Midweek update

Medicare

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Healthcare Dive reports,
    • “U.S. healthcare spending spiked 7.3% last year to reach $5.7 trillion, driven by soaring spending on hospital services and pricey prescription drugs like GLP-1s, according to new government data.
    • “The sharp spending growth isn’t primarily caused by increasing prices. Cost growth has been moderate. Instead, Americans are consuming more healthcare after a lag during the coronavirus pandemic, CMS actuaries said. It’s the same trend they called out in the national health expenditures report for 2024.
    • “But the high rate of growth last year was still surprising, according to Jacqueline Fiore, an economist with the CMS’ Office of the Actuary.
    • “Spending growth continuted to grow more rapidly for 2025 than we had expected,” Fiore said on a call with press Wednesday to discuss the projections, which the CMS released in the journal Health Affairs.
    • “The forces accelerating spending, however, are no surprise. Retail prescription drug spending is forecast to grow at the fastest clip over the next decade, but especially in 2025 and 2026 due to more Americans utilizing expensive drugs for conditions like cancer — and rabid demand for GLP-1s.”
  • Modern Healthcare adds,
    • “National health expenditures will rise to nearly $9 trillion and comprise 20.6% of gross domestic product by 2034, according to a federal report released Wednesday. * * *
    • “Health expenditures are forecast to rise an average 5.4% per year through 2034, when they will reach $8.97 trillion, the study found. Healthcare spending will continue to outpace the economy, which the actuaries anticipate will grow an average 4.1% annually over that time. * * *
    • “Hospital spending is projected to have risen 8.2% to $1.8 trillion in 2025, below the 8.9% rate in 2024. Spending on physician and clinical services is projected to have increased 6.2% to $1.2 trillion, down from an 8.1% growth rate in the prior year.”
  • NPR relates,
    • “Helped by pausing payments to worker retirement funds, the U.S. Postal Service is no longer on track to run out of money and stop deliveries next year, Postmaster General David Steiner confirmed to Congress on Wednesday.
    • “But with people and businesses still sending a lot less mail compared to decades ago, the self-funded federal agency remains close to a financial cliff as it struggles to continue delivering mail six days a week to just about every address in the country.
    • “A cash crisis at USPS may now come sometime between 2031 and 2034, according to the agency’s latest projections.
    • “What we are doing right now is we’re basically borrowing money from our retirement plans to fund current operations,” Steiner told lawmakers at a hearing before the Senate Homeland Security and Governmental Affairs Committee. “I’m not particularly comfortable with that. I promise you our employees are not particularly comfortable with that. You all shouldn’t be comfortable with that. None of us should be comfortable with that. To me, that’s why we have to have this discussion of how we fix this broken business model.”
  • Beckers Hospital Review tells us,
    • “A bipartisan group of senators led by Senator Brian Schatz, a Democrat from Hawaii, introduced the Ensuring Access to General Surgery Act of 2026, legislation that would create the first formal federal shortage designation for general surgeons and direct the Health Resources and Services Administration to map gaps in surgical care access nationwide.
    • “According to a June 23 news release by The American College of Surgeons, who also backed the bill, the proposal would require HRSA to study and define general surgery workforce shortage areas and collect data on the adequacy of surgical services across the country. It would also authorize the HHS secretary to establish a formal general surgery shortage area designation — a tool that currently exists for primary care and other specialties but has never been applied to general surgery.”
  • Per an HHS news release dated June 23,
    • “The U.S. Department of Health and Human Services (HHS) today announced the successful conclusion of the federal public health response to the Hantavirus exposure event associated with the M/V Hondius cruise ship. The final 42-day monitoring period ended on June 21 at 2 p.m. EDT. No individuals in the United States remain under public health monitoring for Hantavirus exposure.
    • “Under the leadership of Secretary Robert F. Kennedy, Jr., HHS worked closely with federal, state, and local public health partners to identify potentially exposed individuals, conduct monitoring, provide clinical guidance, and ensure readiness across the United States healthcare system. As a result of these efforts, no sustained transmission of Hantavirus occurred in the United States, and all monitoring activities related to the event have been completed.
    • “Proponents argue the absence of that designation has left policymakers without a standardized mechanism to identify underserved communities, recruit surgeons to those areas, or direct federal resources toward access gaps. The legislation is the Senate companion to House bill HR 7198, introduced earlier this year.”
  • Per a CMS fact sheet,
    • “On June 24, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies under the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2027. This rule also proposes updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2027 and proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2027, CMS is proposing to increase the ESRD PPS base rate to $299.55, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 1.1%. This amount includes a proposed $15.96 increase to account for the incorporation of phosphate binders into the ESRD PPS base rate. The CY 2027 ESRD PPS proposed rule also proposes changes to the low-volume payment adjustment, changes to the payment adjustments for pediatric patients, an increase to the home and self-dialysis training add-on amount and technical modifications to the transitional drug add-on payment adjustment (TDAPA), and a post-TDAPA add-on payment adjustment.” * * *
    • The proposed rule can be downloaded from the Federal Register at: https://www.federalregister.gov/d/2026-12925.
  • Fierce Healthcare unpacks for us “CMS’ decision to recalculate 2026 MA star ratings after Clover Health ruling.”
  • Healthcare Dive notes,
    • “The Rural Health Transformation Program is beginning to reshape how hospitals in rural America deliver care. But with nearly a trillion dollars in Medicaid cuts looming and pressure to show results or risk losing funding, many states are pursuing the safest path available: paying hospitals to downsize.” * * *
    • “Framing the program as incentivizing hospitals to shrink is misleading, said Robert Parris, a managing director who leads government-focused healthcare advisory work at consulting firm Huron. What’s actually happening, he said, is that communities are getting more of what they need and less of what they don’t.
    • “It’s more about reallocation as opposed to taking away,” Parris said.
    • “The program is also shifting how leaders think — from what services a facility can provide within its own walls to what care the surrounding population actually has access to, said Paul Johnson, a managing director who works directly with rural hospital clients at Huron.
    • “Many hospitals had these changes on their wish lists for years, but they couldn’t justify the investment because they were focused on surviving the next budget cycle.
    • “It’s almost like a license for them to pivot into things that they know they’ve had to do,” Johnson said.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The game is on for TROP2 antibody-drug conjugates in first-line triple-negative breast cancer.
    • “Less than a month after an approval for Daiichi Sankyo and AstraZeneca’s Datroway for front-line TNBC patients who are not candidates for PD-1/L1 inhibitors, the FDA has handed Gilead Sciences’ Trodelvy a rivaling approval that allows the drug to be used regardless of patients’ PD-L1 status.
    • “The new FDA approval for Trodelvy in first-line TNBC now allows the first-in-class TROP2 ADC to be used either alone for patients who aren’t eligible for PD-1/L1 inhibitors or in combination with Merck & Co.’s Keytruda for those with PD-L1-positive tumors, defined as a combined positive score of at least 10.”
  • and
    • “It’s been seven years since Pfizer scored an expansion for its breast cancer blockbuster Ibrance, and during that time, the drug has started to lag sales of two others in its class—Eli Lilly’s Verzenio and Novartis’ Kisqali.
    • “But on Wednesday, the FDA gave the CDK4/6 inhibitor a shot in the arm, signing off on Ibrance as a maintenance option for patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer after induction treatment.
    • “CDK4/6 inhibitors such as Ibrance are well-established treatments for HR-positive, HER2-negative breast cancer, but the HR+/HER2+ indication represents a new frontier. 
    • “With today’s FDA approval, Ibrance becomes the first and only CDK4/6 inhibitor indicated for patients with HR+ metastatic breast cancer regardless of HER2 status, extending its impact to patients who continue to face challenges with treatment resistance,” Aamir Malik, Pfizer’s U.S. commercial chief, said in a Jun. 24 statement.” 
  • Cardiovascular Business relates,
    • “GuideAI Health, a Boston-based medtech company founded by radiologists, has secured U.S. Food and Drug Administration (FDA) clearance for artificial intelligence (AI)-powered software that flags early warning signs of peripheral artery disease (PAD).
    • “VascularAssist Occlusion Triage (VAOT) alerts clinicians when it detects a suspected vascular occlusion, ensuring the patient receives a prioritized review. The newly approved software has been linked to high patient-level sensitivities for both 2D and 3D analyses of medical imaging exams of the lower extremities.
    • “Receiving FDA 510(k) clearance for VAOT is a defining milestone for GuideAI and for the patients we ultimately aim to serve,” Raj Shah, MD, MBA, CEO of GuideAI Health, said in a prepared statement. “Peripheral vascular disease is too often missed or detected late, with devastating consequences. VAOT brings AI-powered triage directly into the radiology workflow, helping clinicians identify vascular disease sooner so patients can be directed to the right care faster. This clearance marks the first step in our broader vision to set a new standard in AI-driven vascular care.”
  • and
    • “Pathway Labs, a New York-based artificial intelligence (AI) company founded by a cardiologist, has received U.S. Food and Drug Administration (FDA) clearance for its EchoNext screening tool that detects signs of structural heart disease in electrocardiograms (ECGs).
    • “We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease,” Pierre Elias, MD, Pathway Labs founder and CEO, medical director for artificial intelligence at NewYork-Presbyterian and assistant professor of medicine and biomedical informatics at Columbia University Vagelos College of Physicians and Surgeons, said in a statement. “Through EchoNext, we are able to diagnose critical, high-risk conditions that the human eye can’t, and potentially deliver lifesaving treatment earlier.”
    • EchoNext was cleared to identify a total of six different types of heart disease, flagging ECG results when a follow-up echocardiogram is recommended. The advanced algorithm was trained on more than 700,000 ECG-echo pairs. Recent studies have found that it can identify structural heart disease with a greater accuracy than trained cardiologists.
    • “Pathway Labs celebrated these clearances by officially launching EchoNext. The company has also partnered OpenEvidence to help expand access to the algorithm throughout the United States.” 
  • MedTech Dive tells us,
    • “The Food and Drug Administration has dropped a warning letter against wearable device firm Whoop following changes the company made to its blood pressure feature.
    • “In a closeout letter posted Tuesday, the FDA said it does not intend to enforce device requirements on the modified version of Whoop’s feature, consistent with guidance the agency issued earlier this year that would exempt more wearable features from oversight.
    • “Whoop CEO Will Ahmed said in a Wednesday LinkedIn post that the regulatory update was a “major development” and praised the updated wellness guidance.”
  • Healio informs us,
    • “The FDA announced approval of generic Priftin tablets to treat two types of tuberculosis caused by Mycobacterium tuberculosis, marking the first generic of this drug, according to an agency notice.
    • “The FDA outlined that the generic of Priftin (rifapentine) is for patients aged 12 years and older with active pulmonary TB and for patients aged 2 years and older with latent tuberculosis infection at high risk for progression to TB disease.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Cancer death rates in the U.S. have dropped dramatically in the past 35 years, falling by 35%, according to a report from the American Association for Cancer Research published Wednesday. The decline, which translates to nearly 5 million fewer cancer deaths since 1991, has been driven in large part by increased screening and advances in cancer treatments.
    • But the progress has not been seen equally across the country. 
    • “African American communities and American Indian and Alaska Native populations have the highest overall cancer death rates of any U.S. racial or ethnic group, and this means higher incidence and mortality for multiple cancers,” said the chair of the report, Mariana Stern, a professor of clinical population and public health sciences and urology at the Keck School of Medicine of the University of Southern California.
    • “Black people in the U.S. have long had higher cancer death rates than white people, though the gap has narrowed in recent years. Still, Black people are about twice as likely to die from multiple myeloma and cancers of the stomach, prostate and gallbladder as white people. For breast cancer, mortality rates are 35% higher among Black women than among white women. 
    • “Colorectal cancer — which is rising in people under 50 — also has higher mortality rates among Black and American Indian/Alaska Native populations, compared with white people.” 
    • “Increased screening has contributed to 79% of the colorectal cancer deaths averted, according to the AACR report. During a colonoscopy, doctors remove precancerous polyps before they have the chance to turn into cancer. People at average risk are advised to begin screening at age 45.
    • “But screening rates are lower among non-white populations, the report found.”
  • Following up on the Fierce Pharma articles above, the Wall Street Journal reports,
    • “Drug companies have found promising new options for one of the most aggressive and hardest-to-treat forms of breast cancer after decades with few breakthroughs.
    • “Gilead Sciences won Food and Drug Administration approval Wednesday to sell its drug Trodelvy as a first treatment for newly diagnosed patients with the advanced form of a type of breast cancer known as “triple negative” because it has characteristics that render common treatments ineffective. 
    • “It is the second such approval in about a month: AstraZeneca and Daiichi Sankyo’s rival drug, Datroway, was approved for a similar group of patients in May.
    • “Both of the drugs are antibody-drug conjugates—a type of targeted therapy that uses an antibody to identify a protein found on most triple-negative tumor cells and then delivers a concentrated dose of chemotherapy directly into the cancer. 
    • “The aim is to spare more healthy tissue than standard chemotherapy, which attacks growing cells throughout the body. These drugs both reduced the risk of progression of the disease by around 40% when compared with chemo.
    • “The progress is a lot more palpable right now and bringing us a greater deal of hope and excitement,” said Dr. Carmen Calfa, a breast medical oncologist at the Sylvester Comprehensive Cancer Center in Miami who wasn’t involved in either study.”
  • STAT News adds,
    • “It is one of the oldest mysteries in medicine: Why do fundamentally healthy people drop dead? Sudden cardiac arrest kills upward of 350,000 people a year in the U.S., a fate that is particularly tragic because it’s preventable with an implantable defibrillator.
    • “The challenge is figuring out who needs one.
    • “A study published in Nature on Wednesday uses artificial intelligence to identify those people, and pinpoints a possible reason why they so often evade detection. It reports that a culprit once considered relatively benign — cardiac fibrosis, or scar tissue scattered throughout the heart — is commonly present in people with the highest risk of sudden death.
    • “In a nice normal heart, everything happens at the same time, things are synchronized,” said Ziad Obermeyer, a University of California, Berkeley, scientist and lead author of the paper. “When you have fibrosis, you have these little dead areas that cause a breakdown of order.”
    • “The resulting disorganization, and its deadly implications, can be detected by AI on widely available electrocardiogram, or EKG, tracings, opening up the possibility that the technology could help direct lifesaving treatment to exactly the people who need it, the study found. Currently, about two-thirds of the defibrillators implanted in patients based on medical guidelines never deliver a lifesaving shock, a gap that exposes patients to risks of complications and imposes significant costs on the health care system.”
  • Fierce Pharma informs us,
    • A Nature Medicine paper landed on Feb. 2 like a stone in a pond, sending out ripples that quickly turned into tidal waves across biomedical circles. By midday, renowned physician-scientist Eric Topol, M.D., had signaled its importance to his more than 700K followers on X, then hailing it as “probably the best proof of the importance of timing of therapy that we’ve seen in medicine to date.” By the time the Super Bowl kicked off on Feb. 8, the study’s 3 p.m. threshold has become a punchline, as longtime biotech investor and TV host Brad Loncar jested that the Patriots’ sluggish offense was “like immunotherapy administered after 3:00 PM.”
    • “However, by Feb. 19, the journal would put up an editor’s note, alerting readers to several concerns around the article, titled “Time-of-day immunotherapy in non-small cell lung cancer: a randomized phase 3 trial.” Topol apparently deleted his comment at some point as well.  
    • “At the time, concerns raised against the article ran the gamut from major revisions to trial design and inconsistent trial protocol, to unusual efficacy and safety data patterns.
    • “Now, after a four-month investigation, Nature has decided to pull the study.”
  • Side note – Beckers Clinical Leadership identifies “The top 25 U.S. healthcare institutions for research in 2025 were, according to Nature.” “Boston-based Massachusetts General Hospital was the highest-performing U.S. healthcare institution on Nature‘s 2026 Research Leaders ranking.” 
  • The National Institute of Standards and Technology lets us know about its test of seven “At-Home Gut Microbiome Test Kits.”
  • Health Day points out,
    • “That juice box you hand your child as a daily treat could be setting them up for poor heart health later on, a new study says.
    • “Drinking fruit juice or sugary sodas throughout childhood may be linked to an increased risk of high blood pressure in adulthood, researchers reported June 22 in the journal Circulation.
    • “Kids who drank 12 ounces or more of fruit juice every day had a 35% higher risk of developing high blood pressure in adulthood, researchers found.
    • “Likewise, those who drank 24 ounces or more of sugary sodas or sports drinks had a 52% higher risk.
    • “The study also found that substituting either with a piece of whole fruit lowered a child’s future risk of high blood pressure.”

