Thursday report

CMS

Thursday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • On July 2, 2025, the U.S. Office of Personnel Management’s Inspector General issued a Flash Report titled “OPM’s Postal Service Health Benefits Program: Critical Resource Issues,” which Govexec discusses here. The FEHBlog believes and has repeatedly stated that the eligibility program for FEHB and PSHB could be vastly improved if OPM used the widely adopted HIPAA 820 Electronic Enrollment Roster Transaction. The HIPAA 820 transaction would allow carriers to promptly and systematically identify situations where no, or an incorrect, premium payments.
  • The American Hospital Association News reports,
    • Senior leaders from the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, along with White House representatives, visited pharmaceutical company Phlow Corp.’s new production system that manufactures key starting materials, active pharmaceutical ingredients and finished dose forms for 15 medicines used in the U.S. health system. Phlow laboratories and manufacturing facilities are located in the Mid-Atlantic, keeping the complete manufacturing cycle contained in one region. HHS-ASPR and Phlow have collaborated since May 2020 to bring pharmaceutical supply chains into the U.S. and reduce dependency on foreign countries. China and India, for example, account for more than 70% of APIs and KSMs imported to the United States. 
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today unveiled its groundbreaking Functional Repair of Neocortical Tissue (FRONT) program, a transformative initiative to restore brain function and position the U.S. as the global leader in brain repair technology. The FRONT program aligns directly with the priorities set by President Trump and Secretary Robert F. Kennedy, Jr., demonstrating a strong commitment to innovation, public health, and the economic well-being of the American people.
    • “Millions of Americans are living with the damage caused by strokes and traumatic brain injuries. Current treatments are not enough. ARPA-H hopes to deploy regenerative medicine to transform the treatment of neurological diseases and relieve the suffering,” said HHS Deputy Secretary Jim O’Neill.
    • ‘The neocortex, the largest part of the brain, is critical for sensory perception, motor control, and decision-making. Damage to this area—due to conditions like stroke, traumatic injury, or neurodegeneration, such as Alzheimer’s disease—has long led to irreversible damage, leaving individuals dependent on costly therapies or caregivers. The FRONT program aims to change that, using cutting-edge neurodevelopmental principles and stem cell technology to regenerate brain tissue and restore lost functions.”
  • The Brown & Brown actuarial consulting firm helpfully summarizes here the employee benefit provisions of the One Big Beautiful Act.
  • CMS announced resources and flexibilities to address the public health emergency in the State of Texas.

From the judicial front,

  • Govexec reports,
    • “The federal judge who temporarily blocked the Trump administration from implementing mass layoffs before the Supreme Court intervened has suggested she still plans to litigate the legality of individual agency workforce reduction plans. 
    • “The high court this week struck down the injunction that impacted most major agencies, allowing the administration to move forward with widespread RIFs. New layoff notices have not gone out since that decision on Tuesday, but they are expected imminently at several agencies. The court made clear, however, that its ruling applied only to the overall finding of President Trump’s capacity to order staffing cuts and not to the legality of individual agency RIF plans. 
    • “The content of those individual plans “thus remains squarely at issue in this case,” California-based U.S. District Judge Susan Illston, whose original decision led to the RIF pause, said in a new order Wednesday evening.” * * *
    • “Attorneys for the Trump administration previously noted it had 40 RIF actions underway at 17 agencies that were paused by Illston’s injunction. The federal employee unions, local governments and non-profit organizations that originally brought the lawsuit issued an “urgent request” following the Supreme Court decision asking the administration to submit those plans to the court for a decision on their legality. Illston ordered the administration to reply to that request by Monday and suggested she agreed the plans should be submitted for examination. 
    • “The administration previously argued it could not release them because they were predecisional and subject to executive privilege, but the judge on Wednesday suggested that final decisions on the RIFs must have been made if her injunction had paused them from taking effect. She added the court was “not inclined” to allow for significant redactions.” 
    • Here is a Dropbox link to the Court’s order.
  • The New York Times adds,
    • “A federal judge on Thursday blocked the Trump administration from enforcing a contentious executive order ending birthright citizenship after certifying a lawsuit as a class action, effectively the only way he could impose such a far-reaching limit after a Supreme Court ruling last month.
    • “Ruling from the bench, Judge Joseph N. Laplante of the U.S. District Court for the District of New Hampshire said his decision applied nationwide to babies who would have been subject to the executive order, which included the children of undocumented parents and those born to academics in the United States on student visas, on or after Feb. 20.
    • “The Trump administration has fought to challenge the longstanding law, laid out in the Constitution, that people born in the United States are automatically citizens, regardless of their parents’ immigration status. Judge Laplante’s order reignites a legal standoff that has been underway since the beginning of President Trump’s second term.
    • “The judge, an appointee of President George W. Bush, issued a written order formalizing the ruling on Thursday morning. He also paused his order for seven days, allowing time for an appeal.”

From the Food and Drug Administration front

  • BioPharma Dive lets us know,
    • The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease.
    • The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season.
    • In May, Health and Human Services Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant people. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.

From the public health and medical research front,

  • The American Journal of Managed Care tells us,
    • “Ovarian cancer mortality rates have declined, but disparities exist across age, race, and geographic regions, with older women and non-Hispanic White women having the highest rates.
    • “Despite treatment advances, late-stage diagnosis remains a barrier due to the lack of routine screening, resulting in low survival rates for advanced-stage ovarian cancer.
    • “Geographic disparities show the Northeast with the highest mortality rates, while both metropolitan and non-metropolitan areas experienced declines, with metropolitan areas showing a steeper decline.
    • “The study’s limitations include the absence of individual-level data on lifestyle factors, tumor histology, and treatment protocols, hindering causal conclusions.”
  • Radiology Business points out,
    • “Shared decision-making visits significantly boost patients’ adherence to low-dose CT lung cancer screening, according to new research published Wednesday. 
    • “Numerous studies have explored poor uptake of LDCT, with rates as low as 18% among eligible individuals.
    • “Researchers with the American College of Radiology’s Neiman Policy Institute recently explored whether “shared decision-making” visits—required by Medicare as part of CT referrals—can boost screening adherence. They found a clear correlation, with imaging rates nearly 27% higher than those who did not meet with their primary care provider to discuss their risks and benefits of lung cancer screening, according to the study results, published in Chest. 
    • “Shared decision-making is more than just a billing requirement—it’s a valuable opportunity to engage patients in informed, personalized discussions about screening,” study author Farouk Dako, MD, MPH, associate professor of radiology, with the Perelman School of Medicine in Philadelphia, said in a July 9 announcement from the Policy Institute. “There is an opportunity to leverage this new evidence in national campaigns to raise awareness of lung screening and the importance of prioritizing SDM in routine clinical care to improve early detection and outcomes for one of the deadliest forms of cancer.” 
  • Gen Edge relates,
    • Scientists have produced the first detailed characterization of the changes that weight loss (WL) causes in human adipose tissue (AT) by analyzing hundreds of thousands of cells from morbidly obese individuals undergoing weight loss surgery. They found a range of positive effects, including clearing out damaged, aging cells and increased metabolism of harmful fats.
    • The team, headed by William R Scott, PhD, at the MRC Laboratory of Medical Sciences and at Imperial College London, analyzed gene expression in more than 170,000 cells that made up the fat tissue samples from 70 people. They generated a high-resolution single-nucleus and spatial atlas of human AT in people with extreme obesity undergoing therapeutic weight loss and in healthy lean counterparts. The investigators suggest that their findings could help scientists better understand how weight loss leads to health improvements at a molecular level, which in the future could help to inform the development of therapies for diseases such as type 2 diabetes.
    • “We’ve known for a long time that weight loss is one of the best ways to treat the complications of obesity, such as diabetes, but we haven’t fully understood why,” Scott said. “This study provides a detailed map of what may actually be driving some of these health benefits at a tissue and cellular level.”
    • “Scott and colleagues reported on the study in Nature, in a paper titled “Selective remodeling of the adipose niche in obesity and weight loss,” in which they stated, “This rich representation of human AT biology and pathophysiology offers a valuable resource for mechanistic and therapeutic exploration.”
  • The New York Times considers “Just How Harmful Is Vaping? More Evidence Is Emerging. A new study that found high levels of heavy metals in popular nicotine vapes adds to concerns about the products.”
  • Per Fierce Pharma,
    • “Pfizer and Astellas are underlining the benefits of Xtandi as part of a combination therapy for certain patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with an overall survival win.
    • “The new data come from the companies’ phase 3 Embark study, which in 2023 led to the FDA approval of Xtandi in patients with nmHSPC with biochemical recurrence (BCR) at high risk of metastasis.
    • “In the trial, Xtandi was studied as a single agent and in combination with leuprolide against placebo and leuprolide. For the trial’s primary endpoint, the Xtandi combo delivered a statistically significant improvement in metastasis-free survival compared with placebo and leuprolide.
    • “At the time, the trial’s overall survival data were mature.
    • “Now, Xtandi plus leuprolide has proved it can, in fact, extend the lives of these patients, demonstrating a “statistically significant and clinically meaningful improvement” in overall survival, Pfizer announced in a July 10 press release.”

