Thursday report

Uncategorized

Thursday report

David Ermer–CDC, CMS, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • The OPM Director Scott Kupor announced an Award for Savings program which is open to OPM employees.
    • “For all savings identified between now and October 31, we will share 5% of the annual savings with whomever discovers it, up to $10,000 per award. To qualify, savings must be new actions not already identified, and we must be able to implement them.” 
  • Federal News Network reports,
    • “The Office of Personnel Management says new questions for federal job candidates, asking how they will advance the Trump administration’s policies, will appear on nearly all job applications, but candidates can still choose not to answer them without being penalized.
    • “OPM is telling agencies it is “mandatory” to include the Trump administration’s four new essay questions on nearly all applications on USAJobs, as part of the federal hiring process.” * * *
    • “In follow-up guidance, however, OPM downplayed the importance of the essays as just one piece of a candidate’s overall application. The HR agency said it’s optional for job candidates to answer the essays, and that candidates won’t be disqualified from consideration if they skip them.”
  • Federal News Network interviews Tammy Flanagan about smart tips to use when filling out the online federal retirement application.
  • NextGov/FCW tells us,
    • “The Trump administration is pushing forward in its deregulatory effort to overhaul the primary rules for how the government purchases goods and services, known as the Federal Acquisition Regulation.
    • “The FAR Council released new text for six parts of the FAR on Thursday — parts 4, 8, 12, 38, 40 and 51 — including the section dealing with commercial acquisition. 
    • “We’re removing hundreds of unnecessary requirements,” a senior administration official told Nextgov/FCW about the changes, offering the removal of requirements for commercial contractors to report the names and compensation of the five most highly paid executives as an example. 
    • “The goal is to reduce costs and time to deliver and increase competition, they said.”
  • The Wiley law firm has been doing a good job staying abreast of the FAR changes on its Decoding the FAR Overhaul website.
  • The American Hospital Association News points out,
    • “The White House Aug. 13 released an executive order directing the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response to develop a list of 26 drugs considered critical for national health and security. The order calls for the ASPR to gather a six-month supply of drug ingredients and place them in the Strategic Active Pharmaceutical Ingredients Reserve with a preference for domestic sourcing and manufacturing. The ASPR is also instructed to update a 2022 list of 86 essential medicines and propose a plan to obtain and store a six-month supply of drug ingredients for those remedies.”
  • and
    • “The Trump administration Aug. 13 issued an executive order revoking a 2021 order by the previous administration that established a “whole-of-government” effort to promote competition in the U.S. economy. The 2021 order encompassed 72 initiatives by more than a dozen federal agencies to address competition issues across the economy, including in health care, financial services, technology and agriculture. It also established a White House Competition Council tasked with coordinating, promoting and advancing federal efforts to improve competition in the U.S. economy.”
  • and
    • “The Department of Health and Human Services Aug. 14 announced it will reinstate the Task Force on Safer Childhood Vaccines, a federal panel to provide oversight on vaccines for U.S. children. The original task force was disbanded in 1998. HHS said the new group will work with the Advisory Commission on Childhood Vaccines to provide recommendations on developing, promoting and refining childhood vaccines that result in fewer and less serious adverse reactions than vaccines currently available, as well as improvements in vaccine development, production, distribution and adverse reaction reporting. 
    • “The new group will be led by senior leadership from the National Institutes of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention. NIH Director Jay Bhattacharya will serve as chairman.” 
  • AHIP notes,
    • “A new peer-reviewed study published by The American Journal of Managed Care (AJMC) found that Medicare Advantage (MA) plans consistently delivered higher quality care than fee-for-service (FFS) Medicare before and during the COVID-19 pandemic.” * * *
    • “Nearly 35 million seniors and individuals with disabilities nationwide choose MA for their health coverage because it provides them with better care at lower costs than FFS. The new study’s findings add to a growing body of evidence that MA’s coordinated, value-based approach delivers superior quality and better health outcomes—while saving beneficiaries an average of more than $3,400 per year versus FFS.”
    • “Read the full study at AJMC, and learn more about the superior value of MA.”
  • Per Modern Healthcare,
    • “Penn Medicine and Saint Francis Health System recently received federal go-ahead to launch hospital-at-home programs, despite the program’s uncertain future.
    • “The Centers for Medicare and Medicaid Services’ Acute Hospital Care at Home waiver is set expire at the end of next month. Congress still must decide if it will extend or end the program, which provides Medicare reimbursement at the same rate for in-home care as in-facility care.
    • “Still, CMS approved waivers about two weeks ago for Tulsa, Oklahoma-based Saint Francis Health System’s program at two facilities.” 
  • and
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The Centers for Disease Control and Prevention (CDC) has not updated national measles statistics since August 6.  A notice on the CDC website that appeared after last week’s shooting said, “The data on this page will not be updated on Wednesday, August 13, 2025. CDC will resume updates as soon as possible.” * * *
    • “Colorado has reported a measles case in an unvaccinated child from Adams County who had recently traveled to Chihuahua state, which is Mexico’s measles hot spot. The child is under 5 years old and is hospitalized. * * *
    • “Idaho has confirmed its first measles case since 2023, in an unvaccinated child from Kootenai County. This county includes Coeur d’Alene, where measles was recently detected in wastewater. This marks the first confirmed case of measles in the Idaho panhandle since 1991.”
  • MedPage Today lets us know,
    • “In a nationally representative survey, 34% of U.S. adults were unaware of HPV and 38% were not aware of the HPV vaccine.
    • “Even individuals who were aware of HPV often didn’t know about its links to cervical and oral cancers.
    • “Public awareness of HPV and the HPV vaccine was lowest in Midwestern and Southern states.” * * *
    • “Given that the HPV vaccine has been approved in the U.S. for nearly two decades, “it was indeed surprising that a third of U.S. adults have not heard of HPV or the HPV vaccine,” Sonawane told MedPage Today. “Our hypothesis was in the range of 10% to 15%.”
  • Per the American Journal of Managed Care,
    • “Coinfection of HIV and HCV [Hepatitis C] leads to worse outcomes, necessitating effective HCV treatment in this population.
    • “Direct-acting antivirals show over 95% efficacy, yet HCV clearance rates in coinfected individuals remain below national targets.
    • “Study across seven U.S. jurisdictions showed modest increases in HCV clearance and testing rates among coinfected patients.
    • “Undetectable HIV viral loads and certain demographics, such as men who have sex with men, were linked to higher HCV clearance rates.
    • “Study limitations included incomplete data and potential COVID-19 pandemic impacts on results.”
  • Per Medscape,
    • “Hearing aid use was linked to fewer neuropsychiatric symptoms (NPS) in patients with dementia, such as apathy and irritability, than nonuse, new research showed.
    • “In a cross-sectional cohort study of more than 10,000 participants, hearing loss was not associated with a significantly greater number of symptoms than no hearing loss. However, the use of hearing aids in individuals with both dementia and hearing loss was linked to significantly fewer and less severe NPS than nonuse.
    • “Hearing aid use may represent an underutilized, nonpharmacological intervention to address NPS,” lead study author Ahjeetha Shankar, Johns Hopkins University School of Medicine, Baltimore, and colleagues wrote.”
  • Per Cardiovascular Business,
    • “Palliative care should play a significant role in the day-to-day management of heart failure (HF) patients, according to new recommendations from the Heart Failure Society of America (HFSA).
    • “HF patients are associated with high mortality and a considerably worse quality of life, the group wrote. Care teams should be doing everything in their power to help patients control their symptoms and live the best lives possible. 
    • “The HFSA guidance is available in full in the Journal of Cardiac Failure. * * *
    • “Click here to review the full consensus statement.”
  • STAT News reports,
    • “A study in rural China demonstrating the power of intensive blood pressure control clinched the deal. The large, cluster-randomized controlled trial convincingly demonstrated that well-controlled blood pressure — below 130/80 mm Hg — lowered the risk of dementia by 15% and cognitive impairment by 16%. 
    • “That was the solid evidence reviewers needed to form the foundation for a new guideline from leading medical groups on how to treat high blood pressure, Dan Jones, chair of the guideline writing committee and a past president of the American Heart Association, told STAT. He called the study from China the first one to definitively show that rigorous lowering of blood pressure with a goal of below 120 systolic does decrease the risk of dementia.”
    • “We don’t have recommended changes related to dementia but we are able to say with certainty that lowering blood pressure reduces the risk of dementia and that’s such good news for people around the world and for Americans,” said Jones, a former dean of the University of Mississippi School of Medicine.”
  • and
    • “In a small study, an engineered antibody showed “amazing” promise in countering metastatic cancer.
    • “That is, according to a Phase 1 clinical trial published Thursday in Cancer Cell. Researchers directly injected the drug, which stimulates the immune system to attack cancer cells, into 12 patients’ tumors. Six of the patients had significant tumor reduction even in non-injected sites, with two experiencing complete remission. The research could lay the groundwork for new treatments for the most advanced cancer patients.
    • “Seeing this in humans is really great news,” said Katelyn Byrne, a cancer biologist at Oregon Health and State University who was not involved in the study. “Especially for patients where we don’t have any options on the table, to be able to put this on the table now — it’s amazing.” 
  • The New York Times adds,
    • “Treating chronic pain is hard. An experimental approach shows promise.
    • “A guitarist in a death metal band was one of several people who found that personalized deep brain stimulation eased their pain and helped them reduce pain medication.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans tells us,
    • “U.S. employers project a median health care cost increase of 10% for 2026, according to new survey results from the International Foundation of Employee Benefit Plans. A similar Foundation survey conducted in 2024 projected a median cost increase of 8% for 2025.” * * *\
    • “When I spoke to Julie Stich, CEBS, Vice President of Content at the International Foundation, she shared that the 10% projected increase is attributed to a variety of factors impacting organizations’ medical plan costs, with catastrophic claims and specialty/costly prescription drugs topping the list. Employers have indicated that cost-sharing, plan design and purchasing/provider initiatives will be the most impactful techniques to manage costs.”
  • The Wall Street Journal reports,
    • “Pharma giant Eli Lilly said it is negotiating to raise drug prices in Europe, starting in the U.K. with the weight-loss drug Mounjaro, so that it can comply with the Trump administration’s goal of bringing down prices in the U.S.
    • “Lilly said Thursday that it has an agreement with the U.K. government to raise the list price of Mounjaro for patients who pay for it out-of-pocket. Lilly will more than double the list price of Mounjaro’s highest dose from about $165 to about $446. The new price is in line with the prices paid in the rest of Europe and other developed countries, Lilly said. 
    • “Mounjaro is the only Lilly medicine with a significantly lower list price in the U.K. than average prices in Europe and other developed countries, so we are adjusting the list price to bring it into line with these countries,” a Lilly spokesman said. 
    • “The higher price, however, won’t apply to those who get it prescribed through the U.K.’s National Health Service, the spokesman said.
    • “The move is part of the pharmaceutical company’s talks with foreign governments to raise prices in developed nations, the company said. It plans to implement any price adjustments by Sept. 1.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys have officially closed their $3.3 billion merger deal just one week after securing a key settlement agreement with the feds that allowed proceedings to advance.
    • “In a filing with the Securities and Exchange Commission, Amedisys said that the deal had officially closed Thursday, just over two years from when it was announced in late June 2023.
    • “That makes the home health company now a wholly-owned subsidiary of UnitedHealth, where it will join the company’s Optum unit. Amedisys was originally set to be acquired by Option Care Heath, but the organization was outbid by UnitedHealth.
    • “To make sure the merger was consummated, the two parties agreed last week to divest 164 home health and hospice facilities across 19 states, securing approval from the Department of Justice to move forward.”
  • and
    • “Humana and health tech company DrFirst are joining forces in a bid to close gaps in care for people with chronic health needs.
    • “The program’s initial launch focuses on boosting the use of statins among eligible members, which can improve care for people with cardiovascular conditions or diabetes while also meeting a key Medicare metric set by the Centers for Medicare & Medicaid Services.
    • “DrFirst’s prescription orchestration platform is embedded in the provider’s workflow, and through it, Humana can send the clinical team prescription recommendations for high-risk patients. Should they agree with the suggestion, the provider can then with one click submit a script and document why the care was necessary.
    • “I think it’s a very simple and very elegant way of helping the insurer and the provider get on the same page without requiring external workflows, external portals, external faxes,” Colin Banas, M.D., chief medical officer for DrFirst, said in an interview with Fierce Healthcare.
  • Per MedTech Dive,
    • “Apple said Thursday that it is updating its watches with a redesigned blood oxygen feature after a recent U.S. customs ruling. The software update will go out to the Apple Watch Series 9, Series 10 and Ultra 2 devices on Thursday.” * * *
    • “With the update, sensor data from Apple’s blood oxygen app will be measured, calculated and displayed in the paired iPhone app. Previously, the readings were displayed on the user’s watch. Apple said that there will be no change to previously purchased Apple Watches that have the original blood oxygen feature or devices sold outside of the U.S.”