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

  • Beckers Payers Issues reports that “A year after promising ‘change and reform,’ UnitedHealth opens its doors.”
    • “It’s not every day the country’s largest healthcare company provides on-the-record access to its senior leadership team, no topics barred. But that is exactly what UnitedHealth Group has done, inviting reporters and social media influencers to its corporate headquarters in June for a daylong showcase of where the company is heading.
    • “Staged across sleek suburban-Minneapolis campuses, the day felt closer to a Silicon Valley product keynote than an insurer’s media event, complete with live software demos, an AI assistant making medical appointments, and a walk through of the company’s intelligence center it uses to triage member and patient issues across the country. 
    • “Across nearly every session, UnitedHealth presented itself as a technology and data company, one that can build tools for its tens of millions of members, patients and customers – and also sell solutions to the rest of the industry. Coming about two years after the Change Healthcare cyberattack laid bare how much of the nation’s claims plumbing already runs through Optum, the ambition is notable.” 
  • Beckers Hospital Review relates,
    • “New York City-based Memorial Sloan Kettering Cancer Center has broken ground on a $2.3 billion inpatient facility, the Kenneth C. Griffin Pavilion.
    • “The new facility will be connected to the cancer center’s main hospital by a dedicated patient bridge, according to a Memorial Sloan Kettering news release shared with Becker’s.
    • “Memorial Sloan Kettering expects to start serving patients at the new facility in 2030.”
  • and
    • “Houston Methodist has received a $110 million gift, its largest single commitment in the system’s more than 100-year history.” * * *
    • “The funding will establish a new innovation fund supporting research and care within the Houston Methodist Academic Institute and Neurological Institute, as well as an excellence fund for women’s health initiatives in the department of obstetrics and gynecology.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare has agreed to sell 31 home health and hospice agencies across eight states to Deaconess Associations Incorporated, a Cincinnati-based company that manages a diversified portfolio of $1 billion in healthcare services, programs, investments and community grant initiatives.
    • “Upon closing, the agencies will become part of Central Pyramid, one of Deaconess Associations Incorporated’s four owned subsidiaries and a home health and hospice operator with nearly four decades of experience. The agreement expands Central Pyramid’s geographic footprint and positions it to serve patients across more communities.
    • “Deaconess framed the deal as part of a strategy to invest in organizations that strengthen its existing operations and expand access to care as services move beyond traditional clinical settings.”
  • Fierce Healthcare points out,
    • “The past several years have seen strong growth in life insurance, in part thanks to the COVID-19 pandemic, with half of Americans owning a policy today. 
    • “While life insurance has traditionally been seen as a death benefit—something that offers families financial assurance after a loved one has passed—part of the industry is expanding into wellness benefits for the living. 
    • “This reflects burgeoning demand: a third of consumers are interested in free mental health and wellness services to go along with their life insurance, trade group LIMRA finds. Nearly a quarter are also interested in gym memberships, health coaching and diet planning. 
    • “John Hancock has been leading the way for over a decade. In 2015, it launched its Vitality program with the idea of encouraging healthy living. Discounts on fresh produce, wearables and various health memberships are just one part of the array of offerings.
    • ‘John Hancock CEO Brooks Tingle is honest about the business incentive. Life insurers make money by investing their customers’ premiums. That means the longer they live, the more money the company stands to make.” 
  • The American Hospital Association News notes,
    • “Results from a KFF poll published June 17 found that 31% of adults use social media at least monthly to seek health information and advice, similar to 29% who said they use artificial intelligence for the same purposes. Most adults said they either “never” or “occasionally” use AI (71%) or social media (69%) to find health information. Among adults who use social media for health information, 36% said learning from people with the same health condition or who share similar experiences was a “major reason.” A smaller share (17%) said that not having a regular healthcare provider or not being able to afford the cost of seeing a provider was a “major reason” for turning to social media.”

Monday report

David Ermer–Agentic & Generative AI, CDC, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The solstice this weekend marked the start of astronomical summer — and in Washington, D.C., that means the legislative clock is ticking.
    • “Lawmakers are eager to head home and campaign on a housing bill that’s nearing passage, but progress on several other issues has stalled, and it’s unclear whether a visit from President Donald Trump will break the logjam or cause further obstruction.”
  • Congress.gov finally has updated this week’s Committee hearings list. No hearings were held today. Of note,
    • Senate Committee on Homeland Security and Governmental Affairs
    • Wednesday, June 24, 2026
    • 9:30 AM (EDT) – Senate | 342 Dirksen Senate Office Building, Washington, D.C.
    • Open Hearing: Hearings to examine reforming the U.S. Postal Service’s business model.
    • Meeting Details
  • Federal News Network tells us,
    • “The Federal Regulatory Council is giving the federal community one more chance to speak up before the first set of major revisions to acquisition regulations becomes final.
    • “In Tuesday’s Federal Register, the FAR Council will release the first tranche of proposed rules for 17 sections of the FAR.
    • “Industry and government have largely seen these changes in the deviations, but there are additional differences or changes from what we have in deviations,” said an OMB official, who requested anonymity in order to discuss the proposed rules. “The general premise for each of the rules should already be familiar to most people. This is now to tell us where we missed something or how to refine a particular area.”
  • Kevin Moss, writing in Federal News Network, points out,
    • “Benjamin Franklin famously wrote, “In this world nothing can be said to be certain, except death and taxes.” If Flexible Spending Accounts had existed in his time, he might have added one more certainty: If you use an FSA, you’ll save money on your healthcare expenses.
    • “Yet despite rising healthcare costs and tighter budgets, most federal employees are leaving this guaranteed savings opportunity on the table. In fact, only one in five participate in the FSA program, meaning most employees are paying more than they need to.
    • “The good news? FSAs aren’t complicated, and you don’t have to be a benefits expert to take advantage of them.
    • “In this article, we’ll break down how they work, share a simple strategy to help you use one successfully (even if it’s your first time), and show why this is one of the easiest ways federal employees can immediately reduce their out-of-pocket healthcare costs.”
  • The FEHBlog heartily agrees with Mr. Moss.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a coordinated department-wide effort [PDF, 2.10 MB]* to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.
    • “For decades, randomized clinical trials have served as the gold standard for evaluating the safety and effectiveness of new medical treatments. Yet in recent years, a growing share of early-stage clinical research has moved overseas, threatening America’s position as the global leader in biomedical innovation. Under President Trump’s leadership, HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery.”
  • Beckers Payer Issues relates,
    • “Earlier in June, the HHS Office of Inspector General published two reports shedding light on post-acute care denials and overturned appeals from Medicare Advantage organizations. AHIP is pushing back.
    • “The reports ignore serious, well-documented concerns about wide variations in the cost and quality of post-acute care and skilled nursing facilities. More than 35 million Americans actively choose MA because it provides them with better, more affordable care — including helping seniors transition to high-quality, clinically appropriate care settings to support their rehab and recovery,” an AHIP spokesperson said in a June 11 statement.
    • “AHIP cited previous OIG research from 2018 that raised concerns about spending and quality with post-acute care. Based on a sample, OIG estimated Medicare paid inpatient rehabilitation facilities across the country $5.7 billion for unnecessary or unreasonable beneficiary care. The news release also featured Stanford (Calif.) University research from 2022 on risks of skilled nursing facility overuse based on Medicare’s reimbursement approach.
    • “AHIP also pointed to a lack of context in the OIG reports. Administrative issues — including out-of-network providers, services excluded from coverage and missing documentation — could all contribute to denials, not just denials that did not meet medical necessity standards. AHIP said reports also excluded common rationales for overturned denials, such as providers’ offices adding information that was initially missing from a claim.
    • “When combined with timely clinical information from our provider partners, prior authorization supports safe, effective and affordable care,” a CVS spokesperson previously told Becker’s. “We review requests promptly, offer a clear appeals process and are leading the way for continuous patient-centered improvements.”
    • “AHIP commissioned insights from analytics firm Inovalon, finding that, compared to fee for service, MA patients had 30% fewer inpatient days and 71% fewer preventable hospitalizations.”

From the Food and Drug Administration front,

  • The American Hospital Association reports,
    • “The Food and Drug Administration June 22 announced multiple actions to help accelerate early- and late-stage drug development. The actions are part of a larger Department of Health and Human Services initiative announced June 22 on clinical research efforts, called Operation TrailBlazer. The FDA’s efforts include a request for information on a new drug pilot program that would shorten the period from drug identification to first-in-human studies and protect clinical trial participants. The program would create a network of qualified research institutions, including academic medical centers, healthcare networks, contract research organizations, regulatory advisors and other research organizations, to partner with sponsors and develop and review protocols for first-in-human clinical trials intended for new drug submissions to the FDA.” 
  • The Wall Street Journal relates,
    • “The Food and Drug Administration has agreed to reverse its rejection of Regenxbio’s RGNX experimental gene therapy for a rare and fatal brain disease, the company said, the latest about-face by the agency under new leadership.
    • “The FDA didn’t respond to requests for comment.” * * *
    • “Regenxbio’s Navsunli therapy targets Hunter syndrome, a rare genetic disease that causes irreversible brain damage and cell death, usually leading to death in a patient’s midteens. 
    • “The disease affects about 2,000 people worldwide—nearly all boys—and about 50 people are diagnosed a year in the U.S.
    • “Navsunli promises to replace a defective gene, allowing boys who take the drug to start producing a protein that prevents the buildup of harmful substances in the brain and tissues.”
  • MedTech Dive tells us,
    • “Johnson & Johnson’s Abiomed alerted physicians to a risk associated with eight instances of major bleeding in patients treated with its Impella heart pumps.
    • “The Food and Drug Administration, which posted an early alert notice about the issue Thursday, said Abiomed and its manufacturing partner, Oscor, wrote to users about the catheter introducer issue this month.
    • “Hospitals can continue to use existing inventory. However, physicians should consider a device exchange or using the repositioning sheath to minimize blood loss if they see a potential leak.”
  • and
    • “Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm handles complaints. 
    • “The warning letter focused on MRI compatibility problems with some of Zoll’s portable ventilators. It also cited concerns with automated external defibrillators and electrodes used with the company’s defibrillators.
    • “Zoll, a subsidiary of Asahi Kasei that makes ventilators, defibrillators and other medical devices, received the warning letter on April 30, and the FDA posted the letter on Tuesday. The warning followed an inspection of Zoll’s facility in Chelmsford, Massachusetts, where the company is headquartered, between February and April 2025. 
    • “The FDA uses warning letters to flag significant violations after an inspection.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Utah has spent the past year fighting measles outbreaks — a grim milestone that could affect whether the United States can keep its measles-free designation. 
    • “More than 680 people have gotten sick since the state’s first outbreak began on June 20, 2025.
    • “Unlike measles outbreaks in Texas, South Carolina and Arizona, the spread in Utah has been tough to contain to one region — infecting undervaccinated communities in nearly every county. 
    • “Measles popped up in healthcare settings, big-box stores and restaurants, and youth sporting events. In February, an exposure at a state high school wrestling championship sparked at least 46 cases among attendees.” * * *
    • “More than 16% of the region’s kindergarteners were missing their measles vaccines in the last school year, according to state data. Statewide, 12.8% were missing their vaccine, putting the state far short of the 95% vaccination rate needed to prevent measles outbreaks.”
  • The American Medical Association lets us know what doctors want their patient to know about rib injuries.
    • “Rib injuries can range from bruises and stress injuries to fractures with overlapping symptoms.”
  • The Wall Street Journal tells us,
    • “Elementary school-age children are receiving GLP-1 weight-loss drugs such as Wegovy, despite that the medications aren’t being approved for obesity in this age group.
    • “Doctors prescribing GLP-1s to young children cite the severity of childhood obesity and its complications, seeing significant BMI decreases in some patients.
    • “Some doctors express concern about potential long-term effects on bone growth and brain development, while a guideline recommends medication only for children 12 and older.”
  • MedPage Today informs us,
    • “Adults ages 80 and older with unusually fast gait had about half the cognitive impairment risk as others, data from several studies suggested.
    • “Earlier research showed that super movers — people 80 and older who walk as fast as people 30 years younger — had a lower burden of disease, a healthier lifestyle, and a younger biological age.
    • “Findings suggested that mobility may reflect broad resilience across brain, cardiovascular, and muscle systems.”
  • and
    • “Previous research showed that combining the multicomponent blood-based biomarker Stockholm3 test with an MRI-targeted biopsy approach decreased overdetection of prostate cancers, while still detecting clinically significant cancers.
    • “In this analysis, the Stockholm3 test identified more clinically significant prostate cancers, while missing fewer cases, compared with standard PSA screening.
    • “These results support the use of the Stockholm3 test in the context of a risk-adapted screening approach, researchers said.”
  • and
    • “A major health system tested one multilevel approach to antithrombotic stewardship in the face of antiplatelet overprescribing among [direct oral anticoagulants] DOAC users.
    • “Antiplatelet use dropped following an initial educational outreach and a subsequent clinical pharmacist-facing electronic flag within a DOAC population management tool.
    • “The greatest benefit was observed in patients with stable [cornary artery disease] CAD, a group appropriate for antiplatelet deimplementation.”
  • STAT News notes,
    • “Pfizer said Monday that an experimental drug it hoped could replace a widely used chemotherapy in one of the most common forms of lung cancer fell short in a clinical trial.
    • “Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year Pfizer’s CEO, Albert Bourla, said on an earnings call the drug “could be a driver of growth later this decade.” In a note to investors in May, Leerink analyst David Risinger called the upcoming data readout a “major oncology catalyst” and said he had spoken to a doctor who was “optimistic” about its potential.” * * *
    • “The drug is an antibody-drug conjugate targeting integrin beta-6, a protein that is involved in tissue repair and is undetectable in normal cells but upregulated in cancer cells and is expressed in 90% of non-small cell lung cancer tumors. Pfizer was studying it compared to docetaxel in patients with locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer.
    • “But the drug did not result in a statistically significant improvement in overall survival over docetaxel. This was the study’s main goal, which means researchers will likely view other potentially encouraging conclusions from the clinical trial as requiring further proof.”

