Monday report

Medicare

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, Obesity, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Federal News Network informs us,
    • “Top Republicans on the House Education and Workforce Committee are pushing for an investigation into the long-standing workers’ compensation program for federal employees, saying the program is particularly “susceptible to waste, fraud and abuse.”
    • “In a letter to the Government Accountability Office on Monday, Committee Chairman Tim Walberg (R-Mich.) and Rep. Ryan Mackenzie (R-Pa.), chairman of the workforce protections subcommittee, requested a further examination into areas for reforms of the Federal Employees’ Compensation Act (FECA) program, which provides benefits to federal employees who get injured or become ill from work.
    • “In their letter, the GOP committee leaders argued that the program is “overly generous” to federal employees. The FECA program, which dates back to 1916, hasn’t seen any major updates in over 50 years.” * * *
    • “This year, bipartisan lawmakers have also been attempting to reform the FECA program through the “Improving Access to Workers’ Compensation for Injured Federal Workers Act.” If enacted, the legislation would revise FECA to allow physician assistants and nurse practitioners to treat federal employees in workers’ compensation cases — something that is currently prohibited by law.”
  • Per a Centers for Medicare and Medicaid Services news release,
  • Beckers Hospital Review shares highlights from the proposed rule.
  • Bloomberg Law reports,
    • “The US Department of Health and Human Services officially laid off employees on Monday, following an order from the Supreme Court on July 8 that allowed its restructuring plans to proceed, according to emails viewed by Bloomberg. 
    • “Many employees who were supposed to be released during the agency’s first round of 10,000 layoffs in April have been in limbo as the effort made its way through the court system and was paused by federal judges. The reorganization, in addition to cutting staff, was supposed to consolidate the department’s 28 divisions into 15 and cut regional offices from 10 to five.” 
  • KFF issued an analysis of the Competitiveness of Medicare Advantage Markets.
    • “The average beneficiary has access to 34 Medicare Advantage plans with prescription drug coverage in 2025, double the number available in 2018. However, recent analysis suggests that Medicare Advantage markets are highly concentrated, with only a few firms accounting for the lion’s share of enrollment.
    • “Among other key takeaways, the new analysis finds that nine in ten (90%) Medicare beneficiaries lived in a county where at least half of all Medicare Advantage enrollees were in plans sponsored by one or two insurers in 2024. Medicare Advantage markets were more concentrated in rural counties than in urban counties. Among insurers, UnitedHealthcare  or Humana had the highest enrollment in two-thirds of counties in 2024.”
  • and an analysis of the 988 Suicide & Crisis Lifeline Data on the Third Anniversary of the National Hotline.
    • “The 988 service has received 16.5 million contacts since its launch in July 2022, including 11.1 million calls, 2.9 million texts, and 2.4 million chats. Monthly contact volume has steadily increased, consistently surpassing 500,000 contacts per month over the past year and approaching or exceeding 600,000 per month since early 2025—more than double the contacts recorded just before launch (277,000 in June 2022).
    • “Most states now answer 80% or more of 988 calls in-state, a significant improvement compared to before 988’s launch. In-state answer rates in May 2025 ranged from 58% in Arkansas to 99% in Rhode Island. Calls not answered in-state are redirected to national backup centers, where counselors may be less familiar with local resources. 
    • “The overall number of suicide deaths remained stable from 2022 to 2023 (49,476 to 49,316), according to the latest data available from the CDC. Provisional CDC data suggest this stabilization may have continued into 2024 (48,796). It is too soon to fully determine the impact of 988.” 
  • The American Hospital Association (AHA) News tells us,
    • The AHA today responded to a Department of Health and Human Services request for information regarding lawful regulation and innovation to promote better health. The AHA said it agreed with HHS’ stance that reducing unnecessary administrative burden could foster improved health, and highlighted recommendations on deregulation opportunities relevant for hospitals and health systems to address chronic disease. The AHA made initial recommendations that included reducing administrative and coverage barriers to care, advancing the sustainable adoption of technology and innovation, facilitating whole-person care and sustaining the health care workforce. The AHA also shared a comprehensive list of 100 ways to free hospitals from burdensome administrative requirements and highlighted a report of programs across all 50 states to demonstrate the critical work hospitals do daily to combat chronic illness.

