From Washington, DC,

• Bloomberg Law reports,
  • “Mehmet Oz, President Donald Trump’s nominee to lead the Centers for Medicare & Medicaid Services, used his Senate confirmation hearing Friday to tout the benefits of artificial intelligence to help streamline the prior approval process for Medicare managed care plans.
  • “But consumer policy watchers were immediately leery, noting the string of recent legal challenges stemming from AI-influenced coverage denials by Medicare Advantage plans.
  • “We are very concerned that increasing the use of AI will only make the prior authorization situation worse,” Alice Bers, litigation director at the Center for Medicare Advocacy, said in a statement.” * * *
  • “Sen. Tina Smith (D-Minn.) expressed similar concerns about lawsuits against MA insurers alleging use of AI to determine length of hospital stays and to deny claims. “This is a big concern,” Smith told Oz. “My view is that a human needs to have a final say in these decisions.”
  • “Oz said he agreed with Smith about the need for humans to make final coverage decisions. But Oz maintained that he thinks “AI can play a vital role in accelerating pre-authorization.”
  • “He also said the CMS should be using AI to identify insurers that are misusing the technology.”

• Beckers Hospital Review adds,
  • “CMS will not change the Biden administration’s plan to negotiate prices for 15 previously named prescription drugs, and the agency’s next potential leader says he will defend the program in court.
  • “In January, CMS selected Ozempic, Rybelsus, Wegovy, Trelegy Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Breo Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, and Otezla to be included in the second round of negotiations aimed at reducing drug costs for Medicare beneficiaries. 
  • “On March 14, CMS said it had signed agreements with manufacturers, who will now participate in meetings and roundtables throughout 2025 to negotiate maximum fair prices for the 15 drugs, with final agreements due by Nov. 1.
  • “Mehmet Oz, MD, President Donald Trump’s pick for CMS administrator, told the Senate Finance Committee March 14 he would defend the negotiation program in court.
  • “It’s the law. I’m going to defend it and use it,” he said, adding that it is one of multiple approaches he would pursue to lower drug costs.
  • “The selected drugs account for approximately $41 billion in total spending under Medicare Part D between November 2023 and October 2024, or about 14% of Medicare Part D’s prescription drug costs, according to CMS. The negotiated prices for the drugs will take effect in 2027.”

• HUB International tells us,
  • “Following on the enactment late last year of two bills to simplify employer reporting under the Affordable Care Act (“ACA”), the IRS has now released its first bit of guidance in the form of Notice 2025-15. The notice provides guidance on how employers can avoid providing individual Forms 1095-C to their employees. Perhaps unsurprisingly, it essentially piggybacks on existing guidance that applies to insurance carriers and other coverage providers.”

• STAT News adds, “FTC highlights new concern over ‘pay-to-delay’ deals that determine when generics are sold. The agency noted restrictions on how many drugs a generic company may sell as part of a patent settlement.”

• Per MedTech Dive,
  • “The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines.
  • “The letter said the disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
  • “The FDA linked to a letter B. Braun sent to customers in January. B. Braun said “additional supply and labor constraints over the holidays” had reduced production and it would run out of product on Jan. 20.”

• Per Fierce Pharma,
  • “A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.
  • “The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls.” 

From the judicial front,

• A panel of the U.S. Court of Appeals for the Ninth Circuit denied the Justice Department’s request for an immediate stay of the lower court’s decision to reinstate terminated probationary employees from six federal agencies. The panel set a briefing schedule on the Justice’s Department’s underlying motion to stay.

