Monday report

No Surprises Act

Monday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports on this week’s anticipated activities on Capitol Hill.
    • “After a weeklong recess, Senate Republicans return Monday with their focus set on ways to move their budget reconciliation package, which hit several hurdles before the Memorial Day break. 
    • “The House, which has been on standby while Senate leadership works out how much of the White House wishlist they can salvage, is returning later this week, with its first vote scheduled for Wednesday.”
  • The Wall Street Journal adds,
    • “The Trump administration signaled a retreat Monday on its nearly $1.8 billion “anti-weaponization” fund, which met powerful pushback from members of Congress and threatened to derail the president’s efforts to pass immigration-enforcement funding.”
  • Yesterday, the FEHBlog described OPM’s family member documentation guidance as an interim final rule because OPM had not issued a proposed rule. However, it turns out that OPM decided that public comment was unnecessary so it declared the guidance to be a final rule. The final rule will be published in the Federal Register tomorrow which means that the final rule’s effective date is July 2, 2026.
  • Federal News Network also relates,
    • “Agencies will soon be able to pay as much as $400,000 a year to certain employees with skillsets in the national security sector. President Donald Trump told the Office of Personnel Management on Friday to establish new regulations to pay experts in specific fields related to supply chain resilience, secure access to critical minerals and advanced technologies and advance priority investment programs essential to national defense and economic security. The memo said this increase in the top line pay for these positions is necessary to advance the rapid recruitment of the exceptionally skilled investment, engineering, financial and legal professionals needed to expand the nation’s capacity.”
  • Govexec notes,
    • “For the second straight month, each portfolio offered by the federal government’s 401(k)-style retirement savings program finished May in the black.”
  • The final rule making changes to the No Surprises Act’s independent dispute resolution process is scheduled to be published in the Federal Register on June 4, 2026.
  • Radiology Business tells us,
    • “Radiologists, anesthesiologists and emergency medicine physicians are jointly praising recently announced changes to the No Surprises Act while also pushing for further reform. 
    • “Medical societies representing all three specialties shared their official response to the independent dispute resolution, or IDR, final rule on Friday. Released by the Centers or Medicare & Medicaid Services May 28, the rule finalizes many updates to the NSA first proposed back in 2023.
    • “The American College of Radiology, American Society of Anesthesiologists and the American College of Emergency Physicians commended the rule, calling it a “thoughtful and collaborative approach.” They see the changes as an “important step forward,” one that will hopefully create a “more functional, transparent dispute resolution system.” 
  • These comments confirm the FEHBlog’s opinion that a follow up rule or perhaps a statutory change is needed to level the IDR process playing field which currently favors this healthcare providers.
  • The American Hospital Association News informs us,
    • “President Trump signed an executive order May 29 that directs the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices to review a scientific assessment by the Department of Health and Human Services on childhood vaccine recommendations from other developed nations. The order recommends the CDC and ACIP take any appropriate steps to update the U.S. childhood and adolescent vaccine schedule to align it with those from other nations. The administration also recommended that all immunizations on the schedule should continue to be covered without cost sharing by private insurers and covered by Medicaid, the Children’s Health Insurance Program and the Vaccines for Children Program.”
  • and
    • “The Centers for Medicare & Medicaid Services June 1 issued an interim final rule with comment period implementing the statutory requirement that certain adult Medicaid enrollees meet community engagement (work) requirements. Under the rule, certain adults must complete 80 hours per month of “qualifying activities,” such as employment, education, community service or participation in a work program, or meet equivalent income thresholds.
    • “CMS said that states must generally implement the requirement no later than Jan. 1, 2027. The rule maintains exemptions for certain populations, including individuals who are pregnant or postpartum, disabled or medically frail, or caregivers, and allows states to offer exemptions for short-term hardships. See the CMS fact sheet for more details.
    • “Provisions in the rule are effective on July 31, 2026, and comments must be submitted by that date.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA approved the oral antiviral agent ensitrelvir (Xocova) to help prevent COVID-19 in people ages 12 years or older who were exposed to the SARS-CoV-2 virus, drugmaker Shionogi announcedopens in a new tab or window.
    • “Ensitrelvir is a SARS-CoV-2 main protease inhibitor also approved in Japan as COVID-19 postexposure prophylaxis (PEP) and as a treatment for mild to moderate COVID. The drug is not approved to treat COVID-19 in the U.S.
    • “The FDA’s decision was based on the phase III SCORPIO-PEP trial, which showed the risk of getting sick from a household contact with COVID-19 dropped by more than half among those who took ensitrelvir compared with placebo.”
  • Contemporary OB/GYN relates,
    • “Wockhardt has announced that the FDA has approved cefepime and zidebactam (ZAYNICH; Wockhardt), a novel intravenous antibiotic designed to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. The approval offers a new therapeutic option for patients facing aggressive, drug-resistant infections. Prior to this approval, the drug received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
    • “In the United States, cUTIs are responsible for over 600,000 hospitalizations annually. A growing proportion of these infections are driven by antimicrobial-resistant bacteria, which represent a leading cause of bacteremia and carry significant morbidity and mortality risks. These multidrug-resistant infections place a heavy burden on the healthcare system, as affected patients typically require more intensive, prolonged care and experience higher rates of life-threatening complications.
    • “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH is a monumental step forward in validating a new option for these underserved populations,” said Dr. Dennis Deruelle, Chief Medical Officer at Wockhardt.”

From the judicial front,

  • CMS posted a notice of a court decision that will appear in tomorrow’s Federal Register,
    • SUMMARY: This is to inform the public that, on October 22, 2025, the United States District Court for the Southern District of Mississippi issued an order in Tennessee v. Kennedy, No. 1:24-cv-161-LG-BWR (S.D. Miss. Oct. 22, 2025), vacating portions of the final rule titled “Nondiscrimination in Health Programs and Activities,” published May 6, 2024 (89 FR 37522).
    • Specifically, the court vacated certain provisions of the regulation to the extent they expand Title IX’s definition of sex discrimination to include gender-identity discrimination. Pursuant to the court’s order, the vacated provisions are legally void. The other provisions of the Section 1557 Rule remain in force.
    • DATES: The Tennessee court issued its vacatur order on October 22, 2025. As long as the specified provisions of the 2024 Section 1557 Rule remain vacated, OCR and CMS cannot and will not enforce the vacated provisions.

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “An outbreak of a rare strain of Ebola in the Democratic Republic of Congo is already the third largest in history, just weeks after it likely began.
    • “It is spreading rapidly in one of the most volatile and vulnerable regions of the world, worrying U.S. and international health officials.” * * *
    • “What are the chances that Ebola will spread to the U. S.?
    • “The risk is low, according to the Centers for Disease Control and Prevention. U.S. officials have prohibited foreigners who have been to Congo, Uganda or South Sudan in the last three weeks from entering the country. U.S. citizens who have been to those countries are being directed to four U.S. airports and screened there, the CDC said. Those airports are: Washington-Dulles International, Hartsfield-Jackson Atlanta International, George Bush Intercontinental and John F. Kennedy International.
    • “The U.S. has a network of specialized treatment centers around the country to care for patients with dangerous pathogens like Ebola and hantavirus, at hospitals such as the University of Nebraska Medical Center and Emory University Hospital. However, U.S. authorities evacuated an American medical missionary who contracted Ebola in Congo to a hospital in Germany with similar capabilities, and aim to build an Ebola quarantine and treatment facility in Kenya. A Kenyan high court put the U.S. plan on hold.”
  • The American Medical Association lets us know what doctors wish their patient knew about lupus.
    • “Lupus is a complex autoimmune disease with varied symptoms. Early diagnosis and ongoing care can help patients manage flares and protect long-term health.”
  • MedPage Today relates,
    • “The cigarette smoking rate among U.S. adults dropped to another all-time low last year, with one in 11 adults saying they were current smokers, according to new government survey data.
    • “Cigarette smoking is a risk factor for lung cancer, heart disease, and stroke, and it’s long been considered the leading cause of preventable deathopens in a new tab or window.
    • “The preliminary findingsopens in a new tab or window from the CDC were based on survey responses from more than 24,200 adults. In the survey, CDC officials defined current cigarette smoking as smoking at least 100 cigarettes in a lifetime and now smoking every day or some days.” * * *
    • “In 2024, the percentage of current adult smokers fell below 10% for the first time. Last year, it was 9%, according to the new survey.
    • “The use of electronic cigarettes has been inching up among adults, but has held about steady in 2025, at about 7%.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) today announced that its Investigational New Drug (IND) application for mitragynine, the primary psychoactive compound found in Mitragyna speciosa (kratom), has taken effect with the U.S. Food and Drug Administration (FDA). The IND paves the way for an NIH-led phase I clinical trial to evaluate mitragynine as a potential treatment for opioid use disorder.
    • “Researchers at NIH and the University of Florida developed the purified formulation of mitragynine to be used in the trial, as well as the preclinical work that led to the submission of the IND application.
    • “This IND is a major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder, which has contributed to historically high overdose mortality rates,” said Nora Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA).”
  • The American Journal of Managed Care tells us,
    • “People living with alopecia areata (AA) may not face a heightened risk of skin cancer despite reduced scalp hair coverage, according to a new systematic review and meta-analysis that found a significantly lower incidence of melanoma among this patient population.
    • “The analysis, published in Frontiers in Oncology, evaluated data from more than 860,000 patients across 8 retrospective studies conducted in the US, Sweden, Denmark, Taiwan, and the Republic of Korea. Researchers reported that AA was associated with a statistically significant reduction in melanoma incidence, whereas rates of basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and overall skin cancer also trended lower but did not consistently reach statistical significance.
    • “The findings arrive as clinicians increasingly prescribe Janus kinase (JAK) inhibitors for moderate to severe AA, raising questions about long-term malignancy risks and the need for baseline disease-specific cancer data.”
  • Fierce Pharma informs us,
    • “AstraZeneca is polishing the case for its Imfinzi (durvalumab) and Imjudo (tremelimumab) combo in liver cancer with a new phase 3 readout from its Emerald trial program assessing the immunotherapy duo in a locoregional setting. 
    • “The phase 3 Emerald-3 study, presented June 1 at the Annual Society of Clinical Oncology (ASCO) 2026 annual meeting in Chicago, positions AZ’s Imfinzi/Imjudo regimen as a “compelling therapeutic option” for patients with unresectable embolization-eligible hepatocellular carcinoma (HCC), ASCO expert Vishwanath Sathyanarayanan, M.D., commented in an ASCO press release.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The public and private sector are committed to value-based care as a solution to high healthcare spending.
    • “Decades of value-based care interventions have not reversed perpetually rising health expenditures.
    • “UnitedHealth Group, CVS Health and other companies have made value-based care central to their business plans.
    • “The fragmented healthcare system remains an obstacle to cost containment.”
  • Beckers Hospital Review relates,
    • “Orlando (Fla.) Health recorded an operating income of $47.4 million (1.9% operating margin) in the second quarter of 2026, down from $94.7 million (3.9% margin) during the same period last year, according to its May 26 financial report.”  
  • KFF Health News, writing in Fierce Healthcare, tells us,
    • “Most patients who have taken a GLP-1 received their prescription through a primary care doctor or a specialist, KFF polling data shows. But as the uptake of telehealth has grown substantially since the start of the covid pandemic, * * * millions of Americans who have used online companies to meet a variety of their medical needs.
    • “Many of the companies have started offering GLP-1 medications for weight loss as demand for these drugs has exploded. But certain medication errors tied to GLP-1s have exploded too, according to a KFF Health News review of Food and Drug Administration data, and physicians and telemedicine researchers worry that adverse experiences tied t”o telehealth companies are becoming more common.
    • Bad outcomes aren’t unique to telehealth providers or to the compounded weight loss drugs many of them offer. In fact, product liability lawsuits alleging patient injuries have been filed overwhelmingly against pharmaceutical giants Eli Lilly and Novo Nordisk, which manufacture name-brand weight loss drugs, court data shows. The drugmakers have defended their products.
    • “However, some critics are also concerned that getting a weight loss prescription online is usually much easier than getting one through an in-person appointment. Not only do many telehealth companies write quick prescriptions for GLP-1s, but they often sell the medications, too, allowing patients to bypass in-person pharmacy visits. This one-stop shopping isn’t necessarily a good thing, according to critics who say some telehealth providers are writing prescriptions for people who should not be taking GLP-1s and then providing little or no follow-up care.
    • “It gives a black eye to telemedicine,” said Elizabeth Krupinski, an experimental psychologist at Emory University who has conducted research on the effectiveness of telehealth.”
  • Fierce Healthcare informs us,
    • “Weight loss company Noom is offering an at-home biomarker testing kit for its U.S. members, expanding its platform into diagnostics and metabolic health monitoring.
    • “It marks an expansion of the company’s proactive health program, which rolled out in December, offering microdose GLP-1 medications combined with at-home biomarker testing and insights.
    • “The at-home blood collection and lab testing service enables members to establish baseline labs and track improvements in markers such as, HbA1C, ApoB, triglycerides and hs-CRP over time, according to the company. Testing gives users with insights into biological outcomes, such as blood sugar regulation, lipid profiles and inflammation markers. By using the kit, members can skip a lab visit and receive results within about a week, paired directly with access to medication and behavior change programs, according to executives.
    • “Noom says it now provides a platform where members can test, act and track A1C improvement in a single, integrated experience.
    • “The biomarker test kits cost $125.”
  • Fierce Pharma points out,
    • “In its seventh week on the market, which ended May 22, Eli Lilly’s obesity pill Foundayo continued to track below the pace of Novo Nordisk’s rival Wegovy pill at the same point in its launch.
    • “At the same time, analysts at Jefferies and Citi again flagged caveats that could be skewing the numbers, with the Jefferies team espousing confidence that Lilly’s oral GLP-1 can still meet consensus sales projections for both the second quarter and 2026 as a whole. 
    • “Breaking down the numbers, the Jefferies team put seventh-week total Foundayo prescriptions lower versus the previous week at roughly 11,700, with the clarification that the data’s source, IQVIA, had to use a “best-estimate” tally for the latest week’s prescription trends. 
    • “That trend remains “numerically lower” than the course charted by Novo’s Wegovy pill, which racked up an impressive 67,000 prescriptions in its seventh week, although Foundayo’s performance still tracks ahead of Novo’s injectable Wegovy and Lilly’s first obesity incretin med Zepbound at the same point in their respective rollouts, the analyst team said.” 

