FEHBlog

Weekend Report

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

From Washington, DC,

  • Roll Call reports,
    • “The top four congressional leaders will head to the White House on Monday for a meeting with President Donald Trump in a last-ditch effort to prevent a partial government shutdown.
    • “The meeting, confirmed by sources familiar with the plans, comes after the president scrapped a separate discussion planned with just the two Democratic leaders.” * * *
    • “The Senate is back in session on Monday with 48 hours until agencies would have to start shutting down Oct. 1. The House, which on Sept. 19 passed a partisan GOP-drafted stopgap funding bill that would keep the government operating for seven weeks until the Thanksgiving recess, isn’t planning to return until at least Oct. 7.
    • “Speaker Mike Johnson wrote Friday on X that House Republicans “have done our job” and now it’s the Senate’s turn to act.” 
  • Here is link to the Congressional committee schedule for this week.
  • Roll Call notes,
    • “The Senate does have another option in the queue aside from leadership-driven proposals [for a continuing resolution], with a procedural vote expected Monday on a bill from Sen. Ron Johnson, R-Wis., to provide for automatic two-week continuing resolutions.
    • “My new bill simply provides for automatic two-week rolling continuing resolutions for any department for which an appropriation bill or longer-term continuing resolution hasn’t been passed. This would keep spending flat by prorating the previous year’s spending level,” Johnson wrote in a Sept. 21 Wall Street Journal opinion piece.”
  • SCOTUSblog informs us,
    • “Edward Lazarus, a former clerk to the late Justice Harry Blackmun, called it a “single marathon session.” Gregory Garre, who served as the U.S. solicitor general during the George W. Bush administration, described it as the place “where petitions go to die.” Lazarus and Garre were both referring to the “long conference” – a private meeting, taking place this year on Sept. 29, at which the justices will consider the roughly 2,000 petitions for review that have built up since their last regularly scheduled conference (on June 26) before their summer recess.
    • “The long conference is the unofficial start to the court’s new term, which by law officially begins on the first Monday in October. The tradition of a “long conference” at the end of September or in early October, before the justices take the bench to hear oral arguments, dates back to the early 1970s, according to a book by the late Chief Justice William Rehnquist. Until then, the court held its long conference during the first week in October and had oral arguments thereafter. But Blackmun suggested that the court should move its meeting to the last week in September, allowing it to begin oral arguments on the first Monday in October instead.”
  • Modern Healthcare lets us know,
    • “Medicare Advantage enrollment could slip next year, the Centers for Medicare and Medicaid Services announced Friday.
    • “Health insurance companies project Medicare Advantage membership will fall from 34.9 million this year to 34 million in 2026, CMS said in a news release. 
    • “That would mark the first annual decline in Medicare Advantage enrollment since at least 2007, according to CMS data analyzed by the health policy research organization KFF. The annual enrollment period runs Oct. 15-Dec. 7.
    • “Insurers also predict that Medicare Advantage will lose ground to fee-for-service Medicare next year. The privatized program surpassed traditional Medicare in 2023 but will cover 48% of beneficiaries in 2026, down from 50% this year, according to industry estimates reported to CMS.
    • “CMS offered a rosier assessment. “Based on recent historical experience and enrollment trends, CMS anticipates that enrollment in [Medicare Advantage] in 2026 will be more robust than the plans’ projections and that enrollment will be stable,” the agency said in the news release.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has granted de novo classification to a continuous glucose monitor made by Biolinq for people with Type 2 diabetes.
    • “Biolinq says its device is the first CGM that does not require a needle to place the sensor beneath the skin, instead using a microsensor array that sits less deep in the skin.
    • “People with diabetes have a growing number of CGM options as the FDA has authorized new sensors in recent years, including the first over-the-counter sensors and implanted CGMs that can be worn for one year.“
  • P.S. The OPM Director did not add a new post to his Secrets of OPM blog on Friday.

From the public health and medical / Rx research front,

  • Healio tells us,
    • “A federal law required all new cars to be equipped with backup cameras after May 2018.
    • “The mandate was associated with a 62% reduction in back over injuries in a trauma center in Houston.”
  • and
    • “COVID-19 vaccination during pregnancy provides significant protection for mothers and their babies with no associated increase in risk, according to data from more than 1.2 million pregnancies presented at the AAP’s annual meeting.
    • “COVID-19 vaccination reduced admission, mortality and pregnancy-specific complications,” Nikan Zargarzadeh, MD, a postdoctoral research fellow in the division of fetal medicine and surgery at Boston Children’s Hospital, told reporters on Saturday. “On the neonatal side, it reduced NICU admission.”
  • and
    • “Many women suffer complications in the time between giving birth and the 6-week visit.
    • “A Women in Medicine Summit presenter discussed how her own journey informs her work and what she is doing to help new moms.”
  • NPR Shots reports,
    • “For more than four years, Lynn Milam’s life was bound by the pain that radiated from her swollen joints.
    • “My children could not hug me,” she says. “I couldn’t hold my husband’s hand.”
    • “Milam also couldn’t climb stairs or help raise her teenage son. She spent most days on the couch.
    • “The reason was rheumatoid arthritis, which occurs when the immune system starts attacking the lining of joints.
    • “Milam tried everything: physical therapy, acupuncture, steroids and even the latest immune drugs. Nothing worked.
    • “That changed in October of 2023, when a surgeon implanted an experimental device in Milam’s neck. For a minute each morning, it delivers pulses of electricity to her vagus nerve, which connects the brain with internal organs.
    • “Three weeks in, my elbow pain was completely gone,” she says. “Then my hands didn’t hurt anymore, the swelling started going away.”
    • “Eventually, all symptoms of rheumatoid arthritis had vanished. Milam, 60, says she and her husband have regained the life they enjoyed before she got sick.”
  • Per Medscape,
    •  “Tirzepatide was associated with improvements in body weight and body composition, and with lower insulin doses, in the first-ever randomized controlled trial (RCT) of the drug in people with type 1 diabetes (T1D).
    • “Tirzepatide may play a role in weight management in adults with T1D and obesity, even at low doses,” Jennifer R. Snaith, MD, of the Garvan Institute of Medical Research and St. Vincent’s Hospital Sydney, both in Darlinghurst, Australia, said at European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.” * * *
    • [A]sked to comment, independent industry consultant Charles Alexander, MD, noted that, while the data look good, it’s a small study and that Lilly’s two much larger ongoing phase 3 trials of tirzepatide in T1D, SURPASS-T1D-1 (NCT06914895), and SURPASS-T1D-2 (NCT06962280), aimed at obtaining FDA approval, will produce more definitive results.
    • Alexander also pointed out that Novo Nordisk is not conducting a similar RCT of semaglutide in T1D. “At the end of the day,” if it’s approved, “all you’re going to have [in terms of incretin drugs] is tirzepatide licensed for T1D.” 
    • Snaith’s team is also conducting a further study, TIRTLE2, with insulin resistance as the primary outcome.

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Amid rising healthcare costs, Amazon announced benefit updates Sept. 17 that include a “reduced-cost” healthcare plan for its fulfillment and transportation employees. Workers on the plan will only need to pay $5 a week and $5 for copays starting in 2026.
    • “Those costs amount to about $22 per month or $260 per year for employees. This results in reductions of weekly contributions by workers by 34% and copays for primary care, mental health and nonspecialist visits by 87%, Amazon said.
    • “The changes were made based on feedback offered by workers, Udit Madan, senior vice president of Amazon Worldwide Operations, said in the announcement.”
  • Fierce Pharma notes,
    • “Serial entrepreneur Robert Wessman, who has had a golden touch creating, acquiring and spinning off companies that primarily sell generic drugs, has brought together two of his fastest-growing enterprises as Lotus Pharmaceuticals has acquired a 100% equity stake in [U.S. based] Alvogen.
    • “The move, which transforms Alvogen into a subsidiary, catapults Taiwan-based Lotus into a top-20 specialty pharmaceutical company worldwide, according to a release. The deal has a total value of up to $2 billion.
    • The deal could also help shield Lotus—which does most of its business in Asia—from U.S. tariffs on pharmaceutical products. Thursday night, in a post on social media, President Donald Trump wrote that starting Oct. 1, the U.S. would impose a 100% levy on drugs imported by companies that aren’t in the process of building U.S. facilities.
    • “The transaction gives Lotus “access to U.S. R&D, manufacturing and commercial capabilities alongside our established strengths in Asia,” the company said in a release.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Health ISAC reminds us,
    • “Despite widespread public and private interest in reauthorizing the U.S. Cybersecurity Information Sharing Act of 2015 (“CISA 2015”)[i], we are rapidly approaching September 30th, the date when the Act is set to expire barring congressional action to extend it. With time running short, let’s assess the options still being considered and breakdown how and why reauthorization is going down to the wire.” * * *
    • “The current most likely path for a CISA 2015 reauthorization is not a simple standalone bill that is quickly passed by both chambers. Instead, the most likely path runs through a short term extension as part of a continuing resolution (“CR”) and then through the National Defense Authorization Act (“NDAA”).
    • “For those who are unfamiliar, a CR is a “temporary spending [bill] that [allows] federal government operations to continue when final appropriations have not been approved by Congress and the President. Without final appropriations or a CR, there could be a lapse in funding that results in a government shutdown.”[ii] The NDAA is an annual end of year bill that provides appropriations for the Department of Defense (“DOD”). It is generally considered to be a “must pass” piece of legislation that lawmakers attempt to add otherwise unrelated policy matters.”
  • Nextgov/FCW tells us,
    • “Greg Barbaccia, the federal chief information officer, says that the Office of Management and Budget is backing the General Services Administration’s overhaul of FedRAMP, the government’s cloud security assessment and authorization program. 
    • “GSA launched FedRAMP 20x — meant to use more automation in place of annual assessments, cut red tape and speed up authorizations — in March. It announced its phase two pilot on Wednesday.
    • “Barbaccia acknowledged the past problems with FedRAMP at a Wednesday event held by the Alliance for Digital Innovation. 
    • “I have done FedRAMP in my past life,” said Barbaccia, who previously worked at Palantir and more recently at a machine-learning enabled asset manager. “What a pain in the butt.”
    • “The FedRAMP program is planning on pursuing 10 pilot authorizations at the Moderate security level as part of the new phase of FedRAMP 20x, said FedRAMP Director Pete Waterman.”
  • Per a Cybersecurity and Infrastructure Security Agency (“CISA”) news release,
    • Today [September 23, 2025], the Cybersecurity and Infrastructure Security Agency (CISA) announced the appointment of Stephen L. Casapulla as the Executive Assistant Director for Infrastructure Security.
    • “I am pleased to have Steve expand his role on CISA’s leadership team,” said Acting Director Madhu Gottumukkala. “With his extensive experience in critical infrastructure security and working with stakeholders, he is perfectly poised to lead our efforts in securing the nation’s critical infrastructure. I look forward to working with him on this important mission.”
    • Prior to joining CISA, Casapulla served as the Director for Critical Infrastructure Cybersecurity in the Office of the National Cyber Director. He previously spent over thirteen years at CISA and its predecessor, holding a variety of senior roles. His prior federal service includes work at the Small Business Administration and at the Department of State in Iraq. He also serves as an officer in the U.S. Navy Reserve, with over twenty years of service and multiple overseas deployments.

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive reports,
    • “The Cybersecurity and Infrastructure Security Agency on Thursday [September 25, 2025,] ordered U.S. government agencies to patch multiple vulnerabilities in Cisco networking products, saying an “advanced threat actor” was using them in a “widespread” campaign.
    • “This activity presents a significant risk to victim networks,” CISA said in an emergency directive that laid out a mandatory timeline for agencies to identify, analyze and patch vulnerable devices.
    • “The hacking campaign — an extension of the sophisticated “ArcaneDoor” operation that Cisco first revealed in April 2024 — has compromised multiple federal agencies, two U.S. officials told Cybersecurity Dive. Both officials requested anonymity to discuss a sensitive and evolving investigation.”
  • Cyberscoop adds,
    • “Cisco said it began investigating attacks on multiple government agencies linked to the state-sponsored campaign in May. The vendor, which attributes the attacks to the same threat group behind an early 2024 campaign targeting Cisco devices it dubbed “ArcaneDoor,” said the new zero-days were exploited to “implant malware, execute commands, and potentially exfiltrate data from the compromised devices.” 
    • “Cisco disclosed three vulnerabilities affecting its Adaptive Security Appliances — CVE-2025-20333, CVE-2025-20363 and CVE-2025-20362 — but said “evidence collected strongly indicates CVE-2025-20333 and CVE-2025-20362 were used by the attacker in the current attack campaign.” 
    • “The Cybersecurity and Infrastructure Security Agency said those two zero-days pose an “unacceptable risk” to federal agencies and require immediate action.”
  • Dark Reading points out,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) this week disclosed that threat actors breached a federal agency last year by exploiting a critical vulnerability in the open source GeoServer mapping server.
    • “In the advisory, CISA said it conducted incident response at a large, unnamed federal civilian executive branch (FCEB) agency after malicious activity was flagged by the agency’s endpoint detection and response (EDR) platform, but found the agency’s response playbook to be lacking; so lacking in fact that it hampered CISA’s investigation and allowed the attackers to burrow deeper into the network unchecked.
  • Cybersecurity Dive adds,
    • “[On September 23, 2025,] the Cybersecurity and Infrastructure Security Agency urged security teams to monitor their systems following a massive supply chain attack that struck the Node Package Manager ecosystem. 
    • “The attack, tracked under the name Shai-Hulud, involved a self-replicating worm that compromised more than 500 software packages, according to StepSecurity. 
    • “After gaining access, a malicious attacker injected malware and scanned the environment for sensitive credentials. The credentials included GitHub Personal Access Tokens and application programming interface keys for various cloud services, including Amazon Web Services, Google Cloud Platform and Microsoft Azure. 
    • “The stolen credentials were uploaded to an endpoint controlled by the attacker and then uploaded to a public repository called Shai-Hulud. 
    • “Researchers at Palo Alto Networks said the attacker used an LLM to write the malicious script, according to an updated blog post released Tuesday.” 
  • Cybersecurity Dive relates,
    • “Hackers are conducting brute force attacks against the MySonicWall.com portal in order to access the company’s cloud backup service for firewalls, SonicWall and federal authorities warned in advisories released Monday [September 22, 2025].
    • “SonicWall said its investigation found that hackers gained access to 5% of backup firewall preference files. The company warned that while credentials inside the files were encrypted, the files contained other information that could help attackers exploit the firewall, according to the advisory.  
    • “SonicWall also released a video explaining the scope of the incident. 
    • “In an advisory on Monday, the Cybersecurity and Infrastructure Security Agency urged customers to log into their accounts to determine whether their devices are at risk.” 
  • Cyberscoop reports,
    • “The Secret Service said Tuesday [September 23, 2025] that it disrupted a network of electronic devices in the New York City area that posed imminent telecommunications-based threats to U.S. government officials and potentially the United Nations General Assembly meeting currently underway.
    • “The range of threats included enabling encrypted communications between threat groups and criminals or disabling cell towers and conducting denial-of-service attacks to shut down cell communications in the region. Matt McCool, special agent in charge of the Secret Service’s New York field office, said the agency’s early analysis of the network indicated “cellular communications between foreign actors and individuals that are known to federal law enforcement.”
    • “In all, the agency said it discovered more than 300 servers and 100,000 SIM cards spread across multiple sites within 35 miles of the U.N. meeting. The Secret Service announcement came the same day President Donald Trump was scheduled to deliver a speech to the General Assembly.
    • “The potential for disruption to our country’s telecommunications posed by this network of devices cannot be overstated,” U.S. Secret Service Director Sean Curran said in a news release.”
  • Cyberscoop warns,
    • “Ambitious, suspected Chinese hackers with a slew of goals — stealing intellectual property, mining intelligence on national security and trade, developing avenues for future advanced cyberattacks — have been setting up shop inside U.S. target networks for exceptionally long stretches of time, in a breach that the researchers who uncovered it said could present problems for years to come.
    • “Mandiant and Google Threat Intelligence Group (GTIG) researchers described the campaign as exceptionally sophisticated, stealthy and complex, calling those behind it a “next-level threat.” But they don’t yet have a full handle on who the hackers are behind the malware they’ve dubbed Brickstorm, or how far it stretches. A blog post the company posted Wednesday sheds light on the group.
    • “The primary targets are legal services organizations and tech companies that provide security services, the researchers said. But the hackers aren’t limiting their interest to the primary targets, since they’ve used that access to infiltrate “downstream” customers. The researchers declined to describe those downstream customers or say whether U.S. federal agencies are among those targeted. A great many of them don’t know yet that they’re victims, they said.
    • “By stealing intellectual property from security-as-a-service (SaaS) firms, the hackers aim to find future zero-day vulnerabilities, a kind of vulnerability that is previously unknown and unpatched and thus highly prized, in order to enable more attacks down the line, the researchers from Mandiant and its parent company Google said.”
  • Per Dark Reading,
    • “Salesforce Web forms can be manipulated by the company’s “Agentforce” autonomous agent into exfiltrating customer relationship management (CRM) data — a concerning development as legacy software-as-a-service (SaaS) providers race to integrate agentic AI into their platforms to zhuzh up the user experience and generate buzz among investors.
    • “Agentforce is an agentic AI platform built into the Salesforce ecosystem, which allows users to spin up autonomous agents for most conceivable tasks. As the story often goes though, the autonomous technology appears to be the victim of the complexity of AI prompt training, according to researchers at Noma Security. 
    • “To wit: The researchers have identified a critical vulnerability chain in Agentforce, carrying a 9.4 out of 10 score on the CVSS vulnerability-severity scale. In essence it’s a cross-site scripting (XSS) play for the AI era — an attacker plants a malicious prompt into an online form, and when an agent later processes it, it leaks internal data. In keeping with all of the other prompt injection proofs-of-concept (PoCs) coming out these days, Noma has named its trick “ForcedLeak.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “RTX Corp., the parent firm of Collins Aerospace, confirmed that ransomware was used in the hack of its airline passenger processing software, in a filing with federal regulators. 
    • “The attack, discovered on Sept. 19, has disrupted flights across Europe since last week, including at London’s Heathrow Airport, Brussels Airport, and airports in Berlin and Dublin. 
    • “The Multi-User System Environment software, known as MUSE, is used by multiple airlines to check-in and board passengers and is also used to track baggage, according to the filing with the U.S. Securities and Exchange Commission. 
    • “Virginia-based RTX said the MUSE system operates on a customer-specific network outside of the company’s enterprise network.
    • “U.K. authorities said Wednesday that a man in his 40s had been arrested on suspicion of violating the Computer Misuse Act. The police investigation is ongoing.” 
  • Dark Reading points out,
    • “Volvo Group North America (Volvo NA) has been breached via a third-party human resources (HR) software provider.
    • “At the root of the story is Miljödata, a Swedish company specializing in occupational software-as-a-service (SaaS), whose cloud infrastructure was breached in August. Thanks to its centralized, multi-tenant arrangement, hundreds of customers and millions of individuals have been affected. In a recent letter to its staff, Volvo NA, whose parent company is based in Sweden, revealed itself to be one such victim.
    • “Like other Miljödata customers, Volvo NA’s systems were untouched by the attack. Still, its employees’ names and Social Security numbers (SSNs) were stolen, and potentially published to the Dark Web. According to its website, Volvo NA employs just shy of 20,000 people.
    • “For municipalities, universities, and even big corporations like Volvo, this isn’t just a security issue, it’s an integrity issue,” says Anders Askasen, vice president of product marketing at Radiant Logic. “People suddenly wonder whether the systems handling their most sensitive data are fit for the purpose, and with good reason. That loss of confidence is as damaging as the leak itself.”
  • Industrial Cyber tells us,
    • “The Rhysida ransomware gang claimed responsibility for a late-August data breach at the Maryland Transit Administration. Exposed data includes names, surnames, dates of birth, driver’s licenses, SSNs, passports, and confidential information.
    • “The group is said to have demanded a ransom of 30 bitcoin, around US $3.4 million at the time of writing, to be paid within seven days. To support its claim, Rhysida posted images of documents allegedly stolen from the MTA, including scans of a Social Security card, driver’s license, passport, and several other records.
    • “Comparitech identified that to prove its claim, Rhysida posted images of what it says are documents stolen from the MTA. They include scans of a Social Security card, driver’s license, passport, and several other documents. 
    • “The Maryland Transit Administration is a division of the state’s Department of Transportation. It operates buses, light rail, subways, commuter trains, taxis, and a paratransit system. The MTA specifically mentioned the paratransit system, MobilityLink, being disrupted by the cyber attack.”
  • Per the Record,
    • “Ransomware hackers stole Social Security numbers, financial information and more during a recent cyberattack on Union County in Ohio. 
    • “The county government began sending out breach notifications to 45,487 local residents and county employees this week. The letters say ransomware was detected on the county’s network on May 18, prompting officials to hire cybersecurity experts and notify federal law enforcement agencies.  
    • “The hackers stole documents that had names, Social Security numbers, driver’s license numbers, financial account information, fingerprint data, medical information, passport numbers and more.  
    • “No ransomware gang has taken credit for the attack publicly, and the letters said the county has been monitoring internet sources but have not found any indication the stolen information was released or offered for sale.  
    • “The county has about 71,000 residents and is 45 minutes outside of Columbus — which dealt with its own ransomware attack one year ago.” 
  • HIPAA Journal lets us know,
    • “There’s good and bad news on the ransomware front. Attacks are down year-over-year; however, successful attacks are proving even costlier to mitigate, according to the Mid-Year Risk Report from the cyber risk management company Resilience. The company saw a 53% reduction in cyber insurance claims in the first half of the year, which indicates organizations are getting better at preventing attacks; however, when ransomware attacks succeed, they have been causing increased financial harm, with losses 17% year-over-year. While ransomware accounted for just 9.6% of claims in H1, 2025, ransomware attacks accounted for 91% of incurred losses.
    • “On average, a successful ransomware attack causes $1.18 million in damages, up from $1.01 million in 2024, and the cost is even higher in healthcare. Resilience’s healthcare clients suffered average losses of $1.3 million in 2024, and in the first half of 2025, some healthcare providers faced extortion demands as high as $4 million. While it is too early to tell what the severity of claims will be in 2025 until claims are settled, Resilience said there are indications that the average severity of incurred losses for healthcare ransomware attacks this year could be $2 million, up from an average of $705,000 in 2024 and $1.6 million in 2023.”

