Monday Roundup

David Ermer

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

Monday Roundup

David Ermer–CMS, COVID-19 vaccine, Medical / Rx research, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

Happy Bobby Bonilla Day!

“The calendar has turned to July 1, and that means one thing: It’s time for Mets fans everywhere to wish each other a Happy Bobby Bonilla Day! Why? On Monday, 61-year-old Bobby Bonilla will collect a check for $1,193,248.20 from the New York Mets, as he has and will every July 1 from 2011 through 2035.”

The FEHBlog is not a Mets fan. It’s a fun story.

From Washington, DC,

  • The American Hospital Association News reports,
    • “Changes to the Centers for Medicare & Medicaid Services’ Hospital Price Transparency Rule took effect July 1. Going forward, hospitals are required to use a standard machine-readable file format, which includes some new data elements, such as the negotiated rate methodology and an accuracy and completeness statement.”  
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced more than $200 million to support 42 programs across the country aimed at improving care for older Americans, including those experiencing Alzheimer’s disease and related dementias.”
    • “HRSA’s Geriatrics Workforce Enhancement Program will train primary care physicians, nurse practitioners, and other health care clinicians to provide age-friendly and dementia-friendly care for older adults.  The program also focuses on providing families and other caregivers of older adults with the knowledge and skills to help them best support their loved ones.” * * *
    • “For a full list of award recipients, visit: https://bhw.hrsa.gov/funding/apply-grant/gwep-awardees.”
  • The Washington Post lets us know,
    • “The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals, citing the company’s refusal to take down about two dozen patents for its asthma and COPD inhalers, according to confidential agency documents reviewed by The Washington Post.
    • “The FTC last week sent a civil investigative demand — effectively a subpoena — ordering Teva to provide internal communications, analysis and financial data related to the contested patents listed in a federal registry known as the Orange Book. The agency has argued that pharmaceutical companies such as Teva have wrongly made minor tweaks to their products to keep patents in the Orange Book and fend off generic competition. Teva charges hundreds of dollars for inhalers in the United States that the company sells for a fraction of the price overseas.
    • “Teva has until July 24 to cooperate with the FTC’s demand.”
  • The New York Times reports,
    • “The Supreme Court on Monday gave companies more time to challenge many regulations [under the Administrative Procedure Act], ruling that a six-year statute of limitations for filing lawsuits begins when a regulation first affects a company rather than when it is first issued.
    • “The ruling in the case — the latest in a series of challenges to administrative power this term — could amplify the effect of the blockbuster decision last week overturning a foundational legal precedent known as Chevron deference, which required federal courts to defer to agencies’ reasonable interpretations of ambiguous statutes. That decision imperils countless regulations, particularly on the environment, and advances a longstanding goal of the conservative legal movement.
    • “The vote was 6 to 3, split along ideological lines. Justice Amy Coney Barrett, writing for the conservative majority, rejected the government’s argument that the time limit to sue begins when an agency issues a rule.
    • FEHBlog note — The Supreme Court has completed its October 2023 term.

From the public health and medical research front,

  • Per an NIH press release,
    • “A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.” * * *
    • “The study aims to enroll 60 adult participants, ages 18 to 64 years old, who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine. The trial sites are Baylor College of Medicine, Houston; The Hope Clinic of Emory University, Decatur, Georgia; and New York University, Long Island. Hana M. El Sahly, M.D., at the Baylor College of Medicine Vaccine Research Center, is leading the study.” * * *
    • “More information about the trial is available at clinicaltrials.gov using the identifier NCT06441968.”
  • MedPage Today informs us,
    • “Getting an mRNA COVID-19 shot during the first trimester of pregnancy didn’t lead to an increased risk of major structural birth defects, a multisite retrospective cohort study found.
    • “Major structural birth defects occurred in 1.48% of infants after a first-trimester vaccination and in 1.41% of those without a first-trimester vaccination (adjusted prevalence ratio 1.02, 95% CI 0.78-1.33), Elyse Kharbanda, MD, MPH, of the HealthPartners Institute in Bloomington, Minnesota, and colleagues reported in JAMA Pediatrics.”
    • “Additionally, secondary analyses revealed that there were no significant differences between groups when birth defects were grouped by organ system.
    • “These findings should provide reassurance to pregnant people and their obstetric care practitioners,” the authors concluded.”
  • The Washington Post relates,
    • “People with leg amputations were able to control their prosthetic limbs with their brains in a significant scientific advance that allows for a smoother gait and enhanced ability to navigate obstacles, according to a study published Monday in the journal Nature Medicine.
    • “By creating a connection between a person’s nervous system and their prosthetic leg, researchers at the K. Lisa Yang Center for Bionics at MIT and Brigham and Women’s Hospital paved the way for the next generation of prostheses.
    • “We were able to show the first full neural control of bionic walking,” said Hyungeun Song, first author of the study and a postdoctoral researcher at MIT.”
  • Beckers Hospital Review points out,
    • “The national supply of the cancer drug cisplatin now exceeds demand, FDA Commissioner Robert Cailiff, MD, said June 28. 
    • “The drug, which treats multiple cancers, had been in shortage since February 2023. The shortage occurred after the FDA halted imports from Intas Pharmaceuticals’ manufacturing plant in India in late 2022 due to quality issues. In May 2023, 70% of cancer centers lacked sufficient cisplatin supply, according to a report from the National Comprehensive Cancer Network. 
    • “Low supplies of cisplatin and other cancer drugs have complicated treatments for many patients, with some U.S. cancer centers still struggling to maintain adequate supplies.” 
  • The Washington Post and Consumer Reports identify cures for constipation.
  • BioPharma Dive calls attention to ten clinical trials to watch in the second half of 2024.

From the U.S. healthcare business front,

  • Mercer explains why healthcare cost – and volatility – has CFOs worried. 
    • “As we head towards the third quarter of 2024, top concerns around health programs are affordability for both employees and employers, the potential impact of GLP-1s on cost trends, and the increased volatility in claims. For fully insured sponsors, claims volatility makes it difficult to predict cost from year to year, while self-insured sponsors may also experience the effects of claims volatility within a given year. Healthcare trends have been impacted by broader economic inflationary pressures with a lag, and the environment will remain challenging for some time to come. While we expect medical cost trends to be similar to last year’s, we see growing cost pressure from prescription drugs, which account for approximately one-third of total health plan costs.”
    • The article compiles Mercer’s findings from a survey of eighty CFOs.  
  • Beckers Hospital Review notes,
    • “If current trends continue, Michael Murphy, PharmD, said all payers will come to recognize pharmacists as healthcare providers by the end of the decade. 
    • “Dr. Murphy, the American Pharmacists Association’s adviser for state government affairs, said there has been “an explosion” of health plans increasing coverage for pharmacists’ services. In a June 26 blog post, he said momentum is building among commercial plans and state Medicaid fee-for-service and managed care plans. 
    • “Pharmacists are being enrolled as providers in much the same way that health plans enroll physicians, nurse practitioners and physician assistants,” Dr. Murphy said. “Pharmacists are also billing for their services in similar ways as other providers. Often, pharmacists submit the same billing codes that other healthcare providers submit for a comparable visit.”
  • STAT News reports,
    • “For 15 years, a formidable CEO-CFO duo often called “the two Tonys” ushered their St. Louis-based health system through a period of explosive growth, adding hospital after hospital until it became one of the country’s biggest health systems.
    • “The year after former CEO Anthony Tersigni and former finance chief Anthony Speranzo stepped down, their sprawling empire of roughly 140 hospitals underwent the ultimate stress test: the Covid-19 pandemic. Ascension has lost almost $4 billion on operations from fiscal 2020 through fiscal 2023, triggering deals to offload almost 30 hospitals. Just last week, Ascension said it would sell its remaining five hospitals in Alabama.
    • “They are going hard on the expense side,” said Stephen Infranco, managing director and head of the nonprofit health care team at S&P Global. “It’s a wait and see approach to how successful it is.”
    • “In a statement, Ascension spokesperson Sean Fitzpatrick said reviewing the hospital portfolio is an ongoing exercise at Ascension. “We are constantly looking for opportunities to prudently prune and grow our care delivery system in an effort to best serve patients in our communities,” he said.”
  • Per Fierce Healthcare,
    • “Amedisys, a large home health provider, plans to divest a number of care centers to an affiliate of VitalCaring Group in advance of its planned merger with UnitedHealth Group later this year.
    • “VitalCaring also acquired some UnitedHealth Group care centers in the deal, according to a filing with the U.S. Securities and Exchange Commission on Friday.
    • “The completion of the divestiture hinges on the closing of the merger between Amedisys and UnitedHealth Group, which is expected to close in the second half of 2024, Amedisys said in the SEC filing.” * * *
    • “This news is unsurprising and relatively on schedule,” wrote Matt Larew, a healthcare research analyst and partner at William Blair in an analyst note. “In May, a report originally surfaced that UnitedHealth and Amedisys were working with regulators on a divestment package of over 100 locations and a short time after it was reported that VitalCaring had emerged as the buyer.”
  • Per Healthcare Dive,
    • “Health technology startup Fabric is acquiring Walmart’s telehealth assets as the retailer exits its healthcare delivery business. 
    • “Fabric, which offers patient intake, care navigation and telehealth services, said Friday it purchased Walmart’s MeMD for an undisclosed amount. MeMD, which Walmart acquired in 2021, provides virtual behavioral, urgent and primary care benefits for 30,000 corporate partners and five million members.
    • “Walmart said in April it would close its healthcare business, citing a challenging reimbursement environment and growing operational costs that limited profitability.”
  • and
    • “Amazon is folding its telehealth marketplace into primary care chain One Medical, unifying its healthcare delivery services under a single brand — and placing One Medical in front of the eyes of engaged telehealth customers, potentially creating a new source of subscriptions.
    • “Amazon is rebranding the marketplace, previously called Amazon Clinic, to Amazon One Medical Pay-Per-Visit. The service, which automatically connects patients to a provider via virtual video or messaging for a flat fee, is also getting more affordable.
    • “Messaging visits are $29, down from around $35, and video visits are $49, down from $75.”

