From Washington, DC,

• NBC News informs us,
  • “House Republicans on Wednesday defeated their own plan to avert a government shutdown at the end of the month, with the party divided over the length of a short-term funding bill and what, if anything, should be attached to it.
  • “It was an embarrassing blow to Speaker Mike Johnson, R-La., who had yanked the same funding package off the floor last week amid growing GOP defections, only to watch it collapse on Wednesday in a vote that seemed doomed from the start.
  • “The vote was 202-220 with two members voting present. In all, fourteen Republicans voted against the package and three Democrats voted for it.
  • “Thirteen days before money runs out for the federal government, there is still no bipartisan plan to stave off a shutdown. While the GOP-led House could try again, the focus now likely shifts to the Senate, where leaders in both parties agree a shutdown would be disastrous weeks before the election.”

• Govexec adds,
  • “Legislation to cover a $3 billion shortfall in veterans’ benefits through the end of the month passed the House Tuesday, three days before benefits could be disrupted.  
  • “Lawmakers passed the Veterans Benefits Continuity and Accountability Supplemental Appropriations Act by voice vote Tuesday evening, sending it to the Senate ahead of a Friday deadline to ensure the Veterans Affairs Department can process benefit payments for 7 million veterans. * * *
  • “Senate Veterans’ Affairs Committee Chairman Jon Tester, D-Mont., said in a statement Tuesday that it was critical that the Senate move with haste to pass the legislation.”
    
• STAT News reports,
  • “A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities, and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives.
  • “Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth. The two-year telehealth extension unanimously passed on Wednesday by the House Energy & Commerce Committee is very similar to bills advanced in May by Commerce’s health subcommittee and the House Ways & Means Committee. 
  • “The two bills set up the House position heading into negotiations with the Senate on extending the telehealth policies, which expire at the end of December.” 
    
• Per Federal News Network,
  • “House Democrats are pushing harder to try to help federal employees more easily access IVF treatments. A new bill, called the Right to IVF Act, rolls together four previous bills all aiming to broaden fertility coverage nationwide. Part of the legislation would require carriers in the Federal Employees Health Benefits Program to increase their coverage of IVF for FEHB enrollees. The Democrats who introduced the bill are calling for a House floor vote, but so far, the legislation has no Republican co-sponsors.(Right to IVF Act – Reps. Gerry Connolly (D-Va.), Susan Wild (D-Pa.), Rick Larsen (D-Wash.) and Rosa DeLauro (D-Conn.))”
• and
  • “Federal benefits for health and retirement are a major recruitment and retention influence for employees, especially for early-career talent.
  • “Women as well as individuals in younger generations ranked the importance of federal benefits more highly than older or male employees, according to the results of the 2023 Federal Employee Benefits Survey (FEBS) from the Office of Personnel Management, obtained exclusively by Federal News Network.
  • “The benefits stemming from the Federal Employees Health Benefits (FEHB) program and the paid parental leave program are particularly important to younger generations of employees, OPM’s survey showed. Specifically, 94% of millennial and Gen Z respondents said the FEHB was either “important” or “extremely important” to them, compared with 84% of baby boomers and older generations who gave the same response.
  • “It is clear that these major benefit programs have an impact on both recruiting and retaining talent in the federal government, making it critical to continuously improve these benefits to meet employee needs,” OPM wrote in the survey results.”

• A commentator writing in Real Clear Health commends the FEHB Program for being a catalyst for change in women’s health care and suggests three improvements:
  • Provide solutions for perimenopause and menopause
  • Provide a safety net for caregivers, and
  • Provide enhanced family planning and maternal care.

• Mercer Consulting offers FAQs on the Supreme Court’s recent Loper Bright decision.
  • “The US Supreme Court overturned a 40-year-old principle of administrative law known as the Chevron deference doctrine (Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al.). That doctrine required courts to defer to administrative agencies’ reasonable interpretation of a federal law that is silent or ambiguous. Now, federal courts must exercise independent judgment when determining the best interpretation of a statute and cannot simply defer to agency interpretations, even when they are reasonable. This will likely increase courts’ scrutiny of federal agency regulations that are subject to legal challenges. These FAQs provide high-level information about the case and its potential impact on employee benefit plans and their sponsors. Also, this Mercer US Health News 15-minute video highlights the practical implications of this opinion on employer-sponsored health plans.”

