Cybersecurity Saturday

Agentic & Generative AI

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the frontier artificial intelligence front

  • The Wall Street Journal reports,
    • “Rogue AI models have hacked companies and tried to break into government websites. Now one has submitted a fake tip for an unsolved crime.
    • “Police in Philadelphia say Anthropic alerted them this week that one of its artificial-intelligence models submitted a false homicide tip through PhillyUnsolvedMurders.com. 
    • In a blog post, Anthropic said the fake tip was among a group of rogue actions the company uncovered recently. The rogue activity also involved websites run by U.S. government agencies at the federal, state and local levels. The company said it has briefed the White House on these cases and notified each agency involved, and plans to report new instances of unintended AI behavior as it uncovers them.
    • “While these cases had minimal impact, we do not want to diminish the findings, because the same behaviors could do far more harm as models become more powerful,” Anthropic said in the blog post.
    • “The false-report incident happened in July. Anthropic didn’t realize it until September.”
  • and
    • “Anthropic edged to the front of the AI race earlier this year with cutting-edge models and a coding tool that corporate America loved. By some measures, OpenAI is now hot on its heels.
    • Demand for Anthropic’s Claude Code was so strong in the spring that the company faced frequent outages and a computing crunch. 
    • “But businesses grappling with mounting costs as more employees experimented with artificial intelligence realized they didn’t always need the most advanced options for most tasks. Companies, which now use a variety of models, increasingly turned to low-cost, open-weight models from China for some tasks. And some Claude users balked at guardrails Anthropic put on its powerful Fable 5 model when it was released in early June.
    • “OpenAI stoked the price war this summer with the release of its GPT-5.6 lineup—Sol, Terra and Luna—giving customers access to models with varying capabilities, including some that are less expensive to run. Its Codex coding product and other business tools are now gaining ground, and it has released additional iterations of its cost-efficient models.
    • “An analysis from OpenRouter, a startup that allows developers to access different models, found that among some 120,000 companies that use Anthropic and OpenAI tools, the share of spending was roughly even between the two AI giants in September. At the beginning of the year, Anthropic commanded three-quarters of that total. OpenRouter said its data largely represents spending by AI-native startups as well as some slightly older tech companies and large enterprises.”
  • and
    • “Mistral said it would soon release a new open-weight AI model that it claimed would rank among the best globally, part of efforts to grow its appeal, lock in more customers and better compete with U.S. rivals.
    • “The French artificial-intelligence startup said it was launching a public preview of Mistral Large 4, dubbed Le Chonk, on Tuesday so it could work with developers, cybersecurity experts and state authorities to evaluate how the model behaves. It plans to release the weights, or the trained parameters of the model, on Oct. 27.
    • “Since its early days, Mistral has been a staunch advocate of open-weight models that are publicly available for anyone to download and modify, saying they give users the flexibility to tailor them to their needs while protecting their data and intellectual property.”

From the cybersecurity policy and law enforcement front

  • The Wall Street Journal reports,
    • “A new White House task force will have 120 days to report on the risks and opportunities of artificial intelligence—and determine the federal government’s responsibility—according to Jay Clayton, the director of national intelligence who effectively becomes the administration’s AI czar.
    • “The president asked that a group be put together that was going to ensure exactly what he said,” Clayton said, that “we stay the leaders in superintelligence, and that the interests of the American people are put first.” 
    • “Clayton will chair the “Super Intelligence Force” which takes President Trump’s preferred name for AI: super intelligence or SI.
    • “The risk of not being first is high,” Clayton said. “Not being first increases the identified, and unidentified, risks, particularly from our adversaries. Being first will better enable us to address those risks on behalf of the American people,” he added.” * * *
    • “The task force will have three vice chairs: Emil Michael, undersecretary of war for Research and Engineering, who will be responsible for coordination with AI companies; Scott Kupor, director of the Office of Personnel Management, who will be responsible for coordination with critical infrastructure providers and other industry stakeholders; and Andrew Ferguson, chairman of the Federal Trade Commission, who will oversee consumer interests and groups advocating for people of faith, children, privacy, freedom of speech, freedom of expression, and freedom of association.”
  • Cyberscoop relates,
    • “Federal government contractors that handle sensitive information could soon face a “sea change” in rules about how they protect that information and report when it has been part of a breach.
    • “Pending federal regulations on the handling of “controlled unclassified information,” or CUI, a category of sensitive data that falls short of classified — including people’s personal information such as Social Security numbers, information that could expose vulnerabilities in critical infrastructure and more — could arrive as soon as the end of this year, but likely no later than the end of President Donald Trump’s term, attorneys who specialize in federal procurement rules said. The changes are part of a larger overhaul of federal contracting rules.
    • As currently written, the proposed CUI rules mandate that unauthorized access of such data, including as a result of a cyberattack, would have to be reported to the federal government within 72 hours of discovery. The rules are a companion for most federal agencies to existing  Defense Department rules that cover the same subject. The 72-hour notice also is deliberately aligned with forthcoming rules from the Cybersecurity and Infrastructure Security Agency (CISA) for critical infrastructure owners and operators to report major cyber incidents under the Cybersecurity Incident Reporting for Critical Infrastructure Act (CIRCIA).” * * *
    • The other major aspect of the proposed rule is that contractors handling CUI would have to abide by certain cybersecurity standards set by the National Institute of Standards and Technology known as SP 800-171, which [Trayce] Howard and her Wiley [Rein] coauthors said would be imposed “on a broader group of contractors than ever before.” Some contractors might also have to meet other cybersecurity requirements, too.
    • “Another thing that will affect contractors is they’re going to have to flow down these requirements to their subcontractors,” she said. “So they’re going to have to identify what CUI am I giving to my subcontractors, and do some sort of oversight to make sure that their subcontractors are appropriately handling CUI.”
  • Cybersecurity Dive tells us,
    • “U.S. government agencies are failing to prepare for the transition to post-quantum encryption, creating the risk that their sensitive data will still be vulnerable to decryption by quantum computers whenever those machines are deployed, according to the Government Accountability Office.
    • Experts are divided over when the advent of cryptographically relevant quantum computers (CRQC) will occur, but GAO bluntly declared in a report published Tuesday [October 6]  that “threats from a CRQC could have devastating impacts to federal systems reliant on vulnerable cryptography.” * * *
    • “In a version of the report not publicly released, GAO recommended 89 actions that CISA and other agencies could take to increase their preparedness. Of the 23 agencies to which GAO assigned recommendations, only 12 fully agreed to implement them. “We continue to believe that all of the recommendations made in the sensitive report are warranted,” GAO said.”
  • The Wall Street Journal notes,
    • A bipartisan group of federal lawmakers is pressing Congress to increase mental-health funding for personnel at U.S. Cyber Command in the wake of several suicides this summer at the command and the National Security Agency. In separate letters, members of the House Armed Services cyber subcommittee and Maryland lawmakers urged leaders of the House and Senate Appropriations panels to back an $11 million request for “High Performance Team Training” at the command. (The Baltimore Banner)
  • and
    • German officials said they infiltrated ransomware group Qilin and detained a 28-year-old Russian national believed to be one of the group’s leaders. The arrest follows months of covert monitoring of Qilin’s activities, the official said. The group is alleged to have demanded more than $3 billion in ransom payments over the past two years from targets around the world. (LIGA)
  • The New York Times adds,
    • “The F.B.I. has arrested a Canadian cybersecurity expert in Pennsylvania on suspicion of carrying out the computer hack that stole sensitive information about thousands of F.B.I. employees, according to two people familiar with the matter.
    • “The theft of reams of personal data last month by a criminal hacking group that calls itself ShinyHunters left the nation’s premier law enforcement agency racing to respond to the investigators and the victims of one of the worst breaches of government data in recent years.
    • “The arrested man is Edward Dubrovsky, who has helped firms victimized by hackers and is now considered by federal authorities to be a primary co-conspirator in the ShinyHunters attack on F.B.I. data, the people said.
    • “Mr. Dubrovsky is the author of a book published last month titled “Cyber Extortion Strategic Response.” While the details of the charges against Mr. Dubrovsky remain under seal in Texas, federal court records in Philadelphia show that he was charged with conspiracy to commit extortion. Mr. Dubrovsky is expected to be transported to Texas to face the charges.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) today announced a settlement with Linda L. Shen d/b/a Shen Smiles, P.C. (Shen Smiles), a Pennsylvania-based healthcare provider that offers dental services, for potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The settlement resolves an investigation of a complaint alleging a failure to provide timely access to an individual’s protected health information (PHI).”
    • “The Notice of Proposed Determination may be found here.
    • “The Resolution Agreement may be found here [PDF, 161 KB].”

From the cybersecurity breaches and vulnerabilities front

  • HIPAA Journal reports,
    • “The scale of a 2025 data breach involving electronic protected health information stored on Oracle Health’s legacy Cerner servers is becoming clearer. While not independently verified, Bloomberg reports that the Texas Attorney General released information suggesting that the protected health information of almost 20 million individuals was compromised in the incident. Oracle Health has not publicly disclosed how many Cerner clients were affected, or the total number of individuals affected.”
  • Security Week relates,
    • “Healthcare organizations Clover Health Investments and AngMar Management Services are notifying more than 250,000 people that their information was stolen in separate data breaches.
    • “Jersey City, New Jersey-based Clover Health Investments was hacked in early July, after attackers used social engineering to compromise three non-managerial health plan employee accounts.
    • “The incident resulted in the theft of personally identifiable information (PII) and protected health information (PHI), the company said in an SEC filing in July.
    • “The potentially affected information included names, dates of birth, insurance identifiers, and account identification numbers, the company revealed.
    • “In mid-September, Clover Health Investments told the US Department of Health and Human Services (HHS) that 138,677 people were affected. HHS added the company to its data breaches portal last week.
    • “Mansfield, Texas-based AngMar Management Services identified suspicious activity on its systems in mid-July and confirmed in early September that hackers stole patient PII and PHI.
    • “AngMar Management Services provides business operations, administration, and support network management for home health and hospice care providers.”
  • The American Hospital Association News tells us,
    • “The FBI and Secret Service released an advisory Oct. 6 warning of ongoing activities by FortiBleed, a global credential-compromise campaign used by threat actors to target internet-facing Fortinet FortiGate firewalls and virtual private network gateways at critical infrastructure organizations. The agencies said the campaign exploits reused or leaked credentials and legacy password storages, allowing threat actors to harvest and decode authentication data at scale. Impacted organizations could be locked out of their systems if threat actors disable accounts or change passwords and would require remediation actions beyond typical patching and password resets. The advisory includes indicators of compromise and mitigation actions to defend against potential attacks.”
  • and
    • “A joint advisory released Oct. 8 by U.S. and international agencies warns of Chinese government-linked cyber threat actors using automated and hands-on hacking tools to steal sensitive data from critical infrastructure organizations, including healthcare, across the U.S. and abroad. The advisory said that the threat actors are enabled by the Integrity Technology Group, a China-based company with links to the Chinese government. The agencies said the threat actors are using automated scanning tools, large-scale botnets and hands-on exploitation techniques to attack Microsoft Exchange servers and virtual private network software. The advisory includes recommendations to help mitigate risk from potential attacks.” 
  • Cyberscoop adds.
    • “The Justice Department and FBI announced that they had seized two hacking tools connected to the Chinese government-linked group Flax Typhoon and a China-based company that the U.S. government has repeatedly taken action against, including with a new multi-agency advisory Thursday.
    • “The domain name seizures were meant to deny hackers access to the vulnerability scanning tool Microscan and the spearphishing tool FishHub created by the Chinese firm Integrity Technology Group, which the United States sanctioned last year. The U.S. government in 2024 also made the company the focus of a takedown operation, saying it was behind a massive botnet.
    • “U.S. agencies paired the announcement of the seizures with an Oct. 8 advisory from the FBI, Cybersecurity and Infrastructure Security Agency and National Security Agency.”
  • CISA added one known exploited vulnerability to its catalog this week.
    • October 4, 2026
      • CVE-2026-88779 Citrix NetScaler Improper Restriction of Operations within the Bounds of a Memory Buffer Vulnerability
        • Cyber Press discusses this KVE here.
  • Bleeping Computer notes,
    • “Attackers are exploiting a maximum-severity vulnerability in SonicWall SMA1000 appliances (CVE-2026-102255) that was patched on Tuesday, three days ago.
    • “Tracked as CVE-2026-102255, the flaw affects the Appliance WorkPlace interface on SMA1000 6210, 7210, and 8200v models, but does not affect the SMA 100 Series product line or SSL-VPN running on SonicWall firewalls.
    • “By abusing this path, a remote unauthenticated attacker could potentially exploit this vulnerability to direct the appliance to issue requests on their behalf and reach internal functionality and perform unauthorized operations,” SonicWall explained.”
  • and
    • “Citrix has warned IT administrators to patch systems immediately against a new critical vulnerability affecting NetScaler ADC networking appliances and NetScaler Gateway secure remote access solutions.
    • “Tracked as CVE-2026-107406, this flaw stems from a memory overflow weakness that attackers can exploit to gain remote code execution (RCE) on targeted devices or trigger a denial-of-service state that can cause crashes.
    • “To be vulnerable, NetScaler ADC and NetScaler Gateway appliances must be configured as a Security Assertion Markup Language (SAML) Identity Provider (IdP) or Service Provider (SP).
    • “We strongly urge affected customers to review the advisory and upgrade impacted NetScaler instances to the recommended versions as soon as possible,” the company said. “As of the publication of the bulletin, Citrix is not aware of any unmitigated exploits of this vulnerability.”
  • Per Cybersecurity Dive,
    • “Hackers may be using AI more frequently and in more ways, but their top priority is still subverting identity controls, the identity-security firm Okta said in a report published on Wednesday.
    • “The report included data about the frequency of different kinds of account takeovers and a reality check to enterprises that AI shouldn’t fundamentally change their calculus when it comes to identity management.
    • “In a separate report also published on Wednesday, Okta detailed how hackers are trying to bypass strong authentication controls to sneak into accounts, underscoring the need for vigilance among both system administrators and regular employees.”
  • Security Boulevard adds,
    • “An analysis of 150 billion transactions flowing through Domain Name System (DNS) servers published today by EfficientIP finds that malware has overtaken phishing as the threat vector now being detected most.
    • “The latest DNS Threat Intelligence Report from EfficientIP finds malware has climbed from fourth place in the second half of 2025 to first in daily activity, having roughly quadrupled between a January and an April peak of 32.6 million instances.
    • “Yaelle Harel, principal security market strategist for EfficientIP, said that while there is no conclusive evidence, that level of increase suggests cybercriminals may now be leveraging artificial intelligence (AI) tools to both create malware and launch attacks faster using newly acquired IT infrastructure resources.”

From the ransomware front

  • Info Security Magazine reports,
    • “Ransomware attacks reached their highest ever quarterly volume in the third quarter of 2026, according to an analysis by Comparitech.
    • “The firm identified a total of 2627 claimed attacks during the three-month period from July to September 2026. This is a 27% increase on the previous quarter, Q2 2026, and a 61% rise compared to Q3 2025.
    • “The finance and technology sectors experienced the biggest growth in ransomware incidents in Q3 compared to Q2 2026, up by 72% and 70%, respectively.
    • “Other critical sectors faced a significant rise in attacks, including education (up 50%), healthcare (39%), government (36%) and utilities (32%).
    • Of the 2627 attacks claimed by ransomware groups in Q3, 247 have been confirmed by the entity involved, Comparitech found.
    • “Rebecca Moody, head of data research at Comparitech, said that the figures are highly unusual, and represent a significant cause for concern.: * * *
    • “A possible explanation for the surge is developments in AI technology, which is enabling ransomware attackers to increase the scale and speed of campaigns, as well as their effectiveness.” * * *
    • “The report highlighted an increase in attackers using triple extortion tactics on victim organizations. In this model, in addition to encrypting systems and exfiltrating data, threat actors also target individuals impacted in the attack.
    • Moody added that this tactic further demonstrates that paying a ransom is no guarantee that the attacker will keep to their word regarding deleting stolen data.
  • Recorded Future News relates,
    • “The University of Illinois Chicago (UIC) recently discovered a ransomware attack that limited access to some systems at its College of Medicine.  
    • “A spokesperson for the university told Recorded Future News the hackers were able to steal some information held on the college’s servers and an investigation is underway to determine whether “any personal, research or academic information was compromised.” 
    • “As a result of this ransomware event, some College of Medicine systems were temporarily unavailable,” the spokesperson said. “However, all affected systems have since been restored. The university’s main network was not affected, and there was no impact on patient care delivery at UI Health.” * * *
    • “The attack was claimed last week by a ransomware gang known as Booba, which claimed to have stolen 344 gigabytes of data. The group emerged at the end of July and has already claimed 49 attacks. 
    • “SentinelOne’s Brett Williams said the group appears to be a rebrand of the Frag ransomware based on the leak site’s style and negotiation flow. Encrypted files are renamed with the .booba extension and there appears to be variants for Linux as well as Windows.  
    • “The group has targeted several companies and small county governments, including Merrimack County, New Hampshire.” 
  • Cyberscoop tells us,
    • “Authorities accuse the owner of a so-called ransomware remediation company of swindling clients victimized by ransomware attacks into paying the company inflated fees under false pretenses.
    • “Zohar Pinhasi, owner and operator of MonsterCloud, claimed he could decrypt and recover victims’ data with specialized, proprietary tools and avoid paying cybercriminals. Yet, no such tool existed, the Justice Department said Wednesday [October 7]. 
    • “Pinhasi allegedly used MonsterCloud clients’ fees to pay off cybercriminals and recover encrypted data without telling clients ransom payments were made on their behalf. The dual “U.S.-Israeli national is accused of charging hundreds of clients more than $19 million and paying more than $8 million in ransom payments during a five-year period ending in 2023.
    • “It baffles me that companies fall for this,” Jon DiMaggio, principal researcher at Arkem Cyber, told CyberScoop. “I mean, they just got hacked and they go straight to a shady source.”

From the cybersecurity business and defenses front,

  • Cybersecurity Dive discusses what the C-suite needs to know about AI governance
    • “As AI adoption surges, executives are learning tough lessons about security, oversight and accountability.”
  • The American Hospital Association News tells us,
    • The National Security Agency Oct. 8 released guidance for critical infrastructure organizations that recommends adopting high-impact zero trust strategies to improve cybersecurity for operational technology. For healthcare, such technology includes tools that manage energy control, HVAC, life-safety systems, door access controls, physical security systems, alarms and medical gasses. Zero trust is a security principle that assumes a compromise is possible or already present and continuously verifies users and devices. The guidance also highlights recent nation-state attacks, including the People’s Republic of China’s prepositioning of disruptive malware known as Volt Typhoon on critical infrastructure entities that healthcare depends on, such as energy. The guidance also explains how threat actors’ use of artificial intelligence is making cyberattacks more sophisticated and potentially more severe.
  • Security Week points out,
    • “All enterprises conduct security awareness training for their employees. But whether this has tangible benefits is debatable.
    • “Empirical evidence suggests that security awareness training isn’t working – successful attacks keep increasing. But opinions on the efficacy of awareness training range from it doesn’t work to it does work, with sometimes, perhaps and depends between the two extremes.
    • “Awareness training focuses on two tasks: to reduce the effect of bad judgment turning an employee into an insider threat; and to harden employees against falling to malicious social engineering. We focus on social engineering.” * * *
    • “Sanny Liao, co-founder and CPO at Fable Security, says bluntly, “For the most part, security awareness training as done today does not work. Social engineering continues to succeed because attackers exploit context, timing, and psychology, while most training remains generic, infrequent, and removed from the moments when employees are actually making decisions.”
    • “She hints at a novel approach. “One place the industry can look for inspiration is adtech. Marketers have gotten remarkably good at changing behavior by delivering the right message at the right time based on context. Security awareness has largely done the opposite by giving everyone the same training at the same time, regardless of the decisions they’re making or the risks they face. When organizations change behavior instead of simply raising awareness, employees stop being viewed as the weakest link and start becoming an active part of the organization’s security defenses.”
  • Per a NIST news release,
    • “For small businesses who are often confronted with limited resources, knowing how to get started and where to find support with planning, implementing, or evaluating a cybersecurity risk management strategy can be challenging — sometimes making cybersecurity feel like an insurmountable hurdle. However, there is good news.
    • “Many non-profit organizations across the United States have created programs for their local small business communities (in addition to local schools, municipal governments, and non-profits) that often extend beyond general cybersecurity education to include services like conducting risk assessments and penetration tests, performing compliance consulting services, helping with incident preparedness and response measures, and more.
    • “The NIST Small Business Cybersecurity Support Program Finder brings these programs together into one tool, connecting small businesses with local non-profit community partners who help with cybersecurity risk management.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, NCQA, U.S. Healthcare–

Simplicity is a virtue.

From Washington, D.C.,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 9 released its first report on how states are implementing funds from the Rural Health Transformation Program, which will distribute $50 billion to rural providers from fiscal year 2026 to FY 2030. The report covers the period from Dec. 29, 2025, to July 31, 2026. The report details how much each state has allocated for the first year of the program, which would be spent by September 2027.”
  • Over the past week, CMS has issued news releases about contributions to the following State rural health programs:
  • Per Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS) today launched the Newborn Essentials Support Toolkit (NEST) Program at West Virginia University Medicine Golisano Children’s Hospital in Morgantown, West Virginia, marking the next phase of a federal initiative designed to support mothers and babies during the critical first days and weeks after birth.
    • “Led by HHS through the Office of Intergovernmental and External Affairs (IEA) in coordination with the Health Resources and Services Administration (HRSA), NEST provides families with a one-time kit of essential newborn and postpartum supplies, maternal health items, and trusted information and resources around the time of birth.” * * *
    • “NEST Kits are distributed through hospitals, federally qualified health centers, and other organizations providing maternity care to mothers late in pregnancy or around the time of birth. Through these trusted partners, HHS is working to reach families in communities across the country while prioritizing areas where mothers and babies face greater barriers to care and resources.
    • “Through NEST, HHS is building on what families and healthcare providers said worked: providing useful, high-quality supplies at a moment when families need them most, while connecting mothers with trusted information to help care for themselves and their newborns.
    • “For more information, visit hhs.gov/newbaby.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), today announced the recipients of three falls prevention initiatives totaling up to $27.8 million over three years. The funding will expand proven programs, strengthen connections between health care providers and community organizations, and help states and local partners reach more older adults before a fall leads to injury or loss of independence.
    • “Falls are the leading cause of injury for people 65 and older. One in four older adults falls every year, and a fall is rarely just a fall. It can result in an injury or hospital stay, and non-fatal falls account for an estimated $80 billion in healthcare spending per year. A fall can also shake a person’s confidence and make everyday activities — from walking and shopping to visiting friends — more difficult. Healthcare and aging network providers can help prevent many falls by identifying risks early. They can then connect older adults with programs and support that build strength, improve balance, and make their homes safer.
    • “The three initiatives put prevention first and advance the Trump Administration’s Make America Healthy Again agenda. They will connect screening with community support, expand proven programs statewide, and help organizations deliver and sustain them.” * * *
    • “Learn more about ACL’s Falls Prevention Program here.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) provided a new recommendation to the Drug Enforcement Administration (DEA) that establishes science-based thresholds for 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI), potent opioid compounds associated with products marketed as kratom.
    • “The Department of Justice today announced that DEA issued new Notices of Intent reflecting HHS’ updated scientific analysis and recommendations, including a new Notice of Intent for 7-OH and MGPI incorporating HHS’ recommended concentration and ratio thresholds.
    • Following a review of available scientific data and comments, HHS Assistant Secretary for Health Admiral Brian Christine, M.D., recommended that DEA use concentration or ratio-based thresholds to determine which products containing 7-OH and MGPI are subject to Schedule I control for purposes of temporary scheduling of these substances under the Controlled Substances Act.
    • “The recommendation is designed to target concentrated or chemically altered products while distinguishing them from natural botanical kratom products, which may contain trace amounts of 7-OH and MGPI.”
  • Beckers Clinical Leadership adds,
    • “The National Institutes of Health plans to launch a public-private partnership in December to speed development of personalized cancer vaccines, according to an Oct. 9 New York Times report.”
  • NCQA, writing in LinkedIn, tells us,
    • “At the opening of the 2026 Health Innovation Summit in Atlanta, NCQA President and CEO Dr. Vivek Garg, MD, MBA reflected on his first year leading the organization, honored the legacy of healthcare quality pioneers and invited attendees to help shape what comes next. Addressing a room filled with health plans, clinicians, policymakers, researchers, employers, technology leaders and patient advocates, he framed the Summit theme, Quality’s Next Chapter, as both a moment of reflection and a call to action.
    • “A year ago, many of you met me for the first time on this stage, when Peggy O’Kane handed off an organization she spent more than three decades building,” Dr. Garg said. “I’ve spent the year since mostly listening.”
    • That year of listening, he said, clarified NCQA’s mission and reinforced a central belief: “we cannot write quality’s next chapter alone.”