Tuesday report

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

From Washington, DC,

  • Bloomberg informs us,
    • “Scott Kupor, the new director of the US government’s human resources agency [OPM], wants to make it easier to fire federal workers and drop college degree requirements for certain jobs.
    • “Kupor is exploring ideas to lure young talent from Silicon Valley and other industries, including relieving student debt and creating “information exchanges” between the private and public sectors.
    • “Kupor also suggests potentially investing pension money in a sovereign wealth fund, saying “every other major country has a sovereign wealth fund where they have professional money managers who actually manage their retirement assets on behalf of the population.” * * *
    • “[Kupor] acknowledged that he can’t move on many of these ideas without the support of the White House, Congress or other agencies, like the Treasury Department. Kupor hasn’t raised many of these proposals with the White House yet, but said his team is engaged with the executive branch on a daily basis.”
  • MedTech Dive tells us,
    • “The U.S. is extending its pause on additional retaliatory tariffs for imports from China until Nov. 10, according to an executive order signed by President Donald Trump on Monday.
    • The order said the extension is appropriate following “significant steps” from China on addressing U.S. trade concerns in ongoing discussions between the two countries.
    • Since May 14, the U.S. has been charging many imports from China an extra 30% duty. That rate — a combination of 20% tariffs tied to fentanyl trafficking and a 10% baseline reciprocal tariff — came as the two countries agreed to pause duties imposed as part of a tit-for-tat tariff escalation for 90 days. The pause was originally set to expire Aug. 12.

From the Food and Drug Administration front,

  • Per HCPLive,
    • “FDA approval of PharmaTher’s ketamine for surgical pain management follows minor application deficiencies, without requiring new trials.
    • “Ketamine’s inclusion on the WHO’s Essential Medicines list and its shortage since 2018 have led to the use of compounded products with potential risks.
    • “The ketamine market is expected to grow from $750 million to $3.42 billion by 2035, with a 16.4% compound annual growth rate.
    • “This approval supports further ketamine development for psychiatric, neurological, and chronic pain disorders, aligning with PharmaTher’s strategic goals.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has identified a Class I recall of Draeger SafeStar and TwinStar Filters due to a risk of misleading carbon dioxide readings. The readings could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations. Using the affected filters could result in serious injury or death.
    • “In addition, the FDA Aug. 9 released a notice on a voluntary DermaRite recall of its DermaKleen, Dermasarra, Kleenfoam and Perigiene products due to a microbial contamination that can result in serious and life-threatening infections.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Bayer BAYN said it would commercialize and complete research into a new potential cancer drug developed by U.S. biotech company Kumquat Biosciences.
    • “Under the global exclusive license deal, announced by both companies on Tuesday, Kumquat will be responsible for the Phase 1a study of its KRAS G12D inhibitor, while Bayer will work on taking the drug to market.
    • “The inhibitor targets a type of change in the DNA of genes that drives the growth of tumors, and is most frequently linked to pancreatic, colorectal and nonsmall cell lung cancers.
    • “As part of the agreement, Kumquat will receive up to $1.3 billion, and additional tiered royalties on net sales, they said.”
  • BioPharma Dive lets us know,
    • “Padcev, an antibody-drug conjugate Pfizer acquired in its $43 billion buyout of Seagen, met the primary goal of a bladder cancer trial, helping people ineligible for chemotherapy when used in combination with Merck & Co.’s Keytruda before and after surgery, the companies said Tuesday.
    • “The drugmaker said it will discuss approval applications with health regulators, which could expand Padcev’s use in bladder cancer into the so-called neo-adjuvant and adjuvant settings. Padcev is currently used with Keytruda in locally advanced and metastatic disease that can’t be operated on, and alone in people whose disease has progressed after treatment.
    • “Padcev, which is co-promoted with Astellas in the U.S., is a fast-growing drug in Pfizer’s oncology business — on track to record around $2 billion in sales in 2025. Pfizer has been under pressure because of declining revenue from its COVID-19 vaccine and drug, and is looking to new products to lift sales.”
  • Medscape discusses the repurposing cancer drugs to treat Alzheimer’s Disease.
  • Per MedPage Today,
    • “The risk of new-onset diabetic retinopathy (DR) increased slightly, but significantly, in patients taking GLP-1 receptor agonists for diabetes, despite a lower risk of vision-threatening complications, a large retrospective study suggested.
    • “A propensity-matched comparison showed a 7% higher incidence of new DR among users of GLP-1 agonists. The risk of ischemic optic neuropathy did not differ significantly between users and non-users. Moreover, in a subgroup of patients with existing DR, use of the drugs was not associated with an increased risk of progression to proliferative retinopathy or diabetic macular edema (DME).
    • “The findings suggest that patients with type 2 diabetes treated with GLP-1 agonists require regular screening and monitoring for ophthalmic complications, regardless of baseline DR status, reported Sarju Ganatra, MD, of Beth Israel Lahey Health in Burlington, Massachusetts, and co-authors in JAMA Network Open.”

From the U.S. healthcare business front,

  • Beckers Hospital Reviews tells us,
    • “Physicians and advanced practice providers are logging more work than ever, but rising productivity isn’t translating into higher reimbursement, according to Kaufman Hall’s “Physician Flash Report,” published Aug. 11. 
    • “Productivity levels, measured in work relative value units per full-time employee, reached 6,449 for physicians and 5,030 for advanced practice providers in the second quarter of 2025. That marks a 12% increase for physicians and an 11% increase for APPs year over year.
    • “Increases in productivity metrics, coupled with higher compensation and expenses, reflect a reality that physicians and advanced practice providers are working more than ever before,” Matthew Bates, managing director and physician enterprise service line leader at Kaufman Hall, said in a news release. “Revenue has increased because physicians and providers are working more, but the data also show that reimbursement is not keeping pace. In the coming months if more patients lose insurance coverage, this trend will likely get worse.”
    • “Kaufman Hall analysts said changes to the Medicare physician fee schedule that took effect in 2021 — which initially increased wRVU totals for evaluation and management services — no longer account for the recent growth in productivity. The increases now reflect rising workloads rather than changes in how work is measured.
    • “The report also highlighted a troubling staffing trend.  Medical support staff levels continue to fall relative to wRVU generation, a pattern Kaufman Hall has tracked since 2023. The firm cautioned that ongoing workforce challenges could become a barrier to future growth if left unaddressed.
    • “Meanwhile, hospital financial performance improved in June, according to Kaufman Hall’s latest “National Hospital Flash Report.” Outpatient revenue and operating room minutes increased, contributing to stronger performance compared to the previous month.
    • “Higher performing hospitals are nimbler on both the revenue and expense sides,” said Erik Swanson, managing director and data and analytics group leader at Kaufman Hall. “They may be expanding their outpatient footprint, diversifying services, or managing expenses like purchased services by centralizing some functions. They are also more likely to have value-based care or bundled care arrangements in place.”
  • Modern Healthcare reports,
    • “Healthcare systems are reassessing their urgent care strategies as patient demand shifts and tried-and-true business models no longer bring the same returns. 
    • “Many systems are looking to facility acquisitions and joint ventures to access new patients through the lower-cost settings, rather than just provide a one-off visit. However, the booming urgent care business has turned into oversaturation in some areas, leaving systems to decide whether their resources would be better used elsewhere.”
    • Provider groups of all sizes have tapped into the urgent care model, but recent growth is driven by larger institutions, such as private equity-backed platforms and health systems, Urgent Care Consultants President Alan Ayers said. More than 430 urgent care centers opened in new locations in the first half of 2025. Nearly 40% of those centers are affiliated with hospitals, according to data from Urgent Care Consultants. 
    • Systems are increasingly viewing urgent care centers as an entry point into the larger organization that can beef up patient volumes. Health systems have to reevaluate where they stand amid retail clinics, telehealth services and other competitors. Transactional patient interactions at many urgent care centers are not sustainable, system executives said.”
  • and
    • “Cardinal Health announced an agreement to purchase Solaris Health in a $1.9 billion deal, the company’s latest acquisition in the urology category and an expansion of its multispecialty strategy.
    • “Urology is an attractive specialty for us,” said Jason Hollar, chief executive officer of Cardinal Health, in a statement. Among other recent urology acquisitions, Cardinal Health recently completed the purchase of Academic Urology & Urogynecology.
    • “Solaris Health has more than 750 providers in 14 states.”
  • and
    • “Highmark Health and clinical documentation vendor Abridge are developing a tool that uses generative artificial intelligence to approve prior authorization requests at the point of care, the companies announced Tuesday.
    • “The Pittsburgh-based health system and Blue Cross Blue Shield insurer will incorporate the software into its operations, and Highmark Health and Abridge have bigger plans.
    • “The companies intend to eventually market the utility to other health insurance companies, said Highmark Health Chief Analytics Officer Richard Clarke.” 
  • Beckers Hospital Review points out,
    • “Oak Park, Ill.-based West Suburban Medical Center is facing an uncertain future after its sister hospital, Weiss Memorial Hospital in Chicago, closed Aug. 8 prior to CMS’ termination of its Medicare program Aug. 9, NBC 5 Chicago reported.
    • “El Segundo, Calif.-based Pipeline Health System sold West Suburban and Weiss Memorial to Princeton, N.J.-based Resilience Healthcare in late 2022.”
  • Per Fierce Healthcare,
    • “Maven Clinic, a global virtual clinic for women’s and family health, is launching new features to support women and men trying to conceive.
    • “Understanding the menstrual cycle is key to increasing chances of conceiving naturally. Yet Maven providers say that new members in its Trying to Conceive track—intended to support natural conception—often do not understand their ovulation. Even though nearly 75% of members report tracking their cycles in apps, many still struggle to interpret the data. 
    • “Nobody uses a physical calendar anymore. Everyone tracks their fertility on a device or an app,” Neel Shah, M.D., Maven’s chief medical officer, explained. But simply tracking dates may not be enough. “Getting pregnant is about attempts. People might think they’re trying within their fertile window, but they’re not ovulating, and so it’s not going to work.” 
    • “Maven’s new cycle tracker, available to Fertility & Family Building members starting this fall, learns each member’s unique cycle and offers personalized predictions. It can flag possible irregularities and recommend appointments with a Maven specialist to determine potential underlying diagnoses. Finding these out early could save couples money and stress, Shah said. For example, an irregular period might be caused by a thyroid condition that could be addressed with a $5 medication.
    • “The tracker is integrated with the Apple Watch and will soon also be integrated with the Oura Ring. Wearables can offer important insights relevant to a woman’s cycle, such as body temperature, heart rate or and sleep data, according to Shah.
    • “Complementary to the offering are at-home semen test kits for men.” 

