From Washington, DC,

• Roll Call reports,
  • “President Donald Trump is planning to meet with top congressional Democrats this week about the government funding impasse, White House and Capitol Hill officials said Monday, after lawmakers left Capitol Hill for a week on Friday with little movement toward averting a partial shutdown starting Oct. 1.
  • “A date and time haven’t yet been set, and Trump has a packed schedule on most days other than Wednesday.” 

• Govexec explains the extent to which a government shutdown would affect federal employee pay and benefits. As the FEHBlog has previously noted, because Congress is in session in October, a political compromise is more likely than a government shutdown.

• The Government Accountability Office released a report titled “Health Care Consolidation: Published Estimates of the Extent and Effects of Physician Consolidation.”
  • “Studies show physician practices have increasingly been acquired by hospital systems, insurance companies, private equity firms, and other entities.
  • “At least 47% of physicians were consolidated with hospital systems in 2024—up from less than 30% in 2012. Studies show this consolidation can increase spending and prices, with one finding significant increases for office visits occurring in hospitals. Care quality may be the same or lower. It’s unclear how this type of consolidation affects access to care.
  • “There’s less evidence on the effects of physician consolidation with insurance companies or private equity.”

• The American Hospital Association News tells us,
  • “The AHA expressed support Sept. 22 to House and Senate sponsors of the Medicare Advantage Prompt Pay Act (H.R. 5454/S. 2879), legislation that would apply a federal prompt payment standard to MA plans to help ensure that health care providers receive timely payments from MA plans for necessary patient services. The measure calls for plans to pay at least 95% of clean claims within 14 days for in-network claims and 30 days for out-of-network claims. MA plans would face civil monetary penalties if they miss any deadlines and also would have to publicly report compliance data, including the number of claims paid on time.”
• and
  • President Trump Sept. 19 signed a proclamation increasing the fee to $100,000 for new H-1B petitions filed by employers, as well as implementing other restrictions on entry of certain nonimmigrant workers. The restrictions began on Sept. 21 and expire, absent extension, after 12 months. 
  • The proclamation authorizes the Department of Homeland Security and the Department of State to coordinate to take all necessary and appropriate action to implement the policies in the proclamation. 
  • According to an FAQ issued by the U.S. Citizenship and Immigration Services, the proclamation does not apply to any previously issued H-1B visas or any petitions submitted prior to Sept. 21. It also does not change any payments or fees required to be submitted in connection with any H-1B renewals. 
  • The proclamation said that the application fees can be waived if the Secretary of Homeland Security determines the hiring of these workers on an individual basis, or to work for a specific company or industry, is in the national interest. It is currently unclear if health care workers could qualify for the exemption process.” * * * 
    “In a statement shared today with the media, the AHA said, “One of the short-term strategies used by U.S. hospitals to address personnel shortages is the use of foreign-trained health care workers. While we work to educate more health care staff, the H-1B visa program plays a critical role in allowing the hospital field to recruit highly skilled physicians and other health care professionals to ensure access to care for communities and patients, including in rural and other areas where there are well-documented shortages of health care workers. The AHA is reviewing the recent memo from the Department of Homeland Security and evaluating the potential impact of these policy changes on hospitals and the communities they serve. We will also work with the Administration to stress the importance of including health care personnel in potential exemptions to these changes.” 
    
• Bloomberg News informs us,
  • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.
  • “The initiative is part of Trump’s demands that drugmakers reduce their prices to align them with what other developed countries pay, according to the people, who spoke on condition of anonymity to discuss plans that are not yet public. 
  • “The proposed website would allow patients to search for specific medicines and be connected with platforms that sell them, the people said. Officials have discussed creating a Trump brand for the website, with “TrumpRx” one name that’s been considered, they added.
  • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.”