From the cybersecurity defenses front,

  • Cyberscoop advises,
    • “Artificial intelligence is no longer a future concept; it is being integrated into critical infrastructure, enterprise operations and security missions around the world. As we embrace AI’s potential and accelerate its innovation, we must also confront a new reality: the speed of cybersecurity conflict now exceeds human capacity. The timescale for effective threat response has compressed from months or days to mere seconds. 
    • “This acceleration requires removing humans from the tactical security loop. To manage this profound shift responsibly, we must evolve our thinking from abstract debates on “AI safety” to the practical, architectural challenge of “AI security.” The only way to harness the power of probabilistic AI is to ground it with deterministic controls.”
  • A Dark Reading commentator recommends that “With the emergence of AI-driven attacks and quantum computing, and the explosion of hyperconnected devices, zero trust remains a core strategy for security operations.”
  • Per a CISA news releases,
    • “In today’s increasingly interconnected industrial landscape, operational technology (OT) systems are no longer isolated islands of automation—they’re deeply entwined with information technology and business networks, making them prime targets for cyber threats. Recognizing this growing risk, the Cybersecurity and Infrastructure Security Agency (CISA) collaborated with three U.S. federal agencies and five international partners and received contributions from twelve private sector stakeholders to develop and publish, “Foundations for OT Cybersecurity: Asset Inventory Guidance for Owners and Operators”.
    • “This key resource helps owners and operators of OT systems create stronger, more secure infrastructures by building a clear inventory and classification of their assets. By identifying, organizing, and managing OT assets effectively, organizations can not only improve cybersecurity but also enhance operational reliability, safety, and resilience.”
  • Per National Institute of Standards news releases,
    • “NIST has released Special Publication (SP) 800-88r2 (Revision 2), Guidelines for Media Sanitization.
    • “Media sanitization is a process that renders access to the target data on media infeasible for a given level of effort. This guide will assist organizations and system owners in setting up a media sanitization program with proper and applicable methods and controls for sanitization and disposal based on the sensitivity of their information.”
  • and
    • “NIST has released Special Publication (SP) 800-90C, Recommendation for Random Bit Generator (RBG) Constructions. It is the final document in the SP 800-90 series, which supports the generation of high-quality random bits for cryptographic and non-cryptographic use.
    • “SP 800-90C specifies constructions for implementing random bit generators (RBGs) that include deterministic random bit generator (DRBG) mechanisms as specified in SP 800-90A and use entropy sources as specified in SP 800-90B.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NCQA, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec tells us,
    • “Federal employees have been asking a lot of questions since the White House put out guidance this week suggesting large swaths of them would face layoffs under a government shutdown if one occurs next week.
    • “So far the answer many of them are getting is: we are planning to send you home without pay, but only until the shutdown ends. That is to say, agency officials are telling employees they will face their normal shutdown furloughs, but not reduction-in-force notices. 
    • “We were told we won’t be RIF’d, regardless of whether we have to work,” said one General Services Administration employee, whose office is typically furloughed during a funding lapse. 
  • The Centers for Medicare and Medicaid Services announced,
    • [A]verage premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program are expected to remain stable in 2026. Average premiums are projected to decline in both the MA and Part D programs from 2025 to 2026.
    • CMS is committed to ensuring these programs work for Medicare beneficiaries while maintaining access to high-quality, affordable healthcare options, safeguarding taxpayer dollars, and making sure beneficiaries have the information they need to make informed choices about what is best for them. 
    • CMS releases this key information, including 2026 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2025, to December 7, 2025.
    • “Millions of Medicare beneficiaries will continue to have access to a broad range of affordable coverage options in 2026,” said CMS Administrator Dr. Mehmet Oz. “We want every beneficiary to take advantage of Open Enrollment—compare your options and choose the plan that gives you the right care at the best price.”
  • The American Hospital Association News informs us,
    • President Trump, late Sept. 25, announced that starting Oct. 1, the U.S. will impose a 100% tariff on any branded or patented pharmaceutical product, unless a company is building its pharmaceutical manufacturing plant in America. The president’s post on Truth Social said “is building” will be defined as “breaking ground” or “under construction” and that there would be no tariff on “these Pharmaceutical Products if construction has started.”   
    • As of 3 p.m. ET on Sept. 26, the administration has not released any official documents related to the tariff announcement.  
  • BioPharma Dive adds,
    • “The new pharmaceutical tariffs President Donald Trump announced on Thursday, which will go into effect on Oct. 1, could have a limited impact on the pharmaceutical industry due to multiple exemptions for generics, exports from Europe and companies already onshoring manufacturing.
    • “The tariffs, unveiled via a post on the social media platform Truth Social, haven’t been accompanied by legal documents, leaving key details unclear. However, the 100% levies, which are much smaller than the figure previously floated by the Trump administration, alleviate some uncertainty around U.S. drug pricing policy.
    • “The announcement comes days before the expected release of programs meant to align U.S. drug prices with what’s paid in Europe and elsewhere. Published reports have suggested those policies may be more modest than Trump originally proposed, however.”
  • FedWeek points out,
    • “A new bipartisan group of House members has been formed with a focus on the impact on jobs and delivery performance of the Delivering for America reorganization initiative.
    • “The Congressional Postal Service Caucus will focus on improving on-time delivery rates, protecting postal employees, and stopping harmful facility consolidations that reduce access in rural and underserved areas,” said a statement from the founding members. A caucus is a less formal organization than a congressional committee, typically focusing on issues—and trying to build consensus on them—that cross committee areas of jurisdiction.”
  • NCQA, writing in LinkedIn, lets us know about NCQA researchers sharing findings on emerging topics in health care.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza and RSV activity is low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. The percentage of emergency department visits for COVID-19 are highest in children 0-4 years old. Hospitalization numbers and the percentage of emergency department visits are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is low nationally.
  • The University of Minnesota CIDRAP adds,
    • “The current COVID wave began in June, marked by a slow rise that never approached levels seen last summer.
    • “Wastewater SARS-CoV-2 detections are now at the moderate level and are highest in Northeast, followed by the West and the South.”
  • Prevention notes,
    • “The Stratus COVID variant, a.k.a. XFG, is currently the dominant strain of the virus in the U.S., causing 78% of cases in the country, according to CDC data.
    • “It’s an Omicron variant, and it’s a hybrid of two strains—LF.7 and LP.8.1.2,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.
    • Stratus has several mutations to the spike protein, which the virus uses to infect your cells and make you sick, per the World Health Organization (WHO). But the WHO also notes that the threat posed by Stratus is “low.”
  • The Wall Street Journal reports,
    • “President Trump’s return to office has supercharged the debate about childhood vaccinations. Trump himself recently stated that “children get these massive vaccines…like you give to a horse…they get like 80 vaccines,” while Health Secretary Robert F. Kennedy Jr. asserts that babies get up to 92 vaccine doses. In justifying Florida’s decision to end mandatory vaccine mandates for children, state surgeon general Joseph Lapado asked: “Who am I to tell you what your child should put in [their] body? I don’t have that right.”  
    • “These statements misstate the amount and number of vaccines administered to children. Over the course of 18 years, it’s typically 30 doses—in quantities about a tenth of a teaspoon—for about 16 different pathogens. But the critics raise important questions that parents have every right to ask. Why give vaccines so early in a baby’s life? And why shouldn’t parents just pick and choose what goes into their child?  
    • “The crucial context for this discussion is two facts. First, vaccines constitute only a minuscule fraction of the exposure to pathogens that children’s immune systems must contend with. Second, our bodies develop the most enduring antibodies in the early years of life.”
  • JAMA relates,
    • “For years, most observers attributed the higher number of Alzheimer disease cases among women to the simple fact that they live longer than men on average.
    • “Recently, though, scientists have come to recognize that the explanation for the sex gap in the prevalence of Alzheimer disease, the cause of most cases of dementia, is far more nuanced and complex, involving both biological and sociocultural factors.
    • “Research has focused on such potential contributors as women’s exposure to sex hormones, the genes in the X chromosome, the prevalence and effect of risk factors such as hearing loss, the apolipoprotein E ε4 (APOE4) variant, and diminished cognitive reserve related to lower education levels.
    • “Approximately 2 out of every 3 people living with Alzheimer disease in the US is a woman, Harvard neuropsychologist Rachel Buckley, PhD, noted. “Women actually tend to live with dementia for much longer than men.”
  • Per Health Day,
    • “An experimental pill can significantly reduce hot flashes and night sweats for women after menopause a new clinical trial has determined.
    • “Elinzanetant produced a nearly 74% reduction in the frequency and severity of these menopause symptoms within three months, researchers reported recently in JAMA Internal Medicine.
    • “Further, this relief lasted for a year, the trial found.
    • “This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” researcher Dr. JoAnn Pinkerton said in a news release. She’s director of midlife health at University of Virginia Health in Richmond.”
  • and
    • “Routine screening can help find kids who are suffering from undiagnosed asthma in communities with high levels of the breathing disorder, a new study says.
    • “Asthma screening during well-child visits found that more than two-thirds (35%) of children with no previous diagnosis of asthma had at least one risk factor for the disease, researchers will report Monday at an American Academy of Pediatrics’ meeting in Denver.
    • “Further, about 24% of kids with risk factors were subsequently diagnosed with asthma, researchers said.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Commercially insured patients pay substantially different rates for the same procedure, with negotiated costs for inpatient procedures varying by an average ratio of 9.1, according to an August report from market intelligence firm Trilliant Health.
    • “The report reviewed health plan transparency data from Aetna and UnitedHealthcare, focusing on 11 inpatient and outpatient procedures.
    • “A coronary bypass without cardiac catheterization, excluding major complications or comorbidities, had negotiated rates ranging from $27,683 to $247,902. Another finding: Outpatient procedures at ambulatory surgery centers would often cost less than those taking place in a hospital’s outpatient department. Colonoscopies, for example, would cost 67.5% less on average than the median hospital rate.
    • “By reviewing a sample of 10 hospitals featured on a collection of “best hospitals” rankings, the researchers also found no correlation between cost and quality.”
  • and
    • “Regional, nonprofit health plans are falling behind large national insurers, with 71% recording an operating loss in 2024 and more than half having two years or less before regulatory intervention is triggered, according to a Sept. 24 report from HealthScape Advisors.
    • “Executives and boards of directors now face the most important decision of their leadership tenures: How do we survive?” the report said.” 
  • Kauffman Hall explains,
    • “The rise of ambulatory surgery centers (ASCs) marks a shift in how surgical care is delivered across the U.S. Amid soaring healthcare costs, tighter reimbursement and advancing surgical technology, health systems are rethinking where and how procedures are done. Many are moving complex surgeries like total joint replacement and spine out of hospitals and into ambulatory settings. Once limited in scope, ASCs are becoming key players in strategically important service lines like orthopedics.” * * *
    • “ASCs are not a magic wand for health systems. While they offer savings to payers, the economics are fragile for providers. Healthy margins require lean operations, smart sourcing and trusted partnerships.
    • “There’s a growing demand for more complex procedures in outpatient settings, but ASCs need to strategically position themselves to meet this demand in an operationally and financially sustainable way.
    • “With advances in surgical technology and care coordination, ASCs are ready to deliver on the promise of value-based care. The challenge for health systems isn’t just to shift where care is delivered, but to rethink how surgical care is structured, managed and financed for long-term performance.”
  • Optum, writing in LinkedIn, discusses how “breakthrough cancer drugs offer better outcomes – but soaring costs pose challenges.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it will offer its asthma and diabetes drugs at an up to 70% discount in the U.S. ahead of a Trump administration deadline for pharmaceutical companies to cut drug prices.
    • “The company said it would launch a direct-to-consumer platform on which eligible patients with prescriptions will be able to purchase its Airsupra and Farxiga drugs in cash at a discount. The platform will be available beginning Oct. 1.
    • “In July, President Trump sent pharmaceutical companies a letter setting a Sept. 29 deadline to propose cuts to their drug prices.
    • “In response, several drugmakers have rolled out direct-to-consumer platforms to offer discounted drugs. Earlier this week, Bristol Myers Squibb said it would offer its plaque psoriasis drug at an up to 80% discount, expanding on its discounted program for blood clot drug Eliquis, which it announced in July.”
  • Fierce Pharma adds,
    • “In an expansion of its previous moves to cut insulin prices, Sanofi will cap the price of each of its insulin products at $35 per month in the U.S. regardless of a patient’s insurance status.
    • “The move, which goes into effect at the start of next year, comes two years after the company slashed the price of its most popular insulin, Lantus, to $35 monthly for those with commercial insurance.
    • “Before that, in June of 2022, Sanofi reduced the price of an unbranded Lantus biologic from $99 per month to $35 for those in the U.S. without insurance.
    • “Sanofi’s cost-cutting efforts have mirrored those of the world’s other two primary sellers of insulin—Novo Nordisk and Eli Lilly—and come as advanced insulin products and insulin biosimilars are reaching the market.”