Monday update

David Ermer–CDC, CMS, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today issued new government-wide guidance to ensure that performance awards are meaningfully targeted to the highest-performing federal employees. The updated policy directs agencies to strengthen performance management practices, normalize ratings, and reserve the largest awards and bonuses for employees who have demonstrated exceptional contributions to their agencyʼs mission. The guidance also encourages agencies to expand use of non-cash awards, such as time-off and quality step increases, and to recognize real-time accomplishments throughout the year
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. visited the CDC headquarters in Atlanta today in response to Friday’s tragic gunfire attack that claimed the life of DeKalb County Police Officer David Rose. 
    • “CDC security led Secretary Kennedy on a tour of the Roybal Campus, pointing out shattered windows across multiple buildings, including the main guard booth. Health and Human Services Deputy Secretary Jim O’Neill and CDC Director Susan Monarez accompanied him on the tour. 
    • “Secretary Kennedy visited the DeKalb County Police Department, where he met with Police Chief Greg Padrick. Later, he met privately with the widow of Officer David Rose, who courageously gave his life in the line of duty. He offered his deepest condolences and reaffirmed the agency’s commitment to honoring Officer Rose’s bravery, sacrifice, and service to the nation.” 

From the judicial front,

  • It occurred to the FEHBlog this afternoon that we recently passed the August 7 deadline for the parties to submit a joint status report to the federal court considering a challenge to the Biden Administration’s 2024 mental health parity rule amendments.  
    • It turns out that the status report (Dropbox link) was timely submitted on August 7.
    • The parties reported,
      • “The Departments continue to consider whether to issue a notice of proposed rulemaking to revise or rescind the 2024 Rule and to determine when it would be appropriate to add a MHPAEA regulatory action to the agencies’ Semiannual Regulatory Agenda.
      • “Pursuant to the Court’s May 12, 2025, Minute Order, the parties will file another joint status report on or before November 5, 2025, to report on Defendants’ progress.” 
    • The most recent semi-annual regulatory report appearing on reginfo.gov is Fall 2024 dated 12/13/2024.
  • Fierce Healthcare reports,
    • “Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate providers’ concerns before opening its 340B rebate pilot program up to drugmaker applicants. 
    • “In a letter sent to the Health Resources and Services Administration (HRSA), which oversees the controversial subsidy program, seven provider associations requested HRSA extend the timeline for stakeholder comments and give itself a broader window to consider public comments. 
    • “Specifically, the current timeline outlined by HRSA in late July requires comments on the program to be submitted by Sept. 8, and for drugmakers to submit their applications and rebate plans by Sept. 15. Approvals would be made by Oct. 15, and the pilot is slated to begin at the top of the year 
    • “Instead, the associations have floated a Sept. 15 comment period, an Oct. 20 manufacturer application deadline and a Nov. 3 approval date.
    • “With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the associations wrote in their letter (PDF). “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”

From the public health and medical research,

  • The American Medical Association lets us know what doctors wish their patients knew about joint injuries and treatment.
  • Consumer Reports, writing in the Washington Post, discusses “how to get more out of physical therapy. It can reduce pain, boost strength, get you as healthy as possible for surgery and more.”
  • Medscape lets us know what doctors wish their patients knew about “How High-Fiber Diets and Supplements Can Improve Health for Patients With Obesity.”
  • Per MedPage Today,
    • “Previous research on associations between prediabetes and mortality has produced conflicting results.
    • “This study found that prediabetes was statistically significantly associated with mortality only among adults ages 20 to 54 years.
    • “Mortality risk in younger adults could be due to metabolic or behavioral risk factors.” * * *
    • “Elizabeth Selvin, PhD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, who was not involved in the study, told MedPage Today that the findings were “very consistent with [the 2019 study] demonstrating that prediabetes in older adults is not strongly associated with mortality.”
    • “Current definitions of prediabetes are very broad and they capture a lot of people who are not at high risk for poor outcomes, especially in old age,” she said. “In older ages, mild elevations in glucose are extraordinarily common and seem to reflect mild metabolic dysfunction corresponding with aging rather than severe hyperglycemia that leads to diabetes.”
  • BioPharma Dive reports,
    • “An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday. 
    • “IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how the study, which compared a regimen of its shot and Merck & Co.’s immunotherapy Keytruda to Keytruda alone, failed by the slimmest of margins. Executives also pointed to other analyses showing potentially stronger benefits among those who hadn’t previously received drugs like Keytruda or aren’t likely to respond to them. 
    • “It was a very narrow miss, just by a hair,” said Mai-Britt Zocca, IO’s CEO, on a Monday conference call with Wall Street analysts.
    • “Called Cylembio, IO’s cancer vaccine consists of engineered peptides that are supposed to provoke an immune response to certain proteins expressed on tumor cells. Those proteins are two of the immune “checkpoints,” PD-L1 and IDO1, long studied by drugmakers.”
  • and
    • “An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year. 
    • “According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement. 
    • “Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente closed its second quarter of the year with a billion dollars of operating income and a $3.3 billion bottom line—but operating headwinds on the horizon have leadership taking a hard look at the health system’s cost structure and potential efficiencies.
    • “The quarter’s performance is a step ahead of last year, when the integrated nonprofit reported $908 million of operating income and $2.1 billion in net income.
    • “It’s also a fair jump in the scale of Kaiser’s operations. Consolidated operating revenues and expenses during the most recent quarter were $32.1 billion and $31.1 billion, respectively, up from $29.1 billion and $28.2 billion in the second quarter of 2024. These reflect a 3.2% operating margin in the second quarter of 2025 and a 3.1% operating margin in the second quarter of 2024.
    • “Together with the year’s opening quarter, Kaiser now sits at about $63.9 billion of operating revenue and nearly $2 billion of operating income for the first half of the year. Kaiser said its operating income runs highest during the beginning of the year due to the timing of its health plan’s open enrollment”
  • Healthcare Dive tells us,
    • “Major for-profit hospital chains reported lower-than-expected volumes in second quarter earnings results, causing some to cut back on volume and earnings expectations for the year.
    • “Executives at the for-profit hospital chains — HCA Healthcare, Tenet Healthcare, Community Health Systems and Universal Health Services — attributed the volumes to different factors, from lower Medicaid admissions to a decline in consumer confidence, which impacted spending on healthcare services. 
    • “Softer volumes caused HCA, Tenet and CHS to lower their full-year outlooks for admissions. UHS did not report expectations for volume growth.”
  • Here are links to Kaufmann Hall’s June 2025 flash reports on hospitals and physicians, both of which were released today.
  • Beckers Hospital Review points out CMS’s 290 five star and 229 one star hospitals.
    • “Every year, CMS assigns star ratings to U.S. hospitals based on 46 hospital quality measures, which are divided into five categories: mortality, safety, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2020 to December 2024, depending on the measure. The ratings were updated in July and released Aug. 6.” “
  • The American Journal of Managed Care informs us,
    • “Prescribing semaglutide in routine clinical practice was associated with meaningful—but smaller than seen in clinical trials—improvements in cardiovascular risk factors, along with an unexpected rise in non-drug health care spending, according to a new study published in JAMA Network Open.1
    • “Analyzing data from more than 23,500 adult patients across Yale New Haven Health System and Sentara Healthcare, researchers found that patients experienced an average 3.8% reduction in body weight and significant reductions in blood pressure (–1.5 mm Hg for diastolic; –1.1 for systolic), total cholesterol (–12.8 mg/dL), and hemoglobin A1c (HbA1C) at 13 to 24 months following their first semaglutide prescription. However, during the same time period, monthly health care expenditures rose by $80 per patient, not including the cost of semaglutide itself.
    • “These findings highlight a disconnect between clinical benefits and short-term cost savings, warranting caution when extrapolating trial-based projections to clinical settings,” the researchers said.”

Midweek report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
  • Fedsmith lets us know,
    • “The summer of 2025 experienced an unusually high surge in incoming retirement claims, starting in May and continuing into June. This surge can be largely attributed to the significant number of federal employees who have left federal service through various programs, including deferred resignation, Voluntary Early Retirement Authority (VERA), and others.
    • “According to OPM, approximately 154,000 federal employees have resigned under the deferred resignation program, and OPM Director Scott Kupor said recently that he anticipates the total federal workforce reduction to be at least double that number in the near future.”
  • Per an OPM press release,
    • The U.S. Office of Personnel Management (OPM) today announced that registration is now open for its innovative Executive Development Programs, designed specifically for Senior Executives Service (SES), GS-15, and GS-14 leaders.
    • These programs are closely aligned with President Trumpʼs new Executive Core Qualifications (ECQs) for senior executives, ensuring participants develop the critical competencies needed for todayʼs federal leadership roles.
    • By focusing on these updated standards, OPM is empowering leaders to deliver meaningful results and advance the mission of government agencies nationwide, drive President Trumpʼs ambitious agenda, and improve performance and accountability across the federal government. The program is highlighted by training videos from key Trump Administration leaders and distinguished career Senior Executives.
  • The American Hospital Association News tells us,
    • “A new analysis published Aug. 6 by the Peterson Center on Healthcare and KFF found that Health Insurance Marketplace insurers will propose a median premium increase of 18% for 2026. A previous analysis reported 15% based on preliminary findings. The new findings were examined from individual market filings, which provide additional details and are publicly available. The proposal more than doubles last year’s 7% median proposed increase.
    • “Insurers are citing the increase on higher prescription drug costs as well as labor costs, inflation, the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The report found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase costs of certain drugs, medical equipment and supplies. Final rates will be determined in late summer.”
  • Bricker Graydon informs us,
    • “As employers increasingly struggle with rising health plan costs, the IRS has provided some good news.  Recently, the IRS announced that the Affordable Care Act (ACA) affordability threshold will increase to 9.96% of household income for plan years starting in 2026.  This is an increase from the 9.02% that applied to 2025.  This significant increase means employers have more room to potentially increase the employee portion of premiums for 2026. 
    • “The ACA affordability percentage is used to determine if ACA employer penalties may apply to employer-provided coverage. An employer’s health coverage will be considered affordable as long as the employee’s required contribution for the lowest-cost, self-only coverage does not exceed 9.96% of their income (or an IRS-approved safe harbor equivalent, such as the W-2, rate-of-pay, or federal poverty line methods). For example, under the federal poverty line safe harbor, monthly employee contributions will need to remain below approximately $129.89 in 2026.”

