Friday Report

U.S. Healthcare

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, HSA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Benefits Link calls to our attention:
    • “Text of IRS Rev. Proc. 2026-24: 2027 Inflation Adjusted Amounts for Health Savings Accounts (HSAs) and Maximum Amount for Excepted Benefit Health Reimbursement Arrangements (HRAs) (PDF)
    • “For calendar year 2027, the annual limitation on deductions under section 223(b)(2)(A) for an individual with self-only coverage under a high deductible health plan [which thereby entitles the enrollee to contribute to a health savings account] is $4,500. For calendar year 2027, the annual limitation on deductions under Section 223(b)(2)(B)for an individual with family coverage under a high deductible health plan is $9,000.
    • “For calendar year 2027, a DPCSA [Direct Primary Care Service Arrangement] is not treated as a health plan with respect to an otherwise eligible individual if the aggregate monthly fees for all DPCSAs with respect to the individual do not exceed $150 or, if the individual is covered by a DPCSA that covers more than one individual, $300.
    • “For calendar year 2027, a ‘high deductible health plan’ is defined under section 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,750 for self-only coverage or $3,500 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,700 for self-only coverage or $17,400 for family coverage.
    • “For plan years beginning in 2027, the maximum amount that may be made newly available for the plan year for an excepted benefit HRA under Section 54.9831-1(c)(3)(viii) is $2,250.” 
  • Healthcare Dive shares industry reactions to yesterday’s final rule on the No Surprises Act Independent Dispute Resolution process.
    • “No Surprises has largely been successful in that goal, preventing millions of Americans from being hit with unexpected out-of-network charges. But the law came with an unintended consequence, creating a multi-billion dollar industry enabling doctors to get paid significantly more than they normally would for providing care.
    • “This rule is a missed opportunity to restore the balance that Congress intended — a balance that has been badly warped by activist courts and predatory provider interests,” James Gelfand, the CEO of the ERISA Industry Committee, which lobbies on benefits issues for large employers, said in a statement.
    • “Payers and providers have been at odds over independent dispute resolution, or IDR. Each side has long complained that the process unfairly benefits the other.
    • “But over the past few years, data has emerged suggesting that doctors and medical groups are raking in the dough from IDR — filing snowballing disputes, winning an exceptional share of awards and garnering massive payouts.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced a series of major initiatives to strengthen the nation’s response to Lyme disease and other tick-borne illnesses. HHS actions include a multi-million-dollar pilot program focused on tick control, up to $2.5 million in innovation challenges, funding for NIH researchers to combat Alpha-gal syndrome, and a public-private collaboration to help patients connect with experienced providers.
    • “Secretary Kennedy delivered these announcements during a press conference in New Hampshire — one of the states hardest hit by Lyme disease — after convening a roundtable with state lawmakers and Lyme disease advocates as part of his “Take Back Your Health” tour.”
  • The American Hospital Association reports,
    • The Centers for Medicare & Medicaid Services May 28 issued a final rule making changes to the Increasing Organ Transplant Access Model beginning July 1. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1, 2025. CMS finalized its proposal to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. The agency also finalized its proposal to include Medicare Advantage beneficiaries in the calculation of upside and downside risk payments. Although CMS considered lowering the maximum upside risk payment to $10,000 per transplant, it will remain $15,000 due to comments in opposition submitted by the AHA and other stakeholders. In addition, CMS adopted requirements for notifying patients of changes in waitlist status; however, in response to many concerns raised by the AHA and other commenters, it did not finalize its proposals regarding notifications of declined organ offers. Finally, in a modification of its original proposal, CMS adopted an updated risk adjustment methodology for performance on the model’s one quality measure that is consistent with the widely used Scientific Registry of Transplant Recipients framework.
  • Fierce Healthcare relates,
    • “Elevance Health has earned a reprieve from potential federal sanctions on its Medicare Advantage plans.
    • “The Centers for Medicare & Medicaid Services sent a letter (PDF) to the company Friday, saying that it has completed key steps to remedy the agency’s concerns. CMS was set to suspend enrollment in Elevance’s MA plans on March 31 if the insurer did not comply.” * * *
    • In Friday’s letter, CMS said the Elevance has completed initial data submissions through the designated channels, and sent a wire transfer for overpayments based on “all auditable estimates” in the case. How much money that amounts to was not disclosed.
    • But despite the good news, the company is not out of the water yet. CMS said it must complete further steps by June 30 to avoid sanctions, as well as tie up any loose ends from previous steps in the process by July 31.
    • Sanctions would be implemented on July 1 if new steps are not met, or on Aug. 1 if these incomplete processes are not resolved, CMS said.

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • The U.S. Food and Drug Administration (FDA) is once again warning the public about a safety concern with Johnson & Johnson MedTech’s line of Impella heart pumps. 
    • This latest alert was put in place after the company learned that certain Impella CP sets with SmartAssist “do not meet design specifications” and could experience a low purge pressure event. 
    • “Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support,” according to the FDA’s advisory. “Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.”
    • One patient died as a result of this issue.
  • Fierce Pharma relates,
    • “With a pediatric approval in hand for Afrezza, MannKind believes that it finally has the boost it needs to make an impact in the market after struggling for more than a decade with the inhaled insulin powder.
    • “On Friday, the FDA signed off on an expansion for Afrezza to treat adolescents and children ages 6 and older with Type 1 or Type 2 diabetes. The drug must be used alongside basal insulin in patients with Type 1 disease, according to a May 29 press release. 
    • “The nod comes 12 years after the U.S. regulator cleared Afrezza as a fast-acting, before-meal option for adults with diabetes.”
  • and
    • “Johnson & Johnson has bolstered the psoriatic arthritis (PsA) nod for its IL-23 inhibitor Tremfya in the U.S., picking up an FDA expansion that covers the med’s ability to thwart the progression of structural joint damage in adults with active disease. 
    • “Patients with active PsA can start to suffer joint damage as early as 6 months after the onset of their condition, reinforcing the need for a treatment like Tremfya that can provide daily symptom relief and protection from structural joint damage over the long term, Philip Mease, M.D., of the Swedish Medical Center and University of Washington School of Medicine in Seattle, said in a J&J press release.” 
  • The Wall Street Journal tells us,
    • “Replimune Group REPL said Friday it has reached an agreement with the Food and Drug Administration on a path to resubmit its application for its experimental treatment for advanced melanoma.
    • “It wasn’t immediately clear whether Replimune would submit new clinical data or additional analyses of existing trial results to help secure approval.
    • “The company plans to resubmit the application in the coming days, the company said.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 29, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 31 new measles cases in a nationwide outbreak that has now reached 1,983 infections, as experts describe sometimes-serious symptoms that can warrant hospital stays, including brain inflammation and pneumonia. 
    • “All but nine of the US infections are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.” * * *
    • “According to the CDC measles map, South Carolina has recorded the most cases so far this year, at 669, but its outbreak is now over. Utah is next, with 484 cases—although the Utah health department lists 476,just two more than last week. The state recorded eight new cases the previous week and 10 the week before, for a three-week total of 20.
    • “Texas has 182 cases, and Florida 139, four of them new, according to the CDC map.
    • “Fortunately, the outbreak in our region does appear to be slowing,” said Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah. He was part of a media briefing this week sponsored by the Infectious Diseases Society of America (IDSA).”
  • The Wall Street Journal relates,
    • “Trump administration officials are asking states to ensure 24/7 monitoring for [over a dozen] Americans exposed to hantavirus to allow home isolation.
    • “Federal officials require states to issue quarantine orders if people fail to comply, with health officials checking symptoms twice daily.
    • “The World Health Organization recommended a 42-day quarantine for high-risk exposure to the Andes strain of hantavirus.”
  • MedPage Today tells us,
    • “Alzheimer’s pathology appeared as early as midlife and correlated with poorer cognitive performance in a cohort study.
    • “Blood biomarkers identified Alzheimer’s pathology in 6% of middle-age adults.
    • “Baseline pathology predicted steeper 5-year declines in verbal memory and processing speed.”
  • and
    • “Strong preclinical evidence suggested PCSK9 inhibitors may overcome immunotherapy resistance by preventing tumor cells from evading the immune system.
    • “In patients with lung cancer, melanoma, or kidney cancer, use of PCSK9 inhibitors, in addition to immunotherapy, was associated with better survival in this matched-cohort study.
    • “The survival benefit was independent of cardiovascular outcomes, suggesting an alternative biological pathway.”
  • and
    • “Enhanced, abbreviated MRI (AMRI) outperformed ultrasonography (US) as a screen for early liver cancer in high-risk patients with cirrhosis, according to a single-center, randomized clinical trial.
    • “Overall, AMRI yielded significantly more early-to-advanced stage cancer among 759 patients: the per-patient detection rate in Barcelona-Clinic Liver Cancer (BCLC) stage 0, A, B, or C hepatocellular carcinoma (HCC) was significantly greater in those randomized to screening with hepatobiliary-phase image AMRI (HBP-AMRI) using gadoxetic acid than in those screened with US, at 8.5% versus 3.1% (P=0.002).”
  • tctMd informs us
    • “The likelihood that patients with hypertension will stop taking their prescribed blood pressure-lowering medications varies by drug regimen, a meta-analysis of short-term clinical trials suggests.
    • “Combination therapies—particularly angiotensin II receptor blockers (ARBs) paired with calcium channel blockers (CCBs)—generally were better tolerated than monotherapies, researchers reported today in JAMA, and some meds even had discontinuation rates lower than seen with placebo.
    • ‘High blood pressure is notoriously undertreated, something that’s often attributed to the  perceived tolerability, or lack thereof, of antihypertensive drugs. 
    • “Fear of adverse events remains a major reason for undertreatment of high blood pressure, the leading modifiable risk factor for death and cardiovascular disease worldwide. For years, we have assumed that more blood pressure-lowering treatment equates to worse tolerability, and hence most patients are started and remain on single drug monotherapy,” Nelson Wang, MD, PhD (University of New South Wales, Sydney, Australia), told TCTMD in an email.”
  • The Journal of American Managed Care informs us that “Endometriosis Surgery Becomes More Complex With Older Age Despite Plateauing Severity, Study Finds.”

From the American Society of Clinical Oncology conference front,

  • BioPharma Dive reports,
    • “A regimen combining Bristol Myers Squibb’s experimental mutliple myeloma drug mezigdomide with standard therapies delayed disease progression or death about 10 months longer than typical care alone, according to Phase 3 data unveiled Friday at the American Society of Clinical Oncology meeting.
    • “Trial enrollees who got mezigdomide along with Amgen’s Kyprolis and a steroid were 52% less likely to have progressed or died during the trial period compared with people receiving only those two other therapies. Study recruits in the “SUCCESSOR-2” trial had already seen their disease advance after at least one treatment line. Many had previously received two or more therapies.
    • “Mezigdomide is one of two protein-degrading drugs Bristol Myers has already submitted to U.S. regulators and hopes to position as successors to its popular multiple myeloma therapies Revlimid and Pomalyst. The treatment lanscape has become more competitive, though, with the emergence in recent years of cell therapies and bispecific antibodies that are becoming part of early-stage treatment.”
  • and
    • “Merck & Co. has said many new products will be needed to absorb the coming financial impact when its blockbuster cancer medicine Keytruda loses patent protection. One, discovered by China-based Kelun-Biotech and licensed to Merck a few years ago, has now come to the forefront.
    • “Dubbed sacituzumab tirumotecan, or sac-TMT, the therapy is part of a class of “antibody-drug conjugates” drugmakers see as potentially supplanting traditional chemotherapy in many cancers. Merck has been so encouraged by the clinical results it’s seen so far that it’s put the drug into a sprawling Phase 3 program consisting of 17 studies in a range of tumor types.
    • “Sac-TMT “could be one of our cornerstone ADCs, and that’s why you see our conviction in all of these trials,” said Shweta Jain, who oversees Merck’s oncology assets, in an interview with BioPharma Dive.”
  • STAT News adds,
    • “Investors have never really been excited about Pfizer’s Lorbrena, a targeted drug that is the successor to the company’s earlier targeted drug, Xalkori, to treat non-small cell lung cancer that is caused by any of a number of genetic alterations to the gene including ALK and ROS1. For patients, it has been a breakthrough.”
    • “Lorbrena was approved as second- or third-line treatment in 2018, and then as first-line treatment in 2021. Its main benefit over Xalkori is that Lorbrena can penetrate the brain. Non-small cell lung cancer often metastasizes there, but the large size of the earlier molecule meant that patients would have their disease controlled throughout their body, except inside their heads.
    • “Two years ago at ASCO, Pfizer presented data showing that five years out, Lorbrena reduced disease progression by 81% in patients with altered versions of the ALK gene. Today, researchers presented data that are even more remarkable. At seven years, patients had a 55% likelihood of being alive without disease progression, compared to 3% for those who were taking Xalkori. In an interview, Jeff Legos, Pfizer’s chief oncology officer, said that this appeared to be the longest progression-free survival ever reported in metastatic or advanced non-small cell lung cancer.
    • ‘ALK+ non-small cell lung cancer accounts for less than 5% of cases of disease. But in those patients, about a third will develop brain metastases within two years. Lorbrena reduced those metastases by 91% compared to Xalkori.” 

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group plans to stop requiring doctors to get approvals for an array of pediatric procedures, tests and services, further cutting back on a process that has long been detested by physicians and patients.
    • “UnitedHealth, parent of the biggest U.S. health insurer, on Friday said that the changes will eliminate roughly two-thirds of prior-authorization requirements for members under the age of 18 by the end of the year.
    • “UnitedHealthcare said it will stop requiring signoffs for many diagnostic services, routine surgical procedures and specialty care services across pediatric subspecialties such as cardiology, neurology, pulmonology and orthopedics.
    • “The insurer will additionally introduce authorization waivers for certain procedures performed at pediatric hospitals.
    • “UnitedHealthcare said it is conducting a rigorous and data-driven review of all pediatric prior authorization requirements in order to determine which services can be safely removed.”
  • Beckers Payer Issues informs us,
    • “The forces reshaping health plans over the next several years are converging fast. Across the industry, executives and clinical leaders point to three trends that will define which organizations will thrive: the rapid maturation of AI from pilot projects into core operational workflows, the intensifying pressure to make healthcare genuinely affordable, and the rising tide of consumer expectations for transparency, simplicity and personalized care. 
    • “Becker’s asked 16 health plan executives which trend they think will most influence health plans over the next few years.”
    • You can read the exec’s thoughts in the article.
  • Beckers Hospital Review ranks 66 health systems by long term debt.
    • “Long-term debt continues to weigh on health system balance sheets, even as many reported improved operating margins in 2025. Some systems have been actively deleveraging through hospital divestitures, debt refinancings and operational improvements, while others have taken “on new debt to fund capital projects, acquisitions and EHR investments.
    • Highly leveraged systems are looking to sell hospitals, facilities or business lines to reduce leverage and secure long-term sustainability, while systems with stronger balance sheets are using the dislocation to pursue growth through M&A.”
  • Healthcare Dive points out,
    • “The Coalition for Health AI released a series of governance resources this week that aim to help health systems safely roll out artificial intelligence tools. 
    • “The playbooks, developed through community workshops and work groups that included more than 150 clinicians and health AI leaders, provide examples and guidance on implenting AI, including resources on setting up AI policies, managing third party developers and assessing risks. 
    • “The goal is to provide a standardized, but flexible framework that health systems can use to deploy AI tools, regardless of their size or available resources, CHAI said.”

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Mental health care, No Surprises Act, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The departments of Health and Human Services, Labor and the Treasury [and the Office of Personnel Management] issued a final rule May 28 intended to improve the functioning of the No Surprises Act (NSA) independent dispute resolution process. The rule streamlines communication between payers, providers and certified IDR entities and clarifies timelines and processes. It improves the functionality of the IDR process by finalizing various changes, including allowing up to 50 items and services to be batched in the same payment dispute. The final rule also increases access to the IDR process by reducing the administrative fees associated with it. The AHA supported many of these changes in comments on the proposed rule.”
  • The rule decreases the federal government fee for handling an NSA arbitration from $115 per party to $15 per party. The FEHBlog expects the arbitrators’ fees to increase accordingly over time. No good deed, etc.
  • The FEHBlog also expected the final rule to include an administrative remedy that would allow providers and payers to enforce or challenge arbitration awards.
  • The FEHBlog agrees with AHIP’s comments on the final rule.
    • “While the focus on addressing flawed incentives in the IDR process is a significant first step, more action is needed to protect Americans from unconscionable price gouging by some PE-backed providers and IDR middlemen.” – Chris Bond, AHIP spokesman”
  • Tammy Flanagan, writing in Govexec, discusses “[w]hat retiring feds should do before asking for help.
    • “Clear timelines, complete records and focused questions can make retirement problems easier to resolve, especially as agencies face mounting workloads.”
  • Federal News Network tells us,
    • “The Postal Service is putting immediate restrictions on nonessential spending to avoid running out of cash sooner than expected.
    • “Postmaster General David Steiner wrote in a memo Tuesday that the restrictions will impact hiring, travel and training as well as other areas of spending. Departments within USPS may be asked to provide a summary of “cost-containment actions taken and expected savings.”
    • “Steiner told members of the House Oversight Committee in March that USPS will run out of cash in early 2027, as long as it continues to pay its bills on time. But USPS is relying on some emergency measures to conserve cash.
    • “As you are aware, we are currently experiencing a temporary cash-flow shortage that requires us to take decisive steps to manage our available resources responsibly,” Steiner wrote in the memo. “To protect core operations and ensure that we can continue meeting all essential obligations, we are implementing immediate restrictions on non-essential spending across all departments.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA’s vaccine advisors voted 8 to 0, with one abstention, in favor of a monovalent XFG vaccine for COVID-19 shots for the 2026-2027 season.
    • “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) also discussed the need to target the long-simmering BA.3.2 variant, also known as “cicada,” though most expressed confidence that targeting XFG was the right way to go.
    • “The XFG variant is the most common variant in the U.S. right now, and looking at the other JN.1 variants that may be coming up, I still think that the BA.3.2 variant is not as common. I think we have to keep surveillance very vigilant though,” said Anna Durbin, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, adding that the “immunogenicity of the vaccines looks good, so I was very comfortable voting yes.”
  • Fierce Pharma relates,
    • “AstraZeneca has fired another volley in its bladder cancer competition with Merck’s Keytruda, with the FDA on Thursday clearing its PD-L1 inhibitor Imfinzi as part of the first immunotherapy combo regimen in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who haven’t previously received standard of care Bacillus Calmette-Guérin (BCG) treatment. 
    • “The green light clears Imfinzi in the indication alongside BCG induction and maintenance therapy, AZ said in a May 28 release. 
    • “This marks the second recent bladder cancer nod for Imfinzi, which was approved in March of last year in muscle invasive bladder cancer (MIBC), in that instance in combination with the chemotherapies gemcitabine and cisplatin ahead of bladder-removing surgery and then on its own following the procedure.”
  • and
    • “As AbbVie continues to capitalize on its ImmunoGen deal, the growth of commercial antibody-drug conjugate (ADC) Elahere, another of the acquired company’s clinical assets has crossed the FDA finish line. 
    • “The FDA on Wednesday announced the approval of AbbVie’s CD123-direct ADC pivekimab sunirine-pvzy, which will hit the market under the Decnupaz moniker, as a treatment for adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN). 
    • “The condition is a rare and aggressive cancer of the bone marrow and blood that can also affect organs like the lymph nodes, spleen and skin. Most patients with BPDCN present with purple-colored skin lesions and the malignancy is often diagnosed in more men than women, with most patients aged 60 years and older.” 
  • Health Exec tells us,
    • “The U.S. Food and Drug Administration (FDA) said it’s aware of an issue with IV tubes, where black matter has been found within the walls of the plastic walls, signaling a contamination issue.
    • “ICU Medical said samples containing the particulates are being returned for analysis to help identify the problem. Until then, the devices are being removed from use and distribution.
    • “Typically sterile, these tubes are used to connect medication and fluid bags to patients, as administered through an IV line.
    • “ICU Medical and the FDA said in an announcement this could be a potentially high-risk issue, though there was no mention of patient injuries. The FDA described the notice as an early alert regarding a potential safety issue.”

