Monday report

U.S. Healthcare

Monday report

David Ermer–CMS, Congress, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC.

  • The Wall Street Journal reports,
    • “Senate Republicans trudged through a marathon session Monday, aiming to pass the party’s “big, beautiful bill” and move the legislation one step further toward President Trump’s desk ahead of lawmakers’ self-imposed July 4 deadline.
    • “Voting on amendments and procedural motions started midmorning and dragged through the day as Republican leaders worked to find a balance of policies that could pass both the Senate and later the House. Trump spoke with congressional leaders by phone, and the White House said it was confident that the bill was on track even as its fate and final content remained uncertain.” * * *
    • “A final Senate vote could come late Monday or early Tuesday. If it passes, the measure would then move back to the House, where Republicans have a 220-212 majority. Moderate House Republicans argue that the Senate cut Medicaid too deeply. Others warn that the Senate is violating the House’s target that keeps tax cuts at most $2.5 trillion larger than spending cuts.” 
  • Modern Healthcare reports,
    • “Home health companies stand to lose more than $1 billion in Medicare payments under a proposed rule the Centers for Medicare and Medicaid Services published Monday.
    • “The proposed changes would represent a decrease of 6.4%, or $1.14 billion, in Medicare payments to home health agencies in 2026 compared with 2025, CMS said in a fact sheet.
    • “The proposed home health prospective payment system update includes a 2.4%, or $425 million, increase, which is offset by a 3.7%, or $655 million, decrease reflecting a proposed behavior adjustment required by statute. It also includes a 4.6%, or $815 million, decrease that reflects a proposed temporary adjustment and an estimated 0.5%, or $90 million, decrease based on a proposed update to the fixed dollar loss ratio.”
  • Per a CMS announcement,
    • “On June 30, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2026. This proposed rule would also update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2026 and proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2026, CMS is proposing to increase the ESRD PPS base rate to $281.06, which CMS expects would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 1.9%. The CY 2026 ESRD PPS proposed rule also includes a proposed payment adjustment for certain non-labor costs for ESRD facilities located in Alaska, Hawaii, and the United States (U.S.) Pacific Territories. 
    • “CMS is proposing shortening the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey to 39 questions, removing 23 questions, and eliminating three health equity reporting measures from the ESRD QIP. Additionally, CMS is seeking input on health IT use in dialysis facilities; and input on future measure concepts. CMS also is proposing the early termination of the ESRD Treatment Choices Model.”
  • The public comment deadline for both rules is sixty days after publication in the Federal Register.
  • Per another CMS announcement,
    • “The Justice Department today announced the results of its 2025 National Health Care Fraud Takedown, which resulted in criminal charges against 324 defendants, including 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals, in 50 federal districts and 12 State Attorneys General’s Offices across the United States, for their alleged participation in various health care fraud schemes involving over $14.6 billion in intended loss. The Takedown involved federal and state law enforcement agencies across the country and represents an unprecedented effort to combat health care fraud schemes that exploit patients and taxpayers.
    • “Demonstrating the significant return on investment that results from health care fraud enforcement efforts, the government seized over $245 million in cash, luxury vehicles, cryptocurrency, and other assets as part of the coordinated enforcement efforts. As part of the whole-of-government approach to combating health care fraud announced today, the Centers for Medicare and Medicaid Services (CMS) also announced that it successfully prevented over $4 billion from being paid in response to false and fraudulent claims and that it suspended or revoked the billing privileges of 205 providers in the months leading up to the Takedown. Civil charges against 20 defendants for $14.2 million in alleged fraud, as well as civil settlements with 106 defendants totaling $34.3 million, were also announced as part of the Takedown.
    • “Today’s Takedown was led and coordinated by the Health Care Fraud Unit of the Department of Justice Criminal Division’s Fraud Section and its core partners from U.S. Attorneys’ Offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), the Federal Bureau of Investigation (FBI), and the Drug Enforcement Administration (DEA). The cases were investigated by agents from HHS-OIG, FBI, DEA, and other federal and state law enforcement agencies. The cases are being prosecuted by Health Care Fraud Strike Force teams from the Criminal Division’s Fraud Section, 50 U.S. Attorneys’ Offices nationwide, and 12 State Attorneys General Offices.”
  • The Washington Post shares some details about the Takedown.
  • The GAO issued a report today titled “Highlights of a Forum: Reducing Spending and Enhancing Value in the U.S. Health Care System.”
    • “Health care spending per capita is higher in the U.S. than in any other high-income country. Yet, people living in the U.S. don’t live as long in comparison and are more likely to die of conditions that can be prevented or treated.
    • “To find ways to help address this disparity, we convened a forum in October 2024. Experts from government, academia, and industry identified changes to the health care system that could lower costs and improve patients’ outcomes. These include improving primary care, expanding the health care workforce, and reforming health care pricing and payments.”

From the judicial front,

  • The Supreme Court accepted the Solicitor General’s recommendation by declining to review a U.S. Court of Appeals for the 10th Circuit pro-ERISA preemption opinion captioned PCMA v Mulready (S. Ct. No 23-1213). What’s good for ERISA preemption is good for FEHB preemption.

From the public health and medical research front,

  • Health Day reports,
    • “A person’s body fat percentage provides a better estimate of their risk for early death than their body mass index (BMI), a new study says.
    • “People with a high body-fat percentage were 78% more likely to die within 15 years from any cause and 3.6 times more likely to die from heart disease, researchers reported June 24 in the Annals of Family Medicine.
    • “On the other hand, BMI — an estimate of body fat based on height and weight — was not associated with a statistically significant higher risk of death from any cause, researchers found.
    • “Waist circumference also proved to be more accurate than BMI in assessing the risks posed by excess weight, researchers added.
    • “This is a game changer for body composition assessment,” lead researcher Arch Mainous III, a professor of health services, management and policy at the University of Florida, said in a news release.”
  • The American Medical Association lets us know what doctors wish patients knew about cosmetic dermatology.
  • Endocrinology Advisor tells us, “Compared with self-monitoring, continuous glucose monitoring did not improve obstetric or neonatal outcomes among women with gestational diabetes.”
  • Per Medscape,
    • The American College of Gastroenterology (ACG) has issued updated guidance on the management of Crohn’s disease (CD) that reflects the surge in development of therapeutic options available since 2018, when the last guideline was published.
    • These newer treatment options include interleukin-23 (IL-23) blockers risankizumab, mirikizumab, and guselkumab; the anti-IL-12/23 agent ustekinumab; the Janus kinase inhibitor upadacitinib; and the anti-integrin vedolizumab.
    • The intent of the guideline is to suggest “preferable approaches” to CD management established through “interpretation and collation of scientifically valid research, derived from extensive review of published literature,” said the writing group, led by Gary Lichtenstein, MD, director, Inflammatory Bowel Disease Center, Hospital of the University of Pennsylvania, Philadelphia.
  • Per a National Institutes of Health press release,
    • “Scientists at the National Institutes of Health (NIH) have found that two common types of hormone therapy may alter breast cancer risk in women before age 55. Researchers discovered that women treated with unopposed estrogen hormone therapy (E-HT) were less likely to develop the disease than those who did not use hormone therapy. They also found that women treated with estrogen plus progestin hormone therapy (EP-HT) were more likely to develop breast cancer than women who did not use hormone therapy. Together, these results could help to guide clinical recommendations for hormone therapy use among younger women.
    • “The two hormone therapies analyzed in the study are often used to manage symptoms related to menopause or following hysterectomy (removal of uterus) or oophorectomy (removal of one or both ovaries). Unopposed estrogen therapy is recommended only for women who have had a hysterectomy because of its known association with uterine cancer risk.
    • “Hormone therapy can greatly improve the quality of life for women experiencing severe menopausal symptoms or those who have had surgeries that affect their hormone levels,” said lead author Katie O’Brien, Ph.D., of NIH’s National Institute of Environmental Health Sciences (NIEHS). “Our study provides greater understanding of the risks associated with different types of hormone therapy, which we hope will help patients and their doctors develop more informed treatment plans.”
  • The Wall Street Journal reports,
    • “Moderna said Monday its seasonal influenza vaccine candidate, mRNA-1010, showed superior efficacy in a Phase 3 study that compared it with a licensed standard-dose seasonal flu vaccine in adults aged 50 years and older.
    • “MRNA-1010 achieved the most stringent superiority criterion prespecified in the study protocol, with a relative vaccine efficacy of 26.6% in the overall study population, Moderna said.
    • “Subgroup analyses confirmed a consistently strong relative vaccine efficacy point estimate across age groups, risk factors and previous influenza vaccination status, it said. In participants aged 65 years and older, mRNA-1010 demonstrated a relative vaccine efficacy of 27.4%.
    • “The severity of this past flu season underscores the need for more effective vaccines,” Moderna Chief Executive Stephane Bancel said.”
  • BioPharma Dive points out the top 10 clinical trials to watch in the second half of 2025.
    • “Expected readouts in obesity, lung cancer and atopic dermatitis headline a series of study results that could give the biotechnology sector a boost in another down year.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “Clear answers to questions are the top driver of members’ experience with their insurers, according to a report from Forrester. 
    • “The research firm scored insurers on the brand experience index, which measures customers’ and noncustomers’ brand perception, and customer experience index, which rates customer service and loyalty. 
    • “The health insurance industry had the lowest overall consumer ratings of the 10 industries studied by Forrester. 
    • “Based on consumer responses, Forrester rated answering questions with clear answers as the top driver of customer experience. Across the industry, 60% of consumers said their insurer answered questions clearly. CareFirst BlueCross BlueShield, the industry leader in this category, scored 71%. 
      • “Here are the five other key drivers of total experience for insurers, and insurers’ average scores, according to Forrester:
      • “Keeps personal and financial information secure: 54% 
      • “Helps manage care: 53% 
      • “Offers needed healthcare plans and services: 59% 
      • “Resolves problems on the first call: 56% 
      • “Has a website that meets customers’ needs: 58%” 
  • Modern Healthcare reports,
    • “OptumRx is removing prior authorization mandates for more drugs. 
    • “So far this year, the pharmacy benefit manager has eliminated reauthorizations for 140 medications patients use to treat chronic conditions, the UnitedHealth Group subsidiary said in a news release Monday. Insurance companies and PBMs require patients and clinicians to obtain reauthorizations for some drugs in cases of long-term safety concerns or potential dosing changes. Beginning Tuesday, OptumRx will cut prior authorizations for another 60 medications that treat seven chronic conditions, including HIV, high cholesterol, hypertension and and others. 
    • “Eliminating reauthorization requirements for established and effective treatments underscores our commitment to make these needed drugs more accessible, which also supports better health outcomes,” Dr. Sumit Dutta, chief medical officer, said in the release.”
  • OptumRx, writing in LinkedIn, discusses taking action against drug price hikes.
  • Healthcare IT News notes, “Taking a patient history upfront via telemedicine has been very fruitful for the high-demand specialty provider [the Kennedy-Krieger Institute]. By combining history via virtual care with a then more limited in-person visit, care can be delivered more efficiently to more patients.”
  • Per Beckers Hospital Review,
    • “Nearly 800 rural U.S. hospitals are at risk of closure due to financial problems, with about 40% of those hospitals at immediate risk of closure.
    • “The count is drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through June 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure. * * *
    • [The article] includes a state-by-state listing of the number of rural hospitals at risk of closure in the next six to seven years and at immediate risk of closure over the next two to three years. 
  • BioPharma Dive reports,
    • “Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion, the companies announced Monday. 
    • “The acquisition will hand AbbVie access to technology developed by Capstan that uses small fatty spheres known as lipid nanoparticles to deliver into the body genetic instructions able to engineer specific cells. It’s an ambitious scientific approach that blends the science behind CAR-T cell therapy with that of messenger RNA vaccines.
    • “Capstan is a few weeks removed from dosing the first patient in a Phase 1 trial of its lead drug candidate, which it’s testing as treatment for B cell-mediated autoimmune diseases. Dubbed CPTX2309, the therapy is designed to reprogram immune T cells to target a protein called CD19 that’s commonly found on B cells.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump stuck to his July 4 deadline for Republicans’ tax-and-spending megabill while signaling there might be some wiggle room as GOP senators struggled to resolve disagreements over Medicaid cuts and other provisions.
    • “Senators said they were aiming for an initial procedural vote as early as noon Saturday, which would let them pass the bill sometime Sunday. Before that, they are aiming to release the final text of the bill and ensure that it can work procedurally in the fast-track process they are using for the party-line legislation.
    • “As of Friday afternoon, Senate Republicans were still negotiating details over the state and local tax deduction, considering a new proposal to set the cap at the House-preferred level of $40,000 for five years before it shrinks. They are also debating changes to Medicaid, including limits on state-financing mechanisms that could squeeze rural hospitals—and a rural-hospital fund to mitigate the effects of their plans. 
    • “Asked at a press conference if he was sticking with his Independence Day target, Trump said: “It’s not the end-all. It could go longer, but we’d like to get it done.”
  • Federal News Network tells us,
    • “A bipartisan bill to revise the rules for federal workers’ compensation cases unanimously advanced out of a House committee this week. The legislation would revise the Federal Employees’ Compensation Act to allow physician assistants and nurse practitioners to treat feds in workers’ compensation cases. A previous version of the bill passed the House in 2022, but did not clear the Senate. Cosponsors of the bill say they’re hopeful it will pass both chambers this Congress.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is announcing a new Innovation Center model aimed at helping ensure people with Original Medicare receive safe, effective, and necessary care. Through the Wasteful and Inappropriate Service Reduction (WISeR) Model, CMS will partner with companies specializing in enhanced technologies to test ways to provide an improved and expedited prior authorization process relative to Original Medicare’s existing processes, helping patients and providers avoid unnecessary or inappropriate care and safeguarding federal taxpayer dollars. This model builds on other changes being made to prior authorization as announced by the U.S. Department of Health and Human Services and CMS on Monday.” * * *
    • “To view the Model Overview fact sheet, visit: https://www.cms.gov/files/document/wiser- fact-sheet.pdf.
    • “For more information on the WISeR Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/wiser.
    • “The WISeR Model can be seen on the Federal Register at: https://www.federalregister.gov/d/2025-12195.
  • Fierce Pharma informs us,
    • “Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now.
    • “The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved BCMA- and CD19-directed CAR-T therapies, the agency said Thursday.
    • “Existing commercial CAR-T products, including Bristol Myers Squibb’s Abecma and Breyanzi, Gilead Sciences’ Yescarta and Tecartus, Johnson & Johnson and Legend Biotech’s Carvykti, and Novartis’ Kymriah, stand to benefit from the update. Autolus’ CD19 CAR-T Aucatzyl was approved in November for B-cell precursor acute lymphoblastic leukemia without a REMS requirement. The FDA’s website only has updated prescribing information for Carvykti as of publication time, but the agency’s announcement said the REMS requirements have been removed for all these drugs.” * * *
    • “These changes should facilitate patient access, particularly for those who do not live near centers of excellence where CAR-Ts are commonly administered,” Citi analysts wrote in a Friday note.”
  • Federal News Network notes,
    • “June 28th is National Insurance Awareness Day, offering a timely reminder for federal employees to reassess their current healthcare needs and determine whether their FEHB plan remains the best fit.
    • “It’s important to review your coverage outside of Open Season, know what to expect for 2026, and be aware of trusted resources that can help guide your decisions.”
    • The article shares information on these points.

From the judicial front,

  • The Supreme Court completed its October 2024 term today.
  • Roll Call reports,
    • The Supreme Court curtailed the power of district courts to issue “universal injunctions” in a decision Friday in the legal clash over the Trump administration’s push end birthright citizenship.
    • The 6-3 decision [liberals dissenting] found that most of those broad orders that stop government actions — and there have been dozens issued against the Trump administration this year — exceed the power Congress gave to federal district courts.
    • The decision sends litigation over the legality of President Donald Trump’s birthright citizenship effort back to the lower court and is likely to set off an avalanche of litigation in more than 100 lawsuits against Trump’s administrative actions.
  • The FEHBlog expects that plaintiffs will be converting their lawsuits to class actions.
  • Govexec adds,
    • “The Supreme Court on Friday limited individual judges’ capacity to strike down government policy on a nationwide basis, a decision with potentially far-reaching impacts on how federal agencies carry out their work. 
    • “The high court left in place some carve outs, however, including one that could—at least temporarily—protect a judge’s ruling that is currently blocking the Trump administration from carrying out widespread layoffs. While the Trump administration applauded the Supreme Court’s decision and lamented the influence that lower-level judges have exerted over the president’s control of the federal workforce, attorneys who helped bring the lawsuit forward suggested it did not apply to the order preventing large-scale reductions in force.” * * *
    • “The victory for federal employees, to the extent they can claim one after the Supreme Court’s decision, may be short lived. The administration has already appealed both RIF cases to the [Supreme Court], where it is now awaiting resolution. It has done so seeking emergency relief and a decision is expected any day.” 
       