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.”  

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.”

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.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “If and when the next government shutdown rolls around, the laundry list of consequences will now include a pay freeze for U.S. senators.
    • “On a voice vote, the Senate passed a resolution from Sen. John Kennedy, R-La., that requires the Senate secretary to withhold compensation for the duration of a shutdown.
    • “The change in Senate rules is set to take effect on the date of the 2026 midterm elections to comply with the 27th Amendment to the Constitution, which prohibits a change in congressional salaries from being enacted until after an intervening election.
    • “The speedy passage, which followed a 99-0 procedural vote Wednesday, underscored a growing frustration among lawmakers with the frequency of partial shutdowns.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services has released details on downloading its upcoming fiscal year 2025 Program for Evaluating Payment Patterns Electronic Report, or PEPPER, for critical access hospitals. The report, set to release this month, summarizes provider-specific Medicare data statistics for areas often associated with improper Medicare payments due to billing, diagnosis related group coding and/or admission necessity issues. CMS said the report would be available through its PEPPER Portal to authorized officials, access managers and users with the staff end user business function in the CMS Identity and Access Management System. A guide and FAQ on accessing the PEPPER are also available for users.”
  • Tammy Flanagan, writing in Govexec, advises federal and postal employees that “Waiting to retire could be worth thousands of dollars.”
    • “Before you rush out the door, consider how a few more years of service can permanently boost your FERS annuity and Social Security benefits.”
  • Fierce Healthcare informs us,
    • “A new ad campaign takes aim at the “misaligned incentives” in the No Surprises Act arbitration process, arguing they “create a ‘fox guarding the hen house’ dynamic.”
    • “The seven-figure campaign from the Coalition Against Surprise Medical Billing, called “Judge Fox,” features a court battle between a pair of chickens and a pair of foxes. The chickens confer and say that a “reasonable judge” would not allow these foxes to freely set prices for medical bills.
    • “Then the judge also turns out to be a fox, meant to illustrate that private equity firms that own providers that purportedly flood the dispute resolution system may also operate the independent entities meant to mitigate these disputes.
    • “The coalition said in a press release that the campaign comes “amid mounting evidence that some private equity-backed providers and IDR middlemen are relentlessly abusing the IDR process to maximize their own profits at Americans’ expense.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “A lawyer is leading the FDA for the first time, after President Donald Trump‘s selection Tuesday of Kyle Diamantas to serve as acting commissioner after Marty Makary resigned.
    • “The promotion of Diamantas to acting FDA commissioner also marks the second time in history someone leading the agency’s food oversight has been put in charge, a move that comes as the Trump administration advances a range of food policy changes aligned with the “Make America Healthy Again” movement.”
  • Fierce Pharma relates,
    • “BeOne Medicines has entered the BCL-2 arena, securing an FDA green light for Beqalzi that carves out a unique piece of territory ahead of a potential broader clash with market leader Venclexta.
    • “The FDA has granted an accelerated approval to BeOne’s Beqalzi (sonrotoclax) for the treatment of patients with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy, including a BTK inhibitor, the company said Wednesday.
    • “The go-ahead makes Beqalzi the first BCL-2 inhibitor specifically approved for MCL in the U.S., as AbbVie and Roche’s first-to-market Venclexta has only been used off-label for this type of blood cancer.”
  • and
    • “Taiho Pharmaceutical nabbed an expanded FDA approval for its Inqovi, which can now be taken alongside AbbVie and Roche’s Venclexa (venetoclax) to treat newly diagnosed acute myeloid leukemia in patients who are 75 and older and ineligible for intensive induction therapy. 
    • “The therapy is the first all-oral combination treatment regimen cleared for this specific patient population and represents an alternative to standard-of-care parenteral hypomethylating agent-based regimens, which require frequent visits to the clinic. With a more convenient offering that can potentially reduce the overall treatment burden associated with receiving the standard-of-care at hospitals or infusion centers, Taiho figures that its approach can make a “meaningful impact for patients and caregivers,” chief medical officer Harold Keer, M.D., Ph.D. pointed out in a company release.” 
  • BioPharma Dive tells us,
    • “An experimental Duchenne muscular dystrophy gene therapy from Regenxbio has met its main objective in a pivotal trial, positioning the company to seek an accelerated regulatory clearance in the U.S.
    • “Three months after treatment with Regenxbio’s therapy, RGX-202, 28 of the 30 study participants receiving muscle biopsies produced at least 10% of normal levels of a diminutive protein, “microdystrophin,” believed to help Duchenne patients. That result hit the trial’s main goal and passed a key threshold needed to support an approval. Nine volunteers with at least one year of follow-up also demonstrated statistically significant improvements, from the study’s start, on multiple tests of motor function.
    • “Regenxbio did report two serious adverse events among treatment recipients — one case of heart inflammation and another of asymptomatic liver injury. Both were “easily managed and resolved within weeks” without further incident, and the average levels of liver inflammation markers in those who got RGX-202 didn’t surpass the “upper limit of normal.” Still, company shares fell by more than 35% as the safety findings “muddy the update,” wrote Leerink Partners’ analyst Mani Foroohar.”

