From Washington, DC,

• Federal News Network tells us,
  • “Despite being less than a week away from the government’s funding deadline, and with lawmakers still far from reaching a spending agreement, agencies have not published their plans for what would happen during a government shutdown.
  • “Often, leading up to a possible government shutdown, agencies will publish or update their shutdown contingency plans, which are made publicly available on the Office of Management and Budget’s website. Those plans typically detail how many federal employees at each agency would continue to work — and how many would be furloughed — if a shutdown were to happen.
  • “But even with the fast-approaching deadline for Congress to reach a spending agreement for fiscal 2026 appropriations, OMB’s webpage that usually hosts that contingency information is completely blank.
  • “OMB did not respond to multiple requests for comment from Federal News Network, asking if the Trump administration intends to publish agencies’ contingency plans, or if there were any alternative government shutdown planning efforts currently in the works.”

• Politico adds
  • “The White House budget office is instructing federal agencies to prepare reduction-in-force plans for mass firings during a possible government shutdown, specifically targeting employees who work for programs that are not legally required to continue.
  • “The Office of Management and Budget move to permanently reduce the government workforce if there is a shutdown, outlined in a memo shared with POLITICO ahead of release to agencies tonight, escalates the stakes of a potential shutdown next week.
  • “In the memo, OMB told agencies to identify programs, projects and activities where discretionary funding will lapse on Oct. 1 and no alternative funding source is available. For those areas, OMB directed agencies to begin drafting RIF plans that would go beyond standard furloughs, permanently eliminating jobs in programs not consistent with President Donald Trump’s priorities in the event of a shutdown.
  • ‘The move marks a significant break from how shutdowns have been handled in recent decades, when most furloughs were temporary and employees were brought back once Congress voted to reopen government and funding was restored. This time, OMB Director Russ Vought is using the threat of permanent job cuts as leverage, upping the ante in the standoff with Democrats in Congress over government spending.”

• Axios reports,
  • “Big drug companies so far are responding to President Trump’s demand they commit to his “most favored nation” pricing policy by raising prices abroad without cutting them in the U.S.
  • “That only gets halfway toward Trump’s goal of ending what he calls “global freeloading” and getting other developed countries to foot more of the cost while lowering costs for Americans.” * * *
  • “The pharmaceutical industry says it agrees with the goal of making other countries pay more and putting an end to “foreign freeloading.” But drastically cutting U.S. prices to match those abroad would hurt innovation, officials argue. 
    • “Industry is more receptive to other Trump ideas like offering sales directly to patients who pay on their own without insurance. 
    • “We must reject foreign price control models that ration care and suppress innovation,” PhRMA CEO Steve Ubl wrote in an op-ed in Stat in June. 
    • “If we instead required hospitals and [pharmacy benefit managers] to pass along the steep discounts they already receive — and ensured wealthy nations paid their fair share — U.S. prices could fall without jeopardizing our life sciences edge.”

• Per an HHS press release,
  • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced it has awarded more than $45 million in new supplemental funding to State Opioid Response (SOR) program recipients to focus on sober or recovery housing among young adults. This investment advances President Trump’s Executive Order, Ending Crime and Disorder on America’s Streets, by providing sober housing and recovery support services, which are critical to combatting our Nation’s challenge of homelessness, addiction, and illness.
  • “President Trump has elevated this issue as a key public health and public safety priority,” said HHS Secretary Robert F. Kennedy, Jr. “All too often, young adults with opioid or stimulant use disorders lack safe housing to support their recovery. This funding can make a life-changing difference for young people working toward long-term recovery.”
  • “Firsthand experience has shown me that wraparound services, especially sober housing, play a vital role in breaking the cycle of addiction,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “This supplemental funding will help expand that lifesaving care and help people pursue a fulfilling life in recovery.”
  • “Sober housing for those in early recovery is a safe and supportive alcohol- and drug-free residence where people can live, build stability and work toward independence. This therapeutic model allows people to actualize their hopes and dreams to live a fulfilling and self-directed life.”

