Friday report

Government Contracting

Friday report

David Ermer–CDC, CMS, FDA, Government Contracting, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Avalere Health offers insights concerning HHS Secretary’s decision to fill out the membership of the U.S. Preventive Services Task Force announced yesterday.
    • “For life sciences companies and health plans, the USPSTF’s ability to resume its work—and potential new approaches to evidence review with its new members—will be consequential. The Task Force’s recommendations influence preventive care practice, clinical quality strategies, and, most notably, health plan preventive service coverage requirements.” * * *
    • “Health plans should prepare for the potential release of delayed recommendations and for a more active USPSTF agenda. This includes maintaining processes to assess coverage requirements, benefit configuration, coding, provider-network capacity, member communications, and implementation timelines once final A or B recommendations are issued. USPSTF last shared a recommendation update in August 2025, with four topics pending final recommendation statements.
    • “As the Task Force resumes activity under new leadership and a substantially different membership profile, transparency, methodological consistency, and implementation relevance will be central to maintaining trust in its recommendations.”
  • Per a Centers for Medicare and Medicaid Services (CMS) news release.
    • “The Centers for Medicare & Medicaid Services (CMS) is working to end skyrocketing drug costs as the agency announces today that all 50 states, plus the District of Columbia and Puerto Rico, have applied to participate in an initiative which provides most-favored-nation pricing for certain prescription drugs to people with Medicaid. Forty states and Puerto Rico have already signed agreements to participate in this historic program that will lower Medicaid drug costs to what other countries pay, saving an estimated $64.3 billion in taxpayer dollars over the next ten years, while preserving or enhancing beneficiaries’ quality of care.” * * *
    • “The GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model is a landmark CMS Innovation Center initiative designed to not only lower drug spending in Medicaid but also improve quality of care and health outcomes by increasing access to critical medications and strengthening the Medicaid program overall. Under the GENEROUS Model: 
      • “Participating manufacturers will make covered outpatient drugs available at most-favored nation pricing to participating state Medicaid programs.
      • “Under agreements with states, participating manufacturers will be invoiced by states for supplemental rebates to effectuate international prices. CMS will monitor pricing accuracy. CMS will share in rebates with states via a reduction in the federal share of Medicaid payments.” * * *
    • “Remaining states have until Sept. 30, 2026, to sign agreements with CMS to participate in the model. The GENEROUS Model launched in January 2026 and runs for five years.
    • “For information on states participating the GENEROUS Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/generous.” 
  • In today’s Federal Register, the Federal Acquisition Council promulgated proposed rules implementing the Revolutionary FAR Overhaul’s (RFO) FAR provision deviations.
  • The FAR Council explains on the acquisition,gov website,
    • “The RFO Phase 2 rule-making process has been organized in 12 FAR Cases, as outlined in the chart. The FAR Council has published Proposed Rules (PR) for the first 4 of 12 RFO-related FAR cases.
    • “With this publication, it’s the perfect time to show how public feedback informed key changes from the model deviations to the proposed rules. Your voice made a difference. The FAR Council received almost 1,600 valuable comments, primarily from industry (80%), but also from industry associations (7%) and federal government employees (13%). The public feedback received informed the FAR Council’s work in preparing the proposed rules. 
    • ‘While all public comments received may not be reflected, the tables below highlight examples of key policy updates that resulted from some of the public feedback submitted via acquisition.gov. The tables are organized by the RFO-related FAR rules, and will be continuously updated as the remaining RFO-related rules are published over the coming months.” 
  • Per Department of Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Financial Resources (ASFR), today announced a new Department-wide policy establishing the HHS Personal Protective Equipment (PPE) Forecast. This is the first official, recurring process to identify, consolidate, and publish anticipated HHS purchases of personal protective equipment covered by the Make PPE in America Act.
    • “The new forecast will give U.S. PPE manufacturers a clearer and more predictable signal of future HHS demand. By turning the Department’s acquisition plans into actionable market visibility, the initiative will help domestic companies make better-informed decisions about hiring, production, capital investment, and manufacturing capacity while strengthening the supply chains HHS relies on during routine operations and public health emergencies.” * * *
    • American manufacturers and small businesses can review HHS procurement forecast opportunities through the HHS Small Business Customer Experience platform.
  • and

From the U.S. Office of Personnel Management front,

  • OPM Director Scott Kupor resorted to his Secrets of OPM blog [found on Substack) to ably debunk recent challenges to the cost savings created by last year’s massive reduction in federal employment.
    • “GAO estimates that agencies spent about $9.5 billion on all paid administrative leave in 2025 and attributes about $6.7 billion of that to the Deferred Resignation Program. For the sake of argument, let’s charge the entire $9.5 billion to DRP anyway. It was a one-time expense.
    • “What did the taxpayer get for it? Using rough averages, the fully loaded cost of a federal employee is about $150,000 per year. For 270,000 employees, that is more than $40 billion in annual costs. These are not one-time costs, but costs incurred every year in perpetuity.
    • “So, for a one-time expense of at most $9.5 billion, taxpayers save more than $40 billion each year. That’s a 400+% annual return, and the outlay paid for itself in under six months.”
  • Here is a link to Senator Adam Schiff’s (D CA) news release about the letter that he and fifteen other Democrat Senators sent to OPM on October 16 questioning the OPM’s use of FEHB and PSHB protected health information to help OPM’s effort to combat fraud, waste, and abuse in hose programs.
    • “We support responsible efforts to protect the integrity of federal health-benefit programs. However, OPM’s proposals create an unnecessarily broad, decades-long, re-identifiable medical history of millions of workers, retirees, spouses, children, and other family members. We strongly urge OPM to suspend further implementation while these concerns are addressed and to work with Congress, federal employees and retirees, health plans, privacy and civil-rights experts, reproductive-health advocates, and other affected stakeholders to establish safeguards commensurate with the sensitivity of the information at issue. 
    • “We request a written response and briefing by OPM on the office’s efforts related to the above requested actions no later than September 25, 2026.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy.
    • “The approval, announced Sept. 18, 2026, applies to patients whose ESR1 mutation is identified using an FDA-authorized test. The FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1-mutated breast cancer who may be eligible for the treatment combination.
    • “Inluriyo and Verzenio are both manufactured by Eli Lilly and Company.”
  • MedTech Dive relates,
    • “Cognita Imaging recently received a $1.29 million research contract from the Food and Drug Administration to test a new method of evaluating artificial intelligence-generated radiology reports. The goal is to assess whether a “jury” of large language models can evaluate another AI model’s report, and which cases need radiologist oversight.
    • “The contract, which started on June 22 and will run for 18 months, is intended to address a core problem with generative AI. Currently, most tools are evaluated against a panel of radiologist experts, but for models that can evaluate a wide variety of cases and generate different outputs, this becomes more challenging and time-consuming.”
  • STAT News tells us,
    • “In January, a paper published in Science analyzed government mortality figures, data on drugs seized by the DEA, and Reddit posts to determine that decreasing fentanyl potency due to Chinese government crackdowns could explain the recent decline in U.S. opioid overdose deaths. But when another research team tried to replicate that study, they didn’t come to the same conclusion.
    • “A simplistic supply shock is not supported by the evidence,” the authors wrote yesterday in Science Advances.
    • “The researchers noted that as fentanyl purity increased across the country, there was no associated national drop in overdose rates. While there did seem to be a broad association between declining purity and overdoses, it was shared with other, unrelated trends. And importantly, the DEA acknowledged at the time that increasing purity in its drug seizures was likely due to a change in its sampling plan.
    • “It’s also critical not to overlook geographic variability in the drug supply, the replication study authors wrote. As one of them told Lev Facher when the first study was published, many regions had declining overdose rates before potency apparently began to drop. — Theresa Gaffney

From the public health and medical /Rx research front,

  • The Centers for Disease Control and Prevention announced today
    • “As of September 18, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low overall.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 177 new cases added today, the US measles count has climbed to 3,471. * * *
    • “Today’s increase marks the sixth straight week of triple-digit increases in cases.
    • “The CDC today noted 39 outbreaks, one more than last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level in July. 
    • “The 2026 total is already 52% higher than the 2025 total, with more than three months left in the year.
    • “All but 17 of this year’s cases have been locally acquired, with the rest tied to international travel. Cases have been confirmed in 45 states plus New York City and Washington, DC.
  • The Washington Post tells us,
    • “Paul Nestadt is about as steeped in suicide prevention as a person can be.” * * *
    • “Nestadt has sought to intervene in ways that don’t require pinpointing people at risk.
    • “Chief among them: making it harder for people to carry out the act of killing themselves.
    • “Instead of asking every doctor to figure out which patient will die by suicide and locking that patient up, it might be that we need to make sure there aren’t loaded guns available,” Nestadt said.
    • “Although medication and therapy are lifesaving measures, many clinicians, researchers and people who have lost loved ones to suicide agree that more is needed. When it comes to firearms, however, broad policy approaches face major constitutional and political challenges.
    • “Research shows that limiting access to lethal means is one of the most promising approaches to save lives. It can involve erecting barriers on buildings and bridges to prevent people from jumping, as well as decreasing the number of pills someone can buy or be prescribed at once.
    • “And reducing access to guns, which are the most common and lethal method used for suicide in the United States.”
  • Beckers Behavioral Health shares summaries of “34 new behavioral health study findings to know.”
  • MedPage Today lets us know,
    • “A quarter of patients with cirrhosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD) presented before the age of 50 with distinct risk profiles, data from a prospective study showed.
    • “In models adjusting for demographic and metabolic factors, a high genetic risk score and type 2 diabetes were independently associated with early-onset MASLD cirrhosis.
    • “Reliance on age-dependent first-line liver fibrosis tools can miss cases, the researchers suggested.”
  • Per Health Day,
    • “Wearable sensors might be the key to better tracking and treating a person’s knee arthritis, a new study says.
    • “Strapped to the foot, these sensors work as well as motion capture cameras in tracking a person’s natural stride, researchers reported recently in the journal JMIR Formative Research.
    • “This stride data could be used to track how a person with knee arthritis walks, allowing doctors to track arthritis progression and potentially offer individualized therapy, researchers said.”
  • and
    • “More people are seeking emergency help for gambling problems in the face of expanded online betting markets, a new study says.
    • “ER visits for gambling disorders nearly doubled following the legalization of single-event sports betting and expansion of online gambling markets in Ontario, researchers reported Sept. 15 in the American Journal of Preventive Medicine.
    • “Most people experiencing gambling problems will never seek care, so the concern is that the increases in ED visits for gambling disorders we observed may be revealing much larger increases in gambling-related harm,” senior researcher Dr. Daniel Myran said in a news release. He’s research chair at North York General Hospital in Toronto.”
  • Per Genetic Engineering and Biotechnology News,
    • “Diabetic kidney disease is one of the most common and serious complications of diabetes, yet the chain of events linking high blood sugar to kidney damage remains incompletely understood. Now, a stem cell-based model suggests that glucose itself may help trigger an inflammatory response inside kidney tissue—one that can damage key epithelial cells.
    • “Researchers led by Benjamin S. Freedman, PhD, at the University of Washington and University of Miami, report that human kidney organoids exposed to elevated glucose developed tissue-intrinsic inflammation and epithelial cell detachment, including detachment of podocytes, specialized cells essential for the kidney’s filtration barrier. The study, “Elevated glucose in kidney organoids induces tissue-intrinsic inflammation driving epithelial detachment,” was published recently in Stem Cell Reports.
    • “High sugar causes inflammation in these organoids even though they lack an immune system,” Freedman said. “This was unexpected and gives us a new way to think about how diabetes can affect kidneys and other organs.”
  • Per Beckers Hospital Review,
    • “An investigational immunotherapy was found to almost double median overall survival in patients with previously treated squamous non-small cell lung cancer, according to new trial data.
    • “Gotistobart, developed by BioNTech and OncoC4, showed a median overall survival of 18.5 months, nearly double the 10-month median among patients who received standard of care chemotherapy, according to a Sept. 14 news release from the companies.
    • “The trial results were presented Sept. 14 at the International Association for the Study of Lung Cancer’s World Conference on Lung Cancer in Seoul.”

From the U.S. healthcare business and artificial intelligence front,

  • Modern Healthcare reports.
    • “Molina Healthcare is pulling its all of its Medicare plans from three states for the 2027 plan year, the company notified third-party marketers Friday.
    • “The health insurer announced in February that it would completely exit the national market for individual Medicare Advantage plans to focus on Dual Eligible Special Needs Plans, or D-SNPs, for people who qualify for both Medicare and Medicaid. The company tried to sell the individual Medicare Advantage business but failed to find a buyer.
    • “In Connecticut, Mississippi and Nevada, Molina Healthcare is going a step further by ending individual, D-SNP and other Medicare plan sales, according to the notice.”
  • Beckers Clinical Leadership relates,
    • “Two UC Health emergency departments avoided more than 3,500 unnecessary head and cervical spine CT scans over 23 months with no missed injuries identified, according to a study published in the Western Journal of Emergency Medicine.
    • “The quality improvement campaign ran at University of Cincinnati Medical Center and West Chester Hospital in West Chester Township, Ohio. The campaign paired continuing education on clinical decision rules for head and cervical spine imaging with decision-support software embedded in the EHR, plus quarterly feedback showing physicians how their own ordering compared with peers’. Teams also created patient handouts to reassure those who expected a scan they did not need.
    • “Physician-researchers estimated the effort eliminated 3,542 scans in low-risk trauma patients, avoiding $6.2 million in patient charges at roughly $1,750 per scan and saving 14,168 hours of patient waiting time. The campaign also avoided 6,021.4 millisieverts of radiation exposure — the equivalent of roughly 2,000 years of background radiation for one person.
    • “A safety review identified no patient harm and no missed injuries.” * * *
    • “View the full study here.”
  • Beckers Hospital Review tells us,
    • “Paul Krakovitz, MD, became CEO of Greensboro, N.C.-based Cone Health on March 16, roughly 15 months after the five-hospital system joined Risant Health, the nonprofit created by Oakland, Calif.-based Kaiser Permanente. Dr. Krakovitz previously held leadership roles at Cressey & Company, Intermountain Health and Cleveland Clinic.
    • “Now, Risant is involved in Cone Health’s value-based care work, bringing tools developed through Kaiser Permanente’s experience with the model to the community health system. Risant is also helping fund Cone Health’s $40 million effort to rebuild its Epic platform after years of technical debt limited the system’s ability to adopt newer capabilities.
    • “Dr. Krakovitz discussed with Becker’s the system’s work with Risant, its Epic investment and Cone Health’s efforts to move away from volume and toward more proactive care.
    • “He said Risant has brought additional resources and focus to Cone Health’s value-based care strategy while the health system remains focused on its local community.
    • “The value-based care tools that Risant brings from a national scale is just something that is incredibly unusual to be able to deploy in a community health system, and it’s a huge benefit, both for our clinicians and for our community,” Dr. Krakovitz said.”
  • Beckers Health IT adds,
    • “Techstars and the Mid-Atlantic Permanente Medical Group selected nine startups for a healthcare accelerator focused on emerging technologies and care delivery.
    • “More than 1,200 startups applied for the 2026 Techstars Healthcare Accelerator powered by Permanente Medicine Mid-Atlantic States, according to a Sept. 18 news release.
    • “The three-month program began Sept. 14 and will connect participating companies with Techstars investors and mentors as well as physicians and healthcare leaders from the Mid-Atlantic Permanente Medical Group.”
  • Beckers Hospital Review points out,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • “Here [in the article] are 60 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1, 2026.
  • Fierce Healthcare informs us,
    • “Angle Health raised $600 million in equity financing, reaching a total valuation of $2.7 billion, to continue expanding its artificial intelligence-native healthcare benefits platform for small businesses.
    • “According to the company, the financing includes a $200 million series C funding round and a $400 million tender offer. The startup’s valuation has more than doubled since its December series B round when it raised $134 million, the Wall Street Journal reported. The company raised a $58 million series A round in January 2023.
    • “Vitruvian Partners led the round, with participation from new investor Town Hall Ventures and existing investors Blumberg Capital, Portage Ventures, PruVen Capital and Y Combinator. They expect to close the round later in September.”
  • and
    • “Oura and Counsel Health are teaming up to participate in CMS’ 10-year chronic condition management program, betting that continuous health data from Oura’s smart ring paired with medical AI can help move the needle on conditions like hypertension.
    • “Counsel Health, an AI-native primary care company, plans to participate in CMS’ Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model under the early cardio-kidney-metabolic (eCKM) track, with smart ring maker Oura serving as the preferred wearable partner.
    • “It is an early example of how the CMS chronic care initiative could become a proving ground for AI-powered, wearable-enabled care delivery.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.
    • “The research was published in the Expert Review of Pharmacoeconomics & Outcomes Research.”
  • Fierce Pharma notes,
    • “As expected, the past U.S. Labor Day holiday took a toll on obesity drugs’ prescription numbers. According to IQVIA data cited by Citi, weekly scripts for Novo’s Wegovy pill dropped roughly 12% sequentially to about 161K for the last week. The decline for Foundayo was modest, at just 1%, as the Lilly drug still managed to rake in more than 47K scripts. 
    • “Lilly this week said Foundayo captured more than 30% of new patients in the U.S. market for oral obesity ​treatments, Reuters reported. 
    • “Citing Bloomberg Symphony data, Jefferies analysts suggested in a Friday note that Foundayo’s recent acceleration “has been driven primarily by retail/commercial channels.”
    • “Elsewhere, Lilly’s total Zepbound scripts were down 8.5% week over week, but the GIP/GLP-1 drug expanded its market share by 0.4% versus Novo’s Wegovy franchise, whose scripts decreased 10% during the period.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansion advances the Trump Administration’s Great American Recovery and A Home for Every Child initiatives by equipping states with evidence-based resources to help parents overcome addiction, thereby strengthening families and reducing the number of children entering foster care.
    • “HHS Secretary Robert F. Kennedy Jr., White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Initiative Kathryn Burgum, and ACF Assistant Secretary Alex J. Adams joined Governor Kim Reynolds in Des Moines to make the announcement.
    • “Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump’s Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care.”
    • “Iowa is proud to be first in the nation to adopt new peer-support interventions,” said Iowa Governor Kim Reynolds. “By responding to addiction and supporting struggling families, we’re building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone.”
  • Federal News Network relates,
    • “Kevin Rhodes, the administrator of the Office of Federal Procurement Policy, is leaving federal service.
    • “A person with knowledge of the situation confirmed that Rhodes’s last day will be Sept. 4.
    • “The Senate confirmed Rhodes in October 2025, making him the first permanent OFPP administrator since 2019. He started working at OMB as a senior advisor in February 2025.
    • It’s unclear who will be acting OFPP administrator once he leaves.”
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) said Monday it “welcomes” updated guidance from the U.S. Centers for Medicare and Medicaid Services (CMS) that strengthens federal transparency requirements for prior authorization.
    • “The country’s largest physician organization had documented concerns and recommended specific corrective actions to the agency in May (PDF), following the group’s review of how 15 Medicare Advantage contracts were implementing transparency provisions of the CMS Interoperability and Prior Authorization final rule. 
    • “The 2024 final rule requires payers to publicly post prior authorization requirements and outcomes, with a three-day deadline for urgent requests and a seven-day deadline for standard requests.” * * *
    • “The updated metrics reporting framework (PDF) clarifies that posting required metrics only through password-protected portals or “other locations that cannot be reached through ordinary navigation from the payer’s public-facing website” does not satisfy the rule’s “publicly accessible” requirement.
    • “The agency now also specifies that plans must publicly identify all medical items and services requiring prior authorization and identify omission of entire categories of care from disclosures. Moreover, it clarifies disclosures must be understandable and turnaround-time metrics must include a unit of time.”
  • The American Hospital Association informs us,
    • “The Centers for Medicare & Medicaid Services yesterday announced the launch of QualTech, a new event created to identify innovative technology that improves health outcomes. CMS is seeking participants from U.S-based teams, academic institutions, nonprofit organizations, private sector companies, industry associations and other stakeholders to propose technology solutions in advance of the event. Applicants must align proposal submissions to one of four priority opportunity areas: using artificial intelligence to protect patients and strengthen healthcare quality; leveraging AI to increase annual wellness visits in Medicare; proposing a next-generation digital quality measure calculator; and supporting the development of a national quality hospital dashboard. CMS will select finalists to present at QualTech, which will be held at CMS headquarters, to CMS and Center for Clinical Standards and Quality leadership and other attendees. CMS said it may continue engagement with select organizations following the event, which could include future demonstrations, pilots, collaboration discussions and a potential role in the 2027 CMS Quality Conference. Applications must be uploaded to the QualTech submission link by Sept. 4, 2026.” 
  • Managed Healthcare Executive points out,
    • “CMS implemented MFPs for 10 high-volume Part D drugs in January 2026 after 2024 discount announcements, with projected net savings of ~$6 billion (≈22%) across those products. 
    • “Surveyed beneficiaries reported countervailing cost signals: 46% paid more for at least one negotiated drug, 39% saw premium increases, and coverage changes increased out-of-pocket exposure for 29%. 
    • “Access friction intensified, with 30% reporting 2026 barriers versus 25% in 2025, most commonly prior authorization and drug availability constraints. 
    • “Knowledge gaps were substantial, as ~40% were unaware of the $2,100 out-of-pocket cap or the Medicare Prescription Payment Plan, undermining uptake of IRA cost protections. 
    • “Payer responses appear consistent with broader market behavior, including expanded step therapy, higher premiums, and stronger generic/biosimilar preferencing, particularly affecting diabetes, dermatology, and rheumatology.”