From the U.S. healthcare business front,

  • The WTW consulting firm discusses how to strategically manage health and wellness costs in 2025.
  • Healthcare Dive reports,
    • “UnitedHealth has tapped longtime insurance executive Mike Cotton to lead its Medicaid business, filling a role that has stood empty since the company reshuffled its executive team earlier this year, the company confirmed to Healthcare Dive.
    • “Meanwhile, Bobby Hunter, who leads the healthcare juggernaut’s Medicare division, is stepping up as CEO of government programs, with oversight of both Medicare and Medicaid.”
  • Fierce Healthcare notes,
    • “Health Care Service Corporation is launching the HealthSpring brand for its Medicare products after closing the deal to acquire Cigna’s Medicare plans.
    • “Plans under the HealthSpring label were included in the deal, and HCSC said in an announcement that it refreshed the brand identity for a national rollout. The insurer will offer its first plans under the HealthSpring umbrella later this year, pending needed regulatory approvals.”
  • Fierce Biotech informs us,
    • “AbbVie is paying Ichnos Glenmark Innovation (IGI) $700 million upfront for a next-generation rival to Johnson & Johnson’s Tecvayli, positioning the Big Pharma to advance a new option for multiple myeloma patients.
    • “The deal gives AbbVie rights to ISB 2001, a trispecific antibody that targets CD38, BCMA and CD3. J&J’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic hit BCMA and CD3. Adding CD38 to the mix could boost binding to tumor cells with low expression of BCMA and stop cancers from becoming resistant by downregulating the antigens.
    • “AbbVie has placed a high price on that potential, coughing up $700 million for a phase 1 candidate and offering up to $1.225 billion in development regulatory, and commercial milestones. In return, IGI has granted AbbVie rights to the trispecific across North America, Europe, Japan and Greater China.”