From the public health and medical research front,

• MedPage Today lets us know,
  • “The new COVID-19 variant XEC may overtake others in circulation to become dominant in the coming months, experts said but will not prompt a meaningful change in symptoms or vaccine response.” * * *
  • “XEC represents a fairly minor evolution relative to the SARS-CoV-2 diversity currently in circulation, and is not a highly derived novel variant such as those that were granted Greek letters,” like Alpha, Delta, and Omicron, Francois Balloux, PhD, a computational biologist at University College London and director of the UCL Genetics Institute, said in a Science Media Centre statement.
  • “Experts noted that while XEC may have a small advantage in transmission, available vaccines are still likely to provide protection from serious illness.
  • “XEC is a “recombinant variant of some of the other Omicron lineages that have been around for a while, and it does appear to be more immune evasive, giving it a transmissibility advantage in the population with the immunity that it has,” Amesh Adalja, MD, of the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today. “But it doesn’t really change anything, just like the last variant didn’t change anything, or the one before that, one before that, or the one before that.”

• NBC New points out,
  • “Black women are more likely than white women to die from even the most treatable types of breast cancer, a study published Tuesday in the Journal of Clinical Oncology found.
  • “The findings, experts say, underscore that it’s racial disparities, not biology, driving the biggest differences in death rates between Black and white women. While Black women and white women are diagnosed with breast cancer at similar rates, Black women are 40% more likely to die from the disease.” * * *
  • “If you look at breast cancer data from 40 years ago, there really weren’t differences in mortality for breast cancer between Black and white women. We weren’t very good at treating and diagnosing it. But as we’ve gotten better, the gap between white and Black women has grown,” [lead author Dr. Erica] Warner said. “That is problematic, but that also tells us we have our foot on the pedal for these differences. If we can create them, we can eliminate them.” 

• STAT News reports,
  • “A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up.
  • “On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks. 
  • “Notably, only two of 71 patients who received a high dose of therapy have shown signs of ocular inflammation, 4D said. In 2021, another leading contender, Adverum, was set back after a patient with a related disease went blind in one eye. 
  • “I think it’s very positive and there’s a good chance they’ll be able to move toward approval,” said Ron Crystal, chair of genetic medicine at Weill Cornell Medical Hospital, who has served as a scientific adviser to and has stock in Adverum.”

• The New York Times notes,
  • “Adults under age 50 have been developing breast cancer and colorectal cancer at increasingly higher rates over the last few decades, and alcohol use may be one factor driving the trend, according to a scientific report published on Wednesday.
  • “The report, by the American Association for Cancer Research, highlights scientific breakthroughs that have led to new anticancer drugs and improved overall survival.
  • “But the authors also described a troubling pattern: Even as cancer death rates have declined, the overall incidence of several cancers has been rising inexplicably, with an especially alarming increase among younger adults in cancers of the gastrointestinal system, like colorectal cancer.
  • “The report estimates that 40 percent of all cancer cases are associated with modifiable risk factors. It recommends reducing alcohol consumption, along with making lifestyle changes such as avoiding tobacco, maintaining a healthy diet and weight, exercising, avoiding ultraviolet radiation and minimizing exposure to pollutants.”

• Per NIH press releases,
  • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.”
• and
  • “Researchers at the National Institutes of Health (NIH) and their collaborators have identified a protein, known as RNF114, that reverses cataracts, a clouding of the eye’s lens that occurs commonly in people as they age. The study, which was conducted in the 13-lined ground squirrel and rats, may represent a possible surgery-free strategy for managing cataracts, a common cause of vision loss.  The study published in the Journal of Clinical Investigation.
  • “Scientists have long searched for an alternative to cataract surgery, which is effective, but not without risk. Lack of access to cataract surgery is a barrier to care in some parts of the world, causing untreated cataracts to be a leading cause of blindness worldwide,” said Xingchao Shentu, M.D., a cataract surgeon and the co-lead investigator from Zhejiang University, China.” * * *
  • “According to the scientific team, these findings are proof-of-principle that it is possible to induce cataract clearance in animals. In future studies, the process will need to be fine-tuned so scientists can stimulate specific protein degradation to see how to precisely regulate protein stability and turnover. This mechanism is also an important factor in many neurodegenerative diseases, they said.”
• and
  • “A clinical trial supported by the National Institutes of Health (NIH) was stopped early after researchers found sufficient evidence that a drug used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide. The trial results, which are published in the New England Journal of Medicine, detail how patients with HHT given the drug, called pomalidomide, experienced a significant reduction in the severity of nosebleeds, needed fewer of the blood transfusions and iron infusions that HHT often demands, and showed improved quality of life.
  • “Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success story,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Heart, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discovery will give people who suffer with this disease a positive outlook and better quality of life.”
    