Thursday report

David Ermer–CMS, Congress, FDA, Generative AI, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The U.S. government is hurtling toward a shutdown in a matter of days with no exit ramp in sight, as Republicans and Democrats latch onto starkly different positions and the White House threatens to lay off more federal workers.
    • “Republicans are seeking a seven-week extension in federal funding at current levels, and they have dismissed Democrats’ demands for hundreds of billions of dollars in healthcare spending. In a move to raise the political pressure, President Trump’s budget chief late Wednesday vowed to use any lapse in funding to make deeper cuts in the federal workforce, a threat Democrats rejected as blackmail.
    • “Democrats see the funding deadline as a rare opportunity to shape legislation, and the party’s base voters are desperate for elected representatives to show more fight after months of demoralizing political defeats. Republicans are loath to offer any concessions, putting both parties on a collision course ahead of the Oct. 1 deadline.
    • “Democrats have “asked us to do something that’s totally unreasonable,” President Trump told reporters on Thursday. Asked about the possibility of a shutdown, he said: “Could be. Because the Democrats are crazed. They don’t know what they are doing.”
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) has said he plans to stand firm this time and demand bipartisan talks, rather than acquiesce to a Republican plan to keep the government open, like he did in March. He said Democrats won’t be intimidated by the latest threat of federal layoffs.
    • “This is one of their threats, and their threats are not going to succeed,” Schumer said in an interview. “A lot of my colleagues who I’ve talked to today are very angry about this.”
  • Per Roll Call,
    • “Sources on both sides of the aisle and nonpartisan analysts agreed that, beyond the tough talk, top congressional Democrats have a weak hand to play and no discernible strategy for extracting the concessions from President Donald Trump and GOP leaders that they want on health care policy.
    • “A shutdown for the sake of a shutdown doesn’t help anyone,” a former Democratic congressional aide granted anonymity to speak candidly said. “If there is a shutdown, there also needs to be a plan to get out of it — and it will require a deal on all sides to end it, at a time when tensions would be even higher. It’s hard to turn back to bipartisan negotiations after that.”
  • Federal News Network adds,
    • “The Trump administration is taking a more aggressive approach than usual to what would happen in a government shutdown, after a White House memo Wednesday night told agencies to plan for further reductions in force if government funding lapses early next week.
    • “But with just days left before a government shutdown, many are questioning the ability for agencies to put together further RIF plans at all, since the reduction-in-force process is typically complicated and time-consuming, often taking months or longer.”
  • Bloomberg reports,
    • “The US will impose a 100% tariff on branded or patented pharmaceuticals, President Donald Trump announced Thursday.
    • “Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America,” Trump said in a social media post.
    • “Trump said there would be no tariffs on pharmaceutical products if companies have broken ground on a US manufacturing plant, or if such a plant is under construction.”
  • and
    • “Pharmacy middlemen are working on a proposal to voluntarily change some of their business practices to avoid new regulation from the Trump administration.
    • “The proposals under discussion include ensuring patients don’t pay more than a pharmacy would charge to someone without insurance and increasing the use of lower-cost versions of expensive biologic drugs.
    • “The Pharmaceutical Care Management Association has drafted proposals to bring to the Centers for Medicare and Medicaid Services, according to a document viewed by Bloomberg News.”
  • The American Medical Association adds,
    • “The Department of Commerce Sept. 24 released a notice seeking public comment on an investigation it launched Sept. 2 on imports of personal protective equipment, medical consumables and medical equipment under Section 232 of the Trade Expansion Act of 1962. The provision authorizes the president to impose tariffs or other trade restrictions if an investigation determines that the importation of particular goods affects national security. The department is seeking comment on a range of criteria, including the current and projected demand for PPE, medical consumables and medical equipment; the extent to which production can meet demand; the role of foreign supply chains in meeting U.S. demand; the concentration of U.S. imports of those products and more. Comments are being accepted for 21 days following publication in the Sept. 26 Federal Register.”
  • Bloomberg tops it off with this,
    • “Three hours inland from Chennai, India, traffic crawls on a half-finished road past rice fields and cow crossings until it reaches a newer complex of neat white buildings. Among them is the cancer wing of a hospital founded over a century ago by American missionaries.
    • “By morning, the line of people waiting to be seen at Christian Medical College Vellore’s Ranipet Campus snakes from the parking lot to the front door. In a basement treatment room one day in May, several of those who’ve made it inside sit in beds getting an intravenous drip of a Bristol Myers Squibb Co. drug called Opdivo or a competing Merck & Co. drug, Keytruda. A single infusion might cost at least $7,000 at the standard dose in the US, and a year’s treatment more than $200,000. Here, by financial necessity, most of the patients are getting as little as one-sixth of that.  
    • “The remarkable thing is that the radically low doses may also be effective at keeping cancer sufferers alive, doctors here and in other hospitals across India say. The science isn’t settled, but hospitals in Israel, France, the Netherlands, Canada and the UK are all testing or implementing more modest dose reductions. A small trial in the US also found some benefits. The consequences could be dramatic, expanding access to cancer treatment in poor countries and bending the curve of skyrocketing drug prices in the developed world. Smaller doses could also help limit the serious side effects many patients endure, from diarrhea to thyroid problems.
    • “A broad reevaluation of dosing has the potential to benefit hundreds of thousands of people in developing countries who otherwise wouldn’t be able to afford the drugs. One obstacle has stood in the way: the drugmakers themselves. Paid per dose, they stand to lose billions of dollars if doctors prescribe less medicine to their patients.”
  • From ARPA-H news releases
    • The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new research and development opportunity through its Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) program. THRIVE intends to develop integrated platform technologies to accelerate precision genetic medicines (PGMs) and provide single-intervention precision treatments to slow, reverse, or prevent diseases at the genetic level. The program is designed to optimize affordability, scalability, and sustainability of lifesaving PGMs for patients through existing regional treatment centers and virtual clinics. This will allow patients to be seen and treated where they live.” * * *
    • “Learn more about THRIVE on its program page, including information about the solicitation and Proposers’ Day.” 
  • and
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. With cutting-edge production technologies, the program seeks to establish the U.S. as a frontrunner in advanced manufacturing methods for high-quality genetic medicines.” * * *
    • “Learn more about GIVE on its program page, including information about the ISO solicitation and Proposers’ Day registration.”
  • Per a U.S. Office of Personnel Management news release,
    • The U.S. Office of Personnel Management (OPM) today announced record levels of engagement and leadership from the Chief Human Capital Officers Council (CHCOC) under the Trump Administration, underscoring the Council’s critical role in driving forward personnel policy and workforce reform across the federal government. The Chief Human Capital Officers Council is the principal interagency forum for federal human capital leaders, bringing together the Chief Human Capital Officers from across the Executive Branch to coordinate policy, share best practices, and advance government-wide workforce initiatives.
    • Since January of this year, the Council has held 71 sessions, an increase of almost double compared to the 40 sessions held last year. These sessions cover everything from discussing the Deferred Resignation Program and return-to-office policies to SES performance and collective bargaining. Between January and March alone, the Council convened 34 times in just 50 workdays. Alongside these sessions, the Council has distributed more than 200 communications to federal agencies this fiscal year, including official memos, weekly updates, and special notices.
  • OPM also recently posted Benefits Administration Letter 25-102 about FEHB Enrollment Coordination for Married Federal Employees and Annuitants.
  • Avalere Health discusses an upcoming meeting at which new ICD-10 codes for 2026 will be selected.

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “Capricor Therapeutics executives came out of a meeting with Food and Drug Administration officials confident that they can reverse a rejection of their experimental cell therapy for Duchenne muscular dystrophy. 
    • “The FDA turned down Capricor’s application for the drug, deramiocel, in July after questioning the research supporting its effectiveness. At the time, Capricor CEO Linda Marbán said the rejection was a surprise and that no major issues had been raised during the review.
    • “Now, FDA officials are indicating that they will reconsider the application with new data from a clinical trial called Hope-3 that’s already been completed, Capricor said Thursday. That’s important because Capricor won’t have to start all over with a new submission. “This is a giant win for us,” Marbán said during a conference call with analysts. Initial trial results are expected in the middle of the fourth quarter.”
  • and
    • “The Food and Drug Administration on Thursday approved a new medicine for breast cancer, clearing Eli Lilly’s Inluriyo for people with a specific genetic mutation.
    • “Previously known as imlunestrant, the drug has been cleared for use in a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one hormone therapy. The approval makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1 — an alteration Lilly believes to occur in about half of people with that form of the disease either during, or after, exposure to hormone therapy.
    • “The clearance was based on results published in the New England Journal of Medicine last year. Those findings, from a study called EMBER-3, showed that Inluriyo helped reduced the risk of disease progression or death among those with ESR1 mutations by 38% when compared to standard hormone-suppressing therapies. Inluriyo delayed tumor progression by a median of 5.5 months, or close to 2 months longer than those on typical drugs.”  
  • and
    • “Heartflow has received 510(k) clearance for an updated version of its plaque analysis algorithm, the company said Monday.
    • “The updated algorithm shows a 21% improvement in plaque detection, compared to the original version of the technology, the company said. 
    • “Heartflow disclosed the clearance alongside news that Cigna has become the second national insurer after UnitedHealthcare to update its policies to cover the plaque analysis product.”
  • MedPage Today points out,
    • “A risk evaluation and mitigation strategies (REMS) program is no longer required for the thyroid cancer therapy vandetanib (Caprelsa), the FDA announced on Thursday.
    • “The agency had required the safety program for vandetanib to ensure appropriate heart rhythm monitoring and safe use since its approval in 2011opens in a new tab or window as treatment for medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed.
    • The approval of vandetanib was based on results from the phase III randomized ZETA trial in which patients randomized to receive vandetanib experienced a 65% reduction in the risk of disease progression compared to patients on placebo. A REMS was required for vandetanib due to potential for QT prolongation and reported cases of torsades de pointes and sudden death in patients taking the drug.
  • Fierce Pharma informs us,
    • “After nearly two decades in the endocrine scene, Crinetics is making its commercial debut with the approval of a game-changing treatment for the rare growth disorder acromegaly.
    • “The FDA on Thursday signed off on Crinetics’ paltusotine—now christened Palsonify—as a first-line treatment for adults with acromegaly for whom surgery didn’t work or isn’t an option.
    • “The drug is a selectively targeted somatostatin receptor type 2 (SST2) agonist. Unlike other somatostatin drugs that make up the bulk of current acromegaly care options, Palsonify is a small molecule, non-peptide therapy that can be taken orally, freeing up patients from frequent and often painful injections.
    • “The treatment marks the “next level of care for patients with acromegaly,” Scott Struthers, Ph.D., co-founder and CEO of Crinetics, said in a recent interview with Fierce Pharma, staking that claim on the drug’s ability to both help control patients’ hormone levels and address their symptoms in a once-daily treatment option.”
  • Per FDA news release,
    • “Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court has tossed a rule outlining how auditors must review Medicare Advantage insurance companies for overpayments, adding uncertainty to the federal government’s plan to audit every plan annually.
    • “On Thursday, Judge Reed O’Connor, of the U.S. District Court for the Northern District of Texas in Fort Worth, vacated the 2023 Medicare Risk Adjustment Data Validation, or RADV, rule, on the grounds that regulators violated the Administrative Procedure Act of 1946.”
    • “Under the rule, which was finalized in January 2023, the Centers for Medicare and Medicaid Services eliminated a key statistical tool, the fee-for-service adjuster, used to compare error rates in traditional Medicare versus Medicare Advantage. Regulators planned to apply the new audit method retroactively to insurers’ risk-adjustment code reviews dating back to 2018. When the rule was finalized, CMS estimated that the more stringent reviews would result in insurers returning $4.7 billion to the agency between 2023 and 2032. 
    • “Humana sued over the rule in September 2023, alleging the new audit methodology held private Medicare insurers to a higher standard than the fee-for-service program. 
    • “O’Connor sided with the insurer.  In a Thursday order, he ruled that CMS failed to adequately notify the industry that actuarial equivalence between traditional and Medicare Advantage plans no longer applied.
    • “Because there was no meaningful notice of defendants’ ultimate finding that actuarial equivalence does not apply to RADV audits, there was no meaningful dialogue regarding the costs and benefits of the surprise changes,” O’Connor wrote in the order.” 

From the public health and medical / Rx research front,

  • MedPage Today lets us know,
    • “Women who missed their first screening mammogram had a 53% higher risk of stage III breast cancer over the next 25 years and almost a fourfold higher risk of stage IV breast cancer.
    • “Breast cancer mortality was 40% higher among screening nonparticipants.
    • “Breast cancer incidence was nearly identical, suggesting the increased risk of later-stage diagnosis and breast cancer mortality resulted from delayed detection.”
  • Per Health Day,
    • “During August 2021 to August 2023, only 36.4 percent of U.S. adults had no cardiovascular disease (CVD) risk factors, according to a September data brief published by the National Center for Health Statistics.
    • “Catharine A. Couch, Ph.D., R.D., from the National Center for Health Statistics in Baltimore, and colleagues presented prevalence estimates for none, one, or two or more CVD risk factors (uncontrolled high blood pressure, uncontrolled high blood lipids, uncontrolled high mean blood glucose, and high body mass index) in U.S. adults from August 2021 to August 2023.
    • “The researchers found that 36.4, 34.9, and 28.7 percent of U.S. adults had no, one, and two or more CVD risk factors, respectively. More men than women had two or more CVD risk factors (31.7 versus 25.8 percent). With age, there was a decrease in the percentage of adults with no CVD risk factors, while a higher percentage of older adults had one or two or more CVD risk factors. Those with family income 350 percent or more of the federal poverty level had the highest percentage of adults with no CVD risk factors and the lowest percentage with two or more CVD risk factors. The percentage of adults with two or more CVD risk factors increased from 2013 to 2014 to August 2021 to August 2023.”
  • and
    • “Physical frailty may contribute to the development of dementia, according to a study published online Sept. 17 in Neurology.
    • “Xiangying Suo, from the School of Public Health of Zhengzhou University in China, and colleagues conducted a prospective cohort study based on U.K. Biobank participants without dementia to examine the link between physical frailty and dementia. Five criteria were used to define physical frailty (weight loss, exhaustion, physical inactivity, slow walking speed, and low grip strength).
    • “A total of 8,900 dementia cases were documented during a median follow-up of 13.58 years among 489,573 participants. The researchers found that the risk for dementia was significantly higher in those with prefrailty and frailty compared with nonfrail individuals (hazard ratios, 1.50 and 2.82, respectively). Compared with those with low genetic risk and nonfrailty, the highest risk for dementia was seen for participants with frailty and high genetic risk (hazard ratio, 3.87 for high polygenic risk score; 8.45 for APOE-ε carriers). A potential causal relationship was seen between physical frailty and dementia in the forward Mendelian randomization (MR) analysis (odds ratio, 1.79), while a null causal association was suggested in the reverse MR. Potential underlying mechanisms linking physical frailty to dementia include genetic background and neurologic and immunometabolic function.”
  • BioPharma Dive considers “Cancer patients are living longer than ever. Pain drugmakers haven’t kept up. Decades of slow-moving research, along with broader failures of the healthcare system, have left millions of people in daily pain. Doctors fear that’s bound to continue.”
  • BioPharma Dive also notes,
    • “Eli Lilly has canceled one clinical trial of an experimental muscle-sparing obesity drug, citing “strategic business reasons,” according to a federal database. The study was one of two Phase 2 trials testing the drug, known as bimagrumab, alone or with Lilly’s marketed medicine in people with obesity. The now-halted study included Type 2 diabetics as well.
    • “In an email to BioPharma Dive, a Lilly spokesperson said company executives “routinely evaluate our clinical development programs to optimize the potential for each product” and noted that a separate trial involving non-diabetic people with obesity is still underway. The trial stoppage was first reported by Bloomberg.
    • “Bimagrumab is among the drugs designed to preserve muscle in people taking weight loss drugs like Zepbound and Novo Nordisk’s Wegovy, which can cut lean mass as well as fat. But at least one biotech has said that additive weight loss effects are an approval requirement, suggesting higher clearance standards have been established by the Food and Drug Administration.”
  • The Washington Post explains why the brain hangs on to some memories but allows others to fade. Tying “fragile” memories to emotional events could help people remember them better in the future, researchers at Boston University believe.”
  • Per a National Institutes of Health news release,
    • “Today, the National Institutes of Health (NIH) announced the award of contracts for launching the Standardized Organoid Modeling (SOM) Center, a national resource that will be dedicated to using cutting-edge technologies to develop standardized organoid-based new approach methodologies (NAMs) that deliver robust, reproducible, and patient-centered research findings. With contracts totaling $87 million for the first three years, the center will be housed at the Frederick National Laboratory for Cancer Research (FNLCR), a facility supported by NIH’s National Cancer Institute (NCI). The center’s goal will be to leverage the latest technologies to enable real-time optimization of organoid protocols.
    • “This groundbreaking initiative will transform how we conduct biomedical research through innovative approaches to advancing human-based technologies,” said NIH Director Dr. Jay Bhattacharya. “By creating standardized, reproduceable, and accessible organoid models, we will accelerate drug discovery and translational science, offering more precise tools for disease modeling, public health protection, and reducing reliance on animal models.”