From the judicial front,

  • Per Justice Department news releases,
    • “A federal jury in the Southern District of Florida convicted the founder and owner of HealthSplash yesterday for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.” * * *
    • “According to court documents and evidence presented at trial, Brett Blackman, 42, of Johnson County, Kansas, and his co-conspirators aggressively targeted hundreds of thousands of Medicare beneficiaries to get them to accept medically unnecessary orthotic braces and other items. They then arranged for purported telemedicine doctors to sign bogus prescription orders for these items, so that their co-conspirators could bill Medicare for them. All told, Blackman and his co-conspirators billed Medicare and other federal health care benefit programs over $1 billion for this unnecessary equipment.
    • “Blackman owned, controlled, and was the CEO of HealthSplash, which acquired Power Mobility Doctor Rx, LLC (DMERx) in September 2017. DMERx was an internet-based platform that generated false and fraudulent doctors’ orders for durable medical equipment (DME) and prescriptions for other items. As part of the scheme, Blackman and his co-conspirators connected pharmacies, DME suppliers, and marketers with telemedicine companies that would accept illegal kickbacks and bribes in exchange for signed doctors’ orders created using the DMERx platform. Blackman and his co-conspirators took a cut for themselves in exchange for the referrals.”
  • and
    • “Takeda Pharmaceuticals, U.S.A. Inc. has agreed to pay $13,670,921 to resolve allegations that it knowingly caused the submission of false claims to Medicare and other federal health care programs by paying kickbacks to healthcare providers to induce prescriptions of Trintellix, an antidepressant medication that Takeda marketed and sold to treat major depressive disorder.”
    • “The Department of Justice is committed to vigorously pursuing violations of the False Claims Act arising from illegal kickbacks,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “Such conduct can erode the trust that patients place in their healthcare providers and lead to higher drug costs for American taxpayers.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Health officials in the United States and around the world are assessing and managing potential exposures linked to the hantavirus outbreak on an expedition ship. Some of the American passengers on the ship are quarantining in Nebraska and Georgia. Others returned home earlier.” * * *
    • “David Fitter, the Centers for Disease Control and Prevention official leading the response, told reporters Thursday during a media briefingthat 41 people across the U.S. are under monitoring, but there are no cases.
    • “The people being monitored for symptoms fall into three groups. The first are the 18 passengers who were recently flown back to the United States from the Canary Islands and are being monitored in special facilities in Nebraska and Georgia. The second group comprises passengers who had already left the ship and returned home before the outbreak was identified. 
    • “In the third group are people who may have been exposed during flights with a known and symptomatic patient. That patient was the wife of the Dutch man, the first known patient to became sick, who died April 11 on board the ship. She left the ship and flew to Johannesburg, where she died on April 26.”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has isolated and mapped in detail the first comprehensive group of human antibodies targeting the measles virus. The findings reveal previously unknown details about how the human immune system fights measles and identify specific antibodies capable of reducing the virus to undetectable levels in an animal model. The research could serve as the foundation for development of a measles treatment.
    • “Measles cases have recently increased in the United States and worldwide. More than 470,000 measles cases were reported globally in 2024, and at least 72 outbreaks have been recorded in the United States since January 2025. While effective prevention in the form of vaccination is available, no safe and effective therapies have received regulatory approval in the United States. This leaves people who cannot safely receive the vaccine – the immunocompromised, pregnant women, and infants too young to be vaccinated – with a lack of medical options.
    • “With measles cases increasing, we urgently need effective therapeutics to protect the most vulnerable,” said Jeffrey K. Taubenberger, M.D., Ph.D., acting director of NIH’s National Institute of Allergy and Infectious Diseases. “This research gives us a clear picture for the first time of the most promising targets for antibody-based medicines that could protect or treat people for whom measles vaccination is not an option.”
  • Medscape tells us,
    • “Two new studies have identified risk factors that may be associated with the increasing incidence of colorectal cancer (CRC) among younger Americans.
    • “The majority of cases are sporadic, suggesting modifiable, nongenetic factors may play an important role,” said Mohamed Eldesouki, MD, internal medicine resident at New York Medical College at Saint Michael’s Medical Center in Newark, New Jersey, at Digestive Disease Week (DDW) 2026.
    • “In the first study, Eldesouki and colleagues identified a distinct phenotype, based on multiple factors, associated with an elevated risk in people aged 18-49 years. In addition, they found that inflammatory bowel disease, family history of CRC, severe obesity, and obesity were independent predictors that increased the risk for early-onset vs late-onset CRC more than twofold.
    • In the second study, a history of oral antibiotic exposure was associated with an increased risk for colorectal adenomas, especially among people with a greater or longer history of using these agents.”
  • Med Page Today informs us,
    • “Dementia with Lewy bodies — a disease characterized by faster progression and greater functional decline than Alzheimer’s disease — was confirmed as a predominantly late-onset dementia with incidence rising sharply with age, a systematic review and meta-analysis showed.
    • “Across 12 population-based studies, the pooled incidence was 46.85 per 100,000 person-years (95% CI 23.78-92.30) for people ages 65 and older, and the pooled prevalence was 352.26 per 100,000 population (95% CI 112.25-1,099.79), reported Daniele Urso, MD, MPH, of the University of Bari Aldo Moro in Italy, and co-authors in JAMANeurologyopens in a new tab or window.
    • “In people younger than 65, the pooled incidence was 0.34 per 100,000 person-years (95% CI 0.14-0.83) and the prevalence was 2.52 per 100,000 population (95% CI 1.43-4.44).”
  • Health Day points out,
    • “Women entering menopause are twice as likely to have lower heart health scores than those still having regular periods, a new study says.
    • “Perimenopausal women are more likely to have high cholesterol and blood sugar levels, researchers reported today in the Journal of the American Heart Association.
    • “These problems likely are fueled by varying estrogen levels, which can negatively affect cholesterol, insulin resistance, blood pressure and weight, researchers said.
    • “But diet also plays a powerful role, with women’s healthy nutrition scores declining as they begin and then enter menopause, the study found.
    • “Mid-life women should think of the perimenopausal period as a ‘window of opportunity.’ They should be proactive and not wait until they reach menopause to start checking their blood pressure, cholesterol and blood sugar levels,” said senior researcher Dr. Garima Arora, an professor of medicine at the University of Alabama at Birmingham.”
  • and
    • “Abdominal obesity (AO) is associated with a higher prevalence and greater severity of menopausal symptoms, according to a study published online May 5 in Menopause.” * * *
    • “Educating women early about healthy lifestyle interventions to prevent midlife weight gain is key to improving mental and physical well-being during a tumultuous time frame,” Monica Christmas, M.D., associate medical director for The Menopause Society, said in a statement.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Companies such as UnitedHealth Group, CVS Health, Cigna and Centene recorded strong first quarters.
    • “Earnings reports suggest chronically high medical costs may be subsiding.
    • “Insurers outperformed Wall Street expectations and upgraded earnings guidances, driving share prices higher.
    • “Seasonal factors, a shift toward higher-deductible plans and incomplete claims data cloud insights into cost trends.”
  • and
    • “UnitedHealth Group division Optum Rx has rolled out a new pharmacy benefit manager model the company describes as transparent.
    • “Optum Rx, first in PBM market share, will phase out practices tying revenue to drug prices and shift toward fees.
    • “The company is attempting to respond to criticisms from its customers, the public and policymakers about how PBMs operate.
    • “Chief rivals CVS Caremark and Express Scripts previously announced similar changes.”
    • * * * “The fact that we’re having this discussion shows progress,” said Robert Andrews, CEO of the Health Transformation Alliance, a coalition of large employers that lobbies Congress.”
  • The Wall Street Journal relates,
    • “Much of the public debate over cancer blood tests has focused on early detection products like the Galleri test from a company called Grail, which promises to screen healthy people for more than 50 types of cancer. 
    • “While these tests capture headlines and Super Bowl ads, the more proven opportunity for investors has been in a less glamorous market: checking for cancer recurrence.
    • For a patient who has just had a tumor surgically removed, the critical question is whether every cancer cell is gone. Many oncologists now use blood tests to answer that question months before a traditional scan could. 
    • “Natera NTRA, based in Austin, Texas, holds a near-monopoly in this market, known as minimal residual disease (MRD) testing. Its stock has roughly quadrupled over three years. The company is now valued at about $31 billion, making it the dominant player in what may be a new era of blood-based cancer testing. It has even surpassed Illumina, the sequencing giant on whose technology much of the industry depends. Revenue has grown from roughly $1 billion in 2023 to $2.3 billion last year and is projected by analysts on FactSet to reach $2.77 billion this year.”
  • and
    • “Merck KGaA lifted its full-year sales and earnings guidance, causing its shares to rise 8.2% in European midday trading.
    • “The company now forecasts net sales of 20.4 billion to 21.4 billion euros and organic sales growth of up to 3%.
    • “Merck cited strong momentum in its life-sciences unit and greater resilience in its healthcare division for the improved outlook.”
  • and
    • “State laws restricting private-equity involvement in the medical sector have taken their first scalps, as authorities signal an aggressive approach to enforcement.
    • “Last year, lawmakers in California and Oregon passed measures to prevent corporate healthcare investors from encroaching on medical care, part of a broad backlash against private equity’s role in the sector.
    • “The new laws started to bite last week. In California, Attorney General Rob Bonta unveiled the first settlement for violating the new law, penalizing Aspen Dental Management, which is backed by asset managers Leonard Green & Partners and Ares Management.
    • “Just a day earlier, Oregon hospital operator PeaceHealth scrapped plans to bring in an out-of-state medical-staffing company after a federal judge said the move looked like an end-run around the state’s strictest-in-the-nation ban on corporate medicine.”
  • Beckers Hospital Review tells us,
    • “Becker’s has compiled a list of the hospitals with a CMS 5-star rating for cleanliness.
    • “CMS’ Patient survey (HCAHPS)-Hospital database listed hospital ratings based on the Hospital Consumer Assessment of Healthcare Providers and Systems surveys. This is a national, standardized survey of hospital patients about their experience during a recent inpatient hospital stay. The surveys were completed between July 1, 2024, and June 30, 2025. The data was updated May 13. 
    • “In 2025, 374 hospitals had a five-star cleanliness rating and Wisconsin had the most highly rated hospitals for cleanliness at 30.
    • “This year, 22 more hospitals made it to 5-star ratings, and Texas had the hospitals recognized for cleanliness with 36.”
    • The article includes the list.
  • and
    • Americans are unlikely to see generic versions of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — until at least the end of 2031, according to a May 13 NBC News report.
    • Novo Nordisk first applied for a U.S. patent on semaglutide in 2006. While standard drug patents last 20 years, patent extensions and secondary patents have delayed generic competition in the U.S., experts told NBC News.
  • and
    • “Lentocilin, a penicillin G benzathine product, is back in stock and available to hospitals, clinics and pharmacies nationwide on Cost Plus Drugs’ marketplace.
    • “The restock comes as healthcare organizations continue managing supply disruptions affecting penicillin G benzathine products across the market, according to a May 11 company news release.
    • “Penicillin G benzathine is the only recommended treatment for syphilis during pregnancy and for preventing congenital syphilis — a condition whose national diagnosis rate has risen 203% over five years, according to an alert from the New Mexico Department of Health. The branded equivalent, Bicillin L-A, has been in shortage since 2023 and was further disrupted by a Pfizer recall in July 2025 due to particulates in prefilled syringes.” 
  • MedTech Dive points out,
    • “Johnson & Johnson has launched a new iteration of its Shockwave coronary intravascular lithotripsy catheter that is designed to make it easier for physicians to treat complex calcified lesions and restore blood flow in the arteries.
    • “Called Shockwave C2 Aero, the improvements in the fifth-generation platform are intended to allow clinicians to use the catheter in a broader range of cases. 
    • “The device is available in the U.S. and Japan and will be introduced in Europe and Canada in the coming months, J&J said Tuesday.”
  • Beckers Payer Issues discusses “How AI is turning UnitedHealth, CVS and Elevance into software companies.”