From the U.S. Office of Personnel Management front,

  • Fedweek reports,
    • “OPM has told agencies that they “must verify 100 percent of Open Season elections in which a family member is added” in FEHB/PSHB enrollments for calendar year 2027, sending them a survey for them to verify their readiness to do so.
    • “Enrollment of ineligible persons has been a long-running issue, the subject of congressional oversight and reports from the OPM inspector general and the GAO—most recently, in a GAO report on high-priority recommendations to the agency. The cost of claims from ineligible persons is widely estimated at $1 billion a year, raising premium costs for both enrollees and the government.
    • “In a benefits administration letter dated July 15 but only recently posted, OPM noted scrutiny has been tightened in a series of administrative steps, including in a prior letter requiring at least 10 percent of new family member enrollments and recommending review of all. Language in a broader budget measure enacted last year “codifies and elevates this standard by requiring verification of family member eligibility when an enrollee adds a family member during Open Season,” it said.
  • and
    • “Recently finalized rules requiring that employee performance evaluations fit a mandated pattern will apply to the rating cycle closing next month, OPM has said, a process that will involve “calibration” by senior agency officials that potentially will reduce many of the ratings set by employees’ supervisors.
    • “While a recent memo on carrying out the changes does not specify an implementation schedule, in response to questions from FEDweek, OPM said that what it calls “standardized” rating “applies to both the FY26 and FY27 performance appraisal cycles.”
    • “Agencies must establish a calibration program for the FY26 performance appraisal closeout no later than September 20, 2026 (end of FY26 appraisal cycle). Additionally, agencies must design their new GS performance management systems, and have them approved by OPM, prior to October 1, 2026 (for FY27 implementation),” it said.
    • “Applying a standardized distribution of ratings, and designing and implementing a calibration program, is effective for the closeout of the FY26 cycle,” it said, adding that it “will be publishing FY2026 performance appraisal cycle close-out guidance separately. We expect that guidance to be released in the next few weeks.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “President Donald Trump has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, according to a person familiar with the matter, after a turbulent year at the agency marked by high-profile staff exits and industry complaints.
    • “Overton is a deputy assistant to the president for domestic policy at the White House working on health issues. She previously worked at the think tank America First Policy Institute. Overton is a medical doctor and has a doctorate in clinical investigation from Johns Hopkins University. She was also a White House fellow in the first Trump administration.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial intelligence-enabled medical devices. The paper includes considerations for risk assessment, premarket evaluation, post-market monitoring and other areas. The agency intends to gather early stakeholder input and advance broader discussion on policy frameworks for generative AI. The FDA said comments must be submitted by Oct. 19.”  
  • MedPage Today adds,
  • Per a corporate news release,
    • “LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence.
    • “The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy.” * * *
    • “LEROCHOL autoinjector is expected to be available by January 2027 with a direct-to-patient cash price to match that of the already available pre-filled syringe at $199 per month.
  • BioPharma Dive explains that an “FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax.”
    • “Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.”

From the judicial front,

  • Beckers ASC Review reports,
    • “The American Association of Nurse Anesthesiology said July 21 that a U.S. Court of Appeals for the Sixth Circuit ruling wrongly declined to force HHS to enforce a provider nondiscrimination provision that protects certified registered nurse anesthetists from reduced insurance reimbursement.
    • “The Sixth Circuit based its ruling on associational standing, upholding a lower court’s finding that AANA lacked standing to bring the case. Mr. Molter said AANA is evaluating what the decision means for how trade associations pursue their members’ interests in federal court and is urging other associations to do the same.
    • “AANA President Jeff Molter, MSN,  MBA, CRNA, said the ruling does not endorse insurers’ practice of reimbursing CRNAs less than physician anesthesiologists for the same services. He called the decision procedural and said AANA maintains that such reduced reimbursement remains unlawful and discriminatory under current statute.”
  • The article points out nine other current anesthesia controversies.
  • Bloomberg Law relates,
    • “A federal judge in Massachusetts mostly upheld a 2025 Trump administration rule tightening oversight of Affordable Care Act exchange enrollment, adding to the legal saga dragging on over a 2026 version of the annual rule.
    • “Judge Nathaniel M. Gorton of the US District Court for the District of Massachusetts on Friday granted summary judgment for the administration in regard to provisions reducing the grace period for premium tax credit recipients to reconcile their income from two years to one year, shortening states’ open enrollment periods, increasing insurers’ flexibility to decrease the value of their plans, and changing the methodology for calculating cost-sharing amounts.
    • “But Gorton sided with the states in determining the administration did not follow the law in excluding certain “sex-trait modification procedures” from the ACA’s essential health benefits, noting that the government refused to issue a mandated report to Congress certifying that the provisions were aligned with a “typical employer plan.”
    • “When asked about the issue at oral argument, the government maintained its position that the Agency is not required to submit such a report, notwithstanding the Court’s clear ruling that it was required to do so,” he wrote in his opinion.” * * *
    • “Gorton’s opinion conflicts with the Maryland court, which rejected CMS’s ability to limit enrollment periods and increase flexibility for insurers to vary the value of their plans.
    • “CMS finalized several of the same provisions in its 2026 rule, prompting Democratic cities and states to sue again. The rule is now mostly frozen by the Maryland court.
    • “The case is California v. Kennedy , D. Mass., No. 1:25-cv-12019, opinion filed 8/14/26.”
  • The AP informs us,
    • “Luigi Mangione’s state murder trial in the killing of UnitedHealthcare CEO Brian Thompson, which was slated to begin Sept. 8, has been postponed indefinitely as his lawyers seek to have the case thrown out on double jeopardy grounds following his guilty plea last week to federal charges.
    • “Judge Gregory Carro issued an order Monday canceling the trial and giving the Manhattan District Attorney’s office, which is prosecuting the state case, until Oct. 9 to respond to the defense’s double jeopardy claims. A hearing will be held on Dec. 10, Carro said, about a week before Mangione is scheduled to be sentenced in the federal case.”

From the public health and medical / Rx research front,

  • The New York Times lets us know,
    • “What the Newest Research on Wildfire Smoke Tells Us
      • “Scientists have found that people are being exposed to more toxins than previously known.”
  • Cardiovascular Business adds,
    • “Long-term exposure to air pollution is associated with more advanced coronary atherosclerosis, including greater plaque burden and obstructive coronary artery disease, according to a large cardiac CT study published in Radiology.[1]
    • “Researchers led by Kate Hanneman, MD, MPH, associate professor and vice chair of research in the department of medical imaging at the University of Toronto, analyzed cardiac CT data from 11,128 adults who underwent clinical scans at three Toronto hospitals between 2012 and 2023. The study linked patients’ residential postal codes with air-quality data to estimate their average exposure to pollution during the 10 years before their CT examinations.
    • “What we found is that higher air pollution exposure, both gaseous and particulate, was associated with higher coronary calcium scores, higher plaque burden, and obstructive coronary disease in unadjusted models,” Hanneman explained a video interview with Cardiovascular Business at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting. “When we adjusted for age, sex, and traditional cardiovascular risk factors, we found that in women, higher air pollution was also associated with obstructive disease, even in these multi-variable models. So this really builds on the existing literature that tells us that higher air pollution is not good for us and it’s not good for our heart.”
  • Genetic Engineering and Biotechnology News reports,
    • “Mass General Brigham Cancer Institute researchers found that consuming one or more sugar-sweetened beverages every day was associated with an increased risk of developing gastric cancer, while artificially sweetened beverages were not associated with an increased risk. Results from the study were published in Gastro Hep Advances, in an article titled “Association between sugar-sweetened and artificially sweetened beverage intake and gastric cancer incidence.”
    • “Previous research has linked sugar-sweetened beverages with an increased risk of colorectal, breast, and liver cancers, but evidence on gastric cancer has been limited. The study analyzed data from 112,284 participants in the Nurses’ Health Study and Health Professionals Follow-Up Study. Both studies gathered detailed diet, lifestyle, and health information on U.S. adults over many decades. During the follow-up period, which spanned decades, 278 participants developed gastric cancer.
  • MedPage Today adds,
    • “A group of physicians and scientists are calling on the National Collegiate Athletic Association (NCAA) to make changes to its massive collaboration between Big 12 athletics and Monster Energy, citing potential health risks and teen deaths associated with energy-drink consumption.
    • “As part of the partnership announced last month, Big 12 football and basketball athletes will don Monster Energy-branded jerseys during the regular seasons, and the fields and courts where teams play will display the popular energy drink’s logo.
    • “Virginia-based ophthalmologist David Jacobs, MD, noticed the prominent branding of the energy drink when he went to visit his kid’s Big 12 school, and later became concerned about how the campaign could influence children.
    • “Jacobs is an alum of a Big 12 school, as is his friend, Idaho-based cardiologist Matthew Nelson, MD. The two began reaching out to other cardiologists and created the Protect Young Fansopens in a new tab or window public health initiative, which, as of press time, has gathered over 250 signatures on their petitionopens in a new tab or window asking the NCAA to end the Monster Energy partnership.
    • “We’re concerned about an increase in energy drink consumption among children and youth,” Jacobs told MedPage Today. He noted that with high-profile Big 12 sports in particular, impressionable kids will be looking up to and copying their sports idols.
    • “Their concerns are not abstract, according to an email to NCAA leadership from Jacobs, Nelson, and other physicians and scientists that was shared with MedPage Today.”
  • The American Hospital Association News relates,
    • “For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year, according to data released yesterday by the Centers for Disease Control and Prevention. Exemptions rose in 41 states and Washington, D.C. Vaccination coverage declined for all reported vaccines from the previous year. Coverage with the measles, mumps and rubella, or MMR; diphtheria, tetanus, and acellular pertussis, or DTaP; polio and varicella vaccines decreased in more than half of states. The CDC said there were approximately 280,000 kindergartners that attended school in 2025-2026 without documentation of completing the two-dose MMR vaccine.” 
  • MedPage Today adds,
    • :The hepatitis A vaccine is recommended for high-risk children and adults, while the hepatitis B vaccine is recommended for all adults under 60 years.
    • “In this study, researchers estimated that 40% of U.S. adults had immunity to hepatitis A and 27% were immune to hepatitis B virus.
    • “Levels of immunity against hepatitis A and hepatitis B viruses were “suboptimal” and persisted across high-risk groups, according to the researchers.”
  • and
    • “Despite routine rotavirus vaccination in over 140 countries, the virus still causes an estimated 25% of diarrhea deaths in children younger than 5 years.
    • “In a retrospective study of children ages 3 months to 4 years, receiving at least one dose of a rotavirus vaccine was 75.8% effective at preventing rotavirus-positive acute gastroenteritis death.
    • “Rotavirus vaccination was less effective against all-cause acute gastroenteritis mortality, at 20.8%.”
  • Beckers Clincal Leadership tells us,
    • “Blacklegged ticks carrying Lyme disease have expanded into the mountains of western North Carolina, far south of the disease’s traditional Northeast and Upper Midwest range, according to an Aug. 13 CDC report.
    • “Researchers surveilling 22 residential properties in Biltmore Forest, N.C., near Asheville, collected 373 ticks from November 2024 through August 2025, according to the CDC’s “Morbidity and Mortality Weekly Report.” Blacklegged ticks — the primary Lyme vector — made up 287, or 76.9%, of them.
    • “Nearly 40% of the adult blacklegged ticks, or 19 of 48 specimens, tested positive for Borrelia burgdorferi, the bacterium that causes Lyme disease. Three of seven nymphs also carried it.
    • “Nineteen residents across 17 households reported at least one tick-borne illness while living in the town, the CDC report said. Lyme disease was the most common, with 17 cases, followed by two cases of babesiosis and one of ehrlichiosis.
    • “The findings point to an emerging clinical blind spot. Many clinicians across the South have little experience diagnosing or managing tick-borne disease, the report’s authors said, and may not consider Lyme in patients with no travel history to endemic regions.”
  • Beckers Hospital Review informs us,
    • “Nearly every U.S. hospital screens patients for sepsis, but far fewer have dedicated personnel to ensure screening is successful, the CDC found. Moreover, separate research links a lack of specific accountability to higher mortality.
    • “In its latest annual survey of hospital sepsis programs, covering 2025, the CDC found that 93% of 5,430 hospitals have a standard process to screen for sepsis and 87% use order sets tailored to their patients. But only 36% employ a sepsis coordinator to oversee day-to-day operations, and 32% have support from staff with expertise in data, analytics and information technology.
    • “When it comes to reporting, 31% of hospitals share sepsis data with nursing, physician, unit and hospital leadership at routine intervals. At the remaining two-thirds of U.S. hospitals, that data does not reach leaders on a regular basis.
    • “Sepsis accounts for about 1.7 million adult hospitalizations per year, 350,000 of which end in death or discharge to hospice — more than a third of all hospital deaths, according to the CDC.”
  • The American Medical Association lets us know “this superbug’s toll exceeds 3,400. How to protect your loved ones.”
    • “The Candida auris fungus is spreading. Here’s what to know about the superbug, who’s most at risk, symptoms and what your next steps should be.”
  • Health Day points out,
    • “Many smokers still haven’t absorbed the fact that smoking and secondhand smoke cause heart attacks and strokes, despite decades of messaging around tobacco’s health risks, a new study says.
    • “More than 90% know that smoking causes lung cancer, but fewer know about its links to other fatal conditions, researchers report in the journal BMJ Open.
    • “Only about 80% knew smoking contributes to heart disease and heart attacks, and 70% are aware it causes strokes, researchers found.
    • “In fact, across two decades they found almost no progress in knowledge of the health risks associated with smoking.
    • “Knowledge gaps about the major health effects of smoking and secondhand smoke are deeply concerning,” said lead researcher Janet Chung-Hall, a research scientist for the International Tobacco Control Policy Evaluation Project at the University of Waterloo in Canada.”
  • and
    • “There’s been a nearly 400% increase in calls to U.S. poison centers related to liver injuries, mostly related to Tylenol and other medications, a new study says.
    • “Liver injuries caused by foreign substances skyrocketed from an estimated 11 cases per million people to nearly 53 cases per million between 2000 and 2024, researchers reported Aug. 13 in the journal Clinical Gastroenterology and Hepatology.
    • :Medications accounted for most of these liver injuries, including 85% of cases among men and 94% of cases among women, researchers found.
    • “Acetaminophen (Tylenol) was the drug most frequently implicated in liver injuries reported to poison centers, researchers said. About 33% of men and 45% of women reported injuries due solely to Tylenol.”
    • “Liver injuries reported to poison centers have increased substantially over the past 25 years, with acetaminophen emerging as a growing contributor,” researcher Dr. Christopher Holstege, director of the University of Virginia Health’s Blue Ridge Poison Center, said in a news release.”
  • Per BioPharma Dive,
    • A once high-flying Boston-area drug company mounted somewhat of a comeback Tuesday, reporting positive results from a clinical trial testing a potentially first-of-its-kind treatment for the dangerously low blood sugar levels some patients experience after bariatric surgery.
    • Amylyx Pharmaceuticals said its medicine, known as avexitide, hit the main goal of the late-stage study by spurring a 55% reduction in serious to severe hypoglycemic events compared to a placebo. Such events starve the brain of the sugar it needs for fuel, leading to confusion, dizziness, slurred speech and loss of coordination. In more dire cases, patients can faint, have seizures or become comatose.
    • “According to Amylyx, its medicine also appeared safe. Researchers classified a majority of the adverse events seen in the trial as mild or moderate, with the most common being diarrhea and bruising or redness at the injection site. Amylyx now plans to, before the end of the year, formally ask the Food and Drug Administration to approve avexitide.”

