From Washington, DC

• Per a White House press release,
  • “On Thursday, September 26, 2024, the President signed into law:
  • “H.R. 9747, the ”Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.”
• Bye, bye Congress. See you in November.

• MedTech Dive adds,
  • “Congress has again deferred Medicare reimbursement cuts of up to 15% for clinical laboratory tests with the passage Wednesday of a short-term government funding bill.
  • “The appropriations bill pushes back by one year the implementation of Medicare payment rates scheduled to take effect in January for about 800 lab services.
  • “We are pleased that Congress has delayed pending reductions, recognizing the harm repeated Medicare reductions would have on the nation’s health care system that relies on clinical laboratory testing every day to inform patient care,” Susan Van Meter, president of the American Clinical Laboratory Association, said in a Wednesday statement.”

• Here are links on yesterday’s OPM’s 2025 FEHBP/FEDVIP premium announcement from Govexec, Fedweek and FedSmith. Govexec also reports, “Biden administration officials said that two nationwide insurers in the federal government’s employer-sponsored health care program [Blue Cross FEP and GEHA] will offer $25,000 worth of in vitro fertilization and other fertility treatments.

• Per an HHS press release,
  • “Today, the U.S. Department of Health and Human Services (HHS) through the Advanced Research Projects Agency for Health (ARPA-H) announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats (TARGET) project, which will use AI to speed the discovery and development of new classes of antibiotics. This program is another action to support the United States’ longstanding commitment to combating antimicrobial resistance (AMR), from groundbreaking innovation to international collaboration. The U.S. is a global leader in the fight against AMR and has a demonstrated track record of progress in protecting people, animals, and the environment from the threat of AMR domestically and globally.”

From the public health and medical research front,

• Per an FDA press release,
  • “Today, the U.S. Food and Drug Administration approved [Bristol, Myers, Squibb’s] Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
  • “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”

• BioPharma Dive offers an excellent explanation of the various factors affecting sales of this drug.

• KFF Health News points out that “Deadly High Blood Pressure During Pregnancy Is on the Rise.”

• The Washington Post reports,
  • “A New York resident has died amid a nationwide listeria outbreak tied to Boar’s Head deli meat, the Centers for Disease Control and Prevention announced Wednesday, bringing the death toll to 10 in the largest outbreak of the foodborne illness since 2011.
  • “The agency also reported two new hospitalizations associated with the outbreak. In total, 59 people have been hospitalized in 19 states since late May.
  • “Deaths have occurred in Illinois, New Jersey, New York, Virginia, Florida, Tennessee, New Mexico and South Carolina. In its latest update, the CDC noted that illnesses have started to decrease. The number of sick people is probably higher than the official case count, the agency said, since those who do not seek medical care are not tested for listeria.
  • “Boar’s Head identified the production process for liverwurst at its plant in Jarratt, Va., as the culprit for contaminating the meat. This month, the company announced it would indefinitely close the southern Virginia plant and permanently discontinue liverwurst.”

• The NIH Director writes in her blog,
  • “Genetic mutations affect nearly all human diseases. Some genetic disorders such as cystic fibrosis are caused by mutations in a single gene that a person inherits from their parents. Other diseases can be caused by changes in multiple genes or from a combination of gene mutations and environmental factors. We still have a lot to learn about the complex ways that variations in our genes affect health and disease.
  • “Researchers investigating genetic disorders have primarily studied mutations that cause our cells to alter the makeup of proteins, like the most common mutations that cause cystic fibrosis. Less research has been done on alterations called synonymous mutations, which have been called “silent” because they don’t alter the makeup of proteins, leading scientists to long assume that these kinds of mutations don’t produce any noticeable differences in our biology or health. However, recent research has shown that synonymous mutations can lead to significant changes in a cell’s ability to survive and grow. A new NIH-supported study reported in Proceedings of the National Academy of Sciences sheds additional light on the impact of synonymous mutations and their effect on the way proteins are made.” * * *
  • “The researchers behind this study, at the University of Notre Dame in Notre Dame, IN, wanted to understand how synonymous mutations may affect how much protein is made and whether proteins are folded correctly in cells. Misfolded proteins are known to play roles in numerous diseases, including cystic fibrosis, Alzheimer’s disease, and some cancers. The study team, led by Patricia L. Clark, who received an NIH Director’s Pioneer Award in 2021 for this work, has shown that synonymous mutations in a particular gene in Escherichia coli (E. coli) bacteria can alter how the encoded protein folds as it is being made, by altering the rate at which cells produce each copy of the protein. The new research goes a step further and shows that silent mutations in one gene can affect the amount of protein produced from a separate, neighboring gene.” * * *
  • “This discovery in E. coli may have important implications for understanding the bacteria’s biology and evolution. Clark’s team continues to study this system to learn more. Their findings may also prove to have broader implications for biology, including for some genetic disorders. It’s an area that warrants more study and attention, to better understand the roles that synonymous mutations may be playing in genes and their effects on human health.”

