Thursday update

Federal employment benefits

Thursday update

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

  • Smart Brief reports,
    • “AHIP26: How data sharing, simplicity can improve care
    • “Panelists at the conference discuss the challenges that data fragmentation and siloing, as well as an unwieldy system, present — and offer solutions.”

From Washington, DC,

  • Govexec reports,
    • “A bipartisan trio of House lawmakers on Thursday reintroduced legislation aimed at expanding federal workers’ access to paid leave to handle illnesses and other circumstances not included in the 2019 law granting feds paid parental leave.
    • “The Comprehensive Paid Leave for Federal Employees Act, introduced by Reps. Don Beyer, D-Va., Brian Fitzpatrick, R-Pa., and Chrissy Houlahan, D-Pa., would grant federal employees up to 12 weeks of paid family leave each year to attend to a serious health condition or to care for a spouse, child or parent. The measure would also cover absences needed to help a family member who is the survivor of domestic violence, sexual assault or stalking, as well as to attend to a family member’s deployment into active duty military service.
    • “When Congress passed the 2020 National Defense Authorization Act, the House’s version included a provision providing 12 weeks of paid parental and family leave to feds. But during negotiations with the Senate, the measure was stripped down to remove the family leave portions, and feds became eligible for paid parental leave in October 2020.”
  • The Wall Street Journal reports,
    • “If you’re a senior, the Medicare plan you choose may have a major impact on whether you can get nursing-home care when you need it—and a new federal investigation shows the largest insurers had some of the highest denial rates.
    • “Medicare insurers had widely varying rejection rates for patients seeking nursing-home stays, as well as for long-term care hospitals and inpatient rehabilitation facilities, according to two new reports from the Office of Inspector General for the Department of Health and Human Services. * * *
    • “Appealing does appear to pay off: Of the 18% of patients who did appeal, nearly all of them were able to overturn the initial denial of skilled nursing care.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services June 11 released guidance detailing plans to implement new guidelines and standards for determining budget neutrality for Medicaid section 1115 demonstrations, which give states flexibility to design and test experimental approaches to Medicaid, including modifying eligibility, benefits, delivery systems and coverage, in ways not otherwise permitted under standard Medicaid authority. The guidance is intended to support implementation of a statutory requirement under the July 2025 reconciliation bill that the CMS Chief Actuary certifies that a demonstration is projected to be budget neutral, meaning it would not increase federal Medicaid spending relative to what expenditures would have been absent the demonstration. CMS said it plans to issue a rule with its proposed changes to budget neutrality.”
  • and
    • “The Centers for Medicare & Medicaid Services June 10 announced the establishment of a new Office of Health Technology and Products. CMS said the OHTP would modernize CMS healthcare technology and digital products, and transform platforms and services to support Medicare, Medicaid, the Children’s Health Insurance Program and other CMS-administered programs. The office will work closely with the CMS Chief Information Officer and be subject to CIO-led IT governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, among other areas. The OHTP will include new divisions, such as an Open Source Program group to develop policies and guidance around open-source frameworks, a Division of Data and Interoperability Platforms, and a Division of Policy responsible for the development of interoperability policies, regulations and sub-regulatory guidance. Additionally, the OHTP includes a Division of Core Products, responsible for the management and modernization of Medicare claims systems and provider-facing components such as the National Provider Directory. The OHTP and organizational changes became effective June 9.”
  • KFF explains how “Medicare Advantage Rebates Disadvantage Medicare’s Stand-Alone Drug Plan Market.
    • “Medicare Advantage Rebates Undermine Competition with Stand-Alone Drug Plans by Lowering Medicare Advantage Drug Plan Premiums.”
  • Beckers Hospital Review points out that “The 340B rebate fight escalates: 14 key developments.”
    • “From the first lawsuit to Lilly’s ultimatum: 18 months that reshaped the 340B program.”
  • Tammy Flanagan, writing in Govexec, discusses “Why Social Security’s funding gap matters to federal retirement.”
    • “Most federal employees under FERS rely on Social Security as part of retirement. The latest trustees report suggests the choices to preserve full benefits are getting tougher.”
  • Per a National Institutes of Health News release,
    • “National Institutes of Health (NIH) Director Jay Bhattacharya, M.D., today announced the selection of Raymond H. Jacobson, Ph.D., as the director of NIH’s Center for Scientific Review (CSR), which ensures expert and fair review of the tens of thousands of grant applications received by the agency each year. Dr. Jacobson will begin his role on June 14, 2026.
    • “Dr. Jacobson will continue strengthening NIH’s centralized peer review system so that we can continue backing the most scientifically meritorious research ideas in support of NIH’s mission,” said Dr. Bhattacharya. “His leadership will help ensure the first level of NIH review remains rigorous, fair, and transparent for all applicants.”
    • “Prior to his selection, Dr. Jacobson served as CSR’s acting director following the retirement of Dr. Bruce Reed. Dr. Jacobson helped guide NIH’s centralization of peer review, and as Acting Deputy Director of the NIH Office of Extramural Research in 2025, he advanced efforts to reduce administrative burden and address challenges faced by applicants. Additionally, he was the director of the CSR Division of Receipt and Referral beginning in December 2024, where he led efforts to simplify application receipt and referral policies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “When millions of soccer fans descend on North America [beginning today] for the 2026 FIFA World Cup, they will bring more than team jerseys and national pride.
    • They will also bring the microbes that travel with people.
    • Public health officials have spent years preparing for the tournament, which is expected to draw visitors from more than 100 countries to the United States, Canada and Mexico. Although diseases such as Ebola and hantavirus have been in the headlines, public health experts say the diseases most likely to show up in clinics, emergency departments or urgent care centers are likely to be less exotic.
    • “Instead, their top concerns include measles, dengue, respiratory viruses and sexually transmitted infections that are already circulating. These diseases are likely to spread more easily as fans crowd into airports, hotels, stadiums and festivals.
    • “Measles is what I’m most worried about,” said Krutika Kuppalli, an infectious diseases physician and associate professor at UT Southwestern Medical Center in Dallas.
    • “Texas will host 16 World Cup matches in 2026 — more than any other state — with nine matches in the Dallas-Arlington area and seven in Houston. Dallas will host more matches than any other World Cup venue, including a semifinal. The first U.S. match is Friday, in Los Angeles, when the U.S. faces off against Paraguay.”
  • and
    • “Neuroscientist Miia Kivipelto’s life’s work has been about preventing dementia. Now, at 52, she has begun thinking more about her own vulnerability.
    • “Midlife is the time,” said Kivipelto, a neuroscientist who recently joined the Yale School of Nursing as the inaugural director of its Center for Aging Well in New Haven, Connecticut. “It’s the last best chance to lower risk.”
    • “The idea that dementia prevention may hinge on what people do in their mid-30s to their 60s is rapidly reshaping the field. Scientists increasingly believe the disease is driven not only by changes in the aging brain, but also by years of metabolic stress, inflammation and vascular damage accumulating across the body. Many researchers now think the biological process that leads to dementia begins 15 to 20 years before the first memory problems emerge. By the time symptoms become noticeable, the disease likely will already be well established.
    • “Neuroscientists now see midlife as a critical window when the brain becomes especially vulnerable to aging — but also more responsive to intervention. 
    • “The implications are profound: The ordinary habits of middle age may matter far more than scientists once realized, and cognitive decline may not be inevitable.”
  • Per a National Institutes of Health news release,
    • “A research consortium funded by the National Institutes of Health (NIH) has established a new framework to identify and catalog senescent cells – cells that stop dividing but remain active in the body. Because senescent cells accumulate with age and are thought to contribute to many age-related conditions, researchers are working to better understand the roles they play in health and disease. In a compendium of papers published in the June 11 issue of Cell, the consortium presents the first comprehensive atlas of senescent cells across the human body, a foundational step toward developing new therapies for age-related diseases.
    • ‘In healthy tissues, senescent cells support wound healing and serve as a defense mechanism by preventing the growth of tumors. They are normally cleared by the immune system, but as immune function declines with age, senescent cells accumulate in the body instead of being eliminated. Over time, these cells then release harmful signals that contribute to chronic disease and other age-related conditions. While removing these cells has been shown to diminish the impact of aging, their rarity and diversity have made them difficult to study.
    • “To address this challenge, the NIH Common Fund launched the Cellular Senescence Network (SenNet) program in 2021 to identify and characterize senescent cells across the human body.
    • “Through the new papers, researchers in the consortium are introducing the concept of “senotypes,” a new classification system that groups senescent cells based on where they are found in the body and the conditions surrounding them.
    • “By mapping where different senotypes are found and what makes them unique, we aim to build a more complete picture of senescent cells across the body,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives (DPCPSI), who leads the NIH Common Fund. “This knowledge could help researchers move toward more targeted therapies that focus on harmful cells while preserving beneficial ones.”
  • MedPage Today tells us,
    • “Research has suggested that consumption of sugar-sweetened beverages is linked to increased risks of certain cancers.
    • “A pooled analysis of 11 studies showed that sugar-sweetened beverage intake was not associated with overall liver cancer risk but was tied to increased risks of hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
    • ‘Of note, there was no association between consumption of artificially sweetened beverages and liver cancer overall, or by subtype.
  • Health Day informs us,
    • “Sleep apnea might affect women worse than men.
    • “Women had similar outward symptoms of sleep apnea.
    • “However, they reported higher levels of side effects.”
  • STAT News lets us know,
    • “A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, including higher response rates in patients treated at an earlier stage of their disease.
    • “The updated early-stage study results reported Thursday for the Enliven drug, ELVN-001, compare favorably to a current blockbuster medicine sold by Novartis and an upstart experimental drug recently bought by Merck.” * * *
    • “Enliven has met with the Food and Drug Administration and received clearance to start a Phase 3 study later this year that will enroll patients with CML previously treated with one or more drugs. The study will compare ELVN-001 against a physician’s choice of currently approved CML drugs, excluding Scemblix.
    • “The company believes the addressable commercial market for ELVN-001 as a “second-line plus” treatment option for CML is worth $5 billion.”
  • Biopharma Dive adds,
    • “Takeda’s experimental autoimmune drug zasocitinib bested Bristol Myers Squibb’s marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday.  
    • “Takeda didn’t provide detailed data but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It’s the second time Takeda’s drug has beaten an approved therapy, following positive results in a trial testing it against Amgen’s Otezla. 
    • “Zasocitinib is a newer kind of “TYK2 inhibitor,” a class of oral autoimmune medicines that have attracted significant industry investment in recent years. It’s become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.”
  • and
    • “An RNA drug Novartis acquired as part of its $12 billion bet on Avidity Biosciences succeeded in a trial of patients with a rare neuromuscular disease, Novartis said Thursday.
    • “Called delpacibart braxlosiran, the experimental drug met its primary biomarker endpoint in a Phase 1/2 study evaluating the treatment in a muscle-wasting disease known as facioscapulohumeral muscular dystrophy, or FSHD. The drug, a so-called “antisense oligonucleotide conjugate” or AOC, is designed to restore muscle function and help slow progression of the disease.
    • “Del-brax targets a gene called DUX4, which is expressed incorrectly in patients with FSHD.”

