Monday report

CDC

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.”

Friday report

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

From Washington, DC,

  • STAT News reports,
    • “Republicans’ first major policy bill this year was a partisan affair: They cut Medicaid funding by some $1 trillion to help fund tax cuts prized by President Trump.
    • “Now, though, there are some bipartisan health care policies, from pharmacy-benefit manager reform to Medicare doctor payment changes, that the two parties could work on — and many health care programs with bipartisan support that are set to expire this year if lawmakers don’t act. 
    • “The Food and Drug Administration’s user fee program for over-the-counter drugs also expires this year.
    • “The reason that some of these health care measures get tacked onto appropriations bills is that the government has to be funded, or it will shut down. Passing government-spending legislation requires 60 votes, so it takes support from both parties. 
    • “Congress typically uses annual appropriations bills to renew many health care programs and policies in Medicare and Medicaid, collectively called health care extenders. Well over a dozen expire or run out of cash after Sept. 30, including a popular Medicare program that makes telehealth services widely available, and funding for community health centers, hospitals that care for large numbers of uninsured, and certain pandemic preparedness activities. 
    • But Democrats are signaling they may not work with Republicans on this process. * * *
    • “Senate Minority Leader Chuck Schumer (D-N.Y.) warned of precisely that scenario on Tuesday, saying that Republicans would poison any remaining relationship with Democrats if they vote for the rescissions bill.
    • “Plus, some key Republican lawmakers have raised the idea of pursuing another budget reconciliation bill — the same partisan pathway they used to extend Trump’s tax cuts.” 
  • Time will tell, but here are a couple of examples of bipartisan bills.
  • The American Hospital Association News tells us,
    • “A bill was introduced July 10 to extend certain Medicare waivers authorizing the hospital-at-home care program. The bill was introduced in the House by Reps. Vern Buchanan, R-Fla., Lloyd Smucker, R-Pa., and Dwight Evans D-Pa., and in the Senate by Sens. Tim Scott, R-S.C., and Rev. Raphael Warnock, D-Ga.”
  • Per a Congressional news release,
    • Rep. Earl L. “Buddy” Carter (R-GA) today led 11 bipartisan members of Congress in introducing the PBM Reform Act, which protects patients and pharmacies from the harmful and anticompetitive business practices of pharmacy benefit managers (PBM). * * *
    • Read the full text here.
  • MedTech Dive tells us,
    • “The Centers for Medicare and Medicaid Services has agreed to cover transcatheter edge-to-edge repair for tricuspid valve regurgitation, including Abbott’s TriClip system.
    • “In a LinkedIn post, Abbott called the national coverage determination a milestone for patients with severe tricuspid regurgitation that will support broader access to a minimally invasive treatment for those who are not good candidates for surgery.
    • “This decision helps open the door to treatment for more people living with symptomatic severe tricuspid regurgitation – many of whom have had few options in the past. It also provides additional clarity for care teams working to bring minimally invasive solutions to these complex patients,” Sandra Lesenfants, senior vice president of Abbott’s structural heart division, said on LinkedIn.”
  • and
    • “The Centers for Medicare and Medicaid Services on Thursday posted a proposed national coverage determination for renal denervation, a new procedure for lowering blood pressure in people with uncontrolled hypertension.
    • “Medtronic and Recor Medical, a subsidiary of Otsuka Medical Devices, obtained Food and Drug Administration approval for the first-of-a-kind treatments in late 2023, with Medtronic’s Symplicity Spyral device overcoming resistance from an advisory panel of outside experts to ultimately win the FDA’s backing.
    • “William Blair analyst Brandon Vazquez said a CMS national coverage decision for renal denervation could pave the way for the treatment to become “one of the largest growth drivers in recent history” for Medtronic, noting the device maker has estimated more than 18 million people in the U.S. have high blood pressure that is not well managed with medication and lifestyle changes. “While this is only a proposed rule, we view the positive readout as a meaningful first step toward Symplicity’s ramp-up,” Vazquez wrote in a report to clients Friday.”

From the judicial front,

  • Bloomberg Law reports,
    • “MSN Laboratories Ltd. can sell its copies of Novartis AG’s Entresto upon FDA approval after a federal judge found they don’t infringe a key patent for the heart-failure drug.
    • :MSN’s proposed generics don’t infringe Novartis’ US Patent No. 11,096,918, Judge Richard G. Andrews ruled in an opinion issued Friday in the US District Court for the District of Delaware. He also denied Novartis’ related request to prevent MSN from launching during any appeal.
    • “MSN’s tablets don’t contain the crystalline sacubitril-valsartan compound described in the ‘918 patent, Andrews said, so they don’t infringe. The ruling followed a December 2024 bench trial focused solely on infringement. Novartis warned in a status update earlier Friday that MSN could receive final approval from the US Food and Drug Administration as soon as July 16. Entresto’s pediatric exclusivity expires July 15.
    • “A Novartis spokesperson said the company “is disappointed with the decision” and plans to appeal it. “Novartis is confident in our intellectual property and regulatory rights related to Entresto and will continue to defend our rights,” the statement said. “There are currently no generic versions of Entresto available in the US.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza and COVID-19 activity is low. RSV activity is very low.
    • “COVID-19
      • “COVID-19 wastewater activity and laboratory percent positivity are low nationally. Emergency department visits for COVID-19 are very low but increasing. Model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in many Southeast, Southern, and West Coast states.
    • Influenza
    • RSV
      • “RSV activity is very low.”
  • Newsweek reports,
    • “A nationwide recall of chocolate products has been issued the highest risk warning by the U.S. Food and Drug Administration (FDA).
    • “Weaver Nut Company, Inc., based in Pennsylvania, announced a voluntary recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the possible undeclared presence of milk, a major food allergen.
    • “The FDA subsequently issued a Class 1 risk classification for the recall on July 8.” * * *
    • “The recall was initiated due to the undeclared presence of milk, one of the nine major food allergens as defined in law. The others are eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.”
  • Beckers Clinical Leadership lets us know,
    • “Three cities in Texas have the highest percentage of adults with fair or poor health, according to WalletHub’s annual ranking, published July 7.
    • “To determine the ranking, WalletHub compared 182 cities across four dimensions — work stress, financial stress, family stress, and health and safety stress — and evaluated those dimensions using 39 weighted metrics. Each metric was graded on a 100-point scale, with a score of 100 representing the highest levels of stress.”
  • Per Beckers Payer Issues,
    • “A virtual diabetes management program offered by UnitedHealthcare has shown measurable changes in members’ behavior, and for some employers, a return on investment.
    • “The Level2 program, originally launched under Optum in 2019, combines continuous glucose monitors, personalized coaching, and a virtual care model. It targets employees with type 2 diabetes and aims to improve clinical outcomes through self-management and simplified access to care.
    • “A lot of the cost for diabetes is with the highest-risk patients, so we had our physicians and team focus on how to engage more patients that are high-risk,” David Moen, MD, a physician executive at Level2, told Becker’s. 
    • “In a June study published by the American Diabetes Association, UnitedHealth researchers analyzed 3,773 Level2 Specialty Care participants with at least 180 days of CGM usage between January 2023 and June 2024. The patients used the CGM for an average of 83.6% of days, and 82% of them logged actions in the Level2 app. The most common types of actions were related to nutrition (36%) and movement (33%), followed by tracking (19%), mindfulness (9%), and treatments such as medications or talking to a physician (1%).”
  • STAT News discusses a bionic knee that MIT researchers are now testing on human subjects.
    • The study involved putting three groups of volunteers with above-the-knee amputations through tests that included climbing stairs, standing without a handrail, and avoiding a foam block obstacle when walking on a treadmill. One group, which served as a control, used the bionic knee without any other interventions.
    • “The two other groups underwent a surgical procedure developed by Herr and Dr. Matthew Carty of Brigham and Women’s Hospital that reconnects pairs of muscles that are typically severed during amputation. The muscles take turns stretching and contracting, conveying sensory information to the brain. The surgery, known as agonist-antagonist myoneural interface, or AMI, allows amputees to regain a push-and-pull dynamic in their leg muscles so they have a vivid feeling of their phantom joint moving around.
    • “[The article’s protagonist Thomas] Gee was in the only group to have the prosthesis fully integrated in their bodies, with electrode wires from the prosthesis to their thigh muscles. The other two groups used electrodes attached to the skin surface of their amputated legs to the prosthesis to collect information about electrical activity of the leg muscles.
    • “The study found that patients who were using the bionic knee with electrodes implanted within their muscles could complete the tasks more accurately and with a greater sense the prosthesis was part of their bodies.”