Weekend Update

David Ermer–CDC, CMS, Congress, Medical / Rx research, Mental health care, U.S. Healthcare–

From Washington, DC,

  • The Supreme Court will end its October 2023 term tomorrow by releasing a final batch of three opinions.
  • The New York Times reports,
    • “The Biden administration said this week that it opposed gender-affirming surgery for minors, the most explicit statement to date on the subject from a president who has been a staunch supporter of transgender rights.
    • “The White House announcement was sent to The New York Times on Wednesday in response to an article reporting that staff in the office of Adm. Rachel Levine, an assistant secretary at the Department of Health and Human Services, had urged an influential international transgender health organization to remove age minimums for surgery from its treatment guidelines for minors.” * * *
    • “The Supreme Court agreed on Monday to hear a challenge — brought in part by the Biden administration — to a Tennessee law that bans treatments including puberty blockers, hormone therapy and surgery for transgender minors. This will be first time the justices will decide on the constitutionality of such statewide bans.”
  • The Washington Post lets us know,
    • House Republican leaders are asking government watchdogs to investigate health insurance sign-ups through the Affordable Care Act, citing reports that allege insurance brokers are fraudulently enrolling customers into some ACA health plans and that millions of Americans may be wrongly benefiting from federal insurance subsidies.
    • The House Energy and Commerce, Ways and Means, and Judiciary Committees requested Friday that the Government Accountability Office and the inspector general at the Department of Health and Human Services open investigations into the “astonishing level” of potential enrollment fraud, according to letters shared with The Washington Post.

From the public health and medical research front,

  • Reuters tells us,
    • “The U.S. Food and Drug Administration has begun testing more dairy products for evidence of the bird flu virus as outbreaks spread among dairy herds across the country.
    • “More than 120 dairy herds in 12 states have tested positive for bird flu since March, according to the U.S. Department of Agriculture. Federal officials have warned that further spread among dairy cows could heighten the risk of human infections.
    • “The focus of additional testing is to ensure that pasteurization inactivates the virus, said Don Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, on a call with reporters.
    • “Prior FDA testing of 297 retail dairy samples came back negative for evidence of the virus.
    • “The agency continues to strongly advise against consumption of raw milk products, Prater said.”
  • The Washington Post informs us,
    • “People over 50 with anxiety may be up to twice as likely to develop Parkinson’s disease as their peers without anxiety, a new analysis suggests.
    • “The study, published in the British Journal of General Practice, looked at primary care data from the United Kingdom. Researchers compared a group of 109,435 people 50 and older who were diagnosed with a first episode of anxiety between 2008 and 2018 with a control group of 987,691 people without anxiety.
    • “Researchers said, of those in the study, 331 patients with an anxiety diagnosis developed Parkinson’s disease over the decade, and the average patient who developed the disease did so 4.9 years after their first anxiety diagnosis.
    • “After adjusting for age, lifestyle factors, mental illness and other factors, people with anxiety were still twice as likely to develop Parkinson’s disease than those without an anxiety diagnosis. Those who developed the disease were also likelier to be male and in higher socioeconomic groups.”
  • STAT News adds,
    • “Fighting Alzheimer’s disease is a race against time. By the time most patients are diagnosed and treated, their cognitive symptoms have already advanced significantly.
    • “New research, though, pinpoints protein changes in cerebrospinal fluid highly associated with the development of Alzheimer’s disease. A better biological understanding of the brain disorder could foster new treatments and earlier intervention — as early as 20 years before onset of symptoms according to models from the study.
    • “The findings, published Wednesday in Science Translational Medicine, coincide with revised criteria from the Alzheimer’s Association that lean into the need for biology-based diagnosis and staging of the disease. The underlying biology of Alzheimer’s is still a scientific conundrum, but the approval of a drug targeting the disease’s amyloid pathology has sparked a push for blood and other tests to detect proteins associated with disease progression earlier, when treatment can be more successful.
    • “The study tracked upwards of 5,000 proteins to capture a dynamic picture of protein activity in patients with Alzheimer’s. “We take all these different proteins that we measure and we cluster them into these things called modules, that reflect different biological pathways, or processes, or cell types,” said study author Erik Johnson, assistant professor of neurology at Emory University. Those clusters of protein activity can serve as a springboard for both disease prediction and drug treatment experiments, he said.
  • Per NPR Shots,
    • “About 170 billion cells are in the brain, and as they go about their regular tasks, they produce waste — a lot of it. To stay healthy, the brain needs to wash away all that debris. But how exactly it does this has remained a mystery.
    • “Now, two teams of scientists have published three papers that offer a detailed description of the brain’s waste-removal system. Their insights could help researchers better understand, treat and perhaps prevent a broad range of brain disorders.
    • “The papers, all published in the journal Nature, suggest that during sleep, slow electrical waves push the fluid around cells from deep in the brain to its surface. There, a sophisticated interface allows the waste products in that fluid to be absorbed into the bloodstream, which takes them to the liver and kidneys to be removed from the body.
    • “One of the waste products carried away is amyloid, the substance that forms sticky plaques in the brains of patients with Alzheimer’s disease.
  • Medscape notes,
    • “Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease. 
    • “Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.
    • “These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”
    • “The findings were published online on June 19, 2024, in Neurology.”
  • BioPharma Dive discusses “microscopic tunnels [which] are a goldmine for new medicines. Ion channel research made Vertex Pharmaceuticals one of the world’s most valuable biotechs. Now, other drug hunters have joined in, betting the field is ready to treat an array of illnesses.”
    • “It can be difficult to picture just how small a human cell is. On average, it’s one-tenth as wide as a strand of hair and 25 times smaller than a grain of salt. Tinier still are the thousands of ion channels anchored into the fluid, oily shell that encases these microscopic worlds.
    • “The channels act as canals; though, instead of water, they control the movement of electrically charged particles like sodium, potassium, calcium and chloride. When cells are stimulated in certain ways, the canals open, permitting ions to flood in or out. They then shut and return to a “resting” state. The opening and closing happens hundreds of times a second and actually jolts the cell, in essence telling it, “Something is happening, react!”
  • STAT News points out,
    • “A few years ago, the Centers for Medicare and Medicaid Services launched a big experiment. The agency wanted to see if financial incentives and penalties would improve care for people with end-stage kidney disease. So far, it hasn’t worked, a new study finds.
    • “The End-Stage Renal Disease Treatment Choices (ETC) model is a historic effort, both because it’s the largest such experiment in the history of American health care and because, unlike previous CMS Innovation Center pilot programs, it’s mandatory. About 30% of dialysis providers in the country participate, while the other 70% are used as a control group. It’s shaped like a gold-standard, randomized control trial, and run by the entity that covers the majority of health care related to end-stage renal disease, including dialysis. 
    • “Each year, providers are graded on how many patients they can move to home dialysis, which is more affordable for the health care system, and how many people go on to receive kidney transplants, among other metrics. If they do well, they receive some extra money. Those who don’t do well face financial penalties. Both amounts increase with each year of the experiment, up to an 8% bonus or 10% penalty by the end of the program.
    • “Those sticks and carrots don’t seem to be doing much. In a paper published in JAMA Health Forum on Sunday, researchers report a null effect: Providers enrolled in the experiment aren’t moving more patients to home dialysis or transplant than those in the control group.” 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • The Wall Street Journal reports,
    • “Insurers told a congressional hearing Thursday {June 27, 2024] that they need the flexibility to determine what they will and won’t cover under cyber policies, saying they are still trying to understand the risks associated with cyberattacks.
    • “The House Committee on Homeland Security’s subcommittee on cybersecurity and infrastructure protection held the hearing to explore how cyber insurance is being used by critical-infrastructure operators, amid warnings of hacking efforts from China and Russia.
    • “Insurers have tightened underwriting standards and raised premiums for cyber policies in recent years, spooked by an increase in losses starting in 2019 as cyberattacks spiked during the coronavirus pandemic. Many now require a raft of cybersecurity controls for organizations to qualify for coverage, such as multifactor authentication and network monitoring, and carriers have restricted what they will cover. 
  • Cybersecurity Dive adds,
    • “In an effort to qualify for cyber insurance three-quarters of companies have invested in cyber defense, according to a report released Wednesday by Sophos and Vanson Bourne. 
    • “These investments were either required to obtain coverage, helped organizations secure lower premiums or, in other cases, improved the coverage terms of their insurance plans. The research is based on a survey of 5,000 IT and cybersecurity leaders across 14 countries in the Americas, Asia Pacific and Europe, the Middle East and Africa.
    • “Despite the investments, significant gaps remain between recovery costs and the coverage provided by insurance providers, Sophos found.”
  • The National Institute of Standards and Technology announced,
    • “The U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) are excited to announce the return of the “Safeguarding Health Information: Building Assurance through HIPAA Security” conference for October 2024. After a 5-year absence, the conference is returning to Washington, D.C.
    • “DATES: October 23–24, 2024
    • “LOCATION: HHS Headquarters (Hubert H. Humphrey Building) in Washington, D.C. * * *
    • “Registration will open later in the summer.“
  • Fedscoop tells us,
    • “Chris DeRusha, the former federal chief information security officer and deputy national cyber director, is joining Google Cloud to lead the tech giant’s global public sector compliance work, according to a Tuesday press release.
    • “DeRusha, who left the federal government last month after more than three years as the federal CISO, will lead the expansion of Google Cloud’s suite of artificial intelligence, cloud computing and security products within the public sector, both in the United States and abroad.”