From the judicial front,

  • Modern Healthcare reports,
    • “Clover Health won a lawsuit [in the U.S. District Court for the Southern District of Georgia] challenging its 2026 Medicare Advantage star ratings.
    • “A federal court ruled that 20 quality measures the Centers for Medicare and Medicaid Services used are improper.
    • “The decision could have industrywide implications because CMS rated all Medicare Advantage insurers on those metrics. 
    • “CMS filed a motion to reconsider the ruling.

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention today released a report highlighting data on patients hospitalized during a 2025 measles outbreak centered in West Texas. There were 762 confirmed cases during the outbreak, which lasted from late January through mid-August 2025. The report found that of the 60 hospitalized patients, nearly 91% were children and adolescents under age 18 and nearly 56% were age 4 or younger. Additionally, 4 out of 5 hospitalized adults age 18-44 were pregnant women in their third trimester. Available medical records of 54 patients were reviewed. All 54 were found to be unvaccinated or had an unknown vaccination status.”
  • Healio relates,
    • “Measures of ideal heart health including healthy levels of physical activity, BMI, BP and sleep were associated with lower risk for severe COVID-19 among people with no history of heart disease during the pandemic, researchers reported.
    • “For every 1 standard deviation increase in total American Heart Association’s Life’s Essential 8 score, individuals without prior CVD experienced an approximately 20% reduced risk for severe COVID-19 infection, according to data published in the Journal of the American Heart Association.”
  • Health Day adds,
    • “Being incredibly fit shouldn’t increase a young adult’s risk of dangerous irregular heart rhythm, a new study says.
    • “Young male athletes and fitness buffs aren’t more likely to develop atrial fibrillation, despite earlier studies that showed an apparent link, researchers reported May 21 in the journal Circulation.
    • “Our study shows that there are good reasons to nuance and tone down the message, which has been widespread at times, that high levels of fitness or participating in races would pose a big risk to a person’s cardiovascular health,” said lead investigator Marcel Ballin, an associated researcher at Uppsala University in Sweden.
    • “The risk of atrial fibrillation is certainly not zero, but that said, the benefits are significantly greater,” he said in a news release.”
  • and
    • “Adopting low-insulinemic and planetary health diets during menopause is associated with optimized weight management, according to a study published online May 20 in JAMA Network Open.
    • “Tong Xia, M.D., Ph.D., from Brigham and Women’s Hospital in Boston, and colleagues compared dietary patterns and their associations with weight gain and obesity risk in the years surrounding menopause. The analysis included 38,283 women participating in the Nurses’ Health Study II, with 12-year observations surrounding menopause.
    • “The researchers found that after adjusting for age, race and ethnicity, marital status, income, postmenopausal hormone therapy use, parity, smoking, alcohol, energy intake, physical activity, and baseline body mass index, the reverse empirical dietary index for hyperinsulinemia (EDIH; quintile 5 versus 1) was associated with the largest reduction in weight gain (mean, −0.28 kg/year). The lowest risk for incident obesity was seen with the Planetary Health Diet Index (PHDI; hazard ratio, 0.46) and reverse EDIH (hazard ratio, 0.51). The largest positive correlations in the EDIH were seen with red or processed meats, sodium, and French fries, while for the PHDI, the largest positive correlations were seen with nuts, unsaturated fats, whole-grain carbohydrates, and vegetable protein.” 
  • The Washington Post informs us,
    • Ozempic was supposed to be a gut story. Then Allison Shapiro looked at the brain scans.
    • An assistant professor at the University of Colorado Anschutz, she was part of a team studying 13 teens and young women with a hormonal disorder affecting the ovaries who were put on GLP-1 drugs. As part of testing to catalogue the effect of the medication on their bodies, Shapiro took snapshots of their brains before and after.
    • She was astonished to find extensive changes.
    • Within only a few months, the brain connections in the salience network, which helps target attention, had multiplied.
    • “We didn’t expect to see this effect, and we really don’t know what it means,” Shapiro said.”

  • BioPharma Dive tells us,
    • “An RNA-based shot developed by GSK and Ionis Pharmaceuticals helped wipe out hepatitis B in about a fifth of the patients who received it in a pair of clinical trials, according to study results published Thursday in the New England Journal of Medicine.
    • “Called bepirovirsen, the shot could represent an important advance for people with chronic hepatitis B infections, less than 1% of whom can achieve such a “functional cure” with the help of oral antivirals. None of the participants who received a placebo hit that mark in the two trials presented Thursday.
    • ‘The Food and Drug Administration is already reviewing an approval application for bepirovirsen, and has granted the drug “fast track” and “breakthrough therapy” designations that could speed up its evaluation. An approval decision is expected no later than Oct. 26.”
  • Genetic Engineering and BioTechnology News points out,
    • “Biohub, the non-profit research organization co-founded by Priscilla Chan, MD, and Mark Zuckerberg, has now unveiled the latest update to the ESM protein language model family, with expanded capabilities in binder design and protein function mapping for therapeutic discovery. The release comes just seven months after Biohub recruited the team behind EvolutionaryScale. 
    • “The system includes ESMC (Evolutionary Scale Modeling Cambrian), a language model trained on approximately 2.8 billion sequences drawn from a breadth of life, including organisms adapted to extreme environments, and more than 20,000 types of proteins found in the human body. Evolutionary information encoded in ESMC is translated into atomic-resolution protein structures and interactions using the design engine and prediction model, ESMFold2. 
    • “Alex Rives, PhD, head of science at Biohub and former chief scientist at EvolutionaryScale, presented the work at this week’s “AI in Biology” symposium at Cold Spring Harbor Laboratory.  
    • “These models aim to transform the earliest stages of drug discovery by making biology more programmable. While traditional discovery workflows rely on slow and resource intensive experimental screens to identify promising drug candidates, rational protein design guided by in silico predictions has the potential to dramatically accelerate development timelines. 
    • “We’re at an exciting point in protein biology where accurate digital representations allow asking experimental questions at a scale that wouldn’t be possible in the laboratory,” Rives told GEN Edge.”  

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Highmark Health recovered in the first quarter after reporting losses last year, the health system and insurer announced Thursday.
    • “The Pittsburgh-based nonprofit company reported a 1,308% jump in first-quarter net income to $183 million and a 1,340% improvement in operating income to $216 million. Revenues grew 3.8% to $8.3 billion. Highmark Health lost $175 million in 2025.
    • “Highmark Health Plans’ strategic adjustments in Medicare and Medicaid drove the rebound, Highmark Health Chief Financial Officer and Treasurer Carl Daley said.” 
  • Fierce Pharma relates
    • “The top pharmacy benefit manager (PBM) in the U.S., CVS Caremark, will restore coverage to obesity products from Eli Lilly, allowing a significant number of patients to gain access to the drugs through their existing insurance.
    • “CVS will begin covering Lilly’s GLP-1 pill Foundayo on Monday of next week, June 1, while coverage of Lilly’s injected treatment Zepbound begins on October 1. CVS Caremark, which is the pharmacy chain’s drug benefits unit, is the largest PBM in the country.”
  • and 
    • “CVS Health is growing its partnership with Salesforce, leveraging its agentic AI-driven Agentforce Health to boost personalization in its call centers.
    • “The companies announced on Thursday morning that the platform will connect data across CVS, including Aetna and Caremark, to make it easier for call center teams to address a member’s unique needs in a single interaction when possible.
    • “The Agentforce tool will surface critical insights to call center teams in advance, preparing them more effectively for conversations. The goal, the partners said, is to improve the experience for both the member and the workers through a more streamlined interaction.”
  • OptumRx, writing in Linked In, discusses the four drug classes that drive spending.
    • Inflamatory conditions drugs,
    • Oncology drugs,
    • Diabetes drugs, and
    • Obestty Drugs.
  • Beckers Payer Issues points out,
    • “CVS Health’s insurance branch will roll out “Aetna Mental Health On Demand” in 2027, the company said in a May 28 news release.
    • “Aetna members who are at least 13 years old will be able to access licensed clinicians via chat, phone or video. These professionals are trained on a “single-session intervention model” to drive immediate impact, such as through crisis management. Clinicians can provide a personalized plan, advocate for members, connect them with more resources and help with follow-ups and further care coordination.
    • “The platform also contains integrated AI tools for note-taking and administrative tasks. Clinicians participated in hundreds of chats and were able to respond to members within 13 seconds, the news release said about an initial rollout.” 
  • Healthcare Dive tells us,
    • “Teladoc Health said Thursday it is partnering with Walmart to add its virtual care services to the retail giant’s digital healthcare platform.
    • “With the partnership, Teladoc’s virtual care offerings — including urgent care, dermatology and nutrition support — are now available through Walmart’s Better Care Services platform, which connects customers to third-party digital health providers. 
    • “The deal should put Teladoc’s services in front of more potential patients, Kelly Bliss, president of the company’s U.S. group health business, told Healthcare Dive. “We have the largest nationwide network of virtual care providers in the country, and so we want to activate that network and our clinical services wherever people are making health decisions,” she said.”
  •  and
    • “Amazon’s healthcare leader is stepping down from this summer, and the co-founder of telehealth company Amwell will replace him, the retail and technology giant said Wednesday. 
    • “Neil Lindsay, who became senior vice president of Amazon Health Services in 2021, is leaving to pursue personal projects, he said in a message to Amazon employees.
    • “Dr. Roy Schoenberg, the former co-CEO of Amwell who helped found the telehealth provider two decades ago, will start as new head of Amazon’s health business on July 1. Lindsay will stay on as an advisor to Schoenberg through the end of the year.”
  • Per MedTech Dive.
    • “Ōura plans to roll out a swath of health and wellness features in June, following the launch of its latest smart ring.
    • “Among the new additions will be a tool to track nighttime blood pressure patterns and the ability to view nighttime breathing data over a 30-day period. Ōura announced the features, along with its Ōura Ring 5, on Thursday.
    • “Jason Russell, vice president of consumer software product at Ōura, told MedTech Dive that the blood pressure feature is intended to show trends in overnight changes and the relationship to daily habits, such as sleep, stress and exercise. 
    • “Ōura plans to offer blood pressure signals as a wellness feature, meaning it would not be regulated as a medical device, but there are some limitations on what it can tell users.”  

Midweek Update

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare–

Simplicity is a Virtue.

From Washington, DC,

  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today proposed a rule to eliminate the federal government’s time-in-grade requirement, an outdated rule that forces many General Schedule federal employees to wait 52 weeks before becoming eligible for promotion.
    • “The proposed rule would shift federal advancement away from time served and toward merit, performance, skills, and demonstrated readiness for higher-level work. Employees would still be required to meet OPM qualification standards and any additional job-related agency requirements.
    • “Federal employees should be rewarded for what they can do, not how long they have waited,” OPM Director Scott Kupor said. “This proposed rule strengthens merit, gives managers more flexibility to recognize high performers, and helps agencies move talented people into mission-critical roles faster.” * * *
    • “Read the proposed rule here“
  • The OPM Director, writing his Secrets of OPM blog in Linked In, discusses the proposed rule that would require federal employees to sign a non-disclosure agreement.
    • “Every well-functioning organization, whether it’s a startup, Fortune 500 company, nonprofit, law firm, university, or government agency, depends on the ability to have candid internal discussions about strategy, policy, personnel, operations, and decision-making.
    • “There’s a reason this principle is embedded throughout federal law. Under the Freedom of Information Act (FOIA), pre-decisional deliberations are generally protected from disclosure because organizations work better when people can debate ideas openly and honestly before a final decision is made. If every brainstorming session, disagreement, or draft proposal is instantly leaked into public view, people stop speaking candidly. Collaboration suffers. Decision-making suffers. Organizations become slower, more political, and less effective.
    • “Put differently: you cannot run a functional organization if employees believe internal deliberations will immediately be broadcast outside the organization.
    • “And contrary to some headlines, this proposal does not eliminate whistleblower protections. If someone witnesses illegal conduct, fraud, abuse, or misconduct, longstanding whistleblower laws remain fully intact. Protected disclosures are protected disclosures.”
  • The public comment deadline for this proposed rule is June 26, 2026.
  • Per a Justice Department news release,
    • “Today, the Civil Division announced reforms to accelerate the review of False Claims Act whistleblower complaints alleging fraud against federally funded, state-administered benefits programs. These reforms will empower the Department to move quickly on meritorious qui tam cases, maximize finite enforcement resources, and focus on dismantling sophisticated fraud schemes that exploit taxpayer-funded programs.” * * *
    • “The Civil Division will now prioritize qui tam complaints alleging fraud against public benefits programs by performing its initial review within 60 to 120 days. At the conclusion of that review, the Department will decide whether to:
      • “Permit the relator to proceed with the action and to assume primary responsibility for litigating it, subject to the government’s ongoing supervision and ultimate control of the matter;
      • “Conclude the allegations warrant further government investigation; or,
      • “Determine the qui tam should be dismissed under 31 U.S.C. §3730(c)(2)(A) because the allegations lack adequate specificity or are legally deficient.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin (bevacizumab) in the U.S., with the FDA now agreeing that the drug has demonstrated its effectiveness as a treatment for wet age-related macular degeneration. 
    • “The FDA’s change of heart comes after it granted an appeal of Outlook’s formal dispute resolution (FDR) request, which the company initiated last month following its third rejection of Lytenava (ONS-5010).
    • “As a result of the proceedings, the FDA’s Office of New Drugs (OND) concluded that clinical trial results, coupled with natural history and other mechanistic and pharmacodynamic data, were enough to establish “substantial evidence of effectiveness” for the drug, Outlook explained in a Tuesday release.” * * *
    • “The decision stipulates that Outlook can resubmit its biologics license application for Lynteva, which will be given an FDA decision date that should fall within 60 days of receipt of resubmission.
    • “Outlook expects to file the resubmission next month, it said.” 
  • Fierce BioTech relates,
    • “The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed after an advisory committee voted against the breast cancer prospect.
    • “AstraZeneca filed for FDA approval of the oral SERD based on a phase 3 switching study. Patients in the Serena-6 trial received an aromatase inhibitor and a CDK4/6 inhibitor. After detecting an ESR1 mutation, investigators swapped the aromatase inhibitor for camizestrant. AstraZeneca linked switching to its oral SERD to a 56% jump in progression-free survival.
    • “However, the FDA raised questions about the study design, and its advisory committee voted six to three that AstraZeneca failed to show camizestrant provides a clinically meaningful benefit. The vote was a blow to AstraZeneca’s hopes of winning approval, although the FDA can go against advisory committees.
    • “After the setback, AstraZeneca provided additional analyses requested by the FDA. The analyses include data on circulating tumor DNA clearance linked to longer-term efficacy outcomes, which AstraZeneca will share next week at the American Society of Clinical Oncology annual meeting. The FDA has pushed back its ruling on whether to approve camizestrant while it reviews the analyses.” 
  • MedTech Dive tells us,
    • “Insulet is recalling 7 million insulin patch pumps due to a manufacturing issue where devices may have a small tear in the tubing just above the skin.
    • “The problem can cause insulin to leak outside of the body, with the potential for people to not receive enough medication. For people with diabetes, this can lead to serious complications associated with high blood sugar, such as diabetic ketoacidosis, a medical emergency caused by a severe lack of insulin.
    • “Insulet said in a Tuesday notice that it has received 24 reports of serious adverse events, including hospitalization and diabetic ketoacidosis. The company has not reported any deaths related to the recall.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The American Cancer Society released updated colorectal cancer screening guidelines May 27 that include the addition of a blood-based screening test to be taken in a doctor’s office. The blood test, which detects tumor DNA in the blood, is only recommended for individuals who decline or do not complete preferred screening tests. The organization said a colonoscopy remains the primary recommendation for screening. The blood test has been found to be less effective in detecting advanced precancerous lesions and stage I cancers, according to the ACS. In addition, the organization announced guidelines for using stool-based tests by Cologuard and ColoSense. The ACS reaffirmed that individuals at average risk for colorectal cancer begin screening at age 45.”
  • MedPage Today relates,
    • “In advanced heart failure, cardiac remuscularization with BioVAT was associated with an increase in the target heart wall thickness, left ventricular ejection fraction, and quality of life in a small early-stage study.
    • “BioVAT consists of thin patches of engineered cardiac muscle that can be surgically attached to the outside of the ventricle where cardiomyocytes have been lost.
    • “Questions of efficacy and potential electrical dysfunction require longer-term follow-up and further clinical investigation.”
  • Health Day tells us,
    • “The college years are prime time for the emergence of mental illnesses involving psychosis, according to a new study.
    • “However, almost 60% of college students who seek mental health care after a psychotic episode do not get the recommended treatment, researchers recently reported in the journal Social Psychiatry and Psychiatric Epidemiology.
    • “Going without even one of the recommended three components of treatment — counseling, therapy and medication — could have consequences, researchers warned.
    • “Early intervention and access to services such as therapy and medication in this population are important because it improves outcomes related to overall quality of life, school involvement, employment, symptom severity and relapse rate,” lead author Clara Godoy-Henderson said in a news release. She’s a graduate student in health services and policy research at the Boston University School of Public Health.
    • “It’s estimated that about 3% of Americans are affected by psychosis, a condition in which individuals lose touch with reality and may experience delusions or hallucinations, researchers said in background notes.”
  • BioPharma Dive informs us,
    • “Kailera said Wednesday its triple-acting obesity shot spurred double-digit weight loss in a short Phase 1 dosing trial conducted in China by partner Hengrui Pharmaceuticals, with investigators reporting that enrollees lost up to 16% of their body weight over 12 weeks.
    • “The data compare favorably to early-stage data reported by Zepbound maker Eli Lilly with its so-called “triple-G” agonist drug, which hadn’t reached 10% at the 12-week time point, wrote T.D. Cowen analyst Yaron Werber. Kailera is readying its own Phase 1 trial outside China, which will have data in 2027, while Hengrui is advancing the drug into Phase 2 in China.
    • “Data from the triple-G drug, called KAI-4729, follows positive mid-stage data for Kailera and Hengrui’s dual-acting Zepbound competitor, which has already entered a Phase 3 study. The rapid advancement of Kailera’s pipeline licensed from Hengrui has driven investor enthusiasm for the company and allowed it to enter the publicly traded markets with one of biotech’s largest-ever initial public offerings.”
  • and
    • “Apogee Therapeutics is set to begin Phase 3 studies of an eczema treatment designed to compete with the mega-blockbuster medicine Dupixent after another round of successful Phase 2 testing.
    • “The late-stage research will kick off in the second half of this year, Apogee said Wednesday. It will include three placebo-controlled trials with about 400 patients each, with one study evaluating the medicine in combination with topical corticosteroids. Patients will be followed for a year after an initial 16-week induction period.
    • “Apogee released the plans as it shared the latest positive Phase 2 results and announced as much as $1.3 billion in financing from a collaboration with Blackstone Life Sciences. Apogee says it now won’t need any future equity financing.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “On a sunny Wednesday morning last month, dozens of preschoolers filed into a Compleat Kidz autism clinic in Concord, N.C. One wore light-up sneakers. Another had a Spider-Man lunchbox. They settled into tiny green cubicles, each accompanied by a staff member, and started their work.
    • “A decade ago, this Charlotte suburb had no clinics providing therapy to children with autism. Now it has 12. Inside this one, children buzzed with activity as they worked long sessions with therapists. One 6-year-old girl, exhausted after hours of therapy, fell fast asleep in her therapist’s lap.
    • “Soon, a supervisor, Stephen Schroeder, intervened.
    • “How long?” Mr. Schroeder asked Courtney Evans, the therapist.
    • “I set the timer for 7. We’re almost done,” Ms. Evans said. A couple of minutes later, she nudged the child awake. The girl cried.
    • “At Compleat Kid, a fast-growing chain of autism clinics based in North Carolina, the policy is firm: Naps cannot be longer than seven minutes before children are awakened to resume therapy. The company says this is necessary to prevent fraud since clinics can be paid only when children are awake and getting services. But it also allows the clinic to bill insurers or Medicaid for more hours.
    • “Across the United States, where treatment for autistic children was once fairly rare, thousands of clinics have sprung up, turning a once obscure therapy into a multibillion-dollar industry. The growth has been fueled by rising autism diagnoses, state insurance mandates and a federal requirement that Medicaid cover the therapy. Private equity investors have rushed into the business, buying up chains and opening new clinics.”
  • Beckers Payer Issues relates,
    • “Member satisfaction with commercial health plans has held nearly flat for a third consecutive year, even as rising premiums and deductibles continue to strain the member-plan relationship, according to J.D. Power’s 2026 U.S. Commercial Member Health Plan Study.
    • “J.D. Power published its annual ranking of the top commercial health plan in each region on May 27. Now in its 20th year, the study measures satisfaction among members of 148 health plans in 22 regions based on eight dimensions including trust, digital channels, claims resolution and cost. This year’s results are based on responses from 37,768 commercial members surveyed from September 2025 through March 2026.
    • “The study rates health plans on a 1,000-point scale. The average satisfaction score for commercial plans in 2026 is 562, down one point from 2025 and three points from 2024. 
    • “More than half of surveyed members saw their monthly premium rise this year, a shift the study linked to a 116-point drop in satisfaction. Another 34% faced higher annual deductibles, contributing to an 111-point decline. Claims resolution emerged as one of the clearest opportunities for plans to differentiate. Members who rated their claims experience as excellent scored 734 on satisfaction, compared to 404 among those who described it as good, just okay, or poor.”
  • and
    • “Health plans that aren’t built around provider networks will be allowed on the ACA individual marketplace beginning in 2028, marking a structural change to a system that has operated exclusively on network-based models since the ACA launched more than a decade ago.
    • “For Sidecar Health, an insurer that sells employer-sponsored plans without provider networks, the change opens a market it has long wanted to enter. The company administers benefits for hundreds of employer clients, ranging from companies with 51 to 60,000 covered lives across 25 industries in 48 states.
    • “The individual population and individual people and families — they’re a critical piece of our mission,” Sidecar CEO Patrick Quigley told Becker’s. “Today we only serve employers. What this does is open the door for us to serve even more people, and an audience that is frankly often left behind.”
    • “Sidecar’s model sets fixed benefit amounts based on average local prices rather than contracting with providers. Its members pay at the point of care using a company-issued Visa card and keep half the savings when a provider charges less than the benefit amount. The company says that in 2025, fewer than 1% of claims were clinically denied.”
  • Fierce Healthcare tells us,
    • “GoodRx announced Wednesday the launch of GoodRx Companion, a subscription program that offers access to virtual healthcare services and prescription medications at discounted prices.
    • “Through the $14.99 monthly GoodRx Companion subscription, users can access free and low-cost generic medications, online care visits and additional healthcare services. The company says the new subscription advances its strategy by adding broader offerings alongside its weight loss, erectile dysfunction and hair loss programs.
    • “More than 200 generic medications are free through the telehealth platform, with “hundreds more” for less than $10 across pharmacies nationwide, according to the company. Telehealth visits are $19 through GoodRx Companion to address common health conditions, such as influenza, urinary tract infections (UTIs) and more.”
  • and
    • “Humana’s CenterWell Pharmacy has invested $83 million in its latest distribution center, opening in Florida.
    • “The company announced Wednesday that the new facility will build out the company’s prescription delivery infrastructure in the state, offering an easier and more coordinated experience for members and CenterWell patients.
    • “In addition to home delivery options for Humana members, the 162,000-square-foot facility in Orlando will also offer payer-agnostic services such as direct-to-consumer and direct-to-employer partnerships, which are growing in popularity as prescription costs rise.
    • “The facility can process up to 64,000 prescriptions each day, and will employ 165 people, Humana said.”
  • Healio informs us,
    • The number of U.S. dialysis facilities closing has risen since 2018, particularly smaller, rural and Midwest facilities, according to study data published in American Journal of Kidney Diseases. * * *
    • “The annual opening-to-closure ratios decreased from 8.9 in 2018 to 0.8 in 2024.
    • “More research is needed to determine whether closures impact patient outcomes.”
  • Per a KFF news release,
    • “Drew Altman, Founding President and CEO of KFF, Announces Retirement Plans; Board Appoints Larry Levitt and Mollyann Brodie as Next Leadership Team.”
  • Best wishes in retirement, Mr. Altman.