From the AI front,

  • STAT New reports,
    • “Artificial intelligence may help radiologists spot disease, but throwing the technology at millions of CT scans or mammograms is not without risks to patients and may drive up costs without showing much benefit. Katie Palmer reports on two efforts to prove out the potential.
    • “A large randomized controlled trial will explore the value of AI-aided mammography in screening for breast cancer. The technology is already widely used in the U.S., but the best evidence that it’s useful comes from Europe. The $16 million trial is funded by the Patient-Centered Outcomes Research Institute. Read more on what researchers may find here.
    • “Next month, NYU Langone Health will begin checking bone density in CT scans of people over 65 for osteoporosis, a condition that often goes undetected until someone breaks a bone. The health system may expand the work if it’s proven to help. This kind of opportunistic screening, which repurposes otherwise acquired scans, could be used to identify many treatable conditions. Katie’s interview is worth a read.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health closed another fiscal year with operations in the red, with the large Catholic nonprofit pointing to expenses growth outpacing revenues “despite strong volume, salary cost management and higher productivity.”
    • “The 138-hospital system reported an as-recorded operating loss of $687 million (-1.8% operating margin) for the fiscal year ended June 30, 2025, as compared to the prior year’s $581 million operating loss (-1.5% operating margin).
    • “However, after adjustments to normalize delayed income from the California Provider Fee Program, CommonSpirit somewhat improved its stature with a $225 million operating loss (-0.6% adjusted operating margin) as opposed to fiscal 2024’s $875 million operating loss (-2.4% adjusted operating margin).
    • “Net income in fiscal 2025 was $1.1 billion as recorded and nearly $1.6 billion as adjusted, both increases over the prior year’s respective $797 million and $503 million.”
  • and
    • “Value-based cancer care navigation company Thyme Care raised $97 million in series D funding backed by major strategic investors across payers, employers, health systems and retail health.
    • “The latest funding propels Thyme Care’s valuation to north of $1 billion, a 2x increase from its valuation in July 2024 when it raised $95 million, according to a company spokesperson.
    • “The company plans to use the new funding to expand its business across verticals and to take on more breaking points in the oncology journey that drive up costs and cause friction in the patient experience, Robin Shah, CEO and co-founder of Thyme Care, told Fierce Healthcare.
    • “Thyme Care is now focused on tackling treatment denials, high drug costs and “the barriers that delay or prevent access to timely, affordable and appropriate care,” Shah said.’
  • and
    • “Medicare Advantage (MA) has been a consistent earnings booster for insurers, but recent challenges in this space are likely to ding profitability, according to a new report.
    • “Analysts at AM Best found that elevated utilization trends beginning in 2023 led to a $5.7 billion underwriting loss in 2024 for MA plans, while insurers reported gains in the previous five years. Underwriting gains in MA accounted for 40% of total gains from 2019 to 2022, but that dropped to 20% in 2023.
    • “The report found that close to three-quarters of companies with a significant concentration in MA reported underwriting losses in 2024.
    • “Medicare Advantage enrollment and premium continue to grow as more people are aging into the program. However, plans have experienced an increase in utilization and medical trends that have persisted longer than expected,” said Jason Hopper, associate director for industry research and analysis at AM Best, in a press release.“
    • “Changes to the risk-adjustment payment model by the Centers for Medicare and Medicaid Services, as well as lower Star Ratings across the industry, also have contributed to recent underwriting losses,” Hopper said.
  • MedTech Dive informs us,
    • “Guardant Health and Quest Diagnostics will collaborate to offer Guardant’s Shield blood-based colorectal cancer test through Quest’s distribution network, the companies said Wednesday.
    • “Physicians will be able to order the test through their Quest accounts and electronic health record starting in the first quarter of 2026.
    • “In an investor day presentation, Guardant Co-CEO AmirAli Talasaz also revealed plans to expand Shield to include multi-cancer detection. The multi-cancer offering will be available nationally in October.”
  • Modern Healthcare reports,
    • “As more upstarts strive to make a splash in the pharmacy benefit manager sector, RxBenefits CEO Robert Gamble thinks his company has devised something truly novel.
    • “Like other companies seeking to disrupt a market dominated by CVS Health subsidiary CVS Caremark, UnitedHealth Group division Optum Rx and Cigna unit Express Scripts, Illuminate Rx promises pharmacy benefits without spread pricing or hidden fees, and with transparency and a focus on generic and biosimilar drugs. The company launched Illuminate Rx this month.
    • “What Gamble said differentiates this offering is that RxBenefits has added an in-house PBM to its marketplace platform, where self-funded employers, brokers and benefits consultants can select among Illuminate Rx and other PBMs for the best deals.”
    • “RxBenefits, which serves 3 million insurance members and manages $3 billion in annual pharmacy spending, named veteran executive Gamble as CEO last December following Wendy Barnes’ departure to become president and chief executive of the pharmaceutical discount vendor GoodRx.”

Midweek update

David Ermer–CDC, CMS, FDA, Medical / Rx research, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “Despite being less than a week away from the government’s funding deadline, and with lawmakers still far from reaching a spending agreement, agencies have not published their plans for what would happen during a government shutdown.
    • “Often, leading up to a possible government shutdown, agencies will publish or update their shutdown contingency plans, which are made publicly available on the Office of Management and Budget’s website. Those plans typically detail how many federal employees at each agency would continue to work — and how many would be furloughed — if a shutdown were to happen.
    • “But even with the fast-approaching deadline for Congress to reach a spending agreement for fiscal 2026 appropriations, OMB’s webpage that usually hosts that contingency information is completely blank.
    • “OMB did not respond to multiple requests for comment from Federal News Network, asking if the Trump administration intends to publish agencies’ contingency plans, or if there were any alternative government shutdown planning efforts currently in the works.”
  • Politico adds
    • “The White House budget office is instructing federal agencies to prepare reduction-in-force plans for mass firings during a possible government shutdown, specifically targeting employees who work for programs that are not legally required to continue.
    • “The Office of Management and Budget move to permanently reduce the government workforce if there is a shutdown, outlined in a memo shared with POLITICO ahead of release to agencies tonight, escalates the stakes of a potential shutdown next week.
    • “In the memo, OMB told agencies to identify programs, projects and activities where discretionary funding will lapse on Oct. 1 and no alternative funding source is available. For those areas, OMB directed agencies to begin drafting RIF plans that would go beyond standard furloughs, permanently eliminating jobs in programs not consistent with President Donald Trump’s priorities in the event of a shutdown.
    • ‘The move marks a significant break from how shutdowns have been handled in recent decades, when most furloughs were temporary and employees were brought back once Congress voted to reopen government and funding was restored. This time, OMB Director Russ Vought is using the threat of permanent job cuts as leverage, upping the ante in the standoff with Democrats in Congress over government spending.”
  • Axios reports,
    • “Big drug companies so far are responding to President Trump’s demand they commit to his “most favored nation” pricing policy by raising prices abroad without cutting them in the U.S.
    • “That only gets halfway toward Trump’s goal of ending what he calls “global freeloading” and getting other developed countries to foot more of the cost while lowering costs for Americans.” * * *
    • “The pharmaceutical industry says it agrees with the goal of making other countries pay more and putting an end to “foreign freeloading.” But drastically cutting U.S. prices to match those abroad would hurt innovation, officials argue. 
      • “Industry is more receptive to other Trump ideas like offering sales directly to patients who pay on their own without insurance. 
      • “We must reject foreign price control models that ration care and suppress innovation,” PhRMA CEO Steve Ubl wrote in an op-ed in Stat in June. 
      • “If we instead required hospitals and [pharmacy benefit managers] to pass along the steep discounts they already receive — and ensured wealthy nations paid their fair share — U.S. prices could fall without jeopardizing our life sciences edge.”
  • Per an HHS press release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced it has awarded more than $45 million in new supplemental funding to State Opioid Response (SOR) program recipients to focus on sober or recovery housing among young adults. This investment advances President Trump’s Executive Order, Ending Crime and Disorder on America’s Streets, by providing sober housing and recovery support services, which are critical to combatting our Nation’s challenge of homelessness, addiction, and illness.
    • “President Trump has elevated this issue as a key public health and public safety priority,” said HHS Secretary Robert F. Kennedy, Jr. “All too often, young adults with opioid or stimulant use disorders lack safe housing to support their recovery. This funding can make a life-changing difference for young people working toward long-term recovery.”
    • “Firsthand experience has shown me that wraparound services, especially sober housing, play a vital role in breaking the cycle of addiction,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “This supplemental funding will help expand that lifesaving care and help people pursue a fulfilling life in recovery.”
    • “Sober housing for those in early recovery is a safe and supportive alcohol- and drug-free residence where people can live, build stability and work toward independence. This therapeutic model allows people to actualize their hopes and dreams to live a fulfilling and self-directed life.”

From the Food and Drug Administration front,

  • Per MedTech Dive,
    • “Olympus told customers last week to stop using certain lots of its ViziShot 2 FLEX (19G) needles due to the risk that components may detach during procedures. 
    • “Olympus started the recall after receiving reports of patient injuries and one death. Olympus did not immediately respond to a request for comment or specify how many injury reports it had received.
    • “The medtech company has faced quality concerns in recent years, with the Food and Drug Administration sending multiple warning letters to Olympus in 2023 related to its endoscopes, and blocking some of the devices from entering the U.S. in June.”
  • and
    • “Johnson & Johnson has recalled certain automated controllers for its Impella heart pumps over a fault linked to five serious injuries, the Food and Drug Administration said Tuesday.
    • “The company’s Abiomed unit told customers to return the affected devices when contacted by its field servicing team because of potentially fatal purge pressure issues. Abiomed will make a design change during device servicing to correct the problem. Hospital inventory can continue to be used, according to the FDA’s alert.
    • “J&J’s recall, which triggered an FDA early alert, follows other recent safety actions to address two problems with Impella that were collectively linked to four deaths.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit confronted the limits of agency rulemaking in arguments over a Biden administration rule for a surprise medical billing law.
    • “The en banc appellate court in New Orleans heard an appeal Wednesday on whether federal agencies exceeded their authorities in a rule on the calculation of a key figure under the No Surprises Act. That law is meant to protect patients from excessive medical bills.
    • “The billing law mandates that medical providers and health insurers settle out-of-network disputes through arbitration. The measure is aimed at protecting patients from medical bills stemming from out-of-network emergency care and from out-of-network clinicians’ care received at in-network facilities.
    • “Justice Department attorney Kevin Soter told the appellate court’s 17 active judges that the statute left it up to federal agencies—the Department of Labor, the Department of Health and Human Services, and the Office of Personnel Management—to come up with details on the arbitration process for surprise medical bill disputes.
    • “Judges Leslie Southwick and Catharina Haynes asked about impact of the US Supreme Court’s 2024 ruling in Loper Bright Enterprises v. Raimondo, which eliminated deference to agencies in interpreting vague laws. Soter said that through the statute, “Congress did clearly put this in the hands of the departments.” * * *
    • “The case is Texas Medical Association v. HHS, 5th Cir. en banc, No. 23-40605, oral argument 9/24/25.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “In its weekly measles update, the Centers for Disease Control and Prevention (CDC) said there are now 1,514 confirmed measles cases in the United States reported this year, with 23 new cases reported in the past week. 
    • “Eighty-six percent of the cases have been part of 40 outbreaks reported to the CDC. Of note, 92% of case-patients are unvaccinated or have unknown vaccination status, 4% have only one measles, mumps, and rubella dose, and 4% were fully vaccinated. 
    • “Twelve percent of cases have required hospitalization, with 29% of those hospitalized aged 19 years or younger. There have been 3 confirmed measles deaths this year.” 
  • The Centers for Disease Control and Prevention announced,
    • “A new report from the Centers for Disease Control and Prevention (CDC), published in the Annals of Internal Medicine, highlights a dramatic increase in a dangerous type of drug-resistant bacteria called NDM-producing carbapenem-resistant Enterobacterales (NDM-CRE). 
    • “In a 2022 special report, COVID-19: U.S. Impact on Antimicrobial Resistance, CDC noted that in 2020 there were approximately 12,700 infections and 1,100 deaths in the U.S. due to CRE. The rise in NDM-CRE, documented in the new study, threatens to increase CRE infections and deaths.
    • “Between 2019 and 2023, NDM-CRE infections surged by more than 460% in the United States. These infections —including pneumonia, bloodstream infections, urinary tract infections, and wound infections—are extremely hard to treat and can be deadly. Detection is also challenging, as many clinical laboratories lack the necessary testing capacity.
    • “This sharp rise in NDM-CRE means we face a growing threat that limits our ability to treat some of the most serious bacterial infections,” said Danielle Rankin, an epidemiologist in CDC’s Division of Healthcare Quality Promotion. “Selecting the right treatment has never been more complicated, so it is vitally important that healthcare providers have access to testing to help them select the proper targeted therapies.”
  • Per MedPage Today,
    • “Sexually transmitted disease (STD) rates for U.S. adults fell last year, but syphilis in newborns continued to rise, according to new government data posted Wednesday.
    • “The CDC provisional data for 2024 showed a third consecutive year of fewer gonorrhea cases, and the second year in a row of fewer adult cases of chlamydia and the most infectious forms of syphilis.
    • “But congenital syphilis cases, in which infected moms pass the disease to their babies, aren’t seeing the same improvements. Such infections in infants can lead to deaths or lifelong health problems such as deafness, blindness, and malformed bones.”
  • and
    • “Drinking any amount of alcohol increased dementia risk, data from a combined observational and genetic study suggested.
    • “Light alcohol consumption was associated with low dementia risk in observational analyses, and genetic analyses showed a monotonic increasing dementia risk with higher alcohol intake, reported Anya Topiwala, DPhil, of the University of Oxford in England, and co-authors.
    • “Mendelian randomization suggested a causal role of alcohol consumption in increasing dementia risk with no evidence supporting a protective effect at any consumption level, Topiwala and colleagues wrote in BMJ Evidence-Based Medicine.”
  • BioPharma Dive informs us,
    • “UniQure said Wednesday it will ask the Food and Drug Administration next year to approve its gene therapy for the neurodegenerative disorder Huntington’s disease following positive data from a Phase 2 study that showed it slowed signs of disease progression by 75% after three years.
    • “Though from only 12 patients who’d received the highest tested dose of the therapy, AMT-130, and had been evaluated for at least 36 months, the effects were “greater than what we even anticipated and expected and hoped for,” said Sarah Tabrizi, director of the University College London Huntington’s Disease Center, on a conference call.”
  • and
    • “Acadia Pharmaceuticals is giving up on a drug to treat the insatiable hunger associated with Prader-Willi syndrome after a Phase 3 trial failed to prove the experimental medicine was more effective than a placebo.
    • “The 12-week study tested the effects of ACP-101 in 175 patients with the rare genetic syndrome. The main goal was improvement on a questionnaire measuring the hunger, known as hyperphagia. But the drug didn’t show advantages over a placebo on that primary endpoint or any secondary endpoint, Acadia said Wednesday.”
  • MedPage Today notes,
    • “Supplementing digital breast tomosynthesis (DBT) with molecular breast imaging (MBI) increased the detection of cancers in women with dense breasts, a prospective study suggested.
    • “In an analysis involving nearly 3,000 women with dense breasts, adding MBI to DBT led to incremental cancer detection rates of 6.7 and 3.5 cancers per 1,000 screenings in year 1 and year 2, respectively (both P<0.001), reported Carrie B. Hruska, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.
    • “Supplemental MBI also increased invasive cancer detection by more than 2.5 times that of DBT alone at both screening rounds, they noted in Radiology.
    • “Across both screenings, there were 30 cancers detected in 29 women with MBI only. Most of these incremental cancers (71%) were invasive. Additionally, 90% of the cancers detected only with MBI were node negative, “indicating that MBI screening provides early detection,” Hruska and colleagues wrote.”
  • Per Health Day,
    • “Providing immediate bedside hepatitis C virus (HCV) consultation at discharge from labor and delivery for women with HCV-affected pregnancies is associated with higher rates of treatment completion than referral for outpatient follow-up, according to a study published in the October issue of O&G Open.
    • “Leah Madeline McCrary, M.D., from Washington University in St. Louis (WashU), and colleagues evaluated the associations of a traditional postpartum outpatient referral (92 women) compared to an opportunistic inpatient consultation (33 women) for HCV treatment initiation on HCV treatment completion. 
    • “The researchers found that all individuals in the inpatient referral group had an inpatient consultation; however, a majority (55.4 percent) of those in the outpatient referral group did not present for consultations. Inpatient referral was associated with higher rates of HCV treatment completion (20 of 30) among women who were prescribed direct-acting antivirals compared with standard care (14 of 41). Inpatient treatment was associated with higher odds of treatment completion (adjusted odds ratio, 4.7).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Premier is going private through an acquisition by healthcare-focused investment firm Patient Square Capital, the companies announced Monday.
    • “The deal values Premier at roughly $2.6 billion and is set to take the company, which provides supply chain, technology and consulting services to thousands of U.S. providers, off the public markets after more than a decade.
    • “Premier and Patient Square expect the deal to close by the first quarter of 2026 subject to regulatory approval and other closing conditions.”
  • and
    • “Privia Health is acquiring a value-based primary care business from Evolent Health as the physician enablement company continues to expand its care delivery network into new geographies.
    • “Evolent has agreed to sell its accountable care organization business, called Evolent Care Partners, for $100 million in cash, the companies announced aftermarket Tuesday. Another $13 million is contingent on the ACO’s performance in traditional Medicare’s largest value-based care program in 2025.
    • “The transaction is expected to close in the fourth quarter and positively contribute to Privia’s adjusted earnings next year. Analysts said the deal is favorable for both parties.”
  • Fierce Healthcare relates,
    • “UnitedHealthcare is rolling out a new offering that aims to make it easier for employer plan members to shop for health and wellness solutions that meet their needs.
    • “The UHC Store is embedded in the insurer’s member portal and app and is now available to 6 million people enrolled in its employer-sponsored health plans. The payer giant plans to expand to 18 million members this year.
    • “Members who access the store are eligible for discounts of up to 15% of health and wellness programs of their choice, according to its announcement. The team initially focused on programs that fit within some of the most in-demand and high-cost areas, such as women’s health, musculoskeletal conditions and diabetes, according to Amy Jordan, vice president of consumer experience for UnitedHealthcare’s commercial business.”
  • and
    • “Harbor Health continues to expand its clinical footprint in Texas with the acquisition of 32 clinics from VillageMD.
    • ‘The deal expands the company’s reach into three new markets: San Antonio, El Paso and Dallas. Harbor Health also grew its established clinical footprint in its home base of Austin. Financial terms of the deal were not disclosed.
    • “The acquisition nearly quadrupled Harbor Health’s clinical presence, growing from 11 to 43 total clinics and adding more than 80 clinicians to its team of physicians and advanced practice providers. The acquisition also advances the company’s philosophy that having a denser network of clinics improves quality of care through enhanced accessibility.” 
  • Fierce Pharma informs us,
    • “Excitement around Fujifilm Biotechnologies’ massive new cell culture facility in Holly Springs, North Carolina, has been growing steadily since 2021, prompting a beefed-up investment from the company last April and a string of high-profile manufacturing contracts this year.
    • “Now, some four years since the project’s reveal, Fujifilm Biotechnologies is opening the doors to the facility, which might look familiar to anyone who’s worked with the CDMO in Denmark.
    • “The opening of the Holly Springs site, which will focus on antibody-based drugs, marks the debut of one of the largest cell culture biomanufacturing sites in the U.S., Fujifilm Biotechnologies said in a Sept. 24 press release.”
  • and
    • “Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.
    • “Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.
    • “The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.”
  • Beckers Payer Issues discusses an Experian Health report about the 2025 State of [Health Plan] Claims.
  • Avalere Health explains how “CMS Continues to Refine Value-Based Care Approach for Kidney Care.”
  • Radiology Business reports,
    • “Medical imaging accounts for 4 of the 5 most prevalent low-value healthcare services among Medicare beneficiaries, according to new research published Friday. 
    • “Imaging for plantar fasciitis” was the most frequently delivered unnecessary exam, occurring nearly 84 times per 100 Medicare beneficiaries, experts write in JAMA Health Forum. Low-value imaging for headache (76/100), syncope (72/100) and lower back pain (39/100) also made the top five, with vertebroplasty and kyphoplasty at No. 4. 
    • “The findings are based on a review representing claims from over 3.7 million Medicare beneficiaries treated between 2018 and 2020. Altogether, the payment program spent approximately $484 million on 15 different low-value imaging services, a figure that balloons to nearly $584 million when factoring in beneficiaries’ out-of-pocket costs.  
    • “Findings of this cross-sectional study highlight that reforms aimed at reducing spending for low-value services are feasible to achieve billions in savings without compromising patient health,” David D. Kim, PhD, and A. Mark Fendrick, MD, with the universities of Chicago and Michigan, respectively, wrote Aug. 1.”