From the cybersecurity vulnerabilities and breaches front,

  • Health IT Security tells us,
    •  “Third-party data breaches have been a top concern for healthcare cybersecurity leaders in recent years, following a string of high-profile cyberattacks across the healthcare supply chain.
    • “Threat research from SecurityScorecard, a company that provides cybersecurity ratings for corporations, showed that 35% of third-party breaches that occurred in 2023 affected healthcare organizations, overtaking all other sectors.
    • “SecurityScorecard analyzed the security ratings and historical breach data of the 500 largest US healthcare companies to glean insights into the sector’s top risk factors. Despite the perception that healthcare is behind other industries when it comes to cyber defense, healthcare organizations averaged a security score of 88.”
  • For example, Dark Reading points out,
    • “A full 791,000 of patients have had their personal information compromised in a cyberattack that resulted in Lurie Children’s Hospital in Chicago taking its systems offline.
    • “Cybercriminals accessed the children’s hospital’s systems, disrupting its patient portal, communications, and ability to access medical records.
    • “In a data breach notification this week, the hospital cited the investigation as ongoing and said that the threat actors accessed the systems between Jan. 26 and 31, 2024.
    • “Once the hospital went offline, it implemented standard response procedures, including its downtime procedures, though it has remained open throughout the duration of the investigation thus far.”
  • Health IT Security adds,
    • “Geisinger began notifying upwards of one million individuals of a data breach that occurred in November 2023, when a former Nuance Communications employee accessed certain Geisinger patient information two days after being terminated. The individual has since been arrested and is facing federal charges.
    • “Geisinger serves 1.2 million people across Pennsylvania in rural and urban care settings. Geisinger used Nuance, a Microsoft-owned company, for information technology services.”
  • Cybersecurity Dive further informs us,
    • “Microsoft has notified additional enterprise customers this week that a password-spray campaign by the state-linked Midnight Blizzard threat group led to a compromise of their emails. 
    • “Microsoft also provided additional detail to other customers that were previously notified about the intrusions. Customers who received the notifications took to social media, as they feared they were being potentially phished. The new disclosures were first reported by Bloomberg.
    • “This week we are continuing notifications to customers who corresponded with Microsoft corporate email accounts that were exfiltrated by the Midnight Blizzard threat actor, and we are providing the customers the email correspondence that was accessed by this actor,” the company said in an emailed statement. “This is increased detail for customers who have already been notified and also includes new notifications.”
  • HHS’s Health Sector Cybersecurity Coordination Center (HC3) issued a Threat Actor Profile on a Russian cyber threat group known as Seashell Blizzard.

Cybersecurity Dive relates,

  • “UPDATE: June 27, 2024: Progress Software upgraded the severity score of a MOVEit file-transfer service vulnerability, CVE-2024-5806, from a 7.4 to 9.1 on Tuesday. “A newly identified vulnerability in a third-party component used in MOVEit Transfer elevates the risk of the original issue mentioned above if left unpatched,” the company said in the updated advisory. “While the patch distributed by Progress on June 11 successfully remediates the issue identified in CVE-2024-5806, this newly disclosed third-party vulnerability introduces new risk.”
  • CISA added three known exploited vulnerabilities to its catalog on June 26, 2024
    • “CVE-2022-24816 GeoSolutionsGroup JAI-EXT Code Injection Vulnerability
    • “CVE-2022-2586 Linux Kernel Use-After-Free Vulnerability
    • “CVE-2020-13965 Roundcube Webmail Cross-Site Scripting (XSS) Vulnerability”
  • The American Hospital Association News reports,
    • “The Health Information Sharing and Analysis Center June 27 issued a threat bulletin alerting the health sector to active cyberthreats exploiting TeamViewer. H-ISAC recommends users review logs for any unusual remote desktop traffic. Threat actors have been observed leveraging remote access tools, H-ISAC said. The agency recommends users enable two-factor authentication and use the allowlist and blocklist to control who can connect to their devices, among other measures.”
  • and
    • “The FBI and Department of Health and Human Services June 24 released an advisory about cyberthreat actors targeting health care organizations in attempts to steal payments. The agencies have recommended mitigation efforts to help reduce the likelihood of being impacted. Threat actors have been found to use phishing efforts to gain access to employees’ email accounts, and then pivoting to target login information related to the processing of reimbursement payments to insurance companies, Medicare or similar entities, the agencies wrote. In some instances, threat actors would call an organization’s information technology help desk posing as an employee of the organization to trigger a password reset for the employee’s account. 
    • “The AHA was initially made aware of this type of scheme in January, and HHS issued an advisory on similar threats in April. 
  • Pharmacy Practice News calls attention to an
    • “increasingly popular tool for hackers trying to sneak around information technology (IT) protections.
    • “Smishing is a variant of phishing (the by now familiar practice of sending fraudulent emails to steal personal information). In this case, the attacker “uses a compelling text message to trick targeted recipients into clicking a link, which sends the attacker private information or downloads malicious programs to a smartphone,” the Department of Health and Human Services (HHS) explained in an August 2023 report. (The term comes from combining SMS, which refers generally to text messaging, with “phishing.”)
    • “If you have ever received a text message insisting that a UPS package could not be delivered [and the FEHBlog has], or warning you that you’re in trouble with the IRS and urgently requesting that you click the embedded link, then you’ve been a target of attempted smishing. And if you think you’ve seen more of these messages lately, you’re not alone.

From the cybersecurity defenses front,

  • Cybersecurity Dive reports,
    • “Cloud security is a top priority for organizations around the world, Thales found in a study released Tuesday. The report is based on a survey of 3,000 IT and security professionals from 18 different countries.
    • “More than 2 in 5 respondents said they have had their cloud environments breached in the past, with 14% of respondents reporting a breach in the past year. 
    • “For nearly one-third of incidents, human error and misconfiguration are to blame. Respondents also cited the exploitation of known vulnerabilities in 28% of breaches and failure to use multifactor authentication in 17%.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday Factoids

David Ermer–CDC, FDA, HSA, Medical / Rx research, Mental health care, NIH, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News reports,
    • “The U.S. Supreme Court June 28 overturned a 1984 ruling in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which required courts to defer to federal agencies to interpret ambiguous laws. Decided by a 6-3 vote [written by Chief Justice Roberts], the Court held:
    • “Chevron is overruled. Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the Administrative Procedure Act requires. Careful attention to the judgment of the Executive Branch may help inform that inquiry. And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation, while ensuring that the agency acts within it. But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
  • FEHBlog observation: In short, the Supreme Court’s sensible, prospective decision creates a level playing field for American businesses and other citizens challenging administrative actions.
  • Fierce Healthcare tells us,
    • “Attorney General Merrick Garland announced Thursday [June 27, 2024,] a two-week operation in which 193 people across the country, including 76 licensed healthcare providers, were charged for their alleged participation in healthcare fraud schemes.
    • “The 145 cases highlighted by the Department of Justice (DOJ) involved over $2.75 billion of intended losses and $1.6 billion in actual losses, Garland said. Among allegations highlighted by the DOJ were medically unnecessary amniotic wound grafts, diverted HIV medications, online distribution of Adderall and other telemedicine schemes.
    • “As healthcare fraud schemes continue to evolve, so will the Justice Department’s investigative and prosecutorial strategies,” Garland said during a Thursday press conference. “Our messages to those seeking to exploit patients and defraud government programs is clear: You cannot hide your crimes. We will find you, and we will hold you accountable.”
  • Kauffman Hall reports,
    • “In late April, the Centers for Medicare & Medicaid Services (CMS) established new staffing standards for long-term care (LTC) facilities, mandating a minimum of 3.48 hours of nursing care per patient per day, with 33 minutes of that care from a registered nurse, at least one of whom must be always on site. The rule is slated to go into effect in two years for urban nursing homes and three years for rural nursing homes, with some facilities able to apply for hardship exemptions. 
    • “Although about one in five LTC facilities nationwide currently meet these staffing standards, staffing levels vary greatly by both state and facility ownership profile. In 28 states, fewer than a quarter of LTC facilities meet the new standards, and in eight states fewer than 10% of facilities are already in compliance. 
    • “Facilities in Texas are the least ready, with only 4% meeting the new staffing minimums. In terms of ownership structure, only 11% of for-profit facilities—which constitute nearly three quarters of all LTC facilities nationwide—have staffing levels that meet the new staffing minimums. 
    • “The Government Accountability Office projects this new rule will cost LTC facilities $43B over the first ten years, a significant expense at a time when recruiting and retaining nursing talent is already challenging. 
    • “Citing the risk of mass closures from facilities unable to comply, nursing home trade groups are suing to stop the mandate from going into effect, and there is also a bill advancing in the House that would repeal the staffing ratios. That bill is backed by the American Hospital Association, which fears the mandate “would have serious negative, unintended consequences, not only for nursing home patients and facilities, but the entire health continuum.”
  • HR Dive reminds us,
    • “While there’s still a small chance it could be blocked, the first step of the U.S. Department of Labor’s overtime final rule is set to go into effect Monday — raising the minimum salary threshold for overtime from $35,568 to $43,888.
    • “Almost every workplace should be prepared with needed adjustments, but there are still a few last-minute actions HR should undertake if they haven’t to protect their organizations, Victoria Lipnic, partner at Resolution Economics and former EEOC commissioner, and Jonathan Segal, partner at Duane Morris LLP, said at a Monday panel at the Society for Human Resource Management’s annual conference.”
    • The three items are explained in the article. 