• Per HHS news releases,
  • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today allocated more than $1.5 billion in FY25 continuation funding awards for the State Opioid Response (SOR) and Tribal Opioid Response (TOR) grants. This funding provides critical resources to states and Tribal communities to address the overdose crisis through prevention, opioid overdose reversal medications, treatment (including medications for opioid use disorder, or MOUD), and recovery support.
  • “America’s addiction and overdose crises are tearing apart families and communities, and meeting this challenge requires honesty, courage, and bold action,” said HHS Secretary Robert F. Kennedy Jr. “We are putting power back in the hands of states and Tribes to build solutions that reflect their people and their traditions. This investment is about saving lives, restoring hope, and making our communities whole again.”
  • “With the rise of polysubstance abuse and increasing role of stimulants in overdose deaths, it has never been more important to comprehensively address the disease of addiction and the root drivers of this crisis,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “State and Tribal Opioid Response funding provides critical resources to help prevent addiction, provide evidence-based treatment, and support long-term recovery and sobriety.”
• and
  • “The U.S. Department of Health and Human Services (HHS) today announced the mobilization of more than 70 Public Health Service officers from the U.S. Public Health Service (USPHS) Commissioned Corps to Indian Health Service (IHS) facilities across the country. This action delivers on Secretary Kennedy’s promise to strengthen the IHS, revitalize tribal health care, and ensure Native communities receive the high-quality medical support they deserve.
  • ‘Public Health Service officers, drawn from both leadership and frontline ranks, will be detailed to priority IHS sites identified as facing the most urgent staffing shortages. Senior Public Health Service officers will be detailed to strengthen leadership and operations, while additional officers will address the most urgent frontline staffing needs at IHS facilities. Today’s announcement represents one of the largest single details of Public Health Service officers to the IHS in recent years and underscores the Trump Administration’s commitment to improving health outcomes in Indian Country.”

From the Food and Drug Administration front,

• Per FDA News releases,
  • “The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The agency also issued a related letter alerting physicians nationwide.  
  • “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.” 
• and
  • “The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination.
  • “The FDA has conducted a systematic analysis of literature published between 2009-2024, including published case reports with patient-level information, as well as mechanistic data, and has determined that the information supports a finding that leucovorin calcium can help individuals suffering from CFD.  
  • “We have witnessed a tragic four-fold increase in autism over two decades,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people.”  
  • “The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD. As the New Drug Application (NDA) holder for this medicine, GSK has preliminarily agreed to work with the FDA on this relabeling effort.”

• The Wall Street Journal explains “What to Know About Taking Tylenol During Pregnancy”
  • Studies looking at a link between acetaminophen and autism are inconclusive; some show a link between its use during pregnancy and autism risk, while others don’t. 
  • A 2019 study published in JAMA Psychiatry found that higher concentrations of acetaminophen in umbilical cord blood samples taken at birth were linked to greater risk of autism and attention-deficit hyperactivity disorder. 
  • Another in JAMA in 2024 of nearly 2.5 million children in Sweden found no increased risk in children when mothers took acetaminophen during their pregnancy, compared with their siblings who weren’t exposed to the medication in the womb.  
  • Part of the challenge with such studies is wading through the myriad other confounding factors when analyzing the results. 
  • Women take Tylenol during pregnancy because they are running a fever or have pain or an infection. Those problems could be the root of a potential autism risk, rather than the medication used to alleviate them, researchers said. 
  • “All of those factors in fact pose a somewhat higher risk to the developing fetus than does the Tylenol itself,” said Helen Tager-Flusberg, director of the Center for Autism Research Excellence at Boston University. 
  • “For studies that control for that, we see a far reduced or lowered impact of the Tylenol.”

• STAT News discusses “What the evidence tells us about Tylenol, leucovorin, and autism. The questions of whether acetaminophen can cause the condition, or leucovorin can treat it, have been studied to a fair degree.”
  • “The case of leucovorin is simpler to explain: There are several studies that indicate the medicine can improve the performance of people with autism on standardized tests used to measure verbal ability. But these studies are quite small.
  • “One study, published in the European Journal of Pediatrics, followed 80 patients between the ages of 2 and 10 who were randomly assigned to receive either leucovorin or a placebo. Neither their families nor their doctors knew who received the treatment. At the end of 24 weeks, the children who received leucovorin scored 1.2 points higher on a 60-point scale used to measure autism severity than the children who did not.
  • “The result was statistically significant, but smaller studies are prone to false positive results. The normal course for researchers before making a recommendation would be to conduct a much larger randomized controlled trial to verify that the treatment is beneficial. Most such trials include hundreds or thousands of patients and provide the best evidence of efficacy and safety.
  • “For both acetaminophen and leucovorin, another problem exists: Generally, high-quality studies of medicines are done by pushing manufacturers to test them. But even though Tylenol, the leading brand of acetaminophen, is a big seller, both acetaminophen and leucovorin are available as generics, which means companies are less likely to pay for large observational studies or randomized controlled clinical trials.”