From the Food and Drug Administration (FDA) front,

  • From an FDA news release,
    • “Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice. It is the fourth color derived from natural sources approved by the FDA for use in foods in the last two months.”
    • * * * In addition to approving a new color additive, the FDA also announced today that it had sent a letter to manufacturers encouraging them to accelerate the phase-out of FD&C Red No. 3 in foods, including dietary supplements, sooner than the January 15, 2027, required deadline. This earlier phase-out was another of the series of measures introduced by Secretary Kennedy in April. * * *
    • “On Friday, July 11, Consumer Brands—a national trade association for manufacturers of consumer-packaged goods—announced their voluntary commitment to encourage the makers of America’s food and beverage products to remove certified Food, Drug & Cosmetic (FD&C) colors from products served in schools nationwide by the start of the 2026–2027 school year.”
  • Fierce Pharma notes,
    • “The use of SGLT2 inhibitors has been a game-changer in the treatment of heart failure (HF). Now, another drug class has reached the market that could further alter the HF landscape.
    • “The FDA has expanded the label of Bayer’s Kerendia, a nonsteroidal selective mineralocorticoid receptor antagonist (MRA), to include treatment of patients with two types of heart failure. Kerendia can now be used by HF patients with either preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF).
    • “The U.S. regulator originally approved Kerendia four years ago to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes.
    • The new nod allows Kerendia to be given to HF patients who do not have CKD linked to type 2 diabetes.

From the judicial front,

  • Federal News Network tells us,
    • “The Supreme Court is allowing President Donald Trump to put his plan to dismantle the Education Department back on track — and to go through with laying off nearly 1,400 employees.
    • “With the three liberal justices in dissent, the court on Monday paused an order from U.S. District Judge Myong Joun in Boston, who issued a preliminary injunction reversing the layoffs and calling into question the broader plan. The layoffs “will likely cripple the department,” Joun wrote. A federal appeals court refused to put the order on hold while the administration appealed.
    • “The high court action enables the administration to resume work on winding down the department, one of Trump’s biggest campaign promises.”
  • The AHA News points out,
    • “The U.S. District Court for the Eastern District of Texas July 11 vacated a rule issued by the previous administration that would have banned medical bills from appearing on credit reports and prohibited lenders from using medical information in lending decisions. U.S. District Judge Sean Jordan said in the order that the rule exceeded the authority of the Consumer Financial Protection Bureau and violates the Fair Credit Reporting Act.”
  • and
    • “The U.S. District Court for the Eastern District of Missouri July 11 granted a motion by the state to dismiss claims by AbbVie that the state’s 340B contract pharmacy law is invalid and should not be enforced. The Missouri law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. The court found that AbbVie lacked standing to bring action against the state where the injuries alleged in its complaint were attributable to the federal 340B statute — not the state law.”