Tuesday Report

David Ermer–CMS, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a Virtue.

From Washington, DC,

  • USAFacts.org tells us,
    • “Defense Department data shows that 63,670 active-duty military members have passed away since 1980. Eighty-four percent of these deaths were due to accidents, illness, and suicide or self-inflicted wounds. Two-hundred and sixty military members have died from the beginning of 2026 to May 13. Thirteen of these deaths resulted from Operation Epic Fury.
    • “Detailed record-keeping about the ways in which active-duty military members die began in 1980. Historical records from The Department of Veterans Affairs (VA) show that approximately 1.2 million service members died between 1775 and 1991.” * * *
    • “The US global war on terrorism began after Al Qaeda operatives carried out the September 11th attacks. The US invaded both Afghanistan and Iraq in the resulting conflict to remove the regimes of the Taliban and Saddam Hussein from power.
    • “From the onset of military operations in October 2001 to May 2026, the United States has lost 7,073 military personnel in Afghanistan and Iraq. Another 53,560 members have been wounded.” * * *
    • “The US began Operation Epic Fury on February 28, 2026 to dismantle Iran’s security infrastructure. As of May 13, thirteen US service members have died in the operation and 404 have been wounded in action.”
  • May they all rest in peace.
  • Modern Healthcare reports,
    • “U.S. Centers for Medicare and Medicaid Services Administrator Mehmet Oz is reorganizing leadership roles at the agency, a spokesperson told Bloomberg.
    • “Rebekah Armstrong, who currently leads the agency’s office of legislation, will be the new chief of staff, spokesperson Christopher Krepich said. Before joining the administration, Armstrong worked on Capitol Hill, for health insurance lobby group AHIP, and the first Trump administration.
    • “Stephanie Carlton, who had led the agency as deputy administrator and chief of staff, will now be focused on her deputy administrator role, according to Krepich. Her portfolio will include work on clinical artificial intelligence and modernizing Medicaid quality measures, he said.”
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today issued, for public comment, a template non-disclosure agreement (NDA) for federal employees with access to sensitive government information including personally identifiable information, operational plans, personnel records, and other protected materials.
    • “The template NDA comes amid a series of recent unauthorized disclosures involving sensitive government information, including leaks related to planned immigration enforcement operations, disclosures of confidential operational details prior to a US action overseas, and the release of personal information belonging to approximately 4,500 ICE employees, including frontline enforcement personnel.
    • “The template NDA would allow agencies to use standardized confidentiality agreements for covered employees and contractors whose duties involve routine access to sensitive systems or protected information. If finalized, it would become an official government form that agencies could use as a standard part of the employee onboarding process.
    • “In much of the private sector, employees handling sensitive business or customer information are routinely required to sign confidentiality agreements, and the federal government should not be held to a lower standard,” OPM Director Scott Kupor said. “Americans should be able to trust that their personal data and sensitive government information are being handled responsibly. This proposal reinforces accountability across the federal workforce while helping agencies better protect against unauthorized disclosures.” * * *
    • “Read the proposed NDA, and accompanying Federal Register notice, here.” The public comment deadline will occur in late June 2026.
  • The American Hospital Association informs us,
    • “The AHA commented May 26 to the Federal Trade Commission and the Department of Justice on potential changes to the Hart-Scott-Rodino Antitrust Improvements Act’s premerger notification form. The AHA urged the agencies to exclude hospital mergers from any revisions to the form, reiterating its previous position, and said that changes would impose burdens that outweigh any expected benefits. The AHA highlighted how mergers can be important in helping hospitals and health systems overcome financial challenges, and that there has been no indication that hospital mergers have historically evaded FTC review. Additionally, the AHA said that new questions on the form do not weigh in on issues that typically arise in hospital mergers or use language that fits within the context of hospitals.” 

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA’s vaccine advisors will meet Thursdayopens in a new tab or window to vote on whether an XFG monovalent vaccine should be preferred for COVID-19 shots for the 2026-2027 season.
    • “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will also discuss what circumstances would warrant a non-JN.1 lineage variant — such as BA.3.2, also called “Cicada” — for next season’s vaccines.
    • “In an FDA briefing documentopens in a new tab or window, the agency noted that in the U.S., descendants of the JN.1 variant of Omicron remain prominent and have diversified into multiple lineages, including XFG, NB.1.8.1, and LF.7.”
  • Fierce Pharma relates,
    • “More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA due to manufacturing and delivery concerns, the treatment has since redeemed itself by scoring a green light in the U.S.
    • “Just before the Memorial Day weekend, the FDA signed off on Gilead’s Hepcludex as the first treatment for chronic hepatitis D virus infection in the United States, granting the entry inhibitor an accelerated approval in adults without cirrhosis or with compensated cirrhosis—a complication of long-term liver inflammation that leads to progressive scarring of the organ.
    • “The FDA cleared the therapy based on data from Gilead’s late-stage MYR301 study, in which Hepcludex helped patients achieve statistically significant improvements in a combined virologic and biochemical response at 48 weeks versus a control group that received delayed treatment, the company explained in a release.” 
  • STAT News adds,
    • “People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025. 
    • “They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.
    • The credentials didn’t scream qualified. And Diamantas was stepping into a center rocked by DOGE layoffs and a defiant resignation by former leader Jim Jones. 
    • “But more than a year later, leaders in the food industry, public health groups, and FDA career staffers have found that Diamantas exceeded expectations. As Diamantas takes the reins at the FDA, STAT spoke with more than 10 of these stakeholders, as well as former FDA commissioners and Diamantas’ former colleagues. They all described him as thoughtful and serious, someone who does his homework before meetings and listens to the experts in the room. 
    • “Crucially, Diamantas has earned the trust of key career staff. That simple quality was a rarity among top leaders working at former commissioner Marty Makary’s FDA.”

From the public health and medical / Rx research front,

  • Cigna Healthcare, writing in Linked In, points out everyday mental health signs that we overlook and their impact.
    • “Missed early signs show up later with consequences: “Normal stress” that’s dismissed tends to surface downstream in productivity, quality, mistakes, and relationship friction.
    • “Early detection is pattern-based, not crisis-based: Small changes that persist for days often precede visible performance issues and escalation.
    • “Benefits can operationalize early support at scale: Integrated benefits can spot non-obvious patterns and route people to the right support earlier, helping reduce escalation and making costs more predictable.”
  • The American Medical Association lets us know “what doctors want patients to know about pancreatic cancer.”
    • “Pancreatic cancer is a challenging form of cancer. It is notoriously difficult to detect early and often requires treatment across physician specialties.”
  • MedCity News reports,
    • “While conversations around GLP-1s typically center on adults, a new report sheds light on prescribing trends among adolescents and offers recommendations for how employers can manage coverage and care.
    • “The Nomi Health report, shared with MedCity News exclusively, analyzed four years of GLP-1 prescription claims data for adolescents ages 12 to 17 enrolled in a national population of self-insured employer health plans from 2022 through 2025. 
    • “It found that during this time period, GLP-1 adoption among adolescents rose more than 60% and total spend increased 111% from $857,000 to $1.8 million. In addition, scripts per member rose 30%, and cost per member increased 32%.” * * *
    • “Nomi Health provided several recommendations for how employers can act based on these findings:
      • “Analyze adolescent GLP-1 claims across at least four years to gain a better understanding of prescribing and cost trends.
      • “Check that the correct support is in place, such as behavioral counseling and lifestyle support alongside medications.
      • “Plan ahead for the gap. Rising obesity prevalence, coupled with low treatment rates, could drive significant future costs, making it important to model the impact before it becomes a surprise in the budget.”
  • Cardiovascular Business adds,
    • “New research presented at Heart Rhythm 2026 suggests taking GLP-1 receptor agonists (GLP-1-RAs) may reduce the risk of atrial fibrillation (AFib) and improve survival through mechanisms that extend beyond weight loss alone.
    • “Kenneth Bilchick, MD, MS, director of electrophysiology research and a professor of cardiovascular medicine at the University of Virginia, presented those findings at the conference. He then spoke to Cardiovascular Business for a video interview. 
    • “Bilchick said GLP-1 drugs have an anti-inflammatory effect, which may what led to the lower AFib rates in GLP-1 patients.
  • Health Day relates,
    • “Quitting smoking might protect your future brain health, a new study says.
    • “People who quit smoking had a lower risk of developing dementia, especially if they didn’t gain excess weight afterward, researchers reported May 20 in the journal Neurology.
    • “People often worry about what happens after they quit smoking — including weight gain and associated metabolic changes,” said lead researcher Hui Chen, dean of psychological and behavioral sciences at Zhejiang University School of Medicine in Hangzhou, China.
    • “What we found is that quitting is still associated with better brain outcomes but maintaining your weight may help preserve those benefits,” Chen said in a news release.”
  • Genetic Engineering and Biotechnology News notes,
    • “Researchers at Cincinnati Children’s Hospital Medical Center and Nantes Université in France have designed 3D-printed scaffolding trays that will reportedly allow scientists to produce larger versions of functional human gut organoids twice as fast as previous methods—and these organoids grow their own nerve cells.
    • “This improved technology could help accelerate production of human mini-organ tissues that are large enough to be useful in patching damage or restoring diminished functions of a person’s small intestine, stomach, or colon. Such tissues also would be valuable for future disease studies and to more accurately evaluate organ damage risks linked to oral medications, according to the investigators.”
    • Details of the study “Large-scale and innervated functional human gut tissues for transplantation via transient spheroid confinement” appear in Nature Biomedical Engineering.

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY agreed to acquire three vaccine developers in deals valued at up to nearly $4 billion combined, the company said Tuesday.
    • “The deals mark a new push by the weight-loss drug market leader into infectious-disease prevention.
    • “The details
      • “Indianapolis-based Lilly has agreed to acquire Curevo, LimmaTech Biologics and Vaccine Company, confirming an earlier report in The Wall Street Journal. 
      • “Curevo is developing a shingles vaccine that Lilly believes could be as effective as the current standard but with reduced side effects, said Daniel Skovronsky, Lilly’s chief scientific and product officer. Lilly could pay up to $1.5 billion in cash for Curevo, including an undisclosed upfront payment and a potential subsequent payment if a certain milestone is met. 
      • “LimmaTech is developing vaccines against bacterial pathogens including Staphylococcus aureus. Lilly agreed to pay up to $780 million in cash for LimmaTech, including an undisclosed upfront payment and additional payments for certain clinical and regulatory milestones.
      • “Vaccine Company is developing a vaccine against Epstein-Barr virus. Lilly agreed to pay up to $1.55 billion in cash, including an undisclosed upfront payment and potential clinical and commercial milestone payments.”
  • Fierce Healthcare relates,
    • “Trinity Health is outperforming some of its large Catholic peers, reporting $200 million of operating income (1% operating margin) over the nine-month period ended March 31, 2026, according to a recent filing. 
    • “The tally reflects a 5.4% year-over-year rise in both operating revenue and operating expenses ($20 billion and $19.8 billion, respectively), and is a narrow, $2.1 million improvement over the prior year’s nine-month operating income.” * * *
    • “Trinity’s steady operating gain places the nonprofit ahead of the country’s other 11-figure faith-based systems with offset fiscal years: CommonSpirit Health and Ascension. The former recently disclosed a $743 million adjusted operating loss (-2.4% operating margin) across three quarters, a decline that excludes the substantial on-paper costs of an early contract termination. Ascension’s operations, while broadly on the upswing, also posted a nine-month loss of $203 million (-1.1% operating margin).” 
       
  • Healthcare Dive tells us,
    • “PacificSource Health Plans, a nonprofit health plan offering coverage in four states in the Pacific Northwest, is exiting the Affordable Care Act market next year and ending all operations in Montana.
    • “PacificSource is the latest insurer to flee the exchanges as rising costs and policy turbulence make it more difficult for smaller payers to remain operational.
    • “As a not-for-profit organization, PacificSource is making difficult decisions to ensure we can continue fulfilling our mission and serving members for the long term amid growing pressures across the healthcare industry,” a spokesperson told Healthcare Dive.”
  • Modern Healthcare informs us,
    • “WakeMed Health & Hospitals rejected an unsolicited proposal from UNC Health to combine.
    • “The proposal followed Atrium Health’s May 1 announcement it plans to merge with WakeMed.
    • “A UNC Health spokesperson said the Chapel Hill, North Carolina-based system submitted a proposal to WakeMed for a “broader partnership” May 5.
    • “WakeMed, which is based in Raleigh, North Carolina, reviewed the proposal but felt the partnership with Atrium was the best path forward, a WakeMed spokesperson said. 
    • “Combined, WakeMed and UNC Health would control 80% of the healthcare market in Wake County. We have heard from numerous stakeholders, including the state treasurer, that maintaining robust competition is important for our rapidly growing region,” the WakeMed spokesperson said.” 
  • Per an Institute for Clinical and Economic Review news release,
  • Fierce Healthcare points out,
    • “Health tech companies Wheel and b.well Connected Health are partnering to offer turnkey infrastructure for next-generation AI-first virtual care.
    • “AI-first healthcare experiences and consumer-centered care models are driving innovation in healthcare. Consumer health data is widespread and embedded in daily life, with information available from apps, wearables, devices and medical records. At the same time, retailers and pharmacies are becoming care access points, while life sciences companies are going direct-to-consumers. And the Centers for Medicare and Medicaid Services (CMS) is pushing forward initiatives to open up patients’ access to health data.
    • “Wheel’s partnership with b.well gives AI-native companies, retailers, life sciences companies, payers, health systems and consumer health brands a faster, more complete way to compete in the consumer-driven healthcare race, according to the two companies.”
  • Per MedTech Dive,
    • “Olympus said Tuesday it has agreed to buy Israel-based BioProtect for $270 million to expand its product portfolio in oncology and urology. 
    • “BioProtect makes a balloon spacer system that separates the prostate from other structures during cancer radiation treatment.
    • “The transaction is expected to increase patient access to BioProtect’s technology through Olympus’ global reach and relationships with healthcare providers.”

Holiday Weekend Update

David Ermer–Congress, Medical / Rx research, No Surprises Act, U.S. Healthcare–

“Simplicity is a virtue”

From Washington, DC,

  • Congress is taking a State / District work break this week following Memorial Day.
  • The Office of Management and Budget’s Office for Information and Regulatory Affairs has completed its review of the No Surprises Act Independent Dispute Resolution final rule, which indicates that this significant final rule will be published in the Federal Register this week.