From the U.S. healthcare business and artificial intelligence front,

  • Healthcare Dive reports,
    • “CVS has added Teresa Heitsenrether, JPMorgan Chase’s chief data and analytics officer, to its board of directors as the healthcare behemoth continues to progress on its financial turnaround.
    • “Heitsenrether has spent four decades in financial services, according to Monday press release announcing her appointment. She’ll be joining CVS effective Nov. 18.
    • “CVS also said that Larry Robbins, who served on the board’s audit and public policy and external affairs committees, left earlier this month. Robbins, the CEO of Glenview Capital Management, joined the board in 2024 after the hedge fund pushed for changes at CVS.”
    • “As the leader of JPMorgan’s data and analytics, Heitsenrether sets strategy and governance standards, while driving the bank’s adoption of artificial intelligence.”
  • Beckers Payer Issues relates,
    • “UnitedHealthcare expanded its child and family behavioral coaching program, giving approximately 13 million eligible commercial members access to behavioral health support. 
    • “The 2026 expansion adds access for an additional 5 million members at no added cost for employers with fully insured plans. More than 500 employers now offer the program, according to an Aug. 18 news release from the company. 
    • “The program addresses mild to moderate anxiety, attention-deficit/hyperactivity disorder, bullying, depression and sleep difficulties, with participants being 12 years old on average. It offers up to four virtual coaching sessions per month, appointments within 48 hours, unlimited secure messaging and educational resources, and access to health and wellness coaches. Members can also be referred to licensed clinicians when higher-level care is needed.”
  • and 
    • “Blue Cross Blue Shield of Tennessee has the highest-ranked Medicare Advantage plan for member satisfaction in 2026, according to JD Power’s 12th annual Medicare Advantage study.
    • “The consumer insight firm published its annual ranking of the top MA plans in 12 markets on Aug. 18 after surveying more than 14,500 enrollees and evaluating plans on eight factors, including level of trust, ability to get health services when and how members want, helping save time or money, product and coverage offerings, ease of doing business, customer service representatives, problem resolution and digital channels.
    • “The average member satisfaction rating for MA plans this year is 611 on a 1,000-point scale, down 12 points from 2025 and down 41 points from 2024, marking a second consecutive year of decline.
    • “Satisfaction dropped across all dimensions of the member experience, with the largest two-year declines in areas tied to helping members save time and money, level of trust and whether coverage offerings met member needs. Fewer than half of plan members said they strongly agreed their plan is a trusted partner in their health and wellness. High-performing plans distinguished themselves through stronger new-member onboarding and communication, while special needs plans delivered significantly higher satisfaction and trust scores overall.”
  • Fierce Healthcare tells us,
    • “While operating margins trended upward in June, hospitals’ overall performance still lags 2025 and is seeing “intensifying” uncompensated care pressures and faster-than-inflation expense growth, according to the latest monthly benchmarks from Kaufman Hall. 
    • “The healthcare advisory firm reported a calendar year-to-date operating margin index of 2.5% and a single-month operating margin index of 4.5% (both including health system allocations for the cost of shared services). The former is a 6% lag compared to the first half of 2025, while the latter reflects a 6% bump over this May’s median operating margin.
    • “Echoing commentary from some of its preceding reports this year, Kaufman Hall’s primary red flag was a 2% month-over-month increase in daily bad debt and charity logged by hospitals, which year-to-date is 17% higher than the same cutoff in 2025. As a percentage of hospitals’ gross operating revenue, year to date, uncompensated care is 8% higher than 2025.” 
  • STAT News adds,
    • “For Bon Secours Mercy Health, Ensemble Health Partners is the gift that keeps on giving. 
    • “Seven years after the nonprofit health system sold stakes in its in-house billing and collections company to private equity investors, it still rakes in eye-popping amounts of cash from its minority position, with payments topping $1 billion so far this year.
    • “About two weeks ago, the Cincinnati-based system said it got a hefty $671 million payment from Ensemble Health Partners when the company signed a new private equity sponsor. That’s on top of a $427 million distribution Bon Secours Mercy recorded in February. Both payments were reported on the nonprofit system’s financial report for the second quarter, which ended June 30. 
    • “The $1.1 billion Bon Secours Mercy received from its 41% stake in Ensemble across the two payments far exceeds the system’s operating income in the first half of the year, which was $225 million. The health system generated $7.5 billion in revenue in the first six months of 2026, compared with $6.9 billion in the first half of 2025.” 
  • Beckers Hospital Review adds
    • “After years of high length-of-stay averages, hospitals are reporting significant length-of-stay reductions.”
      ,
  • Beckers Payer Issues notes,
    • “Montgomery, Ala.-based Jackson Hospital has filed to exit bankruptcy and signed a four-year deal with Blue Cross Blue Shield of Alabama, John Quinlivan, CEO of Jackson Hospital, said during an Aug. 17 news conference. 
    • “The BCBS agreement will become active once the exit is complete.
    • “The agreement does not give us everything we felt we needed, but combined with the continued support of Blue Cross Blue Shield of Alabama, Jackson Investment Group, the City of Montgomery, Montgomery County and the State of Alabama, it enables us to execute our strategic plan,” Mr. Quinlivan said. “We will enhance operational discipline, improve quality, expand services and add new services as we grow and innovate to better serve Montgomery and the Central Alabama region.”
  • Per Beckers Physician Leadership,
    • “Corporate entities now employ 82% of U.S. physicians, and about nine out of 10 physicians in employed settings are reporting symptoms of burnout, according to a new survey.
    • “The Physicians Advocacy Institute and Healthsperien’s Center for Health Research, Policy & Strategy surveyed more than 1,000 hospital- and corporate-employed physicians and found widespread burnout, administrative burdens and pressure to put corporate interests ahead of patient care.”
  • Per Fierce Healthcare,
    • “Four health systems are now using real-time prior authorization checks embedded in the Epic electronic health record, tackling a major pain point for providers.
    • “The electronic health record giant collaborated with insurers UnitedHealthcare, Network Health and Aetna to set up the electronic workflows to modernize the manual and time-consuming prior auth process.
    • “Epic launched real-time insurance reviews directly into EHR workflows using an industry-standard application programming interface (API) called Coverage Requirements Discovery (CRD). Epic is testing the API with 16 additional payers to support wider industry adoption, the company announced Monday as its annual Users Group Meeting kicks off in Verona, Wisconsin.”

Pre-holiday weekend report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

Note — The FEHBlog will be writing his weekly cybersecurity report tomorrow and will resume regular FEHBlog posts on Sunday July 5. Happy Independence Day! We are so blessed to be Americans.

From Washington, DC,

  • Roll Call reports,
    • “As America gets ready to celebrate its 250th birthday, Congress is taking a road trip back to the place where it all began — Independence Hall in Philadelphia. 
    • “Led by Pennsylvania Democratic Rep. Brendan F. Boyle, members will gather for a ceremonial event Thursday in his hometown, an effort Boyle said was two years in the making. 
    • “This is going to be truly one of the highlights of my tenure in Congress, to be sitting there where our Founding Fathers sat exactly 250 years prior, to the exact day,” Boyle said, adding he hoped it could be a rare “unifying moment.” 
    • “While July 4 gets most of the fanfare, Boyle said its lesser-known neighbor, July 2, deserves more attention as the day the Second Continental Congress voted to declare independence from Great Britain in 1776. 
    • “It was always the date that John Adams thought would be celebrated as America’s birthday. Unfortunately, this was another instance in which Adams lost to [Thomas] Jefferson — because Americans came to, of course, celebrate two days later the Fourth of July, which is the date Congress adopted the Declaration of Independence,” he said.” 
  • OPM Director Scott Kupor added a third post (OPM.gov link) to his Secrets of OPM blog this week. In this post, Director Kupor commemorates the new paperless federal retirement system by spurning the altar of Michael Scott, the fictious paper czar of Scranton, PA.
  • Healthcare Dive reports,
    • “The CMS proposed a rule on Thursday that would slash Medicare payment rates for a program [known as 340B] that hospitals use to buy discounted drugs and implement site-neutral payments for some imaging services next year.
    • Reforming the 340B drug discount program and better equalizing payments between sites of care have been priorities in the second Trump administration. Thursday’s proposed rule builds upon those agendas, including by expanding the services subject to site-neutral payments and more aggressively tamping down on discounts given to hospitals in the 340B drug program, which regulators previously tried to overhaul before dialing down their efforts in the face of opposition from the industry.
    • Medicare officials said the proposed rule would control costs and ensure Medicare money is directed toward “clinically appropriate” care. * * *
    • “The 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center rule proposes to increase pay for outpatient care by 2.4%, slightly less generous than the 2.6% rate update finalized last year.
    • “The rule would request information from stakeholders about how hospitals post publicly available price data, an ongoing priority for the Trump administration. Additionally, if finalized, the rule would allow certain accrediting organizations to assess hospitals on their compliance with laws regarding emergency care.”
  • The American Hospital Association News tells us,
    • “The House Education and Workforce Subcommittee on Health, Employment, Labor and Pensions July 1 examined whether direct health care contracts between employers and providers could help address rising health care costs. During the hearing, lawmakers from both parties expressed interest in arrangements that bypass traditional insurers, with supporters citing lower costs, reduced administrative burdens and improved access to care. Witnesses highlighted advantages such as simplified billing, price transparency and direct primary care services, while lawmakers also discussed the need for greater insurer transparency and access to health plan data. The committee did not signal specific legislative proposals following the hearing.”
  • and
    • “The Trusted Exchange Framework and Common Agreement Recognized Coordinating Entity published updated standard operating procedures for the individual access services exchange protocol and new FAQs. The revised SOP removed references to “TEFCA IAS Consent” workflows and associated patient matching methodologies, retaining the ability for providers to verify requests for access and use of data. Updates were made based on recommendations that the AHA and other stakeholders provided to SOP proposals. The SOP will be effective Aug. 3, 2026.”

No Surprises Act news

  • Federal Hearings and Appeals Services, which is certified IDR entity, tells us about
    • “The Cooling Off Period: What Providers and Health Plans Need to Know
      • “What is actually changing with the cooling off period under the final rule for the federal IDR program? To help clarify both the ongoing rules, the coming changes, and their timing, FHAS is offering two new tools to support parties.
        • “First, a new guide to the cooling off period explains which claims are subject to the cooling off period, how long it lasts, what will change under the final rule, and when those changes are coming.
        • “Second, FHAS has launched a new Cooling-Off Calculator which parties can use today to determine cooling off period dates and new dispute initiation timeframes. FHAS can help your team understand, anticipate, and implement changes directed by the final rule.”

From the judicial front,

  • Healthcare Dive reports,
    • “Elevance is suing the CMS after the agency recalculated the Medicare Advantage star ratings of a competitor in a more favorable way than it did for other plans.
    • “After losing a lawsuit earlier this year, the CMS reran 2026 quality scores for Clover Health, dropping 20 measures that a judge ruled could not be factored in. Regulators then recalculated stars for other MA insurers last month, but cut out extra measures, too — measures that Elevance performed well on, the insurer argued in its complaint filed Wednesday in Georgia district court.
    • “Elevance says it lost out on $115 million in bonus payments as a result. The company is asking the court to force CMS to redo its own ratings using the same methodology as for Clover.”
  • STAT News relates,
    • “In a victory for the pharmaceutical industry, a federal judge blocked a Colorado state panel from placing a cap on the price of a blockbuster drug sold by Amgen after deciding the company is “likely to be significantly harmed.”
    • “The ruling pauses a controversial, first-in-the-nation move by the Colorado Prescription Drug Affordability Board, which was created four years ago in response to the rising cost of prescription medicines and is permitted to set upper payment limits on what most state residents will pay for selected drugs.” * * *
    • “Last October, the board then voted to limit what health plans in the state will pay for the drug. The board capped Enbrel prices at $600 for a ​50-milligram weekly dose, or $30,350 a year per person, effective on January 1, 2027. That compared with roughly $53,000 that the average plan in the state paid in 2023, according to a state claims database.
    • “The drugmaker then quickly filed a second lawsuit, reiterating its earlier arguments. Meanwhile, the company had until July 5 to decide whether to continue selling the treatment, which has a list price exceeding $100,000 a year and generated $2.23 billion in sales last year, in Colorado.
    • “But Judge Daniel Domenico of the U.S. District Court in Denver agreed with the company. In his ruling, which was issued on Wednesday, he noted that the state has a ​legitimate interest in helping patients afford Enbrel, but “capping the price of a patented drug” is not an ​option.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The U.S. overall death rate in 2025 fell to its lowest point on record, even as influenza and pneumonia are now among the nation’s top 10 causes of death for the first time in years, according to new data from the Centers for Disease Control and Prevention.
    • “The death rate fell 4.6% last year, to 689.2 deaths per 100,000 people, down from 722.1 in 2024, according to the CDC’s National Center for Health Statistics. The death rate declined across every age group and nearly every demographic group tracked in the provisional report.
    • “The main driver of the record low was a continued drop in drug overdose deaths, said Farida Ahmad, a health scientist at the CDC and one of the report’s co-authors. Another factor, she added, was that Covid-19 no longer contributed to as many deaths.
    • “Against that backdrop, influenza and pneumonia stood out—moving from 11th to eighth place in all age groups—with 56,511 deaths in 2025 compared with 48,139 in 2024. It is the first time the influenza category has cracked the top 10 since 2020.”
  • AAMC relates,
    • “Patients arrive in the emergency department (ED) doubled over in pain and retching uncontrollably, a brew of symptoms physicians have nicknamed “scromiting” — a combination of screaming and vomiting. The problem: an underrecognized consequence of cannabis use called cannabinoid hyperemesis syndrome (CHS), and emergency medicine physicians say few conditions leave patients more obviously miserable.
    • “My heart breaks for them,” says Kathleen Clem, MD, an emergency medicine physician at Dartmouth Health in Lebanon, New Hampshire, and interim associate dean for faculty affairs at the Geisel School of Medicine at Dartmouth. “They come in because they absolutely cannot keep anything down. They’re dehydrated and their belly is sore from vomiting so much. Sometimes they vomit so much, they’ll break little blood vessels in their esophagus, and little bits of blood come up with that.”
    • “The leading cause of marijuana-related ED visits, CHS is associated with the chronic and long-term use of marijuana products, and it is becoming more prevalent, likely due to the increased legalization of marijuana. Some 24 states have legalized recreational marijuana use since 2012, and 40 states allow its use as a medicinal treatment. An additional eight states allow “limited-access” medical cannabis, which refers to low-THC (tetrahydrocannabinol) products and CBD (cannabinoid) oil.
    • “In the United States, cannabis use has nearly doubled in the past decade, with 22.3% of individuals 12 years and older — 64.2 million people — reporting its use in the past year, up from 12.6% in 2013, according to data from the Substance Abuse and Mental Health Services Administration. And research shows a 15-fold increase in the number of people reporting daily or near daily cannabis use from 1992 to 2022.”
  • The Today Show adds,
    • “Cyclosporiasis, a nasty parasitic infection that causes “explosive” watery diarrhea, has sickened dozens of people in Michigan and other parts of the United States.
    • “Cases of the gastrointestinal illness, caused by a parasite that spreads through contaminated food, have been on the rise in multiple states since May, according to the U.S. Centers for Disease Control and Prevention. At least 20 people have been hospitalized nationwide so far. 
    • “The CDC is working to identify potential sources of the parasitic infection, which is commonly linked to fresh produce.” * * *
    • “The U.S. typically sees several hundred cases of cyclosporiasis annually. In recent years, the number of infections reported in the U.S. has increased significantly.” * * *
    • “The best way to prevent infection is to avoid consuming food or water that may be contaminated with feces, the CDC says. Following proper hand hygiene and safe food handling practices can also lower your risk of foodborne illness.”
  • The New York Times points out,
    • Habitual users of fentanyl have developed such a strong tolerance to the drug that standard doses of medications to manage withdrawal and initiate recovery are no longer working for many patients, a team of researchers in Los Angeles has found.
    • Their study, published in the journal Drug and Alcohol Dependence, presents a picture of the dangerous volatility of the city’s street supply and the capacity of users to tolerate ever greater amounts of pure fentanyl, which is at least 50 times more potent than heroin.
    • “In a summary of the findings, Morgan Godvin, one of the lead authors of the study and a health services researcher at the University of California, Los Angeles, said that a seasoned user’s daily street dose of fentanyl was roughly equivalent to 1,250 hospital doses of 100 micrograms of fentanyl given during and after surgery.
    • “In any other context, that would be unsurvivable,” she wrote. “Among people who use fentanyl every day, it is routine.”
    • “The study reinforces the belief among many addiction experts that, for high-tolerance patients, the standard treatment regimens for opioid addiction have become outdated. Doses of medications such as buprenorphine and methadone, opioids that help satisfy cravings without inducing a high, were calculated to treat addictions to heroin and prescription painkillers. The results of the new research, experts said, support a growing call by clinicians for treatment guidelines to be revised to keep pace with the convulsive drug market.”
  • MedPage Today tells us,
    • “A global study showed that body mass index-associated gaps in blood pressure and cholesterol have diminished from 1990 to 2024.
    • “With more medications being used, older people with obesity were metabolically similar to, and in some countries even lower risk than, people with a normal BMI.
    • “Young adults with obesity remain metabolically higher risk, however, and should be a focus of prevention and treatment, some say.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For nearly half a century, scientists have known that malaria parasites force their way into human red blood cells (RBCs) through a ring-shaped structure called the moving junction (MJ). What no one could work out was what it actually does. The structure assembles, does its job, and dissipates in the space of 60 seconds—gone before anyone can get a close look.
    • “A team at Columbia University has now finally caught the moving junction in the act. By freezing parasites at the onset of invasion and lifting the intact complex straight out of the cell, the researchers obtained the first high-resolution view of its three-dimensional structure. What they saw overturned a decades-old assumption about how the parasite gets in. Rather than a passive doorway, the moving junction turns out to be a molecular machine that actively remodels the host cell’s membrane to help the parasite force its way inside.
    • “The findings detail how the team obtained the structure and then used it as a blueprint to design a mini-protein, from scratch, that blocks invasion—a proof of concept for a new kind of antimalarial drug.”
  • The Washington Post lets us know,
    • “When it comes to dementia risk, certain factors, such as genetics, are out of your control. However, plenty of research suggests lifestyle behaviors— things you can change — may help improve your chances of staying sharp as you age. In a new study, people with an elevated risk of dementia were less likely to develop the condition if they followed a healthy dietary pattern, particularly a less inflammatory one.”
  • Per BioPharma Dive,
    • “Roche’s experimental medicine divarasib helped patients with a certain type of lung cancer live longer than two approved treatments in a new study.
    • “The Phase 3 trial compared divarasib with Amgen’s Lumakra and Bristol Myers Squibb’s Krazati in patients with KRAS G12C non-small cell lung cancer who had already received previous treatment. Researchers found significant improvements in both overall survival and progression-free survival for the group taking divarasib, Roche said Thursday.
    • “Roche did not release detailed data, saying the results would be presented at an upcoming medical meeting. There were no new safety findings of concern and most treatment-related side effects were “manageable and reversible,” the company said.”