Tuesday report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “President Donald Trump abruptly canceled his meeting with top Democratic leaders that had been planned for Thursday to search for a deal that might avert a partial government shutdown next week.”
  • The American Hospital Association News tells us,
    • ‘The Department of Homeland Security today released a proposed rule to amend the process for selecting among prospective applicants — known as registrants — for H-1B visas that are subject to statutory numerical caps. The rule would change the agency’s current process of conducting random selections to a weighted selection process. Weighted selections would be based on an individual’s wage level, with higher wage levels weighted more heavily. The rule would also apply the process to registrations subject to the regular cap and to those asserting eligibility for the H-1B advanced degree exemption. The proposal would require the use of additional wage level information, including the Occupational Employment and Wage Statistics wage level, Standard Occupational Classification code and the area of intended employment.”
  • and
    • “The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following reports of device components detaching during procedures. The company was alerted to incidents resulting in one patient death and one injury. The product is designed to be used with ultrasound endoscopes for lung cancer biopsies. In response to the reports, Olympus has implemented an automated inspection procedure during assembly to help improve the detection of device damage, which is a step that was previously done through a visual inspection. The FDA said health care personnel treating patients with the product must ensure it is not from an affected lot.”
  • Milliman delves into why “many Medicare beneficiaries will spend less than expected to reach the IRA’s new $2,000 out-of-pocket spending limit.”
    • “Among other changes to the standard Part D benefit design, the IRA introduces a hard MOOP—once the beneficiary attains $2,000 in TrOOP costs in 2025, they are no longer responsible for any cost sharing—aligning the TrOOP more closely with the typical definition of a MOOP.5 Another important change introduced by the IRA is that cost sharing for basic Part D coverage counts toward the MOOP, even if that basic coverage is reduced by certain other payers.6 Federal regulators refer to the amount of drug cost that accumulates (or counts) toward the MOOP in Part D as “TrOOP eligible cost.”7 For enhanced plans,8 TrOOP eligible cost is based on the greater of defined standard benefit cost sharing and the actual patient out-of-pocket (including any cost-sharing subsidies), such that actual patient out-of-pocket will never be higher than TrOOP eligible costs.9 This regulatory guidance has been referred to as the “greater of” logic.
    • “This “greater of” provision is impactful because the defined standard benefit is frequently leaner (i.e., has higher cost sharing) than the benefit a beneficiary may actually have. In fact, around 90% of non-low-income (unsubsidized) beneficiaries are enrolled in plans with enhanced benefits.10 Enhanced plans generally offer fixed copays on generic tiers, either coinsurance or copays on brand tiers, and coinsurance on specialty tiers. Plans are considered “enhanced” if they are meaningfully richer than the defined standard benefit. Other plans are considered “basic” and are roughly equivalent in richness to the defined standard benefit.11
    • “The IRA’s accumulation logic means many beneficiaries who satisfy their MOOP will do so without spending $2,000 out-of-pocket—i.e., their specific MOOP will be less than their $2,000 limit in TrOOP eligible costs. Assuming enhanced benefits similar to 2024, we expect roughly half of non-low-income beneficiaries who reach MOOP will spend less than $1,200 out-of-pocket in 2025.12
    • “Most likely, the only beneficiaries who will pay the full $2,000 to satisfy their MOOPs in 2025 will be non-low-income beneficiaries who are enrolled in a plan with basic Part D coverage13 or who are in an enhanced plan but exclusively utilize drugs with cost sharing greater than or equal to what is under (i.e., leaner than) the defined standard benefit. The most common instance of the latter occurs for specialty drugs on tier 5, which are almost always subject to a coinsurance greater than or equal to the defined standard coinsurance amount. In some cases, this could also occur for non-preferred brand (tier 4) drugs, where the plan offers a coinsurance benefit (typically 40% to 50%, compared to the defined standard 25%).”
  • The HHS Inspector General released a report
    • “Congress appropriated $178 billion to HHS to provide funds to eligible providers for health care-related expenses or lost revenue attributable to COVID-19 under the Provider Relief Fund (PRF) program. HHS was responsible for initial PRF program oversight and policy decisions, and HRSA administered the PRF program.
    • “Under the PRF terms and conditions, if a patient had health insurance and sought COVID-19 treatment from an out-of-network provider that received PRF payments, the provider would not seek to collect out-of-pocket payments greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. (We refer to this as the “balance billing requirement.”)
    • “This audit assessed whether selected hospitals that received PRF payments complied with the balance billing requirement for COVID-19 inpatients.
    • “Of the 25 selected hospitals, 17 billed patients an amount that did not comply or may not have complied with the balance billing requirement. For example, one hospital billed a patient $6,000 when the patient’s insurance carrier had waived all patient cost-sharing responsibility.
    • “Hospitals stated that they were uncertain how to comply with the requirement because HRSA did not provide sufficient guidance. If HRSA developed and provided early and detailed guidance, hospitals might not have improperly billed selected patients a total of $637,035 for services provided.”
  • Per a Justice Department news release,
    • “The Justice Department’s Criminal Division today announced the expansion of its Health Care Fraud Unit’s New England Strike Force to the District of Massachusetts. This expansion brings enhanced federal enforcement resources to one of the nation’s most significant health care and life sciences hubs.
    • “The U.S. Attorney’s Office for the District of Massachusetts has a national reputation in health care enforcement and has developed a significant record of success in investigating and prosecuting health care fraud, including complex cases involving pharmaceutical and medical device companies, providers, and executives. In FY 2025 alone, working together on health care fraud enforcement, the U.S. Attorney’s Office’s Health Care Fraud Unit and Affirmative Civil Enforcement Unit recovered more than $450 million in fraudulently obtained funds. Building on the U.S. Attorney’s Office’s historic track record and the success of the Criminal Division’s Health Care Fraud Unit’s specialized prosecutors and data-driven, multi-agency Strike Force model, the Department is deploying a powerful force multiplier, allowing it to accelerate the detection, investigation, and prosecution of complex fraud schemes throughout the District of Massachusetts.”

From the public health and medical/Rx research front,

  • NBC News reports,
    • “One of the largest measles outbreaks in the U.S. is now centered in bordering areas of southwestern Utah and Arizona. 
    • “In Southwest Utah, all but one of the 23 confirmed cases are among unvaccinated, school-age kids, the Southwest Utah Public Health Department reported. In Mohave County, Arizona, which health officials believe is connected to the Utah outbreak, there have been 42 confirmed cases of the highly contagious virus.
    • “An NBC News investigation, done in collaboration with Stanford University, has found that much of the United States doesn’t have the vaccine protection to prevent outbreaks of communicable diseases such as measles.”
  • Cardiovascular Business informs us,
    • “Approximately 6.7 million Americans over the age of 20 have heart failure, according to a new data-driven analysis published by the Heart Failure Society of America (HFSA). That number is expected to rise, the group added and could hit approximately 11.4 million by 2050.
    • “Those were just some of the eye-opening statistics included in a new HFSA report published in the Journal of Cardiac Failure.[1] In addition, the group wrote, approximately one in four Americans will develop HF in their lifetime. And the odds are even greater for Black individuals than those from other racial and ethnic groups.”
  • The Washington Post points out what researchers suspect may be fueling cancer among millenials.
  • Genetic Engineering and Biotechnology News notes,
    • “Neurological disorders, such as schizophrenia and bipolar disorder, remain challenging to diagnose due to the absence of objective biomarkers. Current assessments largely rely on subjective clinical evaluations. 
    • “In a new study published in APL Bioengineering titled, “Machine Learning-Enabled Detection of Electrophysiological Signatures in iPSC-Derived Models of Schizophrenia and Bipolar Disorder,” researchers from Johns Hopkins University (JHU) present a computational analysis pipeline designed to identify disease-specific electrophysiological signatures from patient-derived cerebral organoids and two-dimensional cortical interneuron cultures. The findings may help reduce human error when diagnosing mental health disorders that currently only rely on clinical judgement.”
  • Health Day lets us know,
    • “Tattoos might protect against melanoma
    • “People with more tattoos were less likely to develop melanoma
    • “They might take better care of their skin, or the tats might provide some sort of screen from UV rays, researchers say.”
  • Per the American Journal of Managed Care,
    • “Colorectal cancer (CRC) screening rates remain lower in rural areas compared with urban communities, according to a new analysis of more than 535,000 adults in the US. Although education, income, insurance coverage, and provider access explain part of the disparity, more than 70% of the gap remains unaccounted for, pointing to deeper structural and cultural barriers that require equity-focused interventions.
    • ‘This analysis is published in Cancer Causes & Control.“
  • Per Fierce Pharma,
    • “Moderna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus.
    • “Moderna’s updated mNEXSPIKE vaccine showed an average greater-than-16-fold increase in neutralizing antibodies against the LP.8.1 sublineage in individuals 12 years of age or older, the company said Tuesday. The result comes from a postmarketing clinical study of the latest 2025-26 formula of mNEXSPIKE, which is designed to target LP.8.1.
    • “By comparison, the company’s first-generation mRNA vaccine, Spikevax, generated a greater-than-eightfold increase in LP.8.1-neutralizing antibodies across the same age groups, Moderna said.”
  • Per BioPharma Dive,
    • “A drug combination involving Bristol Myers Squibb’s experimental medicine iberdomide met one of its main goals in a Phase 3 clinical trial, helping to eliminate signs of multiple myeloma in significantly more enrollees than a standard regimen, the company said Tuesday.
    • “The data are from an interim analysis of a study that will continue so trial investigators can measure other goals like an impact on disease progression and survival. Bristol Myers will submit the results to health regulators, although executives have previously said an approval would probably only come if iberdomide meets its other objectives.
    • “Iberdomide is one of three protein-degrading drugs Bristol Myers is positioning as successors to blockbuster blood cancer drugs like Revlimid and Pomalyst, which it acquired through its merger with Celgene. Many of the products in its large portfolio of cancer drugs have either plateaued or are in decline.”
  • Per Medscape,
    • “A compound comprising five agonists that together tackle weight loss, glucose reduction, insulin sensitization, and blood fat normalization has shown promise in mouse models of obesity.
    • “The compound under investigation is called a quintuple agonist because, together with GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, it contains lanifibranor, a molecule that activates three different peroxisome proliferator-activated receptors (PPARs) — the alpha, delta, and gamma variants — all of which are involved in energy regulation.
    • “Notably, this is not a combination therapy — the five agonists are included in a single molecule.
    • “Daniela Liskiewicz, PhD, Institute for Diabetes and Obesity, Helmholtz Zentrum München, Neuherberg, and the German Center for Diabetes Research, both in Munich, Germany, discussed the development of the novel agonist at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.”
  • Here’s a link to the National Institutes of Health’s Research Matters newsletter.
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • Per MedTech Dive,
    • “Multi-cancer blood tests, with the promise of detecting many cancer types from a single sample, have the potential to transform cancer screening.
    • “However, evidence is lacking to support broad use of the tests in people who do not have symptoms, according to research commissioned by the Agency for Healthcare Research and Quality and published last week in Annals of Internal Medicine.
    • “Researchers identified no completed, controlled studies reporting benefits in cancer detection, mortality or quality of life from screening with multi-cancer detection tests. They also found insufficient evidence on the accuracy and potential harm of the tests, mostly due to study limitations and unknown or inconsistent findings.
    • “Researchers from the RTI International – University of North Carolina Evidence-based Practice Center and The Ohio State University College of Medicine conducted the review.”

From the AI front,

  • The Wall Street Journal relates,
    • “AI models are being designed to predict a woman’s near-future risk of breast cancer using mammograms.
    • “Clairity’s AI model received FDA authorization and can predict a woman’s five-year breast-cancer risk.
    • “AI models outperform older risk-score calculators, but some doctors want more evidence of long-term impact.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY said it plans to build a $6.5 billion facility in Houston to make active pharmaceutical ingredients, including for a new oral weight-loss drug.
    • “The plant will bring 615 jobs to the area, including engineers and lab technicians, as well as 4,000 construction jobs while it is being built, the company said Tuesday.
    • “Eli Lilly plans to manufacture orforglipron, its first oral, small molecule GLP-1 receptor agonist, at the facility. The company expects to submit orforglipron to global regulatory agencies as a treatment for people with obesity by the end of this year.”
  • Per Fierce Healthcare,
    • “Compared to their peers, hospitals acquired by private equity reduced salary spending, cut staffing levels and experienced higher mortality rates within their emergency departments, according to a Medicare claims analysis published this week in Annals of Internal Medicine.
    • “The research, which reviewed data from 2009 to 2019, also found salary and staffing cuts among the acquired hospitals’ intensive care units, but, unlike EDs, there was no significant difference in mortality compared to other hospitals. Patient transfer rates increased in both settings among the private-equity-acquired hospitals, particularly among sicker patients, and ICU length of stay decreased.
    • “The analysis from University of Chicago, Harvard Medical School and University of Pittsburgh researchers is the latest contribution to a body of peer-reviewed evidence critical of private equity’s increasing presence among healthcare providers. It also follows a similar analysis from 2023 conducted by many of the same authors that spotted a rise in hospital-acquired adverse events among inpatients receiving care at a private-equity-acquired facility.”
  • and
    • “Pharmacy benefit manager Capital Rx has secured $400 million in fresh funding and announced a rebrand to better reflect its expansion beyond the pharmacy space.
    • “The investments include a $252 million series F round and other funding toward its securities, which is expected to close in October. Wellington Management and General Catalyst led the round, and additional supporters include Generation Investment Management, Growth Equity at Goldman Sachs Alternatives, 9Yards Capital, B Capital, Edison Partners, Prime Health Investments and Transformation Capital.
    • “With the infusion of cash, Capital Rx said it plans to lean more into its broader capabilities as a health benefits technology provider and will rebrand as Judi Health, the name of its proprietary tech stack. The company said the shift “marks a pivotal moment in addressing the fundamental inefficiencies of health benefits administration and the rising cost of care in the U.S.”
    • “The funding will also support the expansion of its PBM operations, Capital Rx said.”
  • and
    • “Health insurance startup Sidecar Health inked a partnership with Carrum Health to bring its specialty care network onto its platform.
    • “Carrum Health, a Fierce 15 of 2025 honoree, launched 10 years ago to develop value-based Centers of Excellence for employers, with the aim to revamp how the healthcare industry pays for and delivers specialty care. 
    • “Sidecar Health members will now have access to more than 1,200 vetted COE providers for surgical, cancer and substance use treatment—accessible to 90% of Americans within 50 miles of a Carrum provider, according to the companies. 
    • “Carrum’s solution makes specialty care services available at bundled prices and connects members to dedicated care navigation. The service also includes a 30-day warranty on surgery and two years on cancer care.”
  • Beckers Hospital Review relates,
    • “Walmart has expanded same-day pharmacy services to include refrigerated and reconstituted medications. 
    • “The expansion includes refrigerated access for medications such as insulin, GLP-1s and pediatric amoxicillin, according to a Sept. 22 news release from the company. Refrigerated medications make up over 30% of Walmart pharmacy sales and the company is the first retailer to deliver refrigerated prescriptions alongside everyday orders. 
    • “Once a prescription is filled, customers are notified through their Walmart pharmacy account and from there, can choose same-day scheduled delivery, on-demand delivery and express delivery with insurance applied.” 
  • BioPharma Dive tells us “why Xoma, a drug royalty firm, is hunting biotech ‘zombies.’ Distressed biotechs are facing rising investor pressure to close down, giving firms like Xoma an opportunity to step in and liquidate them for a profit.”
  • MedTech Dive explains “how SS Innovations is expanding robotic surgery’s reach. Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in over 5,000 surgeries.”