  • The Wall Street Journal sums it up as follows:
    • The Supreme Court ruled against nationwide injunctions, limiting the scope of lower-court rulings against presidential policies.
    • The high court ruling might lead to more lawsuits against the administration, as individuals and groups must bring their own cases.
    • Lawyers are exploring class-action suits, and state attorneys general might gain influence challenging White House policies.
  • The American Hospital Association News relates,
    • “The Supreme Court today voted 6-3 [conservatives dissenting] to uphold an Affordable Care Act provision creating an independent task force charged with making recommendations of preventive services that insurers must cover at no cost. The ruling reverses a June 2024 decision by the U.S. Court of Appeals for the 5th Circuit, which partially affirmed a district court judgment that the U.S. Preventive Services Task Force, the group charged with determining coverage of certain preventative services, was unconstitutional.” 
    • The Court held that the USPSTF members, who are volunteers, are inferior officers of the United States, who can be appointed by someone other than the President, in this case, the HHS Secretary, without Senate confirmation.
    • The opinion helpfully preserves the ACA preventive care status quo.
  • KFF calls attention to legal issues that the Court’s opinion may not have resolved.
  • SCOTUSblog covers the other Supreme Court decisions issued today.
  • The AHA News also tells us,
    • “A U.S. District Court for the District of Columbia judge today ruled against Johnson and Johnson and sided with the Department of Health and Human Services and hospitals in a lawsuit brought by J&J challenging the government’s authority to reject J&J’s proposed 340B rebate model.  
    • “In sum, based on the plain and unambiguous language of the 340B statute, and supported by its purpose and history, HRSA has the authority to ‘provide’ for discounts, rebates, or both,” Judge Rudolph Contreras wrote. “This conclusion defeats J&J’s claim that HRSA lacked the authority to require prior approval of J&J’s rebate model.” 
    • “The AHA in a friend-of-the-court brief urged the court to uphold the government’s decision to reject J&J’s proposed 340B rebate model. Others joining the AHA in the filing were the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals. 
    • “Earlier this year, a second district judge reached the same conclusion in cases brought by five other drug companies.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity is low. COVID-19 and RSV activity is very low.
    • “COVID-19
      • “COVID-19 wastewater activity, emergency department visits and laboratory percent positivity are at very low levels.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • Per Health Day,
    • “Updated COVID-19 vaccines are keeping up with new coronavirus strains and remain effective for keeping people out of the hospital, a new study says.
    • “The study, which examined the effectiveness of the 2023-2024 COVID vaccines against the XBB and JN.1 Omicron variant waves, found that the updated shots caused:
      • “A 24% lower risk of ER and urgent care visits related to COVID.
      • “A 29% lower risk of hospitalization.
      • “A 48% lower risk of ICU admission or death in hospital.
    • “This protection stretched from a week after vaccination out to 299 days afterward, researchers reported June 25 in JAMA Network Open.
    • “Maximum protection came during the first two months after vaccination, reducing severe cases of COVID by up to 68%, results show.
    • “However, vaccine effectiveness waned over time, particularly beyond the six-month mark.”
  • The University of Minnesota’s CIDRAP reports,
    • “The US Centers for Disease Control and Prevention (CDC) is now updating its measles totals on Wednesdays, and on June 25 it reported 13 more cases, putting the national total at 1,227 in 37 states. The nation’s cases are just 48 cases shy of passing the record number of cases reported in the 2019 surge, which was the most since measles was eliminated in the United States in 2000.
    • “The number of outbreaks remained at 23, and 89% of the confirmed cases are linked to outbreaks. Of the confirmed case-patients this year, 95% were unvaccinated or have an unknown vaccination status. So far, 148 people have been hospitalized, and the number of deaths remains at 3.”
  • and
    • “The percentage of US adults reporting high confidence in the Centers for Disease Control and Prevention (CDC) fell from 82% in February 2020 to 56% in June 2022, along with decreasing trust in other US health institutions, according to a study yesterday in PLOS Global Public Health.
    • “For the study, researchers from the University of Texas Southwestern Medical Center in Dallas conducted four surveys from February 2020 to October 2024 that assessed Americans’ confidence in US health institutions including the CDC, National Institutes of Health (NIH), Department of Health and Human Services (HHS), state and local health departments, professional medical organizations, the White House, and their own doctor. Sample sizes were 718, 672, 856, and 828, respectively.
    • “All four surveys asked participants their perceptions of public health organizations and who they thought should lead the US response to infectious disease outbreaks. Surveys 1 and 2 also asked questions on the COVID-19 pandemic, while surveys 3 and 4 asked questions around the 2022 and 2024 mpox outbreaks.” * * *
    • “The rate of those expressing high confidence then rebounded only slightly, to 60%, in October 2024.” * * *
    • “In a press release from PLOS, which published the journal, first author Hannah Melchinger says, “We need to take this decline seriously if we want to preserve the credibility of these entities and their public health recommendations.”
  • Per MedPage Today,
    • “Maternal flu vaccination was associated with a reduced risk of influenza infection during infants’ first 6 months of life, an age when they are too young to be vaccinated, a cohort study of nearly a quarter-million women and their babies found.
    • “Flu vaccination during pregnancy was associated with an adjusted 44.4% (95% CI 31.4-54.9) reduction in the risk of infant influenza infection, with protection strongest during the infants’ first few months of life, reported researchers led by Ousseny Zerbo, PhD, of Kaiser Permanente Northern California (KPNC) in Oakland, in Obstetrics & Gynecology.”
  • Health Day notes,
    • “People living with an autoimmune disease are nearly twice as likely to suffer from mood problems like depression, anxiety or bipolar disorder, a new large-scale study says.
    • “The risk of mood disorders is 87% to 97% higher in people suffering from rheumatoid arthritis, inflammatory bowel disease, lupus, multiple sclerosis, psoriasis and Graves’ syndrome, researchers reported June 24 in the BMJ Mental Health.
    • “This risk remains higher even after accounting for other factors like age, income and family history of psychiatric disorders, researchers found.
    • “Together, these results support the hypothesis that exposure to chronic inflammation may be associated with a greater risk for affective disorders,” concluded the research team led by Arish Mudra Rakshasa-Loots with the University of Edinburgh Center for Clinical Brain Sciences in the U.K.”
  • UConn which the FEHBlog’s alma mater writes in Linked In,
    • “Millions of Americans suffer from osteoarthritis, a painful joint disease that wears down cartilage and can severely impact mobility. Pain medications only mask symptoms, and surgical option carry risks of infection and immune rejection.
    • “At the University of Connecticut, a research team led by Thanh Nguyen, associate professor of mechanical engineering and biomedical engineering, believes the future of joint repair might lie in a tiny electrical spark—and a simple injection.
    • “Backed by a $2.3M grant from the National Institutes of Health (NIH) and National Institute of Biomedical Imaging and Bioengineering (NIBIB), Nguyen and his team are developing an injectable hydrogel designed to stimulate cartilage regeneration in large animal models.
    • “With current treatments, we’re managing the pain, not healing the tissue,” says Nguyen. “We’re hoping that the body’s own mechanical movements—like walking—can generate tiny electrical signals that encourage cartilage to grow back.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know about nine major hospital construction projects unveiled or advanced this year and notes that “Eliminating a $45 out-of-pocket fee for 3D mammography, also called digital breast tomosynthesis, increased utilization of the procedure by 7.8%, according to a study published June 19 in the Journal of the American College of Radiology.” 
  • Per HealthLeaders,
    • “Hospital at Home, which aims to treat selected patients at home with a combination of virtual care, remote patient monitoring and daily in-person visits instead of keeping them in the hospital, took off during the pandemic, with support from a waiver that enabled health systems and hospitals following the CMS model to receive Medicare reimbursement. That waiver is due to expire in September, and while there’s a strong lobbying effort to make it permanent, many hospital executives have said the program has proven its value and will go on regardless.”
  • Fierce Pharma discusses expert views on the status of the compounding industry now that the shortage of Novo and Lilly GLP-1 drugs is over.
  • Healthcare Dive reports,
    • “Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to run up against a fundamental issue: the three major pharmacy benefit managers’ chokehold on the U.S. drug market, experts said during a drug pricing transparency forum in Washington, D.C. this week.”
    • The FEHBlog thinks that this is Pharma distraction.

Thursday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Several of Republicans’ largest proposed spending reductions can’t be done as written in the fast-track budget process they are using to advance their megabill, the Senate parliamentarian determined, dealing a setback to the GOP’s hopes of passing their plans quickly. 
    • “The ruling affects several of the largest and most controversial reductions in President Trump’s “one, big, beautiful bill,” and Republicans will likely be forced to drop or rewrite them. The changes could amount to hundreds of billions of dollars, making it harder for Republicans to hit their budget targets.
    • “But the ruling wasn’t the final word, and Senate Republicans said by Thursday afternoon that they thought some slight tweaks to the wording of some proposed Medicaid cuts would be enough to break the logjam.
    • “There are things that we can do, there are other ways of getting to that same outcome,” said Senate Majority Leader John Thune (R., S.D.). Sen. John Hoeven (R., N.D.) said that such a plan was already under way, and that Republicans expected to hear back soon from the parliamentarian. 
    • “We’ve proposed some things to the parliamentarian that we think can work,” Hoeven said.’
  • Fierce Pharma tells us,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) has blessed Merck’s new respiratory syncytial virus (RSV) shot Enflonsia, but the decision was hardly resounding from Robert F. Kennedy Jr.’s newly formed panel of advisors.
    • “The ACIP signed off on recommending Merck’s newly approved monoclonal antibody by a vote of 5 to 2. The committee endorses one dose of Enflonsia to be given to infants younger than 8 months of age who are born during or entering their first RSV season and who are not already protected by a maternal vaccine.” * * *
    • “The new recommendation for Enflonsia, which was approved by the FDA just two weeks ago, matches that of Sanofi and AstraZeneca’s Beyfortus, which has been on the market for the last two years and generated sales of $1.8 billion in 2024.”
  • BioPharma Dive adds,
    • “Advisers to the Centers for Disease Control and Prevention recommended Thursday that influenza vaccines used in the coming flu season be free of the preservative thimerosal, addressing unproven fears the mercury-containing substance can lead to developmental disabilities.
    • “If confirmed by the CDC, the recommendation from the Advisory Committee on Immunizaiton Practices, or ACIP, would affect about 5% of flu shots administered in the U.S., distributed in multidose vials that necessitate the use of a preservative to prevent bacterial or fungal contamination. Only three such vaccines are approved for U.S. use, two from CSL and one from Sanofi.
    • “Meeting for the first time with members appointed by Health and Human Services Secretary Robert F. Kennedy Jr., ACIP also reviewed a change in its recommendations for measles vaccines, although it won’t vote on that proposal until a meeting later this year.”
  • The Wall Street Journal sums it up as follows:
    • “The Advisory Committee on Immunization Practices, or ACIP, was established in 1964 to offer the federal government advice on which vaccines Americans should get and when. After Kennedy dismissed its 17 members and picked new ones, the committee spent two days examining science’s weapons to combat flu, measles and other diseases—with a new emphasis on the risks of the weapons themselves.
    • “Vaccines are not all good or bad,” said the committee’s new chair, Martin Kulldorff, a former Harvard professor. “No questions should be off-limits.” * * *
    • “In a joint statement after the two-day session concluded Thursday, the committee said it had “no predetermined ideas and will make judgments as if we are treating our own families,” adding that “unbiased scientific thinking is fundamental to the committee’s charge.”
  • The Census Bureau informs us,
    • “The U.S. population age 65 and older rose by 3.1% (to 61.2 million) while the population under age 18 decreased by 0.2% (to 73.1 million) from 2023 to 2024, according to the Vintage 2024 Population Estimates released today by the U.S. Census Bureau.
    • “The data show the population continued to age, with the share of the population age 65 and older steadily increasing from 12.4% in 2004 to 18.0% in 2024, and the share of children declining from 25.0% to 21.5%.
    • “Ongoing growth among the older population, coupled with persistent annual declines in the population under age 18 has reduced the size difference between these two age groups from just over 20 million in 2020 to just below 12 million in 2024. From 2020 to 2024, the older population grew by 13.0%, significantly outpacing the 1.4% growth of working-age adults (ages 18 to 64), while the number of children declined by 1.7%.
    • “Children still outnumber older adults in the United States, despite a decline in births this decade,” said Lauren Bowers, chief of the Census Bureau’s Population Estimates Branch. “However, the gap is narrowing as baby boomers continue to age into their retirement years. In fact, the number of states and counties where older adults outnumber children is on the rise, especially in sparsely populated areas.”
  • Tammy Flanagan, writing in Govexec, offer guidance to those who are “Retired and confused about Medicare Part B. You’re not alone. From late penalties to premium reimbursements, here’s what every retired fed should understand about enrolling in Medicare Part B—and how it works with your FEHB plan.

From the judicial front,

  • The Supreme Court will complete issuing opinions from its October 2024 term tomorrow morning at 10 am.
  • Beckers Hospital Review relates,
    • “Several Iowa businesses and health plans are suing to block a new state law regulating pharmacy benefit managers, arguing it violates federal law and the Constitution, Iowa Capital Dispatch reported June 23. 
    • “The lawsuit, filed June 23 in the U.S. District Court for the Southern District of Iowa, challenges Senate File 383, a measure signed in early June by Gov. Kim Reynolds. The plaintiffs include the Iowa Association of Business and Industry, Des Moines Orthopaedic Surgeons PC, Iowa Springs Manufacturing & Sales Co., and health plans like the Iowa Bankers Benefit Plan and Iowa Laborers District Council Health and Welfare Fund. 
    • “While supporters said the provisions will help struggling pharmacies in many Iowa communities, the lawsuit argued the new law will “raise healthcare costs for businesses across the state — large and small — by tens of millions of dollars.” 
  • Bloomberg Law adds,
    • “Four lawsuits seeking to invalidate a first-of-its kind Arkansas law prohibiting companies that manage prescription drug benefits from acquiring pharmacies will be heard together in federal court, a judge ruled Tuesday.
    • “The order from Judge Brian S. Miller for the US District Court for the Eastern District of Arkansas grants an unopposed motion filed by the Arkansas attorney general’s office to consolidate the cases. The challenges were brought by pharmacy benefit managers Express Scripts, CVS Health Corp., and OptumRx, as well as the industry group Pharmaceutical Care Management Association.” * * *
    • “Miller ordered Tuesday that all future filings in the four cases be filed in the docket for Express Scripts’ lawsuit. The members of the Arkansas pharmacy board, who are represented by the state attorney general’s office, must file by July 11 a consolidated response to PBMs’ motion for a preliminary injunction on the law, according to the order. 
    • “The case is Express Scripts v. Richmond , E.D. Ark., No. 4:25-cv-00520, motions to consolidate granted 6/24/25.” 
  • Beckers Hospital Review lets us know about ten recent healthcare billing fraud cases.