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

  • The Wall Street Journal reports,
    • “AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion to bolster its core immunology franchise.
    • “The deal includes Apogee’s experimental drug zumilokibart, a potential rival to Dupixent for moderate to severe atopic dermatitis.
    • “The acquisition, expected to close in the third quarter, will cut adjusted per-share earnings by 46 cents in 2027.”
  • STAT News adds,
    • “Pharma goes on a spending spree, snapping up biotechs in a hurry.
      • “M&A activity [like the AbbVie deal] has soared in the first half of the year.” * * *
      • “The amount of money put toward M&A in the first three months of 2026 was the highest seen since 2020, according to a report from PwC. 
      • “The flurry of M&A is also a welcome reprieve for biotech startup executives, who have struggled to finance their drug trials or early lab research, as well as venture capitalists searching for investment returns. It’s provided a lifeline to some biotech startups struggling to stay afloat.” 
  • Modern Healthcare relates,
    • “As the federal government expands access to weight-loss drugs for Medicare patients, Walmart and its Sam’s Club subsidiary are ramping up support services for beneficiaries who may be seeking the medications. 
    • “The Medicare GLP-1 Bridge program, which the Centers for Medicare and Medicaid Services is launching July 1, will allow eligible Part D beneficiaries access to certain GLP-1 drugs often used for weight management. 
    • “The retailers noted in a Monday news release Medicare patients may face hurdles understanding eligibility requirements, prescription coverage processes, provider documentation needs and pharmacy fulfillment options.
    • “The initiative, also launching July 1, will offer educational materials, consultations with pharmacists, assistance navigating government and healthcare resources, increased in-store support, digital health tools and connection to additional health services like vision care. 
    • “The retailer said in the release it is not responsible for eligibility determinations, coverage decisions and treatment recommendations.”
  • Beckers Hospital Review adds,
    • “CVS Health is expanding support services for patients using GLP-1 medications, including a new $50 monthly copay option for eligible Medicare beneficiaries and a $49 virtual weight management visit through MinuteClinic.
    • “CVS Pharmacy will begin participating in the CMS’ Medicare GLP-1 Bridge program July 1, according to a June 22 company news release. Established under agreements the Trump administration negotiated with Eli Lilly and Novo Nordisk in November, the program will set a $245 monthly Medicare price for Ozempic, Wegovy, Mounjaro and Zepbound, with patients paying $50 per month out of pocket. 
    • “The company also launched a new MinuteClinic virtual care offering available in 47 states and Washington, D.C. The service connects eligible adults ages 18-64 with licensed clinicians who can evaluate patients for weight loss treatment and, when clinically appropriate, prescribe FDA-approved GLP-1 medications. Visits cost $49 and do not require a recurring membership fee.
    • “CVS said the initiative also includes expanded pharmacist support and over-the-counter products designed to help patients manage common GLP-1 side effects and remain on therapy. The company plans to offer dedicated product displays in select stores focused on nausea, gastrointestinal discomfort, hydration and nutrition support.”
  • HR Dive notes,
    • “SHRM members are shaking up their prescription drug benefits strategies thanks to cost increases that are driven in part by a massive uptake of weight loss medications, analysts for the HR organization said during its 2026 annual conference on Tuesday.
    • “Specifically, GLP-1 drugs have become a “massive line item” for employers, said Kathryn Mayer, senior specialist, content at SHRM. The organization’s 2026 Employee Benefits Survey found that while close to half of the roughly 5,500 employer respondents covered GLP-1s for Type 2 diabetes management, only 15% did so for weight management.
    • “We’re finding that employers are struggling to fund GLPs,” said Calven Engstrom, a SHRM senior researcher. But given strong evidence of the drugs’ effectiveness and high demand from employees — a 2025 KFF poll found that 1 in 8 U.S. adults said they were currently taking a GLP-1 drug— organizations have to weigh competing interests.
    • “Many of these organizations are trying to balance employee health outcomes with the long-term affordability and sustainability of their typical health plan,” Engstrom said, adding that utilization rates for GLP-1s are probably among the most closely monitored by employers at the moment.”
  • Per a Fair Health news release,
    • “The national median total cost for a C-section for commercially insured patients staying in network is $19,911, and for vaginal delivery it is $15,728, according to FAIR Health’s Cost of Giving Birth Tracker. These figures reflect the national median allowed (in-network) amount for the procedures. 
    • ‘The Cost of Giving Birth Tracker is a free, interactive tool, updated today, that tracks the cost of giving birth state by state. Available on FAIR Health’s website fairhealth.org, the Cost of Giving Birth Tracker consists of heat maps that show state-specific and national median charge and allowed amounts for vaginal deliveries and C-sections. The tool draws on the national, independent nonprofit FAIR Health’s database of commercial healthcare claim records—the nation’s largest such repository, which is growing at a rate of more than four billion claim records a year.
    • “The Cost of Giving Birth Tracker includes inpatient and outpatient facility and professional costs. Services include the delivery itself (e.g., pharmacy, nursery, labor and delivery room, medical and surgical supplies, room and board for the mother), anesthesia, fetal nonstress tests, ultrasounds, laboratory work and a breast pump. The data come from the September 2025 release of the vaginal delivery and C-section FH® Total Treatment Cost benchmarks.”
  • Modern Healthcare informs us,
    • “Health systems are investing in remote patient monitoring despite reimbursement rates that often don’t cover technology and staffing costs.
    • “Providers are banking on remote monitoring programs’ long-term, less easily quantified benefits.
    • “Stanford Health Care, UMass Memorial Health, OSF HealthCare and others are using technology to keep an eye on patients outside hospital walls.”
  • Fierce Healthcare notes,
    • “Online portal messages sent to providers more than doubled between 2020 and 2025 as patients now have much more direct access to physicians. But there hasn’t been a corresponding drop-off in clinic visits as digital medicine is adding to clinicians’ workload rather than replacing in-person care, a new study finds.
    • “At least 12% of Americans now communicate with their healthcare providers about appointments, test results and ongoing treatments via secure online patient portals and health apps, according to a study led by researchers at NYU Langone Health and published today in the Journal of the American Medical Association (JAMA) online.
    • “Online portal messages jumped 153% from 2020 to 2025, from an average pace of 2.2 per year in early 2020 to 5.4 per year in late 2025. But these digital messages are not replacing in-office visits, which have returned to an average of between two and three per year per patient. In-person office visits saw a modest 17% increase, going from 2.37 to 2.77 per patient per year, during the study period.
    • “By contrast, total telephone calls decreased by 6% over the same period.”
  • and
    • “Nine months after announcing its seed funding round, Prosper AI banked $30 million to scale its agentic AI platform to power administrative tasks from patient scheduling to insurance verification and patient billing.
    • “While many voice AI companies focus on specific tasks, like patient scheduling or billing, Prosper AI was designed to manage the broader patient journey, according to executives. The platform answers patient calls, schedules appointments directly in the electronic health record, verifies insurance benefits, automates patient billing and contacts insurers on the phone when additional information is needed. 
    • “Prosper AI’s ambition is to build an AI workforce for healthcare operations teams, Xavier de Gracia, the startup’s co-founder and co-CEO, told Fierce Healthcare. Prosper AI first shared the funding news with Fierce Healthcare.
    • “We believe that three to five years from now, larger patient groups and health systems are going to have a layer of workforce that’s going to be AI, not only humans, and it’s going to complement the work that humans are doing, and we believe that EHRs are going to partner and are already partnering to build a layer on top of the electronic health record. Our vision is to be completely agentic.” 

Thursday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

In recognition of Juneteenth, a Friday report will not be posted tomorrow. The FEHBlog will return on Saturday with the latest Cybersecurity Saturday post.

From Washington, DC.

  • Healthcare Dive reports,
    • The CMS is recalculating 2026 Medicare Advantage stars for insurers after the agency lost a court case over its methodology.
    • Only plans that see their stars increase will have their ratings updated and be able to resubmit bids for next year, regulators said in a memo to plans Wednesday. It could be a major boon for insurers, given the stars are linked to lucrative bonuses and competitive advantages in the privatized Medicare program.
    • Still, the recalculation basically results in no change in average star ratings for other insurers besides Clover Health, which brought the lawsuit against the CMS, according to TD Cowen analysts. Some insurers may choose to sue over the approach.
  • STAT News relates,
    • “Making good on its threat, Eli Lilly has begun eliminating mandated price breaks to a few dozen hospitals that participate in a federal drug discount program after failing to receive comprehensive claims data.
    • “The move comes after the company warned earlier this month it would take such a step as part of a policy announced in January in order to reduce what it calls duplicate discounts paid to the hospitals. Trade groups representing hospitals, however, argue the move is unlawful and want Congress to intervene.
    • “At the time, Lilly maintained that more than 2,300 hospitals had complied with its demand, but some larger hospitals systems around the U.S. refused to do so, despite recent follow-up letters regarding the policy, which went into effect Feb. 1. Up to 1,000 had so far not complied, and Lilly indicated it was pressing about 50 larger hospitals to provide data.
    • “A Lilly spokesperson declined to say how many hospitals are now being denied the mandated discounts but sent us a statement saying, “Lilly is collecting claims data to stop the rampant fraud, waste, and abuse in the 340B program that is harming employers, state and federal governments, and patients.”
  • The American Hospital Association News tells us,
    • “The Health Resources and Services Administration Maternal and Child Health Bureau has announced grant opportunities available supporting maternal and child health initiatives. The Maternal Produce Prescription Program, or MP3, will provide grants for the development and implementation of community-based produce prescription programs and related nutrition education for maternal populations at risk of poor health outcomes due to nutrition insecurity and other health-related factors. Grants are also available for the Regional Pediatric Prevention Network, which will provide funding to hospitals working on advancing pediatric emergency and disaster preparedness locally, regionally and nationally, including for children with special healthcare needs and behavioral health concerns, children living in poverty, and children in rural, remote and tribal areas. The network will include at least 10 children’s hospitals, or their university pediatric partners, as well as community partners. The application deadline is July 17 for the MP3 and RPPN programs. 
    • “Funding is also available for the Maternal Health Emergency Management Training program, which seeks to increase capacity and improve the quality of care provided by clinicians and first responders who encounter pregnant and postpartum women in nondelivery and/or low-resource clinical settings. The deadline to apply for the MHEMT program is July 20.” 
  • Federal News Network inteviews Tammy Flanagan about the Federal Employees Group Life Insurance Program.
  • JAMA discusses original research concerning the Inflation Reduction Act.
    • “Question  How did prescription drug use change after the Inflation Reduction Act implemented annual out-of-pocket spending caps in Medicare starting in 2024?
    • “Findings  In this cohort study using a difference-in-differences framework of 3053 medications covering 92.9% of gross Medicare Part D spending in 2023, prescriptions for medications paid by Medicare increased after the out-of-pocket cap was implemented in 2024 compared with those paid by commercial insurance; this change was most pronounced among the highest-cost medications, with a 22.7% increase in 2024-2025.
    • “Meaning  Results of this study suggest that implementing annual out-of-pocket caps in Medicare was associated with higher use of medications and that the policy improved Medicare-insured patients’ access to costly medications.”
  • Fierce Pharma notes,
    • “Before Indian drugmaker Aurobindo can complete its acquisition of Pennsylvania generics specialist Lannet, it will have to divest four drugs from the proposed $250 million buyout to resolve anticompetitive concerns, the Federal Trade Commission said.
    • “Aurobindo’s acquisition of Lannett would combine two of a limited number of competitors in the markets for four different generic pharmaceutical products that provide critical relief for patients,” the FTC wrote of its proposed consent order (PDF).
    • “The U.S. regulator has specified that Aurobindo must sell the products to New Jersey generics maker Quagen Pharmaceuticals.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration advisory committee voted that the benefits of a seasonal flu vaccine from Moderna MRNA outweigh its risks, part of the agency’s review of a potential new treatment.
    • “Moderna said Thursday the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of the vaccine, mRNA-1010, exceed the risks for the prevention of flu in adults 50 through 64 years old, and in adults 65 years of age and older.
    • “The FDA plans to consider the committee’s recommendations as part of its ongoing review of Moderna’s biologics license application for mRNA-1010, the company said. Advisory committee recommendations are nonbinding, and the FDA is responsible for making final approval.”
  • Fierce Pharma relates,
    • “With FDA acceptance of its application, Roche has moved a step closer to gaining a thumbs up for its potential combination treatment of Polivy and subcutaneous Lunsumiofor adults with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy.
    • “The U.S. regulator says it’s aiming to decide whether to approve the application by Feb. 9, 2027.
    • “The application is backed by results from a phase 3 study, which showed that after a median follow-up of 23 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to Rituxan plus the chemotherapies gemcitabine and oxaliplatin.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), announced today that it is requesting updates to the prescribing information for testosterone replacement therapy products following a comprehensive review of new clinical data and existing scientific evidence.
    • “The proposed changes would:
      • “Remove the limitation of use stating that the safety and effectiveness of testosterone replacement therapy in men with age-related hypogonadism have not been established.
      • “Update information related to prostate cancer risk.
      • “Revise warnings regarding benign prostatic hyperplasia, also known as enlarged prostate.
    • “During Men’s Health Month, we are putting science back at the center of men’s healthcare,” said HHS Secretary Robert F. Kennedy, Jr. “By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men.”
  • Cardiovascular Business informs us,
    • “More than 11,000 bottles of a popular blood pressure medication have been recalled due to a failed test. The voluntary recall was initiated on June 5, according to key details provided by the U.S. Food and Drug Administration (FDA).
    • “This recall includes 11,460 bottles of Chlorthalidone Tablets manufactured by India-based Inventia Healthcare Limitedand distributed by New Jersey-based Rising Pharma Holdings. Chlorthalidone is a diuretic or “water pill” used to treat hypertension and reduce excess fluid caused by heart, kidney or liver disease. 
    • “These drugs have been recalled due to “failed dissolution specifications.” This means tablets tested by a regulatory body did not break down correctly, creating a risk of the drug being less effective than intended.
    • “The recalled bottles include either 100 or 1,000 of these tablets. They all have an expiration date of April 2027.
    • “Click here for additional details about this recall from the FDA. The incident has not yet been classified as a Class I or II recall.”