Midweek report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican leaders worked to win over GOP critics of President Trump’s sprawling domestic-policy bill (Senate amendment to H.R. 1) headed into crucial votes expected later Wednesday.
    • “Dozens of lawmakers had raised complaints about the revised “big, beautiful bill,” which passed the Senate a day earlier, with fiscal hawks wanting deeper spending reductions and moderates worried about cuts to the social safety net. 
    • “I feel very positive about the progress,” said House Speaker Mike Johnson (R., La.), who has been meeting with lawmakers all day. “I feel good about where we are and where we’re headed,” he said.” 
  • P.S. The Wall Street Journal reports Thursday morning that the bill cleared another procedural hurdle, passing H.R. Res. 566 which creates a rule for House consideration of H.R. 1. The House now can hold a final vote on the bill on Thursday.
  • Per a Senate news release,
    • “On Wednesday, July 9, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing to examine the future of health care, and how to improve cybersecurity to better protect Americans’ health privacy. This hearing will take place directly after the Committee vote on the nomination of Susan Monarez to be Director of the Centers for Disease Control and Prevention.“
  • Govexec reports,
    • Across the federal government, tens of thousands of blue-collar federal employees are still waiting on their 2025 pay raise, all because of Defense Secretary Pete Hegseth’s purge of advisory committees as the Pentagon.
    • For most federal employees, receiving their share of the (mostly) annual across-the-board pay increase is a simple process. The president issues an alternative pay plan—to avoid massive automatic increases due to the Federal Pay Comparability Act—or Congress stipulates in appropriations legislation how it would override the president, and then the Office of Personnel Management publishes new pay tables in time for the first full pay period in January.
    • Raises for blue collar federal workers, hired under the Federal Wage System, are based on an extrapolation of those pay raises along with a series of wage surveys conducted by the Department of Defense Wage Committee. The committee then votes to implement wages region by region over the course of the year.
    • But in March, Hegseth issued a memo instructing all advisory committees within the Defense Department to halt operations for a 45-day review to “ensure that the department’s advisory committee efforts align with our most pressing strategic priorities.” At the conclusion of that six-week period, Hegseth purged all the members of the Pentagon’s advisory panels and ordered the recommendation of new members within 30 days.
    • As a result, the wage committee, whose members are required by federal regulations to consist of three agency officials and two union leaders, has been unable to meet. According to data provided by the Defense Civilian Personnel Advisory Service and the American Federation of Government Employees, the panel’s shuttering has stalled pay raises for blue collar feds in 87 of the 248 local wage areas, or roughly 60,000 workers.
  • and
    • “The Office of Personnel Management has started to go down a different path than the one it started on in early May when they attempted a sole-source human resources management software contract with Workday.
    • “OPM announced its intentions to award that contract to Workday on May 2 and then cancelled it within the following week. Industry backlash ensued after the initial decision on the sole-source contract, which was set up to help OPM meet the Trump administration’s July 15 deadline for having a new HR system in place.
    • “OPM now appears to be starting on a more traditional procurement process and has scheduled an industry engagement event for July 9-10, according to a Tuesday Sam.gov notice.
    • “The government is now looking at the end of 2028 as its target date to have a new HR management system scaled across all agencies, the notice says.”
  • The American Hospital Association News tells us,
    • “The Departments of Justice and Health and Human Services today announced the creation of the DOJ-HHS False Claims Act Working Group to combat health care fraud. The group will be jointly led by the HHS General Counsel and the Deputy Assistant Attorney General of the DOJ’s Commercial Litigation Branch and include participants from the Office of Counsel to the HHS Office of Inspector General, DOJ’s Civil Division, the Centers for Medicare & Medicaid Services’ Center for Program Integrity and designees representing U.S. Attorneys’ Offices.
    • “The working group’s priority areas for enforcement include Medicare Advantage; drug, device or biologics pricing; barriers to patient access to care; kickbacks related to drugs, medical devices, durable medical equipment, and other products paid for by federal health care programs; materially defective medical devices impacting patient safety; and manipulation of electronic health records systems to drive inappropriate usage of Medicare-covered products and services. The working group is encouraging whistleblowers to identify and report violations of the FCA related to those priority enforcement areas.”
  • Healthcare Dive adds,
    • “The HHS wants to move oversight of 340B from the Health Resources and Services Administration to the CMS, a move that could prove negative for the the two-thirds of U.S. hospitals that rely 340B to fund patient services, cover uncompensated care and, in some cases, keep their doors open.
    • “The potential change is putting providers on edge. And covered entities are right to be worried, given the CMS’ bellicose history with the program, according to experts.
    • “This could be truly devastating for some of these covered entity providers,” said Sarah Bowman, a principal with public accounting firm PYA who advises hospitals and health systems on 340B compliance.
    • “But increased scrutiny of how 340B dollars are being generated and used is probably a good thing, especially amid mounting evidence of fraud and abuse in the drug discount program.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Regeneron Pharmaceuticals has won Food and Drug Administration accelerated approval of its Lynozyfic treatment for certain patients with the blood cancer multiple myeloma.
    • “Regeneron on Wednesday said the FDA green light covers Lynozyfic in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) is alerting the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). The device displays patient data when the company’s line of Impella heart pumps are being used to provide mechanical circulatory support. 
    • “Johnson & Johnson MedTech has received reports of the AIC not detecting the heart pumps when they are connected. If the connection fails without the user noticing immediately, the FDA said it “may result in inadequate hemodynamic support.” 
    • “Patients in cardiogenic shock are at increased risk, as prolonged episodes of inadequate support may not be well tolerated and may lead to life-threatening injuries,” the agency warned in a new advisory.
    • “The issue can occur with all versions of the Impella technology. As of June 13, three patient deaths have been linked to this connection issue. 
    • “Johnson & Johnson MedTech sent a letter to all affected customers, highlighting the importance of keeping a backup AIC on hand. The company also provided specific details about what to look for during console-to-console transfers and the start of each case.” 
  • The AHA News adds,
    • The Food and Drug Administration has issued early alerts for certain Spectrum infusion pumps from Baxter and Abiomed Automated Impella Controllers. The agency said the affected infusion pumps may have an incorrect version of software, while the Abiomed product may not detect an Impella pump when connected.
  • BioPharma Dive calls attention to five FDA decisions to watch out for in the third quarter of 2025. “The agency is set to decide by September on new therapies for Duchenne cardiomyopathy, multiple myeloma and spinal muscular atrophy.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Doctors for America, the Main Street Alliance and three cities have sued the Centers for Medicare & Medicaid Services (CMS) [in Baltimore, Maryland federal court] over a recent Affordable Care Act (ACA) final rule the agency said will help counter improper enrollments.
    • “The plaintiff cities named in the lawsuit are Baltimore, Chicago and Columbus.
    • “The groups and cities say the regulation will cause upward of 1.8 million Americans to lose coverage in 2026, leading to downstream raised premiums and out-of-pocket costs.”
  • MedTech Dive relates,
    • “A bankruptcy judge approved the sale of 23andMe to a nonprofit led by Anne Wojcicki, co-founder and former CEO of the genetic testing company. 
    • “U.S. Bankruptcy Judge Brian Walsh issued an order on June 27 approving the sale to the nonprofit TTAM Research Institute, adding that all objections to the sale are denied unless otherwise noted. In June, TTAM won a bid to buy the company for $305 million.
    • “States that have filed privacy objections, saying the sale does not comply with their state’s privacy laws, have until July 7 to be granted a stay to appeal the case, Walsh ruled.  California, Kentucky, Tennessee, Texas and Utah have said that the proposed sale would violate their genetic privacy statutes because 23andMe does not propose to seek opt-in consent from every customer in their states.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP points out,
    • “In its weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 40 more measles cases today, boosting the number of infections this year to 1,267, which is just 8 shy of passing the total in 2019, which was the highest since the disease was eliminated in the country in 2000.
    • “Though the large outbreak in West Texas has slowed substantially, the number of smaller outbreaks and travel-related cases continues to grow. The CDC this week reported 4 more outbreaks, raising the national total to 27. So far this year, 88% of confirmed cases have been linked to outbreaks. For comparison, the United States had 16 outbreaks for all of 2024.”
  • Per Health Day,
    • “The COVID-19 pandemic took a toll on Americans’ guts, researchers report.
    • “Gut disorders like irritable bowel syndrome (IBS) increased significantly during the COVID-19 pandemic, a new study says.
    • “Rates of IBS nearly doubled among U.S. adults, rising from around 6% in May 2020 to about 11% in May 2022, results show.
    • “Other gut health problems like constipation also increased, researchers report in the journal Neurogastroenterology & Motility.”
  • Per an NIH news release,
    • “Scientists at the National Institutes of Health (NIH) and their colleagues at the University of California, San Diego, have found that fine-particulate air pollution, which includes pollution from vehicles and industry, was strongly associated with increased genomic changes in lung cancer tumors among people who have never smoked. By assembling the largest-ever whole-genome analysis of lung cancer in individuals who have never smoked, researchers were able to link air pollution exposure to increased cancer-driving and cancer-promoting genetic mutations. This could potentially lead to more prevention strategies for never-smokers.
    • “Researchers analyzed lung tumors from 871 never-smoker patients across 28 geographic locations worldwide as part of the Sherlock-Lung study. They found associations between air pollution exposure and changes in the TP53 gene, and other genetic mutational signatures previously associated with tobacco smoking. They also observed a relationship between air pollution and shorter telomeres, which are sections of DNA found at the end of chromosomes. Telomeres shorten naturally with age and shorter telomeres are related to cells inability to continue to replicate. However, scientists found fine particulate air pollution was linked to premature shortening of telomeres.
    • “Prior genomic studies of lung cancer have focused on tobacco smokers, leaving a significant gap in our understanding of how lung cancer develops in people who have never used tobacco. By beginning to uncover the mechanisms through which tissues acquire cancer-causing or cancer-promoting mutations following environmental exposures, this study helps scientists better understand the primary drivers of lung cancer in this population—which represents up to 25% of all lung cancer cases globally.
    • “Interestingly, the researchers found that while exposure to secondhand smoke was associated with slightly higher mutation burdens and shorter telomeres, compared to tumors in patients who were not exposed, it did not lead to an increase in cancer-driving mutations or mutational signatures. This suggests that secondhand smoke may have a lower overall ability to cause genetic mutations, known as mutagenicity, compared to air pollution.
    • This work was led by researchers at NIH’s National Cancer Institute and the University of California, San Diego, and published in Nature on July 2, 2025.”
  • Per STAT News,
    • “An experimental psychedelic therapy from the U.K. company Beckley Psytech significantly reduced symptoms of treatment-resistant depression in a mid-stage trial, newly released data show, raising expectations for a class of drugs racing toward potential approval by U.S. regulators. 
    • “Companies like Beckley, Atai Life Sciences, and Compass Pathways — the first two are in the process of merging — are now vying to bring psychedelic therapies to market at a time when the regulatory and political climate seems to be shifting. The industry has backing from members in both parties, and several psychedelics-friendly figures have been appointed to policy roles under health secretary Robert F. Kennedy Jr.”
    • “In a Phase 2b clinical trial, Beckley’s compound, BPL-003 — an intranasal formulation of mebufotenin, a short-acting compound related to the psychedelic DMT — led to a reduction of 12.1 and 11.1 points on a standard clinical measure of depression called the MADRS scale at day 29, depending on dose. That compares to a 5.8 reduction in the low-dose comparator group, meeting the trial’s primary and key secondary endpoints. There were 193 participants in the study.
    • “This is good news for the field,” said Boris Heifets, an anesthesiologist at Stanford University who studies psychedelic drugs but is not involved with Beckley. “The market may react — people want a miracle, where a single dose is going to undo years of bad living and mood disorders and trauma. That’s unlikely. … [This] suggests moderate efficacy, sustained improvement, and safety.” 
  • BioPharma Dive discusses, “Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment. The success of Vertex’s opioid alternative Journavx could aid a group of biotechs that aim to take a similar development path with NaV1.8 and NaV1.7 inhibitors.”
    • “In January, the Food and Drug Administration approved this molecule [Nav1.8], known commercially as Journavx, as a treatment for the sharp, short-lived “acute” pain felt after an accident or surgery. Ken Harrison, a senior partner at Novo Holdings, said a core reason his firm decided to back SiteOne was that Vertex had established these drugs can be successfully studied and brought to market.
    • “While Journavx has so far proven remarkably safe and absent of addictive properties, doctors remain torn about how useful it will ultimately be for patients. At its best, the drug looks to be only as potent as a weak opioid. At least 5,800 Journavx prescriptions were written during the third week of June; millions more will need to come for it to meet Wall Street’s blockbuster forecasts.
    • “Still, TD Cowen analysts recently described the drug’s approval as a “watershed moment that could pave the way for a new era of non-opioid pain treatments.” Indeed, SiteOne and at least 10 other developers want to follow in Vertex’s footsteps with their own medicines that stopper either the “NaV1.8” sodium ion channel, as Journavx does, or a close cousin, “NaV1.7.”
  • Drug Topics adds,
    • ‘Interventions targeted at inappropriate prescribing can be implemented to safely reduce the number of medications that are prescribed to older adults in primary care settings, according to results of a review in JAMA Network Open. Investigators said future studies should evaluate interventions using standardized criteria and reports on potential harm.” * * *
    • “One intervention could include medication reviews, which can be incorporated as usual care. In one study, investigators implemented MedReviewRx, an application that analyzes a person’s medications and medical conditions to produce a report that simplifies the regimen and enhances safety. Deprescribing interventions, which consists of identifying and discontinuing drugs when the harms outweigh the benefits, is another method that can be effective.”
    • “Community pharmacists are aptly positioned to lead deprescribing efforts. Deprescribing is reliant on individual patients, so pharmacist-led deprescribing can help to reduce the number of medications in an effective way, as pharmacists are the medication experts. Future research should utilize pharmacists’ knowledge to improve health outcomes, especially for older patients and deprescribing efforts.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Value-based care platform Astrana Health acquired some of Prospect Health’s assets Tuesday for $708 million.
    • “The deal includes Prospect Health Plan, Prospect Medical Groups, management services organization Prospect Medical Systems, pharmacy RightRx and Foothill Regional Medical Center in Tustin, California. 
    • “Astrana announced in November it would acquire Prospect Health’s assets for $745 million. Astrana said the lower purchase price announced this week reflects its “commitment to disciplined capital deployment,” but the company is still confident in Prospect’s potential value, according to a Wednesday news release.”
  • Per Fierce Healthcare,
    • “Private equity investor Nordic Capital has acquired healthcare data analytics company Arcadia. Nordic will become the company’s majority owner, which marks an exit for former investor Peloton Equity.
    • “Financial details of the deal were not disclosed.
    • “Arcadia offers a healthcare data platform that integrates data from across the industry and uses artificial intelligence, advanced analytics and performance benchmarks to help insurers and healthcare organizations improve outcomes and quality and save money.” * * *
    • “Nordic Capital’s investment is a powerful endorsement of the strength of Arcadia’s platform and confidence in our ability to deliver value by improving outcomes and reducing costs,” said Michael Meucci, president and CEO of Arcadia, in a statement. “This milestone marks a new phase of growth for Arcadia, grounded in the same mission, but with even stronger backing to scale smarter, invest faster, and accelerate innovation to meet the growing demand for data-driven intelligence in healthcare.”
    • “Arcadia works with national and regional health systems and payers, along with governmental organizations, including Aetna, Highmark Blue Cross Blue Shield, Intermountain Health, Ochsner Health, and the State of California. Arcadia’s portfolio of provider, payer, government and life science customers totals nearly 200.”
  • and
    • “Cadence, a remote monitoring service provider, has stealthily created an advanced primary care business to help health systems provide better care with artificial intelligence and connected devices.
    • Reimbursement continues to decline for physicians, and primary care providers are among some of the lowest-paid providers in healthcare, according to the Assistant Secretary for Planning and Evaluation. Yet, the specialty is of immense import for identifying chronic diseases, annual wellness exams and treating mental health and substance use disorders. 
    • “The Centers for Medicare and Medicaid Services (CMS) has undertaken a variety of initiatives to enhance access to primary care, including through models at its innovation center. CMS took decisive action on the matter when it created the Advanced Primary Care Model (APCM) in November 2024, under its annual physician fee schedule (PFS). Payments for APCM went live on Jan. 1, 2025, with the aim of providing longitudinal primary care for Medicare beneficiaries.”
    • “The APCM model is an additional monthly bundled payment that promotes the ongoing relationship between primary care providers and patients. It pays for things like having 24/7 access to the provider’s team, coordinating care within a week of a hospital discharge, home visits, expanded hours and secure messaging options.”