• Bloomberg Law reports,
  • “Walmart Inc. is suing many of the nation’s largest pharmaceutical companies, alleging they colluded to inflate the price of hundreds of generic drugs and caused the retailer to pay more for the medications than it should have.
  • “Mylan Inc., Teva Pharmaceuticals USA Inc., and Glenmark Pharmaceuticals Inc. are among the defendant companies that exchanged drug price points and bid information as part of a conspiracy that specifically targeted Walmart, according to a nearly 700-page complaint filed Friday in the US District Court for the Eastern District of Pennsylvania.
  • “Walmart is one of the largest pharmacy providers in the US, purchasing hundreds of millions of dollars of prescription drugs every year. 
  • “The suit adds to similar cases against pharma companies brought by independent pharmacies, hospitals, and federal and state law enforcers.”
  • “The case is Walmart v. Actavis Elizabeth LLC, E.D. Pa., No. 2:25-cv-01383, 3/14/25″ 

From the public health and medical research front,

• The Washington Post reports,
  • “By 2050, there will be an estimated 25.2 million people living with Parkinson’s disease worldwide, a 112 percent increase from 2021, according to a new study published in the journal BMJ.
  • “The World Health Organization estimated that 8.5 million people worldwide were living with Parkinson’s disease in 2019.
  • “Researchers used data from the 2021 Global Burden of Disease Study, pulling information from 195 countries and territories. They identified aging and population growth as the main contributors to the projected increase in Parkinson’s numbers, noting that growth rates would differ at regional and national levels.”

• The American Medical Association lets us know what doctors wish their patients knew about pertussis.

• MedPage Today tells us,
  • “A probiotic mixture reduced fever duration by 2 days versus placebo among children with upper respiratory tract infections.
  • “Probiotics have emerged as a new potential approach to managing infectious diseases.
  • “Adverse events were mild, and did not significantly differ between the two groups.
• and fills us in on which adults need a measles booster in the U.S.

• Beckers Hospital Review identifies the “10 most, least overweight and obese cities in the U.S.”
  • “McAllen, Texas, topped WalletHub’s 2025 ranking of the most overweight and obese cities in the U.S., published March 17, while Honolulu is the healthiest-weight city.”

• Per a press release,
  • “The National Institute of Standards and Technology (NIST) has released a human stool reference material that will help scientists accurately measure the gut microbiome. The initiative aims to speed progress in a cutting-edge field of medical research targeting some of humanity’s most serious and intractable diseases.
  • “The human gut microbiome is a rich, teeming ecosystem of microorganisms and their byproducts that line the human gastrointestinal tract. Over the last decade, scientists have linked activity in the gut microbiome to obesity, diabetes, mental illness, cancer and other medical conditions. Researchers believe that a new class of drugs targeting the gut microbiome can treat many of these conditions.”

• Per National Institutes of Health news releases,
  • “Surgical removal of enlarged tonsils and adenoids in children with mild sleep-disordered breathing (SDB) appears to significantly reduce the frequency of medical office visits and prescription medicine use in this group, according to a clinical study supported by the National Institutes of Health (NIH). The findings, published in JAMA Pediatrics, show that the surgery, called adenotonsillectomy, was tied to a 32% reduction in medical visits and a 48% reduction in prescription use among children with a mild form of the condition.”
• and
  • In a preclinical study, rodents treated with uric acid showed improved long-term outcomes after acute ischemic stroke. The findings suggest that the treatment may work as an add-on therapy to standard stroke treatments in humans. The study was funded by the National Institutes of Health (NIH) and published in Stroke.
    
• Consumer Reports, writing in the Washington Post, informs us about “Everything you need to know to keep your teeth healthy. Toothpaste matters, and you might want to consider adding a tongue scraper to your routine.”

• Per BioPharma Dive,
  • “An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with several types of blood cancer by helping avert a potentially dangerous side effect. 
  • “According to clinical trial results announced by Orca on Monday, about three-quarters of people treated with the company’s T cell immunotherapy did not experience moderate-to-severe chronic graft-versus-host disease through one year, compared to only 38% of those given the standard transplant. 
  • “Graft-versus-host disease, or GvHD, is a serious complication of transplants involving cells sourced from matched donors. Orca aims to develop its therapy, which uses a purified mix of donor-derived T cells and stem cells, as a safer transplant alternative in cancers like acute myeloid leukemia.”

