From Washington, DC,

• Federal News Network tells us,
  • “House Republicans are leading a supplemental funding bill to address a multi-billion-dollar budget crunch at the Department of Veterans Affairs.
  • “Leaders of the House Appropriations and House VA committees introduced a bill Friday that would give the VA $3 billion to ensure the department can keep paying benefits to veterans for the rest of the fiscal year.
  • “The Veterans Benefits Continuity and Accountability Supplemental Appropriations Act would ensure the VA has enough funding to keep paying veterans’ compensation, pension and readjustment benefits for the rest of fiscal 2024.
  • “The emergency funding bill, however, does not address a $12 billion shortfall the VA anticipates for fiscal 2025.” * * *
  • “The supplemental spending bill would require the VA to give Congress regular updates on the status of funds needed to pay veterans’ benefits until the end of fiscal 2026.
  • “The bill would also require the VA’s inspector general office to issue a report on the root causes of the VA’s budget shortfall.”
    
• Per an FDA press release,
  • “Today, the FDA issued a draft guidance “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle”. This guidance, when finalized, is intended to provide recommendations on how patient preference information might be collected and shared with the FDA and potentially be considered in FDA decision-making processes. It also provides recommendations on designing patient preference studies that may provide reliable scientific evidence. On Oct. 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance. Please submit comments under docket number FDA-2015-D-1580 at www.regulations.gov by Dec. 5, 2024, to ensure the FDA considers comments before it begins work on the final version of the guidance.”

• Healthcare Dive lets us know,
  • “The Federal Trade Commission is urging Indiana to block a hospital merger that antitrust regulators say will raise costs and lead to worse outcomes for patients.
  • “On Thursday, the FTC submitted a comment with the Indiana Department of Health asking it to oppose the combination of Union Hospital and Terre Haute Regional Hospital on the state’s western border — two hospitals that proposed their merger under a controversial certificate that opponents say allows problematic mergers to pass regulatory review.
  • “Union’s proposed acquisition of Terre Haute Regional — a facility owned by mammoth for-profit hospital operator HCA Healthcare — will likely increase hospital costs while negatively impacting healthcare services in Indiana, the FTC argued in its letter. It could also depress wages for registered nurses in the state.”

• The American Journal of Managed Care informs us,
  • “The trend of food insecurity persists in the United States, with food insecurity, food expenditures, and need of assistance all reported in the country throughout 2023, according to a a new report from the US Department of Agriculture (USDA).
  • “The USDA defines food insecurity as either have a reduced quality, variety, or desirability of diet or having multiple indications of disrupted eating patterns and reduced food intake. Food insecurity is different than hunger according to the USDA, as hunger is a physiological condition that comes as a result of food insecurity whereas food insecurity itself is an economic and social condition that indicates uncertain or limited access to food.
  • “The new report found that 13.5% of households in the US were food insecure, totaling approximately 18 million households. Food insecurity in this context was defined as households who had difficulty providing enough food for their residents at some point during the year. The percentage increased from 2022 when it was 12.8%, from 2021 when it was 10.2%, and 2020 when it was 10.5%.¹Low food security was reported in 5.1% of households in the country, which wasn’t different from the 2022 number but an increase from 3.8% reported in 2021. This food insecurity led to disrupted eating patterns through the year.
  • “A total of 8.9% of households with children were food insecure, which is similar to the 8.8% reported in 2022 but higher than the 6.2% reported in 2021. A total of 1.0% of households reported children experiencing very low food security, which is similar to the 1.0% reported in 2022 and 0.7% reported in 2021. Skipping a meal, not eating for a whole day due to lack of resources, and children being hungry was common in these households.”

• Tammy Flanagan, writing in Govexec, discusses how to prepare for retirement as a federal employee.

From the public health and medical research front,

• STAT News reports,
  • “A person in Missouri who didn’t report any contact with animals has tested positive for H5 bird flu, the state’s Department of Health and Senior Services and the Centers for Disease Control and Prevention said Friday. It’s not yet clear if the person was infected with the same virus strain that’s causing the ongoing outbreak among dairy cattle.
  • “The individual, who had been hospitalized on Aug. 22, had a number of underlying health issues. The person has since recovered and has been released, the state said in its statement.
  • “The CDC said this is the first case of H5 bird flu detected through the country’s national flu surveillance system, and the first H5 case in an individual without occupational exposure to infected cows or poultry.
  • “While news of an H5 infection in a person without known exposures to infected animals is unsettling, experts who spoke with STAT cautioned that it is too early to jump to any conclusions.”

• The Centers for Disease Control and Prevention issued its weekly summary on respiratory illnesses in the U.S.
  • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
  • “COVID-19
    • “COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
  • ‘Influenza
    • “Nationally, seasonal influenza activity remains low. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
  • “RSV
    • “Nationally, RSV activity remains low.
  • “Vaccination
    • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.
  • “Season Outlook
    • “CDC expects the upcoming fall and winter virus season will likely have a similar or lower peak number of combined hospitalizations from COVID-19, influenza, and RSV compared to last year. However, peak hospitalizations from all respiratory viruses remain likely to be substantially higher than they were before the emergence of COVID-19. COVID-19 activity this fall and winter will be dependent on the progression of the ongoing summer COVID-19 wave. Influenza and RSV seasons generally begin in October, although they can vary in timing and burden. Read the entire 2024-2025 Respiratory Season Outlook here.
    • “CDC will update this outlook every two months during the fall and winter virus season and if there are big changes in how COVID-19, flu, or RSV are spreading.”