From the U.S. healthcare business front,

  • Healthexec reports,
    • With Election Day only four months away, healthcare is again emerging as a major source of idealistic campaign promises. Many of these are driven by widespread public angst. What sorts of changes can U.S. healthcare stakeholders realistically expect once the results are in? 
    • “Professional prognosticators at the global accounting and consulting firm PricewaterhouseCoopers, aka PwC, have considered the policy possibilities and are sharing their thinking in writing. * * * PwC offers forward-looking insights and advice for organizations across healthcare’s four major subsectors. 
      • “PROVIDERS: Policy drivers are reshaping delivery and access. 
        Healthcare providers will do well to “examine their care delivery footprints, leverage automation and technology to reimagine the workforce and operations in order to mitigate economic strain,” PwC comments. 
        ‘This should include identifying opportunities to diversify revenue sources, partnerships or M&A with other stakeholders, and prioritizing investment in new technology to reduce impacts of the increase in uncompensated care and workforce constraints.’
      • “PAYERS: Policy drivers are reshaping cost structures. 
        “Healthcare payers will likely need to strengthen care management capabilities as they expand their holistic support to members, the analysts forecast. 
        ‘This will include, in the future, leveraging sophisticated data models and interactive real-time communications to understand and influence member behavior patterns, accelerate paths to appropriate cost-effective care, and drive financial savings for members and plans.’
      • “PHARMA: Policy drivers are reshaping pipeline decisions, regulatory strategy and market access. 
        “In the future, pharmaceutical manufacturers, propelled by accelerating science and shifting patient expectations, “should expand from drug manufacturers to ‘lifespan partners,’ requiring more agile operating models and greater collaboration across technology, and ecosystem players,” the authors write.  
        ‘In the interim, pharmaceutical manufacturers can embrace innovative approaches to access, affordability and evidence generation to meet the needs of today’s consumer and keep pace with pipeline and pricing pressures.’
      • “MEDTECH: Policy drivers are reducing federal oversight of AI-powered and wellness devices. 
        “Going forward, the subsector is expected to become a broader ecosystem player, building interoperable, intelligent systems that connect care across hospitals and the home, PwC remarks. 
        ‘MedTech should strengthen capabilities for post market surveillance as FDA shifts oversight focus from a premarket review paradigm to an emphasis on performance and safety once on the market, particularly for low risk, consumer devices.’
  • Cardiovascular News relates,
    • “The American College of Cardiology (ACC) reached a major milestone this summer; its highest honor, the HeartCARE Center National Distinction of Excellence, has officially been awarded to 100 U.S. hospitals [all of which are listed in the article]. 
    • “The ACC established the HeartCARE Center designation in 2018 to celebrate hospitals and health systems that “demonstrate ongoing excellence through comprehensive accreditation, data-driven performance measurement and continuous quality improvement initiatives.” Recipients must be “forward-thinking organizations” that participate in ACC Accreditation Services programs, NCDR registries and other quality improvement campaigns focused on cardiovascular health.
    • “Reaching 100 hospitals recognized as ACC HeartCARE Centers marks an important milestone in our ongoing effort to elevate the standard of cardiovascular care,” Steven B. Deitelzweig, MD, chair of the ACC Accreditation Oversight Committee, said in a statement. “Each of these institutions has demonstrated a deep commitment to evidence-based care, continuous quality improvement and measurable outcomes—ensuring that patients receive the highest level of cardiovascular care, no matter where they live.”
  • Beckers Hospital News tells us,
    • “The Kroger Co. will acquire supermarket chain Giant Eagle, Inc. for $1.65 billion, expanding its pharmacy footprint across northern Ohio, western Pennsylvania, West Virginia, Maryland and Indiana.
    • “Giant Eagle operates 11 standalone pharmacies, according to a July 1 news release. Kroger said the acquisition will strengthen its presence in adjacent markets and build on Giant Eagle’s pharmacy business, loyalty program and private label portfolio. 
    • “The deal adds to Kroger’s pharmacy footprint at a time when retail pharmacy access is contracting elsewhere in the industry, with Walgreens restructuring into five standalone companies following multibillion-dollar operating losses and Rite Aid’s footprint largely gone — a gap health systems have increasingly stepped in to fill by opening their own pharmacies.” 
  • MedTech Dive informs us,
    • “Guardant Health said Wednesday its Shield test for colorectal cancer is now covered by UnitedHealth, the first major private U.S. health insurer to reimburse for the screening.
    • “The decision by UnitedHealth, the largest private U.S. health insurer, expands access to the screening to about 100 million Americans, the company said.
    • “Canaccord Genuity analyst Kyle Mikson, in a note to clients, called the coverage decision a “watershed moment” for liquid biopsy-based cancer screening and for the category of blood-based cancer testing.”

Monday report

David Ermer–Agentic & Generative AI, CDC, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The solstice this weekend marked the start of astronomical summer — and in Washington, D.C., that means the legislative clock is ticking.
    • “Lawmakers are eager to head home and campaign on a housing bill that’s nearing passage, but progress on several other issues has stalled, and it’s unclear whether a visit from President Donald Trump will break the logjam or cause further obstruction.”
  • Congress.gov finally has updated this week’s Committee hearings list. No hearings were held today. Of note,
    • Senate Committee on Homeland Security and Governmental Affairs
    • Wednesday, June 24, 2026
    • 9:30 AM (EDT) – Senate | 342 Dirksen Senate Office Building, Washington, D.C.
    • Open Hearing: Hearings to examine reforming the U.S. Postal Service’s business model.
    • Meeting Details
  • Federal News Network tells us,
    • “The Federal Regulatory Council is giving the federal community one more chance to speak up before the first set of major revisions to acquisition regulations becomes final.
    • “In Tuesday’s Federal Register, the FAR Council will release the first tranche of proposed rules for 17 sections of the FAR.
    • “Industry and government have largely seen these changes in the deviations, but there are additional differences or changes from what we have in deviations,” said an OMB official, who requested anonymity in order to discuss the proposed rules. “The general premise for each of the rules should already be familiar to most people. This is now to tell us where we missed something or how to refine a particular area.”
  • Kevin Moss, writing in Federal News Network, points out,
    • “Benjamin Franklin famously wrote, “In this world nothing can be said to be certain, except death and taxes.” If Flexible Spending Accounts had existed in his time, he might have added one more certainty: If you use an FSA, you’ll save money on your healthcare expenses.
    • “Yet despite rising healthcare costs and tighter budgets, most federal employees are leaving this guaranteed savings opportunity on the table. In fact, only one in five participate in the FSA program, meaning most employees are paying more than they need to.
    • “The good news? FSAs aren’t complicated, and you don’t have to be a benefits expert to take advantage of them.
    • “In this article, we’ll break down how they work, share a simple strategy to help you use one successfully (even if it’s your first time), and show why this is one of the easiest ways federal employees can immediately reduce their out-of-pocket healthcare costs.”
  • The FEHBlog heartily agrees with Mr. Moss.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a coordinated department-wide effort [PDF, 2.10 MB]* to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.
    • “For decades, randomized clinical trials have served as the gold standard for evaluating the safety and effectiveness of new medical treatments. Yet in recent years, a growing share of early-stage clinical research has moved overseas, threatening America’s position as the global leader in biomedical innovation. Under President Trump’s leadership, HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery.”
  • Beckers Payer Issues relates,
    • “Earlier in June, the HHS Office of Inspector General published two reports shedding light on post-acute care denials and overturned appeals from Medicare Advantage organizations. AHIP is pushing back.
    • “The reports ignore serious, well-documented concerns about wide variations in the cost and quality of post-acute care and skilled nursing facilities. More than 35 million Americans actively choose MA because it provides them with better, more affordable care — including helping seniors transition to high-quality, clinically appropriate care settings to support their rehab and recovery,” an AHIP spokesperson said in a June 11 statement.
    • “AHIP cited previous OIG research from 2018 that raised concerns about spending and quality with post-acute care. Based on a sample, OIG estimated Medicare paid inpatient rehabilitation facilities across the country $5.7 billion for unnecessary or unreasonable beneficiary care. The news release also featured Stanford (Calif.) University research from 2022 on risks of skilled nursing facility overuse based on Medicare’s reimbursement approach.
    • “AHIP also pointed to a lack of context in the OIG reports. Administrative issues — including out-of-network providers, services excluded from coverage and missing documentation — could all contribute to denials, not just denials that did not meet medical necessity standards. AHIP said reports also excluded common rationales for overturned denials, such as providers’ offices adding information that was initially missing from a claim.
    • “When combined with timely clinical information from our provider partners, prior authorization supports safe, effective and affordable care,” a CVS spokesperson previously told Becker’s. “We review requests promptly, offer a clear appeals process and are leading the way for continuous patient-centered improvements.”
    • “AHIP commissioned insights from analytics firm Inovalon, finding that, compared to fee for service, MA patients had 30% fewer inpatient days and 71% fewer preventable hospitalizations.”

From the Food and Drug Administration front,

  • The American Hospital Association reports,
    • “The Food and Drug Administration June 22 announced multiple actions to help accelerate early- and late-stage drug development. The actions are part of a larger Department of Health and Human Services initiative announced June 22 on clinical research efforts, called Operation TrailBlazer. The FDA’s efforts include a request for information on a new drug pilot program that would shorten the period from drug identification to first-in-human studies and protect clinical trial participants. The program would create a network of qualified research institutions, including academic medical centers, healthcare networks, contract research organizations, regulatory advisors and other research organizations, to partner with sponsors and develop and review protocols for first-in-human clinical trials intended for new drug submissions to the FDA.” 
  • The Wall Street Journal relates,
    • “The Food and Drug Administration has agreed to reverse its rejection of Regenxbio’s RGNX experimental gene therapy for a rare and fatal brain disease, the company said, the latest about-face by the agency under new leadership.
    • “The FDA didn’t respond to requests for comment.” * * *
    • “Regenxbio’s Navsunli therapy targets Hunter syndrome, a rare genetic disease that causes irreversible brain damage and cell death, usually leading to death in a patient’s midteens. 
    • “The disease affects about 2,000 people worldwide—nearly all boys—and about 50 people are diagnosed a year in the U.S.
    • “Navsunli promises to replace a defective gene, allowing boys who take the drug to start producing a protein that prevents the buildup of harmful substances in the brain and tissues.”
  • MedTech Dive tells us,
    • “Johnson & Johnson’s Abiomed alerted physicians to a risk associated with eight instances of major bleeding in patients treated with its Impella heart pumps.
    • “The Food and Drug Administration, which posted an early alert notice about the issue Thursday, said Abiomed and its manufacturing partner, Oscor, wrote to users about the catheter introducer issue this month.
    • “Hospitals can continue to use existing inventory. However, physicians should consider a device exchange or using the repositioning sheath to minimize blood loss if they see a potential leak.”
  • and
    • “Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm handles complaints. 
    • “The warning letter focused on MRI compatibility problems with some of Zoll’s portable ventilators. It also cited concerns with automated external defibrillators and electrodes used with the company’s defibrillators.
    • “Zoll, a subsidiary of Asahi Kasei that makes ventilators, defibrillators and other medical devices, received the warning letter on April 30, and the FDA posted the letter on Tuesday. The warning followed an inspection of Zoll’s facility in Chelmsford, Massachusetts, where the company is headquartered, between February and April 2025. 
    • “The FDA uses warning letters to flag significant violations after an inspection.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Utah has spent the past year fighting measles outbreaks — a grim milestone that could affect whether the United States can keep its measles-free designation. 
    • “More than 680 people have gotten sick since the state’s first outbreak began on June 20, 2025.
    • “Unlike measles outbreaks in Texas, South Carolina and Arizona, the spread in Utah has been tough to contain to one region — infecting undervaccinated communities in nearly every county. 
    • “Measles popped up in healthcare settings, big-box stores and restaurants, and youth sporting events. In February, an exposure at a state high school wrestling championship sparked at least 46 cases among attendees.” * * *
    • “More than 16% of the region’s kindergarteners were missing their measles vaccines in the last school year, according to state data. Statewide, 12.8% were missing their vaccine, putting the state far short of the 95% vaccination rate needed to prevent measles outbreaks.”
  • The American Medical Association lets us know what doctors want their patient to know about rib injuries.
    • “Rib injuries can range from bruises and stress injuries to fractures with overlapping symptoms.”
  • The Wall Street Journal tells us,
    • “Elementary school-age children are receiving GLP-1 weight-loss drugs such as Wegovy, despite that the medications aren’t being approved for obesity in this age group.
    • “Doctors prescribing GLP-1s to young children cite the severity of childhood obesity and its complications, seeing significant BMI decreases in some patients.
    • “Some doctors express concern about potential long-term effects on bone growth and brain development, while a guideline recommends medication only for children 12 and older.”
  • MedPage Today informs us,
    • “Adults ages 80 and older with unusually fast gait had about half the cognitive impairment risk as others, data from several studies suggested.
    • “Earlier research showed that super movers — people 80 and older who walk as fast as people 30 years younger — had a lower burden of disease, a healthier lifestyle, and a younger biological age.
    • “Findings suggested that mobility may reflect broad resilience across brain, cardiovascular, and muscle systems.”
  • and
    • “Previous research showed that combining the multicomponent blood-based biomarker Stockholm3 test with an MRI-targeted biopsy approach decreased overdetection of prostate cancers, while still detecting clinically significant cancers.
    • “In this analysis, the Stockholm3 test identified more clinically significant prostate cancers, while missing fewer cases, compared with standard PSA screening.
    • “These results support the use of the Stockholm3 test in the context of a risk-adapted screening approach, researchers said.”
  • and
    • “A major health system tested one multilevel approach to antithrombotic stewardship in the face of antiplatelet overprescribing among [direct oral anticoagulants] DOAC users.
    • “Antiplatelet use dropped following an initial educational outreach and a subsequent clinical pharmacist-facing electronic flag within a DOAC population management tool.
    • “The greatest benefit was observed in patients with stable [cornary artery disease] CAD, a group appropriate for antiplatelet deimplementation.”
  • STAT News notes,
    • “Pfizer said Monday that an experimental drug it hoped could replace a widely used chemotherapy in one of the most common forms of lung cancer fell short in a clinical trial.
    • “Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year Pfizer’s CEO, Albert Bourla, said on an earnings call the drug “could be a driver of growth later this decade.” In a note to investors in May, Leerink analyst David Risinger called the upcoming data readout a “major oncology catalyst” and said he had spoken to a doctor who was “optimistic” about its potential.” * * *
    • “The drug is an antibody-drug conjugate targeting integrin beta-6, a protein that is involved in tissue repair and is undetectable in normal cells but upregulated in cancer cells and is expressed in 90% of non-small cell lung cancer tumors. Pfizer was studying it compared to docetaxel in patients with locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer.
    • “But the drug did not result in a statistically significant improvement in overall survival over docetaxel. This was the study’s main goal, which means researchers will likely view other potentially encouraging conclusions from the clinical trial as requiring further proof.”