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

  • Modern Healthcare reports,
    • “Group healthcare costs are expected to rise 9% in 2027 as Americans use more services. 
    • “The growing use of expensive drugs, the proliferation of mental health issues and reimbursement pressures will drive healthcare cost inflation, according to a Thursday report from consultancy PwC.”
    • “Researchers spoke with actuaries at 27 health insurers that cover 103 million employer-sponsored members and 8 million Affordable Care Act enrollees to forecast healthcare inflation. 
    • “PwC projected an 8.5% increase for the individual market. In addition to the 2027 projections, the consultancy retroactively adjusted last year’s group cost growth estimate to 9% from 8.5% and the individual market projection to 8.5% from 7.5%.”
  • and
    • “U.S. companies plan to charge more for employee health plans next year, as soaring drug prices drive up insurance costs.
    • “Two-thirds of large companies expect to raise monthly premiums for employee health coverage through paycheck deductions in 2027, according to a survey of businesses with at least 500 employees by benefits consultancy Mercer. And about half (48%) of employers say they will make other changes, such as raising deductibles and copays, that will increase how much workers pay out of pocket for care.”
    • “It isn’t just employees who will be paying more. Health insurers are raising costs for employers, too, with the cost of group plans set to increase by more than 6% for the fourth year in a row, said Beth Umland, Mercer’s director of research. Annual increases previously hovered around 3% for more than a decade.
    • “Although employers initially tried to absorb those higher costs, they are beginning to pass them onto workers, Umland said. This year, employers expect to pay more than $18,500 per employee for health care benefits, a 6.7% increase from 2025 and the biggest jump in 15 years.”
  • MedCity News adds
    • “If you want to know where healthcare finance is headed, ask the people who lend hospitals money. 
    • “During a Tuesday panel at the HFMA Annual Conference in National Harbor, Maryland, two veteran healthcare credit analysts said they think the window for deliberate strategic action is closing faster than most health system leaders realize.
    • “We love incremental change in healthcare — it’s not going to work anymore,” said Kevin Holloran, senior director of nonprofit healthcare group at Fitch Ratings. “We’ve got to have some really bold thoughts and really bold moves if we’re going to be ready for 2030 and then beyond.”
    • “His urgency stems from a stark demographic reality. In 2030, the last of the Baby Boomer generation will officially reach age 65 and become Medicare-eligible. This is the same year that the most significant cuts from the federal budget reconciliation legislation will begin to bite.” * * *
    • “2030 scares me to death,” Holloran declared. “Right when you get fewer people in the workforce, you’re going to see your payer mix decline. You’re going to go from commercial to Medicare — and you’re not going to have enough people, as they’ve left the workforce.”
  • Healthcare Dive relates,
    • “Health plans are projecting commercial healthcare costs will rise 9% next year, driven in part by increased adoption of artificial intelligence billing tools by providers, according to a report released Thursday by professional services firm PwC.
    • “Nearly 70% of surveyed plans ranked providers’ use of AI documentation and coding products as a top three inflator next year, while about 20% called AI the number one inflationary trend. 
    • “Still, AI isn’t a major driver of growing healthcare costs compared with labor and supply cost inflation or increased healthcare utilization, said Glenn Hunzinger, U.S. health industries leader at PwC. “The ability to use technology and AI to more appropriately code or code things that they were never able to, that’s the trend we’re seeing,” he said. “It does have an impact on that 9%, albeit it’s not the biggest piece.”
  • Fierce Healthcare adds,
    • “Since launching eight years ago with an ambient medical transcription tool, Abridge has set is sights more broadly on building out a full-scale AI clinical assistant. The company is steadily developing tech and features to assist with billing, prior authorization and clinical decision making.
    • “Today, the company announced a major platform expansion to integrate payer and life sciences workflows. Described as an “AI-native clinician intelligence platform,” Abridge says it now connects care delivery, payment and evidence-based treatment.
    • “Abridge CEO and co-founder Shiv Rao, M.D., announced Thursday at an event in New York City that pharma giant Eli Lilly and Company made a strategic investment in the company to “support evidence-based care and research.” The financial details of the investment were not disclosed.”
  • Coviti points out,
    • “Improper use of modifier codes in radiology can lead to excessive billing, often misrepresenting radiology services and diminishing trust between providers and health plans. As new requirements and measures emerge, special investigative units (SIUs) should remain vigilant with claims analyses and proper documentation to reduce overpayments.
    • “This month’s edition of FWA Insights dives into outlier billing for modifier codes and excessive services in radiology, revealing the ramifications of medical coding discrepancies and providing practical steps to prevent fraud, waste, and abuse (FWA).”
  • Per an Institute of Clincal and Economic Research (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its revised Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “Covid-19 infections continue to occur year-round, sometimes leading to serious illness or death,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “For any preventive care, the goal is always to understand whether the potential benefits outweigh the potential harms. ICER evaluated the evidence for Covid-19 vaccines in 12 US sub-populations. Current evidence suggests that the greatest net benefit of Covid-19 vaccination is in pregnant women; infants aged 6 months to one year; and adults over the age of 65, with the net benefit increasing further with increasing age. Declining rates of serious Covid-19 year over year necessarily create some uncertainties. We hope this report will be a useful resource to policymakers and public health officials as they consider vaccination recommendations for Covid-19 for the 2026-2027 season.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on June 25, 2026. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.“
  • Fierce Healthcare tells us,
    • “Humana announced this week that it intends to divest its minority stake in Gentiva, the largest provider of end-of-life care in the country.
    • “The company said Wednesday that it has entered into a definitive agreement to sell off “all or substantially all” of its stake in Gentiva to a “consortium of investors.” The agreement puts the value of Humana’s stake in Gentiva at about $900 million, according to an announcement.
    • “Other financial terms related to the deal were not disclosed, and it’s expected to close in the third quarter of 2026, pending regulatory approval. Details on which investors are involved were also not made public.
    • “Humana said in the announcement that it plans to use the funds from the sale for “general corporate purposes,” and said it does not expect that the deal will have a material impact on its earnings for the year.”
  • BioPharma Dive informs us,
    • “Parabilis Medicines, a high-profile startup making medicines for “undruggable” targets, raised $670 million in an initial public offering on Wednesday, a record haul for a venture-backed biotechnology company.
    • “Parabilis boosted the size of its offering and ultimately sold 33.5 million shares at $20 apiece, eclipsing the amounts secured by Moderna in 2018 and Kailera Therapeutics earlier this year. It added another $75 million through a discounted private stock sale to new research partner Regeneron Pharmaceuticals.
    • ‘The IPO extends a streak this year for large new biotech stock offerings. So far in 2026 a dozen drugmakers have gone public and raised a median of about $300 million each, more than doubling the median total biotech startups secured in IPOs last year, according to BioPharma Dive data.” 
  • Per MedTech Dive,
    • “Danaher has completed its $9.9 billion takeover of Masimo, establishing itself as a competitor to Medtronic in the pulse oximetry market. 
    • “The completion of the purchase, which Danaher reported Wednesday, positions the company to start integrating Masimo in pursuit of more than $125 million of annual cost synergies and more than $50 million of annual sales synergies by the fifth full year after the deal closure.
    • “Masimo will slot into a diagnostics portfolio that features Radiometer, a Danaher business that specializes in blood gas analysis and other testing in acute care settings.”
  • and
    • “Insulet is developing an automated insulin delivery system that will be “completely different” than its competitors, Chief Medical Officer Trang Ly said in an interview after the American Diabetes Association’s Scientific Sessions. 
    • “The system, which Insulet calls “fully closed loop,” is for people with Type 2 diabetes and does not require carb-counting or insulin bolusing ahead of meals. Physicians also don’t need to program the starting settings, and dose titration is automated. 
    • “With our system there’s no bolusing at all. There’s actually no bolus button. … It’s completely different to what Medtronic and Tandem and everyone else is working on,” Ly said. “There are no settings for anyone to enter.” 
    • “Insulet shared results of its Evolution 3 study of the planned system at the conference on Saturday. The study built on previous results the company shared at another diabetes conference in March.”

Tuesday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Wall Street Journal reports,
    • The House [of Representatives] passed a Republican-led $70 billion immigration-enforcement bill Tuesday, ending a monthslong stalemate over the slice of federal spending, and funding the contentious operations through the rest of President Trump’s second term.
    • The bill, which passed 214-212, comes after the Senate narrowly cleared funding for the agencies last week, using a special budget process that allowed Republicans to bypass the 60-vote threshold for most bills. Congress had approved funding for most of the Department of Homeland Security earlier this year, but Democratic opposition had held up money for Immigration and Customs Enforcement and Border Patrol. Trump is expected to sign the measure into law.
  • Healthcare Dive relates,
    • “A key House panel voted unanimously Tuesday to end a pilot program testing prior authorizations in fee-for-service Medicare.
    • “The House Appropriations Committee approved legislative language that would bar the Centers for Medicare and Medicaid Services from spending money to implement the Wasteful and Inappropriate Service Reduction Model, or WISeR, which the agency launched in six states this January. This provision was amended to a bill to fund the Health and Human Services Department in fiscal 2027, which the panel is still considering.”
    • Providers have blasted WISeR, a six-year demonstration that is partly reliant on artificial intelligence and is being managed by technology companies. 
    • The HHS appropriations bill must clear more hurdles, including advancing out of committee, passing the House and being reconciled with the Senate’s pending version of the spending package, before the WISeR provisions would become law.
  • Govexec tells us,
    • “Rep. Raja Krishnamoorthi, D-Ill., on Tuesday said the Trump administration’s recently unveiled plan to make federal employees sign a non-disclosure agreement “threatens” the federal workforce’s constitutional rights and creates a chilling effect on would-be whistleblowers and demanded information into how it was developed.
    • “Last month, the Office of Personnel Management formally proposed requiring all federal employees to sign NDAs barring them from divulging “confidential” information in most cases, prompting swift outcry from civil service groups and employment lawyers. A draft copy of the document bars signatories from disclosing information related to internal agency operations, personnel and procurement matters and “any sensitive, pre-decisional or deliberative material.”
    • “In a letter to OPM Director Scott Kupor, the Illinois Democrat criticized the proposal as “over-broad” and likely to make it more difficult for whistleblowers to divulge allegations of waste, fraud and abuse.” * * *
    • “The Democrat demanded information on OPM’s legal analysis of whether the proposed NDA comports with the First Amendment and the Whistleblower Protection Act, a definition of “confidential” for the purposes of the document, as well as any potential consequences federal employees who refuse to sign the agreement would face, and whether it would apply equally to both career employees and political appointees.”
  • Federal News Network discusses “OPM[‘s] details [about] changes for federal employees in Schedule Policy/Career.”
    • “As agencies gear up for implementation, OPM detailed what Schedule Policy/Career will mean for recruitment, adverse actions and other personnel policies.” * * *
    • “Implementation instructions for agencies on Schedule Policy/Career are now available in guidance that the Office of Personnel Management published Monday.” 
  • The Government Accountability Office issued a report titled “Federal Workforce: Executive Actions Reshaped Probationary Employment Rules and Reduced Staff Levels at Selected Agencies.”
    • “Since January 2025, in response to presidential directives and accompanying Office of Personnel Management (OPM) guidance, many federal agencies have taken steps to reduce their probationary and trial employee staffing levels. These are employees who have not yet completed the service requirements necessary to finalize their appointments, either after being newly hired or after being appointed as a supervisor or manager. Probationary periods are generally 1 or 2 years during which probationary and trial employees have limited job protections.” * * *
    • “GAO’s analysis of OPM’s Federal Workforce Data (FWD) found that, in 2025, probationary employees separated from 11 selected agencies at a slightly higher rate (19 percent) compared to all employees who separated from these agencies (15 percent). Over two-thirds of these separating probationary employees did so voluntarily as did all employees who separated from these agencies.
    • “Across most selected agencies in 2025, a greater proportion of probationary employees separated compared to all employees who separated. At the Department of Energy, for instance, about 34 percent of probationary employees separated, compared with 19 percent of all employees. The Department of Defense recorded the largest number of probationary separations—about 20,000 employees—but separation rates for probationary employees and the overall Defense workforce were nearly identical, at about 14 percent.”
  • The Wall Street Journal lets us know,
    • “Social Security is expected to deplete the fund that helps pay out retirement benefits by late 2032, the program’s trustees said Tuesday.
    • “That is earlier than their projection last year of 2033, partly because the fund expects to collect less revenue after President Trump’s new tax law. Passed last summer, the law gave senior citizens an extra deduction that reduced taxes on benefits for many Social Security recipients. 
    • “Revenues are also shrinking because declining fertility rates and immigration are reducing tax revenue by cutting the number of workers paying into the system, according to the trustees.
    • “The trustees reduced their long-term expectations for fertility rates on Tuesday, indicating they will remain lower for longer than previously projected.” * * *
    • “Unless Congress shores up the retirement program, the depletion of reserves would trigger a 22% reduction in benefits in late 2032. Because incoming payroll tax revenue doesn’t fully cover promised benefits, the program is forced to make up the difference by pulling money from its two Social Security trust funds—one for disability benefits and the other for the larger program for retirees.
    • Congress could temporarily use money from the disability trust fund to prop up the retirement fund. But that is a short-term solution because on a combined basis, the two funds are projected to become insolvent in the third quarter of 2034, according to the trustees.” * * *
    • “To shore up the system, lawmakers could borrow more, raise taxes, reduce benefits or reach an agreement that combines those measures.”
  • Fierce Healthcare points out,
    • “More than 500 hospitals falling short on price transparency requirements have received warnings from the federal government since April, with more “likely” to receive similar notices soon, the AP reported Tuesday morning. 
    • “The outlet’s report cited an unnamed “senior administration official” who shared a list of 519 nationwide hospitals that recently received either a warning notice or a Corrective Action Plan (CAP) request. 
    • “The former is an initial 90-day warning from the Centers for Medicare and Medicaid Services with instructions to correct any deficiencies, while the latter is a subsequent 45-day deadline for a hospital to submit a more concrete plan to address its compliance deficiencies. 
    • “For hospitals that do not come into compliance following these, CMS issues a civil monetary penalty that scales with bed count. These can run as high as $5,500 per day, or over $2 million per year. Twenty-eight hospitals have been issued civil monetary penalty notices to date, according to CMS.
    • “Among the list of warned hospitals obtained by the AP, Texas led other states with 42 notified facilities, followed by 38 in California, 34 in Indiana and 27 in Louisiana.” 
  • The American Hospital Association News notes,
    • “The Department of Health and Human Services June 8 released a request for information on research, policy and strategies to improve addiction and mental illness prevention, treatment and recovery. HHS said it it seeks to identify successful initiatives, recommend novel policy ideas and address research gaps. Comments are due to HHS by July 5.”

