From Washington, DC.

• The Wall Street Journal reports, “Congress quickly and smoothly certified President-elect Donald Trump’s election victory Monday, a contrast to four years earlier, when a pro-Trump mob stormed the Capitol and temporarily halted the confirmation of President Biden’s win.” 

• Federal News Network confirms,
  • “President Joe Biden signed the Social Security Fairness Act into law Sunday afternoon, the final step needed for nearly 3 million public sector employees, retirees, spouses and surviving spouses to begin receiving larger monthly Social Security payments.
  • “The legislation repeals the Windfall Elimination Provision and Government Pension Offset — two longstanding provisions of Social Security that reduce or eliminate benefits for certain government retirees, including Civil Service Retirement System annuitants, as well as teachers, firefighters, police officers and others who have worked in a public sector position.”

• The American Hospital Association News tells us,
  • “The Centers for Medicare & Medicaid Services Jan. 6 announced the 15 participants for its state Transforming Maternal Health Model: Alabama, Arkansas, California, Washington, D.C., Illinois, Kansas, Louisiana, Maine, Minnesota, Mississippi, New Jersey, Oklahoma, South Carolina, West Virginia and Wisconsin. The model will provide technical support and resources to state Medicaid agencies to develop programs that address new mothers’ physical health, mental health and social needs during pregnancy and postpartum. The model launched Jan. 1 and will run for 10 years.”

• Per FiercePharma,
  • “In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory trials at least be underway at the time of these conditional nods. But, after hearing some mixed messaging from the agency, drugmakers were left wondering what exactly “underway” means in this context.
  • “Now, a new draft guidance document tries to clear the air on the agency’s interpretation of the term “underway.”
  • “The FDA on Monday posted a draft guidance document titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” Although the guidance doc was uploaded by the Oncology Center of Excellence, which has issued the majority of accelerated approvals, the policies are slated to apply to the entire FDA.”

• BioPharma Dive points out “five FDA decisions to watch in the first quarter of 2025. Over the next three months, the regulator could approve new medicines for pain, a deadly heart disease and a rare condition that’s long bedeviled drugmakers.”

From the public health and medical research front,

• The New York Times reports,
  • “A Louisiana patient who had been hospitalized with severe bird flu has died, the first such fatality in the United States, state health officials reported on Monday.
  • “The patient was older than 65 and had underlying medical conditions, the officials said. The individual became infected with the bird flu virus, H5N1, after exposure to a backyard flock and wild birds.
  • “There is no sign that the virus is spreading from person to person anywhere in the country, and Louisiana officials have not identified any other cases in the state. Pasteurized dairy products remain safe to consume.
  • “I still think the risk remains low,” said Dr. Diego Diel, a virologist at Cornell University.
  • “However, it is important that people remain vigilant and avoid contact with sick animals, sick poultry, sick dairy cattle, and also avoid contact with wild birds,” he added.”

• The Washington Post informs us,
  • “The rate of triplet and higher-order multiple births in the United States declined 62 percent from 1998 to 2023, according to the Centers for Disease Control and Prevention. 
  • “Most of the downturn occurred since 2009. Triplet and higher-order births are pregnancies involving three or more babies. Because maternal and infant health problems are more frequently associated with higher-order multiple births than with twins and single births, the increase was of public health concern, the CDC report noted.” * * *
  • “The period that preceded the current study, 1980 to 1998, saw an extraordinary fivefold increase in births of triplets and higher-order multiple births — from 37 per 100,000 births in 1980 to 194 births per 100,000 in 1998. Researchers attributed the spike to higher maternal age and increased use of fertility treatments. Since that period, the rates of multiple births have trended in the opposite direction.”

• The American Medical Association discusses “What doctors wish patients knew about bacterial meningitis” and “RSV vaccines: Questions patients may have and how to answer.”

• Medscape adds,
  • “Respiratory syncytial virus prefusion F vaccine significantly reduced severe RSV-related lower respiratory tract disease (LRTD) requiring hospitalization or emergency department (ED) visits in an older adult population, including substantial representation from the oldest age groups.”
    
• In related news,
  • Per the New York Times, “Can Paxlovid treat long Covid? A new report suggests it might help some patients, but which patients might benefit remains unclear. The report, published Monday in the journal Communications Medicine, describes the cases of 13 long Covid patients who took extended courses of the antiviral drug. Results were decidedly mixed: Nine patients reported some improvement, but only five said it lasted. Four reported no improvement at all.”
  • Per Infectious Disease Advisor, “Nirmatrelvir/ritonavir (Paxlovid^TM) reduced COVID-19-related hospitalization and all-cause death, as well as the duration of COVID-19 symptoms and utilization of health care resources among patients at high risk for severe diseases, according to study findings published in Clinical Infectious Diseases.”

• “The National Institutes of Health calls attention to a newly released publication, Recent Developments in Women’s Health Research at the U.S. National Institutes of Health.”

• The Institute for Clinical and Economic Review announced today “that it will assess the comparative clinical effectiveness and value of apitegromab (Scholar Rock) for the treatment of spinal muscular atrophy (SMA). ICER will also assess new evidence (since ICER’s 2019 Final Evidence Report) on the clinical effectiveness of nusinersen (Spinraza®, Biogen) and onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), as well as the evidence for risdiplam (Evrysdi®, Genentech). Risdiplam was not evaluated in the 2019 report.”

From the U.S. healthcare business front,

• Fierce Healthcare reports,
  • “All of the commercial prescriptions dispensed at CVS pharmacies will be processed through its CostVantage reimbursement model beginning this year, the healthcare giant announced on Monday.
  • “Under the model, prescriptions are priced based on the underlying cost with a delineated markup and dispensing fee to cover the services provided by CVS in the transaction. The company says that this model makes it less necessary to raise the cost for certain prescriptions to cover losses on other drugs.
  • “The model also seeks to increase transparency for insurers and pharmacy benefit managers, making it potentially easier for PBMs to establish their own more transparent programs for plans and clients.
  • “Prem Shah, group president for CVS Health, said that the team is also working with the Centers for Medicare & Medicaid Services to expand the program to Medicare and Medicaid prescriptions.”

• Modern Healthcare relates,
  • “Although the pharmacy benefit manager market has long been controlled by three large, established players, many smaller PBMs are seeing a spike in interest. But the newer entrants will continue to face stiff competition this year as they seek more business.
  • “Smaller PBMs that advertise themselves as transparent have gained traction over the last few years as health insurers, employers and government entities look to deviate from the traditional spread pricing model. Many of these companies have said 2024 was their largest selling year, with an increasing number of large customers showing interest.”
  • “Companies that had never even spoken to us prior to this past year now are talking to us and are including us as a finalist,” said David Fields, president and CEO of Navitus Health Solutions, which serves employers with up to 500,000 workers and dependents. Navitus will manage pharmacy benefits for about 18 million people in 2025.”

• McKinsey & Company notes,
  • Technology leaders and enthusiasts are convening in Las Vegas this week for CES—formerly known as the Consumer Electronics Show—to hear from industry leaders, get immersed in demos and interactives, and learn about the latest solutions to society’s greatest challenges. This year’s conference program features topics including artificial intelligence, digital health, vehicle technology and future mobility, and more. 
  • Whether you’re attending in-person or via livestream, prepare for #CES2025 by learning about the adoption, development, and effects of 15 top technology trends in an analysis by McKinsey’s Lareina Yee, Michael Chui, and Roger Roberts.