From the U.S. healthcare business front,

• Beckers Hospital Review relates,
  • “Median hospital margins remained stable to kick off 2025, as many reported higher service volumes and expenses.
  • “Kaufman Hall’s “National Hospital Flash Report” revealed January median operating margins hit 4.4%, up from 3.7% in December and 0.6% last January. Without allocations, the median operating margin grew to 8%, a 12-month high. the averages are based on data from more than 1,300 hospitals and gathered by Strata Decision Technology. 
  • “January was a relatively stable month for hospitals, as more people received care due in part to seasonal challenges like flu and other respiratory diseases. Hospitals are also experiencing more rapid revenue growth from inpatient than outpatient services. Expenses are also rising, driven primarily by drug costs, though the rate of cost growth has slowed,” said Erik Swanson, managing director and group leader, data and analytics, of Kaufman Hall.”

• Fierce Healthcare notes,
  • “Highmark Health reported $29.4 billion in revenue and $50 million in net income for 2024 as the organization continues to weather notable headwinds that have battered health insurers.
  • “Highmark also posted $209 million in operating losses, according to its earnings report released last week. The full year results “reflect the negative operating performance of Highmark Health Plans,” the company said in a press release, as the team faced cost pressures throughout the year.
  • “United Concordia Dental and HM Insurance Group, the company’s stop-loss division, were bright spots with steady performance. Highmark said that trend was backed by growing dental membership and a disciplined pricing approach.
  • “Its health system, Allegheny Health Network, also saw improvements as patient volumes increased across “all delivery areas.”
  • “While our consolidated revenue improved, we continue to face significant industry headwinds and medical cost trends, including high costs for prescription drugs, especially GLP-1s, the impact of Medicaid redeterminations and nationwide high utilization, especially within the Medicare Advantage portfolio,” said Carl Daley, chief financial officer and treasurer of Highmark Health.” 

• Fierce Pharma points out “the top 10 drugs losing US exclusivity in 2025.”
  • “While each year features high-profile losses of exclusivity in the pharma industry, this year’s list is something of a doozy.”

• The Wall Street Journal reports,
  • “Pfizer PFE had a problem. Doctors weren’t prescribing its migraine drug Nurtec because they assumed insurance coverage would be too much of a hassle.
  • “So last year the company created a phone line for doctors and patients to call Pfizer directly for help. Pfizer now credits that and other changes for a 31% increase in Nurtec’s U.S. sales last year.
  • “The beleaguered drugmaker’s shares still haven’t recovered from their post-Covid slump, and shareholders are wary. But sales of products such as Nurtec and the vaccine Abrysvo that the company has been counting on are rising, and an activist shareholder’s push has lost steam. 
  • “Pfizer did it by shaking up its U.S. sales strategy, shifting where it deploys its sales representatives, how they market to doctors and how the company helps patients pay for their prescriptions.”

• Per Modern Healthcare,
  • “Scripps Health plans to build a $1.2 billion medical campus that will include a 200- to 250-bed hospital and outpatient facilities.
  • “The San Diego-based health system’s board last week approved the 13-acre development in San Marcos, California. The first phase of the project will feature space for specialty and primary care offices, ambulatory surgery, cancer care, imaging, lab and other services, and the second phase includes the hospital, according to a Monday news release.
  • “The outpatient center will be built in two to three years, and the hospital will take about six years, a spokesperson estimated.”
• and
  • “Sharon Regional Medical Center is set to reopen Tuesday, about two months after the former Steward Health Care facility in Pennsylvania closed.
  • “On Friday, the Pennsylvania Department of Health approved Pasadena, California-based Tenor Health Foundation’s plans to reopen the 163-bed hospital. In January, Judge Christopher Lopez of the U.S. Bankruptcy Court for the Southern District of Texas in Houston signed off on the hospital management company’s takeover of the facility, which employed more than 800 workers“

• From BioPharma Dive,
  • “AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.
  • “The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.”