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.

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.”

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.”

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.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) today released legislative text within the Finance Committee’s jurisdiction for inclusion in Senate Republicans’ budget reconciliation bill.” * * *
    • “Click HERE to view bill text.
    • “Click HERE for a section-by-section.
    • “Click HERE for a bill overview.”
  • STAT News adds,
    • “To help pay for President Trump’s tax cuts, the Senate is clamping down on tactics that states use to boost federal Medicaid funding, according to legislation released by the Senate Finance Committee on Monday.
    • “The text includes harsher restrictions on Medicaid provider taxes than a version of the bill recently passed by the House. It also places stricter limits on programs that states use to boost Medicaid funding to health care providers, known as State directed payments.
    • “The Finance Committee, led by Sen. Mike Crapo (R-Idaho), is responsible for the largest portion of the budget reconciliation bill that Republicans are using to make good on Trump’s promise to extend expiring tax cuts and create new ones. The House passed its version of the One Big Beautiful Bill last month, and Senate Republicans are now negotiating it.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services June 13 announced it approved state plan amendments to expand Medicaid access to care for tribal communities in six states: Minnesota, New Mexico, Oregon, South Dakota, Washington and Wyoming. The approvals allow the Indian Health Service and tribal clinics to provide Medicaid clinic services in homes, schools and other community locations.” 

