Cybersecurity Saturday

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the CrowdStrike outage front,

  • TechTarget offers lessons learned from the CrowdStrike outage.
  • Cybersecurity Dive includes an opinion piece from Deepak Kumar, the founder and CEO of Adaptiva.
    • “Patching remains a top priority for every organization, but slow, manual, and reactive patching presents far more risk than benefit. Automated patching without the capability to pause, cancel, or roll back can be reckless and lead to disruptions or worse. 
    • “Automated patching, with the necessary controls, is undoubtedly the best path forward, offering the speed needed to thwart bad actors and the control required to prevent an errant update from causing widespread issues.”

From the cybersecurity policy front,

  • Cyberscoop informs us,
    • “Federal contractors would be required to implement vulnerability disclosure policies that align with National Institute of Standards and Technology guidelines under a bipartisan Senate bill introduced last week.
    • “The Federal Contractor Cybersecurity Vulnerability Reduction Act of 2024 from Sens. Mark Warner, D-Va., and James Lankford, R-Okla., is a companion to legislation from Rep. Nancy Mace, R-S.C., which was advanced by the House Oversight Committee in May.
    • “The bill from Warner and Lankford on vulnerability disclosure policies (VDPs) aims to create a structure for contractors to receive reports of vulnerabilities in their products and then act against them before an attack occurs.
    • “VDPs are a crucial tool used to proactively identify and address software vulnerabilities,” Warner said in a statement. “This legislation will ensure that federal contractors, along with federal agencies, are adhering to national guidelines that will better protect our critical infrastructure, and sensitive data from potential attacks.”
  • Cybersecurity Dive reports from the Black Hat cybersecurity conference held at Las Vegas in the first week of August,
    • Despite a stream of devastating cyberattacks or mistakes that halt or disrupt large swaths of the economy, Jen Easterly, director of the Cybersecurity and Infrastructure Security Agency, says the war against malicious activity is not lost.
    • It is possible to elevate organizations’ ability to repel or mitigate attacks and place a greater emphasis on vendors’ responsibilities, Easterly said Wednesday during a media briefing at Black Hat. “We got ourselves into this, we have to get ourselves out,” she said.
    • Easterly’s optimism isn’t the result of blind trust. “We have made enormous progress, even just over the past several years,” she said.” * * *
    • “We have to recognize that the cybersecurity industry exists because technology vendors for decades have been allowed to create defective, flawed, insecure software that prioritizes speed to market features over security,” Easterly said. 
    • “There is more we can do but that’s where the war will be won,” Easterly said. “If we put aside the threat actors and we put aside the victims and we talk about the vendors.”
  • and
    • It’s time to stop thinking of threat groups as supervillains, experts say
    • “These villains do not have superpowers. We should not treat them like they do,” * * *
    • “The vast majority of organizations don’t have the time or resources to keep up with the chaos of tracking cybercriminal groups, Andy Piazza, senior director of threat intel at Palo Alto Networks Unit 42, said in an interview at Black Hat.
    • “You as a defender shouldn’t care about that,” Piazza said. Defenders can better serve their organizations by developing capabilities to detect and respond to malicious tactics, techniques and procedures, Piazza said.
    • “It’s hard to ignore the drama when groups are given names like Scattered Spider, Midnight Blizzard and Fancy Bear, but mythologizing the criminals responsible for cyberattacks can diminish defenders’ ability to detect and thwart malicious activity.”
  • FedScoop lets us know,
    • “The National Institute of Standards and Technology has officially released three new encryption standards that are designed to fortify cryptographic protections against future cyberattacks by quantum computers.
    • “The finalized standards come roughly eight years after NIST began efforts to prepare for a not-so-far-off future where quantum computing capabilities can crack current methods of encryption, jeopardizing crucial and sensitive information held by organizations and governments worldwide. Those quantum technologies could appear within a decade, according to a RAND Corp. article cited by NIST in the Tuesday announcement.
    • “Quantum computing technology could become a force for solving many of society’s most intractable problems, and the new standards represent NIST’s commitment to ensuring it will not simultaneously disrupt our security,” Laurie E. Locascio, director of the Department of Commerce’s NIST and undersecretary of commerce for standards and technology, said in a statement. “These finalized standards are the capstone of NIST’s efforts to safeguard our confidential electronic information.”
    • “The new standards provide computer code and instructions for implementing algorithms for general encryption and digital signatures — algorithms that serve as authentication for an array of electronic messages, from emails to credit card transactions.”
  • Federal News Network adds,
    • “CISA Director Jen Easterly said in a keynote at The White House Office of Management and Budget will soon direct agencies to map out plans for adopting post-quantum encryption to protect their most sensitive systems and data.
    • “Federal Chief Information Office Clare Martorana said the new guidance will help agencies begin to adopt new cryptographic standards from the National Institute of Standards and Technology.
    • “We will be releasing guidance directing agencies to develop a prioritized migration plan to ensure that the most sensitive systems come first,” Martorana said during an event hosted by the White House today. “We can’t do it alone. It’s critical that we continue to foster robust collaboration and knowledge sharing between public and private sectors, which is why conversations like the one we’re having today are so incredibly critical.”

From the cybersecurity vulnerabilities and breaches front,

  • The Cybersecurity and Infrastructure Security Administration (CISA) added seven known exploited vulnerabilities (KEV) to its catalog this week. NIST initially identifies the KEVs, which explains the Senate bill discussed above, and then CISA publicizes those KEVs in its catalog
  • Cybersecurity Dive notes,
    • “A vulnerability in the common log file system of Microsoft Windows can lead to the blue screen of death, impacting all versions of Windows 10 and Windows 11, researchers from Fortra said Monday.  
    • “The vulnerability, listed as CVE-2024- 6768, is caused by improper validation of specified quantities of input data, according to a report by Fortra. The vulnerability can result in an unrecoverable inconsistency and trigger a function called KeBugCheckEx, leading to the blue screen. 
    • “A malicious hacker can exploit the flaw to trigger repeated crashes, disrupting system operations and the potential loss of data, according to Fortra.”
  • TechTarget explains why “recent cyberattacks against OneBlood and McLaren Health Care shed light on the operational challenges that targeted organizations face.”

From the ransomware front,

  • A Dark Reading commentator explains that to avoid losing the ransomware battle, companies that are “institutionalizing and sustaining fundamental cybersecurity practices” also must “commit to ongoing vigilance, active management, and a comprehensive understanding of evolving threats.”
    • “The challenge of institutionalizing and sustaining fundamental cybersecurity practices is multifaceted. It requires a commitment to ongoing vigilance, active management, and a comprehensive understanding of evolving threats. However, by addressing these challenges head-on and ensuring that cybersecurity practices are implemented, measured, and maintained with rigor, organizations can better protect themselves against the ever-present threat of ransomware attacks. Focusing on the basics first — such as implementing foundational controls like 2FA, fostering maintenance skills to integrate IT and security efforts, and adopting performance management practices — can lead to significant improvements in cybersecurity, providing robust protection with less investment.”
  • Cybersecurity Dive points out,
    • “Cyber risk company Resilience said in a report unveiled Tuesday that ransomware has remained a top threat since January 2023, with 64% of related claims in its portfolio resulting in a loss during that period.
    • “Increased merger-and-acquisition activity and reliance on ubiquitous software vendors created new opportunities for threat actors to unleash widespread ransomware campaigns by exploiting a single point of failure, the report said.
    • “Now more than ever, we need to rethink how the C-suite approaches cyber risk,” Resilience CEO Vishaal Hariprasad said in a press release. “Businesses are interconnected like never before, and their resilience now depends on that of their partners and others in the industry.”
  • Per Bleeping Computers,
    • “RansomHub ransomware operators are now deploying new malware to disable Endpoint Detection and Response (EDR) security software in Bring Your Own Vulnerable Driver (BYOVD) attacks.
    • “Named EDRKillShifter by Sophos security researchers who discovered it during a May 2024 ransomware investigation, the malware deploys a legitimate, vulnerable driver on targeted devices to escalate privileges, disable security solutions, and take control of the system.
    • “This technique is very popular among various threat actors, ranging from financially motivated ransomware gangs to state-backed hacking groups.”
  • and
    • “Background check service National Public Data confirms that hackers breached its systems after threat actors leaked a stolen database with millions of social security numbers and other sensitive personal information. 
    • “The company states that the breached data may include names, email addresses, phone numbers, social security numbers (SSNs), and postal addresses.”

From the cybersecurity defenses front,

  • The American Hospital Association’s National Advisor for Cybersecurity and Risk, John Riggi, explains how healthcare entities should prepare for third party cyber risk.
  • The Wall Street Journal shares remarks from a June 2024 WSJ conference on what can be learned from the Change Healthcare cyber-attack. “Two security experts explain why the hack affected so many institutions and people—and what could be done to protect the healthcare system.”
  • For several months, the FEHBlog has not been able to access the HHS 405(d) program website. Magically this week, he regained access. Here is a link to the program’s July 2024 post which concerns the urgent need for data security in healthcare AI.

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The battle to empower the federal government to negotiate lower prices for Medicare enrollees was years in the making. The war has just begun. 
    • “After years of opposition from the pharmaceutical industry and lawsuits seeking to halt the law that led to the new prices, resistance paled and legal efforts failed. The talks settled into a sometimes testy back and forth: hundreds of pages of paperwork, offers and rejected counteroffers, then rounds of meetings in windowless rooms with strict rules on how many people could attend.
    • During the meetings, many manufacturers lowered counter offers while federal officials moved up from their initial offers, said Meena Seshamani, director of the Center for Medicare and a deputy administrator of Medicare’s parent agency, the Centers for Medicare and Medicaid Services.” * * *
    • “Round two is just around the corner. 
    • “Companies and officials are already preparing for negotiations over more drugs that could take a bigger bite out of high drug costs, and possibly their bottom lines. Next up are prices of 15 more drugs the government will identify by Feb 1. 
    • “The two sides are also fighting over how the talks should work. Among the drug industry’s demands: clarity on how CMS determines the price of a drug. Drug companies are also fighting the agency’s potential changes for next year, including possibly cutting back the number of in-person meetings to fewer than three.”
  • Federal News Network informs us,
    • “Scores of House Democrats are calling on the Postal Service to adopt stricter workplace protections for extreme heat.
    • “The 77 House Democrats are calling on USPS to “immediately implement” the standards in the workplace heat rule the Occupational Safety and Health Administration (OSHA) proposed last month.
    • “Proactively implementing this rule would save lives by ensuring that your workforce is protected with the most up-to-date heat safety standards,” the lawmakers wrote in a letter to Postmaster General Louis DeJoy.
    • “The proposed rule, if finalized, would be the nation’s first-ever federal heat rule.”
  • and
    • “Federal employees on official travel will soon enjoy another bump in reimbursable travel costs, as the General Services Administration has increased per diem rates for lodging and meals.
    • “Starting Oct. 1, the reimbursable daily limit will rise to $178, from $166 last year. This increase marks the third consecutive year feds saw lodging rates go up, while rates for meals and incidental expenses (M&IE) last went up in 2022.
    • “The standard per diem lodging rate within the continental United States (CONUS) went up from $107 to $110, while the rates for M&IE increased from a range of $59 to $79, to a range of $68 to $92.
    • ‘Agencies [and experience rated FEHB contractors] use per diem rates to reimburse employees for lodging and M&IE during official travel. Even with inflation growth in the U.S. now losing steam, the continued increase in per diem rates reflect the persistent rise in overall costs that Americans face across the board.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention tells us,
    • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • COVID-19
      • “Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
    • Influenza
    • RSV
      • “Nationally, RSV activity remains low.”
    • Vaccination
  • Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 are at the very high level for the second straight week. The highest levels are still in the West and South, followed by the Midwest and the Northeast. The CDC’s latest update, however, shows downward trends from high levels in the South and Midwest.” 
  • The Washington Post reports,
    • “Federal authorities are preparing to approve updated coronavirus vaccines targeting the latest virus variants late next week, a move that could make shots available before Labor Day, according to a federal health official and a person familiar with the plans who spoke on the condition of anonymity to discuss a confidential process.
    • “The mRNA shots manufactured by Pfizer-BioNTech and Moderna designed to target the KP.2 variant can hit the market within days of approval by the Food and Drug Administration. A third protein-based vaccine made by Novavax, preferred by people who are cautious about mRNA vaccines or who have had bad reactions to them, will probably take longer to be approved and will be distributed in subsequent weeks, according to the federal health official.
    • “Consumers should be able to start getting shots at pharmacies within a week after approval and at doctor’s offices soon after.”
  • and
    • “The Food and Drug Administration on Friday authorized the first at-home [, over the counter,] syphilis test amid surging cases of the bacterial infection and calls from federal health officials for innovative strategies to detect the disease.
    • “The manufacturer, NowDiagnostics, anticipates the 15-minute test called First to Know, being available in pharmacies, major retail stores and online as early as September. FDA staff hailed the new product as an advancement in testing for sexually transmitted illnesses but noted that an additional test by a health-care provider is needed to confirm a positive result.
    • “Syphilis was nearly eliminated in the 1990s, but rates have since soared to a 70-year high. Between 2018 and 2022, cases rose nearly 80 percent, according to the most recent data from the Centers for Disease Control and Prevention.
  • Per BioPharma Dive,
    • “Pfizer and BioNTech on Friday said a combination flu and COVID-19 shot they’ve been developing met one of its main goals in a Phase 3 trial but missed another, leaving the vaccine’s future in doubt. 
    • ‘The study tested Pfizer and BioNTech’s vaccine against separately administered, marketed COVID and flu shots in more than 8,000 people between the ages of 18 and 64. While the combination vaccine spurred a comparable immune response against COVID and influenza A, it didn’t meet that mark against the “B” strain of the flu.  
    • “As a result, two companies are “evaluating adjustments” that would improve the vaccine’s performance against influenza B while discussing next steps with health authorities.”
  • STAT News adds,
    • “The National Institutes of Health said Thursday that an antiviral often used to treat mpox did not resolve patients’ symptoms faster than placebo in a randomized trial.
    • “The results are notable because the drug, tecovirimat, has rarely been studied clinically for mpox, despite its wide use during the 2022 and 2023 outbreaks in the U.S. and Europe.”  
  • The American Medical Association shares “Top health tips sleep medicine physicians want you to know.”
  • Per Healio,
    • “Among a select group of women with uterine factor infertility, uterus transplant was feasible and associated with a high live birth rate after successful graft survival, data from a case series show.
    • “In an analysis of the Dallas Uterus Transplant Study (DUETS), researchers also found that although adverse events were common, including complications requiring surgical intervention, infants born to women who received a uterine transplant had no congenital abnormalities or developmental delays, though follow-up of the cohort is ongoing.
    • “We show that uterus transplantation is not only feasible and safe, but also associated with a success rate that is comparable with and even favorable to other infertility treatments,” Liza Johannesson, MD, PhD, of the Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center, told Healio. “[What is] important is that the children born after uterus transplant are healthy and developing normally.”
  • Medscape offers an interview with a Harvard medical professor about preventing dementia.
    • “Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a new report on the preventability of dementia that is both exciting and paradigm-shifting. The new study, published in The Lancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors.”