From the public health and medical research front,

  • GoodRx offers insights into signs of colon cancer.
    • “Changes in stool shape or blood in stool may suggest colon cancer. But most people with colon cancer do not have symptoms.
    • “Screening for colon cancer is important whether or not you have changes in your stool. Talk with your provider about when and how you should get screened.
    • “In its early stages, colon cancer is preventable and treatable. This is why early detection through regular screening or at the first sign of symptoms is important.”
  • The American Medical News tells us what doctors wish their patients knew about “water warts.”
    • “Molluscum contagiosum, more commonly known as “water warts,” is a highly contagious skin infection caused by a poxvirus. While the condition is generally harmless, its persistent and sometimes unsightly lesions can cause anxiety and confusion for families. Becoming familiar with the signs, symptoms and best practices for preventing the spread of this surprisingly common viral skin infection is key.”
  • Per the AHA News,
    • “To help hospitals across the country improve sepsis care, the Centers for Disease Control and Prevention created the Hospital Sepsis Program Core Elements, consisting of seven strategies designed to enhance early detection and treatment. The AHA’s Living Learning Network recently visited Ochsner Health, a system at the forefront of implementing this framework, highlighting how leadership, systemwide coordination and team-based practices are improving sepsis outcomes. LEARN MORE” 
  • BioPharma Dive reports,
    • “A new kind of sleeplessness medicine developed by Takeda met its goals in late-stage testing, positioning the company to capitalize on what Wall Street analysts believe could be a multibillion-dollar market opportunity.
    • “The drug, formerly known as TAK-861 but now called oveporexton, was evaluated in two Phase 3 studies in a main type of narcolepsy. According to Takeda, oveporexton hit every main and secondary trial endpoint, helping improve patient-reported scores on measures of wakefulness, excessive daytime sleepiness, muscle weakness, and other symptoms after 12 weeks of treatment.”
  • and
    • “An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus placebo in a Phase 3 study of people with either uncontrolled or treatment-resistant hypertension, the pharmaceutical firm said Monday.
    • “The reduction in mean seated systolic blood pressure associated with AstraZeneca’s drug was clinically meaningful, the company added. Called baxdrostat, the drug also met all of the study’s secondary endpoints and was “generally well tolerated.”
    • “AstraZeneca plans to share the trial data with health authorities around the world and will present detailed study findings at the European Society of Cardiology Congress next month.”
  • The Washington Post reports,
    • “Nearly a fifth of U.S. adults previously deemed “overweight” would be categorized as “obese” under a 2024 obesity classification framework, according to a new study published in Annals of Internal Medicine.
    • “Using the recent obesity framework, 18.8 percent of the adults who had previously been categorized as “overweight” now fit under the “obese” category, researchers said.
    • “Last year, the European Association for the Study of Obesity (EASO) released the framework, which incorporates fat mass’s effects on health in addition to body mass index (BMI).
    • “In the Annals of Internal Medicine study, researchers applied the framework to a representative sample of 44,030 U.S. adults ages 18 to 79, testing how the distribution of obesity compared with a traditional measure that uses BMI only.”
  • STAT New explains “how an elite rehab center is using GLP-1s to ‘obliterate’ all kinds of cravings.”
    • “In recent months, doctors at Caron Treatment Centers, an elite nonprofit rehab facility, have begun prescribing semaglutide to patients not to address obesity or diabetes but to help treat the addictions that brought them here in the first place.” * * *
    • “Caron is, without a doubt, in uncharted territory. While the medications show significant promise as addiction treatments, only a handful of clinical trials are underway to measure their ability to reduce substance use. Several are unlikely to publish results within the next two years.” 
    • “At this idyllic facility 70 miles outside Philadelphia, however, [Steve] Klein and two fellow doctors are bypassing the speculation and the slow-moving scientific enterprise. No program has so openly and aggressively touted GLP-1s as a means of treating substance use disorder. And while their operation is backed by limited clinical data, their own eyes are giving them more confidence day by day.” 
  • STAT News adds,
    • When anti-vaccine activists and others argue that the immunizations used to protect children from infectious diseases are risky, they often point to aluminum salts, a product added to many childhood vaccines to increase their effectiveness.
    • A new large study from Denmark directly counters those claims. After mining the vaccination and medical records of more than 1.2 million children over a 24-year period, researchers could see no evidence that exposure to aluminum in vaccines led to a statistically significant increase in a child’s risk of developing any of a wide variety of conditions that can be diagnosed in childhood, including asthma and autism.

From the U.S. healthcare business front,

  • MedTech Dive reports,
    • “Waters has agreed to combine with BD’s biosciences and diagnostic solutions business in a deal valued at about $17.5 billion, the companies said Monday. The combined company will continue to operate under the Waters name and retain its listing on the New York Stock Exchange.
    • “The BD business will be spun off generally tax-free to BD shareholders and simultaneously merged with a subsidiary of Waters, through a structure known as a Reverse Morris Trust. Waters CEO Udit Batra will lead the new entity, and Waters’ headquarters will remain in Milford, Massachusetts.
    • “The transaction doubles Waters’ total addressable market to about $40 billion, with an annual growth rate of 5% to 7%, according to the statement. Waters shares fell more than 11% to $313.66 in early NYSE trading on Monday, while BD shares were down about 1% at $174.12.”
  • and
    • “Zimmer Biomet said Monday that it plans to buy Monogram Technologies, an orthopedics company with a robot for knee replacement procedures, for about $177 million.
    • “Monogram’s mBôS robot received Food and Drug Administration clearance in March for total knee replacement surgeries. The system uses CT scans and AI navigation for orthopedic procedures.
    • “Monogram’s robot will be sold with Zimmer implants in early 2027, the companies said in the announcement. They expect the merger to close later this year, if approved by regulators and Monogram’s shareholders.” 
  • HR Dive informs us,
    • “Most U.S. employers are expected to maintain their salary budgets for 2026, with increases remaining flat at 3.5%, matching actual increases for 2025, according to a July 8 report from WTW, a global advisory firm.
    • “In a survey of more than 1,500 U.S. organizations, 3 in 5 said their salary budgets changed in the last pay cycle. While 53% reported no change in their anticipated and actual pay budgets for 2025, 31% projected lower salary increase budgets than last year.
    • “While top-line budgets are generally holding steady, the real shift is happening beneath the surface,” Brittany Innes, director of rewards data intelligence for WTW, said in a news release. “Organizations are being more deliberate about how they allocate pay, where they focus investment and what outcomes they expect to drive. Employers are no longer simply reacting to economic signals; they’re reimagining how to best support broader business goals despite uncertainty.”