From the U.S. healthcare business front,

  • Managed Healthcare Executive reports,
    • “Commercial insurers pay hospitals much more than Medicare in some areas than others, and a new study found that local market factors, including hospital dominance, help explain these growing price gaps.
    • “These findings, published in JAMA Health Forum, could help guide future efforts to control rising healthcare costs.
    • “From 2000 to 2020, medical care prices in the U.S. rose nearly twice as fast as prices for other goods and services—growing at an average of 4.9% per year, compared to 2.5%. Hospital services saw even steeper increases, averaging 10.2% annually.
    • “While price growth slowed during the COVID-19 pandemic, the study showed that federal projections expect it will return to previous levels and continue outpacing the rest of the economy through 2032.
    • “Another analysis from KFF and the Peterson Center on Healthcare found that overall health spending rose 7.5% from 2022 to 2023 and is expected to rise another 4.2% in 2025. Key drivers include high-cost drugs, federal funding cuts, and workforce shortages—factors expected to remain central to the policy debate in 2025.”
  • Per Beckers Hospital Review,
    • Becker’s is pleased to release the 2025 edition of its “Great community hospitals” list.
    • Community hospitals play a vital role in the fabric of the U.S. healthcare system, delivering accessible, affordable care to patients beyond major metropolitan areas. Whether serving rural regions or suburban neighborhoods, these hospitals are essential to keeping communities healthy and connected to quality care.
    • The community hospitals recognized on this list are dedicated to clinical excellence, academic advancement and personalized, whole-person care delivery. Their mission is to elevate health outcomes within the communities they serve. 
  • and
    • “Forty-one hospitals have converted to rural emergency status since the designation took effect in 2023. 
    • “Under the designation, hospitals end inpatient services and instead offer emergency, observation and other outpatient services.
    • “While providing an opportunity to preserve critical healthcare services in rural communities, it is also offering a path to revive hospitals that have closed, Kaufman Hall said in a July 10 report. The healthcare consulting firm noted that three hospitals that have closed in recent years are eyeing a return as rural emergency facilities. 
    • “The fact that several of these announcements involve the reopening of closed hospitals — albeit in a different form — is a promising sign that different ways of thinking about rural healthcare could help maintain or restore access to essential services and enable a vehicle for such transformation,” Kaufman Hall said. “This trend also suggests that the partners in these transactions believe that there is a viable path forward for rural healthcare.”
  • and
    • “While the total number of drug shortages in the U.S. appears to be decreasing in 2025, some shortages of essential medications have yet to be resolved. 
    • “Erin Fox, PharmD, senior pharmacy director at University of Utah Health, said a few persistent shortages continue to strain health systems, especially certain drugs essential to emergency, surgical and outpatient care. 
    • “There are a number of ongoing shortages. But a few of them are ongoing or are becoming worse, so they are definitely top of mind,” she said. 
    • “Here are four high-impact shortages Dr. Fox said her team is focused on for the rest of 2025.”
      • Lorazepam injection 
      • Injectable steroids
      • IV fluids, and
      • Generic injectables.
  • Fierce Healthcare reports,
    • Walgreens Boots Alliance shareholders have voted to approve the company’s sale to Sycamore Partners.
    • The pharmacy giant announced Friday morning that 96% of the shareholder votes at a special meeting favored the merger, which would take Walgreens private, according to preliminary results. That includes 95% of unaffiliated shareholders voting for the deal.
    • “Under the terms announced earlier this year, stakeholders will receive $11.45 in cash per share, for a total deal value of about $10 billion.
    • “The company expects the sale will close in the third or fourth quarter of 2025, per the announcement.”
  • Healthcare Dive informs us,
    • “Genesis Healthcare, one of the largest providers of skilled nursing facilities in the country, filed for Chapter 11 bankruptcy protections on Wednesday.
    • “Pennsylvania-based Genesis, which operated about 175 skilled nursing facilities across 18 states at its filing, said it struggled with post-pandemic challenges, legacy liabilities and inadequate Medicaid reimbursement. Staff will retain their positions, and the filing is not expected to impact patient care, a Genesis spokesperson told Healthcare Dive.
    • “Affiliates of Genesis’ investor ReGen Healthcare, a private equity firm, have entered into a deal to acquire Genesis, according to bankruptcy court documents filed Thursday.”