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP points out,
    • “Clarametyx Biosciences said this week that its investigational antibody treatment for cystic fibrosis patients plagued by chronic bacterial lung infections will receive priority review and development incentives from the US Food and Drug Administration (FDA).
    • “The company said in a press release that the FDA had granted CMTX-101, a monoclonal antibody designed to rapidly collapse bacterial biofilms, Fast Track and Qualified Infectious Disease Product (QIDP) designations under the Gaining Antibiotic Incentives Now Act. The two designations mean Ohio-based Clarametyx will get more frequent interactions with the agency, an expedited review process and potentially accelerated approval, and an additional 5 years of market exclusivity if CMTX-101 is approved.”
  • Cardiovascular Business reports,
    • “Boston Scientific’s Watchman device is associated with a heightened risk of air embolism events if the implant procedure is performed without positive pressure-controlled ventilation, according to the U.S. Food and Drug Administration (FDA). Air embolism is a rare, but potentially fatal complication that occurs when air enters the bloodstream and creates a blockage in a patient’s blood vessel. 
    • “According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress,” according to a new FDA advisory. “This risk is especially prevalent in patients with preexisting low left atrial pressure, hypovolemia and partial upper airway collapse.”
    • “The FDA emphasized that air embolism can lead to “severe outcomes, including life-threatening or fatal consequences.” 
    • “Because of this risk, which has been associated with 120 serious injuries and 17 deaths as of July 30, Boston Scientific is updating the assembly instructions of several access systems used to implant the Watchman device in patients with nonvalvular atrial fibrillation.”
  • and 
    • “The U.S. Food and Drug Administration (FDA) is sharing additional details about a safety issue with certain Boston Scientific defibrillation leads. 
    • “According to the agency, some of the company’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) have been associated with a potential risk of rising low-voltage shock impedance (LVSI). This issue, linked to calcification, may make the devices less effective as time goes on.
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” according a new FDA advisory. “As of July 24, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with this issue.”
    • “The FDA is still reviewing the situation. At this time, the agency has not determined if this is a Class I recall. The goal of this early alert is to provide details as quickly as possible.” 

From the judicial front,

  • MedTech Dive relates,
    • “The Federal Trade Commission has moved to block Edwards Lifesciences’ planned acquisition of JenaValve Technology, citing concerns that the deal threatens to reduce competition in the market for devices to treat aortic regurgitation.
    • “The agency alleged that over two days in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices to market to treat the potentially fatal heart condition. Edwards closed the acquisition of JC Medical in August 2024.
    • “The FTC said Edwards’ proposed $945 million acquisition of JenaValve would combine the only two companies conducting U.S. clinical trials for a TAVR aortic regurgitation, or TAVR-AR, device.
    • “The deal threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers,” the agency stated in a federal court complaint.
    • “The commission voted 3-0 to issue an administrative complaint and seek a temporary restraining order and a preliminary injunction to halt the transaction pending an administrative proceeding. The complaint and injunction request were filed in the U.S. District Court for the District of Columbia.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP relates,
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 23 more measles cases, bringing the national total for the year to 1,356 cases, the most since the United States achieved measles elimination in 2000.
    • “One more state reported cases, Wisconsin, lifting the number of affected states to 41. Three more outbreaks were reported, putting the nation’s total at 32 for the year. For comparison, the country had 16 outbreaks for all of 2024. 
    • “Of confirmed illnesses this year, 87% were part of outbreaks, compared with 69% for 2024. And of infected patients, 92% were unvaccinated or had unknown vaccination status. Though about 65% of cases occurred in children, 34% were recorded in adults ages 20 years and older.”
  • NBC News reports,
    • “A second person has now died and more than 50 people have fallen ill as part of a growing Legionnaires’ cluster in Harlem, city health officials reported Monday.
    • “The disease was initially detected on July 25; since then, two people have died and 58 people have been diagnosed, the New York City Health Department revealed in its latest update.
    • “Legionnaire’s, a type of pneumonia, is caused by the bacteria Legionella, which grows in warm water. The cases from the cluster have been found in five Harlem ZIP codes: 10027, 10030, 10035, 10037 and 10039, along with the bordering communities, according to health officials.
    • “If you’re in those ZIP codes that have demonstrated exposure, then we want you to monitor your symptoms and get to a healthcare provider as soon as you can so you can get access to antibiotics, because it is treatable,” said Dr. Tony Eyssallenne, the deputy chief medical officer for the city’s Health Department.”
  • STAT News notes,
    • “Hundreds of wildfires burning across the Canadian provinces of Manitoba and Saskatchewan are pushing smoke across Canada and the American northeast. Canadian towns close to the wildfires are experiencing the worst of the smoke pollution, but even here in Boston, there was a brief ground stop at the airport Monday due to smoke and haze. 
    • “It’s getting better, but here’s a reminder: 
      • “Wildfire smoke is particularly harmful to kids’ respiratory health. One study found that a 10-unit increase of fine particulate matter from wildfire smoke was associated with a 30% spike in pediatric admissions for respiratory problems. “It’s quite a big bit of a difference,” the lead author said.
      • “Researchers have found that people who live in areas with high levels of fine particulate matter could have a greater risk of developing dementia, with a particularly strong link seen between the condition and exposure to wildfire emissions. Still, there are a lot of questions remaining about other long-term effects.
      • “In California, between 2008 and 2010, somewhere between 52,480 and 55,710 people died prematurely due to chronic exposure to wildfire smoke. The economic impact of those deaths was at least $432 billion.”
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Aug. 5 announced a new campaign educating youth ages 12-17 on substance use, mental health and how they are connected. The campaign includes facts about drugs, including prescription medications, and how they can lead to addiction and other health problems. It also includes tips and resources to help improve mental health and recognize the link between mental health and substance use.”
  • The Washington Post reports,
    • “Seven years of investigation by scientists at Harvard Medical School has revealed that the loss of the metal lithium plays a powerful role in Alzheimer’s disease, a finding that could lead to earlier detection, new treatments and a broader understanding of how the brain ages.
    • “Researchers led by Bruce A. Yankner, a professor of genetics and neurology at Harvard Medical School, reported that they were able to reverse the disease in mice and restore brain function with small amounts of the compound lithium orotate, enough to mimic the metal’s natural level in the brain. Their study appeared Wednesday in the journal Nature.
    • “The obvious impact is that because lithium orotate is dirt cheap, hopefully we will get rigorous, randomized trials testing this very, very quickly,” said Matt Kaeberlein, former director of the Healthy Aging and Longevity Research Institute at the University of Washington, who did not participate in the study. “And I would say that it will be an embarrassment to the Alzheimer’s clinical community if that doesn’t happen right away.”
    • “Yankner, who is also the co-director of the Paul F. Glenn Center for Biology of Aging Research at Harvard, said: “I do not recommend that people take lithium at this point, because it has not been validated as a treatment in humans. We always have to be cautious because things can change as you go from mice to humans.” He added that the findings still need to be validated by other labs.”
  • Per MedPage Today,
    • “Most therapies for low back pain provide only short-term relief; it’s unclear, however, whether benefits from cognitive functional therapy (CFT) may last longer.
    • “Investigators in this study performed 3-year follow-up with participants in a 6-month trial of CFT versus usual care.
    • “Compared with usual care, patients receiving CFT either with or without biofeedback for 6 months continued to show more improvement after 3 years.”
  • Per Beckers Hospital Review,
    • “Healthcare experts are calling for the end of routine use of diphenhydramine, the active ingredient in a common allergy medication, sold as Benadryl, citing safety concerns that outweigh benefits, CNN reported Aug. 1. 
    • “It’s time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,” said Anna Wolfsen, MD, an allergist at Massachusetts General Hospital in Boston. “I’ve had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.”
    • “The widely used, first-generation antihistamine is commonly used to treat allergies. However, other second-generation antihistamines, including brand names such as Claritin, Zyrtec and Allegra, offer the same or better relief with fewer side effects, experts told CNN.” 

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Hinge Health beat investor expectations on revenue in the digital musculoskeletal care company’s first public earnings results.
    • “Revenue increased 55% year over year to $139.1 million in the second quarter, the firm said in earnings released Tuesday. 
    • “The digital health company reported an operational loss of $580.7 million, compared with $17.6 million last year, driven by a stock-based compensation expense largely related to Hinge’s recent IPO, a spokesperson told Healthcare Dive.”
  • STAT News tells us,
    • “Exact Sciences announced on Wednesday that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome.
    • “Exact is paying Freenome $75 million for exclusive rights in the United States to current and future versions of the Bay Area company’s test, which is currently under review by the Food and Drug Administration. Freenome is eligible for up to $700 million in additional milestone payments.
    • “The deal ratchets up Exact’s intense competition with Guardant Health, which received FDA approval last year for its own blood-based colon cancer test.
    • “Exact had been developing its own blood-based colon cancer test. Last year, the company reported promising initial results from a study of more than 3,000 samples. But on Wednesday, the company disclosed that additional testing showed that the liquid biopsy test wasn’t quite accurate enough to win Medicare reimbursement. Instead, Exact will now look to market Freenome’s test to patients, pending approval.” 
  • Per Fierce Healthcare,
    • “Days after decreasing full-year guidance by about half a billion dollars, Oscar Health missed earnings projections for the second quarter.
    • “The insurer posted a higher-than-anticipated loss per share of 89 cents, according to estimates by FactSet, reported Sherwood News.
    • “Oscar also recorded a net loss of $228 million, one quarter after having a net profit of $275 million. The insurer saw quarterly revenues hit $2.86 billion and its medical loss ratio (MLR) climb to 91.1%.
    • “The stark jump from a MLR of 79% was due to an increase in market morbidity in the Affordable Care Act exchanges, leading to a net risk adjustment transfer accrual, CEO Mark Bertolini told investors.”
  • and
    • “Blue Shield of California is teaming up with Gemini Health to roll out a new member tool that offers greater transparency at the pharmacy counter.
    • “The tool, called Price Check My Rx, will be available in the insurer’s existing member app, allowing members to see in real time the out-of-pocket price for any new or refilled prescriptions submitted by their provider and covered under their pharmacy benefits.
    • “When the prescription is submitted electronically, the platform will send the member a push notification that prompts them to look at the pricing details and explore alternatives, including low-cost options, if they prefer. Jigar Shah, chief marketing and strategy officer for Blue Shield, told Fierce Healthcare that the tool fits within the payer’s broader goal of simplifying the patient experience.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy sales jumped 67% in the second quarter, despite generic competition in the U.S. market.
    • “The company reduced its full-year guidance due to the impact of copycat versions of its diabetes and obesity drugs.
    • “Outgoing CEO Lars Fruergaard Jorgensen expressed confidence in future growth under incoming CEO Maziar Mike Doustdar.”
  • BioPharma Dive adds,
    • “Scientists at Nxera Pharma have worked for the past year to develop a pipeline of wholly owned obesity drug candidates that the Tokyo and Cambridge, U.K.-based pharmaceutical company unveiled Wednesday. Chief among the seven new programs is an oral GLP-1 agonist that Nxera says is based on “differentiated chemistry” and is distinct from a compound it discovered together with Pfizer under a research alliance. Coincidentally, Pfizer disclosed Tuesday it discontinued development of that compound, a decision Nxera said was made “due to a portfolio decision.” 
  • Per MedTech Dive,
    • “BD is investing more than $35 million to expand production of prefilled flush syringes at a facility in Columbus, Nebraska, the company said Monday.
    • “The investment will add around 50 jobs at the site and equip BD to make hundreds of millions of additional units a year to meet growing demand from U.S. hospitals and health systems.
    • “BD framed the spending as part of an ongoing commitment to its Posiflush line, which has seen it invest more than $80 million to expand production of the syringes over the past three years.”