• Per an NIH press release,
  • “Scientists at the National Institutes of Health (NIH) and their colleagues have identified a gene responsible for some inherited retinal diseases (IRDs), which are a group of disorders that damage the eye’s light-sensing retina and threatens vision. Though IRDs affect more than 2 million people worldwide, each individual disease is rare, complicating efforts to identify enough people to study and conduct clinical trials to develop treatment. The study’s findings published today in JAMA Ophthalmology.
  • “In a small study of six unrelated participants, researchers linked the gene UBAP1L to different forms of retinal dystrophies, with issues affecting the macula, the part of the eye used for central vision such as for reading (maculopathy), issues affecting the cone cells that enable color vision (cone dystrophy) or a disorder that also affects the rod cells that enable night vision (cone-rod dystrophy). The patients had symptoms of retinal dystrophy starting in early adulthood, progressing to severe vision loss by late adulthood.
  • “The patients in this study showed symptoms and features similar to other IRDs, but the cause of their condition was uncertain,” said Bin Guan, Ph.D., chief of the Ophthalmic Genomics Laboratory at NIH’s National Eye Institute (NEI) and a senior author of the report. “Now that we’ve identified the causative gene, we can study how the gene defect causes disease and, hopefully, develop treatment.”
  • “Identifying the UBAP1L gene’s involvement adds to the list of more than 280 genes responsible for this heterogeneous disease.”

• The U.S. Preventive Services Task Force posted a “Final Research Plan for Enhanced Risk Assessment for Cardiovascular Disease: Coronary Artery Calcium Scoring.”

From the U.S. healthcare business front,

• The FEHBlog was surprised to read in Beckers Hospital Review that
  • Johnson & Johnson will discontinue upfront 340B drug rebates for certain hospitals, raising concerns among healthcare providers and advocacy groups. The proposed policy, set to take effect Oct. 15, would prevent certain hospitals from accessing 340B discounts for Stelara, used to treat plaque psoriasis, psoriatic arthritis and other conditions; and Xarelto, a blood thinner.
    
• Per Fierce Healthcare,
  • “While consumers give telehealth high marks for convenience, overall experience is fairly mixed, according to a new report.
  • “J.D. Power released its annual Telehealth Satisfaction Study on Thursday, and found patients overall gave a score of 730 out of 1,000 for direct-to-consumer telehealth platforms. Payer-provided telehealth earned a lower score of 708, which suggests patients encounter differences in quality and ease of access between providers.
  • “The study also found the highest satisfaction scores for people enrolled in Medicaid, those living in urban areas, millennials and Gen Zers. The lowest scores were among people enrolled in Medicare or commercial coverage, those living in suburban regions and members of the Boomer generation or older.”

• McKinsey and Company explore “Reimagining healthcare industry service operations in the age of AI.”

• KFF offers “A Snapshot of Sources of Coverage Among Medicare Beneficiaries” and tells us “Nearly 7 in 10 Medicare Beneficiaries Did Not Compare Plans During Medicare’s Open Enrollment Period.”