From the judicial front,

  • USA Today, via Yahoo Finance, reports
    • “CVS sued Tennessee state officials on May 22 to block legislation the pharmacy giant said would force the closure of the chain’s 136 Tennessee pharmacy locations.
    • “CVS filed the U.S. District Court lawsuit in Nashville after Tennessee Gov. Bill Lee signed legislation to prohibit companies from owning both pharmacy benefit managers and retail pharmacies. The Tennessee legislation takes effect July 1, 2028.”

From the public health and medical /Rx research front,

  • STAT News reports,
    • “Eli Lilly said Monday that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol.
    • “Lilly acquired the therapy, VERVE-102, in its $1 billion buyout of Verve Therapeutics last year. Executives tout it as a potential treatment to broadly prevent heart disease, the world’s leading killer, as many patients struggle to stay on existing, more conventional medicines for reducing cholesterol levels.
    • “There were no treatment-related serious adverse events in the Phase 1 study — a notable finding, given that Verve had to shelve its first candidate due to safety concerns. 
    • “The data were simultaneously published in the New England Journal Medicine and presented at the European Atherosclerosis Society in Athens.
    • “Lilly now plans to begin a Phase 2 trial in an unspecified number of patients. It will likely need to then run Phase 3 trials in thousands of patients for the treatment to earn approval.” 
  • The Washington Post relates,
    • “Pancreatic cancer is an exquisitely cruel diagnosis, leaving only 13 percent of people alive after five years. But in the early 1980s, scientists discovered a weakness — a mutated protein called KRAS — that spurred the aggressive growth and spread an array of tumors. In pancreatic cancer, it would turn out to be a key driver of nearly every case. 
    • “There was just one problem. The KRAS protein they needed to block was flat and smooth, without the crevices and cracks, pockets and sockets that a drug needs to get a toehold.
    • “No longer.
    • “In the span of a few weeks, the conventional wisdom on pancreatic cancer and KRAS has been upended. In April, biotech company Revolution Medicines announced that its experimental pill, called daraxonrasib, had notched an unprecedented success — patients lived for 13 months, twice as long as those given regular chemotherapy. The full details will be presented next weekend at the American Society of Clinical Oncology meeting in Chicago, but federal regulators have already expanded access to the drug while it is being reviewed.
    • “It’s the start of a huge wave for this disease,” said Eileen O’Reilly, a gastrointestinal medical oncologist at Memorial Sloan Kettering Cancer Center. Following behind are other drugs that may work better and the potential to use the approach against lung and colorectal cancers.”
  • Medscape informs us,
    • “GLP-1 receptor agonists, like semaglutide, are gaining importance in liver disease treatment, notably for metabolic-associated steatohepatitis (MASH) and alcohol use disorder (AUD), offering benefits beyond weight loss, including potential hepatoprotection.
  • and
    • “CAR T-cell therapy, initially for cancer, shows promise in treating autoimmune diseases like multiple sclerosis. While offering hope, it poses risks and uncertainties, including potential long-term side effects and high costs, necessitating further research.”

From the U.S. healthcare business front.

  • Beckers Payer Issue points out,
    • ‘Point32Health reported an adjusted net income of $248 million in the first quarter, a sharp reversal from a $21 million adjusted net income a year prior.
    • “The insurer, parent company of Harvard Pilgrim Health Care and Tufts Health Plan, said the Q1 results included an operating income of $86 million, investment income of $6 million, and a gain from the sale of its Integra Partners subsidiary. Revenues were $2.4 billion and membership was nearly 2 million.
    • “In the first quarter of 2025, the company reported an operating loss of $39 million and investment income of $61 million, on revenues of $2.4 billion and membership of approximately 2 million.
    • “While we are optimistic for the remainder of the year, we recognize that medical and pharmaceutical cost trends remain volatile and will continue to present challenges,” CFO Michael Marrone said.’
  • Per a Health Care Cost Institute news release,
    • “Conventional wisdom and economic theory suggest that more competition means lower prices. In health care, there is longstanding evidence that geographic areas with less competition among hospitals are associated with higher negotiated commercial prices. Regulators and researchers use the Herfindahl-Hirschman Index (HHI) to measure market concentration at a geographic area. HHI can range from 0 (competitive market) to 10,000 (monopoly market). Hospital markets that are considered “highly concentrated,” (HHI greater than 2,500) generally means that there are a limited number of hospitals or health systems that dominate the market. There also is evidence in the economic literature that geographic areas that have a limited number of insurance companies are associated with lower negotiated commercial prices. These insurance markets are considered “highly concentrated.” 
    • “In this cross-sectional analysis of 2022 data, we examine the impact of competition on prices across the US.  Specifically, we compared a measure of hospital prices – the inpatient hospital price index from HCCI’s Health Cost Landscape – in areas with varying levels of hospital and insurance company concentration. We focused on inpatient hospital prices because they are most directly related to hospital and health insurance market dynamics.      
    • “We find that inpatient hospital prices are the highest in metro areas where hospital markets are very highly concentrated (least competitive) and insurance markets were moderately concentrated (the most competitive among the markets in the Landscape). Inpatient hospital prices in these metro areas were, on average, about 25% higher than the national median in 2022. Inpatient prices were lowest, in contrast, in metro areas where hospital markets were the least concentrated but the health insurer market was highly concentrated.  Among metro areas where health insurers are highly concentrated and hospitals are least concentrated, inpatient hospital prices were about 10% lower than the national median.”  
  • Kaufmann Hall lets us know,
    • “[H]ospitals across the country are facing difficulty placing patients into SNFs and other post-acute sites of care, delaying discharge of medically ready patients. Post-acute access constraints are structural and systemic and are reshaping hospital performance—including hospital margins, capacity, throughput, quality metrics, staff morale, and patient experience. Health systems that proactively redesign their post-acute strategy, particularly through aligned SNF and other post-acute partnerships, can materially improve performance across these dimensions and mitigate risk, while also equipping these facilities with the alignment and financial resources necessary to thrive.” * * *
    • “SNF bed supply fell 2.5% between 2019 and 2024, creating a sustained imbalance between supply and demand. As this imbalance persists, access challenges are likely to intensify rather than normalize. Hospitals in regions with SNF bed under capacity tend to experience greater mean length of stay, percentage of stays 28 days or more, and median distance traveled to admitting SNFs.” * * *
    • “Ultimately, improved SNF access is driven by alignment, incentives, and operating expertise—not [hospital] ownership alone. 
    • “Several health systems, such as Stanford Health Care, Scripps Health, and UC Davis Health, have also had success with the bed reservation / bed lease program as an aligned alternative for post-acute care access and patient throughput.”
  • Healthcare Dive tells us,
    • “Private equity-owned hospital operator Quorum Health plans to transition to nonprofit status this year through a deal with Healthside Partners.
    • “The definitive agreement announced Thursday is meant to help put Quorum, which has struggled to recover following its bankruptcy in 2020, on more stable financial footing through access to the tax and funding benefits nonprofit hospitals receive.
    • “The deal appears to be structured as straight asset transfer, wherein the nonprofit system Healthside will acquire Quorum’s assets without inheriting its liabilities and obligations. Quorum will remain a separate company that will then be dissolved, a spokesperson for the system said. The transition is expected to close this fall.”

Friday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Patient safety, U.S. Healthcare, Uncategorized–

Simplificity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The House Appropriations Committee advanced a draft fiscal 2027 Legislative Branch spending bill on Wednesday that would slash the budget for the Government Accountability Office by nearly one-quarter and give a boost to Capitol Police.
    • “The party-line vote of 34-28 came after a contentious markup stretching late into the evening, as Democrats argued the GAO cut would undermine its mission.”
  • The Hill informs us,
    • “Federal Reserve Chair Kevin Warsh was sworn in Friday beside President Trump, kicking off his term as the new head of the central bank at a critical time for the U.S. economy.” * * *
    • “Warsh, 56, returns to the Fed board after serving as a member from 2006 to 2011. He was nominated to the Fed by former President George W. Bush, whom he served as a White House economic adviser before becoming the youngest Fed board member in history.
    • A graduate of Stanford University and Harvard Law School, Warsh also worked at Morgan Stanley and served in various academic and advisory roles outside of his government service. 
    • Warsh was most recently a fellow at Stanford’s Hoover Institution, an influential conservative think tank known for its close ties to prominent Republican policymakers.
  • Healthcare Dive relates,
    • “The HHS is continuing its crackdown on healthcare fraud, launching a program that will use artificial intelligence to examine audits from states and other federal grant recipients — and potentially affect Medicaid funds.
    • “The Office of the Assistant Secretary for Financial Resources will look across all states to analyze at least five years of audits that grantees file annually with the federal government, the department said Thursday. 
    • “The agency says past audits include internal control issues and “chronic” noncompliance. If recipients aren’t able to fix those problems, the HHS could temporarily withhold payments, hold back future funds, or suspend or terminate awards.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions. The FDA said that Abiomed identified an issue where if a patient is treated with a left ventricular Impella device and experiences an extended period longer than 80 minutes with no residual pulsatility, the Abiomed Automated Impella Controller may be forced to restart due to an internal software error.” 
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis (scarring), liver cancer, liver failure, and even death.
    • “Today’s approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” said Wendy Carter, D.O., Acting Director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.”

From the judicial front,

  • Bloomberg Law reports,
    • “The importance of the $885 million antitrust verdict this week against Takeda Pharmaceuticals Co. Ltd. had less to do with the nine-figure damages than ending private plaintiffs’ losing streak challenging deals delaying cheaper generics.
    • “The Boston federal jury’s finding that Takeda improperly paid a competitor to delay it from bringing a generic version of its Amitiza constipation medication to market marked the first time a private plaintiff won at trial in a reverse-payment case.
    • “Most challenges to deals between branded drug companies and generic makers either settle or are dismissed before reaching trial, with the more nuanced agreements sometimes making it to a jury. Three have been tried before a jury since the US Supreme Court put drugmakers on notice that the dealings could run afoul of antitrust laws. Until Monday, juries had rejected plaintiffs’ claims each time. 
    • “I expect the case to send ripples through legal departments — if not boardrooms — across the country,” said Robin Feldman, a law professor at the University of California in San Francisco who studies pharmaceutical regulation and intellectual property. She called the verdict a “groundbreaking decision.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country. Because of the later start, some areas of the country may continue to see higher levels of RSV through May. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is low in most areas of the country. Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “As the nation moves closer to topping last year’s measles total in just the first half of 2026, the Centers for Disease Control and Prevention (CDC) today confirmed 59 new cases in a nationwide outbreak that has now reached 1,952 infections. 
    • “All but nine cases are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.”
  • and
    • “Although an Ebola outbreak is growing rapidly in central Africa, experts say it doesn’t pose a public health threat to the United States.
    • “The outbreak, centered in the Democratic Republic of the Congo (DRC), has grown to nearly 750 suspected cases and more than 170 deaths, the World Health Organization (WHO) announced today. Although the risk from Ebola in the DRC is high, the risk of global spread is low, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said. 
    • “Many US infectious diseases experts agree.
    • “This is a horrible situation in affected areas of Africa,” said Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, which publishes CIDRAP News. “But for the world, it is not.”
    • “That’s because Ebola, which spreads through contact with bodily fluids, is far more difficult to spread than the airborne respiratory viruses that Americans have confronted in recent years, such as influenza, COVID-19, measles, and even the Andes strain of the hantavirus, which recently caused an outbreak on a cruise ship.”
  • BioPharma Dive points out,
    • “ASCO26: 5 data snapshots ahead of the year’s biggest cancer drug meeting.
    • “Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting gave a peek at anticipated datasets from Merck, BioNTech, Eli Lilly and Moderna.”
  • Per a National Institutes of Health news release,
    • “A team of researchers at the National Institutes of Health (NIH) have unveiled new details about the events GLP-1 receptor agonists trigger within neurons, which have been largely unexplored until now. A study in mice identified key intracellular signaling processes that are tied to the weight-loss effects of the GLP-1 drug semaglutide. The findings improve our understanding of how increasingly prevalent GLP-1s may influence human behavior and identify new opportunities to potentially enhance treatment.
    • “The weight-loss benefits of GLP-1s are well documented and scientists generally know the brain regions associated with these effects. However, several questions remain, such as why responses to medication differ between patients and why the effects for most eventually plateau.
    • “We know much less about the nuts and bolts of what goes on within the neurons that these medications target. By digging into these mechanisms, we’re beginning to answer some of these questions,” said co-corresponding author Andrew Lutas, Ph.D., an investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).”
  • CNN reports,
    • “Pregnant women are routinely advised to take prenatal vitamins for their health and their baby’s development. Now, a new study published Monday in JAMA Network Open concluded that children whose mothers received higher-dose vitamin D supplements during pregnancy performed better on certain memory tests at age 10.”
  • MedPage Today relates,
    • “Preserved global brain structure appeared to buffer cognitive decline in people with Alzheimer’s pathology.
    • “Younger-appearing brains had weaker links between pathology and poorer outcomes in multiple cognitive domains.
    • “Other measures of brain reserve or cognitive reserve showed no clear protective cognitive effect.”
  • Health Day tells us,
    • “Middle-aged people who have migraine with an aura could be more at risk for stroke.
    • “Those who had migraine with aura had a 73% increased risk of stroke
    • “Middle-aged men who suffered any kind of migraine had a more than 3.5-fold increased risk of stroke.”
  • and
    • “Use of calcium, vitamin D, or combined supplementation has little to no effect on the prevention of fractures and falls in adults, according to a review published online May 20 in The BMJ.
    • “Olivier Massé, Pharm.D., from CIUSSS du Nord-de-l’Île-de Montréal, and colleagues conducted a systematic review and meta-analysis to examine the effect of calcium, vitamin D, or combined supplementation on fractures and falls in adults. A total of 69 trials, with 153,902 participants, were included in the review.
    • “Most trial participants were community dwelling (87 percent) and not at high fracture or fall risk (73 percent). The researchers found that little to no effect was found from use of calcium supplements (risk ratio, 0.91), vitamin D supplements (risk ratio, 1.00), or combined supplementation (risk ratio, 0.91) for the primary outcome of any fracture. There was little to no effect on other fracture and fall outcomes seen for calcium, vitamin D, or combined supplementation, based mainly on moderate-to-high certainty of evidence. After extensive exploration of heterogeneity across multiple subgroup analyses, the findings remained robust.”
  • BioPharma Dive informs us,
    • “The outlook for an experimental Parkinson’s disease drug dimmed on Thursday with the announcement that it had failed a key clinical trial.
    • “Developed through a partnership Denali Therapeutics and Biogen, the drug is designed to inhibit an enzyme tied to one of the most common genetic drivers of Parkinson’s: a gene called LRRK2. When this gene mutates, it causes the waste disposal systems in cells to malfunction, leading to the buildup of toxic proteins that damage and destroy neurons.
    • “In 2022, Biogen and Denali kicked off what would ultimately become a nearly 650-person trial that pitted their drug against a placebo. The companies are now saying this mid-stage study showed the drug — codenamed BIIB122 — was not significantly better at slowing the disease progression, as measured by a well-known scale clinicians use to assess how Parkinson’s is affecting a patient’s movement and daily life.”

From the U.S. healthcare business and artificial intelligence front,

  • Per an EBRI news release,
    • “The Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey found that the majority of insured individuals still receive health insurance through their employer.
    • “Employment-based health coverage remained the dominant source of health insurance for privately insured adults, with six in 10 receiving coverage through their own job.” * * *
    • “Coverage patterns have been largely stable, with about one-third enrolled in individual-only coverage and most others covering a spouse or partner.”
  • Fierce Pharma relates,
    • “With both Novo Nordisk’s and Eli Lilly’s oral GLP-1s establishing their footing in the U.S. obesity market, the companies’ respective Wegovy pill and orforglipron tablet Foundayo are making their mark on prescription trends for a class previously confined primarily to injectables.
    • “Looking at the past four weeks, total U.S. GLP-1 prescriptions were up 3.6%, compared to 1.8% at the same time last year, analysts at Citi wrote in a Friday note to clients, citing script tracking data from IQVIA. The Citi team attributed that momentum to the ability of Novo’s and Lilly’s new oral launches to “broaden and reshape the market” for obesity incretin drugs.”
  • MedCity News considers whether “Mark Cuban’s Cost Plus Wellness Appeal to Employers?”
    • Employer advocates said Cost Plus Wellness could help spur more direct contracting and transparency in healthcare, though they questioned whether the model can scale and adequately measure provider quality and outcomes.
  • Beckers Hospital Review reports,
    • “Philadelphia-based Penn Medicine reported an operating income of $238.5 million (2.4% margin) for the nine months ended March 31, up 46.3% from $163 million (1.9% margin) in the same period last year, according to financial documents filed May 20.
    • “The results follow the April 1, 2025, acquisition of Doylestown (Pa.) Health. Doylestown Hospital, a 245-bed teaching hospital, became Penn Medicine’s seventh hospital and is now known as Penn Medicine Doylestown Health.”
  • STAT News tells us,
    • “Retro Biosciences, the longevity startup backed by OpenAI CEO Sam Altman, has raised more money at a $1.8 billion valuation, it announced Friday. 
    • “Retro has a big mission: Add 10 healthy years to the human lifespan. It is seeking to do that by using a variety of technologies, including in vivo gene therapies, cell replacement therapies, and other approaches to spur younger, healthier cells into aging tissues.
    • “The company is currently running its first clinical trial — testing a pill designed to enhance the body’s ability to better clear out protein aggregates in patients with Alzheimer’s disease. Retro CEO Joe Betts-LaCroix told the audience at STAT’s Breakthrough Summit West on Tuesday that the trial is going “super good” and that researchers haven’t seen any dose-limiting toxicities. He said he anticipates releasing some data from the trial around August.”  
  • Fierce Healthcare informs us,
    • “Innovaccer acquired CaduceusHealth to combine its AI platform with the company’s revenue cycle management services and staff to serve ambulatory care providers.
    • ‘Innovaccer, founded in 2014, built software solutions to unify enterprise data and applies AI to automate manual tasks and streamline workflows for payers and providers. Last year, it rolled out Flow Auth, an AI-powered prior authorization solution that is part of Flow by Innovaccer, an AI-powered revenue cycle suite designed to modernize financial operations for health systems. Other capabilities include Flow Capture, an autonomous medical coding solution and Flow Collect, an AI-powered denial management and revenue recovery tool.
    • “Innovaccer claims that it now serves over 200 health systems and payers, 95% of community pharmacies and 80 million patient lives across the United States. Flow is built on Gravity, Innovaccer’s healthcare AI infrastructure platform.”
  • and
    • “Eugene, Ore.-based Ksana Health is undertaking a multi-institutional research effort aimed at creating a new class of artificial intelligence to advance mental health and substance use disorder treatment and prevention.
    • “The software company was awarded a $17.9 million contract by the U.S. Department of Health and Human Services (HHS) to create a Large Health Behavior Model (LHBM). Its goal is to train AI models on smartphones and other wearables data, including sleep, mobility and language use linked to large scale electronic health records (EHRs).
    • “This initiative augments Ksana’s current efforts to shift behavioral healthcare from episodic, subjective assessment toward continuous, data-driven health promotion, reducing healthcare spending, improving quality of life, and reaching populations that currently lack access to effective behavioral health support,” said Tony Scripa, Ksana Health COO and project co-investigator, in a statement.”
  • and
    • “More than seven in 10 Medicare members report feeling confusion or uncertainty when navigating online health information, a new whitepaper from CVS Health found. 
    • “The research (PDF) drew insights from Medicare-eligible consumers through surveys, interviews and ethnographic studies. 
    • “Seventy-one percent of respondents report an eagerness to use more digital health care tools and 86% report an eagerness to use them. However, 58% of respondents report that low digital health literacy is negatively impacting their ability to manage their health. 
    • “We’re caring for the fastest-growing and most clinically complex population in the country, and what we found in the research challenges a common assumption—older adults actually are more open to engaging with technology than many think,” said Dr. Benjamin Kornitzer, M.D., Aetna senior vice president and CMO, in a statement. “It creates a real opportunity to meet them where they are and provide day-to-day support, whether it’s managing medications, following up after a visit, or staying on track with chronic conditions. Technology and engagement can help them live healthier, more independent lives.”
    • “As a result, CVS said it is applying insights from the research across its digital offerings, including clearer navigation, stronger accessibility features and added privacy and security transparency.” 

