Monday report

CMS

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC.

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC,

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

From the judicial front,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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