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, Congress, FDA, Medical / Rx research, Mental health care, OPM, SDOH, U.S. Healthcare–

From Washington, DC,

  • At 6:45 pm ET, the Senate confirmed by a 49-46 vote the President’s nomination of Scott Kupor to be Office of Personnel Management Director for a four-year term. The confirmation vote followed a 51-46 vote in favor of Mr. Kupor to close debate on his nomination. (Link to Govexec story) Congratulations and best wishes, Mr. Kupor.
  • Govexec tells us,
    • “President Donald Trump’s candidate to lead the Centers for Disease Control and Prevention advanced out of a Senate committee Wednesday following a party-line vote, moving her one step closer to confirmation.
    • “Susan Monarez’s nomination now goes to the floor, where she will likely secure the backing needed to officially take on the role of CDC director after garnering support from Republicans across the political spectrum during the committee’s 12-11 vote.
    • “Senate Majority Leader John Thune, R-S.D., will be in charge of scheduling that vote, though if it isn’t held during the next few weeks, Monarez will have to wait until after the chamber’s August recess.”
  • BioPharma Dive informs us,
    • “President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high rate, like 200%” on pharmaceutical products, he said at a cabinet meeting Tuesday.
    • “Trump indicated official announcements of the tariffs would come “very soon” but did not elaborate on an exact timeline. He did say, however, that the U.S. would give pharmaceutical importers at least a year to shift their strategies before the implementation of the levies.” * * *
    • “In a note to clients, Leerink Partners David Risinger wrote how the planned grace period is a “positive” for the sector, which has for years built up production capacity in countries like Ireland, Switzerland and the Netherlands. Many generic medicines and drug ingredients, meanwhile, are sourced from India and China.”

