Friday report

Uncategorized

Friday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, No Surprises Act, Obesity, U.S. Healthcare, Uncategorized–

From Washington DC

  • The Wall Street Journal reports,
    • “Lawmakers are exploring options to end the government shutdown or mitigate its impact on federal workers and lower-income households.
    • “Some Republicans are considering stand-alone measures to pay specific groups of workers or fund certain programs during the shutdown.
    • “Democrats are facing increased pressure from constituents to end the shutdown, despite their stance on healthcare spending and federal workers.”
  • and
    • “The Pentagon said it received a $130 million donation from an anonymous private donor to cover military salaries during the government shutdown.
    • “The donation was accepted under the Defense Department’s “general gift acceptance authority” and is designated for servicemembers’ pay and benefits.
    • “President Trump announced the donation, calling the unnamed benefactor a “patriot,” as military members faced missing paychecks.”
  • Healthcare Dive tells us,
    • “Senators on both sides of the aisle expressed support for reforming the 340B drug discount program during a Thursday hearing of the Health, Education, Labor, and Pensions Committee — though lawmakers also cautioned that a careful approach is needed to ensure changes don’t harm rural hospitals and health centers.
    • “The hearing centered around concerns that 340B, although well-intentioned, has grown too large and may not ultimately benefit patients.” * * *
    • “Efforts are being led by a bipartisan working group formed in March, comprised of Sens. Jerry Moran, R-Kan.; Tammy Baldwin, D-Wis.; Shelley Moore Capito, R-W.V.; Tim Kaine, D-Va.; Markwayne Mullin, R-Okla.; and John Hickenlooper, D-Colo.” 
  • Per a Social Security news release,
    • “Social Security benefits and Supplemental Security Income (SSI) payments for 75 million Americans will increase 2.8 percent in 2026. On average, Social Security retirement benefits will increase by about $56 per month starting in January.
    • “Over the last decade the cost-of-living adjustment (COLA) increase has averaged about 3.1 percent.  The COLA was 2.5 percent in 2025.”
  • CMS announced today that “The Federal IDR Team released updates to the Federal IDR Portal’s Notice of IDR Initiation web form to improve the duplicate dispute validation process.” Duplicate arbitration requests were one on the principal concerns raised by the AHIP/BCBSA NSA survey noted in yesterday’s FEHBlog post.
  • Federal News Network adds,
    • “Starting in January 2026, many federal retirees will see a 2.8% cost-of-living adjustment (COLA) increase in their Social Security benefits and federal retirement annuities.
    • “That’s a higher rate than last year, and higher than projections set by AARP and the Senior Citizens League. About 75 million people, including retirees and individuals with disabilities, receive Social Security benefits.
    • “The annual COLA is meant to keep federal retirees’ and Social Security recipients’ benefits on pace with rising inflation. But not everyone will receive the full adjustment.
    • “Retirees in the Federal Employees Retirement System (FERS) usually receive a smaller cost-of-living adjustment each year for their annuities, based on the following formula:
      • “COLA is over 3%: FERS annuitants receive 1% less than the full COLA
      • “COLA is between 2% and 3%: FERS annuitants receive a 2% COLA
      • “COLA is less than 2%: FERS annuitants receive the full COLA
    • “According to those parameters, FERS retirees will receive a “diet” 2026 COLA of 2% for their retirement benefits, starting in January.”
  • FedWeek gives federal and postal employees and annuitants advice on how to approach the upcoming open season.

From the Food and Drug Administration front,

  • Fierce Pharma informs us,
    • “Following a slight delay earlier this year—and a world-first green light in the U.K. over the summer—Bayer has clinched an FDA nod to bolster the limited arsenal of nonhormonal treatments for some of the most common symptoms of menopause.
    • “Friday, the FDA approved Bayer’s dual neurokinin (NK) targeted therapy elinzanetant, which will now be marketed in the U.S. under the brand name Lynkuet, to treat moderate to severe vasomotor symptoms—comprising hot flashes and night sweats—in people with menopause.
    • “Lynkuet comes in a soft gel capsule and is taken once a day at bedtime, Bayer noted in an Oct. 24 press release. The drug is designed to target both the NK1 and NK3 receptors in the brain, which play a role in temperature regulation, the German drugmaker explained.”
    • “Bayer plans to launch Lynkuet in the U.S. starting next month.”
  • and
    • “Azurity Pharmaceuticals has scored an FDA approval for its blood pressure medicine Javadin. The oral solution was developed for patients who have difficulty swallowing tablets or capsules.
    • “Javadin becomes the first immediate-release, ready-to-use oral clonidine formulation for the treatment of hypertension. The berry-flavored treatment can eliminate the need for tablet cutting, compounding or the use of transdermal delivery products to lower blood pressure.
    • “According to the Massachusetts-based company, a recent study showed that more than a third of primary care patients have difficulty swallowing oral medications, with many resorting to splitting or crushing their tablets or opening their capsules to ingest them.”

From the public health and medical / Rx research front,

  • The American Hospital Association News informs us,
    • “Getting an annual flu vaccination is the best way to prevent flu and its potentially serious complications. 
    • “The Centers for Disease Control and Prevention recommends that anyone 6 months of age and older get vaccinated, particularly people who are at a high risk for flu complications. This includes people 65 years and older, young children, and people with chronic conditions such as asthma or heart disease. Individuals who care for or live with these high-risk populations also should get vaccinated.
    • “The 2024-2025 flu season was intense, with high levels of activity and hospitalizations across the country. Somewhere between 47-82 million people fell ill, causing an estimated 27,000-30,000 deaths. The flu vaccine is updated for the 2025-2026 season and is now available at many workplaces, hospitals, clinics, pharmacies and other locations.
    • “Making the case for the value of flu vaccination is easy, but individuals and communities must be proactive in committing to receive them. For 10 years, the AHA has been pleased to lead United Against the Flu, a collaborative effort by several national health care organizations to amplify the importance of getting the annual vaccine.”
  • BioPharma Dive adds,
    • “Sanofi on Friday reported a sharp decline in quarterly vaccine sales, a development the French company partially tied to lower immunization rates in the U.S.
    • “In its latest earnings report, Sanofi said that its overall vaccine sales fell by 7.8% to €3.4 billion, or $3.9 billion, between July and September. The pullback was largely driven by a slowdown in influenza shots, which, combined with the revenue Sanofi derives from Novavax’s COVID-19 vaccine Nuvaxovid, decreased by 16.8%, to €1.5 billion. Sanofi’s COVID-19 and influenza vaccine sales are down a total of 14% this year, the company said.” * * *
    • “It’s early. We’re still in October. But I think it’s fair that with the first few weeks that we observed a little bit of vaccination rate on the soft side when it comes to flu vaccination, particularly in the U.S.,” Thomas Triomphe, Sanofi’s head of vaccines R&D, told analysts.”
    • [Absent the shutdown, we would have had CDC info on this topic.] 
  • The University of Minnesota’s CIDRAP relates,
    • “New research suggests that nearly 1 in 5 urinary tract infections (UTIs) in Southern California may be caused by strains of Escherichia coli that originated in food-producing animals.
    • “For the study, a team led by scientists at George Washington University and Kaiser Permanente Southern California (KPSC) conducted molecular analysis of more than 5,700 extraintestinal pathogenic E coli (ExPEC) isolates collected from UTI patients and retail meat samples from stores in the neighborhoods where those patients lived. Using comparative genomic analysis and a model they developed to infer the host origin of each isolate, they found that 18% of the UTIs were linked to ExPEC strains that came from the meat.
    • “They also discovered that UTIs in patients from high-poverty neighborhoods were 60% more likely to be caused by these zoonotic (animal-to-human) ExPEC strains. 
    • “The findings were published yesterday in the journal mBio.
    • “These findings underscore the contribution of zoonotic ExPEC to the UTI burden in Southern California and the need for targeted interventions to reduce risk in vulnerable communities,” the study authors wrote.”
  • Per STAT News,
    • “Telehealth companies that have seized on the boom in weight loss drugs are playing a bigger role not just in treating patients with obesity but also shaping how the medical mainstream understands obesity.
    • “A dominant player in the field, Ro, said Friday it has launched a new questionnaire designed to measure “food noise,” a term that people with obesity often use to describe incessant and debilitating thoughts about food. One of the aims of the scale, which was developed by academic researchers with funding from Ro, is to help assess whether treatments can “quiet” patients’ level of food noise, a concept that has become more popular in recent years with the advent of new GLP-1 drugs Wegovy and Zepbound.
    • “The telehealth firm is already using the scale to track patients’ progress as they go through treatment, and it’s also licensing it out to pharma companies to use in clinical trials.
    • “WeightWatchers, which also provides telehealth care, earlier rolled out its own food noise scale.
    • “Proponents of these scales say that food noise anecdotally appears to be a common experience for people with obesity, so it’s important to measure it in an objective way to understand a range of questions — for instance, whether certain populations experience it more, how much of it is tied to a person’s weight, and ultimately, which interventions can help.”
  • Per Healio,
    • “Decreasing alcohol intake, even if an individual reports having two or fewer drinks per day, may have a positive impact on blood pressure, researchers reported.
    • “New data published in the Journal of the American College of Cardiology showed how small reductions in alcohol intake can lower BP for both men and women. 
    • “The implications are quite direct. For individuals with hypertension — as well as for the general adult population — stopping alcohol intake can be viewed as a practical, non-pharmacological strategy associated with lower BP,” Takahiro Suzuki, MD, MPH, clinical fellow at St. Luke’s International Hospital and PhD student at the Institute of Science Tokyo, told Healio. “Importantly, this recommendation should not be limited to heavy drinkers. Our findings demonstrate that even light to moderate drinkers can gain measurable benefit from stopping alcohol. A reduction of just 2 mm Hg in systolic BP can meaningfully decrease the risk of stroke and CV death at the population level. Thus, encouraging minimal alcohol intake for everyone could have significant population-level health benefits. … These results align with and support the 2025 American College of Cardiology/American Heart Association guidelines that include recommendations for alcohol abstinence or limiting intake.”
  • Per MedPage Today,
    • “A risk model showed promise for risk-stratifying women for breast cancer treatment-related heart failure or cardiomyopathy.
    • “The model achieved an overall accuracy of about 80% over 10 years.
    • “Older age, specific systemic therapies, and pre-existing cardiac risk factors contributed the most to the model.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare reported a net income of $1.6 billion (8.6% margin) in the third quarter, a significant improvement on the $1.3 billion net income (7.3% margin) posted in the third quarter of 2024. HCA said the strong financial results were driven by higher revenue, improved earnings and growth in same-facility admissions.
    • “For the nine months ending Sept. 30, 2025, HCA reported a net income of $4.9 billion (8.7% margin) compared to $4.3 billion (8.3% margin) in the prior-year period. 
    • “Our teams continued to execute our agenda at a high level, and we remain disciplined in our efforts to improve care for our patients by increasing access, investing in advanced technology, and training our people,” CEO Sam Hazen said in an Oct. 24 earnings release. “Across many operational measures, including quality and key stakeholders’ satisfaction, outcomes were better.”
  • and
    • “More hospitals have closed in Pennsylvania than in any other state this year, reflecting a growing crisis in the state’s healthcare infrastructure. 
    • “Of the 22 hospital closures Becker’s has reported on in 2025, four were in Pennsylvania. One additional hospital — Sharon (Pa.) Regional Medical Center — closed in 2024 but was acquired and reopened in May by Tenor Health Foundation, a newly formed nonprofit.
    • “Pennsylvania’s hospital challenges are multifaceted, involving a combination of overextended acquisition strategies, reimbursement shortfalls, workforce shortages and a rising tide of high-severity malpractice settlements.
    • “According to Radha Savitala, co-founder and CEO of Tenor Health Foundation, part of the issue stems from Pennsylvania’s high number of hospitals — many of them rural — and the fact that some health systems likely overpaid for certain acquisitions in the state more than a decade ago.”
  • MedCity News interviews interviews Puneet Maheshwari, UHC senior vice president and general manager of Optum Real, about the new AI driven claims processing system.
  • Beckers Payer Issues adds,
    • “Elevance Health is deepening its use of artificial intelligence enterprise-wide, focusing on enhancements to its member services, clinical workflows and provider operations as part of long-term efforts to simplify care delivery and reduce costs.
    • “Chief Digital Information Officer Ratnakar Lavu told Becker’s the company’s goal is “to keep the patient at the center and a focus on the experience, not technology for the sake of technology.”
    • “Elevance’s strategy is among a broader industry shift among large insurers using AI not just for automation, but for personalization and decision support that spans both administrative and clinical processes.”
  • BioPharma Dive relates,
    • “Adverum Biotechnologies, a gene therapy developer, has agreed to sell all its outstanding shares to Eli Lilly for an upfront amount that is less than the company’s most recent closing stock price.
    • “Lilly, through an acquisition announced Friday, plans to pay $3.56 in cash for each share — reflecting a nearly 15% discount from the $4.18 price they traded at the day prior. Yet, Adverum investors would also receive so-called contingent value rights that may be worth up to $8.91 per share if the company’s most advanced therapy hits certain goals.
    • “Altogether, the deal value could reach roughly $261 million.
    • “Adverum, formerly named Avalanche Biotechnologies, has been working for nearly two decades to develop genetic medicines for sight-threatening eye diseases. The company raised $102 million in 2014 by going public, and changed its name not long after as part of a reverse merger. Its lead research program is evaluating whether a gene therapy known as “ixo-vec” can help patients with the “wet” form of a degenerative eye condition that affects millions of people in the U.S. alone.”

Weekend Update

David Ermer–Congress, Congress, COVID-19 vaccine, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • On Thursday, the Senate Committee on Aging will hold a hearing at 3:30 pm ET “to examine modernizing health care, focusing on how shoppable services improve outcomes and lower costs.”
  • The Wall Street Journal reports that “Congress Is running out of time to decide the fate of Obamacare subsidies. Republicans decry the ‘Biden bonuses’ of enhanced ACA, while Democrats say pressure will rise on GOP to extend subsidies.”
    • “Enhanced Affordable Care Act subsidies, benefiting more than 20 million people, are set to expire this year, prompting a political standoff.
    • “Republicans seek major changes to the ACA, including addressing alleged fraud.
    • “ACA sign-ups have more than doubled since 2021. More than three-quarters of policyholders now reside in states that voted for President Trump.”
  • Roll Call adds,
    • “President Donald Trump is expected to host Senate Republicans for a Rose Garden lunch Tuesday, while the ongoing partial government shutdown continues to have no end in sight.
    • “A GOP source confirmed the plan for the White House visit, which comes as the Senate majority will also try this week to call up a bill that would pay federal workers who are on the job during the shutdown. The Senate this week is also expected to continue to confirm Trump’s judicial nominees.”