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • COVID-19
      • During April and May 2024, COVID-19 activity was lower than at any time since the start of the pandemic. Recent increases need to be considered from that baseline. This includes increases in COVID-19 test positivity and emergency department visits, suggesting growth in COVID-19 activity across several states, and increases in rates of COVID-19–associated hospitalizations among adults 65+ at some Western sites. While there are indications for the potential start of a summer surge, nationally COVID-19 activity remains low. CDC will continue to monitor to see if these recent increases persist.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
    • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remained low for children and adults for the 2023-24 respiratory illness season. COVID-19 vaccines continue to be recommended and can provide a layer of protection.”
  • The Hill lets us know,
    • “The CDC recommended [on June 27, 2024] that all Americans 6 months and older receive the flu vaccine, noting that it will offer protection against the against H1N1, H3N2, and a B/Victoria lineage virus.
    • “And during the 2023-24 flu season, more than 44,900 people are estimated to have died from flu complications.
    • “The CDC emphasized that it was safe to receive the flu and COVID shots at the same time.”
  • Per MedTech Dive,
    • “Cepheid said Thursday it received de novo authorization for the only molecular test in the U.S. to detect hepatitis C virus RNA directly from fingerstick blood samples. 
    • “The Food and Drug Administration authorization positions healthcare professionals to diagnose hepatitis C at the point of care. The agency said that patients could be diagnosed and treated at the same healthcare visit.
    • “Cepheid’s authorization establishes special controls, clearing other companies to bring similar tests to market in the U.S. via the 510(k) pathway.” 
  • Fierce Pharma points out,
    • “After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer and its dominant Prevnar franchise.
    • “At a meeting this week, the CDC’s Advisory Committee on Immunization Practices (ACIP) gave a unanimous vote, with one abstention, in favor of the vaccine in millions of adults. Specifically, the vaccine experts recommended the shot for adults 65 and older who have not yet received a pneumococcal conjugate vaccine, plus for those 19 to 64 with certain underlying medical conditions or other risk factors.
    • “Adults 19 years old and up who have started their pneumococcal vaccine series with Pfizer’s Prevnar 13 but have not received all of the recommended Merck’s Pneumovax 23 doses are also included in ACIP’s endorsement.
    • “The ACIP vote recognizes the clinical profile of Capvaxive for adults in the U.S., and we look forward to the CDC’s final, published recommendations,” Merck’s chief medical officer Eliav Barr, M.D., said in a press release.
    • “Capvaxive protects against 21 serotypes of the bacterial infection that comprise 84% of the pneumococcal disease contracted by adults 50 and older, according to epidemiologic data from the CDC. Pfizer’s leading pneumococcal disease vaccine, Prevnar 20, protects against 20 serotypes that comprise 52% of the disease in that population.
  • The Institute for Clinical and Economic Review announced yesterday,
    • “ICER released a Final Evidence Report assessing the comparative clinical effectiveness and value of MDMA-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).
    • “ICER’s Chief Medical Officer David Rind, MD stated:
      • “PTSD can be a severe condition affecting nearly all aspects of an individual’s life, and many current therapeutic options are insufficient for many people with PTSD. Despite two randomized trials of MDMA-AP, functional unblinding in the trials and additional concerns around trial design and conduct led to ICER concluding that the publicly available evidence is insufficient to assess the balance of benefits and harms. It was encouraging to learn that FDA is investigating such issues, including those brought to light at our Public Meeting.”
    • “For every report, ICER follows a process that includes numerous opportunities for stakeholders to engage and be involved throughout its development. Our reports always begin with an initial scoping phase, followed by development of a Draft Evidence Report. We consider all of the public comments on the Draft Evidence Report as we put together the revised Evidence Report, which is discussed at a public meeting with patients, clinical experts, manufacturers, payers, and policy experts. After that public discussion, we release the Final Evidence Report.”
  • Per Health Day,
    • “An immunotherapy/chemotherapy combo drug can help early-stage breast cancer patients remain cancer-free following treatment, a new trial shows.
    • “The combo drug, Kadcyla, is already approved to treat patients with advanced HER2-positive breast cancer, researchers said.
    • “The new results show that stage 1 breast cancer patients who received Kadcyla stayed free of invasive cancer five years after treatment.
    • “One year of [Kadcyla] after surgery for patients with a stage 1 HER2-positive cancer leads to outstanding long-term outcomes, making it a reasonable treatment approach for select patients,” said senior study author Dr. Sara Tolaney, chief of breast oncology at Dana-Farber Cancer Institute in Boston.”
  • and
    • “Just 25% of people battling opioid use disorder are getting medications aimed at helping them quit and potentially avoid an overdose, new data shows.
    • “Boosting access to proper treatment might save countless lives.
    • “In 2022, 81,806 opioid-involved overdose deaths were reported in the United States, more than in any previous year,” noted a team led by Deborah Dowell, chief medical officer at the U.S. Centers for Disease Control and Prevention’s Division of Overdose Prevention.
    • “Dowell and her colleagues looked at data collected for 2022 as part of the National Survey on Drug Use and Health. The survey involved almost 57,000 adults.”
  • The National Institutes of Health adds,
    • “Results from a national survey indicate that many Americans, 61%, are unaware that primary care physicians can prescribe medications for opioid use disorder, and 13% incorrectly believed that they could not. The survey, funded by the National Institutes of Health (NIH), also found that 82% of the people who reported ever misusing prescription or illicit opioids expressed comfort in going to their primary care physicians for medications for opioid use disorder. Among those who had not misused opioids, a majority, 74%, reported they would be comfortable referring their loved ones to primary care for these medications.
    • “Notably, Black American respondents were most likely to incorrectly believe they could not receive medications for opioid use disorder via primary care, pointing to an important disparity in information that may further impede access to treatment. The findings suggest there is an important opportunity to increase awareness of these treatments and how to access them – using efforts that employ culturally specific strategies to reach different groups. Decades of research have shown the overwhelming benefit of existing medications for opioid use disorder, such as buprenorphine and methadone.
    • “Primary care is often people’s first point of contact in the health care system and can serve as a crucial setting to talk about addiction and receive lifesaving medications,” said Nora D. Volkow, M.D., Director of NIH’s National Institute on Drug Abuse (NIDA). “We need to provide education and support so that patients feel empowered to seek help from their primary care physician, and their doctors feel prepared to help them.”
  • Behavioral Health Business explains why “Feeding Disorder Treatment Programs Are Urgently Needed for Children with Autism.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Optum will not bid on Steward Health Care’s physician group, Stewardship Health, during the bankrupt health system’s upcoming auction, a Massachusetts state official has confirmed.
    • “The news is a major setback for Steward, which has repeatedly identified selling Stewardship as critical for its financial stabilization. 
    • “Steward took out $150 million in loans to fund the transaction in February. Its attorneys have claimed during federal bankruptcy proceedings that the sale proceeds would be enough to cover debts to certain lenders and, as recently as June 13, the Dallas-based system tied $75 million of new debtor-in-possession financing — which funds operations during restructuring — to the successful completion of a Stewardship sale.
    • “While Steward hammered the importance of selling Stewardship, it only had one public buyer at the table: UnitedHealth-owned Optum. 
  • and
    • “Amwell is implementing a reverse stock split to avoid being kicked off the New York Stock Exchange, the telehealth vendor said Friday. 
    • “The company has struggled to reach profitability, and its stock price has declined precipitously since entering the public markets in 2020. In April, the telehealth company received a warning notice from the NYSE that its stock was trading below minimum standards, closing at less than $1 per share for 30 consecutive days. 
    • “The company’s board of directors approved a 1-for-20 reverse stock split, a maneuver that consolidates the number of existing shares of stock to boost its share price. The split will be effective at market close on July 10.”
  • MedCity News shares expert observations on recent acquisitions by Kaiser Permanente’s Risant Health subsidiary.
    • “Is Risant Health the rising star of scalable, profitable value-based care models for health systems?
    • “It’s a little early to break out the champagne and toast to the company’s success, but it might soon be time to start thinking about ordering some flute glasses should a celebration be in order.”
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Rhode Island is eliminating nearly 65% of prior authorization requirements for primary care providers by early 2025. 
    • “BCBSRI reviewed data to identify some of the most common orders that create additional work for PCPs. Radiology and cardiology services lead the list of requirements being cut, and the changes will apply across commercial and Medicare plans, according to a June 27 news release. * * *
    • “BCBSRI removed all prior authorization for outpatient behavioral services in 2018. Other payers such as UnitedHealthcare, Cigna, BCBS Michigan, Point32Health and Aetna have all reduced prior authorization requirements recently.”
  • The Employee Benefits Research Institute presents an EBRI Issue Brief titled “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Medication Adherence.”
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 drug classes and other health services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. In this Issue Brief, we used claims data to quantify the effect of expanding pre-deductible coverage on medication adherence among enrollees with certain chronic conditions. We found some evidence that expanding pre-deductible coverage in HSA-eligible health plans increased medication adherence in 2022, but not earlier.”