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency’s efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
    • ““As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
    • “FDA finalized this action within seven months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.
    • “Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for an updated version of its Nellcor pulse oximetry system.
    • “The 510(k) clearance, which Medtronic disclosed Monday, covers a device with a new processor designed to support more consistent and reliable results across diverse skin tones. 
    • “Concerns about the accuracy of pulse oximeters in people with darker skin pigmentation led the FDA to publish draft guidance on the devices last year.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “[M]illions of Americans [suffer] with cardiovascular-kidney-metabolic syndrome, a disorder defined in 2023 by the American Heart Association. It describes a cluster of conditions—heart disease, diabetes, kidney disease—that have common risk factors and fuel one another. Long treated as isolated or individual diseases, the conditions are interrelated, usually tied to excess abdominal fat, and a major driver of heart disease, according to the AHA.
    • “On Tuesday, the AHA and three other medical societies published the first guidelines to help clinicians prevent and manage CKM, as it is called, urging them to focus on their patients’ overall metabolic health. The goal is to prevent or slow the progression of conditions that may ultimately lead to heart attacks and strokes, which are becoming more common in younger adults.
    • “The new guidelines call for doctors—from primary care to cardiology—to screen patients for metabolic risk factors and kidney function routinely. Risk from excess fat should be measured both by body-mass index (BMI) and waist circumference, according to the new guidelines, which were developed by the AHA and the American College of Cardiology with the American Diabetes Association and American Society of Nephrology.
    • “In the 1970s, smoking, high blood pressure and cholesterol were the classic risk factors for heart disease, said Dr. Chiadi Ndumele, chair of the committee that wrote the new guideline and a preventive cardiologist at Johns Hopkins University School of Medicine. Today, excess abdominal fat is a major risk factor because it can trigger chronic inflammation that damages arteries, cardiac tissue and kidneys, he said.”
  • The New York Times relates,
    • “A government alcohol study published on Tuesday concluded that the health risks of alcohol start at a single drink a day. The report was caught up in controversy after drawing the ire of the alcohol industry.
    • “At one drink a day, the researchers found, there was an increased risk of premature death from an illness or injury directly attributable to alcohol, though it was small — one in 1,000 people. But the risk of premature death jumped to one in 25 for those who had two drinks a day, a level long considered safe for men, according to the study, which was published in the Journal of Studies on Alcohol and Drugs.
    • “The Alcohol Intake and Health Study was one of two reports commissioned during the Biden administration to inform an update to the U.S. dietary guidelines.
    • “The second report, from a panel appointed by the National Academies of Sciences, Engineering and Medicine, or NASEM, came to very different conclusions. It suggested that moderate drinking (up to two drinks a day for men and one for women) was healthier than not drinking at all, although it noted that moderate drinking was also linked to a higher breast cancer risk. Some of the panelists behind that report had financial ties to the alcohol industry.”
    • * * * “One reason the studies reached such different conclusions is that while the new study examined deaths from causes directly attributable to alcohol, the NASEM report commissioned by Congress looked at overall death rates of moderate drinkers, including deaths not causally related to alcohol.
    • “Critics of the NASEM report say that people who drink in moderation often have other healthy lifestyle habits that contribute to their longevity. The moderate drinking group also included many people who consumed less than two drinks a day. Both of these factors could make the health effects of moderate drinking look less significant than they might be.
    • “Dr. Ned Calonge, an epidemiologist at the University of Colorado Anschutz Medical Campus who led the NASEM study, said he stood by its conclusions.
    • “Alcohol research is complex and I am not surprised by different methods producing different results,” Dr. Calonge said, adding that modeling studies like the Alcohol Intake and Health Study, which use data to estimate the lifetime risk of diseases and deaths caused by alcohol, also come with potential biases.
    • “At the same time, he added “I don’t believe anyone should start drinking for health reasons.”
  • and
    • “The U.S. Department of Agriculture announced three new cases of New World screwworm, including the first cases in dogs and goats, on Monday, bringing the nation’s total case count to five. It also pledged to ramp up and expedite mitigation efforts for screwworm, a parasitic fly that the nation declared eradicated in the 1960s.
    • “At a news briefing on Monday, federal and Texas state officials said that they were using technology driven by artificial intelligence to monitor screwworm populations, training ranchers to recognize infections in their livestock and expanding the number of facilities that produce and disperse sterile flies, which are the primary tool for managing screwworm.
    • “Officials are also considering whether to grant an emergency authorization of a new, genetically engineered strain of flies that could make sterile fly production faster and more efficient.
    • “We prevented and eradicated this pest before,” Gov. Greg Abbott, Republican of Texas, said during the briefing. “We can do it again.” * * *
    • “The New World screwworm is a blowfly that feeds on living flesh. Adult females lay their eggs in open wounds or orifices of warm-blooded animals. When the eggs hatch, the larvae burrow into the wound, consuming the animal’s tissue. Untreated, screwworm infections can kill animals within a week.
    • “In humans, screwworm infections are rare. Last year, American health officials confirmed a travel-related case in a Maryland resident who had recently traveled to El Salvador, but no domestically acquired human cases have been reported yet.”
  • Health Day adds,
    •  There’s a biological reason why booze makes a person crave bar snacks like chips, nuts, fries and pizza, a new study argues.
    • Alcohol appears to trigger a hormone associated with cravings for savory flavors, researchers reported recently in the journal Obesity Reviews.
    • This hormone, FGF21, is linked to protein appetite and, when activated, can shift cravings toward salty, umami-flavored foods, researchers found.
    • “Many people will recognize the experience of having a few drinks and suddenly craving something salty, like chips, French fries, pizza or other savory foods,” said lead researcher Amanda Grech, a research associate at the University of Sydney’s Charles Perkins Center.
    • “Now we have a better understanding of the hormonal dynamic at play, which may be driving overconsumption of ultra-processed foods,” Grech said in a news release.
  • Cigna Healthcare, writing in LinkedIn, discusses “Men’s Mental Health Awareness Month [meaning this month]: Making Room for What Men Carry—At Work and Beyond.”
    • “Men’s Mental Health Awareness Month is an invitation to redefine strength as something sustainable: self-awareness, early help-seeking, and staying connected under pressure. In any workplace, the most meaningful shift isn’t a grand statement—it’s a steady message, reinforced over time, that dignity comes first and support is not something you have to earn. When men are met with respect, privacy, and real permission to be human, it becomes easier to speak earlier, connect more honestly, and get care before strain becomes a crisis.”
  • MedPage Today tells us,
    • “While the American Academy of Pediatrics now recommends introducing certain allergenic foods by ages 4-6 months for all children, guidelines from the 1990s and 2000s had recommended delaying introduction until 1-3 years.
    • “As the proportion of infants introduced to egg by 6 months of age increased from 2007-2011 to 2018-2019, egg allergy prevalence adjusted for changes in known allergy risk factors fell from 9.2% to 7.6%.
    • “Infants with early-onset eczema saw the biggest impact, with egg allergy prevalence decreasing from 34.6% to 21.9%.”
  • and
    • “Respiratory tract infections (RTIs) continue to be a substantial cause of mortality in children under 5 and contribute to morbidity, hospitalizations, and healthcare costs.
    • “Nearly one in four of the current study’s hospitalized pediatric patients with acute RTIs developed severe disease.
    • “Increased risk was highest in kids with two or more underlying conditions or who were transferred from a referring hospital.”
  • The National Institutes of Health’s Reseach in Context considers “Understanding the exposome.”
    • “Tracking how the environment affects health
    • “The world around us influences our health in countless ways. This special Research in Context feature explores how scientists are using new technologies and approaches to measure the exposome—the total set of environmental exposures people encounter throughout life and their biological response to them.
  • Genetic Engineering and Biotechnology News points out,
    • “When Jingkun Zeng, PhD, joined the lab of Nobel laureate, Jennifer Doudna, PhD, as a postdoctoral researcher in 2024, he was not interested in applying CRISPR for gene editing. 
    • “The molecular scissors had demonstrated extraordinary clinical promise in correcting single-point mutations, most strikingly in Baby KJ’s case, where a rare metabolic disorder once presented a 50% mortality rate in infancy. 
    • “Yet, Zeng had his ambitious sights on stopping cancer progression, where the biology “became messy.” Cancer can be driven by hundreds of thousands of mutations, making it nearly impossible to correct each mutation one-by-one to restore healthy function. 
    • “Zeng, who completed his PhD training in cancer evolution at The Francis Crick Institute, aimed to develop new CRISPR-based technology that could therapeutically access the undruggable tumor suppressor protein, p53. Mutations in this “guardian of the genome” are found in nearly half of all cancers, and up to 70–90% of cases of the most deadly tumors, including ovarian, pancreatic, and non-small cell lung cancer. 
    • “In a new study published in Nature titled, “Targeting Cancer-Specific Mutations with RNA-Triggered Chromatin Shredding,” Zeng and colleagues from Innovative Genomics Institute (IGI), University of California (UC) Berkeley, UC San Francisco (UCSF), and Gladstone Institutes, have now engineered a CRISPR system to selectively trigger cancer cell death by chromatin shredding.  
    • “The approach recognizes cancer cells using the RNA-guided nuclease, CRISPR-Cas12a2, to recognizemutant p53 mRNA transcripts. Therapeutic effectiveness was demonstrated in mouse models of lung and liver tumors.” 
  • Per Fierce Pharma,
    • “A combination of Merck’s islatravir and Gilead’s lenacapavir has succeeded in two phase 3 trials and is in line to become the first long-acting oral HIV treatment that can be taken weekly.
    • “Both trials of the combination regimen—which includes a 2 mg dose of islatravir and a 300 mg dose of lenacapavir—included people with HIV who are virologically suppressed and both achieved their primary efficacy endpoint. 
    • “In the Islend-1 study, the combo showed its non-inferiority in those who had switched off Gilead’s once-daily pill Biktarvy. In Islend-2, the combo measured up in those who had switched off standard-of-care antiretroviral regimens. No new safety concerns were identified in either study.”
  • and
    • “Following another phase 3 failure for Gilead Sciences’ Trodelvy, the race to bring a TROP2 antibody-drug conjugate (ADC) to patients with first-line non-small cell lung cancer (NSCLC) has narrowed. 
    • “Monday, Merck & Co. and Gilead announced that they are pulling the plug on the phase 3 Evoke-03 trial, also known as Keynote-D46, following the recommendation of an external data monitoring committee. 
    • “The study was evaluating Trodelvy, combined with Keytruda, as a first-line treatment in patients with PD-L1-high NSCLC versus Keytruda alone.” * * *
    • “Without a win in first-line NSCLC, Trodelvy’s commercial future will mainly depend on its triple-negative breast cancer uses, which won’t be able to justify the $21 billion price tag that Gilead paid for the med’s developer, Immunomedics. Gilead already took major write-offs tied to Trodelvy’s second-line NSCLC failure and a market withdrawal in bladder cancer in 2024.”

