Happy Pi Day!

U.S. Healthcare

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.

Thursday Report

David Ermer–CDC, Congress, FDA, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats took the threat of a government shutdown off the table, following a grueling intraparty fight in which lawmakers struggled with how best to resist President Trump’s fast-paced efforts to slim down federal agencies.
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) said he would vote to advance a Republican measure, set for Friday morning, to fund the government through September. Earlier, in a closed-door lunch, he also said that enough Democrats would join him to help the Republicans clear the chamber’s critical 60-vote hurdle, people familiar with the matter said.
    • “I will vote to keep the government open and not shut it down,” Schumer said on the Senate floor, characterizing Democrats’ alternatives as a Hobson’s choice with no good option. He said that in a shutdown, Trump could decide “to cherry pick which parts of the government to reopen in a protracted shutdown.”
  • The American Hospital Association News tells us,
    • “The White House March 13 withdrew the nomination of former Republican congressman Dave Weldon for director of the Centers for Disease Control and Prevention.
    • “Meanwhile, the Senate Committee on Health, Education, Labor and Pensions advanced the nominations of Jay Bhattacharya for director of the National Institutes of Health and Marty Makary for commissioner of the Food and Drug Administration. Both nominees will next be considered by a full Senate vote.”
  • Federal News Network informs us,
    • “The Postal Service is letting a team from the Department of Government Efficiency take a closer look at its reform plans.
    • “Postmaster General Louis DeJoy, in a letter sent to congressional leaders Thursday, said he signed an agreement last night with DOGE representatives and the General Services Administration to “assist us in identifying and achieving further efficiencies.”
    • “DeJoy told lawmakers that USPS is heading in the right direction under his 10-year Deliverying for America reform plan and that DOGE’s work is “aligned with our efforts.”
    • “While we have accomplished a great deal, there is much more to be done. We are happy to have others to assist us in our worthwhile cause,” DeJoy wrote.”

From the judicial front,

  • The Wall Street Journal relates,
    • “A federal judge has ordered six federal agencies to reinstate thousands of probationary employees who were fired last month, dealing a blow to the Trump administration’s efforts to rapidly scale back the size of the federal workforce.
    • “The Trump administration has encountered a number of legal challenges in its push to slash the government’s size and spending, including a lawsuit from a coalition of 20 states over plans to eliminate nearly half of the staff of the Education Department.
    • “The Education Department, with around 4,500 employees as of last year, is the smallest cabinet-level agency. Polls show most Americans oppose eliminating the department.”
  • FEHBlog note — The Justice Department has noticed an appeal of the reinstatement order to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law adds,
    • “A US judge in Maryland directed 18 agencies to temporarily rehire thousands of terminated employees, dealing another judicial defeat to Trump administration efforts to shrink the federal sector.
    • “The government gave no advance notice before firing newer workers, known as probationary employees, and conducted no individual assessments to justify their discharge based on performance, Judge James Bredar of the US District Court for the District of Maryland said Thursday in granting a temporary restraining order. 
    • “Bredar, an Obama appointee, found the terminations were unlawful workforce reductions that negatively impacted 19 states and the District of Columbia, which sued to challenge the firings.
    • “The ruling will apply for 14 days to workers at agencies including the Labor, Health and Human Services, Education, and Energy departments; the Environmental Protection Agency; the Consumer Financial Protection Bureau; and the US Agency for International Development. 
    • “It comes after a separate federal judge in California ordered six federal agencies to rehire probationary employees they fired since Feb. 13. Both decisions add to mounting setbacks for President Donald Trump and billionaire Elon Musk, who have attempted to cull the federal workforce in the name of efficiency.”