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare, Uncategorized–
  • Roll Call adds,
    • “President Donald Trump gave Senate Republicans permission to begin their August recess Saturday night [August 2, 2025], shortly before Democratic and Republican leaders agreed to quickly vote on seven final civilian nominees but none of the more than 100 still pending on the calendar.
    • “The agreement allowed for votes to begin on cloture and confirmation of the nominees without debate. Among those confirmed under the deal was Jeanine Pirro, who was nominated by Trump to be U.S. attorney for the District of Columbia.
    • “The directive from Trump took pressure off of Senate Majority Leader John Thune, R-S.D., to clear the executive calendar and confirm all of Trump’s pending nominees before the recess.” 
  • The Wall Street Journal reports,
    • “The Senate late Friday [August 1, 2025,] passed more than $180 billion in funding for veterans programs, new military facilities, the Agriculture Department and the Food and Drug Administration, as lawmakers moved to reassert their control over federal spending amid challenges from the Trump administration.
    • “The Senate approved the bulk of the spending in a 87-9 vote. It separately cleared a measure funding Congress’s own operations as well as related entities that audit federal spending and evaluate the budgetary implications of federal laws. The legislation must go back to the House, which is on recess and will return for legislative business in September.
    • “We are on the verge of an accomplishment that we have not done since 2018, and that is, pass appropriations bills across the Senate floor prior to the August recess,” Senate Appropriations Committee Chair Susan Collins (R., Maine) said shortly before the measures passed. “That is exercising our constitutional responsibility for the power of the purse.”
    • “Sen. Patty Murray (D., Wash.), the top Democrat on the panel, said, “I believe Congress should decide how to spend taxpayer dollars. This is how we do it.”

From the public health and medical research front,

  • The Wall Street Journal points out,
    • “Falls are the leading cause of injury for people 65 and older, but the factors that lead to falls can start much earlier.
    • “The risk of falling in a given year doubles with every additional related issue—including reduced muscle strength, balance problems, medication side effects and even forgetting to take that medicine—according to a recent research paper.
    • “That’s why medical experts say that, beginning at age 65, everyone should have an initial screening to determine their personal risk level.
    • “Many people think only frail older people in nursing homes fall. But even the youngerold—those who are healthy and active—can fall,” says Emily Nabors, associate director of innovation at the National Council on Aging.
    • “The nonprofit offers a short online questionnaire that provides a fall-risk score, but Nabors suggests people also get a more comprehensive assessment from a doctor or physical therapist.
    • “Even if you’re at low risk now, there are things you can do to stay that way. And they go beyond removing trip hazards in your home.”
  • The Washington Post lets us know,
    • “Shortly after finishing breakfast six years ago, Brian Farrington felt some discomfort and thought it was heartburn. He popped a few Tums but hours later began perspiring profusely and experiencing chest pain.
    • “The next morning, Farrington, who was 53 and seemingly healthy, headed to the hospital and was shocked to learn he had suffered a heart attack. He had several blockages in his right artery. Previously, Farrington had been told his cholesterol was “borderline high” but did not require medication.
    • “As the resident of Columbus, Ohio, recovered, he considered a nagging question: Why was there so much premature heart disease in his family? His grandfather and three great-uncles had died of heart disease in their 40s, and his father had gotten a stent in his 60s. He decided to dig deeper.
    • “Farrington eventually discovered he had a heart threat that he — and many other people — had never even heard of: High levels of a fatty particle called Lipoprotein(a). The molecule is similar to LDL, the “bad” cholesterol that circulates in the blood and can promote coronary plaque, increasing the risk of heart attacks.
    • “But Lp(a) carries an extra protein that makes it an even bigger cardiac risk factor than LDL, studies have shown. Higher-than-normal levels encourage the development of blood clots as well as plaque, sharply raising the risk of stroke, heart attack and other severe problems — even among younger people with normal levels of LDL, doctors say.“
  • and
    • “In March 2024, radiation oncologist Sanjay Mehta had been dealing with painful Achilles tendinitis on his left ankle for over a year. He’d tried steroid injections and PRP (platelet-rich plasma) injections, which Mehta said eventually did the trick.
    • “But when his right Achilles started hurting three months later, he opted for a different approach. He had recently started offering low-dose radiation therapy to treat some patients suffering from inflammatory conditions and thought: Why not try it himself? After six self-administered low-dose X-rays, covered by insurance, he found he was pain-free — and he began offering the therapy to more patients with similar noncancerous conditions.
    • “The main surprise was … why didn’t I think of this earlier?” he said.
    • “Mehta is part of a growing trend among U.S. radiation specialists, who have begun offering low-dose X-ray therapy for benign conditions such as arthritis, plantar fasciitis, Peyronie’s disease and thick raised scars, or keloids.
    • “After the American Society for Radiation Oncology discussed the use of low-dose radiation therapy for nonmalignant conditions in its spring 2024 quarterly newsletter, its use began to pick up steam, Mehta said. Unlike radiation therapy for cancer, LDRT, as its name suggests, uses low doses to suppress inflammatory cells. Mehta said six LDRT treatments expose the patient to about the same amount of radiation as in one cancer treatment or what someone might get from “a few” CT scans.”
  • The New York Times tells us that “‘Japanese Walking’ Is a fitness trend worth trying. The workout is simple, and its health benefits are backed by nearly 20 years of research. Check it out.
  • Per MedPage Today,
    • “An investigational subcutaneous autoinjector showed comparable efficacy and safety to the IV formulation of lecanemab (Leqembi) for maintenance treatment in early Alzheimer’s disease, researchers said here.
    • “Continued lecanemab treatment with 360 mg subcutaneous dosing resulted in a similar additional reduction of amyloid PET over 4 years of treatment as continuing biweekly IV lecanemab, reported Larisa Reyderman, PhD, of drugmaker Eisai, at the Alzheimer’s Association International Conference (AAIC).

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Per a Congressional press release,
    • “Congressman Raja Krishnamoorthi (D-IL) and Congresswoman Diana Harshbarger (R-TN) introduced [on July 15, 2025] the Fair Pharmacies for Federal Employees Act, legislation to protect federal employees and retirees from anti-competitive practices by pharmacy benefit managers (PBMs) and insurers. Under the bill, the Office of Personnel Management (OPM) is prohibited from contracting with entities in the Federal Employee Health Benefits Program (FEHBP) that both manage prescription drug benefits and own or control a pharmacy. The federal government administers and oversees the largest employer-based health care system in the country. By implementing comprehensive reform at the federal level, a proven model will be created that will lower health care costs across the board beyond the federal workforce and reach millions of Americans impacted by anti-competitive practices used by PBMs.” * * *
    • “The full text of the legislation is available here.”
  • This proposal would be very disruptive to the FEHB Program’s prescription drug benefits. Indeed, the FEHB Program’s prescription drug benefits would benefit from deregulation. 
  • Federal News Network reports,
    • “Employee departures at the Office of Personnel Management are contributing to the agency’s ongoing challenges with addressing fraud risks in the Federal Employees Health Benefits program.
    • “A new report from the Government Accountability Office dug into whether OPM had considered assessing various factors that create risks for fraud in the government’s health insurance program for federal employees. But partially due to recent staffing vacancies, OPM was unable to provide a clear answer.
    • “OPM officials “could not explain or provide documentation as to whether these inherent risks were considered as part of the assessment process, and why the resulting fraud risk profile does not address these risks,” GAO wrote on Thursday.
    • “Amid the overhauls that have taken place in OPM’s internal workforce over the last several months, agency officials who were previously responsible for conducting fraud risk assessments have left their jobs, according to GAO’s report.”
  • FEHB carriers, which hold the insurance risk, bear the laboring oar on fraud risk assessments. Carriers work closely with the Office of Inspector General.
  • STAT News informs us,
    • “The Trump administration is opening the floodgates for more surgeries to be done in outpatient facilities like ambulatory surgery centers, proposing a Medicare policy that could accelerate the shift away from hospital-based care. 
    • “The administration is aiming to scrap Medicare’s list of 1,700 procedures that the program will only pay for in inpatient settings. Medicare officials unveiled their decision to eliminate the so-called inpatient only list in a proposed rule on Tuesday, reprising an effort from the first Trump administration. 
    • “The agency had already removed common surgeries like hip and knee replacements from the list in recent years, but it said that getting rid of it entirely will give patients more choices and allow doctors to use their professional judgment to decide where procedures should take place. 
    • “Doctors, for their part, raised a number of concerns with the change, noting that it could jeopardize insurance coverage for inpatient surgeries and raise out-of-pocket costs for patients. But far and away their main issue with eliminating the list was the potential to endanger patients if the shift happens too quickly and with the wrong patients.
    • “I wouldn’t say that most doctors are going to be cowboys about it, but they may be working in health systems where they say, ‘Hey we want to get x-percent of these procedures done in the outpatient setting,’” said Andrew Ibrahim, an associate professor of surgery at the University of Michigan. “There may be nudges from their health system or the way their practice is set up.” 
  • The Washington Post reports,
    • “Partnerships between telehealth companies and pharmaceutical giants Pfizer and Eli Lilly raise concerns about conflicts of interest and inappropriate prescribing, according to a Senate investigation released Thursday.
    • “The report by offices of several Democratic senators said the arrangements appear intended to steer patients to medications manufactured by those companies, which maintain websites touting drugs and providing links directing them to doctors who can prescribe them.
    • “Such partnerships undermine the independent medical judgment of doctors, who may default to prescribing medications first instead of exploring other options and potentially “glossing over the comprehensive evaluation necessary for high-quality patient care,” concluded the report from the offices of Sens. Dick Durbin (D-Illinois), Bernie Sanders (I-Vermont), Elizabeth Warren (D-Massachusetts) and Peter Welch (D-Vermont).
    • “In statements, Eli Lilly and Pfizer said their online portals are meant to make it easier for patients to navigate health care and they do not pressure clinicians to prescribe their drugs.”
  • Per a CMS press release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $14 billion annually.
    • “A recent analysis of 2024 enrollment data identified 2.8 million Americans either enrolled in Medicaid or the Children’s Health Insurance Program (CHIP) in multiple states or simultaneously enrolled in both Medicaid/CHIP and a subsidized Affordable Care Act (ACA) Exchange plan. 
    • “CMS is taking action to ensure individuals are only enrolled in one program and to stop the federal government from paying multiple times for these individuals to receive health coverage. In addition, as a result of the One Big Beautiful Bill Act, CMS now has new tools to prevent the federal government from paying twice for the same person’s care—saving billions and restoring integrity to the system.”
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services July 17 issued two letters to states regarding policies on continuous eligibility and workforce initiatives. The agency said it does not anticipate approving new or extending existing section 1115 demonstration authorities, which expand continuous eligibility. Additionally, CMS said it does not anticipate approving new or extending existing Medicaid-funded workforce initiatives for training or employment-related activities.”
  • Govexec tells us,
    • “In his first public memo since his Senate confirmation last week, Office of Personnel Management Director Scott Kupor wrote that due to the 2023 Supreme Court case Groff v. DeJoy, which held that employers must demonstrate “substantial increased costs” if they deny an employee’s religious accommodation request, federal agencies should work to honor such requests from their employees.
    • “Agencies are encouraged to adopt a generous approach to approving religious accommodations, prioritizing employee needs while maintaining operational efficiency,” Kupor wrote. “Further, federal agencies must adhere to the requirements of Title VII [of the 1964 Civil Rights Act] and the Groff clarification of the ‘undue hardship’ standard when addressing religious accommodation requests.”
    • “Agencies may use a number of workplace flexibilities to address an employee’s religious accommodation request, including telework, compensatory time off, flexible and maxiflex work schedule, and both paid and unpaid leave. Telework in particular can be useful to accommodate observing—or preparing to observe—a religious holiday or sabbath observance, to engage in religious fasting or other time-specific prayer observances.”
  • Tammy Flanagan, writing in Govexec, lets us know that “OPM’s digital retirement application is live. What that means for feds planning to retire. The new electronic retirement system promises a faster, more accurate process, but some users are still adjusting to the change.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “In a surprise, advisers to the Food and Drug Administration on Thursday voted that the risks tied to a blood cancer drug from GSK outweighed the benefits it had demonstrated in trials, as concerns about sometimes serious eye-related side effects and questions about the dose the company selected dominated a hearing.
    • “The FDA is set to decide whether to approve the drug, called Blenrep, by as soon as next week. The agency often follows its advisers’ recommendations but does not have to.”
  • The AHA News relates,
    • “The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and potentially life-threatening health consequences. Sandoz has not received any reports of adverse events or injuries related to the mislabeling but has received a complaint of the mislabeled product being administered to a patient.” 
  • Per MedTech Dive,
    • “Integra Lifesciences has recalled cranial drills over a defect linked to 10 injuries, the Food and Drug Administration said Wednesday.
    • “The company has asked customers to return Codman cranial perforators because they may break apart during use, causing the device to become lodged in the patient’s skull or injure the brain.
    • “Integra began the recall months after the FDA sent a warning letter to three facilities that make products including cranial perforators.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “A new lawsuit brought by 20 Democratic attorneys general says a recent final rule by the Centers for Medicare & Medicaid Services (CMS) will make it unfairly difficult to obtain health insurance through the Affordable Care Act (ACA).
    • “The lawsuit mirrors a challenge by three cities and liberal advocacy groups earlier this month. Plaintiffs in both cases say the regulation will cause up to 1.8 million people to lose coverage, starting in 2026. Many more will see premiums increase and out-of-pocket costs soar.
    • “Thursday’s suit (PDF) also takes issue with a provision in the rule, finalized in June, barring federal funds toward gender-affirming care services as an essential health benefit under the ACA.
    • “The states hope to delay the rule from taking effect in August.”