From the 2025 European Society for Medical Oncology congress in Berlin,

  • STAT News reports,
    • “Patients with a highly aggressive form of breast cancer will likely have new treatment options for the first time in years after AstraZeneca and Gilead Sciences both presented successful trial results here Sunday, dual achievements that will also leave clinicians having to figure out which drug to choose when treating triple-negative tumors. 
    • “Both studies tested what’s known as an antibody-drug conjugate — essentially, a next-generation type of chemotherapy — compared to traditional chemotherapy regimens as a first-line medicine in patients with metastatic triple-negative breast cancer who couldn’t receive an immunotherapy. The women largely weren’t eligible for treatments like checkpoint inhibitors because their tumors did not express the protein that the drugs target. For these patients, there hasn’t been a new first-line drug approved in over a decade.
    • “Researchers were already going to be comparing the results of the two Phase 3 studies in the difficult-to-treat tumors, but the stakes were upped with the trials being presented back-to-back here at the European Society for Medical Oncology’s annual conference. A single discussant also analyzed the results together, parsing the outcomes for Gilead’s Trodelvy as well as for Datroway, made by AstraZeneca and its partner Daiichi Sankyo.” 
  • and
    • “mRNA-based Covid vaccines from Pfizer-BioNTech or Moderna may have an unexpected benefit for cancer patients who undergo immunotherapy. 
    • “A new study suggests that these vaccines might boost the effects of immunotherapy drugs, perhaps by alerting the immune system and helping direct immune cells to attack tumors. That’s in addition to helping protect against Covid, which can be particularly important for cancer patients who can sometimes have weakened immune systems. 
    • “The study found that advanced cancer patients who received a Covid vaccine within 100 days before taking an immunotherapy drug during the pandemic lived longer than patients who did not, in a retrospective analysis. Researchers from MD Anderson Cancer Center presented the study at the European Society for Medical Oncology conference in Berlin on Sunday. 
    • ‘The results are intriguing cancer immunologists and oncologists, who reacted with both excitement and caution.” 
  • Fierce Pharma adds,
    • “Novartis has shared detailed data showing its radioligand therapy Pluvicto could slow the progression of certain hormone-sensitive prostate cancers ahead of a planned application with the FDA.
    • “Pluvicto plus standard of care significantly reduced the risk of radiographic progression or death by 28% versus standard of care alone in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), according to Novartis. The standard of care includes androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) such as Pfizer and Astellas’ Xtandi.
    • “Details from the phase 3 PSMAddition trial will be presented Sunday at the 2025 European Society for Medical Oncology congress in Berlin.”
  • and
    • “The standing ovation for Keytruda and Padcev in metastatic bladder cancer at the 2023 European Society for Medical Oncology (ESMO) Congress still echoes, and, now, the pair from Merck & Co., Pfizer and Astellas has pulled off similarly showstopping results in certain patients with muscle-invasive bladder cancer (MIBC).
    • “The combination of Merck’s Keytruda and Pfizer and Astellas’ Padcev reduced patients’ risk of death by a whopping 50% when used before and after bladder removal surgery in those with MIBC who are not eligible for or declined cisplatin-based chemotherapy compared with surgery alone, according to results to be presented at the 2025 ESMO Congress.
    • “The PD-1/antibody-drug conjugate combo also significantly improved event-free survival (EFS) by 60% versus surgery alone. A negative event includes progression of disease that precludes surgery or failure to undergo surgery, gross residual disease left behind during surgery, cancer recurrence or death.”
  • and
    • “Merck’s efforts to make headway in a cancer type that was an elusive target for its superstar oncology med Keytruda prove to be fruitful, as demonstrated through its Keynote-B96 trial in ovarian cancer. 
    • “The latest data drop is a more detailed look at a win from previously reported positive analyses of the phase 3 study, which tested Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer who have tried one or two prior lines of therapy, including at least one platinum-based chemotherapy.”

From the public health and medical / Rx research front,

  • The Washington Posts offers expert advice on when to obtain Covid and flu boosters for this coming, winter infection season. Both infectious disease physicians encouraged getting the shots in October.
    • “[Dr.] Pavia encourages getting a shot whenever you have an easy opportunity. If you’re getting groceries and the pharmacy is offering flu shots, take five minutes to get one, because you are less likely to follow through by scheduling an appointment, Pavia said.
    • “The Centers for Disease Control and Prevention now recommends that people consult a clinician before receiving a coronavirus shot, but that process can be as simple as a brief conversation with a pharmacist. The Post previously published a guide to getting covid shots under these new conditions.
    • “By now, many people know how they react to flu and coronavirus shots. The coronavirus shot can give some people quite a sore arm. If that’s the case, avoid getting both shots in the same arm, they said. [Dr.] Rivers got her shots in two different arms during the same visit, but the rest of her family got them in the same arm. For people who don’t have much a reaction, there is no disadvantage to getting two shots at the same time, [Dr.] Pavia said. He got his shots at different times because that’s when it was convenient for him.”
  • The American Medical Association offers healthcare providers advice on how to answer patients’ questions about vaccinations.
  • The New York Times explains why more older adults have turned to cochlear implants after Medicare expanded eligibility for the devices.
    • “Twenty-five years ago, “it was a novelty to implant people over 80,” said Dr. Charles C. Della Santina, director of the Johns Hopkins Cochlear Implant Center. “Now, it’s pretty routine practice.”
    • “In fact, a study published in 2023 in the journal Otology & Neurotology reported that cochlear implantation was increasing at a higher rate in patients over 80 than in any other age group.
    • “Until recently, Medicare covered the procedure for only those with extremely limited hearing who could correctly repeat less than 40 percent of the words on a word recognition test. Without insurance — cochlear implantation can cost $100,000 or more for the device, surgery, counseling and follow-up — many older people don’t have the option.
    • “It was incredibly frustrating, because patients on Medicare were being excluded,” Dr. Della Santina said. (Similarly, traditional Medicare doesn’t cover hearing aids, and Medicare Advantage plans with hearing benefits still leave patients paying most of the tab.)
    • “Then, in 2022, Medicare expanded cochlear implant coverage to include older adults who could identify up to 60 percent of words on a speech recognition test, increasing the pool of eligible patients.”

From the U.S. healthcare business front,

  • Medscape considers whether the obesity drug battleground is offering wins for clinicians and patients?
  • TechTarget reports,
    • “Teladoc Health has launched new AI capabilities that enable care teams to monitor and mitigate violence in healthcare workplace settings.
    • “The virtual care provider has integrated the new AI features into its Clarity monitoring solution. The AI technology utilizes video and audio cues to assess facial expressions, gestures and language to determine threats. If a situation is deemed potentially aggressive and appears to be escalating, the solution will notify the appropriate care teams and staff. For example, it will identify safety risks, such as a person aggressively tampering with medical equipment.”
  • The Wall Street Journal relates,
    • “Provalus, an outsourcing company, is expanding revenue by 35% to 40% annually as it invests in rural American towns.
    • “The company recruits and trains individuals from small towns, offering jobs in IT and professional services with competitive benefits.
    • “Provalus aims to create middle-class jobs in overlooked areas.”
  • Per HR Dive,
    • “While 7 in 10 U.S. hiring managers say they typically consider overqualified candidates, many also express concerns about low engagement and quick exits, according to an Oct. 8 report from Express Employment Professionals and The Harris Poll.
    • “In fact, three-quarters of employers said they believe overqualified hires struggle to stay motivated in lower-level roles, and they worry these hires will leave as soon as a better opportunity comes along. In response, 58% said they’d rather train someone new than risk disengagement.”

Columbus Day Holiday Report

David Ermer–Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Supplementing yesterday’s Weekend Update

From Washington, DC,

  • The AP reports,
    • “President Donald Trump said Saturday that he has directed the Defense Department to use “all available funds” to ensure U.S. troops are paid Wednesday despite the government shutdown, a short-term fix that will not apply to the hundreds of thousands of federal workers who have been furloughed.
    • “Trump said in a social media post that he was acting because “our Brave Troops will miss the paychecks they are rightfully due on October 15th.”
    • ‘The Republican president’s directive removes one of the pressure points that could have forced Congress into action, likely ensuring that the shutdown — now in its 11th day and counting — extends into a third week and possibly beyond. But no similar action seems forthcoming for federal employees also working without pay while thousands are now being laid off during the lapse in government operations.”
  • Federal News Network tells us,
    • “The number of federal employees filing retirement claims in September was the lowest all year. Just over 6,300 employees submitted their retirement paperwork to the Office of Personnel Management. At the same time, OPM also processed the fewest number of current claims in September, just over 7,900. Despite the lower number of claims, OPM said it took six days longer, on average, in September than in August to process claims. The current retirement claims backlog is at 23,500, which dropped for the fourth straight month.”
  • The Washington Post interviews OPM Director Scott Kupor and others about the coming surge of retirement applications.
  • Per Beckers Payer Issues,
    • “The No Surprises Act is succeeding in protecting patients from unexpected medical bills, but insurers and provider groups remain divided on what is driving rising costs tied to the Independent Dispute Resolution process and how regulators should respond.
    • “Since the arbitration system launched in 2022, providers have won the vast majority of disputes. In 2024, they prevailed in about 85% of cases, with median payment determinations reaching 459% of the qualifying payment amount in the fourth quarter. The process has also generated at least $5 billion in costs, much of it from administrative fees and higher payments.
    • “As those costs have climbed, payers have said that the system is inflating prices across the healthcare system, while providers say it is correcting years of underpayment.
    • “The concern now is that the law hasn’t met its second objective, to contain costs,” Jennifer Jones, senior director of legislative and regulatory policy at the Blue Cross Blue Shield Association, told Becker’s. “That’s primarily because of the challenges we’re seeing with the independent dispute resolution process.”
  • The FEHBlog agrees with Ms. Jones.

From the public health and medical / Rx research front,

  • MedPage Today informs us,
    • “Among older adults who received at least one dose of the recombinant shingles vaccine, vaccine effectiveness against any herpes zoster-related outcome was 56.1%.
    • “Getting a second dose yielded a relative vaccine effectiveness of 67.9% against any herpes zoster outcome.
    • “The findings emphasize the importance of completing the full vaccination series.”
  • The Washington Post reports,
    • “The tendency to use cannabis is associated with genes linked to impulsive behavior, obesity, schizophrenia and bipolar disorder, among other traits, according to a study released Monday by researchers at the University of California at San Diego.
    • “The research, published in the journal Molecular Psychiatry, explored the genetic traits of casual and frequent cannabis users in hopes of eventually identifying medications and other therapies to treat or prevent problematic marijuana use.
    • “The study adds to a growing body of genetics research into cannabis use as policymakers and researchers weigh how to balance the benefits and consequences of the drug’s growing popularity.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Many nonprofit hospitals and health systems have made steady progress on financial turnarounds since the end of the COVID-19 pandemic — though others continue to struggle — but new and persistent challenges threaten to derail those efforts.
    • “Operating margins have inched upward across the sector, yet most remain far below the pre-pandemic “magic number” of 3%. The latest data from Strata Decision Technology shows that health system margins improved slightly to 1% in August, up from 0.9% in July, but remain relatively unchanged for the year. 
    • “While operating revenue has generally increased, it continues to be offset by rising costs — particularly in non-labor categories (such as supply and drug costs), which rose 5.7% year over year compared to a 4.6% rise in labor expenses.
    • “These pressures could intensify in the months ahead.” 
  • Beckers Payer Issues adds,
    • “When a critical patient’s prognosis is unclear, often because they are unable to wean from the ventilator, care teams begin to discuss palliative care, advance care planning, and even hospice.  Making decisions about long-term care goals can be challenging for patients and their families as they navigate the complexities of their conditions. Discussions often take place over many days while patients and families evaluate the options.  Including long-term-acute care hospital (LTACH) referral in these discussions benefits the patient for three reasons [explained in the article].

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI, Uncategorized–

From the cybersecurity policy front,

  • Federal News Network reports,
    • “The Cybersecurity and Infrastructure Security Agency typically marks October’s awareness month with a range of public engagements and outreach campaigns. But under the ongoing government shutdown, CISA has furloughed nearly two-thirds of its staff and curtailed most public communication.
    • “CISA is not actively managing its website under the shutdown. But the agency did establish a landing webpage for cybersecurity awareness month prior to the shutdown, detailing the campaign’s theme and linking to a toolkit.
    • “CISA Director of Public Affairs Marci McCarthy said, “CISA remains fully committed to safeguarding the nation’s critical infrastructure,” as part of a statement.” * * *
    • “Chris Cummiskey, a former state chief information officer and former chief management officer at DHS, said CISA typically retains enough employees to staff the agency’s watch floor, maintain technology that monitors federal networks for cyber threats, and collaborate with cyber defenders at other federal organizations, like U.S. Cyber Command.
    • “But if a major cyber incident were to occur, CISA may not have enough staff immediately on hand to manage the event.
    • “A key concern is, do you need to start recalling people?” Cummiskey said. “You probably wouldn’t have the onsite capacity to cover a major exploit without the additional help.”
    • “In addition to the shutdown, key privacy and liability protections under the Cybersecurity Information Sharing Act of 2015 expired on Sept. 30. Those protections had been pivotal to encouraging the private companies to share cyber threat data with each other and with government agencies, including CISA.
    • “Cyber experts say companies may be more hesitant to share information about new cyber threats and vulnerabilities without the statute’s protections.”
  • Cybersecurity Dive adds,
    • “Michael Daniel, president of the Cyber Threat Alliance, an information-sharing group, predicted that some companies will “suspend some sharing activities with the government,” but he added that a lot will depend on “each company’s risk tolerance.”
    • “I think some collaboration will continue,” he said, “but likely at reduced levels and requiring more human oversight.”
    • “Ari Schwartz, managing director of cybersecurity services at the law firm Venable, said, “There will just be many more lawyers involved, and it will all go slower, particularly new sharing agreements.” Venable has advised clients on what to consider when establishing such agreements.
    • “As for companies sharing information with each other, that likely will continue for now because of a lack of near-term concern about antitrust investigations, Daniel said. But companies’ attitudes could change if the program isn’t reauthorized.”
  • The National Institute of Standards announced on September 29, 2025,
    • “As part of ongoing efforts to strengthen the protections for securing controlled unclassified information (CUI) in nonfederal systems [which includes FEHB and PSHB claims data], NIST has released the following drafts for comment:
    • “SP 800-172r3 (Revision 3) fpd (final public draft), Enhanced Security Requirements for Protecting Controlled Unclassified Information, provides new enhanced security requirements that support cyber resiliency objectives, focus on protecting CUI, and are consistent with the source controls in SP 800-53r5.
    • “SP 800-172Ar3 ipd (initial public draft), Assessing Enhanced Security Requirements for Controlled Unclassified Information, provides a set of assessment procedures for the enhanced security requirements. These procedures are based on the source assessment procedures in SP 800-53Ar5.” * * *
    • “A public comment period will be open from September 29 through November 14, 2025. Reviewers should submit comments on all or parts of the drafts to 800-171comments@list.nist.gov.”
  • Cybersecurity Dive tells us,
    • “Barely any U.S. defense contractors say they’re fully prepared to comply with the Department of Defense’s new cybersecurity assessment program.
    • “Only 1% of companies say they’re completely ready to be assessed through the Cybersecurity Maturity Model Certification (CMMC) program, which takes effect on Nov. 10, according to a report that the managed security provider CyberSheath published on Wednesday.
    • “The percentage of respondents expressing confidence in their readiness has dropped over the past two years.”