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.”

Weekend update

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care–
  • From Washington, DC
  • The Wall Street Journal reports,
    • “The Senate geared up Sunday for an all-night session of debate and amendment votes on the GOP’s “big, beautiful bill” [HR 1], after Republicans narrowly advanced the measure in a 51-49 vote that set up more push-and-pull before final passage.
    • “The 940-page legislation is driving a wedge between the GOP’s two wings, just as the party is racing to pass the measure early this week. Centrists have raised concerns about cutting benefit programs and straining state budgets, while fiscal conservatives are pushing for even more cuts to rein in federal budget deficits. 
    • “Proponents maintain that the opportunity to pass President Trump’s core agenda items—and pressure from Trump on holdouts—would propel the package over the finish line in the Senate, where the GOP has a 53-47 majority. 
    • “It’s a big, beautiful bill if you believe in cutting people’s taxes, securing the border, having a strong military and controlling government spending,” Sen. Lindsey Graham (R., S.C.) said on the Senate floor Sunday. “The bottom line is, we’re about to make history,” he said.”
  • Here’s a link to the Journal’s explanation of the key provisions in the bill under Senate consideration. The Senate press gallery notes “The Senate will convene on Monday at 9:00 a.m. and begin the Vote-A-Rama on H.R. 1.” If the Senate passes the bill, then the Senate bill, which is based on the bill that the House passed in May, will go back to House for a vote. If the House approves the bill, then the bill will go to the President for signature into law.
  • Beckers Payer Issues calls attention to five Medicare Advantage bills pending in Congress.
  • The Wall Street Journal lets us know how “the Supreme Court dipped its toes into Trump 2.0” during its October 2024 term ended last Friday.