A Busy Thursday

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News tells us,
    • “A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity drugs and cancer screening blood tests and place guardrails around Medicare’s discretion in covering drugs and devices approved by the Food and Drug Administration.
    • “[By a 36-4 bipartisan vote],the House Ways & Means Committee passed obesity drug coverage legislation that would offer a limited pathway for adults 65 and older to get their weight loss drugs paid for by Medicare. Right now, Medicare is prohibited from covering medications used for weight loss, like Wegovy and Zepbound. 
    • “However, the new plan is significantly more restrictive than prior proposals. It’s primarily targeted at making sure that people currently taking weight loss drugs don’t get kicked off when they enter the Medicare program, such as by turning 65.” * * *
    • “Another bill that gained even more support would expand Medicare coverage of cancer screening. The legislation passed on a 38-0 vote. 
    • “Medicare is allowed to pay for FDA-approved tests that diagnose diseases, but it doesn’t cover tests that simply screen healthy people for cancer. The bill would open the door for Medicare to pay for cancer screening tests, including Grail’s Galleri.” 
  • MedPage Today informs us,
    • “Value-based care — in which medical practices are paid based on the value of their care, not on volume — is a good idea but the Centers for Medicare & Medicaid Services (CMS) need to improve its implementation, doctors and a healthcare executive told members of the House Ways & Means Health Subcommittee.
    • “I am a proponent of the need to move to value-based care, improving quality while decreasing wasteful spending and ensuring access,” Robert Berenson, MD, an institute fellow at the Urban Institute in Washington, D.C., said at Wednesday’s subcommittee hearing on improving value-based care for patients and providers. “However, I believe that value-based payment as a mechanism to promote better care delivery has gotten off track and needs a thorough reevaluation and reformulation.”
  • Fierce Pharma relates,
    • “Leading health legislators say they are focused on reducing prescription drug prices while minimizing unintended consequences of the Inflation Reduction Act (IRA).
    • “House Rep. Scott Peters, D-California, and Rep. Mariannette Miller-Meeks, R-Iowa, shared their priorities during a program put on by The Hill and the Alliance for Aging Research.
    • “Peters stressed that the drug manufacturing industry needs to stay in the U.S., unlike how the country let chip manufacturing business slip away and go offshore. He also wants lawmakers to budget healthcare expenditures differently.
    • “Innovation might cost more money upfront, even if it saves money down the line,” he said. “In the Budget Committee, which I also serve on, we’re talking about how to think about balancing the budget over time. If we don’t think about the future costs of all these diseases, as part of that calculation, I think we’re going to miss the mark.”
  • Per CMS fact sheets,
    • On June 26, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which would update Medicare payment policies and rates for Home Health Agencies (HHAs). These changes can support timely admission to home health services, which has demonstrated improvements for patient outcomes and reducing risk of hospital readmissions. 
  • and
    • “On June 27, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies and includes requests for information under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2025.
    • “For CY 2025, CMS is proposing to increase the ESRD PPS base rate to $273.20, which would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%.”
  • HHS’s Office for Civil Rights announced,
    • “At the HHS Office for Civil Rights, we believe patient privacy is essential to ensuring high quality reproductive health care. HHS OCR is encouraging HIPAA covered entities and business associates to begin implementing the new HIPAA Privacy Rule to Support Reproductive Health Care Privacy to help protect patient privacy and ensure compliance later this year. To aid in this, we have compiled resources for both community members and HIPAA Covered Entities or Business Associates. 
      • “For resources to help communicate with stakeholders and community members click here.
      • “For a fact sheet summary of the rule click here (en español).
      • “To hear directly about the rule from Director Melanie Fontes Rainer click here (en español).
      • “To view a recorded briefing by Deputy Director for Health Information Privacy, Data and Cybersecurity Timothy Noonan click here.
      • “For a model attestation for a requested use or disclosure of protected health information potentially related to reproductive health care click here.
    • “The effective date of the Final Rule was June 25, 2024. This is the date that HIPAA covered entities and their business associates may begin implementing the new requirements. Covered entities and business associates are not required to comply with the new requirements until December 23, 2024, except for the new changes to the HIPAA Notice of Privacy Practices which has a compliance date of by February 16, 2026.”
  • Healthcare Dive lets us know,
    • “The U.S. Supreme Court ruled 6-3 on Thursday to allow Idaho doctors to perform abortions to stabilize a patient’s life and health. 
    • “However, the court declined to take up the fundamental legal question underlying the case: whether a federal law mandating hospitals provide medical services during emergencies [known as EMTALA] supersedes near-total state abortion bans.
    • “It is the court’s first ruling on statewide abortion restrictions since Roe v. Wade was overturned in 2022, ending the constitutional right to abortion in the United States.”
  • CMS observed,
    • “CMS’ first responsibility is to the people we serve, including anyone who steps into the emergency department of a Medicare-participating hospital. If any individual believes their EMTALA rights have been violated, they should continue to report the circumstances to CMS or their state survey agency. To the maximum extent permitted by law, we will continue to investigate complaints and hold hospitals accountable to provide the emergency stabilizing treatment that EMTALA has required for decades.”
  • The Wall Street Journal reports,
    • “The Supreme Court rejected a bankruptcy plan for OxyContin-maker Purdue Pharma that would have allocated billions of dollars from members of the wealthy Sackler family to combat opioid addiction in exchange for shielding them from civil lawsuits over their alleged role in fueling the drug epidemic.
    • “The 5-4 decision marks a victory for the minority of opioid victims who voted to reject the settlement plan because they want to continue pressing lawsuits against the Sackler family members who own Purdue, and a loss for the majority of opioid victims and state and local governments who voted to accept it.”
    • “The high court said U.S. bankruptcy law doesn’t allow for a release of the Sacklers’ legal liabilities stemming from their ownership of Purdue when not all opioid-related plaintiffs have accepted the terms offered by the company’s family owners, whose wealth has been estimated at $11 billion.” * * *
    • “Thursday’s ruling—among the highest-profile bankruptcy decisions ever from the high court—weakens the ability of corporations and their insiders to use bankruptcy to resolve mass litigation alleging they harmed consumers. 
    • “The Sacklers didn’t file for bankruptcy themselves and didn’t agree to place “anything approaching their full assets on the table” for distribution to opioid victims, [Justice Gorsuch] wrote [for the Court’s majority]. “Yet they seek a judicial order that would extinguish virtually all claims against them for fraud, willful injury, and even wrongful death, all without the consent of those who have brought and seek to bring such claims,” he wrote. 
    • “Nothing in U.S. bankruptcy law authorizes that outcome, [Justice] Gorsuch said.
  • Fierce Pharma adds,
    • “The Supreme Court decision sends the case back to bankruptcy court for future deliberations, according to a statement from Connecticut Attorney General William Tong.”

From the public health and medical research front,

  • The New York Times reports,
    • “All Americans ages 6 months and older should receive one of the new Covid-19 vaccines when they become available this fall, the Centers for Disease Control and Prevention said on Thursday.
    • “The recommendation comes as the nation faces a summer wave of Covid, with the number of infections rising in at least 39 states and territories.
    • “Most Americans have acquired immunity against the coronavirus from repeat infections or vaccine doses, or both. The vaccines now offer an incremental boost, remaining effective for only a few months as immunity wanes and the virus continues to evolve.
    • “Still, across every age group, a vast majority of Americans who were hospitalized for Covid did not receive one of the shots offered last fall, according to data presented at a meeting on Thursday of the C.D.C.’s Advisory Committee on Immunization Practices.
    • “Dr. Mandy Cohen, the agency’s director, accepted the unanimous advice of the panel on Thursday to recommend another round of immunizations.”
  • The NIH Director writes in her blog,
    • “Cancer arises when changes in genes that normally control cell division lead to unchecked growth at the expense of healthy tissues. One of the most common genetic alterations across human cancers—occurring in 95% of pancreatic cancers but also many non-small cell lung cancers, colorectal cancers, and others—is in a gene known as KRAS. While promising new treatments targeting KRAS to shrink cancerous tumors have recently gained approval, less than 40% of pancreatic cancers respond to treatment with KRAS inhibitors for reasons that aren’t well understood.
    • “There’s much more to learn about how KRAS spurs cancer growth—and how KRAS-mutant cancers resist treatment with existing KRAS inhibitors. To address this need, researchers behind two studies in Science have established the most comprehensive molecular portrait yet of the workings of KRAS and how its many downstream impacts may influence outcomes for people with pancreatic cancer. The findings could lead to new treatment approaches, including ways to potentially guide treatment for individuals with pancreatic cancer, the third leading cause of cancer-related death in the U.S.
    • “These studies, supported in part by NIH, come from a team led by Channing Der  and Adrienne Cox, together with Jeffrey Klomp, Clint Stalnecker, and Jennifer Klomp, at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. The researchers were inspired in part by the Food and Drug Administration’s recent approval of treatments that block a mutated version of KRAS that drives many pancreatic cancers. The team was also motivated by the realization that many patients whose cancers initially respond to the new treatments relapse rather quickly as the cancers find ways to reactivate underlying growth pathways.” * * *
    • “Importantly, the researchers found that the molecular signatures they’ve uncovered may predict tumor responses in patients treated with KRAS inhibitors or ERK inhibitors. Based on their findings, they suspect that the reason so many pancreatic cancers don’t respond to KRAS inhibitors may be because the drugs simply don’t block KRAS well enough—and not because the cancers no longer depend on KRAS signals for their growth. The researchers suggest it may be beneficial to monitor these underlying molecular pathways in patients to better understand treatment outcomes and guide treatment decisions.
    • “The team plans to continue exploring the role of these and other important drivers of cancer growth and treatment resistance. Ultimately, their goal is to help advance the development of the next generation of KRAS inhibitors that will work even better for many more people with pancreatic or other KRAS-driven cancers.”
  • Health Day notes,
    • “A full third of American adults take multivitamins, despite prior studies suggesting they do little to boost health.
    • “Now, a study involving almost 400,000 people finds zero benefit from multivitamin use in helping folks live longer.
    • “Among people “without a history of major chronic diseases, we did not find evidence to support improved longevity among healthy adults who regularly take multivitamins,” concluded a team led by Erikka Loftfield. She’s with the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute (NCI).
    • “Her team published its findings June 26 in the journal JAMA Network Open.
  • Healio calls to our attention a study finding
    • “Alcohol intake of more than 12 g per day was associated with increased risk for hypertension.
    • “Hypertension risk plateaued at higher levels of alcohol intake for men, but risk continued to rise for women.”
  • STAT News offers a detailed article titled “By the numbers: America’s alcohol-related health problems are rising fast.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Walgreens is pulling back its focus on healthcare services after the strategic shift failed to bolster the struggling retailer’s financial health.
    • “Walgreens plans to reduce its stake in value-based medical chain VillageMD, and will no longer be the company’s majority owner, CEO Tim Wentworth told investors on a Thursday morning call after announcing third quarter earnings below analyst expectations.
    • “Walgreens also plans to close a “significant portion” of its roughly 8,700 stores in the U.S., Wentworth said. The company didn’t share a specific figure, but said it is reviewing one-quarter of its stores that are underperforming financially. Walgreens has already closed hundreds of stores over the past few years.” * * *
    • “Walgreens plans to launch a retail pharmacy action plan to improve customer experience in its stores, better align its pharmacy and healthcare businesses and focus on reliable products in areas like women’s health, Wentworth said.
    • “The company is also in discussions with health insurers and pharmacy benefit managers to change how its pharmacies are paid, to create more stability in a challenging reimbursement environment.”
  • Modern Healthcare reports,
    • “At-home emergency care is gaining momentum — and could cost millions less — but reimbursement challenges create an access barrier for some patients.
    • “Deploying healthcare in patients’ homes gained traction during the COVID-19 pandemic as a way to ease overcrowding at hospitals and prevent the virus from spreading. Emergency department care at home lets patients bypass the waiting room through referrals from hospitals or primary care providers if they determine patients do not have life-threatening illnesses or injuries. While many private insurers reimburse for such care, traditional fee-for-service Medicare and Medicaid do not pay for it as a stand-alone service.
    • “Emergency department-at-home programs deploy paramedics or nurses to check vital signs, draw blood and take x-rays with portable imaging devices. Physicians supervise the visits via telehealth, then refer patients to primary care providers for further treatment or to hospital emergency departments if more complex care is needed.
    • “Healthcare technology company Medically Home and primary care provider Atrius Health, a division of UnitedHealth Group’s Optum Health, offer emergency department-care-at-home through a partnership in the Boston area. A study they published last week in the New England Journal of Medicine found more than 83% of 3,668 patients who received emergency care at home over two years did not require a trip to the hospital, saving Atrius approximately $4.5 million.
    • “Medically Home launched its service in 2020 and has served approximately 7,000 patients through contracts with three provider groups, including Atrius. The primary care provider has value-based care contracts with most of its patients and takes on the full risk for their care.”
  • FEHBlog observation: Intriguing!
  • Per Fierce Healthcare,
    • “Nineteen rural Minnesota hospitals and their 50-plus clinics have banded together to form a clinically integrated network (CIN) serving more than 750,000 people.
    • “The so-called Headwaters High-Value Network, announced Thursday, stitches the independent hospitals’ services together so that Minnesotans can coordinate their care across care sites. Together, the member groups employ about 9,000 people and bring in $1.3 billion of annual net revenue.
    • “Members of the network also said the approach will help their hospitals control rising care costs through reduced administrative burden and shared services. The CIN said it is “in discussions” with other interested rural Minnesota hospitals and “expects to grow.”
  • Beckers Hospital Review identifies the ten best states for hospital experience. Nevada leads the pack.
  • Beckers Hospital Review adds,
    • “Mark Cuban Cost Plus Drug Co. will serve as a wholesale drug distributor for all 71 hospitals affiliated with Community Health Systems, the organizations announced June 27. 
    • ‘Cost Plus Drugs launched the wholesale services in early 2024, but for the first time, the company is rolling out the offering to a large health system.
    • “The pharmaceutical company has direct relationships with 38 of the 40 largest generic manufacturers and multiple secondary distributors, according to Cost Plus Drugs’ CEO and co-founder, Alex Oshmyansky, MD, PhD.