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion to bolster its core immunology franchise.
    • “The deal includes Apogee’s experimental drug zumilokibart, a potential rival to Dupixent for moderate to severe atopic dermatitis.
    • “The acquisition, expected to close in the third quarter, will cut adjusted per-share earnings by 46 cents in 2027.”
  • STAT News adds,
    • “Pharma goes on a spending spree, snapping up biotechs in a hurry.
      • “M&A activity [like the AbbVie deal] has soared in the first half of the year.” * * *
      • “The amount of money put toward M&A in the first three months of 2026 was the highest seen since 2020, according to a report from PwC. 
      • “The flurry of M&A is also a welcome reprieve for biotech startup executives, who have struggled to finance their drug trials or early lab research, as well as venture capitalists searching for investment returns. It’s provided a lifeline to some biotech startups struggling to stay afloat.” 
  • Modern Healthcare relates,
    • “As the federal government expands access to weight-loss drugs for Medicare patients, Walmart and its Sam’s Club subsidiary are ramping up support services for beneficiaries who may be seeking the medications. 
    • “The Medicare GLP-1 Bridge program, which the Centers for Medicare and Medicaid Services is launching July 1, will allow eligible Part D beneficiaries access to certain GLP-1 drugs often used for weight management. 
    • “The retailers noted in a Monday news release Medicare patients may face hurdles understanding eligibility requirements, prescription coverage processes, provider documentation needs and pharmacy fulfillment options.
    • “The initiative, also launching July 1, will offer educational materials, consultations with pharmacists, assistance navigating government and healthcare resources, increased in-store support, digital health tools and connection to additional health services like vision care. 
    • “The retailer said in the release it is not responsible for eligibility determinations, coverage decisions and treatment recommendations.”
  • Beckers Hospital Review adds,
    • “CVS Health is expanding support services for patients using GLP-1 medications, including a new $50 monthly copay option for eligible Medicare beneficiaries and a $49 virtual weight management visit through MinuteClinic.
    • “CVS Pharmacy will begin participating in the CMS’ Medicare GLP-1 Bridge program July 1, according to a June 22 company news release. Established under agreements the Trump administration negotiated with Eli Lilly and Novo Nordisk in November, the program will set a $245 monthly Medicare price for Ozempic, Wegovy, Mounjaro and Zepbound, with patients paying $50 per month out of pocket. 
    • “The company also launched a new MinuteClinic virtual care offering available in 47 states and Washington, D.C. The service connects eligible adults ages 18-64 with licensed clinicians who can evaluate patients for weight loss treatment and, when clinically appropriate, prescribe FDA-approved GLP-1 medications. Visits cost $49 and do not require a recurring membership fee.
    • “CVS said the initiative also includes expanded pharmacist support and over-the-counter products designed to help patients manage common GLP-1 side effects and remain on therapy. The company plans to offer dedicated product displays in select stores focused on nausea, gastrointestinal discomfort, hydration and nutrition support.”
  • HR Dive notes,
    • “SHRM members are shaking up their prescription drug benefits strategies thanks to cost increases that are driven in part by a massive uptake of weight loss medications, analysts for the HR organization said during its 2026 annual conference on Tuesday.
    • “Specifically, GLP-1 drugs have become a “massive line item” for employers, said Kathryn Mayer, senior specialist, content at SHRM. The organization’s 2026 Employee Benefits Survey found that while close to half of the roughly 5,500 employer respondents covered GLP-1s for Type 2 diabetes management, only 15% did so for weight management.
    • “We’re finding that employers are struggling to fund GLPs,” said Calven Engstrom, a SHRM senior researcher. But given strong evidence of the drugs’ effectiveness and high demand from employees — a 2025 KFF poll found that 1 in 8 U.S. adults said they were currently taking a GLP-1 drug— organizations have to weigh competing interests.
    • “Many of these organizations are trying to balance employee health outcomes with the long-term affordability and sustainability of their typical health plan,” Engstrom said, adding that utilization rates for GLP-1s are probably among the most closely monitored by employers at the moment.”
  • Per a Fair Health news release,
    • “The national median total cost for a C-section for commercially insured patients staying in network is $19,911, and for vaginal delivery it is $15,728, according to FAIR Health’s Cost of Giving Birth Tracker. These figures reflect the national median allowed (in-network) amount for the procedures. 
    • ‘The Cost of Giving Birth Tracker is a free, interactive tool, updated today, that tracks the cost of giving birth state by state. Available on FAIR Health’s website fairhealth.org, the Cost of Giving Birth Tracker consists of heat maps that show state-specific and national median charge and allowed amounts for vaginal deliveries and C-sections. The tool draws on the national, independent nonprofit FAIR Health’s database of commercial healthcare claim records—the nation’s largest such repository, which is growing at a rate of more than four billion claim records a year.
    • “The Cost of Giving Birth Tracker includes inpatient and outpatient facility and professional costs. Services include the delivery itself (e.g., pharmacy, nursery, labor and delivery room, medical and surgical supplies, room and board for the mother), anesthesia, fetal nonstress tests, ultrasounds, laboratory work and a breast pump. The data come from the September 2025 release of the vaginal delivery and C-section FH® Total Treatment Cost benchmarks.”
  • Modern Healthcare informs us,
    • “Health systems are investing in remote patient monitoring despite reimbursement rates that often don’t cover technology and staffing costs.
    • “Providers are banking on remote monitoring programs’ long-term, less easily quantified benefits.
    • “Stanford Health Care, UMass Memorial Health, OSF HealthCare and others are using technology to keep an eye on patients outside hospital walls.”
  • Fierce Healthcare notes,
    • “Online portal messages sent to providers more than doubled between 2020 and 2025 as patients now have much more direct access to physicians. But there hasn’t been a corresponding drop-off in clinic visits as digital medicine is adding to clinicians’ workload rather than replacing in-person care, a new study finds.
    • “At least 12% of Americans now communicate with their healthcare providers about appointments, test results and ongoing treatments via secure online patient portals and health apps, according to a study led by researchers at NYU Langone Health and published today in the Journal of the American Medical Association (JAMA) online.
    • “Online portal messages jumped 153% from 2020 to 2025, from an average pace of 2.2 per year in early 2020 to 5.4 per year in late 2025. But these digital messages are not replacing in-office visits, which have returned to an average of between two and three per year per patient. In-person office visits saw a modest 17% increase, going from 2.37 to 2.77 per patient per year, during the study period.
    • “By contrast, total telephone calls decreased by 6% over the same period.”
  • and
    • “Nine months after announcing its seed funding round, Prosper AI banked $30 million to scale its agentic AI platform to power administrative tasks from patient scheduling to insurance verification and patient billing.
    • “While many voice AI companies focus on specific tasks, like patient scheduling or billing, Prosper AI was designed to manage the broader patient journey, according to executives. The platform answers patient calls, schedules appointments directly in the electronic health record, verifies insurance benefits, automates patient billing and contacts insurers on the phone when additional information is needed. 
    • “Prosper AI’s ambition is to build an AI workforce for healthcare operations teams, Xavier de Gracia, the startup’s co-founder and co-CEO, told Fierce Healthcare. Prosper AI first shared the funding news with Fierce Healthcare.
    • “We believe that three to five years from now, larger patient groups and health systems are going to have a layer of workforce that’s going to be AI, not only humans, and it’s going to complement the work that humans are doing, and we believe that EHRs are going to partner and are already partnering to build a layer on top of the electronic health record. Our vision is to be completely agentic.” 

Midweek report

David Ermer–CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
  • Federal News Network reports,
    • “Following more than a year of sweeping reductions across the federal workforce, Office of Personnel Management Director Scott Kupor told House lawmakers on Wednesday that he would be open to hiring more federal employees — with one crucial caveat.
    • “Kupor said he would be “perfectly happy” to see an increase in federal workforce staffing if it meant that the number of federal contractors went down. The OPM director described contractors as a “shadow” workforce and argued that creating that type of shift would save taxpayer costs and improve government services.
    • “Contractors, I think, can be very valuable where you have temporary assignments, or you have skill gaps where potentially the government can’t recruit those,” Kupor told the House Appropriations Committee’s subcommittee on financial services and general government. “Instead, we have people who are contractors for five, 10, 15, 20 years. They are basically full-time employees in disguise, and they get paid anywhere from 25% to 100% higher than what a federal employee would.”
  • Payment accuracy.gov commends OPM for being one of the three highest performing agencies. OPM’s annual agency financial report for FY 2025 (p. 112) adds the following detail
    • “In FY 2025, FEHB ERC [experience rated carriers, which includes all nationwide plans] activity is reporting a statistically valid improper and unknown payment estimated amount and rate. The ERC activity reports one year in arrears, based on the time necessary to collect, test, report and aggregate the data. Because the ERC activity reports in arrears, PSHB data is not included in the IP estimate being reported in 2025.
    • “Independent public accountants (IPAs) provide the data by conducting sampling, testing and reporting of transactions performed by carriers as required in the Financial Reporting and Audit Guide’s Agreed Upon Procedures.” * * *
    • Based on the results of the sampling and testing for 2024, the FEHB ERCs properly paid 99.86 percent of payments. The FEHB ERCs had an improper and unknown payment rate of 0.14 percent.
  • That information shows that carriers have strong controls over benefit payments.
  • The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20. 
  • The Wall Street Journal points out,
    • “Indiana is barring Piece by Piece Autism Centers from billing its Medicaid program after a Journal article detailed the company’s practices.
    • “Piece by Piece received the highest per-patient payments in 2023, averaging $340,000, in part by raising list prices up to $640 an hour.
    • “Indiana’s Medicaid director, Mitch Roob, issued an ultimatum to providers to self-report abuses by April 3 or face federal scrutiny.”
  • Modern Healthcare relates,
    • “The Republican congressional majority is weighing further cuts to health programs a year after taking $1 trillion out of the system.
    • “The GOP would use an expedited process called budget reconciliation to prevent Senate Democratic filibusters.
    • ‘The measure could be a vehicle for cuts that didn’t make it into last year’s tax law and for President Donald Trump’s health proposals.
    • “Trump’s demands for Iran war funding and voting restrictions provide the GOP with an opportunity to advance more spending cuts.”
  • Federal News Network further notes,
    • “The U.S. Postal Service is adding a temporary surcharge to most of its standard package shipping options, citing higher fuel and transportation costs.
    • “USPS told its regulatory agency on Wednesday that it plans to implement an 8% across-the-board increase in prices for its core package and shipping services on April 26, and would remain in place until Jan. 17, 2027.
    • “At that time, the Postal Service can determine if a different long-term approach is needed,” USPS said in a press release.
    • “Previously, USPS has only sought limited-time price increases on its package services during its busy holiday peak season, which runs from October through December. But agency officials told the Postal Regulatory Commission that this surcharge is now necessary to account for the higher cost of fuel and contracted transportation services.”
  • Beckers Hospital Review tells us,
    • “The White House has delayed nominating a new CDC director, allowing Jay Bhattacharya, MD, director of the National Institutes of Health, to continue leading the agency past the March 26 deadline, The Washington Post reported March 25.
    • “Dr. Bhattacharya has served as acting CDC director since Feb. 18. Although he will no longer hold that title due to federal rules, he will retain authority over the agency’s delegable duties, an HHS spokesperson told the Post.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20.” 
  • Fierce Pharma relates,
    • “The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates.
    • “In approving Denali’s tividenofusp alfa, now known as Avlayah, the FDA has greenlit the first treatment for Hunter syndrome that can address the condition’s pernicious cognitive symptoms. 
    • “Avlayah is the first product approved to address neurologic complications of Hunter syndrome,” Tracy Beth Høeg, M.D., Ph.D., acting director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a March 25 release. “This accelerated approval was based on a surrogate endpoint: reduction of cerebrospinal fluid heparan sulfate, which the review team determined was reasonably likely to predict Avlayah’s clinical benefit.”
  • and
    • “With a new U.S. green light in certain ovarian cancer patients, Corcept Therapeutics has redeemed its lead asset relacorilant after stumbling at the finish line in a separate indication late last year. 
    • “The FDA has given the all-clear to Corcept’s class-first selective glucocorticoid receptor antagonist (SGRA) to treat adults with platinum-resistant ovarian cancer. Patients must have tried one to three prior lines of systemic treatment, at least one of which had to include bevacizumab (Avastin). 
    • “The FDA approval covers a regimen of relacorilant, to be sold as Lifyorli, alongside the chemotherapy nab-paclitaxel (Abraxane), according to a March 25 press release. The drug is taken orally the day before, of and after treatment with the regimen’s chemotherapy component, Corcept explained.” “

From the public health and medical / Rx research front,

  • Infectious Disease Advisor relates,
    • “The high rate of persistent physical and psychosocial sequelae of mpox suggests clinicians should consider screening affected individuals for symptoms of depression as well as social and occupational disruptions following acute illness.”
  • Health Day adds,
    • “New fathers might be proud poppas, but their mental health might be shaky as they adapt to their increased responsibilities, a new study says.
    • “Men have a 30% increased risk of depression and stress disorders by the end of their first year of fatherhood, researchers reported March 23 in JAMA Network Open.
    • “This follows a mental health boost among men during pregnancy and the first few months following birth, researchers found.”
  • Healio tells us,
    • “Limiting sedentary time and increasing light-intensity physical activity may reduce risk for developing a hypertensive disorder of pregnancy, according to study findings.
    • “Clinicians should consider counseling pregnant patients not only about exercise, but also about their everyday movement patterns. Based on our findings, limiting sedentary time to no more than 10 hours per day, and ideally closer to 8 hours, may help reduce the risk of developing a hypertensive disorder of pregnancy. Encouraging frequent light-intensity movement throughout the day appears to be an important and achievable target for improving pregnancy health,” Kara M. Whitaker, PhD, MPH, FAHA, associate professor in the department of health, sport and human physiology at University of Iowa, told Healio.”
  • Pharmacy Time adds,
    • “Compositional modeling of sedentary time, light activity, moderate-to-vigorous physical activity (MVPA), and sleep quantified insulin-resistance impacts of time reallocation while adjusting for sociodemographic and seasonal covariates. 
    • “Replacing 30 sedentary minutes with MVPA correlated with approximately 15% lower the homeostatic model assessment of insulin resistance, a clinically meaningful shift in a validated proxy for type 2 diabetes risk. 
    • “Shifting sedentary time to sleep also improved insulin resistance, supporting sleep duration as a metabolic cotarget alongside physical activity in adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck MRK has reached a nearly $6 billion cash deal to buy the cancer biotech Terns Pharmaceuticals TERN and its promising leukemia treatment.
    • If it proves to work safely, the experimental drug would give Merck a boost as the company prepares for its top-selling drug, Keytruda, to lose patent protection [in 2028].
    • Under the terms, Merck would pay $53 a share for Terns, Merck said Wednesday. The deal is worth $5.7 billion including the cash that Terns has on hand.” * * *
    • “Merck said it expects the deal to close by the end of June and result in a second-quarter charge of about $5.8 billion, or about $2.35 a share.”
  • MedTech Dive relates,
    • “Thermo Fisher Scientific said Tuesday that it has closed the $8.9 billion takeover of Clario, expanding its capabilities for handling clinical trial endpoint data.
    • “The buyout, which was announced in October, gives Thermo Fisher a platform for capturing and managing safety data, efficacy results and patient-reported outcomes in clinical trials.
    • “Thermo Fisher will integrate Clario’s platform with its existing capabilities for analyzing biological samples to create a high-growth business, CEO Marc Casper said at a recent investor event.”
  • BioPharma Dive informs us,
    • “Sarepta Therapeutics shares jumped 25% Wednesday morning after the company unveiled promising early clinical data for two medicines that it gained rights to through a deal with Arrowhead Pharmaceuticals worth more than $1 billion.
    • “The experimental drugs, dubbed SRP-1001 and SRP-1003, aim to treat two rare, genetic conditions that cause dangerous muscle deterioration. The therapies work by delivering small interfering strands of RNA, or siRNA, into muscle tissue to target the genetic abnormalities.
    • “Results from two Phase 1/2 studies released Wednesday show both medicines achieved high muscle concentrations without severe side effects, according to Sarepta. The company said it also has proof-of-concept data showing these treatments can hit their genetic targets.”

Tuesday report

David Ermer–CDC, Congress, FDA, Government Contracting, Medical / Rx research, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “President Donald Trump said Tuesday he wants Republicans to reach a deal on health care insurance assistance by being willing to bend on a 50-year-old budget policy that bars federal money from being spent on abortion services.
    • “You have to be a little flexible” on the Hyde Amendment, Trump told House Republicans as they gathered in Washington for a caucus retreat to open the midterm election year. “You gotta be a little flexible. You gotta work something. You gotta use ingenuity.”
    • “With his suggestion, Trump, who supported abortion rights before he entered politics in 2015, is asking conservatives to abandon or at least ease up on decades of Republican orthodoxy on abortion and spending policy — something lawmakers and conservatives pushed back on immediately.
    • “At the same time, he is demonstrating his long-standing malleability on abortion and acknowledging that Democrats have the political upper hand on health care after Republicans, who control the White House, the Senate and the House, allowed the expiration of premium subsidies for people buying Affordable Care Act insurance policies. As negotiations on Capitol Hill continue on the matter, some Democrats are pushing to end the Hyde restrictions as part of any new agreements on health care subsidies.”
  • The Wall Street Journal relates,
    • “Republican Rep. Doug LaMalfa, who represented a district in Northern California for 13 years, has died, shocking colleagues and further narrowing the GOP’s slim majority. 
    • “Colleagues of LaMalfa, 65 years old, praised the farmer and former state legislator for his long record of advocating for rural communities and farmers.” * *. *
    • “LaMalfa’s death further shrinks the already thin House GOP majority to 218-213. Rep. Marjorie Taylor Greene (R., Ga.) formally resigned from the House in the middle of her term this week. There are now four empty seats—two in red-leaning districts, and two in blue districts. 
    • “Also, Rep. Jim Baird (R., Ind.) was in a car accident, sidelining him at least temporarily. His office said he was in the hospital and is expected to make a full recovery.”
  • Federal News Network gives us an update on implementation of the Federal Acquisition Regulation overhaul.
    • “The Office of Federal Procurement Policy (OFPP) and the FAR Council have issued FAR Companion guides and practitioner albums to help the training and education of the acquisition workforce on the new rules.
    • “Additionally, OFPP Administrator Kevin Rhodes held a series of roundtables with contractors, industry associations and others to gain their perspectives of the FAR overhaul. OFPP says these contractors and associations “shared feedback on five priority goals: increasing competition, reducing costs, accelerating the acquisition system, changing cultural norms and deploying best practices.”
    • “Rhodes said in a statement that “the feedback we received will help inform our efforts for the next phase of the RFO.”
    • “OFPP is accepting more feedback through Jan. 12 through its IdeaScale on ways to continue to improve the FAR across the five priorities.”
  • The American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration has released updated resources on the 988 Suicide and Crisis Lifeline. An updated fact sheet features an overview of the 988 hotline and what people can expect when using the service. It also includes testimonials from individuals who have used it and an FAQ. Another resource highlights key differences between 988 and 911 and explains when the use of each service is appropriate. SAMHSA also provides digital assets on the 988 hotline for sharing on social media.” 

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Amneal Pharmaceuticals received FDA approval for two denosumab biosimilars referencing Prolia and Xgeva.
    • “The approval, announced Dec. 22, covers Boncresa (denosumab-mobz) and Oziltus (denosumab-mobz), both used to treat conditions related to bone loss and cancer. The drugs are administered by a healthcare provider and are intended to improve access to lower-cost biologic therapies.
    • “With the addition of the new products, Amneal expects to commercialize six biosimilars across eight presentations by 2027. U.S. sales for Prolia and Xgeva totaled about $5.3 billion in the 12 months ending October 2025.” 