From the cybersecurity vulnerabilities and breaches front,

  • NextGov/FCW reports on September 29, 2025,
    • “A “widespread cybersecurity incident” at the Federal Emergency Management Agency allowed hackers to make off with employee data from both the disaster management office and U.S. Customs and Border Protection, according to a screenshot of an incident overview presentation obtained by Nextgov/FCW.
    • “The hack is also suspected to have later triggered the dismissal of two dozen Federal Emergency Management Agency technology employees announced late last month, according to internal meeting notes and a person familiar with the matter.
    • “The initial compromise began June 22, when hackers accessed Citrix virtual desktop infrastructure inside FEMA using compromised login credentials. Data was exfiltrated from Region 6 servers, the image says. That FEMA region services Arkansas, Louisiana, New Mexico, Oklahoma and Texas, as well as nearly 70 tribal nations.” * * *
    • “DHS security operations staff were notified of the breach on July 7, the screenshot adds. On July 14, the unnamed threat actor used an account with high-level access and attempted to install virtual networking software that could allow them to extract information. Initial remediation steps were taken on July 16. 
    • “On Sept. 5, additional remediation actions were taken, including changing FEMA Zscaler policies and blocking certain websites, the screenshot says. Those actions were previously reported by Nextgov/FCW.”
  • Following up on last Saturday’s post about the Cisco KVEs, Cybersecurity Dive lets us know,
    • “Nearly 50,000 Cisco firewall devices with recently disclosed vulnerabilities are connected to the internet, according to new data.
    • “Statistics from the Shadowserver Foundation illustrate the extent of the world’s exposure to the three flaws in Cisco’s Adaptive Security Appliance devices and Firepower Threat Defense devices, which earned a rare emergency patching directive from the Cybersecurity and Infrastructure Security Agency (CISA) after the Sept. 25 disclosure.
    • “The United States has by far the most devices that have not been patched to block exploitation of the flaws, with Shadowserver tallying more than 19,000 vulnerable U.S. devices. The U.K. ranks second, with more than 2,700 vulnerable devices, followed by Japan, Germany and Russia. Other European countries have fewer than 1,000 vulnerable devices each.
    • “Shadowserver’s records will reveal how quickly different countries are reducing their exposure as the organization continues collecting data in the coming days and weeks.
    • “A sophisticated threat actor has been using two of the new Cisco flaws, CVE-2025-20362 and CVE-2025-20333, in a stealthy cyberattack campaign that has breached multiple federal agencies and other organizations worldwide. Both vulnerabilities involve improper validation of HTTPS requests, which could allow Cisco firewalls to accept malicious requests that bypass authentication. CVE-2025-20362 could allow hackers to access restricted VPN-related URLs, while CVE-2025-20333 could let intruders run arbitrary code as root.”
  • Cyberscoop points out,
    • “Red Hat on Thursday [October, 2, 2025] confirmed an attacker gained access to and stole data from a GitLab instance used by its consulting team, exposing some customer data. The open-source software company, a subsidiary of IBM, said the breach is contained and an investigation into the attack is underway. 
    • “Upon detection, we promptly launched a thorough investigation, removed the unauthorized party’s access, isolated the instance, and contacted the appropriate authorities,” Red Hat said in a security update. “Our investigation, which is ongoing, found that an unauthorized third party had accessed and copied some data from this instance.”
    • “Red Hat said the compromised GitLab instance contained work related to consulting engagements with some customers, including project specifications, example code snippets and internal communications about the consulting services. 
    • “This GitLab instance typically does not house sensitive personal data,” Red Hat said. “While our analysis remains ongoing, we have not identified sensitive personal data within the impacted data at this time.”
  • Dark Reading informs us,
    • “The month-long outage for luxury car maker Jaguar Land Rover appears to be at an end, with the company working through a “controlled, phased restart” of its manufacturing operations this week, following a massive cyberattack that forced the company to shut down its systems.
    • “JLR said on Sept. 2 that it had “proactively” shut down operations following a cyber incident, initially stating that customer data did not seem to be stolen, but revising that statement a week later. JLR, a subsidiary of Tata Motors, likely suffered $50 million to $70 million in lost revenue per week, with the total cost of the incident estimated at a staggering $1.7 billion to $2.4 billion.
    • “The attack, and its vast impact, should be a warning for companies, says Chris Gibson, executive director of the Forum of Incident Response and Security Teams (FIRST).
    • “The outage “highlights that even large corporations with substantial resources can be completely disrupted and that critical industries may be more vulnerable than previously thought,” he says. “This was far beyond data theft; it was a complete operational outage.”
  • Security Week adds,
    • “Japanese brewing giant Asahi Group Holdings on Monday [September 29, 2025] announced that its operations in the country have been disrupted by a cyberattack.
    • “The incident, the company said, resulted in system failures that affected orders and shipments at all its subsidiaries in the country, as well as call center operations, customer service desks included.
    • “Reuters reported that production at some of Asahi’s 30 domestic factories has been suspended due to the cyberattack.
    • “At this time, there has been no confirmed leakage of personal information or customer data to external parties,” the company said in a Monday notice.
    • “Asahi said it is investigating the attack and working on restoring the affected systems but could not provide an estimated timeline for recovery.
    • “The system failure is limited to our operations within Japan,” it said.
    • “The company has not disclosed the nature of the cyberattack it fell victim to, but the system-wide outage could indicate that file-encrypting ransomware might have been used.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Corporate executives are being targeted in an email-based extortion campaign by a threat actor claiming affiliation with the notorious Clop ransomware gang, according to security researchers from Google Threat Intelligence Group and Kroll. 
    • “The hacker claims to have data stolen from breached Oracle E-Business Suite applications and has been demanding payment from various corporate executives, according to a LinkedIn post from Austin Larsen, principal threat analyst at GTIG.
    • “While researchers have not been able to substantiate the claims of a data breach, they have confirmed important links to a financially motivated threat group tracked under the name FIN11, which has prior associations with Clop.” 
  • Cyberscoop provides us with “the email Clop attackers sent to Oracle customers. The emails, which are littered with broken English, aim to instill fear, apply pressure, threaten public exposure and seek negotiation for a ransom payment.”
  • Dark Reading adds,
    • After announcing its farewell last month, the cyber extortion group known as Scattered Lapsus$ Hunters returned on Friday with a website featuring stolen Salesforce data and a list of dozens of alleged victims.
    • Scattered Lapsus$ Hunters is an apparent combination of the Scattered Spider, Lapsus$, and ShinyHunters cybercriminal groups, which first emerged over the summer in a public Telegram channel. However, just a few weeks later, the collective published a goodbye letter on Telegram and the Dark Web marketplace BreachForums, saying the three groups, as well as other threat actors, had “decided to go dark.”
    • “But Scattered Lapsus$ Hunters burst back into the limelight this week with a Dark Web leak site devoted to the recent spate of Salesforce data thefts; one of the two distinct campaigns targeting Salesforce environments recently has been attributed to a threat group tracked by Google as UNC6040, which has claimed to be ShinyHunters in its extortion attempts.
    • “According to Google, UNC6040 actors used vishing calls to convince IT support personnel at targeted organizations to grant them access to or credentials for the organizations’ Salesforce environments. Mandiant researchers this week said the threat actors have impersonated third-party vendors in the vishing calls and had also targeted users in victim organizations with elevated access to other SaaS applications.’
  • The American Hospital Association points out,
    • “A Health-ISAC (Information Sharing and Analysis Center) bulletin released Oct. 1 warns of a recently released LockBit 5.0 ransomware variant that poses a threat to health care and other sectors. LockBit 5.0 is the latest version of the ransomware-as-a-service group that has previously attacked hospitals and other organizations in the U.S. and abroad. The notice said the new variant directly targets virtual environments and has improved and enhanced technical capabilities, evasion techniques and affiliate engagement. The variant is known to target Windows, Linux and VMware ESXi software. Health-ISAC said the new variant’s technical capabilities make it faster, more flexible for affiliates and harder for security to detect and analyze. LockBit was disrupted by authorities last year before resurfacing last month.
    • “This is a very technical bulletin, but it’s important to note that it addresses a new version of a well-known ransomware,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “Hospitals should ensure that they have defensive measures in place and that those measures are tuned and working properly.”
  • HackRead reports on September 29,
    • “The Medusa ransomware group is claiming responsibility for a ransomware attack on Comcast Corporation, a global media and technology company best known for its broadband, television, and film businesses.
    • “According to the group’s dark web leak site, they exfiltrated 834.4 gigabytes of data and are demanding $1.2 million for interested buyers to download it. The same sum has been set as ransom for Comcast if the company wants the data deleted rather than leaked or sold.
    • “To back its claims, Medusa has posted around 20 screenshots allegedly showing internal Comcast files. The group also shared a massive file listing of 167,121 entries, suggesting access to actuarial reports, product management data, insurance modelling scripts, and claim analytics.” * * *
    • “Medusa ransomware is known for publishing file listings and partial screenshots as proof of compromise while holding back the bulk of the data to increase ransom pressure. In this case, the nature of the files points toward actuarial and financial datasets, some of which appear to involve insurance calculations, customer data processing, and claim management systems.”
  • HelpNetSecurity provides us background about and advice on how to avoid Akira ransomware.
  • Wired notes that “Google has launched a new AI-based protection in Drive for desktop that can shut down a [ransomware] attack before it spreads—but its benefits have their limits.”

From the cybersecurity defenses front,

  • Per ISACA,
    • “Cybersecurity professionals from around the world recently weighed in on some of the key findings from ISACA’s latest State of Cybersecurity survey report. Aparna Achanta, security leader, IBM (US); Simon Backwell, head of information security, Benefex (UK); Donavan Cheah, senior cybersecurity consultant, Thales (Singapore); Jenai Marinkovic, vCISO/CTO, Tiro Security, and CEO & chairman of the board, GRCIE (US); Kannammal Gopalakrishnan, cybersecurity and GRC professional (India), and Carlos Portuguez, Sr. Director BISO, Concentrix (Costa Rica)—all of whom are also members of ISACA’s Emerging Trends Working Group—reflect on how these stats show up for them in the profession.”
  • and
    • “Phishing has escalated beyond masquerading techniques. Traditional attacks depended on typos, being in a rush and not so well-disguised social engineering. But hackers today use generative AI, such as WormGPT or FraudGPT, and even deepfakes, to create perfect messages with contextual background that can effortlessly be mixed with everyday corporate messages. Cofense has noted that it receives an AI-enhanced malicious email every 42 seconds, with that pace expected to accelerate in the months to come. This hypergrowth is an indication that phishing is not an outlying issue anymore but a mainstream cyber-crime, now with AI-driven precision. 
    • “The next pivot is neuro-phishing, which can tie in the details of biometric and psycho-physiological indicators, like the EEG, micro-hesitation spikes, blink frequency, and the focus of the eyes, to see the response of the user in real-time and work a different approach. Previous and extensive studies have already established the reliability of finding recognition and stress using the EEG, when users are stimulated with phishing. This is not passive baiting anymore, but a dynamic, cognitive feedback loop, which transforms human users into interactive targets.”
    • The article offers advice on creating resilience against neuro-phishing.
  • Dark Reading adds,
    • “Email security has long dominated the enterprise security conversation — and rightfully so. It remains a key vector for phishing, credential theft, and social engineering. But in 2025, the threat landscape has shifted. Quietly yet decisively, attackers increasingly are bypassing the inbox and expanding their reach across multiple channels. 
    • “Recent data from TechMagic shows that 41% of phishing incidents now employ multichannel tactics, including SMS (smishing), voice calls (vishing), and QR codes (quishing). The trend is clear: While email still matters, adversaries are shifting to mobile-first platforms like text, iMessage, WhatsApp, and social direct messages. These attacks are harder to spot, more difficult to control, and more likely to succeed, because they target the most vulnerable point in the chain: the human behind the screen.
    • “To address this growing threat to mobile platforms, new security approaches are emerging that leverage AI-driven defenses to identify and prevent social engineering attacks in real-time. By training large language models (LLMs) to understand the content and intent behind messages, these systems can flag suspicious activity and enforce protective measures before users fall victim. Whether it’s a text message posing as IT support or impersonating a vendor, these next-generation solutions focus on stopping threats at the human layer — not just at the device.”
  • Infosecurity Magazine explains how “AI-Generated Code Used in Phishing Campaign Blocked by Microsoft.”
  • Per CISO Online,
    • “A surge in vulnerabilities and exploits leaving overloaded security teams with little recourse but to embrace risk-based approaches to patching what they can.
    • “Enterprise attack surfaces continue to expand rapidly, with more than 20,000 new vulnerabilities disclosed in the first half of 2025, straining already hard-pressed security teams.
    • “Nearly 35% (6,992) of these vulnerabilities have publicly available exploit code, according to the Global Threat Intelligence Index study by threat intel firm Flashpoint.
    • “The volume of disclosed vulnerabilities has more than tripled while the amount of exploit code has more than doubled since the end of February 2025 alone.
    • “These increases make it no longer feasible for most organizations to triage, remediate, or mitigate every vulnerability, Flashpoint argues, suggesting enterprises need to apply a risk-based patching framework. But some experts quizzed by CSO went further — arguing a complete operational overhaul of vulnerability management practices is needed.
    • The article delves into that approach.
  • Per the National Institute of Standards,
    • “The NIST National Cybersecurity Center of Excellence (NCCoE) has finalized a guide, NIST Special Publication (SP) 1334, Reducing the Cybersecurity Risks of Portable Storage Media in Operational Technology (OT) Environments, to help organizations protect their industrial control systems from cybersecurity threats when using removable media devices.
    • “Portable storage media devices, like USB flash drives, are commonly used to transfer data between computers. However, using them in OT environments and industrial control systems, such as those used in power plants or manufacturing facilities, can pose a cybersecurity risk. If a USB device is infected with malware, it can spread to the industrial control system and cause problems, such as disrupting operations or compromising safety.
    • “This NCCoE resource suggests implementing physical and technical controls to limit access to these devices and ensure they are used securely.”
  • Here is a link to Dark Readings’ CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NCQA, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec tells us,
    • “Federal employees have been asking a lot of questions since the White House put out guidance this week suggesting large swaths of them would face layoffs under a government shutdown if one occurs next week.
    • “So far the answer many of them are getting is: we are planning to send you home without pay, but only until the shutdown ends. That is to say, agency officials are telling employees they will face their normal shutdown furloughs, but not reduction-in-force notices. 
    • “We were told we won’t be RIF’d, regardless of whether we have to work,” said one General Services Administration employee, whose office is typically furloughed during a funding lapse. 
  • The Centers for Medicare and Medicaid Services announced,
    • [A]verage premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program are expected to remain stable in 2026. Average premiums are projected to decline in both the MA and Part D programs from 2025 to 2026.
    • CMS is committed to ensuring these programs work for Medicare beneficiaries while maintaining access to high-quality, affordable healthcare options, safeguarding taxpayer dollars, and making sure beneficiaries have the information they need to make informed choices about what is best for them. 
    • CMS releases this key information, including 2026 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2025, to December 7, 2025.
    • “Millions of Medicare beneficiaries will continue to have access to a broad range of affordable coverage options in 2026,” said CMS Administrator Dr. Mehmet Oz. “We want every beneficiary to take advantage of Open Enrollment—compare your options and choose the plan that gives you the right care at the best price.”
  • The American Hospital Association News informs us,
    • President Trump, late Sept. 25, announced that starting Oct. 1, the U.S. will impose a 100% tariff on any branded or patented pharmaceutical product, unless a company is building its pharmaceutical manufacturing plant in America. The president’s post on Truth Social said “is building” will be defined as “breaking ground” or “under construction” and that there would be no tariff on “these Pharmaceutical Products if construction has started.”   
    • As of 3 p.m. ET on Sept. 26, the administration has not released any official documents related to the tariff announcement.  
  • BioPharma Dive adds,
    • “The new pharmaceutical tariffs President Donald Trump announced on Thursday, which will go into effect on Oct. 1, could have a limited impact on the pharmaceutical industry due to multiple exemptions for generics, exports from Europe and companies already onshoring manufacturing.
    • “The tariffs, unveiled via a post on the social media platform Truth Social, haven’t been accompanied by legal documents, leaving key details unclear. However, the 100% levies, which are much smaller than the figure previously floated by the Trump administration, alleviate some uncertainty around U.S. drug pricing policy.
    • “The announcement comes days before the expected release of programs meant to align U.S. drug prices with what’s paid in Europe and elsewhere. Published reports have suggested those policies may be more modest than Trump originally proposed, however.”
  • FedWeek points out,
    • “A new bipartisan group of House members has been formed with a focus on the impact on jobs and delivery performance of the Delivering for America reorganization initiative.
    • “The Congressional Postal Service Caucus will focus on improving on-time delivery rates, protecting postal employees, and stopping harmful facility consolidations that reduce access in rural and underserved areas,” said a statement from the founding members. A caucus is a less formal organization than a congressional committee, typically focusing on issues—and trying to build consensus on them—that cross committee areas of jurisdiction.”
  • NCQA, writing in LinkedIn, lets us know about NCQA researchers sharing findings on emerging topics in health care.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza and RSV activity is low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. The percentage of emergency department visits for COVID-19 are highest in children 0-4 years old. Hospitalization numbers and the percentage of emergency department visits are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is low nationally.
  • The University of Minnesota CIDRAP adds,
    • “The current COVID wave began in June, marked by a slow rise that never approached levels seen last summer.
    • “Wastewater SARS-CoV-2 detections are now at the moderate level and are highest in Northeast, followed by the West and the South.”
  • Prevention notes,
    • “The Stratus COVID variant, a.k.a. XFG, is currently the dominant strain of the virus in the U.S., causing 78% of cases in the country, according to CDC data.
    • “It’s an Omicron variant, and it’s a hybrid of two strains—LF.7 and LP.8.1.2,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.
    • Stratus has several mutations to the spike protein, which the virus uses to infect your cells and make you sick, per the World Health Organization (WHO). But the WHO also notes that the threat posed by Stratus is “low.”
  • The Wall Street Journal reports,
    • “President Trump’s return to office has supercharged the debate about childhood vaccinations. Trump himself recently stated that “children get these massive vaccines…like you give to a horse…they get like 80 vaccines,” while Health Secretary Robert F. Kennedy Jr. asserts that babies get up to 92 vaccine doses. In justifying Florida’s decision to end mandatory vaccine mandates for children, state surgeon general Joseph Lapado asked: “Who am I to tell you what your child should put in [their] body? I don’t have that right.”  
    • “These statements misstate the amount and number of vaccines administered to children. Over the course of 18 years, it’s typically 30 doses—in quantities about a tenth of a teaspoon—for about 16 different pathogens. But the critics raise important questions that parents have every right to ask. Why give vaccines so early in a baby’s life? And why shouldn’t parents just pick and choose what goes into their child?  
    • “The crucial context for this discussion is two facts. First, vaccines constitute only a minuscule fraction of the exposure to pathogens that children’s immune systems must contend with. Second, our bodies develop the most enduring antibodies in the early years of life.”
  • JAMA relates,
    • “For years, most observers attributed the higher number of Alzheimer disease cases among women to the simple fact that they live longer than men on average.
    • “Recently, though, scientists have come to recognize that the explanation for the sex gap in the prevalence of Alzheimer disease, the cause of most cases of dementia, is far more nuanced and complex, involving both biological and sociocultural factors.
    • “Research has focused on such potential contributors as women’s exposure to sex hormones, the genes in the X chromosome, the prevalence and effect of risk factors such as hearing loss, the apolipoprotein E ε4 (APOE4) variant, and diminished cognitive reserve related to lower education levels.
    • “Approximately 2 out of every 3 people living with Alzheimer disease in the US is a woman, Harvard neuropsychologist Rachel Buckley, PhD, noted. “Women actually tend to live with dementia for much longer than men.”
  • Per Health Day,
    • “An experimental pill can significantly reduce hot flashes and night sweats for women after menopause a new clinical trial has determined.
    • “Elinzanetant produced a nearly 74% reduction in the frequency and severity of these menopause symptoms within three months, researchers reported recently in JAMA Internal Medicine.
    • “Further, this relief lasted for a year, the trial found.
    • “This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” researcher Dr. JoAnn Pinkerton said in a news release. She’s director of midlife health at University of Virginia Health in Richmond.”
  • and
    • “Routine screening can help find kids who are suffering from undiagnosed asthma in communities with high levels of the breathing disorder, a new study says.
    • “Asthma screening during well-child visits found that more than two-thirds (35%) of children with no previous diagnosis of asthma had at least one risk factor for the disease, researchers will report Monday at an American Academy of Pediatrics’ meeting in Denver.
    • “Further, about 24% of kids with risk factors were subsequently diagnosed with asthma, researchers said.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Commercially insured patients pay substantially different rates for the same procedure, with negotiated costs for inpatient procedures varying by an average ratio of 9.1, according to an August report from market intelligence firm Trilliant Health.
    • “The report reviewed health plan transparency data from Aetna and UnitedHealthcare, focusing on 11 inpatient and outpatient procedures.
    • “A coronary bypass without cardiac catheterization, excluding major complications or comorbidities, had negotiated rates ranging from $27,683 to $247,902. Another finding: Outpatient procedures at ambulatory surgery centers would often cost less than those taking place in a hospital’s outpatient department. Colonoscopies, for example, would cost 67.5% less on average than the median hospital rate.
    • “By reviewing a sample of 10 hospitals featured on a collection of “best hospitals” rankings, the researchers also found no correlation between cost and quality.”
  • and
    • “Regional, nonprofit health plans are falling behind large national insurers, with 71% recording an operating loss in 2024 and more than half having two years or less before regulatory intervention is triggered, according to a Sept. 24 report from HealthScape Advisors.
    • “Executives and boards of directors now face the most important decision of their leadership tenures: How do we survive?” the report said.” 
  • Kauffman Hall explains,
    • “The rise of ambulatory surgery centers (ASCs) marks a shift in how surgical care is delivered across the U.S. Amid soaring healthcare costs, tighter reimbursement and advancing surgical technology, health systems are rethinking where and how procedures are done. Many are moving complex surgeries like total joint replacement and spine out of hospitals and into ambulatory settings. Once limited in scope, ASCs are becoming key players in strategically important service lines like orthopedics.” * * *
    • “ASCs are not a magic wand for health systems. While they offer savings to payers, the economics are fragile for providers. Healthy margins require lean operations, smart sourcing and trusted partnerships.
    • “There’s a growing demand for more complex procedures in outpatient settings, but ASCs need to strategically position themselves to meet this demand in an operationally and financially sustainable way.
    • “With advances in surgical technology and care coordination, ASCs are ready to deliver on the promise of value-based care. The challenge for health systems isn’t just to shift where care is delivered, but to rethink how surgical care is structured, managed and financed for long-term performance.”
  • Optum, writing in LinkedIn, discusses how “breakthrough cancer drugs offer better outcomes – but soaring costs pose challenges.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it will offer its asthma and diabetes drugs at an up to 70% discount in the U.S. ahead of a Trump administration deadline for pharmaceutical companies to cut drug prices.
    • “The company said it would launch a direct-to-consumer platform on which eligible patients with prescriptions will be able to purchase its Airsupra and Farxiga drugs in cash at a discount. The platform will be available beginning Oct. 1.
    • “In July, President Trump sent pharmaceutical companies a letter setting a Sept. 29 deadline to propose cuts to their drug prices.
    • “In response, several drugmakers have rolled out direct-to-consumer platforms to offer discounted drugs. Earlier this week, Bristol Myers Squibb said it would offer its plaque psoriasis drug at an up to 80% discount, expanding on its discounted program for blood clot drug Eliquis, which it announced in July.”
  • Fierce Pharma adds,
    • “In an expansion of its previous moves to cut insulin prices, Sanofi will cap the price of each of its insulin products at $35 per month in the U.S. regardless of a patient’s insurance status.
    • “The move, which goes into effect at the start of next year, comes two years after the company slashed the price of its most popular insulin, Lantus, to $35 monthly for those with commercial insurance.
    • “Before that, in June of 2022, Sanofi reduced the price of an unbranded Lantus biologic from $99 per month to $35 for those in the U.S. without insurance.
    • “Sanofi’s cost-cutting efforts have mirrored those of the world’s other two primary sellers of insulin—Novo Nordisk and Eli Lilly—and come as advanced insulin products and insulin biosimilars are reaching the market.”