From the judicial front,

  • Healthcare Dive reports,
    • “Pharmacy benefit managers want to make sure that an Illinois law creating drug pricing transparency and reforming health benefits administration doesn’t apply to them.
    • “On Tuesday, powerful PBM lobby the Pharmaceutical Care Management Association filed a complaint in federal court against the Illinois Department of Insurance, arguing that the Prescription Drug Affordability Act signed into law last summer clashes with federal oversight of employee benefit plans and that PBMs should be carved out from its provisions.”
  • Beckers Hospital Review relates,
    • “A federal judge has denied The Leapfrog Group’s attempt to reverse a ruling that found its hospital safety grades violated Florida consumer protection law, and separately put a $10.5 million fee dispute on hold, pending appeal.
    • “On June 17, U.S. District Judge Donald Middlebrooks rejected Leapfrog’s motion to reconsider his March 6 ruling, which found the organization violated Florida’s Deceptive and Unfair Trade Practices Act by penalizing hospitals that declined to participate in its voluntary survey with artificially low safety grades.”
  • The Wall Street Journal informs us,
    • “Luigi Mangione’s defense team said Thursday they no longer intended to present a psychiatric defense at his coming New York state-court murder trial, abruptly reversing course after a judge made public the unusual strategy a day earlier.
    • ‘In a single-sentence letter to the presiding judge, the lawyers wrote that, at this time, they were withdrawing a defense in which Mangione would have argued he killed UnitedHealthcare Chief Executive Brian Thompson due to an emotional disturbance.
    • “Mangione’s defense team and a spokesman for the Manhattan district attorney’s office declined to comment.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “While infant formula in the U.S. has a good overall safety record, the stakes are incredibly high if something goes wrong. Food safety experts who spoke with STAT say they want regulators and the industry to take even stronger measures to prevent disease outbreaks that put babies’ lives at risk. And they want consumers to be wary of marketing from newer, high-end formula companies like ByHeart and Nara that position their products as safer than other options.
    • “I think a lot of parents can be confused and think that if they spend more money on a formula, it’s safer,” said Steven Abrams, a professor of pediatrics at Dell Medical School at the University of Texas at Austin. In fact, formulas are remarkably similar to one another because they’re required to use a blend of 30 ingredients necessary to give babies the nutrition they need. All formulas are also subject to annual FDA inspections and requirements to test for the pathogens salmonella and Cronobacter.
    • “Of designations like organic, GMO-free, or added probiotics and prebiotics, Abrams said, there’s no evidence that such features “have the slightest health effect on babies.”
    • “Nara and ByHeart were both manufacturers “claiming to produce a healthier type of infant formula because they were using whole milk,” said Frank Yiannas, a former deputy commissioner for food policy and response at the FDA. The fact that both brands have been linked with infant botulism, he said, suggests that “reformulating powdered infant formula should be done with extreme due diligence and caution.”
  • and
    • “If you’re an older adult, getting vaccinated against shingles could lower your risk of developing dementia.
    • “A new study found that elderly nursing home residents who received at least one dose of the shingles vaccine known as Shingrix, the only shot of its kind available in the United States, were 24 percent less likely to develop dementia over a four-year period compared to those who were not vaccinated, according to results published this week in the peer-reviewed journal Annals of Internal Medicine.
    • The research adds to the growing body of evidence showing a connection between the viral infection and cognitive decline.
    • “The fact that this is a super high-risk population for dementia and we’re still seeing a potential benefit is really remarkable and important evidence for this population,” said Kaleen Hayes, the study’s lead author and an assistant professor at Brown University who studies the use of medications for chronic conditions in older adults.”
  • and
    • “Fentanyl is by far the biggest opioid killer in the U.S. With more than a quarter of a million deaths since 2021 and about 200 fatalities a day, fentanyl is one of the country’s most urgent public health crises. But drug experts warn that nitazenes can be even more potent and are being mixed with fentanyl and other substances, creating increasingly lethal combinations.
    • “We’re always concerned about fentanyl being mixed in with other drugs — cocaine, meth, heroin,” said Frank Tarentino, associate chief of operations for the DEA’s northeast region. “You add nitazenes to that and it makes it exponentially more dangerous and frightening for drug law enforcement, parents, caregivers, educators, and the young.”
    • “Data obtained from the DEA’s National Forensic Laboratory Information System (NFLIS) show reports of confirmed seizures from nitazenes rising sharply — from 43 positive tests in 2019 to almost 2,000 in 2024 (the most recent year for which data are available). By March this year, more than 8,000 nitazene reports had been recorded since 2019. But experts said that not all laboratories can test for nitazenes — which come in many forms including powders, pills, and sprays — and many don’t feed into the NFLIS system, meaning these numbers are almost certainly an underestimate.” * * *
    • “Nitazenes are predominantly sold online, both on the clear web and dark web, and are often laced into other substances to increase their potency. Experts say this puts unsuspecting users seeking more common drugs, such as oxycodone, fentanyl, or stimulants like cocaine, at risk of fatal overdoses.”
  • The Washington Post tells us “7 unexpected takeaways from the newest research on cannabis and brain effects.”
    • “Whether it’s used in adolescence, midlife or older age may make a big difference.”
  • The American Medical Association lets us know “What doctors want patients to know about summer skin safety.”
    • “Too much sun exposure can have damaging effects on skin, but following proper precautions can help. Follow these summer sun safety tips.”
  • Health Day points out,
    • “Pregnant women are exposed to dozens of common chemicals linked to early delivery and low birth weight, according to a new study.
    • “Researchers tested urine samples from more than 5,000 women who gave birth between 2000 and 2021, and compared the findings with pregnancy outcomes.
    • “They screened for 113 chemicals commonly found in food, water, air pollution, personal care products, fragrances and other household items.
    • “On average, the tests detected 45 chemicals in each sample, with as many as 64 found in some participants.
    • “Among them were phthalates used to make plastics more flexible, as well as some newer plasticizers.
    • “Some of these compounds were consistently associated with earlier delivery and lower birth weight, according to the results.” * * *
    • “The researchers are calling on governments and companies to do more to reduce harmful chemicals in everyday products and ensure new ones are safe.”
  • MedPage Today informs us,
    • “In a cohort study, U.S. women logging at least 2 hours a week of resistance training had a 20% lower risk of incident major cardiovascular disease (CVD) over nearly 15 years.
    • “The benefit of resistance training persisted even if women also engaged in aerobic activity and limited sedentary time.
    • “A lower risk of major CVD could also be observed in those who reached ≥1 hour of weekly resistance training and were consistent about it over the years.”

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

  • The American Hospital Association News reports,
    • “Hospital and health system leaders gathered June 17 and 18 in Washington, D.C., for U.S. News & World Report’s Healthcare of Tomorrow Conference, focusing on the future of healthcare delivery. AHA Chair-elect Bill Gassen, president and CEO of Sanford Health in Sioux Falls, S.D., participated in a panel titled “Reimagining Healthcare: The Hospital and Health System of Tomorrow.” The session included discussion on challenges and opportunities shaping the future of hospitals and health systems, and involved topics such as artificial intelligence and digital transformation, care delivery models, community partnerships and sustainable financial performance.  
    • “When I think about the future of health care, I believe success will be defined by how well organizations can connect care across settings, specialties and communities to better serve patients,” said Gassen. “The organizations that will be best positioned for the future are those that can combine deep local relationships and community trust with the capabilities needed to deliver increasingly complex care, invest in innovation, develop the workforce and keep care accessible and affordable over the long term.” Former AHA Board Member Warner Thomas, president and CEO of Sutter Health, and Redonda Miller, M.D., president and CEO of The Johns Hopkins Hospital, also participated on the panel.” 
  • Kaufmann Hall relates,
    • The latest issue [April 2026] of the National Hospital Flash Report covers these and other key performance metrics.
    • Key Takeaways:
      • Hospital performance remains under pressure in 2026. Mixed performance on key volume indicators, staffing challenges, and expense growth continue to pressure hospital operations, reinforcing the need for focused prioritization and strategic planning.
      • Expense growth continues to outpace inflation. Drug and labor expense remains a key contributor to expense growth, driven by both cost and utilization as the population ages, underscoring the importance of strategic spend management across the board.
      • Payer mix continues to erode. Year-over-year climbs in bad debt and charity care reflect broader shifts in payer mix, shifts in coverage, and growth in uninsured populations, requiring hospitals to proactively adapt and manage long-term revenue risks.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Hospital Review ranks 81 health systems by annual revenue and identifies four hospital closures that have happened in 2026.
  • Bloomberg tells us,
    • “Johnson & Johnson has no plans to enter the booming obesity market, opting instead to focus on diseases such as cancer, Chief Executive Officer Joaquin Duato said in an interview for an upcoming episode of The David Rubenstein Show: Peer to Peer Conversations.
    • “The comments set J&J apart from many of its rivals trying to develop or acquire obesity medicines following blockbuster weight-loss drugs from Eli Lilly & Co. and Novo Nordisk A/S.“
  • Fierce Pharma informs us,
    • “What’s been Novo Nordisk’s secret weapon to turn the tables on Eli Lilly and win the current market battle over their oral GLP-1 obesity drugs? Name recognition.
    • “That’s according to Jim Hickey, an analyst with Spherix Global Insights, who has studied the competition by surveying 50 primary care physicians (PCPs) and 50 endocrinologists in the United States, as well as writing monthly reports on the uptake of the drugs, both of which debuted on the market earlier this year. 
    • “It’s interesting to see how strongly Novo Nordisk has come out of the gate,” Hickey said in an interview with Fierce. “It’s a very strong launch from what we can see. That lines up with the data Novo Nordisk has shared. I think a big difference between the two really comes down to familiarity. We see the familiarity ratings for the Wegovy pill as being much stronger than what we can see for Foundayo.”
  • Fierce Healthcare points out,
    • “Lantern and Marathon Health are joining forces to launch an integrated model that brings together primary and specialty care, a key concern for employers as costs rise.
    • “The partnership combines Marathon’s advanced primary care model with Lantern’s specialty care platform, simplifying the patient care journey, better managing costs and reducing unnecessary procedures. Marathon clients that do not currently work with Lantern can purchase its services through Marathon, making the process easier for employers, too.
    • “The two initially collaborated on a pilot program with early adopters, focused on orthopedic care, and found between a 37% and 100% increase in referrals to Lantern. Referrals from Marathon led to a 47% increase in either completed or averted surgical procedures, the companies said.”
  • Per BioPharma Dive,
    • “Biogen plans to buy startup RayThera to gain access to a portfolio of immunology drug candidates, including one slated to enter the clinic in the third quarter. 
    • “Founded in 2023, RayThera says its mission is to develop safer, more effective therapies for immunological diseases. But the company has said little publicly about what it’s doing. RayThera’s website doesn’t detail what it’s been working on, instead touting the company’s “nimble and adaptable approach” and containing a pipeline page with three prospects listed only as “anti-inflammatory.”
    • “The deal with Biogen is also rather opaque, per a statement released Wednesday. RayThera investors will get an undisclosed upfront payment and could reap as much as $1 billion if unspecified clinical and regulatory goals are met.”
  • and
    • “An emerging area of drug development got more crowded Wednesday, with the debut of a biotechnology startup trying to create new migraine prevention therapies.
    • “Vedana Therapeutics formed in response to an earlier class of migraine-thwarting medicines that first hit the market toward the end of the last decade. These medicines inhibit specific proteins, “CGRPs,” that play a key role in migraines by transmitting pain signals, widening blood vessels and triggering inflammation in the tissues around the brain. While effective for many, a large portion of patients — more than half, by some estimates — don’t respond to, or stop taking, CGRP-blocking therapies.”
  • McKinsey & Co. discusses “The health system CEO imperative: Turning AI’s promise into performance.”
  • The Wall Street Journal reports,
    • “The clash over AI doctors has begun, and its front line is in Utah.
    • “It started with technology from the startup Doctronic. The state launched a project in January that will allow the service to renew prescriptions for patients. The hope is it will improve medication access.
    • “Any Utah adult can log in to get a refill on cholesterol medications or antidepressants, among other prescriptions. When fully implemented, the project will break new ground by letting an artificial-intelligence product, acting on its own, perform this job typically done by physicians.
    • “Doctors aren’t happy about it.
    • “People can have life and death reactions to medications,” said Dr. Alan Smith, a family physician who chairs the Utah medical board but said he wasn’t speaking for the group. “And then I worry about liability. Who is actually liable for problems that may occur because of a refill of a medication?”
    • “Most of the state’s medical licensing board, including Smith, signed a letter calling for the project to be suspended on safety grounds. They said Doctronic’s tool hasn’t been vetted enough, and prescribing can create risks because drugs cause side effects or might not be appropriate to continue. The Utah Medical Association said it agreed with the letter.
    • “State officials overseeing the pilot program said that the medical board has no authority over the project but that they will consult with it.
    • “The debate over AI doctors extends far beyond Utah’s borders.” 