From the U.S. healthcare business front,

• Per Beckers Hospital Review,
  • “St.-Louis-based Ascension reported a $79 million operating loss (-0.3% margin) for the 10 months ending April 30, a substantial improvement on the $1.2 billion operating loss in the previous 10-month period. 
  • “The results include $402 million in one-time, non-cash write-downs and non-recurring losses.
  • “In May and June 2024, operations were hampered by the May ransomware attack, resulting in reduced revenues from the associated business interruption along with costs incurred to address the issues and other business-related expenses.
  • “Despite this incident, Ascension drove a $1.2 billion operational improvement year over year for the 10 months ending April 30. The 136-hospital system’s economic improvement plans focused on volume growth, rates and pricing, and cost levers. 
  • “The results are a notable improvement on the $3 billion operating loss (-5.5% margin) reported in fiscal year 2023. Including the cyberattack, Ascension reported a $1.8 billion (-4.9% margin) loss in FY 2024. 
  • “Ascension is also reorganizing its portfolio with several transactions in multiple markets.”

• Healthcare Dive tells us,
  • “Community Health Systems’ Northwest Urgent Care has signed a definitive agreement to purchase 10 Arizona urgent care centers from Carbon Health for an undisclosed price, according to a press release this week.
  • “The acquisition, which is expected to close in the fourth quarter, will grow CHS’ integrated health network to more than 80 care sites in the Tucson, Arizona region, according to CHS.
  • “The acquisition is a reversal from CHS’ recent string of hospital divestitures, which have been integral to helping the operator deleverage its portfolio.”

• Per BioPharma Dive,
  • “Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion in potential additional payments if certain milestones are hit.
  • “With the acquisition, Organon will gain Dermavant’s cream called Vtama, which was approved in 2022 to treat plaque psoriasis. The medicine is also awaiting action from the Food and Drug Administration that could expand its use to include atopic dermatitis, commonly known as eczema.
  • “Approval in eczema, expected in the fourth quarter, would trigger a $75 million payment, Organon said Wednesday. The deal also includes $950 million in potential commercial milestone payments as well as tiered royalties on net sales to Dermavant shareholders. Roivant owns the majority of Dermavant.”

• Fierce Healthcare points out,
  • “If a patient receives a continuous glucose monitor device through their medical benefit, they may be more adherent and may have lower costs, according to a new analysis.
  • “Researchers at CCS, which offers clinical services and home delivery for medical supplies for people with chronic conditions, published the peer-reviewed study this week in the Journal of Medical Internet Research Diabetes (JMIR) and found that patients who secured the monitors through their medical coverage had 23% higher rates of adherence.
  • “The study included data on 2,356 people, with 1,178 in the pharmacy benefit group and 1,178 in the durable medical equipment cohort. In addition to greater adherence, the study found that people who received the devices through their medical benefit had 35% lower average annual total costs of care.
  • “And, for patients who were not adherent to their devices, there was a higher rate of reinitiation (22%) for those in the medical benefit compared to those who received the glucose monitors through their pharmacy benefit (11%).”

• Per MedTech Dive,
  • “Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice. 
  • “Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.” 
  • “Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) flagged a higher risk of thigh bone fracture after surgery with the CPT Hip System, compared with similar hip replacement devices. While the analysis is currently unpublished, the British Hip Society and the British Orthopaedic Association advised against using the implant for elective surgery unless in exceptional circumstances.”