Thursday report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

A commenter, Patrick Morselli, accurately observed in response to the OPM Director’s blog post that “Simplicity has a high cost in most organizations. Feels like the hardest work is undoing complexity other smart people left behind.”

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Republicans broke with President Trump over his administration’s plan to create a $1.8 billion settlement fund to pay people who claim political persecution, with widespread opposition forcing party leaders Thursday to abandon votes on immigration-enforcement funding and send lawmakers home early for their Memorial Day break.
    • “The “anti-weaponization” fund is a Trump priority, after he alleged for years that his supporters, including those prosecuted over the Jan. 6, 2021, attack at the Capitol, had been targeted unfairly by the Biden administration. But its creation has run into blowback in the Senate, and the immigration-enforcement bill gave senators leverage to dig in their heels.
    • “I don’t like the fund at all,” said Sen. John Curtis (R., Utah), who added he didn’t think any guardrails could fix it. Sen. Thom Tillis (R., N.C.), a frequent target of Trump criticism who is retiring, called it a “payout pot for punks.”
    • “With no resolution in sight, Senate Majority Leader John Thune (R., S.D.) sent senators home for their weeklong Memorial Day recess, putting the Republican-led Congress on course to miss Trump’s deadline to have the Immigration and Customs Enforcement and Border Patrol measure on his desk by June 1.”
  • Healthcare Dive relates,
    • “Lawmakers are mulling reform of how Medicare pays physicians, concerned that insufficient reimbursement in the federal insurance program is incentivizing consolidation and increasing healthcare costs.
    • “Physician pay has declined over the past two decades when accounting for inflation, spurring independent providers to be acquired by hospital systems rather than go it alone, provider witnesses told representatives during a House Energy and Commerce subcommittee hearing Wednesday. And representatives agreed that’s a concern.
    • “Making sure that independent physician practices stay open […] is one of the most critical ways we can ensure competition and drive down costs,” said Rep. Kim Schrier, D-Wash.”
  • The American Hospital Association adds,
    • “Rep. Randy Feenstra, R-Iowa, introduced the Rural Maternity Options for Medical Support Act on May 19. The bill would guarantee that beds used solely for labor and delivery are not counted toward the 25-bed limit for critical access hospitals. The bill is co-sponsored by Reps. Darin LaHood, R-Ill., Jill Tokuda, D-Hawaii, and Kim Schrier, D-Wash. 
    • “New and expecting moms deserve access to high-quality labor and delivery services,” said Lisa Kidder Hrobsky, AHA senior vice president for advocacy and political affairs. “The Rural Maternity Options for Medical Support Act of 2026 strengthens access to maternal health services for mothers in rural areas by ensuring that higher volume critical access hospitals have labor and delivery beds available, even if their other patient beds are full. The AHA appreciates Rep. Feenstra’s leadership to support critical access hospitals and families across the nation.” 
  • and
    • “The House Education and Workforce Committee May 21 unanimously passed the Transparency in Billing Act (H.R. 8684). The bill would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and it would impose civil monetary penalties on hospitals that violate the requirement. 
    • The AHA has previously opposed this policy, saying that hospitals are already transparent about the location of care delivery on their bills and that it would create a significant administrative burden to providers and the health care industry at large.” 
  • Fierce Healthcare tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. removed two key leaders of the U.S. Preventive Services Task Force (USPSTF), a key advisory panel that offers guidance on preventive services, according to media reports.
    • ‘Vice chairs John Wong, M.D. and Esa Davis, M.D. were dismissed from the task force in letters sent to them by Kennedy on May 11, The New York Times reported on Wednesday, citing copies of the letters obtained by reporters. STAT, CNN, Politico and The Hill also reported the terminations, citing the letters.” * * *
    • “The terminations leave the panel with just eight sitting members. Five other members saw their terms expire at the start of this year, and Kennedy did not replace them, and the previous chair, Michael Silverstein, departed on his own, STAT reported.”
  • Federal Network News informs us,
    • “Shane Stevens, the top official for the Office of Personnel Management’s healthcare and insurance arm, is stepping down from his role, Federal News Network has learned.
    • “Stevens, a political appointee, has been serving as associate director of healthcare and insurance at OPM since last summer. He announced in an email Thursday afternoon that he is voluntarily resigning, effective immediately.”
  • Best wishes, Mr. Stevens. Thanks for your service.
  • Tammy Flanagan, writing in Govexec, lets us know “what federal employees get wrong about divorce and retirement.”
    • “Errors involving survivor benefits, health coverage and court orders can create financial problems years after a marriage ends.”
  • FedWeek explains “Insuring Children at College and Federal Benefits Considerations (with a Checklist).”

From the Food and Drug Administration front,

  • Radiology Business reports,
    • “Medtronic is recalling more than 18,000 surgical devices due to a risk of contamination. The recall includes certain lots of the company’s Gundry and DLP retrograde cannulae, which are cardiopulmonary bypass vascular catheters used to perform open heart surgeries.
    • “This recall was put in place due to the potential of a sterile barrier breach. Only certain lots of these devices are included in the recall.
    • ‘The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall. This means the agency believes these devices could cause “temporary or medically reversible adverse health consequences.”
  • STAT News relates,
    • “Wearable maker Whoop has not resolved a dispute with the Food and Drug Administration over a blood pressure feature the company launched last year, according to a top health executive at the company. 
    • “FDA warned Whoop last July over the feature that gives users a daily estimate of their systolic and diastolic blood pressure, saying that it’s a medical device that requires agency review. Whoop argues that the feature is exempt from FDA review because it is intended for wellness purposes.” * * *
    • “The dispute between FDA and Whoop turned up the heat in a simmering debate about how the agency ought to oversee low-risk products. Proponents of deregulation argue that the time and expense required for FDA authorization impede innovation and that FDA review is unnecessary to ensure the safety of many products that potentially benefit consumers.”

From the judicial front,

  • Federal News Network reports,
    • “Some federal employees may now have an easier time qualifying for disability retirement benefits, following a recent precedential decision from the U.S. Court of Appeals for the Federal Circuit.”
    • “In April, the court ruled that federal employees’ disability retirement applications cannot be denied solely based on a lack of “objective” medical evidence. The ruling applies in cases where federal employees have already been removed from their jobs due to a “medical inability to perform.”
    • “Objective documentation, like lab tests or prescription lists, can support an argument but cannot be the sole basis for denying claims, the court said. “Subjective” medical evidence, like a diagnosis based on self-described symptoms, must also be considered. If employees’ disability retirement claims rely on subjective evidence, they won’t automatically be denied benefits.
    • “The decision last month overturned a 2024 ruling from the Merit Systems Protection Board, which had upheld the Office of Personnel Management’s denial of a disability retirement application from a former OPM employee in 2016.”
  • The New York Times relates,
    • “The Justice Department announced charges on Thursday against 15 people for attempting to defraud Minnesota Medicaid and other social service programs in the state of more than $90 million. 
    • “Top officials, including Robert F. Kennedy Jr., the health and human services secretary, and Mehmet Oz, head of the Centers for Medicare and Medicaid Services, appeared in Minneapolis to announce the charges. “The fraud here in Minnesota is shocking,” said Colin McDonald, an assistant attorney general overseeing the administration’s crackdown on fraud.
    • “Among the defendants are an owner and an employee of autism clinics, who are charged with submitting $46.6 million in fraudulent claims to Medicaid, the public health plan that covers low-income people. Additional defendants were charged with filing bogus claims to Medicaid for other services, including those that assist disabled people with obtaining housing and living independently.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The world’s most popular weight-loss and diabetes drugs are linked to a powerful new possible benefit: better outcomes for cancer patients. 
    • “A suite of four new studies suggest that people taking so-called GLP-1 drugs like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro saw reductions in tumor progression, lower overall chance of death and less risk of developing breast cancer.
    • “It’s really provocative that they showed, in several cancers, that people who took these drugs seem to have a lower risk of their cancer returning,” said Dr. Jennifer Ligibel, a breast oncologist at the Dana-Farber Cancer Institute who wasn’t involved in any of the studies.
    • “One study from researchers at the Cleveland Clinic Cancer Institute tracked more than 10,000 patients with early-stage cancers who started GLP-1 drugs after diagnosis and compared their disease progression to those on a different diabetes medication. Those on GLP-1s were less likely to see their cancer spread.
    • “In lung cancer patients, the rate of progression to advanced disease was cut roughly in half—10% in GLP-1 users versus 22% in the comparison group. Breast cancer patients showed a similar pattern, with progression rates of 10% versus 20%. Colorectal and liver cancers also showed statistically significant reductions.”
  • and
    • “An investigational drug developed by Eli Lilly LLY  delivered clinically meaningful weight loss in a trial, the company said as it looks to expand its obesity treatment portfolio amid soaring demand.
    • “Lilly said Thursday that retatrutide, designed to be taken once a week, met the primary endpoint in a phase 3 clinical trial, as well as key secondary endpoints.
    • “According to Ania Jastreboff, a Yale School of Medicine professor and lead investigator for the trial, every dose of retatrutide assessed resulted in clinically meaningful weight reduction for nearly all participants. On average, those with severe obesity on the highest dose lost 30% of their body weight over two years, Jastreboff added.
    • “The trial evaluated the therapy’s efficacy and safety on adults who are overweight and had other medical conditions such as type 2 diabetes, chronic pain and cardiovascular issues.
    • “More results will be shared later this year, Lilly added.”
  • Healio adds,
    • “Studies show that GLP-1 receptor agonists have significant potential for treating glaucoma, diabetic retinopathy and other eye diseases, but important nuances remain to be investigated, according to a review published in BMC Ophthalmology.
    • “Although GLP-1 RAs have revolutionized metabolic disease management, their potential therapeutic role in ocular diseases — particularly those driven by shared metabolic and inflammatory pathways — remains underexplored,” Yu Luo, of Beijing University of Chinese Medicine, and colleagues wrote. “Their multifaceted neuroprotective properties and anti-inflammatory mechanisms present a distinctive therapeutic opportunity for ophthalmic pathologies, potentially offering direct ocular benefits beyond systemic metabolic control.”
  • and
    • “Adults with obesity achieved greater long-term weight loss if they partook in a nutrition plan designed for rapid weight loss compared with one designed for gradual weight loss, according to trial data.
    • “Line Kristin Johnson, RD, PhD, senior researcher at Vestfold Hospital Trust in Norway, said there has been debate among researchers regarding whether rapid weight loss leads to worse long-term outcomes for people with obesity. In findings from a randomized pragmatic trial presented at the European Congress on Obesity, Johnson and colleagues found implementing a calorie-restricted eating pattern for rapid weight loss can induce a larger decrease in body weight at 1 year than a gradual weight-loss eating pattern.”
  • Endocrinology Advisor points out,
    • “Life-course body size progression, particularly transitioning from a thinner childhood body size to adult obesity, significantly increases risks for stroke, coronary artery disease, and heart failure.”
  • Healio also notes,
    • “Only a third of cancer survivors receive advice on weight control and improving their diet from health care professionals, and less than half are informed about the benefits of physical activity.
    • “Individuals who do receive advice on losing weight, salt and fat intake, and exercise are three to eight times more likely to engage in healthy behaviors than those who did not.
    • “We need more effort to deliver lifestyle behaviors to patients,” Chao Cao, PhD, MPH, instructor in the department of medical oncology at Dana-Farber Cancer Institute, told Healio.”
  • Fierce Pharma tells us,
    • “Phase 3 data for Merck & Co. and Kelun-Biotech’s antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) suggest the race is heating up to establish a new standard of care in first-line non-small cell lung cancer.
    • “According to an abstract released ahead of the ASCO 2026 annual meeting, combining the TROP2-directed ADC with Keytruda slashed the risk of disease progression or death by a major 65% compared with Keytruda alone in treatment-naïve, PD-L1-positive NSCLC. The p-value is below 0.0001, suggesting high statistical significance.
    • “Key overall survival results, which will underpin regulatory considerations in first-line NSCLC, were not mature at the Sept. 29, 2025, data cutoff, but a strong trend with a preliminary 45% improvement in favor of the combo arm was observed.” 
  • Per MedPage Today,
    • “Undetected attention deficit-hyperactivity disorder (ADHD) was not uncommon among adults hospitalized after traffic accidents, according to a cross-sectional study from the Dominican Republic.
    • ‘Among 95 adults admitted for traffic-related injuries without a prior diagnosis, more than a third (34.7%) screened positive on the Adult ADHD Self-Report Scale, reported Amanda Abreu, MD, of the Universidad Iberoamericana in Santo Domingo, Dominican Republic.
    • “High-risk driving behaviors — including violations, mistakes, and slips — were more common among adults who screened positive (66.6% vs 30.6%, P=0.0016), she reported at the American Psychiatric Association annual meeting.
    • “We’re not saying that ADHD alone caused the accidents, nor are they unsafe drivers, but these findings suggest that this is a really vulnerable population we should look into, and we should help protect,” Abreu said.”
  • and
    • “Low-risk pancreatic cystic lesions were found to be associated with a long-term risk of pancreatic cancer in a retrospective cohort study.
    • “The incidence rate of pancreatic cancer among patients with pancreatic cystic lesions was higher than that of the general population (1.89 vs 0.14 per 1,000 person-years).
    • ‘Over a quarter of patients were diagnosed with pancreatic cancer more than 5 years after detection of lesions, suggesting longer-term follow-up is needed to avoid missed diagnoses.”
  • Per the Wall Street Journal,
    • “New French research links natural food color additives to increased risks of Type 2 diabetes and cancer, similar to synthetic dyes.
    • “Beta-carotene, curcumin and anthocyanins used as color additives were linked to a higher risk of Type 2 diabetes. Beta-carotene used as a food coloring was also linked to breast cancer.
    • “The findings challenge the Trump administration’s push for natural dyes and food companies’ shift away from artificial colors.”
  • Per BioPharma Dive,
    • “BioMarin is looking to expand the use of its top-selling medicine, Voxzogo, with positive study results released Wednesday.
    • I’n 2021, Voxzogo became the first drug approved to improve growth in children with achondroplasia, the most common form of dwarfism. The new results pertain to a related condition called hypochondroplasia that generally presents in less severe ways and might not be noticed until later in a child’s life.
    • ‘In the Phase 3 trial, researchers found participants given Voxzogo were growing faster than those who received a placebo. After a year, the Voxzogo patients also had significant increases in standing height and arm span, a key finding that could help children function better in daily tasks and retain more independence.”

From the U.S. healthcare business and artificial intelligence front,

  • Managed Healthcare Executive reports,
    • ‘For the average person, healthcare costs rose 7.9% in 2026 to $8,460, which is the highest annual increase in more than a decade, according to the 2026 Milliman Medical Index
      (MMI). For a hypothetical family of four, healthcare costs reached $37,824, Milliman found. The Milliman Medical Index measures healthcare costs covered by a typical employer-sponsored health insurance plan.”
    • “The increase reflects structural forces that are not going away, Milliman Principal and Consulting Actuary Deana Bell said in a news release. “Outpatient costs have quadrupled for the MMI’s family of four since the MMI was first published in 2005, with much of the trend exacerbated by delivery system consolidation, specialty drug growth, and site-of-care shifts.”
  • Beckers Hospital Review relates,
    • “The National Council of State Boards of Nursing found the District of Columbia has the most licensed nurses per capita, while Utah is the state with the fewest for the second year in a row.
    • “The organization created a course of nursing licensure statistics in the U.S. and its territories. The data was compiled using the NCSBN’s database and Nursys, an electronic information system where regulatory bodies enter licensure data. All of the council’s 58 members shared licensure data, which amounted to 6,903,665 registered and practical nurses — up from 6,870,362 last year.
    • ‘According to the data, Wyoming and Vermont had the fewest licensed nurses in their states overall, at 9,620 and 13,528, respectively. Meanwhile, California and New York had the most licensed nurses at 708,141 and 610,207, respectively.” 
  • Healthcare Dive tells us,
    • “Nonprofit health system Providence is throwing in the towel on the majority of its health insurance businesses, citing the difficulty of running a regional health plan amid regulatory pressures and rising costs.
    • “Starting next year, Providence, which covers about 440,000 people in a handful of western states, will no longer offer Medicaid, Affordable Care Act or employer-sponsored plans, the Renton, Washington-based system announced on Wednesday.
    • ‘The decision comes as Providence attempts to shore up its financial footing and refocus on delivering care. Still, the company plans to maintain its Medicare Advantage operations through a partnership with a national carrier, according to the release.”
  • Modern Healthcare tells us,
    • “Sutter Health and Allina Health have moved a step closer to joining forces.
    • “Sacramento, California-based Sutter and Minneapolis-based Allina said Thursday they signed a definitive agreement to form a $26 billion combined system with 39 hospitals. The agreement follows a letter of intent announced in March. The proposal is on track to close by the end of the year pending customary regulatory approval, the organizations said in a news release.” 
  • BioPharma Dive informs us,
    • “Eli Lilly has snagged Engage Biologics, a biotechnology company that aims to deliver genetic medicines without viral payloads, in a deal worth up to $202 million.
    • “Lilly said Wednesday it has acquired the preclinical biotech in an all-cash deal, including an undisclosed upfront payment, with the possibility of future payouts based on research, development and commercialization milestones. The acquisition gives Lilly non-viral DNA delivery technology, dubbed the “Tethosome” platform.
    • “We believe that the combination of Engage’s platform with Lilly’s significant capabilities will meaningfully accelerate development of new genetic therapies,” Will Olsen, co-founder and CEO of Engage, said in a statement.”
  • Fierce Healthcare lets us know,
    • “Electronic medical record (EMR) company Canvas Medical launched Canvas Studio Thursday, a no-code interface that allows clinicians and other healthcare professionals to build custom EMR workflows.
    • “Canvas Medical CEO Adam Farren told Fierce Healthcare the company was “serving a market” for software developers to customize workflows for end users within its ONC-certified EHR platform. 
    • “What Studio does is replace the developer with an AI agent, so that the end user, the clinician or administrative staff user, can directly customize and extend Canvas themselves using the agent,” Farren said.”
  • and
    • “Employers are set to significantly increase their use of AI in health benefits, a new survey shows, even as they continue to face barriers to rolling out the tech.
    • “WTW polled 312 employers with about 4.6 million workers for the 2026 AI Use in Health and Benefits Survey, and found that 72% of those surveyed plan to embed AI into their benefits programs in the next two years. By comparison, only 20% said they are currently doing so.
    • “The employers cited several key areas where they see AI likely supporting benefits at work, such as improved communication, cited by 68%, and data insights and analytics, noted by 59%. In addition, 57% of those surveyed said AI would likely support greater personalization.
    • “Jeff Chandler, North America commercialization leader for Health & Benefits at WTW, said in a press release that these top priorities are all “areas where AI can materially improve how benefits teams make decisions and support employees.”