Tuesday Report

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

Simplicity is a virtue.

Fron Washington, DC,

  • Beckers Hospital Review reports,
    • “Senate Finance Committee minority staff has released a request for information outlining three policy options aimed at lowering prescription drug prices, reducing patient out-of-pocket costs and supporting biopharmaceutical innovation. 
    • “The proposal, released June 16, builds on a February plan led by Sen. Ron Wyden, D-Ore., and several Senate Democrats and is the latest in a string of Democratic actions targeting drug pricing under the Trump administration. Most recently, Mr. Wyden and 18 fellow Senate Democrats introduced the Drug Deal Disclosure Act in April, which would require HHS to release contracts and communications tied to the administration’s drug pricing agreements with major pharmaceutical companies and direct the Congressional Budget Office and Government Accountability Office to analyze their impact on Medicare, Medicaid and patient costs.” * * *
    • “Stakeholders have until Aug. 17 to submit comments.”
  • Avalere Health adds,
    • The US Pharmacopeia Convention (USP) is a nonprofit organization that disseminates public compendial quality standards for medicines and maintains two drug classification systems: the Medicare Model Guidelines (MMG) for Part D plans and the Drug Classification (DC) for non-Part D plans.
    • “Statute required Part D plan formularies to include at least two drugs per class. The Centers for Medicare and Medicaid Services (CMS) determines the categories and classes of clinical concern—commonly known as the six protected classes¹—and requires Part D plans to cover “all or substantially all drugs” within each class in their formularies.
    • Under a cooperative agreement with CMS, USP updates these drug categories and classes “every three years in the MMG. These updates, made in consultation with manufacturers and other stakeholders, adjust for the market entrance of new Part D eligible drugs and for drugs with newly approved indications.
    • “On June 1, USP released the draft MMG version 10.0 (v.10.0) for public comment. The finalized v.10.0 is expected in September.”
  • MedTech Dive informs us,
    • “The Centers for Medicare and Medicaid Services on Monday proposed an updated national coverage determination for transcatheter aortic valve replacement that could expand the treatment to more patients, benefiting Edwards Lifesciences.
    • “The proposed NCD adds Medicare coverage for beneficiaries with asymptomatic severe aortic valve stenosis who are enrolled in a CMS-approved study.
    • “We are encouraged the draft coverage policy has the potential to improve timely access to lifesaving TAVR therapy for Medicare beneficiaries,” an Edwards spokesperson wrote in an email.”
  • Moreover, the Centers for Medicare and Medicaid Services issued a
    • “request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers (“PBMs”) and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative requirements that are effective beginning calendar year 2028: restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs; and data reporting requirements.”
    • The public comment period will expire on July 20, 2026.
  • Fierce Healthcare tells us,
    • “Beneficiaries face a series of complex decisions in enrolling in Medicare coverage, and a key federal panel outlines some of the pain points.
    • “The Medicare Payment Advisory Commission (MedPAC) released its June report to Congress on Monday, where it notes that when an individual becomes Medicare eligible, they have to immediately make a series of decisions about coverage that may be confusing.
    • “Eligible individuals are also tasked with similar decision points at other times in the year, which adds to the complexity, per MedPAC.” * * *
    • “The advisory group’s report undercuts a key argument often cited by providers seeking additional support from policymakers: that the increased penetration of Medicare Advantage plans, particularly in rural markets, is dangerously dragging providers’ financial stability.”
    • * * * “MedPAC’s report also included familiar recommendations for Congress regarding Medicare payment system incentives.
    • “For instance, “to bring [fee-for-service] Medicare’s overall payment levels closer in line with provider costs,” the group reiterated its support for “slightly” higher hospital outpatient and inpatient payments and physician payments compared to current law. MedPAC also recommends Medicare adopt site-neutral payment rates “for certain services that can be safely provided in more than one ambulatory setting,” and called for various new data sources and formulas to more accurately set relative payments.” 
  • The Congressional Budget Office made a “Call for New Research on the No Surprises Act.”
    • “CBO will continue to monitor evidence about outcomes of the No Surprises Act as it prepares cost estimates and projections for Congress. The agency could benefit from additional research that relies on more-recent data to understand trends related to network participation, prices, and ownership structure. The claims data used in existing studies end in 2023, when patterns from arbitration were only beginning to develop.
    • “Additionally, determining whether trends in prices are causally related to the No Surprises Act is difficult because prices for some specialties affected by the law may have been trending downward before it was enacted and because the rollout of the law coincided with a period of historic inflation. Quasi-experimental evidence could isolate the effects of the law from other trends in prices. Evidence that helps determine whether changes in prices or network participation vary with the degree to which the IDR system is used in a particular market might also help identify changes attributable to the law instead of other factors.
    • “CBO would welcome additional quantitative or qualitative research on the arbitrators’ decision-making process and any incentives they face. Because of the lawsuits challenging the use of the QPA as a guideline, the alternative benchmarks that are being used to determine outcomes from arbitration are unclear.
    • “And finally, CBO would welcome research about how health care markets continue to evolve in the wake of the law. Early evidence suggests that large organizations dominate arbitration activity, potentially disadvantaging smaller providers and encouraging consolidation (Adler, Fiedler, and Agarwal 2026; Hoadley and Watts 2025). Continued analysis of market structure and competition will be critical for understanding the law’s long-term effects.”
  • The American Hospital Association relates,
    • “The Administration for Strategic Preparedness and Response June 16 announced the launch of the Digital Stockpile and Manufacturing Response Network Challenge, a three-phase competition to improve the rapid domestic production of key medical supplies for emergencies. ASPR will award up to $2.04 million to participants from industry, academia, nonprofit organizations and the government for concepts for the network. The agency said it will host a series of virtual information sessions on the challenge beginning in July.” 
  • and
    • “The Health Resources and Services Administration announced June 16 that it will award a total of $2.8 million in grants through its Delta Rural Integrated Health Network Program. The program supports the development of integrated health networks among rural hospitals, primary care clinics, behavioral health providers and other essential services. HRSA will issue eight awards of $350,000 per year for two years. Applications are due by July 17. A recording of a technical assistance webinar on the program is also available.” 

From the Food and Drug Administration front,

  • Bloomberg reports,
    • “Nara Organics recalled all of its whole milk infant formula after three babies were hospitalized with confirmed or suspected botulism, the second total recall of a baby formula brand after it was linked to the deadly illness. 
    • “The US Centers for Disease Control and Prevention warned parents not to use Nara’s formula, which is sold on the company’s website and at Target, on Saturday after three babies confirmed to have consumed it contracted botulism. They are from California, Pennsylvania and Washington, the CDC said. No deaths have been reported.”
  • Cardiovascular Business points out,
    • “Medline, the Illinois-based medical supplier that went public in December 2025, has recalled nearly 50,000 procedure kits used in the cardiac cath lab and other parts of the hospital. 
    • “The recall was put in place due to a risk of issues with the Mastisol Liquid Adhesive included in these procedure kits. Developed by Ferndale Laboratories, Mastisol is commonly used to secure dressings, tapes and medical devices for long periods of time.
    • “Medline has identified a risk of the adhesive’s packaging cracking, which renders it “unusable for application.”
    • “No kits need to be returned. However, a warning label should be added that tells clinicians to use an alternative adhesive.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. This action aligns with President Trump’s Great American Recovery Initiative, a federal effort to address the U.S.’ addiction and substance use disorder crisis and coordinate the government’s approach to prevention, treatment, and long-term recovery.” * * *
    • “The number of overdose deaths has dramatically decreased since the first FDA approval of an OTC naloxone nasal spray in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl. In the 12-month period ending in August 2023, 111,451 overdose deaths were reported; in the 12-month period ending in December 2025, 68,632 overdose deaths were reported.” * * *
    • “The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.”
  • BioPharma Dive relates,
    • “Food and Drug Administration scientists evaluating a potentially new messenger RNA flu vaccine from Moderna have expressed skepticism about the evidence supporting its benefits, according to documents filed days before a crucial advisory committee meeting. 
    • “On Thursday, the FDA will convene a panel of experts to discuss use of the shot, dubbed mFlusiva and in development for seasonal influenza. Panelists are set to vote on whether the benefits of vaccination outweigh the risks in people either between the ages of 50 and 64, or those who are 65 and older. Moderna hopes the discussion will set the stage for approval of a vaccine U.S. regulators controversially refused to review earlier this year before abruptly changing course.” 
  • Genetic Engineering and Biotechnology News adds
    • “Flu shots reduce hospitalizations and deaths for the roughly one billion people worldwide that get the flu each year. But they are less effective when the vaccine strains don’t closely match the viruses circulating in the community. Today’s vaccines are made months in advance of the flu season due to a long manufacturing process. When projections are off, strain mismatch can reduce the efficacy of the flu vaccines from about 60% (in a good year) down to 19%. A broader immune response could translate to a more effective vaccine even when the virus is changing faster than vaccine makers can update their shots.
    • “Now, an investigational mRNA influenza vaccine, developed by Moderna, helps the immune system recognize a wider range of influenza viruses than today’s standard flu shot, offering stronger and potentially longer-lasting protection. The vaccine is currently under review by the U.S. Food and Drug Administration and, if approved, would be the first mRNA vaccine against influenza.
    • The findings are published in Nature Immunology in the paper, “mRNA-based influenza vaccine expands the breadth of the B cell response in humans.”

From the judicial front,

  • HR Dive reports,
    • “A federal judge agreed to dismiss an LGBTQ+ advocacy organization’s lawsuit claiming that the U.S. Equal Employment Opportunity Commission “abdicated” its duty to enforce federal workplace protections for transgender workers because the plaintiffs lacked standing, according to a decision issued Friday.
    • “FreeState Justice filed the lawsuit last July, alleging that EEOC unlawfully denied transgender workers access to its charge-investigation process and other enforcement protections as part of a “Trans Exclusion Policy.” But courts lack authority to review such discretionary agency decisions, Judge George Russell III held, quoting the November 2025 decision of a separate court in a lawsuit challenging alleged nonenforcement by EEOC.
    • “Russell dismissed the case without prejudice, writing that the EEOC’s decision to alter investigations of gender identity discrimination claims was “deeply troubling” but nonetheless unreviewable. FreeState did not immediately respond to a request for comment.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Cybele Maylone, 46, has been hearing about hormone therapy nonstop. Whether it is her friends going through menopause or posts from influencers on her social media feed, the subject has seemed unavoidable: who was on it, which doctor finally took their symptoms seriously and, most importantly, how good it felt to be on the medication. The hot flashes waning. Brain fog lifting. Sleep returning.
    • “To Ms. Maylone, it sounds like a miracle drug. But for her and millions of other women, it is not an option.
    • “She was diagnosed in 2023 with a type of breast cancer fed by estrogen, and now takes a drug that suppresses the hormone to reduce her risk of recurrence. While breast cancer is the most widely recognized reason women may not be able take hormone therapy, which delivers estrogen or progesterone through pills and patches, the list also includes endometrial cancer, certain cardiovascular issues, severe liver disease and blood clotting disorders.
    • “Ms. Maylone and other women said they feel deeply frustrated that they can’t take a drug that so many women around them seem to have benefited from.” * * *
    • “Ms. Maylone said that when she tried to raise the subject with her providers, she hit a wall. “Through no fault of their own, they’re like, ‘We’re trying to have you not have cancer,’” she said. “It just feels like you hit a dead end.”
    • “There is a “humongous provider knowledge gap” when it comes to menopause care, said Dr. Rajita Patil, director of the Comprehensive Menopause Program at UCLA. While demand has exploded, many clinicians are still not up to speed on the full range of treatments, including nonhormonal options, she said.”
  • The American Hospital Association News relates,
    • “A report issued by the Centers for Disease Control and Prevention June 11 found that 15.2% of pregnant women in the U.S. reported current alcohol consumption. The report, which examined 2021-2024 data from the Behavioral Risk Factor Surveillance System, also found that 4.9% of pregnant women reported binge drinking, and 2.2% reported heavy drinking during the past 30 days.” 
  • On the bright side, STAT News tells us,
    • “Infant mortality in the U.S. dropped to a new all-time low in 2025, according to preliminary government data.
    • There were slightly fewer than 5.4 infant deaths per 1,000 live births in 2025, according to the Centers for Disease Control and Prevention.
    • “While that appears to be a small decline from about 5.5 in 2024 and 5.6 in the two years preceding, researchers say it is statistically meaningful and translates to hundreds of fewer infant deaths per year.
    • “It’s difficult to pinpoint what’s driving the recent developments, but “this is an encouraging data point, and we hope that this trend will continue,” said Dr. Michael Warren, chief medical and health officer for the March of Dimes.”
  • The Wall Street Journal informs us,
    • “For years, doctors relied only on written memory tests, invasive spinal taps and expensive imaging to diagnose Alzheimer’s disease. Now, two Food and Drug Administration-cleared blood tests are simplifying the diagnosis.
    • “The tests, from manufacturers Fujirebio Diagnostics and Roche Holding, were cleared last year and look for different versions of tau, a protein that forms into tangles in the brain and can lead to memory loss. Fujirebio’s test also measures a protein called beta-amyloid, which can form sticky plaques that are a hallmark of Alzheimer’s disease and the target of recently approved drugs for the condition. 
    • “These tests, which use different methods and report results in different ways, can help evaluate patients with early signs of cognitive decline, neurologists say, but they aren’t designed to predict Alzheimer’s risk in healthy people. Even if they could, there are no approved treatments to prevent the onset of the disease yet.”
  • Per BioPharma Dive,
    • “Edgewise Therapeutics said its experimental heart disease drug hit the goals of a Phase 2 clinical trial, reducing signs of disease and biological markers in two types of cardiomyopathy and supporting advancement of the medicine into pivotal studies.
    • “The Colorado-based biotechnology company is testing its pill, called EDG-7500, in both the obstructive and non-obstructive forms of cardiomyopathy, seeking to improve blood flow and relieve heart failure symptoms in people whose hearts have thickened and weakened as their disease progressed.
    • “The trial data come two weeks after Edgewise wagered the company’s future on cardiovascular disease by selling off its experimental muscular dystrophy pipeline. In cardiomyopathy, Edgewise will have hefty competition, however, as it would face Bristol Myers Squibb’s Camzyos and Cytokinetics’ Myqorzo in the obstructive form of the disease.”
  • and
    • “Shares of Neumora Therapeutics lost half their value after one of the company’s drugs failed a pair of Phase 3 trials in major depressive disorder. Neumora’s drug navacaprant is part of a class of medicines that target kappa opioid receptors and have been hailed as potential blockbusters. But two prospects — navacaprant and J&J’s aticaprant— have now missed key goals in depression studies, and Neumora said Monday that it plans to end development of its drug altogether. The latest findings are “disappointing but not unexpected,” wrote William Blair analyst Myles Minter in a Monday note to investors. Minter referred to the setback as a “clearing event” that shifts focus to a pipeline that now includes drugs for obesity, schizophrenia and Alzheimer’s disease agitation. Neumora has lost most of its value since going public in 2023.” 