From the public health and medical research front,

  • Cardiovascular Business points out,
    • “U.S. patients are significantly less likely to die from heart failure-related cardiac arrest now than they were 25 years ago, according to new data published in the American Journal of Cardiology. However, the authors noted, certain disparities still exist, suggesting cardiologists and other healthcare providers have much more work to do. 
    • “Heart failure currently affects over 64 million adults worldwide, with about 6 million impacted in the United States, a number expected to rise to 8 million by 2030, wrote corresponding author Sivaram Neppala, MD, an assistant professor with the cardiology division at The University of Texas Health Sciences Center, and colleagues. “Patients diagnosed with heart failure face a significantly higher risk of cardiac arrest, contributing to 30-50% of mortality cases within this population. Those with systolic dysfunction are six to nine times more likely to experience sudden cardiac death. Cardiac arrest and heart failure can lead to irregular heart rhythms and myocardial fibrosis, increasing the risk of ventricular arrhythmias and highlighting the need for urgent care.”
    • “Neppala et al. explored U.S. Centers for Disease Control and Prevention data from 1999 to 2023, tracking changes in the overall age-adjusted mortality rate (AAMR) for cardiac arrest in patients with heart failure. All patients included in their analysis were 25 years old or older.
    • “Overall, the researchers found that the AAMR for heart failure-related cardiac arrest dropped from 25.3 per 100,000 adults in 1999 to 20.6 in 2023. The reduction was the most pronounced from 1999 to 2011, with an annual percentage change of -2.95%, but then remained largely unchanged from 2011 to 2018. The overall AAMR then increased from 2018 to 2021—a time when the COVID-19 pandemic was at its most severe—before dropping yet again from 2021 to 2023. 
    • “The subsequent decline from 2021 to 2023 (APC: -4.05%) indicates recovery and improved access to healthcare, highlighting the pandemic’s effects on cardiovascular outcomes and the necessity for resilient healthcare systems,” the authors wrote.”
  • STAT News discusses the importance of improving the availability of HIV self-testing.
    • “In May 2024, the Massachusetts Department of Public Health released a troubling report on a cluster of HIV infections, with more than 200 new cases since 2018 attributable to injection drug use in the Boston region. These findings have national implications: Similar HIV outbreaks have been described nationwide during the overdose crisis, including in West Virginia, Indiana, and Ohio. The increase in HIV cases amid the U.S. drug overdose crisis underscores the urgent need for a comprehensive response tailored to the unique challenges faced by people who use drugs. The importance of such efforts cannot be understated. In fact, in Massachusetts, 14% of new HIV diagnoses every year are attributed to injection drug use — nearly twice the national average.
    • “One potential solution is HIV self-testing, which would allow for rapid identification and treatment. Identifying HIV cases is the first step in addressing clusters, and quickly learning one’s status allows people to rapidly seek both treatment and prevention. Unlike traditional laboratory-based testing, which may take several days for results delivery, HIV self-testing relies on saliva and provides results in 20 minutes. The test is easily performed outside of a clinical setting by swabbing gums and collecting a sample of saliva. HIV self-testing has been available since 2012 and is recommended by the Centers for Disease Control and Prevention for accurate HIV diagnosis. It’s even part of the Department of Health and Human Services’ plan for Ending the HIV Epidemic (EHE) by 2030.
    • “But HIV self-testing remains underutilized among not only the general public, but especially people who use drugs. As the nation emerges from the Covid-19 pandemic, during which self-testing for infectious diseases became commonplace, increasing HIV self-testing among people who use drugs may limit the spread of a virus that, while manageable with medication, can lead to significant health risks if left untreated.”
  • MedPage Today lets us know,
    • “Better midlife diet was tied to better brain connectivity and white matter integrity later in life.
    • “Lower waist-to-hip ratio was associated with better memory and executive function at 70.
    • “Diet improvements over time were linked with better white matter integrity in several brain regions.”
  • The National Cancer Institute aggregated its latest research news while the National Institute of Diabetes and Digestive and Kidney Diseases reflects on its 75th anniversary.
  • Per Beckers Hospital Review,
    • “A recently approved drug for acute ischemic stroke works as well as the treatment used in most U.S. hospitals and may offer advantages for some patients, according to a study led by a researcher from Dallas-based UT Southwestern Medical Center. 
    • “The study, published March 12 in JAMA Network Open, compared the newly approved tenecteplase in a single quick injection to alteplase, the stroke treatment that has been used for decades and requires an hourlong infusion. “

