Monday Roundup

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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.”

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.”     

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington DC,

  • Federal News Network lets us know,
    • “For federal employees, a bill pending in the Senate would bring expanded coverage of fertility treatments through the Federal Employees Health Benefits (FEHB) program.
    • “But the Right to IVF Act, which Sens. Tammy Duckworth (D-Ill.), Patty Murray (D-Wash.) and Cory Booker (D-N.J.) introduced last week, did not garner the 60 votes needed to move forward with a floor vote Thursday afternoon. Almost all Republicans voted against the measure to advance the legislation, resulting in a 48-47 tally.
    • “The legislation rolls together three previous bills all aiming to improve access and insurance coverage for in-vitro fertilization (IVF). In part, the bill would have impacts specifically on FEHB enrollees. One component of the Right to IVF Act aims to set higher requirements for FEHB carriers to offer IVF coverage.
    • “The Office of Personnel Management increased FEHB carrier requirements for IVF treatments for plan year 2024. But the legislation looks to further extend the requirements of IVF to cover both treatments and medications, as well as expanding to more types of assisted reproductive technology (ART).”
  • Many large FEHB plans cover ART procedures. Competition will cause other plans to follow their lead.
  • Federal News Network also identifies House of Representatives policy riders to FY 2025 appropriations bills that are relevant to federal employees and their benefit programs.
  • The American Hospital Association News relates,
    • “The House Energy and Commerce Health Subcommittee June 13 held a hearing about transitioning to value-based care. The AHA submitted a statement to the subcommittee for the hearing, expressing support for value-based care and sharing principles the Center for Medicare and Medicaid Innovation should consider when designing alternative payment models. Those principles include adequate on-ramp and glidepath to transition to risk; adequate risk adjustment; voluntary participation and flexible design; balanced risk versus reward; guardrails to ensure participants don’t compete against themselves when they achieve optimal cost savings and outcomes; and upfront investment incentives.” 
  • Healthcare Dive informs us,
    • “The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a drawn-out and high-profile court battle.
    • “The court held the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA’s actions around mifepristone.
    • “The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote in the court’s opinion. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
  • The Wall Street Journal adds,
    • “An appeals panel [in August 2023] rolled back much of the [district court’s] ruling, saying it was too late to challenge the drug’s original approval. But the appeals court did find that the plaintiffs had standing to sue, and it ruled the FDA’s efforts beginning in 2016 to make the pill more available were unlawful. The Supreme Court had previously put that ruling on hold, preserving the status quo of widespread mifepristone access while it considered the case. * * *
    • “The pill case won’t be the last time the justices weigh in on abortion access this term. The court in the next couple of weeks is expected to decide a separate case out of Idaho that centers around the question of whether a federal law that requires hospitals to provide stabilizing care for patients at risk of death or serious injury trumps state abortion bans that allow doctors to perform the procedure only if a woman’s life is in jeopardy.”
  • STAT News notes,
    • “Both President Biden and former President Trump love to claim credit for getting more Americans $35 insulin.
    • “But the credit should actually go to a giant pharmaceutical company — just the type that both men claim to have challenged.
    • “Eli Lilly, an $800 billion pharma giant and one of three insulin manufacturers in the United States, first proposed an experiment allowing Medicare insurance plans to offer $35 monthly insulin in 2019, CEO David Ricks and former Medicare agency chief Seema Verma said in interviews with STAT.
    • “It is true. We approached CMS with that idea,” Ricks said, referring to the government Medicare agency.
    • “Verma gave Ricks credit. “He is an unsung hero. He was actually the mastermind of all of this,” she said.”
  • Per Department of Health and Human Services press releases,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded more than $11 million to 15 organizations to establish new residency programs in rural communities. HHS Secretary Xavier Becerra and White House Domestic Policy Advisor Neera Tanden announced the new awards while visiting rural health clinic in Wisconsin Rapids, Wisconsin today. Building on HRSA’s Enhancing Maternal Health Initiative, one program will create the first obstetrics and gynecology Rural Track Program in the country, and six others will develop new family medicine residency programs with enhanced obstetrical training in rural communities.”
    • “For more information about the Rural Residency Planning and Development Program, visit https://www.hrsa.gov/rural-health/grants/rural-health-research-policy/rrpd.”
  • and
    • “The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is announcing up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
    • “We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” said HHS Secretary Xavier Becerra. “We are making progress on the development of cutting-edge treatments, such as vaccines administered as a nasal spray or as a pill. The Biden-Harris Administration won’t stop until we have the next generation of innovative vaccines, therapeutics, and other tools to protect against COVID-19, or any other pathogen that could threaten the American public.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Avoid raw milk. Lay off cheeses made with unpasteurized milk. And cook your beef to medium- or well-done temperatures.