From the U.S. Food and Drug Administration front,

  • Bloomberg Law reports,
    • “Food manufacturers can now use salt substitutes in common foods including bread, canned peas, and sour cream under a federal rule regulators updated in an effort to reduce Americans’ sodium intake.
    • “A final rule published Friday in the Federal Register under public inspection loosens requirements that certain foods contain salt under the Food and Drug Administration’s standards of identity, which regulate what a product must contain to be marketed as a specific food.
    • “The regulatory update allowing food makers to use salt substitutes actualizes a proposal from the Biden administration to improve consumers’ diets, as officials raised concern that the average American consumes a level of sodium that’s 50% above the limit recommended by scientists.” 
  • Reuters relates,
    • “Teva (TEVA.TA), opens new tab ​said on Friday it had received approval ‌from the US Food and Drug Administration for Weltruza, a once-monthly injection for adults with ​schizophrenia.
    • “Weltruza is the second US-approved product ​from Israel-based Teva’s partnership with French ⁠biotech company Medincell (MEDCL.PA), opens new tab after Uzedy, a long-acting ​injectable form of antipsychotic drug risperidone, which ​the FDA approved in 2023.”
  • Medical Life Sciences News tells us,
    • “The Alliance for Clinical Trials in Oncology (Alliance) today announced that the U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq®) in combination with fluoropyrimidine and oxaliplatin chemotherapy, for the adjuvant treatment of patients with stage III colon cancer with deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR).
    • “The approval is based on findings from the phase III Alliance ATOMIC (A021502) trial, sponsored by the National Cancer Institute (NCI) and conducted in partnership with Genentech, a member of the Roche Group, and the German group Arbeitsgemeinschaft Internistische Onkologie (AIO). The study demonstrated that patients with stage III colon cancer whose tumors had mismatch repair deficiency (dMMR) experienced significantly improved disease-free survival, a surrogate for overall survival, when atezolizumab was added to standard adjuvant chemotherapy following surgery.”
  • Healio adds,
    • “Medicare coverage is now available for the Fsyx ocular pressure adjusting pump, a device indicated to lower IOP in patients with glaucoma while they are sleeping.
    • “The device consists of pressure-sensing goggles connected to a compact pump that counteracts IOP overnight using negative pressure. CMS reimbursement for the Fsyx ocular pressure adjusting pump (Balance Ophthalmics) became effective on Oct. 1.”

From the Medicare Advantage front,

  • Healthcare Dive reports,
    • “Medicare Advantage star ratings are slipping in 2027, though one major insurer clinched an extreme upgrade.
    • “Humana, which suffered a major ratings collapse two years ago, saw the percentage of its members in 4+ star plans rocket from 41% in 2026 to 93% in 2027, according to a Healthcare Dive analysis of stars data released Thursday by the CMS.” * * *
    • “Alignment Healthcare, which covers some 280,000 members in five states, was one of the biggest losers, after its largest contract slipped below 4 stars for 2027.
    • “It’s a serious setback for the California-based insurer, given the contract covers around three-fourths of its total membership. Next year, Alignment will only have 25% of members in plans rated above that threshold, down from 98% currently.”
  • Beckers Payer Issues delves into Humana’s star rating turnaround.

From the judicial front

  • The American Hospital Association News reports,
    • “The AHA, the Maine Hospital Association and four safety-net hospitals Oct. 9 filed a lawsuit in the U.S. District Court for the District of Maine challenging changes by the Department of Health and Human Services to the 340B Drug Pricing Program that would expand the use of a proposed rebate model previously halted by the courts.  
    • The lawsuit seeks to prevent implementation of the new program, which is scheduled to take effect on Jan. 1, 2027. The rebate program would impose significant new financial and administrative burdens on hospitals that participate in the 340B program. Estimates show the new program could impose more than $1 billion in annual administrative costs on already-strapped hospitals. 
    • “When the government makes a change of this magnitude, it must fully consider what it will mean for the patients and communities that rely on 340B hospitals every day,” said Steve Walsh, president and CEO of the AHA. “The AHA and its member hospitals provided detailed evidence showing that the Rebate Program would impose massive new costs and divert resources that support care for millions of patients. We also proposed viable alternatives that would address concerns about transparency and program integrity without imposing the same financial price tag. For the sake of our shared goal of protecting patients and expanding access to care, those costs, consequences and alternatives cannot be treated as afterthoughts. It’s unfortunate that we are back in court challenging the same flawed program.” 
    • “Following HHS’ attempt to launch a similar rebate program in 2025, both the U.S. District Court for the District of Maine and the 1st U.S. Circuit Court of Appeals faulted HHS for moving forward with a rebate mechanism without adequately accounting for what it would cost the hospitals required to operate it. Shortly thereafter, HHS moved forward with a revised version of the same Rebate Program — only twice as large and even more expensive. 
    • “The AHA and Maine Hospital Association are joined in this action by Eastern Maine Medical Center, Unity Medical Center in North Dakota, Dallas County Medical Center in Arkansas, and Nathan Littauer Hospital and Nursing Home in New York — all community-based healthcare providers that participate in the 340B program.  
    • “See the press release for more details.  

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity.
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • Seasonal flu activity is increasing in many parts of the country but remains low.
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • The American Hospital Association News adds,
    • “There are now 1,136 confirmed measles cases in Pennsylvania this year amid the state’s outbreak, the Pennsylvania Department of Health announced Oct. 9. Of those, 219 individuals have been hospitalized and five people have died. Nationally, there have been 4,080 confirmed cases of measles this year, according to the latest update by the Centers for Disease Control and Prevention. Of those, the vaccination status of 95% of cases is unvaccinated or unknown.”
  • and
    • “A study by the University of Minnesota Rural Health Research Center found that between 2007 and 2023, the percentage of midwife-attended births rose in both rural and urban settings and was higher in states that had full midwifery practice authority policies. The study, supported by the Federal Office of Rural Health Policy, used data from the Centers for Disease Control and Prevention and the American College of Nurse-Midwives. In 2007, 13 states and Washington, D.C., had full practice authority policies. From 2008 to 2023, 20 more states passed such policies. Overall, there was growth during the study period among states without full practice authority policies, states that passed policies in 2007 or earlier, and states that passed policies during the study period.”
  • Beckers Clinical Leadership breaks down the measles cases by State and tells us,
    • “Flu season is arriving weeks earlier than usual this year, with health system, retail pharmacy and federal surveillance data all showing activity rising ahead of schedule.”
  • Health Day informs us,
    • “HPV vaccination may reduce pregnancy complications.
    • “Women vaccinated against HPV had lower risks of preterm birth, early rupture of the amniotic sac and having a very small baby.
    • “Women vaccinated before age 17 showed stronger benefits.”
  • and
    • “Exercise might help slow the mental and physical problems associated with Parkinson’s disease.
    • “Patients who got the most exercise had slower declines in movement, thinking and memory.
    • “More than eight hours of physical activity weekly produced the greatest benefits.
  • and
    • “Among patients with cancer with a genetic variant that increases the risk for hereditary cancers, personalized support significantly increases the likelihood that their first-degree relatives complete genetic testing as well, according to a study published online Sept. 29 in the Journal of Clinical Oncology.”
  • Per NewsNation,
    • “The American Society of Hematology (ASH) has adjusted the standards for diagnosing iron deficiency in order to address the underdiagnosis of the condition.
    • “Iron deficiency impacts about two billion people worldwide and about 10 million American adults, according to a statement published by ASH. If left untreated, the condition can progress to iron deficiency anemia. One of the most common types of anemia. 
    • “It occurs when there’s a lack of iron in the blood, preventing the body from making hemoglobin. This is the molecule that carries oxygen throughout your body, according to the Cleveland Clinic.“
  • Medical Economics notes,
    • “Adding a brief safety reminder to the instructions given to artificial intelligence (AI) models reduced potentially harmful clinical choices in 19 of 20 models tested, according to a new study from researchers at the Icahn School of Medicine at Mount Sinai.
    • “The study, published September 26 in Communications Medicine, a Nature Portfolio journal, evaluated more than 10 million responses from 20 large language models (LLMs). Without a safety reminder, potentially harmful choices made up 16.6% of model responses. With a brief reminder added, that rate fell to 10.1%.
    • “Across all responses, the models made about 1.18 million potentially harmful clinical choices, the researchers reported.
    • “The researchers said the findings suggest that how AI systems are prompted and guided remains an important consideration in building safe and reliable clinical applications, even as newer models and AI agents become better at understanding a user’s intent without lengthy or detailed instructions.”
  • The New York Times points out,
    • “Last year, nearly 100 people tried a new form of medical care at Beth Israel Deaconess Medical Center in Boston. After scheduling a visit with the hospital’s urgent care facility, they discussed their ailments with a Google chatbot before meeting with their doctors.
    • “The bot explored their symptoms, the possible causes of their maladies and the potential treatments, before generating a summary of each conversation. Doctors could then review the bot’s summary in preparation for a patient’s visit.
    • “These patients were part of an eight-month clinical trial that explored whether this specialized chatbot could assist primary care physicians without providing misleading or otherwise harmful information.
    • “In the first-of-its-kind study, published on Thursday in the medical journal The Lancet, the hospital’s primary care physicians said that the bot was helpful in about 75 percent of patient cases, and that the technology may have changed the way they handled more than half of those cases. “They compared it to a high-performing medical student or resident,” said Peter Brodeur, a resident physician at Beth Israel.”

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

  • Fierce Pharma reports,
    • “As GSK works on a nearly $1 billion expansion at one wing of its Pennsylvania operations, the U.K.-headquartered Big Pharma is unveiling a similarly sized outlay to soup up another site across the state. 
    • “All told, GSK is plugging more than $800 million into an overhaul of its facilities in Upper Merion Township, where construction is slated to kick off next year, according to an Oct. 9 release from the office of Pennsylvania Governor Josh Shapiro. 
    • “The goal is to set up a biopharma “innovation and manufacturing hub,” per the Governor’s release, which will ultimately wed commercial production and R&D activities at a single site with the aid of digital technologies.”
  • and
    • “Prescriptions for Lilly’s Foundayo and Novo’s Wegovy pill pulled back a little during the last week. In its 26th week of launch, Foundayo achieved 57,920 total scripts, down 9.9% sequentially, according to IQVIA data cited by Citi. 
    • “For oral Wegovy, Citi said IQVIA recorded roughly 179K scripts, while Jefferies quoted 180K. To reconcile the discrepancy between the two numbers, we used 179.5K, which translates into a 1.4% weekly decline.
    • “In fact, scripts for all major GLP-1s declined last week across diabetes and obesity care, save for Lilly’s Zepbound KwikPen, a prefilled injection pen that delivers four fixed weekly doses of tirzepatide, according to Jefferies. Overall Zepbound scripts dipped below 800K in a 0.8% decrease sequentially, just as Novo’s total Wegovy scripts fell 2.7% to 505.5K, according to Citi.
    • “Based on the numbers, Jefferies now models $208 million for Foundayo sales in the third quarter, which the team noted is in line with consensus.” 
  • Beckers Payer Issues relates,
    • “Fortune recognized five healthcare companies on its 2026 “AIQ 75” ranking.
    • “Fortune partnered with Enterprise Technology Research and pulled from ServiceNow’s Enterprise AI Maturity Index. The team assessed how Fortune 500 companies, the largest U.S. companies by revenue, deploy AI and value those investments. Fortune released its first inaugural AIQ ranking in 2025.” * * *
      Here is where the five healthcare companies landed:
      • 30. UnitedHealth Group (No. 3 on Fortune 500)
      • 31. Elevance Health (No. 18 on Fortune 500)
      • 36. DaVita (No. 331 on Fortune 500)
      • 48. Pfizer (No. 73 on Fortune 500)
      • 75. Thermo Fisher Scientific (No. 106 on Fortune 500)
  • and
    • “The Blue Cross Blue Shield Association is bringing its data and analytics work “under one internal umbrella,” the organization confirmed to Becker’s Oct. 9.
    • “The former CEO of Blue Health Intelligence, an analytics company that has been a BCBSA licensee, said he wrapped up his work with the association in September after “supporting the integration of Blue Health Intelligence back into BCBSA.”
    • “I’m excited about the opportunity for the combined team to have an even greater impact on healthcare quality and affordability,” former BHI CEO Bob Darin said in an Oct. 8 LinkedIn post.
    • “A BCBSA spokesperson said the integration will help the association “better leverage data-driven insights to identify how we can lower costs, reduce friction and improve the healthcare experience for patients, employers and providers.”
  • Beckers Hospital Review tells us,
    • “Revised federal price transparency rules have made hospital price data clearer, but several issues still complicate price comparisons, according to an Oct. 7 analysis from the Peterson-KFF Health System Tracker.
    • “The revisions to the 2021 hospital price transparency rule took effect in January, and CMS began enforcing them in April. Hospitals must now post a negotiated rate as a dollar amount whenever the final payment can be known before care is delivered. When a rate is a percentage or a formula, hospitals must also report “allowed amount” data: the median, the 10th and 90th percentile payment amounts, and the number of payments.
    • “The researchers reviewed machine-readable files compiled by Turquoise Health and downloaded between July 17 and Aug. 2. They examined two common inpatient admission codes, MS-DRGs 280 and 807, in several local markets and reviewed national patterns across 6,445 hospitals.
    • “These complications reflect the complexity of payment arrangements between hospitals and payers,” the report stated.”
  • and
    • “Fifty-seven hospitals across 22 states have converted to rural emergency facilities since the law that created the designation took effect in January 2023, according to data from CMS.
    • [The article identifies] the hospitals that have converted to rural emergency status, by state.
  • and
    • “A $75,000 donation from Covenant Presbyterian Church in Austin, Texas, has helped erase $14 million in medical debt for 10,865 residents through a partnership with nonprofit Undue Medical Debt, The Austin American-Statesman reported Oct. 9.
    • “The church used part of a $200,000 budget surplus to fund the relief, targeting residents in an area of Travis County with significant financial need, according to the report. Recipients are being notified by mail the week of Oct. 9 and do not need to take any action to receive the relief.”
  • Beckers ASC Review points out,
    • “Cardiology is shaping up to be the next big ASC specialty, following the path GI took in the 1990s and orthopedics in the 2010s. Medicare’s 2026 decision to pay for cardiac ablation in ASCs, a proposed 2027 rule that keeps widening the door and payer pressure on site-of-care have pushed cath and EP labs onto ASC leaders’ agendas.”
  • Beckers Physician Leadership notes,
    • “Health systems want physicians to be more productive, and physicians want to be paid fairly for the work they do. 
    • “Somewhere between those two goals, many compensation models break down — either rewarding volume at the expense of everything else or offering so much guaranteed pay that productivity has no meaning.
    • “Westchester Medical Center Health Network, based in Valhalla, N.Y., is working through that tension now. The system is building a new physician compensation structure as it expands its medical group, which includes roughly 1,100 to 1,200 academic and community practitioners, and shifts from an inpatient-centric mix close to 80/20 toward something nearer 50/50 or 60/40 ambulatory.” * * *
    • “The risk in any productivity-based model, Dr. Tedjarati said that physicians start to feel like a cog in a machine. The structure has to signal that the organization still values them for who they are and what they bring, and that they remain part of a larger mission. Because institutions are constantly competing for the same physicians, he said, getting that balance wrong carries a real cost.
    • “It’s really about agility. It’s about agility and creating comp models that people can understand,” he said.
    • “When those pieces are in place, Dr. Tedjarati said, the incentive structure becomes something physicians can see themselves succeeding in rather than something imposed on them.
    • “I think people do well when they know where they’re starting and where they’re going to, and that if they happen to be more productive and more efficient, maintaining the quality that is required, then they should be appropriately rewarded and compensated,” he said.”

Thursday report

David Ermer–Agentic & Generative AI, AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue

From Washington, DC

  • The Wall Street Journal reports,
    • “Newly installed Centers for Disease Control and Prevention Director Dr. Erica Schwartz said she wants to change a culture of “paternalism” at her agency.
    • “Americans need to be better informed about how and why the CDC makes its recommendations, and the agency needs to be willing to listen to people’s concerns, she said. 
    • “There is a sense of paternalism that we have had at the CDC,” Schwartz said. “It shouldn’t be this black box that we say, ‘Verily thou shalt, and then that’s the answer.’”
    • Schwartz made the comments Wednesday at a Wall Street Journal Future of Health event in Washington, D.C.
    • “Schwartz said Wednesday that parents should prioritize receiving measles vaccines for their children amid current U.S. outbreaks, saying the shot is “absolutely safe, absolutely effective.” She defended the secretary, a skeptic of vaccines who has said they are a “personal decision,” saying he channels concerns from parents who are wary of the full slate of childhood immunizations.
    • “The secretary does represent the voices of a number of Americans who are asking questions about certain vaccines,” she said, adding that doctors shouldn’t approach vaccine-skeptical parents with “a paternalistic way of thinking.”
  • Casey B. Mulligan, HHS chief economist and chief regulatory officer, writes in STAT News,
    • “Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.
    • “Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.
    • “A new report from the Department of Health and Human Services shows other unintended consequences of this well-intended program. The spread grows with the price of the drug. It therefore rewards hospitals for using more and costlier drugs and makes physician practices and infusion clinics more valuable after a 340B hospital acquires them. The patient’s treatment needn’t change. The owner and billing site do.” * * *
    • “On April 18, 2025, President Trump directed HHS to obtain the cost information the statute requires. CMS surveyed hospitals from January through April 2026 and has proposed paying for affected 340B drugs at ASP minus 33.4% in 2027. CMS estimates that Medicare drug payments would fall by $4.55 billion in the first year and beneficiary drug copayments by $1.15 billion.
    • “For a drug with an ASP of $1,000, a beneficiary’s standard 20% coinsurance would fall from $212 to $133.20. The prescription hasn’t changed. The patient’s share of the hospital’s bill has. Narrowing the spread also weakens the incentive to steer patients toward costlier drugs and to acquire physician practices and infusion clinics — the very behaviors that have made care more expensive.” * * *
    • “Medicare patients should not pay coinsurance as though the discount did not exist.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) this week launched a series of actions to strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and generating better evidence about potential vaccine-related injuries.
    • “To address health problems Americans report after vaccinations, HHS:
      • Opened a new National Institutes of Health (NIH) clinic dedicated to studying and caring for patients experiencing health problems following vaccination;
      • Proposed reimbursing physicians for reporting suspected vaccine-related injuries to the Vaccine Adverse Event Reporting System (VAERS) through a new Centers for Medicare & Medicaid Services (CMS) policy, bringing vaccine reporting in Medicare in line with typical Medicare reimbursement policies;
      • Will require electronic health records to capture vaccine-related adverse events so that information can follow patients across the health care system; and
      • Is modernizing the Centers for Disease Control and Prevention’s (CDC) VAERS to make reporting simpler and improve the tools available to researchers and medical professionals investigating potential safety signals.
    • “We must listen to patients and families who report vaccine injuries—not dismiss or gaslight them,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions.”
  • Beckers Hospital Review informs us,
    • “The Trump administration is preparing a stopgap that would allow certain previously restricted peptides to be sold temporarily while federal health officials write new regulations, according to an Oct. 7 Washington Post report citing two people familiar with the matter.
    • “The move would let some compounding pharmacies dispense peptides marketed as medical treatments and wellness products, even though the claims for what they treat have not been fully safety tested. The plan has not been announced, and the Post reported that its timing is unclear, it could still change and it is not known which peptides would be included. The sources said federal officials are seeking guardrails around the policy, and HHS did not comment.
    • “The FDA has been weighing whether to let compounding pharmacies produce seven peptides for conditions such as insomnia, obesity and wound healing. FDA scientists said there is not enough evidence on their safety and effectiveness, but the agency’s Pharmacy Compounding Advisory Committee, which was reshaped with wellness clinic physicians before the meeting, voted in July to recommend six of the seven. It voted against emideltide, a proposed treatment for opioid withdrawal and insomnia.
    • “The FDA is not required to follow the panel’s advice, and the Post said it is not clear when formal rulemaking will be released. Safety groups ECRI and ISMP warned after the vote that gaps in safety and efficacy data remain unresolved.”
  • The American Hospital Association News points out,
    • “The Department of Homeland Security Oct. 8 issued a proposed rule that would establish new fees for foreign students seeking Optional Practical Training, a program that allows F-1 students to work in the U.S. in positions related to their field of study after graduation. Specifically, DHS proposes a fee of $70,000 for an initial OPT authorization and $30,000 for any subsequent OPT authorization, citing concerns about fraud, program integrity and protection of U.S. workers. The agency is accepting comments through Nov. 9.
    • “The proposal could have significant implications for hospitals and health systems that rely on international graduates, including nurses, physicians, pharmacists and other healthcare professionals, as OPT often serves as a pathway into the healthcare workforce. The AHA will review the proposed rule and evaluate its potential impact on workforce recruitment and retention.”
  • and
    • “The Agency for Healthcare Research and Quality Oct. 7 announced the launch of the Super Intelligence for Healthcare Improvement Initiative, a two-part artificial intelligence competition focusing on medical evidence reviews and data. The first competition, called the Clinical Evidence Synthesis Transformation Challenge, aims to reduce analysis times from a year or longer to hours. This competition consists of two phases, where up to five finalists will receive $100,000 each after the first, and one winner will receive $5.35 million following the second. The challenge submission period will run from Jan. 11 to March 12, 2027.
    • “The next part of the initiative, called the SI Tech Sprint for Healthcare Research and Implementation Quality and Safety, aims to use AI to leverage AHRQ’s cost, utilization and quality databases to establish an AI-enabled ecosystem of applications for research, quality improvement and public access. The total prize pool is $2.1 million for selected winners. Submissions will be accepted from March 1 to Sept. 9, 2027. AHRQ’s webpage for the competition provides additional details, including information on registration, resources and an FAQ.”

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

  • FedWeek reports,
    • “Federal employees who have been watching the government’s renewed focus on reductions in force (RIFs) should pay close attention to one development in particular: newly finalized changes that make performance ratings far more important in determining who stays and who goes.
    • “These regulations are now final law and apply to any agency issuing a specific RIF notice on or after September 2, 2026. As a result, many employees will find that their last several performance appraisals carry greater weight in whether they keep their jobs. That means the time to review your record is now, not after an RIF notice arrives.
    • “This article is not legal advice for any individual employee. But it outlines practical steps federal employees can take now to protect their retention standing, preserve appeal rights, and avoid being caught flat-footed under OPM’s finalized RIF framework.”
  • Federal News Network relates,
    • “There’s a new way to look at data about the federal workforce. The Office of Personnel Management has launched an AI chatbot to answer the public’s questions about workforce trends. The new feature has been added to OPM’s “federal workforce data” website, which details employment numbers and other information about the civil service. Users can enter questions and get AI-generated answers about government hires and separations, as well as workforce demographics like age, veteran status and education level. — Drew Friedman(FWD Chat – Office of Personnel Management)”
  • Edward Zurndorfer, writing in My Federal Retirement, discusses “The Biggest Medicare Mistakes That Can Cost Federal Retirees.”
  • Tammy Flanagan, writing in Govexec, advises “Don’t let 5% become your TSP retirement strategy.”
    • “Getting the full agency match is a good baseline, but if retirement is around the corner there’s more to consider before deciding what to do with the rest of your paycheck.”

From the U.S. Food and Drug Administration front,

  • NBC News reports,
    • “The Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday.
    • “In the filing, the FDA said it plans to compare mifepristone’s safety to that of surgical abortions through 10 weeks’ gestation. Its review will measure the frequency of side effects among roughly 100,000 women who took mifepristone, it said. 
    • “Results of the FDA’s review are expected in mid-December. From there, the agency will analyze the data and draft a final report — a process it expects to wrap up in March.” * * *
    • “The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.
    • “The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.
    • “In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.”
  • Food Safety relates,
    • “The U.S. Food and Drug Administration (FDA) has issued a draft guidance that, if finalized, will provide enforcement discretion from the requirements of the Food Traceability Rule, also known as Section 204(d) of the Food Safety Modernization Act (FSMA 204),  for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule. 
    • “FDA said it believes “this additional flexibility will maintain the intended public health benefits of the rule, as it would only impact a small percentage of total food sales, while also providing relief to numerous smaller RFEs and restaurants.”
  • MedPage Today tells us,
    • “The FDA flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, Newron Pharmaceuticals said Thursday.
    • “The notice follows an announcement in April that the agency halted patient enrollment in the phase III ENIGMA-TRS 2 trial after the sudden death of a participant in an evenamide clinical trial. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added.
  • Cardiovascular Business informs us,
    • “Houston-based Leader Formulas is recalling one lot of its Rapture Preworkout dietary supplement due to the presence of 1,3-dimethylamylamine (DMMA), an ingredient not listed on the product label. 
    • “DMMA, often referred to as “geranium extract,” has been linked to a heightened risk of high blood pressure. It is also known to lead to certain cardiovascular problems, including heart attack, shortness of breath and chest pain. Its presence was first identified by the U.S. Food and Drug Administration (FDA) during a routine test. 
    • ‘This voluntary recall includes three different products—Rainbow Twist, Electric Lemonade and Berry Mojito—that were all part of lot 260327-4.
    • “Consumers who have purchased the Rapture Preworkout products which are being recalled should stop using the products and return to the place of purchase for a full refund,” according to Leader Formulas statement.”
  • Beckers Hospital Review adds,
    • “The FDA has flagged patient safety risks tied to nine products sold through Amazon that the agency said are unapproved new drugs marketed to treat sexually transmitted infections or their symptoms.
    • ‘The agency identified the violations after reviewing labeling for products it purchased from Amazon in July 2026, according to an Oct. 1 warning letter. The FDA said the products were introduced or delivered for introduction into interstate commerce by Amazon through its Fulfillment by Amazon service.
    • “The FDA said no OTC drug product has been approved for the treatment, cure, mitigation or prevention of any STI. The agency said effective treatment requires diagnosis and supervision by a licensed healthcare professional.” * * *
    • “Amazon was directed to respond within 15 business days of receiving the letter with steps taken to correct the violations and prevent their recurrence.”