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna is revamping its C-suite and consolidating oversight of its two main businesses — insurance and health services operations — under one executive, the company announced Thursday.
    • “Brian Evanko, currently chief financial officer and the head of Cigna’s health insurance division Cigna Healthcare, will serve as Cigna’s chief operating officer, managing both Cigna Healthcare and health services division Evernorth. Ann Dennison, who was deputy CFO under Evanko, will step up as enterprise CFO. The changes are effective at the end of this month.
    • “Meanwhile, Eric Palmer, the current CEO of Evernorth, is departing the company at the end of April, an apparent victim of the restructuring. A spokesperson for Cigna did not respond to a request for comment on the reason behind Palmer’s departure.”
  • Modern Healthcare notes,
    • “Highmark Health’s insurance business challenges weighed on the organization’s overall financial performance in 2024, the company reported Thursday.
    • “The nonprofit Blue Cross Blue Shield licensee saw its net income plummet 90.6% to $50 million while revenue rose nearly 9% to $29.4 billion. The company also reported operating losses of $209 million, compared with an operating gain of $338 million in 2023.
    • “Our entire industry faces strong financial headwinds. That underscores the need for a more economically sustainable approach that delivers better health experiences and outcomes,” Highmark Health President and CEO David Holmberg said on a telephone briefing announcing the financial results.”
  • Per BioPharma Dive,
    • “Mallinckrodt and Endo Pharmaceuticals, which have struggled through bankruptcies related to opioid litigation, said Thursday that they will merge in a cash and stock transaction that will leave a combined company valued at $6.7 billion.
    • “Shareholders of Mallinckrodt will end up with 50.1% of the combined company and current Mallinckrodt CEO Siggi Olafsson will take the top job at the new entity as well. Per deal terms, Endo shareholders will receive Mallinckrodt stock and a share of $80 million in cash.
    • “After the merger, a business made up of Endo’s sterile injectables and both companies’ generic pharmaceuticals will be separated out. The companies haven’t yet decided what that separation will look like, Olafsson told analysts and investors on a conference call. The board will “make the best decision going forward” after the combination of the businesses, he said.”
  • Per MedTech Dive,
    • “Vivani Medical said Wednesday it plans to spin off its neurostimulation business to form an independent, publicly traded company. 
    • “Formerly Second Sight Medical Products, the independent company will trade as Cortigent and advance brain implants to help people recover body functions such as vision and movement.
    • “Vivani, which is focused on GLP-1 implants, acquired the neurostimulation technology through a merger in 2022 and first filed paperwork to list Cortigent as an independent company in 2023.”

Midweek Report

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

From Washington, DC

Capitol Hill News

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

HHS News

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

FDA News

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Report

David Ermer–Congress, FDA, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call lets us know,
    • “President Donald Trump alleged Sunday that “the Democrats want” a government shutdown at the end of this week, but he predicted that a lapse in appropriations probably will not take place this time.
    • “I think the CR is going to get passed. We’ll see. But it could happen,” Trump told reporters aboard Air Force One, referring to a continuing resolution that would extend current funding until the end of the fiscal year on Sept. 30. The current funding extension expires at the end of Friday.”
  • Modern Healthcare adds,
    • “Physicians looking to Congress for relief from falling Medicare payments may have to keep waiting.
    • “House Speaker Mike Johnson (R-La.) unveiled what’s known as a continuing resolution, or CR, on Saturday to keep the government open through the end of fiscal 2025 on Sept. 30, and Congress may vote on the measure as soon as Tuesday. The legislation does not address the 2.9% Medicare reimbursement cut for physicians that took effect Jan. 1.
    • “The Johnson legislation would, however, extend telehealth and hospital-at-home authorities under Medicare and delay cuts to Medicaid disproportionate share hospital payments for safety-net providers. The bill also includes six-month funding extensions for community health centers, graduate medical education and other health programs that are due to expire on March 31.”
  • The Senate confirmed Lori Chavez-DeRemer to be Secretary of Labor by a 67-32 vote.
  • The Associated Press reports,
    • “Most of the 80,000 federal workers responsible for researching diseases, inspecting food and administering Medicare and Medicaid under the auspices of the Health and Human Services Department were emailed an offer to leave their job for as much as a $25,000 payment as part of President Donald Trump’s government cuts.
    • “Workers cannot start opting in until Monday and have until 5 p.m. on Friday to submit a response for the so-called voluntary separation offer. The email was sent to staff across the department, which includes the Centers for Disease Control and Prevention in Atlanta, and the National Institutes of Health as well as the Food and Drug Administration, both in Maryland.
    • “The mass email went out to a “broad population of HHS employees,” landing in their inboxes days before agency heads are due to offer plans for shrinking their workforces. HHS is one of the government’s costliest federal agencies, with an annual budget of about $1.7 trillion that is mostly spent on health care coverage for millions of people enrolled in Medicare and Medicaid.”
  • Govexec offers us the opportunity to meet the 2025 inductees into the Government Hall of Fame.