• The University of Minnesota’s CIDRAP adds,
  • “New research from a randomized controlled trial presented at the European Respiratory Society (ERS) Congress in Vienna, Austria, this week suggests that simple saline nasal drops can reduce the length of the common cold in children by 2 days, according to an ERS news release.
  • “The authors also said using saline nasal drops can reduce forward transmission often virus to household members.”

• The Wall Street Journal reports
  • “The Food and Drug Administration starting Sept. 10 will require that women nationwide be notified whether their mammograms reveal dense breast tissue. Mammography reports will also encourage women to speak with doctors about their breast density and personal risk.
  • “Nearly 40 states already require that women be notified about dense breast tissue. But there isn’t consensus on what to do with such results. Many doctors encourage women with dense tissue to consider additional tests including an ultrasound or MRI. Others say further tests could lead to unnecessary procedures. Some aren’t caught up on the trade-offs.
  • “The U.S. Preventive Services Task Force, a government-backed group that sets guidance on screening and preventive care, says there isn’t enough evidence to recommend more testing. And insurance coverage for ultrasounds or MRIs varies by state and insurer. 
  • “It’s a very challenging, patchwork landscape,” said Dr. Wendie Berg, a radiologist and breast-imaging researcher at the University of Pittsburgh. “And it’s hard to see women who could have had a better outcome and just didn’t know.” 

• Healio adds,
  • “Less than three in 10 women are aware that a healthy diet can help reduce the risk for breast cancer, according to a recent survey.
  • “Public education programs on breast cancer have focused on mammograms, which play a vital role, but are not enough,” Neal Barnard, MD, president of the Physicians Committee for Responsible Medicine (PCRM), said in a press release. “It is essential to empower people with steps they can take to protect themselves, and a healthy diet is at the top of the list.”

• Per BioPharma Dive,
  • “GSK on Friday said its Nucala medicine succeeded in a Phase 3 study of patients with chronic obstructive pulmonary disease, offering the British drugmaker another shot at an expanded approval for the drug
  • “The trial, known as MATINEE, included COPD patients suffering from chronic bronchitis and/or emphysema who were already taking inhaled therapies and showed evidence of a certain type of inflammation. Adding Nucala to the patients’ treatment regimens significantly reduced disease exacerbations compared with placebo, GSK said.
  • “Researchers followed the progress of patients in the study for as long as two years, GSK said. The company didn’t release detailed data on safety or efficacy but said the preliminary results on side effects were consistent with previous research on Nucala.”

From the U.S. healthcare business front,

• The Peterson-KFF Health System Tracker projects that “In the private insurance market, 57.4 million adults under 65 could be potentially eligible for GLP-1 drugs.”
  • “These broad estimates indicate the potential number of non-elderly adults who meet the clinical criteria for GLP-1 drugs, although employers and insurers may have more restrictive eligibility standards for coverage. Additionally, because many people with diabetes or who are overweight may control their condition with diet, other medications and therapies, or choose to not seek treatment, not all people who meet these clinical criteria would use GLP-1 drugs. This analysis of survey data finds that over 40% of adults under 65 with private insurance could be indicated for a GLP-1 drug though relatively few have a claim, suggesting that a much smaller share seeks treatment through healthcare providers. Therefore, the potential market size for GLP-1 drugs suggests the broadest possible impacts on private insurance premiums and health system spending.”

• Not surprisingly, Beckers Hospital Review points out,
  • Pharmaceutical company Eli Lilly may become the first healthcare company to hit a market value of $1 trillion, according to a Sept. 5 CNBC report. 
  • This growth is fueled by the company’s popular weight loss and diabetes drugs, Zepbound and Mounjaro. When discussing its second-quarter results in August, company officials said the two drugs accounted for almost 40% of Eli Lilly’s total sales.
  • Eli Lilly’s current market value is close to $900 million, as of this writing.

• STAT News reports,
  • “Private equity firms are leading the buyout of R1 RCM, a major provider of billing and administrative services for hospitals and physician groups. But R1’s hospital customers — some of the biggest systems in the country — were influential in steering the company to that outcome.
  • “Ascension, a nonprofit Catholic health system, is R1’s largest client and biggest shareholder through an investment fund with private equity firm TowerBrook Capital Partners. Throughout the process of taking R1 private, Ascension and TowerBrook had no intention of giving up their ownership of R1, according to new financial disclosures from R1. TowerBrook ultimately partnered with private equity firm Clayton, Dubilier & Rice on the $8.9 billion deal.
  • “The company’s other largest customers — the nonprofits Intermountain Health, Providence, and Sutter Health and the for-profit Lifepoint Health — also supported Ascension and TowerBrook preparing a takeover offer to rival New Mountain Capital. New Mountain is a private equity firm and R1’s second-largest shareholder. It started the R1 sweepstakes in February by offering to buy the company at $13.75 per share.”

• Speaking of New Mountain Capitol, Healthcare Dive notes,
  • “New Mountain Capital is combining three of its portfolio companies to create a new payment accuracy firm for health plans, the private equity firm said Thursday.
  • “The deal will merge The Rawlings Group, an analytics firm that finds third parties responsible for paying medical claims, the payment integrity platform of health tech provider Apixio and overpayment identification firm Varis. 
  • “David Pierre, previously the chief operating officer of home healthcare company Signify Health, will head up the newly combined company.”