• Per a related NIH press release,
  • “The National Institutes of Health has launched the Autism Data Science Initiative (ADSI), a landmark research effort that will harness large-scale data resources to explore contributors to the causes and rising prevalence of autism spectrum disorder. More than $50 million in awards will support 13 pioneering projects that draw on genomic, epigenomic, metabolomic, proteomic, clinical, behavioral and autism services data. These projects will integrate, aggregate and analyze existing data resources, generate targeted new data and validate findings through independent replication hubs.
  • “Our Autism Data Science Initiative will unite powerful datasets in ways never before possible,” said NIH Director Jay Bhattacharya, M.D., Ph.D., “By bringing together genetics, biology, and environmental exposures, we are opening the door to breakthroughs that will deepen our understanding of autism and improve lives.”

From the public health and medical/Rx research front,

• Swiss Re, a life insurance company, considers “The future of metabolic health and weight loss drugs; Projecting mortality reductions in the US and UK populations.
  • “In the US and UK general populations, our modelled baseline scenario projects 4% and 3.2% reductions in cumulative all-cause mortality respectively by 2045, based on GLP-1 drug use. Here we assume majority use in the target overweight and obese population, with some sustained lifestyle changes but variable weight loss outcomes.
  • “Under our pessimistic scenario, in which drug use is limited and impacts are modest, the cumulative reduction would be 2.3% (US) and 1.8% (UK), we project. Yet semaglutide and tirzepatide are not risk-free drugs, and our assessment incorporates many caveats. In real world use, where people do not benefit from support to alter their lifestyle, the risks of discontinuation of the treatment, weight regain and rebound effects are all common. The loss of lean muscle mass and bone density as well as fat is also a risk.”

• Per Beckers Clinical Leadership,
  • “In 2024, healthcare facilities voluntarily reported 1,575 serious harmful events to The Joint Commission, which has been tracking sentinel events since 1996. 
  • ‘The Joint Commission defines a sentinel event as a patient safety event that results in severe temporary harm, permanent harm or death. Because the reports are voluntary, the organization says its dataset represents a small portion of actual sentinel events and that “no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”
  • “Of the 1,575 events, 21% were associated with patient death, 49% with severe harm, 21% with moderate harm, 5% with mild harm, 2% with psychological harm and 2% with no harm, according to the commission’s report. 
  • ‘With 776 voluntarily reported events, patient falls were the most frequently reported sentinel event in 2024. Falls led The Joint Commission’s annual lists in 2021, 2022 and 2023. In 2024, 51 of the reported falls resulted in patient death, 503 in severe harm and 199 in moderate harm.” 
  • The article goes onto list the other ten most common sentinel events last year.

• Beckers Hospital Review points out,
  • “Sixty-two National Cancer Institute-designated cancer centers are urging health systems, physicians and hospital leaders to promote human papillomavirus vaccination as a form of cancer prevention.
  • “The cancer centers, alongside leading cancer research organizations and advocacy groups, have published a joint statement to raise awareness of lagging HPV vaccination rates.
  • “Even though 90% of HPV-related cancers are preventable through on-time vaccination by a child’s 13th birthday, HPV vaccination coverage has stagnated over the last three years, according to a Sept. 16 news release from MD Anderson.” * * *
  • “Read the full joint statement here.” 

• Per MedPage Today,
  • “Adenotonsillectomy wasn’t better than just keeping an eye on young children with mild to moderate obstructive sleep apnea (OSA) over 3 years of follow-up in a small, randomized trial.
  • “Watchful waiting did result in many crossovers to surgery during follow-up, particularly among those with large tonsils at baseline.
  • “Researchers suggested that clinical decisions weigh Obstructive Apnea-Hypopnea Index values if available, evaluation of symptoms, tonsil size, the age of the child, risks of surgery, and evaluation of obesity or other comorbidities associated with increased risk of OSA.”

• The American Medical Association lets us know what doctors wish patients knew about women’s sleep health.

• Per Health Day,
  • “Type 2 diabetes appears to double a person’s risk for life-threatening sepsis, a new study says.
  • “Men and people under 60 with diabetes are particularly at risk for sepsis, a condition in which the immune system overreacts to infection, researchers reported this week at the annual meeting of the European Association for the Study of Diabetes in Vienna.
  • “The research confirms an association between type 2 diabetes and sepsis that’s been noted in earlier studies, said lead researcher Wendy Davis, a principal research fellow with the University of Western Australia.
  • “The best way to prevent sepsis is to quit smoking, normalize high blood sugar and prevent the onset of the micro- and macrovascular complications of diabetes,” Davis said in a news release. “That’s why this study is important.”