From the Medicare Advantage front,

  • In a CMS fact sheet, CMS published 2027 Medicare Advantage and Part D Star Ratings.
    • “The information included in this Fact Sheet is based on the 2027 Medicare Advantage (MA) and Part D Star Ratings published on the Medicare Plan Finder on Oct. 8, 2026. For details on the methodology of the MA and Part D Star Ratings, please refer to the 2027 Part C & D Star Ratings Technical Notes available at http://go.cms.gov/partcanddstarratings.”

No Surprises Act News,

  • Bloomberg Law reports,
    • “Insurers and providers share common concerns about ineligible claims under a federal surprise billing law, bolstering Senate HELP Committee Chair Bill Cassidy’s push for a legislative fix before he leaves Congress, Erin Durkin and Victoria Knight report.
    • “The No Surprises Act, a 2020 statute designed to protect patients from unexpectedly large bills from emergency rooms and other out-of-network providers, established an arbitration process for payment disputes between providers and insurers. A flood of ineligible claims is clogging that process — and closed-door meetings convened by Cassidy have put the issue on the table as a shared concern
    • “Cassidy says he’d like to put out legislation before he departs the Senate at the end of the year. While time is running short, the veteran legislator signaled the issue is gaining traction.
    • “Believe it or not, there’s common ground there,” Cassidy said.”
  • STAT News adds,
    • “A new proposal in Congress to scrap a surprise billing ban’s controversial arbitration system will need to to survive an onslaught of attacks from provider groups, for whom arbitration has been a gold mine.
    • “After Rep. Frank Pallone (D-.N.J.) unveiled his Lower Premiums, Faster Payments Act on Thursday, it quickly garnered praise from academics and consumer advocates, as well as condemnation from provider groups. It would dismantle the problem-plagued process that’s currently used to resolve disputes between health insurers and out-of-network providers and replace it with a payment system based on median in-network rates.”
  •  FEHBlog observation — Good luck, Rep. Pallone.

From the fraud, waste and abuse front,

  • NextGov reports,
    • “The Centers for Medicare and Medicaid Services is exploring a new contract operating model and technologies so that the agency can more effectively prevent fraud, instead of chasing after money already in the hands of bad actors, according to documents posted on SAM.gov Monday.
    • “CMS has traditionally contracted with private companies to boost its investigative capabilities and support administrative actions, such as imposing payment suspensions, according to the listing. But under a draft operating model, CMS wants to take a greater role in leading the development, prioritization and direction of those investigations, the website adds.
    • “The old model “worked in the past but new technology and new techniques mean it is time to see if it still works as well,” Kimberly Brandt, a CMS Deputy Administrator, posted on LinkedIn.
    • “Under the draft model, CMS would assign fraud investigations to contractors whose primary role is to develop the investigation and administrative actions under the agency’s oversight, according to a draft Statement of Objectives posted on SAM.gov.”
  • Per a Justice Department news release,
    • “Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division (the Fraud Division) today released Directive 26-13, outlining the Division’s comprehensive approach in the fight against fraud.
    • “Expanding on earlier guidance regarding the Division’s priorities (available here) and corporate enforcement policy (available here), Directive 26-13 sets out the Division’s prosecutorial methodology for investigating, disrupting, and prosecuting fraud. This directive marks a significant operational shift, requiring the Division’s prosecutors to attack fraud from all angles using the Division’s tax, securities fraud, consumer fraud, and cybercrime authorities.
    • ‘This directive also requires Division prosecutors to deploy early, pre‑indictment asset seizures and digital‑infrastructure takedowns to halt fraud schemes and freeze assets in real time. Finally, this directive urges Division prosecutors to develop practice cooperators, zealously prosecute corporate bad actors, seek arrest and detention in appropriate cases, and deliver fulsome advocacy at sentencing. This new, comprehensive approach will drive the Division forward in its mission to preempt, disrupt, and dismantle fraudulent networks before they can inflict widespread harm.
    • “Read the full memo here.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Taylor Farms, the produce giant linked to last summer’s deadly cyclospora outbreak, is suspending sales of iceberg lettuce from central Mexico during the parasite’s peak season. 
    • “Chief Executive Bruce Taylor said the company won’t sell iceberg lettuce in the U.S. or Canada that was harvested or processed in the region between May 1 and Aug. 31, starting next year. The period covers central Mexico’s rainy season, Taylor said, and it matches the time when the Centers for Disease Control and Prevention sees an increase in illnesses caused by the cyclospora parasite. 
    • “The company hasn’t determined when the suspension will be lifted.”
  • Reuters relates,
    • “Centers for Disease Control and Prevention Director ​Erica Schwartz said on Wednesday the risk to the US ‌from an unconfirmed pneumonic plague case in Siberia was extremely low, but the agency was prepared to monitor and screen travelers.
    • “We are working with Department of Homeland Security, ​working (with) Department of State, Department of War, and other agencies within ​the government to make sure that we know exactly if ⁠anyone from that area comes into the United States,” Schwartz said at ​the Wall Street Journal’s The Future of Health event in Washington.”
  • and
    • “Using artificial intelligence, researchers may have found a way to make vaccines based ‌on mRNA technology, such as Moderna’s (MRNA.O) and Pfizer’s (PFE.N) COVID shots, storable at room temperature, which would lower costs and make them available in regions where ultra-cold storage is not possible.”
  • and
    • “AI may improve doctors’ ability to detect heart transplant rejection without surgery and appeared to be more accurate than standard blood tests, according to a report in Journal of Heart and Lung Transplantation.”
  • Fierce Healthcare adds,
    • “Utah is expanding the state’s AI regulatory sandbox program with new pilots to test AI-supported prescription renewals, dermatology and physical therapy, while stepping up physician oversight and adding independent third-party evaluators.
    • “Utah is bringing the Utah Department of Health and Human Services, Intermountain Health, University of Utah Health, medical licensing officials and outside experts into the state’s AI policy process. State officials and health systems leaders say the initiative is designed to test AI in real-world clinical settings, generate evidence on its benefits and risks and address key questions around liability, privacy and regulation.”
  • The Washington Post tells us,
    • “Brandon Luu began thinking about the body’s circadian machinery as a teenager, when he was routinely unable to fall asleep until late, sometimes well past 2 a.m. The schedule made mornings miserable and school harder.
    • “But it also left him with a question: What happens when the body’s sense of time falls out of sync with the world around it?
    • “Fifteen years later, Luu is exploring that question through one of psychiatry’s most common disorders: attention-deficit/hyperactivity disorder (ADHD). Sleep problems have long been seen as a consequence of the condition. But now researchers are looking at the possibility that the relationship might run in reverse: that disruptions to circadian rhythms — the biological machinery governing when we sleep and wake — might be a cause.”
  • MedPage Today notes,
    • “Adults with ADHD had substantially higher risks of mild cognitive impairment or dementia.
    • “Genetic ADHD risk predicted cognitive impairment, supporting an association beyond clinical diagnoses.
    • “Findings do not prove a causal link; treatment effects and other variables require further study.”
  • Beckers Clinical Leadership informs us,
    • “Suicide became the 10th-leading cause of death in the U.S. in 2024, up from No. 11 in 2023, according to final mortality data from the CDC’s National Center for Health Statistics. Suicide deaths fell 1% over the same period, from 49,316 in 2023 to 48,824 in 2024, and accounted for 1.6% of all deaths in both years. Suicide’s move into the top 10 happened as COVID-19 deaths declined 37%, dropping COVID-19 from 10th to 15th.
    • “Recent data show patterns that differ by method, age and geography. Gun suicides reached record levels for a fifth straight year even as the overall suicide rate trended down. Emergency department visits for suspected suicide attempts declined among adolescents but rose among adults 26 and older. In 2025, rates ranged from 5.3 per 100,000 in the District of Columbia to 31 in Alaska. At the same time, researchers, children’s hospitals and states are pursuing a range of prevention approaches, from smartphone-based risk forecasting and universal ED screening to firearm access laws.
    • [The article notes] seven things to know about the state of suicide in the U.S.
  • The National Cancer Institute points out,
    • “Mutations in a family of genes called RAS, and the rogue proteins they produce, help drive roughly a third of all cancers, including more than 90% of pancreatic cancers. Yet RAS has long been one of the most elusive drug targets in cancer research. Unlike other proteins targeted by cancer drugs, RAS proteins have relatively smooth surfaces, with no obvious place for a drug molecule to bind. That made RAS notoriously “undruggable.” 
    • “Despite the long odds, federally funded research continued to push the field forward. Researchers eventually revealed the structure of RAS proteins and how they function, and those insights led to new approaches for blocking mutant RAS, particularly KRAS, which is involved in the vast majority of RAS-driven cancers.
    • “Today, three RAS inhibitors—sotorasib (Lumakras), adagrasib (Krazati), and, most recently, daraxonrasib (Rasonque)—are helping patients live longer, and many additional molecules that block mutant RAS are moving through the research pipeline.”
    • “These life-changing drugs would not have been possible without the sustained public investments that laid the groundwork for the field, said Harold E. Varmus, M.D., former Director of the National Cancer Institute (NCI) and the National Institutes of Health, who launched NCI’s RAS Initiative.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Hospitals continue to shift care to outpatient settings, according to a new analysis of data from the first half of the year by Strata Decision Technology.
    • “As a result, hospitals are seeing sicker patients in their inpatient wards as they send lower-acuity patients to outpatient departments. 
    • “Patients in some service lines, like gynecology, had procedures done less in hospitals as minimally invasive surgery options in outpatient settings grew. However, other service lines like breast health saw more, sicker patients in the hospital, likely due to an increase in breast cancer testing and diagnoses, according to the data.”
  • Beckers Hospital Review relates
    • “In early January, Tamar Goldblatt was named vice president of payer revenue strategy and contracting at St. Louis-based Ascension. 
    • “Since then, Ms. Goldblatt has worked closely with system and ministry leaders to understand the distinct needs of each market and align them with Ascension’s broader payer strategy. Her work comes at a time where Medicare Advantage instability, rising denial rates and growing administrative burden have turned once-routine payer discussions into high-stakes negotiations. 
    • “Becker’s connected with Ms. Goldblatt to discuss her top priorities nearly one year into the role, the trends that are reshaping payer partnerships and how she approaches payer collaboration.”
  • and
    • “CVS Health unveiled its first pharmacy-focused CVS Pharmacy in the Boston area Oct. 7. The site is meant to expand access to medications, immunizations and other pharmacist-provided services in the community.
    • “Nearly 20 pharmacy-focused locations will open in select communities across the country in 2026. The sites average about 3,000 square feet and include a full-service pharmacy with a limited selection of over-the-counter products.
    • “CVS has already opened pharmacy-focused locations in Birmingham, Ala., Chicago, Detroit, Houston and Washington, D.C. The company also plans to open more than 40 new CVS Pharmacy locations this year, including traditional stores and pharmacies inside Target stores. CVS cited its 2025 Rx Report, which found 80% of patients prefer face-to-face pharmacy care and 48% would switch pharmacies if limited to digital-only options.”
  • The Wall Street Journal tells us,
    • “Viatris VTRS has agreed to buy pain-drug maker Pacira BioSciences PCRX for $1.65 billion in a deal that expands the healthcare company’s medicines portfolio.
    • “Viatris on Thursday said it would pay $36.50 a share in cash for Pacira, a roughly 45% premium to Wednesday’s closing price of $25.20 for the Brisbane, Calif., company.
    • “The deal is slated to close by the end of the year.
    • “Shares of Pacira were recently up 44% at $36.33 in premarket trading, while shares of Viatris edged down 0.1% to $17.47.
    • “Viatris said the addition of Pacira’s Exparel and Zilretta products to its proposed meloxicam treatment for moderate-to-severe acute pain, positions the Canonsburg, Pa., company as a leader in non-opioid pain-management therapies.”
  • and
    • Argenx ARGX shares fell sharply after the biotech company stopped a late-stage clinical trial of its Vyvgart drug due to lack of efficacy for the treatment of autoimmune condition Sjogren’s disease.
    • “Shares in Argenx were down 18% in European morning trading Thursday, wiping out the stock’s gains in the year to date. If sustained until close, this would be the stock’s biggest one-day percentage drop since December 2023.
    • “The Amsterdam-based company said it would discontinue the study following the recommendation from an independent data-monitoring committee, which concluded that the trial would fall short of its primary goal.
    • “The study evaluated the effects of Vyvgart in subcutaneous formulation in adults with moderate-to-severe Sjogren’s disease, a chronic autoimmune disorder that can cause symptoms including dry eyes and mouth, fatigue and joint pain. No new safety signals were identified in the trial, and safety data were consistent with the drug’s known profile, Argenx said.”
  • BioPharma Dive adds,
    • “On Wall Street, a major search is underway to find struggling public companies that can serve as the raw materials for a niche but booming business. A promising candidate may have just emerged.
    • “This business revolves around “reverse mergers,” a type of deal where a private company combines with a public counterpart, often as a quick way to access the broad and deep-pocketed array of investors found on marketplaces like the Nasdaq. While previously disparaged, reverse mergers have recently become so popular that some deal experts question whether there are enough quality “shell” companies to meet the demand.
    • “Shell hunters could have another option following a Tuesday announcement from Caribou Biosciences, the once high-flying biotechnology startup co-founded by CRISPR gene editing pioneer Jennifer Doudna. In a statement, Caribou CEO Rachel Haurwitz said the current financing environment has made it “increasingly challenging” to secure the money needed to advance the company’s two main research programs, which focus on a hard-to-make form of medicine known as “off-the-shelf” cell therapy.” * * *
    • “To Daina Graybosch, an analyst at Leerink Partners who covers Caribou, the natural end for the company now is either a reverse merger or an acquisition by Tang Capital, a San Diego-based investment firm that made a name for itself by buying up cash-rich biotechs and returning much of their value to shareholders. Caribou ended the second quarter with $114 million worth of cash, cash equivalents and marketable securities.”

Midweek update

David Ermer–Agentic & Generative AI, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Fierce Healthcare reports,
    • “A group of 17 senators penned a letter to U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. seeking more information on recent appointments to a key health panel—echoing concerns of key medical groups.
    • “In the letter (PDF), the legislators called the appointments a “major break from the historic makeup of [the] U.S. Preventive Services Task Force (USPSTF) membership,” as it is typically comprised of primary care practitioners and preventionists.
    • “Kennedy named eight new members to the USPSTF in mid-September—five of whom were specialists and one healthcare finance expert. The new appointments came months after Kennedy dismissed the panel’s vice chairs and did not replace five other members after their terms expired at the start of 2026.
    • “Legislators expressed concerns over an April 23 Federal Register notice seeking nominations for the panel, given the change in nominee parameters—outside of primary care and preventive medicine—and timeline. The letter notes members in specialty areas have “always played a role” in the panel’s operations, though primarily in consultant roles in part to avoid conflicts of interest.”
  • The American Hospital Association News relates,
    • “The Health Resources and Services Administration Maternal and Child Health Bureau has released the latest data from the National Survey of Children’s Health. The survey provides national and state-level data on children’s physical and mental health, healthcare access and quality, special healthcare needs, adverse childhood experiences and family and community well-being. HRSA also plans to release a data brief featuring survey findings on the health and well-being of children living in rural communities.”
  • Beckers Hospital Review tells us,
    • “CMS is penalizing 2,334 hospitals, about 80% of those evaluated, under the Hospital Readmissions Reduction Program in fiscal 2027, according to new CMS data. The penalties took effect on Oct. 1.” * * *
    • “The share of hospitals receiving no penalty will drop to 19.8% (578 hospitals) from 21.8% (641) in 2026. The bulk of hospitals, 71.8% in fiscal 2027 compared with 70.1% in 2026, will see penalties below 1%.”

From the U.S. Food and Drug Administration front,

  • Reuters reports,
    • “The US Food and Drug Administration has expanded the use of Novartis’ (NOVN.S), drug to treat adults with ​a chronic skin condition that causes recurring itchy welts [Rhapsido], ‌the Swiss drugmaker said on Wednesday.
    • “The condition, called symptomatic dermographism, is a form of chronic hives in which scratching, rubbing or ​friction on the skin can trigger itchy welts.
    • “The ​approval adds to momentum for the drug, remibrutinib, which investors ⁠have increasingly focused on after recent late-stage failures of the ​company’s cholesterol drug pelacarsen and muscle-wasting disease therapy del-desiran ​increased scrutiny of its pipeline.”
  • PharmExec relates,
    • “The FDA has approved Pfizer’s Tukysa (tucatinib) in combination with trastuzumab and pertuzumab as maintenance treatment for adults with unresectable locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have completed induction therapy, the company announced Oct. 7.1
    • “The decision moves the oral therapy from later-line use into the first-line setting, where it is added to an established antibody pair.”
  • Stock Titan adds,
    • “vTv Therapeutics (Nasdaq: VTVT) received FDA Orphan Drug Designation for HPPD, its investigational oral treatment for sickle cell disease.
    • “Preclinical studies at Augusta University used the Townes sickle cell disease mouse model. HPPD was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling. Fetal hemoglobin increases were time- and dose-dependent, with effects comparable to or exceeding hydroxyurea, the current standard fetal hemoglobin-inducing therapy.
    • “vTv said the designation supports partnering discussions for HPPD while it continues to prioritize cadisegliatin, its lead late-stage type 1 diabetes program. HPPD remains investigational; its safety and efficacy have not been established, and approval or commercial availability is not guaranteed.”

No Surprises Act News

  • The Coalition against Surprise Medical Billing reports,
    • “After a new federal rule slashed the administrative fee for initiating IDR disputes by 87% — from $115 to just $15, nearly 400,000 disputes were initiated in July 2026 alone. This 24% jump in just one month is one of the latest signals that the IDR process has veered even further off course and needs an overhaul.
    • “IDR was supposed to be a last resort for resolving legitimate payment disputes between providers and health plans. Instead, organizations built to file disputes at scale have turned it into a profit center — initiating over 7 million disputes between April 2022 and the end of July 2026. The result is more administrative burden, more unnecessary costs, and more pressure on the employers, workers, and families who ultimately pay the bill. IDR costs have increased to $22.4 billion, according to recent data published in Health Affairs.” * * *
    • “An overused IDR system drives up costs across the entire healthcare system. Every dispute requires employers and health plans to spend resources processing and defending claims, while arbitration outcomes drive higher payments that ultimately put pressure on premiums and healthcare costs.”

From the fraud, waste, and abuse front,

  • Beckers Hospital Review reports,
    • “Federal prosecutors have secured guilty pleas or prison sentences in at least six durable medical equipment fraud cases tied to more than $1.5 billion in claims since late May, and CMS has barred 11 DME suppliers from Medicare Advantage payments.
    • “The cases follow a familiar pattern: telemarketers target Medicare beneficiaries, practitioners sign orders for orthotic braces without examining patients and DME companies bill Medicare for equipment no one needed. Becker’s tracked DME fraud actions against 10 people between March 24 and May 26.
    • “CMS imposed a six-month moratorium on new Medicare enrollment for certain DME, prosthetics, orthotics and supplies providers in February, citing more than $1.5 billion in suspected fraudulent billing stopped in 2025.  The moratorium expired Aug. 27, according to the American Orthotic & Prosthetic Association. On Sept. 8, CMS barred 11 DMEPOS suppliers from future Medicare Advantage and Part D payments, citing more than $3.4 billion in suspected fraudulent billing in 2025 and 2026.”
  • STAT News adds,
    • “In a warning to life sciences companies, the Department of Justice last week issued a new directive for combating fraud that made a point of noting the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.
    • “Typically, the agency has pursued health fraud cases centered on providers, clinics, home health agencies, and hospices. By expressly including the Federal Food, Drug, and Cosmetic Act in the directive, the National Fraud Enforcement Division appears to be placing drug and device makers, among others, more clearly in its crosshairs.
    • “This is a subtle but significant expansion of their jurisdiction,” said Kevin Lowell, a member of the Miller & Chevalier law firm, who spent a decade at the DOJ, where he most recently had been a deputy chief in the National Fraud Enforcement Division’s health care fraud section.
    • “The directive brings into focus all of the FDA-regulated companies and the division is pointing to a specific statute that refers to a part of the health care industry that has not previously been a focus. … And it’s one of first items on the list of priorities” for investigating potential fraud.”

From the judicial front,

  • STAT News reports,
    • “The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.
    • “The Pharmaceutical Research and Manufacturers of America said Wednesday that it had filed a complaint in the U.S. District Court for the District of Columbia asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority.
    • “The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. 
    • “But it would set a precedent that the industry wants to nip in the bud. PhRMA says the voluntary agreements are acceptable, but the mandatory GLOBE program is not.
    • “The administration is still considering a separate pilot, called GUARD, that would require MFN prices in Medicare Part D. The status of that proposal is not clear.”
  • Beckers Hospital Review adds,
    • “Hospitals affiliated with Nashville, Tenn.-based HCA Healthcare have sued multiple insurers over alleged claim denials and reimbursement issues in 2025 and 2026. These cases contribute to a broader landscape of legal battles between providers and insurers.
    • “Most recently, seven hospitals filed a lawsuit Oct. 5 against Anthem Blue Cross and Blue Shield Georgia, part of Elevance Health. The complaint argued the insurer is on the hook for more than $501,213 in reimbursement, alleging underpaid or denied claims.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “The overall mortality rate for U.S. patients with cardiovascular disease (CVD) has improved significantly in the last two decades, according to new findings published in JACC.[1] However, despite the continued efforts of cardiologists and other cardiovascular care professionals, disparities remain for certain racial and/or ethnic groups. 
    • “This new analysis represents a county-by-county dive into the heart health of Americans from 2000 to 2019. Data came from both the U.S. National Vital Statistics System and the National Center for Health Statistics.
    • “In total, the study’s authors found that CVD mortality rates “varied substantially” from one county to the next. There were often considerable differences in the same state. This highlights the importance of ensuring all patients, no matter where they live, receive high-quality care. 
    • In 2019, the overall age-standardized mortality rate (ASMR) for CVD in the United States was 237.8 deaths per 100,000 adults. The ASMR was the highest for Black patients and the lowest for Asian patients.” 
  • Beckers Clinical Leadership relates,
    • “A coalition of Texas health systems, professional organizations and community groups has launched a five-year plan to eliminate cervical cancer in the state.
    • “The Texas Lone Star Cervical Cancer Elimination Plan 2027-2032 was developed by the Cancer Alliance of Texas Cervical Cancer Elimination Priority Area Workgroup, according to an Oct. 7 news release from Houston-based University of Texas MD Anderson Cancer Center.
    • “Cervical cancer elimination is defined as fewer than four new cases per 100,000 women a year. Texas’ current cervical cancer rate is 9.5 cases per 100,000, with rates in some counties reaching 15 to 21 per 100,000. Uninsured, rural, border and minority communities carry the heaviest share of cases, the release said.
    • “The plan is built on three pillars: vaccination, screening, and timely follow-up, diagnosis and treatment. Read the full plan here.” 
  • The American Hospital Association News tells us,
    • “As part of the AHA’s Opportunities for Innovations in Rural Maternal Care initiative, a recent Commonwealth Fund blog discusses strategies hospitals can use to sustain maternal care within the communities they serve. Hear from Julia Resnick, AHA senior director of health outcomes and care transformation, and Aisha Syeda, AHA senior program manager of health outcomes and care transformation, on ways to solidify leadership commitment, build a skilled workforce, strengthen partnerships and address community needs. LEARN MORE“
  • The latest post of NIH Research Matters covers the following topics:
    • Device helps people with paralysis communicate
      • “A brain-computer interface linked to a virtual avatar helped people with paralysis express speech and body language at the same time.
      • “Translating neural signals for both types of communication could enable people with paralysis to express themselves more fully.”
    • Improving lung cancer detection
      • “Researchers developed a protein-based MRI contrast agent that could detect a common lung cancer in mouse models and determine if it spread to other organs.
      • “With further development, the approach could help doctors detect lung cancer earlier and tailor treatment to the needs of each patient.”
    • Estimating cognitive impairment risk, timing
      • “Combining blood p-tau217 levels together with APOE4 gene status improved predictions of dementia risk.
      • “The findings may help doctors better assess patients’ risk for cognitive impairment and estimate when symptoms may develop.”
  • Radiology Business points out,
    • “A minimally invasive, image-guided procedure can provide lasting relief for carpal tunnel syndrome, according to new research published in RSNA’s Radiology. 
    • “This common occupational ailment is frequently encountered among the middle-aged, leading to morbidity and loss of work hours. Common carpal tunnel syndrome management strategies may include conservative therapy or surgical decompression, experts note. 
    • “However, image-guided interventions such as steroid shots or nerve hydrodissection—which involves carefully injecting fluid around the impacted area—have emerged as alternatives for mild to moderate cases. Researchers in India recently aimed to investigate the efficacy of these options, sharing their findings Tuesday. 
    • “Most of our patients had been suffering from carpal tunnel syndrome for months to years and did not get much relief despite trying various treatments like pain medications, splints, lifestyle modification and corticosteroids,” study co-author Anupama Tandon, MD, a professor with the University College of Medical Sciences and Guru Teg Bahadur Hospital in Delhi, India, said in a statement Oct. 6. “It came as a pleasant surprise to find that a simple procedure of dissecting the median nerve under ultrasound guidance with normal saline provided them long-term relief.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of research headed by a team at the University of Birmingham suggest that inflammatory conditions in the brain, including traumatic brain injury (TBI) and degenerative diseases such as Alzheimer’s disease and Parkinson’s disease, could be targeted with an existing developmental drug.
    • “Using live cultures of human brain cells and slices of brain tissue obtained during neurosurgery, the researchers, headed by Nicholas Barnes, PhD, professor at the University of Birmingham College of Medicine and Health, investigated the role of the P2X7 receptor, which is responsible for triggering inflammatory signaling. Their findings revealed that these P2X7 receptors drive the release of cytokines involved in controlling inflammation. By blocking this receptor with a specific antagonist, the team was able to significantly reduce the inflammatory response in human brain tissue.
    • “The team suggests that their results could open the door to treating a wide spectrum of chronic neurological conditions, including TBI, neurodegenerative diseases, and even psychiatric disorders such as depression and psychosis, which are increasingly understood to have a neuroinflammatory component.”