Monday report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump is planning to meet with top congressional Democrats this week about the government funding impasse, White House and Capitol Hill officials said Monday, after lawmakers left Capitol Hill for a week on Friday with little movement toward averting a partial shutdown starting Oct. 1.
    • “A date and time haven’t yet been set, and Trump has a packed schedule on most days other than Wednesday.” 
  • Govexec explains the extent to which a government shutdown would affect federal employee pay and benefits. As the FEHBlog has previously noted, because Congress is in session in October, a political compromise is more likely than a government shutdown.
  • The Government Accountability Office released a report titled “Health Care Consolidation: Published Estimates of the Extent and Effects of Physician Consolidation.”
    • “Studies show physician practices have increasingly been acquired by hospital systems, insurance companies, private equity firms, and other entities.
    • “At least 47% of physicians were consolidated with hospital systems in 2024—up from less than 30% in 2012. Studies show this consolidation can increase spending and prices, with one finding significant increases for office visits occurring in hospitals. Care quality may be the same or lower. It’s unclear how this type of consolidation affects access to care.
    • “There’s less evidence on the effects of physician consolidation with insurance companies or private equity.”
  • The American Hospital Association News tells us,
    • “The AHA expressed support Sept. 22 to House and Senate sponsors of the Medicare Advantage Prompt Pay Act (H.R. 5454/S. 2879), legislation that would apply a federal prompt payment standard to MA plans to help ensure that health care providers receive timely payments from MA plans for necessary patient services. The measure calls for plans to pay at least 95% of clean claims within 14 days for in-network claims and 30 days for out-of-network claims. MA plans would face civil monetary penalties if they miss any deadlines and also would have to publicly report compliance data, including the number of claims paid on time.”
  • and
    • President Trump Sept. 19 signed a proclamation increasing the fee to $100,000 for new H-1B petitions filed by employers, as well as implementing other restrictions on entry of certain nonimmigrant workers. The restrictions began on Sept. 21 and expire, absent extension, after 12 months. 
    • The proclamation authorizes the Department of Homeland Security and the Department of State to coordinate to take all necessary and appropriate action to implement the policies in the proclamation. 
    • According to an FAQ issued by the U.S. Citizenship and Immigration Services, the proclamation does not apply to any previously issued H-1B visas or any petitions submitted prior to Sept. 21. It also does not change any payments or fees required to be submitted in connection with any H-1B renewals. 
    • The proclamation said that the application fees can be waived if the Secretary of Homeland Security determines the hiring of these workers on an individual basis, or to work for a specific company or industry, is in the national interest. It is currently unclear if health care workers could qualify for the exemption process.” * * * 
      “In a statement shared today with the media, the AHA said, “One of the short-term strategies used by U.S. hospitals to address personnel shortages is the use of foreign-trained health care workers. While we work to educate more health care staff, the H-1B visa program plays a critical role in allowing the hospital field to recruit highly skilled physicians and other health care professionals to ensure access to care for communities and patients, including in rural and other areas where there are well-documented shortages of health care workers. The AHA is reviewing the recent memo from the Department of Homeland Security and evaluating the potential impact of these policy changes on hospitals and the communities they serve. We will also work with the Administration to stress the importance of including health care personnel in potential exemptions to these changes.” 
  • Bloomberg News informs us,
    • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.
    • “The initiative is part of Trump’s demands that drugmakers reduce their prices to align them with what other developed countries pay, according to the people, who spoke on condition of anonymity to discuss plans that are not yet public. 
    • “The proposed website would allow patients to search for specific medicines and be connected with platforms that sell them, the people said. Officials have discussed creating a Trump brand for the website, with “TrumpRx” one name that’s been considered, they added.
    • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.”
  • Per HHS news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today allocated more than $1.5 billion in FY25 continuation funding awards for the State Opioid Response (SOR) and Tribal Opioid Response (TOR) grants. This funding provides critical resources to states and Tribal communities to address the overdose crisis through prevention, opioid overdose reversal medications, treatment (including medications for opioid use disorder, or MOUD), and recovery support.
    • “America’s addiction and overdose crises are tearing apart families and communities, and meeting this challenge requires honesty, courage, and bold action,” said HHS Secretary Robert F. Kennedy Jr. “We are putting power back in the hands of states and Tribes to build solutions that reflect their people and their traditions. This investment is about saving lives, restoring hope, and making our communities whole again.”
    • “With the rise of polysubstance abuse and increasing role of stimulants in overdose deaths, it has never been more important to comprehensively address the disease of addiction and the root drivers of this crisis,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “State and Tribal Opioid Response funding provides critical resources to help prevent addiction, provide evidence-based treatment, and support long-term recovery and sobriety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today announced the mobilization of more than 70 Public Health Service officers from the U.S. Public Health Service (USPHS) Commissioned Corps to Indian Health Service (IHS) facilities across the country. This action delivers on Secretary Kennedy’s promise to strengthen the IHS, revitalize tribal health care, and ensure Native communities receive the high-quality medical support they deserve.
    • ‘Public Health Service officers, drawn from both leadership and frontline ranks, will be detailed to priority IHS sites identified as facing the most urgent staffing shortages. Senior Public Health Service officers will be detailed to strengthen leadership and operations, while additional officers will address the most urgent frontline staffing needs at IHS facilities. Today’s announcement represents one of the largest single details of Public Health Service officers to the IHS in recent years and underscores the Trump Administration’s commitment to improving health outcomes in Indian Country.”

From the Food and Drug Administration front,

  • Per FDA News releases,
    • “The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The agency also issued a related letter alerting physicians nationwide.  
    • “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.” 
  • and
    • “The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination.
    • “The FDA has conducted a systematic analysis of literature published between 2009-2024, including published case reports with patient-level information, as well as mechanistic data, and has determined that the information supports a finding that leucovorin calcium can help individuals suffering from CFD.  
    • “We have witnessed a tragic four-fold increase in autism over two decades,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people.”  
    • “The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD. As the New Drug Application (NDA) holder for this medicine, GSK has preliminarily agreed to work with the FDA on this relabeling effort.”
  • The Wall Street Journal explains “What to Know About Taking Tylenol During Pregnancy”
    • Studies looking at a link between acetaminophen and autism are inconclusive; some show a link between its use during pregnancy and autism risk, while others don’t. 
    • A 2019 study published in JAMA Psychiatry found that higher concentrations of acetaminophen in umbilical cord blood samples taken at birth were linked to greater risk of autism and attention-deficit hyperactivity disorder. 
    • Another in JAMA in 2024 of nearly 2.5 million children in Sweden found no increased risk in children when mothers took acetaminophen during their pregnancy, compared with their siblings who weren’t exposed to the medication in the womb.  
    • Part of the challenge with such studies is wading through the myriad other confounding factors when analyzing the results. 
    • Women take Tylenol during pregnancy because they are running a fever or have pain or an infection. Those problems could be the root of a potential autism risk, rather than the medication used to alleviate them, researchers said. 
    • “All of those factors in fact pose a somewhat higher risk to the developing fetus than does the Tylenol itself,” said Helen Tager-Flusberg, director of the Center for Autism Research Excellence at Boston University. 
    • “For studies that control for that, we see a far reduced or lowered impact of the Tylenol.”
  • STAT News discusses “What the evidence tells us about Tylenol, leucovorin, and autism. The questions of whether acetaminophen can cause the condition, or leucovorin can treat it, have been studied to a fair degree.”
    • “The case of leucovorin is simpler to explain: There are several studies that indicate the medicine can improve the performance of people with autism on standardized tests used to measure verbal ability. But these studies are quite small.
    • “One study, published in the European Journal of Pediatrics, followed 80 patients between the ages of 2 and 10 who were randomly assigned to receive either leucovorin or a placebo. Neither their families nor their doctors knew who received the treatment. At the end of 24 weeks, the children who received leucovorin scored 1.2 points higher on a 60-point scale used to measure autism severity than the children who did not.
    • “The result was statistically significant, but smaller studies are prone to false positive results. The normal course for researchers before making a recommendation would be to conduct a much larger randomized controlled trial to verify that the treatment is beneficial. Most such trials include hundreds or thousands of patients and provide the best evidence of efficacy and safety.
    • “For both acetaminophen and leucovorin, another problem exists: Generally, high-quality studies of medicines are done by pushing manufacturers to test them. But even though Tylenol, the leading brand of acetaminophen, is a big seller, both acetaminophen and leucovorin are available as generics, which means companies are less likely to pay for large observational studies or randomized controlled clinical trials.”
  • Per a related NIH press release,
    • “The National Institutes of Health has launched the Autism Data Science Initiative (ADSI), a landmark research effort that will harness large-scale data resources to explore contributors to the causes and rising prevalence of autism spectrum disorder. More than $50 million in awards will support 13 pioneering projects that draw on genomic, epigenomic, metabolomic, proteomic, clinical, behavioral and autism services data. These projects will integrate, aggregate and analyze existing data resources, generate targeted new data and validate findings through independent replication hubs.
    • “Our Autism Data Science Initiative will unite powerful datasets in ways never before possible,” said NIH Director Jay Bhattacharya, M.D., Ph.D., “By bringing together genetics, biology, and environmental exposures, we are opening the door to breakthroughs that will deepen our understanding of autism and improve lives.”

From the public health and medical/Rx research front,

  • Swiss Re, a life insurance company, considers “The future of metabolic health and weight loss drugs; Projecting mortality reductions in the US and UK populations.
    • “In the US and UK general populations, our modelled baseline scenario projects 4% and 3.2% reductions in cumulative all-cause mortality respectively by 2045, based on GLP-1 drug use. Here we assume majority use in the target overweight and obese population, with some sustained lifestyle changes but variable weight loss outcomes.
    • “Under our pessimistic scenario, in which drug use is limited and impacts are modest, the cumulative reduction would be 2.3% (US) and 1.8% (UK), we project. Yet semaglutide and tirzepatide are not risk-free drugs, and our assessment incorporates many caveats. In real world use, where people do not benefit from support to alter their lifestyle, the risks of discontinuation of the treatment, weight regain and rebound effects are all common. The loss of lean muscle mass and bone density as well as fat is also a risk.”
  • Per Beckers Clinical Leadership,
    • “In 2024, healthcare facilities voluntarily reported 1,575 serious harmful events to The Joint Commission, which has been tracking sentinel events since 1996. 
    • ‘The Joint Commission defines a sentinel event as a patient safety event that results in severe temporary harm, permanent harm or death. Because the reports are voluntary, the organization says its dataset represents a small portion of actual sentinel events and that “no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”
    • “Of the 1,575 events, 21% were associated with patient death, 49% with severe harm, 21% with moderate harm, 5% with mild harm, 2% with psychological harm and 2% with no harm, according to the commission’s report. 
    • ‘With 776 voluntarily reported events, patient falls were the most frequently reported sentinel event in 2024. Falls led The Joint Commission’s annual lists in 2021, 2022 and 2023. In 2024, 51 of the reported falls resulted in patient death, 503 in severe harm and 199 in moderate harm.” 
    • The article goes onto list the other ten most common sentinel events last year.
  • Beckers Hospital Review points out,
    • “Sixty-two National Cancer Institute-designated cancer centers are urging health systems, physicians and hospital leaders to promote human papillomavirus vaccination as a form of cancer prevention.
    • “The cancer centers, alongside leading cancer research organizations and advocacy groups, have published a joint statement to raise awareness of lagging HPV vaccination rates.
    • “Even though 90% of HPV-related cancers are preventable through on-time vaccination by a child’s 13th birthday, HPV vaccination coverage has stagnated over the last three years, according to a Sept. 16 news release from MD Anderson.” * * *
    • “Read the full joint statement here.” 
  • Per MedPage Today,
    • “Adenotonsillectomy wasn’t better than just keeping an eye on young children with mild to moderate obstructive sleep apnea (OSA) over 3 years of follow-up in a small, randomized trial.
    • “Watchful waiting did result in many crossovers to surgery during follow-up, particularly among those with large tonsils at baseline.
    • “Researchers suggested that clinical decisions weigh Obstructive Apnea-Hypopnea Index values if available, evaluation of symptoms, tonsil size, the age of the child, risks of surgery, and evaluation of obesity or other comorbidities associated with increased risk of OSA.”
  • The American Medical Association lets us know what doctors wish patients knew about women’s sleep health.
  • Per Health Day,
    • “Type 2 diabetes appears to double a person’s risk for life-threatening sepsis, a new study says.
    • “Men and people under 60 with diabetes are particularly at risk for sepsis, a condition in which the immune system overreacts to infection, researchers reported this week at the annual meeting of the European Association for the Study of Diabetes in Vienna.
    • “The research confirms an association between type 2 diabetes and sepsis that’s been noted in earlier studies, said lead researcher Wendy Davis, a principal research fellow with the University of Western Australia.
    • “The best way to prevent sepsis is to quit smoking, normalize high blood sugar and prevent the onset of the micro- and macrovascular complications of diabetes,” Davis said in a news release. “That’s why this study is important.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer PFE has agreed to pay up to $7.3 billion for weight-loss drug developer Metsera MTSR in a deal that gets the New York drugmaker back into the burgeoning market for obesity drugs.
    • “Pfizer on Monday said it would pay an initial $47.50 a share, or about $4.9 billion, for Metsera, a nearly 43% premium to Friday’s closing price of $33.32 for the New York company.
    • “The deal, slated to close by the end of the year, includes up to an additional $22.50 a share tied to milestones that could bring the total consideration to $70 a share, more than double Friday’s closing price.
    • “Pfizer, which earlier this year scrapped its experimental weight-loss pill danuglipron over concerns about potential liver damage, said the Metsera acquisition adds four clinical-stage programs to its pipeline, including a GLP-1 receptor agonist that is in Phase 2 development as both a weekly and monthly injectable treatment.
    • “Metsera also has two weight-loss pill candidates expected to begin clinical trials imminently.”
  • and
    • “Roche plans to move one of its weight-loss treatment candidates to late-stage trials next year, as the Swiss pharmaceutical group aims to become a top-three player in the booming market.
    • “The group said Monday that the experimental drug, called CT-388, showed strong efficacy in early-stage studies and that mid-stage trials were under way. A late-stage, or phase 3, study is set to begin in the first half of 2026, it said.
    • “Roche’s aim is to become a strong entrant in the weight-loss market before 2030 and eventually a top-three competitor in the field, the head of the group’s pharmaceuticals business, Teresa Graham, said at a company event with investors in London.” * * *
    • “CT-388 is a medication injected weekly that, like Lilly’s Mounjaro and Zepbound drugs currently on the market, activates both glucagon-like peptide 1, or GLP-1, hormones and a second class of hormones to help suppress appetite and shed weight.
    • “Roche said the drug stands out by more precisely activating appetite- and metabolism-related pathways while avoiding those linked to side effects such as nausea and vomiting. Phase 1 results showed participants lost an average 18.8% of their body weight over 24 weeks.”
  • Per BioPharma Dive,
    • “MapLight Therapeutics, a biotechnology company making medicines for neurological diseases, filed plans for an initial public offering on Friday.
    • “In outlining an offering, MapLight aims to become the second drugmaker to recently price a sizable IPO following a monthslong drought. LB Pharmaceuticals raised $285 million earlier this month, but the last company to carry out a large offering before that was Aardvark Therapeutics in February, according to BioPharma Dive data. 
    • “The Redwood City, California biotech is developing its lead drug as a potential treatment for schizophrenia and Alzheimer’s disease psychosis. MapLight’s ML-007C-MA activates a pair of proteins called muscarinic receptors, which help control the release of the neurotransmitter acetylcholine. In that way, the drug is designed similarly to Cobenfy, the focus of Bristol Myers Squibb’s $14 billion acquisition of Karuna Therapeutics.”
  • Beckers Payer Issues notes,
    • “Aetna is expanding a program that aims to reduce readmissions for its Medicare Advantage members to ten hospitals by the end of 2025.
    • “The insurer is currently implementing the clinical collaboration program at Merriam, Kan.-based AdventHealth Shawnee Mission, Houston Methodist, and Raleigh, N.C.-based WakeMed Health & Hospitals, according to a Sept. 22 news release. 
    • “The initiative aims to reduce 30-day readmission rates and hospital stays by integrating Aetna nurses directly into hospital care teams, focusing on post-discharge care to help MA members transition back home or into skilled nursing facilities.” 
  • Modern Healthcare adds,
    • “The number of hospitals faced with readmissions penalties of at least 1% come Oct. 1 is set to rise to the highest number since fiscal 2022.
    • “Prior to fiscal 2026, the number of hospitals facing readmissions penalties of 1% or more had dropped for five consecutive years. But preliminary data released Friday by the Centers for Medicare and Medicaid Services showed the number of hospitals set to pay penalties of 1% or more under the Hospital Readmissions Reduction Program will increase to 8.1%, or 240 hospitals, in fiscal 2026 compared to 7%, or 208 hospitals, in fiscal 2025.
    • “However, the number of hospitals facing no readmissions penalties next fiscal year, which starts Oct. 1, remained relatively flat compared to fiscal 2025, rising to 21.8%, or 641, from 21.4%, or 638.”
  • Healthcare Dive reports,
    • “CVS pharmacy services subsidiary Omnicare has filed for Chapter 11 bankruptcy after being hit with a $949 million federal judgment over improper billing of government healthcare programs.
    • “Omnicare claimed up to $500 million in assets and between $1 billion and $10 billion in debts in its bankruptcy petition with a Texas court on Monday.
    • “Omnicare has brokered an agreement to receive $110 million in debtor-in-possession financing, a type of loan which it expects will allow it to continue operating through the bankruptcy process, the company said.”