From the public health and medical research front,

  • Fox Business reports,
    • Trader Joe’s said Friday [June 20] that a “single lot code” of the cheese curds have been recalled in response to the potential risk of Listeria monocytogenes contamination.
    • The recalled product was offered at some Trader Joe’s locations in Northern California as well as stores in the Nevada cities of Carson City, Reno and Sparks, according to a notice posted on the popular grocery store chain’s website. 
    • The stores in Northern California included those in Monterey, Fresno and “all locations North,” Trader Joe’s said. 
    • “The recalled cheese curds have a use-by date of “082925” on their container.” 
  • Beckers Hospital Review ranks states by opioid overdose deaths.
    • “West Virginia had the highest rate of fatal opioid overdoses of any state in 2023, according to a new analysis from KFF. 
    • “The analysis is based on finalized 2023 opioid overdose death totals from the CDC’s WONDER database, which uses ICD-10 codes to identify deaths where synthetic and prescription opioids are listed as a contributing cause.
    • “Becker’s calculated each state’s death rate per 100,000 residents using 2023 U.S. Census population estimates to enable fair comparisons across states.
    • “The national opioid overdose death rate was 23.69 per 100,000 residents in 2023.”
  • News Medical points out,
    • “Weight loss surgery has long been an effective treatment for the more than 40 percent of American adults struggling with obesity. Previous studies have shown that Black patients lose less weight overall following bariatric surgery compared to other racial groups, but less attention has been paid to the relationships between economic and social factors that may help explain differences in weight loss.
    • “New research led by NYU Langone Grossman School of Medicine found that Black patients who had a sleeve gastrectomy, the most common weight loss surgery, between 2017 and 2020 lost 6.2 percent less weight than their White counterparts, and 4.9 percent less than Hispanic patients, after one year. However, further analyses found that a lot more complexity and interplay between non-biological factors than previously known appear to impact weight loss surgery incomes.
    • “Published online in the journal Obesity, this is the first study to investigate the relationship between a variety of economic and social factors that include income, sleep disturbances and stress, and weight loss differences among racial groups, the study authors said.”
  • Per Health Day,
    • “Fitness trackers aren’t accurately assessing the physical activity of people with obesity, a new study argues.
    • “Differences in walking gait, speed, energy burn and other factors mean that folks with excess weight aren’t getting an accurate read from their devices, researchers wrote in the journal Scientific Reports.
    • “People with obesity could gain major health insights from activity trackers, but most current devices miss the mark,” senior researcher Nabil Alshurafa, an associate professor of behavioral medicine at Northwestern University Feinberg School of Medicine in Chicago, said in a news release.
    • “Alshurafa’s team has developed a new algorithm that enables smartwatches to more accurately monitor the calories burned by people with obesity, researchers said.
    • “Lab tests show that the new algorithm achieves over 95% accuracy in real-world situations, the study says.
    • “Without a validated algorithm for wrist devices, we’re still in the dark about exactly how much activity and energy people with obesity really get each day — slowing our ability to tailor interventions and improve health outcomes,” Alshurafa said.”
  • Per MedPage Today,
    • “AS01-adjuvanted RSV and shingles vaccines were tied to a lower dementia risk in older adults.
    • “Compared with flu vaccine recipients, those who had the AS01 RSV shot had 29% more dementia-free time over 18 months.
    • “No differences emerged between the two AS01 vaccines, implying the adjuvant may play a role.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The leader of UnitedHealth Group Inc.’s Optum Health care delivery unit has left the role, an early indication of management changes under Stephen Hemsley, UnitedHealth’s new chief executive officer.
    • “The division will now be led by Patrick Conway, who was recently promoted to CEO of the broader Optum division that includes Optum Health. Conway will add the title of Optum Health CEO, according to a company memo reviewed by Bloomberg News.
    • “Amar Desai had been CEO of Optum Health since 2023. He’ll become president of Optum integrated care and vice-chairman of Optum Health, according to the memo, and will continue to work with Conway and Hemsley.”
  • Healthcare Dive tells us,
    • “Declines in Walgreens’ front-of-store retail sales continued in Q3, falling 5.3% year over year, due largely to store closures and lower same-store sales. The drugstore retailer last year announced it would shutter 1,200 U.S. stores over three years.
    • “Weak sales in grocery and household, health and wellness, and beauty drove store comps down 2.4%. The international and U.S. healthcare segments fared better, helping drive a 7.2% overall Q3 sales increase to $39 billion.
    • “The drugstore retailer swung into the red with a net loss of $175 million, a decrease of $519 million compared to last year’s $344 million in net earnings.”
  • Per MedTech Dive,
    • “Johnson & Johnson has partnered with Nvidia and Amazon Web Services, or AWS, to support the use of artificial intelligence in surgery, the medtech company said Wednesday.
    • “The Polyphonic AI Fund for Surgery builds on J&J’s existing collaboration with Nvidia and creation of a digital platform for in-house and third-party surgical applications.
    • “Through the fund, J&J, Nvidia and AWS will evaluate, and support projects related to AI model development, data engineering and management, and AI governance.”
  • Per Tech Target,
    • The Lown Institute is recognizing 125 hospitals nationwide for their performance on health equity, value and outcomes, honoring these for this corporate social responsibility in healthcare.
    • “These hospitals show that no matter how tough the environment gets, putting patients and communities first is always possible,” Vikas Saini, M.D., president of the Lown Institute, said in a press release. “Those returning to the list prove that equitable, high-value care doesn’t have to be rare; it’s a standard that hospitals can uphold year after year.” * * *
    • “The top 10 acute care hospitals for health equity, value and outcomes include the following:
      • “Duke Regional Hospital (Durham, N.C.).
      • “Fort Loudoun Medical Center (Lenoir City, TN..).
      • “Baylor Scott & White Medical Center – Pflugerville (Pflugerville, TX.).
      • “Denver Health Main Campus (Denver, CO.).
      • ‘Methodist Medical Center (Oak Ridge, TN.).
      • “Prisma Health Baptist Hospital (Columbia, S.C.).
      • “TriStar Horizon Medical Center (Dickson, TN.).
      • “Sharon Hospital (Sharon, CT.).
      • “Inspira Medical Center Vineland (Vineland, N.J.).
      • “Southern California Hospital at Hollywood (Los Angeles, CA.).”
  • MedCity News reports,
    • “Novavax’s alliance with Sanofi came at an opportune time for the beleaguered vaccine developer. Its protein-based Covid-19 vaccine never reached the revenue highs achieved by the messenger RNA vaccines for the novel coronavirus. A corporate restructuring slashed headcount and R&D spending, but Novavax’s financial reports still flagged concerns about the company’s ability to continue.
    • “The Sanofi partnership(Opens in a new window) inked a little more than a year ago infused Novavax with $500 million up front, staving off the immediate financial worries. Starting this year, Sanofi will record sales of the Covid-19 shot vaccine Nuvaxovid, paying Novavax royalties on those sales. The deal is more than a financial lifeline. Beyond sharing in Nuvaxovid’s commercialization, Sanofi can research potential combinations of the Covid-19 shot with its own influenza vaccines. The pharmaceutical giant may also explore using Novavax’s adjuvant in its own vaccines. This agreement is a blueprint for the kinds of alliances Novavax is now pursuing, according to Ruxandra Draghia-Akli, executive vice president, head of research and development.
    • “It’s a multifaceted partnership and we thought that is a model, or maybe components of that model can be developed with other partners,” she said in an interview during the recent BIO International Convention in Boston.”
  • Per Fierce Pharma,
    • “After blueprinting an injectables facility in North Carolina in 2020, it didn’t take long for Eli Lilly to draw up designs for a second in the Tar Heel State.
    • “Following declines in the manufacturing, textiles and tobacco industries that once formed the core trades in the state, North Carolina has increasingly put its chips behind biotechnology. It’s a strategy that has attracted not only Lilly but myriad other pharma majors like Fujifilm Biosciences, Johnson & Johnson and Thermo Fisher Scientific.
    • “For Lilly, building a new parenteral products and devices facility in the city of Concord was a natural evolution following the decision to throw down $470 million on a similar injectables plant at North Carolina’s famed Research Triangle Park back in 2020.” * * *
    • “Together, Lilly’s two North Carolina facilities—which are used in part to make incretin medicines such as Zepbound and Mounjaro—are part of the drugmaker’s ongoing, multibillion-dollar investment in U.S. infrastructure. They also form part of a bulwark against the immense demand for Lilly’s dual GIP/GLP-1 products for diabetes and obesity.”
  • and
    • “Novo Nordisk continues to expand its partnerships with telehealth companies to broaden access to its blockbuster weight loss drug Wegovy.
    • “The pharma giant is now partnering with WeightWatchers to offer consumers access to Wegovy, using CenterWell Pharmacy to fulfill and deliver the medications. CenterWell is owned by Humana.
    • “WeightWatchers aims to provide patients with a more streamlined experience, along with convenient access to FDA-approved medication with the lifestyle support shown to improve outcomes, the company said in a press release.
    • “The partnership will start July 1.”




Midweek report

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Republican leaders kept pressing the gas pedal Wednesday to get their “one big, beautiful bill” passed by this weekend, even while hundreds of billions of dollars in crucial decisions are being negotiated, key senators are holding out, and some House lawmakers are crying foul.
    • “President Trump wants the legislation on his desk by July 4, and Republicans hope the megabill’s perceived inevitability overcomes any momentary implausibility. Senators aim to start votes as soon as Friday on the legislation, which would cut taxes, reduce spending on Medicaid and nutrition assistance, and boost spending on border security and national defense. The House could send the bill to Trump early next week. 
    • “For now, there aren’t enough votes for a bill that isn’t finished yet. 
    • “It is this mysterious process of trying to be able to move specific ideas through 53 other people and trying to be able to get ideas and opinions,” said Sen. James Lankford (R., Okla.). “And where do people land? It’s a moving target.”
    • “Senators aren’t quite ready to vote, and they expect to change the legislation in the days ahead. Several senators, including Josh Hawley (R., Mo.) and Dan Sullivan (R., Alaska), said they want to be able to review the whole bill before taking the first procedural step—a vote to open debate. 
    • “Our guys are all going to keep advocating for what they want, till the final minute, till we pass it,” said Sen. John Hoeven (R., N.D.) “That’s how it works.” 
  • and
    • “Health Secretary Robert F. Kennedy Jr.’s new panel of vaccine advisers will re-evaluate the recommended schedule for vaccines for children and teenagers, including for measles and hepatitis B, its new chairman said Wednesday.
    • “The new slate of advisers met for the first time Wednesday in Atlanta, kicking off a two-day meeting with an agenda partially set by political appointees. Meanwhile, on Capitol Hill, the nominee to lead the Centers for Disease Control and Prevention, Susan Monarez, told senators she believes vaccines save lives and there is no causal link between vaccines and autism.” * * *
    • “Monarez, if confirmed, would have the power to decide whether or not to adopt ACIP recommendations. Asked if she agreed with Kennedy’s decision to remove all members of the previous committee, Monarez responded “that the secretary had to make a decision related to ensuring that the ACIP could be supportive of restoring public trust in decision-making.”
    • “The vaccine advisory panel is set Thursday to hear a presentation on thimerosal, a preservative that antivaccine activists have often blamed for autism, from Lyn Redwood, a nurse practitioner who is president emerita of Children’s Health Defense, an antivaccine nonprofit previously helmed by Kennedy. Antivaccine activists have long claimed that thimerosal causes autism. Rates of the disorder have continued to climb even after thimerosal was removed from most vaccines in the early 2000s.”
  • Beckers Health IT tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. says he wants every American using a wearable health device within four years, Politico reported June 24.
    • “Speaking during a June 24 hearing of the House Energy and Commerce Health Subcommittee, Mr. Kennedy said the department is preparing “one of the biggest advertising campaigns in HHS history” to promote wearable technology.
    • “The devices are central to Mr. Kennedy’s “Make America Healthy Again” initiative. He told lawmakers that wearables give people a way to “take control of their own health.”
  • Govexec fills us in on what happened at yesterday’s House Oversight and Government Reform Subcommittee on Government Operations hearing titled “The Route Forward for the U.S. Postal Service: A View from Stakeholders.”
  • The American Hospital Association News informs us,
    • “The Administration for Strategic Preparedness and Response June 25 announced it conducted an exercise transporting simulated patients with high-consequence infectious diseases in a new portable biocontainment unit from Toronto to U.S. hospitals in the northeast and southeast. The hospitals are all Regional Emerging Special Pathogen Treatment Centers for highly infectious diseases. ASPR said the biocontainment unit is the first domestic resource for isolating and transporting patients with high-consequence infectious diseases, such as Ebola, across long distances to RESPTCs. The unit can be transported by air or by ground.”
  • CMS called attention to its Medicare website explaining how to get medical assistance in a disaster or emergency.

From the state and local government front,

  • Politico lets us know,
    • New York City Mayor Eric Adams announced [June 22] he will not move forward with a contentious effort to cut costs by shifting retired city workers to a Medicare Advantage plan, bringing a sudden end to a four-year saga.
    • “We have heard concerns from retirees about these potential changes at numerous older adult town halls and public events, and our administration remains focused on ensuring that New York City remains an affordable place to live,” Adams said in a statement Friday.
    • Just two days earlier, the state Court of Appeals ruled in City Hall’s favor in a lawsuit over the Medicare Advantage transition, handing Adams a rare win in the long legal battle to implement a plan he inherited from former Mayor Bill de Blasio.

From the Food and Drug Administration front,

  • STAT News reports,
    • Outgoing Food and Drug Administration regulator Jacqueline Corrigan-Curay acknowledged to staff [June 24] that much is still in flux at the agency, weeks before she retires.
    • “We are leaner and therefore we have to find ways to be efficient and do things in new ways,” she told staff, according to a recording of a town hall meeting obtained by STAT. 
    • She did not say who will be the next leader of the Center for Drug Evaluation and Research once she retires next month. Her retirement is the latest in a series of departures of senior officials at the FDA, who have either chosen to take early retirements, left for other jobs, or been forced out by political appointees.
    • “CDER has filled one leadership position, though. At the meeting, Corrigan-Curay introduced staff to the new deputy director of CDER, Mike Davis. Davis, a psychiatrist and pharmacologist, was most recently chief medical officer at the Usona Institute, a nonprofit organization developing psychedelic drugs for the treatment of depression and PTSD. He previously spent six years at the FDA as a clinical team leader in the psychiatry division.” 
  • Per BioPharma Dive,
    • “The Food and Drug Administration is investigating two deaths among [over 900] patients treated with Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy. Both patients died this year of acute liver failure after receiving Elevidys, with the second case reported earlier this month. The FDA said their deaths appear to be related to treatment and that it will evaluate “the need for further regulatory action.”
  • Per MedPage Today,
    • “The FDA said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.
    • “Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue.
    • “In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. While the FDA can mandate label changes, the process is often more of a negotiation with companies.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “A study published June 25 by the Journal of the American Heart Association found that heart disease death rates fell 66% from 1970 to 2022. Deaths from heart attacks decreased 89% in that time span. The study attributed the declines to advancements in intervention and prevention efforts. Meanwhile, deaths from other types of heart disease, including arrhythmia, heart failure and hypertensive heart disease, increased by 81% during the same period. The study said the rising prevalence of obesity, diabetes, hypertension and physical inactivity have contributed to those causes.”
  • Cardiovascular Business adds,
    • “A team of surgeons with Baylor St. Luke’s Medical Center in Houston has made history, performing what is believed to be the first fully robotic heart transplant in the United States. 
    • “The procedure occurred in March 2025. Kenneth K. Liao, MD, PhD, chief of cardiothoracic transplantation and circulatory support at Baylor College of Medicine and chief of cardiothoracic transplantation and mechanical circulatory support at Baylor St. Luke’s Medical Center, and colleagues completed the transplant using an advanced Da Vinci surgical system. 
    • “The patient’s chest did not need to be opened all for the procedure—everything was done through small incisions.
    • “Opening the chest and spreading the breastbone can affect wound healing and delay rehabilitation and prolong the patient’s recovery, especially in heart transplant patients who take immunosuppressants,” Liao explained in a statement. “With the robotic approach, we preserve the integrity of the chest wall, which reduces the risk of infection and helps with early mobility, respiratory function and overall recovery.”
    • “The patient in question was a 45-year-old male who had been hospitalized with advanced heart failure for four months. He was discharged after being observed in the hospital for a month. There have been no complications.”
  • Per Medscape,
    • “The investigational non-peptide small-molecule oral GLP-1 agonist orforglipron significantly reduced A1c over 40 weeks in adults with early type 2 diabetes, according to the results of ACHIEVE-1 sponsored by Eli Lilly. 
    • “In the trial, orforglipron reduced A1c to the 6.5% range and produced clinically meaningful weight loss with a safety profile similar to that of other GLP-1 drugs. ACHIEVE-1 is the first of seven phase 3 studies of the safety and efficacy of the drug in over 6000 patients with type 2 diabetes and obesity,
    • “Orforglipron and other similar non-peptide small molecules “have the potential to be widely accepted as a much earlier therapy for type 2 diabetes,” Julio Rosenstock, MD, senior scientific advisor for Velocity Clinical Research and clinical professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said at a press briefing here at the American Diabetes Association (ADA) 85th Scientific Sessions. The findings were simultaneously published in the New England Journal of Medicine.”
  • STAT New relates,
    • “A study tracking nearly 250,000 Swedish people using ADHD medication for 14 years found that these treatments can reduce risks of traffic crashes, injuries, and criminal behavior — and that conclusion remained true even as more girls, women, and adult men received a diagnosis.
    • “I wish we had access to this kind of data for the U.S.,” said Ryan Sultan, who was not part of the study and is a psychiatrist and professor at Columbia University Irving Medical Center where he specializes in ADHD. “Being able to follow them from birth means that their data is really, really powerful.”
    • “The study arrives as providers in the United States contend with twin realities: ADHD medication prescriptions are skyrocketing — largely thanks to telehealthand diminishing stigma — while medication shortages are imperiling people’s access to these critical treatments. Scientists are also learning more about how the condition interacts with other variables, such as how menstrual periods can affect symptoms and treatment. 
    • “We’re in a moment in U.S. society where … everyone and their grandmother are asking whether they have ADHD or not,” said Sultan. “It’s really interesting to be thinking about, when we’re expanding [access], who are we actually expanding it to, and who are we actually treating?”
  • Medical Economics points out,
    • “According to Dexcom’s 2025 State of Type 2 Report, most U.S. physicians now consider continuous glucose monitoring (CGM) one of the most impactful interventions for managing type 2 diabetes, surpassing even medications and lifestyle counseling in future importance.
    • “The findings are based on a national survey of 310 adults with type 2 diabetes and 111 U.S. health care professionals (HCPs), including primary care physicians, nurse educators and diabetes specialists.
    • “CGM adoption remains relatively low among patients — just 16% of U.S. adults with type 2 diabetes currently use the technology — but satisfaction among users is high. The vast majority report improved quality of life, reduced stress and better engagement with their glucose data. Physicians, meanwhile, see CGM as a key solution to longstanding pain points, including poor adherence, low health literacy and difficulty tracking glucose fluctuations outside clinic visits.
    • “The report highlights a disconnect between CGM’s perceived value and its real-world accessibility. Most patients cite cost or insurance coverage as the top reason for not trying it. Most physicians say they lack the tools to educate patients on its benefits. And nearly three-quarters of people with type 2 diabetes say they need better understanding of how diabetes technology can help them manage their condition.”
  • Per the American Journal of Managed Care,
    • The use of pre-exposure prophylaxis (PrEP) for prevention of HIV has helped to curb the spread of the virus nationally. Knowing how much PrEP is needed in certain areas can help to more specifically target vulnerable populations who need it more.
    • A model was developed that could estimate the need for PrEP, according to a study published in Annals of Epidemiology. Public health authorities can use this information to monitor progress and establish resource allocation.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “U.S. households, businesses and governments will spend $8.6 trillion on healthcare in 2033, when the sector will comprise just over one-fifth of gross domestic product, according to a federal report issued Wednesday.
    • “The Centers for Medicare and Medicaid Services Office of the Actuary attributes its forecast to factors such as a rapidly aging population and high demand for healthcare. The independent CMS division published its analysis in the journal Health Affairs.
    • “National health expenditures will increase 5.8% a year on average from 2024 to 2033, the actuaries predict. The healthcare spending trend is expected to continue outpacing economic growth, which the office projects will average 4.3% annually over the coming decade.”
  • Fierce Healthcare adds,
    • “In an uncertain policy and macroeconomic environment, healthcare finance leaders are concerned about what the future holds, a new report showed.
    • “Analysts at Deloitte surveyed 64 finance leaders, split evenly between executives from health systems and insurers, to capture what they view as the biggest challenges and opportunities coming down the pike. Most (84%) of those surveyed said they are worried about business conditions given the cloudy policy outlook, economic concerns and potential disruptions from tariffs and the supply chain.
    • “Over the past several years, workforce challenges, cost reductions and cybersecurity have all been top concerns for finance leaders in healthcare. However, this year’s survey found external factors taking on a much greater role.”
    • “Internal concerns like workforce challenges, cost reduction, and cybersecurity—once top priorities for healthcare chief financial officers in our previous surveys—seem to have become less urgent amid rising external factors, according to survey respondents,” the researchers said.”
  • Per a press release,
    • “Optum is accelerating the adoption of artificial intelligence (AI) for health care technology companies, providers and payers with the launch of the Optum AI Marketplace. The new marketplace is the only health care-specific AI digital platform of its kind, built by health care developers to simplify AI integration across clinical and administrative systems.
    • “Many emerging health care organizations want to modernize their systems but don’t have the time, resources, or infrastructure to build AI solutions on their own. The new marketplace addresses these gaps by offering a centralized, health care-specific ecosystem of curated solutions and APIs that are ready to implement, helping organizations streamline operations, reduce integration costs, and scale AI adoption.
    • “Optum brings decades of health care expertise and advanced data infrastructure to the AI Marketplace. This foundation ensures the platform is built for real-world health care needs and supports faster, more effective AI and API implementation. With more than 1.4 billion API transactions each year, the marketplace powers real-time insights and seamless integrations across the health care landscape.” * * *
    • Discover more at Optum AI Marketplace.
  • Per Beckers Hospital Review,
    • Overall demand for healthcare services is poised to continue its significant growth across various service lines over the next decade, with outpatient care expected to experience the highest growth rate and inpatient services seeing more moderate increases, according to Sg2’s 2025 Impact of Change Forecast published in June.
    • Sg2’s forecasting model integrates a broad range of factors, including national data, institutional data, and market trends. National population changes, epidemiological shifts, economic influences, policy developments and advances in technology were considered in the projections.
    • Sg2 used data from the HCUP National Inpatient Sample and CMS Limited Data Sets, alongside its own analysis of healthcare usage trends.
  • Per Beckers Payer Issues,
    • “Medicare Advantage enrollees experience longer hospital stays before being discharged to post-acute care settings compared to individuals enrolled in traditional Medicare, according to a June 2025 analysis by NORC at the University of Chicago.
    • “The analysis was commissioned by the Coalition to Strengthen America’s Healthcare, a group of more than 5,000 hospitals, businesses and hospital associations that includes the AHA and FAH. 
    • “The researchers found that while hospital discharges overall declined over the five-year study period, discharges to post-acute settings increased for MA enrollees and decreased slightly for traditional Medicare enrollees. At the same time, MA enrollees had longer hospital stays prior to post-acute discharge, with the gap widening over time.
    • “While the data is age-adjusted, the study did not control for clinical or demographic differences that could affect length of stay or discharge destination. Future research is recommended using tools like HCC risk scores and claims-based frailty index to better isolate coverage-related effects.”