Monday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. visited Ohio this week as part of his “Take Back Your Health” tour. He met with the CEOs of the Cleveland Clinic, University Hospitals, and MetroHealth—three of the nation’s leading health systems—following a tour of the Cleveland Clinic. He also visited a Head Start program, a regenerative farm, and an addiction recovery facility, spoke at the City Club of Cleveland, and spent an afternoon at Summa Health. The tour highlighted the Secretary’s commitment to a prevention-first approach to healthcare as the pathway to Make America Healthy Again.
    • “Across Ohio, I saw communities move beyond symptom management and confront the root causes of disease head-on,” said Secretary Kennedy. “From visiting local programs to meeting with the CEOs of the Cleveland Clinic, University Hospitals, MetroHealth, and Summa Health, we are aligning leaders at every level around a prevention-first approach to reverse the chronic disease epidemic and deliver on President Trump’s mandate to Make America Healthy Again.”

  • FedSmith points out,
    • “In late 2025, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for Contract Year 2027, outlining significant changes to Medicare Advantage (Part C) and the Medicare prescription drug program (Part D).
    • “While many federal retirees rely on FEHB coverage, Medicare decisions—especially around Part B and Part D—remain one of the most important and misunderstood planning areas. This proposed rule signals where Medicare is heading next—and what federal retirees should be watching now.”
    • The article explains these changes.
  • Federal News Network reports,
    • “Despite some hiring occurring across agencies, overall employment in the federal government is continuing to decline. That’s according to the latest jobs report from the Bureau of Labor Statistics. BLS reported that in April, federal employment numbers decreased by another 9,000 jobs. Since peaking in October 2024, the federal sector’s numbers are now down by 11.5%, or 348,000 jobs.” 
  • STAT News relates,
    • “Two years ago, my old pal Rachel Cohrs Zhang and I reported how Medicare’s actuaries predicted the new Alzheimer’s drug Leqembi would cost the program $3.5 billion in 2025. It turns out that prediction was way off.
    • “Through the first three quarters of 2025, Medicare spent $139 million on Leqembi (made by Eisai and Biogen) and $74 million on Kisunla (a newer one made by Eli Lilly), federal data show. Together, that equals $213 million across 19,000 patients, and would be around $280 million for the entire year — a small fraction of the original estimate. Uptake for the drugs has been so muted that Medicare is not forecasting significant spending on them in 2026 or 2027.
    • “Predicting the myriad health care needs for a pool of 70 million older adults and people with disabilities is not an easy task. But neurologists and policy experts told me the lower-than-expected spending lines up with the challenges that have faced the Alzheimer’s drugs since their approvals: The intravenous medications are not easy to administer and require a lot of imaging; the population of patients who are eligible is limited; and the drugs continue to have little meaningful benefits while carrying a risk of severe side effects like brain bleeding.
    • Read Bob Hermans’ new story to learn more
  • and
    • “Changes to the no surprise billing law’s controversial arbitration process could come at any moment. Doctors and other providers are getting a lot more face time with the federal officials writing the regulations, my colleague Tara Bannow reports in a new story.
    • “Health insurers say providers are abusing the system by ramming through high volumes of ineligible cases. Providers claim insurers are not paying up when they lose and don’t give enough information. Ultimately, providers are winning more than 80% of cases, getting arbitration awards that are three to nine times the in-network rates. 
    • Read Tara’s story to find out the lobbying pitches from R1, Radiology Partners, the Blues, and employer groups.”

From the Food and Drug Administration front,

  • Beckers Hospital Review tells us,
    • “The fate of FDA Commissioner Marty Makary, MD, remained unclear May 11 after multiple news outlets reported May 8 that President Donald Trump had signed off on a plan to oust him — reports the president publicly waved off the same day.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions. 
    • “Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug’s safety profile. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up to date.”
  • MedPage Today informs us,
    • “The FDA on Friday [May 8] issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics in pregnancy, with the goal of better understanding potential risks for the pregnant patient and fetus.
    • “Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy,” Tracy Beth Hoeg, MD, PhD, the agency’s top drug regulator, said in a press release “This guidance provides specific recommendations about how postmarketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified.”
  • NBC News reports,
    • “The Food and Drug Administration removed the black box warning from hormone replacement therapies late last year, and recently, the most insured type, the estrogen patch, has been in short supply amid a boom in the therapy’s popularity.
    • “it’s unclear when supplies will rebound. Meanwhile, there are other options for hormone replacement therapy.”
  • Fierce Pharma lets us know,
    • “Argenx is poised to expand the reach of its generalized myasthenia gravis (gMG) treatment Vyvgart and subcutaneous Vyvgart Hytrulo with an expanded FDA nod that covers a wider pool of disease serotypes. 
    • “The label expansion now covers “all serotypes of adult patients living with gMG,” including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive and triple seronegative gMG, argenx said. In the company’s phase 3 Adapt Seron study, the overall population of Vyvgart-treated patients experienced “rapid, significant and sustained improvements” in symptoms including speech, vision, physical function and other disease measures.” 
  • and
    • Roche’s intravenous-infused relapsing-remitting multiple sclerosis (RRMS) treatment Ocrevus scored a pediatric indication from the FDA, clearing the therapy for patients 10 and older and introducing a new treatment option to the underserved population. 
    • The agency based its approval on a clinical trial comparing Ocrevus to Novartis’ Gilenya (fingolimod), which was until now the only FDA-approved pediatric RRMS treatment. In the study, Ocrevus proved noninferiority to Gilenya in reducing patients’ annualized relapse rate and superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions. 