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase that in clinical trials, reduced dangerous episodes of brain swelling, the company said Tuesday.
    • “That side effect, called ARIA, has made physicians reluctant to prescribe the drug and resulted in its use being blocked in some countries. The new dosing protocol will “aid healthcare professionals in evaluating appropriate treatment options for their patients,” said Brandy Matthews, Lilly’s vice president for Alzheimer’s medical affairs, in a statement.
    • “Approved in 2024, Kisunla was the third drug cleared by the FDA to slow Alzheimer’s progression by targeting toxic plaques of a protein called amyloid beta. Despite its potency, sales were only a modest $21 million in the first quarter of 2025.”
  • Mobihealth News points out,
    • “Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision. 
    • “Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible. 
    • “Among Focalist’s features are touchscreen targeting, robotic needle positioning and continuous needle depth tracking, enabling a reproducible procedure experience.
    • “While needle placement is used for a variety of procedures and in a broad range of clinical settings, the initial focus of the system will be in urology. Full commercialization is expected in 2026.”
  • Per Fierce BioTech,
    • “The FDA has cleared its first cuffless blood pressure monitor that will be available over-the-counter, with the Hilo wristband developed by Aktiia. 
    • “According to the Swiss company, the wearable’s optical sensors can capture continuous blood pressure readings similar to the traditional inflated cuff with monthly calibrations, and they have demonstrated accuracy across a variety of skin tones—as well as while the user is sitting, standing or lying down. 
    • “The system previously obtained a CE Mark approval in Europe, and Aktiia said its newly 510(k)-cleared product will reach the U.S. sometime in 2026. The Hilo bracelet has also been given go-aheads in Canada, Australia and Saudi Arabia, and more than 120,000 have already been sold, the company said.
    • “This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management,” Aktiia’s co-founder and chief technology officer, Josep Sola, said in a statement. “With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The US Centers for Disease Control and Prevention (CDC) today reported 21 more measles cases from the past week, pushing the year’s total above a record set in 2019 for the most cases since the disease was eliminated in the United States in 2000.
    • “So far this year, 1,288 cases have been reported from 39 states, and 88% have been part of 27 outbreaks. Among confirmed cases, 92% occurred in people who are unvaccinated or have unknown vaccination status. 
    • “Measles isn’t just striking young children and their school-age peers: about one-third of cases have been reported in those ages 20 and older. The measles surge was initially fueled by a large outbreak in West Texas that began in January, but smaller outbreaks have now been reported from multiple states, along with numerous infections in unvaccinated people who traveled abroad.
    • ‘Measles activity has increased globally, including in North America, where the virus is spreading in communities with large numbers of unvaccinated people—including Mennonite communities linked to large outbreaks in the United States, Canada, and Mexico. Canada has reported 3,703 measles cases this year, the most since it eliminated the disease in 1998.”
  • and
    • “A study of more than 70,000 US pregnancies suggests a commonly used antibiotic for urinary tract infections (UTIs) may be tied to increased risk of congenital malformations when taken during the first trimester of pregnancy.
    • “The study, published today in JAMA Network Open, found that exposure to trimethoprim-sulfamethoxazole (TMP-SMX) during the first trimester was associated with increased risk of any malformation, severe cardiac and other cardiac malformations, and cleft lip and palate compared with beta-lactam antibiotics. No increased risk of congenital malformations was observed with nitrofurantoin, which is also commonly used to treat UTIs.
    • “The study partly substantiates the concerns of the American College of Obstetricians and Gynecologists (ACOG), which has suggested that TMP-SMX and nitrofurantoin be avoided during the first trimester when possible because of uncertainty about the risk of congenital malformations, though studies to date have produced mixed results. Despite the ACOG recommendation, the two antibiotics still account for more than half of first-trimester UTI prescriptions, according to the study authors.” 
  • STAT News adds,
    • “When several countries endorsed the notion of some high-risk people taking the antibiotic doxycycline after unprotected sex to lower their chances of contracting a sexually transmitted disease, as the U.S. did last year, there was a theoretical concern the shift could drive antibiotic resistance in some bacterial infections.
    • “That risk no longer appears to be theoretical.
    • “In a newly published letter in the New England Journal of Medicine, researchers reported a steep rise in resistance to tetracycline — the antibiotic class to which doxycycline belongs — in gonorrhea isolates collected from across the country since results of the studies investigating the use of so-called doxy PEP were made public. PEP is short for post-exposure prophylaxis. 
    • “An earlier report out of the University of Washington showed a similar trend in the Pacific Northwest, as well as a rise in tetracycline resistance in other bacteria carried by people who took doxy PEP, specifically Staphylococcus aureus and group A Streptococcus.”
  • and
    • About 1 in 3 young people who are 12 to 17 years old have prediabetes, new national data show, putting them at risk not just for type 2 diabetes but also for heart disease and stroke. Developing chronic diseases early in life also heightens their chances for worse outcomes from these conditions. 
    • Experts said the data reflect a concerning rise in obesity among teens but also noted that not all teens with prediabetes will progress to diabetes.
    • “The new report from the Centers for Disease Control and Prevention relied on the long-running National Health and Nutrition Examination Survey, which asked adolescents if they’d ever been diagnosed with diabetes and analyzed results of their fasting blood glucose or hemoglobin A1c tests. Its conclusion: In 2023, an estimated 8.4 million adolescents, or 32.7% of 12- to 17-year-olds, had prediabetes.”
  • Health Day lets us know,
    • “Three-quarters of stomach cancer cases could be prevented if doctors eradicate infection by a common type of bacteria, a new study says.
    • “The bacteria, Helicobacter pylori, is linked to 76% of future stomach cancer cases, researchers reported July 7 in the journal Nature Medicine.
    • “Most stomach cancers “are caused by chronic infection with H. pylori and can be prevented by treatment of the infection with a combination of antibiotics and proton pump inhibitors,” wrote the research team led by Jin Young Park, a scientist with the International Agency for Research on Cancer in Lyon, France.” * * *
    • “About 30,300 new cases of stomach cancer will occur in the U.S. this year, and about 10,780 people will die from this type of cancer, according to the American Cancer Society. Most cases occur in seniors.” * * *
    • “In the USA, there are currently no national guidelines or formal recommendations for gastric cancer prevention, although gastric cancer disproportionately affects Asian Americans, Hispanic Americans, African Americans and American Indian-Alaska Native individuals, and an increasing trend in young individuals (age <50 years) has been observed between 2016 and 2022, most notably in women,” researchers wrote.
    • “While H. pylori infections can be easily treated, researchers said it would be best if a vaccine for the bacteria is developed.
    • “Currently, only one H. pylori vaccine has passed phase 3 of a clinical trial,” researchers noted. “More investment in future vaccine trials focusing on pediatric populations should be made, clarifying the mechanisms of vaccine-associated immunoprotection.”
  • and
    • “Uterine cancer incidence and mortality rates are projected to increase significantly through 2050, according to a study published online July 1 in Cancer Epidemiology, Biomarkers & Prevention.
    • “Jason D. Wright, M.D., from the Columbia University College of Physicians and Surgeons in New York City, and colleagues developed a natural history model for uterine cancer to project trends through 2050.
    • “The researchers reported that uterine cancer is projected to increase in incidence and mortality through 2050. Black women will experience a disproportionate rise in incidence compared with White women between 2020 and 2050 (86.9 and 74.2 per 100,000, respectively), as well as a rise in mortality (27.9 and 11.2 per 100,000, respectively). For nonendometrioid tumors, White women will experience only a slight increase, while Black women will experience a substantial increase (10.8 and 36.3 per 100,000, respectively). Hypothetical screening and intervention methods were most effective when introduced at age 55 years with declines in cancer incidence that lasted up to 15 years in White women and up to 16 years in Black women.”
  • and
    • A healthy plant-based diet might protect people from inflammatory bowel diseases, a new study says.
    • People noshing healthy plant-based foods had a 14% lower risk of Crohn’s disease and an 8% lower risk of ulcerative colitis, researchers found.
    • On the other hand, an unhealthy diet containing more animal fats and vegetable oils was associated with a 15% increased risk of Crohn’s disease, results show.
    • “Our research indicates that a healthy plant-based diet may protect against inflammatory bowel disease, with its anti-inflammatory properties playing a key role,” senior researcher Dr. Zhe Shen of the Zhejiang University School of Medicine in China said in a news release.
  • The New York Times reports,
    • “Few practices in mental health are debated more than the long-term use of antidepressant medications, which are prescribed to roughly one in nine adults in the United States, according to data from the Centers for Disease Control and Prevention.
    • “A reassessment began in 2019, when two British researchers published a study that found that 56 percent of patients suffered from withdrawal symptoms when they stopped antidepressant medications and that 46 percent of those described their symptoms as severe.
    • “The findings made headlines in Britain and had a powerful ripple effect, forcing changes to psychiatric training and prescribing guidelines. And they fed a growing grass-roots movement calling to rein in the prescription of psychotropic drugs that has, in recent months, gained new influence in the United States with the rise of Robert F. Kennedy Jr. as health secretary.
    • “A new study, published on Wednesday in the journal JAMA Psychiatry, makes the case that these warnings were overblown. The authors of the new paper found that a week after quitting antidepressants, patients reported symptoms like dizziness, nausea and vertigo, but that they remained, on average, “below the threshold for clinically significant” withdrawal.”
  • Per MedPage Today,
    • “About half of teen vapers said they had tried to quit in the past year, and about a third wanted to try quitting in the next 6 months.
    • “The most common nicotine cessation tools used in these attempts were apps.
    • “No nicotine replacement therapy is approved for youth, but the American Academy of Pediatrics recommends considering off-label use for some adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck will buy Verona Pharma for roughly $10 billion, adding Ohtuvayre to its cardiopulmonary pipeline and portfolio.
    • “The acquisition helps Merck prepare for the loss of patent exclusivity for Keytruda in 2028.
    • “Verona shareholders will receive $107 per share, a 23% premium to Tuesday’s closing price.”
  • Healthcare Dive notes,
    • “Health insurers are steadily expanding their control over the U.S. primary care market — especially in areas with a lot of seniors eligible for Medicare Advantage plans, according to new research.
    • “In 2023, payer-operated practices accounted for 4.2% of the national Medicare primary care market by service volume, up from 0.8% in 2016, the study published in Health Affairs Scholar found. It’s the first concrete estimate of insurer ownership of physician practices nationwide and suggests that vertical consolidation is being driven by the potential for profits in nudging MA members to owned clinics, researchers said.
    • “The paper could also intensify the microscope on UnitedHealth as lawmakers and regulators scrutinize the healthcare behemoth’s outsized control over the industry. UnitedHealth-owned Optum was the largest operator of primary care clinics of all the insurers included in the analysis, holding more than 2.7% of market share nationally and more than 35% in several large counties.”
  • Per Beckers Health IT,
    • “A recent survey from the American Medical Association found that 66% of medical providers used AI in some capacity in the past year. That represented a dramatic 78% increase from the prior year.  
    • “Usage is only going up, but many providers remain skeptical about AI. Resistance to change is understandable—particularly when AI-focused headlines often seem better described as “clickbait” than substantive. However, practices that dismiss the idea of AI-enabled workflows are missing out on valuable opportunities to measurably boost efficiency, increase patient satisfaction, and reduce costs.  
    • “When applied strategically, AI can make a real impact in day-to-day practice operations and throughout the patient journey. So, how should a practice best determine where to focus efforts when it comes to AI enablement? 
    • “First and foremost, AI adoption should be thoughtful, not frenzied,” says Dr. Sanjeev Kumar, Ph.D., chief data and analytics officer at NextGen Healthcare and a globally recognized AI expert. “An AI-driven tool should always address real need and make life easier for the humans using it.” 
  • Fierce Healthcare adds,
    • “Nabla is integrating its AI medical scribe with Navina’s AI-enabled copilot to provide doctors with an AI layer that supports clinical workflows.
    • “The aim is to deliver real-time support through the full clinical encounter, according to the companies.
    • “The integration combines Navina’s clinician copilot with Nabla’s in-visit ambient documentation, reconciling historical patient records with live patient dialogue to help improve patient outcomes and financial performance.” 
  • Per Beckers Clinical Leadership,
    • “Columbus-based Ohio State University Wexner Medical Center and James Comprehensive Cancer Center researchers found about 1% to 2% of all inpatient hospitalizations resulted in patients discharging against medical advice — and these patients led to more than $800 million in annual associated healthcare costs.
    • “The study, published June 26 in Journal of the American College of Surgeons, used the data from 1,768,752 surgical patients between 2016 and 2020 in the Nationwide Readmissions Database. All patients underwent major surgeries in various medical specialties. Researchers evaluated trends in DAMA incidence, postoperative outcomes, risk factors for DAMA and 30-day healthcare expenditures.”