From the U.S. healthcare business front,

  • MedCity News discusses the future of retail healthcare.
  • Behavioral Health Business lists the 40 fastest growing behavioral health companies in the U.S.
  • Per Reuters,
    • “Older Americans are having little success getting prescriptions for weight-loss drug Wegovy covered by Medicare despite the federal healthcare program’s decision to pay for patients with obesity at risk of heart disease, according to their doctors.
    • “In interviews with Reuters, seven obesity and heart disease specialists from various parts of the United States said their prescriptions for the Novo Nordisk (NOVOb.CO), opens new tab drug have been denied repeatedly by the healthcare companies that administer Medicare drug benefits, with some prescriptions approved only following an appeal for each application.”
  • Per Fierce Healthcare,
    • “Massachusetts’ governor has announced that deals in principle have been reached for Steward Health Care’s four remaining hospitals in Massachusetts.
    • “Should the deals be finalized, Lawrence General Hospital will operate both campuses of Holy Family in Haverhill and Methuen. Lifespan would take over operations of Morton Hospital and Saint Anne’s Hospital. Boston Medical Center will take over operations of Good Samaritan Medical Center.
    • “Boston Medical Center also intends to operate Saint Elizabeth’s down the line. The state is first taking control of the hospital through eminent domain, according to an announcement from the governor’s office.”

Thursday Miscellany

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Aug. 15 announced it negotiated lower prices with drug makers for 10 high-cost, sole-source drugs, with the new prices becoming effective in 2026 for individuals with Medicare Part D coverage. The drugs treat conditions such as heart disease, diabetes and cancer, and about nine million Medicare beneficiaries use at least one of the 10 drugs selected for negotiation. The new prices are estimated to save $1.5 billion in out-of-pocket costs for individuals with coverage. A CMS fact sheet includes more information about the newly negotiated prices. The agency last year announced the first list of 10 Medicare Part D drugs subject to price negotiations.”
  • STAT News cautions,
    • “The White House is touting just how much its new Medicare negotiation process cut drug prices. The problem is the numbers it’s using don’t actually mean much.”
    • “In a striking side-by-side comparison, President Biden tweeted out a graphic showing newly negotiated prices that Medicare will pay for 10 drugs including blood thinners, cancer treatments, and diabetes medications, among others. The table compares the new prices to the list price of the medicines last year, showing discounts ranging from hundreds to thousands of dollars. 
    • “However, Medicare generally doesn’t pay list prices for medications. Currently, prescription drug plans negotiate discounts off of the list prices at a smaller scale than the new program — but those prices are secret, even in a public program.
    • “The White House did release more meaningful overall numbers tied to the amount Medicare actually pays for drugs that show discounts of roughly 22% on the 10 drugs collectively, compared to what the program paid last year. That’s more modest than the exaggerated discounts based on list prices that show price reductions of up to 79%.”
  • In any case, why didn’t Congress align the effective dates for the enormous consumer improvements in Part D, discussed yesterday, with the “negotiated prices”?
  • Govexec tells us,
    • “The Biden administration on Wednesday announced a new initiative aimed at improving the hiring process for federal job applicants, hiring managers and other agency HR officials alike, as the White House continues to search for ways to speed up the process and better compete for top talent.
    • “Strategic human capital management has been on the Government Accountability Office’s famed High-Risk List, a biennial report highlighting issues that present potential liabilities of at least $1 billion for the federal government, for more than two decades. In 2021, GAO found that the government had actually regressed in its effort to address difficulties in hiring new federal workers during the final two years of the Trump administration.
    • “The Office of Personnel Management and Office of Management and Budget worked jointly on the effort, announced Wednesday in a memo to agency heads entitled “Improving the Federal Hiring Experience.” The document encompasses plans to improve strategic workforce planning, making it easier for potential job applicants to find jobs they are interested in and making the hiring process both faster and more transparent for jobseekers, as well as making hiring less agonizing for the hiring managers and other human resources personnel.”
  • The Food and Drug Administration announced,
    • “Today, the U.S. Food and Drug Administration marked a milestone building on Phase I of its voluntary sodium reduction targets and issued draft guidance for Phase II in a data-driven, stepwise approach to help sodium reduction across the food supply. Prior to 2021, consumer intake was approximately 3,400 milligrams per day on average, far higher than the limit recommended by the Dietary Guidelines for Americans of 2,300 milligrams per day for those 14 years and older. If finalized, the new set of voluntary targets would support reducing average individual sodium intake to about 2,750 milligrams per day. This reduction is approximately 20% lower than consumer intake levels prior to 2021. 
    • “The Phase II voluntary sodium reduction targets follow an initial set of targets issued in October 2021. The initial set of targets encouraged the food industry to reduce sodium levels in a wide variety of processed, packaged, and prepared foods. Preliminary data from 2022 show about 40% of the initial Phase I targets are very close to or have already been reached indicating early success of this effort.”
  • FedWeek explains the uncommon exceptions to the FEHB Program’s five-year rule which governs whether a federal employee can continue FEHB coverage into a civil service retirement with the full government contribution.

From the public health and medical research front,

  • CNN reports,
    • “Americans, and especially those under age 35, are changing their tune on alcohol use, with a growing share endorsing the view that moderate drinking is bad for health — and a new study backs them up.
    • “According to a Gallup poll released Tuesday, almost half of Americans, 45%, say that having one or two alcoholic drinks a day is bad for a person’s health. That’s the highest percentage yet recorded by the survey, which has been conducted 10 times since 2001.”
  • The National Institutes of Health (NIH) Director, writing in her blog, discusses “Mapping Psilocybin’s Brain Effects to Explore Potential for Treating Mental Health Disorders.”
    • “Psilocybin is a natural ingredient found in “magic mushrooms.” A single dose of this psychedelic can distort a person’s perception of time and space, as well as their sense of self, for hours. It can also trigger strong emotions, ranging from euphoria to fear. While psilocybin comes with health risks and isn’t recommended for recreational use, there’s growing evidence that—under the right conditions—its effects on the brain might be harnessed in the future to help treat substance use disorders or mental illnesses.
    • “To explore this potential, it will be important to understand how psilocybin exerts its effects on the human brain. Now, a study in Nature supported in part by NIH has taken a step in this direction, using functional brain mapping in healthy adults before, during, and after taking psilocybin to visualize its impact. While earlier studies in animals suggested that psilocybin makes key brain areas more adaptable or “plastic,” this new research aims to clarify changes in the function of larger brain networks and their connection to the experiences people have with this psychedelic drug.”
    • The blog explains the latest research.
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has launched a program that will support Native American communities to lead public health research to address overdose, substance use, and pain, including related factors such as mental health and wellness. Despite the inherent strengths in Tribal communities, and driven in part by social determinants of health, Native American communities face unique health disparities related to the opioid crisis. For instance, in recent years, overdose death rates have been highest among American Indian and Alaska Native people. Research prioritized by Native communities is essential for enhancing effective, culturally grounded public health interventions and promoting positive health outcomes.”
  • The New York Times reports that “In an experiment that surpassed expectations, implants in an ALS patient’s brain were able to recognize words he tried to speak, and A.I. helped produce sounds that came close to matching his true voice.” Truly amazing.
  • Per Healio,
    • “Women with vs. without cognitive impairment had more intense menopause symptoms.
    • ‘Lower BMI, sexual activity, exercise, hormone therapy use, and higher education were tied to lower cognitive impairment odds.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Employer-sponsored health plan costs are expected to rise 9% in 2025, totaling more than $16,000 per employee before cost-saving measures, according to professional services and consulting company Aon.
    • “Aon predicts that demand for prescription drugs such as glucagon-like peptide-1 agonists and growth in medical claims for high-cost treatments such as gene and cell therapies are among the main drivers of rising costs for employers.
    • Janet Faircloth, senior vice president of innovation and integrated solutions for Aon, said employers are expected to apply cost-saving strategies used in previous years, including raising out-of-pocket costs for employees and bidding between insurers for the best price.
    • For 2024, Aon predicted health plan costs would increase by 8.5%, but the firm projects employer cost-saving efforts are likely to hold the increase to 6.4% overall.
    • “We generally see a 1% to 2% reduction from the initial trend expectation after employers make their changes,” Faircloth said.
    • The International Foundation of Employee Benefit Plans released a similar report Thursday, estimating employer-sponsored health plan costs would rise 8% in 2025 due to the same factors Aon cited.
  • Per Healthcare Dive,
    • “Health insurers have invested heavily in building out their Medicare and Medicaid businesses in recent years, tempted by the prospect of healthy margins and growing membership in the government-run insurance programs.
    • “But privately run Medicare Advantage and safety-net Medicaid plans are seeing their profitability shrink amid ongoing operational pressures, creating a sharp reversal in expected fortunes — much to health insurance executives’ chagrin.
    • “For much of the past year, insurers bemoaned the headwinds in MA as seniors using more medical care caused spending to snowball. But in the second quarter, many payers suggested Medicaid has become a bigger problem, as states remove ineligible beneficiaries from the safety-net coverage, sickening insurers’ risk pools and saddling them with higher costs.”
  • Beckers Payer Issues illustrates the fact that “The CEOs of the six largest for-profit insurers have different perspectives on Medicare Advantage.” 
  • Per a Health Care Cost Institute announcement,
    • “Technological medical advancements have shifted an array of procedures previously rendered in inpatient hospitals to ambulatory surgical centers (ASCs). For example, same-day procedures (e.g., cataracts surgery) that do not require an overnight hospital stay and musculoskeletal procedures, such as arthroscopy, are commonly performed at ASCs. 
    • “Because they operate independently of brick-and-mortar hospital facilities, ASCs are considered “off site.” Compared to procedures rendered in hospital outpatient departments, ASC’s receive lower reimbursement. For low-risk procedures, ASCs may be a cost-efficient site of care. Recent market analysis found that procedures at ASCs have grown over time and now account for half of all outpatient surgeries. 
    • “In this brief, we compare employer-sponsored insurance (ESI) ASC reimbursement amounts for a subset of procedures to Medicare fee-for-service (FFS) payment for the same procedures. We find that, on average, ESI pays two times more than Medicare FFS for procedures provided at ASCs. If ESI reimbursed at Medicare average rates, spending would have been nearly $9 billion lower in 2021.”
  • Per Beckers Hospital Review,
    • “Cleveland Clinic saw an operating income of $45.3 million at a 1.2% margin in the second quarter of 2024 for the three months ended June 30, a 312% increase from a $21.4 million operating loss (-0.6% margin) during the second quarter of 2023, according to its Aug. 16 financial report.
    • “Total revenue for the system was $3.9 billion in the second quarter of 2024, up from $3.6 billion during the same period last year. 
    • “Net income for the health system was $187.8 million for the three months ended June 30, 2024, up from $145.2 million during the second quarter of 2023.
    • “Expenses increased 8% to $3.7 billion, with salaries, wages and benefits also increasing 8% to $2.3 billion. Cleveland Clinics outstanding and long term debt was $5.4 billion, the report said.” 
  • Per MedTech Dive,
    • “Neuronetics said Monday it has agreed to merge with Greenbrook TMS to acquire treatment centers that use its mental health devices.
    • “Greenbrook provides transcranial magnetic stimulation (TMS) and other mood treatments from 130 sites. Neuronetics sells a TMS device to treat major depressive disorder (MDD).
    • “William Blair analysts said in a note to investors that the merger changes Neuronetics’ profile “from device-centric to a device-service business operating brick-and-mortar facilities.”
  • Per Reuters,
    • “Eli Lilly (LLY.N) has sent cease-and-desist letters to U.S. healthcare providers in recent days to stop the promotion of the compounded versions of its drugs for weight loss and diabetes, as their supply increases, the company said on Wednesday.
    • “The letters were sent to telehealth companies, wellness centers and medical spas selling compounded versions of the drugmaker’s popular treatments Zepbound and Mounjaro, a spokesperson told Reuters.”