Midweek Update

David Ermer–ACA, Congress, FDA, Federal employment benefits, Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Beckers Payer Issues reports,
    • “Making expanded ACA subsidies permanent would add $335 billion to the national deficit between 2025 and 2034, the Congressional Budget Office estimated. 
    • “Premium tax credits have spurred record enrollment in ACA marketplace plans. These subsidies, implemented in 2021, are set to expire at the end of 2025 unless Congress votes to extend them. 
    • “In a June 24 letter to the chairs of the House ways and means and budget committees, the CBO estimated making subsidies permanent would cost $415 billion overall — the result of a $250 billion increase in spending and a $164 billion decrease in tax revenue. 
    • “These costs would partially be offset by a decline in offers of employment-based insurance, the CBO estimated, resulting in a total add of $335 billion to the budget.  * * *
    • “Payer executives have told investors they are optimistic Congress will cut a deal to extend the subsidies or make them permanent.”
  • Fierce Healthcare tells us,
    • “A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services (CMS) to better enforce Medicare Part D program requirements for pharmacy benefit managers.
    • “By evading such requirements, PBMs are threatening the financial health of the country’s smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter (PDF).
    • “I am alarmed to hear reports that PBM contracting practices are straining the finances of pharmacies and directly contributing to their closures,” he said. “Specifically, I am concerned PBMs are not adhering to the new rule reining in direct and indirect remuneration (DIR) fees that took effect on January 1 and undermining Medicare’s pharmacy access standards as intended by Congress.”
  • The National Academies of Sciences, Engineering, and Medicine released a report titled “Ending Unequal Treatment: Strategies to Achieve Equitable Health Care and Optimal Health for All” which follows up on a well-known 2003 report on social determinants of health.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. * * *
    • “Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.”
  • Federal News Network informs us,
    • “For more than a week, federal employees enrolled in FSAFEDS have not been receiving payments for approved reimbursement claims made in their Flexible Spending Accounts.
    • “The program suspended all reimbursement payments beginning June 16 as an effort to further strengthen anti-fraud and security measures, Federal News Network confirmed with a government source who explained the issue on the condition of anonymity.
    • “At this time, the FSAFEDS is holding all claims payments out of an abundance of caution,” FSAFEDS wrote Tuesday in a post on X. “FSAFEDS has taken this action due to recently discovered fraudulent claims activity. We are working to resolve and restore all claims payment activities as soon as possible.”
    • “The pause on reimbursement payments, however, has been lifted and payments to employees should resume soon, Federal News Network has learned. FSAFEDS plans to process all reimbursements currently on hold by the end of the week.

From the public health and medical research front,

  • MedPage Today tells us,
    • “All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).
    • “Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.
    • “These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.
    • “There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy) Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).
  • The American Hospital Association News notes,
    • “The Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of H5N1 bird flu in humans. The strategy, released through ASPR’s Biomedical Advanced Research and Development Authority, has four objectives: strategic implementation and deployment of the national pre-pandemic influenza vaccine stockpile; enhanced protection through novel vaccines; leverage therapeutics through deployment, early availability and development of novel products; and ensure rapid and effective diagnostics tools to inform rapid antiviral prescription and treatment.” 
  • BioPharma Dive calls attention to the fact “Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help? There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.”
  • Per Fierce Pharma,
    • “[Verona Pharma’s] Ohtuvayre [which the FDA approved for marketing today] becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies.
    • “As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.
    • “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in an interview with Fierce Pharma. “We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
  • The Washington Post reports,
    • “A few of your favorite ice cream products might no longer be in the freezer this summer after a prominent supplier to brands such as Hershey’s and Friendly’s issued a recall notice over a potential listeria contamination.
    • “Maryland-based Totally Cool recalled products from 13 brands distributed nationwide in retail locations and through direct delivery after sampling by the Food and Drug Administration discovered the presence of Listeria monocytogenes, the bacterium that causes listeria infections, the agency said Monday.
    • “The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.”

From the U.S. healthcare business front,

  • Kaufmann Hall discusses the state of play in healthcare antitrust enforcement.
  • The Wall Street Journal predicts “The War Over Cheaper Ozempic Won’t End Well for Some Investors. Once Eli Lilly and Novo Nordisk increase supply of weight-loss medications, companies such as Hims & Hers may find it trickier to sell compounded versions of the drugs [due to the nuances of FDA law.]”
  • MedTech Dive points out “Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech. Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.”
  • Per Fierce Healthcare,
    • “Blue Shield of California is making it easier for members to access their personal health data through its new Member Health Record.
    • “The platform will combine health data both from claims as well as from providers in one place and is available both online and through Blue Shield’s app so members can connect virtually. The Member Health Record will first launch for a “select group” of Medicare Advantage members and will be rolled out to all of its members by the end of the year.
    • “The health record will include information on lab results, immunizations, diagnoses and conditions alongside historical health data that have been shared with the plan, including details tallied before the member joined Blue Shield.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • KFF Health News reports,
    • “U.S. Surgeon General Vivek Murthy declared firearm violence a public health crisis, as gun deaths and injuries punctuate daily life in America.
    • “On nearly every day of 2024 so far, a burst of gunfire has hit at least four people somewhere in the country. Some days, communities have endured four or five such shootings.
    • “The nation’s top doctor called on policymakers to consider gun safety measures such as bans on assault weapons and high-capacity ammunition magazines and universal background checks for all firearm purchases. His advisory also urges a “significant increase” in funding for research on gun injuries and deaths, as well as greater access to mental health care and trauma-informed resources for people who have experienced firearm violence.”
  • NPR discusses what the declaration will do.
  • The U.S. Public Health Service Task Force issued a draft recommendation today which “concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.” The public comment period ends on July 22, 2024.
  • Reg Jones, writing in FedWeek, explains “Earning, Accumulating and Using Sick Leave in the Federal Government.”

From the public health and medical research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention warned clinicians, health authorities and the public Tuesday about an increased risk for dengue virus infections in the United States because of the record-breaking global incidence of the mosquito-borne viral disease.
    • “In the first six months of 2024, countries in the Americas have reported more than 9.7 million dengue cases, twice as many as in all of 2023, exceeding the highest number ever recorded in a single year, the CDC said in a health advisory. Puerto Rico declared a public health emergency because of the unusually high number of cases reported in the winter and spring, the dry season, when dengue cases are typically low.
    • “Since January, 745 dengue cases have been identified among U.S. travelers who became infected abroad, the agency said. Dengue cases typically increase during the warmest months that are yet to come. Last year, there were 1,829 travel-associated cases in the U.S. * * *
    • “With increased global and domestic incidence of dengue, the CDC is urging health-care providers to be on the lookout for dengue among people with fever who have been in areas with dengue transmission within 14 days of the start of illness. Infants, pregnant people, adults over 65 years old and people with certain medical conditions are at increased risk for severe dengue.”
  • Beckers Hospital Review lets us know,
    • “Teva Pharmaceuticals is launching the first authorized generic of Victoza, the first generic GLP-1 product available in the United States.
    • “By launching an authorized generic for Victoza (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva, said in a June 24 news release.”
  • Highlighting the importance of a generic GLP-1 product is this Wall Street Journal article reporting that
    • “Blockbuster obesity drug Wegovy has been approved in China, opening the door for maker Novo Nordisk to begin selling it in the world’s second-largest economy, where the appetite for similar treatments is surging. * * *
    • “Novo Nordisk’s Ozempic drug—which contains the same semaglutide active ingredient as Wegovy—was approved to treat diabetes in China in 2021. Sales of the drug in the country more than doubled on year in 2023, reaching 4.82 billion Danish kroner ($693.6 million).
    • “Demand for weight-loss drugs is surging in China, where the proportion of overweight and obese adults reached almost 51% in 2022, creating a frenzy among local manufacturers to develop their own versions of the popular treatments, especially as Novo Nordisk’s semaglutide patent expires there in 2026, which will pave the way for generic versions.”
  • MedPage Today notes,
    • “Disrupted circadian rhythms in cognitively normal adults were tied to higher subsequent amyloid-beta levels, prospective data showed.
    • “Higher daily variability at baseline — an indicator of fragmented 24-hour activity rhythms — was associated with higher PET amyloid burden 8 years later (β=0.15, P=0.02) after adjusting for age, sex, APOE4 status, and other factors, according to Julia Neitzel, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, and co-authors. * * *
    • “Considerable interest surrounds the role of sleep dysfunction in the development of Alzheimer’s disease and dementia,” observed Matthew Pase, PhD, of Monash University in Victoria, Australia, who wasn’t involved with the study.
    • “If poor sleep contributes to dementia, improving sleep symptomatology could be one strategy to lower dementia risk,” he told MedPage Today.
  • NPR discusses why “Your gut microbes may influence how you handle stress.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “The University of Alabama System’s board of trustees unanimously approved an agreement to acquire Ascension St. Vincent’s Health System.
    • “Birmingham-based UAB will assume ownership of all Ascension St. Vincent’s care sites under the agreement, announced June 25. The transaction still needs approval from federal regulators and the Catholic Church. UAB and Ascension expect the $450 million deal to close in the fall of 2024, according to the Shelby County Reporter.
  • and
    • identifies the twenty most socially responsible hospitals in the U.S., per Lown Institute. Duke Regional Hospital, in Durham, NC, leads the pack.
  • Per Fierce Pharma,
    • “Physicians don’t mind patients choosing at-home testing options over coming in for an in-person clinic visit—in fact, they overwhelmingly support it, according to the results of a new survey.
    • “Ixlayer’s report this week is based on a poll of more than 140 U.S. physicians representing a variety of specialties. All together, nearly 90% agreed that at-home tests are more convenient to many patients and can improve access to diagnostic care, and almost as many said they believe offering at-home testing options can help speed up diagnoses and, ultimately, improve patient outcomes.
    • “There is a large subset of my patients where making routine office visits is difficult, either complicated by age, travel time, costs, or time constraints. So I see having a convenient, at-home solution as a plus for improving medical care,” one of the survey’s respondents said.
    • “The overwhelming majority of the doctors surveyed, 91% of the group, said they were open to providing at-home testing kits to their patients, and 80% agreed that the remote tests could support or even enhance the healthcare system’s existing workflows.