From the public health and medical / Rx research front,

  • The Wall Street Journal shares what the Journal “knows about hantavirus drugs and vaccines in development.”
  • The New York Times reports,
    • “For about a decade, scientists have had remarkable success curing some blood cancers by modifying a patient’s own immune cells to recognize and kill the malignant cells.
    • “That same approach may help control H.I.V., among the wiliest of viruses, scientists will report on Tuesday. After a single infusion of immune cells engineered to recognize the virus, two people in a new study have suppressed their H.I.V. to undetectable levels, one of them for nearly two years.
    • “The data is scheduled to be presented at a gene therapy conferencein Boston, but the researchers shared an early copy with The New York Times.
    • “The treatment is years, if not decades, from being widely available, but the study offers what scientists call “proof of concept,” and the tantalizing hope that a single shot could one day offer lifelong relief from H.I.V.
    • “It is inspiration and a potential road map to get to where we need to go,” said Dr. Steve Deeks, an H.I.V. expert at the University of California, San Francisco, who led the trial.
    • “Other scientists were enthusiastic about the milestone.”
  • Radiology Business relates,
    • “Vigilance is needed to ensure patient safety in pediatric MR imaging, experts warn in new research published Friday by JACR. 
    • “Safety events remain relatively common in pediatric imaging, though most do not result in significant patient harm. However, these occurrences have the potential for serious consequences for patients, their parents or guardians, and MRI staff. 
    • ‘The conclusions are based on an analysis of safety data from five leading pediatric hospitals, spanning 2017 to 2022. Over the course of five years, there were about 146 pediatric MRI safety incidents that occurred, out of nearly 541,000 scans conducted. 
    • “Although uncommon, MRI safety incidents do occur in Zone IV of pediatric imaging departments,” corresponding author Jonathan R. Dillman MD, MSc, with the Department of Radiology at Cincinnati Children’s Hospital, and colleagues concluded. “While most cause no serious harm, their persistence and potential for catastrophic outcomes highlight the need for continued vigilance and ongoing safety improvements.”
    • “Zone 4 refers to the MRI scanner room, which presents the greatest risk of harm for both patients and staffers.” 
  • Med City News considers “Why We’re Still Finding Cancer Too Late>’
    • “The truth is there are ways to understand our cancer risk more precisely than we do today, and there are tools to manage it. What’s missing is awareness, access, and a system built to help us use these tools before something goes wrong.” * * *
    • “Healthcare innovators are shifting how we define and assess cancer risk, but education on evidence-based screening and risk-reduction practices needs to be front and center alongside these efforts so fewer people will ever have to say, “I wish I knew earlier.” Just like treatment options, prevention is not “one size fits all,” but a highly personalized approach. Individuals today can understand their risk of cancer far more clearly than any prior generation and, with the right information, resources, and support, can take powerful steps to reduce it. It won’t happen automatically. Our system is built to react to disease rather than anticipate it, which means personalized prevention rarely starts unless providers and patients help initiate it. 
    • “Instead of waiting for a cancer diagnosis, it’s time to ask the question: “What is this patient’s personal risk of cancer, and what can we do, starting now, to lower it and increase their chances of catching it early?”
  • A National Institutes of Health press release adds,
    • “Findings from a study supported in part by the National Institutes of Health (NIH) have identified a new model for predicting outcomes for hypertrophic cardiomyopathy (HCM), a heart condition with a prevalence of 1 in 500 people and a frequent cause of sudden cardiac death. Specifically, the findings demonstrate that incorporating prospective data including clinical history, imaging, and blood biomarker data into risk assessment can improve prediction of adverse cardiac events in people with HCM.
    • “The large, international study, called the Hypertrophic Cardiomyopathy Registry, was initially funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI). The findings were published in JAMA.
    • “Current risk prediction guidelines for hypertrophic cardiomyopathy are imperfect, as they predict only sudden cardiac death, and not heart failure or other fatal and nonfatal cardiac adverse events,” said Christopher Kramer, M.D., a principal investigator of the study and cardiologist at the Heart and Vascular Center of the University of Virginia Health System. “This study is a major advance in that it provides evidence that incorporating these additional assessment methods better predicts risk of adverse outcomes.”
  • Health Day tells us,
    • “People hospitalized for opioid overdose have a higher rate of subsequent OD than previously thought, a new study says.
    • “Previously, it was estimated that about 6% of people who survived an opioid overdose wound up with a repeat overdose during the following year.
    • “But new results indicate that 21% experience a repeat OD after an emergency department visit for opioid overdose, researchers reported May 7 in the Journal of the American Medical Association.
    • “Patients’ risk of death also increased alongside their number of additional overdoses, the study found.
    • “Increased use of powerful synthetic opioids like fentanyl are fueling the rising risk of repeat overdose, researchers said.”
  • and
    • “Exposure therapy can successfully protect preschool children from peanut allergies, a new study says.
    • “Children ages 1 to 3 fed small amounts of peanut daily slowly became accustomed to them, researchers reported May 6 in The Lancet Regional Health Europe.
    • “All children who followed the protocol achieved the goal of eating three and a half peanuts without experiencing an allergic reaction, and most were able to consume up to 25 peanuts,” researcher Caroline Nilsson said in a news release. Nilsson is an associate professor of clinical science and education at the Karolinska Institute in Sweden.
    • “We consider the treatment to be safe if it is carried out under controlled conditions in a healthcare setting,” she said.”
  • MedPage Today points out,
    • “Human papillomavirus (HPV) vaccination rates varied substantially across and within U.S. regions, according to estimates in a retrospective, cross-sectional analysis, suggesting targeted interventions should focus on the needs of individual states.
    • “Comparing adolescents ages 13-17 years across the country against Alabama — where the 21% without at least one dose of the HPV vaccine approximates the national goal — several Northeast states did significantly better, including Rhode Island (adjusted OR 3.05, 95% CI 1.40-6.66), Massachusetts (aOR 2.19, 95% CI 1.24-3.88), and New Hampshire (aOR 1.72, 95% CI 1.03-2.88).
    • “Several Southern states significantly lagged Alabama in likelihood of HPV vaccination, including Mississippi (aOR 0.41, 95% CI 0.26-0.65), Georgia (aOR 0.45, 95% CI 0.27-0.76), Oklahoma (aOR 0.46, 95% CI 0.30-0.72), Kentucky (aOR 0.55, 95% CI 0.35-0.87), and West Virginia (aOR 0.56, 95% CI 0.36-0.87), reported Chinenye Lynette Ejezie, PhD, of Towson University in Maryland, and colleagues in a JAMA Pediatricsopens in a new tab or window research letter.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For decades, physicians and scientists have thought that metformin, a biguanide drug that is prescribed for millions of people worldwide for type 2 diabetes (T2D), mainly targets the liver to suppress glucose production. A Northwestern University-led study in mice has now found that this “wonder drug” instead acts primarily on the gut, and prevents glucose levels from rising in the blood by driving glucose utilization inside cells lining the intestine.
    • “The research found that metformin slows mitochondrial energy production in gut cells by inhibiting mitochondrial complex I in the intestinal epithelium. This then “co-opts” the intestines to function as a glucose sink, forcing the intestine to metabolize extra sugar. The study also found that another biguanide drug, phenformin, and the structurally unrelated supplement berberine, which is known as “nature’s Ozempic,” appear to engage the same pathway in the gut as does metformin.
    • “The preclinical findings could help to explain several gut-related clinical effects in people who take metformin and suggest that modulating mitochondrial metabolism in the gut may represent an effective strategy for controlling blood sugar. “Metformin essentially helps the intestine suck the glucose out of the bloodstream, which further highlights that the gut plays a major role in regulating blood sugar levels,” said corresponding author Navdeep Chandel, PhD, professor of biochemistry and molecular genetics at Northwestern University Feinberg School of Medicine.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente’s first-quarter operating performance took a step back in 2026 compared to the year prior, though investments and other sources of income picked up the slack to push the large integrated nonprofit’s bottom line past $2 billion. 
    • “The system reported operating income of $711 million for the quarter, or a 2.1% operating margin, in a Friday evening press release. It had logged $932 million in operating income, or a 2.9% operating margin, in the first three months of 2025.
    • “The organization’s performance came on the back of $34.6 billion in consolidated operating revenue, a roughly 8.7% year-over-year increase, and $33.9 billion of operating expenses, a 9.6% year-over-year increase.
    • “Though it grew in scale, Kaiser noted that it and its subsidiary Risant Health “continue to manage elevated costs in care delivery while taking steps to improve efficiency and maintain affordability.” 
  • and
    • “Omada Health reported revenue of $78 million in the first quarter, up 42% year over year as the company continues to expand its commercial reach and is seeing traction from its big investments in GLP-1 capabilities.
    • ‘The virtual chronic care provider reported strong adoption of its GLP-1 Care Track program while the company also continues to successfully sell multiple chronic condition programs to its existing customer base of employers and health plans, executives said during the company’s Q1 earnings call on Thursday.
    • “Q1 was the strongest first quarter in Omada’s history; on members, on revenue, on gross margin and on adjusted EBITDA,” Steven Cook, Omada Health’s chief financial officer, said during the earnings call. “Over the past year, we have been building capabilities to position Omada for durable growth, prescribing infrastructure, AI-empowered care delivery and an expanding set of GLP-1 and cardiometabolic solutions.”
  • Modern Healthcare relates,
    • “UnitedHealth Group Inc. said it will move away from having profits in its pharmacy benefits unit linked to the list prices of medications, the latest shift to address longstanding criticisms of its business model.
    • “Optum is UnitedHealth’s services arm. UnitedHealth’s Optum Rx unit helps determine which drugs are covered by health insurance plans, including UnitedHealthcare’s and others, and what prices patients must pay to access them. The company handled about 1.7 billion prescriptions last year.
    • “Optum Rx plans to shift to what a top executive called a more transparent fee structure that gives clients clarity into the money it gets from drugmakers. The way those details have been determined has been shrouded in secrecy, leading to claims that Optum Rx benefits from higher drug prices. The new approach is designed to refute those criticisms.” * * *
    • “We want our earnings based on service to the client,” Optum Chief Executive Officer Patrick Conway said in an interview. “We do not want any of those earnings tied to the list price of drugs, period.”
    • “The shift is expected to be complete by the end of next year, Conway said. It’s part of a series of changes the company is making to transform a business model that’s faced criticism from regulators, employers and lawmakers.”
  • The Wall Street Journal tells us,
    • “AstraZeneca is inching closer to its goal of reporting $80 billion in revenue by 2030 as the U.K. drugmaker pushes further into the U.S. and develops new oncology, rare disease and weight-loss drugs.
    • “The pharmaceutical giant has made progress on a pipeline of more than 25 medicines, each expected to generate more than $1 billion in revenue by the close of the decade, Chief Financial Officer Aradhana Sarin said. AstraZeneca hopes those drugs, along with new U.S. manufacturing investments and a direct listing of its shares in New York, will fuel growth.
    • “Revenue has been on the upswing since the company set its $80 billion target in 2024, with 2025 coming in at $58.74 billion. That was up from $45.81 billion in 2023, the year before it set the 2030 target.”
  • Beckers Health IT informs us,
    • “Whoop is rolling out new features to include virtual clinician visits and EHR integration.
    • The Boston-based fitness wearable company announced the updates May 8, positioning the new offerings as part of its broader shift from fitness and performance tracking toward clinical-grade health support, according to a Whoop news release.
    • “The new offerings include live, on-demand video consultations with licensed clinicians, which are expected to launch in the U.S. this summer. Whoop said the feature will allow members to connect with clinicians directly through the app, using months of biometric data, and when available, bloodwork and medical history, to provide a more comprehensive understanding of a member’s health.
    • “Whoop also announced plans to support electronic health record syncing through a partnership with HealthEx. The integration will allow members to access clinical information, including diagnoses, medications and procedures, directly within the app.”
  • Healthcare Dive notes,
    • “An influential group that advises Congress on Medicaid is recommending increasing transparency into artificial intelligence-backed prior authorization and boosting human oversight over automated pre-approvals for care. 
    • “The recommendations come as states and the federal government say they have limited insight into payers’ use of the technology in the safety-net insurance program, which can make it challenging for regulators to monitor for data bias or inaccuracies, analysts said during the meeting.”
  • Tech Target adds,
    • “The Workgroup for Electronic Data Interchange launched a free directory for organizations seeking testing partners for the CMS Advancing Interoperability and Improving Prior Authorization Final Rule (CMS-0057-F), in advance of the Jan. 1, 2027, compliance deadline. WEDI encouraged all organizations impacted by the rule to post their information on the directory and use it to test APIs with eligible partners.
    • “CMS-0057-F requires entities to implement certain HL7 FHIR APIs: Prior Authorization, Payer-to-Payer, Patient Access and Provider Access. The Prior Authorization API can identify documentation requirements for prior authorization approval, while the Payer-to-Payer API enables the exchange of claims and encounter data. The Patient Access API allows patients to access their health information, and the Provider Access API allows payers to share patient data with in-network providers.” * * *
    • “Organizations that want to test can complete a questionnaire that includes contact information, specific APIs available for testing and a link to their website. Organizations can also look for testing partners using the directory and contact the organizations they want to test with. The directory will display summaries of completed testing.
    • “At the time of publication, six entities had posted their information on the directory: Wellmark, Mayo Clinic, Veradigm, Blue Cross Blue Shield of Michigan, NextGen Healthcare and ZeOmega.”


Thursday report

David Ermer–ACA, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

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

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Midweek report

David Ermer–Congress, FDA, Generative AI, Mental health care, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • Per a House of Representatives news release,
    • “Today, the House Appropriations Committee met to consider the Fiscal Year 2027 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 34 to 28.” * * *
    • “A summary of the bill is available here.” * * *
  • Federal News Network adds,
    • “The prospects of a civilian federal pay raise next year are continuing to diminish, after House appropriators made no mention of a pay increase in their 2027 spending legislation.
    • “The House Appropriations Committee’s financial services and general government (FSGG) bill for fiscal 2027, which advanced along party lines Wednesday evening, says nothing on funding for a civilian pay raise. Although not yet final, that increases the chances federal employees will miss out on a salary increase next year.”
  •  A House Education and Labor subcommittee shared the testimony presented to its members during its PBM business model hearing today.
  • The Wall Street Journal offers seven takeaways from HHS Secretary Robert F. Kennedy Jr.’s numerous recent appearances before Congressional committees.
  • Healthcare Dive informs us,
    • “Prices for some healthcare services after arbitration under the No Surprises Act were much higher than the same in-network commercial prices before the law was passed, according to new research out this week.
    • “In 2024, prices for imaging after arbitration were 767% higher than average prices in Medicare. For comparison, the same imaging prices were roughly 200% higher than Medicare prices before the No Surprises Act was passed, according to an analysis published by the Brookings Center on Health Policy.
    • “Arbitration decisions in emergency care, imaging and pediatric critical care tended to skew more closely to amounts that providers offered during negotiations, rather than those offered by insurers, according to the analysis.” * * *
    • [This] Brookings research compliments other studies that have found the No Surprises arbitration process raises healthcare costs. One study published in Health Affairs last year found that IDR created an estimated $5 billion in costs between 2022 and 2024, which could eventually result in higher insurance premiums for consumers.”
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), is today announcing the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative, which will collectively fund up to $139.4 million to help spur new, effective therapies for behavioral health. As part of the Trump Administration’s Executive Order to Accelerate Medical Treatments for Serious Mental Illness, EVIDENT will allocate at least $50 million to match state government investments in psychedelic research for populations with serious mental illness.”
  • MedPage Today adds,
    • “From July 2022 [when the 988 mental health line was launched] through December 2024, 35,529 suicides among individuals ages 15 to 34 were observed compared with 39,901 expected suicides based on trends before the launch of the lifeline, corresponding to an 11% reduction (95% CI 8.7-13.1), reported Anupam B. Jena, MD, PhD, of Harvard Medical School in Boston, and co-authors in a research letter in JAMA.
    • “After replacing the previous 10-digit number for suicide and crisis services with the 3-digit number and investing more than $1.5 billion to expand crisis center capacity and workforce nationwide, “988 appears to be working where it matters most, in reducing suicide deaths among the young people who use it the most … saving lives, at scale, within a few years of launch,” said co-author Vishal R. Patel, MD, MPH, also of Harvard Medical School.
    • “Prior evidence for the lifeline was mostly indirect: higher call volumes, positive caller surveys, reductions in same-day distress,” Patel told MedPage Today. In contrast, this study shows that the lifeline actually affects suicide mortality at the population level, he noted.”
  • HR Dive relates,
    • “The U.S. Department of Labor’s Wage and Hour Division on Wednesday announced a proposed rule to streamline joint employer status under the Fair Labor Standards Act, the Family and Medical Leave Act, and the Migrant and Seasonal Agricultural Worker Protection Act, according to a department press release.
    • “The rule would create “a single nationwide standard that both derives from commonalities in federal court precedent where available and resolves significant differences among the circuit courts where they exist,” DOL said, to “ensure employees and employers have a clear, consistent understanding of when multiple employers are jointly responsible for protecting the wages and other rights of an employee.”