Tuesday report

David Ermer–ACA, AHRQ, CMS, Congress, FDA, Medical / Rx research, NIH, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump is urging Republicans to get their “one big, beautiful bill” to his desk by July 4. That’s just a week from Friday, and lawmakers still face a series of hurdles and headaches on issues ranging from artificial intelligence to deficit spending to rural hospitals.
    • “Senate GOP leaders are revising their version in advance of potential votes later this week, searching for a mix that can garner a majority in the chamber, which is divided 53-47. Anything that gets through the Senate must pass the House, which is divided 220-212 in Republicans’ favor; any subsequent House changes would require another Senate vote. Lawmakers are scheduled to leave Washington for a recess next week but signaled they were prepared to stay to finish the bill.”
  • The American Hospital Association News tells us,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. today appeared before the House Energy and Commerce Subcommittee on Health for a hearing to testify on the HHS fiscal year 2026 budget proposal, which requests $94.7 billion.”  
  • Modern Healthcare informs us,
    • Prescription drug middlemen should end the complicated system of drug rebates before the government steps in to change it, Medicare and Medicaid chief Mehmet Oz said Tuesday.
    • The remarks signal the Trump administration may revive attempts to eliminate the payments drugmakers send to pharmacy benefit managers after prescriptions are filled. In his first term in 2019, President Donald Trump considered regulations that would have eliminated that system, but officials abandoned them before they went into effect.
    • “There’s a possibility that we have a window now where the three big PBMs might actually consider doing away with the rebate-slash-kickback system,” Oz told a meeting hosted by Transparency-Rx, a coalition of smaller PBMs committed to more open pricing. The three largest companies in the industry, CVS Health Corp., UnitedHealth Group and Cigna Group, handle about 80% of US prescriptions.” * * *
    • “Oz met with large insurers about separate issues on Monday. The insurers voluntarily committed to reduce the use of preapprovals for medical care, and Oz said that there could be an opportunity for insurers to take similar voluntary action to change how they pay for medicines.”
  • Healthcare Dive also discusses the CMS Administrator’s presentation at this meeting with a focus on drug price transparency.
  • Federal News Network lets us know,
    • “Rep. Robert Garcia was elected the top Democrat on the powerful House Oversight Committee on Tuesday, charting a new direction for the party’s opposition to congressional Republicans and President Donald Trump’s administration.
    • “Garcia, of California, won the job overwhelmingly in a closed-door vote of the House Democratic caucus. He beat out Rep. Stephen Lynch of Massachusetts, 150-63.”
  • Fierce Healthcare summarizes the public comments submitted in response to the May 13, 2025, CMS and National Coordinator of Health IT RFI “on how to ease data exchange among the healthcare ecosystem for patients, providers, payers, vendors and value-based care organizations.”
  • Fierce Healthcare also points out,
    • “While major provider organizations welcomed insurers’ pledge earlier this week to reform prior authorization, these groups withheld praise without yet seeing the efforts bear fruit.
    • “Bobby Mukkamala, M.D., president of the American Medical Association, said in a statement that patients and physicians both will need to see the promises made yield significant results to ease the headaches around prior auth.
    • “Mukkamala said that many of the elements of Monday’s pledge echo a 2018 consensus statement from major payer and provider organizations, such as reducing the number of required prior authorizations, preserving the continuity of care for the patient and expanding automation.
    • “He said the AMA will “closely monitor” the rollout of the prior authorization changes and continue to work with regulators and legislators on this issue.”
  • The U.S. Preventive Services Task Force today gave a Grade B to “screening women of reproductive age, including those who are pregnant and postpartum for intimate partner violence.” The USPSTF also “concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults [Grade I]. Both grades are consistent with the conclusions that the USPSTF reached in 2018 following a similar analysis.
  • MedPage Today adds,
    • “Expanding eligibility criteria for lung cancer screening to include 20-year smoking history without requiring a certain number of pack-years yielded a relative 28% increase in the number recommended for screening.
    • “The number of lung cancers identified would have increased by a relative 17%.
    • “The increase in detection was particularly seen among women and Black persons, groups with under-detection by current criteria.”
  • Per PR Newswire,
    • “More than 1.3 million women in the U.S. enter menopause every year. Menopause affects every woman—but not every woman gets the care, clarity, and support she deserves. A new national program, “Menopause for All,” intends to change that and will launch in Baltimore, MD and Washington, D.C., on June 28th and 29th, respectively.
    • “The National Menopause Foundation, a leading patient advocacy organization dedicated to empowering women with the knowledge and resources they need to navigate menopause through igniting community and harnessing science, has teamed up with Perry, a pioneering digital health platform transforming perimenopause care through expert-led community support, evidence-based education, and training of health care professionals. Together, they believe menopause care should be local, personal, and accessible.
    • From trusted medical professionals and wellness experts to culturally sensitive support groups, the Menopause for All program will help women and their families connect with resources in their own local communities—because navigating menopause shouldn’t be done alone or in the dark.
    • Menopause for All events are free and open to the public, but space is limited. On Saturday, June 28, 2025, the event will be held at Enoch Pratt Free Library, 400 Cathedral Street in Baltimore, MD from 1:30-4:30 p.m. On Sunday, June 29, 2025, the event will be held at the Hill Center at the Old Navy Hospital, 921 Pennsylvania Avenue, SE Washington, D.C., from 2:30-5:30 p.m.
    • “Our expert-led sessions will provide women with practical, scientifically-backed guidance and real solutions ensuring every woman has the care and support she deserves,” added Claire Gill, founder and President of NMF. “We’re grateful to our presenting sponsor [and FEHB, PSHB and FEDVIP carrier] Government Employees Health Association (G.E.H.A) and supporting sponsor Clearblue for their commitment to advancing women’s midlife health.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The FDA has blessed AstraZeneca and Daiichi Sankyo’s Datroway to treat patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The accelerated nod—which could hinge upon verification of clinical benefit in a confirmatory trial—applies to patients who have received prior EFGR-related treatment and platinum-based chemotherapy.
    • “The label expansion comes five months after Datroway secured its first FDA nod, for patients with previously treated metastatic, HR-positive, HER2-negative breast cancer. With the nod, Datroway becomes the first TROP2-directed therapy in the U.S. for NSCLC.
    • “Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available,” Jacob Sands, M.D., of the Dana-Farber Cancer Institute and an investigator in two trials that paved the way for the latest approval, said in a June 23 press release.”
  • STAT News relates,
    • “A sutureless device for peripheral nerve repair could be available on the market in the coming months.
    • “The Food and Drug Administration has authorized a polymer-based device developed by medical technology company Tissium. The authorization, announced Tuesday, will give physicians a new method for treating peripheral nerve injuries.
    • “This approval is really a game-changer for patients with peripheral nerve injuries,” said Jeffrey Karp, a Tissium co-founder who developed the device’s technology. “For the first time, surgeons now have a sutureless, bio-inspired option that can really simplify the procedure while improving outcomes.”
  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) has announced an expansion of an earlier Medtronic recall, now issuing a new Class 1 recall for Medline Industries’ procedure kits that contain Medtronic aortic root cannulas. The recalls indicate that there may be excess material in the male luer, which could potentially lead to serious adverse events, including procedure delays, neurological deficits, strokes, or even death.”
  • Per Health Exec,
    • “In what is being referred to as a recall, the U.S. Food and Drug Administration (FDA) released a notice on behalf of GE HealthCare for a line of its Carestations due to a risk the ventilation systems may not work properly. Despite the serious risk of death or injury caused by inadequate respiration, the problem has been isolated and can be fixed with updated use instructions. 
    • “Although no devices have been removed from care settings, this recall has been designated a Class I by the FDA, reserved for the most serious issues. Luckily, no injuries or deaths have been reported. 
    • “The systems are typically used to aid with anesthesia in patients of all ages. They can be found in many hospitals and surgery centers across the country.” 

From the public health and medical research front,

  • MedPage Today tells us,
    • “Over the last two decades, U.S. neonatal mortality has generally declined, though not all leading causes of death followed this trend.
    • “There were 283,696 neonatal deaths from perinatal complications, with the top leading causes being disorders related to short gestation and low birth weight; maternal complications of pregnancy; and complications of placenta, cord, and membranes.
    • “Mortality due to slow fetal growth and fetal malnutrition increased annually, and mortality from maternal complications and bacterial sepsis of the newborn remained stable.”
  • Per Endocrinology Advisor,
    • “Individuals with celiac disease or thyroid disease have a significantly increased risk of developing type 1 diabetes (T1D), according to study findings published in Diabetes, Obesity and Metabolism.”
  • Per Pulmonology Advisor,
    • “Obstructive sleep apnea (OSA) is highly prevalent in those age 50 years and older, but manifests differently by race/ethnicity and sex, with the most rapid-eye-movement (REM) sleep respiratory events in Black women and the highest oxygen saturation (SpO2) levels in Mexican American women. These were among study findings published in the Annals of the American Thoracic Society.”
  • BioPharma Dive lets us know,
    • “A targeted lung cancer drug from Nuvalent led to tumor responses in about half of people who previously received at least one therapy like it, and 44% of those who had received at least two similar medicines, according to results from a clinical trial the company shared Tuesday.
    • “The study of Nuvalent’s drug, zidesamtinib, involves people whose metastatic non-small lung cancer has alterations in the gene ROS1. In addition to past treatment with so-called tyrosine kinase inhibitors, some participants had also received chemotherapy beforehand. Nuvalent will use the data to support a U.S. approval application for these “pre-treated” patients, which it expects to complete in the third quarter.
    • ‘Nuvalent is also studying zidesamtinib in ROS1-positive lung cancer patients who haven’t yet been treated and is discussing with the Food and Drug Administration the possibility of a “line-agnostic expansion” for the drug. A similar medicine from Nuvation Bio was approved this month for patients regardless of whether they’d previously been given a tyrosine kinase inhibitor.”
  • Per Healio,
    • “COPD mortality rates varied across North Carolina, often correlating with access to care and other risk factors, according to a pair of posters presented at the American Thoracic Society International Conference.
    • “What we’re looking at is your risk of COPD mortality based on your ZIP code,” Alexa M. Zajecka, MD, a first-year pulmonary critical care fellow at East Carolina University Medical Center, told Healio.”
    • “The researchers noted that although COPD is a leading cause of mortality and that North Carolina has one of the highest COPD-related death rates in the United States, there has been little research into its spatial clustering at the local level.” 
  • Gen Edge reports,
    • Amyotrophic lateral sclerosis (ALS) remains one of the most devastating and biologically elusive neurodegenerative diseases. Despite decades of research, its underlying mechanisms are still not fully understood. The condition presents a complex and highly variable interplay of genetic mutations, environmental factors, and cellular dysfunctions that differ widely across patients. This heterogeneity has slowed the development of effective diagnostics and therapeutics, leaving researchers to chase a moving target across a fragmented molecular landscape.
    • Yet much of ALS research still relies on static models—snapshots of a disease in motion. The condition unfolds dynamically, impacting multiple neural and non-neural cell types in real time. Capturing that progression requires lifelike systems that can replicate ALS as it unfolds in the human body. Without that, critical windows for intervention may remain hidden in plain sight.
    • “In a new study published in Cell Stem Cell titled, “An organ-chip model of sporadic ALS using iPSC-derived spinal cord motor neurons and an integrated blood-brain-like barrier,” researchers at Cedars-Sinai have developed a dynamic ALS model using patient-derived stem cells. This system may help uncover both the causes of ALS and new therapeutic targets.”
  • Per an NIH Intramural Research Program release,
    • It seems like every news report touting the health benefits of a daily glass of wine is soon followed by another that claims consuming any amount of alcohol harms health. While the jury is still out on this issue for younger individuals, a recent IRP study suggests that alcohol consumption may accelerate the typical age-related erosion of the cardiovascular system

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “It is becoming more difficult for insured and uninsured Americans to access affordable healthcare services, according to a new report from S&P Global Ratings.
    • “The United States spends more on healthcare services than any other country by any metric, according to the report. As of 2023, an individual could expect average out-of-pocket annual healthcare costs to run them an average of $6,159 annually and ancillary costs to account for approximately 6% of their average annual income before taxes.
    • “Efforts to rein in healthcare spending thus far have been mixed, and recent cost pressures could cause costs to climb further still, according to the report. Should headwinds continue, providers may be forced to make tough choices about what services they offer and where.”
  • and
    • “Ascension CEO Joseph Impicciche will retire at the end of the year, the nonprofit health system announced Tuesday.
    • “The health system’s board of directors has appointed President Eduardo Conrado to succeed Impicciche, effective Jan. 1, 2026.
    • “Ascension said it has been preparing for Impicciche’s departure for some time, adding the executive will be “actively engaged” in Conrado’s transition.”
  • Per BioPharma Dive,
    • “Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40 million to a spinout of genetic medicine maker Lexeo Therapeutics to that will aim to advance drugs for heart conditions.
    • “The new biotech will focus on RNA-based medicines for genetically mediated cardiac conditions using a non-viral delivery method, according to a Tuesday announcement from Lexeo.
    • “Under the agreement, Lexeo will hold double-digit percentage equity in the new company, and could receive future milestone payments, royalties and opt-in rights to its programs.”
  • MedCity News informs us,
    • “Cohere Health, a clinical intelligence company, launched a new solution called Review Assist, which speeds up medical necessity reviews for health plans, the company announced on Monday.
    • “Boston-based Cohere Health provides AI-powered prior authorization solutions to help improve the relationship between payers and providers. The new tool is meant to help health plan clinical staff with prior authorization reviews, which are often extremely burdensome, according to the company. The typical process requires reviewers to analyze hundreds of pages of clinical records in order to determine if a patient procedure is medically necessary.
    • “Review Assist operates within existing utilization management workflows. It uses Cohere’s AI and large language models to analyze unstructured and structured clinical data and provide actionable insights for reviewers, as well as links to its source for this information. In addition, it has an AI chatbot that can answer questions for the reviewer and find additional insights.”
  • and describes Cigna Healthcare’s six new digital tools to improve the customer experience.
  • Per Beckers Health IT,
    • “Amazon One Medical and Edison, N.J.-based Hackensack Meridian Health continue to open clinics across New Jersey to expand access to primary care.
    • “The two organizations joined forces in 2023 to co-open the offices and make Hackensack a specialty care referral partner of Amazon One Medical.
    • “We hope to have 20 or maybe even more of these types of centers,” Hackensack CEO Robert Garrett said at a ribbon-cutting of the latest clinic June 17 covered by NJBiz. “It’s so well-needed. We’re going to be looking at different locations throughout the state of New Jersey in terms of where we think there’s a need for greater access to care.”
  • Modern Healthcare reports,
    • Current Health cofounder Chris McGhee has reacquired the at-home care company from Best Buy Co.
    • Financial details of the transaction were not disclosed.
    • “McGhee is returning as Current’s CEO. Former Chief Technology Officer Stewart Whiting and other former team members are also returning, according to a Tuesday announcement on the company’s website.”