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

  • Beckers Payer Issues reports,
    • “When Katerina Guerraz, Aetna’s COO, stepped into her role in mid-2024, the company was having, by her own admission, a really tough year. Rather than look for incremental fixes, she and her team decided to set a new direction entirely — one focused on fundamentally redesigning how Aetna operates, not just for the company, but for the providers and members it serves.
    • “We completely need a different north star — figure out how do we work differently with providers, how do we really design around the member experience, and then where can, how fast can we accelerate and apply technology for automation, and just have more smart workflows and streamline the work, not just for our constituents, but also for our colleagues,” Ms. Guerraz told Becker’s. “That’s the big difference — how you apply this, so it actually makes the healthcare system better, simpler, and you take a lot of the friction out.”
    • “The result is a sweeping operational push tackling claims processing, workforce training, provider relationships and member navigation — all connected by a single goal: taking friction out of the healthcare system.
    • “The push for real-time claims.”
  • and
    • “ICHRA, reference-based pricing, narrow networks, direct contracting, cash pay — it seems you can’t escape these terms today in the employer health benefits market. Each is traceable back to the same gradual shift happening among the leverage structures that have defined the payer-provider relationship for decades.
    • “Much of that shift is because of a departure from fully insured coverage, in which an employer pays an insurer to take on risk, to self-funded plans, where the employer pays claims directly and hires an insurer to handle the back-end administrative functions. From 2015 to 2025, self-funding among large employers stayed flat at roughly 80%, while the real movement came from small firms, according to KFF. Among small employers, fully self-funded enrollment rose from 17% to 27% over the decade and level-funded coverage (a self-funded variant paired with stop-loss coverage) surged from 7% in 2019 to 37% in 2025.
    • “As employers have taken on more risk and gained more visibility into what their plans actually pay (or at least try to), more scrutiny is arising around the value of insurers’ provider networks and their ability to actually negotiate lower prices.
    • “I don’t think provider networks are disappearing. I think they’re being questioned in ways they weren’t five years ago,” Stacy Mays, a former senior health insurance executive, told Becker’s. Since her time at organizations such as UnitedHealth and Capital Blue Cross, Ms. Mays has gone on to start her own consulting firm, Copeland Road Health Ventures.
    • “Before federal price transparency rules took effect, she said, most employers had little visibility into the rates their plans actually paid and were told that discounts were broadly similar across carriers. The data has since shown otherwise, revealing wide variation across networks and, in some cases, cash prices below contracted rates. If a network’s main value was negotiating better prices, she said, employers and providers are now positioned to see when that may not be the case.
    • “If you look at networks from the employer perspective, you have to ask whether employers are really getting value from a network or whether the network is simply the accepted way that healthcare is organized,” Ms. Mays said.”
  • Beckers Hospital Review lets us know the “days of cash on hand figures for 50 health systems as of March 31, according to their most recent financial reports.”
  • Fierce Healthcare relates,
    • “Telehealth utilization increased 10.1% across the U.S. from the fourth quarter of 2025 to the first three months of 2026, a new report from Fair Health found.
    • “Telehealth utilization, measured as a percentage of medical claim lines, increased from 5.01% of medical claim lines in the fourth quarter of 2025 to 5.51% in Q1 2026. The relative increase was 12% in the Midwest, 11.8% in the Northeast, 9% in the South and 8.1% in the West, Fair Health data indicated.
    • “The percentage of patients with a telehealth claim also increased nationally and in all four regions from the fourth quarter of 2025 to the first quarter of 2026. Nationally, that percentage increased from 17.3% in the fourth quarter to 18.4% in the first quarter, a 6.3% rise. The largest relative increase was in the Northeast, at 7.3%.
    • “The data is part of Fair Health’s newly launched Quarterly Telehealth Regional Tracker, building on data from the non-profit’s National Private Insurance Claims database. The database is built on commercial medical and dental claims from more than 75 contributors nationwide, the company says.”
  • BioPharma Dive tells us,
    • “Continuing a string of acquisitions this year, Eli Lilly said Tuesday it will buy non-opioid pain drug developer 4E Therapeutics.
    • “The deal hands Lilly a pipeline full of experimental pain treatments that 4E says are designed to be non-addictive. The biotechnology company specializes in MNK inhibitors, which go after a variant of enzymes involved in a signaling pathway that translates information outside of the cell to its interior. Its lead asset, “4ET1103,” is in development for nerve damage-related pain and has completed an early trial in humans demonstrating safety.
    • “Other drugs in 4E’s portfolio include experimental treatments for migraines and acute pain. The Austin, Texas-based startup raised just under $10 million across private funding and grants from the National Institutes of Health to advance its drug.
    • “The companies did not disclose the financial terms of the deal.”
  • MedCity News informs us,
    • “AI is rapidly gaining traction in the health insurance industry. But according to one health insurance executive, AI shouldn’t be used for the “sake of AI,” but to empower what the health insurer is trying to accomplish.
    • “During an interview at AHIP 2026 last week, Elevance Health Chief Digital Information Officer Ratnakar Lavu shared the company’s three key priorities for AI:
      • Simplifying and personalizing the member experience
      • Simplifying the provider experience, and
      • Making sure employees have the right information at the right time.
  • STAT News points out,
    • “A biotech is doing something that doesn’t happen enough: Talking about its failure.
    • “Verge Labs, formerly known as Verge Genomics, recently announced that its Phase 1b trial for an ALS drug failed. Now it’s trying to explain why, actually, this was a good thing. The company tells Brittany Trang it used the learnings to develop an artificial intelligence neurology model that predicts which patients are more likely to respond to treatment. The tech could help the company recruit candidates for clinical trials in the future. The new model reflects Verge’s “frontier AI lab” pivot  announced at the end of May.
    • “Read more here.”
  • and
    • “For decades, brain-computer interface research has been confined to small, tightly-controlled experiments in the lab. That era may be coming to a close.
    • “Casey Harrell, a man with ALS whose speech is very difficult to understand,  used a BCI system to communicate at home for more than 3,800 hours over the course of nearly two years. He operated it independently at an average speed of 56 words per minute, according to a study published Monday in Nature Medicine.
    • “Harrell is part of the BrainGate clinical trials, which includes researchers from several institutions and which STAT has written about in the past. His BCI system was developed by University of California, Davis researchers.
    • “Harrell’s not the first person to have a long-term brain implant, and other studies have demonstrated communication rates that more accurately reflect speaking. But experts suggest this study reflects where the field should go, if it wants to ensure the technology will be embraced by both users and regulators.”

Monday Report

David Ermer–ACA, CMS, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NIH, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“In her 1789 book The Female Reader, writer and philosopher Mary Wollstonecraft wrote: “Simplicity and sincerity generally go hand in hand, as both proceed from a love of truth.” (Source: https://tinyurl.com/4fzesrp4)