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • ‘Merck is carving out its own place in the evolving HIV treatment space with an FDA approval for its Idvynso, a combination regimen that brings its novel islatravir to market for the first time and serves as the cornerstone of what could be a lucrative HIV franchise for the company. 
    • “Idvynso is a once-daily, two-drug oral pairing of Merck’s doravirine and islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that has been commercialized since 2018 as part of Merck’s Pifeltro and Delstrigo, while islatravir is a newer nucleoside reverse transcriptase translocation inhibitor (NRTTI) that represents the “anchor medicine” in a number of other HIV combos that the company is advancing.
    • “The doravirine and islatravir combo’s debut is specifically targeted at patients who are switching from other HIV treatments and will be available in pharmacies after May 11, Merck said in its April 21 press release.” 
  • STAT News relates,
    • “The Swiss drugmaker Roche on Tuesday presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval for a medicine that it believes can cut relapse rates and slow the progressive disability the disease causes.  
    • “Now the test is whether the drug, called fenebrutinib, can win the regulatory green light.
    • “While three late-stage trials of the drug have shown it to be effective, analysts have homed in on some potentially worrying liver safety signals, an issue that previously prompted the Food and Drug Administration to reject an MS therapy developed by Sanofi. In data released Tuesday, researchers also disclosed that there were two drug-related deaths among patients who took fenebrutinib.  
    • “Roche has touted the potential of fenebrutinib — an oral tablet — noting that it hit its efficacy mark across different types of MS and offers a new approach for treating the disease. It’s also sought to differentiate its therapy from Sanofi’s rejected drug, called tolebrutinib.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Revolution Medicines’ closely watched pancreatic cancer drug helped control tumors when administered early in a patient’s disease course, stimulating a response in at least half of those who got it either as a single treatment or alongside chemotherapy, according to trial results unveiled at a medical meeting Tuesday.
    • “The findings disclosed at the American Association for Cancer Research’s annual convention come from studies testing the therapy, daraxonrasib, in first-line pancreatic cancer. They follow, by a week, Phase 3 data showing the drug nearly doubled survival in people whose disease had progressed after an earlier treatment, sparking a share surge that has launched the company’s valuation past $30 billion.
    • “The Food and Drug Administration gave Revolution a special regulatory fast-pass that could lead to a clearance within weeks of an approval submission.”
  • and
    • “A three-drug combination involving Merck & Co.’s Welireg failed to significantly delay tumor progression or extend survival in a Phase 3 trial of patients newly diagnosed with the most common form of kidney cancer, setting back the big drugmaker’s plans to further expand use of the medication.
    • “The study evaluated Welireg alongside Merck’s immunotherapy Keytruda and Eisai’s Lenvima in first-line clear cell renal cell carcinoma and compared that regimen to the Keytruda-Lenvima tandem alone. Merck didn’t provide specifics but said that drug trio — as well as a separate one also tested in the trial — missed the study’s dual main objectives at an interim analysis.
    • “Merck noted how the findings don’t affect other ongoing studies in “Litespark,” the broad program it’s jointly conducting with Eisai and that includes other Welireg tests. The Food and Drug Administration is reviewing an application based on results from one Litespark study that would expand use of Welireg earlier in kidney cancer.”
  • MedPage Today relates,
    • “In a survey of roughly 45,000 U.S. adults representing more than 257 million people, 9% said they had obesity and drank heavily over the past month, while 3.8% said they had both obesity and met criteria for alcohol use disorder (AUD) over the past year, reported researchers led by Bryant Shuey, MD, MPH, of the University of Pittsburgh.
    • “Overlapping heavy drinking and obesity was most common among men ages 35 to 49 (13.6%), women ages 26 to 34 (11.9%), and Black individuals (11.9%). AUD and obesity overlap was highest for men and women ages 26 to 34 (6.2% and 5.1%), people without insurance, and those on Medicaid, the findings in JAMA Internal Medicine showed.
    • “Shuey and colleagues said the findings on this high-risk population call for public health and clinical interventions tailored to younger and middle-age adults, especially the uninsured and those on Medicaid, to prevent liver disease and liver-associated deaths.” * * *
    • “Given the effectiveness of GLP-1 drugs “for weight loss and metabolic dysfunction–associated steatohepatitis, expanding access for patients with co-occurring risky alcohol use and obesity may reduce liver disease burden,” they argued.”
  • Health Day tells us,
    • “Pregnancy-related deaths in the U.S. increased sharply during the COVID-19 pandemic, particularly among Black women, a new study reports.
    • “Deaths remain significantly higher today for Black mothers, even though they’ve returned to pre-pandemic levels for most other groups, researchers reported in the journal Obstetrics & Gynecology.
    • “We saw a dramatic increase in pregnancy-related deaths during the COVID-19 pandemic, but the recovery has not been equal across all groups,” said senior researcher Dr. Lindsay Admon, an associate professor of obstetrics and gynecology at the University of Michigan Medical School.
    • “We need to better understand what’s driving these differences so we can develop solutions that reduce maternal deaths and improve outcomes for everyone,” she said in a news release.”
    • * * * “Results showed that maternal deaths during or just after pregnancy rose more than 60% during the pandemic, from about 20 deaths per 100,000 live births in 2019 to 33 per 100,000 in 2021.
    • “Most of the pandemic increase was linked to COVID-associated deaths, researchers found. Early pregnancy death rates rose by 7.5 per 100,000 live births, and later pregnancy deaths by 3.7 per 100,000.
    • “By 2023 and 2024, early pregnancy deaths had returned to pre-pandemic levels, but those late in pregnancy and after pregnancy remained elevated.
    • “All death rates remained notably higher for Black mothers, researchers found.”
  • Per an NIH news release,
    • “In a National Institutes of Health (NIH)-funded study, researchers developed a cancer assessment tool that can identify high-risk patients and the tumor cells linked to that risk. The model, called scSurvival, uses a machine learning framework designed to analyze large-scale data at single-cell resolution. 
    • “With NIH support, Oregon Health & Science University (OHSU) tested the model on clinical data from more than 150 cancer patients. The tool predicted survival outcomes and linked specific cell populations to higher risk. 
    • “A risk assessment tool that not only tells you who may be at higher risk, but also provides clues as to why, could really help in these difficult cancers” said Anthony  Letai, M.D., Ph.D., director of NIH’s National Cancer Institute (NCI).”  

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

  • Beckers Hospital Review relates,
    • “Franklin, Tenn.-based Community Health Systems reported an operating income of $281 million (9.5% margin) on revenues of $3 billion in the first quarter of 2026, down slightly from a $284 million operating gain (9% margin) in the same period last year. 
    • “However, after interest payments on debt and other expenses, CHS reported a net loss of $58 million in the first quarter, compared to a $13 million loss in the first quarter of 2025. 
    • “We are pleased with the continued, tangible progress on our key priorities, demonstrated by improvements in quality scores, patient experience and physician satisfaction measures, and investments in growth opportunities,” CEO Kevin Hammons said in an April 21 news release. “In the face of a dynamic macroeconomic environment, we remain focused on the variables within our control and believe we are positioning the company for long-term success and value creation.”
  • and
    • “Optum Rx — the pharmacy benefit manager for UnitedHealth Group — claims its “PreCheck” prior authorization tool not only cuts prescription approval times but also reduces denials and appeals.
    • “UnitedHealth Group gave an update on the tool in an April 21 earnings call. Optum CEO Patrick Conway, MD, said denials due to missing information dropped by 68% and appeals were down 88%, thanks to PreCheck. He said PreCheck has been “easing interactions for clients, members and providers.”
    • “Dr. Conway reaffirmed that PreCheck has axed prescription approval time from eight hours to fewer than 30 seconds. 
    • “Optum Rx announced an expansion of PreCheck in November, alongside its decision to eliminate reauthorization requirements for 40 medications. In the November release, UnitedHealth Group said, as of this year, the PreCheck platform covers more than 45 medications and is leveraged across 20 health systems.”
  • Healthcare Dive tells us,
    • “Amazon is launching a weight management program with access to GLP-1s through its One Medical primary care chain, in a bid to help consumers more easily access the popular weight loss drugs alongside supportive care, the retail and technology giant said Tuesday. 
    • “Under the program, users work with a dedicated provider to receive a GLP-1 medication as well as follow-up care, so patients can adjust their treatment and address related health concerns like cardiovascular disease and diabetes. 
    • “Patients can also access prescriptions for “transparent pricing” on Amazon Pharmacy, the company said. New GLP-1 pills start at $25 per month with insurance or through cash-pay options as low as $149 per month.”
  • Fierce Pharma informs us,
    • “As pharma giants slash headcounts and routinely strike billion-dollar M&A deals, another trend is steadily playing out at many of the largest drugmakers: adoption of AI on a corporate scale.
    • “Mark Merck as a participant in this movement. On Wednesday, the company revealed a partnership with Google Cloud as it works to undergo an “agentic AI enterprise transformation.”
    • “As part of an investment in Google Cloud valued at up to $1 billion, Merck will get access to the tech giant’s agentic AI platform across its R&D operations, manufacturing, commercial teams and corporate functions.
    • “Notably, the deal involves Google Cloud engineers working directly with Merck’s teams to onboard the tech, according to the April 22 press release. In a statement, Dave Williams, Merck’s chief information and digital officer, noted that the AI push comes “as we enter one of the most significant launch periods in our company’s history.”
  • Beckers Health IT adds,
    • “UnitedHealth Group is betting big on AI in 2026 — $1.5 billion to be exact. 
    • “During the company’s Q1 earnings call, leaders fleshed out how that investment is materializing.
    • “Think about it this way: A third of this is explicitly invested into software products and platforms, accelerating Optum Insight’s transition of business models into an AI-first software and services firm. The remaining two-thirds is spent across signature end-to-end processes and functions across UnitedHealth Group,” Optum Insight CEO Sandeep Dadlani said. 
    • “Optum Insight, the technology-enabled services business under UnitedHealth, will manage internal AI use cases, which could eventually be translated and commercialized beyond the company. UnitedHealth expects a 2-to-1 return, much of it within the next 12 to 18 months.”
  • and
    • “Michael and Susan Dell have surpassed $1 billion in total giving to the University of Texas at Austin, becoming the university’s first billion-dollar donors, according to an April 21 news release.
    • “The latest investment will support development of the UT Dell Campus for Advanced Research, anchored by an AI-focused UT Dell Medical Center expected to open in 2030. The Dells’ investment will also support expanded supercomputing capabilities, student scholarships and housing.
    • “The medical center will integrate Houston-based University of Texas MD Anderson Cancer Center to provide cancer care as part of the new campus.
    • “The university plans to break ground on the medical center later in 2026.”
  • Fierce Pharma points out,
    • “After AbbVie earlier this year pledged a whopping $100 billion in U.S. R&D and capital investments over the next decade, the company is filling in more details on its expansion plans. And like with many other pharma giants, it’s putting down roots in North Carolina.
    • “The North Chicago-based drugmaker on Wednesday revealed its largest-ever capital investment in a single campus, plotting a 185-acre production hub in Durham. The project will cost some $1.4 billion and add more than 730 roles to the company’s headcount, according to an April 22 press release. The site will produce certain AbbVie medicines in its immunology, neuroscience and oncology portfolios.”

