of the highest rates of school-aged children in Texas who have opted out of at least one vaccine. The county is home to a large Mennonite community with low vaccination rates.
    • “DSHS officials said they have determined that three of the case-patients previously listed as vaccinated were not vaccinated. Two had received their measles, mumps, and rubella (MMR) vaccine doses 1 to 2 days before their symptoms started and after they had been exposed to the virus. The third had a vaccine reaction that mimicked a measles infection and has been removed from the case count.”
  • The University of Minnesota CIDRAP also notes,
    • “The US Food and Drug Administration (FDA) yesterday announced the strains it recommends manufacturers include in seasonal flu vaccines for the 2025-26 flu season, and [as usual] they mirror recommendations announced by the World Health Organization (WHO) last month.” 
  • Gallup reports,
    • “Americans’ assessments of their mental and physical health are the least positive they have been in Gallup’s 24-year trend, reflecting a decadelong decline that began around 2013 and accelerated sharply with the onset of the COVID-19 pandemic in 2020.
    • “Three in four U.S. adults in Gallup’s latest annual reading rate their mental health (75%) and, separately, their physical health (76%) as either “excellent” or “good.” This contrasts with a record-high 89% rating their mental health positively as recently as 2012, and a high of 82% for physical health in 2003.
    • “As fewer Americans have rated their mental and physical health positively, most of the change has been in the percentages rating each aspect “excellent” — shrinking to 31% for mental health and 24% for physical health.”
  • The National Science Foundation points out,
    • “A team of researchers led by the recipient of a U.S. National Science Foundation Faculty Early Career Development grant has developed a new storage method for protein-based drugs that could potentially eliminate the need for refrigeration of important medicines. Using an oil-based solution and a molecule acting as a coating to enclose the proteins in these drugs, researchers demonstrated a technique to prevent the proteins from degrading rapidly — a protection that traditionally requires refrigeration.
    • “The research is led by Scott Medina at Pennsylvania State University and published in Nature Communications. It demonstrates a possible practical application to eliminate the need to refrigerate hundreds of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
    • “The work could eventually reduce the cost of refrigerating such drugs throughout the supply chain and enable greater use of protein-based therapies where constant refrigeration isn’t possible, including military environments. 
    • “Over 80% of biologic drugs and 90% of vaccines require temperature-controlled conditions. This approach could revolutionize their storage and distribution, making them more accessible and affordable for everyone,” says Medina.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have determined that dermatitis resulting from topical steroid withdrawal (TSW) is distinct from eczema and is caused by an excess of an essential chemical compound in the body. Scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) identified treatments that could be studied in clinical trials for the condition based on their potential to lower levels of the chemical compound—called nicotinamide adenine dinucleotide (NAD+), a form of vitamin B3. The findings were published today in the Journal of Investigative Dermatology.
    • “Dermatitis is characterized by inflammation, itching, or burning sensations on the skin, and can result from various conditions including TSW and eczema. Eczema, also known as atopic dermatitis, is a common cause of dermatitis and affects 10 to 30% of children and 2 to 10% of adults each year in the United States. Topical steroids—specifically glucocorticoids or topical corticosteroids—have long been used as a first-line treatment for dermatitis caused by eczema because the drugs are safe, effective, easy to apply, and considered well-tolerated.” * * *
    • “The scientists provisionally established criteria that can be used by health care providers to identify TSW in people. People who have stopped topical steroid treatment and meet the criteria may be diagnosed by practitioners as having TSW. The researchers suggest that patients identified as having TSW could be treated using the proposed mitochondrial complex I-blocking drugs.
    • “The results of this study may help practitioners identify TSW in patients and work towards developing safe and effective treatments. According to the researchers, more research is needed to determine whether all patients with TSW have an excess of NAD+, or if there are other features that define TSW. Additionally, the diagnostic criteria will help health care providers and researchers to better understand the prevalence of TSW and evaluate the effects of using topical steroids.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.
    • “But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?
    • “The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.
    • “To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)”
  • Per STAT News,
    • “Biotech company Altimmune announced in an investor call yesterday that it will study its obesity drug, which targets receptors of the GLP-1 and glucagon hormones, in alcohol use disorder, as mounting evidence supports the potential of GLP-1 drugs to help with addiction.
    • “Altimmune executives think that their molecule, called pemvidutide, could be particularly helpful for liver conditions, since there are glucagon receptors located in the liver. The company has already been studying the drug in weight loss and in the liver disease MASH, and are now expanding into alcohol-related conditions.
    • “The company plans to start a study in alcohol use disorder in the second quarter of this year, and another study in alcohol-related liver disease in the third quarter.
    • “Eli Lilly has also started studying mazdutide, a GLP-1/glucagon drug it’s developing with Chinese biotech Innovent, in alcohol use disorder. Lilly CEO Dave Ricks has said the company also plans to test obesity drugs in other areas of addiction, like nicotine and drug use disorders.
    • “Novo Nordisk is running a study of its obesity drugs in alcohol-related liver disease but has not yet started any trials in addiction.”
  • Per Beckers Hospital CFO Report,
    • As healthcare organizations continue to navigate shifting financial and operational landscapes, new data from Kaufman Hall and Strata highlights significant trends in physician productivity, compensation, and costs.
    • In the fourth quarter, median work relative value units per full-time physician varied across specialties, with medical specialties leading at 7,139 wRVUs. Physician compensation followed a similar pattern, with surgical specialists earning the highest median paid compensation at $491,000 per FTE.
    • Despite an encouraging increase in net revenue per physician, rising expenses remain a challenge. These figures underscore the mounting financial pressures and workforce challenges facing healthcare organizations. For executives, balancing rising costs, evolving productivity demands, and compensation structures will be critical in sustaining financial stability and operational efficiency.
  • Beckers Hospital Review points out ten drugs poised to be top sellers next year.

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.”

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.” 

Monday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

Happy Washington’s Birthday (one day early)

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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