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

Medium adds, “Simplicity, though not traditionally viewed as a virtue, is the greatest virtue of all because it makes practicing every other virtue that much easier.”

From Washington, DC,

  • Healthcare Dive reports,
    • “Senate Democrats are trying to roll back a pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare. 
    • “Sens. Ron Wyden, D-Ore., Maria Cantwell, D-Wash., Richard Blumenthal, D-Conn., and Kirsten Gillibrand, D-N.Y., introduced a resolution Wednesday that would invoke the Congressional Review Act — a legislative tool lawmakers can use to overturn agency actions — to end the WISeR model, which went into effect in six states this year. 
    • “Democrats have railed against the pilot for months, arguing the model delays or denies Medicare beneficiaries’ care. “Americans are sick and tired of abusive prior authorization tactics putting needed health care out of reach,” Wyden said in a statement. “The last thing seniors need is even more AI denying the care they need.”
  • The American Hospital Association relates,
    • “The AHA May 20 provided comments to the House Energy and Commerce Subcommittee on Health for a hearing on the physician fee schedule, the Medicare Access and CHIP Reauthorization Act and potential payment reform. The AHA highlighted responses to previous congressional requests for information on reform to MACRA and physician payments. They include asking Congress to provide conversion factor updates for the physician fee schedule that reflect changes in input costs and inflation, and to improve cost measures used in the Merit-based Incentive Payment System. The AHA also outlined policy considerations for alternative payment model design, advanced APM participation incentives and accountable care organizations.” 
  • STAT News tells us,
    • “Health secretary Robert F. Kennedy Jr. has elevated a senior health official to serve as an interim surgeon general until that position is filled by a Senate-confirmed nominee. 
    • “Stephanie Haridopolos, a family medicine physician who is currently a senior adviser and chief of staff for the Office of the U.S. Surgeon General, is now the office’s director of health communications, Kennedy told staff in an email sent late Tuesday. According to that email, Assistant Secretary for Health Brian Christine used his “delegation of authority powers” to allow Haridopolos to carry out the duties of surgeon general. 
    • “She will “promote [U.S. Surgeon General] public health actions, advisories, and guidance until our next Surgeon General is sworn into office,” Kennedy said.”
  • An HHS news release adds,
    • “The U.S. Department of Health and Human Services (HHS) Office of the Surgeon General today released the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents, which raises national awareness about the growing risks associated with excessive and harmful screen use among young people.
    • “Children and adolescents now spend as much or more time on screens as they do sleeping or in school. National estimates show that adolescents average seven to nine hours a day on entertainment screens, and most report using their devices right before bed. What they encounter online and the excessive, and sometimes compulsive, use of screens is increasingly linked to real-world harm.” * * *
    • The Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents is available at https://www.surgeongeneral.gov. Additional resources for families, schools, and communities are available here.
  • Govexec informs us,
    • “Federal employee morale dropped last year, as President Donald Trump downsized and otherwise overhauled the civil service, according to a new data analysis from Gallup. 
    • “[A]fter the reforms took effect, federal workers experienced declines in employee engagement and job satisfaction, alongside increases in burnout and job-search activity,” the researchers wrote. “These shifts were larger than those observed among comparable state and local government workers — and private sector counterparts — during the same period.”
    • “The analytics firm noted, however, that the data shows there was a “rebound” in some areas by the end of 2025.” 
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) proposed today a sweeping crackdown on state Medicaid payment practices that have driven payment rates well above Medicare levels, leading to excessive federal costs. The Medicaid Managed Care State Directed Payments (SDP) and Medicaid Fee-for-Service (FFS) Targeted Practitioner Payments Proposed Rule would set clear caps and better align Medicaid payments with Medicare standards. If finalized, the proposed rule would generate an estimated $775 billion in total savings over 10 years, including $510 billion in federal savings. Our goal: to refocus Medicaid dollars on individuals and families instead of inefficient payment schemes.
    • “The proposed rule would:
      • “Cap SDP provider payment rates at 100% of Medicare payment rates for expansion states and 110% of Medicare payment rates for non-expansion states (or 100% of the Medicaid state plan rate if a comparable Medicare rate is not available), consistent with section 71116 of the WFTC legislation and historical Medicaid FFS payment levels,
      • “Apply similar limits to certain targeted Medicaid fee-for-service payments, and
      • ‘Establish consistent national standards to improve transparency and accountability.
    • “CMS is seeking public comment on the proposed rule, including feedback on implementation. “To view the proposed rule on the Federal Register, visit: https://www.federalregister.gov/d/2026-10292. 
    • “To view the fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/medicaid-managed-care-state-directed-payments-medicaid-fee-service-targeted-medicaid-practitioner“

From the Food and Drug Administration front,

  • BioSpace reports,
    • “No child deaths were directly linked to COVID-19 vaccines, according to the FDA’s long-awaited analysis of adverse events.
    • “Late last year, former CBER director Vinay Prasad claimed in a leaked internal memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The FDA, after much blowback from the industry and independent experts, promised to disclose its analysis by the end of 2025, but the agency largely kept its specific findings under wraps.
    • “Those findings were made publicly available last week as part of a letter from Sen. Ron Johnson (R-WI) to health secretary Robert F. Kennedy, Jr., seeking for greater transparency around the safety of COVID-19 vaccines.”
  • Fierce Pharma relates,
    • “Patrick Soon-Shiong’s ImmunityBio has convinced the FDA to weigh its case for a potential expansion of its bladder cancer med Anktiva, citing “overlapping features” in the indication it’s targeting with the interleukin-15 agonist’s existing approval. 
    • “The FDA has now accepted ImmunityBio’s application for Anktiva plus the Bacillus Calmette-Guérin (BCG) vaccine in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA has set a target decision date of Jan. 6, 2027, ImmunityBio said in a May 19 release.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention yesterday issued an advisory on the Ebola disease outbreak in the Democratic Republic of the Congo and Uganda. The agency said the risk of spread to the U.S. is currently considered low. The notice includes recommendations for clinicians and guidance for U.S. travelers visiting DRC or Uganda. The World Health Organization declared a public health emergency of international concern May 17 due to the outbreak.” 
  • The Washington Post relates,
    • “Teens averaged over 50 minutes of smartphone use between the hours of 10 p.m. and 6 a.m. on school nights, researchers found, and nearly half of the teens used their phones between midnight and 4 a.m. The majority of that phone use was spent on social media apps like YouTube, Instagram or TikTok, the study found. Others were looking at streaming apps or playing games like Roblox or Clash Royale.
    • “The study, published Monday in the journal JAMA Pediatrics, followed the screen use of 657 adolescents, a cohort with an average age of 15. All are participants in the national Adolescent Brain Cognitive Development Study, which includes a racially and economically diverse sample of children and is the largest long-term study of brain development and child health in the United States. 
    • “Researchers drew data from an app installed on the teens’ phones that passively tracked their screen use patterns, said Jason Nagata, the lead author and an associate professor of pediatrics at the University of California at San Francisco. This is significant because “a lot of prior studies have relied on self-reporting of screen use,” he said, which isn’t as thorough or accurate.” * * *
    • “And the full impact on sleep likely goes beyond the minutes spent staring at a glowing screen, Nagata adds. Social media use in particular “is very emotionally activating,” he says. “There’s a lot of stimulation, and that can make it harder for teens in particular to wind down, even after you’ve turned the phone off.”
  • Genetic Engineering and BioTechnology News tells us,
    • “Researchers headed by a team at Icahn School of Medicine at Mount Sinai have discovered that many gut bacteria use a flexible survival strategy—known as epigenetic “bet-hedging”—to withstand disruptions such as antibiotics and diet changes.
    • “Studying infant and gut microbiomes, the investigators showed that microbes can switch between functional states, rather than relying solely on genetic mutations, to try to survive shifting conditions. While bet-hedging has been observed in disease-causing bacteria, this is the first study to show that it is widespread among the beneficial microbes that make up the healthy human gut.
    • “The findings shed light on a previously hidden layer of microbiome biology and may help explain why probiotics and fecal microbiota transplantation (FMT) produce inconsistent benefits across individuals.
    • “Gang Fang, PhD, professor of genetics and genomic sciences and director of the Center for Genomic AI and Microbiome Medicine at the Icahn School of Medicine at Mount Sinai, is senior and corresponding author of the team’s published paper in Cell Host & Microbe, titled “Epigenetic phase variation in the gut microbiome enhances bacterial adaptation
  • STAT News adds,
    • “While Tippi MacKenzie was a postdoctoral fellow in the early 2000s, she and her lab mates experimented with using the then-new technology of gene replacement therapy to try to treat inherited disorders in mice before they were born. Over and over it worked. They cured mice with hemophilia and mice with tyrosinemia. And the whole time, people kept telling her that gene therapy in human fetuses was just around the corner, just five years away. 
    • “It’s now been 25 years, and such a reality has yet to materialize. But after promising discussions with the Food and Drug Administration, MacKenzie is now closer than anyone’s ever been.
    • “Her team has submitted an investigational new drug (IND) application to the agency seeking approval for a small trial that aims to treat five fetal patients with a rare lysosomal storage disorder. The agency told them they could bypass animal testing, because the safety profile of the vector they plan to use already has been so well characterized by other academics and companies developing gene therapies for kids and adults.
    • “Thinking back on it, of course, you can’t really do in utero gene therapy until the field of adult and pediatric gene therapy has been well established,” MacKenzie said Tuesday at STAT’s Breakthrough Summit West. “So we basically had to wait for everything to catch up.”
  • Per a National Institute of Standards and Technology news release,
    • “My Research Is Working Toward a Pain-Free Mammogram Alternative.”\
      • “A woman in the U.S. has a one in eight chance of developing breast cancer. That’s a scary number, but the good news is that more women are being diagnosed early and surviving than ever before. 
      • “We have a long way to go before low-field MRI becomes a common alternative to mammograms. But my fellow researchers and I will continue to work to make this happen, because all patients deserve a highly accurate and pain-free approach to screening for breast cancer.” 
  • Medscape informs us,
    • “Digital tools can enhance GLP-1 therapy for obesity and diabetes by bridging gaps in patient education and follow-up. However, clinicians must focus on meaningful outcomes and personalized guidance to ensure effective use and adherence.”
  • MedPage Today points out,
    • “Antibiotics are sometimes prescribed for lower back pain when more conventional therapies don’t work, based on some studies showing bacteria in affected spinal discs.
    • “In this randomized trial, no benefit from amoxicillin-clavulanate could be discerned for patients with refractory low back pain and herniated discs at 1 year.
    • “The authors recommended that antibiotics no longer be prescribed for this indication.”
  • Per Healio,
    • “Data collected from a number of clinical trials found that despite recent “buzz,” there is no significant link between GLP-1 receptor agonists and the progression of diabetic retinopathy, according to a speaker.
    • “These medications have been labeled not to be good for patients who have preexisting diabetic retinopathy, but I don’t think that is fair,” Majda Hadziahmetovic, MD, associate professor of ophthalmology at Duke University, said during a virtual presentation at Real World Ophthalmology.“Those conclusions actually came from two main clinical trials, and both of those clinical trials were cardiovascular outcome trials. Diabetic retinopathy and retinal health were just the side effects that they were not looking at very carefully.”
  • and
    • “Self-collection may be as effective as clinician-collected HPV tests and improve screening rates.
    • “But its implementation requires OB/GYNs to first transition [from pap smears] to primary high-risk HPV screening.”
  • Infectious Disease Advisor adds,
    • “Screening recommendations for HCV [hepatitis C] have expanded in recent years to include universal screening among adults, with an emphasis on reflexive testing strategies in which a positive HCV antibody (Ab) result automatically triggers confirmatory RNA testing. This approach is intended to reduce delays in diagnosis and improve identification of patients eligible for treatment. To evaluate how these recommendations have influenced testing practices, researchers conducted a retrospective analysis of HCV testing patterns from 2018 to 2024 within a large US commercial laboratory network.” * * *
    • “Increased adoption of reflexive HCV testing, alongside laboratory stewardship initiatives and updated screening recommendations, has contributed to more complete and timely diagnostic evaluation of HCV infection.”
  • Per MedTech Dive,
    • “Medtronic on Wednesday said two analyses of its Symplicity Spyral renal denervation system, presented as abstracts at the EuroPCR meeting in Paris, showed the procedure significantly reduced blood pressure in patients over three years.
    • “Outcomes after renal denervation for 787 patients who had prior cardiovascular events were evaluated in one study, while the second followed 903 people with severe hypertension.
    • “The analyses, from the global SYMPLICITY registry, add to a growing body of evidence supporting renal denervation, Medtronic said.”

From the U.S. healthcare business and artificial intelligence front,

  • 401k Specialist reports,
    • “While some workers believe they’ll be employed past retirement age, the truth is that some may be forced into an early retirement.  
    • “Findings from the 2026 Annual Retirement Study from the Allianz Center for the Future of Retirement show that over half of Americans (53%) currently have a target age they plan to retire at.
    • “However, the reality is that many depart the workforce earlier than initially expected. While the findings report that 53% of Americans retired on their own schedule, 42% had to retire earlier than planned. In fact, only 5% of retirees surveyed reported leaving their role later than anticipated.
    • “The findings emulate recent research from the Society of Actuaries, which showed that 59% of its respondents retired earlier, and only 6% left the workforce later than planned.
    • “When asked why they exited the workforce earlier, Allianz found that most reasons were beyond the retiree’s control. Common causes included health issues that prevented job performance (30%) and unexpected job loss (21%), while others realized they were financially ready earlier than expected (21%).
    • “Finances, as expected, play a major role when deciding when to retire. Retirees must consider day-to-day costs and inflation numbers, along with necessary expenses like medical expenditures as they age.
  • Fierce Healthcare relates,
    • “Patient collections are playing a bigger and bigger role in health systems’ total revenues, bringing a new focus on the difficulties organizations face in securing timely, or any, payments for their services, a new survey report warns. 
    • ‘The poll of 205 healthcare revenue heads, conducted by healthcare fintech vendor PayZen and the Healthcare Financial Management Association, found that 22% of respondents named patient balances as their top priority, roughly double the 11% rate reported a year prior. Patient balances were a “nearly universal” presence among the respondents’ concerns, also up from the 73% rate of a year prior. 
    • “Commercial revenue remained the respondents’ overall top priority, though the portion who indicated so dipped from last year’s 75% to 62%. Government program revenue also inched upward from 13% to 16%, naming it their top revenue concern.” 
  • and
    • “Maven, a virtual provider for women’s and family health, has launched its direct-to-consumer products featuring a virtual care clinic, a GLP-1 offering and a hormone therapy offering.
    • “They are available through cash-pay for now. The goal is to close gaps between prescriptions and follow-ups that GLP-1s and hormone therapies require. 
    • “In terms of pricing, the GLP-1s start at $150 a month. For the hormone product, there is a $150 1-time fee, which includes two virtual visits, in addition to medication costs. Specialty care visits in the virtual clinic are currently pay-per-visit, though insurance coverage for those is the eventual goal.”
  • BioPharma Dive tells us,
    • “Privately held Mentari Therapeutics plans to hit the public markets through a reverse merger with InMed Pharmaceuticals, creating a combined company focused on antibody drugs that can prevent migraines.
    • “The deal, announced Tuesday, has already received approval from the boards of both parties and is expected to close in the back half of this year. Terms hold that InMed shareholders would own roughly 1.5% of the combined company, which is slated to have a pro forma equity value of about $421 million. Baked into that value is a concurrent private placement that will result in gross proceeds of approximately $290 million.”
  • MedTech Dive informs us,
    • “Medtronic said Wednesday it has agreed to buy SPR Therapeutics, a company making a device that uses peripheral nerve stimulation to treat chronic pain.
    • “Under the terms of the deal, Medtronic would pay $650 million in cash to buy all outstanding equity in SPR Therapeutics. The purchase would add to Medtronic’s neuromodulation business, allowing the company to provide more pain relief options earlier in people’s care.
    • “The deal is Medtronic’s third major acquisition announced so far this year. In March, Medtronic agreed to buy neurovascular technology company Scientia Vascular for $550 million, and in February, the company announced plans to buy CathWorks, which makes tools to help detect coronary artery disease, for up to $585 million. Medtronic closed the CathWorks acquisition in April.”
  • Per Healthcare Dive,
    • Aetna’s chief digital and technology officer on how the insurer is using AI for patient engagement
    • Nathan Frank discusses how the insurer is using AI to engage members, how the company thinks about risks, and the importance of monitoring the tools and soliciting feedback.
  • Per Fierce BioTech,
    • “The big new thing in medtech for 2026 is AI-powered apps and chatbots designed to help patients navigate their laboratory test results. Now, testing giant Labcorp is getting in on the act. 
    • “The company is launching “MyLabcorp,” a mobile app that brings together lab results with AI-enabled features and clinical guideline-based content.
    • “The idea is that this can be viewed on a user’s phone via the app, giving users “additional context about their health and support more informed conversations with healthcare providers,” according to a May 20 statement.” 
  • Per Fierce Healthcare,
    • “Doximity plans to accelerate its spending on artificial intelligence this year as it aims to become a leading AI platform for doctors.
    • “The health tech company plans to up its R&D and compute spend along with more investments in brand marketing and its AI-enabled peer review capabilities, executives said during the company’s recent earnings call for its fiscal 2026 fourth quarter and full year results. The company’s 2027 fiscal year began April 1.
    • “The company plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask (formerly DoxGPT).” 

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–

A few years ago, the FEHBlog stopped including pictures because they disrupted the blog’s flow. It occurred to the FEHBlog that it could not hurt the flow to add a slogan which the FEHBlog appropriately am borrowing from the OPM Director Scott Kupor:

“Simplicity is a virtue.”

The FEHBlog chose this slogan to remind us that we should aim to simplify the healthcare system in our country, including the beloved FEHB and PSHB programs.