    • “These are the precautions that public health officials and doctors recommend as they track the H5N1 bird flu outbreak in U.S. cattle. Ten states have H5N1 outbreaks in cows, according to the Centers for Disease Control and Prevention, and at least three U.S. dairy farmworkers have been diagnosed with bird flu. 
    • “A man in Mexico contracted a different strain of bird flu—H5N2—earlier this month and died, though he died from underlying conditions, according to the Mexican government.
    • “Doctors and federal officials say the public health risk of getting H5N1 is currently very low unless you work on a farm, and stress that there has been no evidence of human-to-human transmission. What’s raised concern is that the most recent case—found in a dairy worker in Michigan earlier this month—had respiratory symptoms unlike the previous two cases where the primary symptom was pinkeye. 
    • “Viruses with respiratory symptoms are more contagious and transmissible than conjunctivitis, or pinkeye, so doctors and scientists say they are watching closely. For now, it has been more than a week since the worker tested positive and there have been no known cases of transmission.”  
  • The NIH director in her weekly blog tells us,
    • We know stress can take a toll on our mental health. Yet, it’s unclear why some people develop stress-related mental health disorders and others don’t. The risk for developing a stress-related mental health disorder such as post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) depends on a complex interplay between the genetic vulnerabilities we are born with and the impact of traumatic stress we experience over our lifetimes.
    • Given this complexity, it’s been difficult for researchers to pinpoint the underlying biological pathways in the body that ultimately produce changes associated with PTSD, major depression, or other mental health conditions. Now, a study reported in a special issue of Science on decoding the brain uses a comprehensive approach to examine multiple biological processes across brain regions, cell types, and blood to elucidate this complexity. It’s an unprecedented effort to understand in a more holistic way the essential biological networks involved in PTSD and MDD. * * *
    • “There’s clearly much more to discover in the years ahead. But these insights already point to important roles for known stress-related pathways in fundamental brain changes underlying PTSD and MDD, while also revealing more novel pathways as potentially promising new treatment targets. With further study, the researchers hope these findings can also begin to answer vexing questions, such as why some people develop PTSD or major depression after stressful events and others don’t.”
  • STAT News points out that “With placenta-on-a-chip, researchers hope to gauge how drugs and toxins impact pregnancy.”
    • “[Mechanical engineer Nicole] Hashemi and her colleagues received a three-year, $350,000 grant from the National Science Foundation to advance their current placenta-on-a-chip model. They plan on designing systems that can be integrated into the model to help collect data in real time. Hashemi told STAT that one system could look at changes in the shapes of cells when exposed to chemicals or physical stressors.
    • “The placenta-on-a-chip technology is simple but potentially powerful, and similar efforts are being made to replicate the environments of other human organs. The small chip is usually about the size of a rubber eraser, etched with tiny channels through which fluids move — offering a simplified, functional model of an organ to test drugs or to study the progression of disease. Researchers can grow cells and run fluids that act like blood through chambers in the chip to create environments similar to those in the human body.
    • “According to Dan Huh, a professor of bioengineering at the University of Pennsylvania and a leader in developing many organs-on-a-chip including the placenta and lung, maintaining the environment is almost like tricking the cells into thinking that they’re still in the body so that they “do what they’re supposed to do.”
  • MedPage Today tells us,
    • “Disrupted access to prescription stimulants for patients with attention deficit-hyperactivity disorder (ADHD) may increase risks of injury or overdose, the CDC warned on Thursday following the indictment of an online ADHD medication prescriber over fraud allegations.
    • “Several ADHD stimulants such as immediate-release amphetamine (Adderall) are already in shortage, and the new federal healthcare fraud indictment may further disrupt care for as many as 50,000 patients with ADHD, the CDC detailed.
  • The Journal of the American Medical Association released a research letter about trends in Naloxone dispensing from U.S. retail pharmacies.
    • “Naloxone prescriptions dispensed from retail pharmacies increased from 2019 to 2023, with the largest single-year increase observed in 2022. This increase may reflect efforts to expand naloxone prescribing, including state-level standing orders3 and clinical practice guidelines. Although statistically significant increases were observed among most prescriber specialties between 2019 and 2023, nearly two-thirds of dispensed naloxone was prescribed by advanced practitioners and primary care specialties in 2023. Continued efforts such as evidence-based academic detailing and electronic health record alerts can support clinicians in prescribing naloxone.
    • “The observed decrease in retail pharmacy–dispensed naloxone prescriptions during Q3 and Q4 2023 may be due to naloxone becoming available over the counter,4 though trend analysis indicated the decline was not statistically significant. Studies have found that over-the-counter naloxone has a higher out-of-pocket cost than insurance-paid naloxone prescriptions,5 indicating the continued importance of prescribed naloxone and naloxone accessed in community-based settings. * * *
    • “Although naloxone dispensing has increased in recent years, opportunities remain to expand access given the continued high burden of opioid overdoses,1 such as by increasing co-prescribing of naloxone for patients with high-risk opioid prescriptions2,6 and reducing financial barriers.5“