From the public health and medical research front,

  • Fortune Well reports,
    • For all of the advancement in treating stroke victims over the past couple of decades, some concerns have remained almost constant. In medicine, we like to say that “time is brain,” meaning that every moment a stroke goes untreated, the potential for long-term brain damage or death escalates. In fact, every minute that the brain goes without blood flow, the average patient loses around 1.9 million neurons and about a week of independent life, experts say.
    • “As the vast majority of strokes are ischemic, with a blood clot blocking the flow of oxygen to the brain, clearing that clot swiftly is critical. This is true whether the clot is small or large and regardless of its density—but reliably removing the densest clots via mechanical means has proved an elusive task.
    • “Though these concerns, time and density, are not necessarily linked, both matter—one reason, researchers suggest, that a newly developed technology from Stanford University holds the potential to reshape how stroke patients are treated.
    • “The device, called a milli-spinner, is a tiny, powerfully rotating hollow tube outfitted with fins and slits. In action, both lab and swine tests demonstrate the ability to dramatically compact and shrink the size of blood clots, making it easier to remove them quickly and effectively—often on the first try.
    • “This has the potential to be a game changer,” says Greg Albers, director of the Stanford University Stroke Center and a longtime expert in the field. “The results are likely to translate well to clinical trials.”
  • The New York Times tells us,
    • “Gary Sergott felt weary all the time. “I’d get tired, short of breath, a sort of malaise,” he said. He was cold even on warm days and looked pale with dark circles under his eyes.
    • “His malady was not mysterious. As a retired nurse-anesthetist, Mr. Sergott knew he had anemia, a deficiency of red blood cells. In his case, it was the consequence of a hereditary condition that caused almost daily nosebleeds and depleted his hemoglobin, the protein in red blood cells that delivers oxygen throughout the body.
    • “But in consulting doctors about his fatigue, he found that many didn’t know how to help. They advised Mr. Sergott, who lives in Westminster, Md., to take iron tablets, usually the first-line treatment for anemia.
    • “But like many older people, he found a daily regimen of four to six tablets hard to tolerate. Some patients taking iron complain of severe constipation or stomach cramps. Mr. Sergott felt “nauseated all the time.” And iron tablets don’t always work.
    • “After almost 15 years, he found a solution. Dr. Michael Auerbach, a hematologist and an oncologist who is the co-director of the Center for Cancer and Blood Disorders in Baltimore, suggested that Mr. Sergott receive iron intravenously instead of orally.
    • ‘Now Mr. Sergott, 78, gets an hourlong infusion when his hemoglobin levels and other markers show that he needs one, usually three times a year. “It’s like filling the gas tank,” he said. His symptoms recede, and “I feel great.”
    • “His story reflects, however, the frequent dismissal of a common condition, one that cannot only diminish older adults’ quality of life but lead to serious health consequences, including falls, fractures and hospital stays.”
  • The Washington Post informs us,
    • In her mid 70s, Argie, a widowed former teacher, began feeling poorly. She was tired. Her stomach hurt. Sometimes she got agitated. And she seemed forgetful.
    • Worried, her grown children urged the woman, who asked that only her first name be used for privacy reasons, to consult a memory specialist in Baltimore, not far from her home.
    • Argie’s cognitive powers, the doctor concluded, were reasonably good. But her medicine cabinet was a real hazard: She was taking 21 different prescription drugs, for diabetes, high blood pressure and her kidneys. After an assessment by a team that included a clinical pharmacy specialist well versed in drug interactions, she’s now down to eight.
    • “Every time I went in to a doctor, they gave me another pill,” Argie said. She’s now less confused. Less agitated. Less nauseated. She said cognitive challenges are manageable, and she’s more energetic and steadier on her feet.
    • “That overload of drugs, known as polypharmacy, can be dangerous at any age but it’s particularly hazardous for elderly people, who often have multiple health conditions and whose bodies may not handle meds the same way they did when they were younger, said Nicole Brandt, a leading expert on geriatric prescribing at the University of Maryland.”
  • Per Medscape,
    • “Posttraumatic headache (PTH) is frequently misdiagnosed and undertreated in nonspecialist settings, highlighting a critical gap in diagnostic accuracy, treatment access, and integrated care for this complex condition, new research showed. 
    • “Investigators found that patients with the condition are frequently misdiagnosed and undertreated in nonspecialist settings. Further, most are only correctly diagnosed with a migraine phenotype after evaluation by a headache specialist.
    • “A central message of our work is that the diagnosis of ‘headache’ is too often treated as a monolith — an endpoint rather than the beginning of a diagnostic journey,” study investigator Natalia Murinova, MD, clinical professor of neurology, and director of the headache clinic at the University of Washington (UW), Seattle, told Medscape Medical News.
    • “The results of the retrospective analysis were presented at the American Headache Society (AHS) Annual Meeting 2025.”

Midweek report

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

From Washington, DC,

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

From the state and local government front,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC,