Tuesday Report

David Ermer–AHRQ, CDC, CMS, Electronic health records, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services today announced prescription drug reforms that will become effective Oct. 1 originating from the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule. Health IT tools certified by the HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology will allow drug prescribers to compare drug prices in real time and identify lower-cost alternatives available under a patient’s insurance coverage, particularly if they are covered under Medicare Part D. Providers will also be able to submit prior authorizations for medical services electronically to accelerate the process. The HTI-4 rule was released in July as part of the Centers for Medicare & Medicaid Services’ inpatient prospective payment system final rule for fiscal year 2026.”
  • Beckers Hospital Review informs us,
    • “HHS launched a [public] dashboard Aug. 27 to track organ transplants that skip patients next in line on transplant waiting lists. 
    • “The practice, called “allocation out of sequence,” is growing in frequency. In 2024, organ procurement organizations skipped waitlisted patients for 19% of transplants from deceased donors, six times more often than from a few years prior. The frequency increase is partly driven by clinicians prioritizing favoritism and ease over fairness, according to The New York Times. 
    • “The Organ Procurement and Transplantation Network’s policies and national law mandates organ allocation follow a “match run” to rank eligible recipients based on medical urgency, distance and other factors, according to HHS. 
  • Beckers Payer Issues points out,
    • “Medicare Shared Savings Program Accountable Care Organizations generated record savings and continued to improve quality performance in 2024, CMS said Aug. 28.
    • “In 2023, the program saw $2.1 billion in net savings.” * * *
    • “Nearly all ACOs met quality reporting requirements, with more shifting to digital measures that use electronic health information. ACOs also saw health outcomes improve around controlled blood pressure, poor A1c control and depression screenings.” 
  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM), in collaboration with the Assistant to the President for Domestic Policy, today sent a comprehensive Frequently Asked Questions (FAQ) document to agencies to help support the implementation of the Merit Hiring Plan, pursuant to President Trump’s Executive Order 14170. The FAQ provides detailed guidance to federal agencies on reforming the hiring process to prioritize merit and fairness.
    • A key highlight of the Merit Hiring Plan is the introduction of a two-page resume limit for federal job applications submitted through USAJOBS, taking effect September 27, 2025. This reform ensures hiring managers focus on the most relevant qualifications and experience, streamlining the review process. OPM is providing a transition period until the deadline, along with updated USAJOBS guidance and resume-building tools online to assist applicants in meeting the new standard.
  • The Government Accountability Office released a report titled “Illicit Fentanyl: DHS Has Various Efforts to Combat Trafficking but Could Better Assess Effectiveness.
    • “With about 48,000 deaths in 2024, fentanyl continues to be the primary cause of overdose deaths in the United States.
    • “The Department of Homeland Security has various efforts to combat the trafficking of illicit fentanyl. For example, it inspects incoming travelers and shipments and conducts patrols along the border.
    • “We reviewed these efforts and found issues with how DHS assesses their effectiveness. For example, DHS hasn’t set performance goals and measures—so it’s hard to know if DHS is making progress in its efforts to stop the flow of fentanyl.
    • ‘We recommended, among other things, that DHS set such performance goals and measures.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.
    • Nicotine pouches contain concentrated nicotine that can be harmful or potentially fatal to young children, even in small amounts. Toxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams. Symptoms of nicotine poisoning may include confusion, vomiting, and loss of consciousness. 
    • “I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children. Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion.” 
    • “The FDA is also issuing information for consumers on how to properly store nicotine pouches and prevent accidental exposure to children.” * * *
    • To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging, which are listed at www.fda.gov/authorizednicotinepouches.  

From the public health and medical/Rx research front,

  • The AP reports,
    • “A New York City hospital and another city-run building were sources for a deadly outbreak of Legionnaires’ disease in Harlem that killed seven people and sickened dozens of others, health officials announced Friday. 
    • “The New York City Health Department said bacteria from cooling towers atop Harlem Hospital and a nearby construction site where the city’s public health lab is located matched samples from some of the ill patients.
    • “The agency said they consider the bacterial cluster officially over since the last day anyone reported symptoms of Legionnaires’ disease was three weeks ago on Aug. 9. Since the outbreak, seven people have died and 114 people have been diagnosed with Legionnaires’ disease, while six people are in the hospital.” * * *
    • “City health officials said all facilities in the affected area have cleaned and disinfected their cooling towers. 
    • “They also are considering a series of changes to try to prevent future outbreaks. Among them are requiring building owners to test for Legionella every 30 days instead of the current 90-days and increasing the fines for violations for failure to comply with local cooling tower regulations.”
  • Beckers Hospital Review points out,
    • “Following almost a decade of decline, prostate cancer incidence in the U.S. increased 3.0% per year between 2014 through 2021, according to a report published Sept. 2 in CA: A Cancer Journal for Clinicians. Incidence of advanced-stage prostate cancer at diagnosis had the highest rate of increase at about 4.7% per year.
    • “At the same time, prostate cancer mortality continued to decline, though at a slower rate than the previous two decades. Prostate cancer mortality declined by 0.06% over the past decade, compared to the 3% to 4% annual decline seen in the late 20th and into the early 21st centuries.
    • “For the report, researchers analyzed cancer incidence and mortality data collected by the CDC and the National Cancer Institute through 2021 and 2023, respectively.” * * *
    • “Read the full report here.” 
  • NPR Shots relates
    • “People who inherit two copies of a gene variant called APOE4 have a 60% chance of developing Alzheimer’s by age 85.
    • “Only about 2% to 3% of people in the U.S. have this genetic profile, and most of them don’t know it because they’ve never sought genetic testing.
    • “But three scientists are among those who did get tested and learned that they are in the high-risk group. Now, each is making an effort to protect not only their own brain, but the brains of others with the genotype known as APOE4-4.”
  • Check out their stories.
  • Per Health Day,
    • “Common over-the counter painkillers might be quietly fueling antibiotic resistance, a new study warns.
    • “Ibuprofen and acetaminophen appear to enhance mutations in E. coli, making the common bacteria more resistant to the broad-spectrum antibiotic ciprofloxacin, researchers reported in the journal npj Antimicrobials and Resistance.
    • “What’s more, the two drugs amplify this effect when used together, researchers found.
    • “Antibiotic resistance isn’t just about antibiotics anymore,” said lead researcher Rietie Venter, an associate professor with the University of South Australia.
    • “This study is a clear reminder that we need to carefully consider the risks of using multiple medications – particularly in aged care where residents are often prescribed a mix of long-term treatments,” she said in a news release.”
  • BioPharma Dive relates,
    • “Ionis on Tuesday said its new lipid-lowering drug Tryngolza met the main goals of two Phase 3 clinical trials that could expand its use. Results showed the drug significantly reduced triglyceride levels in people with severely elevated levels of the fat in their bloods and prevented accompanying pancreatitis episodes.
    • “The company will ask the Food and Drug Administration by the end of the year to add severe hypertriglyceridemia to Tryngolza’s label. The drug, Ionis’ first wholly owned product, gained approval in December for a rare inherited condition called familial chylomicronemia syndrome, for which it recorded $25.6 million in sales over the first six months of 2025.”
  • Per a corporate news release,
    • “United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its TETON-2 study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo.
    • “Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. Benefits of Tyvaso were observed across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental oxygen use.
    • “Statistically significant improvements relative to placebo were also observed in most secondary endpoints, including time to first clinical worsening event, as well as changes from baseline to week 52 in percent predicted FVC, King’s Brief Interstitial Lung Disease quality of life questionnaire (K-BILD), and diffusion capacity of lungs for carbon monoxide (DLCO). While not statistically significant, both time to first acute exacerbation of IPF and overall survival at week 52 trended in favor of Tyvaso. Treatment with Tyvaso was well-tolerated, and the safety profile was consistent with previous Tyvaso studies and known prostacyclin-related adverse events. No new safety signal was seen.
    • “It is a profound honor to witness the power of scientific innovation realized for patients in need,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “TETON-2’ssuccessful outcomeaffirms the anti-fibrotic power of Tyvaso. We have unlocked new hope for patients with IPF and their families.”
  • The American Medical Association lets us know what doctors wish their patients knew about rebound congestion.
  • Per MedPage Today,
    • “Patients with type 2 diabetes who were treated with GLP-1 receptor agonists were less likely to develop peptic ulcer disease (PUD), a nationwide study found.
    • “In an analysis of more than 65,000 patients, GLP-1 users had 44% lower odds of PUD compared with non-users (adjusted OR 0.56, 95% CI 0.45-0.71, P<0.001), reported Trisha Pasricha, MD, MPH, of Beth Israel Deaconess Medical Center in Boston, and colleagues.
    • “In a subgroup of patients with a history of metformin use, switching to a GLP-1 receptor agonist for second-line treatment was associated with a 56% lower hazard of PUD compared with switching to insulin (adjusted HR 0.44, 95% CI 0.30-0.63, P<0.001). By 2 years, the cumulative PUD risk was 1.8% in the GLP-1 group versus 4.5% in the insulin group, the authors reported in Clinical Gastroenterology and Hepatology.”
  • and
    • “A personalized message about advanced colorectal neoplasia risk to patients and providers had no effect on colorectal cancer screening uptake, a randomized trial showed.
    • “Among 1,084 average-risk patients, the predicted probability of completing colorectal cancer screening with a personalized decision aid was 36.8% versus 41% with a generic decision aid (P=0.18), reported Peter H. Schwartz, MD, PhD, of the Indiana University School of Medicine in Indianapolis, and colleagues.
    • “For the 214 providers who were sent personalized notifications about patients’ risk, the predicted probability of the patient completing screening was 41.5% versus 36.4% for those who received a generic notification (P=0.135), they noted in the Annals of Internal Medicine.
    • “The overall result was negative, although there were some really interesting results in subgroups,” Schwartz told MedPage Today.”
  • and
    • “Among older adults, the incidence of myocarditis or pericarditis was lower among those who received the high-dose inactivated flu vaccine versus the standard-dose vaccine.
    • “There were only two cases of myocarditis observed among over 300,000 study participants, both in the standard-dose group.
    • “These results may not be generalizable to younger people, who are at greater risk of inflammatory cardiac conditions.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s health services division Evernorth has invested $3.5 billion in Shields Health Solutions as the company continues to build out its lucrative specialty pharmacy business.
    • “Shields, which helps hospitals and other providers create and manage their own specialty pharmacies, is one of five standalone businesses created from pharmacy behemoth Walgreens, which was acquired and chopped up by private equity firm Sycamore Partners last week.
    • “Evernorth’s investment in the form of preferred stock does not give Evernorth a controlling stake in Shields and is not expected to materially impact Cigna’s earnings guidance for 2025. The deal does give the company the option to invest more in Shields in the future.”
  • Fierce Healthcare announced its “FIERCE 50 OF 2025, the people and organizations advancing what’s possible in health, science and patient care.”
  • Beckers Hospital Review tells us,
    • “The University of Texas at San Antonio merged with The University of Texas Health Science Center at San Antonio on Sept. 1 to become The University of Texas at San Antonio. 
    • “The University of Texas System shared plans to merge the two entities into a unified institution in late August 2024. 
    • “The institution, which is now Texas’ third-largest public research university, comprises 15 colleges and schools across six campuses, around 40,000 students, 17,000 employees, more than 320 undergraduate and graduate degrees, $486 million in annual research expenditures and a $1.3 billion endowment, according to a Sept. 1 news release.”
  • Hook’em. 
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative effectiveness of apitegromab (Scholar Rock Holdings), as well as the disease-modifying therapies nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). Apitegromab is an investigational new drug seeking FDA approval for improving motor function in patients with SMA.” * * *
    • ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.\
    • ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, carers and patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include: 
      • The manufacturer should set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments. Given the small average improvement in motor function for patients treated with apitegromab and the uncertainty about serious adverse events, manufacturer pricing should reflect ICER’s value-based price range in moderating launch pricing.
      • The use of SMN-directed therapy after gene therapy or in combination should only be done in the context of research studies.
      • A randomized trial should be performed of first-line therapy in asymptomatic patients identified through newborn screening to better understand the comparative advantages and disadvantages of each of the three SMN-directed therapies.
    • ICER’s detailed set of policy recommendations is available in the Final Evidence Report and in the standalone Policy Recommendations document. 
  • Per Healthcare Dive,
    • “Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. 
    • “The study, published on Aug. 22, looked at 950 AI medical devices authorized by the Food and Drug Administration through November 2024. Sixty of the devices were associated with 182 recall events. 
    • ‘The most common causes of recalls were diagnostic or measurement errors, followed by functionality delay or loss. About 43% of all recalls also took place within one year of FDA authorization. 
    • “Tinglong Dai, lead author of the study and a professor at the Johns Hopkins Carey Business School, said the “vast majority” of recalled devices had not undergone clinical trials. For the majority of AI-enabled devices, which went through the FDA’s 510(k) pathway, clinical studies are not required. 
    • “Unfortunately, it’s not required, and so people don’t do it,” Dai said in an interview. “So, that’s why we believe it is one of the most important drivers of the recalls.”
    • “By comparison, the study found that devices that had gone through retrospective or prospective validation were subject to fewer recalls.” 
  • Per BioPharma Dive,
    • “Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions of dollars.
    • “The deal, announced Monday, revolves around a preclinical drug that Arrowhead designed to silence the genetic instructions for “alpha-synuclein,” a protein tied to Parkinson’s disease and other brain-eroding illnesses. Novartis has now agreed to pay $200 million for an exclusive license to research, develop, manufacture and commercialize the drug.
    • “Arrowhead could receive an extra $2 billion or more by hitting certain development goals and collecting royalties on any resulting products. Per deal terms, Novartis will also be able to select additional disease targets outside of Arrowhead’s current pipeline to advance using the latter’s drug making technology, which centers on a technique called RNA interference.
    • “The companies plan to close their agreement sometime this year.”
  • and
    • “The biotechnology careers of John Maraganore and Clive Meanwell have brought them into collaboration time and time again.
    • “As the respective founders of Alnylam Pharmaceuticals and The Medicines Company, the two previously partnered on the drug that would ultimately become Leqvio, which was later bought in a $10 billion acquisition of Medicines Co. by Novartis. And before Alnylam, Maraganore had led development at Biogen of Angiomax, which was later licensed to Meanwell’s company.
    • “Now, the two have partnered to launch and run Corsera Health, which aims to make a preventive medicine for cardiovascular disease as well as an artificial intelligence tool to identify who could benefit from earlier heart intervention. 
    • “Corsera’s target are younger people who are not “willing to wait 40 years to see whether they have a heart attack,” Meanwell said. “They’re saying, ‘What can I find that will help me?’”
    • “Corsera’s lead drug, an RNA interference therapeutic now in preclinical testing, is designed to be a once-yearly injection that blocks two targets known to drive cardiovascular disease: PCSK9 and angiotensinogen. The company expects to begin clinical testing by the end of the year.”