Monday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Obesity, U.S. Healthcare–
  • Govexec tells us,
    • “Last week, Senate Homeland Security and Governmental Affairs Committee Chairman Rand Paul, R-Ky., unveiled his panel’s portion of congressional Republicans’ budget reconciliation package, which aims to reduce federal spending to partially pay for extended tax cuts for the ultrawealthy and increased immigration enforcement. The measure abandoned a series of House-passed proposals to cut the retirement benefits of currently serving federal workers but would have required future federal hires to pay nearly 15% of their paychecks toward their retirement benefits if they wished to accrue civil service protections.
    • “But Sen. Jeff Merkley, D-Ore., top Democrat on the Senate Budget Committee, announced Sunday that the Senate parliamentarian had ruled that most of the Senate’s proposals governing federal benefits and workforce policies violated the Byrd rule, which aims to limit reconciliation measure—and its simple majority threshold for passage—to topics that are budgetary in nature.” * * *
    • “Provisions that would require a 60-vote majority to advance include the plan to require all new federal employees to pay 9.4% toward the Federal Employees Retirement System and to choose between paying an additional 5 percentage points toward FERS or serving as at-will employees; a requirement that federal employees challenging an adverse action before the Merit Systems Protection Board pay a $350 filing fee, as well as a proposal to charge federal employee unions for use of agency property and official time on a quarterly basis.
    • “The parliamentarian also said that a provision effectively giving the Trump administration “carte blanche” to reorganize federal agencies and lay off thousands of federal workers would similarly run afoul of the Byrd rule. Earlier this month, Senate Majority Leader John Thune told reporters that he would not consider overruling the parliamentarian as part of the bid to send the reconciliation package to President Trump’s desk by July 4.
    • “Still remaining in the package is a provision tasking the Office of Personnel Management with conducting an audit of enrollees in the Federal Employees Health Benefits Program to ensure family members remain eligible as dependents, and a requirement that the government charge a 10% fee on deductions from federal workers paychecks, such as unions dues and charitable contributions as part of the Combined Federal Campaign.”
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services June 23 announced an initiative coordinated with multiple health insurance companies to streamline prior authorization processes for patients covered by Medicare Advantage, Medicaid managed care plans, Health Insurance Marketplace plans and commercial plans. Under the initiative, electronic prior authorization requests would become standardized by 2027. HHS stated that these reforms complement ongoing regulatory efforts by CMS to improve prior authorization, including building upon the Interoperability and Prior Authorization final rule. 
    • “The plan is expected to make the prior authorization process faster, more efficient and more transparent, the agency said. Participating insurers pledged to expand real-time responses by 2027. HHS said that the insurers would also commit to reducing the volume of medical services subject to prior authorization by 2026, including those for common procedures such as colonoscopies and cataract surgeries. 
    • “During a news conference, HHS Secretary Robert F. Kennedy Jr. said unlike previous attempts by insurers, this initiative would succeed because the number of insurers participating represent 257 million Americans. “The other difference is we have standards this time,” he said. “We have … deliverables. We have specificity on those deliverables, we have metrics, and we have deadlines, and we have oversight.” 
    • “Mehmet Oz, M.D., CMS administrator, said that the pledge “is an opportunity for industry to show itself.” Sen. Marshall, R-Kan., said that Congress could pursue codifying at least some portions of the initiative in the future. 
    • “Additionally, participating insurers would honor existing prior authorizations during coverage transitions.” 
  • Here are links to AHIP and BCBSA announcements concerning this prior authorization development.
  • Think Advisor points out,
    • “Most Medicare programs use current premium revenue and government contributions to pay for their operations.
    • “One Medicare program, the Medicare Part A inpatient hospitalization program, is supposed to use the earnings on assets stored in a trust fund to cover some costs.
    • “Assets at the trust fund have fallen below $209 billion — less than the asset total at UnitedHealth or CVS Health.
    • ‘Medicare trustees say they now expect the trust fund to run dry in 2033. That’s down from a depletion year of 2036 included in last year’s report.
    • “But if the Part A trust fund runs dry, and Congress makes no changes, payroll taxes and premium revenue should be high enough to cover about 89% of the promised inpatient hospitalization benefits, according to the trustees.
    • “The trustees’ estimate of the share of promised benefits ongoing revenue can pay is unchanged from last year.”
  • HHS lets us know,
    • “On June 18, 2025, [as the FEHBlog noted at the time] the U.S. District Court for the Northern District of Texas issued an order declaring unlawful and vacating most of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy at 89 Federal Register 32976 (April 26, 2024).
    • “With regard to the modifications to the HIPAA Privacy Rule Notice of Privacy Practices (NPP) requirements at 45 CFR 164.520, the court vacated only the provisions that were deemed unlawful, namely 164.520(b)(1)(ii)(F), (G), and (H).
    • “The remaining modifications to the NPP requirements are undisturbed and remain in effect, see Carmen Purl, et al. v. U.S. Department of Health and Human Services, et al., No. 2:24-cv-00228-Z (N.D. Tex. June 18, 2025).
    • “Compliance with the remaining NPP modifications is required by February 16, 2026. HHS will determine next steps after a thorough review of the court’s decision.”
    • In the FEHBlog’s view, it’s a safe bet that HHS will not appeal this decision.
  • BioPharma Dive notes,
    • “A top Food and Drug Administration official responsible for overseeing drug reviews is reportedly retiring from the agency, adding to an exodus of senior staff who have either left or been forced out by Trump administration leadership.
    • “Jaqueline Corrigan-Curay, who serves as acting head of the FDA’s Center for Drug Evaluation and Research, will depart next month, according to reports from Endpoints News, Stat News and other publications.
    • “Corrigan-Curay became acting CDER director after Patrizia Cavazzoni left the position shortly before the Trump administration took office. A physician and lawyer, Corrigan-Curay joined the FDA in October 2016 and was appointed principal deputy center director at CDER in 2021.”
  • Bloomberg Law reports,
    • “Republican Senator Bill Cassidy is seeking to delay a scheduled meeting of vaccine advisers selected by Health and Human Services Secretary Robert F. Kennedy Jr. out of concern they’re not sufficiently qualified.
    • “Cassidy, who’s from Louisiana and leads the Senate’s health committee, publicly called on the Trump administration to put off the meeting slated for Wednesday via a post on the social platform X on Monday.
    • “Wednesday’s meeting should not proceed with a relatively small panel, and no CDC Director in place to approve the panel’s recommendations,” posted Cassidy.” * * *
    • “Cassidy will run the hearing for President Donald Trump’s CDC director nominee, Susan Monarez, on Wednesday. That’s the same day that the vaccine advisers are expected to begin their meeting. 
    • “Spokespeople for CDC and HHS did not immediately respond to requests for comment.”

From the public health and medical research front,

  • Health Day reports,
    • “Hypertension is the most common chronic condition among adults aged 85 years and older, with prevalence higher among women than men, according to a report published in the June Health E-Stats, a publication of the National Center for Health Statistics.
    • “Yelena Gorina, M.P.H., and Ellen A. Kramarow, Ph.D., from the National Center for Health Statistics in Hyattsville, Maryland, used data from the 2022 and 2023 National Health Interview Survey to present estimates of the percentage of adults aged 85 years and older with 11 selected chronic conditions.
    • “The number of American adults aged 85 years and older was 6.1 million in 2023 and is projected to reach 13.7 million by 2040. The authors note that the most common of the selected chronic conditions reported were hypertension, arthritis, and high cholesterol among civilian noninstitutionalized adults aged 85 years and older (66.9, 55.9, and 46.5 percent, respectively). For both men and women, hypertension was the most common chronic condition reported, with a higher prevalence for women than men (68.9 versus 63.7 percent). The prevalence of arthritis was also higher for women than men (63.2 versus 44.2 percent), but men had a higher prevalence of high cholesterol (50.5 versus 44.0 percent), cancer (39.8 versus 28.6 percent), heart disease (31.5 versus 26.3 percent), and diabetes (19.3 versus 14.5 percent).”
  • The American Medical Association tells us what doctors wish their patients knew about thyroid cancer.
  • Beckers Hospital Review lists by state the 514 U.S. hospitals 514 hospitals with “a catheter associated urinary tract infection rate of zero, as based on the healthcare-associated infections dataset from CMS.”
  • The New York Times reports at length on the impact of the measles outbreak on healthcare providers and public health officials in rural America.
  • Consumer Reports, writing in the Washington Post, discusses “using cannabis for health problems It’s being used for everything from pain to insomnia. When it might help and when it won’t — in any case, don’t vape or smoke it.”
  • FiercePharma relates,
    • “Roche has demonstrated the power of combining two of oncology’s hottest modalities—bispecifics and antibody-drug conjugates (ADCs)—in a Lunsumio-Polivy regimen in large B-cell lymphoma (LBCL).
    • “The combination of the CD20xCD3 bispecific Lunsumio and the CD79b-directed ADC Polivy significantly reduced the risk of progression or death by 59% versus the traditional R-GemOx regimen in patients with previously treated LBCL who are not eligible for stem cell transplant. R-GemOx includes Roche’s own Rituxan and the chemotherapies gemcitabine and oxaliplatin.
    • “Patients in the Lunsumio-Polivy group went a median 11.5 months without disease progression versus 3.8 months for R-GemOx, according to the primary analysis of the phase 3 Sunmo study presented at the International Conference on Malignant Lymphoma.
    • “Roche said it will submit the trial results to global health authorities, including the FDA. While Lunsumio is currently approved as an intravenous infusion to treat follicular lymphoma, the Sunmo trial uses a subcutaneous formulation of the drug. Polivy, meanwhile, received the FDA’s approval as part of a combination for certain previously untreated patients with LBCL in 2023.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s new weight-loss drug helped patients lose even more weight on average than its current Wegovy blockbuster treatment, an early-stage trial showed, as the drugmaker races to develop the next generation of obesity medicines.
    • “The company’s drug, known as amycretin, helped patients lose over 24% of their weight, which compares with an average of about 17% for its Wegovy treatment.
    • “The drug mimics the same gut hormone as the Wegovy treatment to suppress appetite, delay stomach emptying and control blood sugar, but combines it with amylin, a hormone in the pancreas that also regulates appetite.
    • “The new treatment was administered as a once-weekly shot and a daily pill, with results showing that side effects were mostly in line with other obesity medications. Patients taking the amycretin injection lost an average of 24.3% of their weight when dosing up to a 60-milligram shot over 36 weeks of treatment, while those on the pill lost up to 13.1% over 12 weeks.” * * *
    • “The data was published in the Lancet and presented at the American Diabetes Association conference over the weekend. Novo Nordisk plans a late-stage trial for the new drug early next year.”
  • STAT News also reports from the American Diabetes Association meeting,
    • “An investigational therapy from Eli Lilly helped preserve lean mass and drive greater loss of fat in patients taking the popular obesity treatment Wegovy.
    • “In a Phase 2 trial, patients taking the highest-dose combination of Wegovy and the drug, called bimagrumab, lost 22% of their weight at 72 weeks. Ninety-three percent of that was fat mass, and the rest was lean mass. People taking Wegovy alone lost a smaller 16% of their weight, and 72% of that was fat mass, according to results that will be presented Monday at the American Diabetes Association meeting.”
  • and
    • “Amgen’s monthly obesity candidate led to substantial weight loss but a high rate of side effects and discontinuations in a mid-stage trial, results that support the company’s decision to use a slower dosing schedule to make the drug more tolerable in further testing. 
    • “In the Phase 2 study, patients with obesity taking the injectable drug, called MariTide, lost up to 16.2% of their weight in one year when taking into account all participants regardless of discontinuations. Patients lost up to 19.9% when analyzing only those who stayed on treatment.”
  • and
    • “Obesity drugs were first approved to treat type 2 diabetes, but there’s a growing movement to test them in type 1 diabetes, too. Research presented Monday at a large diabetes meeting showed some promise for this approach.
    • “Patients who took a GLP-1 drug fared better than those in a control group at keeping their blood glucose levels in a healthy range while also losing more weight than those who weren’t taking the drug.”
  • Per BioPharma Dive,
    • “One of the most closely watched clinical trials in the burgeoning field of psychedelics research has delivered results that, while positive, appear to have unnerved some investors.
    • “Sponsored by U.K.-based biotechnology company Compass Pathways, the trial enrolled 258 people with treatment-resistant depression. Participants were given either a placebo or the company’s proprietary version of psilocybin — a psychedelic compound found in many mushroom species — and evaluated for an initial period of six weeks.
    • “According to Compass, a single dose of its drug significantly reduced scores on a 60-point scale that healthcare providers use to gauge depressive symptoms.”
    • The article explains why investors were not impressed by these results.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses the top ten nonprofit health systems by 2024 operating revenue, and points out
    • “Despite an uncertain regulatory environment and higher hold period for investments in healthcare, deal volumes remain steady.
    • “So says a new report from PwC. In addition to regulatory scrutiny, persisting valuation gaps between buyers and sellers have contributed to hesitation in the market. Nonetheless, deals continue to pace significantly ahead of pre-COVID levels—though are down from the boom years of 2020 to 2022. The three-year running average of the number of healthcare transactions weighs in at 1,375. 
    • “The subsector leading with the most deals (454) in the last 12 months was a group of services that includes contract research organizations, ambulatory surgical centers, home infusion care and medical office buildings. These deals represented more than $31 billion in value. In second place were physician groups (413 deals totaling $11.3 billion) followed by labs and diagnostics (110 deals worth $7.6 billion).”
  • and
    • “Concern about the cost of GLP-1s remains high, and a new study suggests it’s not uncommon for patients to overpay for these drugs.
    • “E-prescribing company DoseSpot released a study Monday that analyzed more than 100,000 prescriptions for GLP-1s and found they likely overpaid by a collective $10.2 million. Most (92%) of prescriptions included at the study could have been obtained at a lower price.
    • “The data were provided exclusively to Fierce Healthcare. The report said that the $10.2 million in savings extrapolated across the approximately 32 million individuals who currently take GLP-1 ones mean there’s an opportunity here for potentially billions in savings.
    • “The bulk of the savings identified in the study, or about $7 million, would have been generated by being in one of the manufacturers’ savings programs. Josh Weiner, CEO of DoseSpot, told Fierce Healthcare in an interview that stakeholders can do more to keep providers in the loop about what patients may be eligible for.”
  • The Wall Street Journal reports,
    • “Novo Nordisk ended its partnership with Hims & Hers, accusing it of illegally selling copycats of Wegovy and deceptive marketing.
    • “Hims & Hers accused Novo Nordisk of pressuring it to steer patients to Wegovy, regardless of whether it was the best option.
    • “Hims & Hers’ shares dropped after the deal was scrapped. Novo Nordisk will continue to make Wegovy available via telehealth.”
  • Beckers Health IT takes a look at Google Healthcare’s moves.
  • Per Healthcare Dive,
    • “Ohio’s attorney general has conditionally approved venture capital firm General Catalyst’s acquisition of Summa Health, according to a press release Wednesday. 
    • “General Catalyst’s Health Assurance Transformation subsidiary, or HATCo, and the Akron, Ohio-based health system must meet 10 conditions to allow the deal to move forward, including increasing the purchase price by $15 million in cash and an additional $15 million in equity to the surviving nonprofit foundation, according to a letter sent by Attorney General Dave Yost’s office. The equity interest can’t be sold for three years. 
    • “HATCo will also have to file a yearly report with the attorney general to show it’s complying with post-closing obligations, as well as provide notice of new deals that could trigger antitrust concerns.”
  • Per MedTech Dive,
    • “Illumina said Monday it agreed to acquire SomaLogic and other assets from Standard BioTools for $350 million in cash to expand in the proteomics market.
    • “The deal includes additional near-term payments of up to $75 million tied to performance milestones, plus royalties.
    • “Illumina said the acquisition of SomaLogic, a leader in data-driven technology, will advance the company’s multiomics strategy and strengthen the value of its NovaSeq X products.
    • “Illumina and SomaLogic have partnered closely for more than three years, and this combination increases our ability to serve our customers and accelerate our technology roadmap towards advanced biomarker discovery and disease profiling,” Illumina CEO Jacob Thaysen said in a statement.”