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

From the judicial front,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the State law front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.
  • This afternoon, the House of Representatives passed by voice vote the Esophageal Cancer Awareness Act, HR 3490.
    • “This bill requires the Government Accountability Office to report to Congress on (1) the impact of esophageal cancer-related health care spending under the Federal Employees Health Benefits Program (FEHBP) for federal employees and retirees diagnosed with esophageal cancer, and (2) how often FEHBP participants with a high risk of esophageal cancer undergo screenings according to established guidelines.” 
    • The bill honors the late Rep. Gerald Connelly (D VA) who died from the disease. The bill now heads to Senate.
  • The New York Times reports,
    • “President Trump on Tuesday ratcheted up pressure on Senate Republicans to quickly embrace and pass legislation carrying his domestic agenda, intensifying a battle inside the G.O.P. about what should be in the measure and how much it should cost.”
  • Govexec adds,
    • “The Trump administration plans to send its first spending cuts request to Congress on Tuesday, asking lawmakers to swiftly eliminate $9.4 billion in funding for the Corporation for Public Broadcasting and various foreign aid programs.
    • “The request for what are called rescissions allows the White House budget office to legally freeze spending on those accounts for 45 days while the Republican-controlled Congress debates whether to approve the recommendation in full or in part, or to ignore it.
    • “The proposal calls on lawmakers to eliminate $1.1 billion from the Corporation for Public Broadcasting, which provides funding for National Public Radio and the Public Broadcasting Service. That means NPR and PBS would lose their already approved federal allocations, if the request is approved by Congress.”
  • Fierce Healthcare points out,
    • “The Centers for Medicare and Medicaid Services plans to undertake several new health tech initiatives, senior leaders announced today at a closed meeting with stakeholders. 
    • “The Department of Health and Human Services held a meeting today to discuss health tech policy and its recent request for information on health tech initiatives. CMS seems to be moving ahead with some of the initiatives it asked stakeholders to provide feedback on in its RFI — among them a national provider directory and modern identity verification for Medicare beneficiaries.
    • “This comes as the HHS’ health IT office announced a new leader this morning, Thomas Keane, M.D. Keane spoke at the meeting of stakeholders today at the Hubert H. Humphrey building in Washington, D.C.” 
  • Healthcare Dive adds,
    • Thomas Keane, a software engineer and interventional radiologist, began his role as national coordinator [for health information technology] Monday, the spokesperson said. He previously worked at the ASTP and served as a senior advisor to the deputy secretary of the HHS, according to his biography on the agency’s website. 
  • Healthcare Dive also relates,
    • “The Trump administration rescinded guidance on Tuesday directing hospitals to perform abortions during medical emergencies, even in states with restrictive abortion bans. 
    • “The Biden administration published the guidance in 2022, shortly after Roe v. Wade was overturned, asserting doctors were required to perform emergency care, even if that included abortions, under the Emergency Medical Treatment and Labor Act. * * *
    • “The CMS now says that guidance “does not reflect the policy of this Administration.” The new guidance is effective May 29, and furthers an executive order from President Donald Trump seeking to remove regulatory red tape, the CMS said.” * * *
    • “Texas and Idaho, which have some of the nation’s most restrictive abortion bans, have repeatedly argued that there is no conflict between EMTALA and their policies, because both states allow abortion when the mother’s life is at risk.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal district court judge on Tuesday denied motions to dismiss complaints in two lawsuits against data analytics firm MultiPlan — now operating as Claritev — and a number of insurers.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois denied Claritev’s motion to dismiss complaints in two lawsuits involving federal and state antitrust and consumer protection claims.” * * *
    • “Both lawsuits allege Claritev colluded with insurers to reduce pay for out-of-network providers, violating state and federal antitrust laws under the Sherman Act.
    • “We remain confident in the strength of our legal position and look forward to presenting the facts as the case moves forward,” Claritev said in a statement Tuesday. “These lawsuits will only serve to increase healthcare cost for employers and patients. We will vigorously defend ourselves through the legal process while remaining focused on delivering value to our customers and the broader healthcare ecosystem.”
  • Per Healthcare Dive,
    • “Centene is being sued for wrongful death after one of its members died after failing to get the mental healthcare he needed because of the insurer’s inadequate provider networks, according to the lawsuit filed by the member’s mother.
    • “The suit, filed late May in the Superior Court of Maricopa County in Arizona, accuses Centene’s subsidiary in the state, Health Net, of maintaining “ghost networks” — wherein insurers say providers are in network that aren’t, inflating the care options available under their plans to the detriment of actual access.
    • “As a result, Centene violated state and federal laws requiring network accuracy and adequacy, according to the suit, which also accuses the St. Louis-based payer of negligence and fraud. Centene did not respond to a request for comment.”
  • Per MedTech Dive,
    • “The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, according to two lab industry groups.
    • “The 60-day window for the FDA to appeal the ruling by the U.S. District Court for the Eastern District of Texas expired over the weekend. The Association for Molecular Pathology supported the FDA’s move not to appeal.
    • “This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statement.”