Midweek Update

David Ermer–CDC, FDA, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Kevin Moss, writing in Govexec, explains the pros and cons of Medicare Part D coverage for FEHB annuitants over age 65. The key point is that for 2025 the Medicare Part D out of pocket maximum is $2000. Also, Part D members with higher Part D cost sharing can spread out the Part D cost sharing over the plan / calendar year using Medicare Part D’s new Medicare Prescription Payment Plan (MPPP). The MPPP savings coupled with the $2000 out of pocket max could make Part D valuable for folks who otherwise would use manufacturer coupons.  
  • Although not discussed in the Govexec article, Postal Service Health Benefit (PSHB) annuitants over age 65 generally will be required to use the PSHB plan’s Part D EGWP. Those who opt out are ineligible for the PSHB plan’s regular Rx benefits, and there’s no concomitant premium reduction. We are waiting for OPM’s final supplemental PSHB rule which will include the Part D opt out penalty details.
  • Politico discusses a Biden Harris administration initiative to subsidize standalone Part D plans with a a $15 per Part D member payment to stabilize Part D premiums in consideration of these significant Part D improvements. The article observes,
    • “The Part D market has two types of plans. One is a standalone plan that only offers drug coverage, and the other is coverage included in a privately run Medicare Advantage plan that covers other health services.
    • “Medicare Advantage plans can absorb higher costs better than a standalone option, according to a 2023 analysis from the consulting firm Avalere Health.
    • “Since a Medicare Advantage plan offers a wide array of both medical and drug benefits, it can spread out the cost impact. Standalone plans do not have such flexibility, and the law is causing some to exit the market.”
  • It’s worth noting that Part D EGWPs absorb the basic Part D premium typically charged to the Medicare beneficiary. Part D EGWPs do not absorb the extra IRMAA tax on high income Medicare beneficiaries.
  • Last week, the Centers for Medicare and Medicaid Services released 2025 enrollment and disenrollment guidance for Medicare Advantage and Part D plans.
  • KFF adds,
    • “Among the 167 million people with employer-sponsored insurance in 2022, 3.4 million used at least one of the first 10 drugs identified for Medicare price negotiations, according to a new KFF analysis. Medicare is expected to release the negotiated drug prices, which will go into effect in 2026, by no later than September 1, 2024.
    • “The most used drug for people with employer-sponsored health insurance was Jardiance, a drug used to treat diabetes and heart failure, which was taken by more than 911,000 enrollees.
    • In the future, the Medicare program will negotiate prices for additional drugs, which millions more people with employer coverage could also be taking. As the policy currently stands, lowering drug prices in Medicare has no direct effect on private insurance plans, and the indirect effects are still unclear. Some argue lower negotiated prices in Medicare will result in higher prices in private insurance plans, while others suggest Medicare prices could serve as a benchmark and lead to savings.
    • “The full analysis and other data on health costs are available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
  • Per HHS press releases,
    • “This week, the Africa Centres for Disease Control and Prevention (Africa CDC) declared the mpox clade I outbreak a Public Health Emergency of Continental Security, and the World Health Organization (WHO) declared this outbreak a Public Health Emergency of International Concern. The United States government supports those declarations. The United States will continue to work closely with African governments, Africa CDC and WHO to ensure an effective response to the current outbreak and to protect the health and lives of people of the region.” * * *
    • “The risk to the general public in the United States from clade I mpox circulating in the DRC is very low, and there are no known cases in the United States at this time. Due to efforts over the last nine months, the United States is well prepared to rapidly detect, contain, and manage clade I cases should they be identified domestically. The United States has a robust surveillance system in place, including through clinical testing and wastewater analysis. We continue to encourage those at high risk to get vaccinated with the JYNNEOS mpox vaccine, which has been demonstrated to be safe and highly effective at preventing severe disease from mpox. Those who have already had clade II mpox or are fully vaccinated against mpox are expected to be protected against severe illness from clade I mpox.
    • “CDC has issued an updated Health Alert Network advisory urging clinicians to consider clade I mpox in people who have been in DRC or neighboring countries in the previous 21 days; clinicians are also asked to submit specimens for clade-specific testing for these patients if they have symptoms consistent with mpox. Given the geographic spread of clade I mpox, the U.S. CDC issued an updated Travel Health Notice on Aug. 7, 2024, recommending travelers to DRC and neighboring countries practice enhanced precautions.”
  • and
    • “The federal interagency National Integrated Heat Health Information System (NIHHIS) today released a National Heat Strategy for 2024-2030. The strategy aims to promote proactive coordination related to heat planning, response, and resilience. * * *
    • “For more information on the National Heat Strategy, please click here – PDF. To learn more about HHS’ climate change-related efforts, please visit HHS’ Office of Climate Change and Health Equity. To find more information about the federal government’s heat-related initiatives and resources, please visit heat.gov.”
  • STAT News informs us,
    • “The Food and Drug Administration on Wednesday approved a new treatment for primary biliary cholangitis, an autoimmune liver disease mainly affecting women that causes decreased liver function, debilitating itching, and fatigue.
    • “The drug, called Livdelzi, will be sold by Gilead Sciences, following the $4.3 billion acquisition of CymaBay Therapeutics, its developer, earlier this year.
    • “Regulators cleared Livdelzi for patients with primary biliary cholangitis, or PBC, that doesn’t respond adequately to initial treatment with a commonly used medicine. Gilead estimates there are approximately 130,000 people in the U.S. who are impacted by PBC, of which about 30,000 to 40,000 don’t respond to first-line therapy.
    • “Competition will come primarily from two drugs: Ipsen’s Iqirvo, which won FDA approval in June; and an older medicine called Ocaliva, developed by Intercept Pharma and recently acquired by Alfasigma, an Italian pharmaceutical firm.
    • “There’s still a real need out there for patients with PBC today, despite all the new arrivals. We believe Livdelzi can make a real difference for these people,” said Gilead Chief Commercial Officer Johanna Mercier.”

From the public health and medical research front,

  • The American Hospital Association News lets us know,
    • “The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a seasonal respiratory virus spread by respiratory droplets through symptomatic or asymptomatic individuals. Many people are asymptomatic, but immunocompetent children and adults with symptomatic disease typically develop a biphasic illness, CDC said. The first phase lasts approximately five days and includes symptoms of fever, myalgia and malaise, which develop about a week after infection. During the second phase, children often develop a facial rash which may be followed by reticulated body rash or joint pain one to four days later. For immunocompetent adults, the most common symptoms of parvovirus B19 disease typically occur during the second phase and include a reticular rash on the trunk and joint pain. Parvovirus B19 infection could also lead to adverse health outcomes among people without pre-existing immunity who are pregnant, immunocompromised or have chronic hemolytic disorders.”
  • Here is a link to the National Cancer Institute’s latest cancer information highlights.
  • Per National Institutes of Health press releases,
    • “Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages. Both dosages of the vaccine candidate conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over a span of two years without the need for a booster dose—a first for any malaria vaccine. In an exploratory analysis of women who conceived during the study, the vaccine significantly protected them from malaria in pregnancy. If confirmed through additional clinical trials, the approach modeled in this study could open improved ways to prevent malaria in pregnancy.
    • “Spread by Anopheles mosquitoes, malaria parasites, including those of the species Plasmodium falciparum (Pf), can cause illness in people of any age. However, pregnant women, infants and very young children are especially vulnerable to life-threatening disease. Malarial parasitemia in pregnancy is estimated to cause up to 50,000 maternal deaths and 200,000 stillbirths in Africa each year.  
  • and
    • “National Institutes of Health (NIH) researchers discover that while artificial intelligence (AI) tools can make accurate diagnoses from textbook-like descriptions of genetic diseases, the tools are significantly less accurate when analyzing summaries written by patients about their own health. These findings, reported in the American Journal of Human Genetics, demonstrate the need to improve these AI tools before they can be applied in health care settings to help make diagnoses and answer patient question.” * * *
    • “For these models to be clinically useful in the future, we need more data, and those data need to reflect the diversity of patients,” said Dr. Ben Solomon [,the study’s senior author]. “Not only do we need to represent all known medical conditions, but also variation in age, race, gender, cultural background and so on, so that the data capture the diversity of patient experiences. Then these models can learn how different people may talk about their conditions.”
    • “Beyond demonstrating areas of improvement, this study highlights the current limitations of large language models and the continued need for human oversight when AI is applied in health care.
    • “These technologies are already rolling out in clinical settings,” Dr. Solomon added. “The biggest questions are no longer about whether clinicians will use AI, but where and how clinicians should use AI, and where should we not use AI to take the best possible care of our patients.”
  • The Washington Post reports,
    • For many, middle age is associated with midlife crises and internal tumult. According to new research, it is also when the human body undergoes two dramatic bouts of rapid physical transformation on a molecular level.
    • In a new study, scientists at Stanford University tracked age-related changes in over 135,000 types of molecules and microbes, sampled from over 100 adults. They discovered that shifts in their abundance — either increasing or decreasing in number — did not occur gradually over time, but clustered around two ages.
    • “Obviously you change throughout your entire life. But there are two major periods when there are lots of changes: One is when people hit their mid-40s, and one is they hit their 60s,” said Michael Snyder, a geneticist at Stanford University who co-wrote the study, in a phone interview. On average, the changes clustered around the ages of 44 and 60.” * * *
    • “The exact reason these molecular changes cluster at the mid-40s and 60s is unclear. But the study’s authors say their findings show that from your 40s, people stand to gain particular benefits from taking care of their health. This includes getting regular medical check ups — at least twice a year once you hit your 40s, Shen suggested — as well as making lifestyle adjustments.”
  • Reuters tells us,
    • “The U.S. Department of Agriculture said on Tuesday it will expand bird-flu testing of beef entering the food supply as part of its response to the ongoing outbreak among dairy cattle, adding that U.S. beef and dairy products remain safe to consume.
    • ‘USDA officials, in a call with reporters along with staff from other U.S. health agencies, said the tests will begin in mid-September and urged livestock workers to remain vigilant.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Elevance and its private equity partner have officially introduced their care delivery platform, called Mosaic Health, after teasing the joint venture earlier this spring.
    • “Mosaic is comprised of two of Clayton, Dubilier and Rice’s primary care portfolio companies — Apree Health and Millennium Physician Group — along with the care delivery and enablement assets of Elevance’s health services division Carelon.
    • “However, Mosaic is launching without Carelon’s advanced primary care platform, according to the announcement on Wednesday. Carelon’s assets will join Mosaic subject to ongoing regulatory approvals. An Elevance spokesperson did not respond to a request for comment on the timeline of approvals.”
  • Per MedTech Dive,
    • “Otsuka’s digital health subsidiary has launched its first product, an app-based treatment for major depressive disorder. 
    • “The app, called Rejoyn, is available only by prescription and is intended to be used in addition to medications. It consists of a six-week program with cognitive behavioral therapy-based video lessons and exercises for identifying emotions. Otsuka announced the launch on Tuesday.
    • “Sanket Shah, president of the Japanese pharmaceutical company’s new Otsuka Precision Health subsidiary, said the treatment was priced at $50 on a cash-pay basis, with the goal of making it accessible. “This is, to be honest, not going to make money,” Shah said in an interview. “We have to put the investment into this to build this out because we do believe in the [digital therapeutics] model and digital solutions and using technology to really help patients.” 
  • Per Fierce Healthcare,
    • “Startup Abridge has notched its largest partnership to date as Kaiser Permanente is making the company’s AI-powered medical note-taking app available to more than 24,000 doctors across its system.
    • “The integrated nonprofit is rolling out Abridge’s technology at 40 hospitals and more than 600 medical offices in eight states and Washington, D.C., the organization announced Wednesday. The health system’s clinical staff includes 24,600 physicians and 73,600 nurses.
    • “Kaiser Permanente’s venture arm also is one of Abridge’s investors. The company, founded in 2018, has raised $212.5 million to date, including a $150 million series C funding round in February.
    • “The health system has worked with Abridge over the past year to implement the AI-based medical documentation technology. Desiree Gandrup-Dupre, senior vice president of care delivery technology services at Kaiser Permanente, said it was the largest implementation to date of ambient listening technology.
    • “At Kaiser Permanente, we have a long history of successfully deploying proven technologies on a broad scale, as we continue to provide health care and services when, how, and where our patients need it,” Gandrup-Dupre said in a statement.
    • “The goal is to help doctors reduce time spent on administrative tasks, allowing them to be more present with patients during medical visits, Kaiser Permanente executives said.”
  • Morningstar points out,
    • “The Social Security cost-of-living adjustment for 2025 could shrink in 2025 from this year’s 3.2% increase as inflation cools. 
    • “COLA could be 2.6% in 2025, according to Mary Johnson, an independent Social Security and Medicare analyst and former analyst with the Senior Citizens League. The new forecast compares to her forecast in July that called for a 2.7% increase. 
    • “The 2.6% increase would be the lowest COLA since 2021, but average for the past 20 years, Johnson said.”