From the public health and medical / Rx research front,

  • AP reports,
    • “U.S. flu infections surged over the holidays, and health officials are calling it a severe season that is likely to get worse.
    • “New government data posted Monday [January 5] — for flu activity through the week of Christmas — showed that by some measures this season is already surpassing the flu epidemic of last winter, one of the harshest in recent history.
    • “The data was released the same day that the Trump administration said it will no longer recommend flu shots and some other types of vaccines for all children.
    • “Forty-five states were reporting high or very high flu activity during the week of Christmas, up from 30 states the week before.
    • “The higher numbers appear to be driven by the type of flu that’s been spreading, public health experts say.
    • “One type of flu virus, called A H3N2, historically has caused the most hospitalizations and deaths in older people. So far this season, that’s the type most frequently reported. Even more concerning, more than 90% of the H3N2 infections analyzed were a new version — known as the subclade K variant — that differs from the strain in this year’s flu shots.”
  • STAT News adds,
    • “Australia’s 2025 flu season lasted weeks longer than it normally does. Hong Kong’s hit so early that the rollout of seasonal flu shots hadn’t yet started. New York has reported record-breaking flu hospitalizations for the past two weeks. 
    • “Welcome to the winter of subclade K.” * * *
    • “Influenza viruses come in many forms, but the ones that cause the most disease in humans are the flu A viruses H1N1 and H3N2, and influenza B. 
    • “Subclade K is a variant of the H3N2 family of viruses, which can trigger more severe seasons and which seem to be harder on older people, who are among the most vulnerable to flu.” * * *
    • “Subclade K viruses weren’t on the radar when influenza experts from around the globe gathered last February to select the strains the 2025-2026 flu shots should target. 
    • “Even when the vaccine contains viruses that are well matched to those that are circulating, the H3N2 component often under-performs. It offers protection against severe disease, but may not prevent infection.”
  • Beckers Hospital Review informs us,
    • “The U.S. has recorded 7,045 clinical Candida auris cases as of Dec. 20 — a 56.1% increase from the 4,514 cases logged in 2023, according to CDC data. 
    • “About half of those cases are in Nevada and California, which each reported about 1,500 C. auris clinical cases in 2025. 
    • “C. auris is an emerging multidrug-resistant fungus that can cause infections and spread quickly in healthcare settings, particularly among immunocompromised patients.”
    • The article lists the number of 2025 C. auris cases in each State.
  • Health Day lets us know,
    • “Telehealth might not be the best option for a parent with a sick baby or toddler, a new study says.
    • “Children 3 months to 2 years of age are nearly 50% more likely to land in an ER within three days of a virtual doctor’s visit than those who have an in-person visit, researchers recently reported in JAMA Network Open.
    • “Our study showed that children under 2, whose communication of their needs and symptoms is more subtle, should probably be seen in person,” senior investigator Dr. Natasha Saunders said in a news release. She’s a pediatrician and senior associate scientist with The Hospital for Sick Children in Ontario, Canada.”
  • Per a National Institutes of Health news release,
    • “In a world first, a team of researchers at the National Institutes of Health (NIH) and Emory School of Medicine, Atlanta, has successfully performed a coronary artery bypass — a normally open-heart surgery — without cutting the chest wall. The team employed a novel intervention to prevent the blockage of a vital coronary artery, which is a very rare but often lethal complication following a heart-valve replacement. The results suggest that, in the future, a less traumatic alternative to open-heart surgery could become widely available for those at risk of coronary artery obstruction.
    • “Achieving this required some out-of-the-box thinking but I believe we developed a highly practical solution,” said first author of the study Christopher Bruce, MBChB, an interventional cardiologist at WellSpan York Hospital and NIH’s National Heart, Lung, and Blood Institute (NHLBI), as well as an adjunct assistant professor of cardiology at Emory School of Medicine.”
  • The Washington Post relates,
    • “The stimulants Ritalin and Adderall have been used to treat attention-deficit/hyperactivity disorder (ADHD) for decades, but research shows they don’t act on the brain’s attention circuitry as had long been assumed.
    • “Instead, the medications primarily target the brain’s reward and wakefulness centers, according to a new study published in the journal Cell. The research, which used brain imaging data from almost 5,800 children ages 8 to 11, also pointed toward the important role that lack of sleep plays in the disorder.
    • “When I first saw the results, I thought I had just made a mistake because none of the attention systems are changing here,” said Benjamin Kay, one of the study’s authors and a professor of neurology at Washington University School of Medicine in St. Louis.
    • “It’s not that the stimulants are ineffective.
    • “The paper clearly shows that they help,” said Nico Dosenbach, another of the authors and a professor of neurology at the university. “They help kids who have a diagnosis of ADHD do better in school and do better on tests, and they help kids who don’t sleep enough ― and a lot of Americans don’t sleep enough.”
  • STAT News points out,
    • “Arrowhead Pharmaceuticals said Tuesday that its gene-silencing candidates helped people with obesity lose fat, very early results that could intensify the competition among biotechs to develop longer-lasting weight loss drugs.
    • “In an ongoing Phase 1/2 study, a cohort of patients took two doses of a candidate called ARO-INHBE, spaced one month apart, in combination with Eli Lilly’s Zepbound. They lost 9.4% of their weight after 16 weeks, while those on Zepbound alone lost 4.8%. These data were from patients with obesity and diabetes, who typically don’t lose as much weight on treatments as those who don’t have diabetes.”
    • “Participants on the combination also lost 23% of their visceral fat, the most harmful type of fat that’s stored around the organs, as well as 15% of their total fat and 77% of their liver fat. Excess liver fat can lead to inflammation and scarring in the organ. Meanwhile, those taking Zepbound alone lost 7%, 5%, and 20%, respectively.
    • “While the drug was effective in combination with Zepbound, it’s not clear yet if it can be a viable product on its own. Obese patients taking only two doses of ARO-INHBE experienced a 16% placebo-adjusted reduction in visceral fat, but that has not yet translated into significant overall weight loss, CEO Christopher Anzalone said.”
  • Per BioPharma Dive,
    • “Immune drug developer Alumis said on Tuesday that its top prospect has succeeded in two Phase 3 trials, helping people with psoriasis eliminate most of their skin lesions after four months of treatment. 
    • “Called envudeucitinib, the drug is a newer type of medicine aimed at a popular target known as TYK2. The first TYK2 blocker, Bristol Myers Squibb’s Sotyktu, was approved in 2022. But Alumis, Takeda and many other biotechs are working on successor drugs and testing them against psoriasis and other immune disorders. Takeda’s medicine produced positive Phase 3 results in December.
    • “Alumis’ data, though, suggest that envudeucitinib has the potential for “class-leading” TYK2 inhibition and a treatment effect approaching what’s observed with injectable biologics, wrote Leerink Partners analyst Thomas Smith. Company shares more than doubled in morning trading, changing hands at around $17 apiece. The company intends to seek U.S. approval of envudeucitinib later this year.” 
  • Per Fierce Pharma,
    • “Fresh off of a European approval for a subcutaneous version of Saphnelo, AstraZeneca is doubling down on the benefits of the self-administered drug formulation in lupus patients with a positive phase 3 showing.
    • “In the phase 3 Tulip-SC trial, 56.2% of patients with systemic lupus erythematosus (SLE) who received a subcutaneous dose of Saphnelo experienced a reduction in disease activity at week 52, the company reported Tuesday. In the placebo group, the result was 37.1%.
    • “The readout adds more detail to the trial’s prior interim analysis, which confirmed a statistically significant result for subcutaneous Saphnelo and a safety profile on par with the currently marketed intravenous infusion version.” 

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Eli Lilly is in advanced talks to acquire Ventyx Biosciences for over $1 billion.
    • “Ventyx specializes in one of the hottest spaces in drug development, developing pills to treat diseases like Crohn’s and rheumatoid arthritis.
    • “The acquisition would enhance Eli Lilly’s portfolio in autoimmune conditions, obesity, and related disorders.”
  • Modern Healthcare tells us,
    • The University of Alabama at Birmingham Health System acquired Southview Medical Group Jan. 1, the system said Jan. 5. 
    • Under the agreement, UAB Health owns all of Southview Medical’s facilities and will employ its more than 30 providers. 
    • Southview Medical had locations at two UAB facilities, UAB St. Vincent’s Birmingham and UAB Medicine St. Vincent’s One Nineteen, prior to the acquisition.
  • and
    • RWJBarnabas Health announced Jan. 5 that it signed a definitive agreement to make Englewood Health part of its system. 
    • Financial details were not disclosed, but RWJBarnabas said it plans to make “significant capital investments” that will improve care access and quality. The transaction is pending regulatory approval. 
    • A timeline for when the deal would be completed was not disclosed.
  • and
    • “A joint venture between Kaiser Permanente and healthcare investment firm Town Hall Ventures has launched a second integrated program for older adults in California.
    • “Habitat Health opened its Program of All-Inclusive Care for the Elderly center in Compton, California, on Thursday. It began enrolling eligible adults older than age 55 last month, a Habitat Health spokesperson said. 
    • “The company plans to roll out other PACE programs in California and expand to Illinois, the spokesperson said.”
  • Fierce Healthcare informs us,
    • “Health system and hospital executives see the promise of automation and artificial intelligence to customize patient outreach and help address persistent engagement challenges.
    • “AI-powered personalization technology can nudge patients to take action, which could help address long-standing challenges with medication adherence while also reducing no-show rates and closing care gaps. 
    • “According to a recent survey from Lirio and Sage Growth Partners, 60% of executives from U.S. health systems, independent hospitals and physician groups cited automating patient outreach to ease administrative burden as their top priority. Most executives (96%) said AI and automation can reduce administrative burden related to patient engagement. About half of executives said their organizations struggle to personalize engagement content, such as text messages or emails, at the patient level.
    • “But this operational priority doesn’t currently match up with AI investment strategies.
    • “Among the surveyed executives, 35% said their organizations have yet to make investments in AI tools for patient outreach. At the same time, most health systems are channeling AI investment into operational efficiency. The majority of executives (83%) said their organization has invested in AI-based solutions for automated documentation and other tasks to improve clinician workflows.
    • “The disconnect between AI priorities and investments often comes down to the speed at which different technologies demonstrate value,” Amy Bucher, M.D., chief behavioral scientist at Lirio, told Fierce Healthcare.” 

Friday Report

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Government Contracting, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A dispute over a Trump administration plan to consolidate federal firefighting operations may be close to resolution, in a sign of modest progress toward Senate passage of a major fiscal 2026 spending package.
    • “Sen. Tim Sheehy, R-Mont., said Thursday he was prepared to release his hold on the Interior-Environment bill, a prime candidate for the “minibus” spending package, after cutting a deal to remove language that threatened to delay, if not derail, the firefighting reorganization.
    • “Sheehy, a former firefighting pilot and founder of an aerial firefighting and aerospace services company, is a key backer of the plan and rejected any effort to delay it.
    • “But we’ve cleared that language, so we should be good now,” he said.” * * *
    • “While Sheehy’s hold on the spending package may be lifted, Thune continued to negotiate with several other Republicans who have their own holds as they push for various causes, including a concern from some conservatives that spending levels are too high.
    • “Thune, R-S.D., told reporters Thursday that negotiators were still working “through the concerns that our members have,” but added he’s hopeful they “can land something soon.”
    • “A lot of conversations going on around that, but we just need to — we’ve got to get on the package of bills,” Thune said.
    • “Thune wants to add some combination of the Commerce-Justice-Science, Interior-Environment, Labor-HHS-Education and Transportation-HUD bills to the Defense bill in a package he could bring to the floor in coming days.”
  • Fierce Healthcare adds,
    • “As Congress continues to debate next steps on the Affordable Care Act’s enhanced subsidies, insurers are urging legislators to consider an extension with additional program integrity measures in place.
    • “AHIP said in a statement Wednesday that “common sense” steps to promote integrity can help mitigate the risks related to fraudulent enrollment in ACA plans or subsidies. The commentary comes after analysts at the Government Accountability Office were largely able to enroll in coverage and in the tax credits using fake profiles.
    • “GAO notes in the report that when the Centers for Medicare & Medicaid Services took steps to address fraudulent enrollments by improving identity verification and implementing three-way calls to stymie broker misbehavior, which have already had an impact on reducing unauthorized activity, AHIP said.
    • “With open enrollment underway and 24 million Americans facing the largest-ever spike in healthcare costs in 2026, Congress should take bipartisan action to preserve the health care tax credits and further strengthen program integrity,” AHIP said.”
  • The American Hospital Association News tells us,
    • “The Advisory Committee on Immunization Practices Dec. 5 recommended individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. If not receiving the vaccine at birth, ACIP recommended infants receive the initial dose no earlier than 2 months of age. However, ACIP made no change to the existing Centers for Disease Control and Prevention recommendations to vaccinate infants born to women who test positive for the virus or have an unknown virus status. The recommendations also maintain consistency with all current health coverage options for payment, according to the Department of Health and Human Services. ACIP’s recommendations must be formally adopted by the director of the CDC before becoming part of the CDC immunization schedule.”
  • The Wall Street Journal explains what the ACIP recommendations means for readers.
    • “Under these recommendations, parents who wish to have their infants vaccinated at birth, if the mother isn’t infected with hepatitis B, will be able to do so after discussing it with their doctor. Doctors might face additional hurdles in administering the vaccine at birth for some families, including additional time spent counseling. 
    • “Insurers will likely still cover the shots if administered earlier than recommended. AHIP, a group representing insurers, said its members will cover vaccines recommended by ACIP through Sept. 1 until the end of 2026. Insurers typically handle coverage decisions yearly.”
  • Healthcare Dive lets us know,
    • “The HHS on Thursday released its plan to deploy and centralize artificial intelligence use within the agency, as part of a broader push by the Trump administration to cut costs and adopt the technology in the federal government.
    • “The agency said it will prioritize sharing AI resources among HHS departments, create a governance structure for new tools and promote use of the technology for public health initiatives.
    • “Although the strategy is internally focused to start, HHS said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools.” 
  • FedWeek calls to our attention a hiccup in the relatively new PSHBP Open Enrollment system that may require enrollee work arounds.

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.
    • “Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
    • “We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”
  • Per MedTech Dive,
    • “Advisers to the Food and Drug Administration on Wednesday voted 15-0 against use of Johnson & Johnson’s V-Wave shunt for heart failure patients not helped by medications.
    • “Members of the circulatory system devices panel were unanimously opposed to recommending approval of the implant based on effectiveness and its benefit-risk profile. On the question of safety, the panelists voted 9-6 in favor of the device.
    • “J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions.
    • “Following the vote, a J&J spokesperson said the company is reviewing the FDA advisory panel’s recommendation for additional clinical evidence on the device.
    • “We will continue to work closely with the FDA, clinicians and other stakeholders to determine next steps,” the spokesperson wrote in an email.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
      • “Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds
    • “Although this year’s flu season could be challenging, fewer adults have been vaccinated against influenza, a new study shows.
    • “Much less than half of US adults have been immunized against any respiratory virus, according to a survey of 1,015 adults released this week by the National Foundation for Infectious Diseases (NFID).
    • “Just 34% of adults have gotten a flu shot; 25% have had a COVID-19 shot; 8% have received a vaccine to prevent pneumococcal disease, caused by bacteria that can lead to pneumonia, meningitis, and sepsis; and 6% have been vaccinated against respiratory syncytial (RSV), a leading cause of hospitalization in infants and older adults.
    • “New data from IQVIA, which provides health care statistics, show similar declines over the past year. Retail pharmacies have seen falling numbers of vaccinations for three major respiratory viruses:
      • “34% decline in RSV vaccinations
      • “27% drop in COVID-19 vaccinations
      • “6% reduction in flu shots
    • “Pneumococcal vaccinations are the one bright spot in IQVIA’s data, with vaccinations rising 27% in the past year. The uptick is likely due to the Centers for Disease Control and Prevention’s (CDC’s) decision last year to lower the age at which people are eligible for pneumococcal vaccine from 65 to 50, said Robert Hopkins, NFID’s medical director.
  • Beckers Clinical Leadership tells us,
    • “Twelve percent of nearly 3,000 norovirus tests during the week ending Nov. 22 came back positive — a notable increase from the 6.82% positivity rate three months earlier, according to CDC data. 
    • “During the week ending Aug. 23, 6.82% of 4,034 norovirus tests were positive. A CDC system that tracks viral activity in the U.S. shows a 12% positivity rate among 2,825 norovirus tests, as of Nov. 22, the most recent data available.” 
  • Per Medscape,
    • “A newly cleared point-of-care test will enable rapid identification of whooping cough, according to a press release from manufacturer Roche.
    • “The molecular test uses the cobas liat system and earned an FDA clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for the detection of Bordetella infections, including pertussis.
    • “The CLIA waiver means that the test is approved for use in settings outside of a traditional lab, including a doctor’s office or pharmacy, and is considered sufficiently simple that it can be performed by healthcare personnel without extensive medical training.
    • “The test is currently available and provides polymerase chain reaction (PCR) results after approximately 15 minutes at the point of care, according to the company. Early symptoms of pertussis are similar to other respiratory illnesses, and a quick-turn test can confirm a diagnosis and facilitate timely treatment to prevent further spread of illness and protect patients from severe complications.”
  • and
    • “Current cardiac screening tools used to prevent myocardial infarction (MI) failed to identify nearly half of people who are at risk for MI, according to a new study. Those patients had low or borderline risk as per both standard and newer risk calculators for atherosclerotic cardiovascular disease (ASCVD). Most developed symptoms within 48 hours before the event, and many would not have been recommended statins or further testing if evaluated 2 days earlier.”
  • MedPage Today informs us,
    • “In a French cohort, the incidence of all-cause mortality among those who received a first dose of an mRNA COVID vaccine was 0.4% after a median follow-up of 45 months, compared with 0.6% of those who were unvaccinated.
    • “After standardizing characteristics between the two groups, all-cause mortality incidence was 25% lower in those who had received a COVID shot.
    • “Vaccinated people were 74% less likely to die in a hospital because of COVID-19 compared with those who weren’t vaccinated.”
  • and
    • “Three ancillary studies to the U.S. POINTER trial collectively demonstrated that a structured 2-year lifestyle intervention for older adults at increased risk of cognitive decline led to better overall health.
    • “In main results from the U.S. POINTER trial released in July, two lifestyle interventions — one structured, the other self-guided — improved cognitive scores in over 2,000 older adults, said Rema Raman, PhD, of the University of Southern California in Los Angeles, who co-chaired a symposium at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting.
    • “Both 2-year interventions in U.S. POINTER encouraged physical activity, cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but they differed in structure, intensity, and accountability.
  • Per Health Day,
    • “Your brain health might be linked to how well your kidneys are working, a new study says.
    • “People with impaired kidney function have higher levels of proteins in their blood that are linked to Alzheimer’s disease, researchers reported Dec. 4 in the journal Neurology.
    • “Our study found that when the kidneys are not functioning properly, there may be higher levels of Alzheimer’s biomarkers in the blood,” lead researcher Dr. Francesca Gasparini, a geriatrician with the Karolinska Institutet in Stockholm, Sweden, said in a news release.
    • “While we did not find that having reduced kidney function increased the risk of developing dementia, we did find that impaired kidney function may accelerate the onset of dementia in people who have higher levels of biomarkers.,” Gasparini said. “This highlights the need for doctors to consider kidney function when interpreting results of Alzheimer’s biomarkers in the blood.”
  • STAT News reports,
    • “Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for clearance.
    • “Developed with Click Therapeutics, the app, CT-155, is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. Schizophrenia affects millions of people in the U.S. and is commonly associated with psychotic behavior and delusions. However, there are other common and often serious negative symptoms, including lack of motivation and the inability to experience pleasure, for which there are no approved drugs.”