From the U.S. healthcare business front,

• The Wall Street Journal reports,
  • “Pfizer PFE has agreed to pay up to $7.3 billion for weight-loss drug developer Metsera MTSR in a deal that gets the New York drugmaker back into the burgeoning market for obesity drugs.
  • “Pfizer on Monday said it would pay an initial $47.50 a share, or about $4.9 billion, for Metsera, a nearly 43% premium to Friday’s closing price of $33.32 for the New York company.
  • “The deal, slated to close by the end of the year, includes up to an additional $22.50 a share tied to milestones that could bring the total consideration to $70 a share, more than double Friday’s closing price.
  • “Pfizer, which earlier this year scrapped its experimental weight-loss pill danuglipron over concerns about potential liver damage, said the Metsera acquisition adds four clinical-stage programs to its pipeline, including a GLP-1 receptor agonist that is in Phase 2 development as both a weekly and monthly injectable treatment.
  • “Metsera also has two weight-loss pill candidates expected to begin clinical trials imminently.”
• and
  • “Roche plans to move one of its weight-loss treatment candidates to late-stage trials next year, as the Swiss pharmaceutical group aims to become a top-three player in the booming market.
  • “The group said Monday that the experimental drug, called CT-388, showed strong efficacy in early-stage studies and that mid-stage trials were under way. A late-stage, or phase 3, study is set to begin in the first half of 2026, it said.
  • “Roche’s aim is to become a strong entrant in the weight-loss market before 2030 and eventually a top-three competitor in the field, the head of the group’s pharmaceuticals business, Teresa Graham, said at a company event with investors in London.” * * *
  • “CT-388 is a medication injected weekly that, like Lilly’s Mounjaro and Zepbound drugs currently on the market, activates both glucagon-like peptide 1, or GLP-1, hormones and a second class of hormones to help suppress appetite and shed weight.
  • “Roche said the drug stands out by more precisely activating appetite- and metabolism-related pathways while avoiding those linked to side effects such as nausea and vomiting. Phase 1 results showed participants lost an average 18.8% of their body weight over 24 weeks.”

• Per BioPharma Dive,
  • “MapLight Therapeutics, a biotechnology company making medicines for neurological diseases, filed plans for an initial public offering on Friday.
  • “In outlining an offering, MapLight aims to become the second drugmaker to recently price a sizable IPO following a monthslong drought. LB Pharmaceuticals raised $285 million earlier this month, but the last company to carry out a large offering before that was Aardvark Therapeutics in February, according to BioPharma Dive data. 
  • “The Redwood City, California biotech is developing its lead drug as a potential treatment for schizophrenia and Alzheimer’s disease psychosis. MapLight’s ML-007C-MA activates a pair of proteins called muscarinic receptors, which help control the release of the neurotransmitter acetylcholine. In that way, the drug is designed similarly to Cobenfy, the focus of Bristol Myers Squibb’s $14 billion acquisition of Karuna Therapeutics.”

• Beckers Payer Issues notes,
  • “Aetna is expanding a program that aims to reduce readmissions for its Medicare Advantage members to ten hospitals by the end of 2025.
  • “The insurer is currently implementing the clinical collaboration program at Merriam, Kan.-based AdventHealth Shawnee Mission, Houston Methodist, and Raleigh, N.C.-based WakeMed Health & Hospitals, according to a Sept. 22 news release. 
  • “The initiative aims to reduce 30-day readmission rates and hospital stays by integrating Aetna nurses directly into hospital care teams, focusing on post-discharge care to help MA members transition back home or into skilled nursing facilities.” 

• Modern Healthcare adds,
  • “The number of hospitals faced with readmissions penalties of at least 1% come Oct. 1 is set to rise to the highest number since fiscal 2022.
  • “Prior to fiscal 2026, the number of hospitals facing readmissions penalties of 1% or more had dropped for five consecutive years. But preliminary data released Friday by the Centers for Medicare and Medicaid Services showed the number of hospitals set to pay penalties of 1% or more under the Hospital Readmissions Reduction Program will increase to 8.1%, or 240 hospitals, in fiscal 2026 compared to 7%, or 208 hospitals, in fiscal 2025.
  • “However, the number of hospitals facing no readmissions penalties next fiscal year, which starts Oct. 1, remained relatively flat compared to fiscal 2025, rising to 21.8%, or 641, from 21.4%, or 638.”
    
• Healthcare Dive reports,
  • “CVS pharmacy services subsidiary Omnicare has filed for Chapter 11 bankruptcy after being hit with a $949 million federal judgment over improper billing of government healthcare programs.
  • “Omnicare claimed up to $500 million in assets and between $1 billion and $10 billion in debts in its bankruptcy petition with a Texas court on Monday.
  • “Omnicare has brokered an agreement to receive $110 million in debtor-in-possession financing, a type of loan which it expects will allow it to continue operating through the bankruptcy process, the company said.”