From the U.S. healthcare business front,

  • The Wall Street Journal reports good news for Medicare Advantage insurers,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, according to people familiar with the matter, a move that would deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services could be announced as soon as Thursday. It comes in the wake of two court rulings that faulted the agency’s ratings, in cases filed by insurers SCAN Health Plan and Elevance Health.
    • “By paving the way for higher payments, the CMS move would provide a win for Medicare insurers at a time when their business is under pressure from rising healthcare costs and rates for next year that came in lower than investors had expected.'”
  • Mercer Consulting explores “Unlocking the power of [healthcare] price transparency data.”
  • MedTech Dive informs us,
    • “Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday.
    • “The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. 
    • “Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business.”
  • and
    • “Medline has asked hospitals to remove thousands of endotracheal tubes because of a risk that components can tear or detach, blocking a patient’s airway. 
    • “The company recalled more than 168,000 Medline Sub-G Endotracheal Tubes and more than 13,000 kits, according to a Food and Drug Administration notice posted on May 28. The tubes are used for mechanical ventilation and have ports to prevent fluid from draining into patients’ lungs and causing pneumonia. 
    • “Medline recalled the products because the inflation tube and other components can detach or tear from the main tube, causing it to leak or deflate. If the device comes apart during use, it could also obstruct the patient’s airway or cause choking, the FDA said in a Tuesday notice.
  • and
    • “Abbott is recalling a system monitor used with the Heartmate cardiac pump because screen display issues could pose a risk to patients. The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 database entry by the Food and Drug Administration.
    • “In an urgent medical device correction letter to physicians in May, Abbott said no serious adverse health consequences were reported and no devices are being removed from the market.
    • “The latest recall follows three others from earlier this year involving the Heartmate left ventricular assist system, the only such mechanical circulatory support device on the U.S. market after Medtronic stopped selling its Heartware pump in 2021.”

Tuesday Tidbits

David Ermer–AHRQ, Congress, FDA, Generative AI, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Chief Healthcare Executive lets us know,
    • Telehealth advocates have said this year represents the Super Bowl for virtual healthcare, and the game is about at halftime.
    • On the upside, telehealth leaders remain confident that Congress will approve legislation that would allow health systems and providers to continue offering virtual care and hospital-at-home programs.
    • But lawmakers may not act until late in the fourth quarter [in other words, the expected lame duck session following the November’s national election].
  • Roll Call informs us,
    • “The Supreme Court will decide a dispute about hospital reimbursement rates under Medicare, with hundreds of hospitals arguing the government had shorted them for treating low-income patients.
    • More than 200 hospitals in more than 30 states, led by Advocate Christ Medical Center in Illinois, have asked the justices to overturn a lower court ruling that allows the Department of Health and Human Services to reimburse a lower rate for treating a high proportion of low-income patients. The dispute, which the hospitals said could affect more than $4 billion in federal funds, hinges on how to determine which patients count toward that reimbursement rate and follows a 2022 Supreme Court decision over the same program.
    • The justices announced Monday that they would decide the case, which means oral arguments and a decision would come in the next term that starts in October.
  • Federal News Network tells us,
    • “The Chief Human Capital Officers (CHCO) Council has a new face taking the lead to collaborate on human capital initiatives and strategies across government.”
    • “Colleen Heller-Stein, formerly deputy CHCO at the Treasury Department, has stepped in as executive director of the CHCO Council, Federal News Network has learned. The senior-level position within the Office of Personnel Management leads agency CHCOs and other human capital leaders to innovate on best practices for managing the recruitment and retention of the federal workforce.
    • “Heller-Stein is the first career federal executive to serve in the CHCO Council leadership role. She took over the position a few weeks ago from Latonia Page, who had been working as acting executive director of the CHCO Council since September 2023. Prior to Page’s time on the job, Margot Conrad — currently deputy chief of staff at OPM — served as the council’s executive director for about two and a half years.”‘