From the Food and Drug Administration front,

• Per MedTech Dive,
  • “Olympus told customers last week to stop using certain lots of its ViziShot 2 FLEX (19G) needles due to the risk that components may detach during procedures. 
  • “Olympus started the recall after receiving reports of patient injuries and one death. Olympus did not immediately respond to a request for comment or specify how many injury reports it had received.
  • “The medtech company has faced quality concerns in recent years, with the Food and Drug Administration sending multiple warning letters to Olympus in 2023 related to its endoscopes, and blocking some of the devices from entering the U.S. in June.”
• and
  • “Johnson & Johnson has recalled certain automated controllers for its Impella heart pumps over a fault linked to five serious injuries, the Food and Drug Administration said Tuesday.
  • “The company’s Abiomed unit told customers to return the affected devices when contacted by its field servicing team because of potentially fatal purge pressure issues. Abiomed will make a design change during device servicing to correct the problem. Hospital inventory can continue to be used, according to the FDA’s alert.
  • “J&J’s recall, which triggered an FDA early alert, follows other recent safety actions to address two problems with Impella that were collectively linked to four deaths.”

From the judicial front,

• Bloomberg Law reports,
  • “The full Fifth Circuit confronted the limits of agency rulemaking in arguments over a Biden administration rule for a surprise medical billing law.
  • “The en banc appellate court in New Orleans heard an appeal Wednesday on whether federal agencies exceeded their authorities in a rule on the calculation of a key figure under the No Surprises Act. That law is meant to protect patients from excessive medical bills.
  • “The billing law mandates that medical providers and health insurers settle out-of-network disputes through arbitration. The measure is aimed at protecting patients from medical bills stemming from out-of-network emergency care and from out-of-network clinicians’ care received at in-network facilities.
  • “Justice Department attorney Kevin Soter told the appellate court’s 17 active judges that the statute left it up to federal agencies—the Department of Labor, the Department of Health and Human Services, and the Office of Personnel Management—to come up with details on the arbitration process for surprise medical bill disputes.
  • “Judges Leslie Southwick and Catharina Haynes asked about impact of the US Supreme Court’s 2024 ruling in Loper Bright Enterprises v. Raimondo, which eliminated deference to agencies in interpreting vague laws. Soter said that through the statute, “Congress did clearly put this in the hands of the departments.” * * *
  • “The case is Texas Medical Association v. HHS, 5th Cir. en banc, No. 23-40605, oral argument 9/24/25.”

From the public health and medical / Rx research front,

• The University of Minnesota’s CIDRAP tells us,
  • “In its weekly measles update, the Centers for Disease Control and Prevention (CDC) said there are now 1,514 confirmed measles cases in the United States reported this year, with 23 new cases reported in the past week. 
  • “Eighty-six percent of the cases have been part of 40 outbreaks reported to the CDC. Of note, 92% of case-patients are unvaccinated or have unknown vaccination status, 4% have only one measles, mumps, and rubella dose, and 4% were fully vaccinated. 
  • “Twelve percent of cases have required hospitalization, with 29% of those hospitalized aged 19 years or younger. There have been 3 confirmed measles deaths this year.” 

• The Centers for Disease Control and Prevention announced,
  • “A new report from the Centers for Disease Control and Prevention (CDC), published in the Annals of Internal Medicine, highlights a dramatic increase in a dangerous type of drug-resistant bacteria called NDM-producing carbapenem-resistant Enterobacterales (NDM-CRE). 
  • “In a 2022 special report, COVID-19: U.S. Impact on Antimicrobial Resistance, CDC noted that in 2020 there were approximately 12,700 infections and 1,100 deaths in the U.S. due to CRE. The rise in NDM-CRE, documented in the new study, threatens to increase CRE infections and deaths.
  • “Between 2019 and 2023, NDM-CRE infections surged by more than 460% in the United States. These infections —including pneumonia, bloodstream infections, urinary tract infections, and wound infections—are extremely hard to treat and can be deadly. Detection is also challenging, as many clinical laboratories lack the necessary testing capacity.
  • “This sharp rise in NDM-CRE means we face a growing threat that limits our ability to treat some of the most serious bacterial infections,” said Danielle Rankin, an epidemiologist in CDC’s Division of Healthcare Quality Promotion. “Selecting the right treatment has never been more complicated, so it is vitally important that healthcare providers have access to testing to help them select the proper targeted therapies.”