News from the American Society of Clinical Oncology’s conference

  • The New York Times reports,
    • “A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year.
    • “They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice.
    • “They all got immunotherapy, in a study that was a last-ditch effort.
    • “A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease.
    • “These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words “potential cure.”
    • “The new study, reported Tuesday at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech.”
  • Per Fierce Pharma,
    • “Though they are both multiple myeloma drugs with the same mechanism of action, Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s powerhouse Darzalex, largely because it reached the market five years later.
    • “But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody.
    • “Tuesday, at the American Society of Clinical Oncology annual meeting in Chicago, Sanofi presented data from two trials that showed Sarclisa administered subcutaneously (SC) from an investigational on-body injector (OBI) reduced treatment time and produced similar efficacy and safety compared to intravenous (IV) infusion.”
  • Per BioPharma Dive,
    • “An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company.
    • “The study, known as Oasis-4, is the fourth successful trial test of Bayer’s drug, called elinzanetant. Detailed data presented at the American Society of Clinical Oncology’s annual meeting Monday showed treatment reduced vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer.”
  • and
    • “A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial.
    • “Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncology’s meeting in Chicago. They could potentially expand the number of people able to receive J&J’s Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga.”
  • The Wall Street Journal reports,
    • “Roche said Tecentriq combined with lurbinectedin shows significant survival benefits for patients with extensive-stage small cell lung cancer.
    • “The Swiss pharmaceutical company said Tuesday that late-stage trials showed the combination led to a 46% reduction in the risk of the disease progressing or death, and 27% reduction in the risk of death.
    • “The combination can be used a as a first-line maintenance treatment for people with the cancer following induction therapy with carboplatin, etoposide and Tecentriq, it said.
    • “The safety profile of the combination was consistent with the known safety profiles of Tecentriq and lurbinectedin, Roche said.”

In other medical research and public health news,

  • Cigna, writing in LinkedIn, explains why early detection is so important to fighting breast cancer.
  • The latest issue of the National Institutes of Health’s Research Matter covers “Customized gene therapy | Parents with substance use disorders | Ultra-processed food consumption.”
  • The New York Times discusses “Anorexia in Middle Age and Beyond. A growing number of older women are seeking treatment for eating disorders. Many have struggled without help for decades.”
  • MedCity News informs us,
    • “The World Health Organization estimates that about 10% of women and girls of reproductive age around the world — roughly 190 million people — suffer from chronic pain as a result of endometriosis. 
    • “Take this estimate with a grain of salt, though — it’s likely too low. The average diagnostic delay for endometriosis patients is eight years, driven in large part by the fact that the standard method used to diagnose the disease is an invasive surgical procedure.”
    • Boston-based biotech startup Heranova Lifesciences is working to address this problem by developing a non-invasive blood-based test. Just this spring, the company announced the LDT validation and U.S. launch of this product, which is called HerResolve. * * *
    • “The gold standard that doctors use to diagnose endometriosis is laparoscopy followed by histological confirmation. With this method, doctors put patients under anesthesia and perform a laparoscopy to look at the tissue and lesions growing outside the uterus — then, the doctor takes a tissue sample to confirm the diagnosis under a microscope.
    • “This method of testing is invasive — and not very quick. Heranova’s test seeks to address these issues by using machine learning to analyze a panel of biomarkers in a patient’s blood sample to determine whether or not they have endometriosis. 
    • “The test’s accuracy is on par with laparoscopy followed by histopathology, said Farideh Bischoff, Heranova’s chief medical officer.”
  • Per Health Day,
    • “Clinicians consider administration of human papillomavirus (HPV) vaccine as feasible at age 9 to 10 years, and parents appear to be receptive to discussing vaccination at this age, according to a study published online June 2 in Pediatrics.
    • “Caroline K. Tietbohl, Ph.D., from the University of Colorado and Children’s Hospital Colorado in Aurora, and colleagues conducted an explanatory sequential mixed-methods study as part of an ongoing randomized trial that compared initiation at ages 9 to 10 years (intervention) versus 11 to 12 years (control) across 17 practices in Colorado (nine intervention) and 16 practices in California (eight intervention). At one month after study initiation, practice clinicians were surveyed, and semi structured interviews were conducted at three months after study initiation.” * * *
    • “The results of our prospective trial will determine if initiating vaccination earlier increases vaccination completion rates, especially by age 13 years,” the authors write.
  • The Wall Street Journal reports,
    • People are more likely to get cancer as they age. Dr. Miriam Merad has an unconventional idea of how that might be reversed: using allergy drugs and other seemingly unlikely medications to damp a condition known as “inflammaging.”
    • The immunologist and oncologist has spent years examining malignant tumors to learn why people over age 50 account for nine in 10 cancer diagnoses in the U.S. She and her research team at the Icahn School of Medicine at Mount Sinai in New York City have homed in on an answer: the aging immune system. Their studies of individual immune cells in human lung tumors, as well as in old mice, have revealed how chronic, or pathogenic, inflammation in older people—dubbed inflammaging—interferes with the immune system and fuels cancer growth.
    • Merad and other researchers are testing whether existing anti-inflammatory medications usually used to fight rheumatoid arthritis or allergy conditions like asthma or eczema can slow cancer in older patients. They are also searching for new drugs. “Aging is something that we think we can transform,” says Merad, director of the Marc and Jennifer Lipschultz Precision Immunology Institute at Mount Sinai.”