Monday Roundup

David Ermer–CDC, FDA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • MedPage Today reports about FDA Commissioner Robert Califf’s speech given this past weekend.
    • “We are wowing the world in technology — much of it related to the field that you’re interested in [diabetes],” he told attendees at the keynote opening session of the American Diabetes Association Scientific Sessions. “We are not succeeding in implementation of the things that we know. We need to bring these things together so that we harness technology, particularly digital technology and AI [artificial intelligence], to the benefit of the people that we care about.” * * *
    • “High fasting glucose, poor diet, and high BMI are all in the top five factors behind death and loss of disability-adjusted life years in the U.S. And according to some sources, diabetes has now surpassed cancer as the leader in the economic cost of healthcare in the U.S., with some 34 million adults having some form of diabetes in 2020, he said. “This is an honor I’m not sure I’d want to have, but it does give you a lot of power to do things to make this better.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services June 24 released a final rule that would disincentivize health care providers for interfering with the access, exchange or use of electronic health information. AHA previously expressed concern when the rule was proposed, saying it could threaten the financial viability of economically fragile hospitals.”
    • “In the final rule, hospitals under the Medicare Promoting Interoperability Program found to have committed information blocking would experience a reduction of the market basket update by 75%. Critical access hospitals would see a reduction from 101% to 100% of reasonable costs, while clinicians in Medicare’s Merit-based Incentive Payment System would receive a score of zero in the MIPS Promoting Interoperability performance category. Providers in accountable care organizations that commit information blocking would be ineligible to participate in the Medicare Shared Savings program for at least one year and may not receive revenue they may have earned through the program.” 
  • HHS adds,
    • “This HHS final rule complements OIG’s final rule from June 2023 that established penalties for information blocking actors other than health care providers, as identified in the Cures Act (health information technology (IT) developers of certified health IT or other entities offering certified health IT, health information exchanges, and health information networks). If OIG determines that any of these individuals or entities committed information blocking, they may be subject to a civil monetary penalty of up to $1 million per violation.
    • “The Office of the National Coordinator for Health Information Technology (ONC) and CMS will host a joint information session about the final rule on June 26, 2024, at 2 pm ET. More information can be found at healthit.gov/informationblocking and via ONC’s X account, @ONC_HealthIT 
  • Per Govexec,
    • “The U.S. Postal Service is not living up to its projected cost savings from its plan to overhaul the agency, according to a new [USPS Inspector General] audit, which found the 10-year initiative is no longer offering insight for measuring the success of the reforms. 
    • “USPS is bringing in more revenue than it anticipated when it first laid out its Delivering for America plan in 2021, though its costs have also accelerated in a way it did not project. That has led to overall losses of $950 million in fiscal 2022 and $6.5 billion in fiscal 2023, despite postal management predicting it would have broken even by now.” 
  • Fierce Healthcare lets us know,
    • “The [U.S.] Supreme Court will not hear a legal challenge to the nearly $2.7 billion Blue Cross Blue Shield [antitrust] settlement. * * *
    • In a statement to Reuters, BCBSA said it welcomes the decision as well as “the opportunity to begin to implement this settlement.”

From the public health and medical research front,

  • BioPharma Dive points out
    • “An experimental medicine helped people with a deadly heart disease stay out of the hospital and live longer in a closely watched clinical trial, a finding that could pave the way for a regulatory approval and help its developer, Alnylam Pharmaceuticals, rebound from a significant setback.
    • “Trial data released Monday showed trial participants with the disease, transthyretin amyloidosis cardiomyopathy, and treated with Alnylam’s drug had a 28% lower risk of death from any cause or recurrent cardiovascular event, compared to those given a placebo. Alnylam said its drug was associated with a 33% risk reduction versus placebo among people who weren’t on another drug for the condition, Pfizer’s tafamidis, at the study’s start.”
  • and
    • “Novo Nordisk on Sunday disclosed detailed clinical trial results for an experimental hemophilia treatment dubbed Mim8, showing once-weekly and once-monthly doses of the antibody drug controlled bleeding in people with the more common “A” form of the disorder.
    • “The data, which were presented at the International Society on Thrombosis and Haemostasis Annual Congress in Thailand, fill in a positive picture for Mim8’s effectiveness and safety. Novo had said in May that the Phase 3 trial, called Frontier-2, succeeded and shared topline findings.
    • “Among people who had not previously been on preventive treatment, researchers reported zero bleeds in 86% of study participants who received once-weekly Mim8, and 95% of those given the once-monthly dose. Those figures were 66% and 65%, respectively, among people in the trial who had prior preventive treatment.”
  • Per MedTechDive,
    • “Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration. 
    • “Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine.
    • “Insulet’s filing comes as other diabetes technology companies look to expand their offerings for people with Type 2 diabetes. Tandem Diabetes Care has published results showing how its T:slim x2 pump with Control IQ improved time in range for people with Type 2 diabetes, and Dexcom and Abbott recently gained FDA clearance for continuous glucose monitors tailored for people with Type 2 who don’t take insulin.”
  • Per Beckers Hospital Review,
    • “Orlando, Fla.-based AdventHealth Cancer Institute launched a first-of-its-kind bladder cancer vaccine trial that will use patient-customized mRNA vaccines.
    • “The Phase II trial participants will receive pembrolizumab combined with a customized immunotherapy injection designed using the unique proteins present in each patient’s tumors, according to a May 23 system news release. Participants will receive infusions every six weeks for one year and then receive one vaccine injection every three weeks for nine doses.
    • “This vaccine is precision medicine at its best,” Guru Sonpavde, MD, medical director of genitourinary oncology at the AdventHealth Cancer Institute, as well as a member of the trial’s global steering committee, said in the release.”
  • The Centers for Disease Control last week released a report on loneliness in the U.S. 2022. The study found that loneliness was most prevalent among sexual and gender minorities.
  • STAT News notes,
    • “New research shows that, in spite of recommendations discouraging use of aspirin in primary prevention of cardiovascular disease among older adults, nearly a third of adults 60 years and older are still using it for this very purpose.
    • “The study, published on Monday in Annals of Internal Medicine, found that 18.5 million adults 60 and older without cardiovascular disease reported using preventative aspirin in 2021. Of those, 3.3 million were using the pills without medical advice. * * *
    • “John Wong, vice chair of the USPSTF, emphasized increased physician-patient conversations in deciding how to best prevent cardiovascular disease. “There are things at the individual level our population evidence-based recommendations don’t take into account,” Wong said.
    • “If a patient and their physician decide that daily aspirin is too risky, they can still plan to manage obesity, stop smoking, and regularly screen for high blood pressure and metabolic disease, said Wong. “Those are all evidence-based, proven methods to prevent that first heart attack or first stroke.”
  • Scientific American discusses exercises that can help older Americans reduce the risk of dangerous falls.
  • The Washington Post and Consumer Reports offer “tips can help you move [heavy] objects safely — and with less effort — even as you get older.

From the U.S. healthcare business front,

  • Fierce Healthcare explores UnitedHealthcare’s top selling health insurance product Surest.
  • Beckers Hospital Review explains why “Walgreens is on a mission to attain provider status for its pharmacists.” 
  • FiercePharma reports,
    • “GLP-1 heavyweights Eli Lilly and Novo Nordisk are trading haymakers as they scale up production to meet the overwhelming demand for their revolutionary obesity drugs.
    • “A month after Lilly revealed a $5.3 billion investment to increase its manufacturing capacity, Novo has answered.
    • “On Monday, the Danish drugmaker said it will spend $4.1 billion to construct a second fill-finish plant at its sprawling campus in Clayton, North Carolina. At 1.4 million square feet, the site will match the combined floor space of Novo’s three current manufacturing sites in the state, the company said.
    • “At the new plant, Novo will produce blood sugar modulating treatments Ozempic, for diabetes, and Wegovy, for obesity. The outlay is part of Novo’s planned $6.8 billion investment in manufacturing this year, up from $3.9 billion in 2023.”     