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

  • Fierce Healthcare reports,
    • “Health insurance executives convene this week in Las Vegas at a time when the industry is facing significant pressure on cost, access and policy changes.
    • “AHIP’s annual conference kicks off Tuesday morning, with two days of sessions and discussions that center on the major challenges facing insurers today, from new technologies to consumer engagement to rising medical costs.
    • “Fierce Healthcare will be on-site this week to provide key insights from the show floor, but before the conference opens, [the article offers] a look at some of the biggest themes to watch on the agenda.”
  • Beckers Hospital Review relates,
    • “Springfield, Mass.-based Baystate Health is planning to acquire a financially challenged hospital in the city from Hartford, Conn.-based Trinity Health of New England for $293 million through a member substitution valued at $293 million. 
    • “Baystate signed a definitive agreement in April to acquire Mercy Medical Center, a 182-bed acute care hospital, as well as Mercy’s joint ventures and affiliated medical groups from Trinity Health of New England, which is part of Livonia, Mich.-based Trinity Health. 
    • “As part of the regulatory approval process, Baystate is required to get a determination of need from the Massachusetts Department of Public Health. According to a filing with the department, MMC has experienced “significant and continued operating losses in recent years.”
  • and
    • “The American Medical Association’s House of Delegates voted to formally oppose use of the term “provider” when referring to physicians, adopting the new policy at its Annual Meeting in Chicago this week.
    • “The vote builds on existing AMA policy that already calls on healthcare entities to specify the type of clinician — using their recognized title and credentials — when using the term “provider” in contracts, advertising and other communications. It also directed AMA to prohibit use of the term in its own publications.
    • “The new policy goes further, directing the AMA to actively oppose the term when it encompasses physicians and to implement the existing policy’s external advocacy provisions, which had not yet been fully advanced.
    • “The AMA argues that the term “provider” undermines patient education, transparency and physician professionalism, and poses risks to patient safety by obscuring the distinctions among clinician types and their training, according to a June 9 news release.”
  • Radiology Business adds,
    • “The radiologist shortage is real, but it may be smaller and more local than previous reports might indicate, according to new research. 
    • “About 47% of “open” radiologist jobs are reposts of the same role. However, the “real shortage” appears to be “concentrated and stubborn,” according to an analysis shared by RadBoard, an artificial intelligence-powered platform for researching jobs in the specialty. 
    • ‘Approximately 1,470 of active radiologist openings have been sitting unfilled for over two months or more. 
    • “Most aren’t underpaid—they’re geographically inconvenient,” writes report author Kirill Lopatin, founder and CEO of xAID, which offers AI solutions to radiology groups.” 
  • The Wall Street Journal tells us,
    • GSK GSK [symbol]  agreed to buy U.S. cancer-drug developer Nuvalent NUVL for $10.6 billion, the British pharmaceutical company’s latest move to bolster its oncology business.
    • The acquisition is set to give GSK two drug candidates for lung cancer that are currently under review by the U.S. Food and Drug Administration as well as a third, earlier-stage medicine, the London-based company said Tuesday.
    • The deal comes as GSK works to rebuild its position in the market for cancer treatments, one of the most lucrative areas of the pharmaceuticals industry. GSK exited oncology in 2015 as part of a broader asset-swap deal with Switzerland’s Novartis. The company has since returned to the market with the acquisitions of Tesaro, Sierra Oncology and IDRx as well as licensing deals.
    • “Our strategy has been a brick-by-brick building approach,” GSK Chief Executive Luke Miels said, adding that the company would continue to look for further opportunities.
  • STAT News informs us,
    • “The number of prescription drug shortages in the U.S. fell by 23% last year, marking the second consecutive year of declines and the lowest level since 2017, according to a new analysis that otherwise found troubling signs about medicines that are in short supply.
    • “For instance, the average drug shortage lasted 5.3 years, exceeding the 4.3 years seen in 2024 and greatly outpacing the average two-year shortage experienced in 2019. Moreover, nearly two-thirds of out-of-stock medicines were in short supply for more than three years, and 39% were unavailable for more than five years.
    • “Meanwhile, the 75 drugs that were in short supply last year spanned 130 therapeutic categories, indicating that shortages affected a wide range of diseases and patient populations, according to the analysis by U.S. Pharmacopeia, an independent organization that develops standards for medicines.”
    • “At first glance, the numbers do appear conflicting and suggest some progress, but the overall trends are troubling, said Matthew Christian, director of supply chain insights at the organization. “The problems we have are systemic. They are not resolved and they are not new. They’re old and not going away.”
  • A commentator in Healthcare IT Today explains “The Emerging Role of AI Platforms in Healthcare Delivery: What Healthcare Leaders Need to Know.”
    • “With the launch of ChatGPT Health and Claude for Healthcare, AI has moved from the margins of healthcare IT to its center. It will define how patients engage with care and how clinicians deliver it.
    • “Participation is inevitable. Leadership is not. Organizations that act now will shape the future of care. Those that wait will inherit it.”
  • Fierce Healthcare adds,
    • “More than one-third of clinicians say artificial intelligence use is allowing them to see more patients, with a median of five additional patients per week, a new report from Philips found.
    • “The Future Health Index 2026 (PDF) drew insights from more than 2,000 healthcare professionals and more than 20,000 patients across 10 countries. 
    • “Nearly three-quarters (74%) of clinicians say their use of AI-enabled tools provided by their organization has increased over the past year. Among surveyed clinicians, 52% are using AI to transcribe clinical notes and close to half (46%) are using generative AI as a professional “buddy” to discuss work-related ideas. AI use is also growing for clinical decision support as 45% use AI tools to suggest diagnoses based on patient symptoms and 44% use AI-enabled tools to flag potential dangerous drug combinations.”
  • Per MedTech Dive,
    • “Research shared by Dexcom at the American Diabetes Association’s Scientific Sessions last weekend showed that people who have Type 2 diabetes but don’t take insulin could still benefit from wearing a glucose sensor.
    • “Dexcom telegraphed the study results ahead of the conference in a May earnings call, with CEO Jake Leach saying he expected the results could support a Medicare coverage decision “between now and the end of this year.”
    • “Thomas Martens, a medical director at the International Diabetes Center in Minneapolis and co-author of the study, said the research was intended to answer the question of whether continuous glucose monitors, or CGMs, can improve diabetes management for people who don’t take insulin. The study was funded by Dexcom.” * * *
    • “People who used the CGM had an average hemoglobin A1C reduction of 1.6% from the baseline level of 8.8%. The result was a 0.9% greater A1C reduction than the control group, which Martens said was “striking.” 
    • “People who used the CGM also had better time in range, a measure of how much time during the day a person stays within a target blood glucose range. The Dexcom G7 users had a 62% time in range compared with 41% in the control group.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Appropriations Committee June 4 released the fiscal year 2027 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies. The bill provides a total discretionary allocation of $189.3 billion. HHS is provided with $110.8 billion, which is $4 billion, or 4%, below the FY 2026 enacted level. The bill provides support for rural health, primary care, workforce, behavioral health and other programs. The appropriations subcommittee approved the bill today on a party-line basis, and additional details are expected to be released before a full committee markup currently scheduled for June 9.” 
  • Beckers Payers Issues relates
    • “CMS has logged nearly 40,000 complaints alleging potential violations of federal health insurance law since the agency began tracking them in 2022, with the vast majority of closed complaints related to the No Surprises Act, according to an enforcement report covering data through December 2025.
    • “The report tracked complaints under Title XXVII of the Public Health Service Act, which includes the NSA, Mental Health Parity and Addiction Equity Act, and ACA compliance. 
    • “The agency closed 15,145 complaints in total, which were defined broadly to include stakeholder feedback, congressional and state referrals, No Surprises Help Desk submissions, and news articles. Of those, 2,086 were closed with a violation found and 7,838 with no violation found; the remainder were duplicates or withdrawals. Complaints referred to other agencies were not included in the data.”
  • FedSmith tells us,
    • “The average federal employee salary has reached a record high, exceeding $112,000 for the first time according to data from the Office of Personnel Management. For critics, that figure may confirm a long-held belief that government employees are overpaid. For supporters of federal employees, it reflects the reality of an aging, highly educated workforce that performs increasingly complex work.” * * *
    • “The average federal employee salary has reached a record high, exceeding $112,000 for the first time according to data from the Office of Personnel Management. For critics, that figure may confirm a long-held belief that government employees are overpaid. For supporters of federal employees, it reflects the reality of an aging, highly educated workforce that performs increasingly complex work.”
  • KFF informs us
    • Three new KFF analyses examine the latest data about Medicare Advantage, including trends in enrollment, premiums, out-of-pocket limits, supplemental benefits and prior authorization.
    • The first analysis, focusing on enrollment trends, finds that 55% of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2026, though the pace of enrollment growth continued to slow. Nearly one quarter (23%) of Medicare Advantage enrollees are in special needs plans (SNPs), which limit enrollment to beneficiaries with specialized health needs or who are eligible for both Medicare and Medicaid. Most (85%) of the net increase in Medicare Advantage enrollment between 2025 and 2026 across all plan types was among SNPs. Medicare Advantage enrollment remains highly concentrated, with UnitedHealth Group leading the market, and, together with Humana, accounting for nearly half (46%) of all Medicare Advantage enrollees nationwide, the same as last year.
    • A companion analysis finds that three quarters (75%) of enrollees in individual Medicare Advantage plans with prescription drug coverage pay no premium other than the Medicare Part B premium, a selling point for enrollees. Nearly a third of enrollees (31%) are in plans that also reduce the Part B premium. Nearly all Medicare Advantage enrollees (99%) are in plans that require prior authorization for some services. Most Medicare Advantage enrollees are in plans that offer supplemental benefits not covered by traditional Medicare, such as vision, hearing and dental. Access to those three benefits remained stable, though there were decreases in the share of enrollees in plans providing other benefits, such as over-the-counter benefits, meals, and transportation.
    • Also recently available is a KFF analysis with a more detailed examination of out-of-pocket limits in Medicare Advantage plans in 2026, including variation by plan type, the distribution of enrollees facing different out-of-pocket limits, and trends over time.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration launched a safety study of the abortion pill mifepristone, potentially leading to restrictions on its distribution.
    • “The FDA study, using existing drug-safety systems, is expected to take six months and aims to withstand legal criticism.
    • “Antiabortion advocates target mifepristone’s mail and telehealth distribution rules; 65% of U.S. abortions use the pill.”
  • Fierce Pharma relates,
    • “Three times as many deaths in the study arm versus the control arm in a trial of ADC Therapeutics’ Zynlonta have raised questions about the antibody-drug conjugate (ADC), which has been on the market since the FDA granted it accelerated approval in 2021.
    • “In the phase 3 LOTIS-5 trial, which included 440 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), there were 27 deaths (13.2%) in the study arm compared to nine (4.6%) in the control group. Zynlonta was paired with Roche’s monoclonal antibody Rituxan, while those in the control arm received Rituxan plus the chemotherapies gemcitabine and oxaliplatin.
    • “Most of the deaths in the treatment arm were among patients age 75 and older and were due to infections, ADC execs said on a conference call on Wednesday. The company added that the higher rate could also be chalked up to extended monitoring of patients in the treatment arm as opposed to those in the control arm.”
  • Healio tells us,
    • “The FDA has approved a label expansion for the interleukin-23 inhibitor guselkumab to include the inhibition of structural joint damage progression in adults with psoriatic arthritis.
    • “The label update follows data from the APEX trial, in which guselkumab (Tremfya, Janssen) yielded significantly lower rates of radiographic progression compared with placebo at 24 weeks. The analysis, which was published by Philip J. Mease, MD, of Swedish Medical Center and the University of Washington, and colleagues in the Annals of the Rheumatic Diseases in December, included more than 1,000 biologic-naïve adults with active PsA.”