Tuesday report

David Ermer–CDC, Congress, FDA, Medical / Rx research, OPM, Patient safety, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog watched the closing of today’s Senate session. He learned that late tomorrow morning the Senate will vote to invoke cloture on the nomination of Scott Kupor to be OPM Director for a four-year term and if cloture is invoked the Senate will vote to confirm Mr. Kupor’s nomination tomorrow afternoon.
  • Govexec tells us,
    • “President Trump on Monday extended his administration’s hiring freeze of all federal civilian positions for another three months, leaving in place the moratorium into the start of fiscal 2026.
    • “The freeze, which the president initially ordered on Jan. 20, the day he took office, prevents the hiring of civilian employees at federal agencies for either vacancies or new positions. The initial executive order was set to run through April 20 and was subsequently extended until July 15.
    • “As with previous orders, the freeze exempts positions related to immigration enforcement, national security or public safety, as well as the components of the Executive Office of the President. The order also reiterated that roles will be filled to protect the “provision of Social Security, Medicare, or veterans’ benefits.” Despite the carveouts, the Defense Department continues to operate under a partial hiring freeze of its own for civilian personnel.” 
  • Per MedTech Dive,
    • “Boston Scientific said Monday it gained Food and Drug Administration approval for use of its Farapulse pulsed field ablation system in people with persistent atrial fibrillation, broadening the pool of patients eligible for the treatment.
    • “Farapulse has become a significant growth driver for Boston Scientific as physicians embrace the technology for its potential safety benefits over traditional cardiac ablation methods to treat AFib, an irregular heartbeat that increases stroke risk.
    • “The label expansion, for both the Farawave and Farawave Nav PFA catheters, was backed by evidence from the first phase of the Advantage AF clinical trial, which met its primary safety and effectiveness goals.”
  • Cardiovascular Business adds,
    • “Boston Scientific has received an expanded approval from the U.S. Food and Drug Administration (FDA) for its Farapulse Pulsed Field Ablation (PFA) System. More U.S. heart patients are now eligible to be treated with the technology than ever before.
    • “The Farapulse PFA system first gained FDA approval to treat patients with symptomatic, paroxysmal atrial fibrillation (AFib) back in January 2024. This new approval covers patients with symptomatic, persistent AFib that is resistant to drug treatment. 
    • “Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AFib treatment with safe and effective ablation technologies,” Brad Sutton, MD, chief medical officer of AFib solutions for Boston Scientific, said in a statement. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court on Tuesday lifted a halt on President Trump’s plan to shrink the federal workforce, clearing the way for potential mass layoffs. 
    • “In February, Trump issued an executive order aimed at drastically reducing the government’s workforce “by eliminating waste, bloat, and insularity.” The order directed heads of agencies to work with the Department of Government Efficiency on hiring decisions and developing plans for layoffs. In May, a federal judge in San Francisco blocked it from taking effect
    • “The high court, in an unsigned order on Tuesday, said it had based its decision on the legality of Trump’s executive order, and didn’t rule on whether any reorganization plans broke the law.  
    • “The Government is likely to succeed on its argument that the Executive Order and Memorandum are lawful,” the court said. 
    • “Justice Ketanji Brown Jackson dissented, accusing the court of greenlighting legally dubious actions.” * * *
    • “Justice Sonia Sotomayor on Tuesday wrote separately to concur with the court’s decision to lift the halt, noting that the plans themselves weren’t before the high court. She said the district court could still consider the legality of the layoff plans.”
       