Friday report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Here’s a link to this week’s blog post from the OPM Director Scott Kupor. The week’s post concerns the federal government’s budget.
  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today announced that its guidance memorandums to federal agencies will now be housed directly on OPM.gov to make them easier to find and more accessible. The former page will be transitioned to a new page on OPM’s website and will also be available here.
  • The New York Times reports,
    • “CVS and Walgreens, the country’s two largest pharmacy chains, are for now clamping down on offering Covid vaccines in more than a dozen states, even to people who meet newly restricted criteria from the Food and Drug Administration.
    • “On Thursday, Amy Thibault, a spokeswoman for CVS, said the vaccine was not available at pharmacies in 16 states, citing “the current regulatory environment” and emphasizing that the list could change.
    • “On Friday, CVS issued an update: It could administer vaccines in 13 of the 16 states, and in the District of Columbia, to people who had obtained a prescription from a doctor or other medical provider. (As of Friday morning, its online scheduling tool still did not allow anybody to book an appointment in those places; Ms. Thibault said an update was in progress.) In Massachusetts, Nevada and New Mexico, CVS still cannot offer the shots at all, Ms. Thibault said.
    • “She did not provide an explanation for the change.
    • “Walgreens said in a statement that it was “prepared to offer the vaccine in states where we are able to do so” to people who met the F.D.A. criteria. When a New York Times reporter tried to schedule vaccine appointments in all 50 states, the Walgreens website said patients would need a prescription in 16 of them. Though there is some overlap, it’s not the same set of 16 as CVS, underscoring the level of confusion.” * * *
    • “CVS will make the vaccines readily available nationwide if the advisory panel recommends them, Ms. Thibault said. (In the 34 states where the company hasn’t set limits, people can simply check a box when they make an appointment online to attest that they meet the F.D.A. criteria, without a prescription or other documentation.) But since the panel hasn’t yet made a decision, the company is holding back in states where it believes its pharmacists need a C.D.C. endorsement.”
  • Fierce Healthcare informs us,
    • “While data released earlier this week raised questions about the administrative costs associated with No Surprises Act (NSA) arbitrations, a second study suggests the legislation is working to reduce out-of-pocket costs for members.
    • “Researchers at Harvard University and Mass General Brigham examined a sample of 17,351 privately insured adults, 8,204 of which lived in states that gained protections against surprise billing thanks to the legislation. The remaining 9,147 lived in states where some kind of program was already in place to protect consumers against these costs.
    • “The study found a significant decrease in out-of-pocket spending for people living in the new intervention states. The study attributes savings of $567 in yearly out-of-pocket costs to the protections.
    • “In fact, the study suggests that these protections are leading to greater savings for consumers than other policy changes such as Medicaid expansion and the drug pricing policies under the Inflation Reduction Act (IRA). Expanded Medicaid was tied to a $152 decrease in annual out-of-pocket spending, while the IRA is estimated to drive $400 in savings each year for people with Medicare Part D coverage.”
    • “Our study findings support anecdotal reports that the NSA has successfully shielded patients from surprise billing,” the researchers wrote.
  • FEHBlog note — The two studies do not contradict each other.
  • The American Academy of Actuaries released a report on Medicare’s financial condition.
    • “Consistent with prior trustees’ reports, the 2025 Medicare Trustees Report stresses the serious financial challenges facing the Medicare program. It remains critical to address the HI [Medicare Part A trust fund] shortfall sooner rather than later. In addition, Medicare spending will continue to grow faster than the economy, increasing the pressure on beneficiary household budgets as well as the federal budget, threatening the program’s sustainability.
    • Medicare’s financial challenges could be more severe than projected, which leaves policymakers with the challenge to address the short- and longer-term challenges of program solvency while understanding the potential implications on beneficiary’s ability to afford and receive appropriate health care. Understanding the implicit and explicit consequences of any potential change or lack thereof requires continued collaboration between actuaries, program and agency staff, consumer advocates, and Congress.

From the Food and Drug Administration (FDA) front,

  • Fierce Pharma reports,
    • “While Sanofi originally had its eye on tolebrutinib when it purchased its partner Principia Biopharma for $3.7 billion five years ago, another one of the BTK inhibitors inherited from the biotech has made it across the FDA finish line first.
    • “The drug rilzabrutinib, which is now approved as Wayrilz in immune thrombocytopenia (ITP), has been hailed (PDF) by Sanofi as a potential “multi-indication blockbuster” that could deliver 2 billion to 5 billion euros at its sales peak. 
    • “The FDA’s approval on Fridayspecifically clears Wayrilz for use in adults with persistent or chronic ITP who haven’t responded to prior therapy. 
    • “The regulatory endorsement marks the first approval for a Bruton tyrosine kinase (BTK) inhibitor to treat ITP in the U.S., where the condition is estimated to affect around 100,000 people, Mike Quigley, Ph.D., Sanofi’s CSO and global head of research, said in an interview with Fierce.”
  • and
    • “Aiming to deliver blockbuster sales of its Alzheimer’s disease-fighting antibody Leqembi in its 2027 fiscal year, Eisai has cleared a key regulatory hurdle in its quest to grow the medicine’s reach.
    • “The FDA has approved a once-weekly subcutaneous maintenance dose of the drug in an autoinjector, dubbed Leqembi IQLIK, according to a joint press release from the Japanese pharma and its commercialization partner Biogen.
    • “In line with the label of the drug’s intravenously infused formulation, Leqembi IQLIK is cleared for use in Alzheimer’s patients with mild cognitive impairment or mild dementia. Patients may switch to the new subcutaneous maintenance dose after 18 months of intravenous (IV) initiation treatment every two weeks, or they can opt to stick with infusions every four weeks for maintenance therapy, Eisai said in its release.
    • “IQLIK’s approval could be a “gamer changer” in Alzheimer’s treatment, Katsuya Haruna, senior group officer and EVP of US business operations at Eisai, said in an interview with Fierce Pharma, noting that the 15-second injection is now the first and only amyloid therapy that can be administered at home.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • “SARS-CoV-2 detections in wastewater are “very high” in Alabama, Hawaii, Louisiana, Nebraska, Nevada, South Carolina, Texas, Utah, and Washington, DC. They are high in 11 states. “Nationally, the wastewater viral activity level for COVID-19 is currently moderate,” the CDC said.
    • “In comparison, flu and respiratory syncytial virus (RSV) wastewater levels are listed as very low nationwide. ED visits for those two diseases are also listed as very low, but they are increasing for flu.”
  • Per Medscape,
    • “For older adults, the vaccine against respiratory syncytial virus (RSV) appears to be most effective in the first year after administration, according to new researchthat shows the benefits of the immunization fall roughly 60% within about 1.5 years.
    • “The database analysis showed that among adults aged 60 years or older, the effectiveness of the RSV vaccine at preventing infections fell from 71% at the 4-month mark to 40% 19 months after receipt.
    • “For clinicians, “the big takeaway is that the RSV vaccine works well, especially in the first year, and remains worth recommending to older patients, especially those at higher risk,” said Kersten Bartelt, RN, a research clinician at Epic Research, an arm of the records company, who helped conduct the analysis.”
  • The New York Times reports,
    • “A salmonella outbreak linked to eggs has sickened 95 people across 14 states, federal health officials said on Thursday. Eighteen people have been hospitalized.
    • “The company Country Eggs, of Lucerne Valley, Calif., has issued a recall of its large brown cage free “sunshine yolks” and “omega-3 golden yolks” eggs, according to the Food and Drug Administration.
    • “The recalled eggs were sold in grocery stores and delivered to food service distributors in California and Nevada between June 16 and July 9 and have sell-by dates between July 1 and Sept. 18. The recalled cartons were also sold under the brand names Nagatoshi Produce, Misuho and Nijiya Markets.
    • “Most of the people who have become ill so far — 73 of the 95 — are from California, according to the Centers for Disease Control and Prevention. But infections have been reported in 13 other states across the country, including in Washington State, Minnesota, New York and Pennsylvania. No one has died.”
  • Kaufmann Hall lets us know,
    • “A new report shows that the difference between expected and observed mortality rates for hospitalized surgical patients continues to improve. Hospitals have achieved nearly a 20% increase in survival rates for these patients compared with expected, reflecting advances in evidence-based care and safety practices. However, the analysis, from Vizient and the American Hospital Association, also finds that the average length of stay has risen by almost a full day over the past five years, due to increasing patient acuity and insurer-related delays in post-acute care placement, particularly in Medicare Advantage plans. This trend suggests ongoing challenges in balancing improved patient outcomes with efficient hospital throughput.”
  • Per Fierce Pharma,
    • “Flying high after an FDA approval four months ago to treat generalized myasthenia gravis (gMG), Johnson & Johnson’s much-touted Imaavy (nipocalimab) has taken a hit, coming up short as part of a combination therapy in a rheumatoid arthritis (RA) trial.
    • “Without revealing data from the phase 2a Daisy proof-of-concept study, J&J said that after 12 weeks, Imaavy provided no added benefit when added to an anti-TNFα therapy in patients with refractory RA.
    • “Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA,” the company said in its release.
    • “Despite the setback, J&J added that it is still “confident” that Imaavy can live up to the $5 billion-plus peak sales potential the company has pegged for the FcRn-blocking monoclonal antibody.”
  • Per Fierce Biotech,
    • “Zydus Therapeutics has racked up a phase 2b/3 win in primary biliary cholangitis (PBC), clearing the path to a filing to establish the company as a challenger to Gilead Sciences, Intercept Pharmaceuticals and Ipsen.
    • “The phase 3 part of the trial randomized 149 people to receive the PPAR agonist saroglitazar or placebo. After 52 weeks of daily oral dosing, 48.5% of patients on the Zydus drug met the biochemical response, achieving the primary endpoint of the trial. Zydus plans to discuss the data with the FDA with hopes of filing for approval in the first quarter of 2026.
    • “If approved, saroglitazar will enter a market served by other drugs, including rival PPAR agonists. The FDA approved two PPAR agonists in PBC last year, clearing Gilead’s Livdelzi and Ipsen’s Iqirvo to compete for the market with Intercept’s FXR agonist Ocaliva.
    • “Gilead reported (PDF) a 62% biochemical response rate in the study that supported approval of Livdelzi. Ipsen’s Iqirvo achieved (PDF) a 51% biochemical response rate in its pivotal trial.
    • “Unlike the PPAR agonists, Intercept’s Ocaliva carries a boxed warning. The FDA rejected a filing for full approval of the product in November—while leaving the accelerated nod in place—and flagged liver injury reports in December.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “The University of Pennsylvania Medical Center (UPMC) continues to flip last year’s losses, reporting this week a $348.6 million operating income (2.1% operating margin) for the six months ended June 30 thanks to increased volumes and a tighter underwriting margin.
    • “The integrated nonprofit had posted a $313.3 million operating loss (-2.2%) during the same period a year prior. Both half-year periods included tens of millions in restructuring costs—$30 million in 2025 and $87.8 million in 2024—under an effort the system had launched last year.
    • “For its second quarter alone, UPMC notched a $111.2 million operating gain compared to the prior year’s $210.3 million operating loss, both inclusive of restructuring costs. Total operating revenue during the first half of 2025 came to $16.5 billion.”
  • Beckers Payer Issues points out “Californians enrolled in Medicare Advantage are facing slower growth in healthcare costs compared to those in traditional Medicare, according to new research from the UCLA Center for Health Policy Research.”
  • Genetic Engineering and BioTechnology News offers its “updated A-List of the top 10 best-selling prescription drugs based on 2024 sales. Top-selling drugs are ranked based on sales or revenue reported for 2024 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, sponsor(s), 2024 sales, 2023 sales, and the percentage change between those years.”
  • BioPharma Dive tells us,
    • “Novo Nordisk is again looking for help outside its own laboratories as it works to build on the success of Ozempic and its sister medicine Wegovy.
    • “In the latest deal, Novo will provide research funding for Replicate Bioscience as well as up to $550 million in payments to work on new treatments for obesity, Type 2 diabetes and other cardiometabolic disorders.
    • “The agreement includes an unspecified amount of cash upfront as well as money tied to certain milestones, Replicate said Thursday.”
  • Per Fierce Pharma,
    • “Pfizer is taking a curtain call for Vyndaqel, the low-dose version of its blockbuster tafamidis franchise for the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM).
    • “Pfizer will discontinue Vyndaqel in the U.S. by the end of 2025, multiple amyloidosis patient groups alerted their members on social media earlier this month.
    • “The move will leave the high-dose Vyndamax as the only tafamidis brand on the market.
    • “This decision was made to enhance patient-centered care and convenience as Vyndamax offers the same active ingredient and clinical benefits as Vyndaqel, but in a single capsule taken once daily, making it easier for patients to take their prescription,” according to the posts, which appear to be relaying a message from Pfizer.”