From the judicial front,

  • The Washington Post lets us know,
    • “The Supreme Court on Monday agreed to take up a Christian therapist’s challenge to a state law barring “conversion therapy” that attempts to change a young person’s sexual orientation or gender identity.
    • “Kaley Chiles, who practices in Colorado, says the state law banning such treatment is unconstitutional and has forced her to deny counseling to potential clients who share her faith, in violation of her religious beliefs.
    • “More than 20 states and the District of Columbia restrict mental health counseling that attempts to change a young person’s gender identity or sexual orientation.” 

From the public health and medical research front,

  • GoodRx informs us,
    • “Women consistently spend nearly 30% more out of pocket on prescriptions than men, totaling $8.5 billion more in 2024 alone.
    • “Women visit doctors more often, fill more prescriptions, and manage more chronic conditions — leading to higher total out-of-pocket costs across the board.
    • “Women 18 to 44 years old face the steepest price gap, spending up to 64% more than men — all while balancing career, family planning, and caregiving.
    • “Women also significantly outspend men on mental health treatments. Women spend 113% more on depression medications and 103% more on anxiety treatments.”
  • Health Day points out,
    • “Getting essential vitamins and minerals during pregnancy can help a woman maintain healthy blood pressure into middle age, new research suggests.
    • “High levels of the minerals copper and manganese in pregnant women were associated with lower blood pressure decades later, as well as a reduced risk of high blood pressure, researchers reported.
    • “Higher levels of vitamin B12 also were associated with lower blood pressure in later life, according to findings published March 6 in the journal Hypertension.”
  • The American Medical Association relates “What doctors wish patients knew about prostate cancer.”
  • The Washington Post points out that “Over 15 percent (15.5) of young adults ages 21 to 24 used electronic cigarettes in 2023, according to a report from the National Center for Health Statistics.”
  • Per Cardiovascular Business,
    • “New technology that directly visualizes inflammation in a patient’s coronary arteries could potentially transform the preventive cardiology landscape. It can evaluate a patient’s risk of a heart attack in a way that goes beyond what we learn from traditional cholesterol readings.
    • “Researchers at Oxford University developed the novel imaging technology, which detects coronary inflammation using coronary computed tomography angiography (CCTA) scans and artificial intelligence (AI) to show inflammation in the perivascular fat surrounding the vessels. It is now being commercialized by Caristo and pending U.S. Food and Drug Administration (FDA) final review. 
    • “It has always been the holy grail of cardiovascular prevention to be able to pick up coronary inflammation, because if you know which artery is inflamed and which patient needs treatments to prevent heart attacks. Up until now, we had only simply biomarkers like high sensitivity C-reactive protein (CRP), which are nonspecific. So, we have developed a technology the last few years that allows you to measure coronary inflammation by analyzing the fat that surrounds arteries,” explained by Charalambos Antoniades, MD, the British Heart Foundation Chair of Cardiovascular Medicine at the University of Oxford. He spoke with Cardiovascular Business about the technology at the American Heart Association (AHA) 2024 meeting, where he presented data on it at multiple sessions.”
  • ECRI lists the top ten threats to patient safety in 2025:
    • “Dismissing patient, family and caregiver concerns
    • “Insufficient governance of artificial intelligence
    • “Spread of medical misinformation 
    • “Cybersecurity breaches 
    • “Caring for veterans in non-military health settings
    • “Substandard and falsified drugs
    • “Diagnostic errors in cancers, vascular events and infections 
    • “Healthcare-associated infections in long-term care facilities 
    • “Inadequate coordination during patient discharge
    • “Deteriorating working conditions in community pharmacies” 

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “CVS is rolling out a dozen new stores focused primarily on pharmacy services, reducing retail offerings as the company responds to a prolonged decline in retail sales, The Wall Street Journal reported March 8. 
    • “The new stores, averaging less than 5,000 square feet, or less than half the size of a normal CVS store, will open over the next year across the U.S.” 
  • BioPharma Dive reports,
    • “Novo Nordisk’s experimental drug CagriSema helped people who are overweight or obese and have diabetes lose about 14% of their body weight over 68 weeks, or 11 percentage points more than those given placebo, the company said Monday.
    • “The Danish company aims to position CagriSema as a more potent successor to its popular obesity drug Wegovy, which recorded sales of 58 billion kroner, or about $8.4 billion, in 2024. But earlier trial results in people without diabetes also fell short of expectations, casting doubt on CagriSema’s potential.
    • “Novo Nordisk shares fell nearly 10% following the announcement, continuing a monthslong stock slide fueled by concerns over the company’s competitive standing versus top rival Eli Lilly. The company has already outlined plans for a new Phase 3 trial to test whether CagriSema can generate greater weight loss at higher doses.”
  • and
    • “An experimental drug from Mineralys Therapeutics succeeded in a pair of trials in people with stubbornly high blood pressure, the biotechnology company said Monday.
    • Mineralys has been developing the drug, dubbed lorundrostat, in people whose high blood pressure can’t be adequately treated with existing medications. The company says more than half of people with hypertension have this “uncontrolled” and “resistant” form, which in many cases is linked to high levels of a blood pressure-regulating hormone released by the kidneys.”