Tuesday Tidbits

David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senator Sherrod Brown (D-OH) announced [on August 12, 2024] the introduction of legislation to make it easier for workers without 4-year college degrees, including veterans, to get federal jobs, and to promote hiring based on workers’ skills rather than the degree they attain.
    • “The Federal Jobs for STARs Act would make federal jobs more accessible for non-degree-holders by taking steps to reduce or remove unnecessary educational requirements and making it easier for Ohioans to search on USAJOBS.com for jobs that match their experience and skills.
  • Federal News Network lets us know,
    • “New instances of fraud in the government’s Flexible Spending Account program, FSAFEDS, are dwindling. But the investigation into the issue remains ongoing. In total, fraudulent activity in the Office of Personnel Management benefits program has now cost more than $1 million. OPM has been working with FSAFEDS vendor HealthEquity to secure impacted federal employee accounts and add security measures to the program. OPM’s inspector general office is also working with the FBI to look into the issue further. But OPM said there’s so far no evidence of the FSAFEDS systems being compromised.”
  • Per a CMS press release,
    • “CMS is encouraging pharmacies and other affected parties to prepare now for the expected transition of coverage from Medicare Part D to Medicare Part B for Preexposure Prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. We expect to release the final National Coverage Determination (NCD) in late September 2024. Coverage under Part B will begin once we release the final NCD.
    • “Do you have questions about pharmacy enrollment?  We’re going to answer your questions so you can prepare your pharmacy for Part B coverage of PrEP for HIV during Pharmacy Enrollment Office Hours on Thursday August 22 from 3:30-4:30 pm ET. 
    • “Register for this webinar. After you register, you’ll receive a confirmation email with information about joining the webinar.”
  • The American Hospital Association News informs us,
    • “The AHA Aug. 13 commented to the Medicare Payment Advisory Commission in anticipation of the commission’s 2024-2025 cycle. The AHA urged MedPAC to carefully consider the negative consequences for beneficiaries, providers and communities if Medicare payments to 340B hospitals are cut; reconsider its pursuit of inpatient rehabilitation facility-skilled nursing facility site-neutral payment policy; support updates to physician reimbursement that more adequately account for inflation; and recommend repealing in-person visit requirements for tele-behavioral health services.

From the public health and medical research front,

  • MedCity News tells us,
    • “There are more than 123 million people in the U.S. living with obesity, and this prevalence is largely due to a lack of access to care, environmental factors, stigma and inadequate coverage, according to a new report. Tackling these issues will take a “multifaceted approach,” the report states.
    • “The publication was released last week in the American Journal of Managed Care and was funded by the Diabetes Leadership Council, a nonprofit patient advocacy organization. The researchers conducted an internet search of relevant studies and government reports.
    • “Our goal is to ensure that people are getting the right treatment at the right time for them. And we understand that this looks differently for everybody … and not everyone fits the same mold,” said Erin Callahan, chief operating officer of Diabetes Leadership Council and Diabetes Patient Advocacy Coalition, in an interview. “So our goal is to ensure that people are well cared for and have equitable access to the things they need along any part of their medical journey.”
  • Cardiovascular Business notes,
    • “Over the past few decades, research has clearly shown that there are distinct characteristics of ischemic heart disease in women that are not seen in men. While women often need tailored diagnostic approaches for diagnosis and treatment, the one-size-fits-all approach using the male heart disease presentations as the standard of care has likely impacted female mortality in terms of cardiac deaths, which is the No. 1 killer in the world for both men and women.
    • “Emily Lau, MD, director of the Cardiometabolic Health and Hormones Clinic at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, shed light on the critical issue of gender differences in chest pain imaging evaluations in sessions at the American College of Cardiology (ACC) 2024 meeting earlier this year. She spoke with Cardiovascular Business about her presentation.
    • “Women are more likely to present with non-obstructive coronary disease,” Lau explained. “This means they may not have significant blockages in their arteries, but they still experience symptoms of heart disease.”
  • Beckers Hospital Review points out,
    • “Adverse drug reactions [affecting the skin] are a known risk of antibiotic use, but it has been unclear which drug classes carry the highest risk — until now. 
    • “To crack at this mystery, researchers in Toronto analyzed two decades worth of data on hospitalizations and emergency department visits for serious skin reactions in older adults, according to a study published Aug. 8 in JAMA. They compared the results for each drug class to macrolides. 
    • “Among the 21,758 older adults, the antibiotics most strongly associated with serious skin conditions were sulfonamides, cephalosporins, nitrofurantoin, penicillins and fluoroquinolones. 
    • For the 2,852 hospitalized patients, the average length of stay was six days, 9.6% required transfer to a critical care unit and 5.3% died in the hospital. 
    • “When clinically appropriate, the researchers recommended prescribers use lower-risk antibiotics.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Kaiser Permanente reported a $2.1 billion net gain in the second quarter, representing a solid end to the nonprofit hospital and health plan’s financial performance in the first half of its fiscal year, according to an analyst.
    • “Kaiser’s operating margin rose to 3.1%, up from 2.9% the same time last year. The Oakland, California-based health system reported an operating income of $908 million as revenues grew at a faster clip than expenses.
    • “The second quarter marked the first time Geisinger Health’s financial performance was fully integrated into Kaiser’s earnings. While Kaiser did not break out Geisinger’s results, one analyst estimated the system contributed up to $2 billion in revenue during the quarter.”
  • and
    • “Orthopedics device company Stryker said Monday it has reached an agreement to acquire Care.ai, a company that offers artificial intelligence-based tools for hospitals. The Orlando, Florida-based startup makes patient monitoring, virtual rounding and AI-assisted decision support tools based on a network of sensors. 
    • “Stryker did not immediately respond to questions about the price or timing of the acquisition.
    • “The acquisition comes about two weeks after Stryker CEO Kevin Lobo forecast a “very active deal pipeline” for the second half of the year.”
  • Per Fierce Healthcare,
    • “Steward Health Care has agreed to sell its physicians network, Stewardship Health, to Rural Healthcare Group, which is owned by a private equity group.
    • “The embattled health system signed a definitive agreement to sell Stewardship, one of the largest primary care provider organizations in the country, for a proposed purchase price of $245 million, according to court documents filed in federal bankruptcy court Aug. 12. The court documents (document 1953 and 1954) can be found on an online portal set up for court filings and other restructuring information about Steward Health Care.
    • “RHG, an affiliate of PE firm Kinderhook Industries, will buy Stewardship through Brady Health Buyer, a company set up by Kinderhook to complete the transaction, according to court documents.
    • “Kinderhook offered $245 million in cash for Stewardship, according to court documents.
    • “The sale is subject to bankruptcy court and regulatory approval.”
  • Per BioPharma Dive,
    • “Galderma on Tuesday said the Food and Drug Administration has approved its antibody drug Nemluvio for adults with prurigo nodularis, a chronic skin condition characterized by intense itch.
    • “A subcutaneous injection, Nemluvio works by blocking cellular signaling via a cytokine called IL-31. Results from two Phase 3 clinical trials showed treatment helped to reduce itch intensity, clear skin and improve sleep, compared to a placebo.
    • “In an email, Galderma declined to disclose the price it plans to charge for Nemluvio. The company said the drug will be available in the coming weeks.” 
  • Per MedTech Dive,
    • “Medtronic said Monday it received Food and Drug Administration approval for deep brain stimulation (DBS) technology that is implanted while the patient is under general anesthetic.
    • “Surgeons traditionally perform DBS procedures, a treatment for medical conditions like epilepsy and Parkinson’s disease, while the patient is awake. However, a series of studies have shown there may be benefits to putting the patient to sleep for the procedure.
    • “Medtronic said it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake. U.S. surgeons have used DBS devices off-label in asleep patients for years.”
  • and
    • “Baxter has agreed to sell its Vantive kidney care business to private equity firm Carlyle Group for $3.8 billion, the companies said Tuesday. Carlyle is partnering with Atmas Health in the investment. 
    • “Carlyle formed Atmas Health in 2022 with healthcare executives Kieran Gallahue, Jim Hinrichs and Jim Prutow to focus on acquiring assets in the medical technology, life science tools and diagnostics sectors. Gallahue will become chairman of Vantive, working with Vantive CEO Chris Toth.
    • “Baxter will target annual operational sales growth of 4% to 5% after the Vantive transaction is complete.”
  • Per Stat News,
    • “The unwinding of Illumina’s ill-fated acquisition of Grail earlier this year left investors and the genomics community with a pressing question: What kind of company is Illumina going to be going forward?
    • “CEO Jacob Thaysen on Tuesday made clear that the sequencing firm, which controls about 80% of the current DNA-sequencer market, is essentially returning to its traditional role of creating instruments for researchers in academia, the biopharma industry, and health care settings.”
  • The Wall Street Journal examines the state of the hospital at home business. “Institutions say it is safe and opens hospital beds, but policymakers fear it’s too pricey and lacks strict standards.”
  • Risk & Insurance alerts us that “Employers are expanding comprehensive wellbeing programs to meet employee needs, while adopting varied cost management strategies amid rising health and drug costs, a Gallagher benchmarking report finds. * * * View the complete benchmark report, including breakouts by region and employer size, on Gallagher’s website.” 

Monday Roundup

David Ermer–CDC, Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports,
    • “A new initiative from the Biden administration aims to quell a varied series of consumer “headaches” by reducing their extraneous time and processes, including for federal employees trying to file health insurance claims.
    • “Detailed in a memo Monday, the “Time Is Money” initiative would touch upon processes across multiple industries that the White House deemed deliberate, time-consuming and burdensome for consumers, such as procuring refunds, canceling subscriptions and filing insurance claims.”  * * *
    • “The memo also outlined plans by the Office of Personnel Management to make it easier for employees on the Federal Employees Health Benefits and Postal Service Health Benefits plans to submit out-of-network claims online, would provide them with better information about which providers are in-network and how to appeal claim denials. 
    • “The proposed OPM requirements are part of a larger proposal within the initiative that would focus on streamlining the insurance claims process, with the Labor and Health and Human Services secretaries calling on insurance carriers to simplify their claims process and move it online, while also improving information access and call center times.” * * *
    • OPM officials were unable to respond by press time to questions about how and when the requirements will be rolled out. 
  • The FEHBlog doubts that many people submit health insurance claims. Dental claims may be a different story.
  • Here’s a link to an HHS and Labor Secretary message to health insurer CEOs about the new initiative.
  • Federal News Network points out six federal workforce bills pending in Congress that are worth tracking.