From the U.S. healthcare business front,

  • Becker Payer Issues lets us know,
    • “Following a tumultuous period for UnitedHealth Group, new CEO and board chair Stephen Hemsley addressed investors on June 2, acknowledging the company’s recent shortcomings and detailing his plan to restore the high performance that investors and customers expect moving forward.
    • “Mr. Hemsley expressed a deep commitment to regaining trust through increased transparency, improved pricing strategies, and a renewed focus on internal operations, particularly at Optum Health and UnitedHealthcare. 
    • “We are well aware we have not fulfilled your expectations or our own,” he said. “We apologize for that performance and we are humbly determined to earn back your trust and your confidence.”
    • The article also provides eight notes on Mr. Hemsley’s talk.
  • STAT News adds,
    • UnitedHealth Group’s new CEO told investors that the company is reevaluating how it tallies Medicare Advantage patients’ diagnoses for reimbursement purposes, an issue currently under investigation by the Justice Department. 
    • Stephen Hemsley’s remarks during the company’s annual shareholder meeting on Monday signal a noteworthy shift: UnitedHealth is now publicly acknowledging potential issues with how it assesses the health of its Medicare Advantage members.” * * *
    • “Our management team has been working with urgency through a comprehensive and methodical review of our operations from end to end,” Hemsley said. “Digging into every part of the organization to evaluate how we have been performing and to improve that performance.”
  • Fierce Pharma notes,
    • “Medicare Part D beneficiaries can now tap into Amazon Pharmacy’s PillPack for pre-sorted medication packets, the retail giant announced on Tuesday.
    • “PillPack sorts a patient’s medications into personalized, tear-away packets that are labeled by date and time, which can make it easier to follow prescribed regimens. The expansion brings this service to more than 50 million Part D enrollees who take daily medications, Amazon said.
    • “Once eligible customers sign up for packets through PillPack, Amazon Pharmacy will coordinate needed refills to ensure prescriptions arrive on time.
    • “In addition to growing its reach in the Part D market, Amazon announced that it will roll out new services to support caregivers in managing medications for a family member or loved one.”
  • Modern Healthcare reports,
    • “Pyx Health, a digital mental health platform, on Tuesday announced its acquisition of FarmboxRx, a company that provides fresh produce food boxes to Medicare and Medicaid members.”
  • Beckers Hospital Review informs us that “Hospitals [are] push[ing] back on low Leapfrog grades.”
  • Per Fierce Healthcare,
    • “In January, H1 picked up provider data management software company Ribbon Health to broaden its reach into the health plan, provider system and digital health sectors.
    • “Five months later, the healthcare tech company has acquired Veda Data Solutions to build out its provider data and automation solutions for payers.
    • “Financial terms of the deal were not disclosed.
    • “Founded 10 years ago, Veda fixes bad provider data for healthcare organizations. Inaccurate and out-of-date health plan provider directories continue to be a thorny problem in healthcare and can make it difficult for patients to find a clinician when they need care.”