  • Fedweek adds,
    • OPM said “hundreds of thousands” of federal employees accepted deferred resignation offers while confirming that “tens of thousands” are facing layoffs in pending RIFs.
    • OPM made that statement in the first—although not exact—accounting of the government-wide impact of those offers, and touted a reduction in the federal employee count on its FedScope site to just under 2.29 million through March, down by some 23,000 from last September.
    • “In addition, hundreds of thousands more workers will drop off the rolls in October 2025, when workers depart the federal government as part of the Deferred Resignation Program; and tens of thousands of employees who have received reduction-in-force or termination notices remain on government payrolls due to court orders that the administration is now challenging,” the OPM said prior to Tuesday’s SCOTUS decision siding with the White House.
  • Per Fierce Healthcare,
    • “Southwest Airlines is buckling up to join in on a long-running legal battle surrounding an alleged price-fixing scheme involving generic medicines in the U.S.
    • “In a 730-page lawsuit filed in federal court in Pennsylvania, the airline targets dozens of drugmakers and argues the companies “deprived the public” of the benefits of cheaper generic drugs by fixing the price of their meds since at least 2009. Among the generic defendants named are Teva Pharmaceutical Industries, Sandoz, Dr. Reddy’s Laboratories, Lupin and Apotex.
    • “The scheme cost Southwest, a large employer that self-funds its employee health plans, “hundreds of millions of dollars” and caused “substantial injury” to its business, the company claims in the recently unsealed lawsuit.” * * *
    • “American Airlines and Target are among other large employers that have sued the group of generic drugmakers. The companies filed a joint lawsuit in the same court back in April 2024, Bloomberg Law reported at the time. 
    • “The issue is also playing out in pending multi-district litigation grouping more than 20 separate lawsuits that date back to 2016. A handful of drugmakers, including Sandoz, Apotex, and Sun Pharma, have so far agreed to multi-million dollar settlements to resolve their end of the claims.” * * *
    • “Southwest, for its part, cited the federal government’s prosecution efforts in its own case. At least seven companies have admitted to criminal wrongdoing, according to the Department of Justice, and have agreed to fork over hundreds of millions of dollars in fines, civil penalties and restitution.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention July 7 announced it is streamlining H5N1 bird flu updates with its routine influenza data given the low public health risk and lack of person-to-person spread. Data on the number of people monitored and tested for bird flu will be reported monthly.
    • “Bird flu detection data in animals will no longer be reported on the CDC website; instead, it will be publicly available on the U.S. Department of Agriculture website.”
  • and
    • “A study published July 7 by JAMA found children’s health has significantly worsened from 2007 to 2023. Researchers studied changes in child mortality; chronic physical, developmental and mental health conditions; obesity; sleep health; early puberty; limitations in activity; and physical and emotional symptoms. Researchers said the findings highlight the need to identify root causes for the decline in health.”
  • Beckers Clinical Leadership lets us know eight things to know about the JAMA report on children’s health.
  • STAT News reports,
    • “Female hearts are different from male hearts, down to their cell populations and up to the thickness of their walls, making cardiovascular care far from one-size-fits-all. There’s a growing appreciation that heart attack symptoms occur on a spectrum. Women may not have the classic crushing chest pain that men do; they may feel a subtler, wider discomfort that can delay care. 
    • “There’s another potentially deadly, dramatic difference. Men are much more likely than women to suffer sudden cardiac arrest, but when female athletes do collapse on the playing field from sudden cardiac arrest, they are less likely than male athletes to be resuscitated right away, despite coaches, trainers, or teammates watching on the sidelines. That’s a disparity women share outside sports events with people of color, whose chances of receiving life-saving help from bystanders are even lower. 
    • “Across disciplines, scientists are arguing for the importance of studying sex differences throughout biomedical research. Sports medicine researchers are also bringing new attention to women, from young competitors in the spotlight to older amateurs trying to stay active.” “
  • Beckers Hospital Review points out,
    • “Mississippi had the highest mortality rate across all cancer types between 2018 and 2022, according to data published by the American Cancer Society. 
    • “The American Cancer Society used data from the North American Association of Central Cancer Registries to calculate mortality rates per 100,000 people for each state and each cancer type.
    • “Read the states with the highest cancer incidence, by type, here.”
  • and
    • “A commonly prescribed medication used to counteract lung cancer therapy side effects could be minimizing a cancer treatment’s efficacy, according to research from Los Angeles-based Keck Medicine of USC. 
    • “To evaluate how baseline steroid use can affect immune checkpoint inhibitor therapy, researchers analyzed clinical outcomes of 277 patients with non-small cell lung cancer. Corticosteroids, a frequently prescribed steroid to treat side effects common to this type of lung cancer, was associated with worse outcomes, the study found. 
    • “Among 88 patients at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and 189 at the University of Southern California in Los Angeles who received immune checkpoint inhibitor therapy, 21 were taking steroids at the start of ICI therapy. Compared to those not taking corticosteroids, these patients experienced a higher number of negative effects. 
    • “The study, published July 7 in Cancer Research Communications, found a worse overall response rate and shorter overall survival and progression-free survival rates among lung cancer patients taking the steroid concurrent with ICI therapy. 
    • “Additionally, higher doses of corticosteroids severely affected ICI therapy and patient outcomes more than small or medium doses.”
  • Per Health Day,
    • “Some women have expressed concerns about the risk of breast cancer associated with using hormone therapy to treat symptoms of menopause like hot flashes and night sweats, and now, new research suggests that one type of hormone therapy might increase your risk if you’re younger than 55.
    • “Women in this age group who were treated with estrogen plus progestin were more likely to develop breast cancer than those not on hormone therapy, researchers report in The Lancet Oncology.
    • “On the other hand, women younger than 55 given estrogen alone, without progesterone, had a lower risk of breast cancer, results show.
    • “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,” lead author Katie O’Brien, an epidemiologist with the National Institute of Environmental Health Sciences, said in a news release.”
  • Per BioPharma Dive,
    • “Biotech and pharma companies are searching for ways to “hijack” the cell’s waste disposal systems in hopes of making more effective drugs.”
  • and
    • “Glucotrack, which is developing a glucose monitor that is implanted through a minimally invasive surgery, said the small study met safety and performance goals.”