From the judicial front,

  • Per a Justice Department news release,
    • “The Justice Department’s National Fraud Enforcement Division today [June 4] announced that its Health Care Fraud Unit, one of the most active white-collar litigating components across the Department, secured federal jury trial convictions in six trials in just under three weeks. The convictions in six trials between May 13 and June 1 spanned federal courtrooms across the United States, including in Fort Lauderdale, Los Angeles, Detroit, New York and Nashville.
    • “Six trial convictions in under three weeks ties the Health Care Fraud Unit record for number of trials to result in a conviction in a single month period. The cases behind these recent convictions, however, represent a greater level of sophistication and complexity: more than $1.1 billion in fraud losses across six distinct schemes, including a digital health platform that industrialized Medicare fraud at national scale, a proactive data-driven prosecution of a physician who out-billed every other Medicare provider in the country for Botox, and prosecutions requiring simultaneous command of health care data analytics, financial forensics, sophisticated digital evidence, and expert testimony. These results reflect not merely the volume of trials but the caliber of the Fraud Division’s trial practice that carried each one of them to conviction. The Health Care Fraud Unit has completed nine trials to date in 2026 (all of which have resulted in convictions) and 17 trials in 2025, maintaining an extraordinary pace of white-collar trial activity.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “As of June 5, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is low in most areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children younger than 4 years old.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.” * * *
    • “Parainfluenza virus (PIV) is elevated nationally. Human metapneumovirus (HMPV) and Rhinovirus/enterovirus (RV/EV) activities are elevated nationally but are beginning to decrease. CDC data show these trends are expected for this time of year. HMPV, PIV, and RV/EV are like other viruses that cause respiratory infections, including cough, fever, nasal congestion, and shortness of breath. Severe infection due to HMPV, PIV or RV/EV may progress to bronchitis or pneumonia. There are no vaccines available for these illnesses. Prevention measures include hand washing, cleaning surfaces, and staying home when sick.”
  • The Hill reports,
    • “The number of U.S. measles cases in 2026 has now exceeded 2,000, quickly approaching the full annual total of last year.
    • “As of June 4, the Centers for Disease Control and Prevention (CDC) has confirmed 2,030 cases so far this year, with 93 percent — or 1,890 cases — associated with outbreaks. Throughout all of 2025, the CDC confirmed 2,288 measles cases. Thirty new measles outbreaks have been confirmed this year.”
  • STAT News relates,
    • “Americans who have high-risk exposures to Ebola in the current outbreak in Central Africa will have access to an antibody treatment that has shown great promise in animal testing but hasn’t yet undergone a clinical trial to show whether it is efficacious in people, the Department of Health and Human Services confirmed Thursday.
    • “The antibody treatment, known as MBP-134, is made by San Diego-based Mapp Biopharmaceuticals, with funding from the Biomedical Advanced Research and Development Authority, an agency within HHS that helps develop medical countermeasures for rare and emerging diseases, and biological threats.
    • “It is not clear how many doses of MBP-134 exist at present. STAT asked the company and was told Mapp Bio could not reveal the number because BARDA owned the doses.
    • “An American doctor who contracted Ebola in the outbreak zone was flown last month to Germany for care; his wife, also a doctor, and their four children were also taken to Germany for quarantine. The ill physician, Peter Stafford, remains in care but is reportedly recovering. Another doctor from the same Christian missionary group who had what was considered a high-risk exposure is in quarantine in the Czech Republic; he remains healthy. There are currently no other known exposures among Americans.
    • “An expert panel advising the World Health Organization on possible therapeutics that could be tested or used in this outbreak — occurring in the northeastern part of the Democratic Republic of the Congo and neighboring Uganda — deemed MBP-134 one of the products to be prioritized for testing.”
  • Health Day tells us,
    • “The age-adjusted Parkinson disease death rate among adults aged 65 years and older declined from 2021 to 2024, according to a June 4 data brief published by the National Center for Health Statistics.
    • “Ellen A. Kramarow, Ph.D., from the National Center for Health Statistics in Hyattsville, Maryland, and colleagues used data from the National Vital Statistics System to examine trends in Parkinson disease mortality among adults aged 65 years and older in the United States.
    • “The researchers found that for adults aged 65 years and older, the age-adjusted Parkinson disease death rate was 72.0 deaths per 100,000 standard population in 2024. From 2014 through 2021, there was an increase in Parkinson disease death rates, from 57.2 to 76.3, followed by a decline, with the rate lower in 2024 than in 2021. Higher Parkinson disease death rates were seen for men than women in each age group (65 to 74, 75 to 84, and 85 years and older) in 2024. Compared with other race and Hispanic origin groups, White non-Hispanic adults had the highest death rates from Parkinson disease. There was variation seen in Parkinson disease death rates by state of residence, ranging from 47.7 to 102.1 in New York and Utah, respectively.”
  • and
    • “Rurality is associated with worse epilepsy outcomes, although the associations are attenuated among privately insured patients, according to a study published online June 3 in Neurology.
    • “Edward R. Bader, M.B., Ch.B., from the Albert Einstein College of Medicine in Bronx, New York, and colleagues conducted a retrospective cohort study using the National Inpatient Sample for 2016 to 2021 to examine the association between rurality and epilepsy outcomes.” * * *
    • “The reduction in disparities among people with private insurance suggests that there may be other factors, not just where someone lives, that could be contributing to these differences,” Bader said in a statement. “Our study highlights the need for additional research and public health efforts aimed at improving access to epilepsy care for people living in rural areas, which might include the expansion of telehealth services.”
  • MedPage Today informs us,
    • “A study of women undergoing breast imaging showed a significantly lower incidence of breast cancer in those who had a history of treatment with GLP-1 agonists.
    • “Involving more than 30,000 women, the study showed an overall breast cancer rate of 1.97%, including 1.62% in patients who received GLP-1 agonists for overweight or obesity and 2.31% in those who did not. The difference represented a 30% lower risk of breast cancer in the GLP-1 group.
    • “The findings, combined with multiple other studies, have provided impetus for a prospective clinical trial of GLP-1 drugs to prevent breast cancer, reported Elizabeth S. McDonald, MD, PhD, of Penn Medicine and Abramson Cancer Center in Philadelphia, at the American Society of Clinical Oncology (ASCO) meeting.
    • “Observational data cannot establish a causal relationship,” said McDonald. “We are seeing signals at this meeting in multiple cancers — colon, lung, liver, leukemia, endometrial, multiple myeloma — for decreased progression to metastatic disease, decreased recurrence, decreased incidence, and increased survival. The time is now to invest in a clinical trial to see if these drugs are causal for cancer prevention.”
  • Medscape points out,
    • “Patients discontinuing GLP-1 treatments often regain weight rapidly, but emerging strategies like endoscopic procedures and new oral medications show promise in maintaining weight loss. These alternatives may offer cost-effective, long-term solutions.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “The injectable form of the polio vaccine has proven effective at preventing illness but it does not block the transmission of the virus as well as the oral version of the vaccine. That is because the virus is usually transmitted through contaminated food or water and is first exposed to the GI tract, where the oral vaccine induces a mucosal immune response. To date, several countries no longer use the oral vaccine because there is a small risk of infection. It is also possible for people who receive the injected polio vaccine to spread the virus even though they are asymptomatic. 
    • “Now according to data from an Massachusetts Institute of Technology-led study, it may be possible to modify the injectable vaccine so that it can also promote a mucosal immune response. This way, the vaccine could support polio eradication efforts without the risks of the oral polio vaccine. Details are published in a new Science Advances paper titled “Am80-Lipid nanoparticles serve as an enteric mucosal adjuvant 3 following parenteral immunization with inactivated polio vaccine.”
  • Cardiovascular Business notes,
    • “Engineers with the Massachusetts Institute of Technology (MIT) have developed a noninvasive pacemaker that uses ultrasound to stimulate the heart. The group shared its early experience with the device in Nature Biomedical Engineering, highlighting its compact, wearable design.
    • “Pacemakers are one of the most important and widely used human implants, and they have saved millions of lives,” Gengxi Lu, the study’s co-corresponding author, said in a statement. “But they are invasive, and they make direct contact with the beating heart. The dream for many years has been noninvasive heart stimulation with ultrasound.”
    • “The team’s device is a small sticker worn on the chest. Tiny transducers on the sticker use ultrasound pulses to stimulate the heart in a way that opens certain ion channels in cardiac cells. Lab experiments have been a success, with the device maintaining healthy contractions in human cardiac cells.
    • “For an ultrasound pacemaker to become a reality, researchers believe they would likely begin the process by giving patient’s a one-time injection that boosts the sensitivity of cardiac cells. Once this injection was done, the patient could then theoretically attach the stamp-sized sticker and start experiencing the benefits of the small device right away.
    • “While it’s still early, the group at MIT is optimistic about this new-look pacemaker’s potential. In fact, they hope to combine this latest approach with previous research into sticker-based medical imaging to deliver a single ultrasound sticker that can simultaneously monitor and regulate a patient’s heart.”
  • Per BioPharma Dive,
    • “A clinical trial testing a migraine prevention therapy from Denmark-based Lundbeck has produced data that some on Wall Street see as mixed but still good enough to forge ahead with further development.
    • “The therapy, called bocunebart, is designed to inhibit a nervous system protein known as PACAP. This protein regulates stress and, when triggered, causes pain-sensing nerves to fire and blood vessels in the head to drastically widen. Lundbeck’s study has been evaluating bocunebart — as a direct infusion to the veins or as an under-the-skin shot — in hundreds of patients who continued experiencing migraines even after trying up to four other treatments.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Hospitals and health systems are losing money on virtual care across every major payer category even as adoption climbs, according Strata’s latest Performance Trends report.
    • “The national analysis found telehealth encounters rose 79% between January 2019 and January 2026, marking the shift from a pandemic stopgap to a permanent fixture of care delivery. Despite that growth, average total cost margins for telehealth stayed negative in 2025 across commercial, Medicare, Medicaid and self-pay patients. Remote patient monitoring has soared 4,000% over the same time period.
    • “Healthcare organizations are increasingly turning to technology and new care delivery models to address workforce shortages and improve patient access,” said Steve Wasson, Strata’s chief data and intelligence officer. “The challenge is that many of these investments, particularly in virtual care, are occurring at a time when margins remain extremely narrow.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare has acquired 17 urgent care clinics from Urgent Care Group in North and South Carolina. 
    • “The clinics include locations in Charleston, Columbia, Myrtle Beach and Spartanburg in South Carolina, and Wilmington in North Carolina, according to a June 2 news release. 
    • “The South Carolina clinics are now operating under the first HCA CareNow brand name, becoming the first such clinics in the state, The North Carolina clinics are continuing to operate under the Medac name used by Urgent Care Group.” 
  • Kaufman Hall opines,
    • “Healthcare leaders must confront whether scorecards are improving patient safety or reshaping priorities in ways that may not benefit patients.”
    • Quick take
      • The debate is no longer about whether hospitals should be measured; it’s about whether the industry is measuring what truly matters.
      • Rankings shape reputation, revenue, and strategic priorities, not just public transparency.
      • Health systems are confronting a growing tension between improving patient care and improving publicly visible scores.
      • The number of public rankings is continuously growing.
      • Leaders are questioning whether current scorecards drive meaningful safety improvements or create administrative distraction.
      • The outcome of this debate could redefine how healthcare approaches transparency, accountability, and patient trust in the years ahead.
  • Health Exec relates,
    • “In a new state-by-state analysis of patient spending on healthcare, Utah, Virginia and California are at one end of the “spend the most” vs. “spend the least” rankings. Alaska, Oregon and Maine land at the other. Can you guess which trio’s residents spend the most and which the least?
    • “Time’s up. Alaska takes the undesirable No. 1 pole position: It’s the most expensive state for people who have to pay out of pocket. On average they shell out 10.1% of the median monthly household income to pay for essential medical services and prescriptions. 
    • “Spending the least are residents of Utah, where wallets only take a hit of 5.11%.
    • “The calculations are from WalletHub, which released a report on the topic May 28.” * * *
    • For WalletHub’s full report, click here.
  • Fierce Healthcare informs us,
    • “Community health system WellSpan Health inked a seven-year strategic alliance with Philips to drive advanced imaging technology across its network and co-develop new AI and tech tools.
    • “Philips’ technology will support WellSpan’s full network of 12 hospitals, diagnostic imaging centers and ambulatory surgery centers across Central Pennsylvania and Northern Maryland. A long-term commercial agreement establishes Philips as WellSpan’s preferred vendor across patient monitoring, enterprise informatics and all applicable imaging modalities, including CT, MR, digital X-ray, ultrasound and image-guided therapy.
    • “The commercial agreement includes a structured approach to technology lifecycle management: WellSpan and Philips will align equipment, services, training and upgrade planning under a single, coordinated framework, according to the organizations.
    • “The alliance marks Philips’s first research and innovation collaboration with a U.S. community health system. The health tech giant and WellSpan plan to co-develop net-new products and features that advance care delivery, drawing on Philips’ R&D pipeline, with WellSpan serving as both a proving ground and a co-creator.”
  • Per Fierce Pharma,
    • “With a new patent settlement, Axsome Therapeutics can lower its sword against prospective generics makers taking aim at its narcolepsy med Sunosi.
    • “The central nervous system-focused drugmaker closed the books on years of Sunosi intellectual property litigation by striking a settlement with “the only remaining first-to-file generic applicant with pending product litigation related to Axsome’s product Sunosi,” the drugmaker announced in a June 3 press release.
    • “Through the settlements, five companies will be cleared to market their generic versions of Sunosi starting on September 1, 2040, if Axsome nabs a pediatric exclusivity period for the drug. If not, the knockoffs can launch on March 1, 2040, the company explained. With that, “no other patent litigation relating to Sunosi remains pending.”

Thursday report

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, NIH, OPM, SCOTUS, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republican senators stopped short of using their political leverage to kill President Trump’s $1.8 billion “anti-weaponization” fund, approving a critical immigration-enforcement bill without adding language reining in the controversial program.
    • “Passage of the $70 billion package funding Immigration and Customs Enforcement and Border Patrol through the end of Trump’s second term came after a more than 19-hour session of amendment votes and intraparty negotiations. The GOP-backed measure passed 52 to 47 shortly before 5 a.m., with Republican Sen. Lisa Murkowski of Alaska voting with Democrats against the bill.
    • “The session’s votes allowed GOP senators in competitive election fights this fall—including Susan Collins of Maine, Dan Sullivan of Alaska, Jon Husted of Ohio and Ashley Moody of Florida—to register their objections to the fund without derailing a bill that is a priority for Trump and the party.
    • “The House is expected to take up the immigration-enforcement measure next week.”
  • The No Surprises Act’s final independent dispute resolution (IDR) rule was published in the Federal Register today. Federal Hearings and Appeals Services, which a certified IDR entity, offers its summary of the rule with helpful charts!
  • Federal News Network reports
    • The Postal Service, on the verge of running out of cash early next year, is pricing out a wide range of possible reforms that, if passed by Congress, could address the agency’s long-term financial problems.
    • Postmaster General David Steiner told House lawmakers in March that USPS is set to run out of cash in early 2027 and that lawmakers need to act soon to keep the agency running.
    • The agency’s wish-list of possible legislative reforms, outlined in a document titled “Accelerating Progress: Elements of Postal Reform,” includes several longstanding proposals supported by postal watchdogs and unions. The document also considers more controversial options, such as closing post offices and reducing delivery days to save USPS billions of dollars each year.
  • Per a House of Representatives Oversight and Government Reform news release,
    • “Subcommittee on Government Operations Chairman Pete Sessions (R-Texas) delivered his opening statement at today’s hearing with the Commissioners of the Postal Regulatory Commission. In his opening remarks, Subcommittee Chairman Sessions highlighted the financial crisis the U.S. Postal Service (USPS) is facing and how actions to reform the agency have fallen short of expectations. He also emphasized that Congress and the American people have to decide what they want out of USPS to help resolve procedural and financial issues in the agency.” 
  • The OPM Director Scott Kupor added to his Secrets of OPM blog (available on LinkedIn and Substack) concerning a Presidential Memorandum approving the use of critical position pay to support investment programs related to national security.
  • Tammy Flangan, writing in Govexec, discusses whether a record number of new retirees this year will slow your retirement claim.
    • “New OPM data offers clues about processing times, potential delays and why retiring employees may need a larger financial cushion than expected.” 
  • Per a National Institutes of Health news release,
    • “National Institutes of Health Director Jay Bhattacharya, M.D., today announced the selection of Steven Schiff, M.D., Ph.D., as the next director of the Fogarty International Center (FIC) and NIH associate director for international research. Schiff began his role on June 4, 2026. 
    • “A pediatric neurosurgeon and global health researcher, Schiff currently serves as the Harvey and Kate Cushing Professor of Neurosurgery, vice chair for global health in the Department of Neurosurgery, and professor of epidemiology and of electrical and computer engineering at Yale University in New Haven, Connecticut.” * * *
    • “As director of FIC, Schiff will lead NIH’s global health research efforts by supporting collaborations between U.S. and international investigators, strengthening partnerships among research institutions worldwide, and training future global health scientists. He will oversee the center’s approximately $95 million annual budget, most of which supports research grants and training programs.” 
  • Beckers Health IT lets us know,
    • “The White House is backing a push for AI to take over more of the duties of physicians, The Washington Post reported.
    • “The Trump administration supports an experiment in Utah where AI is writing prescriptions, plans to offer over $50 million in research awards to developers of conversational AI for cardiovascular care, has created an expedited approval process for digital health products like AI chatbots, and is working on a regulatory pathway for independent AI physicians, according to the June 4 story.
    • “People are seeing the difference the AI is bringing,” Amy Gleason, the administrator of the Department of Government Efficiency who is now a healthcare AI advisor at HHS, told the news outlet. “And it’s like the genie is out of the bottle.”
  • and
    • “HHS, under Secretary Robert F. Kennedy Jr., has sought access to detailed patient records held by state health information exchange systems as part of an effort to research a potential link between vaccines and autism, KFF Health News reported June 4.
    • “Federal officials met with leaders of state-run health information exchanges several times over the past year, asking how the medical records they maintain from hospitals and health systems could be used for vaccine research, according to seven people familiar with the meetings.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Leaders at the Food and Drug Administration on Thursday listened to criticisms and recommendations for how to move forward with a speedy drug review program put in place by former FDA commissioner Marty Makary. 
    • “The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, particularly those whose drugs have already been approved through the program. But most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback.” 
  • Per a corporate news release,
    • “Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis® (Genentech).”
  • Reuters relates,
    • “The U.S. FDA’s Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for ​an artificial intelligence-based drug development tool designed to ‌help predict drug-induced liver injury.
    • ‘Drug-induced liver damage is a major cause of trial failures, and current methods do not reliably ​predict human risk. The U.S. Food and Drug Administration said ​the tool could potentially help improve early safety assessments, reduce reliance ⁠on animal testing and support more informed decisions before human trials ​begin.’