From the public health and medical research front,

  • KFF expresses concern about the general unavailability of bird flu tests.
    • “A recent rule that gives the FDA more oversight of lab-developed tests may bog down authorization. In a statement to KFF Health News, the FDA said that, for now, it may allow tests to proceed without a full approval process. The CDC did not respond to requests for comment.”
    • “But the American Clinical Laboratory Association has asked the FDA and the CDC for clarity on the new rule. “It’s slowing things down because it’s adding to the confusion about what is allowable,” said Susan Van Meter, president of the diagnostic laboratory trade group.
    • “Labcorp, Quest Diagnostics, and other major testing companies are in the best position to manage a surge in testing demand because they can process hundreds per day, rather than dozens. But that would require adapting testing processes for their specialized equipment, a process that consumes time and money, said Matthew Binnicker, director of clinical virology at the Mayo Clinic.
    • “There’s only been a handful of H5N1 cases in humans the last few years,” he said, “so it’s hard for them to invest millions when we don’t know the future.”
  • The Wall Street Journal offers guidance on how people can improve the deathbed experiences of loved ones.
  • Beckers Hospital Review points out,
    • “Baltimore-based Johns Hopkins School of Nursing is addressing community needs by taking primary care door to door, NPR reported June 11.
    • “The Neighborhood Nursing pilot program consists of a team of nurses and community health workers that make weekly visits to three apartment buildings in Johnston Square, a predominantly Black disadvantaged neighborhood. The visits are free to patients and are not dependent on health status, income or what type of insurance, if any, they have. Visits are done in people’s homes, senior centers, lobbies, libraries and anywhere else people can be found. 
    • “In the time it has run, Neighborhood Nursing has successfully helped patients receive care and has expedited physicians’ appointments as needed. However, the greatest challenge is funding.”
  • Per Healio,
    • “From 2010 to 2021, most high and moderate risk factors for preeclampsia increased in the U.S.
    • “Multifetal gestation and nulliparity were the only preeclampsia risk factors to decrease during this period.”
  • Per BioPharma Dive,
    • “Pharmaceutical companies employ many different strategies when building their cancer drug pipelines, but one recent commonality among them is a belief in the future of targeted therapies known as antibody-drug conjugates.
    • “Many of the leading cancer drugmakers have at least one or two antibody-drug conjugates, or ADCs, in development. Others, such as Pfizer, Johnson & Johnson and Merck & Co., have used buyouts or partnerships to build an ADC portfolio.
    • “One of the best-selling ADCs on the market is AstraZeneca and Daiichi Sankyo’s Enhertu, which brought in combined sales of $2.5 billion in 2023, almost double the year before. The two companies formed a $7 billion alliance around Enhertu in 2019 and since then, the drug has secured multiple approvals and changed the way some breast cancers are treated.
    • “Over that time, AstraZeneca has made ADCs a more substantial part of its overall pipeline alongside radiopharmaceuticals and immunotherapies, giving the company many potential combinations to work with, said Carlos Doti, vice president and head of medical affairs for its U.S. oncology division.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS must recalculate the Medicare Advantage star ratings for Anthem Blue Cross Blue Shield of Georgia, a federal judge ruled June 10. 
    • “The judge ruled partially in favor of Elevance Health, which sued to challenge CMS’ star ratings methodology in December. The insurer sought new ratings for several of its subsidiaries, but the judge ruled CMS needs to recalculate ratings only for BCBS of Georgia. 
    • “Elevance’s challenge focused on CMS’ use of the Tukey method, a change announced by CMS in a 2020 final rule and implemented in 2024 star ratings. The method removes extreme outliers from measure scores to prevent outliers from affecting all MA contracts, making it more difficult for plans to earn a high star rating. In 2022, a final star ratings rule from CMS did not mention the new change, which the agency added back in the 2023 rule, citing an inadvertent removal. 
    • “CMS also limits scoring changes to 5% annually. In the lawsuit, Elevance said CMS should have factored in those limits before adding the Tukey change back in 2023 versus the other way around.
    • “Randolph Moss, a judge for the U.S. District Court in Washington, D.C, ruled CMS violated the Administrative Procedure Act in applying the Tukey methodology. However, Mr. Moss ruled Elevance proved the Tukey method affected the star rating only for BCBS of Georgia and not the other plans for which it sought revised ratings.” 
  • This opinion and last week’s Scan Health opinion may wind up before the U.S. Court of Appeals for the D.C. Circuit.
  • Per Healthcare Dive,
    • “Just three days before bankrupt Steward Health Care was set to run out of funds, the health system said it’s struck a deal to capture $225 million of additional debtor-in-possession financing to keep its operations afloat during Chapter 11 proceedings.