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

  • Beckers Payer Issues reports,
    • “Harbor Health, an Austin, Texas-based insurer that also runs its own medical clinics, plans to acquire 27 Village Medical primary care clinics in the Houston area.
    • “The deal is expected to close at the end of the year, according to an Oct. 6 news release, and financial terms were not disclosed. Once the deal closes, Harbor will operate nearly 70 clinics and more than double its count of physicians and advanced practice providers.
    • “The company offers large employer plans in 29 Texas counties, including the four Houston-area counties. It will also offer individual and family plans on the Texas exchange in 13 of those counties for 2027.
    • “Village Medical is the clinic brand of VillageMD, which Walgreens previously owned a majority stake in. VillageMD has operated as a standalone company since private equity firm Sycamore Partners took Walgreens private in August 2025, while Cigna continues to hold a minority stake. Harbor also bought 32 VillageMD clinics in Austin, Dallas, El Paso and San Antonio in September 2025.” 
  • Fierce Healthcare relates,
    • “Cigna is rolling out a new patient experience platform that aims to harness the power of data to drive greater personalization.
    • “Called Health Sense, the tool brings together information on an individual’s health needs, medical coverage, pharmacy benefits, cost exposure and other previous interactions with the health plan. This allows for more complete context, as the insurer’s clinical teams offer tailored experiences to members.
    • “Having a more complete picture of the patient also allows Cigna’s clinicians and care managers to collaborate more effectively with a member’s treating providers, the company said. It surfaces insights for the member about next steps, potential costs for care, any supports available in-network and potential preparation for an upcoming appointment.
    • “Cigna plans to roll out Health Sense in early 2027, with an initial focus on members with cancer or cardiometabolic conditions.”
  • Beckers Behavioral Health tells us,
    • “Mental healthcare, including care for substance use disorders, accounted for 7% of total U.S. healthcare expenditures from 2021 to 2023, Medscape reported Oct. 7. Annualized mental health spending totaled $174 billion, compared with $2.5 trillion in overall healthcare expenditures captured by the survey.
    • “Researchers analyzed data from the 2021 to 2023 Medical Expenditure Panel Survey, which represents the civilian noninstitutionalized U.S. population. The analysis included 67,532 person-year observations, including 15,407 involving outpatient mental healthcare. The study, led by Carlos Blanco, MD, PhD, of the National Institute on Drug Abuse in Bethesda, Md., was published online Sept. 30 in JAMA Psychiatry.”
  • Modern Healthcare informs us,
    • “Prime Therapeutics, one of the largest U.S. pharmacy benefit managers, aims to shift to upfront drug pricing and away from a complicated rebates-based system that critics say increases patient costs. 
    • “The company intends to offer its clients — health insurers and employers — what it calls a net cost model for 2028, Chief Executive Officer Mostafa Kamal said in an interview Wednesday. He said patients should get the discounts that drug companies pay when they fill their prescriptions at the pharmacy. Prime seeks to keep its clients’ overall costs the same or lower than the current setup.” 
  • BioPharma Dive adds,
    • “Caribou Biosciences, one of the first companies founded to advance CRISPR gene-editing technology in medicine, is discontinuing research, laying off staff and looking for “strategic alternatives” because it can’t raise the money to continue.
    • “The decision means the end of Caribou’s work on two “off-the-shelf” CAR-T cancer therapies, one of which was ready for Phase 3 testing. “Despite the progress we’ve made, the current financing environment for allogeneic CAR-T cell therapies has made it increasingly challenging to secure the capital necessary to responsibly advance these programs,” Caribou CEO Rachel Haurwitz said in a statement Tuesday.
    • “The company’s board will consider mergers, acquisitions or other transactions related to the company as a whole or for its assets, Caribou said. In the meantime, a “substantial reduction in workforce” will be mostly completed by the end of the year, the company added.”
  • Healthcare Dive points out,
    • “Telehealth company Teladoc Health is adding new artificial intelligence capabilities to its virtual care platform for hospitals and health systems, it announced Wednesday.
    • “The new capabilities include a “contactless” approach to remotely monitoring patients’ vital signs and an AI scribe that will record and transcribe clinical encounters to create notes, according to the announcement.
    • “The scribing tool is now available but only select customers can currently use the vitals monitoring feature in private preview. The latter is expected to be released broadly in December.”
  • Becker’s Hospital Review notes,
    • “The American Medical Association has honored 92 hospitals, health systems and medical groups through its 2026 Joy in Medicine program.
    • “The Joy in Medicine program recognizes healthcare organizations for their commitment to “reduce burnout and improve the professional fulfillment physicians find in caring for patients,” according to an Oct. 7 news release from the AMA.
    • “There are three levels of recognition in the program, gold, silver and bronze, which are valid for two years. Find the hospitals and health systems honored in the AMA’s 2025-26 Joy in Medicine program here.” 
  • McKinsey & Co. discusses the AI powered future of healthcare.
    • “AI won’t replace clinicians, but it can improve quality, increase access, and reshape the workforce, payments, and patient volumes. Today, AI can perform some 16 to 22 percent of US outpatient care.”

Nobel Prize

  • The Wall Street Journal reports,
    • “Henri Kagan and Kenso Soai were awarded the 2026 Nobel Prize in Chemistry for breakthroughs that have helped advance the development of modern pharmaceuticals.
    • “Kagan, of France’s Université Paris-Sud, and Soai, who is based at Tokyo University of Science, will share the 12 million Swedish kronor, or roughly $1.2 million, prize.
    • “The pair’s research relates to a concept called homochirality, which is the tendency of living systems to use just one of two possible mirror-image forms of a molecule. It’s important for the synthesis of small molecules in drugs that can interact with amino acids and sugars in the body in powerful ways.
    • “Thanks to Henri Kagan and Kenso Soai, we now know how homochirality can emerge,” the Royal Swedish Academy of Sciences said Wednesday. “Their discoveries have been decisive for chemists who design reactions for the manufacture of pharmaceuticals.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services has published its list of participants for its mandatory Comprehensive Care for Joint Replacement Expanded Model, or CJR-X. The payment model focuses on lower extremity joint replacement procedures. CMS is requesting participating hospitals to complete the online primary point of contact form and identify two individuals to serve as their primary points of contact for CJR-X-related communications from the agency. The model, which initially ran in specific geographic areas from 2016-2024, was expanded this year to all acute care hospitals nationwide, except those participating in the Transforming Episode Accountability Model and hospitals located in Maryland. Participation in CJR-X begins Jan. 1, 2028.”
  • Beckers Payer Issues points out “6 payers entering ACA markets in 2027” and “12 insurers exiting ACA market” at the end of this year.
  • Kiplinger projects IRMAA brackets for 2027.
    • “If you have Medicare Part B or Medicare Part D prescription drug coverage, your monthly costs could look drastically different than the standard rates. High-income retirees are subject to the Income-Related Monthly Adjustment Amount (IRMAA) — a progressive surcharge added directly to your Medicare premiums if your income crosses specific thresholds.
    • “Understanding how the projected 2027 IRMAA brackets are calculated and how the two-year tax lag impacts you is essential to preserving your retirement savings. Failing to plan for these thresholds can trigger an unexpected financial “cliff,” at which a single dollar of excess income can cost you thousands in annual surcharges.
    • “This year, forecasting the 2027 numbers has been difficult because the Bureau of Labor Statistics (BLS) did not publish official CPI-W data for October 2025, due to last year’s federal government shutdown. The Centers for Medicare & Medicaid Services (CMS) should release the numbers by early November.”

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

  • FedSmith points out 12 pieces of information to gather and consider before you start comparing FEHB or PSHB plans this coming Open Season.
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Varney & Co. on Fox Business for his first television appearance since President Trump announced his appointment as Vice Chair of the White House Super Intelligence Task Force. Kupor discussed the President’s vision for maintaining American leadership in superintelligence, protecting national security, and holding industry accountable while advancing innovation.”
  • OPM Director Kupor writes about technology development in his Secrets of OPM blog.
    • “In 1980, AT&T hired McKinsey to forecast the size of the future U.S. cell phone market (for the year 2000). McKinsey forecast the market at about 900,000 subscribers, based in large part on the fact that cell phones in 1980 were bulky, had poor battery life, patchy coverage, and high costs. McKinsey was only slightly off; by the year 2000, the actual figure was 109 million, and worldwide, roughly 900,000 new mobile subscribers were being added every three days.
    • “What do these markets and nearly every other technology market have in common?
    • “An over-abundance of focus on the current limitations often blinds people to how quickly the technology is in fact improving. History has taught us repeatedly that one person’s toy is another person’s opportunity.”

From the U.S. Food and Drug Administration front,

  • Per a BridgeBio news release,
    • “BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.
    • “Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia,” said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias. “We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA.”
  • Cardiovascular Businss reports,
    • “Abbott has secured a new approval from the U.S. Food and Drug Administration (FDA) that allows users of its popular CardioMEMS platform to view their own pulmonary artery pressure (PAP) readings and receive personalized updates through a smartphone app. 
    • “Heart failure patients with an implanted CardioMEMS sensor use the CardioMEMS Hero device, which just gained FDA approval in February, to monitor their PAP over time. This approval helps those patients track any PAP changes through the CardioGuide HF App. According to Abbott, this helps patients take a more active role in managing their own health.
    • “Abbott is reshaping heart failure care by bringing meaningful, actionable information directly to patients,” Katie Spayde, vice president of Abbott’s heart failure division, said in a statement. “For many people living with heart failure, managing their condition is part of everyday life. By giving patients greater visibility into their condition, these new capabilities help them stay informed, engaged and connected to their care between doctor visits.”
  • and
    • “Riverain Technologies, an Ohio-based cardiothoracic imaging company, has announced that its U.S. Food and Drug Administration-cleared suite of artificial intelligence (AI) tools is being added to RapidAI’s Rapid Enterprise Platform.
    • “The Rapid Enterprise Platform, a collection of dozens of advanced algorithms, is already helping radiologists evaluate imaging results in more than 2,500 hospitals all over the world. This partnership gives those users access to Riverain’s ClearRead Chest suite, which scans chest CTs and chest X-rays for signs of pulmonary nodules, pneumothoraces and coronary artery calcification. 
    • “ClearRead was developed to help radiologists see subtle chest findings more clearly and confidently within the workflows they already rely on every day,” Steve Worrell, CEO of Riverain Technologies, said in a statement. “By integrating ClearRead Chest into the Rapid Enterprise Platform, we’re expanding access to our advanced chest imaging technology to support earlier detection of leading global killers like lung cancer, and cardiovascular disease and reduce the burden on radiologists facing increasingly complex imaging workloads.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Heart failure contributed to 452,573 U.S. deaths in 2023, a new peak, and the disease is increasingly affecting younger adults, a new Heart Failure Society of America report found. 
    • “The “HF Stats 2026: An Updated Report on Heart Failure Epidemiology and Outcomes Statistics from the Heart Failure Society of America” report compiles principal findings for a comprehensive picture of the changing state of heart failure in the U.S., according to an Oct. 5 association news release. 
    • “Nearly 1 in 4 Americans will develop heart failure in their lifetime, the report found. Heart failure contributed to 452,573 deaths in 2023, representing 14.6% of all-cause deaths. Age-adjusted heart failure mortality rose approximately 37% from 2010 to 2023 — reversing more than a decade of progress. Early 2024 data suggest the increase is continuing. 
    • “Between 2010 and 2022, heart failure hospitalization rates rose in adults younger than 65 but declined in adults over 65.
    • “Between 2001 and 2020, crude heart failure mortality rates jumped 121% for adults 25 to 44 and 96% for those 45 to 64. By comparison, older adults saw an increase of 21% to 23%, “signaling a fundamental shift in the epidemiological landscape of heart failure,” the report said.”
  • and
    • “The CDC is calling for greater surveillance of Cladophialophora bantiana after a clinical reference laboratory recorded a sharp increase in detections of the rare fungus, which is associated with a 60% to 70% case-fatality rate.
    • “The findings were published Oct. 2 in the CDC’s Morbidity and Mortality Weekly Report.”
  • Chief Healthcare Executive adds,
    • “A substantial cohort with early cardivascular disease, occult cancers, metabolic and autoimmune disease produces actionable pre-symptomatic signals, but remains unengaged due to care models optimized for reactive, symptom-driven encounters. 
    • “Existing clinical data are often sufficient for earlier identification; the limiting factor is delivery infrastructure that operationalizes insights into consistent follow-up, diagnostics, referral, and treatment at scale. 
    • “AI and analytics can reduce mortality in acute settings, but predictive models create value only when embedded in workflows that reliably trigger intervention rather than generating unactioned risk flags. 
    • “Precision medicine illustrates the same implementation bottlenecks, with barriers including reimbursement, workflow integration, clinician adoption, data management, and engagement; only ~35% of eligible lung cancer patients receive biomarker-driven therapy. 
    • “Competitive advantage in precision health will hinge less on maximal data acquisition than on building an “operating system” that converts what is already known into earlier, lower-cost, outcome-improving care pathways.”
  • The American Medical Association lets us know what doctors want patients to know about headaches.
    • “Headaches affect nearly everyone, though some can be especially debilitating like migraine attacks. Each type requires specific treatment and approaches.”
  • Health Day relates,
    • “If you’ve developed type 2 diabetes before age 45, it’s possible to push the disease into remission with weight-loss dieting and a fitness program that includes aerobic and muscle-building resistance exercise, a new study confirms.
    • “In early-onset type 2 diabetes, combining structured aerobic and resistance exercise with a low-calorie diet produces high remission rates, induces fat loss while preserving muscle mass, improves muscle quality and function, enhances cardiovascular health, and leads to meaningful improvements in patient-reported outcomes,” concluded a team co-led by Dr. Kaberi Dasgupta. She directs general internal medicine at McGill University in Montreal.
    • “Her team presented its findings Wednesday in Milan at a meeting of the European Association for the Study of Diabetes. The findings were simultaneously published in The Lancet Regional Health Americas.”
  • and
    • “A teenager’s daily step count may improve more than their physical health — it may also help protect their mental health.
    • “Researchers tracked more than 5,500 adolescents (average age: 12), using Fitbits, brain scans and mental health assessments.
    • “After one year, teens who took 12,000 or more steps a day had fewer mental health symptoms than those who took fewer than 5,000.
    • “More steps were also associated with greater thickness in two specific regions of the brain involved in motor and cognitive functions.
    • “Dr. Claudine Higdon, a child and adolescent psychiatrist at Northwell Health in Glen Oaks, New York, called the findings exciting.
    • “The good thing about it is this particular brain region is really linked with decision-making; the attention part of the brain,” said Higdon, who reviewed the study results. “And so that can thereby improve choices and improve impulse control. And that might also lead to improved mental health.”
  • MedScape tells us,
    • “The list of possible side effects attributed to statins is long: muscle pain, memory problems, depression, sleep disturbances, diabetes, and liver damage. However, a meta-analysis by the Cholesterol Treatment Trialists’ (CTT)Collaboration in The Lancet calls many of these associations into question. At the same time, the study confirmed that certain effects on muscles, the liver, and glucose metabolism can indeed occur. What matters, however, is their magnitude — and that is usually significantly lower than what the public criticism of these drugs would suggest.”
  • BioPharma Dive informs us,
    • “A combination of Genmab and AbbVie’s bispecific antibody Epkinly and standard chemotherapy cut the risk of disease progression or death by nearly half when compared to chemo alone in a Phase 3 trial in newly diagnosed lymphoma patients, the companies said Monday.
    • “The data in diffuse large B-cell lymphoma surpassed investor expectations, bested a rival Roche treatment and could significantly propel sales of Epkinly, one Wall Street analyst said. Epkinly is now on track to become the first drug of its kind to gain approval in first-line DLBCL, the most common form of lymphoma. 
    • “Genmab splits ownership rights to Epkinly with AbbVie and reported $312 million in global net sales on the therapy in the first half of the year.”
  • Per an Arrivent news release,
    • “ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the FURVENT (NCT05607550) Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review (BICR). Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BICR. Although not yet mature, a trend toward an improvement in overall survival was also observed.  The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.
    • “These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options,” said Bing Yao, Ph.D., Chairman, Chief Executive Officer of ArriVent. “While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib.”

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

  • Fierce Healthcare reports,
    • “Highmark is making a change at the top, with Karen Hanlon stepping to the role of CEO on Jan. 1.
    • “The Pittsburgh-based insurer announced Tuesday that current CEO David Holmberg, who has held the title since 2014, will transition to executive chairperson at Highmark. Hanlon, who is currently Highmark’s president, will become the company’s first female CEO.
    • “At the helm of Highmark, Hanlon will spearhead strategy, operations and performance across Highmark’s health plans, diversified businesses and Allegheny Health Network. She’s spent nearly three decades at Highmark, during which the organization grew from a $17 billion revenue business in 2014 to a projected $35 billion at the end of this year.”
  • and
    • “Option Care Health, a provider of infusion therapy services, is being acquired by private equity firm CD&R and healthcare conglomerate McKesson in a deal valued at $5.8 billion, the companies announced Tuesday morning. 
    • “The purchase will take Option private at a per-share offer price of $32.05, a 37% premium over the company’s closing price. Its stock had begun trending higher after close when early reports of the definitive agreement began to swirl, and as of Tuesday morning, it is trading at about $31 per share.
    • “The deal is expected to close in the first half of 2027, subject to customary closing conditions like regulatory approvals and shareholder go-ahead. It would leave CD&R with a 51% stake in the company and McKesson a roughly 49% interest, for which it plans to invest about $1.4 billion. The agreement also outlines a framework for McKesson to acquire CD&R’s interest in the future, according to the announcement.”
  • Beckers Hospital Review relates,
    • “HCA Healthcare owned more general hospitals than any other U.S. health system at the end of 2025, according to an analysis from the Lown Institute, published Oct. 6.
    • “The analysis draws on Lown’s hospital ownership dataset, which tracks the ownership of U.S. acute care and critical access hospitals from 2020 through 2025. Counts may differ from systems’ own figures, since Lown includes only those hospital types.
    • “Together, the 10 largest systems own 695 hospitals, or about 16% of general hospitals, and nearly 20% of beds in the dataset. Their hospitals accounted for about 25% of hospital profits in 2024, based on Medicare cost reports.
    • “Seven of the 10 systems owned fewer hospitals in 2025 than in 2020, according to Lown. Advocate Health added the most, 21 hospitals, following the 2022 merger of Advocate Aurora Health and Atrium Health.”
  • and
    • “Hospitals are the leading source of medical debt in the U.S., with more than half of adults with medical debt owing money for hospital services, according to an Oct. 6 Urban Institute report funded by the Robert Wood Johnson Foundation.
    • “The report draws on December 2025 data from the institute’s Well-Being and Basic Needs Survey. The nationally representative survey covers more than 10,000 adults ages 18 and older, who reported debt owed by themselves or family members.
    • “Overall, 26.6% of U.S. adults said they or a family member owed medical debt.”
  • Fierce Healthcare adds,
    • “Datavant is partnering with identity verification company ID.me to help patients request their medical records faster and more easily via simple digital credentials.
    • “By integrating ID.me’s digital identity verification into Datavant’s Patient Request Tool, the companies aim to reduce friction, speed up access to records and strengthen safeguards against unauthorized access.
    • “ID.me is a secure, private digital identity platform that acts as an independent “identity wallet.” Twenty-three federal agencies, 50 state government agencies and more than 100 healthcare organizations use ID.me for secure identity verification and the company boasts more than 175 million users.
    • “Datavant offers a data exchange network that connects more than 80,000 hospitals and clinics, 75% of the 100 largest health systems and an ecosystem of 350-plus real-world data partners. Its platform connects datasets across electronic health records, claims, specialty pharmacy, registries, imaging, labs and social determinants of health. Datavant’s data collaboration platform enables more than 60 million healthcare records to move between thousands of organizations.”
  • and
    • “Gilead Sciences is taking a step into the wellness space to support patients with chronic diseases by offering resources that go beyond physical health. The company is partnering with mindfulness app Calm to provide curated content for those impacted by cancer, HIV and liver conditions. 
    • “More than one-third of people living with HIV in the U.S. experience depression, while 28% have an anxiety disorder, according to Gilead and Calm. Additionally, those with HIV often struggle with stigma that can stir up feelings of shame and anxiety. 
    • “Meanwhile, about 50% of people with cancer experience distress, with some two in ten people with cancer reporting symptoms of depression. For those with liver conditions such as primary biliary cholangitis (PBC), symptoms such as fatigue, chronic itch and brain fog can take a toll on daily life, Gilead points out.”  

Nobel Prize

  • The Wall Street Journal reports,
    • “Belgian particle physicist Francis Halzen was awarded the 2026 Nobel Prize in Physics for his contributions to astronomy and his work on the IceCube Neutrino Observatory at the South Pole.
    • “Francis Halzen has led an international team of researchers and engineers who have provided us with a fantastic instrument,” said Mark Pearce, chair of the Nobel Committee for Physics, on Tuesday.
    • “His tenacity and scientific vision has paved the way for a new kind of astronomy.”
    • “As the spearhead behind the IceCube Neutrino project, Halzen wanted a way to capture and study astrophysical neutrinos—tiny, electrically neutral subatomic particles from deep space.
    • Neutrinos with extremely high energies are created in the same environments as other types of particles, but unlike other particles, neutrinos reach Earth without changing direction or losing energy. This means they can provide information about distant galaxies that isn’t available in any other way.
    • “Halzen, who is 82-years-old and based at the University of Wisconsin-Madison, first presented his vision for capturing high-energy neutrinos at the South Pole—a giant particle detector buried deep in the Antarctic ice—in 1988.”

Weekend update

David Ermer–Agentic & Generative AI, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, SCOTUS, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Both Houses of Congress have left Capitol Hill for the campaign trail.
  • SCOTUSblog reports,
    • The Supreme Court’s 2026-27 term will officially kick off on Monday [October 5]. The justices will hear argument that morning in two cases: Suncor Energy Inc. v. County Commissioners of Boulder County, on whether a lawsuit filed in Colorado state court seeking to hold energy companies responsible for their alleged role in climate change can go forward, or whether federal law instead bars such claims; and Johnson v. United States Congress, on whether a federal district court may hear a constitutional challenge to a law limiting disability benefits for certain incarcerated veterans.”
  • The Centers for Medicare and Medicaid Services announced last Thursday,
    • Medicare Improvement Fund Premium Rebate Frequently Asked Questions
    • Q: What will the Medicare Improvement Fund do for Medicare beneficiaries? 
    • A: The Administration is making a $90 Premium Rebate available for Part B premiums to certain Medicare beneficiaries because the best way to improve Medicare is to put healthcare dollars back where they belong – in the hands of our Medicare beneficiaries – and make coverage more affordable. 
    • Q: How much is the Medicare Improvement Fund Premium Rebate and when will beneficiaries receive it?
    • A: Eligible beneficiaries will receive one $90 rebate in October 2026. Most beneficiaries will receive a direct deposit for $90 on or around October 8th followed by an email or a letter from the President in mid-October. Some beneficiaries will receive a paper check for $90 from the U.S. Department of the Treasury later in October with the following accompanying message “Medicare Improvement Fund Payment; $90 Payment to Offset October Premium.” 
    • Q: Who will receive the Medicare Improvement Fund Premium Rebate?
    • A: The 20.8 million Americans in Original Medicare Part B who are: (1) Living in the United States, are (2) not receiving premium assistance from Medicaid; or, (3) not paying an Income-Related Monthly Adjustment Amount. Beneficiaries enrolled in Medicare Advantage are not eligible.
  • FEHBlog observation — While the FEHBlog is on Original Medicare Part B and lives in the U.S. he is ineligible for the rebate because he pays an IRMAA fee on top of his Part B premiums. It’s still a good deal.
  • The Wall Street Journal reports
    • “A new White House task force will have 120 days to report on the risks and opportunities of artificial intelligence—and determine the federal government’s responsibility—according to Jay Clayton, the director of national intelligence who effectively becomes the administration’s AI czar.
    • “The president asked that a group be put together that was going to ensure exactly what he said,” Clayton said, that “we stay the leaders in superintelligence, and that the interests of the American people are put first.” 
    • “Clayton will chair the “Super Intelligence Force” which takes President Trump’s preferred name for AI: super intelligence or SI.” * * *
    • “The task force will have three vice chairs: Emil Michael, undersecretary of war for Research and Engineering, who will be responsible for coordination with AI companies; Scott Kupor, director of the Office of Personnel Management, who will be responsible for coordination with critical infrastructure providers and other industry stakeholders; and Andrew Ferguson, chairman of the Federal Trade Commission, who will oversee consumer interests and groups advocating for people of faith, children, privacy, freedom of speech, freedom of expression, and freedom of association.
    • “Members of the task force will include Vice President JD Vance, Defense Secretary Pete Hegseth, Richard Walters, White House deputy chief of staff, Bessent, Wiles and others. External participants will include venture capitalists David Sacks, co-chair of the president’s Council of Advisors on Science and Technology and Condoleezza Rice, former Secretary of State in the George W. Bush administration, who will provide advice on national security.”