From the public health and medical research front,

  • The AP reports,
    • “Health officials in Illinois and North Dakota say their states’ measles outbreaks are over, pointing to a continuing slowdown of measles spread in the U.S. during vaccine-preventable disease’s worst year since 1991.
    • “Wednesday’s national case count stood at 1,309 — 21 new cases in a week, according to the U.S. Centers for Disease Control and Prevention. Last week, the U.S. passed the total count for 2019, when the country almost lost its status of having eliminated measles. 
    • “A vast majority of this year’s cases are from Texas, where a major outbreak raged through the late winter and spring. Other states with active outbreaks — which the CDC defines as three or more related cases — include Arizona, Colorado, Georgia, Iowa, Kansas, Kentucky, Michigan, Missouri, Montana, New Mexico, Oklahoma and Utah. 
    • “There have been three deaths in the U.S. this year, and all were unvaccinated: two elementary school-aged children in West Texas and an adult in New Mexico.”
  • The Washington Post relates, “Flesh-eating bacteria has killed 4 in Florida. Here’s what to know. Four people in Florida have died this year after contracting Vibrio vulnificus. Though rare, infections can require intensive care or limb amputation.”
  • The International Foundation of Employee Benefit Plans offers detailed advice on how to improve GI health in the workforce.
  • The National Science Foundation points out “AI that delivers smarter glucose predictions without compromising privacy.”
  • Per MedCity News,
    • “Over the past decade, employer-sponsored healthcare has undergone a significant transformation. Mental health solutions are finally mainstream. Fertility benefits are expanding. Women’s health has received overdue attention and innovation. Yet amid this evolution, one critical area remains largely ignored: men’s health.
    • “More than 88% of working-age men have unmet preventive, reproductive, and hormonal health needs. Despite making up half the workforce, men are falling through the cracks of today’s benefits strategies, often suffering in silence, delaying care, and showing up at the doctor’s only when it’s too late.
    • “For employers, this is more than a missed opportunity. It’s a growing liability financially, operationally, and culturally. Men’s health must be redefined not just as a clinical issue, but as a strategic business lever.”
  • Per STAT News,
    • “After a decade-long rise in suicide rates among young Americans — and with depression diagnoses soaring in this age group during the pandemic — the U.S. surgeon general issued a report in 2021 warning about the “devastating” state of youth mental health. The American Psychological Association declared it a “crisis.”It was part of a prolonged advocacy campaign to raise awareness about the problem and possible solutions, and finally, in 2022 and 2023, there were signs of success: Suicide rates for teens and young adults began to fall.
    • “Meanwhile, another demographic has gone largely overlooked. The people most at risk from suicide aren’t those in crisis in adolescence or midlife, but men age 75 and older. Some 38.2 deaths per 100,000 among men age 75 to 84 are by suicide, which increases to 55.7 among those over 85, according to data from CDC — more than 16 times the suicide rate for women in the same age group. Researchers are calling for a public health effort, much like the one to treat youth mental health, to help address suicide in older men.”
  • and
    • “Expert guidelines that clinicians across the country use to assess the risk of preeclampsia in pregnant women may be ineffective.
    • “The recommendations designed by the U.S. Preventive Services Task Force do not accurately predict risk of developing the condition and lead to nonspecific treatment guidance for the majority of patients, researchers found in a study published Thursday in JAMA Network Open. The findings have implications for reforming risk guidelines and increasing personalized care.
    • “This is a valuable, descriptive study,” Molly McAdow, a maternal-fetal medicine specialist at Yale New Haven Hospital, said. “There is certainly an opportunity for us to do better with a more stringent screening test.”
  • Per Health Day,
    • “Doctors might be overlooking a common cause of high blood pressure.
    • “New guidelines recommend screening for primary aldosteronism.
    • “Too much of the hormone aldosterone causes low potassium and high sodium, leading to high blood pressure.”
  • and
    • “Bedtime dosing with antihypertensive medication yields better nocturnal blood pressure control and improved circadian rhythm, according to a study published online July 9 in JAMA Network Open.”
  • Beckers Hospital Review relates,
    • “Pfizer is warning physicians that it expects a new shortage of Bicillin L-A, a long-acting penicillin injection that is currently the single recommended treatment for syphilis during pregnancy, CNN reported July 16. 
    • “The drugmaker’s alert follows a July 10 recall of certain lots found to contain floating particles, which Pfizer traced to faulty stoppers from an outside vendor. The company said no adverse reactions have yet been reported. 
    • “We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,” the company said in a statement to the news outlet. “We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Elevance on Thursday became the fourth major health insurer to lower or scrap its profit forecast, and executives warned things are going to get worse for the embattled sector before they get better. 
    • “Like its peers, Elevance said its members are getting a lot more care than the company had projected. For Elevance, the uptick is more pronounced in its Affordable Care Act business, but it’s also happening in Medicaid. The company lowered its full-year profit outlook by 13% to account for the higher costs, which are also baked into the plans it’ll sell in 2026. 
    • “We recognize that revising guidance for the second consecutive year is disappointing,” Gail Boudreaux, Elevance’s CEO, said on the company’s earnings call. “We remain committed to transparency and strong execution as we continue to navigate unprecedented cost trends affecting multiple lines of business.” 
  • Modern Healthcare lets us know,
    • “Group healthcare costs are expected to increase by 8.5% in 2026.
    • “PricewaterhouseCoopers’ Health Research Institute based its forecast published Thursday on policy changes, expensive medications including glucagon-like peptide agonists, higher rates of behavioral health claims and increased use of artificial intelligence, among other factors.
    • “For PwC’s annual report, researchers spoke with actuaries at 24 different health insurers covering 125 million employer-sponsored members and 12 million Affordable Care Act members to forecast healthcare inflation. In addition to the predicted 8.5% jump in costs for the group market, the consultancy projected a 7.5% increase for the individual market.”
  • The Wall Street Journal reports
    • “The drugmakers Bristol-Myers Squibb and Pfizer plan to sell the widely used blood thinner Eliquis directly to patients at a discounted cash price—a move that follows the Trump administration’s pressure on the industry to cut drug prices.
    • “The companies, which have a joint venture that markets Eliquis, said the new service will allow uninsured or underinsured patients to buy the pill at more than 40% off the current list price starting Sept. 8. The service will provide direct shipping of the drug to patients in the U.S.
    • “The BMS-Pfizer Alliance is committed to increasing patient access and affordability, which is why we are launching this direct-to-patient offering for Eliquis,” said Bristol-Myers Chief Executive Christopher Boerner.” * * *
    • “Eliquis has a list price of $606 for a 30-day supply but will now offer a discounted cash price of $346 a month.”
  • BioPharma Dive notes,
    • “Abbott lowered its sales forecast for the year, citing a drop in diagnostic testing. CEO Robert Ford told investors on Thursday that the company is seeing a drop-off in COVID-19 testing sales, challenges in China’s core laboratory market and a reduction in U.S. foreign aid funding for HIV testing, with a combined impact of more than $1 billion. 
    • “The company reduced its 2025 organic sales growth forecast to a range of 6% to 7%, from the previous forecast of 7.5% to 8.5% shared in the first quarter.
    • “Even with those billion dollars, we’re still forecasting high single-digit growth and absorbing the impact of tariffs,” Ford said.” 
  • Beckers Hospital Review calls attention to “10 healthcare billing fraud cases that Becker’s has reported on since June 30.”
  • The Institute for Clinical and Economic Review posted today
    • “a revised Evidence Report assessing the comparative clinical effectiveness of nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). ICER is also assessing the comparative clinical effectiveness and value of apitegromab (Scholar Rock Holdings) for SMA.”
    • “SMA, in its most common forms, has been a devastating degenerative neurologic disease of infants and children,” said ICER’s Chief Medical Officer, David Rind, MD. “Disease modifying therapies and newborn screening have dramatically altered the course of disease and represent one of the great medical success stories in the past decade. However, we still have important uncertainties about how best to utilize these therapies to provide maximal benefits to those affected.” * * *
    • “ICER evaluated the cost-effectiveness of apitegromab only because it will most likely be used as an add-on therapy to nusinersen or risdiplam. Apitegromab has not yet been approved by the FDA for SMA, and the manufacturers have not yet announced a US price for the therapy if approved. 
    • “ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.” * * *
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on August 1, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

Happy Juneteenth

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

From Washington, DC,

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

From the public health front,

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

From the U.S. healthcare business front,

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

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.”