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. launched GetActive.gov, a new national resource to help Americans improve their health through movement, fitness, outdoor recreation, and active living, during a series of “Take Back Your Health” tour stops across Colorado.
    • “Secretary Kennedy joined Secretary of the Interior Doug Burgum in Grand Junction to announce the initiative and highlight the Trump Administration’s efforts to expand access to public lands and outdoor recreation opportunities. He then visited Fort Carson to see firsthand how the Army is improving nutrition for servicemembers through its campus-style dining modernization program. The Secretary also toured InnovAge in Thornton, where he met with caregivers and seniors participating in the Program of All-Inclusive Care for the Elderly (PACE).
    • “The key to reversing America’s chronic disease epidemic is empowering people to take back their health,” Secretary Kennedy said. “We are helping people Get Active, Eat Real Food, and Live Real Life. From our public lands to our military bases to our senior care centers, these Colorado visits show how we are putting Make America Healthy Again into action.”
  • The American Hospital Association News reports,
    • “The Medicaid and CHIP Payment and Access Commission June 15 released its June 2026 report to Congress. Among the topics discussed, chapter two focuses on automation in Medicaid prior authorization and makes recommendations to improve oversight and increase disclosure and transparency of managed care plans’ use of automation in PA. The third chapter includes recommendations to improve managed care plan accountability. Chapter seven examines Medicaid provider enrollment and managed care credentialing processes and highlights challenges that have effects on provider participation and state administrative burden.”
  • and
    • “The Centers for Medicare & Medicaid Services and the Department of Health and Human Services issued a request for information June 12 seeking input on CMS’ review of the Affordable Care Act’s Essential Health Benefits framework and the requirement that the scope of EHBs is equal to the scope of benefits provided under a standard employer plan. Specifically, CMS is seeking comments on current interpretations of EHBs, state approaches to selecting and updating EHB-benchmark plans, methodologies to determine the scope of benefits included as EHBs, and how those approaches relate to access and market stability under the ACA. The agencies said the information will impact CMS’ evaluation on whether revisions or additions to current EHB regulations would be appropriate. Comments are due by July 15.”
  • BioPharma Dive relates,
    • “New under-the-skin injections of the cancer immunotherapies Keytruda and Opdivo would be subject to Medicare price negotiations at the same time as their intravenous counterparts under a proposed federal rule published Friday.
    • “The Centers for Medicare and Medicaid Services said the rule would close a “loophole” that allows drugmakers to extend the patent-protected life of blockbuster drugs, commonly called “evergreening.” However, Medicare could exempt the newer formulation from its price ceiling should biosimilars of the IV version enter the market and compete on price.
    • “The rule could most immediately affect Keytruda maker Merck & Co. and Opdivo developer Bristol Myers Squibb, along with Halozyme, which developed the delivery technology that helped Opdivo and Johnson & Johnson’s Darzalex transition from IV to subcutaneous shots. Halozyme, however, said it forecasts “zero to minimal impact to its royalty revenues through at least 2035.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration said Monday that it will allow Colorado to import certain prescription drugs from Canada in an effort to bring prices down for residents, making it the second U.S. state to be granted such authorization. 
    • “For more than a quarter of a century, Americans have sought drugs from Canada for relief from the ever-rising costs of medicines, sometimes taking widely publicized bus trips across the border. It wasn’t until 2020, though, that the first Trump administration officially endorsed the practice, when it published a regulationallowing states and Indian tribes to propose import plans. The Biden administration affirmed this rule with an executive order in 2021. And Florida became the first state to earn FDA approval in 2024. 
    • “But state importation programs have proved extremely difficult to carry out, even with bipartisan support. Florida has yet to actually import any drugs from Canada, in part due to pushback from the Canadian pharmaceutical industry and fears the program will affect Canada’s drug supply. In May, the FDA extended its approval by six months to give the state more time to get its program up and running.”
  • Fierce Pharma relates,
    • “Despite prior concerns from the FDA, a regimen involving AstraZeneca’s AKT inhibitor Truqap (capivasertib) has passed muster in a specific population of prostate cancer patients. 
    • “Late last week, the U.S. regulator signed off on Truqap plus Johnson & Johnson’s Zytiga (abiraterone) and prednisone to treat adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer—the indication previously known as metastatic hormone-sensitive prostate cancer—that is determined to be PTEN-deficient.
  • and
    • Merck & Co.’s first-in-class HIF-2 alpha inhibitor Welireg is touching down in the clear cell renal cell carcinoma (ccRCC) treatment space, notching a Keytruda combination nod that stands to pad the landing for the company’s post-Keytruda outlook. 
    • The June 12 FDA approval is the first for a PD-1 and HIF-2a inhibitor combo, stipulating the regimen’s use as an adjuvant treatment for adults with ccRCC who are at intermediate-high or high risk of recurrence following kidney removal surgery. Welireg can be used in the disease setting with standard Keytruda or subcutaneous Keytruda Qlex. 
    • With that, Welireg can reach earlier-stage ccRCC for the first time following its 2023 clearance in advanced RCC, marking an “important step in addressing the needs of patients with earlier-stage renal cell carcinoma,” kidney cancer advocacy group KidneyCan’s CEO and co-founder Bryan Lewis noted in a Merck press release. 
  • Cardiovascular Busines tells us,
    • “Penumbra, a California-based medtech company known for its vascular technologies, has received U.S. Food and Drug Administration (FDA) clearance for a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.
    • “According to Penumbra, Thunderbolt represents the first CAVT device approved in the United States for the treatment of stroke. It is powered by Penumbra’s Engine technology and uses modulated aspiration to “detect, fatigue and completely ingest” blood clots at the site of occlusion. Thunderbolt will be sent to customers prepackaged with one of the company’s catheters.”
  • MedPage Today tells us,
    • “The FDA cleared medical-grade Australian sheep blowfly (Lucilia cuprina) larvae in what maker Cuprina Holdingsopens in a new tab or window believes marks the first debridement product to use this particular species.
    • “Dubbed Medifly Maggots, the product is indicated for removing dead or infected tissue from non-healing necrotic skin and soft tissue wounds — such as pressure or neuropathic foot ulcers — and non-healing traumatic or post-surgical wounds.
    • “A healthcare worker is required to oversee the application of the prescription maggot product, which was cleared based on demonstration of equivalence to the previously cleared medical-grade green bottle blowfly larvae — Lucilia sericata (Medical Maggots).”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has struck down key provisions in a CMS rule overhauling the Affordable Care Act, in a setback for the Trump administration’s push to combat fraud that critics argue is a smokescreen for weakening the exchanges set up by the Obama-era law.
    • “On Friday, Judge Brendan Hurson of the Maryland District Court vacated eight of the rule’s most consequential provisions, including the creation of a $5 premium penalty for individuals who automatically reenroll in coverage and a policy disqualifying people who fail to reconcile tax credits with their income from receiving subsidies.
    • “The decision is not a surprise after Hurson stayed most of the provisions last year. Still, officially tossing them out is a victory for proponents of expanded ACA coverage — though a short-term one, given many of the changes were codified in the GOP’s “Big Beautiful Bill” passed last summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A pregnant woman in rural Arizona with syphillis could have been treated fairly easily with an injection of penicillin. But the drug, Bicillin L-A, is manufactured only by Pfizer, and has been in short supply for a year now — which meant the drug arrived too late to prevent probable congenital syphilis in her newborn.
    • “The syphilis epidemic is worsening, congenital syphilis cases are up roughly 800% since 2012 — and this Bicillin shortage is expected to continue through 2027. Public health officials say Pfizer’s emergency allocation system is confusing and may disadvantage health departments serving low-income patients.
    • “A box of 10 syringes can cost around $8,000, and the drug is manufactured at only one Pfizer plant in Michigan to supply the whole country.
    • “Most shortages are of not-very-profitable drugs,” said Erin Fox, associate chief pharmacy officer at University of Utah Health.”
  • The American Medical Association lets us know what doctors want patientsto know about allergic rhinitis
    • “Allergic rhinitis, or hay fever, is more than just the sniffles. Understanding triggers and when to talk to a physician are key to managing allergic rhinitis.”
  • Per an National Institutes of Health news release,
    • “A clinical trial supported by the National Institutes of Health (NIH) found that adults with prediabetes assigned to a lifestyle intervention had a significantly lower risk of developing multiple chronic health conditions (known as multimorbidity) over time than those assigned to a placebo. This study, which followed participants for over two decades, also found that participants assigned to receive metformin did not experience a statistically significant reduction in multimorbidity risk. The findings, published in JAMA, highlight the lasting benefits of lifestyle programs that may lower risk of the development of chronic conditions.
    • “Multimorbidity is a common issue, and few interventions have been found to prevent or delay developing multiple chronic conditions,” said Marcel Salive, M.D., first author of the study, from NIH’s National Institute on Aging (NIA). “Our work showing that healthy lifestyle intervention can significantly lower the burden of multimorbidity is a step forward in addressing this growing problem.”
  • MedPage Today relates,
    • “COVID-19 vaccines were associated with a lower risk of major adverse cardiovascular events in “a cohort study of veterans.
    • “The 2024-2025 vaccines also demonstrated effectiveness against COVID-associated emergent care, hospitalization, and critical illness among adults.
    • “Among older adults who received a 2025-2026 vaccine, overall COVID vaccine effectiveness against symptomatic disease was 59%.
  • Healio tells us,
    • “Less than a quarter of patients with stroke and fewer than one in seven with traumatic brain injury were discharged to inpatient rehabilitation.
    • “Clinicians should plan for rehabilitation early and make it an intentional part of care.”
  • and
    • “The American College of Physicians (ACP) has published living clinical guidance to help physicians select medications for patients with overweight or obesity.
    • “Unhealthy weight remains a significant public health issue globally, with 68.5% of American adults and 59% of adults worldwide having overweight or obesity, according to Amir Qaseem, MD, PhD, MHA, MGIN, MRCP, FACP, ACP chief science officer and senior vice president of clinical policy at the Centers for Evidence Reviews, and colleagues.
    • “They wrote in Annals of Internal Medicine that first-line treatments for obesity and overweight include physical activity and nutrition, but the new guidance “addresses additional management using pharmacologic treatments when lifestyle modifications alone do not result in optimal weight loss or weight maintenance for a person.”
  • Pharmacy Times informs us,
    • “Pooling ATTAIN-1/2 female participants, menopausal stage–stratified outcomes at 72 weeks included weight, waist circumference, waist-to-height ratio, and categorical weight-loss thresholds using an efficacy estimand. 
    • “Orforglipron [Lilly’s oral GLP-1 drug] achieved statistically significant placebo-adjusted reductions across premenopause, perimenopause, and postmenopause, reaching approximately 14% body-weight loss and up to 11 cm waist reduction (P<.001). 
    • “Clinically meaningful responder rates favored orforglipron, with up to 83% achieving ≥5% weight loss vs 23% on placebo, and higher rates across ≥10%, ≥15%, and ≥20% thresholds. 
    • “More participants shifted to lower waist-to-height ratio categories on active therapy, supporting potential visceral adiposity and cardiometabolic risk mitigation in menopause-associated fat redistribution. 
    • “Unrestricted oral administration (no food/water requirements) may reduce adherence barriers in midlife women with polypharmacy, strengthening pharmacist-led counseling and referral pathways in obesity care.”
  • BioPharma Dive points out,
    • “An experimental drug that Eli Lilly recently picked up through a potentially multibillion-dollar acquisition appears to have passed its first major test, scoring positive results in a small study of patients with hard-to-treat blood cancer.
    • “Originally developed by Ajax Therapeutics, the drug inhibits an enzyme that spurs blood cell production. Several medicines that block this “JAK2” enzyme, including Incyte’s Jakafi, are already on the market, where they’re mostly used in rare, chronic blood cancers like myelofibrosis. While these medicines can be quite effective at treating symptoms, many patients either don’t respond or stop taking them because their disease progresses or they can’t tolerate the side effects, which range from nausea and fatigue to anemia and increased stroke risk.
    • “Lilly’s pill is designed to work in a slightly different way than its approved counterparts, binding to JAK2 in the “inactive” state. Researchers hypothesize this change should make for a superior therapy that also overcomes drug resistance challenges.
    • That idea now has more support thanks to data presented over the weekend at a major medical meeting in Europe.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. will launch a new line of commercial health plans called Edge across all five of its Blue Cross Blue Shield states beginning in 2027.
    • “The plans, powered by a proprietary plan design called Easify, have no deductibles and no coinsurance for in-network care, leaving members with fixed copays, according to a June 11 news release. 
    • “HCSC said the PPO plans aim to let employees in Illinois, Texas, Oklahoma, Montana and New Mexico anticipate out-of-pocket costs more easily and help employers better manage total medical spend. HCSC also said the new product will steer members toward “high-value” care using behavioral incentives.” 
  • Beckers Hospital Review relates
    • “Middle-age adults who use GLP-1 medications for obesity could save an average of $192,735 in lifetime medical costs, according to a study published in June by the National Bureau of Economic Research. 
    • “Researchers from Los Angeles-based University of Southern California simulated health and economic outcomes for U.S. adults ages 25 and older, comparing lifetime trajectories for people who used GLP-1s for obesity with those who did not. Obesity was defined as a body mass index higher than 30.”
  • and
    • “Virtual nursing for hospital discharge was associated with sharply lower 30-day emergency department readmissions across nine hospitals in a major Southeastern U.S. health system, according to a study published in npj Digital Medicine.
    • “Researchers at the University of North Carolina at Chapel Hill compared 4,662 discharges handled by remotely located virtual nurses with 4,662 traditional in-person discharges, matched on patient and hospital characteristics. Patients discharged through virtual nursing returned to the ED within 30 days at a rate of 3.7%, versus 13.3% for in-person discharge — a 72% relative reduction, or a risk ratio of 0.28. That works out to roughly 1 readmission in 27 virtual-nursing patients, compared with 1 in 8 receiving standard discharge.
    • “The effect held in both settings, with the gap widest in rural hospitals: 3.1% versus 17.9% rural, and 4.1% versus 10.7% urban.
    • “Virtual nurses delivered structured, uninterrupted discharge education — medication reconciliation, teach-back, and care-plan review — from an off-site center operating 7 a.m. to 7 p.m., seven days a week. The health system rolled out the model across the nine hospitals between 2022 and 2024.”
  • MedTech Dive informs us,
    • “Medtronic said Friday it has completed the $550 million takeover of neurovascular technology company Scientia Vascular.
    • “The deal, which Medtronic disclosed in March, covers guidewire technologies for stroke that are designed to equip physicians to access hard-to-reach parts of the brain.
    • “Buying Scientia will enable “every neurovascular procedure to start with Medtronic,” CEO Geoff Martha said on an earnings call with investors this month.”
  • Medical News Today points out,
    • Three AI-based mammography systems were able to identify subtle signs of future breast cancer years before diagnosis, with elevated cancer prediction scores seen in those who later developed the disease. 
    • In the study, approximately 20% of breast cancer cases showed AI-detectable mammographic changes as early as 6 years before diagnosis. 
    • At 90% specificity, the AI systems flagged potential future cancers in up to 19.7% of women 6 years before diagnosis, 25.2% 4 years before diagnosis, and 39.3% 2 years before diagnosis. 
    • The findings suggest AI could support earlier breast cancer detection and help enable more personalized screening strategies by identifying females who may benefit from closer monitoring or earlier intervention.
  • FYI, The Blue Cross Blue Shield Association has a job opening on its Legal Team supporting FEP.

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.”