From the judicial front,

  • Bloomberg Law informs us,
    • “Eli Lilly & Co. and health tech company Kalderos Inc. are seeking to revive lawsuits in the DC Circuit after a federal judge ruled a US health agency acted lawfully when it didn’t approve drugmaker proposals to discount medicines through a rebate model.
    • “The notices to appeal the order were filed Thursday in the US Court of Appeals for the District of Columbia Circuit after a lower court ruled May 15 found the Health Resources and Services Administration didn’t act illegally when it denied drugmaker bids to discount medicines through a rebate model rather than up front to covered entities under the federal 340B Drug Pricing Program.”
  • MedTech Dive lets us know,
    • “When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from the agency, industry groups were relieved that the plan they sued to stop was dead.
    • “The U.S. District Court for the Eastern District of Texas found the FDA’s attempt to expand jurisdiction over LDTs exceeded its statutory authority. Yet regulatory experts think the agency may still see room to assert authority over LDTs in other ways. A recent warning letter to a diagnostics company points to one avenue the agency could take, attorneys said.”
  • The Wall Street Journal reports,
    • “All 55 attorneys general signed onto a $7.4 billion settlement with Purdue Pharma and the Sackler family for their role in the opioid crisis.
    • “The attorneys general, who represent all eligible U.S. states and territories, finished signing the settlement on Monday after it was reached in principle in January.
    • “The deal ends the Sacklers’ control of Purdue, bars them from selling opioids in the U.S. and delivers funding across the country to support opioid-addiction treatment and prevention.
    • “The settlement requires resolution of legal claims by state and local governments. The local government sign-on process will be contingent on bankruptcy-court approval, according to several attorneys general.
    • “The Sackler family has told the attorneys general it plans to proceed with the settlement.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Around 1 in 7 U.S. adults who smoke might have some degree of disability, according to a study published in the journal Tobacco Control.
    • “The researchers used data from the 2019-2023 National Health Interview Survey (NHIS) for about 150,000 people. During that period, 14.1 percent of adults who currently smoked had a disability, and estimates for any kind of disability were significantly higher for current or former adult smokers.
    • “The study looked at different kinds of disabilities and found that the prevalence of vision, hearing, mobility and cognitive disability was two to 2.4 times higher among those who currently smoked. About 16.5 percent of women who smoke and 12.1 percent of men who smoke have a disability, the study says. The study also looked at race and ethnicity, finding that 19 percent of non-Hispanic smokers had a disability vs. 11 percent of Hispanic smokers.”
  • The American Medical Association lets us know what doctors wish their patients knew about tendinitis.
  • STAT News relates,
    • To Rebecca Stone, the single most important fact about ovarian cancer is that it’s usually a misnomer. The most common kind — responsible for 70% of cases and 90% of deaths — often has its silent beginnings not in the ovary, but in the fallopian tube. This isn’t just an interesting factoid; as a gynecologic oncologist at Johns Hopkins, Stone sees it as a reason to evangelize. There’s no way to screen for so-called ovarian cancer, no colonoscopy, mammogram, or Pap smear equivalent. It’s typically found late, once it’s already spread. The treatments are middling at best. Among the best tools is surgical prevention: If someone doesn’t want more kids, and is considering another abdominal surgery, a surgeon can offer to take the tubes out.
    • Opportunistic salpingectomy, it’s called. “Somebody says, ‘Can I get my tubes tied?’ And I will say, ‘Well, actually, we don’t tie tubes anymore, we remove them,’” said Greg Marchand, an OB-GYN in Mesa, Ariz. There are exceptions, but generally, since the American College of Obstetricians and Gynecologists recommended offering it in 2015, he’s gone with salpingectomy.
  • It is odd that the article does not mention FDA Administrator Dr. Marty Makary who discusses this issue in his recent book Blind Spots.
  • Health Day tells us,
    • “Brain changes in sleepless teens could make them more likely to be impulsive and aggressive, a new study says.
    • “Teenagers with less sleep had lower connectivity between the parts of the brain that play a critical role in decision making, self-reflection and information processing, researchers reported June 13 in the journal Brain and Behavior.
    • “Problems in these parts of the brain are also linked to mental illnesses like depression, ADHD and schizophrenia, researchers said.
    • “Sleep isn’t just good for children. It helps keep their mental health intact and helps them regulate their emotions,” senior researcher Assaf Oshri, director of the University of Georgia Center for Developmental Science, said in a news release.”
  • and
    • “Struggling to get a good night’s sleep? A new study suggests that a natural solution might be found right in your fridge: fruits and veggies.
    • “Researchers from the University of Chicago and Columbia University found that eating more fruits, vegetables and whole grains during the day may lead to better sleep that same night.
    • “Dietary modifications could be a new, natural and cost-effective approach to achieve better sleep,” study co-author Dr. Esra Tasali, director of the UChicago Sleep Center, said in a news release.
    • “The study — published June 11 in the journal Sleep Health — is one of the first to show that what you eat during the day may affect your sleep that very night, researchers said.”
  • Per HR Executive,
    • “While it may seem surprising—given the ongoing push by many American workers to stay remote or hybrid post-pandemic—many workers are craving support and connection, as the nation’s loneliness crisis rises. Recent research identified loneliness as a significant and emerging threat to workers’ mental and physical health. And, experts say, it can have widespread effects on the workplace.
    • “In its survey, Loneliness in America 2025, Cigna found that 52% of U.S. workers report feeling lonely. The resulting impact on business is both profound and measurable, according to the Evernorth Research Institute, the research arm of Evernorth, Cigna’s health services business.
    • “Among other concerning results, the research found that lonely employees are more likely to miss work, disengage while at work and/or leave their jobs altogether. This is creating ripple effects that cost employers in productivity, morale and talent retention, researchers wrote.’
  • Per BioPharma Dive,
    • “Roche will advance an experimental Parkinson’s disease drug with a mixed track record into late-stage development, announcing Mondaythat it is “encouraged by the efficacy signals” the medicine displayed in earlier testing despite missing its main objectives in two clinical trials.
    • “The Swiss drugmaker and partner Prothena said continued study of trial enrollees suggested that the antibody drug, known as prasinezumab, delayed progression of symptoms like tremors or joint stiffness in people with early-stage disease.
    • “Roche and Prothena have been developing prasinezumab for more than a decade, having first initiated trials shortly after signing a partnership deal in 2013. The drug targets alpha-synuclein, a protein that can misfold and build up in the brains of Parkinson’s patients, and that’s been the focus of an array of drug programs. Study results have largely disappointed, however.”
  • Per Fierce Pharma,
    • “Roche and AbbVie have once again come up short in their attempt to gain an additional indication for their blockbuster blood cancer treatment Venclexta.
    • “A phase 3 trial of the therapy in previously untreated patients with higher-risk myelodysplastic syndromes (MDS) did not achieve its primary endpoint of overall survival, the companies said Monday. In the global study of approximately 500 patients, the combination of Venclexta plus the chemotherapy azacitidine was pitted against placebo plus azacitidine.
    • “The companies said they will present full data from the trial at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are expanding their ambulatory surgery center networks in a bid to lower costs and manage overcrowded operating rooms.
    • “ASCs can provide a more convenient, lower-cost alternative for lucrative procedures like knee replacements and cataract surgeries. Health system executives say the transition of many services from hospitals to surgery centers is inevitable. Advancing technology, shifting regulations, patient preference and pressure from insurers and lawmakers to reduce hospital costs will make sure of that, they said.”
  • and
    • “Welsh, Carson, Anderson & Stowe made an unspecified investment in Constitution Surgery Alliance, an ambulatory surgery center operator with growth plans.
    • “The private equity firm will help fund a national expansion of the company, which manages 16 facilities in five states, according to a Monday news release.”
  • EXL offers payers a white paper titled “Embrace the new era of Utilization Management: Modernizing ineffective approaches with advanced technology.” Check it out.
  • On a related note, Beckers Hospital Review points out,
    • “As hospitals and health systems face increasing pressure to maintain margins and secure sustainable reimbursement, a growing number of leaders are turning to an old business truth: What gets measured, gets managed.
    • “Payer “scorecards” are gaining traction as hospitals seek to hold insurers accountable, reduce administrative friction and strengthen their negotiating position. By systematically tracking performance metrics such as denial rates, response times and contract compliance, providers aim to shift the balance at the negotiating table.
    • “I often emphasize to my clients that data is their greatest leverage,” Brad Gingerich, vice president of payer strategy at Ensemble Health Partners, said during an episode of the Becker’s Healthcare Podcast. “One of the most important steps is proactively holding payers accountable. The moment a payer fails to meet its contractual KPIs, we flag it immediately — whether through formal demand letters or direct discussions.” 
  • Beckers Hospital Review also informs us,
    • “Total prescription dispensing revenue at U.S. retail pharmacies hit $683 billion in 2024, marking a 9% increase from the previous year, according to a June 16 post from the Drug Channels Institute.
    • “The institute calculated estimated total prescription revenue for the 15 largest pharmacy companies in the U.S. based on 2024 calendar year data. COVID-19 vaccine revenue was excluded from the analysis.
    • “Collectively, the top 15 pharmacy companies accounted for about three-fourths of overall dispensing revenue from retail, mail-order, long-term care and specialty pharmacies. Nearly half of that revenue came from CVS Health, Walgreens Boots Alliance, Cigna and UnitedHealth Group. Elevance Health made the list for the first time after acquiring several pharmacy firms in 2024, including Kroger Specialty Pharmacy. 
    • “GLP-1s were the main driver of revenue increases last year, accounting for more than 80% of the overall growth.”
  • Per Fierce Pharma,
    • “Neurology specialist Supernus Pharmaceuticals will snap up Sage Therapeutics, which was once valued at more than $9 billion, for $561 million up front, with the hope that it can help transform a newly launched treatment for postpartum depression (PPD) into the indication’s standard of care.
    • “The buyout of Massachusetts-based Sage comes after a takeover bid, earlier this year by Biogen, which offered $7.22 per share for the struggling, 15-year-old biotech. 
    • “Six months later, Supernus got the job done with an offer of $8.50 per share, plus a contingent value right (CVR) worth $3.50 per share if a set of milestones are achieved, which would bump up the value of the deal to $795 million.”