    • “The funds come from Steward’s FILO lenders, which include private credit lenders Sound Point Capital and Brigade Agency Services, as well as Chamberlain Commercial Funding, according to a press release shared with Healthcare Dive. 
    • “Steward will present the deal — which the system says is sufficient to finance operations prior to its July asset sales — for approval in bankruptcy court later this week.”
  • According to BioPharma Dive,
    • “Approval of Eli Lilly’s experimental Alzheimer’s disease drug donanemab would help drive sales of Eisai and Biogen’s rival medicine Leqembi, analysts wrote after a Food and Drug Administration panel on Monday supported clearance of donanemab.
    • “A rising tide lifts all boats, in our view,” wrote Myles Minter, an analyst at William Blair, in a client note. Donanemab works similarly to Leqembi by eliminating from the brain a toxic protein called amyloid that scientists see as linked to Alzheimer’s progression.”
  • McKinsey & Co. discusses the ongoing digital transformation in healthcare.
  • The International Foundation of Employee Benefit Plans shares useful insights on the final rules amending the Fair Labor Standards Act that take effect on July 1.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association New tells us,
    • The House Energy and Commerce Oversight and Investigations subcommittee June 4 hosted a hearing to discuss oversight of the 340B Drug Pricing Program. AHA sent a letter to the subcommittee for the hearing, urging Congress to protect the program and highlighted its value to hospitals and health systems.
  • Roll Call offers more details on this policy issue.
  • Per a Health and Human Services press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), today welcomed 10 new states into the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program, after they successfully developed the necessary state-level infrastructure and worked with providers in their states to develop programs that meet CCBHC standards: Alabama, Illinois, Indiana, Iowa, Kansas, Maine, New Hampshire, New Mexico, Rhode Island and Vermont. The CCBHC Medicaid Demonstration Program provides states with sustainable funding that helps them expand access to mental health and substance use services, supporting President Biden’s Unity Agenda and the Biden-Harris Administration’s efforts to tackle the country’s mental health and addiction crises. The expansion of the program directly supports the President’s national strategy to transform our behavioral health system and builds on the Administration’s previous work to build a better crisis continuum of care, including through the transition to the 988 Suicide & Crisis Lifeline, add a new mobile crisis benefit to Medicaid and new crisis codes to the Medicare program.”
  • NBC News reports,
    • A Food and Drug Administration advisory panel on Tuesday declined to recommend the approval of MDMA as a treatment for post-traumatic stress disorder, a major setback for advocates who have long pushed to include psychedelics in treating mental health disorders.
    • The two votes — one for the treatment’s efficacy and one for its safety, by the agency’s Psychopharmacologic Drugs Advisory Committee — marked the first time that FDA advisers have considered a Schedule I psychedelic for medical use. If approved by the FDA, it would be the first new treatment for PTSD in more than two decades.
    • The votes reflected panel members’ struggle to balance the need for new PTSD treatments against serious concerns about the data submitted by drugmaker Lykos Pharmaceuticals, which was marred by inconsistencies, poor study design and allegations of misconduct.
    • “It sounds like MDMA has really impacted a number of people in positive ways, but it seems that there are so many problems with the data,” said Melissa Decker Barone, an adjunct assistant professor in the department of psychiatry at the University of Maryland School of Medicine. * * *
    • Last week, the Institute for Clinical and Economic Review, a non-profit group that evaluates the cost of drugs, said patients and providers in the trial treated psychedelics “more like a religious movement than like pharmaceutical products.” * * *
    • “The decision will now go to the FDA, which is expected to make a final ruling by August 11. The committee’s vote is only a recommendation, and the agency doesn’t have to follow its advice, although it usually does.”
  • Reuters adds,
    • “The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *”The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *
    • “The FDA staff’s review for updating viral strains for vaccines in the U.S. differs from that of the World Health Organization’s advisers, who in April recommended targeting only the JN.1 strain.
    • “Since then, the subvariant KP.2 has become the dominant strain in the U.S., estimated to account for about 28.5% of cases over a two-week period ended May 25, according to data from the U.S. Centers for Disease Control and Prevention.”
  • Healthcare Dive informs us,
    • “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. 
    • “The case centered around recent changes in how the CMS determined quality measures for the private Medicare plans. Scan alleged the agency didn’t follow its stated methodology, causing its rating to drop “precipitously” to 3.5 stars and risking $250 million in quality bonus payments. 
    • “The U.S. District Court for the District of Columbia ruled for the California-based insurer Monday, barring the federal government from using Scan’s original 2024 Star Rating for quality bonus decisions.”