• Per MedPage Today,
  • “Sexually transmitted disease (STD) rates for U.S. adults fell last year, but syphilis in newborns continued to rise, according to new government data posted Wednesday.
  • “The CDC provisional data for 2024 showed a third consecutive year of fewer gonorrhea cases, and the second year in a row of fewer adult cases of chlamydia and the most infectious forms of syphilis.
  • “But congenital syphilis cases, in which infected moms pass the disease to their babies, aren’t seeing the same improvements. Such infections in infants can lead to deaths or lifelong health problems such as deafness, blindness, and malformed bones.”
• and
  • “Drinking any amount of alcohol increased dementia risk, data from a combined observational and genetic study suggested.
  • “Light alcohol consumption was associated with low dementia risk in observational analyses, and genetic analyses showed a monotonic increasing dementia risk with higher alcohol intake, reported Anya Topiwala, DPhil, of the University of Oxford in England, and co-authors.
  • “Mendelian randomization suggested a causal role of alcohol consumption in increasing dementia risk with no evidence supporting a protective effect at any consumption level, Topiwala and colleagues wrote in BMJ Evidence-Based Medicine.”

• BioPharma Dive informs us,
  • “UniQure said Wednesday it will ask the Food and Drug Administration next year to approve its gene therapy for the neurodegenerative disorder Huntington’s disease following positive data from a Phase 2 study that showed it slowed signs of disease progression by 75% after three years.
  • “Though from only 12 patients who’d received the highest tested dose of the therapy, AMT-130, and had been evaluated for at least 36 months, the effects were “greater than what we even anticipated and expected and hoped for,” said Sarah Tabrizi, director of the University College London Huntington’s Disease Center, on a conference call.”
• and
  • “Acadia Pharmaceuticals is giving up on a drug to treat the insatiable hunger associated with Prader-Willi syndrome after a Phase 3 trial failed to prove the experimental medicine was more effective than a placebo.
  • “The 12-week study tested the effects of ACP-101 in 175 patients with the rare genetic syndrome. The main goal was improvement on a questionnaire measuring the hunger, known as hyperphagia. But the drug didn’t show advantages over a placebo on that primary endpoint or any secondary endpoint, Acadia said Wednesday.”

• MedPage Today notes,
  • “Supplementing digital breast tomosynthesis (DBT) with molecular breast imaging (MBI) increased the detection of cancers in women with dense breasts, a prospective study suggested.
  • “In an analysis involving nearly 3,000 women with dense breasts, adding MBI to DBT led to incremental cancer detection rates of 6.7 and 3.5 cancers per 1,000 screenings in year 1 and year 2, respectively (both P<0.001), reported Carrie B. Hruska, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.
  • “Supplemental MBI also increased invasive cancer detection by more than 2.5 times that of DBT alone at both screening rounds, they noted in Radiology.
  • “Across both screenings, there were 30 cancers detected in 29 women with MBI only. Most of these incremental cancers (71%) were invasive. Additionally, 90% of the cancers detected only with MBI were node negative, “indicating that MBI screening provides early detection,” Hruska and colleagues wrote.”

• Per Health Day,
  • “Providing immediate bedside hepatitis C virus (HCV) consultation at discharge from labor and delivery for women with HCV-affected pregnancies is associated with higher rates of treatment completion than referral for outpatient follow-up, according to a study published in the October issue of O&G Open.
  • “Leah Madeline McCrary, M.D., from Washington University in St. Louis (WashU), and colleagues evaluated the associations of a traditional postpartum outpatient referral (92 women) compared to an opportunistic inpatient consultation (33 women) for HCV treatment initiation on HCV treatment completion. 
  • “The researchers found that all individuals in the inpatient referral group had an inpatient consultation; however, a majority (55.4 percent) of those in the outpatient referral group did not present for consultations. Inpatient referral was associated with higher rates of HCV treatment completion (20 of 30) among women who were prescribed direct-acting antivirals compared with standard care (14 of 41). Inpatient treatment was associated with higher odds of treatment completion (adjusted odds ratio, 4.7).”