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–

FEHBlog note: Since the FEHBlog launched in 2006, the FEHBlog has featured a photograph at the top of the post. The FEHBlog learned today that email subscribers to the FEHBlog see a blank spot at the top of the page as the email system blocks photographs. For that reason, the FEHBlog has stopped using photographs in the blog except when necessary.

From Washington, DC,

  • Roll Call informs us,
    • “Senate Republicans say they are looking for ways to safeguard rural hospitals from proposed cuts to a key Medicaid funding method, amid concerns from the powerful hospital lobby and others that the budget reconciliation bill could force many facilities to close.
    • “The draft text that the Senate Finance Committee released this week reduces the ability of states who expanded Medicaid under the 2010 health care law to levy taxes on providers to fund their programs. 
    • “Senate Majority Leader John Thune, R-S.D., told reporters Wednesday he is working on the issue, though he did not offer details. Leadership is attempting to balance directives to cut government spending with demands from senators like Josh Hawley, R-Mo., who said that the bill should protect rural hospitals from the effects of shrinking provider taxes.
    • “The right thing to do is not defund rural hospitals to pay for your pet projects,” Hawley said. “So, if you want your pet project in the bill, go find your own money. Don’t defund rural hospitals.” 
    • “Medicaid is often one of the top payers for rural facilities.”
  • STAT News adds,
    • “Hospitals are now lobbying senators to return to the House’s version of the bill, which also is expected to substantially cut hospitals’ revenues and the number of patients covered — but less so than the Senate’s version of the bill. 
    • “But that lobbying effort is butting up against senators who want to further reduce government spending. The Congressional Budget Office has not yet projected the budget impact of the Senate bill.”
  • The American Hospital Association News tells us,
    • The Centers for Medicare & Medicaid Services June 20 announced it is finalizing its 2025 Marketplace Integrity and Affordability final rule. The rule shortens the open enrollment period for the federal marketplace to Nov. 1-Dec. 15 starting in 2027, and limits open enrollment periods for state-based marketplaces to Nov. 1-Dec. 31. The rule also includes a change to the premium adjustment percentage that would increase the maximum annual cost sharing limitation. Additionally, the rule makes updates to the income verification process and pre-enrollment verification process for SEPs, changes to the essential health benefits, modifications to the redetermination and re-enrollment processes, and ends a special enrollment period for low-income individuals, among other policies. Many of the provisions reinstate policies finalized during the prior Trump administration.
  • Here is a link to CMS’s fact sheet on this final rule.
  • Govexec lets us know,
    • “The White House and its Department of Government Efficiency are spearheading efforts to shake up the Postal Service, according to details of the meetings obtained by Government Executive, with topics including pricing for mail and general reform proposals. 
    • “The meetings were not clearly within the scope of a memorandum of understanding former Postmaster General Louis DeJoy signed with DOGE, which focused on specific cost-cutting measures and real estate planning. Some of the meetings also involved top officials from the Treasury Department, White House attorneys and policy advisors and additional USPS executives. A source familiar with the meetings confirmed DOGE has been active at the Postal Service’s Washington headquarters in recent months.” 
  • Per an OPM news release,
    • This week, the U.S. Office of Personnel Management (OPM) Inspector General (IG) released a report that uncovered widespread compliance failures and weak internal oversight in the agencyʼs telework and remote work programs during the Biden Administration.
    • The report revealed more than half of OPM employees reviewed failed to meet basic in-office requirements and nearly a third of sampled teleworkers had expired or missing agreements. Additionally, 15 percent of remote workers had no approved agreement on file, and many discrepancies flagged by HR remained unresolved for months.
    • Since President Trump took office, OPM has reinstated in-office requirements to restore a culture of accountability and public service.
    • “Under the previous administration, OPMʼs telework and remote work policies were mismanaged and oversight was virtually nonexistent,” Acting Director Chuck Ezell said. “That era of telework abuse is over. At President Trumpʼs direction, OPM has restored in-person operations to ensure federal employees are working for the taxpayers.”
    • OPM has already implemented new internal controls and compliance reviews, and effective March 3, 2025, all employees are required to report to their official duty station full-time.
    • Read the OIG report here.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Sanofi and Regeneron Pharmaceuticals said they got Food and Drug Administration approval for anti-inflammatory drug Dupixent as a treatment for a rare skin disease, adding an eighth indication in the U.S. for their blockbuster medicine.
    • “France’s Sanofi and Tarrytown, N.Y.-based Regeneron said Friday that the FDA gave the green light for Dupixent as a treatment of adult patients with bullous pemphigoid, a skin disease that mainly affects elderly people and is characterized by itch, blisters and lesions, as well as a reddening of the skin.”

From the judicial front,

  • SCOTUSblog reports,
    • In a splintered decision, the Supreme Court did not allow a retired firefighter to sue her prior employer under the ADA. The majority opinion, written by Justice Gorsuch, determined the retiree was not a “qualified individual” under the law. In dissent, Justice Jackson called the majority opinion “counterintuitive.”
  • and
    • “On Friday, the Supreme Court opined on a challenge by retailers of e-cigarettes to an FDA decision. The majority opinion, written by Justice Amy Coney Barrett, held that the challengers were “adversely affected” by the FDA’s decision and could thus seek judicial review in the 5th Circuit.”
  • The AHA News relates,
    • “The U.S. District Court for the Northern District of Iowa June 18 vacated components of the Centers for Medicare & Medicaid Services’ minimum nurse staffing rule requiring nursing homes to have a registered nurse onsite 24/7 and prescribing a minimum total nurse staffing hours per resident day. The court kept in place the rule’s enhanced facility assessment and Medicaid reporting requirements.
    • “CMS’s general rulemaking power to promulgate ‘such other requirements as the Secretary deems necessary’ does not constitute clear authorization to mandate rigid staffing requirements for [long-term care] facilities,” wrote District Court Judge Leonard T. Strand in the ruling. “Therefore, I find that CMS did not have authority to promulgate the 24/7 RN requirement and the HPRD requirements pursuant to its health and safety rulemaking authority.”
    • “A district court in Texas also vacated the minimum staffing mandate in April.”
  • Beckers Payer Issues points out,
    • “New York City can implement an Aetna Medicare Advantage plan for its retirees, the state’s highest court ruled June 18. 
    • “The city has pushed to switch its health benefits for retired city employees to a Medicare Advantage plan since 2021. A group of retired employees sued to block the plan, arguing that the city had promised to provide supplemental Medicare benefits, and that their healthcare benefits would be diminished under an MA plan. 
    • “The New York Court of Appeals ruled against the retirees, reversing lower courts’ decisions. The judges ruled the city was not obligated to offer Medigap plans to its retirees. The court also ruled the retirees did not prove their care would be harmed under an MA plan.” 

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity is low. COVID-19 and RSV activity is very low.
    • “COVID-19
      • “COVID-19 wastewater activity is low and emergency department visits and laboratory percent positivity are at very low levels.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • “New findings presented at the annual meeting of the American Society for Microbiology suggest increased levels of fungal spores in the air are strongly linked to surges in cases of influenza and COVID-19.
    • “The study was based on daily spore samples taken in 2022 and 2024 in San Juan and Caguas, Puerto Rico, where fungal spores and pollen are endemic and present year-round. The data on spores was matched to data on the daily incidence of people diagnosed with COVID-19 and flu.
    • “The researchers found increases in fungal spore counts matched surges in flu and COVID activity. There was no relationship between pollen levels and respiratory illness activity.
    • “The findings from our study suggest that monitoring airborne fungal spore levels could help predict short-term outbreaks (spikes) of flu and COVID-19, giving public health systems an early warning signal,” study author Felix Rivera-Mariani, PhD said in a press release from the American Society of Microbiology. “Our findings also highlight the potential role of environmental factors—not just person-to-person spread—in contributing to the incidence of respiratory viral infections. That could open new doors for targeted public health alerts, especially in areas with high outdoor airborne fungi.” 
  • and
    • “The US Centers for Disease Control and Prevention (CDC) reported 17 more measles cases today in its weekly update, bringing its total for the year to 1,214 confirmed cases from 36 jurisdictions.
    • “Although measles cases have slowed since peaking in late March, the uptick in cases brings the country closer to surpassing the 1,274 cases reported in 2019, which to date is the highest number reported in a single year since the disease was eliminated from the United States in 2020. There were 285 confirmed measles cases in 2024. 
    • “The CDC reported two additional outbreaks (three or more related cases), bringing the 2025 total to 23 outbreaks. Of the 1,214 confirmed US cases, 89% are outbreak associated. Only 16 outbreaks were reported in 2024, with 69% of confirmed cases associated with those outbreaks. The biggest outbreak in 2025 has been in West Texas, which has seen 750 confirmed cases since late January.”
  • and
    • “Since late April, an infectious diseases specialist at Stanford University and his colleagues have been volunteering their time on a project they hope will help educate the public, and combat misinformation, about the safety and efficacy vaccines.
    • “The project, led by Jake Scott, MD, is a spreadsheet of all the randomized controlled trials (RCTs) that have ever been conducted for licensed vaccines. The idea, hatched on the social media site X, was prompted by responses to an old video of current Department of Health and Human Services Secretary Robert F. Kennedy Jr., in which he claims that none of vaccines mandated for US children has ever been tested in preclinical studies against a placebo. In one of the responses, infectious disease physician Brad Spellberg, MD, suggested a crowd-sourced effort to identify and post all of the RCTs in which vaccines have been tested against a placebo.
    • “That night Scott, a self-proclaimed “spreadsheet geek” who has previously collaborated with Spellberg, began building a spreadsheet using Google Sheets, creating criteria for inclusion, and seeding it with seven vaccine RCTs. Each entry has columns for the name of the vaccine, the date the RCT was published, which populations were studied, how many people were involved in the study and, importantly, the types of placebo or active comparator that were used for the control group.
    • “By the next morning, there were 20 vaccine RCTs on the spreadsheet. By May 5, the list had grown to 100. The spreadsheet now stands at more than 270 RCTs and continues to grow. Scott and his colleagues, who aim to eventually publish a peer-reviewed paper on the project in a medical journal, thoroughly review each entry before inclusion and provide links to the RCTs on PubMed.
    • “I think we’re kind of looking at the tip of the iceberg,” Scott told CIDRAP News. “There’s going to be, I would say, easily 400-plus, maybe 500-plus trials with millions and millions of participants.”
  • The AP reports,
    • “Older U.S. adults are increasingly dying from unintentional falls, according to a new federal report published Wednesday, with white people accounting for the vast majority of the deaths. 
    • “From 2003 to 2023, death rates from falls rose more than 70% for adults ages 65 to 74, the report from the U.S. Centers for Disease Control and Prevention said. The rate increased more than 75% for people 75 to 84, and more than doubled for seniors 85 and older.
    • “Falls continue to be a public health problem worth paying attention to,” said Geoffrey Hoffman, a University of Michigan researcher who was not involved in the new report. “It’s curious that these rates keep rising.”
  • MedTech Dive notes five things to watch at the American Diabetes Association’s upcoming scientific session.
    • “At the American Diabetes Association’s Scientific Sessions, companies like Abbott, Dexcom and Beta Bionics will share the latest data on diabetes technology and new partnerships.
    • “The annual conference takes place June 20-23 in Chicago, with industry leaders gathering to discuss new developments in diabetes treatments. This year’s event follows new ADA standards of care that would expand access to continuous glucose monitors, recommending that the devices be used in adults with Type 2 diabetes who are taking glucose-lowering medications other than insulin.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Health insurers will pledge to smooth the preapproval process following backlash after the killing of an executive last year.
    • “Insurers will create a standard for electronic requests by 2027, with 80% answered in real time if documentation is included.
    • “The industry plan includes reducing procedures subject to authorization, improving explanations, and helping patients changing insurers.”
  • and
    • “Planes have been jetting from Ireland to the U.S. this year carrying something more valuable than gold: $36 billion worth of hormones for popular obesity and diabetes drugs.
    • “The frantic airlift of those ingredients—more than double what was imported from Ireland for all of last year—reflects the collision of two powerful forces: tariff-driven stockpiling and weight-loss drug demand.
    • “The peptide- and protein-based hormones feed into a category of drugs that include wildly popular GLP-1 treatments and newer types of insulin known as analogues. Taken together the shipments weighed just 23,400 pounds, according to U.S. trade data, equivalent to the weight of less than four Tesla Cybertrucks.
    • “Fit into temperature-controlled air-cargo containers, the pharmaceutical ingredients have had a huge impact on the U.S. trade imbalance. The shipments have propelled Ireland, a country of only 5.4 million people, to the second-largest goods-trade imbalance with the U.S., trailing only China. They accounted for roughly half of the $71 billion in goods the U.S. imported from the country in the first four months of the year.
    • “Nearly 100% of the imports had a final destination of Indiana, according to U.S. customs records. Eli Lilly, the drug giant behind weight loss and diabetes drugs Zepbound and Mounjaro, is headquartered in Indianapolis.”
  • Mercer Consulting notes,
    • “It’s been over three years since group health plan sponsors and issuers, in order to comply with the Transparency in Coverage final rule, began posting Machine-Readable Files that contain in-network negotiated charges for every medical item and service with providers in their networks, as well as out-of-network allowed amounts and billed charges. This data had previously been considered by insurers as proprietary and confidential, but the government recognized the need to make healthcare costs more transparent. The rule also requires group health plan sponsors and issuers to post files for negotiated rates and historical net prices for covered prescription drugs, but regulators have delayed that particular requirement .
    • “But even though the data has been available to the public since July 2022, almost 70% of very large employers (5,000+ employees) responding to our 2025 Health Policy Survey report that they have yet to meaningfully use the data.
    • “Impeding use is the sheer amount of data that was dropped on the internet all at once, but not all in one place. According to a recent report from the Congressional Review Service, users have faced significant challenge * * *.
  • Per Fierce Healthcare,
    • “Hinge Health, which just went public last month, launched a referral network of in-person providers to complement its virtual physical therapy platform.
    • “The curated provider network for musculoskeletal (MSK) care, called HingeSelect, includes imaging centers and brick-and-mortar physical therapy providers to help bridge the gap between in-person and digital care. The aim is to offer a more comprehensive end-to-end MSK care model, executives said.
    • “Hinge Health’s technology and in-house orthopedic physicians triage and direct downstream care. When in-person care, such as imaging or injections, is required, members are connected to pre-vetted providers at up to 50% below PPO rates.” 
  • Per Beckers Payer Issues,
    • “Philadelphia-based Independence Blue Cross has launched a new GenAI customer service tool to support customer service representatives in improving accuracy and speed of customer interactions, according to a news release shared with Becker’s. 
    • “The pilot, initiated in February 2025, tasked more than 40 customer service representatives with using the tool to assist with member-specific questions, summarize complex medical policies and search benefits. 
    • “The AI tool was found to have reduced the number of steps customer representatives must take to access critical information and improved efficiency by increasing the percentage of customers who receive solutions on their first inquiry. It also documents responses and validates the information with Independence Blue Cross’ existing customer relationship system.”

Happy Juneteenth

David Ermer–CDC, FDA, Medical / Rx research, SCOTUS, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Fierce Healthcare tells us,
    • “At AHIP’s annual conference, the trade group told reporters they oppose the reconciliation bill moving through Congress because of the impacts it would have on Medicaid and the individual market.
    • “AHIP executives said they will continue to work with other prominent healthcare organizations to convince lawmakers to protect federal health programs and help Americans remain insured—both by avoiding the harshest cuts and changes to Medicaid and the Affordable Care Act and extending the ACA enhanced premium tax credits.
    • “We are working arm in arm with hospitals, with physicians, with nurses, with patient advocates to try to mitigate these provisions,” said CEO Mike Tuffin. The group is continuing to meet with lawmakers and Congressional staff members to warn of dangers, should the bill pass.”
  • Per an HHS news release,
    • “Today, at the urging of Vice President JD Vance, under the leadership of U.S. Health and Human Services Robert F. Kennedy, Jr., the National Institutes of Health (NIH) launched a five-year, $10 million research initiative to assess and address the long-term health outcomes stemming from the 2023 train derailment in East Palestine, Ohio.” * * *
    • The multi-disciplinary, community-focused series of studies that will focus on:
      • “Longitudinal epidemiological research to understand the health impacts of exposures on short- and long-term health outcomes including relevant biological markers of risk.
      • “Public health tracking and surveillance of the community’s health conditions to support health care decisions and preventive measures.
      • “Extensive, well-coordinated, communications among researchers, study participants, community stakeholders, health care providers, government officials, and others to establish a comprehensive approach to address the affected communities’ health concerns.
    • “Technical details, application information, and other background material to the public were released today. It is expected that a series of grants will be issued to analyze various types of studies and community activities. The deadline to submit research proposals is July 21. Research projects to start this fall. Learn more here.”