Midweek update

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “Republican James Gallagher took the oath of office Wednesday, filling the seat of the late Rep. Doug LaMalfa in California’s 1st District and giving House leaders some breathing room in what has been a tumultuous year of deaths and resignations in Congress. 
    • “A former state Assembly GOP leader, Gallagher ran with endorsements from President Donald Trump and congressional leadership, easily winning the June 2 special open primary for the remainder of LaMalfa’s term. 
    • “Gallagher gives the House GOP another vote after the April resignation of Texas Rep. Tony Gonzales. Democrats have seen several recent departures of their own, including two scandal-driven resignations and the unexpected death of Georgia Rep. David Scott. 
    • “The addition of Gallagher bumps up the GOP’s hold on the majority to six, including California Rep. Kevin Kiley, who is an independent but caucuses with Republicans.”
  • Federal News Network informs us,
    • “House appropriators are backing the Trump administration’s proposed pay raise for troops in fiscal 2027 as part of a $1.1 trillion defense spending bill released Wednesday.
    • “Military service members could see their paychecks grow by 5% to 7%, depending on their rank. Enlisted troops, particularly those at the lowest levels, would receive the largest raises.”
  • The American Hospital Association News relates,
    • :The House Appropriations Committee June 9 approved their version of the FY 2027 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies by a 34-28 vote. The bill provides a total discretionary allocation of $110.8 billion for HHS, representing roughly $4 billion, or 4%, below the FY 2026 enacted level. Within that total, the Health Resources and Services Administration was allocated $8.35 billion, marking an $873 million decrease overall. However, the agency provided $1.44 billion for workforce initiatives, a roughly $25 million increase, and $576 million for rural health, marking a $158 million increase. 
    • “The bill also maintains funding for Children’s Hospitals Graduate Medical Education ($400 million), National Institutes of Health ($48.8 billion), as well as other key initiatives within the healthcare workforce, behavioral health, and maternal and child health programs. The committee recommended $70 million, a $237 million decrease, for the Hospital Preparedness Program. The Senate Appropriations Committee will release its version of the FY 2027 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies at a later date.”
  • and
    • “The AHA provided a statement to the House Energy and Commerce Subcommittee on Health today for a hearing titled “Lowering Health Care Costs for All Americans: Examining Policies to Increase Health Care Transparency.” Lawmakers considered a range of legislative proposals, including a measure to codify existing price transparency regulations for hospitals and health plans, a bill requiring hospitals to post pricing physically on their walls, a bill requiring health insurers to share overhead costs and claim payments, a measure requiring insurers to publicly display claim denial rates and more. 
    • “The hospital field takes transparency compliance seriously, and we want to continue the work of providing patients with essential information on their care,” the AHA wrote. “We would caution, however, against codifying regulations that do not meet the goals sought by either patients or health care purchasers and instead result in ‘transparency in name only.’ Before Congress considers additional legislative solutions, it will be important to understand how existing policies are performing, as well as the tremendous financial costs of compliance, to ensure that any future policymaking retains what is working and improves upon what is not delivering true transparency.”
  • and
    • “The Hospital Insurance Trust Fund has been projected to become insolvent in 2033, according to the Medicare Board of Trustees’ annual report released June 9. The fund pays benefits under Medicare Part A, which covers inpatient hospital services, care provided by skilled nursing facilities, home health care and hospice care. The projections assume that the trust fund will receive lower levels of revenue due to recent tax law changes. “The projections in this year’s report continue to demonstrate the need for timely and effective action to address Medicare’s remaining financial challenges — including the HI trust fund’s projected depletion, this fund’s long-range financial imbalance, and the rapid growth in Medicare expenditures,” the trustees wrote.” 
  • MedCity News adds,
    • “CMS Administrator Dr. Mehmet Oz is optimistic about Washington’s ability to bend the healthcare cost curve, he said during a Tuesday address at the HFMA Annual Conference in National Harbor, Maryland.
    • “It’s not all rosy, but there’s some opportunities. As a clinician, I’ll tell you, if you have an opportunity to fix a problem, it gives you more hope than if you think the issue is terminal. We’re definitely not terminal,” he declared.
    • “During his talk, Dr. Oz outlined a few key areas that CMS is targeting to make healthcare more affordable. Below are the main pillars of the agency’s affordability agenda.”
      • Fraud, waste and abuse
      • Drug pricing reform
      • Tech modernization
      • Preventive health and nutrition
      • Deregulation
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced a new series of initiatives to combat fraud, waste, and abuse across the Federal Employees Health Benefits (FEHB) Program and Postal Service Health Benefits (PSHB) Program. OPM is undertaking this effort as part of its ongoing work with the White House Task Force to Eliminate Fraud, led by Vice President JD Vance.
    • “President Trump has made eliminating fraud, waste, and abuse across the federal government a top priority,” OPM Director Scott Kupor said. “Working alongside the White House Task Force to Eliminate Fraud, OPM is taking additional steps to safeguard the premiums paid by federal employees and taxpayers, protect beneficiaries, and ensure health insurance companies are meeting the highest standards of accountability.” * * *
    • “OPM is also building a data science and audit team that will review de-identified claims data in partnership with the OPM Office of Inspector General to proactively identify cases of fraud, waste, and over-billing. This will end the practice of relying upon retrospective reviews of data to find and address fraud and will be a proactive approach in identifying problems as they arise and implementing corrective mechanisms that save hard-earned premium dollars paid by federal employees.”
  • The FEHBlog expects that OPM will find that FEHB and PSHB carriers are doing a good job preventing fraud waste and abuse because they hold the insurance risk, not the federal government.
  • Fedscoop tells us,
    • “The Office of Personnel Management on Wednesday awarded its anticipated contract to modernize and consolidate federal human resources functions to Oracle, capping a process that’s been over a year in the making. 
    • “The nearly $400 million award puts Oracle in charge of a process to bring over 100 HR systems under one single platform that the agency is calling its Core Human Capital Management system. OPM says it believes the project will make significant reductions in the overall cost of HR platforms to taxpayers.
    • “Historically, federal agencies have relied on fragmented, aging HR systems that are costly to maintain and difficult to scale,” OPM Director Scott Kupor said in a written statement included in a press release. 
    • “He called the award “a foundational investment in the future of federal workforce management.”
  • OPM Director Scott Kupor, writing in LinkIn, adds a post about this contact award to his Secrets of OPM blog.
  • STAT News points out,
    • “The National Institutes of Health has appointed researcher John Powers III to lead its infectious disease institute on an acting basis, after weeks of being in leadership limbo following reports that the previous director, Jeffery Taubenberger, had stepped down.
    • “The appointment of Powers, previously a senior adviser at the National Institute of Allergy and Infectious Diseases and Taubenberger’s deputy, comes at a moment of heightened attention for the institute.
    • “The NIH’s second-largest agency, responsible for $6.5 billion worth of funding, has been without a permanent leader since the ousting of Jeanne Marrazzo last March. In recent weeks, a handful of other top leaders have also been reassigned to other posts, causing lawmakers to express concern about the bench of infectious disease expertise at a time of alarm over the recent hantavirus outbreak and the Ebola outbreak in Central Africa.” 

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA issued a drug safety communication approving a label change that warns about the risk of kidney stones or kidney injury with the over-the-counter (OTC) weight loss drug orlistat (Alli), the agency saidopens in a new tab or window Wednesday.
    • “The label now recommends that consumers with a history of kidney disease or kidney stones consult a healthcare provider before using the drug.
    • “The FDA advised clinicians to inform patients about reports of acute kidney injury (AKI), hyperoxaluria, calcium oxalate nephrolithiasis, or oxalate nephropathy linked to orlistat. Patients should also stop taking the drug if they develop symptoms like back or groin pain, painful urination, blood in urine, feet or leg swelling, or less frequent urination.”
  • Per a Lilly news release,
    • “Eli Lilly and Company (NYSE: LLY) announced today [June 9] that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of EBGLYSS (lebrikizumab-lbkz) for subcutaneous use in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis. EBGLYSS is already approved for a once-monthly maintenance dose, with long-term data showing durable disease control. Now, EBGLYSS gives patients with moderate-to-severe atopic dermatitis the option to manage their condition with as few as six maintenance injections per year.1
    • “Today’s approval builds on EBGLYSS’ established long-term durability, with a new option for one maintenance dose every eight weeks. For people living with moderate-to-severe atopic dermatitis, that means a treatment they only need to take as few as six times a year—without prescription topicals from the start,” said Adrienne Brown, executive vice president and president of Lilly Immunology. “EBGLYSS now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis.”

From the judicial front,

  • Per a Justice Department news release,
    • “Ahold Delhaize USA Inc. (Ahold Delhaize), headquartered in Quincy, Massachusetts, has agreed to pay the United States and participating states a total of $40 million to resolve allegations that it violated the False Claims Act and state analogs by reporting inflated “usual and customary” prices on claims to federal healthcare programs.” * * *
    • “The United States alleged that Ahold Delhaize supermarkets with in-store retail pharmacies – including supermarket chains operating under the names Giant, Hannaford, Stop & Shop, Food Lion, and others – operated prescription savings programs pursuant to which enrolled members received discounted prices on prescription drugs. The United States contends that, in light of the features and operations of those savings programs, and the applicable Medicare Part D, Medicaid, and TRICARE program requirements (including, where applicable, contractual requirements), the discounted prices should have been reported as “usual and customary” prices on claims submitted to Medicare Part D, Medicaid, and TRICARE. Reported “usual and customary” prices serve as ceiling prices on payments to pharmacies under the applicable healthcare program payment formulas. The United States contends that Ahold Delhaize pharmacies failed to accurately report their discounted prices as their “usual and customary” prices on claims to Medicare Part D, Medicaid, and TRICARE, causing those programs to pay inflated amounts on such claims.”
  • Modern Healthcare reports,
    • “Clover Health received higher Medicare Advantage star ratings following a legal victory against the Centers for Medicare and Medicaid Services.
    • “The health insurer estimated that revised quality scores would trigger $120 million in bonus payments.
    • “CMS also instructed Clover Health to resubmit its bids for the 2027 plan year.
    • “The court ruling may affect similar cases from CareFirst BlueCross BlueShield and Humana.”

From the public health and medical / Rx research front,

  • Health Day reports,
    • “The kids are not all right, at least in the United States, according to a new report showing a nosedive in children’s well-being from 2019 to 2024.
    • “In 29 states, the overall U.S. score fell from 553 to 547 on a 1,000-point scale, a decline that surpasses pre-pandemic numbers, the report found.
    • “This score measures children’s well-being across four categories: economic well-being, education, health, and family and community, according to the Anne E. Casey Foundation’s 2026 Kids Count Data Book.
    • “Here are some notable findings:
      • “Eleven of 15 states that saw the greatest gains in children’s well-being were in the South. South Carolina had the largest spike of any state, 38 points.
      • “Five of the seven states with the largest declines in well-being were in the Northeast, led by Maine.
      • “Scores among the West were widely varied – ranging from 281 in New Mexico to 759 in Utah, which fared at the top in the region.
      • “Four Midwestern states — Nebraska, North Dakota, Iowa and Minnesota — followed behind Maine for the biggest drops in kids’ well-being.”
  • and
    • “Those who prefer to go to sleep later report poorer mental health, which is partially explained by greater reported loneliness, according to a study presented at SLEEP 2026, the annual meeting of the Associated Professional Sleep Societies, held from June 14 to 17 in Baltimore.
    • “Alec Harlow, from Brigham Young University in Provo, Utah, and colleagues examined how chronotype, nocturnal loneliness, and general loneliness relate to mental health. The analysis included 442 survey participants.” 
  • and
    • “Researchers found no clear increase in pregnancy risks found with first-trimester GLP-1 exposure
    • “The findings may reassure women with unintentional early pregnancy GLP-1 use
    • “Although the results are encouraging, the data were less precise for rare outcomes, so additional studies are needed.”
  • STAT News relates,
    • “The American College of Obstetricians and Gynecologists has released a recommended vaccine schedule for pregnant people, one that diverges from the advice currently offered by the Centers for Disease Control and Prevention.
    • “ACOG is recommending four vaccines be routinely administered during pregnancy, with several other vaccines recommended under certain circumstances. The new schedule is endorsed by 13 medical societies and health organizations.
    • “Changing national recommendations coupled with rampant vaccine misinformation are resulting in confusion for both patients and health care professionals,” ACOG President Camille Clare said in a press release. “It is incredibly important for the public to have access to reliable, evidence-based information on maternal immunizations from a trusted source. ACOG is proud to be that source.” 
    • “The current CDC vaccine schedule for pregnant people includes only two recommendations, one for a vaccine to protect against tetanus, diphtheria, and pertussis, known as Tdap, and one to generate protection against respiratory syncytial virus, or RSV, in the developing fetus.” 
  • MedPage Today notes,
    • “Despite being more commonly diagnosed in women ages 40 or younger, an estimated 10% to 15% of early triple-negative breast cancer (TNBC) cases are diagnosed in patients over 70.
    • “Current guidelines recommend the use of adjuvant chemotherapy in early-stage TNBC regardless of a patient’s age; however, recent data published in JAMA Network Open indicated that underutilization of adjuvant chemotherapy may have contributed to worse outcomes in this patient population in the past.
    • “When we use these treatments for elderly patients it is a very well-known fact that most of the time we undertreat,” said Ahmed Elkhanany, MD of Baylor College of Medicine in Houston. “This may lead to a decrease in their outcomes compared with other patients.”
  • The Wall Street Journal points out,
    • “Sanofi stopped a late-stage study of its experimental drug, riliprubart, for a rare immune disorder due to insufficient efficacy.
    • “The decision marks an early setback for Sanofi’s newly appointed Chief Executive Belen Garijo, who took office last month.
    • “Sanofi will evaluate continuing other riliprubart studies and expects no significant cost or change to its 2026 guidance.”

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

  • Fierce Healthcare reports,
    • “CAQH has rebranded as DataSpring, a name leaders say reflects the organization’s push toward a more modern and innovative future.
    • “The Council for Affordable Quality Healthcare was founded more than 25 years ago and has evolved from its initial mission to make healthcare work better for patients, now offering critical data services to both providers and payers. 
    • “The DataSpring name “reflects the organization’s central role in delivering a connected healthcare ecosystem through accurate, authorized data from providers and payers,” per an announcement. The group announced the rebrand at the AHIP 2026 conference this week, with signage across Las Vegas reflecting the new identity.”
  • and
    • “Despite steady demand for obesity medications, 49% of payers who do not currently cover GLP-1s for obesity would not do so at any price, a new report from Pharmaceutical Strategies Group (PSG) found. 
    • “The 2026 Trends in Drug Benefit Design report drew insights from a survey of 237 benefits leaders across employers, health plans and unions. 
    • “Nine in 10 respondents in the survey report being moderately or very concerned about the affordability of GLP-1 medications. Moreover, 72% report discontinuation rates are at least moderately influential in coverage decisions. 
    • When asked the top reason for excluding coverage for obesity, 45% report coverage is too expensive for all members who would be prescribed the medication. Other factors include view of the medications as lifestyle drugs (24%), ongoing cost exposure (18%) and high discontinuation rates resulting in a lack of ROI (5%). Analysts note 9% of respondents selected “other” and described different reasons for excluding coverage.
  • Healthcare Dive tells us,
  • The American Medical Association shares highlights from the Association’s House of Delegates meeting.
  • The Wall Street Journal informs us,
    • “Johnson & Johnson aims to be the No. 1 oncology company by 2030, with its CEO stating a cure for some cancers is a realistic goal.
    • “J&J agreed to acquire biotech company Firefly Bio for $1 billion in cash, adding new cancer-fighting platforms to its portfolio.
    • “Artificial intelligence is helping J&J develop medicines faster, though its impact on the company’s bottom line is yet to be seen.”
  • The Health Care Cost Institute lets us know,
    • “Total spending on a health care service is the result of the price of that service and how frequently it is used.  High spending could be the result of high prices, high utilization, or both. Within imaging, the highest priced service (MRI) was one of the less commonly used. The most frequently used imaging service (x-rays), in contrast, was the lowest price service. It could stand to reason, then, that they would be the imaging services with the most spending.   
    • “Instead, in 2022, the imaging category with the highest spending per person was CT scans ($116 in 2022). CT scans were the second highest priced service, and only the third most commonly used service.  Ultrasounds were the service with the next highest spending per person ($113). They were the second lowest priced imaging service but were the second most commonly used service. X-rays made up the third highest spending per person in 2022 ($112). X-rays were the most used imaging service and the least expensive.”
  • Per Fierce Healthcare,
    • “Almost two-thirds of Americans who have asked artificial intelligence tools for medical advice acted on the guidance without consulting a doctor, an eHealth survey of more than 1,000 people found.
    • “Half of respondents had turned to AI for medical advice. More than four-fifths of AI users said they trust the medical advice the tools provide, with 29% of Americans saying they have complete faith in the outputs. EHealth found 17% of AI users mostly distrust the medical advice the technology provides, while 1% completely distrust the outputs.
    • “While a minority of people using AI for medical advice are skeptical of the tools’ outputs, most users are confident enough in the information to use the technology to shape their care decisions. More than 70% of AI users changed their decision to seek medical care based on a tool’s medical advice. The figure includes 36% of AI users who opted against seeking medical care based on the advice.” 

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.

Friday Report

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

Simplicity is a virtue

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the American Society of Clinical Oncology conference front,

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

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

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