From the public health and medical research front,

  • STAT News lets us know,
    • “The Centers for Disease Control and Prevention issued a new risk assessment of the H5N1 bird flu virus circulating in dairy cows on Friday, increasing slightly its estimate of the chance it poses of triggering a pandemic.
    • “The new assessment, developed using the CDC’s influenza risk assessment tool or IRAT, gauged the risk the virus might someday cause a pandemic at 5.79, up from a previous score of 5.12 from an assessment of a related virus conducted in April 2023. Both numbers are within what the CDC tool terms a “moderate” risk of 4.0 to 7.9. Some swine influenza viruses and the H7N9 bird flu virus have scored higher than this version of H5N1 using the IRAT process.” * * *
    • “Vivien Dugan, director of the CDC’s influenza division, cautioned that the IRAT is a tool for government planning purposes, and isn’t meant to gauge the risk for the public. The agency still characterizes the risk H5N1 poses to the general public as low.”
  • Per an NIH press release,
    • “A National Institutes of Health (NIH)-supported study has found that routine lab tests may not be useful in making a long COVID diagnosis for people who have symptoms of the condition. The study, part of NIH’s Researching COVID to Enhance Recovery (NIH RECOVER) Initiative and published in the Annals of Internal Medicine, highlights how challenging it can be to identify and diagnose a novel illness such as long COVID.” * * *
    • “Future work will use RECOVER’s biobank of cohort samples such as blood and spinal fluid, to develop more novel laboratory-based tests that help us better understand the pathophysiology of long COVID,” said Kristine Erlandson, M.D., professor of medicine-infectious disease at the University of Colorado Anschutz Medical Campus, Aurora.”
  • BioPharma Dive tells us,
    • “Pfizer on Monday said its RSV vaccine Abrysvo led to strong immune responses in immunocompromised adults given the shot in a late-stage study.
    • “The results came from a sub-study of a Pfizer-run Phase 3 trial testing two doses of Abrysvo in adults at risk of severe lower respiratory tract disease associated with respiratory syncytial virus, or RSV. Vaccination was well-tolerated, Pfizer said, and led to a “strong neutralizing response” against RSV subtypes A and B.
    • “The data add to evidence of the effectiveness of Abrysvo, which faces competition from GSK’s rival vaccine Arexvy and Moderna’s mResvia, which gained Food and Drug Administration approval in May.”
  • Beckers Hospital Review informs us,
    • “Labels for GLP-1 medications, like Ozempic and Mounjaro, might see more approved uses as researchers study the drugs’ effects on sleep apnea, dementia and other health issues. Meanwhile, oncologists are looking at a GLP-1 role in cancer care.
    • “Several studies have shown the therapies — currently approved for Type 2 diabetes and weight loss — can diminish the risk of multiple cancers:
      • “Compared with Type 2 diabetes patients taking insulin, those who took the medications were less likely to develop 10 of 13 obesity-related cancers, one study found. 
      • “In another study of Type 2 diabetes patients, GLP-1 users saw a decreased risk of colorectal cancer than those who took insulin, metformin, SGLT2 inhibitors, sulfonylureas and thiazolidinediones. 
      • “Both bariatric surgery and GLP-1 use reduced the risk of obesity-related cancers in a retrospective analysis, according to data presented at the American Society of Clinical Oncologists meeting in June. Post-surgery, the risk declined 22%; with GLP-1s, the risk fell 39%. 
    • “The results are promising, but oncologists will need to see more research before they change their practices.”
  • Per Health Day,
    • “Folks can overcome their genetic risk for type 2 diabetes through healthy diet and regular exercise, a new study says.
    • “A healthy lifestyle reduced the risk of type 2 diabetes by 70% among a group of people with a high genetic likelihood of developing the metabolic disorder, researchers found.
    • “In fact, healthy behaviors had a greater impact on their risk than it did for people with a low genetic propensity for type 2 diabetes, results showed. A healthy diet and exercise had a statistically insignificant impact on the diabetes risk of those with low-risk genetics, researchers found.
    • “Nevertheless, “these findings encourage everyone to make lifestyle changes that promote health,” said lead researcher Maria Lankinen, a lecturer in nutrition with the University of Eastern Finland.
    • “That’s because all participants tended to achieve better blood sugar control and lost weight if they engaged in a healthy lifestyle, researchers said.”
  • The Wall Street Journal notes,
    • “Multiple servings of milk, cheese or yogurt have long been a staple of American nutrition advice. Now a growing number of researchers and doctors say you need less dairy than you think, and maybe even none at all.
    • “The U.S. government, which recommends that adults eat three servings of dairy a day, is taking a fresh look at its guidance. A committee of scientific advisers is analyzing diets with lower amounts of dairy to study what happens to people’s nutrient levels. That is the first step toward possibly changing the recommendation in the next update of the country’s dietary guidelines. Other countries already recommend less dairy than the U.S. does.
    • “The problem? Dairy-rich diets have been linked to increased risks of cardiovascular diseaseand certain cancers in some studies. Foods like ice cream, full-fat cheese and pizza are high in calories and saturated fat. 
    • “However, the research isn’t clear-cut. Some studies link dairy foods to a lower risk of heart disease, some cancers and Type 2 diabetes. When it comes to milk, scientists can’t agree on whether full fat or skim is better. 
    • “Long story short: Go ahead and enjoy your Greek yogurt and that mozzarella in your caprese salad. Just don’t have too much; some experts say one serving a day—one cup of yogurt or 1.5 ounces of the cheese—is good.” 
  • The New York Times warns us,
    • “Even light drinking was associated with an increase in cancer deaths among older adults in Britain, researchers reported on Monday in a large study. But the risk was accentuated primarily in those who had existing health problems or who lived in low-income areas.
    • “The study, which tracked 135,103 adults aged 60 and older for 12 years, also punctures the long-held belief that light or moderate alcohol consumption is good for the heart.
    • “The researchers found no reduction in heart disease deaths among light or moderate drinkers, regardless of this health or socioeconomic status, when compared with occasional drinkers.
    • “The study defined light drinking as a mean alcohol intake of up to 20 grams a day for men and up to 10 grams daily for women. (In the United States, a standard drink is 14 grams of alcohol.)
    • “We did not find evidence of a beneficial association between low drinking and mortality,” said Dr. Rosario Ortolá, an assistant professor of preventive medicine and public health at Universidad Autónoma de Madrid and the lead author of the paper, which was published in JAMA Network Open.
    • “On the other hand, she added, alcohol probably raises the risk of cancer “from the first drop.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “U.S. nonprofit hospitals and health systems’ median days of cash on hand hit a 10-year low in 2023, falling below 200 days for the first time in a decade, according to a report from S&P Global Ratings.
    • “Cash flow did not meaningfully improve from 2022 to 2023, the report said. However, operating expenses grew only modestly at 5%, following a steep 17% growth rate in 2022.
    • “While the sector is making incremental progress toward financial recovery, performance metrics are still below providers’ financial targets. The authors also noted a growing gap between the sector’s top performers and weaker providers.”
  • The American Journal of Managed Care examines “Hospitals’ Strategies to Reduce Costs and Improve Quality: Survey of Hospital Leaders.”
    • “Takeaway Points
    • “A decade after the implementation of value-based payment models, little is known about the strategies hospitals currently use to improve outcomes and reduce costs.
    • “On average, across 20 strategies in 4 domains—inpatient, post-acute, outpatient, and community resources for vulnerable patients—hospitals reported having implemented between 65% and 89% of the strategies queried.
    • “A higher proportion of hospitals participating in bundled payments implemented interventions aimed at reducing post-acute care compared with other hospitals (78.3% vs 37.6%; P < .0001), but patterns were otherwise similar.
  • Beckers Hospital Review looks into why Kaiser Permanente is having success with its retail clinics located inside Target stores in southern California.
  • Beckers Payer Issues explores UnitedHealthcare’s approach to consumerism in 2024.
  • Fierce Healthcare reports,
    • While customer satisfaction with mail order pharmacies is continuing to grow, brick-and-mortar pharmacies are falling behind, according to a new survey from J.D. Power.
    • The firm’s annual Pharmacy Survey found that retail pharmacies saw overall satisfaction scores decrease by more than 10 points, while scores for mail order pharmacies grew by six. The survey found that consumers visiting brick-and-mortal facilities are facing long-wait times and issues in ordering prescriptions, which is worsening the experience.
    • What brick-and-mortar pharmacies do best is communicate clearly with consumers, according to the survey, with 89% of customers indicating that messages from the pharmacist were offered clearly and understood.
    • However, there’s a trust gap. Only 51% said they view their pharmacist as trustworthy, and the same percentage said prescriptions were filled quickly.
    • Building that trust is critical to improving the consumer experience, Christopher Lis, managing director of global healthcare intelligence at J.D. Power, told Fierce Healthcare in an email interview.
    • [T]here is room for improvement for mail order pharmacies as well, the study found. While the key factor consumers enjoy is the convenience of ordering prescriptions, just 18% of consumers said that their pharmacy has a well-designed digital experience.
  • Per Fierce Pharma,
    • “Ascendis Pharma should be well prepared for the U.S. launch of its hormone replacement therapy for hypoparathyroidism, which was approved on Friday by the FDA.
    • “After all, the company was initially set to bring the drug to the market 15 months ago before the FDA rejected it with a surprise complete response letter (CRL). Then three months ago, Ascendis again was ready to roll before the U.S. regulator said it needed an additional three months to make its decision.
    • “Finally, Copenhagen-based Ascendis is now good to go with once-daily Yorvipath (palopegteriparatide), also known as TransCon PTH, which is the first FDA-approved product for hypoparathyroidism in adults.
    • Ascendis expects the initial supply to be available in the first quarter of next year with the potential to move the launch up to the fourth quarter this year, as the company has requested FDA approval to commercialize doses it has already made.
  • and
    • “With Gilead Sciences’ stated focus to grow in oncology, the company’s recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. But, with a unique pre-exposure prophylaxis (PrEP) offering for HIV that could “redefine” the market, the drugmaker is touting lofty ambitions there, too.
    • “After scoring an FDA approval for Sunlenca (lenacapavir) to treat multidrug-resistant HIV, Gilead launched the drug at end of 2022. The drug’s every-six-month dosing schedule has yet to show its full potential given that it must still be paired with other daily drugs to form a complete regimen. The indication isn’t exactly a major sales driver, as Sunlenca’s approved patient population represents just 2% of adults with HIV.
    • “That approval was just “the beginning of the rest of this journey,” Gilead’s vice president of clinical development Jared Baeten, M.D., Ph.D., said in an interview at the time. Now, the company is looking to another milestone late next year with the planned commercial launch of Sunlenca as a long-acting PrEP med, CEO Daniel O’Day said on Gilead’s second-quarter earnings call.” 

Weekend Update

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, OPM–

From Washington, DC,

  • The House of Representatives and the Senate are on District / State work breaks until September 9.
  • Federal News Network reports,
    • “After more than a year of pressure building in Congress, lawmakers now have more answers on federal telework levels, return-to-office policies and office space plans from the White House.
    • “In a report the Office of Management and Budget sent to Congress Friday afternoon, shared with Federal News Network, the Biden administration released details on agencies’ varying policies and approaches to where and how federal employees work, as well as federal real estate holdings and plans to improve office space utilization.
    • “While noting that more than half of the federal workforce is not able to telework at all, OMB reported that agencies are on average exceeding the administration’s 50% in-the-office goal for telework-eligible feds. Governmentwide, roughly 61% of the work hours that telework-eligible federal employees performed have been in person, according to time and attendance data OMB collected from the 24 CFO Act agencies during two pay periods in May.
    • “Also based on agencies’ time and attendance data, OMB reported that out of about 2.2 million federal employees:
    • “About 54% of federal employees worked fully in person due to the nature of their work
    • “About 46% of federal employees were eligible for telework
    • “About 10% of federal employees worked fully remotely.