From the public health and medical research front,

  • The New York Times reports,
    • “Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.”Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.
    • “The patient, Lisa Pisano, 54, who is still hospitalized, went back on kidney dialysis after the pig’s organ was removed. She lived with the transplanted organ for 47 days, Dr. Robert Montgomery, director of the institute, said. The kidney showed no signs of organ rejection.
    • “Lisa is in stable condition, and her left ventricular assist device is still functioning,” Dr. Montgomery said, referring to the heart pump. “We are hoping to get Lisa back home to her family soon.”
  • Health Day lets us know,
    • “As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible use in humans.
    • “Since the outbreak in livestock began this spring, bird flu has been confirmed in three humans who worked on dairy farms in Texas and Michigan, and health experts are concerned the virus could mutate to the point where it could spread easily among humans.
    • “In response, vaccine maker CSL Seqirus announced last week that it has been tasked with making the additional doses of flu vaccine at its North Carolina plant.
    • “It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration,” the company noted in a news release.”
  • ABC News relates,
    • “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows. “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows.
    • “There have been at least 4,864 whooping cough cases reported this year. This is nearly three times higher than the 1,746 cases reported at the same time last year.
    • “The number of cases for 2024 is similar to those seen in 2018-2019, before the COVID-19 pandemic.
    • “The national trends mirror those seen in many U.S. states. The Oregon Health Authority said Thursday that 178 cases have been reported as of May 29, a 770% increase from the 20 cases reported by at the same time in 2023, according to local ABC News affiliate KATU. * * *
    • “There are two types of vaccines used today to protect against whooping cough: diphtheria, tetanus, and pertussis (DTaP) vaccine for babies and children younger age 7 and tetanus, diphtheria, and pertussis (Tdap) vaccines for children aged 7 and older, adults and pregnant women.
    • “People often think ‘Well once you get vaccinated you have lifelong immunity,’ and that’s actually not the case. You certainly need to get those booster doses,” Madad said.”
  • Beckers Hospital Review points out
    • “Mississippi is the unhealthiest state in the nation for older adults in 2024, according to the United Health Foundation’s 12th annual “America’s Health Rankings Senior Report.”
    • “The May 30 report provides a comprehensive look at the health and well-being of Americans 65 and older.   
    • “State rankings were derived from 35 measures across five categories of health: social and economic factors, physical environment, behaviors, clinical care and health outcomes. The full methodology can be viewed here.“
  • The National Institutes of Health shared their most recent research insights.
  • NIH announced in various press releases,
    • “Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN). The HPTN is supported by grants from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.”
  • and
    • “A five-minute cognitive assessment coupled with a decision tree embedded in electronic medical records, known as 5-Cog, improved dementia diagnosis and care, based on a clinical trial funded by the National Institutes of Health (NIH) and conducted in an urban primary care setting. Researchers evaluated the system among 1,200 predominantly Black and Hispanic American older adults who presented to primary care with cognitive concerns. The findings appear in Nature Medicine. * * *
    • “5-Cog combines three metrics designed to test memory recall, the connection between cognition and gait, and the ability to match symbols to pictures. Importantly, these tests are easy to perform, relatively quick, and are not affected by reading level or ethnic/cultural differences among patients. * * *
    • “Cognitive impairment is often difficult to diagnose in the busy primary care setting and, as a result, beneficial care plans are likely underutilized. This can result in lack of detection, which delays the start of support services and critical planning. Underdiagnosis is even more prevalent among older Black and Hispanic patients compared to white patients, suggesting this tool may be even more valuable to the populations represented in the study.”
  • and
    • “For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.”For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.
    • “The trial, which is the largest nationwide study comparing service dog partnerships to usual care alone, included 156 military members and veterans diagnosed with PTSD. Participants were recruited through the database of K9s For Warriors, an accredited non-profit service dog provider. Under U.S. federal law(link is external), service dogs are “individually trained to work or perform tasks for people with disabilities.”