From the public health front,

  • The Washington Post reports this afternoon,
    • Three people have died, and more than a dozen others were hospitalized following an outbreak of listeria that has been linked to premade chicken fettuccine alfredo meals sold nationwide at Kroger and Walmart, federal health officials said Wednesday.
    • FreshRealm, the Texas-based food manufacturer that makes the packaged products, issued a voluntary recall on Tuesday of chicken fettuccine alfredo meals made before June 17 “out of an abundance of caution,” the company said in a statement Wednesday.
    • “FreshRealm is issuing this voluntary recall strictly as a precautionary step with a full commitment to public health and safety,” the company said.
    • The outbreak spans 13 states, including Florida, North Carolina, Texas and Virginia, according to the Food and Drug Administration.
  • Medscape informs us,
    • “The upcoming American Diabetes Association (ADA) 85th Scientific Sessions will focus on new and evolving weight-loss treatments for people with and without diabetes, along with new biological and technological approaches for managing type 1 diabetes (T1D).
    • “Late-breaking symposia will include data from trials of a once-monthly injectable for obesity treatment, a nonpeptide oral GLP-1 receptor agonist (RA), and a medication combining a GLP-“1 RA with another drug designed to augment fat loss while preserving lean mass. Other new findings at the meeting include the use of a GLP-1 RA in T1D and the latest data on stem cell-derived islet cell transplantation in T1D. And always, there’s much more.
    • “The meeting will take place from June 20 to 24, 2025, in Chicago. “This year again, it will be heavily focused on obesity but more on the next generation of obesity drugs. We’re progressing to therapy that may be more amenable to the patient, with less frequent dosing and greater convenience,” Marlon Pragnell, PhD, ADA’s vice president of research and science, told Medscape Medical News.”
  • The New York Times reports,
    • “A cutting-edge cancer therapy offers hope for patients with lupus
    • “Lupus can be debilitating and sometimes deadly for the 3 million people who have it. A treatment called CAR-T appears to stop it in its tracks.”
  • STAT News lets us know,
    • Reliable communication for people with paralysis is nearing reality. Researchers have now demonstrated that a brain-computer interface can reliably translate thoughts into speech, including matching a person’s intended tone and pitch. 
    • It is the second study in as many months to validate the concept’s safety and initial efficacy. The findings are welcome news for a field that has spent decades trying to transform brain activity into reliable communication for people with paralysis. 
    • “Ten years ago … we were talking about point-and-click-based communication for people with paralysis,” said David Brandman, a study co-author and neurosurgeon at the University of California, Davis. “And now we’re talking about creating a digital voice box.”
    • “The findings were published in Nature on June 12. Brandman and the rest of the team showed that a 45-year-old man with amyotrophic lateral sclerosis was able to speak after having a device implanted into his brain.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • Aetna has big plans to revamp the way it interacts with providers and policyholders, President Steve Nelson said during the AHIP 2025 conference this week.
    • The CVS Health subsidiary aims to eliminate some prior authorization requirements, automate precertification approvals and partner with health systems in hopes of smoothing over often-contentious relationships.
    • “We are going through a cultural transformation,” Nelson said in an interview Tuesday at the health insurance industry trade group AHIP’s event, which ran Monday through Wednesday.
    • “The initiative is part of CVS Health’s recently announced $20 billion, decade-long plan to improve the digital experience for members and providers. The healthcare conglomerate’s commitment is part of the larger trend of health insurance companies working to build trust amid widespread industry criticism that erupted after the fatal shooting of UnitedHealthcare CEO Brian Thompson in December.”
  • Per Becker Hospital Review,
    • “A new report from Vizient highlighted the 10 drug shortages placing the most pressure on U.S. hospitals, with the injectable lorazepam topping the list for both general and pediatric facilities. 
    • “These shortages [which are listed in the article] span a range of essential drug categories, including sedatives, crash cart medications, pain management treatments and oncology treatments.”
  • Modern Healthcare adds,
    • “As of April, bad debt as a percentage of gross revenue had increased at a median 2.9% year over year, according to an analysis from consulting firm Kaufman Hall, which pulled data from about 700 hospitals.
    • “Bad debt refers to revenue that providers were expecting to receive from patients or payers, but did not end up collecting despite multiple attempts. Providers often write off these unpaid balances once they are deemed uncollectible. 
    • “The unpaid balances are separate from charity care, which is free or discounted healthcare offered to patients who cannot otherwise pay for treatment. 
    • “Many hospitals are reaping the benefits of higher volumes, but more patients do not necessarily translate into a stronger balance sheet. Much of the payoff depends on payer mix. Hospitals serving a larger portion of uninsured patients or patients covered by government payer plans tend to be more at risk for bad debt balances.”

Midweek Update

David Ermer–CDC, CMS, FDA, Medicare, OPM, Patient safety, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Kelly Sikkema on Unsplash

From Washington, DC,

  • Roll Call tells us,
    • “Higher health care costs and a law Congress passed last year to boost retirement benefits for public sector workers worsened the long-term outlook of Social Security and Medicare trust funds, according to annual reports released Wednesday by the programs’ trustees. 
    • “The trust funds for Medicare and Social Security benefits would be depleted faster than expected compared to last year’s estimates, losing the ability to provide full benefits to retirees in some cases years earlier than previously projected.
    • “The Hospital Trust Fund will only be able to pay 100 percent of scheduled benefits until 2033, three years earlier than the trustees reported last year, according to the trustee report. After that point, the program will only be able to pay 89 percent of total scheduled benefits, a summary says.” * * *
    • “The long-term combined outlook of the Social Security Old-Age and Survivors Insurance Trust Fund and Disability Insurance Trust Fund worsened slightly, speeding up by about three calendar quarters compared to last year’s projection, thanks largely to the passage of a law last year that boosts benefits for public sector retirees.
    • “Absent congressional action to shore up the program, the Social Security Old-Age and Survivors Insurance Trust Fund would lose the ability to pay full benefits to retirees starting in the first quarter of 2033, at which point benefits would face a 23 percent cut. That’s the same calendar year projected last year, but the estimated depletion date moved up three calendar quarters, the trustees said in the report. 
    • “If combined with the Disability Trust Fund, which would require congressional action, the Social Security Trust Fund could pay out full benefits until the third quarter of 2034, three quarters earlier than last year’s 2035 projection. At that point, retirees would see their benefits cut by 19 percent.” 
  • Federal News Network informs us,
    • “The Trump administration is attempting to address what it says are inflated numbers of high-performing federal employees, while also telling agencies to swiftly discipline or remove any feds deemed poor performers.
    • “In a memo published Tuesday, the Office of Personnel Management told agencies to begin adopting a new performance management system designed by the Trump administration. The new system attempts to more strictly delineate between different levels of employee performance and encourage agencies to rate fewer employees as high performers.
    • “For many decades now, performance management across the federal workforce has fallen short of what the American people should expect,” OPM Acting Director Charles Ezell wrote in Tuesday’s memo to agencies. “Too often, this has resulted in a lack of accountability and inflated performance ratings.”
    • “OPM began its reform efforts earlier this year by updating the performance standards and expectations for career members of the Senior Executive Service, as well as those in Senior Level, Scientific and Professional positions. Those performance expectations are now being broadened to cover nearly all career federal employees.”
  • Healthcare Dive notes,
    • “A nascent form of health coverage that creates an alternative gateway for employers to offer Affordable Care Act coverage to their workers is seeing rising uptake, especially among midsize to large employers.
    • “Adoption of individual coverage health reimbursement arrangements, or ICHRA plans, rose 34% from 2024 to 2025 among employers with 50 or more full-time employees, according to a new report from trade association the HRA Council.
    • “Still, the vast majority of ICHRA users remain companies with fewer than 20 employees, most of which are providing health coverage for the first time through the arrangements, the HRA Council said.”
  • Beckers Hospital Review ranks States by percentage of Medicaid births using a new KFF analysis.

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court cleared the way for states to restrict gender-transition treatments for minors, rejecting arguments that Tennessee’s ban on puberty blockers and other medical therapies amounted to unconstitutional discrimination. 
    • “Wednesday’s decision, which broke 6-3 along ideological lines, was the latest setback for transgender rights, after several months in which the Trump administration has adopted policies that range from expelling transgender personnel from the military to halting educational funding for states or institutions that permit transgender athletes on women’s sports teams. 
    • “This case carries with it the weight of fierce scientific and policy debates about the safety, efficacy, and propriety of medical treatments in an evolving field,” Chief Justice John Roberts wrote for the court. “The voices in these debates raise sincere concerns; the implications for all are profound,” he continued, but the Constitution “does not resolve these disagreements. Nor does it afford us license to decide them as we see best.”
    • “That task, he wrote, was best left to the legislature.”
  • KFF adds,
    • “As a result of the decision, minors across the US will continue to see their access to gender affirming care determined at least in part based on where they live. However, access to these services is being debated in venues beyond the judiciary, including in Congress and by the Trump Administration. The Trump Administration has taken a range of actions aimed at limiting access to gender affirming care, especially for minors and Congress too has taken up the issue. The reconciliation bill still being finalized includes a prohibition on Medicaid covering gender affirming care in Senate and House-passed versions. These efforts will likely face, and some cases already have faced, litigation. While the ruling on this case is quite limited (narrowly focused on equal protection claims and Tennessee’s ban), it could have some bearing on the outcome of future challenges.”
  • Bloomberg Law reports,
    • “A Biden administration rule prohibiting health care providers from sharing reproductive healthcare information with law enforcement was invalidated by a federal judge Wednesday.
    • “Judge Matthew J. Kacsmaryk ruled that the US Department of Health and Human Services’ rule was contrary to law since it illegally limits state public health laws, impermissibly re-defines “person” and “public health,” and oversteps the authority delegated by US Congress, he said in an opinion.” * * *
    • “The case is Purl v. Dep’t of Health and Human Services, N.D. Tex., No. 2:24-cv-00228, 6/18/25.”
  • Per Beckers Payer Issues,
    • “A former Medicare Advantage executive has been found not guilty of healthcare fraud. 
    • “A jury found Kenia Valle Boza, the former director of Medicare risk adjustment analytics for HealthSun Health Plans, not guilty of one count of conspiracy to commit healthcare fraud and wire fraud, and three counts of major fraud against the U.S., according to court documents. 
    • “The Department of Justice alleged Ms. Boza orchestrated a scheme to submit fraudulent and false information to CMS to increase the reimbursement HealthSun received from the federal government. 
    • “The department declined to prosecute HealthSun, which was acquired by Elevance Health in 2017, because of the organization’s “prompt voluntary self-disclosure, cooperation, and remediation,” according to a 2023 news release. The company also agreed to pay $53 million in repayments to the government.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Vinay Prasad will now hold three separate jobs at the Food and Drug Administration, solidifying his position as a top adviser to Commissioner Marty Makary.
    • “Prasad will serve as the agency’s chief medical and scientific officer, in addition to leading the center that regulates vaccines, gene therapies, and the blood supply, according to an internal memo obtained by STAT. Traditionally, the agency’s chief scientist and chief medical officer have been two distinct roles. 
    • “In this capacity, he will serve as a trusted advisor to the FDA Commissioner and other senior officials on cross-cutting and emerging medical and scientific issues impacting regulatory science and public health,” Makary wrote in the memo announcing the news to staff. The agency didn’t immediately respond to a request for comment.
    • “The role greatly expands Prasad’s purview, giving him explicit authority to oversee and weigh in on regulatory issues in any center. He will advise Makary on medical policy and regulatory decisions and represent the FDA at advisory committee meetings and external forums.”
  • The Wall Street Journal reports,
    • “FDA approved Gilead’s Yeztugo, a twice-yearly injectable PrEP drug, showing 99.9% effectiveness in trials.
    • “Analysts project Yeztugo sales to reach $1.6 billion in 2028, posing competition to GSK’s Apretude.
    • “Yeztugo, priced at $28,218 annually, offers improved HIV prevention uptake.”
  • Per MedTech Dive,
    • “A problem with Dexcom’s receivers for its glucose sensors may cause people to not get an audible alert for low or high blood sugar levels, the Food and Drug Administration said in an enforcement report posted Monday. More than 2 million devices are affected by the Class I recall, the highest risk category.
    • “The receiver, a handheld device that gives glucose readings, may not provide an audible alert due to a manufacturing problem. Dexcom said in a letter to customers that, as of May, it had received 56 reports of severe adverse events, such as seizure, loss of consciousness, and other hypoglycemic or hyperglycemic symptoms. All of the people recovered, the company said.
    • ‘The recall applies to receivers associated with Dexcom’s G7, G6, One and One+ CGMs. Dexcom is asking users to return the affected devices and is offering replacements.”
  • and
    • “Q’Apel Medical has recalled a device for removing blood clots in the brain over an issue linked to two injuries, the Food and Drug Administration said Tuesday.
    • “The company asked customers to return Hippo 072 Aspiration Systems and Cheetah Delivery Tools after receiving a warning letter in which the FDA raised concerns about the device’s tip.
    • “Using the recalled devices may have serious adverse health consequences including contractions or tears in the blood vessels and death, the FDA said.”
  • and
    • Centerline Biomedical has recalled guidewires used in vascular procedures over a fault that could cause serious injury or death, the Food and Drug Administration said Friday.
    • The company has asked customers to return devices from the affected lots because the coating can come off during the procedure and be left inside the patient.
    • No customers have reported serious injuries or deaths associated with the fault. The potential for serious harm led the FDA to publish a Class I recall notice.

From the public health and medical research front,

  • The Washington Post reports,
    • “A simple test of your balance, strength and flexibility, known as the sitting-rising test, could be an early indicator of how long you’ll live, according to a large-scale new study of mobility and mortality.
    • “The study, published Wednesday in the European Journal of Preventive Cardiology, looked at how well 4,282 men and women aged between 46 and 75 could lower themselves from a standing position to the floor and then stand back up again with as little assistance as possible from their hands, knees, furniture or human helpers.
    • “The test assesses “all the aspects of fitness that are not aerobic,” said Claudio Gil Araújo, the study’s lead author and research director at an exercise-medicine clinic in Rio de Janeiro, where the data were collected. Those aspects include muscular health, balance, flexibility and body composition, he said, each of which is important for longevity and health.”
  • The New York Times relates,
    • As Americans scramble to respond to rising rates of suicidal behavior among youth, many policymakers have locked in on an alarming metric: the number of hours a day that American children spend glued to a glowing screen.
    • But a study published on Wednesday in the medical journal JAMA, which followed more than 4,000 children across the country, arrived at a surprising conclusion: Longer screen time at age 10 was not associated with higher rates of suicidal behavior four years later.
    • Instead, the authors found, the children at higher risk for suicidal behaviors were those who told researchers their use of technology had become “addictive” — that they had trouble putting it down or felt the need to use it more and more. Some children exhibited addictive behavior even if their screen time was relatively low, they said.
  • Health Day lets us know,
    • “People with severe depression who receive electroshock therapy are significantly less likely to commit suicide, a new evidence review says.
    • “Electroconvulsive therapy (ECT) lowered the risk of death by suicide 34% among patients with severe depression, according to findings published June 13 in the journal Neuroscience Applied.
    • “Depression patients receiving ECT also had a 30% lower risk of death from any cause, researchers said.
    • “They said these benefits might be even greater than reflected, given that ECT has improved as a psychiatric treatment.
    • “Modern ECT appears to be more effective than it was in the past,” said lead researcher Dr. Timur Liwinski, a clinician scientist at the University of Basel in Switzerland.
    • “Since our analysis spans many decades, it’s likely that today’s ECT offers even stronger protection against suicide than the 34% reduction we identified overall,” Liwinski said in a news release.”
  • Per MedPage Today,
    • “A meta-analysis of 24 observational studies confirms excess risks of heart attack, stroke, and cardiovascular death among cannabis users.
    • “The report joins a growing body of evidence linking cannabis use to significant health harms.
    • “Nevertheless, the meta-analysis was unable to account for cannabis mode of administration, product potency, or intensity of use.”
  • Per STAT News,
    • “Scholar Rock said Wednesday that its investigational therapy helped preserve lean mass among patients taking a powerful weight loss drug, as concerns grow that patients taking new obesity treatments may be losing too much muscle.”
  • CBS News reports,
    • “At least 3% of measles cases confirmed so far this year have been in people who received two doses of the measles vaccine, meaning they were fully vaccinated, the Centers for Disease Control and Prevention says. 
    • “About three dozen of the nearly 1,200 measles infections in 2025 have been in people with two vaccine doses, the agency said Friday in its weekly update on cases. An additional 2% of cases were in people who received at least one dose of the measles vaccine.
    • “Many of the cases were in Texas, which on Tuesday counted a 21st confirmed measles case in someone with at least two doses of the vaccine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports from the AHIP 2025 conference which concluded today in Las Vegas.
    • “Medicare Advantage has historically enjoyed bipartisan popularity, but, as the program has grown, so too has scrutiny of insurers’ practices.
    • “Mike Hoak, vice president of public policy at Humana, said this is a natural cycle for public programs like MA, where policymakers don’t want to see it fail or kill it outright but want to continue evolving it to ensure it works effectively. 
    • “There was a similar reappraisal of Medicare Part D, he said.
    • “There is a really bipartisan feeling amongst policymakers: ‘I love the program,’ and—for some of them, at least—’I’d like to see it grow, but it is time for some nips and tucks,'” Hoak said. “I think Medicare Advantage is at that inflection point right now.”
  • and
    • Cigna Healthcare’s chief medical officer, Amy Flaster, M.D., joined the insurer at a difficult time for the industry.
    • Flaster stepped into the CMO role in December as health plans grappled with a wave of public outcry and frustration following the murder of UnitedHealthcare CEO Brian Thompson. 
    • She said in the wake of the shooting and public conversation that followed, the insurer “took time to reflect” on what its customers and society as a whole were saying and used that as fuel to make several “commitments to better” that are powering the company’s work moving forward.
    • “I think it was also an interesting turning point at Cigna, where we heard a lot of feedback and loud voices coming from society, from our customers, wanting to see a better system that serves their needs more efficiently, more effectively,” Flaster said in an interview with Fierce Healthcare at AHIP 2025.
  • Per Healthcare Dive,
    • “Ascension has entered a definitive agreement to acquire ambulatory surgery provider Amsurg, the nonprofit health system said Tuesday.
    • “The deal, which Ascension expects to close later this year pending regulatory approval, will add more than 250 ambulatory surgery centers across 34 states to Ascension’s outpatient portfolio.
    • “A spokesperson for the health system declined to comment on the size of the deal. However, sources told Bloomberg that Ascension was paying $3.9 billion for the provider.” 
  • Per Beckers Hospital Review,
    • “Mark Cuban’s Cost Plus Drug Co. and virtual care provider 9amHealth have partnered to offer obesity medications through a new program targeting self-insured employers. 
    • “Under the partnership, 9amHealth will use low-cost oral obesity medications sourced from Cost Plus Drugs alongside branded GLP-1 drugs acquired through direct manufacturer deals, according to a June 17 news release from the company. 
    • “The medications are a part of a broader obesity treatment program that includes telehealth-based support from clinicians specializing in conditions such as diabetes, high blood pressure and high cholesterol. 
    • “The program is aimed at employers who are looking to expand weight management coverage for workers without relying on traditional pharmacy benefit managers, the release said.” 
  • and
    • “Hospital labor costs related to drug shortage management have significantly increased, from $359 million in 2019 to $894 million in 2024 — a nearly 150% increase, according to a Vizient report published June 17. 
    • “Vizient surveyed 132 of its clients to measure the financial toll of medication shortages. Respondents included pharmacy and procurement leaders at health systems, medical centers, children’s hospitals, critical access hospitals, specialty hospitals, clinics and ambulatory care facilities. 
    • “Pediatric facilities were particularly strained, as they monitored 25% more shortages and exceeded pharmacy budgets more often than general facilities. 
    • “Overall, hospitals and other healthcare facilities spent 20.2 million hours in 2024 managing these shortages. In 2019, that figure was 8.6 million hours. 
    • “To cope, most facilities shifted workloads onto already stretched staff, while only a fraction opted to hire additional pharmacy personnel,” the report said. “These findings underscore an urgent issue: Drug shortages aren’t just about supply — they’re draining time, money and an already fragile healthcare system.”