Weekend Update

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

From Washington, DC

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

From the public health front,

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

From the U.S. healthcare business front,

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

Friday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

David Ermer–AHRQ, CDC, Congress, Electronic health records, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Fierce Healthcare reports,
    • “New legislation advanced by a voice vote March 4 would codify 14 pre-deductible healthcare services through high-deductible health plans (HDHPs).
    • “It codifies guidance from President Donald Trump’s first term increasing flexible coverage options for HDHPs. The bill would allow medical products and services like beta-blockers, blood pressure monitors, glucometers, inhalers and cholesterol drugs to be more easily covered by insurance by letting insurers pay for low-cost services before a deductible is reached.
    • “This legislation provides employers and their employees with greater flexibility to design healthcare coverage options that expand access to treatments for chronic diseases,” said Ways and Means Committee Chairman Jason Smith, R-Missouri, in a statement on the House floor. “By providing flexible coverage options for more people living with chronic health conditions, we can help lower their costs and improve their health and well-being.” * * *
    • “The bill must still be passed by the full Senate.”
  • Roll Call tells us,
    • “Senate Republicans called on the Trump administration Wednesday to use the formal rescissions process to claw back money already appropriated by Congress that the “Department of Government Efficiency” has identified as wasteful.
    • “It’s also a way to avoid legal setbacks that have befallen the White House in its push to freeze agency budgets and programs, including foreign aid accounts.
    • “One day after President Donald Trump singled out small-dollar examples of waste in his joint address to Congress, the de facto leader of the DOGE effort, Elon Musk, came to the Capitol to soothe concerns over how some of the cuts have been implemented. Many lawmakers have expressed alarm at the wholesale gutting of agencies and the firing of thousands of federal employees.
    • “Hoping to regain some of their power of the purse, senators asked Musk at a private lunch to have the White House submit a rescissions package for congressional approval for any funding it deems fraudulent or wasteful. Congress would then have 45 days to approve the request, or else the money must be spent as appropriated once the clock runs out.
    • “What we got to do as Republicans is capture their work product, put it in a bill and vote on it,” Senate Budget Chairman Lindsey Graham, R-S.C., told reporters. “So the White House, I’m urging them to come up with a rescission package.”
    • “Graham said Musk was receptive to the idea and hadn’t known about the rescissions process as an available tool to cut spending.”
  • BioPharma Dive lets us know,
    • “Marty Makary, the Johns Hopkins surgeon who President Donald Trump chose to lead the Food and Drug Administration, fended off pressure from Republican and Democratic senators Thursday over a canceled agency meeting on influenza vaccines. 
    • “Questioned by several lawmakers at a hearing held to evaluate his nomination, Makary would not commit to reconvening the meeting, at which agency advisers were set to discuss the composition of this year’s flu shots. Members of the panel were notified last week that they would not meet as scheduled. 
    • “Instead, Makary seemed to indicate he would take a broader look at the role the advisory committee plays in the FDA’s vaccine decision-making and whether it is providing useful advice. 
    • “You have my commitment to review what the committees are doing [and] how they are being used,” Makary told Senator Bill Cassidy, R-La., who serves as chair of the Senate Health, Education, Labor, and Pensions Committee reviewing Markary’s nomination.” 
  • Per an HHS press release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) alerted providers of their obligation to protect American children from often irreversible chemical and surgical mutilation, including interventions that cause sterilization. Hospital providers were alerted of serious quality and safety concerns associated with harmful, medical interventions for gender dysphoria. CMS also announced it may begin taking steps to align its policies and regulations with medical evidence and to safeguard children from often irreversible experiments. CMS will continue to follow any applicable substantive and procedural requirements in taking any future action.” * * *
    • “Similar alerts are also being sent by other HHS agencies to grantees. View the CMS alert here: https://www.cms.gov/files/document/QSSAM-25-02-Hospitals.pdf”  
  • Govexec informs us,
    • “Special Counsel Hampton Dellinger said in a statement to Government Executive that he is dropping his lawsuit to reverse his removal by Donald Trump, enabling the president to name his own person to lead the office that protects federal employees and whistleblowers from prohibited personnel practices.
    • “A district judge on March 1 blocked Dellinger’s firing, but the U.S. Court of Appeals for the D.C. Circuit on Wednesday allowed for him to be removed while it considers the Trump administration’s appeal.”
  • Federal News Network interviewed Tammy Flanagan about RIFs and early retirement for federal employees.