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

  • My Federal Retirement considers whether “Fraud is driving your FEHB premium increase based on what OPM’s numbers reveal.
    • OPM’s numbers fail to consider that the proper payment rate for the carriers that cover the vast majority of FEHB and PSHB members is 99.9% according to paymentaccuracy.gov and what’s more OPM, not withstanding carrier requests, has not implemented the HIPAA 820 electronic roster transaction which would allow carriers to reconcile premiums with individual enrollee coverage. The HIPAA 820 has been around since 2012.
  • FedSmith reports,
    • “Seven months ago, the OPM retirement backlog stood at a record 65,237 claims. At the end of September 2026, it stood at just 8,814, the lowest total in data going back to January 2012.
    • “September also closed out fiscal year 2026 (FY 2026), which ran from October 2025 through September 2026. It was by far the busiest year in the data for both incoming and completed retirement claims.
    • “New claims received: 179,958, up 59% from FY 2025 (112,857) and well above the previous high of 116,463 in FY 2013
    • “Claims processed: 178,551, up 70% from FY 2025 (104,800)
    • “Backlog: began the year at 23,552, peaked at 65,237 in February, and ended at 8,814
    • “The wave of claims that defined the first half of the year followed the end of the deferred resignation period in September 2025 and broader reductions to the federal workforce. Monthly intake has since settled back toward more typical levels, with fewer than 9,000 new claims in three of the last four months.”
  • FEHBlog observation: The favorable change is attributable to the OPM Director’s implementation of a digital retirement claim system. The HIPAA 820 would similarly reduce the time needed to process premiums and for the first time allow carriers to reconcile premiums with individual enrollments.

No Surprises Act News,

  • The Centers for Medicare and Medicaid Services announced last Friday
    • “On November 1, 2026, the Notice of IDR Initiation web form will include new functionality to enforce certain batching provisions under the Federal IDR Operations Final Rule (final rule).
    • “The new functionality to be added to the Notice of IDR Initiation web form includes:
    • Any batched dispute submitted with an open negotiation period start date on or after November 1, 2026, will be limited to 50 dispute line items.
    • “System validations will enforce the timely initiation of a dispute after a 30-business-day cooling off period by preventing any dispute initiated after the cooling off period from being initiated before the end of the cooling off period or more than 4 business days after the end of the cooling off period.
    • “In addition to the Notice of Initiation web form changes, the payment determination letters will reflect the correct cooling off period based on the dispute type and open negotiation period start date.”
  • CMS Notes:
    • “Batched disputes with an open negotiation period start date before November 1, 2026, will continue to be subject to the 90-calendar-day cooling off period.
    • “Single and bundled disputes will also continue to be subject to the 90-calendar-day cooling off period regardless of the open negotiation period start date.
    • “For disputes subject to a 90-calendar-day cooling off period, disputing parties will continue to have 30 business days after the end of the cooling off period to submit a dispute to the Federal IDR process for any items or services whose open negotiation period expired during the cooling off period.
    • “System validations will continue to prevent any dispute from being initiated before the end of the 90-calendar-day cooling off period.
    • “Furthermore, system validations were added on September 24, 2026, to enforce timely initiation of disputes following a 90-calendar-day cooling off period, preventing any dispute initiated after the cooling off period from being initiated more than 30 business days after the end of the cooling off period.”‘

From the public health and medical research front,

  • The New York Times reports.
    • “The Food and Drug Administration said on Friday that it had found two samples of the cyclospora parasite during its investigation of Taylor Farms facilities in Mexico, strong new evidence that an outbreak that sickened thousands in the United States this summer came from lettuce produced by the company.” * * *
    • “Also on Friday, the F.D.A. announced a series of actions intended to prevent future cyclospora outbreaks. Those included greater surveillance of foods that have caused past outbreaks, which can include cilantro and raspberries, and outreach to growers about how to reduce the risk of produce contamination with the parasite.
    • “It is difficult to know whether those steps will be effective at preventing future outbreaks, since the F.D.A. has not yet determined how the lettuce at Taylor Farms was contaminated, said Jim Gorny, a produce safety expert who retired from the agency in 2024.
    • “Aside from that,” he said, “it’s just a recommitment to employ the same strategies and tactics over and over again hoping for a different outcome.”
    • “Bill Marler, a lawyer based in Washington State whose office represents about 500 people sickened in the outbreak, said there is still more to learn from additional analysis of the samples from the inspection and stool samples of those who fell ill.
    • “But before next growing season, he said, it would be ideal if federal officials could invest in the development of a water test to routinely surveil water for cyclospora, which does not currently exist. He would also like to see officials enforce a federal rule requiring food companies to hand over supply chain records in 24 hours after a product is implicated in an outbreak.
    • “The F.D.A. finalized such a rule but delayed its implementation last year, potentially slowing down the response to this outbreak, The New York Times found.”
  • The Independent relates,
    • “Florida is experiencing its largest dengue outbreak in decades, with 252 locally acquired cases reported as of late September, among the highest totals seen in the continental U.S. in several decades.
    • “The vast majority of cases have been reported in Hillsborough County, home toTampa, where officials are ramping up mosquito-control efforts, according to the latest numbers released by state health officials. Florida has also recorded 245 travel-associated cases this year, while at least 13 Hillsborough County cases involved people who had recently traveled.
    • “The surge has prompted Hillsborough, Pasco and Pinellas counties to declare local states of emergency and step up efforts to kill mosquitoes and eliminate standing water where they breed.” * * *
    • “Dengue is a viral infection spread primarily through bites from infected Aedes aegypti and Aedes albopictus mosquitoes, both of which are found in Florida. Some people have no symptoms, while others can develop a sudden fever, severe headache, pain behind the eyes, muscle and joint pain, nausea or vomiting.
    • “Most people recover, but dengue can sometimes become severe, causing bleeding, shock and death. Florida has reported one dengue-related death this year, involving an elderly Tampa woman who died on September 4.”
  • MedPage Today reminds us,
    • “It’s October and time for flu shots.
    • “Medical experts urge getting a flu vaccination soon, before influenza starts spreading widely — and to get up to date on protection against other fall respiratory viruses, too. Updated COVID-19 shots are available now, plus shots for people especially vulnerable to another winter risk, respiratory syncytial virus (RSV).
    • “While these infections make many people feel miserable for a few days before they recover, every year flu alone causes hundreds of thousands of hospitalizations in the U.S. and kills tens of thousands.”
  • Surprisingly, Health Day informs us,
    • “Colon cancer in U.S. adolescents is on the rise, experts say, and a new report finds it’s typically caught in its more deadly later stages.
    • “Colorectal cancer is, unfortunately, becoming more common in adolescents and young adults and represents a different disease than colorectal cancer diagnosed in older adults,” said study author Dr. Erica Arnold, a pediatric surgery research fellow at Nationwide Children’s Hospital in Columbus, Ohio.
    • “She said colon cancer diagnosed in adolescents “is often aggressive, presenting with late-stage disease and associated with high rates of disease relapse and mortality.” She spoke in a news release from the American Academy of Pediatrics (AAP).” * * *\
    • “The study said symptoms that could indicate colon cancer in young people include unexplained weight loss, rectal bleeding, back/abdominal pain and changes in bowel habits. 
    • “Because colon cancer is so unexpected in this age group, diagnosis is often delayed, the study group warned. 
    • “Children and adolescents without known colorectal cancer predisposition syndromes experience delays in diagnosis and the majority do not have a known family history,” the researchers noted in their study. 
    • “Routine colon cancer screening for people at average risk usually begins at age 45.
    • “The study authors urged physicians to consider this cancer in any young person presenting with symptoms such as abdominal pain or rectal bleeding. 
    • “Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal.”

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

  • The New York Times reports,
    • Starting Thursday [October 1], women across the United States will be able to find out their risk of developing breast cancer in the near future with the help of an A.I. tool that examines a single recent mammogram.
    • “Everlywell, a digital health company, announced it would now offer patients nationwide access to Clairity Breast, an A.I. tool approved by the Food and Drug Administration last year to predict a woman’s five-year risk of breast cancer based on imaging. The test, which was previously available only at select locations in Massachusetts and Colorado, will cost $249. It is not covered by insurance.
    • “Doctors use mammograms to detect the presence of cancer, sometimes with the help of A.I. models that can read the images. But Clairity’s software uses the scans for a different purpose: predicting the risk of developing cancer and providing a probability score that reports the patient’s future risk in the form of a percentage, from zero to 100.
    • “That score, which doctors should consider along with other clinical information like family and patient medical history and other risk factors, could aid in efforts to detect cancers earlier, when they are more treatable and more likely to have better outcomes, said Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in Paramus, N.J.”
  • BioEngineer relates,
    • “Sleep problems in children are far more than a nightly nuisance for exhausted families. According to a recent nationally representative study by Carney and colleagues published in the Journal of Clinical Sleep Medicine, sleep disorders among children and adolescents in the United States add an estimated 2.88 billion dollars in health care expenditures every year, a burden significantly higher than that carried by children without sleep disorders.
    • “The finding, highlighted in an open access commentary by pediatric sleep specialist Sally L. Davidson Ward of Children’s Hospital Los Angeles and the Keck School of Medicine of USC, reframes pediatric sleep health as a major economic and public health issue rather than a niche clinical concern. The commentary argues that recognizing, treating, and where possible curing sleep disorders in individual children could simultaneously reduce spending, improve quality of life, boost school attendance, and free parents to work and care for their families.
    • “The underlying evidence comes from the Medical Expenditure Panel Survey, administered by the US Agency for Healthcare Research and Quality, covering the years 2017 through 2022. This survey is unusual in that it captures data from households themselves as well as from their medical providers, including clinics, hospitals, home health agencies, and pharmacies, along with a sample of insurance plans offered by employers. Crucially, the analysis adjusted for covariates and comorbidities that either facilitate or impede access to health care, or that influence the perceived need for care. That methodological rigor matters, because the question of whether sleep disorders drive excess spending, or whether sicker children simply use more services of every kind, is exactly the kind of confounding that national datasets can help untangle when handled carefully.”
  • The Washington Post discusses how to use patient advocates at the time of a family health crisis.
  • Last but certainly not least, AHIP created an illuminating infographic breaking up a dollar bill based on prescription drug spending.
    • “Health plans and PBMs [combined] retain just over one cent of every dollar spent on prescription drugs as profits — compared to 6.5 cents brand manufactures take in profits.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Congress, Cybersecurity, OPM, Uncategorized–

From the frontier AI and Project Glasswing front,

  • OPM’s CIO Adam Starr, writing in the OPM Director’s Secrets of OPM blog, lets us know,
    • “OPM has joined Anthropic’s Project Glasswing and OpenAI’s Daybreak, two industry initiatives that provide cyber defenders with access to advanced AI tools. Early results across Glasswing’s partner organizations are promising — more than 10,000 high- or critical-severity vulnerabilities identified in the first month. OPM will continue to pursue partnerships and capabilities that strengthen our defensive posture and protect the federal workforce data we are entrusted to secure.
    • “That moves the bottleneck. The hard part isn’t finding the hole anymore. It’s patching it.
    • “The flaws attackers are already exploiting have a name: KEVs, for the Known Exploited Vulnerabilities in the Cybersecurity and Infrastructure Security Agency’s catalog. My top security metric at OPM is simple: whether we’ve patched every KEV, and how fast.
    • “Now do that 119 times.
    • “The federal government runs roughly 119 separate HR IT systems. When a vendor ships a critical fix, every agency running that software applies it separately, on its own timeline. An attacker only needs one that’s behind.”
  • Tech Target adds,
    • “When Anthropic introduced Project Glasswing in April, the tech industry braced for impact. Five months in, DevSecOps teams are wading through the glut of discoveries to find out what’s worth patching – and so far, it isn’t much, according to one cybersecurity researcher.
    • “Anthropic updated its Vulnerability Disclosure ledger for the first time in August. A small percentage of initial Mythos vulnerability findings made it into the ledger, and fewer than 1% of the vulnerabilities Mythos found were marked as fixed, according to Patrick Garrity, a security researcher at vulnerability prioritization tool maker Vulncheck.
    • “Garrity and Vulncheck have also been tracking whether vulnerabilities discovered with AI are actually exploited in the wild. This research combined vulnerabilities attributed to Anthropic’s model with data from the Berkeley Vulnerability Research Initiative and correlated them with Vulncheck’s known-exploited vulnerability data.
    • “Of the 1,061 vulnerabilities attributed to AI-assisted discovery, only 14 had been listed as exploited in the wild as of June 2026. That’s roughly 1%.
    • “You discover a vulnerability — that doesn’t mean it’s necessarily useful for an attacker. It doesn’t mean it’s necessarily going to be exploitable with certain conditions,” Garrity said.”
  • The Wall Street Journal relates,
    • “OpenAI says it is scrapping the release of its next-generation AI model over safety concerns that researchers raised during internal testing, in one of the clearest signs so far that agent misbehavior could stymie the industry’s rapid progression.
    • “The move follows a summer punctuated by reports of artificial-intelligence systems industrywide going rogue, and marks a rare case of a major AI developer ditching a new release because of safety concerns.
    • “The company had planned to launch the model, known as GPT-6.1 Astra, in the coming days or weeks, aiming for an October debut. The model was more capable than the company’s previous models in completing challenging tasks from end-to-end without human assistance, as well as writing.
    • “The company instead will focus on improving the safety of future models, which it expects to be even more capable.”
  • and
    • “Nvidia NVDA  launched a software platform to help developers test and deploy artificial-intelligence agents and keep them in a secure environment, ramping up efforts to contain the technology following a string of rogue incidents in recent months.
    • “The chip giant said its Nvidia Open Agent Safety Platform includes tools that let developers continuously monitor and govern AI behavior, ensuring agents follow the rules. Nvidia said the platform included a watchdog that can quarantine agents that attempt to move outside their boundaries in milliseconds, as well as software to enforce what agents can see, do, and interact with.”

From the cybersecurity policy and law enforcement front

  • Beckers Health IT reports,
    • “The Senate passed the bipartisan Health Care Cybersecurity and Resilience Act (S. 3315) by unanimous consent.
    • “The legislation aims to help healthcare providers strengthen their cybersecurity defenses and protect patient information, according to an Oct. 1 news release from the Senate Committee on Health, Education, Labor and Pensions.
    • “Sens. Bill Cassidy, MD, R-La., Maggie Hassan, D-N.H., John Cornyn, R-Texas, and Mark Warner, D-Va., released statements on the Senate’s passage. Sens. Cindy Hyde-Smith, R-Miss., and Angus King, I-Maine, also co-sponsored the bill.
    • “Mr. Cornyn said the legislation would strengthen coordination among federal agencies and improve security practices for rural providers. Ms. Hassan said it would help hospitals and other providers, particularly rural organizations with fewer resources, strengthen cybersecurity and respond faster to attacks.”
  • The Wall Street Journal notes,
    • “President Trump is expected to name Director of National Intelligence Jay Clayton as the new artificial intelligence czar, spearheading AI policy across the administration, according to people familiar with the decision.
    • “The decision isn’t final, the people said, and no official announcement has been made. But the appointment comes as the White House is racing to address the threats posed by the latest models and boost the technology’s popularity. 
    • “Before Clayton was confirmed in July to lead the Office of the Director of National Intelligence, he served as the U.S. attorney for the Southern District of New York. He attended Tuesday’s meeting at the White House with AI leaders including OpenAI President Greg Brockman, Anthropic’s Dario Amodei, and Nvidia CEO Jensen Huang. Afterward, Trump was asked by a reporter if Clayton was under consideration for the role. He responded that Clayton is a “good man” and a “good idea.” CBS News earlier reported the potential appointment.”
  • The Wall Street Journal further relates,
    • “The Federal Trade Commission is investigating Anthropic and OpenAI to determine whether they deceived consumers about the potential harms of their artificial intelligence, the WSJ reports. The agency plans to send civil subpoenas to the two companies in the coming weeks, as well as third-party AI evaluator METR, author of an August report revealing how OpenAI agents secretly collaborated on a message board they built inside OpenAI.
    • “AI CEOs publicly signed White House safety principles alongside President Trump this week, but privately executives like Nvidia’s Jensen Huang pressed Anthropic’s Dario Amodei over his stark public warnings about AI risks, revealing tensions that could complicate the industry’s self-regulation plans, the WSJ reports.”
  • Cyberscoop tells us,
    • “Collaboration with industry is key to balancing AI security risks and benefits, as well as staying ahead of China and other adversarial nations, National Cyber Director Sean Cairncross said Thursday [October 1].
    • “The Trump administration is facing pressure from some quarters of Capitol Hill and even some artificial intelligence executives to establish regulations or embrace legislation to guard against the technology’s risks, something the president himself has rejected.
    • “We’ve never faced a world where our adversaries have the frontier in this space, and so our attempts to optimize that innovation and security is is something that is ongoing, but is increasingly efficient, and it depends on our relationship with industry and our ability to work collaboratively among the the interagency,” Cairncross said at the AI Edge event hosted by The Washington Post.
    • “That collaboration is ever-increasing, he said, such as with the National Institute of Standards and Technology’s Center for Advancing Innovation and Standards for Super Intelligence (CAISSI).
    • “Industry coordination on this, across critical infrastructure sectors, is improving both on industry-to-government and within industry,” he said. “There is collaboration with CAISSI and others as well to do evaluation and testing on these models. That includes work on guardrailing, sandboxing, et cetera.”
  • Cybersecurity Dive points out,
    • Policymakers should fix duplicative and contradictory regulations that currently impede the government’s ability to oversee the cybersecurity of critical infrastructure, industry representatives told the Government Accountability Office during a recent panel discussion.
    • The industry feedback, revealed in a GAO report published on Monday, is the latest evidence that the private sector is deeply unsatisfied with the patchwork of rules governing infrastructure security in the U.S. The new report also comes as the Cybersecurity and Infrastructure Security Agency (CISA) works to finish a congressionally mandated cybersecurity incident reporting rule that could impose sweeping requirements on a broad swath of infrastructure operators.
  • Per a Cybersecurity and Infrastructure Security Agency news release.
    • “The Cybersecurity and Infrastructure Security Agency (CISA) kicks off Cybersecurity Awareness Month today [October 1]. CISA updated our Cybersecurity Awareness Monthpage with additional information, tips, and resources, including for business and government organizations—if you haven’t done so yet, be sure to check out this year’s toolkit.  
    • This year’s theme is Securing the Next 250, highlighting the need for everyone to play their part in strengthening the country’s infrastructure against cyber threats. At a time when nation-state backed cyber threats continue to increase and super intelligence is transforming both threats and security, it is more important than ever that those that own and operate the nation’s critical infrastructure take steps to protect it. 
    • “Whenever critical infrastructure is disrupted, so are the businesses and communities that depend on vital services,” said Acting CISA Director Nick Andersen. “That’s why CISA is prioritizing the security and resilience of critical infrastructure, and state, local, tribal, and territorial government (SLTT), whose systems and services sustain us every day. This includes things like clean water, secure transportation, quality healthcare, secure financial transactions, rapid communications, and more. However great or small—every organization that touches critical infrastructure is vital to ensuring uninterrupted services to America’s communities.” 
  • The American Hospital Association News informs us,
    • “The AHA provided comments Sept. 30 to the Senate Homeland Security and Governmental Affairs Subcommittee on Disaster Management, District of Columbia and Census for a hearing, “Rogue AI: Securing the Homeland Against AI Agent Attacks.” The AHA discussed how it has worked closely with federal agencies to build relationships and channels for the mutual exchange of cyber threat information, risk mitigation practices and resources to implement such practices. The AHA shared information on a rise of cyberattacks in healthcare and increased risk from artificial intelligence tools, the need for federal agencies to protect hospitals and health systems from nation-state-level cyberattacks, and the unique risks rural hospitals face when defending against cyberattacks.”
  • and
    • “The FBI Sept. 29 announced an arrest of one of the alleged leaders of ShinyHunters, a cybercriminal group linked to cyberattacks in the U.S. and internationally on more than 140 organizations, including healthcare, with at least $70 million taken in extortion payments. ShinyHunters has used targeted voice phishing campaigns to deceive personnel into exposing credentials on malicious, medical-themed impersonation domains, Health-ISAC announced in August. ShinyHunters threat actors have been observed contacting employees directly on personal devices through calls, voicemail messages and emails from multiple random accounts.
    • “ShinyHunters is currently one of the most prolific and aggressive cybercriminal groups targeting healthcare and third-party healthcare vendors,” said John Riggi, AHA national advisor for cybersecurity and risk. “They are known for stealing highly sensitive personal information, including health information and extorting victims with threats to publish it. Today’s highly commendable arrest and other recent enforcement actions align with the FBI’s new cyber strategy to impose costs on adversaries, support victims of cybercrime, and join forces with the private sector, including healthcare.”

From the cybersecurity breaches and vulnerabilities front

  • The New York Times reports,
    • “A criminal hacking group known as ShinyHunters revealed last week that it had stolen a vast trove of sensitive personal data from the F.B.I., potentially one of the worst breaches of sensitive government information in the internet age.
    • “The breach may have compromised information about tens of thousands of former and current F.B.I. employees, including data like home addresses, Social Security numbers and even secretive job assignments.
    • “In a series of cryptic statements, ShinyHunters demanded that the F.B.I. retract a public advisory the bureau had issued this springwarning of the group’s cyberattacks. In an email to The New York Times on Friday, ShinyHunters said that the bureau had until the end of Tuesday to fulfill its request. But on Monday, it appeared to walk back that demand, saying it would not publish the data, as it typically does with the information it steals.
    • “In a video posted online on Tuesday, the F.B.I. warned the group that it would aggressively pursue its members as it promoted the recent arrest of a suspect it said was affiliated with the group.”
  • The HIPAA Journal relates,
    • “There has been a 5.9% decline in healthcare breaches compared to H1 2025. Between January 1 and June 30, 2026, 397 data breaches affecting 500 or more individuals were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights – the lowest H1 total since 2023. While the year-over-year reduction in healthcare data breaches is a step in the right direction, healthcare data breaches continue to be reported in high numbers. In the first six months of the year, large healthcare data breaches were reported at a rate of more than 2.2 per day.
    • “Across the 397 reported data breaches, the protected health information of 33.77 million individuals was exposed or impermissibly disclosed. That represents a 22.6% reduction in affected individuals compared to H1 2025, and it is the lowest number of affected individuals in H1 since 2023.”
  • Cybersecurity Dive tells us,
    • “Fortinet on Thursday [October 1] warned of a critical path traversal vulnerability in Fortinet FortiMail, which has been exploited in the wild. 
    • “The zero-day vulnerability, tracked as CVE-2026-104286, allows an unauthenticated attacker to write arbitrary files on a system through the use of specially crafted HTTP or HTTPS requests. 
    • “Fortinet said it has been in touch with government authorities and other stakeholders regarding the threat, and urged customers to apply a workaround. The company did not say when a security patch would be available. 
    • “We are communicating with relevant government organizations, including CISA, on the content of this advisory,” a spokesperson told Cybersecurity Dive.
    • “FortiMail is a platform that provides companies protection from phishing, malware, business email compromise and other potential attacks.”
  • and
    • “Exploitation activity linked to zero-day vulnerabilities in Citrix NetScaler were initially detected on Thursday, days before public disclosure, according to a report Monday [September 28] from GreyNoise. 
    • A malicious cyber actor tried to exploit a zero-day flaw against Citrix NetScaler on Thursday [September 24], according to GreyNoise researchers. At the time, there were no detections available that were specific to this CVE, but researchers labeled the activity malicious. 
    • Two days later, Citrix NetScaler customers began receiving warnings to disconnect their servers due to suspected exploitation activity. By Sunday, Citrix released an official security bulletin warning of multiple vulnerabilities in NetScaler ADC and NetScaler Gateway. 
    • The exploitation activity involved a remote code execution (RCE) vulnerability, tracked as CVE-2026-88771 and a memory overflow vulnerability, tracked as CVE-2026-88772. 
    • Citrix urged customers to immediately patch their systems, warning that successful exploitation could result in RCE, denial of service, HTTP request smuggling and other consequences. 
  • The Cybersecurity Hub Newsletter, posted on LinkedIn, notes,
    • “Dell has released security updates for its Container Storage Modules (CSM) after disclosing vulnerabilities that could allow attackers to take control of infrastructure connecting Kubernetes applications to enterprise storage.
    • “Two flaws carry the maximum CVSS severity score of 10.0. They affect the CSM Authorization module, putting a security component responsible for controlling storage access at the centre of the disclosure. Additional critical vulnerabilities raise concerns about cluster privileges, authentication tokens and sensitive credentials.
    • “The advisory was published on October 1. Dell had not flagged the issues as actively exploited at the time of publication. That distinction matters: the disclosure describes serious opportunities for compromise, but does not establish that customers have already been attacked.
    • “The potential impact deserves attention beyond infrastructure teams. Storage services underpin the availability and integrity of business applications. A failure in the systems governing access to those services can affect several workloads at once, making the scope of a deployment as important to an organisation’s response as the severity score.”