From Washington, DC,

  • Roll Call reports,
    • “The Homeland Security Department would get a new influx of funding to investigate child exploitation cases, including to identify victims of sexual abuse material online, under the GOP budget reconciliation bill. 
    • “The $108.5 million added in a substitute amendment Tuesday would support hiring additional investigators and forensic analysts within the department. The roughly $72 billion immigration enforcement package advanced out of the Senate Homeland Security and Governmental Affairs Committee on an 8-5 vote.
    • “Sen. Josh Hawley, R-Mo., pushed to include the funds in reconciliation, which he said would allow DHS to add 200 new positions to “rescue children who have been captured by sex trafficking, including a new program for local, state and federal law enforcement to coordinate their efforts.”
  • The Hill relates,
    • “The Department of Health and Human Services (HHS) on Monday withdrew its amended charter for a highly influential vaccine advisory committee that would have loosened eligibility requirements, citing administrative errors.
    • “In a notice set to be officially published in the Federal Register, HHS formally withdrew its proposed amendment to the charter for the Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention.”
  • Here’s a link to the White House’s fact sheet on yesterday’s expansion of TrumpRx to include 600 generic drugs.
  • Fierce Healthcare tells us,
    • “A new analysis from the Office of Inspector General found a similar net cost for drugs through vertically-integrated Part D plans compared to other plans.
    • “Vertically-integrated firms accounted for 35% of contracts Part D in 2023, according to OIG’s report. Eleven of the 300 organizations offering Part D coverage that year were considered vertically integrated, meaning they also owned a pharmacy benefit manager.
    • “While net drug costs were on par between the two types of organizations, the study found that vertically integrated firms came to those prices through different means than other organizations. In most cases, vertically integrated Part D plans paid pharmacies more initially but then clawed back more through fees and rebates to reach a net price.
    • “Other Part D plans, meanwhile, generally paid less upfront but also got less back from pharmacies later on.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a $7.5 million investment to expand Americans’ access to high-quality protein, strengthen nutrition security, and reduce food waste nationwide. Through a new agreement with HATCH for Hunger, HHS will support a national initiative to redirect surplus protein to families in need, improve health outcomes, and help reduce the burden of chronic disease. This effort aligns with the Dietary Guidelines for Americans (DGAs), which emphasize the importance of protein-rich foods like meats, eggs, and dairy as part of a healthy diet.
    • “The U.S. Department of Agriculture (USDA) also announced its intent to fund a competitive grant program to strengthen cold chain infrastructure for emergency food assistance operations, including faith-based partners who serve communities in need. USDA will provide up to $7.5 million to help eligible nonprofit organizations safely distribute nutrient-dense proteins such as meat, eggs, seafood, and dairy to Americans in need. Additional information will be forthcoming from the Department.”
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services has released its fiscal year 2025 Program for Evaluating Payment Patterns Electronic Reports, or PEPPERs, for critical access hospitals. The reports help hospitals review their billing data to ensure accurate claims. They can be used to identify billing patterns that may need improvement, locate areas that may need audits or additional monitoring, find diagnosis-related groups that may be under- or over-coded, and track areas where patient stays are becoming longer. The reports can be accessed by authorized officials, access managers and users with the staff end user business function through CMS’ PEPPER Portal. CMS also has a guide and FAQ available for users on accessing the PEPPER. Additionally, CMS said it will host a webinar this summer for CAHs and short-term acute care hospitals.”
  • Modern Healthcare adds,
    • “The Health and Human Services Department Office of Inspector General is auditing every Medicaid Fraud Control Unit as it questions their efficacy.
    • “Medicaid fraud units recovered about $2 billion in fiscal 2025, but data show state to state variation in the level of convictions and recoupments.
    • “Providers should watch for tougher state enforcement as HHS scrutinizes state Medicaid fraud units.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has granted Coya 302 a fast-track designation for ALS, according to a press release from Coya Therapeutics.” * * *
    • “Coya 302 combines a low dose of IL-2 with CTLA-4 immunoglobulin in a subcutaneous form.
    • “The therapy enhances regulatory T-cell function while suppressing pro-inflammatory monocytes and macrophages.”
  • and
    • “The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.
    • “Golimumab-sldi (Immgolis, Accord BioPharma) has been approved as a biosimilar to golimumab (Simponi, Johnson & Johnson) for adults with moderately to severely active ulcerative colitis. It is administered via subcutaneous injection in a single-dose prefilled syringe.”
  • and
    • “The FDA has proposed to withdraw its approval of avacopan for ANCA-associated vasculitis, alleging that employees of the original manufacturer, ChemoCentryx, manipulated data in the sole trial used to assess the drug’s efficacy. 
    • “In a letter to Amgen, which acquired avacopan (Tavneos) in its 2022 purchase of ChemoCentryx, Tracy Beth Høeg, MD, PhD, acting director of the FDA Center for Drug Evaluation and Research (CDER), also asserted that the original new drug application filed by ChemoCentryx contained false statements regarding the trial, known as the ADVOCATE study. The allegations follow post-marketing data released by the FDA in March identifying 76 cases of drug-induced liver injury with possible or probable causal links to avacopan, including seven cases of vanishing bile duct syndrome (VBDS). Of the 76 cases, eight were fatal.”

From the judicial front,

  • Bloomberg Law reports,
    • “At least two lawsuits alleging doctors are abusing arbitration for surprise medical bills are headed to the appeals circuit, escalating yet another issue under the No Surprises Act and creating more pressure on Congress and the Trump administration to revisit the system.” * * *
    • “Last month, Anthem Blue Cross Life and Health Insurance Co. appealed a US District Court’s ruling in California that rejected its ability to sue billing vendor HaloMD and doctor group Sound Physicians over ineligible claims, even though Anthem alerted the arbitrator to the issue. A federal court in Florida in April also ruledagainst Aetna because it didn’t alert the arbitrator that claims submitted by Radiology Partners were ineligible.
    • “The cases are now at the US Court of Appeals for the Ninth and Eleventh circuits, respectively.”
  • STAT News adds,
    • “A new dashboard produced by Turquoise Health, a company that specializes in price transparency data, illustrates just how lucrative the process has become for clinicians. The tool, which is free to use, compares the median in-network rates that health insurers and providers negotiate to the amounts out-of-network providers are being awarded for the same services under federal arbitration. The former comes from federal Transparency in Coverage files, and the latter from the Centers for Medicare and Medicaid Services. 
    • “It also shows the qualifying payment amounts (QPAs) for those services, which is calculated by the insurers and is supposed to represent the median in-network amount for the same service in that area. 
    • “The numbers are striking. Providers took home $9.8 billion in total awards across 5.3 million independent dispute resolution (IDR) decisions between 2023 and the first half of 2025. About 12% of that amount, or $1.2 billion, was fees paid to the arbiters. IDR awards were about nine times the QPA for the same service in the same area, although, as with the lumbar laminectomy, some ran much, much higher. 
    • “This just seems like an area where the costs are rampant and way over where they should be — certainly higher than CMS intended when they set all this stuff up,” said Leland Robbins, Turquoise Health’s senior director of data products.”
  • Per a Justice Department news release,
    • “A jury in the Central District of California convicted a California doctor yesterday in a $45 million scheme to defraud Medicare by submitting claims for Botox injections that were never provided and medically unnecessary, and for obstructing the investigation by manipulating and altering medical records in an attempt to mislead criminal investigators. The investigation was initiated as a result of a referral from the Health Care Fraud Section’s Data Analytics Team, after its analysis showed that the defendant was paid more by Medicare for Botox injections than any other doctor in the United States.
    • “Violetta Mailyan falsely diagnosed patients, fraudulently billed for Botox injections while she was actually on lavish vacations, and tried to trick federal agents with fake records,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “The Fraud Division’s data-driven approach will shine a light on fraud schemes across the country, ensuring that no doctor can engage in these types of brazen schemes to rob Medicare.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “The idea of drinking during pregnancy sounds like a generational punchline: Someone’s grandmother drank beer to fatten her fetus, another had a nightly martini to get a healthy amount of sleep — presumably unthinkable behavior in today’s America. 
    • “Yet after precipitous declines in the last 50 years, rates of alcohol use in pregnancy in the U.S. started climbing upward a decade ago. More than 1 in 8 pregnant adults reported drinking in the past month, according to STAT’s analysis of 2024 government data, making alcohol use a more common national phenomenon than gestational diabetes. Of those who drank, a quarter reported having four or more drinks in one sitting — binge drinking — in the prior month. 
    • “While rates of alcohol use in pregnancy are lower in the U.S. than those of several peer nations, the effects are all around Americans. Alcohol is the key driver of what are, by some estimates, the nation’s top neurodevelopmental conditions: fetal alcohol spectrum disorders, or FASDs.
    • “The exact prevalence of FASDs is difficult to measure, but the most recent federally funded community studies have found as many as 1 in 20 school-aged children may have a disorder caused by prenatal alcohol exposure. By comparison, about 1 in 31 American children has autism, per recent estimates from the Centers for Disease Control and Prevention.
    • “Not all fetuses exposed to alcohol have birth defects or go on to develop intellectual disabilities, researchers say. But every person born with an FASD was harmed by alcohol specifically. They worry this point is being glossed over as Americans question the conventional medical advice of avoiding all alcohol while pregnant.”
  • The latest post of the National Institutes of Health’s Research Matters covers the following topics:
    • Team-based care improves blood pressure control
      • “Researchers found that a multifaceted intervention was better than a standard approach at reducing high blood pressure among low-income patients.
      • “Similar multifaceted, team-based strategies could be implemented widely to benefit underserved populations.”
    • Effects of early exposure to toxic metals
      • “Scientists found that toxic metal exposures during specific time windows increased the risk of brain and mental health symptoms a decade later.
      • “These results support the need for preventing excessive early life metal exposures and associated harms.”
    • Scientists spur growth of implanted liver tissue
      • “Researchers developed a way to control the growth of lab-grown liver tissue after it was implanted into mice.
      • “The technique could one day lead to alternative treatments for people who need organ transplants.”
  • Health Day relates,
    • “Long-term exposure to smog might increase the risk of Lewy body dementia, the brain disease that CNN founder Ted Turner battled for several years before his recent death, a new study says.
    • “Even small increases in particle pollution and nitrogen dioxide are linked to increased risk of Lewy body dementia (LBD) and Parkinson’s disease-related dementia, researchers reported May 14 in JAMA Network Open.
    • “People’s risk of LBD nearly quadrupled for every incremental increase in exposure to particle pollution, researchers found.
    • “Similarly, risk for Parkinson’s-related dementia more than doubled for every such increase in particle pollution exposure, the study found.
    • “While this research does not establish causation, it does show a clear association between air pollution exposure and increased risk of these dementias,” said researcher Dr. Gregory Pontone, chief of the Aging, Behavioral and Cognitive Neurology Division at the University of Florida in Gainesville.”
  • and
    • “New-onset atrial fibrillation (AF) may accelerate kidney function decline, according to a study published online May 14 in JAMA Network Open.
    • “Yuichiro Mori, M.D., from Kyoto University in Japan, and colleagues conducted a retrospective cohort study to examine the association of new-onset AF with subsequent kidney function decline in working-age adults. Participants included screening attendees aged 35 to 59 years in sinus rhythm without previous AF, cardiovascular comorbidities, or end-stage kidney disease. A total of 23,510 adults who developed new-onset AF during the annual screening interval were matched in a 1:5 ratio to 117,550 individuals who did not develop new-onset AF.”
    • * * * “This finding suggests the importance of cardiovascular-kidney-metabolic perspectives in AF management,” the authors write. “Further investigation is needed on the cumulative impact of AF on chronic kidney disease progression and on the effectiveness of AF treatments for improving kidney outcomes.”
  • The Washington Post informs us,
    • “Modern psychiatry has long struggled with one brutal fact: the people most at risk of suicide often cannot wait weeks for therapy or antidepressants to work. Now, a new study suggests researchers may have found the first drug regimen capable of rapid and sustaining relief from suicidal thoughts across a broad group of patients.
    • “Suicide remains one of the nation’s most urgent public health crises, with roughly 13 million Americans seriously considering it each year and about 50,000 dying by suicide annually.
    • “A study to be presented Tuesday at the American Psychiatric Association’s annual meeting found that a surprising combination of drugs — a single ketamine infusion followed by low-dose buprenorphine — significantly sustained reductions in suicidal ideation in adults with major depressive disorder.
    • “This is really a breakthrough study that provides hope and immediate clinical applications,” said Ned Kalin, editor-in-chief of the journal that will publish the paper and chair of the Department of Psychiatry at the University of Wisconsin School of Medicine and Public Health.
    • “But outside experts who were not involved in the study urged caution.
    • “Bertha Madras, a professor of psychobiology at Harvard Medical School, said that while the findings are intriguing, doctors should be careful not to move too quickly.”
  • Genetic Engineering and Biotechnology News points out,
    • “A University of Bath-led research effort received £500,000 to develop an organ-on-chip device that replicates connections between the brain, gut, and pancreas. The GlucoBrain project is designed to allow researchers to track how signals move between the organs and uncover why diabetes may lead to changes in memory and cognition.
    • “Collaborators include investigators from the University of Oxford and Johns Hopkins. Their findings could pave the way for new treatments to improve the lives of millions of people affected by diabetes, dementia, or both, notes the team.
    • ‘Diabetes and Alzheimer’s disease are two of the world’s most pressing health problems, especially in aging societies. While diabetes is widely known to affect the heart, kidneys, and eyes, growing evidence suggests it is also linked with problems in memory, learning, and brain function. However, the biological mechanisms behind this link remain poorly understood.
    • “Our gut, pancreas, and brain are constantly communicating via a network of signals, helping us regulate hunger and blood sugar,”  says Despina Moschou, PhD, project lead. “But we still don’t fully understand how these signals interact at a cellular level and why glucose levels are linked to cognitive decline. “By creating a connected system on a chip, we can study in real time how signals travel between organs, how diabetes may impair brain function, and how new drugs could help.”
  • MedPage notes,
    • “Men treated with GLP-1 receptor agonists had significant increases in testosterone levels, according to findings from a retrospective analysis.
    • “Among men who received semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro, Zepbound), median total testosterone increased from 320 to 419 ng/dL and median free testosterone increased from 9.0 to 10.4 ng/dL (P<0.001 for both), reported Andrés Heriberto Guillén-Lozoya, MD, of the Mayo Clinic in Rochester, Minnesota, at the American Urological Associationopens in a new tab or window annual meeting.
    • “After adjusting for age and body mass index (BMI), total testosterone increased by a median of 97.6 ng/dL, while free testosterone increased by 1.3 ng/dL (P<0.001 for both).
    • “Meanwhile, median BMI decreased from 33.6 to 30.4 (P<0.001).”
  • Per BioPharma Dive,
    • “A drug prospect from Relay Therapeutics has shown signs in a mid-stage clinical trial that it may be able to treat a cluster of conditions associated with the development of abnormal blood vessels.
    • “In 20 people with these “vascular anomalies,” a 12-week regimen of Relay’s therapy, zovegalisib, was associated with a 60% response rate across all doses tested, the company said Tuesday. Nearly all patients experienced an improvement in symptoms, and responses were observed in people with different disease subtypes and “PIK3CA” mutations driving their condition.
    • “Investigators did have to dial back dosing in 23% of people getting one of the doses Relay will take into further testing. But the company also said no patients discontinued treatment, most common adverse events were “low-grade, manageable, and reversible” and the drug appeared safe enough to envision the kind of “chronic use” that’d be necessary for these conditions. Company shares climbed by about 10% in early Tuesday trading.”
  • Per Fierce Pharma,
    • “Two months after UCB revealed the success of Bimzelx in a head-to-head trial against AbbVie’s Skyrizi in patients with psoriatic arthritis (PsA), the Belgian drugmaker has unveiled the detailed results.
    • ‘In the phase 3b study that included 553 patients, 49% of those on Bimzelx achieved reduced disease activity versus 38% of those on Skyrizi at week 16. The result was deemed to be statistically significant, UCB said.
    • “The disease activity primary endpoint was measured by ACR50, which is a composite efficacy measurement, specified by the American College of Rheumatology, which indicates 50% or greater improvement from baseline in tender or swollen joint counts in addition to 50% improvement in three of five other disease markers.”
  • Per MedTech Dive,
    • “Boston Scientific said Tuesday a pivotal study of its coronary intravascular lithotripsy catheter to treat severely calcified coronary artery disease met its primary safety and effectiveness endpoints.
    • “The data, presented at the EuroPCR 2026 conference in Paris, showed a 93.3% rate of freedom from major adverse cardiac events at 30 days, exceeding the primary safety goal of 86.2%. The device demonstrated 93.7% procedural success, defined as stent delivery with residual stenosis of less than 50% and no major adverse events during the hospital stay, exceeding the 85.8% goal.
    • “Boston Scientific said the study results will support its regulatory submission for the Seismiq 4CE catheter to address severe calcium during the lesion preparation phase of percutaneous coronary interventions to open blocked arteries.”

From the U.S. healthcare business and artificial intelligence front,

  • Corporate Insight discusses “How Leading Health Plans Are Rethinking the Claims Experience.”
    • “For years, the claims experience has been one of the most friction-heavy touchpoints in healthcare. Members struggle to understand their Explanation of Benefits, navigate claim submission processes and track reimbursement status—often ending up on the phone with member services when the digital channel fails them. Corporate Insight’s April 2026 Health Plan Monitor Update noted two major plans addressing this from different angles: Aetna through contextual cost explanation at the point of confusion, and UnitedHealthcare through a structured, self-service submission overhaul.
    • “The two approaches are complementary. One tackles post-service, helping members understand a claim after it has been processed. The other addresses submission, reducing friction when members initiate a claim. Together, they reflect a maturing view of what claims look like in the digital experience.”
  • MedCity News calls attention to
    • “What Seasonal Pressures Continue to Teach Us About the Fragility of the US Surgical System
    • “When demand fluctuates, even slightly, the margin for error becomes clear – highlighting the urgent need for greater efficiency to meet rising procedural demand.”
  • Modern Healthcare adds,
    • “Health systems are improving the profitability of their operating rooms through efficiency upgrades.
    • “Trinity Health, WellSpan and UCI Health are among many health systems redesigning spaces and using data to maximize the OR’s potential.
    • “Declining reimbursement will require health systems to become more efficient, executives said.”
  • STAT News relates,
    • “Here’s one more sign of Eli Lilly’s dominance in the drug industry: It took both top spots in a prominent ranking of pharmaceutical innovators and investors.
    • “The index, produced by U.K.-based IDEA Pharma, ranks drug company laboratories on two different sets of criteria: innovation, which takes into account revenue from new products, new drug approvals, and major drug development events; and invention, which looks at the number of drugs a company has in development, its clinical trials, and its R&D investment, among other factors. IDEA is part of SAI MedPartners, a larger consultancy.”
    • “This is the first time that one company — in this case, Lilly — has ranked No. 1 in both categories.”
       