Weekend update

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
  • Congress is on a District/State work break this week.
  • Govexec tells us,
    • “Newly elected Rep. James Walkinshaw, D-Va., this week formally took over for his predecessor, the late Rep. Gerry Connolly, in leading advocacy for an array of bills aimed at improving the pay and civil service protections of federal workers.” * * *
    • “The House on Tuesday granted Walkinshaw’s unanimous consent request to become lead sponsor for four bills that Connolly had previously introduced, all relating to federal personnel policy.”
  • Plan Sponsor lets us know,
    • “The Senate confirmed Daniel Aronowitz as assistant secretary of labor for the Employee Benefits Security Administration on Thursday.
    • “EBSA is responsible for enforcement of the Employee Retirement Income Security Act and related laws and regulations, along with protecting employer-based retirement, health and welfare benefits for workers and retirees.
    • “During his June 5 confirmation hearing, the former president of Encore Fiduciary pledged to streamline retirement plan oversight and end the ‘war’ on employee stock ownership plans, also known as ESOPs.”
  • OPM typically announces the next year’s FEHB / PSHB government contributions in the second half of September. OPM shares this information with Congress before making the announcement which suggests that the announcement will be made next week when Congress returns to Capitol Hill.
  • Nextgov/FCW points out,
    • “The Office of Personnel Management is rolling out ChatGPT to its employees this week, its director told employees Tuesday. 
    • “This is part of our broader effort to equip you with AI tools that help you work faster, think bigger, and collaborate better,” the agency’s director, Scott Kupor, told staff in an email shared with Nextgov/FCW by the agency. 
    • “Employees already can access Microsoft 365 Copilot chat, the email says, but now they’ll have access to OpenAI’s ChatGPT-5, too. 
    • “AI is a great assistant, but you’re still the expert. I know some of you are excited, some are curious, and some are wary. In the coming weeks, [the Office of the Chief Information Officer] will host brown bag sessions to help clarify and ensure you get the most out of these tools,” the email reads. “Let’s lead the way in using AI thoughtfully and effectively — starting now.”

From the ACIP recommendations front,

  • The Pharmacy Times article offers more details about the Covid vaccination decisions made at the ACIP meetings last week. 
    • “The Advisory Committee on Immunization Practices (ACIP) has voted 12-0 to recommend COVID-19 vaccines be administered based on individual-based decision-making, also known as shared clinical decision making, for adults aged 65 and older, rather than a universal recommendation. 
    • “They voted to recommend the same language for individuals aged 6 months through 64 years, with an emphasis that risk-benefit for vaccination is most favorable for individuals at increased risk and lowest for individuals not at increased risk.1
    • “Another vote on the belief that state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccine failed 6-6, with the chair, Martin Kulldorff, PhD, breaking a tie to ensure the vote’s failure.
  • The Covid vaccine is not the first time that ACIP recommended shared decision making. The ACIP website includes an FAQ on shared decision making. A pharmacist is a healthcare provider for purposes of shared decision making. 
  • From a maintaining the status quo standpoint, it’s very important that ACIP rejected a recommendation to require a prescription for Covid vaccines. 
  • The New York Times reports yesterday,
    • Before the C.D.C. panel voted, CVS and Walgreens, the nation’s two largest pharmacy chains, were requiring prescriptions in some states because of laws forbidding pharmacists to administer vaccines in the absence of a recommendation from the panel.
    • But if the head of the C.D.C. adopts the panel’s recommendations, CVS will start providing the shots without prescriptions nationwide, including to people outside the F.D.A.-approved groups, according to a CVS spokeswoman, Amy Thibault.
    • Walgreens did not immediately confirm what it would do.
  • ACIP’s website explains
    • “The Advisory Committee on Immunization Practices (ACIP) develops recommendations on how to use vaccines to control disease in the United States.
    • “These recommendations become official CDC policy once adopted by CDC’s Director.
    • “This page provides resources related to ACIP recommendations and lists recommendations from ACIP meetings that are pending publication in CDC’s Morbidity and Mortality Weekly Report (MMWR).”
  • An HHS news release on Friday states,
    • “I commend the committee for bringing overdue scientific debate on vaccination to the American people,” said Deputy Secretary of Health and Human Services and CDC Acting Director Jim O’Neill. A recommendation from ACIP becomes part of the CDC immunization schedule if it is adopted by the CDC director.”
  • The CDC director typically adopts ACIP recommendations promptly. The FEHBlog will keep an eye out.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The FDA, under President Trump’s directive, is cracking down on direct-to-consumer pharmaceutical ads.
    • “The FDA sent letters to drugmakers citing issues with ads that potentially violate drug-marketing laws.
    • “The FDA is scrutinizing ads that it says overhype drug effectiveness, not just those omitting side effects, marking a shift in enforcement.”
  • The Washington Post informs us,
    • “The Trump administration is expected to unveil new efforts on Monday exploring how one medication may be linked to autism and another one can treat it, according to four people with knowledge of the plans who spoke on the condition of anonymity because the announcement was not yet public.
    • “Federal health officials are expected to raise concerns about pregnant women’s use of acetaminophen, the active ingredient in Tylenol and one of the most widely used medications globally. Officials have been reviewing previous research — including an August review by Mount Sinai and Harvard researchers — that suggests a possible link between Tylenol use early on in pregnancy and an increased risk of autism in children. They plan to warn pregnant women against using Tylenol early on unless they have a fever, according to the four individuals.
    • “In addition, officials plan to tout a lesser-known drug called leucovorin as a potential autism treatment. Leucovorin is typically prescribed to counteract some medications’ side effects and to treat vitamin B9 deficiency. Early double-blind, placebo-controlled trials administering leucovorin to children with autism have shown what some scientists describe as remarkable improvements in their ability to speak and understand others. Officials at the Food and Drug Administration have recently been reviewing new language that could apply to the drug.”

From the public health front,

  • Per Medscape,
    • “Use of GLP-1 receptor agonists (GLP-1s) was associated with a reduction in fragility fractures among older women with type 2 diabetes (T2D) in a retrospective analysis of data from a global health network. The results suggest that GLP-1 therapy could contribute to bone health.”
  • Medscape also identifies benefits and risks to watch out for when older adults take GLP-1 drugs.
    • “In adults over 65, GLP-1 use has both potential benefits and risks for age-related health. Physicians should stay alert, monitor closely, and address side effects proactively.’
  • NPR notes,
    • “Doctors who perform skin cancer surgeries often recommend nicotinamide — which is a form of Vitamin B3 — to their patients. It’s been shown to protect cells from UV radiation damage.
    • “Now, a new study of nearly 34,000 veterans, finds this over-the-counter supplement is linked to a reduction in non-melanoma skin cancers among people who’ve already had skin cancer. The research was published in JAMA Dermatology.
    • “The biggest reduction was seen among people who began taking the supplement after being diagnosed with their first skin cancer. Researchers found those who took 500 mg of nicotinamide, also known as niacinamide, twice daily, for at least one month, had a 54% reduced risk of developing another skin cancer, compared to patients who did not take the supplement.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • The Wall Street Journal reports,
    • “The collapse on Friday [September 19] of an emergency federal funding bill leaves the fate of cybersecurity legislation that provides legal protection for companies sharing cyber-threat intelligence up in the air.
    • Without a reprieve of the expiring cyber legislation that had been included in the funding bill, companies face uncertainty on how to communicate about cyber threats as competing reauthorization bills work through a divided House and Senate.
    • “Both the private sector and the government need certainty, including the ability to allocate resources for long-term cybersecurity planning and implementation,” said Matthew Eggers, vice president of cybersecurity policy at the U.S. Chamber of Commerce. 
    • The 2015 Cybersecurity Information Sharing Act, or CISA, is set to expire at the end of September. Friday’s scuttled emergency funding measure, which applied to a number of federal programs and sought to avert a government shutdown, would have given lawmakers more time [until November 21] to iron out critical differences between House and Senate versions of CISA renewal bills. * * *
    • “A notable difference in the House bill is the forward-thinking inclusion of artificial intelligence in the renewal,” said Justine Phillips, a partner and co-chair of the data and cyber practice group at law firm Baker McKenzie. Despite these updates, she said, “the House bill is the functional equivalent of extending the act as is, because it leaves the legal liability protections intact.”
    • “The cyber bill’s renewal by the Senate may prove more problematic, cybersecurity experts say.”
  • Cyberscoop informs us,
    • “Federal agencies are increasingly incorporating artificial intelligence into the cyber defenses of government networks, and there’s more still to come, acting Federal Chief Information Security Officer Michael Duffy said Thursday.
    • “We’re at an exciting time in the federal government to see that we’re not only putting AI in production, but we’re finding ways to accelerate emerging technology across the government, across all missions and all angles,” Duffy said at FedTalks, produced by Scoop News Group. In his “role overseeing federal cybersecurity policy,” he said, he is “able to see these at the ground level, as agencies bring excitement and enthusiasm and hope for what they can optimize through artificial intelligence.”
    • “Cyber attackers are moving faster than ever, and on a much larger scale than before, he said. They’re also using technology in new ways. But it’s not all “doom and gloom” when it comes to the cybersecurity of federal networks, especially because of feds’ move toward AI, Duffy said.
    • “I’m pleased to say that the advancements that we’ve made over the past decade in the federal government have brought us to this point: Agencies are poised now, postured, positioned, to take advantage of new capabilities, bring them into federal agencies and make them work for the mission,” he said.”
  • In related news, Cybersecurity Dive tells us,
    • “The National Institute of Standards and Technology on Thursday [September 18] published guidance describing how implementation of post-quantum cryptography (PQC) both supports and relies on the safeguards in the agency’s major cybersecurity publications.
    • “The draft NIST document, derived from the output of the agency’s PQC migration project, is designed to illustrate the connections between the tools required for adopting quantum-resistant encryption and the security practices that NIST recommends in its Cybersecurity Framework and other guidance.
    • “The capabilities demonstrated in the project support several security objectives and controls identified” in other NIST guidance documents, the agency said in its new publication. “At the same time, responsible implementation of the demonstrated capabilities is dependent on adherence to several security objectives and controls identified in these risk framework documents.”
    • “Collecting information about which technologies use cryptography supports the Cybersecurity Framework practices of creating hardware and software inventories, the document notes. Similarly, analyzing cryptographic weaknesses supports the CSF practice of identifying vulnerabilities in technology assets.”
  • A September 19, 2025, NIST news release adds,
    • “To help organizations protect their data against possible future attacks from quantum computers, the National Institute of Standards and Technology (NIST) has released a publication offering guidelines for implementing a class of post-quantum cryptography (PQC) algorithms known as key-encapsulation mechanisms, or KEMs.
    • “A KEM is a set of algorithms that can be used by two parties to securely establish a shared secret key over a public channel — a sort of first handshake between parties that want to exchange confidential information. Recent examples of KEMs include ML-KEM and HQC.
    • The new publication, Recommendations for Key-Encapsulation Mechanisms (NIST Special Publication 800-227), describes the basic definitions, properties and applications of KEMs and provides recommendations for implementing and using KEMs securely.
  • Cyberscoop reports,
    • “Two teenagers were arrested in the United Kingdom this week, accused of associating with the sprawling criminal collective known as The Com, and participating in many high-profile and damaging cyberattacks on critical infrastructure globally.
    • “Thalha Jubair, 19 of London, and Owen Flowers, 18 of Walsall, England, were arrested at their residences Tuesday and charged with crimes related to the cyberattack on the Transport for London in September 2024, the U.K.’s National Crime Agency said.
    • “Jubair and Flowers were allegedly highly involved in many other cyberattacks attributed to Scattered Spider, a nebulous offshoot of The Com that commits ransomware and data extortion. The Com is composed of thousands of members, splintered into three primary subsets of interconnected networks that commit swatting, extortion and sextortion of minors, violent crime and various other cybercrimes, according to the FBI.
    • “The Justice Department on Thursday unsealed charges against Jubair, a U.K. national, accusing him of participating in at least 120 cyberattacks as part of Scattered Spider’s sweeping extortion scheme from May 2022 to September 2025, including 47 U.S.-based organizations. Victims of those attacks paid at least $115 million in ransom payments, authorities said.”

From the cybersecurity vulnerabilities and breaches front,

  • While CISA did not add any known exploited vulnerabilities to its catalog this week, SC Media lets us know,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) on Sept. 18 issued a malware analysis report on two sets of malicious code from an organization compromised by threat actors exploiting two bugs in the Ivanti Endpoint Manager Mobile (EPMM) tool.
    • “CISA said the malware exploited two CVEs – CVE-2025-4427 and CVE-2025-4428. After exploitation, the malware let the threat actors inject and run arbitrary code on the compromised server.
    • “Lawrence Pingree, technical evangelist at Dispersive Holdings, said malware that’s instrumented to target specific vulnerabilities in centralized endpoint management solutions like these Ivanti tools is incredibly important to defend against.
    • “Isolating and microsegmenting sensitive systems like this is essential. Patching rapidly, ideally with an automated process, is essential in defending against vulnerabilities,” said Pingree.”
  • Per Dark Reading,
    • “Security vendor SonicWall suffered a data breach that exposed customer firewall configuration file backups.
    • “On Sept. 17, SonicWall, a vendor best known for its network security appliances, published a knowledge base article disclosing what it described as a “cloud backup file incident.” The company said its security teams recently detected “suspicious activity targeting the cloud backup service for firewalls” and confirmed it to be a security event in the past few days.
    • “Unidentified threat actors accessed backup firewall preference files stored in the cloud representing “fewer than 5% of our firewall install base,” according to SonicWall. Attackers were able to access encrypted credentials as well as firewall configuration files “that could make it easier for attackers to potentially exploit the related firewall.”
    • “We are not presently aware of these files being leaked online by threat actors,” SonicWall said in its disclosure. “This was not a ransomware or similar event for SonicWall, rather this was a series of brute force attacks aimed at gaining access to the preference files stored in backup for potential further use by threat actors.”
  • Per Cyberscoop,
    • “Researchers warned that a maximum-severity vulnerability affecting GoAnywhere MFT bears striking similarities with a widely exploited defect in the same file-transfer service two years ago.
    • “Fortra, the cybersecurity vendor behind the product, disclosed and released a patch for the vulnerability — CVE-2025-10035 — Thursday. The deserialization vulnerability “allows an actor with a validly forged license response signature to deserialize an arbitrary actor-controlled object, possibly leading to command injection,” the company said in a security advisory.
    • “File transfer services are a valuable target for attackers because they store a lot of sensitive data. If cybercriminals exploit these services, they can quickly access information from many users at once, making these services especially attractive for large-scale attacks. 
    • “Fortra didn’t provide any evidence of active exploitation and researchers from multiple security firms said they haven’t observed exploitation but expect that to change soon. “We believe that it’s just a matter of time and are monitoring the situation closely,” Ryan Dewhurst, head of proactive threat intelligence at watchTowr, said in an email.
    • “The vulnerability, which has a CVSS rating of 10, is “virtually identical to the description for CVE-2023-0669,” a zero-day vulnerability exploited by Clop, resulting in attacks on more than 100 organizations, and at least five other ransomware groups, Caitlin Condon, vice president of security research at VulnCheck, said in a blog post.”
  • and
    • “Apple’s latest operating systems for its most popular devices — iPhones, iPads and Macs — include patches for multiple vulnerabilities, but the company didn’t issue any warnings about active exploitation. 
    • “Apple patched 27 defects with the release of iOS 26 and iPadOS 26 and 77 vulnerabilities with the release of macOS 26, including some bugs that affected software across all three devices. Apple’s new operating systems, which are now numbered for the year of their release, were published Monday as the company prepares to ship new iPhones later this week.
    • “Users that don’t want to upgrade to the latest versions, which adopt a translucent design style Apple dubs “liquid glass,” can patch the most serious vulnerabilities by updating to iOS 18.7 and iPad 18.7 or macOS 15.7. Most Apple devices released in 2019 or earlier are not supported by the latest operating systems.
    • “None of the vulnerabilities Apple disclosed this week appear to be under active attack, Dustin Childs, head of threat awareness at Trend Micro’s Zero Day Initiative, told CyberScoop.”
  • Cybersecurity Dive points out,
    • “Most companies worry their networks aren’t safe against cyberattacks powered by artificial intelligence.
    • “Only 31% of IT leaders are at least somewhat confident that they can defend their organizations against AI-powered attacks, according to a Lenovo report published on Thursday.
    • “The report delves into why IT and security leaders are worried about hackers’ use of AI — and why they see their companies’ own use of AI systems as vulnerable.”
  • and
    • “The number of healthcare organizations that have lost more than $200,000 to cyberattacks has quadrupled this year compared with the same period in 2024, data security firm Netwrix said in a report published Thursday [September 19].
    • “Nearly half of all healthcare organizations (48%) experienced at least one intrusion between March 2024 and March 2025, the report found.
    • “Healthcare organizations experienced more cyberattack-related losses of at least $500,000 than critical infrastructure firms did, on average: 12% of healthcare organizations, compared with 6% of all organizations.”