From the judicial front,

  • Thompson Reuters relates,
    • A federal trial court [in Maine} has dismissed a proposed class action lawsuit against an insurer/health plan administrator alleging discrimination under Affordable Care Act (ACA) Section 1557 for failure to cover weight-loss drugs. The participant alleged that the insurer’s plan violated Section 1557 (which prohibits discrimination in certain health programs and activities based on race, color, national origin, sex, age, or disability) because it excluded prescription drug coverage for commonly prescribed weight-loss medications if they were prescribed solely to treat obesity. She argued that she did not have access to the prescription medications required to treat her obesity (which she alleged was a disability and diagnosed health condition), while other participants had access to prescription medications medically necessary to treat their diagnosed health conditions, including the same or similar medications.
    • Concluding that the participant’s allegations did not support a finding of disability under Section 1557, the court dismissed the case. It determined that the participant had not plausibly shown that she was disabled merely as a function of her body mass index, nor that the insurer had ever regarded her as disabled. Pointing out that disability is an essential element of a Section 1557 disability discrimination claim, the court held that the participant had failed to state a claim for relief.
  • Fierce Health notes,
    • “Dozens of providers have filed new lawsuits against Blues insurers, arguing that the plans colluded to block competition and reimburse them at lower rates.
    • “The payers reached a tentative $2.8 billion settlement agreement in Alabama court in October, but the new lawsuits opt out of it and instead press for a jury trial. The Blue Cross Blue Shield Association and 33 of its affiliates are named in the new suits.
    • “Providers who have signed on to the filings include the University of Pennsylvania Health System, Geisinger, MedStar, CommonSpirit and physician staffing firm TeamHealth. They argue that the alleged collusion between Blues plans violated antitrust laws.”

From the Food and Drug Administration,

  • Cardiovascular Business reports,
    • “Genentech, part of the Roche Group, has received U.S. Food and Drug Administration (FDA) approval for tenecteplase, the company’s new intravenous treatment for acute ischemic stroke (AIS) in adult patients. Genentech will be marketing and selling tenecteplase under the brand name TNKase. 
    • “Tenecteplase is only the second clot-busting medication for stroke to gain approval from the FDA—and the first in decades. The only other one, alteplase, is also sold by Genentech under the brand name Activase.
    • ‘Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. This is much faster than alteplase, which was administered by giving patients an IV bolus that is then followed by a 60-minute infusion.”
  • The American Hospital Association (AHA) News adds,
    • “The Food and Drug Administration March 5 announced that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws. The FDA said missing motor mounting screws could lead to insufficient or excessive therapy, interruption in therapy or delay in therapy, which can result in serious adverse health consequences. Baxter has reported one serious injury related to the issue.”
  • Per MedTech Dive,
    • “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 public health and medical research front,