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court raised the bar for branded pharmaceutical companies seeking to sue over a competitor’s generic versions of their drugs that are marketed using what’s called a skinny label.
    • “The justices unanimously concluded that a district court judge was right to dismiss Amarin Pharma Inc.’s infringement suit over claims that Hikma Pharmaceuticals USA Inc. was encouraging doctors to prescribe its generic version of Amarin’s Vascepa heart health drug for a still-patented treatment method.
    • “Drugmakers frequently obtain patents not just on chemical compounds they discover for novel drugs, but separately for methods of using such drugs to treat various medical conditions. When some uses are covered by active patents while others aren’t, generics can get government approval of a “skinny label” that carves out the patented uses.
    • “Thursday’s ruling ramps up the evidence that branded drugmakers need in order to sue when they think the generic label in combination with a generic company’s marketing statements or other communications cross a line into actively inducing patent infringement.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Scientists have made a discovery that may help prevent some people from developing lung cancer, which kills more people worldwide than any other cancer. 
    • “A team of more than 80 researchers working across four continents have identified a set of proteins in the blood that accurately predict lung cancers more than five years before diagnosis. The scientists also found early evidence that an existing anti-inflammatory drug could significantly reduce lung cancer risk in people with elevated concentrations of these proteins, which they linked to inflammation.
    • “More research is needed before a test based on these proteins could be ready for use in patients. And scientists would still need to run a randomized trial to determine whether the drug prevents lung cancers. Still, outside experts said the findings, which were published on Thursday in the journal Cell, offer a promising starting point toward a long-held public health goal.”
  • The Washington Post adds,
    • “The story of GLP-1 drugs keeps getting bigger.
    • “First they transformed the treatment of diabetes. Then they upended the science — and culture — of weight loss. Now a growing body of research is raising another possibility: that these drugs may help protect against cancer.
    • “At this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago, more than 40 studies, abstracts, oral presentations and poster presentations examined the relationship between GLP-1-based drugs and cancer. The results were strikingly consistent. Taken together, they suggest that people taking medications such as Ozempic, Wegovy and Mounjaro may develop certain cancers at lower rates than comparable patients who are not taking the drugs — and that those already diagnosed may experience a slower decline and better outcomes.
    • “For oncologists, the accumulation of evidence is hard to dismiss. The findings are “super promising,” said Mark Orland, a cancer researcher at the Cleveland Clinic. “We’re really excited to be on the forefront of looking at the effects of these drugs.”
  • Health Day relates,
    • “A simple urine test might help identify children who are likely to have autism earlier than the best assessment tools now available, a new study says.
    • “Autistic children appear to have specific gut microbe profiles that can be used to distinguish them from neurotypical (or typically developing) children, researchers reported May 26 in the journal Molecular Psychiatry.
    • “A urine test based on these profiles correctly identified 90% of autistic children and did not misidentify any children without autism, researchers found.
    • “What’s really striking about the bacteria is that they make metabolites that are basically altered versions of serotonin and dopamine,” said researcher James Adams, a professor of engineering at the Biodesign Center for Health Through Microbiomes at Arizona State University (ASU) in Tempe.”
  • and
    • “Mailed fecal immunochemical tests (FITs) can significantly increase colorectal cancer (CRC) screening across racial and ethnic groups, according to a study published in the May/June issue of the Annals of Family Medicine.
    • “Anisha P. Ganguly, M.D., from the University of North Carolina at Chapel Hill, and colleagues compared the effects of a CRC intervention (mailed FIT for screening-eligible patients plus patient navigation for positive results) across race/ethnicity. The analysis included 3,734 patients at federally qualified health centers.” * * *
    • “This analysis showed that mailed colorectal cancer screening tests have the power to improve screening rates for diverse populations,” Ganguly said in a statement. “This is really important, because we want these innovations in screening to improve outcomes among the hardest to reach populations and move the needle on colorectal cancer disparities.”
  • The American Journal of Managed Care tells us,
    • “Sudden death has long been considered an abrupt and unpredictable event in patients with heart failure
       (HF). But a new post hoc analysis of the FINEARTS-HF randomized clinical trial challenges that assumption, finding that most sudden deaths in patients with HF with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) are preceded by measurable clinical deterioration in the months before death.”
  • According to Infectious Diseases Advisor,
    • “Maternal SARS-CoV-2 mRNA vaccination during the third trimester reduces risk for infection and related hospitalization in infants through 6 months of age, highlighting the importance of maternal vaccine timing.”
  • STAT News informs us,
    • “Otsuka’s Voyxact slowed the loss of kidney function after one year in patients with a chronic autoimmune kidney disease, but the benefit was less than expected and left room for competing treatments to perform better. 
    • “In a Phase 3 study, patients with IgA nephropathy, or IgAN, who received injections of Voyxact saw their kidneys lose function at an annualized rate of 3 points over one year compared to an annualized function loss of 7.6 points over one year for patients receiving a placebo, the Japanese drugmaker reported Thursday.” * * *
    • “While the relative improvement in kidney function was positive, the result was also less robust than what was seen in an earlier Otsuka study. The data left open the possibility that competing drugs from Vera Therapeutics and Vertex Pharmaceuticals may be able to show a larger effect on kidney function when their respective studies read out results.” 

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

  • Beckers Payers Issues reports,
    • “UnitedHealth Group and CVS Health, Aetna’s parent company, are among the top 10 companies on the Fortune 500 this year.
    • “Fortune‘s June 3 list ranks the top 500 U.S. companies by revenue. Nine health payers [which are listed in the article] made the cut, with 2025 revenues ranging from $11.7 billion to $447.6 billion.
    • “UnitedHealth Group held its third-place standing from 2025. Amazon topped the list, ending Walmart’s 13-year tenure in the top spot.”
  • Beckers Hospital Review relates,
    • “Brentwood, Tenn.-based Lifepoint Health has completed its acquisition of eight community hospitals from Louisville, Ky.-based ScionHealth.
    • “The hospitals are spread across six states, according to a June 2 news release. Lifepoint acquired:
      • “Bolivar Medical Center in Cleveland, Miss.
      • “Ennis (Texas) Regional Medical Center
      • “Livingston (Tenn.) Regional Hospital
      • “Logan (W.Va.) Regional Medical Center
      • “Palestine (Texas) Regional Medical Center
      • “Parkview Regional Hospital in Mexia, Texas
      • “St. Joseph Regional Medical Center in Lewiston, Idaho
      • “Watertown (Wis.) Regional Medical Center
    • “Lifepoint originally signed an agreement to acquire the hospitals in March.
    • “ScionHealth said the eight hospitals will keep their current employees, providers and services. The company described the divestiture as part of a broader effort to strengthen its capital structure and focus on core operations.”
  • Healthcare Dive adds,
    • “West Virginia University Health System has solidified the next phase in its plan to acquire Greensburg, Pennsylvania-based nonprofit Independence Health System, announcing this week the two parties had signed a definitive agreement to combine.
    • “As part of the deal, which was announced last year, WVU Health System will invest $800 million into Independence’s five hospitals in order to install a new electronic health record and upgrade the facilities.
    • “The health systems now expect the acquisition will close in September or October, pending regulatory approval.”
  • Fierce Healthcare tells us,
    • “Due to advances in cancer treatment and early detection, the population of cancer survivors continues to grow, reaching more than 18 million individuals in the U.S. By 2035, that number is projected to exceed 22 million.
    • “But many cancer survivors have ongoing medical and mental health needs after cancer treatment ends. Faced with long-term side effects, behavioral health challenges and hormone therapies, many survivors are left to manage these healthcare challenges on their own.
    • “Value-based cancer care navigation company Thyme Care has expanded its cancer survivorship program, called Next Chapter Care, to provide a personalized, longitudinal approach to survivorship support. That program provides coordinated oncology support beyond active treatment for the more than 15,000 Thyme Care members who have completed cancer treatment.
    • “Rather than treating survivorship as a disconnected phase of care, the program extends the existing relationship Thyme Care already has with members across diagnosis, treatment and recovery, according to the company.”
  • and
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. 
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. “
  • Beckers Hospital Review points out,
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to the American Society of Health-System Pharmacists — and the FDA’s database continues to reflect new discontinuations weekly. The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also lists eight recent additions to the shortage list.

Tuesday Report

David Ermer–CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, OPM, U.S. Healthcare–

Simplicity is a virtue

“Edsger Dijkstra put it best: “Simplicity is a great virtue, but it requires hard work to achieve it and education to appreciate it. And to make matters worse, complexity sells better.” This bias for complexity leads us to give undue credit to convoluted systems and ideas over simple, elegant solutions.”

From Washington DC,

  • CMS reminds us that “June 1 marked the start of Medicare Fraud Prevention Week. While this week shines a spotlight on fraud prevention, protecting Medicare is a year-round mission.” 
  • In that regard, the Wall Street Journal points out that “The Autism-Therapy Business Is Booming—and So Is the Billing Abuse. Insurers warn of fraud and exorbitant charges from providers, including one that stuck a parent with a surprise $911,400 bill.”
  • AHIP posted a news release about how healthplans are combatting fraud, waste, and abuse in Medicaid. In fact, health plans are combatting fraud, waste, and abuse whereever they offer coverage.
  • Last Wednesday, the OPM Inspector General posted his semi-annual report to Congress for the period ended March 31, 2026.
  • OPM posted a news release today on its Family Member Eligibility Documentation rule, which OPM described as “a major step in the administration’s broader effort to eliminate fraud, waste, and abuse across government programs.” As the FEHBlog noted yesterday, this final rule was published in the Federal Register today.
  • The American Hospital Association News reports,
    • “The AHA June 2 released a new report, “Making Health Care More Affordable: A Blueprint to Lower Costs, Improve Access and Enhance Quality.” 
    • “The report contains actionable and achievable strategies and solutions that are focused on improving the health of individuals and communities; transforming care delivery; reducing administrative waste in the system; lowering drug and device costs; and innovating to improve care outcomes. 
    • “The report, as well as an infographic that highlights several action items from the report, was produced with input gathered throughout the year from AHA members across the country.”
  • Healthcare Dive relates,
    • “Eli Lilly is giving hospitals and medical groups in the 340B drug discount program less than a week to comply with the drugmaker’s data sharing requirements or be cut off from valuable savings on Lilly’s medications.
    • “In January, Lilly said it would begin requiring providers to submit claims data for all of its drugs dispensed in 340B. The company hasn’t been enforcing the policy. But now, providers that don’t comply with Lilly’s ultimatum by this coming Monday will lose access to 340B discounts on the drugmaker’s medications, Lilly warned this week.
    • “Lilly argued it needs to collect more data from providers to ensure they aren’t double-dipping discounts in 340B with savings in other programs like Medicaid. However, hospitals argue the move is illegal and, if not stopped by regulators, will empower other pharmaceutical companies to take similar actions.”
  • Adam Fein, writing in his Drug Channels blog, offers his take on the curent state of the 340B drug discount program.