From the U.S. healthcare business front,

  • Per MedTech Dive,
    • “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. 
    • “The device, called Lingo, first debuted in the U.K. last year as a sensor for people who don’t have diabetes to track glucose spikes. Abbott hopes to bring it to the U.S. but has shared few details about its plans. 
    • “With the recent FDA clearance, Abbott will compete with Dexcom for a new category of over-the-counter glucose monitors. Dexcom received FDA clearance for the first over-the-counter CGM in March.”
  • Per Healthcare Dive,
    • “Steward Health Care is aggressively courting new debtor-in-possession lenders to stay afloat amid its Chapter 11 restructuring process. Without additional capital, the health system says it will run out of funds by June 14.
    • “Medical Properties Trust, Steward’s landlord and initial DIP financier, appears unlikely to step up to the plate to offer more funds.
    • “The Dallas-based health system, which employs 30,000 people across eight states, declared bankruptcy last month. At the time, the real estate investment trust put up $75 million of DIP financing and said it might offer up to $225 million more, contingent upon successful asset sales.
    • “But MPT has since shown little interest in providing additional financial support for Steward. As of Friday, Steward’s attorneys told the court that MPT had made no further commitment to pony up funds, leaving the health system in immediate need of new funding.”

 

Happy Memorial Day!

David Ermer–ACA, CDC, Congress, COVID-19, Medical / Rx research, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC —

  • Congress is not in session this week of Memorial Day.
  • FEHB and for the first time PSHBP plans must submit their 2025 benefit and rate proposals no later than this coming Friday May 31.
  • The No Surprises Act RxDC reporting deadline for the 2023 calendar year is this coming Saturday, June 1.

From the public health and medical research front,

  • The Washington Post warns us,
    • “Summer offers a reminder of why covid is unlike the flu, a more predictable fall and winter respiratory virus. Coronavirus ebbs and flows throughout the year, and hospitalizations have always risen in summer months when people travel more and hot weather drives people indoors. For now, covid activity is low nationally, the CDC said Friday. The number of Americans dying of covid is less than half what it was a year ago, with a death toll around 2,000 in April. The virus poses a graver threat to the severely immunocompromised and elderly. But it can still surprise younger healthy people, for whom a bout of covid can range from negligible sniffles to rarer long-term debilitating effects. * * *
    • “The CDC and health authorities continue to promote the coronavirus vaccine, last updated in fall 2023 for a subvariant no longer in circulation, as the best form of protection against the disease. Just 23 percent of adults have received a dose of the latest vaccine, the CDC estimates. Experts say the existing formula should still confer protection against severe illness from the FLiRT variants. People 65 and older qualify for a second dose, but only 7 percent have received two shots.”
  • The Post also lets us know,
    • “When asked, 75 percent of survey respondents said they felt mental health conditions are identified and treated worse than physical health issues, according to a new survey from West Health and Gallup.
    • “The poll surveyed a random sample of 2,266 U.S. adults 18 and older. In addition to perceptions about treatment, the survey also gauged mental health conditions among participants. Of the respondents: 51 percent reported experiencing depression, anxiety or another mental health condition in the previous 12 months. * * *
    • “The main barriers, according to those surveyed, were affordability and difficulty in finding an adequate provider. Participants also cited shame and embarrassment as keeping them from treatment. This was particularly felt among participants who had experienced a mental health issue in the past year: 74 percent of those respondents thought people with mental health conditions are viewed negatively. 
    • “Additionally, 75 percent of adults 65 or older thought mental health conditions carry a negative stigma, but 53 percent of the participants felt psychological counseling or therapy is “very effective” or “effective.” Fewer adults felt medication was effective.”
  • Fortune Well tells us,
    • “Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood, and it’s usually diagnosed in kids. But ADHD tends to be underdiagnosed in women and people of color, which can lead to some people reaching adulthood before realizing they may have the condition.” 
    • The article delves into the signs and symptoms of ADHD in adults and treatment options.
  • Fortune Well also considers,
    • “Could Ozempic be the answer to a longer life?
    • “It’s the question many scientists are asking about the controversial drug, a glucagon-like peptide-1 receptor agonist (GLP-1), as some research suggests it could help humans age with less chronic diseases. The same goes for glucose-dependent insulinotropic peptide receptor agonists (GIP) such as Zepbound and Mounjaro, leaving some experts to start seeing them as potential longevity pills and considering how in the future they can be prescribed safely to more people, especially as rates of obesity continue to rise.
    • “The singular most effective and consistent way of extending lifespan in animals is caloric restriction,” says Dr. Douglas Vaughan, a professor of medicine at Northwestern University and director of the Potocsnak Longevity Institute. “That’s been demonstrated to work on everything from worms to flies to mice to monkeys. If you can find a way to get people to chronically reduce their caloric intake, it sort of makes sense that it might have an effect on aging. It’s probably not as simple as that and there could be unexpected effects of these drugs that might negate or prevent the anti aging effect, but it’s a great hypothesis and it needs to be tested rigorously.”