Monday Report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “The White House is not requesting an increase in pay for federal employees in fiscal 2026. President Donald Trump released more details of his budget request for next year late Friday afternoon. The appendix section of the budget proposals also includes provisions to continue the pay freeze for certain non-career Senior Executive Service members and political appointees. In all, the new budget document details more specific discretionary spending requests for each agency. Unlike the “skinny” budget released in early May, the administration did include funding requests for the Office of Personnel Management, the Education Department and independent agencies like the Consumer Financial Protection Bureau.”
  • Healthcare Dive adds,
    • “The White House released a more detailed budget proposal on Friday that yields more information on how the Trump administration is aiming to reshape the HHS next year, including drastic cuts to the National Institutes of Health.
    • “The updated proposal doubles down on plans to slash the NIH’s budget nearly in half, consolidate the HHS’ 28 operating divisions into 15, eliminate dozens of federal healthcare and social welfare programs and terminate more than 5,000 contracts.
    • “The Trump administration argues the changes are necessary to streamline HHS functions and eliminate priorities around diversity, equity and inclusion panned by conservatives.
    • ‘The administration can’t fully implement the budget without the support of Congress. Lawmakers usually make changes to the executive branch’s spending wish list in appropriations legislation.
  • Beckers Hospital Review points out,
    • “HHS has proposed oversight of the 340B drug pricing program to the Centers for Medicare & Medicaid Services as part of a broader reorganization. 
    • “The move, initially referenced in a preliminary memo from White House officials in April, would place the 340B program under CMS’s Program Management authority, allowing the agency to use its in-house drug pricing expertise and streamline oversight, according to HHS’s Budget in Brief. 
    • “Funding for 340B oversight would be maintained at $12 million to “provide oversight and auditing of covered entities and drug manufacturers, support operational improvements, and increase operational efficiencies,” the document said. 
    • “The 340B drug pricing program requires drug manufacturers to offer discounts on outpatient prescription drugs to eligible safety-net hospitals. CMS Program Management is a key part of the federal health infrastructure, overseeing the administration of Medicare, Medicaid, the Children’s Health Insurance Program and the Federal Exchange.” 
  • Per Federal News Network,
    • “The Trump administration is proposing changes that would make it easier to fire federal employees accused of misconduct in a matter of days, because they no longer meet “suitability and fitness” standards required to join the federal workforce.
    • “The Office of Personnel Management, in a proposed rule it will publish Tuesday in the Federal Register, plans to expand suitability adjudications normally reserved for federal job applicants to include current employees.
    • “The proposed rule, once finalized, would allow the Trump administration to fast-track the firing of federal employees, on the grounds that they no longer meet suitability standards for federal employment.
    • “OPM’s proposed rule states agencies must remove federal employees within five workdays, if it decides they no longer meet the suitability standard.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH), which serves as a bridge to transplant for patients with end-stage heart failure.
    • “BiVacor’s TAH is based on rotary blood pump technology and approximately the size of an adult’s fist. It has no valves or flexing ventricle chambers, and its only moving part is a magnetically suspended double-sided centrifugal pump impeller.
    • “The FDA’s decision signals just how much potential the agency sees in this technology. The breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. Its representatives work directly with the manufacturer, for example, and submissions are prioritized.
    • “This is more than a regulatory milestone,” Daniel Timms, PhD, founder and chief technology officer of BiVacor, said in a statement. “It’s a validation of a concept we’ve spent decades proving that a fully implantable, TAH isn’t just possible, it’s necessary. Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The breakthrough device designation puts us on a faster track to deliver exactly that.”
  • MedPage Today notes,
    • “The FDA granted de novo authorization to the first artificial intelligence (AI) program to support breast cancer risk prediction from screening mammograms.
    • “The program, called Clairity Breast, analyzes mammograms for subtle features that correlate with future breast cancer risk, according to a news release from Clairity. The analysis results in a 5-year risk score validated from analysis of more than 77,000 mammograms from multiple hospital-based and free-standing mammography facilities.
    • “The system can be applied immediately to clinical practice, Larry Norton, MD, a breast cancer specialist at Memorial Sloan Kettering Cancer Center in New York City, told MedPage Today.
    • “We’re very excited about it,” said Norton, who also is founding scientific director of the Breast Cancer Research Foundation, which supported development of Clairity Breast. “We were confident that it’s going to turn out to be something that’s going to help people, something that we think really has great science behind it.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Court of Appeals for the Fifth Circuit granted a Texas doctor group’s request Friday to rehear its challenge to a Biden administration rule governing the arbitration process for surprise medical bill disputes.
    • “The No Surprises Act protects patients from most unexpected out-of-network bills by requiring insurers and medical providers to undergo an arbitration process for payment disputes. But the process is the subject of countless legal battles, and the Texas Medical Association has successfully challenged multiple provisions of the implementation regulations.
    • “A three-judge panel previously upheld several portions of the rule (RIN: 1210-AC17) in a mixed decision regarding the qualifying payment amount—a key factor arbitrators use to settle disagreements. The Texas Medical Association had asked the full panel to reconsider the decision upholding the exclusion of bonuses as well as the inclusion of “ghost rates,” or contracted rates for services that a doctor hasn’t actually provided.”

From the public health and medical research front,

  • CBS News reports,
    • “The Centers for Disease Control and Prevention has updated its warning about the risk of contracting measles while traveling, after the agency tallied dozens of cases so far this year in travelers who were infectious while flying on airplanes within the U.S.
    • “Travelers can catch measles in many travel settings including travel hubs like airports and train stations, on public transportation like airplanes and trains, at tourist attractions, and at large, crowded events,” the agency now says, in an update published Wednesday.”
  • Per HCPLive,
    • “Cardiac deaths have risen since 2020, with more occurring at home, indicating a potential gap in care for heart disease patients during the pandemic.
    • “Hospital data showed a 20–34% reduction in acute myocardial infarction hospitalizations, while at-home cardiac deaths increased, suggesting changes in care-seeking behavior.”
  • MedPage Today informs us,
    • “Measles, mumps, and rubella (MMR) vaccination rates in children declined in some counties across the U.S. during the COVID-19 pandemic, researchers found.
    • “Across 2,066 counties in 33 states with both pre- and post-pandemic vaccination data, the county-level mean MMR vaccination rate decreased from 93.92% to 91.26%, according to Lauren Gardner, PhD, of Johns Hopkins University in Baltimore, and colleagues.
    • “A decline in coverage was reported in 78% of counties during this time, and only four states — California, Connecticut, Maine, and New York — had an increase in median county-level vaccination rates, they reported in a JAMA research letter.”
  • The American Medical Association tells us what doctors wish their patients knew about e-cigarettes.
  • Consumer Reports, writing in the Washington Post, discusses “What to know about nerve pain and tingling hands and feet. Tingling or painful sensations in your hands and/or feet are the main symptoms of neuropathy.”
  • The Wall Street Journal reports,
    • “Novartis said Pluvicto demonstrated positive results in patients with PSMA-positive metastatic hormone-sensitive prostate cancer.
    • “The Swiss pharmaceutical company on Monday said Pluvicto showed statistically significant and clinically meaningful benefits—including combined with hormone therapy versus hormone therapy alone—with positive trend in overall survival.
    • “The results are from a prespecified interim analysis of a Phase 3 trial, it said.
    • “Pluvicto is already approved for metastatic castration-resistant prostate cancer and now shows potential in patients in an earlier disease setting, it said.
    • “The company will present results at an upcoming medical meeting and based on FDA feedback, will submit for regulatory review in the second half of the year, it said.
    • “Pluvicto is a radioactive medication used to treat some types of prostate cancer.”
  • Per BioPharma Dive,
    • “An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future. 
    • “According to Vera, the drug, called atacicept, met its main goal in a Phase 3 trial in IgA nephropathy, a chronic condition that can lead to kidney failure. After 36 weeks of treatment, atacicept was associated with a 42% reduction versus a placebo — and a 46% decline from the study’s start — in the amount of protein in participants’ urine, an important marker of kidney health. 
    • “Without providing specifics, Vera said atacicept’s other efficacy results were “consistent with or better than” what was observed in mid-stage testing and had a safety profile “comparable to placebo.” The company will share the data with the Food and Drug Administration in the coming weeks and intends to file an accelerated approval request in the fourth quarter.”
  • Per Fierce Pharma,
    • “Amgen has detailed a positive phase 3 readout for its T-cell engager Imdelltra in previously treated small cell lung cancer (SCLC).
    • “The DLL3xCD3 bispecific has shown that it can help patients live longer, has a more tolerable safety profile and improves certain cancer-related symptoms compared with chemotherapy in second-line SCLC, according to results from the phase 3 DeLLphi-304 trial. The data will be presented June 2 at the 2025 American Society of Clinical Oncology annual meeting and simultaneously published in The New England Journal of Medicine.
    • “The drug significantly reduced the risk of death by 40% versus chemo in SCLC patients who had tried one line of platinum-based chemotherapy. Patients in the Imdelltra arm lived a median 13.6 months, compared with 8.3 months for chemo.
    • “All patient subgroups appeared to have benefited, regardless of their prior PD-1/L1 exposure, presence of brain metastases or liver metastases, and the type of prior chemotherapy. Among those who had tried a PD-1/L1 inhibitor, Imdelltra’s death risk reduction was 39%. In PD-1/L1-naïve patients, the number was 35%.
    • “These data underscore Imdelltra’s potential to transform patient outcomes and the small cell lung cancer treatment paradigm,” Amgen’s R&D chief, Jay Bradner, M.D., said in a statement.
    • “Findings from the DeLLphi-304 trial could help convert Imdelltra’s accelerated approval earned last year into a full approval.”

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “UnitedHealth Group shareholders signed off on the planned compensation package for newly-reinstated CEO Stephen Hemsley.
    • “Hemsley, who returned to the CEO role last month, will earn a $1 million base salary each year. He will also receive a one-time $60 million equity award in nonqualified stock options.”
  • The Wall Street Journal reports,
    • “BioNTech & Bristol Myers will jointly develop BioNTech’s BNT327 cancer-drug candidate.
    • “Bristol Myers will make a $1.5B upfront payment to BioNTech, with $2B in payments through 2028.
    • “BNT327 is being evaluated in Phase 3 trials as a first-line treatment in lung cancer.”
  • Per Fierce Pharma,
    • “In late April, when Sanofi revealed that it was selling a controlling stake in its consumer health business Opella for 10 billion euros ($11.4 billion), chief financial officer Francois Roger said that the French drugmaker would “explore external growth opportunities for bolt-on acquisitions.”
    • “Just five weeks later, Sanofi has made a deal few would describe as “bolt-on,” as it has bought out Massachusetts-based Blueprint Medicines for up to $9.5 billion.
    • “With the deal, Sanofi gains Blueprint’s portfolio of rare immunological disease treatments, including systemic mastocytosis (SM) pill Ayvakit, which generated sales of $479 million last year and has peak sales potential of $2 billion, the 14-year-old company projected last year.
    • “Blueprint also brings a next-generation SM candidate in elenestinib, a KIT D816V inhibitor which is the subject of a phase 2/3 study, and an early-stage KIT inhibitor BLU-808. KIT plays a central role in mast cell activation, Sanofi said, which is implicated in a broad range of inflammatory diseases.”
  • STAT News lets us know,
    • “Atai Life Sciences, among the most prominent biotechs focused on psychedelic medicines, said Monday it will merge with private psychedelic startup Beckley Psytech, pending results of a trial for a drug based on the practice of “smoking toad.”
    • “The new company will be known as Atai Beckley, with Beckley Psytech shareholders receiving 31% of shares in the entity.  The deal, which values Beckley at $370 million, comes as the Trump administration has expressed support for the field.” 
  • Beckers Hospital Review informs us,
    • “St. Louis-based Ascension is reportedly in talks to acquire ambulatory surgery center company AmSurg for about $3.9 billion, according to Bloomberg.
    • “AmSurg split from Envision Healthcare when the company emerged from bankruptcy in 2023. It is now backed by Pacific Investment Management Co., King Street Capital Management and Partners Group.
    • “A potential acquisition would significantly expand Ascension’s footprint in the ASC space, aligning with the broader trend toward lower-cost, outpatient care settings. AmSurg has a network of more than 250 surgery centers across 34 states and supports nearly 2,000 physicians, according to its website.”
  • and
    • “Blythe, Calif.-based Palo Verde Hospital is at risk of shutting down due to financial challenges over resignations and months of litigation, The Desert Sun reported May 30. Becker’s reached out to the hospital, which remains open as of June 2. 
    • “Congressman Raul Ruiz, MD, raised concern for the 51-bed hospital in a May 28 letter, obtained by the Sun, to California Gov. Gavin Newsom, asking the state for $4 million in emergency funding, otherwise the hospital could shutter “as soon as tomorrow.”
  • Beckers Hospital Review also collected eight GLP-1 updates for your information.
  • Per Healthcare IT News,
    • “The Clinic by Cleveland Clinic, an initiative with telemedicine technology and services company Amwell, has been getting life-changing results from leading-edge virtual care. 
    • “The Clinic has been providing virtual second opinions by the many top specialists at the renowned healthcare organization. The platform connects patients to more than 3,500 specialists across Cleveland Clinic without the need for the patients to travel to a major medical center.
    • “Misdiagnoses contribute to more than 800,000 deaths or disabilities each year in the U.S., Johns Hopkins has found, costing the healthcare system hundreds of billions, beyond the human cost. 
    • “Data from the Clinic by Cleveland Clinic shows that in 67% of cases patients receive a new diagnosis or treatment recommendation after seeking a second opinion.”
  • Per Fierce Healthcare,
    • “Electronic health records giant Epic announced Monday that more than 1,000 hospital customers and 22,000 clinics using its EHR are now live on a government-backed data exchange, as the company doubles down on a commitment it made last year.
    • “Epic said in an announcement that it marks a significant milestone in “making health information seamlessly and securely available wherever care happens.”
    • “In March, Epic reported that more than 2,000 hospital customers and more than 50,000 Epic clinics were either live or preparing to go live on the federal Trusted Exchange Framework and Common Agreement (TEFCA) framework for nationwide health data exchange, according to Becker’s Health IT.
    • “The company’s goal is to have all its customers live on TEFCA by the end of the year, Epic said in August. The health IT company now commands 42.3% of the hospital EHR market, up from 39.1% a year prior, so shifting all its hospital customers to TEFCA would represent a significant share of U.S. hospitals.”
  • and
    • “Digital health company Scripta Insights is joining forces with RxSaveCard with the goal of making it easier for employers to manage drug costs and meet their fiduciary duties.
    • “RxSaveCard offers a proprietary cost management and payment solution for pharmacy benefits, and those tools will be integrated into Scripta’s AI-powered Rx Navigation platform.
    • “For members, the integration is designed so they can better find savings for a variety of drugs, including high-cost specialty products.
    • “The platform is designed to identify lower-cost options both in the member’s prescription drug coverage or through cash-pay, according to an announcement from the companies.”