  • Beckers Health IT adds,
    • “Several startups with a footprint in healthcare [listed in the article] made CNBC’s annual Disruptor 50 rankings May 19, with one AI giant surpassing a rival in 2026.
    • “Anthropic passed OpenAI to rank No. 1 on this year’s list, with both companies having recently unveiled healthcare AI offerings. An advisory board weighs the criteria for the rankings, which are based on detailed quantitative and qualitative information submitted by nominated companies.”
  • Fierce Healthcare lets us know,
    • “Online health and wellness company Hims & Hers posted a $92 million loss in the first quarter as it shifts its business from selling compounded weight loss drugs to branded GLP-1 medications.
    • “During the same period a year ago, Hims & Hers posted a profit of $49.5 million.
    • “The company brought in revenue of $608 million in Q1, up 4% year-over-year. The company’s stock was down about 15% in mid-day trading on Tuesday following the unexpected Q1 loss. Revenue also missed Wall Street analysts’ expectations. Hims & Hers reported a loss of 40 cents per share in Q1 2026 compared to the Zacks Consensus Estimate of EPS of a profit of 4 cents. Revenue also missed the Zacks Consensus Estimate by 1.9%.”
  • and
    • “Nourish, a virtual nutrition-focused metabolic provider, has raised $100 million in a series C round. 
    • “The round was led by Menlo Ventures, with participation from Thrive Capital, Index Ventures, J.P. Morgan Growth Equity Partners, Maverick Ventures, Y Combinator and more. The capital will be used to grow Nourish’s provider workforce, accelerate its investment in AI and deepen partnerships with payers and health systems.
    • “The company is pivoting from being a dietitian-only nutrition platform to a more comprehensive metabolic health clinic by hiring physicians. Nourish patients are typically paired with a registered dietitian, but now lab testing, GLP-1 prescriptions and other virtual care are also becoming available. There is currently a waitlist to see Nourish physicians, though the goal is to rapidly expand by the end of this year to meet the “overwhelming demand,” per executives.”
  • and
    • “Healthcare AI company Commure has banked $70 million in fresh funding, reaching a $7 billion valuation.
    • “General Catalyst led the funding round, which also included participation from Sequoia Capital, Morgan Stanley, and Kirkland & Ellis, according to an announcement. Commure said that it will use the funds to scale its platform and continue building out its technology.
    • “The company offers AI tools and agents that embed in the workflow of health systems and providers. Its tech is largely focused on simplifying administrative work, which Commure said consumes about $1 trillion each year across the country.
    • “Its revenue cycle management tool and advanced clinical workflow tool are deployed across more than 500 organizations that include more than 3,000 sites of care, Commure said in the announcement. Among those are more than 130 of the largest health systems in the country, such as Tenet Healthcare and HCA Healthcare.”
  • MedCity News points out,
    • “John Ayers believes most healthcare AI hype has not yet translated into meaningful patient impact — though he thinks that may soon change. This belief drove Ayers and a team of researchers to create ChatCPR, an AI agent launched this week that coaches users through CPR in real time.
    • ‘Ayers, head of AI at the University of California San Diego’s Altman Clinical and Translational Research Institute, is the lead author of a widely discussed 2023 JAMAstudy that found AI chatbots’ responses to patient messages are often more accurate and empathic than those written by human doctors.” * * *
    • “So, the researchers built ChatCPR to handle more advanced, guideline-critical details. A study published Monday in JAMA not only introduced the tool but also showed that it outperformed 911 dispatchers in guiding bystanders through CPR when tested against recordings from real 911 calls.
    • “The research team rolled out ChatCPR this week as an open-source public resource rather than a commercial product. They are making the training materials, guidelines, prompts and architecture publicly available so that the right companies and emergency-response organizations can build on it, improve it and deploy it broadly, Ayers said.
    • “In his eyes, the key challenge in healthcare AI is implementation — not necessarily having the most advanced model. This is why the team intentionally built ChatCPR on a relatively small, lower-performing language model and still achieved strong results through careful design and domain-specific training. 
    • “Ayers said this means the tool could eventually run directly on smartphones without requiring internet connectivity.”
  • The Wall Street Journal adds,
    • “Yes, AI Can Make Mistakes. AI Can Find Them, Too.
    • “Since chatbots hallucinate their own facts, it’s useful (and easy) to have a second, nitpicking AI that can audit the results for errors.”

Monday report

David Ermer–CDC, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “President Donald Trump on Monday announced that about 600 low-cost generic drugs would be available through TrumpRx.gov, a government website aimed at helping Americans purchase medications at discounted prices. 
    • “By incorporating this massive catalog of low-cost generics at TrumpRx.gov, consumers will now have one source to ensure that they’re getting the lowest possible cost on their prescription,” Trump said in a presentation at the Eisenhower Executive Office Building.”
  • Federal News Network relates
    • “HHS sends RIF notices to dozens of staff it missed during office-wide layoffs last year.
    • “Meanwhile, HHS is looking to convert hundreds of senior positions to a rebranded version of the “Schedule F” classification for federal employees.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a reorganization of its Office for Civil Rights (OCR), the Department’s law enforcement agency charged with enforcing laws protecting civil rights, conscience and religious freedom, and health information privacy and security. The reorganization returns OCR to a program-based structure that aligns OCR’s three critical substantive areas with three distinct subject-matter divisions: the Conscience and Religious Freedom Division, the Civil Rights Division, and the Health Information Privacy, Data, and Cybersecurity Division.
    • “This reorganization restores the HHS Civil Rights Division and the Conscience and Religious Freedom Division and strengthens the Office for Civil Rights’ ability to defend religious liberty, enforce conscience protections, and combat unlawful discrimination,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “Under President Trump’s leadership, HHS will defend these rights with clarity, accountability, and resolve.”
    • “This reorganization reinstitutes a structure that rightly prioritizes civil rights and conscience and religious freedom alongside health information privacy and security,” said HHS Office for Civil Rights Director Paula M. Stannard. “All three areas are deserving of subject-matter expertise and distinct senior executive leadership for OCR to best serve the American people.”
  • The American Hospital Association News adds,
    • “Most hospital outreach laboratories must report private payer clinical diagnostic laboratory data for services furnished during the first six months of 2025 to the Centers for Medicare & Medicaid Services by July 31, the agency announced. This includes Healthcare Common Procedure Coding System codes, associated private payer rates and volume data. CMS previously sent letters to hospitals, which the agency believes have outreach laboratories that are likely required to report their data. CMS also has a guide and other resources for hospital outreach laboratories to determine whether and how they must report.” 

From the Food and Drug Administration,

  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it received U.S. approval for a new hypertension treatment, getting the green light to launch a drug the U.K. pharmaceutical company expects to generate multibillion-dollar annual sales at its peak.
    • “The drug, known until now as baxdrostat, will be marketed under the brand name Baxfendy, the company said Monday. The approval expands AstraZeneca’s cardiovascular, renal and metabolism portfolio shortly after diabetes drug Farxiga—its biggest product in that therapeutic area and the bestselling medicine in the company’s history—went off patent in the U.S.
    • “AstraZeneca said that Baxfendy treats hypertension in a new way by targeting aldosterone, a hormone that raises blood pressure.
    • “Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, said the approval brings a new treatment to a disease that has had little therapeutic progress for the past two decades.”
  • Fierce Pharma relates,
    • “Enhertu’s market conquest is continuing apace. Already tracking at $5 billion in annual sales, the star antibody-drug conjugate from Daiichi Sankyo and AstraZeneca has secured FDA approval to treat early breast cancer, further encroaching on Roche’s Kadcyla territory.
    • “The FDA has simultaneously greenlighted Enhertu for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer, the two companies said Friday [July 15, 2026]. The adjuvant nod came nearly two months ahead of schedule, as the FDA had originally targeted a decision by July 7.”
  • The New York Times tells us,
    • “A California dairy company has issued a recall for five ice cream flavors, warning customers that some tubs may be contaminated with metal.
    • “The company, Straus Family Creamery, recalled some of its organic ice cream, which was sold in 17 states since May 4. It said it ordered the recall because of “the potential presence of metal foreign material,” without giving further details.
    • “The warning applies to its vanilla bean, strawberry, cookie dough, Dutch chocolate and mint chip flavors with specific “best-by” dates in late December 2026.
    • “It did not say how many tubs were affected but said the issue was with a “small number of production runs.”
  • Health Day informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved an AI-powered early warning system to detect sepsis, one of the deadliest infections for hospital patients.
    • “The tool, developed at Johns Hopkins University (JHU), detects sepsis hours faster than doctors. It has already reduced deaths by nearly 20% in dozens of hospitals across the United States, JHU reports.
    • “Pre-suspicion screening is what creates lead time, and lead time is what changes outcomes in sepsis,” said Suchi Saria, director of JHU’s AI & Healthcare Lab. “Once a clinician already suspects sepsis, the clock has been running — often for hours or even days.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court turned away appeals from six pharmaceutical companies seeking to topple the Medicare drug price negotiation program that’s led to billions of dollars in discounts on top-selling treatments.
    • “Making no comment, the justices on Monday refused to hear a variety of constitutional arguments against a program created in 2022 by President Joe Biden’s Inflation Reduction Act. The court rejected separate appeals from units of AstraZeneca Plc, Johnson & Johnson, Bristol Myers Squibb Co., Novartis AG, Novo Nordisk A/S and Boehringer Ingelheim Pharmaceuticals Inc.
    • “The rebuffs leave in force a program the US government said in November will produce a 71% discount on Novo Nordisk’s blockbuster Ozempic and Wegovy drugs for Medicare patients starting in 2027. The Trump administration said that round of discounts, covering 15 drugs, will mean $12 billion in savings compared with 2024 list prices.
    • “The cases at the high court involved the previous year’s negotiated discounts, which covered 10 drugs and took effect in January. The Centers for Medicare and Medicaid Services said in 2024 that the deals would reduce out-of-pocket costs by $1.5 billion this year.”
  • Per a Justice Department news release,
    • “A New York man was sentenced today to 37 months in prison for conspiring to launder nearly $1.5 million in illicit health care fraud proceeds through multiple domestic and global banks on behalf of a Transnational Criminal Organization (Organization).
    • “According to court documents, Elnar Zarbailov, 42, of Staten Island, New York, and dual citizen of the United States and Azerbaijan, was a fixer and money launderer for the foreign-based  Organization that spearheaded the largest health care fraud case ever prosecuted by the Department of Justice, as uncovered by Operation Gold Rush. The Organization, based in Russia and elsewhere, orchestrated a multi-billion-dollar health care fraud and money laundering scheme to target, exploit, and steal from Medicare and private health insurance companies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The CDC announced Monday that an American tested positive for Ebola this weekend while working in Congo and is being transported to Germany for treatment along with six other Americans who are high-risk contacts. 
    • “The Centers for Disease Control and Prevention also is enhancing public health screening and traveler monitoring amid a growing Ebola outbreak, and non-U.S. passport holders face entry restrictions if they have been to Uganda, the Democratic Republic of Congo or South Sudan in the previous 21 days.
    • “To the American public, the risk to the United States remains low,” said Satish Pillai, CDC Ebola response incident manager. “Travelers to the region should avoid contact with sick people, report symptoms immediately, and follow our travel guidance.”
  • Health Exec points out,
    • “A healthcare research firm that provides trend analysis to stakeholders released a new report that examined usage of behavioral health services post-COVID, showing that demand and utilization for mental healthcare and addiction mitigation have intensified since the pandemic.
    • “According to the data from Trilliant Health, while the utilization of care related to emotional health, mental health, autism, and alcohol and drug dependency stand at new highs since the COVID lockdowns, outcomes may not be improving.
    • “Using publicly available data on utilization, provider numbers and demand, Trilliant’s data paints a picture of a mental healthcare system that is overburdened. From 2018 to 2024, the group reports that the number of behavioral health visits jumped 62.6%, standing at 1,346 visits per 1,000 people.
    • “People seeking care for anxiety led the trend, accounting for 89.3% of growth. Women aged 18-44 made up the majority of that cohort. However, Trilliant noted that childhood developmental disorders—autism, attention deficit disorder, speech problems and other issues including anxiety—including attempted self-harm, have risen nearly 48% over 20 years, from 2004-2024.”
  • Health Day adds,
    • Many older adults see cannabis as a more effective or nonpharmaceutical option to manage sleep, pain, or mental health, according to a study published online May 8 in JAMA Network Open.
    • Rebecca K. Delaney, Ph.D., from the University of Utah Intermountain Health Department of Population Health Sciences in Salt Lake City, and colleagues explored the motivations of older adults in Colorado interested in purchasing edible cannabis products to improve sleep, pain, or mental health concerns, as well as the perceived benefits and drawbacks of different cannabinoid profiles. The analysis included 169 interview participants aged 60 years and older.
  • The New York Times relates,
    • “A study of insurance claims for 1.8 million children found that the number of families raising mental health issues at visits to general practitioners rose sharply over a decade, with anxiety by far the fastest-growing complaint.
    • “The study, which was published on Monday in the journal JAMA Network Open, found that the number of pediatric visits rose to 9.7 percent in 2023 from 5.7 percent in 2014.
    • “The study included all insurance claims for children from ages 1 to 18 in Massachusetts, for a total of more than 1.8 million children. Visits were counted as mental health visits if a diagnostic code was included in the claim, either because the child or the family raised the issue or because the child screened positive for mental health symptoms during the visit.
    • “Visits for anxiety rose by more than 250 percent during that period, to 6.1 percent in 2023 from 1.7 percent in 2014.”
  • The American Medical Association lets us know “nine things patients should know about taking creatine.”
    • “The ‘Health vs. Hype’ AMA podcast explores what creatine is, its association with bodybuilders, and whether it’s safe for the general public.”
  • Medpage Today tells us,
    • “A course of azithromycin for preschoolers who presented to the emergency department (ED) with wheezing didn’t improve their symptoms, the AZ-SWED trial showed.
    • :Among children, ages 18-59 months, the 5-day sum of scores on the Asthma Flare-up Diary for Young Children (ADYC) did not differ significantly compared with placebo in either those who initially tested positive for pathogenic bacteria (median 9.59 vs 9.72, P=0.70) or those who tested negative (9.30 vs 9.10, P=0.69). ADYC scores range from 5-35 points, with higher scores indicating more severe symptoms.
    • “While the trial was stopped early for futility — reducing the statistical power of the trial — it was sufficient to show that “a moderate or large true effect is implausible,” Richard M. Ruddy, MD, of the University of Cincinnati College of Medicine, reported at the American Thoracic Societyannual meeting in Orlando. The findings were published simultaneously in the New England Journal of Medicine.”
  • and
    • “The 2025/2026 seasonal COVID vaccination was associated with a roughly 50% reduced risk for illness up to 9 weeks post-vaccination, especially in older Canadian adults, according to an interim analysis by the Canadian Sentinel Practitioner Surveillance Network. The seasonal vaccine, which was specifically formulated to target the LP.8.1 variant, also appeared to offer protection from other strains.
    • “An important aspect of the 2025/2026 season was the simultaneous circulation of influenza and other respiratory viruses, which suggested the need to consider the role that respiratory virus co-circulation might play in estimating vaccine effectiveness (VE).
    • “This year, we were especially interested to check the effects of co-circulating respiratory viruses (eg, influenza and respiratory syncytial virus [RSV]) since COVID circulated at only low levels through the current season,” lead author Danuta M. Skowronski, MD, epidemiology lead for influenza and emerging respiratory pathogens at the BC Centre for Disease Control in Vancouver, told Medscape News Canada.”
  • The American Journal of Managed Care points out,
    • “A retrospective VA cohort (2006–2019) compared ≥75-year-olds with adenoma vs no adenoma at ages 65–75 using registry and National Death Index outcomes. 
    • “Ten-year CRC incidence and CRC death were statistically higher with prior adenoma, but absolute differences were small and clinically overshadowed by competing non-CRC mortality. 
    • “Frailty stratification showed progressively lower CRC incidence and sharply higher non-CRC death, with severe frailty demonstrating <1% CRC versus 82% non-CRC death. 
    • “Advanced adenoma status did not significantly alter CRC risk, and follow-up colonoscopy rates after 75 were not higher among patients later developing CRC. 
    • “Generalizability is limited by a 98% male veteran population, reinforcing the need for confirmatory analyses in cohorts with greater female representation.”
  • Per BioPharma Dive
    • “An experimental cancer immunotherapy from Regeneron failed a late-stage study in melanoma in a surprise setback for the big biotechnology company’s oncology business.
    • “A regimen involving the prospect, fianlimab, and Regeneron’s marketed medicine Libtayo didn’t significantly delay cancer progression compared to Merck & Co.’s Keytruda in patients with unresectable metastatic melanoma. A high-dose combination held tumors in check for a median of 11.5 months, compared to 6.4 months for Keytruda recipients, a difference that narrowly missed statistical significance.
    • “Regeneron didn’t provide additional details but will present them at a future medical meeting. Another Phase 3 study testing fianlimab against Opdualag, a similar cancer immunotherapy sold by Bristol Myers Squibb, is ongoing. Company shares fell by double digits early Monday, erasing billions of dollars in market value.”

From the U.S. healthcare business front

  • Kauffman Hall reports,
    • Key Takeaways
      • March was the best month for hospitals in 2026 so far, despite mixed volumes. Month-over month discharges rose while patient days fell, indicating increased focus on improving average length of stay and a continued shift to outpatient care.
      • Operating margins improved month-over-month but remain below 2025. While bad debt and charity care declined month-over-month, gross revenue continues to outpace net, highlighting eroding payor mix.
      • Expenses declined in March, yet remain elevated year-over-year. Favorable improvements across the board are likely correlated to the decrease in average length of stay. However, drug expenses remain a primary driver of expense growth year-to-date.
      • Two notable outliers emerged in otherwise steady regional trends. The Northeast saw margin improvement, despite historical underperformance, while the West experienced the most dramatic increase in drug expense.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Massachusetts reported a net income of $59.6 million in the first quarter of 2026, a return to profitability after back-to-back annual losses in 2024 and 2025.
    • “The insurer posted revenue of $2.6 billion in the first quarter, reflecting a 2% net margin. Operating and other income came in at $17.4 million (0.6% operating margin), with investment income contributing $42.2 million.
    • “The company attributed the improved results to disciplined cost management, a milder-than-expected flu season and changes to its coverage of GLP-1 medications.
    • “Our first-quarter results reflect the challenging but necessary actions we’ve taken over the past year, including pricing our benefit plans to their true cost, identifying medical and pharmacy spending that doesn’t add value for our members, and keeping rate increases to our provider network at or below the state benchmark,” CFO Ruby Kam said May 15.”
  • Fierce Healthcare relates,
    • “Now three quarters into its fiscal year, Ascension has chopped down its operating losses by more than half and more than tripled its bottom-line gain. 
    • “The nonprofit system reported Friday a $203 million operating loss (-1.1% operating margin) for the nine months ended March 31, 2026, improving on the $466 million operating loss (-2.3%) for the prior fiscal year. 
    • “Both its total operating revenue and operating expenses dipped from the prior year due to a slew of divestitures. The former declined by 7.2% to $18.1 billion while the latter fell by 8.1% to $18.3 billion; on a same-facility basis, total operating revenue grew 9.3% while expenses increased 5.7%.” 
  • Healthcare IT News explains “How one practice combines in-clinic, telehealth and in-home care.”
    • “Dr. Payam Zamani is a practicing family medicine physician and founder and CEO of My Dr Now, one of the largest primary care providers in the Southwest. It’s designed as a hybrid in-person/telehealth/in-home health system.”
    • “When patients engage earlier and follow through consistently, the health system operates more efficiently, My Dr Now’s physician CEO reports: “This is not about technology for its own sake, it’s about designing care delivery around real life.”
  • Modern Healthcare tells us,
    • “Oregon gave the green light for Compassus to acquire a 50% stake in Providence’s home health and hospice operations across the state.
    • “After more than a year of review, Oregon Health Authority’s Health Care Market Oversight program said in a Friday news release it approved the joint venture with conditions.
    • “The Oregon deal is expected to close in the fall, Providence said in an email.”
  • and
    • “RWJBarnabas Health has opened a $7 million food-is-medicine hub to take on chronic disease, making it a potential standard bearer in the Make America Healthy Again movement.
    • “Last week, the New Jersey academic health system opened Harvest — an 8,000-square-foot facility in Newark that is a combination food bank, commercial kitchen and classroom. The center is designed to teach people living in nearby food deserts how to eat healthier and provide them with the food to do it.”
  • Health System CIO informs us,
    • “Epic added 77 acute care hospitals in 2025 while Oracle Health shed 56, according to the new KLAS report, “US Acute Care EHR Market Share 2026.” The five-year picture is even starker. Epic has gained a net 568 hospitals since 2021 while Oracle Health has lost 173. In total, the report covers EHR contracts executed from January through December 2025. Epic now holds 43.7% of acute care hospital market share and 56.9% of beds. Oracle Health, meanwhile, sits second at 21.9% of hospitals and 20.4% of beds, followed by Meditech at 14.7% and 12.5%.” * * *
    • “Hospitals impacted by EHR decisions fell about 40% from 2024 as buyers shifted investment toward AI and operational efficiency tools.”
  • Per MedTech Dive,
    • “Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.
    • “The agreement gives Boston Scientific an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain clinical and regulatory milestones. Boston Scientific said it may opt to acquire the rest of the TAVR business for additional cash payments totaling $3 billion.
    • “The deal comes about a year after Boston Scientific stopped selling its Acurate Neo2 and Acurate Prime TAVR devices, which were CE-marked in Europe, and ended plans to pursue approvals in the U.S. and other locations.”