From the ransomware front,

  • Tech Target lets us know that “August’s ransomware activity hit new high for the year.
    • “NCC Group identified 83 ransomware groups active last month, but it said AI wasn’t necessarily what drove the increase in the number of bad actors.”
  • VMblog reports,
    • “Most ransomware defenses rest on a simple assumption: if files look encrypted, you’ve been hit, and if they look normal, you’re safe. New research suggests that assumption is outdated. After detonating 1,064 real ransomware strains in a controlled environment during the first half of 2026, Index Engines’ CyberSense Research Lab found that directory-entry destruction (47.8%) was far more common than full encryption (18.3%). Some strains even scrambled data while leaving filenames, file sizes, timestamps, and entropy untouched, so corrupted files looked perfectly healthy.
    • “To mark Cybersecurity Awareness Month, we spoke with Jim McGann, CMO of Index Engines, about what these findings mean for detection, recovery, and the role of AI in modern attacks. He explains why signature-based detection is losing ground, how quickly damage can spread, and why leaders should move from asking “Do we have backups?” to “Can we prove our recovery data is clean?”
  • Dark Reading tells us,
    • “German authorities have identified a 16-year-old as the alleged mastermind of the KillSec ransomware operation, following a coordinated law enforcement operation that resulted in the arrests of three suspects and searches of eight properties in Spain, Greece, Romania, and the UK.
    • “In an Oct. 1 statement, Hamburg police said investigators also took control of KillSec’s leak website and secured at least 110TB of data to prevent further unauthorized access.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “Google unveiled its latest AI model, Gemini 4 Argon, with a notice up top that its release would be limited, at least for now, to a list of “trusted cybersecurity vendors.” Such has become the new normal for frontier-model announcements in the post-Mythos age, where touting the guardrails can seem to outweigh posting the wins.
    • “And Gemini 4 Argon, which comes out nearly a year after Gemini 3 enabled the company to leapfrog rivals, clocks some wins. According to the company, the model sets new highs on several coding and knowledge-work benchmarks.
    • “Google says Gemini 4 Argon is already in use inside the company. It has helped quantum computing researchers “optimize the spacetime resources” of certain subroutines and has optimized memory use across its data centers. Argon agents are also migrating C/C++ codebases to Rust across Google.”
  • Beckers Health IT adds,
    • “Google says its new frontier AI model, Gemini 4 Argon, uncovered a critical vulnerability in healthcare software used by hospitals worldwide that put sensitive personal information at risk.
    • “Google-owned cybersecurity company Wiz found the flaw through its Scan for Good initiative, which offers free scanning to find and fix high-risk exposures at organizations that run critical public infrastructure. Koray Kavukcuoglu, senior vice president of Google DeepMind and chief AI architect at Google, described the finding in a Sept. 30 blog post. Mr. Kavukcuoglu said earlier frontier models had missed the risk.
    • “Google did not name the software or its vendor. It also did not say what specific data was at risk or whether the vulnerability has been patched.
    • “Wiz said Sept. 24 that Scan for Good, using Google’s Gemini 3.8 Flash Cyber model, had found exposures at two unnamed hospitals, which it said were fixed before disclosure. Google did not say whether the Argon finding is related to either case.”
  • The New York Times relates,
    • “Epic Systems, the nation’s largest medical records vendor that is relied on by thousands of hospitals and doctors’ offices, is using artificial intelligence tools to patch security risks that could give hackers undetectable access to patient health data, company officials said.
    • “The unusual nature of the vulnerability and the urgency to fix it prompted Epic to slow down development of some product lines while it sent engineers into a sprint to patch security holes.
    • “Judy Faulkner, Epic’s chief executive, revealed the security weakness and a six-week plan to shore up the gaps at an industry conference last week, but most details about the danger have not previously been reported.
    • “You worry that after a month and a half of working almost primarily on safeguarding the software, that new things will be created by those who are trying to bust the software, and it will be in a never-ending cycle,” Ms. Faulkner said.
    • “According to company representatives, Epic deployed Anthropic’s Claude Mythos artificial intelligence agent to stress-test its systems, to hunt for ways that hackers could unleash open-source A.I. agents and unlock confidential patient records.
    • “The security weaknesses pose a particularly acute threat for Epic, which maintains records of 325 million patients in the United States and other countries.
    • “And it underscores the competing forces surrounding the ever-expanding uses of artificial intelligence in health care.”
  • Cyberscoop informs us,
    • “OpenAI said it disrupted a “coordinated campaign” to distill and extract reasoning capabilities from its AI models, pointing the finger at a Chinese rival.
    • “On Wednesday [September 30], OpenAI said it first spotted low-level activity on July 1 that gradually increased until July 24 and 25, when it observed 16,000 prompts from 4,000 users that fit a similar “relevant extraction pattern.” The number of suspicious users had climbed to 15,000 by July 28, when OpenAI said it “fully disrupted” the operation.
    • “The company called the attackers’ method “novel.” They copied encrypted reasoning data from one conversation, then asked the model in a separate conversation to decrypt the content and transcribe it in plain text. Outside researchers reported a similar vulnerability to OpenAI in August.
    • “The operators did not break our encryption, compromise a database, or gain direct access to stored user conversations,” OpenAI wrote in an unsigned blog post. “Instead, they manipulated model interactions so that protected reasoning could be reproduced in forms visible to the requester in a coordinated, scaled manner that violated our terms of service.”
  • Cybersecurity Dive tells us,
    • “Businesses need to prepare for the ways in which AI is changing the cyberattack landscape, Microsoft warned on Thursday [October 1].
    • “AI is speeding up attacks, making advanced techniques easier and putting stress on systems that organizations have long overlooked, the company said in its annual Digital Defense Report.
    • “The report also describes nation-state and cybercrime threat actors’ most significant activity from the past year, including their targets and motivations.”
  • The Wall Street Journal points out,
    • “Cybersecurity startup Armadin has raised $255.5 million to boost its force of AI agents trained to find security flaws cybercriminals are most likely to exploit—in part by attacking customers with swarms of autonomous hackers.
    • “Total funding for Armadin, which security veteran Kevin Mandia founded a year ago, is now $445 million. The company’s market valuation tops $2.5 billion. More here from my colleague Angus Loten.”
  • Here is a link to Dark Reading’s CISO Corner

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • AHIP reports,
    • “The House Ways and Means Committee’s recent advancement of the Apples to Apples Comparison Act (H.R. 4093) signals policymakers recognize the growing need for more accurate data and assessments comparing Medicare Advantage (MA) and fee-for-service (FFS) Medicare. If enacted, this legislation would require Medicare to report more complete expenditure data and direct the Medicare Payment Advisory Commission (MedPAC) to compare MA and FFS using a more transparent and reliable methodology. 
    • “Key Context: Accurate and reliable analyses are essential to understanding how MA compares to FFS. It requires accounting for key differences between the programs – including the benefits provided within MA, different enrollment requirements, and demographics and health characteristics among MA enrollees. 
    • “A growing body of research points to significant questions and concerns with MedPAC’s current approach to comparing spending in MA and FFS, including its estimates of alleged favorable selection into MA and failure to account for the key programmatic, enrollment, and other differences.
    • “The Apples to Apples Comparison Act would address these concerns and ensure that policymakers have the information needed to accurately assess both programs.
    • “Why It Matters: Accurate comparisons between MA and FFS show that MA provides better care at lower costs than FFS. With 36 million American seniors and people living with disabilities choosing MA, policymakers should ensure they protect and strengthen MA for the seniors who count on it.”
  • Beckers Behavioral Health relates,
    • “HHS will provide $96 million over four years to eight communities through its new Safety Through Recovery, Engagement, and Evidence-based Treatment and Support program.
    • “The funding will help communities build coordinated systems of care for people who are homeless and have serious mental illness, substance use disorders or co-occurring disorders.
    • “The program combines street-based engagement and treatment with recovery supports, housing and other community services.
    • “The Substance Abuse and Mental Health Services Administration will administer the STREETS program, according to an Oct. 2 news release from HHS. Each selected community will receive $3 million a year for four years.”
  • and
    • “The 988 Suicide & Crisis Lifeline has brought back specialized crisis support for LGBTQ+ youth through its “Press 3” option, with the service available again starting Sept. 30, the Los Angeles Times reported Oct. 1.
    • “Launched in 2022 in partnership with the Trevor Project, the option connects callers and texters directly with counselors trained to support young LGBTQ+ people. The service was suspended in July 2025 after the Substance Abuse and Mental Health Services Administration said it would “no longer silo LGB+ youth services” from the general hotline.”
  • STAT News tells us,
    • “Finding information from the National Institutes of Health about human health, disease, and biomedical research is about to look a lot different. On Monday, the NIH will unveil a new version of its website that shifts attention away from individual institutes and centers and towards eight thematic hubs focused on health, research, data, clinical studies, rare diseases, technology, cancer, and grants.
    • “Agency officials say the redesign — which is part of an ambitious project to consolidate the NIH’s digital footprint — is intended to streamline what was a sprawling and fractured information ecosystem, requiring users to understand NIH’s organizational structure, into an intuitive experience that more closely reflects what type of information people seek out most often.
    • “The goal, said NIH deputy director for public affairs, Amanda Fine, is “to make trusted NIH information across the agency easier and faster to find.”
    • “The beta version, which was soft-launched this week, is still under development and will continue to evolve in the coming months, NIH officials told STAT. Some functions, including search, do not yet appear to be operational. During this transition period, NIH’s existing websites will continue to remain available, and they will sunset on a rolling basis “as critical and mandated content is verified and redirects are put in place,” Fine told STAT.” 

From the Medicare Advantage front,

  • Beckers Hospital Review reports,
    • “SCAN Health Plan and Costco shared Oct. 1 that their co-branded Medicare Advantage plans will go live in California and Nevada in 2027.
    • “The HMO will be available in 17 California counties and two Nevada counties on Jan. 1, a SCAN news release said. This is Costco’s first time offering MA.
    • “Entering Medicare Advantage is a natural extension of our commitment to delivering quality and value for our members,” Richard Stephens, Costco’s senior vice president of pharmacy, said.
    • “The plans do not include Costco memberships, but non-Costco plan members can use over-the-counter benefits and get hearing aids and eyewear elsewhere.”
  • “KFF Examines the 2027 Marketplace for Medicare Advantage and Part D Stand-Alone Drug Plans.”
    • “A companion analysis of the stand-alone Part D prescription drug plan (PDP) marketplace finds that the number of stand-alone plans available to the average beneficiary will fall for the fourth year in a row, from 11 in 2026 to 9 in 2027. It also finds that many PDP enrollees will see premium reductions or only modestly higher premiums in 2027 if they keep their current plan, while others will face substantially higher premiums unless they switch.
    • “Notably, there will be no zero premium PDPs available for Part D enrollees in 2027 (except low-income beneficiaries who receive extra financial help from the government.) That means that 4 million PDP enrollees who paid no monthly premium in 2026 will face higher premiums in 2027 if they keep PDP coverage.” 

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

  • Govexec reports today,
    • “Federal employees and retirees will pay an additional 10.9% on average toward their health insurance premiums in 2026, the third straight year of double-digit increases, according to the Office of Personnel Management.
    • “The government’s share of Federal Employee Health Benefits Program premiums will increase by an average of 8.6% in 2026, making the overall cost increase 9.3%. This year, the increase in employees’ share of insurance premiums was 12.3%, and in 2025 that increase apexed at 13.5%.”
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *
    • As in past years, OPM encouraged federal workers to shop around from among the more than 100 insurance plan offerings and to take advantage of using pre-tax money to pay for out-of-pocket costs via a flexible spending account. New for next year is the availability of a debit card via FSAFEDS, reducing some of the administrative burden of needing to submit paperwork and receipts for reimbursement.
    • Kevin Moss, a senior editor with Consumers’ Checkbook’s Guide to Health Plans for Federal Employees, said it is more important than ever to actually follow that advice. That’s because hidden behind the average premium increase figures are a number of wide swings on the individual plan level.

From the U.S. Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The FDA has approved Bristol Myers Squibb’s application to expand the label of its cardiac myosin inhibitor, Camzyos, to include pediatric patients.  
    • “Camzyos is used to treat symptoms and improve functionality in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), a genetic condition that causes the heart muscle to thicken. Camzyos was first approved to treat adults in 2022, and the new approval makes it the first oHCM treatment available to pediatric patients.” 
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has accepted CeleCor Therapeutics‘ new drug application (NDA) for zalunfiban (Disaggpro). The investigational drug was developed to treat ST-elevation myocardial infarction (STEMI) heart attacks to dissolve clots and reopen the coronary artery as soon as possible to prevent death or irreversible heart damage.
    • “Zalunfiban is a new type of small-molecule inhibitor of the platelet GPIIb/IIIa receptor that is designed to quickly prevent clotting during a heart attack.
    • “The company presented positive Phase 3 clinical trials results from its CeleBrate study at the 2025 American Heart Association (AHA) Scientific Sessions, and those findings were later published in The New England Journal of Medicine Evidence.[1] The multinational CeleBrate study found that rapid zalunfiban treatment for STEMI at the first point of medical contact reduced the risk of cardiovascular events over 30 days following treatment.”

No Surprises Act news,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “On Thursday, October 1, 2026, the Centers for Medicare & Medicaid Services (CMS) convened leaders from across the federal government and from certified independent dispute resolution (IDR) entities to discuss issues impacting the federal IDR process. CMS Administrator Dr. Mehmet Oz, Department of Labor Assistant Secretary Daniel Aronowitz, and officials from the Departments of Health and Human Services, Labor, and the Treasury (the Departments) met with representatives from all certified IDR entities to address the increasingly high IDR-associated costs affecting the United States healthcare system. The ideas discussed in the meeting build on the system reforms that were a part of the Federal IDR Operations final rule as well as the fundamental technological evolution of the Federal IDR Portal into the IDR Gateway, which will launch in late 2026.” * * *
    • “The No Surprises Act has succeeded in its primary objective: protecting American consumers from surprise medical bills. The Departments and certified IDR entities expressed their shared responsibility to improve the federal IDR process. The participants, representing all active certified IDR entities, are committed to enhancing their processes in collaboration with the Departments. 
    • “The Departments will consider the insights offered by the certified IDR entities as they continue to explore all available regulatory and operational solutions.”

From the judicial front,

  • The SCOTUSblog reports today,
    • “On Thursday, the Supreme Court added three new cases to its oral argument docket for the 2026-27 term, including a case on the Trump administration’s policy of detaining noncitizens apprehended within the United States (as opposed to at the border) without the opportunity for a bond hearing and a dispute over the enforcement of zoning ordinances against religious institutions.” * * *
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *

From the public health and medical /Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • “Seasonal flu activity is low but is increasing.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.”
  • The University of Minnesota’s CIDRAP calls to our attention
    • “With three months left of 2026, the United States is closing in on a number of measles cases that would have been unheard of just a couple years ago. With 228 new cases logged this week, the country reached 3,886 infections, just 114 shy of 4,000, according to the Centers for Disease Control and Prevention’s (CDC’s) weekly update today.
    • “It could top that milestone next week. And US cases could be more than double the 2025 total this month.
    • “The national wave comes as Pennsylvania, the nation’s hot spot, adds more than 100 new cases in the past week to its total for the year. More than two-thirds of the cases in the state involve adults. * * *
    • “Cases in other states are also climbing. The Wisconsin Department of Health Services today added 72 infections to its total, which has now grown to 243. Kentucky added 27 new cases and has 94 for the year. And Ohio’s health department lists 206 measles cases, which is 17 more than last week. Utah lists 527 cases, nine of which are new.”
  • and
    • “Measles infections make people miserable for up to two long weeks, commonly causing dangerously high fevers, a painful sensitivity to light and, of course, a tell-tale red rash.
    • “Sufferers who escape without developing pneumonia, brain swelling, or other serious complications may believe the worst is over. 
    • “Yet the measles virus has only gotten started.
    • “The virus also damages the immune system, leaving people vulnerable to other infections for up to five years.
    • “The rash and the fever, that’s the tip of the iceberg,” Michael J. Mina, MD, PhD, coauthor of two seminal studies in Science on the effect of measles on the immune system, told CIDRAP News. “The majority of the damage being done is under the surface.”
  • The Wall Street Journal reports,
    • “Grip strength is increasingly being viewed as an important biomarker of our overall strength and fitness.
    • “While not used as widely as body-mass index, or BMI, as a screening tool for health, doctors and researchers say awareness of its value is growing. That’s happening as research shows that grip strength is associated with future health risks and even longevity. 
    • “At the University of Michigan Medical School, many clinics test patients’ grip strength, says Mark Peterson, a professor of physical medicine and rehabilitation. 
    • “We do it with our older populations but I have also gotten it pulled into clinics in our neurological population,” he says.
    • “Some doctors think grip strength should be used more routinely in wellness appointments. “I have really tried to encourage geriatricians to think about incorporating grip strength, it seems to trump almost every single measure including cardiovascular fitness training,” Peterson says.
    • “Even in children, studies have found grip strength to be associated with cardiometabolic health.” 
  • Nature relates,
    • “Armed with new tools and fresh optimism, researchers seeking to subdue pancreatic cancer — one of the world’s deadliest — are chasing a radical strategy: cancer interception.
    • “In this approach, tissues that are growing abnormally are treated to keep them from turning cancerous and spreading. Interception is already being trialled for breast and skin cancers, among others. But now the success of a new drug that quashes pancreatic tumours is raising scientists’ hopes that interception could succeed even for this recalcitrant cancer.
    • “Cancer interception was one of the main themes at September’s American Association for Cancer Research Conference (AACR) on Pancreatic Cancer in San Diego, California — the first such meeting since the US Food and Drug Administration approved the landmark pancreatic-cancer drug daraxonrasib (Rasonque) in August. Its success has renewed optimism that researchers can combine it or other emerging therapies with early-detection methods to revolutionize how pancreatic tumours are treated.
    • “A combination of early-detection techniques and interception is “going to be the breakthrough strategy that really changes survival”, says Diane Simeone, director of the Moores Cancer Center at University of California San Diego Health. At the AACR meeting, Simeone argued that such an approach could more than triple the proportion of people who survive for five years after being diagnosed with pancreatic cancer, from 13.7% to 50%.
    • “It’s a lofty aspiration, but other researchers are also eyeing interception. “We’re so excited that we are at this juncture now to even be considering this,” says Anirban Maitra, director of the Perlmutter Cancer Center at New York University Langone Health in New York City. “This wasn’t possible even a few years ago.”
  • CNN adds,
    • “Sugary foods combined with antibiotic treatment can damage the gut microbiome in ways that could leave people vulnerable to dangerous infections, a new study shows.
    • “The new research, published Wednesday in the journal Nature, took advantage of a natural experiment: It looked at what happened to gut bacteria in cancer patients who were hospitalized and treated with sustained antibiotics before receiving stem cell transplants. Because the patients only ate food prepared by the hospital, researchers knew exactly what and how much food they ate – a rarity in nutrition studies, which typically rely on participants to recall what they ate hours or days earlier, something people are notoriously bad at.
  • Health Day tells us,
    • “Functional decline begins many years before clinically apparent cardiovascular disease (CVD) events, according to a study published online Sept. 23 in JAMA Cardiology.
    • “Aung Zaw Zaw Phyo, Ph.D., from Monash University in Melbourne, Australia, and colleagues examined how functional performance trajectories change in the years preceding a CVD event. The analysis included data from 12,015 participants (2,403 cases and 9,612 matched controls) in the Aspirin in Reducing Events in the Elderly cohort.”
    • “Results of this nested case-control study show that declines in functional aging markers were prominent before clinically apparent CVD, suggesting that they may represent the culmination of progressive multisystem aging and indicating a prolonged window of opportunity for closer clinical evaluation and early intervention,” the authors write.”
  • and
    • “Isometric exercises like wall sits may help lower your blood pressure.
    • “And just one session a week could help you maintain those healthier numbers.
    • “A team led by Harry Swift of King’s College London studied 100 adults with an average age of 37 who had normal to high-normal blood pressure. Eighty were assigned to do wall sits three times a week.
    • “After four weeks, their systolic blood pressure — the top number in a blood pressure reading — had dropped by an average of about 9.5 points compared with the control group.
    • “For the next month, participants either kept the same schedule, cut back or stopped.
    • “Cutting back to once a week still left systolic pressure about 6.6 points lower than at the start.
    • “But three sessions a week delivered a much bigger benefit — down nearly 14 points.
    • “When participants stopped exercising, the improvements reversed.”
  • The American Medical Association lets us know how to do a wall sit.
  • Per BioPharma Dive,
    • “An experimental eczema drug from Pfizer met its primary goal in a mid-stage clinical trial, achieving stronger skin clearance in significantly more people at multiple doses compared to a placebo after 16 weeks.
    • “According to detailed data from an ongoing Phase 2 trial shared at a European medical meeting Thursday, a substantially higher percentage of patients given Pfizer’s three-pronged antibody drug, tilrekimig, as opposed to a placebo experienced a 75% reduction in the scope and severity of their disease. The trial enrolled participants with moderate to severe atopic dermatitis, and the latest results build on data previously announced in March.
    • “Analysts described the findings as “very strong” and indicative that Pfizer’s drug could compete with already approved therapies like Eli Lilly’s Ebglyss and Sanofi and Regeneron Pharmaceuticals’ market-leading Dupixent. In a statement Thursday, Pfizer said it has pushed tilrekimig into advanced testing for asthma, chronic obstructive pulmonary disease and atopic dermatitis — including a head-to-head trial against Dupixent.”