From the public health and medical research front,

  • Per NPR Shots,
    • “Four years after SARS-CoV2 sparked a devastating global pandemic, U.S. health officials now consider COVID-19 an endemic disease.
    • “At this point, COVID-19 can be described as endemic throughout the world,” Aron Hall, the deputy director for science at the CDC’s coronavirus and other respiratory viruses division, told NPR in an interview.
    • “That means, essentially, that COVID is here to stay in predictable ways. 
    • “The classification doesn’t change any official recommendations or guidelines for how people should respond to the virus. But the categorization does acknowledge that the SARS-CoV2 virus that causes COVID will continue to circulate and cause illness indefinitely, underscoring the importance of people getting vaccinated and taking other steps to reduce their risk for the foreseeable future.” * * *
    • “We’re going to have to continue to live with COVID,” says Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “It’s one more thing people have to deal with. It’s another reason your kids might miss school, or you might miss work or another thing to think about when planning gatherings. We’re stuck with it.”
  • The Washington Post lets us know,
    • “Mammogram callbacks are common — about 10 out of every 100 womenare told they need more imaging after an initial screening, according to the American College of Radiology — but can be scary, especially if you have to wait for an appointment. The vast majority of the callbacks, however, turn out to be false alarms, according to the American Cancer Society. Fewer than 1 in 10 women who return for more imaging have cancer.
    • “Women should never ignore a callback, which usually involves more extensive pictures, known as a diagnostic mammogram, and sometimes will require a sonogram and biopsy, experts say. Early detection of breast cancer usually means less-invasive treatment and high survival, more than 90 percent five years out, experts say.
    • “Callbacks happen frequently and with good reason, because we want to be sure,” says Karen E. Knudsen, chief executive officer of the American Cancer Society. “Most of the time, nothing is wrong. But if you get a callback, make the appointment.”
  • and
    • “Women who have not been very physically active over the years were 40 percent more likely to experience a fall when they reached their 70s, according to new research published in the British Journal of Sports Medicine.
    • “The study involved over 11,700 participants (with an average age of 54) in the Australian Longitudinal Study on Women’s Health, which has been following the health of over 57,000 Australian women in four different age cohorts.
    • “For this study, which lasted 18 years, women born from 1946 to 1951 reported every three years how much exercise they had been getting. That level of weekly physical activity participation was based on the total of three types of exercise: walking briskly and moderate and vigorous leisure activity. When participants were age 68 to 73, they were also asked about falls and related injuries they had experienced.”
  • Fortune Well offers tips on how to improve your chances of becoming a SuperAger.
    • “Some people have won the longevity lottery—they are among the lucky few known as SuperAgers. 
    • “In a relatively new field, researchers are examining what contributes to people in their 80s and 90s having stronger brain power than their peers. Many are wondering if those findings can be distilled into a longevity routine or pill to help everyone become a SuperAger. Is it possible to increase your odds of becoming a SuperAger? 
    • “It’s not inevitable that we will become disabled and sick as we get older. What we’re learning from these unique individuals is that it is biologically plausible for us to live long and healthy,” says Dr. Sofiya Milman, the director of the Human Longevity Studies at Einstein’s Institute for Aging Research and the lead investigator of the SuperAgers Family Study, which has enrolled 550 SuperAgers since 2022. “Once we know what causes longevity, that it’s not a disease, we can then create therapies that will promote that biological longevity, and ultimately, that’s the goal of what we’re doing.” 

From the U.S. healthcare business front,

  • Per HR Dive,
    • “Employers may continue to use the most recent Form I-9 until May 31, 2027, U.S. Citizenship and Immigration Services said last week, extending the document’s expiration date.
    • “HR professionals must ensure they’re using the form with an Aug. 1, 2023, edition date, according to the agency. Newly downloaded forms will bear the new expiration date but employers may — for now — continue using any previously downloaded or printed forms bearing the previous July 31, 2026, expiration date. 
    • “Either form may be used until its respective expiration date,” USCIS said in a statement. However, “[e]mployers are encouraged to update their electronic Forms I-9 systems to use the [2027] expiration date as soon as possible and must do so no later than July 31, 2026,” it said.
  • Per Legal Dive,
    • “States and local governments should prohibit employers from using non-disclosure and non-disparagement agreements to keep employees from speaking out about sexual and other types of harassment, the American Bar Association says.
    • “NDAs … have effectively resulted in silencing people who experience sexual assault, sexual harassment, and other forms of harassment and discrimination in the workplace, preventing accountability for those who commit these harms and allowing the behavior to persist,” the ABA says.” * * *
    • “The resolution comes at a time when employers could be turning to NDAs even more if a nationwide ban on noncompete agreements takes effect this fall. The Federal Trade Commission passed the ban, but it faces court challenges, one of which has resulted in a partial stay. 
    • “Should the ban take effect, employers are likely to lean more heavily on other types of agreements, like non-disparagement agreements and other types of NDAs, to protect their interests from employees who leave to work for a competitor or to start a competing business.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the CrowdStrike outage front,

  • Dark Reading reports,
    • The CrowdStrike update that hobbled businesses, disrupted consumer travel plans, and took French and British broadcasters offline has predictably led to a host of lawsuits filed by investors and customers of both CrowdStrike and other affected companies.
    • Yet the incident could lead to another destination: software liability.
    • The overall consensus among legal experts is that CrowdStrike is likely protected by its terms and conditions from reimbursing customers for more than they paid for the product, limiting its software liability in what the company now refers to as “the Channel File 291 Incident.” However, the fact that affected businesses and consumers have little recourse to recover damages will likely lend momentum to legislation and state regulations to hold firms responsible for such chaos, says Chinmayi Sharma, associate professor of law at Fordham University.
  • Cybersecurity Dive lets us know,
    • “A mismatched software update in CrowdStrike’s Falcon sensor led to the crash that caused a global IT outage of millions of Microsoft Windows systems on July 19, the company said Tuesday. 
    • “CrowdStrike, in a root cause analysis report, said the Falcon sensor expected 20 input fields in a rapid response content update, but the software update actually provided 21 input fields. The mismatch resulted in an out-of-bounds memory read, leading to the system crash. 
    • “We are using lessons learned from this incident to better serve our customers,” CrowdStrike CEO George Kurtz said in a statement Tuesday. “To this end, we have already taken decisive steps to prevent this situation from repeating, and to help ensure that we – and you – become even more resilient.”
  • and
    • “CrowdStrike is in talks to acquire Action1, a Houston-based patch management and vulnerability specialist. The agreement being discussed would value the company at nearly $1 billion, according to a memo sent to Action1 employees. 
    • “Action1 Co-Founder and CEO Alex Vovk sent a memo to employees Wednesday confirming the discussions, after speculation around the talks gained within the company. A spokesperson for Action1 confirmed the authenticity of the memo to Cybersecurity Dive Friday. 
    • “This proves that Action1 is in a rapidly growing market and explains why Action1 is experiencing hypergrowth and is on track to soon reach $100M AAR,” Vovk wrote in the memo.” 

From the cybersecurity policy front,

  • Per Cybersecurity Dive,
    • “For Cybersecurity and Infrastructure Security Agency Director Jen Easterly the doomed CrowdStrike software update that took global IT systems and networks offline last month holds a “big lesson” for critical infrastructure.
    • “The CrowdStrike incident was such a terrible incident,” Easterly said Wednesday during a media briefing at Black Hat, but “it was a useful exercise, like a dress rehearsal for what China may want to do to us.”
    • “The outage was not the result of a malicious act, but rather a basic field input error that caused an out-of-bounds memory read. Yet, to Easterly, the widespread chaos it caused offers a clear example of what could occur if China-affiliated attackers make good on its efforts to cause systemic disruption to U.S. critical infrastructure.
    • “When Easterly learned of the outage, around 2 a.m. on July 19: “What was going through my mind was ‘oh, this is exactly what China wants to do.’”
  • Per Cyberscoop,
    • “Jen Easterly, the head of the Cybersecurity and Infrastructure Security Agency, told attendees at the Black Hat security conference on Thursday that delivering major improvements in computer security will require a sea change in how companies approach building software. 
    • “Amid an epidemic of breaches, Easterly laid the blame squarely at the feet of the technology industry. “We don’t have a cybersecurity problem. We have a software quality problem,” she said. 
    • “We have a multi-billion dollar cybersecurity industry because for decades, technology vendors have been allowed to create defective, insecure, flawed software,” Easterly said in her remarks.
    • “To address that issue, Easterly and CISA have launched a secure by design pledge, the signatories of which commit to a series of principles to improve the security of how products are developed and deployed. Easterly said 200 companies have now signed that pledge since its launch in March.”   
  • To that end, this week, CISA and the FBI posted their “Secure by Demand Guide: How Software Customers Can Drive a Secure Technology Ecosystem.” Here’s a link to the federal government’s Internet Complaint Center supplement guidance on this effort.
  • Cyberscoop also tells us,
    • “A year after asking the hacker community how they can better help protect the open source software that is the foundation of the digital economy, the White House is looking to better secure the ecosystem through a new office dedicated to study such components in critical infrastructure.
    • “The Office of the National Cyber Director released new details Friday on several projects aimed at securing open source software. The report comes a year after the office asked attendees at DEF CON in 2023 to contribute to a request for information around how to better focus on securing open source software.
    • “The new office runs out of the Department of Homeland Security and will examine the prevalence of open source software present in critical infrastructure and how to secure it, said Nasreen Djouini, senior policy advisor at the Office of the National Cyber Director. The program will have the support of the Department of Energy’s national labs, including at Los Alamos and Lawrence Livermore.”

From the cybersecurity vulnerabilities and breaches front,

  • Again, per Cyberscoop,
    • “An Israeli cybersecurity firm has identified a zero-day vulnerability affecting major web browsers that could allow attackers to bypass normal browser security measures and potentially breach local networks.
    • “The flaw, discovered by Oligo Security, was found in how browsers handle network requests. 
    • “In summary, devices read IP addresses to connect users to websites, with 0.0.0.0 serving as a placeholder until a real address is assigned. Oligo researchers found that a would-be attack can exploit how browsers like Apple’s Safari, Google’s Chrome and Mozilla’s Firefox handle queries to 0.0.0.0, redirecting them to other addresses such as ‘localhost,’ which is typically private. 
    • “This exploit allows attackers to access private data by sending requests to 0.0.0.0. Attackers could then perform all types of nefarious actions, gaining unauthorized access and executing remote code on locally running programs, which could impact development platforms, operating systems and internal networks.
    • Oligo has dubbed the vulnerability “0.0.0.0 day,” and wrote in a blog post that it considers it to be “far-reaching, affecting individuals and organizations alike.”
  • Here are the known exploited vulnerabilities that CISA added to its catalog this week,
  • Security Week points out,
    • The US cybersecurity agency CISA on Thursday informed organizations about threat actors targeting improperly configured Cisco devices.
    • The agency has observed malicious hackers acquiring system configuration files by abusing available protocols or software, such as the legacy Cisco Smart Install (SMI) feature. 
    • This feature has been abused for years to take control of Cisco switches and this is not the first warning issued by the US government. 

From the ransomware front,

  • Per a CISA press release,
    •  “CISA—in partnership with the Federal Bureau of Investigation (FBI)—released an update to joint Cybersecurity Advisory #StopRansomware: Royal Ransomware, #StopRansomware: BlackSuit (Royal) Ransomware. The updated advisory provides network defenders with recent and historically observed tactics, techniques, and procedures (TTPs) and indicators of compromise (IOCs) associated with BlackSuit and legacy Royal activity. FBI investigations identified these TTPs and IOCs as recently as July 2024.
    • “BlackSuit ransomware attacks have spread across numerous critical infrastructure sectors including, but not limited to, commercial facilities, healthcare and public health, government facilities, and critical manufacturing.
    • “CISA encourages network defenders to review the updated advisory and apply the recommended mitigations. See #StopRansomware for additional guidance on ransomware protection, detection, and response. Visit CISA’s Cross-Sector Cybersecurity Performance Goals for more information on the CPGs, including additional recommended baseline protections.”
  • Per Bleeping Computer,
    • ‘​On Tuesday (August 6], IT and phone systems at McLaren Health Care hospitals were disrupted following an attack linked to the INC Ransom ransomware operation.
    • “McLaren is a non-profit healthcare system with annual revenues of over $6.5 billion, which operates a network of 13 hospitals across Michigan supported by a team of 640 physicians. It also has over 28,000 employees and works with 113,000 network providers throughout Michigan, Indiana, and Ohio.
    • “While McLaren Health Care continues to investigate a disruption to our information technology system, we want to ensure our teams are as prepared as possible to care for patients when they arrive,” a statement on the health system’s website reads.”