Midweek Update

David Ermer–CDC, CMS, COVID-19 vaccine, Generative AI, Government Contracting, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Meritalk reports,
    • “With the Office of Personnel Management (OPM) on track to lose one-third of its workforce by the end of the year, OPM Director Scott Kupor said on Tuesday that he’s looking to technology to help steady the agency during its ongoing restructuring.
    • “Kupor, who the Senate confirmed as OPM director last month, said that his team is currently conducting a “reprioritization” effort to determine the top critical areas for the agency to focus on – and whether or not they need more headcount to get the job done.
    • “There may be cases where maybe we actually are short people,” Kupor said during an Aug. 26 event hosted by Federal News Network.
    • “We’re not perfect, and I fully acknowledge that there just may be areas where we need to revisit. So, there will be, I’m sure, some places where we have cut deeper than was appropriate, and we’ll have to make some changes,” he said.
    • “Some of those hiring efforts could target fresh talent, but Kupor said the agency may also look to rehire some employees who chose to participate in the deferred resignation program.”
  • The Wall Street Journal reports at 8:35 pm ET Wednesday,
    • “Susan Monarez, the director of the Centers for Disease Control and Prevention, has been pushed out of the job, a senior Trump administration official said Wednesday.
    • “Monarez, who led the agency for less than a month, clashed with Health and Human Services Secretary Robert F. Kennedy Jr. and members of his staff, the official said. President Trump had nominated her to lead the CDC in March after dropping his first pick. Previously the agency’s acting director, Monarez was the first CDC head without a medical degree in more than 70 years.
    • “Lawyers for Monarez said in a statement that she has neither resigned nor received notification from the White House that she has been fired. They also said she will not resign. “When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda,” they said. “For that, she has been targeted.”
    • “Three senior CDC leaders, including Dr. Debra Houry, the agency’s chief medical officer, submitted their resignations Wednesday, according to emails viewed by The Wall Street Journal.”
  • Healthcare Dive tells us,
    • “The process set up by the No Surprises Act to settle disputes between providers and insurers about out-of-network claims is generating billions of dollars in extra costs for the healthcare system — costs that could trickle down in the form of higher consumer premiums, according to a new analysis.
    • “Independent dispute resolution, or IDR, has created an estimated $5 billion in total costs between its inception in 2022 and the end of last year, according to the report published in Health Affairs on Monday. The high amount of claims, significant provider participation and lofty offer amounts are driving the spending, researchers found.
    • “The analysis raises questions for policymakers concerned about curbing healthcare costs. In particular, Washington should consider tackling the high volume of ineligible disputes clogging up the process — and scrutinize the role of private equity, given providers backed by the firms are responsible for an outsized portion of disputes, researchers said.”
  • FEHBlog note — The No Surprises Act arbitration which is supposed to resemble baseball arbitration fails to include the safeguards found in actual baseball arbitration like a hearing at which the parties have access to both offers and can debate them before the decisionmakers.
  • Fierce Healthcare informs us,
    • “The National Committee on Quality Assurance (NCQA) has launched an artificial intelligence working group to determine how to best measure performance of high-risk AI once it has been deployed by health plans and providers. 
    • “The 35-year-old organization runs a spate of quality measurement and reporting programs, like health plan accreditation and the Healthcare Effectiveness Data and Information Set (HEDIS) measures used by 90% of health plans, according to the Office of the Assistant Secretary for Planning and Evaluation. 
    • “The NCQA has convened more than 30 organizations to share their experiences using AI and help create standards for the technology. Some members of its AI working group are the American Academy of Family Physicians, America’s Health Insurance Plans, Blue Cross Blue Shield of Tennessee, the Community Care Plan, Covered California, the Kaiser Foundation Health Plan and United HealthCare.
    • “As the modality of care, as the channels of healthcare delivery continue to evolve, and as we continue to see a very evolving healthcare delivery landscape, we do want to take a very hard look at what additional things we can do to continue putting that lens on quality and putting quality front and center,” Vik Wadhwani, chief transformation officer at NCQA, said in an interview.”
  • Kushner & Co. reminds us that the time for circulating Medicare prescription drug creditable coverage notices is approaching. The deadline is October 15, 2025.
    • For 2025, with the Inflation Reduction Act lowering the out-of-pocket maximum to $2,000 (from $8,000 in 2024), many employer prescription drug plans—and especially those with High-Deductible Health Plans—may find that their plans are no longer creditable. Further, new changes for 2026 may also impact these notices. Be sure to check with your group medical plan insurance carrier or TPA [or PBM] to ensure you’re in compliance in determining whether your prescription drug plan is creditable or noncreditable.
  • The FAR Council today finalized the inflation adjustments to FAR thresholds which take effect on October 1, 2025. The key change for FEHB carriers is the following:
    • “The cost or pricing data threshold at FAR 15.403–4, for contracts awarded before July 1, 2018, increases from $750,000 to $950,000. For contracts issued on or after July 1, 2018, the threshold increases from $2 million to $2.5 million.”
    • 90 Fed. Reg. 41873 (August 27, 2025)
    • OPM’s FEHBAR treats this threshold as the subcontract preapproval threshold for experience rated carriers and the flow down trigger for the significant events clause. 48 C.F.R. Secs. 1652.222-70, 1652.244-70.

From the Food and Drug Administration (FDA) front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration authorized three new Covid-19 vaccines—from Pfizer and its partner BioNTech, and Moderna and Novavax—that target a variant of the coronavirus known as LP.8.1. This was the dominant circulating strain when FDA advisers picked a target in May. 
    • “The companies are expected to begin shipping doses to pharmacies and other vaccination sites within days. This is the fourth-year companies have updated Covid shots to target the primary variant that is circulating, in hopes the shots will better protect people from severe illness through the fall and winter months.
    • “In a change this year, the FDA cleared use of the updated vaccines in a smaller population. The three vaccines are cleared for everyone 65 and older, and for people in younger populations who have underlying conditions that put them at higher risk of severe Covid-19. 
    • “Pfizer’s vaccine was cleared for at-risk people ages 5 through 64, Moderna’s in at-risk people six months and older, and Novavax for at-risk people 12 and older.
    • “In previous years, U.S. health officials recommended the booster shots in most people six months and older, even if they didn’t have at-risk conditions.” * * *
    • “In deciding on vaccine coverage, health insurers typically follow recommendations by the Advisory Committee on Immunization Practices, or ACIP, which advises the CDC. They may also consider clinical recommendations from medical societies. 
    • “No meeting has been scheduled for ACIP to consider the new updated boosters. Kennedy fired all members of the ACIP in June and replaced them with people including some vaccine skeptics.
    • “A trade group for health-insurance companies, America’s Health Insurance Plans, said health plans will continue to follow requirements for ACIP-recommended vaccines.”
  • FEHBlog note — Indeed, the Affordable Care Act requires that health plans waive cost sharing for in-network administration of vaccines recommended by ACIP and confirmed by the CDC (or the HHS Secretary in the event of a vacancy in the CDC directorship.).
  • Cardiovascular Business adds,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). 
    • “This latest alert was put in place after Johnson & Johnson MedTech received reports that some of the Pump Driver Circuit Assemblies of its AICs contain 25V-rated tantalum capacitors instead of the expected 35V-related tantalum capacitors. This can cause the pump’s performance to suffer, and there a risk of the pump stopping altogether and triggering an “Impella Failure” or “Impella Stopped. Controller Failure” alarm. 
    • “One patient death has been linked to this issue. 
    • “This alert covers a total of 69 AICs. Full lists of the affected product codes and serial numbers are available as part of the FDA’s advisory. Anyone with one of the affected devices is urged not to use it any longer. Instead, the device should be quarantined until additional information is made available.
    • “The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” according to the advisory.”

From the judicial front,

  • Bloomberg Law reports,
    • “Cigna Health & Life Insurance Co. reached a class-wide settlement in a family’s lawsuit saying the insurer breached its fiduciary duties by failing to maintain an up-to-date list of in-network medical providers.
    • “The parties reached a preliminary agreement after a mediation session with a retired judge and plan to file details of the deal for court approval by Sept. 19, they said in a status report docketed Monday in the US District Court for the Northern District of Illinois. The filing didn’t include details about the terms of the settlement.” * * *
    • “Judge Manish S. Shah allowed portions of the case to advance in February, saying the family has a viable fiduciary breach claim based on Cigna’s failure to properly resolve the matter in a way that didn’t force them to foot the bill. But Shah dismissed the family’s claim for wrongfully denied benefits under the Employee Retirement Income Security Act because Cigna correctly paid their benefits according to the terms of their health plan.”

From the public health and medical research front,

  • Fierce Healthcare lets us know,
    • “Advancements in technology, testing and imaging have transformed cancer detection and risk assessment, enabling them to be faster and more precise.
    • “But providing patients with a cancer risk score or identifying those at high risk is only one step in cancer prevention. Getting patients to act on their cancer risk and get supplemental screening is the next big leap, and CancerIQ is focused on closing this gap.
    • “The company, which offers healthcare providers a cancer-focused precision health platform, developed new capabilities to provide patients at elevated risk for cancer with “hyper-personalized” patient education, engagement and navigation support. The new features were built on insights from thousands of high-risk patient journeys and backed by behavioral science with the aim to drive sustained follow-through on supplemental screenings that detect cancer earlier, according to executives.
    • “The first release focuses on screening breast MRI, with plans to support additional patient populations, including those eligible for low-dose lung CT.”
  • BioPharma Dive reports,
    • “People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and standard hormone therapy lived longer than those given hormone therapy alone, the company reported Wednesday.
    • “The summary results come from Lilly’s monarchE study, which began in 2017 and enrolled more than 5,600 adults with high-risk breast cancer that tested positive for hormone receptors but negative for a protein called HER2. Lilly said the improvement in survival was “statistically significant and clinically meaningful.”
    • “The study previously met its main goal, showing the addition of Verzenio improved invasive disease-free survival — data that supported a 2021 approval in this treatment setting. The overall survival findings, which were a secondary endpoint, will be presented at an upcoming medical meeting, Lilly said.”
  • STAT News relates,
    • “Akeso, a Chinese biotech with a drug positioned to rival Merck’s megablockbuster Keytruda, has reported for the first time that the therapy can improve patient survival.
    • “The therapy, ivonescimab, showed a statistically significant survival benefit as a second-line treatment when combined with chemotherapy to treat non-small cell lung cancers. The patients’ cancers had progressed after getting therapies targeting EGFR, a protein that can drive tumor growth. 
    • “The company described the results of the Chinese trial as clinically meaningful in a report for the first half of the year released on Tuesday. But it didn’t delve into details, which Akeso plans to share at an upcoming medical conference.”
  • Per Fierce BioTech,
    • “Amylyx’s withdrawn-from-market Relyvrio has failed to make an impact on primary or secondary endpoints in a rare neurodegenerative disease, prompting the company to discontinue the program.
    • “Oral therapy Relyvrio, which Amylyx is again referring to as AMX0035, was tested in progressive supranuclear palsy (PSP), a fatal and rapidly progressing condition that impacts mobility, eye movements, swallowing and speech. Currently, there aren’t any approved treatments for the disease.”
    • “Amylyx’s phase 2/3b study was measuring AMX0035’s impact on disease progression and severity using a 28-item, condition-specific scale. The phase 2 portion of the trial found no difference in patients receiving AMX0035 compared to placebo at 24 weeks, according to an Aug. 27 company release.
    • “Given the results, the company has discontinued the phase 2b trial, plus a related open-label extension study. Amylyx has also terminated plans for the phase 3 portion of the study.”
  • Per Health Day,
    • ‘Few teens with depression receive treatment, with disparities seen based on residence, gender, and race, according to a study published online Aug. 20 in PLOS Mental Health.
    • “Su Chen Tan, from the University of Tennessee in Knoxville, and colleagues used data from adolescents (aged 12 to 17 years) with major depressive episodes (MDE) participating in the 2022 U.S. National Survey on Drug Use and Health to assess mental health service utilization by rurality, race/ethnicity, gender, age, health insurance coverage, and poverty level.
    • “The researchers found that 19.2 percent of adolescents experienced MDE, but only 47.5 percent received treatment within the past year. There were significantly lower odds of receiving specialist treatment for adolescents in rural areas versus their urban counterparts (adjusted odds ratio [aOR], 0.64). Further, odds of receiving telehealth services were significantly lower for rural adolescents (aOR, 0.64) but were significantly higher for adolescents with insurance (public insurance: aOR, 2.99; private insurance: aOR, 3.82). Compared with younger adolescents, older adolescents had lower odds of utilizing school-based services (aOR, 0.52). Female adolescents had greater odds of utilizing any mental health treatment than male adolescents (aOR, 1.59), while Black adolescents had significantly lower odds of utilizing any mental health treatment versus non-Hispanic White adolescents (aOR, 0.36).”
  • and
    • “Two-thirds of women in their child-bearing years have an increased risk for birth defects due to a lifestyle factor they can change, a new study says.
    • “These risk factors — low levels of vitamin B9 (folate), unmanaged diabetes or exposure to tobacco smoke — increase the odds of a serious birth defect in any child they might have, researchers said.
    • “Heart defects, cleft palates and defects of the brain and spinal cord are among the problems that could be headed off if women took steps to improve their health prior to pregnancy, researchers reported today in the American Journal of Preventive Medicine.”