From the ransomware front,

  • Infosecurity Magazine reports,
    • “Fifteen well-known ransomware groups, including Scattered Spider, ShinyHunters and Lapsus$, have announced that they are shutting down their operations.
    • “The collective announcement was posted on Breachforums, where the groups claimed they had achieved their goals of exposing weaknesses in digital infrastructure rather than profiting through extortion.
    • “In their statement, the gangs said they would now shift to “silence,” with some members planning to retire on the money they had accumulated, while others would continue studying and improving the systems people rely on daily.” * * *
    • “Organizations should take these announcements with a pinch of salt,” Nivedita Murthy, senior staff consultant at Black Duck, said.
    • “It could be possible that some of these groups may have decided to step back and enjoy their payday, [but] it does not stop copycat groups from rising up and taking their place.”
  • IT Pro discusses the “top ransomware trends for businesses in 2025. A splintering of top groups and changing attitudes toward payments are changing attacker tactics at speed.”
  • Morphisec calls attention to “The Top Exploited Vulnerabilities Leading to Ransomware in 2025 — and How to Stay Ahead.” 

From the cybersecurity defenses front,

  • The American Hospital Association News reports,
    • “Microsoft Sept. 16 announced it had disrupted a growing phishing service that had targeted at least 20 U.S. health care organizations. The company said it used a court order granted by the U.S. District Court for the Southern District of New York to seize 338 websites associated with RaccoonO365, a cyber threat group known for stealing Microsoft 365 credentials through phishing tactics. RaccoonO365 offers subscription-based phishing kits that allow individuals to steal Microsoft credentials by mimicking official Microsoft communications. The company said the phishing kits use Microsoft branding to create fraudulent emails, attachments and websites. Since July 2024, the kits have stolen at least 5,000 Microsoft credentials from individuals in 94 countries. The group was recently observed offering a new artificial intelligence-powered service in an attempt to scale their operations.
    • “Credentials stolen through RaccoonO365 enabled ransomware attacks against hospitals, posing a direct threat to patient and community safety,” said John Riggi, AHA national advisor for cybersecurity and risk. “This operation also highlights a disturbing trend — cybercriminals’ increased use of ‘initial access brokers’ to steal credentials and AI to accelerate the effectiveness, sophistication and impact of cyberattacks. The need for continued and evolving social engineering training for staff is essential to defend against the latest deception tactics used by hackers.”
  • Cybersecurity Dive tells us,
    • “Preemptive cybersecurity solutions will account for about half of all IT security spending by the year 2030, a significant increase from its 5% share in 2024, Gartner said in a report published Thursday.
    • “Preemptive cybersecurity will effectively replace standard detection and response technologies as the preferred defense against malicious hacking, Gartner predicted.
    • “The technology uses artificial intelligence and machine learning to anticipate threats and then neutralize them before they can compromise their targets, according to researchers.”
  • Security Week reflects on the fifteen anniversary of the Zero Trust strategy.
    • “The implementation of zero trust is essential for cybersecurity: but after 15 years, we’re still not there. Implementation is like the curate’s egg: good in parts.
    • “Zero Trust turned fifteen years old on September 14, 2025. Its invention was announced with Forrester’s publication of John Kindervag’s paper, No More Chewy Centers: Introducing The Zero Trust Model of Information Security, on that date in 2010 (archived here).
    • “Zero trust recognizes that treating cybersecurity like an M&M (a hard crunchy shell impenetrable to hackers protecting a soft chewy center where staff can work freely and safely) simply doesn’t work. “Information security professionals must eliminate the soft chewy center by making security ubiquitous throughout the network, not just at the perimeter,” wrote Kindervag.
    • “This is the basis of zero trust (or ZT): abandon the old concept of a barrier between two separate networks (one untrusted: the internet; and one trusted: the enterprise). Instead, trust nothing and verify everything, regardless of source or destination. The concept is sound and rapidly gained approval, culminating in EO14028 mandating that federal agencies must move toward a zero trust architecture while private companies should do similar – but never defining how it could be achieved.
    • “There’s the rub. Zero trust is fundamentally a concept where implementation will depend on individual different corporate ecospheres.”
  • Dark Reading recommends “Transforming Cyber Frameworks to Take Control of Cyber-Risk.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NCQA, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democrats blocked Republicans’ stopgap measure that would keep the government funded until late November and insisted that major healthcare spending be added to the bill, raising the odds for a partial shutdown in less than two weeks.
    • “Friday’s vote in the Republican-controlled Senate was 44 in favor and 48 against, short of the 60 votes required. Sens. Rand Paul of Kentucky and Lisa Murkowski of Alaska were the only Republicans to vote against the measure, while Democratic Sen. John Fetterman voted in favor. Several Republicans were absent. 
    • “The GOP-led House narrowly passed the measure earlier in the day in a 217-212 vote largely along party lines.
    • “The failure of the bill in the Senate set the stage for a down-to-the-wire standoff, with both parties standing firm and saying the other one would take the blame for a fall shutdown. * * *
    • Democrats proposed an alternative that would fund the government through Oct. 31 and reverse hundreds of billions of dollars in cuts to Medicaid enacted under the Republican tax-and-spending legislation that Republicans have rebranded the “working families tax cut.” The Democratic alternative would permanently extend certain ACA subsidies that expire at the end of this year. * * *
    • Republicans rejected the Democratic proposal as unserious. It failed in its own vote with 47 in favor and 45 opposed, short of the 60-vote requirement. Republicans control the Senate 53-47.
    • “The Democrats want a ransom payment of more than $1 trillion to keep the government open for only four more weeks,” said Senate Majority Whip John Barrasso (R., Wyo.).
    • [Senator Lisa] Murkowski [(R. AK), who voted against both the Republican plan and the Democratic proposal, said she wants a continuing resolution that extends enhanced ACA subsidies for two years, in addition to addressing some fiscal year 2026 appropriations and funding for the public media.
    • “Both of these were messaging bills,” she said. “They both did what everybody predicted was going to happen, which was, they were going to go down.
  • STAT News reports good news from Atlanta,
    • “A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.
    • “The decision, if signed off on by federal health leaders, would preserve insurance coverage for the shots, and is similar to the Food and Drug Administration’s approvals of the updated vaccines earlier this year. The Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, emphasized that for people under 65, the benefits of vaccination are most clear for people with risk factors for severe Covid-19.
    • “This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services spokesperson said.”
  • and
    • “A key government advisory committee voted Friday to postpone a vote on whether to delay infants’ first hepatitis B vaccine — temporarily alleviating fears that a new recommendation on shot timing could reverse the significant progress made in controlling the disease’s spread in recent decades.
    • “The decision followed a lengthy deliberation on Thursday by the newly reconstituted Advisory Committee on Immunization Practice, which pressed scientists from the Centers for Disease Control and Prevention on the necessity of the birth dose, and brought into question the veracity of the data presented on the risks and benefits of the vaccine. But ultimately, members voted to push the vote.”
    • “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” Robert Malone, a member of the committee, said on Friday. All of the members of the committee, except its chair, Martin Kulldorff, voted to table the vote.”
  • Per a Congressional news release.
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement on the Advisory Committee on Immunization Practices (ACIP) postponing a vote to change the recommendation for the hepatitis B vaccine for newborns. If a recommendation for a vaccine is altered without a scientific basis, insurance companies may decide to no longer cover it for patients free of charge. Additionally, doctors will lack the necessary information to counsel families, so they make the best health care decisions for their children.
    • “At Wednesday’s hearing, Cassidy underscored the importance of families having access to the hepatitis B vaccine at birth.”
  • Here is an informative Blue Cross link to an article about No Surprises Act abusive practices by providers particularly in the arbitration / IDR process.  In my opinion, which supplements the Blue Cross recommendations, the NSA arbitration process would be more equitable if the Tri-Agencies added more substance from the AAA baseball / final offer rules to its IDR procedures. 
  • Beckers Payer Issues informs us,
    • “CMS has finalized a rule requiring Medicare Advantage plans to submit provider directory data for inclusion in the Medicare Plan Finder. 
    • “The change, aimed at improving transparency and beneficiary decision-making, takes effect January 1, 2026.
    • “Under the rule, MA plans must make provider directory information available to CMS in a standardized format for online publication, update the data within 30 days of becoming aware of changes, and attest at least once a year to the accuracy of the information.
    • “CMS said the move is designed to allow beneficiaries to more easily compare provider networks across plans without having to navigate multiple websites. The agency expects to publish an operational guide in the coming months with technical specifications for plans to follow, along with a testing period before the data appears publicly online.”
  • The American Hospital Association News explains that this CMS rule was part of a larger rulemaking.
    • “The Centers for Medicare & Medicaid Services Sept. 18 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2026. Yesterday’s final rule follows one released in April on other changes for MA and prescription drug programs. In the latest final rule, CMS finalized a requirement aimed at increasing beneficiary access to provider directory data in the CMS Medicare Plan Finder platform.”
  • The Government Accountability Office released a report titled “Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services.”
    • “About half of U.S. hospitals are in urban areas. More urban hospitals closed than opened from 2019 to 2023.
    • “All of the 5 hospitals in our review struggled financially before they closed, with inpatient volumes decreasing at 4 of them. The anticipated cost of upgrading or maintaining aging facilities also contributed to the closures of all 5 hospitals.
    • “After closure, 2 of the hospitals still provided outpatient services, while the other 3 stopped all services.
    • “Representatives from local hospitals, providers, and community organizations told us some community residents continued having trouble getting health care after all 5 hospitals closed.”
  • Last but not least, OPM Director Scott Kupor released his regular Friday blog post which concerns OPM’s mine in Boyers, PA, that holds paper personnel records.
    • “The Boyers mine is but one of many examples of opportunities for modernization across the federal government. None of these challenges are rocket science – maybe with the exception of our friends at NASA – but they have been plagued for too long by a system that doesn’t demand inventiveness and efficiency as first-class citizens in the government vernacular. OPM aims to create fluency in this new language – and we are starting with one retirement piece of paper at a time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.
    • “To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.
    • “The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
    • “Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.”
  • Per MedPage Today,
    • “The FDA approved the Altaviva implantable nerve stimulator for urge urinary incontinence (UUI), a common symptom of overactive bladder (OAB), Medtronic announced.
    • “Inserted near the ankle in a minimally invasive procedure, the device generates low-level electronic impulses that stimulate the tibial nerve to restore bladder-brain communication. The device is the third tibial neuromodulator for UUI, joining the eCOIN device approved in 2022opens in a new tab or window and the Revi System approved in 2023.
    • “The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” Kevin Benson, MD, of Sanford Health in Sioux Falls, South Dakota, said in a statement. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
    • “Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients. 
    • “Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.”
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).
    • “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments,” said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Barth syndrome primarily affects males, typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance. The quality of life and daily functioning of patients with Barth syndrome are significantly affected throughout their lives.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in adults 65 years and older. Hospitalization numbers are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is very low nationally.
  • The AHA News points out,
    • “The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a public awareness and education campaign; the launch of an online platform for physicians, researchers and health systems to share best practices and clinical insights; and an Agency for Healthcare Research and Quality report also released Sept. 18 that covers the sources of health coverage for adults with long COVID.” 
  • Fierce Pharma lets us know,
    • “The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. 
    • “The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
    • “Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
  • Per Health Day,
    • “Aspirin can cut by more than half the risk that colon cancer will come back following initial treatment, a new clinical trial has found.
    • “Daily aspirin reduced by 55% the risk of cancer recurrence in patients whose colorectal cancer is driven by a genetic mutation, researchers reported Sept. 17 in the New England Journal of Medicine.
    • “Aspirin is a drug that is readily available globally and extremely inexpensive compared to many modern cancer drugs, which is very positive,” lead researcher Anna Martling, a professor of molecular medicine and surgery at Karolinska Institute in Sweden, said in a news release.
    • “The study focused on people whose colon cancer was driven by a mutation of the PIK3 gene, which helps regulate cell growth and division in the human body.
    • “Every year, about 107,320 new cases of colon cancer and 46,950 cases of rectal cancer are diagnosed in the United States, according to the American Cancer Society.”
  • NBC News reports,
    • “Wildfire smoke is responsible for tens of thousands of deaths each year and will do more harm to U.S. residents by midcentury than any other threat driven by climate change, including extreme heat. 
    • “That’s the conclusion of a new research paper that provides some of the most extensive modeling of the growing health toll of wildfire smoke on public health in the U.S. 
    • “The study, which was published in the journal Nature on Thursday, found that each year, on average, wildfire smoke is causing more than 41,400 excess deaths, or more than would be normally expected without smoke given the demographics of the U.S. That figure is more than twice what was previously recognized in other studies. 
    • “By midcentury, the study’s authors expect that number to grow by an additional 26,500 to 30,000 deaths as human-caused climate change worsens and the risk of wildfires igniting increases. 
    • “Wildfire smoke is a much larger health risk than we might have understood previously,” said Marshall Burke, a professor of environmental social sciences at Stanford University and a study author.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are working directly with employers to improve cancer care and lower costs as demand — and employers’ healthcare expenses — surge.
    • “Providers are gearing up to treat more cancer patients, hoping to ease employers’ mounting frustration with steep premium increases, long appointment wait times and unnecessary treatment, health system and care navigation company executives said. Cutting out insurers through direct contracts could add transparency to employers’ healthcare costs and help standardize treatment strategies, they said.
    • “Employers and unions have no choice but to take a really hard look at solutions that are going to steer patients to high-quality and lower-cost care,” said Emily Kauff, executive director of Memorial Sloan Kettering Cancer Center’s MSK Direct. “Employers are in crisis — they need lower costs and better value in cancer care.”
  • Beckers Payer Issues adds,
    • “Patients who get primary care from older adult-focused, value-based care organizations are more likely to use these services regularly, according to a study published in NEJM Catalyst: Innovations in Care Delivery, a digital journal published by The New England Journal of Medicine. 
    • “The study, produced by Humana Healthcare Research and Suhas Gondi, MD, attending physician at Boston-based Massachusetts General Hospital, covered 3.2 million Medicare Advantage members and included six older adult-focused facilities, most full-risk practices, according to Humana Chief Medical Officer Kate Goodrich, MD. The team found value-based care — as opposed to physicians offering a greater volume of services — is linked to increased use of primary care services.
    • “The exciting thing about this paper is that it shows that in those higher or more mature types of practices that are focused on seniors, they’re getting more primary care, and they’re getting more consistent primary care,” Dr. Goodrich told Becker’s.
    • “This research builds from a 2024 study on how older adult-focused organizations can increase access to primary care, particularly among underserved populations.”
  • Per Modern Healthcare,
    • “UnitedHealth Group has named Sandeep Dadlani CEO of its Optum Insight technology arm, Dadlani announced in a social media post Thursday. 
    • “Dadlani previously served as UnitedHealth’s executive vice president and chief digital and technology officer. He succeeds Dhivya Suryadevara, who had served in that role and CEO of the Optum Financial healthcare banking division since May.
    • “In a LinkedIn post, Dadlani wrote that it was his first week as CEO of Optum Insight, which includes the Change Healthcare claims processing division.” 
  • and
    • “VillageMD is selling 32 Texas clinics to Harbor Health, an Austin-based primary and specialty clinic group that also offers health plans.
    • “The deal includes 10 clinics in Austin, 10 in San Antonio, six in El Paso and six in Dallas. More than 80 clinicians will join Harbor as part of the transaction, according to a Thursday news release. 
    • “Financial details were not disclosed.”
  • Beckers Payers Issues looks into why Blue Cross of Massachusetts consistently achieves a very high NCQA scorecard.