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and regulatory knowledge.
    • “When finalized, the guidance will outline how sponsors can use publicly available information and established platform knowledge, including chemistry, manufacturing and controls (CMC) data, nonclinical study results and clinical information, to streamline regulatory submissions for human gene therapy products that use genome editing in human somatic cells.”
  • Reuters reports,
    • “Drug developer Cingulate (CING.O) said on ​Tuesday the U.S. Food and Drug Administration declined to approve its ‌treatment for attention deficit hyperactivity disorder, citing manufacturing-related concerns.
    • “In its complete response letter, the FDA did not flag any concerns about the drug’s safety or effectiveness, Cingulate said.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Ascension’s $3.9 billion plan to acquire ambulatory surgery management services company AmSurg has received a green light from the Federal Trade Commission, so long as the nonprofit health system divests a handful of facilities in markets the regulator said would otherwise be left with reduced competition. 
    • “The proposed consent order between the FTC and Ascension was announced Tuesday and centers on seven AmSurg ambulatory surgery centers (ASCs) in Panama City, Florida; Tulsa, Oklahoma; Waco, Texas; Wichita, Kansas; and Nashville, where two sites are located. 
    • “The handoffs must be completed by the time of the acquisition’s close, per the proposed consent order. Six of the facilities are earmarked to join SC Affiliates, another national ASC operator, with the seventh center in Panama City going to Florida Gastroenterology Center, a physician group and current minority owner.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “The number of people suffering with long COVID could be double current estimates, a new study suggests.
    • “An AI tool found that about 16% of nearly 460,000 patients with COVID-19 had developed long COVID, researchers reported May 27 in JAMA Network Open.
    • “Applied across the United States, those rates translate to more than 18 million Americans with long COVID, which is twice as high as current estimates, researchers said.
    • “Over 10 million people with long COVID would go entirely undetected by the diagnostic code that health systems and policymakers rely on to track the disease burden,” said senior researcher Hossein Estiri, an associate professor in the Mass General Brigham Department of Medicine in Boston.
    • “And it’s likely the picture is even worse than these estimates, researchers said.
    • “The figures we uncovered are almost certainly an undercount,” Estiri said in a news release.”
  • and
    • “Folks who regularly exercise can lower their risk of heart attack and heart failure linked to a genetic heart condition, a new study says.
    • “People with higher levels of moderate to vigorous physical activity had lower rates of heart health problems caused by genetically driven cardiomyopathy, researchers reported recently in the American Journal of Preventive Cardiology.
    • “Cardiomyopathy is a group of diseases that weaken the heart muscle, causing it to inefficiently pump blood to the rest of the body, researchers said in background notes.
    • “Our findings suggest that, even among people who carry genetic variants for cardiomyopathy but have no signs of disease, staying physically active may be associated with lower rates of future cardiovascular events,” said senior researcher Dr. Pankaj Arora, director of the University of Alabama at Birmingham’s (UAB) Cardiogenomics Clinic Program.
    • “Genetic risk may not be deterministic, and exercise is a modifiable factor that people can act on to help protect their heart,” he said in a news release.”
  • MedPage Today adds,
    • “Losing visceral fat by diet and exercise — regardless of pounds shed or later regained — was tied to long-term improvements in cardiometabolic health, follow-up data from two randomized trials showed. (Circulation)”
  • Gatroenterology Advisor notes,
    • “Higher levels of objectively measured physical activity are associated with significantly lower odds of irritable bowel syndrome (IBS), while greater sedentary behavior is associated with increased IBS prevalence, according to study findings published in the American Journal of Gastroenterology.”
  • The National Institutes of Health’s Research Matters post covers the following topics in today’s release:
    • “Tuberculosis test may improve diagnosis 
      • “Researchers found that a new portable diagnostic test for tuberculosis produced rapid and accurate results.
      • “The new test could offer a low-cost way to more quickly diagnose and treat people across the world.”
    • “Blood test predicts tumor response to treatment”
      • “Researchers identified distinct cellular neighborhoods common to different tumors, some of which correlate with treatment response.
      • “A blood test to analyze these neighborhoods could lead to more effective personalized cancer therapies and improve treatment monitoring and outcomes.”
    • “Short RNAs may prevent neuron death linked to ALS, dementia
      • “In cell and animal models, short RNA molecules stopped or reversed abnormal clumping of the TDP-43 protein, which is linked to brain cell death.
      • “The results suggest RNA-based therapies could one day be used to treat diseases marked by abnormal TDP-43, including ALS and Alzheimer’s disease.”
  • NBC News relates,
    • “Nearly 1 in 5 adolescents and young adults are turning to AI chatbots for advice when they’re sad, angry, nervous or stressed, according to a new study.
    • The findings, from the research institute RAND, represent an increase from early 2025, when the nonprofit conducted a similar survey. At the time, around 13% of respondents said they used chatbots for such advice, but the share rose to 19% in the group’s latest survey in November, the results of which were published Monday in the journal JAMA Pediatrics. 
    • “It’s a sad number, because you’d hope that young people would have the sorts of supportive relationships that they would feel comfortable and empowered reaching out to those around them,” said Ryan McBain, a senior policy researcher at RAND and the lead author of the study.”
  • Fierce Pharma informs us,
    • “A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug’s ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC). 
    • “In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial’s primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said Tuesday. 
    • “The trial included 96 participants ages 18 to 75 who had inadequately controlled PBC. Patients in this group are associated with increased risk of progression to liver transplant or death compared with patients at normalized ALP levels, Gilead explained.”

Wrapping up the American Society of Clinical Oncologists annual meeting,

  • STAT News reports,
    • “The ASCO meeting is about data — lots and lots of data. But above all it is about, or should be about, patients.
    • To that, ASCO’s outgoing president, Eric Small, used his opening address at the meeting to speak about his partner, University of California, San Francisco, oncologist Amy Lin, who passed away in December. She had metastatic clear cell ovarian cancer, a rare disease with few treatment options. Small also brought a different kind of specialist to ASCO’s mainstage: David Kessler, an expert on grief and loss, who gave a talk about compassionate end-of-life care.
    • “I remember the exact moment when I said, ‘You know, someone should do something about this.’ And it dawned on me that I could. I was fortunate enough to have this platform, and could use it to at least raise it as an issue. I don’t know what the solution is, but I do know that if more of us are aware of it, and can talk about it, my hope is that it would have an impact in a room full of oncologists.”
    • :The experience, Small told STAT, made him realize that while he always tells families how profoundly sorry he is for their loss, he was “really just sending them off on a grief journey that is really complicated and really hard.”
    • “And he wanted to do something about it.
    • “Read a Q&A with Small here.”
  • NBC News relates,
    • “An experimental vaccine from Moderna and Merck shows promise in keeping deadly skin cancer from returning for years, according to new clinical trial results. 
    • “The research, presented Monday at the American Society of Clinical Oncology’s annual meeting, found that a personalized mRNA vaccine halved the risk of melanoma returning after five years. The results were also published in the Journal of Clinical Oncology.
    • “Melanoma is the deadliest form of skin cancer, and in about half of patients, the disease will come back within the first five years of treatment.
    • “The treatments we have are not perfect. People relapse,” said Dr. Janice Mehnert, the director of the melanoma and cutaneous medical oncology program at NYU Langone Health in New York and the senior trial investigator.”
  • BioPharma Dive tells us,
    • “Two drug regimens involving an experimental medicine from Celcuity halved the risk of death or disease progression in a late-stage trial in certain people with a type of advanced breast cancer. But the results still fell short of Wall Street expectations, sending the company’s shares plummeting by more than 20%.
    • “Celcuity disclosed last month that its therapy, gedatolisib, succeeded in the latest part of a Phase 3 study evaluating the treatment in breast cancer patients with or without mutations to a gene called PIK3CA. Fresh data presented Tuesday at the American Society of Clinical Oncology’s annual meeting revealed the extent to which patients with those mutations benefited from treatment with Celcuity’s therapy.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “NYU Langone Health is constructing a multibillion-dollar academic medical center and hospital on Long Island. 
    • “The new hospital in Melville will include 500 private inpatient rooms, 70 emergency department bays and the latest diagnostic imaging capabilities, the healthcare system said in a statement on Tuesday. The campus will also have space for scientific research and comprehensive outpatient care.” * * *
    • “While the project is still subject to state and local approvals, it’s estimated to create as many as 8,000 union construction jobs with an additional 2,500 jobs across the region. 
    • “The facility will be the first hospital built on Long Island since 1980, where some communities face long travel times for specialized care. A spokesperson for NYU said the system doesn’t have a final cost estimate for the project but it spent $135.5 million to purchase the land.” 
  • Healthcare Dive relates,
    • “Community Health Systems closed the sale of four hospitals in Arkansas to Missouri-based Freeman Health System for $110 million, the for-profit health system said Monday. 
    • ‘The deal, first announced in March, marks Freeman’s expansion into Arkansas. The purchase includes hospitals in Bentonville, Springdale, Johnson and Siloam Springs, as well as associated outpatient locations, physician practices and around 2,200 employees, Freeman said Monday.”
  • Meanwhile, Beckers Hospital Review points out
    • “Seven hundred and twenty rural hospitals across the U.S. — representing about one-third of all rural facilities nationwide — are at risk of closing due to severe financial problems, according to the Center for Healthcare Quality and Payment Reform’s most recent analysis. 
    • “The data, current as of May 2026, includes 294 hospitals that are at immediate risk of closure over the next two to three years due to the severity of their financial situation, according to the report. Facilities with the greatest risk of closure have more debt than assets or lack enough financial reserves to offset losses on patient services for more than a few years. 
    • “Rural hospitals are at risk of closing in almost every state, according to the report. In the majority of states, more than 25% of rural hospitals are at risk. In 10 states, 50% or more are at risk. 
    • “The number of hospitals at risk of closure represents a slight decrease from CHQPR’s January analysis, which found 734 hospitals were at risk of closure, including 309 that were at immediate risk. Since that report, three hospitals have closed and eight have converted to rural emergency hospitals. CHQPR does not assess converted rural emergency hospitals for closure risk until cost report data is available under their new designation.”  
  • Kaufman Hall tells us,
    • “Use of health-related apps and devices has increased since 2021, even as consumers become more selective about the technologies they adopt, according to a report published this month. While nearly half of consumers track biometrics, sleep, or activity levels, usage patterns vary by age, and interest in many digital health services has declined post-pandemic. This signals shifting consumer expectations and preferences for digital health technology users increasingly want tools that help them track progress conveniently and accurately while fostering motivation, accountability, and a sense of control over their health, according to the report. Integrating patient-generated data from apps and devices into digitally connected care experiences may help health systems strengthen engagement beyond the hospital walls.”
  • Fierce Healthcare adds,
    • “Wearable ownership has risen 33% in the U.S. since 2015, a new analysis from Rock Health found.
    • “Forty-six percent of respondents in the 2025 Consumer Adoption of Digital Health Survey reported owning a wearable specifically, and 57% of respondents report owning at least one wearable or other connected device. However, the report notes first-time wearable user growth has slowed.
    • “Smart watches remained the most popular device among the survey’s 8,000 respondents, with 43% reporting owning a device. Other popular devices are smart scales (13%), connected blood pressure cuffs (13%), continuous glucose monitors (9%) and smart rings (8%).
    • “The next chapter of wearable adoption will come down to whether wearables remain primarily tools for individualized self-optimization—an “N of 1” model—or evolve into infrastructure that improves population health,” the report authors wrote.” 

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.” 

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Per a House notice,
    • “On Thursday, June 4, 2026, at 10:00 a.m. ET, the Subcommittee on Government Operations will hold a hearing titled “Hearing with the Commissioners of the Postal Regulatory Commission.” The hearing will convene in room 2154 of the Rayburn House Office Building.”
  • Late Friday afternoon, the U.S. Office of Personnel Management placed on the Federal Register’s public inspection list an interim final rule on collection of family member status documentation proving eligibility for FEHB or PSHB coverage as a family member.
    • “The FEHB Protection Act of 2025 (FPA) requires OPM to issue regulations and implement a process to verify: The veracity of any qualifying life event (QLE) through which a health benefits plan enrollee seeks to add a member of family to their enrollment and that when an enrollee adds a family member to the health benefits plan, including during any open season, the individual is a qualified member of family. This final rule also clarifies responsibilities for initial family member eligibility determinations for the Postal Service Health Benefits (PSHB) Program.”