From the cybersecurity defenses front,

  • Dark Reading writes about how
    • “Enterprises are implementing Microsoft’s Copilot AI-based chatbots at a rapid pace, hoping to transform how employees gather data and organize their time and work. But at the same time, Copilot is also an ideal tool for threat actors.
    • “Security researcher Michael Bargury, a former senior security architect in Microsoft’s Azure Security CTO office and now co-founder and chief technology officer of Zenity, says attackers can use Copilot to search for data, exfiltrate it without producing logs, and socially engineer victims to phishing sites even if they don’t open emails or click on links.
    • The article explains how to avoid such attacks.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration turned down an ecstasy-based drug.
    • “The agency rejected use of the drug, known as MDMA, along with mental-health therapy in the treatment of post-traumatic stress disorder.  It asked Lykos Therapeutics, which had sought the approval, to test the drug therapy further, the company said Friday.
    • “The decision is a setback for decades of efforts to legalize psychedelics and a disappointment for veterans advocates and other groups that have been seeking a new, better medicine for treating the 13 million Americans with post-traumatic stress.
    • “Yet it isn’t a surprise, after FDA staff and expert advisers raised questions about the studies evaluating whether the MDMA drug from Lykos Therapeutics worked safely.
    • “Lykos said the FDA told the company it couldn’t approve the drug therapy based on the data submitted to date. The company said it would ask the FDA to reconsider its decision, as well as to discuss the agency’s recommendations for submitting another application.”
  • The Washington Post adds,
    • “The Food and Drug Administration on Friday approved a nasal spray for serious allergic reactions to food, medications and insect stings, marking the first needle-free treatment for such conditions.
    • “The epinephrine nasal spray is administered as a single dose in one nostril and will serve as a critical alternative to treating emergency allergic reactions without an injection, the agency said.
    • “The two-milligram spray, called Neffy, is designed to block allergic reactions, including a serious condition called anaphylaxis, which can happen within seconds or minutes of being exposed to an allergen.
    • “The decision introduces an alternative to auto-injector devices such as the EpiPen for blocking severe allergic reactions. It also vindicates the approach of Neffy manufacturer ARS Pharmaceuticals, which pitched its product as a superior way of treating anaphylaxis that overcomes people’s hesitation to inject themselves or someone else. Anaphylaxis can cause constriction of the airway.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity has increased in most areas.
    • “COVID-19
      • “Most areas of the country are experiencing consistent increases in COVID-19 activity, with substantial increases in the southern United States. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • Wastewater detections continue to rise steadily and are now at the very high level. Levels continue to trend upward in all US regions and are highest in the West, followed by the South and Midwest. Test positivity for COVID is still rising and is at 17.6% nationally, up 1.2% compared to the previous week. Test positivity is highest in the region that includes Texas and surrounding states. 
  • and
    • “Among US children born in the past 30 years, childhood vaccines have prevented an estimated 508 million cases of illness, 32 million hospitalizations, and 1.1 million deaths, resulting in direct savings of $540 billion and societal savings of $2.7 trillion, according to a study yesterday in Morbidity and Mortality Weekly Report.
    • “Researchers from the Centers for Disease Control and Prevention (CDC) analyzed data since 1994, when the US Vaccines for Children (VFC) program was launched to cover the cost of vaccines for children whose families might not be able to afford them. They assessed the impact of routine childhood immunizations among both VFC-eligible and non–VFC-eligible children born from 1994 to 2023 for nine vaccines: diphtheria and tetanus toxoids and acellular pertussis vaccine; Haemophilus influenzae type b conjugate vaccine; poliovirus vaccines; measles, mumps, and rubella vaccine; hepatitis B vaccine; varicella vaccine; pneumococcal conjugate vaccine; hepatitis A vaccine; and rotavirus vaccine.”
  • Health Day lets us know,
    • “U.S. doctors should be on the lookout for a more severe strain of mpox that is spreading widely in parts of Africa, federal health officials warned Wednesday.
    • “The alert, issued by the U.S. Centers for Disease Control and Prevention, came just hours after the World Health Organization’s Director-General Dr. Tedros Adhanom Ghebreyesu tweeted that he will be gathering a group of advisers to decide whether the mpox outbreak in Africa should be declared a public health emergency of international concern.
    • “Cases of what is known as the clade 1 strain of mpox haven’t yet been reported outside of central and eastern Africa, the CDC noted in its alert. But the likelihood of additional spread prompted the agency to recommend that doctors in this country consider this more dangerous strain of mpox in patients who have recently been in the Democratic Republic of Congo (DRC) or any neighboring country (Angola, Burundi, Central Africa).
    • “Still, “due to the limited number of travelers and lack of direct commercial flights from DRC or its neighboring countries to the United States, the risk of clade I mpox importation to the United States is considered to be very low,” the CDC added.”
  • The American Hospital Association News alerts us,
    • “The AHA yesterday sent a Special Bulletin to members notifying them of concerns by the American Red Cross, America’s Blood Centers and the Association for the Advancement of Blood and Biotherapies about the nation’s low supply of blood levels. Each of those organizations is urging individuals to donate to boost supplies. The blood groups said this summer’s record heat, as well as recent disruptions in blood collections in the Southeast United States — including a cyberattack on OneBlood and the Tropical Storm Debby — have created additional challenges for blood collection. The AHA is urging its members to ask their communities to donate blood.”
  • Medscape offers a commentary explaining why “Sex, Marriage, Race, Education: Four Factors Account for 18 Years of Life Expectancy.”
  • The FEHBlog post about a link to a Cleveland Clinic press release was missing the following quote from the document.
    • “New Cleveland Clinic research shows that consuming foods with erythritol, a popular artificial sweetener, increases risk of cardiovascular events such as heart attack and stroke. The findings, from a new intervention study in healthy volunteers, show erythritol made platelets (a type of blood cell) more active, which can raise the risk of blood clots. Sugar (glucose) did not have this effect.
    • “Published in Arteriosclerosis, Thrombosis and Vascular Biology, the research adds to increasing evidence that erythritol may not be as safe as currently classified by food regulatory agencies and should be reevaluated as an ingredient. The study was conducted by a team of Cleveland Clinic researchers as part of a series of investigations on the physiological effects of common sugar substitutes.” * * *
    • “I feel that choosing sugar-sweetened treats occasionally and in small amounts would be preferable to consuming drinks and foods sweetened with these sugar alcohols, especially for people at elevated risk of thrombosis such as those with heart disease, diabetes or metabolic syndrome,” [lead researcher] Dr. [Stanley] Hazen advises. “Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck & Co. has struck a deal worth up to $1.3 billion to buy an investigational drug targeting B-cell associated diseases.
    • “Merck on Friday said it will pay an initial $700 million to acquire full global rights to clinical-stage bispecific antibody CN201 from privately held biotechnology company Curon Biopharmaceutical.
    • “Merck said CN201 is currently in studies in patients with relapsed or refractory non-Hodgkin’s lymphoma and B-cell acute lymphocytic leukemia.
    • “The Rahway, N.J., drugmaker said it plans to evaluate CN201 as a treatment for B-cell malignancies and to investigate its potential to provide a novel, scalable option for the treatment of autoimmune diseases.
    • “Merck said Curon also is eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201.
    • “The company said it expects to complete the acquisition in the third quarter, adding that it will book a pretax charge of about $750 million, reflecting the upfront payment and other related costs.”
  • and
    • “Novo Nordisk had a big head start in the race to dominate the weight-loss market. But Eli Lilly is catching up fast.
    • “The two companies’ divergent earnings reports this week showed that Indianapolis-based Lilly is moving faster than its Denmark-headquartered counterpart in the race to win the GLP-1 war.” 
  • Healthcare Finance notes,
    • “Johns Hopkins Health Plans is wading further into the artificial intelligence waters with a partnership meant to ensure member compliance with the No Surprises Act.
    • “By adopting InsightPro from MDI NetworX, Johns Hopkins Health Plans (JHHP) is addressing what it sees as an issue surrounding the No Surprises Act: While the law created transparency for patients and protection against unexpected billing, it also brought new compliance requirements that left many health plans “scrambling,” according to Johns Hopkins.
    • “Ryan O’Donnell, chief operating officer for Johns Hopkins Health Plans, called the technology “innovative” and said it would ensure members have accurate, up-to-date provider information, and would promote trust in the company’s services.”
  • Kaufmann Hall posted an infographic on the state of American medical debt.
    • About 8% of American adults have at least some medical debt, although this percentage is much higher among certain populations including those in poor health, the uninsured, and Black Americans. The 14% of Americans who owe over $10K carry over three-quarters of the nation’s total medical debt burden. In contrast, the nearly 50% of Americans who owe less than $2K are responsible for just 5% of the medical debt total. Reporting changes recently implemented by the three major credit rating agencies have reduced the impact of medical debt on other aspects of consumers’ financial health, but mostly for smaller medical debtholders. By excluding medical debt in collections for less than a year as well as medical debt of less than $500 from appearing on credit reports, the share of Americans whose medical debt affects their credit score has dropped to 5%. 

Thursday Miscellany

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Fierce Healthcare lets us know,
    • “The Department of Health and Human Services’ technology office dropped a new proposed rule on Thursday that would require healthcare entities that contract with HHS to use government-certified health information technology. 
    • “One group said the proposed rule could expand ASTP/ONC’s scope beyond setting standards for electronic health records (EHRs) to include data systems used by public health entities and insurers’ information systems. The proposed rule could potentially impact the regulation of artificial intelligence and cybersecurity in healthcare, a source said.
    • “The  Office of the Assistant Secretary of Technology Policy’s proposed rule, “Acquisition Regulation: Information Technology; Standards for Health Information Technology” proposes that health IT meet ONC standards requirements when: solicitations and contracts issued by or on behalf of HHS entities involve implementing, acquiring or upgrading health IT where individually identifiable health information (IIHI) is exchanged; and, health IT is used by healthcare providers, health plans, or health insurance issuers under HHS contracts.
    • “The proposed rule would also include healthcare providers who have been eligible to participate in CMS’s health IT-focused incentive programs.”
  • MedTech Dive tells us,
    • “The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices. 
    • “The pathway, called Transitional Coverage for Emerging Technologies (TCET), is intended to expedite Medicare coverage of new medical devices. On average, it takes about five years after a device is authorized by the Food and Drug Administration to gain national Medicare and commercial insurance coverage, according to a survey by the Stanford Byers Center for Biodesign. 
    • “The CMS plans to accept up to five candidates per year for the TCET pathway, with the goal of finalizing a national coverage determination within six months of FDA market authorization for technologies that are accepted. The devices must have the FDA’s breakthrough designation, meaning they provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
    • “Medtech lobbying firm Advamed pushed back on the five devices per year cap. CEO Scott Whitaker said in a Thursday statement that the limit “demonstrates clearly to Congress the need for greater resources at CMS” and the exclusion of diagnostics from the pathway is “disappointing.” 
  • The Congressional Research Service posted a legal sidebar titled “Private Equity Investments in Healthcare: Selected Enforcement Issues.”
  • STAT News reports,
    • “A federal judge [who sits on the bench of the U.S. District Court for the Southern District of Ohio] on Thursday tossed out a U.S. Chamber of Commerce lawsuit challenging Democrats’ drug pricing law.”
    • “The decision is yet another loss for the pharmaceutical industry and its allies, which have filed lawsuits across the country arguing that the Inflation Reduction Act, which created a drug price negotiation program in Medicare, is unconstitutional. So far, they have lost every one.” * * *
    • “Because the case wasn’t filed in the correct court, Judge Newman didn’t address substantive issues about whether the law is constitutional or not.
    • “Medicare officials are expected to release the outcome of the price negotiations for the first 10 drugs in the program by Sept. 1.”
  • Per Federal Network News,
    • “The Postal Service is seeing steady growth in revenue, but not enough to outpace its substantial operating costs.
    • “USPS saw a $2.5 billion net loss for the third quarter of fiscal 2024 — higher than the $1.7 billion net loss it saw for the same period last year.
    • “USPS reported $18.8 billion in revenue this quarter — 1% higher than revenue for the same quarter last year. It’s also the agency’s fourth consecutive quarter of revenue growth.
    • “However, the agency also saw a more than 4% increase in its operating costs, which grew to more than $21 billion for the quarter.
    • “Postmaster General Louis DeJoy said Thursday that USPS plans to accelerate efforts to cut costs and boost revenue.”