Tuesday report

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

From Washington, DC,

  • KFF compares the healthcare provisions in the House of Representatives big, beautiful bill against the developing Senate version. Of note the Senate version does not include the House bill’s provisions expanding the utility of health savings accounts.
  • STAT News adds,
    • “The Medicare pay bump for doctors that was part of the House version of Republicans’ tax bill was dropped in the Senate’s version, released Monday evening. 
    • “The provision, which would boost doctors’ payment for treating Medicare patients by tying it to inflation, has long been a top priority for physician groups.” 
  • Federal News Network tells us,
    • “The Trump administration is attempting to address what it says are inflated numbers of high-performing federal employees, while also telling agencies to swiftly discipline or remove any feds deemed poor performers.
    • “In a memo published Tuesday, the Office of Personnel Management told agencies to begin adopting a new performance management system designed by the Trump administration. The new system attempts to more strictly delineate between different levels of employee performance and encourage agencies to rate fewer employees as high performers.
    • “For many decades now, performance management across the federal workforce has fallen short of what the American people should expect,” OPM Acting Director Charles Ezell wrote in Tuesday’s memo to agencies. “Too often, this has resulted in a lack of accountability and inflated performance ratings.”
  • Radiology Business reports,
    • “Radiology Partners has “significantly outmatched other provider groups” via the No Surprises Act, scoring wins at more than 600% of the initial “qualifying payment amount” offer, according to new research. 
    • “The Centers for Medicare & Medicaid Services recently released NSA data from the first half of 2024. As Radiology Business reported previously, industry giant Rad Partners was the No. 1 initiator of these disputes tied to out-of-network healthcare services, with 136,784 between January and July. Georgetown University researchers recently took a closer look at the data, publishing their findings June 11 in Health Affairs. 
    • “They highlighted RP’s significant payment wins via the “independent dispute resolution” (IDR) process in 2024. In Q1, the practice earned a median prevailing offer at 631% of the qualifying payment amount—essentially, the median contracted rate for a service in the same geographic region. These wins continued in Q2, with a median at 610% of QPA.  
    • “These high numbers highlight the disconnect between the two sides as they debate what constitutes a reasonable payment for [out-of-network] services,” Jack Hoadley, PhD, research professor emeritus with Georgetown’s Center on Health Insurance Reforms, and co-authors explained. “Providers believe the high volume of IDR disputes reflects inadequate payment by plans, exacerbated by possible manipulation of the [qualifying payment amount]. Plans respond that their QPAs are accurate and that providers should be willing to accept payments that align closely with in-network rates.”P

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Embracing artificial intelligence. Taking on companies that make ultra-processed foods. And offering a fast-track to approve drugs the Trump administration views as a priority.
    • “Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul the agency, citing what they see as the FDA’s reputation for coziness with pharmaceutical companies.
    • “Makary’s goal is “to deliver more transparency, unleash innovation, eliminate conflicts and lower drug pricing,” said Calley Means, a White House adviser and ally of Makary’s.
    • “The changes are coming so swiftly, and often without input from career scientists, that Makary faces declining staff morale threatening to stymie his efforts. He must also contend with the administration’s staff cuts at the FDA, which have been partly undone but shrank the workforce nonetheless. And critics say Makary is playing fast and loose with the FDA’s commitment to world-class science.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
    • “The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
    • “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary M.D., M.P.H. “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”  
  • Per Modern Healthcare,
    • “Taiwanese surgical robotics company Brain Navi Biotechnology said Tuesday the Food and Drug Administration approved its NaoTrac neurosurgical robot.
    • “It’s designed to assist with brain tumor biopsies, deep brain stimulation and other complex brain surgeries.”
  • Per Cardiovascular Business,
    • “Inquis Medical, a California-based medtech company focused on peripheral vascular treatments, has received U.S. Food and Drug Administration (FDA) clearance for its Aventus Thrombectomy System to be used to treat pulmonary embolism (PE).
    • “The Aventus Thrombectomy System, a next-generation mechanical thrombectomy device, was previously cleared to target blood clots in a patient’s peripheral arteries. This new expanded clearance paves the way for PE patients to be treated using the same technology.”
  • Per MedTech Dive,
    • “Zyno Medical has recalled infusion pumps that shipped with software that had not undergone verification and validation testing, the Food and Drug Administration said Monday.
    • “The company released the Z-800 pumps with incorrect software versions. The software created a risk of incorrect air-in-line detection and audio alarms that could cause serious harm.
    • “Zyno has not reported any serious injuries or deaths. The recall, which the FDA assigned to Class I, started eight months after Zyno removed Z-800 pumps from use over another software issue.”

From the State law front,

  • Healthcare Dive reports,
    • “Iowa passed a law last week that places limits on pharmacy benefit managers, joining a growing number of states cracking down on the drug middlemen in an effort to constrain rising prescription drug costs and protect rural pharmacies. 
    • “The legislation includes numerous provisions aimed at tamping down on PBMs’ “outsized control” over the pharmaceutical supply chain, Gov. Kim Reynolds said in a statement. That includes preventing PBMs from steering patients to particular pharmacies, equalizing reimbursement between pharmacies and reforming how PBMs are paid.
    • “However, some experts have raised concerns that the law could lead to higher costs for health plans and patients.”

From the judicial front,

  • Bloomberg Law reports,
    • “The FDA lawfully determined that Novo Nordisk A/S’s Ozempic drug shortage ended and that drug compounders can’t keep making copies of the weight loss medicine, a federal judge ruled. 
    • “Judge Mark T. Pittman for the US District Court for the Northern District of Texas agreed with the Food and Drug Administration that it lawfully removed semaglutide from the drug shortage list last year, granting on June 13 the agency’s motion for summary judgment against compounders. 
    • “The opinion is currently sealed but will eventually be redacted, according to the court’s docket.”
    • The case number is 4:25-cv-00174.

From the public health and medical research front,

  • Cardiovascular Business reports,
    • “Mayo Clinic in Rochester, Minnesota, is the No. 1 heart hospital in the United States, according to a data-based ranking published by Newsweek. Cleveland Clinic and its Miller Family Heart, Vascular & Thoracic Institute came in at No. 2, followed by Massachusetts General Hospital/the Corrigan Minehan Heart Center at No. 3, NYU Langone Hospitals – Tisch Hospital at No. 4 and Stanford Health Care/Stanford Hospital at No. 5.
    • “The ranking is part of a new America’s Best Hospitals for Specialize Care 2025 report.
    • “Newsweek and Statista partnered on the list, naming their Top 200 Hospitals for Cardiac Care. While 45% of each facility’s overall score was determined by a variety of hospital quality metrics, another 35% was determined by survey responses from U.S. healthcare professionals collected in early 2025. In addition, 15% of the overall scores was determined by patient satisfaction surveys, and the final 5% was based on Statista’s PROMs Implementation Survey.“
  • Per Health Day,
    •  “Rheumatoid arthritis (RA) has steadily increased around the world during the past three decades, a new AI-powered study reports.
    • “The autoimmune disease affected 17.9 million people worldwide in 2021, a 13% increase from 1990, researchers reported today in the Annals of the Rheumatic Diseases.
    • “Results indicate that the global burden of RA has been vastly underestimated, researchers concluded.
    • “Further, the research team projects that rheumatoid arthritis will continue to increase unless steps are taken to prevent it or treat existing cases.”
  • and
    • “A new breakthrough can help people with schizophrenia keep up with their psychiatric meds, researchers said.
    • “A pill taken just once a week, gradually releasing medicine from within the stomach, can greatly simplify the drug schedule faced by schizophrenia patients, researchers reported June 10 in the journal The Lancet.
    • “The newly developed pill maintains consistent levels of the psychiatric drug risperidone in patient’s bodies, and controlled their symptoms just as well as daily doses, results showed.
    • “We’ve converted something that has to be taken once a day to once a week, orally, using a technology that can be adapted for a variety of medications,” researcher Giovanni Traverso, an associate professor of mechanical engineering at MIT, said in a news release.”
  • Per Beckers Hospital Review,
    • “A study found that a once-daily pill called obicetrapib significantly lowered LDL cholesterol in patients at high risk for heart disease. 
    • ‘The clinical trial, published May 7 in The New England Journal of Medicine, enrolled 2,500 participants with either a history of atherosclerotic cardiovascular disease or familial hypercholesterolemia, all of which were already taking the maximum tolerated doses of other cholesterol-lowering drugs. 
    • “After 84 days, those taking NewAmsterdam Pharma’s obicetrapib saw their LDL levels drop nearly 30% while the placebo group experienced a slight increase. The cholesterol-lowering effect was consistent across the treatment group and the rate of side effects was similar among the two groups.”
  • MedPage Today discusses “What the MAHA Report Gets Right, and Wrong, on Nutrition. Time will tell the impact of ensuing policies on health.”
  • and lets us know
    • “A rheumatology trainee who went on TikTok to find information on her own condition may have uncovered a novel and possibly tectonic approach to treating fibromyalgia, her presentation here suggested.
    • “That experience led to an analysis of the massive TriNetX medical records database, which indicated that fibromyalgia patients who used glucagon-like peptide-1 (GLP-1) receptor agonist drugs were less likely to use opioids and to report pain, fatigue, and malaise compared with propensity-matched non-users, according to Nouran Eshak, MBChB, of the Mayo Clinic in Scottsdale, Arizona.
    • “The findings were strong enough, Eshak told attendees at the European Alliance of Associations for Rheumatology annual meeting, that clinicians should “consider using GLP-1 agonists in fibromyalgia patients when comorbidities such as obesity, diabetes, or sleep apnea are present.” Those are approved indications for such agents, and therefore patients would face fewer barriers to access.
    • “Still, these findings are no substitute for prospective data, such as from randomized trials, Eshak stressed.”
  • The NIH’s Reseach Matters covers the following topics this week — “Y chromosome loss and cancer | Cysteine and weight loss | Treating malaria in mosquitoes.”
  • Per Medscape,
    • “When canagliflozin (Invokana) was approved in 2013, the SGLT2 inhibitor was touted as a first in a new medication class that was, at the time, the only oral, once-daily medication to reduce blood glucose as well as body weight and systolic blood pressure.
    • “Since then, additional SGLT2 inhibitors have been approved (dapagliflozin, empagliflozin, bexagliflozin, and ertugliflozin), and the indications for prescribing the medications have expanded.
    • “The medications have gone from targeting glucose-lowering to also providing cardiac protection, including for diabetes-free patients with heart failure.
    • “Next, experts said, discussions will focus on other decisions, such as when and whether to prescribe the SGLT2 inhibitors with GLP-1 receptor agonists for the best outcomes.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies to treat cardiovascular disease. 
    • “The deal announced Tuesday offers Verve stockholders $10.50 a share, plus a contingent value right worth another $3 a share. The non-tradeable CVR would pay out if the company’s experimental VERVE-102 treatment advances enough to dose a patient in a Phase 3 trial within 10 years of the transaction’s closing.
    • “Verve CEO Sekar Kathiresan and other top stockholders have already agreed to tender shares that represent about 17.8% of Verve’s outstanding stock and the gene editing company’s board recommends that all investors agree to the tender offer, Lilly said. A second-step merger will follow if needed. The companies expect to complete the transaction in the third quarter.”
  • The Wall Street Journal reports,
    • “Dozens of companies have pledged to build more manufacturing in the U.S. since President Trump took office. Generic drugmakers aren’t among them. 
    • “And they have no plans to change that anytime soon.
    • “Makers of generics—cheaper copies that make up 90% of Americans’ prescription medications—say further domestic investment is too risky in such a low-margin and unpredictable business, unless the government helps to steady the sector. 
    • “Drugmakers want more clarity from the Trump administration on the potential pharmaceutical tariffs, which some companies warn could lead them to close U.S. plants altogether. 
    • “Where’s the incentive?” said Richard Saynor, chief executive officer of Sandoz, whose U.S. slate of roughly 150 generic drugs range from blood thinners to antipsychotics. “You sell a packet of antibiotics more cheaply than a packet of M&M’s. That’s offensive, and we lose money doing that.”
  • and
    • “Fresenius Medical Care could end up benefiting from blockbuster obesity drugs, according to its chief executive, contrary to concerns that such treatments could be negative for the dialysis specialist.
    • “I believe [the effect] is neutral to positive, not negative,” Fresenius Medical Care’s Chief Executive Helen Giza said in an interview.
    • “Ozempic and others in the class of drugs known as GLP-1 have shown promise in clinical trials beyond their most common uses for diabetes and weight loss to treat heart, kidney and liver diseases, among a growing list of conditions. As signs of their potential emerged, investors raced to look for winners and losers.”
  • Per STAT News,
    • “A central theme in Humana’s plan for boosting Medicare Advantage profitability in the future is a strategy its peers have relied on for over a decade: coaxing members in for their annual wellness visits.”
  • Per Fierce Healthcare,
    • “Lark Health is rolling out a new, artificial-intelligence-enabled platform to manage the costs related to GLP-1s, and it has tapped a former insurance industry executive to lead the charge.
    • “Matthew Gibbs, who previously served as chief pharmacy officer at Blue Shield of California, will join Lark as president. In that role, he will spearhead the launch of LarkVantage, a platform designed to mitigate the challenges associated with utilization reviews for GLP-1s.”
  • Reuters informs us,
    • “Eli Lilly (LLY.N) will ship the two highest doses of its popular weight-loss drug Zepbound to cash-paying customers on its website starting early August, the U.S. drugmaker said on Monday.
    • “With the addition of the 12.5 milligrams and 15 mg doses, all approved doses of Zepbound will be available on the website in single-dose vials for $499 per month or less, regardless of insurance status, the company said.
    • “Lilly and rival Novo Nordisk (NOVOb.CO), opens new tab started offering vials at discounted prices on their respective websites to expand access and stave off competition from compounded versions or cheaper copies of their weight-loss drugs.
    • “The LillyDirect website was launched last year to help patients directly order some drugs.”