From the U.S. healthcare business and artificial intelligence front,

  • Tech Target relates,
    • “Navigating an evolving regulatory landscape is top-of-mind for healthcare payers heading into 2026, with health plan executives saying changing requirements stemming from the Trump tax law has driven new priorities, according to a new HealthEdge report.
    • “The report, based on survey responses from 550 health plan executives in the United States, also flagged rising costs, better member engagement, investment in artificial intelligence (AI) and more collaborative payer-provider relationships as key priorities.”
  • McKinsey & Co. points out,
    • “Women in the United States face steeper barriers to healthcare than men, causing preventable suffering and costing billions each year. The health of women—encompassing the entire care continuum and extending beyond reproductive and sexual health—represents an approximately $50 billion missed annual opportunity for health systems nationally. Addressing the gap in women’s healthcare requires a fundamental transformation in care delivery, with preventive care playing a pivotal role to ensure accessibility, continuity, and comprehensive care.”
  • BioPharma Dive notes,
    • “Hemophilia gene therapies are struggling on the market, even as innovation soars. The business case for hemophilia gene therapy still isn’t adding up due to persistent market barriers.”
  • Per Fierce Healthcare,
    • “It’s been just over a year since Oura announced a partnership with Medicare Advantage insurer Essence Healthcare, and, now, the partners are looking to continue building on that foundation.
    • “The partnership initially launched for Essence’s PPO plan members, and, over the course of the year, grew into HMO plans as well. Saria Saccocio, M.D., chief medical officer for Essence, told Fierce Healthcare that a third of members who were eligible for an Oura ring chose to sign up, and two-thirds of that group was willing to share biometric data with the insurer.
    • “She said the effort began with sleep health and, over time, has shown members are improving their sleep scores. That’s translating to other areas as well, such as an increase in the amount of time engaging in light exercise.
    • “It’s that level of awareness and nudge that I think is helping improve the overall health of our members,” Saccocio said.”
  • and
    • “Wellvana has struck a 20-year affiliation with Mercy that will offer the system’s nonemployed primary care physicians and advanced practice providers participation in value-based care.
    • “The arrangement will give those independent clinicians access to Wellvana’s electronic-health-record-integrated practice tools and clinical and operational care teams, which the new partners say will reduce administrative burdens and help coordinate patient care.
    • “The providers’ participation in value-based arrangements will also bring financial incentives for better patient outcomes within Mercy’s service area and across Medicare, Medicare Advantage and commercial plans, they said. The organizations expect their clinically integrated network to be among the country’s largest.
    • “Mercy has built one of the nation’s most respected systems, and together we’re creating sustainable paths for independent providers to see the rewards of accountable care,” Wellvana CEO Susan Diamond said in Thursday’s announcement. “The more we grow participation in value-based care, the more patients and communities benefit from a better, more connected health experience.”
  • The Wall Street Journal offers readers six questions to ask their doctors before their doctors use AI to record their visits.

Monday report

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, FDA, Government Contracting, Medical / Rx research, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump signaled a willingness to strike a deal on funding healthcare subsidies demanded by Democrats, as the government shutdown entered its second week. 
    • “We have a negotiation going on right now with the Democrats that could lead to very good things,” Trump told reporters in the Oval Office on Monday. 
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) said formal talks hadn’t commenced. “Trump’s claim isn’t true. But if he’s finally ready to work with Democrats, we’ll be at the table,” he said in a statement.” * * *
    • “After Trump’s comments on Monday, Sen. Markwayne Mullin (R., Okla.) said he had spoken with Democrats and the president in an informal way about healthcare, but funding the government must come first. “Once they reopen the government, we’ll be happy to talk about the way we make healthcare better for the American people,” he said.” * * *
    • “At a press conference late Monday, House Minority Leader Hakeem Jeffries (D., N.Y.) said he hadn’t heard from Trump, but it was “an interesting statement that the president has made.” He said that he would be willing to talk with Trump or White House officials at any time.” 
       
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations by the Advisory Committee on Immunization Practices. Patients are now advised to consult their health care provider if they want to receive a COVID-19 vaccine, which would be covered by health insurance like other routine vaccines. In addition, it is now recommended that children through age 3 receive a standalone chickenpox vaccine rather than the combined measles, mumps, rubella and varicella vaccine.”
  • The Washington Post adds,
    • “What does it mean to consult a clinician [/ their health care provider?
    • “The CDC website lists health care providers who can be involved in discussing vaccines with patients. They include anyone else who provides or administers vaccines, including primary care physicians, specialists, pharmacists, physician assistants, nurse practitioners and registered nurses.
    • “That means a person doesn’t necessarily need to make a doctor’s appointment to get a vaccine.
    • “Pharmacists are trained to discuss pros and cons of all medications with patients, including coronavirus vaccines.”
  • Per Health Day,
    • “The U.S. Food and Drug Administration is considering changes to a 20-year-old warning on menopause hormone therapy
    • “Experts say the warning has discouraged safe use of treatment for hot flashes, poor sleep and other symptoms
    • “Research suggests hormone therapy can be safer and more effective when started earlier in menopause.”
  • Bloomberg Law points out,
    • “A new regulatory pilot project from the US Centers for Medicare and Medicaid Services is under review at the White House budget office, suggesting that the Trump administration is seeking to take regulatory action against drugmakers even as it strikes deals with individual companies.
    • “There are no details about the policy CMS plans to test, titled the “Guarding US Medicare Against Rising Drug Costs” pilot, including what drugs or companies could be impacted. Regulatory pilot projects help the government determine if a new regulation will save money, allowing it to experiment with rules before implementing them widely.
    • “The proposed regulation is the agency’s second recent move toward new rules on drug prices; another posted on Sept. 25.”
  • Healthcare Dive informs us,
    • “Arbitration of surprise billing disputes between insurers and providers will continue despite the government shutdown, the CMS said on Friday.
    • “Parties that disagree over how much an out-of-network claim should be reimbursed can still submit disputes via the federal independent dispute resolution portal, and arbiters will continue to process disputes, according to the agency.
    • “However, a prolonged shutdown could throw a wrench in other processes that underlie the implementation of the No Surprises Act, which was passed in 2020 to protect consumers from unexpected out-of-network bills. Since congressional appropriations lapsed last week, Congress has made no progress on a deal to reopen the government.”
  • The Healthcare Financial Management Association lets us know that “No Surprises Act arbitration has been a bonanza for a few provider groups. For-profit provider companies have fared well in the NSA’s independent dispute resolution portal even as the process remains a frequent subject of litigation.”
    • “In a span of 2.5 years through 2024, providers reaped more than $2.2 billion from the No Surprises Act’s arbitration process, relative to the applicable in-network payment rates for the disputed care episodes.
    • “The awards received through the NSA’s independent dispute resolution (IDR) process largely arise from “disputes that are primarily initiated and won by private-equity-backed providers,” said Kennah Watts, research fellow at the Center on Health Insurance Reforms at Georgetown University.
    • “Driven by that handful of groups, the volume of IDR disputes “continues to surpass agency estimates by millions,” Watts said during a webinar presented by Health Affairs.”
    • “Although the involvement of private equity (PE) frequently raises questions in healthcare, some smaller providers might struggle to effectively engage with the IDR process if not for that support, panelists noted during a discussion as part of the webinar.”
  • Per Govexec,
    • “Dr. Kevin Rhodes has received Senate confirmation to lead the White House’s Office of Federal Procurement Policy, a move that designates him as the first permanent leader of that component in six years.
    • “Senate lawmakers approved the nomination of Rhodes on Thursday, five months after the White House announced him as President Trump’s choice for the role.
    • “Rhodes has been acting as a senior adviser to OFPP’s parent agency, the Office of Management and Budget, since February with the responsibility of leading the Trump administration’s push to restructure federal procurement.
    • “All but one section of the Federal Acquisition Regulation has been overhauled since then. OFPP and the FAR Council have collaborated on the effort and gradually rolled out the changes.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Immunologists Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi were awarded the Nobel Prize in Physiology or Medicine for uncovering a process that prevents the immune system from attacking our own tissues, called peripheral immune tolerance. The work unlocked a new field of research and potential therapies.
    • “The trio identified a core feature of how the immune system functions and keeps itself in-check: regulatory T-cells. They prevent other immune cells from harming our own bodies and developing autoimmune conditions including Type 1 diabetes and rheumatoid arthritis. Based on this fundamental knowledge, clinical trials are ongoing to test therapies for autoimmune diseases, cancer and post-organ transplantation.
    • “Their discoveries have been decisive for our understanding of how the immune system functions and why we do not all develop serious autoimmune diseases,” said Olle Kämpe, chair of the Nobel Committee on Monday.
    • “Brunkow is now based at the Institute for Systems Biology in Seattle, Ramsdell at the San Francisco and Seattle-based Sonoma Biotherapeutics, while Sakaguchi is a distinguished professor at Japan’s Osaka University. The group will share the 11 million Swedish kronor, or roughly $1.1 million, prize.”
  • Heath Day reports,
    • “An alarming trend is emerging on America’s roads.
    • “More drivers killed in crashes are testing positive for THC, the active ingredient in marijuana.
    • Researchers in Ohio reviewed autopsy records from 246 drivers killed in crashes between 2019 and 2024.
    • “They found that 41.9% had THC in their system — at levels far above what most states consider impairment.
    • “The average blood level was 30.7 nanograms per milliliter. By comparison, many states set legal limits between just 2 and 5.
    • “The researchers say that means the drivers likely used marijuana close to the time of the crash. The study also found the high rate of THC positivity stayed consistent over six years and didn’t change when recreational pot became legal in Ohio in 2023.
    • “The lead author says from a public health standpoint, there hasn’t been enough attention on the dangers of legalization.”
  • and
    • “When someone has whooping cough, the sound can be unmistakable: A deep, gasping “whoop” as they struggle to catch their breath between fits of coughing. 
    • “Now, this once-rare illness, also known as pertussis, is making a comeback across the United States.
    • “Cases have now surpassed pre-pandemic levels, and while the disease can be exhausting for adults, experts warn it can be life-threatening for newborns and infants, especially those under two months old.
    • “Most babies in this age group who contract pertussis are hospitalized, according to a report published Oct. 3 in the journal Pediatrics.”
    • “Pertussis symptoms are different in infants,” said lead author Dr. Caitlin Li, an infectious diseases specialist at Ann & Robert H. Lurie Children’s Hospital of Chicago and assistant professor of pediatrics at Northwestern University Feinberg School of Medicine. “The characteristic whooping cough may be absent, but apnea, or breathing interruption, is common.” * * *
    • “Given that infants are at high risk for complications, pertussis vaccination of mothers during pregnancy is critical, as it protects newborns against this potentially fatal illness,” Li explained in a news release. “Widespread vaccination is also an important tool to protect everyone.”
  • The American Cancer Society lets health plans know “how to address cancer care gaps to improve cost and clinical outcomes at every step.”
  • Genetic Engineering and Biotechnology News discusses the largest genetic map of human metabolism ever created.
    • “The contribution of genetics to the variability in people’s metabolism has remained largely unknown. This is, in part, because genetic studies of human metabolism have been limited in scale and allelic breadth. Now, the largest genetic map of human metabolism has been created, revealing new insights on the role of metabolites in health and disease and creating a blueprint for further research.
    • “This work is published in Nature Genetics in the paper, “A genetic map of human metabolism across the allele frequency spectrum.”
  • Per Healio,
    • “Adults with obesity who reported more intense tastes while receiving semaglutide or tirzepatide had a higher likelihood for increased satiety and decreased appetite and food cravings, according to a presenter.
    • “In a cross-sectional study presented at the European Association for the Study of Diabetes annual meeting and published in Diabetes, Obesity and Metabolism, researchers surveyed adults with obesity who were using semaglutide (Ozempic/Wegovy, Novo Nordisk) or tirzepatide (Mounjaro, Eli Lilly) and asked about changes in their appetite, satiety and sensory perception after starting an incretin-based therapy. Researchers found some adults reported increased intensity of sweet and salty tastes, and increased intensity of both types of tastes were tied with greater odds for increased satiety. However, change in taste did not affect weight-related outcomes.
    • “This means that taste perception changes may serve as markers of appetite response rather than predictors of treatment success,” Othmar Moser, PhD, professor in the division of endocrinology and diabetology in the department of internal medicine at Medical University of Graz in Austria and in the division of exercise physiology and metabolism at the Institute for Sports Science at University of Bayreuth in Germany, told Healio. “The findings highlight the nuanced ways incretin therapies act beyond pure metabolic regulation.”
  • BioPharma Dive relates,
    • “An experimental weight loss drug from Skye Bioscience failed a mid-stage clinical trial, wiping out most of the San Diego biotechnology company’s market value.
    • “Skye said Monday its therapy, an obesity medicine targeting a kind of cannabinoid receptor, didn’t significantly lower weight loss compared to a placebo after 26 weeks of treatment. Patients who received Skye’s drug, nimacimab, achieved only 1.5% weight loss, compared to less than 0.3% for placebo recipients. In a statement, Skye blamed the findings on the dose it chose for the study, arguing an analysis found that a 200 milligram weekly injection is “suboptimal as a monotherapy.”
    • “Nimacimab fared better when paired with semaglutide, the active ingredient in Novo Nordisk’s Wegovy, and tested against semaglutide alone. In that study cohort, patients on the combination lost just over 13% of their body weight, compared to more than 10% for those only on semaglutide. Skye said the findings support the potential for future studies evaluating combinations of nimacimab and other so-called incretin-based therapies widely used for weight loss.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Physician pay is increasing, largely through sign-on bonuses, but higher salaries alone often aren’t enough to retain physicians or attract top-tier talent.
    • “Advanced technology, paid time off and compensation for on-call requirements are just a few of the demands incoming physicians have for potential employers, according to respondents to Modern Healthcare’s 2025 Physician Compensation Survey. This year’s results reflect data from nine staffing and consulting firms, indicating that the trend of rising physician compensation isn’t likely to slow down anytime soon.
    • “If you’re employing physicians or any staff, you’re probably going to have to pay higher wages, particularly now,” said Chad Stutelberg, a managing director at consulting firm Gallagher. “The physicians have more leverage.”
  • Beckers Hospital Review notes,
    • “Rite Aid has closed its final 89 stores, bringing an end to operations after decades as one of the largest pharmacy chains in the U.S.
    • “All Rite Aid stores have now closed. We thank our loyal customers for their many years of support,” the company said on its website.
    • “The company filed for Chapter 11 bankruptcy protection in October 2023 and shuttered 154 stores. It filed again in May after failing to recover. 
    • “The pharmacy chain once operated more than 5,000 stores at its peak and employed about 45,000 people in 2023, including 6,100 pharmacists.”
  • The Washington Post reports,
    • “Popular weight-loss drugs Ozempic and Wegovy are now being sold at below sticker prices at Costco pharmacies across the United States, as rising obesity levels boost demand for the drugs and cheaper copycat versions.
    • “Novo Nordisk’s U.S. president, David Moore, told NBC News that the drugmaker’s push into Costco is a way to “offer the real, authentic Wegovy and Ozempic where patients seek care.”
    • “It comes as the Danish pharmaceutical giant seeks to head off competition from rival manufacturers, after sales of copycat drugs from compound pharmacies soared amid national shortages.
    • “The drugs, which mimic a natural hormone to curb hunger and make people feel full for longer, will be available on prescription to Costco members for an out-of-pocket price of $499 a month.
    • “The current list price of Ozempic is nearly $1,000 per injectable pen while Wegovy is around $1,350.”
  • Beckers Payer Issues tells us nine things to know about confusion among older adults before Medicare open enrollment.
  • Per Fierce Healthcare,
    • “Online therapy provider Talkspace acquired Wisdo Health to integrate peer support and coaching into its mental health services.
    • “Wisdo is an artificial-intelligence-powered coaching and peer-to-peer support platform that gives users 24/7 access to trained peers, moderated communities and group coaching to help combat social isolation and loneliness.
    • “The acquisition will enhance Talkspace’s service line, offering lower-acuity options and complementing existing therapy and psychiatry services. 
    • “Financial terms of the acquisition were not disclosed.”
  • and
    • “Health data company CertifyOS has unveiled its new Provider Hub platform, technology that allows insurers greater insight into key data across their provider network.
    • “Through Provider Hub, payers can tap into unified and real-time provider data that are critical to operations. The company said in an announcement that these data have traditionally been managed in siloed systems, spreadsheets and outdated tools that hinder effective use.
    • “When payers lack access to complete or usable provider data, it can have a negative impact on a slew of key business functions, Certify said, including compliance with key regulations, member experience and claims processing. 
    • “The Provider Hub takes in and cleanses, normalizes and validates key provider data from multiple sources, including credentialing, directories, claims and other internal systems. The platform leans on artificial intelligence to support this effort, according to the announcement.”
  • Per Beckers Health IT,
    • “AI-powered customer engagement company Qualtrics has agreed to acquire healthcare market research firm Press Ganey for $6.75 billion, the Financial Times reported Oct. 6.
    • “Press Ganey, currently owned by investor Ares Management and private equity firm Leonard Green & Partners, conducts surveys on behalf of over 41,000 health systems and other healthcare organizations.
    • “The deal would give Qualtrics, which deploys AI for such uses as ordering food online and rescheduling hotel stays and flights, a foothold in healthcare alongside other tech players including Oracle and Palantir, the Times reported.”

Weekend Update

David Ermer–CDC, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–
  • Roll Call reported on October 3, 2025,
    • “Senators left town Friday afternoon for the weekend after another set of unsuccessful votes to reopen the government, but a renewed flurry of bipartisan discussions on the floor provided at least a faint glimmer of hope that agreement could be reached.
    • “Republicans involved in the talks said there’s a deal to be had on a stopgap funding bill with a sidecar commitment on two fronts.
    • “One is to take up legislation dealing with expiring health insurance subsidies by Nov. 1, when open enrollment begins. The other is to pass regular, bipartisan full-year appropriations bills that would make it harder for President Donald Trump and White House budget director Russ Vought to arbitrarily cut programs they don’t like.”
  • Govexec adds,
    • “Even as the shutdown drags into its second week, federal workers will not experience any immediate delays to their pay. The next official pay date, in which most feds would be missing parts of their normal paychecks, is not until mid-October, though the exact timing will depend on which federal entity disburses their salaries. Paychecks otherwise set to hit accounts at the end of the month would be delayed in their entirety, if the shutdown continues until that point.”
  • The House of Representatives announced on October 2, 2025, that “Pursuant to clause 13 of Rule I, the Chair announced the Speaker’s designation of the period from Tuesday, October 7, 2025, through Monday, October 13, 2025, as a “district work period.” October 13 is a federal holiday.
  • The U.S. Supreme Court begins its October 2025 term today.
  • NPR Shots lets us know that as of October 2, 2025, the acting CDC Director has not adopted the September 18-19 Covid-19 vaccine recommendations of the Advisory Committee on Immunization Practices.
    • “The [final actions] are necessary for the federal Vaccines for Children Program to start shipping the vaccines to doctors, health departments and others. About half of U.S. kids are eligible for shots through the program.” * * *
    • “The CDC’s delay has also forced adults seeking vaccination to continue navigating an often confusing and frustrating patchwork of state rules that have, in many places, made it difficult if not impossible for them to get vaccinated too. Even though many states have taken steps to make it easier for people to get the vaccines, some still require prescriptions, and some pharmacists are still turning away people who can’t document they meet new eligibility requirements.”
  • Per Fierce Pharma,
    • “After reacquiring the rights to its non-vaccine flu preventative last year, Cidara Therapeutics has secured federal support to develop and produce the candidate, dubbed CD388, in the U.S.
    • “The Department of Health and Human Services’ (HHS’) Biomedical Advanced Research and Development Authority (BARDA) has graced Cidara and its flu asset with an award worth up to $339 million, Cidara said Thursday. The deal includes confirmed funding of $58 million over two years, which will be used to stand up domestic manufacturing for CD388 in the U.S. and help Cidara establish its “initial commercial supply chain,” the company explained in an Oct. 2 press release.
    • “That initial tranche of cash will also fuel a clinical trial comparing a higher-concentration formulation and different presentations of CD388, help the company further characterize the asset’s activity against pandemic flu strains in nonclinical models and kick off development of trial protocols for expanded populations, Cidara said.”
  • and
    • “Friday, the regulator unveiled a new pilot prioritization program that aims to speed up approval review times for generic drug makers that test and manufacture their products in the U.S.
    • “Specifically, generics companies that file abbreviated new drug applications that meet the “FDA’s domestic production and bioequivalence testing requirements—including the use of “exclusively domestic sources for API”—will become eligible for priority review, the agency explained in an Oct. 3 release.
    • “The pilot program aligns with the onshoring ethos that has defined many of the administration’s pharma-related policy maneuvers this year.”
  • HR Dive tells us that last week the Labor Department clarified overtime pay requirements in new opinion letters. The second batch of wage-and-hour letters released during the second Trump administration addressed a joint employer scenario as well as firefighter emergency pay.”