Monday Report

David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports,
    • “House Budget Committee Republicans advanced a sweeping reconciliation bill Sunday night, but for the GOP, the internal debate is far from over. * * *
    • “Rep. Chip Roy, R-Texas, one of four conservative Budget Committee members who agreed to vote “present” Sunday to allow the House to move forward with the bill designed to implement Trump’s policy agenda, said in a statement, “the bill does not yet meet the moment.”
    • “The Rules Committee is scheduled to convene at 1 a.m. Wednesday to set the ground rules for floor debate on the measure after releasing an updated committee print version of the legislative text overnight.
    • “Among the newest changes is the removal of a provision opposed by Rep. Michael R. Turner, R-Ohio, that would force federal agency employees, lawmakers and congressional staff to contribute more of their salaries to their pension plans. The effective dates of two other pension-related provisions would be delayed to 2028.”
    • “Roy said provisions related to curbing spending enacted under President Joe Biden, especially for environmental and energy programs, needed to see further cuts. He also criticized the bill’s Medicaid language.
    • “Roy said in a statement that the bill “fails to end the Medicaid money laundering scam and perverse funding structure that provides seven times more federal dollars for each dollar of state spending for the able-bodied relative to the vulnerable. This all ultimately increases the likelihood of continuing deficits and non-Obamacare-expansion states like Texas expanding in the future,” Roy said in a statement.”
  • STAT News adds,
    • “Although moderate and conservative Republicans disagree over some Medicaid policies that have been considered, both groups support imposing work requirements on adults without kids or disabilities. For that reason, the bill leaned hard on that policy by applying work requirements on beneficiaries up to the age of 64, instead of 55. Those people would keep Medicaid if, twice a year, they document that they’re working at least 80 hours a month. They could also maintain coverage if they perform community service or are enrolled in educational programs.
    • “Those work requirements would take effect in 2029, and conservatives are demanding they start next year.” 
  • Here is a link to a House Budget Committee document that identifies the changes that the Committee approved last night.

From the public health and medical research front,

  • Blue Cross FEP offers a healthcare checklist for women of all ages on LinkedIn.
  • The American Medical Association tells us “what doctors wish patients knew about getting a cesarean section.”
  • The New York Times reports
    • “Men are taller than women, by an average of about five inches. But why? It’s not a genetic inevitability — there are many species in the tree of life where females outclass males.
    • “A new study, published on Monday in the Proceedings of the National Academy of Sciences that involved genetic data from a million people, has found a partial explanation.
    • “It involves a gene called SHOX, which is known to be associated with height. SHOX is present on both the X chromosome — females have two X chromosomes — and the Y chromosome; males have one X and one Y.”
  • Per Medscape,
    • “An oral obesity treatment (SYNT-101) that mimics the metabolic effects of gastric bypass established preliminary safety, tolerability, and efficacy in a first-in-human study.”
  • and
    • “An online obesity clinic named Embla was associated with weight loss like that seen in randomized controlled trials (RCTs) of semaglutide, but with less than half of the semaglutide dose, according to new real-world data.
    • “Average weight loss reached 16.7% after 64 weeks’ use of the digital health platform, which combines tailored semaglutide dosing with intensive behavioral therapy delivered via an app. In clinical trials of semaglutide, the dose was 2.4 mg/wk, but patients in the present study used an average of 1 mg/wk. Similar mean weight loss was observed across baseline body mass index (BMI) classes and with all medication doses.
    • “This [study] showed us that combining an intensive behavioral intervention within an e-health weight management clinic can reproduce some of the results we see in confirmatory trials but in the context of a real-world cohort and with far less medication used,” said lead researcher Henrik Gudbergsen, MD, chief medical officer at Embla and general practitioner.
    • “The intensive behavioral therapy is key, and it goes a long way when you want to lose weight,” Gudbergsen added. He presented the findings at European Congress on Obesity (ECO) 2025. Publication of the study in The Lancet Digital Health is pending, but a preprint version is available.”
  • MedPage Today informs us, “Health officials are making a renewed call for vigilance against bird flu, but some experts are puzzling over why reports of new human cases have stopped.” * * *
    • During a call with U.S. doctors this month one CDC official noted that there is a seasonality to bird flu: Cases peak in the fall and early winter, possibly due to the migration patterns of wild birds that are primary spreaders of the virus.
    • That could mean the U.S. is experiencing a natural — maybe temporary — decline in cases.” * * *
    • “The CDC characterizes the risk to the general public as low, although it is higher for people who work with cattle and poultry or who are in contact with wild birds.
    • “Earlier this month, an agency assessment said there is a “moderate risk” that currently circulating strains of bird flu could cause a future pandemic, but the CDC stressed that other emerging forms of bird flu have been similarly labeled in the past.
    • “Still, research is continuing.”
  • Advice from GoodRx
    • Over the last few years, many artificial tear products have been recalled over safety concerns. These recalls have included products from Global Pharma Healthcare, Kilitch Healthcare India, and Brassica Pharma. Most recently, eye drops made by BRS Analytical Service, LLC have been recalled.
    • Recalled artificial tear eye drops, gels, and ointments had previously been sold in retail stores, such as CVS and Walmart, and online. Before using or buying artificial tears, check the most recent recall list to see if your product is affected.
    • Contact your healthcare team right away if you’ve used artificial tears and notice vision changes or eye infection symptoms.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Regeneron Pharmaceuticals, a biotechnology company with a long history of large-scale genetics research, plans to buy DNA testing firm 23andMe out of bankruptcy, announcing Monday it was named the successful bidder in a court-run auction.
    • “Regeneron’s offer, which is still subject to court and regulatory approvals, is a bet it can do what 23andMe couldn’t and mine the troves of genetics data the testing firm collects to discover new drug targets. Regeneron plans to continue 23andMe’s consumer genome services without interruption — a task made easier by its decade of experience sequencing the DNA of millions of people through its genetics center. * * *
    • “Under the proposed deal, Regeneron will pay $256 million to acquire “substantially all” of 23andMe’s assets, including its personal genome service, health and research service and biobank. It will also offer jobs to all of the employees at those business units.
    • “The purchase would not include the telehealth business Lemonaid Health, which 23andMe will wind down.
    • “Regeneron expects the deal will close in the third quarter, assuming it obtains all the necessary approvals. An ombudsman appointed by the bankruptcy court will review the transaction to assess how it might affect the privacy of individuals who previously used 23andMe to sequence their genome. A report from that review is due to the court by June 10, and a hearing is set for June 17.”
  • Fierce Pharma informs us,
    • “With $27 billion earmarked to expand its U.S. production footprint starting this year, Eli Lilly is busy scouting out potential sites for new drug ingredients plants.
    • “Eli Lilly is jockeying for a tax break in Texas as it weighs whether to build a $5.9 billion active pharmaceutical ingredient (API) manufacturing facility in Houston, according to a recent filing (PDF) with the state.
    • “Should the proposal move forward, Lilly plans to purchase roughly 236 acres at Houston’s Generation Park from the commercial development’s owner, McCord Development. The final project would comprise multiple buildings and outdoor facilities, plus infrastructure buildout and equipment installation, according to the filing.
    • “Assuming Lilly settles in Houston, the drugmaker expects the new plant will employ 604 full-time staffers upon ramp-up completion. The company would look to hire operations technicians and production specialists, as well as a mix of roles across maintenance, quality control, engineering, administration and management functions.”
  • Per Fierce Healthcare,
    • “Vertical consolidation in healthcare has been a hot-button topic of late as regulators eye strategies to bring down healthcare costs.
    • “But do these massive “payvider” firms do more harm than good? The jury is still out, according to a panel of experts hosted by the Brookings Institution. The panelists highlighted both the risks of vertical integration between payers and providers as well as the potential positives of these relationships.”
  • and
    • “A new study suggests “upcoding” practices are growing across outpatient service lines.
    • “The report, compiled by researchers at Trilliant Health, found that the share of visits that were coded at higher intensities grew in emergency care, urgent care and physician office visits between 2018 and 2023. For example, the number of emergency department visits coded as 99284, or level four of five total, grew from 32.5% to 39.6% in the study window.
    • “Providers use standard CPT codes for outpatient visits, ranging from level one to level five, to indicate the intensity of services offered and the amount of time clinicians spent with a patient.
    • “The study similarly found an increase in urgent care visits coded at level four, with the share growing from 34% to 40.6% between 2018 and 2023. For physician office visits, the share of those coded at level four increased from 38.5% to 45%.
    • “In tandem, the study found a decline in the number of patient visits coded at lower intensity. For urgent care, the share of visits coded at level one decreased from 9.5% to 2.9% by 2023.”
  • Beckers Hospital Review lets us know,
    • “U.S. hospitals and health systems in many regions are seeing a sharp rise in uncompensated care, with new data showing big increases in bad debt and charity care deductions during the first quarter of 2025.
    • “Disruptions in health insurance coverage can drive increases in bad debt and charity care deductions for U.S. hospitals and health systems. According to the latest data from Q1 2025, health systems across the country already experienced significant increases in bad debt and charity deductions in recent years,” noted Strata in its “Healthcare Performance Trends: Q1 2025” report.”