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

  • The Wall Street Journal reports,
    • “Bayer BAYN  said it plans to spend $2.2 billion to build a new manufacturing site in Ohio for its pharmaceutical business, becoming the latest European drugmaker to invest in the U.S.
    • “The German agricultural and pharmaceutical group said Friday that its new site in New Albany will create around 600 jobs, with plans to open a first module dedicated to drug substance manufacturing in 2031, followed by a second module for finished products in 2034.
    • “Bayer’s pharma business has been looking to expand in the U.S., betting that an enlarged presence in the world’s largest drug market can help it revive sales growth after two key products went off patent.
    • “With the move, the company joins a growing list of European pharma companies committing to invest in the U.S. Under pressure from the Trump administration’s tariff threats, big drugmakers like AstraZeneca, Novartisand Roche, as well as smaller rivals, pledged to make multibillion-dollar investments in the country and have started to execute their plans.
    • “The U.S. is our largest and fastest-growing market,” Bayer’s U.S. president, Sebastian Guth, said in an interview.”
  • and
    • “Novartis NOVN struck a deal valued at up to $7.8 billion to license a messenger RNA drug candidate from Abogen Biosciences and gain options over future therapies, turning to China to fill its pipeline.
    • “Many of the world’s biggest drugmakers have set their sights on China to look for new drug ideas, seeking to bolster their portfolios in preparation for older medicines going off patent. Novartis has sealed several tie-ups with emerging Chinese biotech players in recent years.
    • “Novartis is paying $575 million upfront and could make additional payments of up to $7.2 billion if options on all programs are exercised and targets are met, Abogen said Friday.
    • “Under the deal, Novartis will acquire worldwide rights over Abogen’s lead drug candidate, called ABO2203, which uses mRNA to boost the production of so-called T-cell engagers within the body to fight malignant cells. Abogen said its lead drug has potential to transform the treatment landscape for patients with autoimmune diseases—those in which the body’s immune system attacks healthy cells instead of protecting them.”
  • Modern Healthcare relates,
    • “HCA Healthcare has completed a deal to sell 31 home health and hospice locations in eight states to Deaconess Associations.
    • “The former HCA sites and their employees are now part of Deaconess subsidiary Central Pyramid, the Cincinnati-based provider announced in a news release Thursday. Neither Deaconess nor Nashville, Tennessee-based HCA disclosed the financial terms of the transaction.
    • “The home health and hospice locations are spread across Colorado, Florida, Kansas, Kentucky, Missouri, Tennessee, Texas and Virginia. The companies agreed to the transaction in June.”
  • Beckers Payer Issues tells us,
    • “San Francisco-based Dignity Health, part of Chicago-based CommonSpirit, reached an agreement to transfer its share of co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna.
    • “CommonSpirit had a 49.75% ownership interest in Mercy Care as of June 30, 2026, and June 30, 2025, according to CommonSpirit’s fiscal year 2026 report. 
    • “Dignity Health co-owns the plan with Ascension, which said it had also reached an agreement with Aetna to transfer its portion of Mercy Care to the company. 
    • “The transaction is expected to close in fiscal year 2027, subject to required regulatory reviews and approvals, a spokesperson for Aetna said in an Oct. 2 statement shared with Becker’s.” 
  • and
    • “New Jersey Democratic Gov. Mikie Sherrill launched the State Health Benefits Program Reform Working Group on Oct. 1 to review and advise on health coverage for public employees.
    • “Ms. Sherrill announced the working group following a Sept. 2 agreement with 17 state employee unions. Along with unions, participants include public employer organizations, legislative offices and healthcare groups, such as the New Jersey Association of Health Plans and New Jersey Hospital Association. Aetna, Horizon Blue Cross Blue Shield of New Jersey, and UnitedHealth Group’s pharmacy benefit manager, Optum Rx, are all vendors serving the benefits program. All three are also members of the working group.
    • “The working group will form advisory recommendations for the governor, focusing on benefits administration, provider network structures and payment, plan pricing and premium contributions, plan design, employer and member participation, and whether the program has resources to manage costs. The working group will have subcommittees targeting these areas.”
  • Fierce Healthcare adds,
    • “Tacoma, Wash.-based MultiCare Health System is set to launch its own health plan next year, the organization announced Thursday.
    • “The creation of the plan—dubbed the MultiCare Health Plan—is part of the organization’s continuing advancement from a traditional provider to an integrated organization, executives say. It will be a wholly owned subsidiary of the health system, with support from MultiCare’s population health partner, PSW.”
  • Beckers Hospital Review informs us,
    • “Chicago-based CommonSpirit Health has launched CommonSpirit Ambulatory Ventures, a new division aimed at organizing and expanding the health system’s ambulatory surgery center portfolio.
    • “The move is part of CommonSpirit’s broader effort to diversify beyond acute care and “accelerate growth” in ambulatory services, according to financial documents published Oct. 1. The system said the new division will establish an ASC vertical “from which to organize and enhance our current and future capability in the ASC space.” 
    • “CommonSpirit currently has 239 ambulatory joint ventures spanning dialysis, imaging, oncology and other services. That portfolio includes 80 ASCs, either wholly owned or operated through partnerships, along with six specialty surgical hospital partnerships.” 
  • Beckers Physician Leadership points out,
    • “After years of steady gains, compensation for registered nurses and licensed practical nurses (LPNs) showed no measurable growth in 2026 for the first time in the past 5 years, according to a report from Medscape. 
    • “The “Medscape RN/LPN Compensation Report 2026: Where Did the Growth Go?,” published Oct. 2, surveyed 3,253 registered nurses and 1,337 licensed practical nurses on compensation and pay trends.” 
  • Per Radiology Business,
    • “Patients grappling with medical debt appear more likely to face later-stage cancer diagnoses, according to new research published Thursday. 
    • “Such financial obligations are a pervasive challenge among U.S. households and a key social determinant of health, experts write in JAMA Network Open. About 1 in 6 individuals here report having at least some medical debt, with millions facing collections—a situation disproportionately impacting low-income households, minorities and the uninsured. 
    • “Researchers aimed to better understand how these IOUs impact patient outcomes, analyzing data spanning nearly 3,000 U.S. counties. They found that higher burden of medical debt was associated with significantly increased incidence of late-stage lung, colorectal, cervical, skin, kidney, bladder, and head/neck cancer. 
    • “These findings suggest that medical debt may be an area-level marker of structural and financial barriers associated with cancer detection and cancer outcomes at the population level,” study co-author Xin Hu, PhD, with the Department of Radiation Oncology at Emory University, Atlanta, and colleagues wrote Oct. 1.” 
  • Per Fierce Pharma,
    • “Eli Lilly’s Foundayo is showing clearer signs of acceleration. Total prescriptions for the oral GLP-1 receptor agonist surged about 21% to 64,268 during last week, according to IQVIA data cited by Citi. That haul came off a 13% sequential increase the week before that.
    • “We’re seeing early signs of growth in Q3 for Foundayo,” Jefferies analysts wrote in an Oct. 2 note.
    • “Recent expansion of Foundayo could be attributed to a direct-to-consumer ad first aired in late August featuring Martha Stewart, as well as the Medicare GLP-1 Bridge program which, as of July, offers eligible seniors GLP-1 obesity drugs at a $50 monthly copay.”
  • Cardiovascular Business adds,
    • “More and more young children are starting to be prescribed GLP-1 drugs to manage their weight, according to new research published in Pediatrics.
    • “The study’s authors focused exclusively on obese children without diabetes between the ages of 8 and 11. In 2019, just 0.03% of those children were on GLP-1 medications. However, that number skyrocketed to 9.3% in 2026. The group estimated that approximately 20,000 children between the ages of 8 and 11 have been prescribed GLP-1 drugs during that time. 
    • “Our study offers the first national overview in young children of the use of GLP-1 drugs to fight the obesity epidemic in the United States and shows that while the absolute numbers of children under the age of 12 receiving GLP-1 treatment is still low, GLP-1 use is accelerating rapidly,” first author Babak J. Orandi, MD, PhD, MSc, a transplant surgeon and obesity specialist with NYU Langone Health’s NYU Grossman School of Medicine, said in a statement. “The careful use of GLP-1s remains a valuable tool in confronting the obesity epidemic among young Americans.”
  • Beckers Payer Issues lets us know,
    • “Booking an appointment with a provider often means confirming they’re in network, working through an automated phone menu and trading available times with a receptionist. But for some UnitedHealthcare and Aetna members, an AI agent is now handling that work.
    • “Senior executives at both insurers have described their scheduling tools publicly in recent months as part of broader AI investments aimed at cutting administrative costs and simplifying how members get care.
    • “If I would usually schedule an appointment, I’d make a phone call, sit on hold, figure out my calendar, juggle my children. All that is gone, because Avery will do it for me,” Prianka Advani, senior vice president of AI delivery and telephony at UnitedHealth Group, said during a media event in June.”  

OPM Releases 2027 Premiums

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

Simplicity is a virtue.

  • Per an OPM news release,
    • “Today, the U.S. Office of Personnel Management (OPM) announced that the 2026 Federal Benefits Open Season will run from November 9 through December 14, 2026. The rates and benefits for the 2027 Federal Employees Health Benefits (FEHB) Program, Postal Service Health Benefits (PSHB) Program, and Federal Employees Dental and Vision Insurance Program (FEDVIP) are now available for review on OPM.gov.
    • “During Open Season, eligible federal employees and annuitants can enroll in, change, or cancel FEHB, PSHB, and FEDVIP coverage. Eligible employees can also make elections for the Federal Flexible Spending Account Program (FSAFEDS).
    • “OPM encourages employees and annuitants to review their coverage and choose the options that best meet their needs and those of their families. FEHB, PSHB, and FEDVIP coverage will continue into 2027 if enrollees make no changes. FSAFEDS participants, however, must make a new election each year to continue that benefit. OPM also encourages eligible employees who do not currently participate in FSAFEDS to consider its pretax benefits and enroll.
    • “Open Season is the time to look beyond your current plan and make sure your coverage still works for you and your family,” OPM’s Associate Director for Healthcare and Insurance Matthew Kiley said. “We encourage employees and annuitants to compare their options, review their costs, and make any changes before the December 14 deadline.”
  • FedWeek adds
    • “Federal employees and retirees enrolled in FEHB will pay an average annual increase of 10.9 percent more for their share of premiums in 2027 (down from 12.3 percent for the current year), according to an OPM announcement. PSHB enrollees will see an average increase in their share by 8.2% (11.3 percent in 2026).
    • “Dental and vision premiums are rising just 1 percent and 1.6 percent on average.
    • “According to the announcement, increases are due largely to “rising prices and utilization across inpatient, physician, outpatient, and surgical services; Continued growth in behavioral and mental health care; and; Higher prescription drug spending—particularly on GLP-1s, specialty drugs, and other high-cost therapies.”
  • Federal News Network also has an article on the OPM announcement.

More News from Washington, DC,

  • The Hill reports,
    • “A group of lawmakers spanning both parties and chambers is introducing legislation that would require insurance plans to cover genetic testing for patients with hereditary risk factors and expand education and outreach about gynecologic cancer risk. 
    • “Sens. Elissa Slotkin (D-Mich.) and Katie Britt (R-Ala.) are leading the bill, the Ovarian Cancer IMPACT Act, which was shared exclusively with The Hill. Their House counterparts on the legislation are Reps. Rosa DeLauro (D-Conn.) and Don Bacon (R-Neb.).” * * *
    • “In addition to some provisions about insurance coverage of genetic screenings, the new bill includes reauthorization of a 20-year-old Centers for Disease Control and Prevention program, Johanna’s Law, that provides funding for a federal education campaign about gynecological cancers.” 
  • The Washington Post adds,
    • “President Donald Trump’s pick for surgeon general cleared a major hurdle Wednesday as the Senate health committee voted to advance her nomination to the floor.
    • “In a 12-11 party line vote, Nicole Saphier — a former Fox News contributor and radiologist at Memorial Sloan Kettering Cancer Center in New York — took a step closer to becoming the nation’s top doctor.” * * *
    • The [12-11] vote included advancing the nomination of Timothy Westlake, Trump’s pick to head the Substance Abuse and Mental Health Services Administration, which leads policy efforts on mental health and addiction. He is a board-certified emergency physician. It also included one more health nominee, Mary Lazare, to be assistant secretary for aging.
  • Bloomberg Law relates,
    • “The Trump administration finalized on Wednesday a new drug payment modeldesigned to help carry out its most-favored-nation policy, cementing a plan that pharmaceutical companies have signaled are ripe for legal challenges.
    • “The pricing demo, known as GLOBE, would test whether alternative methods for calculating rebates for Medicare Part B medicines administered in doctors’ offices, based on international pricing metrics, will reduce drug costs.
    • “Still, over two dozen drugmakers — including Eli Lilly & Co., Novo Nordisk A/S, and Pfizer Inc.— have indicated they’ve gotten exemptions after entering separate agreements with the administration to voluntarily offer discounts on certain medicines to state Medicaid programs known as GENEROUS. The rule text appears to confirm that carve-out.” * * *
    • “The model is set to start Jan. 1, 2027 with the collection of voluntary manufacturer-submitted international drug net pricing data. It will be tested over five performance years, running through March 31, 2032. 
    • “A separate model targeting Medicare Part D drugs, which are prescription medications dispensed at pharmacies, is still under review at the White House.” 
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), today launched a major effort to transform how clinical trials are designed and conducted — using advanced computational models, real-time analysis, shared infrastructure, and automation to evaluate drugs and biologics faster, at lower cost, and with fewer participants. The new Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, together with three complementary projects announced today, aims to remove barriers that slow clinical development and help promising treatments reach patients sooner.
    • “America should lead the world in turning medical breakthroughs into treatments for patients,” said HHS Secretary Robert F. Kennedy, Jr. “HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down. Through ARPA-H, we are building a modern clinical trial system that can generate rigorous evidence faster, reduce the burden on patients, and move effective treatments from discovery to the people who need them sooner.”
    • “Together, these efforts advance the Trump administration’s work to modernize clinical development, reduce unnecessary delays and costs, and strengthen U.S. competitiveness in biotechnology and drug development. By making clinical trials faster, more efficient, and less burdensome for patients, ARPA-H aims to help promising treatments reach patients sooner while reinforcing the United States as a global leader in medical innovation.”
  • The American Hospital Association News tells us,
    • “Two executive orders on artificial intelligence were released Sept. 29 by the White House. One announced a new website that will use AI to deliver federal government information and services. The website, America.gov, is intended to eliminate the need for navigating multiple agency websites, according to a fact sheet. The order directs the Administrator of General Services in coordination with the Director of the Office of Management and Budget to establish and operate America.gov as the lone entry point for accessing covered services online, such as public-facing federal services that serve more than 100,000 users in a 12-month period and can be accessed or applied for online.
    • “The second executive order announced a rebrand of AI as “super intelligence.” The order and correspondingfact sheet said that the administration will use “super intelligence” and “SI” in place of “artificial intelligence” and “AI” in official correspondence, public communications, websites, reports, policy documents and other non-statutory documents.” 
  • Beckers Hospital Review informs us,
    • “The Pharmaceutical Research and Manufacturers of America has named Eric Cantor its next president and CEO, effective Nov. 9.
    • “Mr. Cantor will succeed Stephen Ubl, who has led PhRMA since 2015, according to a Sept. 29 news release. Mr. Ubl will continue to serve as a strategic adviser.
    • “Mr. Cantor represented Virginia in the U.S. House of Representatives from 2001 to 2014 and served as House majority leader from 2011 to 2014. Since leaving Congress, Mr. Cantor has served as vice chairman and managing director at Moelis & Company and as a member of its board of directors. He will continue serving on the board while leading PhRMA.”

From the U.S. Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has accepted an approval application for Roche’s experimental multiple sclerosis pill fenebrutinib, kickstarting a review of the treatment in two forms of the disease.
    • “The agency will begin evaluating fenebrutinib in both the “relapsed” and “primary progressive” types of MS, positioning the treatment to possibly become the first of its kind approved in both settings. Roche didn’t say when a decision might come, though the agency has initiated a “priority review” that has a six-month timeline.
    • “Roche’s application is based on a trio of late-stage studies that met their main objectives. However, an imbalance in the number of deaths observed among treatment recipients and regulators’ pre-existing concerns about the liver safety of drugs like fenebrutinib could complicate the company’s approval chances.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health. As part of an effort to broaden and strengthen participation on its advisory committees, the FDA is publishing two Federal Register notices: one seeking qualified scientific, technical, and professional voting members across all committees with current or anticipated vacancies, and a companion notice seeking consumer representatives to ensure the public’s voice is at the table.  
    • “FDA advisory committees bring together leading scientific minds to engage with the most difficult questions in public health. We are actively inviting people from across the country who are on the forefront of their fields — clinicians, researchers, and community voices who can bring the latest science, real-world experience, and fresh perspectives to the FDA’s deliberations,” said Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, J.D. “These panels provide independent expertise and rigorous scrutiny as the FDA navigates complex and rapidly evolving areas of science. The Trump Administration is deeply committed to strengthening the partnership between the FDA and the nation’s brightest minds.”  

From the Medicare Advantage front,

  • Beckers Payer Issues reports,
    • “There will be four new entrants to the Medicare Advantage market in 2027, according to CMS data.” * * *
      • The Muscogee (Creek) Nation will offer one HMO, called Native Advantage, in 11 Oklahoma counties.
      • Boise, Idaho-based St. Luke’s Health System will offer three HMOs with drug coverage through its health plan in seven counties across Idaho. St. Luke’s launched its health plan with individual and employer coverage in 2023.
      • Tacoma, Wash.-based MultiCare Health System will offer two HMOs with drug coverage in three Washington counties through its newly launched health plan. 
      • MedCare Partners Health Plan of Texas will offer three plans in Harris County, including one HMO and two C-SNPs.
  • Beckers Hospital Review adds,
    • Seven health system-affiliated insurers are among the 11 total health plans exiting the individual Medicare Advantage market for 2027, according to CMS data.
      • Irving, Texas-based Christus Health Plan offered plans in 36 Texas counties and eight New Mexico counties.
      • Wausau, Wis.-based Aspirus Health Plan offered plans in 21 Wisconsin counties.  In February, CMS suspended new MA enrollment into the health plan after its claims processor, UCare, was taken over by Minnesota regulators.
      • Renton, Wash.-based Providence Health Plan offered plans across six Oregon counties, six Washington counties and Orange County, Calif. The MA exit is part of the wider shutdown of the health plan.
      • WellSense Health Plan, part of Boston Medical Center, offered plans in all 10 New Hampshire counties.
      • Houston-based Memorial Hermann Health Plan offered plans in six Texas counties. In July, the plan confirmed it would also shut down its commercial business.
      • Mass Advantage, part of Worcester-based UMass Memorial Health, offered plans in Worcester County.
      • San Diego-based Sharp Health Plan offered plans in San Diego County.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Pennsylvania reported Wednesday that a fifth person who had measles has died as rising infections in the state continue to push up the country’s record-breaking count of cases.
    • “The Pennsylvania Department of Health said an unvaccinated Lancaster County resident who tested positive for measles had died. No additional information about the person was immediately released.”
  • Health Day relates,
    • “Type 2 diabetes dramatically increases a person’s short-term risk of death or life-threatening illness, a new study says.
    • Within five years of their diagnosis, patients with type 2 diabetes have a 33% increased risk of dying or developing kidney disease or heart failure, researchers are slated to report this week at a meeting of the European Association for the Study of Diabetes.
    • “That risk increases to 55% over 10 years, researchers added.
    • “Our findings clearly show how the serious complications associated with type 2 diabetes rise sharply over time as the often-common combination in patients of obesity, abnormal blood fats, high blood pressure and higher blood sugar damages blood vessels and vital organs,” lead researcher Naveed Sattar said in a news release. He is a professor of cardiometabolic medicine at the University of Glasgow in Scotland.”
  • Cardiovascular Business tells us,
    • “The American College of Cardiology (ACC) has published a new scientific statement focused on how eating well can help with the prevention and management of cardiovascular disease (CVD). The document, published in full in JACC, is the work of a committee of experts from the fields of cardiology and nutrition that first met in April.[1]
    • “Suboptimal diet is a key risk factor for CVD, and diet and lifestyle modification is widely considered essential for both primary and secondary prevention,” Frank B. Hu, MD, PhD, chair of the department of nutrition at Harvard T.H. Chan School of Public Health and chair of this document, said in a statement. “However, the concept of a ‘heart-healthy’ diet has evolved over time from nutrient-centric approaches to more holistic, food- and pattern-based strategies that better reflect advances in the understanding of the complex relationship between diet and cardiometabolic health.”
    • “The ACC scientific statement highlights the importance of following a heart-healthy diet, pointing to the Mediterranean diet and dietary approaches to stop hypertension (DASH) diet as two specific examples. Plant-based foods and healthy fats and proteins are recommended over foods high in refined starches, added sugars and unhealthy fats. The document also gets more specifics, emphasizing the benefits of vegetables, fruits, whole grains, nuts and legumes, while warning against the risks associated with eating too many ultra-processed foods.”
  • Health Day informs us,
    • “Insomnia is associated with an increased risk for stroke and with higher odds of hospital admission, according to an umbrella review funded by the European Academy of Neurology and published online Sept. 7 in Sleep Medicine Review.
    • “Luca Vignatelli, M.D., from the IRCCS Istituto delle Scienze Neurologiche di Bologna in Italy, and colleagues identified systematic reviews with meta-analyses (SRMAs) that examined insomnia as a predictive factor for dementia, stroke, depression, suicide, death, occupational injuries, and hospitalization. Sixteen SRMAs were included, and three additional original reviews were conducted for stroke, occupational injuries, and hospitalization.
    • “The researchers found that insomnia was consistently identified as a predictor of dementia, depression, and suicide, but not death, in SRMAs. Insomnia was a predictor of stroke (hazard ratio, 1.26) and of hospitalization for any reason (odds ratio, 1.28) based on two original SRMAs. A meta-analysis could not be performed on the two studies relating to occupational injuries. There was an association with unintentional fatal injuries and commuting injuries, but data were insufficient to draw a conclusion.”
  • and
    • “Chronic stress may hit women’s brain power harder than men’s as they age.
    • “A new study of nearly 3,900 healthy adults age 50 and older without dementia found women with higher levels of ongoing stress had steeper declines in attention and language than men.
    • “Researchers said it’s not yet clear why — or whether the difference is tied to biology, such as hormones, or social factors like gender roles.
    • “Hispanic participants with higher stress also had greater memory decline than non-Hispanic white participants.
    • “But there was an encouraging finding across all groups: Greater social support was linked to less decline in attention.”
  • Beckers Behavioral Health points out,
    • “The prevalence of benzodiazepine dispensing in the U.S. fell 26.7% from 2013 to 2024, with the largest relative decline among adults ages 18-29, according to a study published Sept. 30 in the American Journal of Psychiatry.
    • “Researchers from Rutgers University in New Brunswick, N.J., and Columbia University in New York City analyzed 1.1 billion benzodiazepine prescription fills among 252 million patients age 2 and older using the IQVIA Longitudinal Prescription dataset. The study examined changes in prescription prevalence, prescription counts and mean total dose dispensed by patient age and prescriber type.
    • “The declines may reflect greater caution in benzodiazepine prescribing, potentially tied to growing awareness of the drugs’ role in opioid-related overdoses and to FDA boxed warnings issued in 2016 and 2020, according to the researchers. The 2016 warning cautioned against prescribing benzodiazepines alongside opioids, and the 2020 warning addressed risks of misuse and addiction.” 
  • Health Day adds,
    • “A quick spritz to the nose could bring rapid pain relief to injured kids cared for in emergency rooms, new research shows.
    • “According to experts, too many pediatric ER patients are waiting too long for pain relief.
    • “Nearly a third of children with moderate to severe pain do not receive adequate pain relief within the 15 to 20 minutes recommended in international guidance,” noted study lead author Dr. Shammi Ramlakhan of Sheffield Children’s Hospital in England. 
    • “The new nasal spray combines two medications, sufentanil and ketamine. This combo eased pain within a half-hour for most injured kids in the study, Ramlakhan’s team said. 
    • “The results suggest it helps to reduce pain quickly and effectively, without the need for an injection,” said Dr. Maša Sorić, head of the emergency department at University Hospital Merkur, Zagreb, Croatia.
    • “Sorić, who wasn’t involved in the study, noted that “the treatment did not cause too much drowsiness, and the side effects were mild.”
  • BioPharma Dive notes,
    • “Bristol Myers Squibb has changed a late-stage study of its experimental pulmonary fibrosis drug admilparant to more closely monitor for liver-related side effects, following a “limited number” of instances of liver damage as well as the death of a participant from liver injury, a spokesperson said Wednesday.
    • “The change to the long-term safety extension to its Phase 3 “Aloft” trial raised investor worries about admilparant’s drug class, called LPA1R inhibitors, which are viewed as a new way to slow progression of the lung disease idiopathic pulmonary fibrosis. Shares in Bristol Myers as well as Contineum Therapeutics, the developer of a similar drug, fell sharply in late-day trading Tuesday before rebounding early Wednesday. 
    • ‘A spokesperson confirmed that it’s unclear whether the patient who died received admilparant. Wall Street analysts also called the brief share pullback “overdone,” pointing to multiple factors that could’ve contributed to the death and the relatively mild nature of the other side effects observed. Bristol Myers expects to report study results by the end of the year, an announcement that could shed more light on the safety of admilparant and other drugs in its class.”
  • STAT News lets us know,
    • “An investigational combination therapy from Eli Lilly led to significant weight loss in a mid-stage study, but high rates of people stopping the treatment may raise questions about its tolerability. 
    • “Lilly, which is racing to bring next-generation obesity drugs to the market, tested different combinations of its blockbuster GLP-1 drug Zepbound with eloralintide, a candidate that targets the amylin hormone, in people with obesity and type 2 diabetes.
    • “After 48 weeks, participants who stayed on the treatment at the highest dose of the combination therapy lost 23.3% of their weight, according to results presented Wednesday at the annual meeting of the European Association for the Study of Diabetes. That’s more than the weight loss seen with those taking only Zepbound and those taking only the highest dose of eloralintide — 14.8% and 11.1%, respectively.
    • “The results were also notable because patients with diabetes don’t tend to lose as much weight on medications as those who don’t have diabetes.
    • “However, there were high rates of participants stopping the combination therapy due to adverse events — ranging from 10.8% to 27.0% among the different dose groups. Those taking only eloralintide had discontinuation rates ranging up to 10.8% across dose groups, and those taking only Zepbound had a rate of 2.9%.
    • “The new combination therapy, called EloraTZP, is a potential competitor to Novo Nordisk’s CagriSema, an investigational combination of an amylin drug called cagrilintide and its own Wegovy that’s further along in development. Given the high discontinuation rates in the new trial, it’s difficult so far to compare EloraTZP with CagriSema.”

