Tuesday Report

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.”