From the public health and medical / Rx research front,

  • The New York Times explains why brittle bones aren’t just a woman’s problem. More men are now living long enough to develop osteoporosis. But few are aware of the risk, and fewer still are screened and treated.
  • Per Medscape,
    • “Oral semaglutide showed similar reductions in cardiovascular events in patients with type 2 diabetes (T2D) and cardiovascular or chronic kidney disease with and without peripheral artery disease (PAD), according to a new SOUL trial subanalysis. Overall, however, patients without PAD experienced the most benefit.
    • “Major adverse limb events (MALE), including both acute limb ischemia and chronic limb ischemia, were also lower in patients treated with oral semaglutide than placebo, regardless of whether patients had PAD or not.
    • “PAD is common and significantly increases risk of cardiovascular and limb events, yet [it] is an under-recognized comorbidity in patients with type 2 diabetes,” said Matthew Cavender, MD, interventional cardiologist at the University of North Carolina at Chapel Hill, who presented the data at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.
    • “Therapeutic options that reduce cardiovascular and limb events are limited, and there’s an urgent need for novel strategies to improve outcomes in this vulnerable population,” he said.”
  • and
    • “In the prevention of kidney disease in patients with type 2 diabetes (T2D) and mildly reduced kidney function, SGLT2 inhibitors (SGLT2i) showed a stronger benefit than GLP-1 receptor agonists (RA) and other diabetes drugs, however, an SGLT2i/GLP-1 combination showed greater efficacy than either therapy alone, results of a new study showed.
    • “Importantly, the utilization of a clinical risk score could further improve the treatment efficacy by assigning patients to the most appropriate therapy, the study authors noted.
    • “Our take-home message is that SGLT2 inhibitors give better kidney protection than GLP-1 receptor agonists, regardless of the individual, and clinical risk scores could help identify high-risk individuals who might benefit from SGLT2/GLP-1 combination treatment,” first author Thijs Jansz, MD, University of Exeter, Exeter, England, told Medscape Medical News.
    • “The study was presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.”
  • and
    • “At the 28th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO 2025), Marianela Aguirre Ackermann, MD, presented that limited awareness, stigma, and time constraints during consultations prevent internists from discussing metabolic and bariatric surgery with patients, leaving the vast majority of individuals with obesity without appropriate care.
    • “Aguirre Ackermann is a specialist in diabetes and internal medicine at the Endocrinology, Obesity, and Nutrition Center (Centro CIEN) in Buenos Aires, Argentina.
    • “Speaking with Medscape’s Spanish edition, Aguirre Ackerman highlighted TheLancet Commission’s framework, which distinguishes “preclinical” from “clinical” obesity, as a tool to bridge the gap between consultation and surgery.
    • “It provides a clear definition and emphasizes the health impact of excess weight,” she stated.
    • “A cultural shift is needed; we need to look at the patient differently. In other words, the patient is no longer a scale, no longer an excess of kilograms, but rather an excess of adiposity that can cause disease,” she said.”

From the U.S. healthcare business front,

  • The New York Times points out how private equity oversees the ethics of drug research. Many drug trials are vetted by companies with ties to the drugmakers, raising concerns about conflicts of interest and patient safety.
  • Medscape discusses the potential role of oral GLP-1 drugs in weight management.
    • Only a fraction of the people who could benefit from taking obesity medications are currently doing so. A wider array of affordable, effective treatment options could help more people. Could oral GLP-1s be one of them? Yes, experts say, but there are some caveats [, which are discussed in the article].
  • Per MedTech Dive,
    • “Boston Scientific aims to become the market leader in the electrophysiology category as the device maker looks to pulsed field ablation to drive growth. 
    • “Our new vision is not just to be a leader in pulsed field ablation, but to be a leader in overall electrophysiology,” Nick Spadea-Anello, Boston Scientific’s global president of electrophysiology, said at a Tuesday investor meeting.”
  • and
    • “Boston Scientific is working on a new version of its Watchman device, company leaders said at a Tuesday investor presentation. 
    • “Angelo De Rosa, global president of Boston Scientific’s Watchman business, said the company is working on a version of Watchman that “will provide an answer, stability and unprecedented adaptability to each possible anatomy.”
    • “The company plans to begin enrollment next year for an upcoming U.S. investigational device exemption study and hopes to launch the device in the second half of 2027 or early 2028.”  

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Beckers Health IT informs us,
    • “Federal lawmakers have introduced a bill to extend Medicare telehealth flexibilities and CMS’ hospital-at-home waiver.
    • “The Telehealth Modernization Act of 2025 would prolong the telehealth program through Sept. 30, 2027, and CMS’ reimbursement of acute hospital care at home through 2030. The measures otherwise expire Sept. 30.
    • “Telehealth is a vital part of our healthcare system, and we must ensure that it is available to patients who need it,” said U.S. Rep. Earl “Buddy” Carter, R-Ga., in a Sept. 2 news release. “By extending telehealth flexibilities for patients, we are making healthcare more accessible, regardless of their physical location.”
    • “Mr. Carter introduced the House bill with Rep. Debbie Dingell, D-Mich., while a companion Senate bill is being led by Sens. Tim Scott, R-S.C., and Brian Schatz, D-Hawaii. Nearly 50 health systems have called for the telehealth extension.”
  • Federal News Network reports,
    • “The Office of Personnel Management is taking a closer look at the details for implementing President Donald Trump’s proposal for a larger pay raise for federal law enforcement personnel next year.
    • “The announcement from OPM comes a couple days after Trump called for a 3.8% pay raise in 2026 for federal employees working in law enforcement jobs.
    • “Certain frontline law enforcement personnel are critical to implementing the President’s strategy to secure the border, protect our country and keep American citizens safe,” OPM said this week in new guidance. “Without special salary rates, the government may find it difficult to recruit and/or retain the number of these personnel needed to properly enforce our borders, uphold our immigration laws and protect law-abiding citizens.”
    • “It’s not yet clear which specific positions or how many law enforcement officials will be included in the new special salary rate. OPM said it plans to consult with the departments of Homeland Security, Justice and Interior to define which jobs will be eligible for the larger law enforcement pay raise next year.
    • “Generally, though, OPM said the upcoming special salary rate will cover agents in the Border Patrol and the Drug Enforcement Administration, criminal investigators at Immigration and Customs Enforcement (ICE), Secret Service personnel, officers at the Federal Protective Service and the FBI, and correctional officers at the Federal Bureau of Prisons — among several other groups.”
  • and
    • “After unveiling a series of immediate acquisition changes over the summer, the Trump administration is on track to debut a formal rulemaking to overhaul and streamline the Federal Acquisition Regulation, or the FAR, this fall.
    • “Larry Allen, the associate administrator for General Services Administration’s Office of Government-wide Policy, discussed the ongoing FAR revisions and the forthcoming rulemaking during AFCEA Bethesda’s “Health IT” conference in Washington on Wednesday.
    • “Under an April executive order, the White House Office of Federal Procurement Policy and the FAR Council are leading an effort to “return the FAR to its statutory roots, rewritten in plain language, and remove most non-statutory rules.”
    • “In recent months, the FAR Council has issued a series of “class deviations” for multiple parts of the FAR. Recent deviations have focused on prioritizing the use of governmentwide contracts and simplifying commercial acquisition.” * * *
    • “In follow-up guidance to the executive order, the Office of Management and Budget said the FAR Council will turn to formal rulemaking after it has posted model deviations for all FAR parts.”
  • It’s worth adding that reginfo.gov no longer carries an “under repair” warning and while the regulatory review pages are up to date, the regulatory agenda page still features the Fall 2024 edition.
  • Govexec considers whether FEGLI Option B is really the best life insurance choice? FEGLI plans remain a solid life insurance option for federal employees, but, depending on the coverage, it may also be wise to look to the private market.
  • Following up on yesterday’s FEHBlog, Beckers Hospital Review notes,
    • “A federal rule enabling real-time access to prescription drug pricing, coverage details and prior authorization requirements is set to take effect Oct. 1. 
    • “The regulation, finalized in July as part of the CMS Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System final rule, will require healthcare providers to use certified health IT systems to electronically submit prior authorization requests, check real-time prescription drug pricing during patient encounters and share electronic prescription data with pharmacies and insurers.”
  • Fierce Healthcare adds,
    • “The Department of Health and Human Services’ investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday. 
    • “The news comes as Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability. 
    • “A press release by HHS says Health Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
    • “The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to HHS’ Office of the Inspector General to assist their investigations, Assistant Secretary Thomas Keane said in a statement.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness.
    • “Drug developers – and the patients they hope to treat – deserve clear, consistent information from the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “These principles ensure that FDA and sponsors are aligned on a flexible, common-sense approach within our existing authorities, and that we incorporate confirmatory evidence to give sponsors a clear, rigorous path to bring safe and effective treatments to those who need them most.”    
  • BioPharma Dive reports,
    • “Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago.
    • “After some delays, the Food and Drug Administration is set to issue an approval verdict on this medicine sometime between October and the end of December. If cleared for market, the oral drug would be sold as Vyglxia and used to treat patients with spinocerebellar ataxia, a type of genetic disorder where the progressive erosion of nerve cells causes problems with movement, coordination and brain function.”
  • Per MedTech Dive,
    • “Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
    • “Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
    • “The FDA decision also expands the insulin pump to adults with Type 2 diabetes.”

From the public health and medical/Rx research front,

  • The American Hospital News tells us,
    • “The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory syncytial virus this upcoming respiratory virus season compared to last year’s, according to its 2025-26 outlook released Aug. 25. The agency is predicting higher peak weekly COVID-19 hospitalization rates this season, particularly if a variant with moderate immune-escape properties emerges.”
  • and
    • “The AHA Sept. 3 released a study conducted by KNG Health Consulting that found Medicare patients who receive care in a hospital outpatient department are more likely to come from geographically isolated and medically underserved communities and be sicker and more complex to treat than Medicare patients treated in independent physician offices. Specifically, the study found that Medicare patients who are seen in HOPDs — including those with cancer — are more likely to be from rural and lower-income areas, living with more severe chronic conditions, dually-eligible for both Medicare and Medicaid, previously hospitalized or cared for in a hospital emergency department, and under 65 and eligible for Medicare based on disability.”
  • The Wall Street Journal discusses how to get the new Covid vaccine.
  • NBC News adds,
    • “An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday.
    • “The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown.” * * *
    • “Our findings suggest azelastine could serve as a scalable, over-the-counter prophylactic against Covid, especially when community transmission is elevated or in high-risk settings such as crowded indoor events or travelling,” said Dr. Robert Bals, professor of internal medicine and pneumology at Saarland University and the study’s senior author.
    • “The trial had limitations, namely that the participants were all young and relatively healthy, he said. 
    • “Bals said that azelastine should not be seen as a replacement for vaccinations, and larger studies were needed before recommending it as a routine preventative measure for the general public, and especially vulnerable groups.”
  • Per a National Institutes of Health news release,
    • “Researchers funded by the National Institutes of Health (NIH) have found that a single injection of the antibiotic benzathine penicillin G (BPG) successfully treated early syphilis just as well as the three-injection regimen used by many clinicians in the United States and elsewhere. These findings from a late-stage clinical trial suggest the second and third doses of conventional BPG therapy do not provide a health benefit. The results were published today in The New England Journal of Medicine.
    • “Benzathine penicillin G is highly effective against syphilis, but the three-dose regimen can be burdensome and deter people from attending follow-up visits with their healthcare providers,” said Carolyn Deal, Ph.D., chief of the enteric and sexually transmitted infections branch of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “The new findings offer welcome evidence for potentially simplifying treatment with an equally effective one-dose regimen, particularly while syphilis rates remain alarmingly high.”
    • “Syphilis is a common sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The United States reported 209,253 total syphilis cases and 3,882 congenital syphilis cases in 2023, representing 61% and 108% increases over 2019 numbers, respectively. Without treatment, syphilis can result in neurological and organ damage as well as severe pregnancy complications and congenital abnormalities. Syphilis can also increase a person’s likelihood of acquiring or transmitting HIV.
    • “BPG is one of the few antibiotics known to effectively treat syphilis, and stockouts are common worldwide. The antibiotic is currently being imported to the United States to resolve a nationwide shortage.”
  • Per Beckers Hospital Review,
    • “Researchers have successfully used repurposed cancer drugs to target dormant breast cancer cells, aiding in the delay or prevention of recurrence, according to a study published Sept. 2 in Nature Medicine. 
    • “Researchers from Philadelphia-based University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine enrolled 51 breast cancer survivors to identify and target the cells with existing cancer drugs.” * * *
    • “Read the full study here.” 
  • Per Healio,
    • “Nonsurgical treatments may offer long-term reductions in pain and disability for patients with chronic low back pain.
    • “Treatment options included cognitive behavioral therapy, mindfulness and exercise.”
  • Per Health Day,
    • “Guidelines recommend that preschoolers diagnosed with ADHD first get six months of behavioral therapy before drug therapy is initiated
    • “New research shows this rule is followed by U.S. doctors only about 14% of the time, and that could mean poorer outcomes for kids
    • “A lack of access to therapists is often cited as a reason for starting meds soon, but experts say there are ways around that.”

From the U.S. healthcare business front,

  • Fierce Pharma points out,
    • “After joining multiple other drugmakers on the U.S. investment bandwagon earlier this year, Gilead Sciences is providing further details on where it plans to channel its $32 billion pledge.
    • “Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday.
    • “The new facility, which will reach five stories and cover 180,000 square feet, will serve the company’s technical development and manufacturing teams, leveraging a mix of digitalization, autonomous robotics and real-time digital monitoring. Additionally, the project is expected to boost Gilead’s capabilities and capacity around biologics, which the company described as a “central pillar” of its broader growth strategy.”
  • Beckers Hospital Review lets us know,
    • “Cincinnati-based TriHealth has completed the acquisition of Clinton Memorial Hospital, a 140-bed facility in Wilmington, Ohio, marking its sixth acute care hospital.
    • “The facility will be renamed TriHealth Clinton Regional Hospital and serve as a hub for the system’s specialized services, including women’s health, cancer, heart and vascular, neurosciences and stroke care.
    • “This new name will extend TriHealth’s brand promise to ‘see, to hear and to heal … delivering surprisingly human care’ to the residents of Clinton County,” TriHealth President and CEO Mark Clement said in a Sept. 2 news release. “And it will also affirm TriHealth’s commitment to invest in the hospital and expand services locally, establishing it as a regional hub for TriHealth’s exceptional, nationally recognized care.”
  • Fierce Healthcare reports,
    • “HonorHealth, an Arizona-based health system, is acquiring a number of Evernorth Care Group locations across Phoenix.
    • “Evernorth Care Group lists 18 centers offering integrated primary care services to nearly 80,000 patients throughout the metropolitan area. The clinics will become part of HonorHealth at the close of the deal, slated for January 2026, pending regulatory approvals.
    • “This acquisition enhances the services we offer and expands Valley residents’ access to care,” HonorHealth CEO Todd LaPorte said in the announcement. The financial terms were not disclosed.” 
  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s prior authorization gold card program has seen a more than 40% increase in the number of qualifying provider groups in 2025, the company shared with Becker’s.
    • “Launched in October 2024, the program reduces prior authorization requirements in favor of advance notification for provider groups that consistently adhere to evidence-based care guidelines.
    • “Providers can lose gold-card status because of patient safety issues, failure to cooperate with quality and patient safety activities, failure to make timely responses to requests for information, or because they no longer meet program requirements. UnitedHealthcare conducts annual evaluations for gold card qualification, with determinations effective on Oct. 1 every year. 
    • “On Sept. 1, provider groups could begin viewing their program status in the UnitedHealthcare Provider Portal. Starting Oct. 1, additional groups will be eligible.”
  • and
    • “Economic uncertainty and policy changes from the current administration have changed the way health plans operate over the past year. Many have found workarounds to continue efficiency and growth.
    • “Becker’s connected with five leaders to learn their biggest accomplishments so far in 2025.”
    • Check it out.
  • Milliman has posted its “2025 Milliman Retiree Health Cost Index.”
  • McKinsey & Co. discusses “the quantum revolution in pharma: Faster, smarter, and more precise.”
    • “Quantum computing presents a multibillion-dollar opportunity to revolutionize drug discovery, development, and delivery by enabling accurate molecular simulations and optimizing complex processes.”
  • Radiology Business notes,
    • “Hospital- and private equity-affiliated radiology practices command significantly higher prices than their independent practice counterparts, according to new research published Tuesday. 
    • “Consolidation of imaging groups has accelerated in recent years, with limited evidence on how this change impacts economics within the specialty. Researchers with Brown University recently set out to understand how such M&A activity has changed prices for radiology services, sharing their findings in the Journal of the American College of Radiology (JACR). 
    • “They found a noteworthy gap, with negotiated professional prices for hospital-based radiology services about 43% higher than independents. That’s compared to about 16% higher for investor-backed radiologists versus others in private practice. 
    • “Our findings demonstrate significant differences in negotiated radiologic service prices by practice ownership, with hospital and PE-affiliated practices able to negotiate higher professional fees than independent practices,” corresponding author Yashaswini Singh, PhD, MPA, a healthcare economist and professor with the Providence, Rhode Island, institution, and colleagues concluded. “These results highlight the financial implications of ongoing consolidation in radiology and underscore the need for continued research into how these trends affect radiologists, insurers and patients.”