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

  • Modern Healthcare reports,
    • “Cigna Group is forecasting future growth and billions in cost savings, the company disclosed Wednesday.
    • “The healthcare behemoth reaffirmed its guidance for this year and projected at least $45 in adjusted earnings per shareby 2030 during the company’s investor day.
    • “Cigna Group will also save $3 billion over multiple years, partly from automating workflows and implementing artificial intelligence, said Ann Dennison, executive vice president and chief financial officer. Some of those savings will be invested back into the company, she said.”
    • “Cigna Healthcare is launching Health Sense early next year as part of its new partnership with OpenAI. Health Sense is a personalized clinical support model, which the company claims will reduce inefficient care by 10% by 2030.
    • “The company is also building a fifth “clean room,” a sterile facility where complex drugs are compounded and mixed. It will take up to three years to fully build and license, according to executives.
    • “This will create capacity for millions of new prescriptions to keep up with rising demand,” said Matt Perlberg, president of pharmacy and care delivery at Evernorth Health Services and executive vice president of customer innovation at Cigna Group. 
    • “Evernorth is also launching a wholesale distribution channel alongside its specialty distributor division CuraScript, which serves more than 12,000 healthcare providers, to gain access to new medications.”
  • Beckers Payer Issues relates,
    • “Tom Curtin was named executive vice president of Kaiser Permanente’s National Health Plan after serving as its interim leader since May.
    • “In the role, effective immediately, Mr. Curtin will lead health plan strategy and operations with a focus on growth, affordability and expanding access to the Oakland, Calif.-based system’s value-based care model, according to a Sept. 29 news release. He reports to Chair and CEO Greg Adams.
    • “During his time as interim leader, Kaiser Permanente added more than 223,000 members in 2026, positioning the organization for its strongest membership growth since 2018, the release said.”
  • Fierce Healthcare tells us,
    • “Performance-based contracting is becoming the norm for digital health solutions, with the majority of employers and health plans tying vendor payments to clinical and financial outcomes, according to a new survey from Peterson Health Technology Institute (PHTI).
    • “Specifically, 68% of employers and 55% of health plans are using such contracts. Eighty-five percent of contracts tie at least a quarter of fees to performance while 31% tie more than half, PHTI analysts wrote in the report (PDF).
    • “The report drew insights from 321 digital health professionals responsible for purchasing across health plans, employers and health systems. Four main areas were covered: purchasing approach, artificial intelligence adoption, contracting process and future plans.”
  • and
    • “Satisfaction with pharmacy benefit managers has stabilized in 2026, though the likelihood of contract renewal without a competitive request for proposal declined, a new report from Pharmaceutical Strategies Group (PSG) found. 
    • “The report drew insights from 250 benefits leaders representing employers, health plans, healthcare organizations and union plans. Respondents were asked to rate satisfaction with PBMs on a 10-point scale, with overall satisfaction receiving a 7.2 score, up from 7.1 in 2025. 
    • “On a similar scale, the likelihood to renew contracts without issuing competitive RFP fell to 6.4—which analysts note is the “lowest point in recent history.”
  • MedTech Dive informs us,
    • “Abbott said Wednesday it is launching Freenome’s SimpleScreen CRCblood-based test for colorectal cancer in the U.S. as an option for people who decline to complete medical guideline-recommended screening.
    • “SimpleScreen CRC is an addition to the Cologuard Plus stool-based test in Abbott’s colorectal cancer screening portfolio. Abbott acquired Cologuard in March in the $21 billion buyout of Exact Sciences.
    • “Freenome developed the SimpleScreen test and manufactures it. Abbott will distribute SimpleScreen in the U.S. under a commercial agreement with Freenome. The test, which won Food and Drug Administration approval this summer, will compete in the market with Guardant Health’s Shield blood test for colorectal cancer screening.”
  • Fierce Healthcare points out,
    • “Trinity Health System, a four-hospital system in eastern Ohio, will officially be handed over from CommonSpirit Health to University of Pittsburgh Medical Center (UPMC) on Oct. 1, the large nonprofit organizations shared Wednesday. 
    • “The deal is a geographic expansion for UPMC, which to date has limited its acute footprint to Pennsylvania. Financial terms of the deal still have not been disclosed. 
    • “By integrating Trinity Health System into UPMC, we are building upon a foundation of trusted collaboration to ensure that high-quality, patient-centered care remains accessible and sustainable for years to come,” Dwayne Richardson, interim market president, of Trinity Health System, said in the announcement. “We know that UPMC shares our dedication to clinical excellence.”
    • “Alongside the hospitals—Trinity West and Trinity East in Steubenville, Trinity Twin City Medical Center in Dennison and Trinity St. Clairsville Neighborhood Hospital in St. Clairsville—UPMC is acquiring associated clinics and sites delivering urgent care and behavioral health care.” 
  • Per Beckers Hospital Review,
    • “Dallas-based Baylor Scott & White Health reported operating income of $1.5 billion (8.3% margin) during the fiscal year ending June 30, 2026, down from a $1.7 billion operating gain (10% margin) in the previous fiscal year, according to financial statements published Sept. 30.”
  •  and
    • The number of first-year students at U.S. medical schools that grant MD degrees rose 36.8% from the 2005-06 academic year to 2025-26, but fewer are staying in their home state. 
    • Over the same period, the share of those students who come from the school’s home state declined, according to a study published Sept. 29 in JAMA.
    • The study’s authors, Barbara Barzansky, PhD, and Felicia Walker, work for the American Medical Association, which funded the research. They used data from the Liaison Committee on Medical Education’s 2025-26 Annual Medical School Questionnaire. Of the 160 medical schools the committee accredits, 158 responded.
  • Per MedCity News,
    • “AstraZeneca is making a $2 billion equity investment in Summit Therapeutics, a business deal that also kicks off a research collaboration that could pursue multiple drug combinations with an initial focus on gastrointestinal cancers.
    • “The deal announced after Monday’s market close is a vote of confidence in the Summit cancer drug ivonescimab, a bispecific antibody designed to bind to two targets, PD-1 on T cells and VEGF on cancer cells. Several oncology-focused pharmaceutical companies have already struck deals to add such drugs to their pipelines. Summit’s late-clinical drug gives AstraZeneca access to a contender in the class.
    • “Ivonescimab was developed by China-based Akeso Therapeutics. Phase 3 trial results in lung cancer raised hopes for the molecule as data showed it beat Merck’s blockbuster PD-1 inhibitor Keytruda in a head-to-head study. But those results were from a trial in China, where the drug has approvals in lung cancers and is marketed by Akeso. For Summit, ivonescimab’s prospects ride on the results of clinical trials the company is conducting in outside of China. Summit holds rights to the drug in North and South America, Europe, the Middle East, Africa, and Japan.”
  • Per Radiology Business,
    • “Solis Mammography has inked a new imaging joint venture with HCA Healthcare, the two announced on Monday. 
    • “The Addison, Texas-headquartered breast imaging provider is teaming with America’s largest health system to expand services in South Carolina. It will work with HCA Healthcare’s Trident Hospital, with its breast imaging services now branded under the Solis Mammography name. 
    • “This marks the private equity-backed imaging group’s first foray into South Carolina. Solis said the two have plans to further expand into additional HCA facilities across the greater Charleston area, boosting local access to breast imaging services. 
    • “Partnering with Solis Mammography reflects our deep commitment to the women and families who call the Lowcountry home,” Hugh Tappan, MBA, president of HCA Healthcare’s South Atlantic Division, said in a statement Sept. 28. “We want every woman to feel supported and confident in her breast health journey, with access to exceptional care close to home.”
  • Per Cardiology Business,
    • “Artificial intelligence (AI) is increasingly being incorporated into cardiovascular imaging, but at Mass General Brigham, some of the most practical applications are focused on streamlining the imaging workflow rather than replacing or double-checking what radiologists and cardiac imagers already do.
    • “Brian Ghoshhajra, MD, MBA, medical director of radiology and clinical operations for integrated imaging services at Mass General Brigham and an associate professor of radiology at Harvard Medical School, discussed the health system’s approach to AI and automation with Cardiovascular Business.
    • “Ghoshhajra said imaging can be viewed as a chain that begins with ordering and scheduling, moves through protocoling and quality assurance and ends with interpretation and reporting. While much of the attention surrounding AI has focused on interpretation, he said there may be significant opportunities to improve the earlier steps of the process.
    • “At Mass General Brigham, for example, automation has been used to reduce the amount of manual work required for protocoling cardiovascular CT examinations. Ghoshhajra said the system has grown from performing about five cardiac CT examinations per day when he was a fellow 18 years ago to approximately 85 to 100 studies per day across multiple hospitals using a hub-and-spoke model.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “CMS released initial insights on the 2027 Medicare Advantage landscape Sept. 28, along with data breaking down plans.
    • “One wrinkle gaining attention: enrollment capacity limits. In April, CMS said insurers could include enrollment caps for specific plans in their 2027 MA bids, relying on existing regulatory authority. With these caps, plans cannot disenroll current members. Once a plan hits its cap, it must stay closed to new enrollees until space opens up through natural attrition, according to the April memo. The agency baked enrollment caps into its August guidance for MA payers. 
    • ‘Ceci Connolly, president and CEO of the Alliance of Community Health Plans, recently told Becker’sthat her organization made progress with CMS on “tweaks with respect to the regulatory perspective,” including enrollment caps.” * * *
    • Becker’s reviewed the 65 MA plans — including MA plans with prescription drug coverage and special needs plans — with enrollment caps. [As disclosed in the article, t]hese plans are available in 11 states and span 15 parent organizations. The caps range from 410 to 56,345 members.
  • The New York Times relates,
    • “The Department of Veterans Affairs announced new measures on Monday that will require written informed consent by patients before they are prescribed certain psychiatric drugs.
    • “The shift reflects a growing disenchantment with psychotropic medications that has animated the Make America Healthy Again movement and its chief standard-bearer, Health Secretary Robert F. Kennedy Jr.
    • “The new policy will require veterans under age 30 to sign consent forms before receiving antidepressants, and it mandates documented discussions about the risks and benefits of the treatments, including how to safely discontinue them.
    • “The guidance also requires a signed consent form when patients are concurrently prescribed opioids and benzodiazepines. The measure will go into effect in 2027.”
  • STAT News adds,
    • “A growing number of congressional lawmakers are urging the Trump administration to rethink a federal rule going into effect next month over concerns it will prevent Americans from obtaining prescription medicines from licensed international pharmacies.
    • “The pending rule requires medicines mailed from abroad to go through a customs process that mandates a licensed customs broker and a financial guarantee in the form of an entry bond. This is an added burden — and cost — for Americans who, for years, have been able to receive prescriptions from Canada and other countries with relatively little difficulty as they sought to save money on expensive drugs.”
  • and
    • “In the last month, manufacturers have announced “breakthrough” status from the Food and Drug Administration for a menagerie of devices: triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots, to name a few.
    • “They’re coming in just under the wire: As of October, new breakthrough-designated devices will no longer be eligible for special treatment when it comes to qualifying for extra Medicare payments. These devices, and more than a dozen others, are included in the latest update of STAT’s Breakthrough Device Tracker, which since 2022 has captured nearly 800 devices reported to have FDA breakthrough status.” 
  • Beckers Hospital Review notes,
    • “Section 232 tariffs on patented pharmaceutical products and associated pharmaceutical ingredients take effect today, Sept. 29, for companies not covered by the earlier July 31 implementation date. The tariffs follow a Commerce Department investigation that found U.S. dependence on imported pharmaceuticals and pharmaceutical ingredients threatened to impair national security.” * * *
    • “Companies with qualifying most-favored-nation pricing and onshoring agreements with the administration receive a zero tariff rate through Jan. 20, 2029. As of an Aug. 31 White House announcement, all 17 Annex III companies, including AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer and Sanofi, have signed MFN deals, meaning none currently pay the tariff.”

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

  • Per an OPM news release,
    • The White House Task Force to Eliminate Fraud and the US Office of Personnel Management (OPM) today announced more than $500 million in anti-fraud savings for calendar year 2025.
    • The results cover the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) Programs. $237.7 million was saved from claims stopped or reduced before payment, and an additional $271.9 million in losses were prevented due to changes in billing and policy.  An additional $21.9 million were recovered after payment. This work was done in coordination with the Special Investigation Units of the FEHB and PSHB Carrier organizations that administer the health plans.
    • “Fraud in federal health benefits programs drives up costs for employees, retirees, and taxpayers,” OPM Director Scott Kupor said. “These results demonstrate the importance of strong carrier oversight, better data sharing, and earlier detection. Working with Vice President Vance and the White House Task Force to Eliminate Fraud, OPM is strengthening accountability and protecting the premiums paid by enrollees and the federal government.”
  • Fox News adds,
    • “Kupor’s previous experience working with artificial intelligence has led to his name being floated to serve as the AI czar in the Trump administration – a role cast into the spotlight as data center development and artificial intelligence have become midterm election talking points.” * * *
    • “When asked about whether he has had any conversations with the White House about the role, Kupor said he had seen the reports he was being floated, and discussed President Donald Trump’s views on artificial intelligence broadly.
    • “I’ve read all the same reports you’ve read and don’t have anything to add there,” he said. “What the president has said is exactly 100% right, which is that AI is the most important piece of technology that will determine economic growth for us, national security, sovereignty for our country.
    • “One of the things that I know, again, having spent all my life in the venture world, is there is no limit to the intellect and inventiveness of entrepreneurs in this country. And we just need to make sure that the conditions around, you know, regulatory controls and others continue to allow the U.S. to flourish in the way that it’s always done.”
    • “Kupor did not rule out accepting the role if Trump should offer it to him, saying that while he is focused on his job as director of the agency, he serves “at the will of the president.”
    • “Reports had suggested that Treasury Secretary Scott Bessent was being considered for the AI czar position, but last week Trump said he would not be selecting him for the role.”

From the U.S. Food and Drug Administration front,

  • The Hill reports,
    • “If you are one of millions of Americans taking medication to lower blood pressure, you may want to check the label.
    • “Inventia Healthcare Limited, based in Mumbai, India, is voluntarily recalling 13,567 bottles of chlorthalidone tablets that may not dissolve properly, potentially lowering the dosage that gets absorbed by the body. The bottles of 25 mg tablets being recalled nationwide have the batch number RISA24002 and an expiration date of March 2027.”
  • Cardiovascular Business relates,
    • “Tempus AI has received U.S. Food and Drug Administration (FDA) clearance for a new artificial intelligence (AI) tool designed to evaluate standard 12-lead resting electrocardiograms (ECGs) for signs of undiagnosed mitral regurgitation (MR). 
    • “The newly cleared software, Tempus ECG-MR, identifies signs of moderate or severe MR and then flags clinicians to ensure the patient receives follow-up medical imaging as needed. It was built to assess diagnostic ECG recordings of any patients 65 years old or older who face a risk of developing cardiovascular disease.  
    • “A standard ECG contains far more information than we have traditionally been able to use,” Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, said in a statement. “With the fourth FDA-cleared Tempus ECG-AI product, we’re building a growing portfolio that can identify signals across numerous types of heart and vascular disease from the same ECG, helping provide clinicians with more actionable information from a test already embedded in everyday care.”

From the public health and medical/Rx research front,

  • Beckers Clinical Leadership reports,
    • “The infant mortality gap between Black and white babies in the U.S. increased between 2020 and 2024, with sudden unexpected infant death identified as the largest single contributor to the disparity, according to a study published Sept. 22 in JAMA Network Open.
    • “Researchers analyzed federal birth and infant death records covering nearly 58 million live births and 366,384 infant deaths from 2003 to 2024 to determine the factors behind the Black-white infant mortality gap.” * * *
    • “This study provides evidence that there is an acute crisis right now in sudden unexplained infant death, a category of cause of death that we assumed we got under control a long time ago,” Leslie Root, PhD, study co-author and assistant research professor at the University of Colorado Boulder’s Institute of Behavioral Science, said in a Sept. 23 news release.” 
  • Health Day relates,
    • “A powerful new lab-made opioid is moving through the illegal U.S. drug supply, and federal officials warn it could keep spreading. 
    • “The drug, called cychlorphine, may be up to 10 times stronger than fentanyl, according to the White House Office of National Drug Control Policy (ONDCP).
    • “In an April 30 drug threat notice, the office said cychlorphine had turned up in every region of the country. It was most common in Ohio, Texas and Tennessee.
    • “As of that notice, at least 55 deaths nationwide had been linked to the drug in 2025 and 2026.”
  • and
    • “A diagnosis of type 2 diabetes at a young age is much more likely in people who have autism or attention deficit hyperactivity disorder (ADHD), new research says.
    • “More than 14% of people diagnosed with type 2 diabetes before the age of 20 had an ADHD diagnosis, compared to close to 7% of people of similar age without diabetes. That’s more than double the number, findings being presented at a conference in Italy this week show. 
    • “As for autism, 5.7% of people diagnosed with type 2 diabetes before the age of 20 also had the neurodivergent condition, the study found.”
  • MedPage Today tells us,
    • “Hearing loss is considered a key modifiable risk factor for dementia.
    • “Hearing aids did not reduce progression from mild cognitive impairment to dementia in the CHOICE trial, but cognitive improvement occurred more often with their use.
    • “Low dementia conversion rates in this study underpowered conclusions, making replication and confirmation essential.”
  • Cardiovascular Business adds,
    • “When adults with type 2 diabetes are already being treated 1-mg doses of semaglutide, moving to a 2-mg dose is associated with better cardiovascular outcomes than switching to tirzepatide. That was the primary takeaway from new data presented at the European Association for the Study of Diabetes Annual Meeting 2026 in Milan, Italy.
    • “Researchers explored real-world data from more than 600,000 adults with type 2 diabetes who were receiving once-weekly injections of semaglutide at 1 mg per dose. While 67.2% of patients stayed on that exact same dose, 29.2% made the move to a 2-mg dose of semaglutide. Another 3.6% of patients, meanwhile, switched to taking up to 15 mg of tirzepatide per dose. The number of patients moving to a stronger dose or switching to tirzepatide did increase over time. 
    • “Overall, the study’s authors found that the higher semaglutide dose was associated with a 6% lower risk of major adverse cardiovascular events—an outcome that includes heart attack, stroke and all-cause mortality—than tirzepatide.” 
  • Per Genetic Engineering and Biotechnology News,
    • “Researchers at Washington University School of Medicine in St. Louis have developed a potential antibody-based approach to reducing neurodegeneration in diseases known as tauopathies, including Alzheimer’s disease. Studying mice with Alzheimer’s-like tau protein accumulation in their brains, the team showed that injecting the animals with an antibody to a protein called CXCR3 over several months blocked the route used by T cells to get into the brain, reducing the number of those cells in the brain by about half.
    • “The treated mice kept roughly 40% more tissue in memory centers of the brain and did better on a memory test compared with untreated mice—even though the levels of tau in their brains didn’t change. “In tauopathies, including Alzheimer’s disease, there’s no treatment right now that actually decreases neurodegeneration,” said David M. Holtzman, MD, the Barbara Burton and Reuben M. Morriss III Distinguished Professor in WashU Medicine’s Department of Neurology. “If we can show that we’re really decreasing brain cell death, it’s certainly worth trying to pursue that pathway to prevent the most devastating consequences of these diseases.”
    • “Holtzman is senior author of the team’s published paper in Neuron, titled “Peripheral CXCR3 blockade mitigates T cell infiltration and neurodegeneration in a mouse model of tauopathy,” in which they concluded “Our study defines the CXCR3 axis as a critical target that, when blocked, mitigates CD4+ and CD8+ T cell infiltration and confers neuroprotection in a model of tau-mediated neurodegeneration in vivo without influencing levels of soluble or insoluble tau.”
  • Per STAT News,
    • “An experimental gene therapy for Huntington’s disease, developed by the biotech company UniQure, continued to slow the progression of the neurodegenerative disease four years after it was surgically implanted into the brains of patients, the company reported Tuesday. 
    • “However, the magnitude of the treatment’s benefit has waned compared to a similar analysis conducted one year ago, which may raise questions about its durability just as the Food and Drug Administration begins to review UniQure’s marketing application.” 
  • Per BioPharma Dive,
    • “A CAR-T treatment from Adicet Bio has shown in human testing the potential to drive lupus into remission, providing early but notable evidence that therapies like it could be useful in treating autoimmune conditions.
    • “After a year of follow-up in an early-stage trial, 50% of lupus nephritis patients treated with Adicet’s therapy and evaluable for efficacy had a “complete” kidney response to treatment and 54% met a widely used statistical criteria for remission. All of those patients, who had previously tried multiple other treatments, stopped using immunosuppressive drugs.
    • “Adicet also noted that there were no serious cases of cytokine release syndrome or instances of neurological side effects, both of which are concerns with cell therapy treatments. The company intends to start up a pivotal study in lupus in the fourth quarter.” 

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

  • Beckers Hospital Review reports,
    • “Bloomington, Minn.-based HealthPartners and Duluth, Minn.-based Essentia Health announced Sept. 29 that their boards approved an agreement to combine, forming a nonprofit system with 22 hospitals, more than 135 clinics, 6,000 clinicians and 45,000 colleagues.
    • “The combined organization will be called HealthPartners and led by HealthPartners President and CEO Andrea Walsh. David Herman, MD, CEO of Essentia since 2015, will serve as president of combined clinical care group operations, and Essentia facilities will keep the Essentia Health name while operations are integrated.
    • “No money is changing hands. The organizations will combine their assets under a single community-based board and expect the combination to be effective Jan. 1, pending a Minnesota public interest review and federal filings.” 
  • and
    • “Kansas City, Kan.-based The University of Kansas Health System has signed a definitive agreement to acquire full ownership of St. Francis Campus and its affiliated care sites in Topeka from Brentwood, Tenn.-based Ardent Health.”
  • and
    • Los Angeles-based Cedars-Sinai Health System recorded operating income of $261 million (2.8% margin) for fiscal year 2026, compared with operating income of $239 million (2.8% margin) in fiscal 2025, according to its Sept. 25 financial report. 
  • Per Healthcare Dive,
    • “Oura said Tuesday that it will delay its planned initial public offering due to market uncertainty.
    • “The smart ring maker said in May that it confidentially filed for an IPO, and recently revealed that it sought to raise up to $2.2 billion in the offering. The company has reached profitability, and its revenue has grown over the last three years, according to Oura’s prospectus. The company said it expects revenue to grow 90% year over year for its fiscal 2026; Oura reported $907.9 million in revenue in its 2025 fiscal year. The company has 5.7 million paid members.
    • “We aim to deliver an extraordinary IPO for our employees and investors and we have the luxury of choosing our moment,” CEO Tom Hale said in a statement. “In the meantime, we will execute against the opportunities ahead.”
  •   and
    • “Name: Robert Hunter
    • “Previous title: CEO of government programs, UnitedHealthcare
    • “New title: President, UnitedHealthcare
    • “Hunter, who has held a variety of roles at UnitedHealthcare over the past 15 years, will take on the role of president of Minnesota-based UnitedHealth’s payer arm, he announced in a LinkedIn post on Monday. 
    • “Hunter will focus on helping UnitedHealthcare, the largest insurer in the U.S., escalate its “modernization agenda,” toward “a future where healthcare is more connected, easier to navigate and simpler to understand,” he said in the LinkedIn post. The company is in the middle of an effort to streamline and modernize patients’ digital experience with the insurer.”
  • The Wall Street Journal relates,
    • “Novo Nordisk NOVO.B has signed a licensing deal for a weight-loss treatment being developed by Hengrui Pharma that could be worth up to $2.6 billion.
    • “The Danish drugmaker will pay China-based Hengrui $300 million upfront, with the rest of the potential deal value tied to milestones.
    • “Novo will obtain exclusive rights to develop, manufacture and commercialize HRS-1596 globally, excluding mainland China, Hong Kong, Macau and Taiwan. Hengrui is also eligible to receive royalties based on sales of the drug within the licensed territory.
    • “The move is in line with Novo’s efforts to continuously advance its pipeline across obesity, diabetes and other cardiometabolic diseases, said Martin Holst Lange, chief scientific officer at Novo.”
  • Fierce Healthcare tells us,
    • “Digital health company Waltz Health is teaming up with drugmaker Fresenius Kabi to support direct-to-employer efforts for key biosimilar medications.
    • “Through the partnership, commercial employers, health plans and pharmacy benefit managers can access transparent pricing information for three therapeutic categories: rheumatology, dermatology and gastroenterology. The agreement encompasses three FK biosimilars, which are interchangeable with popular branded drugs Humira, Stelara and Actemra.
    • “Teaming with Fresenius makes for Waltz’s first expansion to its direct-to-employer offering, which initially partnered with Novo Nordisk and Eli Lilly on GLP-1s and went live at the beginning of this year.
    • “Jeff Park, president of Waltz Health, told Fierce Healthcare that while direct-to-consumer platforms like the White House’s Trump Rx have grabbed the lion’s share of attention, there’s significant opportunity in the direct-to-employer space to address affordability and access.”
  • Beckers Hospital Review lets us know,
    • “Elevance Health plans to require hospitals to identify the physical location where care was provided on billing forms and adjust payments for off-campus services accordingly.
    • “The insurer said Sept. 29 the new policies will apply across its commercial, Medicare Advantage and Medicaid plans and are designed to address situations where care delivered at off-campus locations is billed at higher hospital outpatient rates. Elevance said it is the first commercial payer to go public with requiring physical location data on claims and tie reimbursement to that information. The company plans to roll the policies out through the end of 2027.
    • “Catherine Gaffigan, MD, president of health solutions at Elevance, announced the change during a Tuesday morning panel at the MAHA Summit in Washington, D.C., where she appeared alongside leadership from UnitedHealth, AHIP and CMS.
    • “Patients and employers should be able to trust that healthcare bills accurately reflect where care was provided,” Dr. Gaffigan said in a news release.”
  • and
    • “Hospital outpatient departments were paid an average of 102% more per unit than physician offices for the same physician-administered medications, a premium that adds up to about $12.7 billion a year in employer health spending, according to new research from the Washington, D.C.-based Employee Benefit Research Institute.
    • “If HOPDs were reimbursed at physician-office rates, employers and workers could save about $12.7 billion annually, or roughly $101 per covered member, according to a Sept. 28 news release. The analysis examined 2023-24 commercial claims for 106 of the highest-spending physician-administered outpatient drugs, which accounted for about 51% of claims and 77% of spending in the category, using the Merative MarketScan Commercial Database for adults ages 18 to 64 with employment-based coverage.
    • “HOPDs received higher reimbursement for 93 of the 106 medications, with a median per-unit difference of 64%. The median annual difference was $5,531 per patient, reaching $135,306 for one oncology drug. About 59% of administrations occurred in HOPDs, compared with 31% in physician offices. The median HOPD markup on drugs from EBRI’s earlier analysis fell from 98% in 2019 to 70% in 2024, largely because physician-office reimbursement rose rather than HOPD rates falling.”
       
  • Beckers Health IT points out,
    • “AI can perform care represented in 16% to 22% of U.S. outpatient claims, according to an analysis from McKinsey & Co. That work accounts for 13% to 19% of outpatient spending.
    • “The Sept. 28 analysis of 2024 commercial, Medicare and Medicaid claims found that roughly 2 billion to 3 billion outpatient claims involve services clinical AI could potentially perform. McKinsey calls this category “discursive care,” meaning reasoning- and dialogue-based work such as intake, triage, diagnosis, referrals and follow-up that doesn’t require a hands-on exam.
    • Evaluation and management visits involving no additional care, or only low-complexity care, made up 11% to 15% of outpatient claims and 8% to 12% of spending. Interpretation of diagnostic or imaging results accounted for 5% to 7% of both claims and spending.
    • “Physician offices, clinics, virtual settings and urgent care are likely to see the largest share of AI-driven change, the authors said.”