From the U.S. healthcare business front,

  • Healthcare Dive points out Blue Shield of California names interim CEO Mike Stuart to permanent chief executive.
  • Beckers Payer Issues notes,
    • “AM Best has downgraded its outlook for the health insurance sector from stable to negative, citing escalating medical costs and increased utilization across government, commercial and ACA plans.
    • “The credit rating agency noted higher utilization of specialty drugs, increased physician visits, more inpatient admissions and a surge in behavioral health claims. The coding intensity of medical services has also increased, according to an Aug. 25 news release.”
  • STAT News reports,
    • “Dressed in red and black jackets reminiscent of Star Trek uniforms, the heads of Epic’s data and AI divisions, Phil Lindemann and Seth Hain, described an aspirational vision for artificial intelligence at the end of last week’s Epic UGM keynote. Using the data stored in Cosmos — Epic’s de-identified patient record research database — the company trained an AI model that can generate many possible future timelines for a patient, then tell the doctor which outcomes are most likely, like what might happen during a hospital stay, or if the patient might end up in the emergency department in the next year. 
    • “Just as a large language model can be trained once and then used to generate different kinds of text, like an email or a poem, without being specifically trained on how to write either emails or poems, Epic’s “large medical model,” trained on all sorts of medical events and outcomes, could replace individual predictive medical algorithms. If the model, which Epic calls CoMET — the Cosmos Medical Event Transformer — can achieve performance similar to machine learning algorithms specifically trained to predict readmissions or asthma attacks, “that’s a breakthrough in how we can get risk prediction embedded into clinical care,” said Lindemann.
    • “This idea isn’t entirely new. Researchers like Arkadiusz Sitek at Massachusetts General Hospital have built models that predict future patient medical events before. But, Sitek told STAT, the scale of CoMET is impressive and suggests this approach will work in a large population. Epic trained and evaluated its model on 115 billion medical events from 118 million unique patient records collected from January 2012 to April 2025. The work was detailed in a preprint posted last week with Microsoft and Yale researchers.”
  • FIerce Healthcare informs us,
    • “Four hospitals are sending heart failure patients home with a virtual care support team under a newly unveiled collaboration between the American Heart Association (AHA) and remote chronic disease monitoring platform Cadence.
    • “The American Heart Association Connected Care pilot program aims to reduce 30-day readmissions by addressing “critical gaps in heart failure care” that occur after heart failure patients leave the hospital.
    • “It will see the participating hospitals integrate program referrals into their discharge workflows. Enrolled patients are given and taught to use connected vital sign monitors, which a Cadence virtual care team uses to provide ongoing clinical support, adjust treatments or direct the patient to an in-person provider if necessary.
    • “Almost one in four heart failure patients are readmitted to the hospital within 30 days of discharge, and fewer than a fifth receive post-discharge medical therapies in line with clinical guidelines, according to study data cited in the announcement.”
  • Beckers Hospital Review identifies “five new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Monday report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Fierce Healthcare tells us,
    • “Medicare patients have increasingly checked themselves out of the hospital against the advice of medical staff since 2006, with a temporary spike in self-discharges coinciding with the COVID-19 public health emergency, according to a new claims review conducted by the Department of Health and Human Services Office of Inspector General (HHS OIG).
    • “The increasing rate of acute care hospital discharges against medical advice (AMA) was prevalent across most demographics including enrollee type, hospital size, population density and medical condition, the office wrote in its review published Thursday.
    • “That said, discharges AMA increases were higher among hospitals with lower quality-of-care ratings (as measured by overall hospital quality star ratings) and among dually enrolled patients and those with mental health diagnoses.
    • “The HHS OIG said the rate increases are noteworthy, as Medicare patients who left AMA were more than twice as likely to be readmitted to the hospital or die within 30 days of discharge compared to those discharged to their homes.”
  • Beckers Clinical Leadership informs us,
    • The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics are diverging from the CDC’s vaccine recommendations, which no longer advise routine COVID-19 shots for healthy children and pregnant women.
    • On Aug. 22, ACOG published clinical guidance regarding vaccination during pregnancy. The OB-GYN group reaffirmed support for COVID-19 inoculation during pregnancy, adding that data show COVID-19 vaccines protect pregnant patients and infants from COVID-19 complications. 
    • “Three days before, the pediatrics organization released its annual vaccine recommendations. The AAP’s 2025-26 virus season guidance says children between 6 months and 2 years old should receive a COVID-19 vaccine; the CDC advises “shared clinical decision-making” between the clinician and parent or patient.” 
  • The Groom Law Group opines,
    • “On January 17, 2025, the ERISA Industry Committee (“ERIC”) filed suit against the Departments alleging that the 2024 {Mental Health Parity] Final Rule exceeded the Departments’ statutory authority, violates the Due Process Clause of the Fifth Amendment, is arbitrary and capricious, and otherwise violates the Administrative Procedure Act.
    • “In light of the litigation challenging the 2024 Final Rule, the Departments announced a non-enforcement policy of the Final Rule while they reconsider the 2024 Final Rule, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation. The Departments’ announcement noted that MHPAEA’s statutory obligations, including the requirements related to [Non-Quantitative Treatment Limitations] NQTL comparative analyses, as amended by the CAA, 2021, continue to have effect.  The Departments also stated that they will “undertake a broader reexamination of each department’s respective enforcement approach under MHPAEA, including those provisions amended by the CAA, 2021.”
    • “Importantly, plans and issuers are still required to develop and maintain MHPAEA NQTL comparative analyses and provide them to regulators upon request.  In addition, plans must also make NQTL comparative analyses available upon request to:
      • “Applicable state authorities.
      • “A participant or beneficiary (including a provider or other person acting as a participant’s or beneficiary’s authorized representative) who has received an adverse benefit determination related to MH/SUD benefits; and
      • “Participants and beneficiaries who request the comparative analyses at any time under ERISA section 104.”
  • Beckers Hospital Review helpfully explains the 340B drug program.
    • “More than three decades ago, Congress created the 340B program to help safety-net hospitals and clinics​​ expand resources and care for underserved communities. 
    • “By requiring pharmaceutical companies to offer deep discounts on outpatient drugs, the program has become a hallmark resource to help health systems support vulnerable patients. In recent years, however, the program has drawn scrutiny from federal lawmakers as several drugmakers have introduced alternative rebate and drug pricing models, raising questions about the direction of the program. 
    • “Hospitals have also faced increased scrutiny in recent years over how they are utilizing 340B savings. This intensified after a Senate report published in April found some of the largest health systems were exploiting the system. According to the report, Cincinnati-based Bon Secours Mercy Health and Cleveland Clinic generated hundreds of millions of dollars by acquiring discounted 340B drugs and then charged patients significantly higher prices. Both health systems defended their participation in the 340B program, telling Becker’s they operated the program in compliance with federal rules.”
  • Check it out.  

From the Food and Drug Administration (FDA) front,

  • MedPage Today reports,
    • “The PCSK9 inhibitor evolocumab (Repatha) got the FDA’s blessing for cardiovascular protection, with or without a history of cardiovascular disease (CVD).
    • “Evolocumab is now indicated for the wider pool of adults at increased risk for major adverse cardiovascular events (MACE) — namely cardiovascular death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization — 10 years after it first hit the market.
    • “The drug keeps its older LDL cholesterol-lowering indication in adults with hypercholesterolemia, adults and children with heterozygous familial hypercholesterolemia, and individuals with homozygous familial hypercholesterolemia.”
  • Per Fierce Pharma,
    • “Less than three weeks after lifting a pause on the use of Valneva’s chikungunya vaccine Ixchiq, the FDA has done an about-face, banning the use of the shot in the United States.
    • “On Friday [August 22], the agency suspended Valneva’s license “based on serious safety concerns,” citing 21 hospitalizations and three deaths, including one from encephalitis directly attributed to the live-attenuated vaccine. With the decision, the price of the French company’s shares has plummeted by 22%.
    • “In a release, Valneva called (PDF) the FDA’s decision “sudden,” after the regulator had lifted a previous halt on the use of the vaccine in older adults on August 6. The company added that the agency’s move came after it received four reports of side effects from its Vaccine Adverse Event Reporting System (VAERS), each happening outside of the U.S. The reports included one user who was hospitalized for two days.
    • “Valneva believes all cases describe symptoms consistent with those previously reported during clinical trials and post-marketing experience, particularly among the elderly individuals for whom the vaccine’s prescribing information includes warnings and precautions,” the company said in its statement.”
  • MedTech Dive relates,
    • “Boston Scientific has recalled carotid artery stents because of a manufacturing defect that has led to additional interventions to recover the devices.
    • “The Food and Drug Administration, which shared information about the recall Friday [August 22], said the company reported six cases that required additional intervention as of July 29.
    • “Boston Scientific told customers not to use affected Carotid Wallstent Monorail Endoprosthesis devices last month. The recall affected 26,570 devices, 1,333 of which are in the U.S.”

From the public health and medical research front,

  • The Washington Post reports,
    • “A rare human case of a flesh-eating parasite known as New World screwworm has been confirmed in a Maryland resident as the Trump administration is trying to prevent the resurgence of an insect largely eradicated from livestock decades ago.
    • “The case was confirmed Aug. 4 in a person who had traveled to the United States from El Salvador, said Andrew Nixon, a spokesman for the Department of Health and Human Services.
    • “The resident has recovered without evidence of infecting other humans or animals, state health officials said in a statement Monday.
    • “A recent New World screwworm outbreak in Central America has raised concerns that it could spread to the United States and devastate the cattle industry. But state and federal health officials said the Maryland case is not cause for alarm, and plans for a new sterile fly production facility in South Texas aim to tamp down global threats from the pest.
    • “The risk to public health in the United States from this introduction is very low,” Nixon said.
    • Livestock are not at particular risk due to the Maryland case, the National Cattlemen’s Beef Association said.”
  • STAT News points out,
    • “In a milestone for the newly resurgent field of xenotransplantation, a 39-year-old brain-dead person in China has become the first human to receive a lung from a pig. With consent from the person’s family, researchers took the organ from a CRISPR’d pig, trimmed it, and stitched it into their chest, where it remained for nine days.
    • “The procedure was intended to test whether pigs that have been gene-edited to make their organs less recognizable to the human immune system — and thus less prone to rejection — could one day be used to supply hospitals for transplants. In the past few years, surgeons in the U.S. have transplanted pig hearts and kidneys into both living patients and people who had been declared clinically dead because they lacked brain function. Last year, doctors in China became the first to attempt a similar procedure with a liver from a pig. This is the first time anyone has tried it with a lung. 
    • “The clinical need for donor lungs is enormous. According to the Global Observatory on Donation and Transplantation, 8,236 lung transplants were performed worldwide in 2024, an increase of 6% over the previous year, but tens of thousands more patients remain on waitlists. The results of the experiment, which were published Monday in Nature Medicine, are exciting, experts told STAT, because they suggest that lung xenotransplantation could, one day in the future, become an option for patients. But they also point to how much more work has to be done before that day can arrive.” 
  • Per MedPage Today,
    • “People who carried the Alzheimer’s disease APOE4 risk gene had a lower risk of developing dementia if they followed a Mediterranean diet, an observational study of healthcare professionals suggested.
    • “Adherence to the Mediterranean diet more effectively modulated dementia-related metabolites in APOE4 homozygotes than in people with lower genetic risk, wrote Dong Wang, MD, ScD, of Mass General Brigham in Boston, and colleagues in Nature Medicine.
    • “We found that greater adherence to the Mediterranean diet was associated with a lower risk of dementia and slower cognitive decline in the overall study population,” said co-author Yuxi Liu, PhD, also of Mass General Brigham. 
    • “The protective association was most pronounced among individuals carrying two copies of the APOE4allele, where each one-unit increase in the Mediterranean diet score was associated with approximately a 35% lower risk of dementia,” Liu told MedPage Today. “These findings suggest that adherence to the Mediterranean diet may mitigate the elevated genetic risk conferred by APOE4.”
  • Health Day notes,
    • “Pediatricians should screen children annually for mental or developmental issues, the American Academy of Pediatrics (AAP) recommends in a new clinical report.
    • “The recommendation comes in response to a mental, emotional and behavioral health crisis that’s been brewing among America’s youth, the AAP says.
    • “Up to 1 in 5 children in the U.S., including kids as young as 2, are living with a mental or behavioral health problem like depression, anxiety, ADHD or suicidal thoughts and feelings, according to the report published online today in the journal Pediatrics.
    • “And in 2020, suicide became the second-leading cause of death among kids aged 10 to 14 and the third-leading among 15- to 24-year-olds. AAP said the rate increased 41% between 2000 and 2017.
    • “The AAP argues that pediatricians are in the best position to spot early concerns and get children the help they need.”
  • The American Medical Association lets us know what doctors wish their patients knew about taking naps.

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Philadelphia-based Thomas Jefferson University, owner of Jefferson Health, recorded an operating loss of $196 million (-1.2% operating margin) in fiscal 2025, down from an operating income of $1.3 million (0% margin) in 2024, according to its Aug. 22 financial report. 
    • “The results for the year ended June 30 include 11 months of Lehigh Valley Health Network activity, according to the report. Jefferson merged with the Allentown, Pa.-based health system on Aug. 1, 2024. On a 12-month pro forma basis, Jefferson’s operating loss was $197 million.
    • “Due to the Lehigh Valley Health Network acquisition, Jefferson saw significant increases to its operating revenue and operating expenses in 2025. Revenue rose 57.6% year over year to $15.8 billion. Operating expenses rose 59.5% year over year to $16 billion. 
    • “Jefferson attributed the unfavorable financial results in 2025 primarily to the Jefferson Health Plan, pharmacy trend and organizational inflationary pressures.”
  • Health Leaders Media tells us,
    • “Rural health systems and hospitals are struggling to stay open and don’t have the resources on hand to treat more of their patients.
    • “Telemedicine platforms can enable small providers to connect with specialists at larger organizations, giving them the opportunity to treat more patients rather than transferring or referring them elsewhere.
    • “Larger health systems can also use the technology to create a hub-and-spoke platform that allow them to market their specialists and services to other hospitals.”
  • Per BioPharma Dive,
    • “AbbVie has bought a psychedelic compound from a little-known drug company, in a deal that could be worth north of $1 billion.
    • “The acquisition, announced Monday, makes AbbVie one of the few large pharmaceutical firms to significantly invest in an area of drug development that many on Wall Street expect to become quite lucrative. Analysts at RBC Capital Markets recently wrote the psychedelic space is “approaching a tipping point” as larger studies near completion. Just last week, the small biotechnology company Reunion Neuroscience announced plans to push its main drug, which boosts certain brain proteins that interact with psychedelics like LSD and psilocybin, into late-stage testing.
    • “That news came less than two months after U.K.-based Compass Pathways disclosed data from a relatively large study wherein patients with hard-to-treat depression were given a version of a psychedelic compound found in many mushroom species. Gilgamesh Pharmaceuticals also unveiled positive results this year, from a mid-stage clinical trial focused on a drug that works similarly to Reunion’s.”
  • Fierce Healthcare adds,
    • “BeOne Medicines is monetizing its stake in Amgen’s first-in-class lung cancer drug Imdelltra for up to $950 million.
    • “Royalty Pharma will pay BeOne $885 million upfront for certain royalty payments from Amgen tied to ex-China sales of its DLL3 T-cell engager Imdelltra.
    • “Within the next 12 months, BeOne has an option to sell additional royalty rights to Royalty for up to $65 million.
    • “The royalties represent “a significant portion” of “tiered mid-single digit” payments based on Imdelltra’s annual sales above $1.5 billion, BeOne said in an Aug. 25 securities filing. Royalty, in a separate release, said the royalty level is about 7%.”
  • and
    • “With a buyout of scPharmaceuticals worth up to $360 million, MannKind is looking to dive into the large and growing field of cardiometabolic treatments.
    • “Endocrine and orphan lung disease-focused MannKind will shell out $5.35 per share—plus a contingent value right (CVR) of $1.00 per share—to buy scPharmaceuticals and Furoscix, the latter company’s on-body infuser that delivers furosemide.
    • “The total deal value of $360 million represents a 31% premium to scPharmaceuticals’ Aug. 22 closing price, according to a Monday press release.
    • “With the deal, MannKind will add scPharmaceuticals’ Furoscix to its lineup of marketed products. The 2022-approved drug is an on-body infuser that delivers generic furosemide as a self-administered, subcutaneous loop diuretic to help relieve the fluid retention and swelling that accompany heart failure and other conditions.”
  • Per MedTech Dive,
    • “Terumo plans to acquire OrganOx, a maker of organ preservation devices, in a roughly $1.5 billion deal that will allow the Tokyo-based medical device maker to enter the transplantation sector.
    • “OrganOx’s liver perfusion system supplies oxygenated blood, medications and nutrients to the donor organ near body temperature. The device allows functional assessment of the organ to support the decision on whether to transplant.
    • “U.K.-based OrganOx launched the system in 2022 in the U.S., where it competes with an organ preservation device from TransMedics Group. Called Metra, OrganOx’s system is also approved in the U.K., European Union, Australia and Canada.”
  • and covers the key medtech issues to watch in the final months of the year.
  • Fierce Healthcare adds,
    • “As fitness trackers get artificial intelligence updates, Google developed an AI-powered personal health coach for the Fitbit app. Built with Gemini, the AI-based health coach combines a fitness trainer, a sleep coach and a health and wellness advisor.
    • “We set out to build a new kind of coach: world-class expertise that’s always available whenever you need it. It constantly adapts based on your personal health and wellness metrics and is uniquely tailored to your goals and real-life circumstances,” said Andy Abramson, head of product at Fitbit.
    • “Fitbit will roll out a preview of the personal health coach as part of Fitbit Premium in the redesigned app available with the latest Fitbit trackers, Fitbit smartwatches and Pixel Watches.
    • “The health coach can build personalized fitness plans, with detailed workout suggestions and metric targets that focus on weekly progression. The coach can adjust workout plans based on real-time data and daily insights.”