Weekend Update

David Ermer–CDC, CMS, Congress, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–

Happy belated Flay Day!

From Washington, DC

  • The Daily Caller explains,
    • The Senate’s confirmation of Trump nominees as of June 5 outpaced the Biden administration by 16 nominees and the first Trump administration by 33 nominees, according to information compiled by the Senate GOP leadership-aligned Senate Republicans Communications Center (SRCC).
    • Still, nearly 100 nominees are awaiting floor consideration, according to the Senate executive calendar.
    • The backlog is due in part to Senate Democrats placing blanket holds on hundreds of Trump nominees, requiring the Senate to use finite floor time to confirm each civilian nominee individually through multiple roll call votes. As a result, nearly 60% of the votes taken in the Senate during the 119th Congress have been related to nominations, according to the SRCC.
  • Roll Call summarizes other Senate work during this short workweek here.
  • The Supreme Court will be issuing opinions on Wednesday June 18 this week.
  • Tammy Flanagan, writing in Govexec, asks “Think you’re ready to tap your TSP? Here’s what you might be missing. Before touching your Thrift Savings Plan funds, make sure you understand the rules—and the risks—you might not have planned for.”

From the public health and medical research front.

  • STAT News reports,
    • “Sarepta Therapeutics said Sunday that it was halting shipments of its Duchenne muscular dystrophy gene therapy for patients who can no longer walk, following the death of a second [male] person who received the treatment.
    • “Sarepta disclosed the first patient death — a 16-year-old boy — in March. Both occurred from acute liver failure, a side effect that has been seen with other gene therapies. The company said both patients were non-ambulatory, meaning their disease had progressed to the point they relied on a wheelchair. Most children with Duchenne lose the ability to walk by adolescence.
    • “The company said early Sunday it was working with experts to come up with an enhanced immunosuppressive regimen that could make the therapy, called Elevidys, safer for non-ambulatory patients. It said it would talk with the Food and Drug Administration about the the proposed regimen. 
    • “Sarepta also said it was pausing dosing in an ongoing clinical trial of Elevidys, called ENVISION, that’s focused on older ambulatory and non-ambulatory patients.” 
  • Per Fortune Well,
    • “Researchers at the University of California San Francisco have identified the U.S. regions, as defined by the Centers for Disease Control and Prevention, where dementia occurs most often.
    • “The large and comprehensive study, published in JAMA Neurology, examined data on more than 12.6 million veterans 65 and older enrolled in the Veterans Health Administration system; only 2% were women. 
    • “Researchers found the highest incidence in the Southeast (North Carolina, South Carolina, Georgia, Florida) and the lowest in the Mid-Atlantic states (Delaware, Maryland, Pennsylvania, Virginia, West Virginia, New Jersey, Washington D.C.).” 
  • The Washington Post informs us,
    • A common genetic variant is linked to a doubled dementia risk for older men, a recent analysis in Neurology suggests.
    • The study used data from Aspirin in Reducing Events in the Elderly (ASPREE), which followed elderly patients in the United States and Australia with no history of cardiovascular disease, dementia or cognitive decline between 2010 and 2017.
    • Researchers focused on 12,174 Australians of European ancestry over age 70, and looked for variants in the HFE gene. The gene is critical to regulating the body’s iron levels, and variants are common among people of European descent.
    • Those who carry two copies of the p.C282Y variant in the HFE gene can develop hemochromatosis, a condition that causes iron overload in the body, and resulting conditions such as liver cirrhosis, liver cancer, frailty, arthritis and dementia.
    • One in 3 people carry a gene variant called H63D, and 1 in 36 carry two copies, John Olynyk, a professor at the Curtin Medical Research Institute in Perth, Australia, says in a news release about the new study.
    • “Having just one copy of this gene variant does not impact someone’s health or increase their risk of dementia. However, we found having two copies of the variant more than doubled the risk of dementia in [previously healthy] men, but not women,” Olynyk says.
  • NPR offers “Advice for trying GLP-1 drugs for weight loss from a doctor who’s been there.”
  • The New York Times reports,
    • “Many older people embrace vaccines. Research is proving them right.
    • “Newer formulations are even more effective at preventing illnesses that commonly afflict seniors — perhaps even dementia.”
  • and
    • “Many Falls Are Preventable. These Tips Can Help. Small changes and good habits make a difference.”
  • The Wall Street Journal reports,
    • When Officer Chelsea Johnston came across a wanted felon one evening in May, Johnston jerked her cruiser in front of him, sprinted after him and tackled him to the ground. Still catching her breath, Johnston motioned for someone to step out of the cruiser: Joy Bogese.
    • “Thank God,” the man said. “It’s you.” 
    • Bogese, who served time for financial crimes that fed a heroin addiction, now spends many of her evenings in a police cruiser as a recovery specialist helping people with addiction get into treatment. The man asked Bogese to help him get into a drug-treatment program at the local jail, where Bogese occasionally facilitates groups. 
    • She is part of a growing effort in Chesterfield County’s [Virginia] fight against addiction. In this county of nearly 400,000, overdose deaths have dropped by half in a single year—about double the decline of the rest of the country—to levels seen before the crisis began in 2015.
    • The precipitous drops have astounded public officials and health-policy experts, who have traveled across the country in an attempt to learn the formula and replicate it. Governors, members of Congress and sheriffs from as far away as Alaska have all come through, along with an acting U.S. drug czar.
  • Per Medscape,
    • “A prospective study found that increased consumption of olive oil was associated with a reduced risk for breast cancer, particularly oestrogen receptor–negative (ER−) and human epidermal growth factor receptor 2–negative (HER2−) breast cancers. A systematic review revealed that case-control studies more frequently reported this protective association, whereas prospective studies did not report any association.”