From the public health and medical research front,

  • The Hill reports,
    • “Fewer U.S. adults today say it is important to get children vaccinated than in recent years, according to a Gallup poll published Wednesday.
    • “In the July survey, only 40 percent of U.S. adults said it is “extremely important” for parents to vaccinate their children, a marked decline from the 58 percent who said the same in 2019 and the 64 percent who said the same in 2001.
    • “The drop over the last two decades is similarly stark when tracking the combined percentage who said vaccinating children is either “extremely” or “very” important. Taken together, 69 percent of U.S. adults hold this view now, down from 84 percent in 2019 and from 94 percent in 2001.” * * *
    • “The poll included phone interviews conducted July 1-21, with 1,010 adults. The margin of error is 4 percentage points.”
  • The New York Times points out,
    • “Scientists have developed a new weapon against H.I.V.: a molecular mimic that invades a cell and steals essential proteins from the virus.
    • “A study published in Science on Thursday reported that this viral thief prevented H.I.V. from multiplying inside of monkeys.
    • “The new therapeutic approach will soon be tested in people, the scientists said. Four or five volunteers with H.I.V. will receive a single injection of the engineered virus. “This is imminent,” said Leor Weinberger, a virologist at the University of California, San Francisco, who led the new study.” * * *
    • “Asher Leeks, a virologist at Yale University who was not involved in the research, said that it represented a big step forward in the study of so-called cheating viruses. Researchers have been investigating them for decades, but only in recent years have scientists like Dr. Weinberger tried turning them into medical treatments.”
  • Per a Cleveland Clinic press release,
    • New Cleveland Clinic research shows that consuming foods with erythritol, a popular artificial sweetener, increases risk of cardiovascular events such as heart attack and stroke. The findings, from a new intervention study in healthy volunteers, show erythritol made platelets (a type of blood cell) more active, which can raise the risk of blood clots. Sugar (glucose) did not have this effect.
    • Published in Arteriosclerosis, Thrombosis and Vascular Biology, the research adds to increasing evidence that erythritol may not be as safe as currently classified by food regulatory agencies and should be reevaluated as an ingredient. The study was conducted by a team of Cleveland Clinic researchers as part of a series of investigations on the physiological effects of common sugar substitutes. * * *
    • “I feel that choosing sugar-sweetened treats occasionally and in small amounts would be preferable to consuming drinks and foods sweetened with these sugar alcohols, especially for people at elevated risk of thrombosis such as those with heart disease, diabetes or metabolic syndrome,” Dr. Stanley Hazen advises. “Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors.”
  • The Wall Street Journal reports,
    • “Millions of people are flocking to drugs like Ozempic and Wegovy to lose weight and treat health problems. Doctors say one group that could benefit from the drugs is missing out: seniors.
    • “For older people, these medications can help in ways that go beyond losing weight, physicians say. Fewer pounds can lead to more mobility and better balance, allowing older people to become more active. That can boost mood, overall health, and sometimes makes the difference between walking freely or using a wheelchair or cane. 
    • “Doctors say they’re hearing more from older people who are interested in taking the drugs. However, seniors face [Medicare] insurance hurdles to get the drugs covered. And doctors note that older people need to be careful about losing muscle mass when on the drugs, as well as possible interactions with other medications.    
    • “Nine percent of people 65 and older reported taking GLP-1 medications, such as Ozempic, Wegovy and Zepbound, compared with 19% of people ages 50 to 64, according to a May KFF poll.
    • “These drugs would really benefit seniors but there’s always these additional worries,” says Dr. Sun Kim, an associate professor in the division of endocrinology at Stanford University School of Medicine. “I think sometimes we prioritize the risk over benefit when people get older.” 
  • and
    • “Doctors are now capable of saving the lives of babies born at 22 weeks and, in rare cases, a week earlier, with improved techniques to help tiny lungs develop and protect fragile skin and organs. Hospitals with extensive experience resuscitating extremely premature babies report survival rates as high as 67% for babies born at 22 weeks.
    • “Some U.S. hospitals aren’t sufficiently equipped or capable of pulling off the new advances. Others have chosen not to offer the care, saying it is likely to fail, is expensive—typically more than $100,000 a child, and sometimes much more—and subjects tiny, fragile infants to needless pain and the risk of long-term disabilities. 
    • “Instead, they often provide comfort care: wrapping the newborn in a blanket, placing it on the mother’s chest and sometimes giving medicines to ease the child’s final moments.
    • “The difference can be a matter of life or death for the roughly 8,000 infants born between 22 and 24 weeks gestation in the U.S. each year.
    • “Doctors agree that babies born at 25 or 26 weeks can and should be treated as long as they don’t have other complications, while those born at 20 weeks or less are too small to save.
    • “In between is a “gray zone,” as doctors call it, where newborns’ fate can depend on which hospital happens to be delivering.”
  • STAT News tells us,
    • “Since its emergence in 2020, Covid has jumbled the list of the 10 leading causes of deaths in the United States. It roared into third place in 2020 but has now fallen to 10th place, the National Center for Health Statistics reported Thursday. 
    • “Heart disease and cancer remained the first and second leading causes of death, followed by unintentional injuries as No. 3. Overall, deaths in 2023 were 6.1% lower than 2022.
    • “We’re going in the wrong direction for heart disease. We’re going a tad in the right direction for cancer,” said Eric Topol, founder and director of the Scripps Research Translational Institute. A cardiologist and geneticist, he was not involved in the analysis. “A lot of things that are highest on this list, there’s a lot of things we can do to prevent them. And hopefully we’ll keep seeing the numbers come down. But if you just look at pre-pandemic to now, it’s not a good trend.”
  • Per Healio,
    • “The Simplera Continuous Glucose Monitor features a one-hand, two-step insertion process for the sensor that does not require additional tape.
    • “The [recently] FDA-approved device is part of Medtronic’s smart multiple daily injection system.

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Eli Lilly shares jumped after the drugmaker reported earnings that trumped analyst estimates and hiked its annual outlook.
    • “Lilly has become one of the most valuable companies listed in the U.S. due to the popularity of its medications used for obesity.
    • “Quarterly sales for diabetes drug Mounjaro totaled more than $3 billion, while weight-loss injection Zepbound, which launched late last year, rang in at $1.2 billion. Both figures beating analysts’ estimates.
    • “The strong quarter was boosted in part by additional supply of the drugs, which had been in shortage, as well as favorable pricing, Lilly said. Mounjaro prices were higher in the U.S., partly because of increased availability of the drug and lower use of savings card programs.”
  • Following up on a post from yesterday, BioPharma Dive informs us,
    • “[Mounjaro and Zepbound] are available in all dosage forms in the U.S. What that means is we can bill orders as they’re received,” said Lilly CEO David Ricks on an earnings conference call Thursday. “That does not mean that any pharmacy, or certainly every pharmacy, has all 12 dosage forms sitting on their shelves.”
    • “Ricks cautioned that, despite the change in status on the FDA’s shortage list, patients may still have to wait a few days to pick up their prescriptions.
    • “There’s not an abundance of supply. It’s more of a real-time fulfillment situation,” Ricks said. “But product is flowing and it’s flowing at a pretty high rate.”
    • “Still, he added, “the end pharmacy experience will continue to be choppy.”
  • Forbes adds,
    • “More doses of Novo Nordisk’s popular weight loss drug Wegovy are back in stock in the U.S. after years of shortages, according to the FDA, days after all dosage levels of Eli Lilly’s rival injection Zepbound became available. They’re part of a promising and growing class of drugs called GLP-1 agonists, but shortages are set to persist as pharmaceutical companies struggle to ramp up production.”
  • STAT News notes,
    • “As for-profit Tenet Healthcare slims its hospital portfolio, it found an unlikely buyer for its Alabama hospitals: Florida’s Orlando Health.  
    • “Orlando Health draws more than $6 billion in annual revenue and has a profit margin that surpasses most of its peers. A hospital system executive system leader said crossing state lines to buy five Birmingham-area hospitals is part of its focus on serving the Southeastern U.S., even though most of its 17 existing hospitals are still in Florida. 
    • “It’s not at all surprising that a multi-billion dollar health system would have ambitions of expanding beyond its home state. That’s especially true as hospital systems continue to merge at a breakneck pace, increasingly jumping across multiple states to do so. Meanwhile, study after study concludes that hospitals use their newfound market power to drive up prices.”
  • Per Beckers Hospital Review
    • “As the Medicare Advantage landscape evolves, the success of health systems hinges on their ability to adapt and excel in key areas such as star ratings and appropriate coding. 
    • “Health systems’ greatest opportunity is to enter into full-risk arrangements with health plans, shifting the focus from managing illness to maintaining wellness. However, many systems have not made the necessary investments to thrive in this value-based care model, often missing out on its potential benefits and driving ambivalence toward the MA program, according to SCAN Group CEO Sachin Jain, MD.”
  • Fierce Healthcare adds,
    • “Centene is exiting six states through its WellCare Medicare Advantage (MA) subsidiary next year, investment bank Stephens has revealed.
    • “Those six impacted states are Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont, with approximately 12,600 members affected in New Mexico, the most of any state.
    • “In Vermont, Centene accounts for about 9% of the market share in the state. All told, all market exits will impact around 37,300 members and about 3% of Centene’s current MA membership, a research note from Stephens showed.
    • “Notably, CVS and UnitedHealthcare both maintain presences across each impacted market,” the brief said.
    • ‘The insurer will still offer its prescription drug plans in these states. Centene commands the most market share for standalone Part D in the country at 29%, data from the Centers for Medicare & Medicaid Services show.
  • Per Healthcare Dive,
    • “Walgreens is considering a full sale of its stake in VillageMD, after pouring billions of dollars into the unprofitable primary care chain. The decision, disclosed Wednesday in a securities filing, is a sharp reversal to the pharmacy behemoth’s past commitment to building out its healthcare delivery offerings.
    • “Walgreens is “currently evaluating a variety of options” in light of VillageMD’s “substantial ongoing and expected future cash requirements,” the company said in the 8-K. “These options could include a sale of all or part of the VillageMD businesses, possible restructuring options and other strategic opportunities.”
    • :If Walgreens offloads VillageMD entirely, it would be a step up from management’s previous plans for the value-based medical chain. In June, Walgreens said it would reduce ownership in VillageMD but not eliminate it entirely.”
  • STAT News lets us know,
    • “Digital Therapeutics developer Big Health this week received Food and Drug Administration clearance for SleepioRx, a prescription treatment for insomnia.
    • “Big Health already sells a wellness version of the app, called Sleepio, to employers and health plans that make the product available to their members. The app delivers a specialized type of cognitive behavioral therapy for insomnia and the company boasts that it is backed by dozens of studies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics’ yearly financial outlook and quarterly earnings, including sales of Elevidys, its gene therapy for Duchenne muscular dystrophy, have fallen well short of Wall Street expectations.
    • “Sarepta reported Wednesday afternoon that Elevidys sales totaled roughly $122 million between April and June, down from the previous quarter and about $20 million below consensus estimates. Overall product sales of about $361 million, and 2025 revenue projections of $2.9 billion to $3.1 billion, were also lower than analysts anticipated.
    • “Still, executives assured investors that sales should soon climb following the recent decision by the Food and Drug Administration to substantially expand use of Elevidys. The market opportunity ahead of Sarepta is “absolutely massive,” said Dallan Murray, the company’s executive vice president and chief customer officer on a conference call. Sarepta shares initially fell by double digits before rebounding Thursday morning.”
  • Per MedTech Dive,
    • “Zimmer Biomet said Wednesday it agreed to buy Orthogrid Systems, a medtech company that makes artificial intelligence-based surgical guidance systems for total hip replacement. 
    • “Salt Lake City-based Orthogrid uses fluoroscopy imaging to help surgeons track the position of an implant during a hip procedure. It also has two other Food and Drug Administration-cleared solutions for hip preservation and trauma surgeries. 
    • “By using fluoroscopy instead of CT scans, Orthogrid can offer real-time navigation and a more efficient workflow for operating rooms.
    • “The solution will add to Zimmer’s current suite of tools for hip surgery. The company has its own hip application paired with its Rosa surgical robot that also uses fluoroscopy imaging. Zimmer additionally has a co-marketing agreement with HipInsight, which uses Microsoft Hololens 2 glasses to help surgeons visualize a patient’s pelvic anatomy during surgery. 
    • “By comparison, Stryker’s Mako total hip application uses CT imaging, while J&J’s Velys hip navigation uses fluoroscopy.”