Friday report

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

From Washington, DC,

  • Roll Call reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. sought to distance himself from U.S. measles outbreaks on Friday at a House Education and Workforce Committee hearing on the administration’s fiscal 2027 budget request.
    • “The hearing, part of Kennedy’s weeklong tour of Congress on the budget, was relatively light on spending discussions, as Democrats who have repeatedly requested such a hearing with Kennedy looked to pin him down on a range of issues. The hearing was often combative, with Democrats drawing attention to issues such as vaccines and Kennedy’s focus on school nutrition.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services today announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration. He most recently served as the U.S. Small Business Administration’s Chief Counsel for Advocacy.
    • “Mulligan will advise Health and Human Services Secretary Kennedy Robert F. Kennedy, Jr., and other agency leaders on policy development to continue to make health care more affordable for the American people. His portfolio will include cost-benefit analysis of regulation, econometric modeling, and program evaluation of major expenditures.”
  • Fierce Healthcare relates,
    • “Insurers hoping for a reprieve from an out-of-network billing system largely favoring healthcare providers will likely be left wanting as federal policymakers sit on their hands and one large payer’s bid to limit the claims faces an uphill battle, strategy firm Capstone concluded in a new report.” * * *
    • “Capstone expects any meaningful reversal of the IDR trend to most likely stem from direct action by payers. Chief among these is an administrative penalty Elevance Health implemented in 11 states for its Anthem BCBS commercial business. The policy levies a fee equal to 10% of the allowed amount on facility claims involving OON providers.
    • “The policy has faced substantial pushback from provider groups, though it still went into effect Jan. 1 in the 11 states with plans to expand similar fees in two more. Capstone noted that one of the initial states, Indiana, has already enacted legislation against the practice and that the broader policy is primed for legal challenges.
    • “However, if Elevance’s model is adopted more broadly, the OON ecosystem could shrink as facilities internalize the direct financial cost of hosting OON providers,” Capstone wrote. “In that scenario, provider groups would face pressure to either absorb the loss of facility relationships or accept often-lower in-network rates.” 
  • Bloomberg Law points out,
    • “The head of the Department of Labor’s employee benefits regulator defended how he’s changed the agency before lawmakers, saying he’s cut down on excessive litigation and enforcement.
    • “Daniel Aronowitz, leader of the Employee Benefit Security Administration, told members of a House Education and the Workforce subcommittee that the agency had reoriented its approach to follow the Employee Retirement Income Security Act, boasting that it was “the most pro-ERISA EBSA administration ever.” * * *
    • “The agency is revisiting a Biden-era [mental health] parity rule creating a comparative test to ensure employers are covering mental health equally with medical and surgical benefits. EBSA halted enforcement of the rule after The ERISA Industry Committee sued.
    • “Aronowitz noted that he didn’t believe the rule’s comparative analyses “got us anywhere. It just created cost and burden.”
    • “But he said EBSA is conducting investigations on medical necessity denials, exclusions for autism and opioid treatment, so-called “ghost networks” of unavailable doctors, and conflicts of interest.”
  • Thompson Reuters discusses this year’s obligation to provide notices of creditable coverage to Medicare Part D eligible individuals and to CMS.
    • “Sponsors of HRAs and other account-based plans, which are typically offered alongside major medical plans, will welcome the relief from providing burdensome and potentially confusing Part D creditable coverage notices. Sponsors of plans that remain subject to the disclosure requirements should use the 2027 parameters when determining whether their plans’ prescription drug coverage is creditable for that year.”
  • Healthcare Dive tells us,
    • “Employers, lawmakers, patient advocates, price transparency groups and more urged the Department of Labor to quickly finalize a rule that would force pharmacy benefit managers, shadowy middlemen in the drug supply chain, to share more pricing and compensation information.
    • “PBMs did not feel the same, according to industry comments on the proposed regulation.
    • “The rule has been caught up between two powerful industries — healthcare purchasers like employers and the PBMs they contract with to manage their drug benefits — since it was proposed in January, amid growing criticism of PBMs and a broader bet from the Trump administration that better price transparency will lower healthcare costs.”
  • and
    • “The CMS has proposed repealing the alternative pathway for new technology add-on payments, or NTAP, beginning in fiscal year 2028. The change is included as part of the 2027 Inpatient Prospective Payment Systems proposed rule. 
    • “Under the proposal, medical devices with breakthrough device designation would be required to meet the same eligibility criteria as other available technologies to receive the additional payments under the NTAP pathway.
    • “Industry trade group AdvaMed said the alternative pathway policy, implemented by the first Trump administration, has worked well. AdvaMed, in an emailed statement to MedTech Dive, said “it would be disappointing if this progress were rolled back.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has cleared an HPV self-collection kit and approved a related HPV assay for at-home use, enabling patients to obtain their own sample for cervical cancer screening.
    • “The Onclarity HPV Self-Collection Kit (Waters Corp.) is tested with the BD Onclarity HPV Assay (Waters Corp.), which now supports specimens collected both in clinic and at home. The assay detects all high-risk, carcinogenic genotypes and is the only FDA-approved HPV assay to identify “six individually and three groups of pooled results,” according to a manufacturer press release.
    • “The at-home, self-collection kit could help reduce barriers for unscreened or underscreened individuals, who comprise nearly 60% of cervical cancer cases.”
  • MedTech Dive relates
    • “Philips has received Food and Drug Administration clearance for an artificial intelligence-enabled CT system.
    • “The 510(k) clearance, which Philips disclosed Thursday, covers a Verida device that the company claims reduces image noise by 80% and reconstructs scans twice as fast as its predecessor.
    • “Jie Xue, chief business leader for precision diagnosis at Philips, recently said Verida’s throughput sets it apart from photon-counting CT technology. GE HealthCare and Siemens Healthineers sell photon-counting devices.”
  • CVS Health informs us,
    • “New treatments take years of research, clinical trials, and regulatory review before reaching patients. Several therapies approaching FDA decisions this spring could expand treatment options for people managing a range of conditions.
    • “CVS Caremark’s Clinical Pipeline Services team — made up of licensed clinical pharmacists and analysts — monitors new therapies moving through the drug pipeline and evaluates what those approvals could mean for members. The team’s latest Drugs to Watch report identifies several notable therapies with decisions expected between April and June 2026, including:
      • “A new oral option for patients with treatment-resistant hypertension
      • ​​​”A more convenient, at-home format for early Alzheimer’s disease treatment that avoids lengthy IV infusions​​​​​​​​​​
      • “The first FDA-approved treatment for a chronic ​​​​liver infection
      • “An additional non-nicotine option for adults looking to quit smoking.”

From the judicial front,

  • Bloomberg Law reports,
    • “A wave of hospital bankruptcies has brought in its wake high-stakes lawsuits aiming to boost creditor payouts by targeting health insurers over allegedly systemic claim denials.
    • “At least nine different health insurers in the past six months have been sued by bankruptcy estates or trustees appointed under bankruptcy plans for three major health-care businesses, according to court documents reviewed by Bloomberg Law. 
    • “Lawsuits against insurers for Steward Health Care System LLC, CarePoint Health Systems Inc., and Jackson Hospital & Clinic Inc. seek a combined $427.9 million and represent 32,000 patient claims across 32 hospitals and providers and six states.
    • “The litigation is ramping up as hospital bankruptcies accelerate amid disputes over private equity ownership, real estate investment trust structures, and federal cuts.” * * *
    • “A trustee for CarePoint, which operated three New Jersey safety-net hospitals before it filed for Chapter 11 in November 2024, sued Cigna Health & Life Insurance Co. in February. It argued Cigna underpaid its hospitals for various services by more than $114 million.
    • “Steward’s trustee filed at least seven lawsuits against insurers, including Blue Cross of Florida, CareSource Ohio, and Aetna Health, seeking to recover more than $63 million and alleging they withheld valid reimbursements.
    • “Jackson Hospital took a different approach, bringing a more than $250 million antitrust suit against Blue Cross and Blue Shield of Alabama in December. The insurer used market domination to allow for a pattern of baseless claim denials for emergency care, the suit said.”