Tuesday Report

David Ermer–Uncategorized–

From Washington, DC,

  • OPM’s second addendum to its call letter for 2026 benefit and rate proposals now appears on OPM’s website.
  • The reginfo.gov website now features the following advisory:
    • “Reginfo.gov is currently undergoing revisions. Until this temporary issue is resolved, data related to EO 12866 reviews and information collection requests (ICRs) may not accurately update. EO 12866 meeting requests and public comments submitted for ICRs will be handled via email until this issue is resolved.
    • “To request an EO 12866 meeting, please send an email to MBX.OMB.OIRA.EO12866Requests@omb.eop.gov
      • For EO 12866 Meeting Requests, please use the following subject line: “EO 12866 Meeting Request: [RIN] [Rule Title].” The Regulatory Identification Number (RIN) can be found on reginfo.gov. Please list the requestor’s name and affiliation, as well as anticipated attendees in the body of the email request.
    • “To submit a comment on an information collection request, please email your comment to MBX.OMB.OIRA.ICRComments@omb.eop.gov with the subject line: “ICR Comment: [OMB Control Number] [Collection Title].”
  • That’s right; the advisory does not mention the premature semi-annual regulatory update which triggered several days of a blank screen with an “under maintenance” notice.
  • Federal News Network tells us,
    • “Federal employees traveling for business will not see an increase in the rates the government will pay for hotels, meals and incidentals in fiscal 2026. The General Services Administration said the per diem rates for the continental United States will stay the same for next fiscal year. GSA said the decision not to increase the rates reflects the government’s commitment to being a responsible steward of taxpayer dollars, ensuring that federal funds are utilized appropriately, cost-effectively and for core mission-related activities. The standard rate applies to most of CONUS, which for lodging is $110. There are 296 non-standard areas with individual rates that are higher than the standard rate. The meals and incidental rates range from $59 to $92.(Per diem rates for 2026 will not increase – General Services Administration)”
    • The GSA rates also apply to experience rated FEHB and PSHB carrier employee travel expenses.
  • The Beers Hamerman account firm reminds us,
    • A significant shift is underway in how the federal government will deliver some tax refunds and benefit payments. Starting September 30, 2025, paper checks from the IRS, Social Security Administration (SSA) and other federal agencies will become a thing of the past. The move toward a fully electronic system aims to cut costs, minimize fraud and streamline payment delivery — but it will require action from some taxpayers.
    • The shift applies OPM’s retirement program (CSRS and FERS) benefits payment system.
    • Most taxpayers will benefit from faster, safer payments. However, not every scenario fits neatly into this digital transformation. Here are examples of taxpayers that may experience challenges:
      • “Taxpayers abroad. U.S. citizens living overseas may not have access to U.S.-based banks. Because the IRS doesn’t support direct deposit to most foreign accounts, expatriates may face unique challenges. The federal government is expected to address this issue in future guidance, possibly by offering alternative methods.
      • “Estates and trusts. Executors handling final tax returns for deceased individuals may face complications. For example, a tax refund must be deposited into an account matching the taxpayer’s name — an issue when dealing with estate accounts. The American Institute of Certified Public Accountants has asked the U.S. Treasury Department to issue updated procedures and offer flexibility in these cases.
      • “Privacy concerns. Some taxpayers are uncomfortable sharing their banking information with the IRS. While electronic payments are safer overall, public concerns about data privacy remain a barrier for some.”
  • Federal News Network summarizes OPM’s latest guidance about leave, awards, and more for federal employees.
    • “In the last few weeks alone, OPM has offered answers to questions about the Trump administration’s changes to the federal probationary period, as well as updates on the use of paid administrative leave.
    • “On top of that, there are some changing expectations in how the administration wants agencies to manage employee reviews, and how top performers should be awarded for their work.”

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “FDA is actively investigating reports of Cesium-137 (Cs-137) contamination in shipping containers and frozen shrimp products processed by PT. Bahari Makmur Sejati (doing business as BMS Foods) of Indonesia. The U.S. Customs & Border Protection (CBP) alerted FDA to the detection of Cs-137 in shipping containers at four U.S. ports (Los Angeles, Houston, Savannah, and Miami). FDA collected multiple samples for radionuclide analysis, with results confirming the presence of Cs-137 in one sample of breaded shrimp. All containers and product testing positive or alerting for Cs-137 have been denied entry into the country. The agency continues to coordinate with CBP to prevent any contaminated products from reaching consumers and is working with Indonesian seafood regulatory authorities to investigate the root cause of the contamination. 
    • “Although testing to date has not confirmed the presence of contamination in any product in commerce, the product appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with Cs-137 and may pose a safety concern. To date, FDA has learned that Walmart has received implicated raw frozen shrimp, imported after the date of first detection of Cs-137 by CBP, but from shipments that did not alert for Cs-137. FDA has recommended Walmart recall this product. 
    • “Consumers should not eat or serve certain lots of Great Value raw frozen shrimp sold at Walmart stores in AL, AR, FL, GA, KY, LA, MO, MS, OH, OK, PA, TX, and WV:  
      • Great Value brand frozen raw shrimp, lot code: 8005540-1, Best by Date: 3/15/2027 
      • Great Value brand frozen raw shrimp, lot code: 8005538-1, Best by Date: 3/15/2027 
      • Great Value brand frozen raw shrimp, lot code: 8005539-1, Best by Date: 3/15/2027. 
    • If you have recently purchased raw frozen shrimp from Walmart that matches this description, throw it away. Do not eat or serve this product.
  • and
    • “The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling 246.5 Lbs. of 100% Grass-fed Pepper Jack Cheese, sold in 8 oz. packages, 5 lb. loaves and 40 lb. loaves, 2.5 Lbs. of Horseradish Flavored Cheese, sold in 8 oz. packages, 640 Lbs. of Monterey Jack Cheese sold in 8 oz. packages, 5 lb. loaves and 40 lb. loaves, and 4,544.5 Lbs. of White Cheddar Cheese sold in 40 Lb. loaves because of potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
    • “The recalled products were produced on June 16, 2025, June 24, 2025, and July 16th, and distributed in the state of Ohio between July 14, 2025, and August 7, 2025. Products were shipped to manufacturers and distributors and sold in retail stores.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs to treat or prevent infestations caused by the New World Screwworm (NWS). This declaration applies only to drugs for animals.
    • “NWS infests warm-blooded animals, including livestock, pets, wildlife, and, in rare cases, humans, causing severe tissue damage and sometimes death. The risk to human health in the United States remains very low, but the potential future threat to animal populations and the food supply chain requires proactive action. Although eradicated from North America and Central America decades ago, NWS has progressed north since 2022 and is now approaching the U.S. border with Mexico. This parasite poses an emerging threat to livestock and food security, with potential impacts on both national security and animal health.
    • “Today we are taking decisive action to safeguard the nation’s food supply from this emerging threat,” said HHS Secretary Robert F. Kennedy, Jr. “This authorization equips FDA to act quickly, limit the spread of New World Screwworm, and protect America’s livestock.”
  • Per MedTech Dive,
    • “Medtronic has recalled cardiac catheters because of a problem cited in three reports of serious injuries.
    • “The Food and Drug Administration published an early alert about the removal of the products Friday, after Medtronic sent a letter to customers on Aug. 6.
    • “Medtronic asked customers to quarantine three models over reports of problems shaping the malleable materials. The issues could delay procedures or cause cuts to heart tissue.”
  • Per Fierce Pharma,
    • “With a win in a D.C. appeals court, Vanda Pharmaceuticals has earned a point over the FDA in the yearslong face-off between the drugmaker and the drug regulator.
    • “Vanda has been fighting to market its sleep disorder med Hetlioz for jet lag disorder since 2019, when the FDA first rebuffed the bid with a complete response letter (CRL). The company unsuccessfully attempted to dispute the rejection and eventually took the FDA to court after the agency delayed requests for a hearing on the matter.” * * *
    • “Now, the appeals court has agreed with Vanda in a “sweeping win,” setting aside the FDA’s action, Vanda announced in a Monday release. The court determined that the FDA’s “treatment of Vanda’s evidence is cursory” and that each of its trials of Hetlioz in jet lag disorder “showed statistically significant improvement on the primary endpoint measured.”
    • “The court decision throws the ball back in the FDA’s court, where Vanda expects the agency to approve the application or allow a hearing. The company “looks forward to further demonstrating that Hetlioz should be approved to treat jet lag disorder,” it said.
    • “Vanda is no stranger to taking the FDA to court and has done so several times regarding both Hetlioz and other matters. With the latest win against the agency under its belt, the company suggests that other drug manufacturers can do the same.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “The incidence of herpes zoster and herpes zoster ophthalmicus increase after age 50, and both are associated with an increased risk of cardiovascular complications.
    • “For patients ages 50 and older, the adjusted effectiveness of two doses of the recombinant herpes zoster vaccine against herpes zoster ophthalmicus was 72.9%.
    • “The recombinant shingles vaccine also reduced the risks of hospitalization for acute myocardial infarction and stroke.”
  • Patient Care includes the shingles vaccine among the five essential vaccinations for all adults.
  • The Wall Street Journal reports,
    • “A prominent pediatrician group is recommending parents inoculate their young children against Covid-19, diverging from current federal health leaders who have questioned and shifted the guidance for the shots for kids.
    • “The American Academy of Pediatrics, in its immunization guidelines released Tuesday, recommended Covid-19 shots for all children ages 6 months through 23 months. Children in that age group are particularly vulnerable to severe Covid-19 infections and the vaccines would protect them from serious illness, the pediatrician group said. * * *
    • “The CDC now recommends parents of children ages 6 months to 17 years old talk about the risks and benefits of the vaccine with their doctors. The agency previously recommended children and adults ages 6 months and older get Covid-19 vaccines.”
    • “The American Academy of Pediatrics, which has made childhood vaccine recommendations since the 1930s, and other medical groups have criticized the CDC’s shift and sued the Trump administration over these changes earlier this year. The organization has said it has typically collaborated and aligned with the government on vaccination guidance.
    • “The AAP also recommended the Covid-19 shot for individuals ages 2 to 18 if they or people in their household are at high-risk for the severe illness or if they have never been vaccinated, among other considerations. The pediatrician group said children who don’t fall into those categories should have access to the vaccine.”
  • Per a National Institute of Health news release,
    • “The Dietary Approaches to Stop Hypertension (DASH) diet was developed more than 30 years ago by NIH-supported research teams. It was designed to reduce high blood pressure. Studies have since shown that the DASH diet can have positive effects on cardiovascular health and may have other health benefits.
    • A recent study lets us know,
      • “Compared to a typical American diet, a DASH-style eating plan for people with diabetes led to more time with blood glucose in the recommended range.
      • “The results suggest that a modified DASH diet could help control blood sugar levels in adults with type 2 diabetes.”
  • Also check out NIH’s Research Matters which was updated today.
  • Consumer Reports, writing in the Washington Post, notes,
    • “New Dietary Guidelines are expected to be issued this year, and there may be major changes. For the first time, the guidelines advisory committee is recommending that people favor plant protein over animal sources — even those that are considered healthy, such as chicken and fish.
    • “Beans, peas, and lentils would move to the top of the list of protein sources, encouraging people to emphasize those, while red meat moves to the bottom as the protein source you should eat least,” says Christopher Gardner, a professor of medicine at Stanford Prevention Research Center in Palo Alto, California, and one of the committee members.”
    • “The article explains how to eat more plant-based protein.”
  • Health Day points out,
    • “COVID-19 is associated with early vascular aging, as assessed by carotid-femoral pulse wave velocity (PWV), an established biomarker of large artery stiffness, and this association is particularly strong in women, according to a study published online Aug. 18 in the European Heart Journal.” * * *
    • “One of the reasons for the difference between women and men could be differences in the function of the immune system,” [Dr. Rosa] Bruno said in a statement. “Women mount a more rapid and robust immune response, which can protect them from infection. However, this same response can also increase damage to blood vessels after the initial infection.”
  • STAT News reports,
    • “A new oral weight loss drug developed by Viking Therapeutics hit the mark in a mid-stage clinical trial, but the side effect and discontinuation rates have disappointed investors. 
    • “Viking reported Tuesday that its pill, dubbed VK2735, succeeded in a Phase 2 study. The medication led to statistically significant reductions in weight, as much as 12.2% after 13 weeks, on the highest dose of the medication. The company also reported the rate of weight loss didn’t plateau, setting the stage for further weight loss on a longer-term study. 
    • “The rate of gastrointestinal distress was substantial, though. Approximately 38% of the subjects taking the highest dose of VK2735 ultimately discontinued the medication early. Across all of the dose levels, 28% of the trial participants discontinued treatment, compared to 18% of placebo subjects.”
  • Cigna, writing in LinkedIn, explains why “Shared Values and Cultural Backgrounds Matter in Therapy.”
    • “Taking care of your mental and emotional health is just as important as looking after your physical health. Going to therapy can be effective, but how well it works often depends on the kind of connection you have with your therapist. One thing that can really help is when your therapist understands where you’re coming from—culturally and personally.
    • “When you and your therapist share similar values or cultural experiences, you may feel more at ease. You’re more likely to talk honestly, knowing that your therapist understands and respects your background. This helps build trust and makes the whole process feel safer and more supportive.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Employers expect their healthcare costs to increase a whopping 9% next year, which — if the forecast pans out — would represent the largest annual increase in more than a decade, according to a new survey from the Business Group on Health.
    • “Spiking pharmacy spending is fueling much of the cost growth, as are rising incidences of chronic and complex conditions like cancer. Employers expect to lower the cost increase to 7.6% through plan design changes.
    • “But “the story this year is perhaps more daunting and sobering than it has ever been,” Ellen Kelsay, the president and CEO of the BGH, said on a Tuesday call with press.”
  • MedCity News adds,
    • “Market research firm Trilliant Health released research Monday revealing striking differences in the prices providers charge for identical services. The report, which examined data from 2,659 hospitals and 3,491 ambulatory surgery centers, found that commercially insured patients pay widely varying amounts for the same services — and these costs are primarily absorbed by employers. 
    • ‘For instance, it showed that the median rate for a coronary bypass without cardiac catheterization or major complications is $68,194, but negotiated rates ranged from $27,683 to $247,902 — a difference of more than $220,000.”
  • The Milliman consulting firm discusses “approaches to assessing and managing the effects of GLP-1 drugs on health and financial outcomes.”
  • MedCity News considers how interoperability can improve health equity.
  • Fierce Healthcare discusses J.D. Powers’ annual Medicare Advantage plan study.
    • “The highest-scoring plans in the study have robust digital offerings, according to J.D. Power, and most (85%) of the people enrolled in these plans have connected with their member portal. By comparison, 76% of people enrolled in the lower-performing plans used a member portal.
    • “More than half (52%) of people enrolled in the higher-performing plans said the tools offered through their health plan’s website were easy to use.
    • “The study also identified that new members are frequently unsatisfied with the service provided by their plan. Just 38% of first year members said that insurer met their expectations, compared to 45% of established members.”
  • STAT News tells us,
    • “Elaine Chen writes about the limitations of selling drugs directly to consumers. The aim is to lower prices by cutting out insurance companies and their drug middlemen PBMs. 
    • “Some of Trump’s proposals have not been popular with the drug industry, but drug companies are enthusiastic about DTC sales. Some had already started doing so for weight-loss treatments, and others have announced their intention to do so in response to Trump’s demands. 
    • “But the scheme is unlikely to make most drugs more affordable, several health policy and drug pricing experts tell Elaine Chen. Read more for why.”
  • CBS News reports,
    • “Two years after the U.S. Food and Drug Administration approved the first over-the-counter birth control pill, new research is looking at who’s switching to it and why.
    • “In the study, published Monday in JAMA Network Open, researchers used survey data from 986 people, ages 15 to 45, in 44 states who obtained the over-the-counter pill either online or at a pharmacy. They found that a significant portion of users shifted to the over-the-counter pill from a less-effective method of birth control or from using no contraception at all.” * * *
    • “The new research “is one of the first studies to show that over-the-counter birth control pills are reaching the very people they’re meant to help — those who face the greatest barriers to care,” lead author Dr. Maria Rodriguez, professor of obstetrics and gynecology in the Oregon Health & Science University School of Medicine, said in a news release.”