  • The AHA News points out,
    • “The Centers for Disease Control and Prevention March 4 announced it sent agency experts to Texas to assist local officials in responding to the state’s measles outbreak. The CDC said the partnership, known as an Epi-Aid, is a rapid response effort by the agency’s Epidemic Intelligence Service to respond to urgent public health issues such as disease outbreaks. EIS officers will provide onsite support for one to three weeks. 
    • “As of March 4, there were 159 measles cases identified, according to the Texas Department of State Health Services. Twenty-two patients have been hospitalized and a school-aged child died Feb. 26. Texas DSHS officials said additional cases are likely to occur.” 
  • The New York Times reports
    • “Women’s brains are superior to men’s in at least in one respect — they age more slowly. And now, a group of researchers reports that they have found a gene in mice that rejuvenates female brains.
    • “Humans have the same gene. The discovery suggests a possible way to help both women and men avoid cognitive declines in advanced age.
    • “The study was published Wednesday in the journal Science Advances. The journal also published two other studies on women’s brains, one on the effect of hormone therapy on the brain and another on how age at the onset of menopause shapes the risk of getting Alzheimer’s disease.”
  • and
    • “Postpartum depression affects about one in every seven women who give birth, but little is known about what happens in the brains of pregnant women who experience it. A new study begins to shed some light.
    • “Researchers scanned the brains of dozens of women in the weeks before and after childbirth and found that two brain areas involved in the processing and control of emotions increased in size in women who developed symptoms of postpartum depression.
    • “The results, published Wednesday in the journal Science Advances, constitute some of the first evidence that postpartum depression is associated with changes in the brain during pregnancy.”
  • The Washington Post adds,
    • “Bacterial vaginosis, a common vaginal infection also known as BV, has long been treated as a women’s condition; but a new study adds to evidence that it is a sexually transmitted infection and suggests that treating a male partner can help reduce recurrence.
    • “BV affects nearly 1 in 3 women of reproductive age globally. It has been associated with increased risk of adverse birth outcomes, HIV and other sexually transmitted infections, according to the World Health Organization. It has a high recurrence rate, with more than half of those who are treated experiencing the condition again within three months.
    • “The study, led by a team of Australian researchers, was published in the New England Journal of Medicine on Wednesday.”
  • The U.S. Preventive Services Task Force released for public comment a Draft Research Plan regarding Cognitive Impairment in Older Adults: Screening. The public comment deadline is April 2, 2025.
  • Per MedPage Today,
    • “In a retrospective study, semaglutide use leading up to bariatric surgery was not linked with greater weight loss a year after surgery.
    • “Rates of diabetes remission and complications were also comparable between semaglutide users and controls.
    • “Previous studies have found that taking semaglutide after surgery can help patients shed more pounds.”
  • Per Healio,
    • “Using visualized coronary calcium scoring independently reduced plaque progression among patients at intermediate risk vs. usual care.
    • “Improvements in lipid profiles were also reported.”
  • Per Medscape,
    • “Reports of children in the United States with influenza-associated encephalopathy or encephalitis (IAE) increased from none during the 2020-2021 flu season to a preliminary 14% for the 2024-2025 season, based on a new analysis from the Centers for Disease Control and Prevention (CDC).
    • “IAE involves a range of neurologic syndromes triggered by flu infection of the respiratory tract, with diagnosis based on brain lesions detectable on imaging, wrote Amara Fazal, MD, and colleagues at the CDC’s National Center for Immunization and Respiratory Diseases.
    • “A series of anecdotal reports of pediatric cases with IAE in January 2025 prompted the CDC’s investigation; the findings were published in the Morbidity and Mortality Weekly Report (MMWR).”

From the U.S. healthcare business front,

  • Beckers Hospital Review offers five takeaways from this week’s HIMSS conference and lets us know the amount of cash on hand for 35 U.S. healthcare systems as of December 31, 2024.
  • Beckers Payer Issues lets us know,
    • Blue Cross and Blue Shield of North Carolina has restructured to become a subsidiary of a new parent holding company, CuraCor Solutions.
    • CuraCor will include Blue Cross NC and other fully owned companies, allowing the new organization “to quickly partner and invest in new health programs and technologies to benefit customers,” according to a March 6 news release shared with Becker’s.
    • Blue Cross NC members will experience no changes to coverage, services or the open enrollment process. Insurance cards, provider networks and Medicaid and Medicare offerings will also remain the same.
  • Per Fierce Healthcare,
    • “Datavant is beefing up its data retrieval network with a new layer of artificial intelligence that will allow health plans and risk-bearing providers to improve operations and patient care by accessing and analyzing a trove of clinical data.
    • “Value-based care arrangements require health plans and risk-bearing providers to navigate complicated requirements for managing patient data and monitoring population health. While providers and health plans face increasing cost pressure and administrative burden, Datavant touts that the enhanced platform will ease the administrative burden of locating and analyzing patient and member data.
    • “Datavant’s new Clinical Insights Platform is the result of Datavant’s integration with Apixio. It acquired the company’s connected care platform and value-based care solutions in September 2024. With the release of the Clinical Insights Platform, the Apixio brand will sunset and the combined Datavant-Apixio product will be sold.”

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.”