From the U.S. healthcare business front,

  • Kauffman Hall points out,
    • Mehmet Oz, MD, the new CMS Administrator, in a Senate confirmation hearing, expressed support for exploring multi-year products for Medicare Advantage. While his remarks were made in the context of avoiding unnecessary member churn and associated elevated broker commissions, there are much broader ramifications of transitioning from single-year to multi-year health plan products. His remarks have sparked interest in the industry to explore this idea further.” * * *
    • “Multi-year health plan products have the potential to change a lot about how healthcare business models work today. Given the inherent complexity, it is likely to be a slow journey towards the destination. Even so, incumbent health insurers and risk-bearing providers would be well-advised to start strategizing and building / experimenting with prototypes to manage their risk of being disrupted by multi-year-native health plan innovators. The new administration has already shown that it can move with alacrity and is not afraid to be disruptive in the process. The shift to multi-year plans could come sooner than expected. Or it may not. But in any case, it is better to be prepared.”
  • The FEHB Program was offered on a multi-year basis for two years in the 1980’s although an Open Season was held between the two years in which there were no benefit changes.
  • The Washington Post reports, “Nurse practitioners step in as geriatrician ranks shrink. Nurse practitioners are not trying to replace doctors — they’re trying to meet patients’ needs, wherever those patients are, an expert said.”
  • Per MedTech Dive,
    • “Chris Scoggins is taking the helm of Abbott’s diabetes business at a busy time for the company and the diabetes tech industry. Scoggins was promoted to Abbott’s executive vice president of diabetes care in December. Since then, Abbbott has collaborated with insulin pump firms Tandem Diabetes Care and Sequel Med Tech to integrate its planned glucose-ketone sensor with their devices. 
    • “Scoggins spoke with MedTech Dive about the company’s strategic approach ahead of the American Diabetes Association’s Scientific Sessions in June.”
    • The article includes the interview.

Tuesday report

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

From Washington, DC,

  • Politico reports,
    • “House Republicans have finalized changes to the party-line tax and spending package the chamber passed last month, to keep the bill in compliance with Senate rules. 
    • “An early copy of the amendment House Republicans plan to adopt this week, first obtained by POLITICO, would remove $2 billion for Pentagon military intelligence programs and strike policy that would have allowed mining in a protected wilderness in the Midwest, among other changes. By nixing items the Senate parliamentarian has flagged, the bill will retain its “privilege” and has a chance at passing the Senate without having to overcome the filibuster.
    • “House GOP leaders plan to adopt the tweaks on the floor Wednesday, according to House Majority Leader Steve Scalise. 
    • “So, the House doesn’t have to vote again on passage of the bill that was difficult to whip the first time, the changes will be adopted through a fast-track tactic. By approving a resolution this week to tee up floor debate on a separate bill, the House will be voting to amend the megabill before it is officially transmitted to the Senate.”
  • Fierce Pharma tells us,
    • “As President Donald Trump vows to bridge the drug pricing gap between the U.S. and other developed countries with his “most favored nation” (MFN) policy, Pfizer CEO Albert Bourla is calling for a U.S. government-led push to increase overall drug spending outside the U.S.
    • “While the exact mechanism of implementing MFN to reduce drug prices in the U.S. remains unclear, Bourla proposed (PDF) that other countries should spend a certain percentage of their GDP per capita on innovative medicines.
    • “Bourla laid out the concept Monday at the Goldman Sachs annual global healthcare conference, drawing a comparison to how members of the North Atlantic Treaty Organization (NATO) have agreed to commit 2% of their national GDP to defense spending.
    • “The U.S. is spending about 0.8% of GDP per capita on innovative drugs within 10 years of their launch, Bourla said. That’s higher than the 0.5% by Italy and Spain, or 0.4% in Germany, while the U.K. is spending about 0.3%, he said.” * * *
    • “To Bourla, reining in U.S. drug costs and increasing foreign countries’ expenditures are two sides of the same coin. In the U.S., it remains to be seen how the health department will enforce MFN, and Bourla said he doesn’t expect the industry will gain much clarity anytime soon.”
  • MedCity News opines,
    • “[P]olicy leaders overlook the fact that IVF is priced at around $20,000 per cycle because the system can’t expand to meet demand. Adding more insurance money will only inflate the queue, unless general insurers follow the lead of specialized fertility insurers that focus on actual outcomes; they have every incentive to keep costs controlled and success rates high. We risk repeating what happened in higher education, when the federal government expanded funding for college without restraining the total price. College prices continue to rise far faster than inflation. This is not a mistake we can afford with IVF.
    • “President Trump’s plan to fix IVF might look bold in a headline. In reality, it doesn’t create a single new embryology lab. It doesn’t hire one more specialist. It won’t change the fact that right now, only people with plenty of money can afford IVF, and throwing subsidies at a market that’s already bottlenecked only shifts who pays. If we keep ignoring capacity, we prolong the same heartbreak and keep IVF out of reach for many hopeful parents.
    • “We need more clinics, cutting-edge automation, and better oversight so clinics aren’t pressured to cut corners or limit embryo transfers just to stretch funding. We need a fundamental restructuring that rewards a successful pregnancy rather than a never-ending list of procedures.”
  • Per Beckers Payer Issues,
    • “Groups representing insurers are pushing back on proposed tighter regulations on Medicare Advantage coding. 
    • “Senate Republicans are considering targeted changes to Medicare Advantage as part of the sweeping “One Big Beautiful Bill.” Lawmakers are considering adding provisions of the No UPCODE Act to the package. 
    • “The bipartisan proposal was first floated by Sens. Bill Cassidy, MD, and Jeff Merkley in 2023, and would make changes to the risk-adjustment model MA plans use to bill the federal government and limit the ability to include old or unrelated medical conditions in the cost of care.”
  • Per a CMS news release,
    • “As he turns 65 on Wednesday, June 11, CMS Administrator Dr. Mehmet Oz is using his own Medicare enrollment experience to help Americans better understand how to sign up for Medicare and select the coverage that best fits their needs. Through a new video and social media series, Dr. Oz is walking future enrollees through simple steps they can take to get started—beginning with Medicare.gov.
    • Dr. Oz’s public service messages highlight key reminders for those approaching Medicare eligibility:
      • Start early to learn about options.
      • Enrollment paths may vary depending on whether someone is already receiving Social Security benefits or whether you are still working and have employer coverage.
        Use Medicare.gov to get clear, personalized guidance on enrollment and coverage.
      • To watch Dr. Oz’s messages, visit: 
        Dr. Mehmet Oz displays his Medicare card
  • JAMA Open informs us,
    • “The findings of a cross-sectional study suggest that although 988 has been contacted more than 16 million times since its launch [in July 2022], there remains opportunity to increase 988 use. For example, the past-year 988 contact rate of 23.7 per 1000 is less than half that of the rate of adult emergency department visits that include a mental health diagnosis (53.0 per 1000 population).4 Furthermore, there was regional and state-level variation in 988 use. This is consistent with state variation in funding for and legislative attention toward 988, both of which may affect awareness and use. Lower rates of 988 use in the South, which is more politically conservative than other regions, is also consistent with prior research showing less favorable attitudes toward 988 among Republicans than Democrats.
    • “Study limitations relate to 988 contacts being assigned to states according to area code, uncertainty about the 988 repeat contact rates, and state-level variation in the existence of other crisis lines that are not part of the 988 network. Despite these inherent data limitations, our findings suggest that there are opportunities to increase 988 use, especially in southern states.”