From the U.S. healthcare business front,

  • Risk and Insurance reports,
    • “Medical stop loss claims are undergoing significant shifts as cancer diagnoses remain dominant across all deductible levels while million-dollar claims have doubled in frequency over four years, driven by expensive treatments and rising disease prevalence among younger populations, according to analysis by QBE.” * * *
    • “View the full report here.”
  • Check out Adam J. Fein who writes in Drug Channels,
    • “The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared.
    • “Private label strategies, aggressive pricing, and exclusive formulary deals have transformed what might have been a slow-crawling biosimilar introduction into a full-on pricing war. As with Humira, the reality of biosimilar economics is far messier—and more revealing—than the policy narratives suggest.
    • “In this post, I examine how the major PBMs—and some of the smaller ones—are handling Stelara biosimilars, what’s changed since the Humira experience, and why their strategies reflect the growing dominance of private-label rebating schemes.”
  • Beckers Hospital Review calls attention to “18 health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2025, and considers the state of virtual nursing
    • “Virtual nursing has continued to expand since bursting onto the scene a few years ago. But has the care model lived up to its promise?
    • “Health system leaders told Becker’s that virtual nursing still has room to grow but has had positive benefits for the industry thus far.
    • “While virtual nursing has proven effective at boosting patient outcomes and satisfaction, its broader adoption faces significant barriers: high implementation costs, complex regulatory policies and the challenge of integrating new hospital workflows,” said Zafar Chaudry, MD, senior vice president and chief digital, AI and information officer of Seattle Children’s.”
  • Per Fierce Healthcare,
    • “Nearly all states saw declines in the number of acute care hospitals offering obstetric services between 2010 through 2022, with seven states seeing a quarter or more of their hospitals dropping obstetric care, according to new analysis.
    • “The shutdowns were spread across urban and rural hospitals alike, but more pronounced in the latter. Twelve states lost obstetric services among a quarter or more of their hospitals, and by 2022, there were eight states in which more than two-thirds of all rural hospitals did not offer obstetric care, researchers found.” * * *
    • “Rural hospital obstetrics closures exceeded more than 40% in Pennsylvania (46.2%), South Carolina (46.2%), West Virginia (42.9%) and Florida (40%) between 2010 and 2022. Urban hospital closure percentages were less pronounced among individual states, with Rhode Island (28.6%), Oklahoma (27.6%) and Hawaii (25%) leading the way.
    • “Three states—Delaware, Utah and Vermont—had no hospital obstetric service losses during the study window, as opposed to the seven (Iowa; Oklahoma; Pennsylvania; Rhode Island; South Carolina; Washington, D.C.; and West Virginia) that saw cuts among a quarter or more of their hospitals. Rural-urban divides were also spotted within individual states, such as New Hampshire, where 36.4% of rural hospitals lost obstetrics as opposed to zero urban hospitals.
    • “Access to obstetric care is a key determinant of health outcomes among mothers and infants, the researchers wrote. The study’s findings could be a resource for policymakers and others to craft targeted, state-level interventions addressing access disparity.”
  • and
    • “Humana’s senior-focused primary care unit is set to acquire The Villages Health, which provides care to the large Florida-based retirement community.
    • “The Villages Health filed for bankruptcy last week as it seeks to undergo a strategic restructuring designed to “preserve the business’s day-to-day operations and further enhance patient care.” Humana’s CenterWell has entered a “stalking horse” agreement to buy TVH’s assets, according to an announcement.
    • “Finalizing the sale will require a court order after an auction process that accepts additional bids. As it navigates the sale and bankruptcy proceedings, The Villages Health said it will continue to operate as normal, with the goal of averting disruptions to patient care.
    • “As CenterWell is payer-agnostic, current TVH patients are “expected” to be able to maintain the relationship with their existing providers, according to the release.”

Monday update

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog noticed today that the Speaker of the House of Representatives has declared this week to be a District work week for members of the House. As a result, the previously scheduled House Committee meetings have been cancelled or postponed.
  • Fierce Healthcare reports,
    • “Congress has made permanent a pandemic-era telehealth provision for millions of Americans with high-deductible health plans.
    • “In its massive tax package signed into law on July 4, Congress included a last-minute provision to allow employer-sponsored health plans to offer covered telehealth services before employees meet their deductibles.
    • “Under high deductible health plans, patients typically have to pay out of pocket for healthcare services until they meet their deductible, with an exception for preventive care services. 
    • “Now, employers will be able to offer digital healthcare services to their employees for little to no out-of-pocket cost. The telehealth safe harbor policy also allows employers to waive copays for digital health. 
    • “Congress extended the tax provision multiple times throughout the COVID-19 pandemic to allow commercially insured patients the option to receive care from anywhere. The policy was allowed to lapse at the end of 2024 when it did not make it into the end-of-year healthcare package. 
    • “The telehealth safe harbor policy in reconciliation applies to all plan years beginning after December 31, 2024.”
  • MedPage Today tells us,
    • With the CDC director’s chair still empty, HHS Secretary Robert F. Kennedy Jr. endorsed recommendations made months ago by former members of the Advisory Committee on Immunization Practices (ACIP) to expand access to respiratory syncytial virus (RSV) vaccination, as well as to add a new option for meningococcal vaccination. * * *
    • “A notice this [past] week appeared on the CDC’s website, which details the recommendations from the April ACIP meeting: “With no current CDC Director and pending confirmation of a new CDC Director this recommendation was adopted by the HHS Secretary on June 25, 2025, and is now an official recommendation of the CDC.”
    • The new RSV recommendation calls for a single dose of vaccine for adults age 50 to 59 years who are at increased risk of severe RSV disease. 
    • “The CDC also endorsed the previous ACIP members’ recommendation that GSK’s pentavalent Neisseria meningitidis (groups A, B, C, W, and Y) vaccine (Penmenvy) may be used when both the MenACWY and MenB vaccine are indicated at the same visit. That recommendation applies to healthy people ages 16 to 23 years “when shared clinical decision-making favors administration of MenB vaccine.” The recommendation also covers people age 10 years or older “who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).” Committee members also voted to include the shot in the Vaccines for Children program.”
  • The Washington Post informs us,
    • “The Department of Veterans Affairs said Monday [July 7] that it will no longer be forced to conduct a large reduction in workforce, unlike several other federal agencies that were forced to make mass layoffs because of the Trump administration’s U.S. DOGE Service.
    • “In a news release, VA said that it was on pace to reduce its total staff by nearly 30,000 employees by the end of this fiscal year, a push that the department said eliminates the need for a “large-scale reduction-in-force.” The announcement marks a significant reversal for the Trump administration, which had planned for months to cut VA by roughly 83,000 employees, according to plans revealed in an internal memo circulated to agency staffers in March.” 
  • MedTech Dive lets us know,
    • “The U.S. plans to charge up to 70% tariffs on imports from some countries starting Aug. 1 as President Donald Trump’s 90-day pause on his country-specific reciprocal duties nears its expiration date.
    • “Starting Monday at noon EST, the U.S. will send letters detailing tariff rates for specific trading partners that have yet to reach a tariff deal with the Trump administration before the pause ends July 9, the president said Sunday. Trump told reporters Friday that the rates would range between 10% and 70%.
    • “The U.S. is specifically focused on “18 important trading relationships,” Treasury Secretary Scott Bessent said on CNN’s “State of the Union” Sunday. He also indicated that countries that do not reach deals in the next few days will return to the tariff rate Trump first outlined as part of the president’s global reciprocal tariff announcement April 2.
    • “President Trump’s going to be sending letters to some of our trading partners, saying that, if you don’t move things along, then, on August 1, you will boomerang back to your April 2 tariff level,” Bessent said.”
  • The American Hospital Association (AHA) News relates,
    • The National Institutes of Health July 3 announced that all NIH-funded research published in scientific journals must be made publicly accessible immediately upon release, accelerating a policy originally set to begin in December. Previously, many NIH-funded studies in journals were password-protected and not widely available to nonsubscribers.