Weekend Update

David Ermer–Congress, Mental health care, SCOTUS, U.S. Healthcare–

From Washington, DC,

From the public health and medical research front,

  • CNN reports
    • “For some people with depression, finding the right medication can be a process of trial-and-error lasting for months or even years, which can worsen symptoms.
    • “But what if doctors, when diagnosing someone with depression, could assess exactly how depression is affecting a patient’s brain and prescribe a treatment that gets it right the first time?
    • “Scientists may be a step closer to that reality, thanks to new research that has identified six subtypes — or “biotypes” — of major depression via brain imaging combined with machine learning. The study, published Monday in the journal Nature Medicine, also tested how three of those biotypes responded to different antidepressants and therapies.”
  • The Washington Post published one of its occasional Medical Mysteries articles. In this case, the Post explains why a breastfeeding mother experience crippling back pain.

From the U.S. health business front,

  • NPR Shots’ “bill of the month” features a Texas urgent care center bill.
    • “One evening last December, Tieqiao Zhang felt severe stomach pain.
    • “After it subsided later that night, he thought it might be food poisoning. When the pain returned the next morning, Zhang realized the source of his pain might not be as “simple as bad food.”
    • “He didn’t want to wait for an appointment with his regular doctor, but he also wasn’t sure if the pain warranted emergency care, he said.
    • “Zhang, 50, opted to visit Parkland Health’s Urgent Care Emergency Center, a clinic near his home in Dallas where he’d been treated in the past. It’s on the campus of Parkland, the city’s largest public hospital, which has a separate emergency room.
    • “He believed the clinic was an urgent care center, he said.”
  • In short, this in-network facility, which Mr. Zhang visited. twice, turned out to be an extension of Parkland’s emergency room, and he was hit with a $19,543 bill on which he owed $1,000 in copayments. People should be placed on notice when they will be billed at hospital rates.
  • The Wall Street Journal adds,
    • “Rising healthcare prices have long eroded American wages. They are doing that by eating into jobs. 
    • “Companies shed workers in the year after local hospitals raise their prices, new research found. Higher hospital prices pushed up premiums for employees’ health insurance, which businesses help pay for. 
    • “The new study, scheduled to be published Monday as a National Bureau of Economic Research working paper, is a comprehensive look at one-way companies manage those higher premiums: cutting payrolls. 
    • “Employers that face increases in healthcare spending respond by laying off workers who they can no longer afford to retain,” said Zarek Brot-Goldberg, an economist at the University of Chicago and one of the researchers involved in the study. 
  • Fortune Well points out,
    • “Just what is the wellness level of today’s corporate workforce? That all depends on who you ask.
    • “Because while C-suite executives overwhelmingly believe their employees are feeling mentally healthy, professionally fostered, and personally satisfied and included, many workers themselves would beg to differ.
    • “That’s according to the findings of the third annual Workplace Well-being report from Deloitte. The audit and tax consultancy firm collaborated with independent researchers Workplace Intelligence to survey 3,150 executives, managers and workers across four countries (with 57% of respondents from the U.S., and others from the U.K., Canada, and Australia) to check in on the state of human sustainability—which is the degree to which an organization values people and leaves them with greater health and well-being, stronger skills for employability, opportunities for advancement, and a heightened connection to purpose. 
    • “A whopping 82% of executives believe their company is advancing human sustainability in general—but only 56% of workers agree.
    • “Other gulfs in understanding, according to the findings: Around 90% of executives believe working for their company has a positive effect on worker well-being, skills development, career advancement, inclusion and belonging, and their sense of purpose and meaning; only 60% of workers agree.
  • On the bright side, a majority of the workers are in the agreement with the C-suite execs. It could be worse.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Federal News Network lets us know,
    • “Agencies that oversee critical infrastructure should address threats posed by China and work to establish baseline cybersecurity requirements over the next two years.
    • “That’s according to new guidance signed out by Homeland Security Secretary Alejandro Mayorkas on June 14. The document lays out priorities over the next two years for sector risk management agencies. SRMAs are responsible for overseeing the security of specific critical infrastructure sectors.
    • “From the banking system to the electric grid, from healthcare to our nation’s water systems and more, we depend on the reliable functioning of our critical infrastructure as a matter of national security, economic security, and public safety,” Mayorkas said in a statement. “The threats facing our critical infrastructure demand a whole of society response and the priorities set forth in this memo will guide that work.”
  • The Wall Street Journal adds,
    • “The U.S. government is pushing board directors at critical-infrastructure companies to improve cybersecurity oversight amid intense espionage and hacking campaigns from China and other adversaries.  “The U.S. government is pushing board directors at critical-infrastructure companies to improve cybersecurity oversight amid intense espionage and hacking campaigns from China and other adversaries.  
    • “On Tuesday [June 18], the U.S. Secret Service, the Cybersecurity and Infrastructure Security Agency, the National Association of Corporate Directors, credit card giant Mastercard and venture-capital firm NightDragon delivered a one-day course to 16 such directors.
    • “The attending directors, all of whom serve in leadership roles such as chairing audit committees on the boards of critical-infrastructure companies, sat for instruction at the Secret Service’s Laurel, Md.-based training facility. The course isn’t a primer on cybersecurity basics, but practical education on current threats and oversight.
  • The Washington Post reports,
    • “The Biden administration announced Thursday [June 20] that it will ban Kaspersky Lab from distributing its anti-virus software and cybersecurity products in the United States, pointing to national security concerns related to the Russian company.
    • “Commerce Secretary Gina Raimondo told reporters the decision was made following an “extremely thorough investigation,” and that Kaspersky has “long raised national security concerns.” The United States in 2017 banned federal agencies [and contractors] from using those products. * * *
    • “The ban on Kaspersky products comes into full effect Sept. 29, according to a statement from the Commerce Department. Until then, Kaspersky will be allowed to continue providing some services in the United States, including certain updates, to give U.S. consumers and businesses time to find alternatives.
    • “Individuals or businesses that continue to use the products will not face legal penalties, department said, but assume “all the cybersecurity and associated risks of doing so.”

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive informs us,
    • “At least 147,000 ASUS routers are potentially exposed to a critical vulnerability, which can allow a remote attacker to bypass authentication and gain login access, researchers at Censys said Thursday [June 20].
    • “ASUS issued a security advisory on June 14 recommending customers upgrade their firmware or apply mitigation steps if the upgrade was not possible.  
    • “The improper authentication vulnerability, listed as CVE-2024-3080, has a CVSS score of 9.8.”  
  • FEHBlog note — The Cybersecurity and Infrastructure Security Agency did not add new known exploited vulnerabilities to its catalog this week.
  • Cybersecurity Dive adds,
    • “Multifactor authentication appeared in almost half of all security incidents the Cisco Talos incident response teams encountered during the first quarter of the year, according to data released Tuesday. 
    • “In 25% of cases, incident response specialists responded to fraudulent MFA push notifications sent by attackers, Cisco Talos found.
    • “Users did not properly implement MFA in 1 in 5 Cisco Talos engagements, the firm said.”
  • Health IT Security tells us
    • “UnitedHealth Group (UHG) has begun notifying affected entities of the Change Healthcare data breach and will begin mailing breach notifications to individual cyberattack victims in late July, the company stated in a June 20 media notice.
    • “Change said it has completed a review of over 90% of impacted files and continues to see no evidence that full medical histories were exfiltrated from its systems during the cyberattack. Change explained that it only recently obtained a dataset that was safe to analyze, as its own systems were difficult to access during recovery.
    • “Even though the data review is not yet complete, Change has begun notifying the customers it has identified as impacted as of June 20 so they can proactively respond. * * *
    • “Change Healthcare’s latest update further confirmed that the company will make HIPAA and state attorney general notifications on behalf of victim entities unless those entities decide to opt out and handle the notifications themselves.
    • “The affected information varied by individual but may have included contact information, health insurance information, billing and claims information, medical record numbers, diagnoses, test results, Social Security numbers, and other personal information.
    • “Change offered two years of complimentary credit monitoring and identity theft protection services to victims and said that it reinforced its security and privacy policies in light of the incident.

From the ransomware front,

  • NPR reflects on the ransomware attack on Ascension Health.
  • CIS0 Series adds,
    • “As many as 10 companies are facing ransom payments between $300,000 and $5 million following a breach against cloud-based data analytics firm Snowflake earlier this month. According to Mandiant, who has helped lead Snowflake’s case, the hacking scheme has “entered a new stage” as the ransom demands flow in, as well as death threats against the cybersecurity experts investigating the breach. The hackers gained access to the information by targeting Snowflake users using single-factor authentication techniques. Mandiant has said it anticipates the ransomware group to “continue to attempt to extort victims.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services’ Health Sector Cybersecurity Coordination Center (HC3) this week released an advisory about Qilin, formerly “Agenda,” a ransomware-as-a-service group targeting health care and other industries worldwide. The group was observed recruiting affiliates in late 2023, and has variants written in Golang and Rust, HC3 said. Qilin is known to gain initial access through spear phishing, as well as leveraging remote monitoring and management and other common tools in cyberattacks. The group is also known to practice double extortion. HC3 said the group’s targeting appears to be opportunistic rather than targeted.” 
  • Per Cybersecurity Dive,
    • “Crime is paying less often for threat actors as improved corporate security measures — and dramatically higher ransom demands — sway more companies to reject extortion payments for seized data.
    • “Less than a quarter of 1,800 companies that submitted cyber claims to Marsh, or 23%, paid ransom demands last year, despite a 64% jump in extortion events from 2022 to a record 282, the insurance broker and risk advisor said in a June 11 report. 
    • “In 2021, Marsh noted, 63% of its clients paid an extortion demand to protect data.
    • “Companies, especially larger ones, are “just more resilient than they were three, four, five years ago,” Meredith Schnur, managing director of Marsh’s U.S. and Canada cyber practice, told Legal Dive.”

From the cybersecurity defenses front,

  • Dark Reading explains why multi-factor authentication is not enough while Tech Radar points out why we need a password-less world.
  • Tech Target gives advice on how to write a useful cybersecurity incident report.
  • Here’s a link to this week’s CISO Corner in Dark Reading.