From the public health and medical research front,

  • Healio lets us know,
    • “Data show men were less likely to seek care for diabetes, HIV/AIDS and hypertension.
    • “More research is needed to track gender-related health risks and how they change over time, a researcher told Healio.”
  • MedPage Today points out,
    • “Active transportation modes in midlife — notably, cycling — were tied to a lower dementia risk over 13 years.
    • “Cycling was also associated with higher hippocampal volume.”
  • Cardiovascular Business reports,
    • “A nationwide data analysis found that nearly one-third of U.S. adults with hypertension may be eligible for therapy by two catheter renal denervation (RDN) devices cleared by U.S. Food and Drug Administration (FDA). However, the study’s authors noted that eligibility alone does not indicate which of the 35 million patients are most likely to benefit from the treatment. The study was published June 4 online in JACC: Interventions.[1]
    • “Co-author of the study Eric Secemsky, MD—a cardiologist and researcher from Beth Israel Deaconess Medical Center and Harvard Medical—and his team used data from the National Health and Nutrition Examination Survey (NHANES) to estimate the proportion of hypertension patients who meet the FDA’s criteria for consideration of RDN.
    • “The researchers then broke down how many patients would qualify for RDN using the same criteria of each study for the two approved devices. They also looked at how many patients would qualify under the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 RDN position statement on patient selection and best practices.
    • “The authors found that on-medication, sham-controlled randomized trials had the most selective enrollment criteria, matching only about 2% of U.S. adults with hypertension. In contrast, U.S. single-arm registries and the SCAI 2023 position statement estimated a much larger potential eligibility, approaching 25 million Americans. This discrepancy underscores the challenge of generalizing highly selective trial results to a broader patient population in real-world settings.”
  • MedCity News lets us know,
    • “An experimental Metsera obesity drug led to an average 8.4% weight loss(Opens in a new window) in a small clinical trial, preliminary results that keep the biotech competitive in the crowded mix of companies pursuing a promising new metabolic target, but with the potential to offer less frequent dosing than its rivals.
    • “The drug, MET-233i, is a peptide engineered to activate amylin, a hormone that, like GLP-1, plays a role in regulating blood sugar and appetite. New York-based Metsera designed MET-233i with technology enabling the medication to last longer in the body.
    • “The 8.4% weight loss mark reported Monday was achieved by the 1.2 mg dose, the highest of four doses of the drug administered weekly for five weeks in a two-part Phase 1 study. Each part enrolled 40 participants. In the single-ascending dose portion of the study, in which a group of participants received just a single dose, the 1.2 mg dose led to an average 3.8% loss in body weight that was maintained for five weeks.”
    • “Metsera said its drug’s half-life of 19 days supports once-monthly dosing. That would be an advantage over the once-weekly dosing of the GLP-1 drugs currently available and the clinical-stage amylin drugs in development by other companies, such as Novo Nordisk, Roche, and AbbVie.”

From the U.S. healthcare business front,

  • Fierce Healthcare notes,
    • “Employers are aiming to be more strategic in how they administer benefits as costs continue to rise, according to a new survey from the consulting firm WTW.
    • “WTW released its latest Benefits Trends Survey on Tuesday and found that rising benefit costs were the largest factor driving the strategy around coverage for employers. In addition, employers ranked the financial pressures on budgets as the fourth-highest factor.
    • “Close to half (44%) of those surveyed said that they faced challenges in delivering on their health benefit strategies given rising costs, with 44% saying the same about wellness programs and 36% saying they faced challenges around leave offerings.
  • and
    • “The American Medical Association underwent its annual leadership change on Tuesday, inaugurating otolaryngologist Bobby Mukkamala, M.D. as the 180th president of the nation’s largest physician association. 
    • “The organization’s House of Delegates, composed of its member physicians and residents, also chose urologic surgeon William Underwood III, M.D., as its president-elect. Underwood will assume the presidency in June 2026. 
    • “Mukkamala is a Flint, Michigan-based physician who attended the University of Michigan Medical School and completed his residency at Loyola University Medical Center in Chicago. Mukkamala said in an interview with Fierce Healthcare in June 2024 that he hopes to work on prevention of chronic diseases rather than the “sick care” model that costs the health system millions.
    • “He will also continue the heavy-hitting physician group’s advocacy on increasing physician pay and easing the burden of prior authorization, two top concerns for physicians.” * * *
    • “Underwood, the new president-elect, has spent his 25-year career in Buffalo, New York as a urologic surgeon and doing robotic urologic surgery. He holds patents for discovering a biomarker in prostate cancer and has co-authored nearly 120 peer-reviewed publications, book chapters and published abstracts.” * * *
    • “It is an incredible honor to be chosen by my peers to represent physicians and the patients we serve at this critical moment for health care and medicine,” Underwood said in a statement. “The AMA is leading the way in fighting for a rational Medicare payment system, to rein in prior authorization, and reduce physician burnout. I will stand up to advocate for our profession in a way that will inspire, motivate, and activate physicians to join the AMA in our efforts to improve the health of our nation.”
  • Modern Healthcare reports,
    • “Mayo Clinic is investing in an ambient clinical artificial intelligence startup, the health system said Tuesday.
    • “The Rochester, Minnesota-based health system made an undisclosed investment and entered into a collaboration focused on ambient clinical intelligence with Hellocare.ai, a healthcare artificial intelligence and virtual care company.
    • “Mayo becomes the fourth major health system to invest in Hellocare.ai since April. The investment is an extension of Hellocare.ai’s $47 million Series A funding round that included support from a group of health systems including Cincinnati-based Bon Secours Mercy Health, Aurora, Colorado-based UCHealth, OSF Ventures, the corporate investment arm of OSF HealthCare.
    • “Hellocare has developed an AI-enabled software and hardware platform for hospitals and health systems featuring cameras and microphones mounted on patient room televisions to assist clinical staff with tasks such as ambient documentation and patient monitoring. The company also offers a virtual care solution that supports clinicians with rounds, medication checks and patient discharge.”
  • and
    • “Abbott and Tandem Diabetes Care announced Tuesday an agreement to combine Abbott’s upcoming dual glucose-ketone sensor with Tandem’s insulin delivery systems to create integrated diabetes solutions.
    • “The sensor is in development, but once it’s commercially available, it will be able to detect an early rise in ketone levels to help patients avoid diabetic ketoacidosis. The company expects the sensor to be available next year, according to a spokesperson.”
  • Per Beckers Hospital Review,
    • “Cleveland-based University Hospitals recorded a $49.7 million operating loss (-3% operating margin) in the first quarter of 2025, an improvement from a $74.6 million operating loss (-4.9% margin), according to its June 10 financial report.  
    • “The system reported total operating revenue of $1.7 billion for the three months ended March  31, a 9.7% increase year over year. University Hospitals said that revenue growth was driven by a $106 million increase in net patient service revenue. 
    • “Total operating expenses increased 7.6% year over year to $1.7 billion. The growth was primarily driven by increased labor costs and patient care supplies of $39 million and $51 million, respectively.