From the judicial front,

  • Healthcare Dive reports,
    • “Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.
    • Filed Monday, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing public health emergency that demands immediate legal action and correction.”
    • “The Directive is but one example of the Secretary’s agenda to dismantle the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans,” the suit states.
    • “Plaintiffs include the American Academy of Pediatrics, the American Public Health Association, the Infectious Diseases Society of America and several other groups.”
    • The case is captioned American Academy of Pediatrics v. Kennedy, Case No. 1:25-cv-11916 (D. Mass.).

From the public health and medical research front,

  • Last Wednesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced, 
    • “Kraft Heinz Foods Company, a Newberry, S.C., establishment, is recalling approximately 367,812 pounds of fully cooked turkey bacon products that may be adulterated with Listeria monocytogenes (Lm). The turkey bacon was produced from April 24, 2025, through June 11, 2025. The following products are subject to recall [view labels]:
      • “12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548601” printed on the packaging under the barcode,”use by” dates ranging “18 JUL 2025” to “02 AUG 2025,” and lot code “RS40.”
      • “36-oz. packages containing three 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548748” printed on the packaging under the barcode, “use by” dates ranging “23 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
      • “48-oz. packages containing four 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and UPC “071871548793” printed on the packaging under the barcode and “use by” dates ranging “18 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
    • “The products subject to recall bear the USDA mark of inspection on the front of the label. These items were shipped to retail locations nationwide and some were exported to the British Virgin Islands and Hong Kong.” * * *
    • “FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”
  • Per Axios.
    • “It’s not food, it’s not chewing tobacco and it’s not gum — though it might look like it when you see it — but it is becoming America’s new addictive obsession.
    • “Sales of Zyn nicotine pouches are soaring, prompting the tobacco company that makes them to scramble to boost U.S. production to meet demand.” * * *
    • “Threat level: The product is addictive because nicotine is addictive.
      • “But it does not cause cancer since it doesn’t contain tobacco, whose harmful chemicals are carcinogenic. As a result, advocates say nicotine pouches can serve as a safer alternative to smoking.
      • “Philip Morris International U.S. CEO Stacey Kennedy argued that nicotine is “misunderstood” and contains “cognitive benefits.”
      • “You have to be able to separate out the misconceptions of what causes harm — and nicotine is probably one of the most misunderstood compounds, because many people believe that nicotine is responsible for smoking-related disease, and it’s not,” Kennedy said in an interview.
    • Yes, but: Tobacco industry watchdogs say products that contain nicotine, such as pouches and e-cigarettes, can serve as a gateway to smoking, especially for teens.
  • Per MedPage Today,
    • “Parent nudges and clinician feedback/audits boosted HPV vaccination uptake and completion.
    • “Adolescents with the most economic disadvantage, rural kids, and Black children saw the least benefit.
    • “More research is needed to tailor interventions to improve HPV vaccine uptake and completion for these groups.”
  • The American Medical Association lets us know what doctors wish their patients knew about hyperthyroidism.
  • Consumer Reports, writing in the Washington Post, points out “What to eat to protect your aging muscles. The foods you choose are as important as exercise for getting and staying strong.”
  • BioPharma Dive informs us,
    • After a delay due to “resource constraints,” the Food and Drug Administration on Monday [July 7] approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema.
    • Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest from Pharming. Analysts have estimated Ekterly, Kalvista’s first marketed drug, could bring in $600 million a year in U.S. sales at its peak.
    • The FDA delayed the decision beyond its June 17 deadline, Kalvista said, because of a “heavy workload and limited resources.” While Kalvista awaited its decision, the FDA granted approval to another HAE drug, CSL’s Andembry, a preventive shot that won’t compete directly with Ekterly.
  • STAT News reports,
    • “Apogee Therapeutics said Monday [July 7] that its experimental antibody treatment alleviated the signs and symptoms of atopic dermatitis, a common inflammatory skin condition, far more than a placebo — achieving the efficacy goals of a mid-stage clinical trial.
    • “In a side-by-side comparison, the Apogee drug, called APG777, showed similar skin-clearance rates compared to two antibody treatments already on the market: Sanofi and Regeneron’s Dupixent and Ebglyss from Eli Lilly. 
    • “APG777 was designed to be injected quarterly or twice-yearly, which, if proven in later clinical trials, would make it more convenient than the twice-monthly and monthly injections required for its competitors.” 
  • and
    • “Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint Medicines remains muddled. 
    • “In its study, Cogent’s drug, called bezuclastinib, showed a 24-point improvement in a patient-reported symptoms score, compared to a 15-point improvement for participants given a placebo. The nine-point difference was statistically significant. 
    • “Indolent systemic mastocytosis is the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Molina Healthcare warned higher medical costs will hit earnings this year, adding to Wall Street worries.
    • “New legislation will shrink the number of insured, especially Medicaid, creating uncertainty for insurers.
    • “Insurers are seeing that rising mental-healthcare use and costly drugs, like weight-loss medications, increase spending.”
  • Per MedPage Today, “Obesity Drug Prices Are Dropping, but Getting a Steady Supply Remains a Challenge — Insurance coverage remains inconsistent.”
  • Beckers Hospital Review lets us know,
    • “A new study suggests that the introduction of a real-time prescription benefit tool did not lead to meaningful changes in prescription spending or medication use among Medicare Advantage beneficiaries during its first year of implementation. 
    • “The analysis, published in JAMA Network Open, examined more than 2.8 million beneficiaries and compared patients treated with access to the tool to those without it. The tool, integrated into EHRs in 2019, helps provide clinicians with real-time cost and coverage information at the point of prescribing. 
    • “Despite hopes that the tool would lower out-of-pocket costs and increase prescription adherence by guiding prescribers toward lower cost alternatives, the study found no significant difference in total prescription spending, out-of-pocket costs or number of prescription fills between the two groups.” 

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.”

Friday report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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




Midweek report

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

From Washington, DC,

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

From the state and local government front,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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