From the U.S. healthcare business front,

• Healthcare Dive reports,
  • “Premier is going private through an acquisition by healthcare-focused investment firm Patient Square Capital, the companies announced Monday.
  • “The deal values Premier at roughly $2.6 billion and is set to take the company, which provides supply chain, technology and consulting services to thousands of U.S. providers, off the public markets after more than a decade.
  • “Premier and Patient Square expect the deal to close by the first quarter of 2026 subject to regulatory approval and other closing conditions.”
• and
  • “Privia Health is acquiring a value-based primary care business from Evolent Health as the physician enablement company continues to expand its care delivery network into new geographies.
  • “Evolent has agreed to sell its accountable care organization business, called Evolent Care Partners, for $100 million in cash, the companies announced aftermarket Tuesday. Another $13 million is contingent on the ACO’s performance in traditional Medicare’s largest value-based care program in 2025.
  • “The transaction is expected to close in the fourth quarter and positively contribute to Privia’s adjusted earnings next year. Analysts said the deal is favorable for both parties.”

• Fierce Healthcare relates,
  • “UnitedHealthcare is rolling out a new offering that aims to make it easier for employer plan members to shop for health and wellness solutions that meet their needs.
  • “The UHC Store is embedded in the insurer’s member portal and app and is now available to 6 million people enrolled in its employer-sponsored health plans. The payer giant plans to expand to 18 million members this year.
  • “Members who access the store are eligible for discounts of up to 15% of health and wellness programs of their choice, according to its announcement. The team initially focused on programs that fit within some of the most in-demand and high-cost areas, such as women’s health, musculoskeletal conditions and diabetes, according to Amy Jordan, vice president of consumer experience for UnitedHealthcare’s commercial business.”
• and
  • “Harbor Health continues to expand its clinical footprint in Texas with the acquisition of 32 clinics from VillageMD.
  • ‘The deal expands the company’s reach into three new markets: San Antonio, El Paso and Dallas. Harbor Health also grew its established clinical footprint in its home base of Austin. Financial terms of the deal were not disclosed.
  • “The acquisition nearly quadrupled Harbor Health’s clinical presence, growing from 11 to 43 total clinics and adding more than 80 clinicians to its team of physicians and advanced practice providers. The acquisition also advances the company’s philosophy that having a denser network of clinics improves quality of care through enhanced accessibility.” 

• Fierce Pharma informs us,
  • “Excitement around Fujifilm Biotechnologies’ massive new cell culture facility in Holly Springs, North Carolina, has been growing steadily since 2021, prompting a beefed-up investment from the company last April and a string of high-profile manufacturing contracts this year.
  • “Now, some four years since the project’s reveal, Fujifilm Biotechnologies is opening the doors to the facility, which might look familiar to anyone who’s worked with the CDMO in Denmark.
  • “The opening of the Holly Springs site, which will focus on antibody-based drugs, marks the debut of one of the largest cell culture biomanufacturing sites in the U.S., Fujifilm Biotechnologies said in a Sept. 24 press release.”
• and
  • “Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.
  • “Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.
  • “The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.”

• Beckers Payer Issues discusses an Experian Health report about the 2025 State of [Health Plan] Claims.

• Avalere Health explains how “CMS Continues to Refine Value-Based Care Approach for Kidney Care.”

• Radiology Business reports,
  • “Medical imaging accounts for 4 of the 5 most prevalent low-value healthcare services among Medicare beneficiaries, according to new research published Friday. 
  • “Imaging for plantar fasciitis” was the most frequently delivered unnecessary exam, occurring nearly 84 times per 100 Medicare beneficiaries, experts write in JAMA Health Forum. Low-value imaging for headache (76/100), syncope (72/100) and lower back pain (39/100) also made the top five, with vertebroplasty and kyphoplasty at No. 4. 
  • “The findings are based on a review representing claims from over 3.7 million Medicare beneficiaries treated between 2018 and 2020. Altogether, the payment program spent approximately $484 million on 15 different low-value imaging services, a figure that balloons to nearly $584 million when factoring in beneficiaries’ out-of-pocket costs.  
  • “Findings of this cross-sectional study highlight that reforms aimed at reducing spending for low-value services are feasible to achieve billions in savings without compromising patient health,” David D. Kim, PhD, and A. Mark Fendrick, MD, with the universities of Chicago and Michigan, respectively, wrote Aug. 1.”