From the American Society of Clincal Oncology’s annual meeting,

  • The Wall Street Journal reports,
    • “Brain tumors are one of the most devastating consequences of cancer’s spread—hard to treat and highly deadly. Scientists have found that using a radioactive implant precisely where a tumor was removed in the brain can help patients get their cancer treated more quickly and in many cases, live longer.
    • “A new study showed that GammaTile, a radioactive wafer the size of a postage stamp, nearly doubled survival rates and nearly eliminated tumor regrowth in people who had it placed in the spot where brain tumors were surgically removed.
    • “Between 100,000 and 200,000 Americans a year are diagnosed with cancer so advanced it has spread to the brain. Typically, patients get those tumors surgically removed and follow up with radiation therapy from a device outside of their body, rather than from within it.
    • “The tiles are already cleared by the Food and Drug Administration. Until this study, which will be presented at the American Society of Clinical Oncology annual meeting this weekend, no large randomized trial had shown that they worked better than the traditional approach for these types of brain tumors.
    • In the new study, involving 230 people, nearly two-thirds of those given the tiles were alive two years later, compared with around a third of those who got standard radiation after surgery. Tumors grew back at the surgical site in just 1% of patients who got the implants, versus 12% of those who got the standard treatment.
    • “That survival difference is pretty astonishing,” said Dr. Molly Blau, a radiation oncologist at Fred Hutch Cancer Center in Seattle who wasn’t involved in the study. Blau said the results could fuel conversations with surgeons at her institution about investing in a GammaTile program.”
  • BioPharma Dive relates,
    • “An experimental drug from Revolution Medicines has proven broadly effective against an aggressive and tough-to-treat pancreatic tumor in a highly anticipated study result that could quickly change medical practice. 
    • “Revolution disclosed in April that the drug, daraxonrasib, nearly doubled survival compared to standard chemotherapy in a Phase 3 trial. At the American Society of Clinical Oncology meeting on Sunday, study investigators provided fuller details experts described as “unprecedented” and “landscape changing.”
    • Revolution’s primary study objective was to test whether daraxonrasib could benefit pancreatic cancer patients whose disease had spread despite a previous treatment and whose tumors were driven by a particular “RAS G12” mutation. But it also evaluated daraxonrasib’s effects on the entire trial population as a secondary outcome, too.
    • “Data presented at ASCO show Revolution’s drug extended survival by a median of 13.2 months among all recipients. By comparison, those who got chemotherapy and had RAS G12 mutations lived a median of 6.6 months. And that figure was comparable — 6.7 months — for all treated with chemo. 
    • “The benefits were similarly stark on measures of disease progression. For people with a RAS G12 mutation, daraxonrasib held tumors in check for a median of 7.3 months. For all drug recipients, that number was 7.2 months. Both numbers doubled the 3.5 month and 3.6 month median survival observed, respectively, among those groups of chemo recipients. 
    • “These results are landscape-changing for metastatic pancreatic cancer patients with a KRAS mutation,” said Rachna Shroff, hematology and oncology chief at the University of Arizona Cancer Center, in a statement provided by ASCO. “We are seeing unprecedented survival and efficacy in second-line treatment with an expected safety profile.”  
  • and
    • “A double-barreled cancer immunotherapy extended the lives of people with lung cancer in a closely watched trial that’s viewed as important for gauging the potential impact of the drug, known as ivonescimab, as well as others like it. 
    • “Presented at the American Society of Clinical Oncology meeting Sunday, the findings come from a study testing ivonescimab in patients newly diagnosed with advanced, non-small cell lung cancer. Though run only in China, the study is a proxy for a global trial that could be worth tens of billions of dollars to the drug’s developers, Akeso and Summit Therapeutics. Like that global study, the China trial is testing an ivonescimab-chemotherapy combination against the kind of immunotherapy-chemo regimen that’s standard care for many new patients. 
    • “Last year, Akeso and Summit revealed that the ivonescimab regimen reduced the risk of disease progression by 40% when compared to chemo and an immunotherapy called Tevimbra. But they hadn’t yet disclosed whether the drug regimen extended lives, the gold standard for a cancer medicine. 
    • “Success in that objective carries implications not only for Akeso and Summit, but many others developing medicines like ivonescimab, which are known as “PD-1/VEGF inhibitors” because of the two proteins they target. These drugs have shown the potential to top widely used immunotherapies like Keytruda, sparking hope that they may become future cornerstones of cancer care. But modest results in some studies have stirred debate about their additive benefits.
    • “Heading into the ASCO presentation, multiple Wall Street analysts pegged a reduction in death risk of anywhere from 20% to 30% as indicative of a meaningful benefit. Ivonescimab hit that mark, with investigators disclosing Sunday that drug recipients lived a median of 28 months after enrollment, versus 24 months for the control group — a 34% relative risk reduction that was statistically significant.” 
  • Fierce Pharma tells us,
    • “With a new phase 3 win for Erleada (apalutamide), Johnson & Johnson is proposing a solution to a longstanding prostate cancer treatment gap.
    • “For patients with high-risk localized or locally advanced prostate cancer, surgical removal of the prostate (radical prostatectomy) is a key standard treatment alongside radiation therapy. But nearly half of patients who move forward with curative-intent surgery ultimately see their cancer return, requiring additional treatment and potentially missing the window in which a cure is possible.  
    • “Additional therapies often intervene only after the cancer has spread, limiting the chance to improve long-term outcomes. This has been the status quo essentially since the prostatectomy was introduced 125 years ago in 1904, J&J’s U.S. president of oncology for solid tumors, Biljana Naumovic, M.D., told Fierce in an interview on the sidelines of the 2026 American Society of Clinical Oncology (ASCO) annual meeting.”
    • “With its phase 3 Proteus study, J&J sought a solution—a way to meet the “one chance for curing this patient,” Mark Wildgust, Ph.D., J&J’s VP of global medical affairs for oncology, said in the joint interview. 
    • “In Proteus, when Erleada was given to patients with high-risk localized or locally advanced disease alongside hormone therapy (androgen deprivation therapy or ADT) for six months before and after surgery, the drug was able to provide significant improvements in “key short- and long-term clinical outcomes,” the company said in a May 31 release. 
    • “Patients who used Erleada and hormone therapy were nine times more likely to have “little to no” cancer remaining at the time of surgery compared with those on hormone therapy alone, with the treatment arm linked to a 8.9% rate of pathologic complete response/minimal residual disease compared to 1% among the hormone therapy-only group, the company said.
    •  “The regimen also reduced the risk of developing metastasis or death by 20% and extended the time before patients required additional therapy to more than six years, J&J reported. That latter figure nearly doubled the three and a half years experienced by those on hormone therapy alone.” 

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

  • MedCity News reports,
    • “Garner Health, a digital platform connecting patients with high-performing providers, announced Thursday that it has raised $100 million in Series E funding.
    • “The company serves employers and has a dataset of over 60 billion medical records that helps identify the best quality doctors. When members choose high-performing providers through Garner’s dataset, their employer then covers most or all of their out-of-pocket costs. This incentivizes employees to choose better doctors and lowers costs for employers by avoiding unnecessary procedures.
    • ‘This comes at a time when the “cost crisis” for employers is especially acute, according to Nick Reber, Garner Health CEO.” 
  • BioPharma News relates,
    • “Pfizer is the latest multinational pharmaceutical firm to turn to China for help discovering new medicines, striking late Thursday an expansive alliance with Innovent Biologics potentially worth more than $10 billion.
    • “The deal involves up to 12 cancer drugs, eight of which are early-stage prospects from Innovent, while the remaining four are “Pfizer-proposed” discovery programs. All are newer types of “antibody-drug conjugates” or “multispecific” antibodies — technologies that are becoming more popular in treating cancer.
    • “Innovent will handle discovery work and early research, with Pfizer taking over global development after Phase 1 testing. Pfizer will get worldwide rights, and cover all the costs for four programs. It’ll gain ownership outside of greater China to another four of those drugs, and then will equally split rights and development costs with Innovent on the other four prospects in the deal.
    • “All told, Innovent is receiving $650 million up front and is eligible for another $9.85 billion in downstream payouts should a variety of milestones be met. The Suzhou, China-based company would get royalties on the sales of any approved medicines emerging from the deal, too.” * * *
    • “These deals are causing consternation in biotech circles and sounding alarm bells in Washington D.C., as they’ve threatened the U.S.’ long-held edge and given China growing influence over pharmaceutical development. Yet they’ve continued apace without interference and, of late, have started to broaden in scope, with companies in China and the U.S. forming pacts that cater to their respective advantages, discovering medicines and selling them globally.”
  • Beckers Health IT tells us,
    • “Microsoft has launched a preview version of Copilot Health, an AI-powered platform that allows users to aggregate health records, wearable device data and other personal health information in one place.
    • “The tool is available to U.S. users ages 18 and older who subscribe to Microsoft 365 Personal, Family or Premium plans. Users can access the platform through Copilot’s web interface using a consumer account.
    • “According to a May 29 Microsoft news release, Copilot Health enables users to build personal health profiles, connect Apple Health data and access records from more than 50,000 U.S. provider organizations.
    • “Microsoft said the platform can answer health-related questions, provide personalized insights based on users’ health information and help users identify healthcare providers by specialty, language, insurance coverage and location.
    • “Microsoft said health conversations within Copilot Health are kept separate from other Copilot interactions and are not used to train AI models. Users can manage or remove connected health data sources, and information is encrypted in storage and during transmission.”

Midweek Update

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

Simplicity is a Virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

Simplicity is a virtue.

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medicare, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Roll Call offers an overview of this week’s anticipated activities on Capitol Hill.
  • STAT News reports,
    • “Bill Cassidy, a key Republican health care leader in the Senate, will lose his seat, as Louisiana’s Senate primary heads for a runoff between state treasurer John Fleming and Rep. Julia Letlow, who won President Trump’s endorsement.” * * *
    • “Cassidy’s defeat is a win for President Trump and his allies, who have criticized the senator for voting in 2021 to convict the president for inciting the January 6 insurrection.” * * *
    • “Cassidy will likely remain chair of his committee until his term ends at the start of next year, potentially setting up roadblocks for Kennedy as he attempts to fill several vacancies across his department. That includes a new Food and Drug Administration commissioner, and nominees for surgeon general and Centers for Disease Control and Prevention director.”
  • Federal News Network points out four benefits bills in Congress for federal employees, retirees to watch. “Potential adjustments to short-term disability insurance and credit protection for feds during government shutdowns are on the table through new legislation.
  • Per a May 15, 2026, Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) issued a sweeping rule to strengthen oversight of the Affordable Care Act (ACA) Exchanges for plan year 2027 by lowering user fees, tightening eligibility verification, and giving states greater authority over plan oversight.
    • The final rule, “Notice of Benefit and Payment Parameters for 2027; Basic Health Program” (the 2027 Payment Notice final rule) reduces federal Exchange user fees to help lower premiums, establishes new safeguards to prevent improper enrollments, ensures subsidies go only to eligible individuals, increases consumer choice, affordability, access and protections, and expands state flexibility to manage Exchange operations.
    • “The rule strengthens program integrity, expands consumer protections, promotes plan innovation and consumer choice, and restores greater authority to states. 
    • “American taxpayers deserve to know their dollars are going only to people who truly qualify,” said CMS Administrator Dr. Mehmet Oz. “This rule strengthens eligibility checks, cracks down on abuse, and gives insurers more flexibility to offer affordable, consumer-focused coverage options.”
  • Here is a link to the CMS fact sheet on this final rule.
  • Kevin Moss writes in Govexec,
    • “CMS is launching the Medicare GLP-1 Bridge program, which will extend coverage of certain GLP-1 medications for weight loss to eligible Medicare beneficiaries, regardless of whether they have an underlying medical condition” effective July 1, 2026. 
    • “For [FEHB and PSHB} annuitants enrolled in Part D, this program could expand your options. Here’s [in the article] what it covers, who qualifies, and what it means for you.”
  • The U.S. Supreme Court will be releasing opinions at 10 am every Thursday morning until the end of next month.

From the public health and medical / Rx research front

  • The Wall Street Journal considers whether “the Weight-Loss Drug Revolution Causing a Frailty Epidemic? As millions flock to GLP-1s, doctors warn the drugs can cause rapid and significant muscle loss” and assesses “What Science Tells Us About the Risks of Hantavirus. Rare virus has high fatality rate and can spread through the air, research shows, though it is easier to contain than Covid-19.”
  • Health Day reports,
    • “A major women’s health condition is getting a new name—and experts say it could change how millions are diagnosed and treated worldwide.
    • “Polycystic ovary syndrome, or PCOS, will now be known as polyendocrine metabolic ovarian syndrome, or PMOS.
    • “The condition affects more than 170 million women worldwide and is linked to hormone imbalances, weight and metabolic issues, mental health symptoms, skin changes and fertility challenges.
    • “Experts said the old name was misleading because the condition is not actually defined by ovarian cysts.
    • “What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” said Helena Teede, director of the Monash Center for Health Research & Implementation in Australia and an endocrinologist at Monash Health.”
  • BioPharma Dive relates,
    • “A year after Vertex’s big launch, pain drug research faces a pivotal moment.
    • “Journavx started to revive area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?”

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

  • The Wall Street Journal reports,
    • “Nurse practitioners and physician assistants are increasingly filling healthcare gaps, with NP ranks growing 60% to 461,000 between 2019 and 2025.
    • “Doctors’ groups express concern that non-MD providers practicing without physician oversight may pose risks to patients.
    • “A 2023 study found that allowing nurse practitioners to work without physician supervision reduced deaths that could have been prevented through healthcare by 2%”
  • Fierce Healthcare relates,
    • “Even without counting the multi-billion hit tied to the early termination of a major joint venture and outsourcing arrangement, CommonSpirit Health’s operations took a bruising during the three months ended March 31.
    • “The major Catholic nonprofit system reported Friday a $578 million operating loss (-5.8% operating margin) during the third quarter of its fiscal year. That’s after two key adjustments: normalization for delayed income received through California’s provider fee program; and removing the nearly $2.5 billion of “special charges” the system recorded on paper for the quarter that include contract termination and intangible asset impairment stemming from its breakup with Tenet Healthcare’s revenue cycle services business. 
    • “For comparison, CommonSpirit had logged an $85 million operating loss (-0.9% operating margin) a year prior with the California provider fee program adjustment. Across the first nine months of the fiscal year, the system is looking at a $743 million operating loss (-2.4% operating margin) for 2026 and a $282 million operating loss (-1.0% operating margin) in 2025, with the same adjustments.” 
  • Health Exec tells us,
    • “The days when most doctors worked in independent practice settings are fading from memory like old photoprints in a musty scrapbook.
    • “Taking their place is an era dominated by physician employment. And the employers are not only hospitals but also a “vast array of corporate entities with various financial incentives for employing physicians.”
    • “The quote is from the authors of a new report compiled by Avalere Health for the Physicians Advocacy Institute, also known as PAI.
    • “The shift towards corporatization of physician practice, the PAI analysts add, has “significant implications for costs, patient care and the future practice of medicine.”
    • “The report looks at trends in practice acquisitions as well as physician employment over the eight-year stretch from January 2018 to January 2026.”
  • MedCity News informs us,
    • “Anomaly Insights, an AI-powered payer intelligence company, announcedWednesday that it raised $17 million in funding.
    • “The company’s platform analyzes healthcare transactions to identify payer behavior patterns, policy changes and adjudication deviations. It helps predict at-risk payments so providers can proactively ensure claims are paid accurately. It also detects new denial patterns and identifies revenue opportunities. Currently, Anomaly is being used across more than 20 health systems.
    • “Specifically, the company seeks to solve the issue of “not knowing whether a healthcare encounter will be paid for or not before it happens,” said Mike Desjadon, CEO of Anomaly.”