From the public health and medical / Rx research front,

  • The Centers for DIsease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is low in most areas of the country.
    • “Influenza
      • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all HHS regions and influenza B activity continues to trend downward.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News reports,
    • “There are now 602 cases in the Utah measles outbreak, the state’s Department of Health and Human Services reported April 14. Of those, 405 cases have been diagnosed this year. The confirmed total of measles cases reported nationwide in 2026 has increased to 1,748, according to the latest data from the Centers for Disease Control and Prevention. There have been 19 reported outbreaks across 33 jurisdictions. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape adds,
    • Use of preexposure prophylaxis (PrEP) for HIV prevention in adolescents and young adults is “strikingly low,” though youth aged 13-24 years have nearly 1 in 5 new HIV infections in the US, according to a new study in JAMA Pediatrics. Use is particularly low in women and young people who live in the South and Midwest.
    • “Efforts to expand PrEP use among youths should address geographic disparities, legal and policy barriers, and clinician engagement to improve equitable access to HIV prevention,” the authors wrote, led by Nicholas Venturelli, MD, MPH, with Boston Children’s Hospital in Boston.
  • The University of Minnesota’s CIDAP relates,
    • “Historically, shigellosis cases in the United States have primarily been seen in young children in daycare settings and in people who’ve traveled to countries with poor sanitation. Infections with Shigella, a gut pathogen that causes diarrhea and vomiting, have also been fairly easy to treat.
    • “But the profile of who’s most at risk of shigellosis is changing, and the infections is becoming much harder to treat, according to a report published last week in Morbidity and Mortality Weekly Report, the flagship publication of the Centers for Disease Control and Prevention (CDC).
    • “In the report, researchers from the CDC and health departments across the country revealed that the vast majority of US Shigella infections from 2011 through 2023 were in adult men, a high proportion of whom (47%) had HIV. Analysis of nearly 17,000 Shigella isolates found that the proportion of isolates considered extensively drug-resistant (XDR) rose from 0% during 2011-2015 to 8.5% in 2023. 
    • “Approximately one-third of patients were hospitalized. And among patients with travel history, more than 80% reported no recent international travel.
    • “The report’s corresponding author said the findings reflect changes in epidemiology and resistance that are transforming Shigella from a primarily self-limiting infection that rarely required antibiotics into an emerging public health threat with limited treatment options. 
    • “Together, it’s a very concerning pattern of XDR Shigella strains that are being seen among vulnerable populations,” Naeemah Logan, MD, an epidemiologist with the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, told CIDRAP News.”
  • The AP informs us,
    • “The worrisome rise in colorectal cancer deaths in younger adults is concentrated in people with less education, suggesting socioeconomic factors could be driving the escalation, according to a new study.
    • “Celebrity deaths — including Chadwick Boseman in 2020 and James Van Der Beekearlier this year — have highlighted the increase in colorectal cancer deaths among younger adults, but the new paper was called the first to parse which people are most affected by the alarming rise. 
    • “The researchers found that over the last 30 years, the rise in colorectal cancer deaths in young adults occurred almost entirely among people without a four-year college degree.
    • “Of course, getting a college degree doesn’t protect you from getting colon cancer. Rather, experts say it’s a marker for other issues: People without degrees tend to earn less money, have poorer diets, exercise less and get less medical care.
    • “It’s not totally unexpected that the death risk is concentrated in the less advantaged, but the paper published Thursday in JAMA Oncology is the first national study to actually show the connection, said Dr. Paolo Boffetta, a researcher at Stony Brook Cancer Center in New York who wasn’t involved in the work.” 
  • The New York Times points out,
    • “Researchers at the University of Pittsburgh reported on Friday that they had trained the immune systems of a few patients to accept liver transplants without the drugs needed to avoid organ rejection.
    • “Three of eight patients have now been off the drugs for at least three years, perhaps an early step toward a new approach to transplantation that experts in the field have long hoped for. The study was published in Nature Communications.
    • “They’ve gone a long way toward proving a principle,” said Dr. William Jarnagan, chief of liver and transplant surgery at Memorial Sloan Kettering Cancer Center, who was not involved in the study.
    • “With further development, it could really be a game changer,” he added.
    • “Dr. Joohyun Kim, a liver transplant surgeon at Yale who was not involved with the study, said, “Even 10 years ago, people thought ‘tolerance induction’ was a dream.”
  • The Genetic Engineering and Biotechnology News adds,
    • “The American Association for Cancer Research (AACR) Annual Meeting kicks off this weekend in San Diego. A whirlwind of sessions, keynotes, fireside chats, posters, and exhibitors, the meeting is THE annual event for the cancer community.
    • “Before the conference, GEN spoke with AACR program chairs Paul S. Mischel, MD, Professor and Vice Chair for Research for the Department of Pathology at Stanford Medicine of Stanford University and Alice T. Shaw, MD, PhD, Chair of the Department of Medical Oncology and the Chief of Strategic Partnerships at Dana-Farber. In this interview, they share their perspectives on the event, what attendees should be looking out for, and what they, personally, are most looking forward to.”
  • and
    • “For pathogens like HIV, malaria, and rapidly evolving influenza strains, coaxing the immune system to produce the rare, highly potent antibodies needed for protection has long been a scientific bottleneck. Vaccines can train B cells to evolve such broadly neutralizing antibodies, but only under ideal conditions—and only in a small fraction of people. Even attempts to genetically edit mature B cells produced responses that faded as the cells died out.
    • “A team at The Rockefeller University has now taken a more upstream approach: programming hematopoietic stem and progenitor cells (HSPCs)—the source of all B lymphocytes—to carry permanent genetic instructions for therapeutic antibodies or other proteins. Because the immune system naturally amplifies rare, useful cells after vaccination, even a tiny number of edited stem cells can seed a durable, boostable immune response.
    • “The immune system is inefficient in that it produces a vast quantity of cells to protect itself,” said Harald Hartweger, a research assistant professor in Michel Nussenzweig’s Laboratory of Molecular Immunology. “We wanted to take advantage of the immune system’s ability to amplify useful, rare cells.”
    • “The study, published in Science and titled “B lymphocyte protein factories produced by hematopoietic stem cell gene editing,” demonstrates that CRISPR‑edited HSPCs can mature into B cells that express engineered antibodies upon vaccination. A standard vaccination then acts as the trigger: antigen exposure drives those edited B cells to expand, differentiate into plasma cells, and secrete high titers of the inserted antibody that last long-term.”

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

  • Fierce Healthcare reports,
    • “The Purchaser Business Group on Health has released new data that highlights some of the key healthcare priorities of its jumbo employer members, with—perhaps unsurprisingly—the escalating affordability crisis as the biggest challenge.
    • “Rounding out the top three priorities are data analytics and transparency, as well as an interest in advanced primary care. PBGH based the findings of a survey of more than two dozens of its members, which represent some of the largest employers in the United States.
    • “Elizabeth Mitchell, president and CEO of PBGH, said in an interview that the escalating cost pressures have driven “a much more proactive approach from our members to address these concerns, which are simply not being addressed by the industry.”
    • “The urgency of that concern is absolutely growing,” Mitchell said. There is “also a heightened focus on transparency and understanding prices, and we are enabling that because they cannot just keep writing blank checks to the healthcare system when they have poor outcomes and just no demonstrable improvement in quality or value.”
  • Beckers Hospital Review informs us,
    • “Little Rock, Ark.-based Baptist Health reached a definitive agreement to acquire Magnolia (Ark.) Regional Medical Center.
    • “The deal, subject to customary regulatory approvals, is expected to be completed by July 12, according to an April 16 Baptist news release. On that date, the hospital will be rebranded as Baptist Health Medical Center-Magnolia.
    • “While it is an extremely challenging time to operate community hospitals, we have a proven track record of operating rural hospitals successfully in Arkansas,” Baptist President and CEO Troy Wells said in the release.”
  • and
    • “Mark Cuban has a pitch for hospitals: Manufacture drugs in their own parking lot.
    • “Mr. Cuban’s Cost Plus Drugs previously launched a Dallas-based manufacturing facility to address supply issues, starting with epinephrine and norepinephrine production. More recently, Mr. Cuban said his facility can also produce Pitocin, pediatric cancer drugs and sterile water — and that generic tablets can be cheaper when made in Dallas versus purchased from India.
    • “During Becker’s Spring 2026 Chief Pharmacy Officer Summit, Mr. Cuban explained how Cost Plus — which includes pharmacy, contracting, procurement and manufacturing businesses — is “modularizing” its manufacturing facilities.
    • “We’ve been able to take the manufacturing facility we have in Dallas and not only make it much smaller than what everybody else has done to that point, but we’ve been able to modularize them and put them in a pod that is effectively a tractor trailer,” Mr. Cuban said. “The trailers that go on the back that you see going down the road — we can manufacture sterile injectables in that tractor trailer.”
    • “Cost Plus is selling these manufacturing pods, which can be deployed anywhere from hospital sites to disaster zones to research facilities. He said rare disease therapies that historically cost upward of $500,000 and took six months to produce can now cost roughly $50,000 and possibly take less time.
    • “That, literally, over the long term, is going to be our biggest business and will save the most lives and money,” he said. “The more efficient we become at using robotics and AI, the less expensive we can manufacture drugs.” 
  • BioPharma Dive relates,
    • “Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine that’s being tested as a potential therapy for a few seizure disorders as well as Alzheimer’s disease.
    • “UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.
    • “The therapy, codenamed NRTX‑1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the “mesial temporal lobe” part of the brain.”
  • and
    • “Kailera Therapeutics, a high-profile drug startup aiming to compete with Novo Nordisk and Eli Lilly in obesity, said Thursday it banked $625 million in one of the sector’s largest-ever initial public offerings.
    • “The IPO haul far surpasses the $500 million it set out to raise in terms set earlier this week. Kailera sold more than 39 million shares at $16 apiece. It’ll begin trading on the Nasdaq stock exchange on Friday under the ticker symbol “KLRA.”
    • “Kailera’s offering is among the biggest, by total proceeds, raised by a venture-backed biopharmaceutical company, according to BioPharma Dive data. Its IPO eclipses Acelyrin’s $540 million stock sale in 2023, Sana Biotechnology’s $588 million issuance in 2021, and Moderna’s then-record $604 million pricing in 2018.”
  • MedTech Dive lets us know,
    • “GE HealthCare is expanding a mammography collaboration with RadNet subsidiary DeepHealth.
    • “The partnership brings more of DeepHealth’s artificial intelligence tools to GE HealthCare’s mammography machines, including a workflow for complex cases that may benefit from a secondary review.
    • “The companies announced the expanded initiative at the Society of Breast Imaging Annual Symposium on Thursday.”