From the U.S. healthcare business front,

  • Fierce Healthcare notes,
    • “Elevance Health’s philanthropic arm is launching a new initiative that aims to provide loans to small businesses and other organizations in a bid to address health equity.
    • “The Elevance Health Foundation has made a $10 million commitment to the “impact investing” effort, according to an announcement. The loans offered through the program will be offered at below Prime rates, and the partners will deploy the funds to address key social needs like access to care, food insecurity and health disparities.
    • “The foundation also intends to seek out purpose-driven businesses that may not be able to access traditional banking, particularly those owned by women and people of color, who can impact equity in their communities.
    • “Shantanu Agrawal, chief health officer at Elevance Health, told Fierce Healthcare that the foundation has historically offered grant-based programs, which does limit the reach of its work to non-profit organizations. The team “took a step back” and examined other ways it could invest in communities before landing on this loan program, he said.”
  • The Wall Street Journal reports that
    • “the debt-collection spree is an example of how some hospitals in recent years have become more aggressive in recouping bills from the estimated more than 15 million Americans who have medical debt. The issue can be particularly acute in rural areas like Pratt, where residents are more likely to be older and uninsured, and hospitals are under financial stress. 
    • “A nationwide increase in debt-collection cases has drawn scrutiny from some attorneys and judges who say they eat up court and law-enforcement resources. In nine states with easy-to-access court data, debt cases—including those for medical bills, credit cards, and auto and student loans—made up 29% of civil dockets in 2013, compared with 42% in 2021; debt claims were the most common civil cases in 13 of 16 states that year, according to the nonprofit Pew Charitable Trusts.”

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Hill informs us,
    • “Blockbuster weight-loss drug Wegovy could bankrupt the U.S. health care system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.). 
    • “Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.
    • “Pricing drugs based on their value cannot serve as a blank check, or the sole determinant for how we understand what to pay for essential goods,” the report stated. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them.” 
    • “The report ups the pressure from Sanders on Danish drugmaker Novo Nordisk to lower the price of Wegovy and Ozempic.”
  • The good Senator has a point here. Drug manufacturers need a dose or two of price reasonableness.
  • STAT News reports,
    • “A House subcommittee on Thursday advanced legislation that would extend some pandemic-era telehealth policies in Medicare for two years, bringing the panel’s approach in line with another committee.
    • “During the pandemic, Congress extended flexibilities that changed what kinds of care Medicare beneficiaries could receive over telehealth and where. Originally, the House Energy and Commerce health subcommittee had considered a bill that would have enacted the policies permanently, but amended the legislation Thursday to pare it down to a two-year extension. The bill passed to the full committee unanimously on a 21-0 vote.
    • “The approach is in line with that of another panel, the House Ways and Means Committee, which passed a two-year extension earlier this month. Both bills include similar provisions that would pay for the extension in part through reforms to the way in which pharmacy middlemen operate.”
  • American Hospital Association News shares,
    • “The AHA shared a series of proposals to strengthen rural health care with the Senate Finance Committee for a hearing May 16 titled, “Rural Health Care: Supporting Lives and Improving Communities.” The proposals include policies promoting flexible payment options; ensuring fair, timely and adequate reimbursement; bolstering the workforce; and improving maternal health. During the hearing, several members focused on access to obstetric services and augmenting the number of medical residency slots awarded to rural hospitals. Jeremy P. Davis, MHA, president and CEO of AHA-member Grande Ronde Hospital in La Grande, Ore., and other health care leaders and policy researchers testified.”
  • The Department of Health and Human Services celebrates the Administration’s mental healthcare accomplishments.
  • The New York Times reports,
    • “The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. * * *
    • “Each year, about 35,000 Americans are diagnosed with small cell lung cancer and face a grim prognosis. The cancer usually has spread beyond the lung by the time it is detected. * * *
    • “The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. Forty percent of those who got the drug responded.
    • “After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.
    • “I feel it’s a light after a long time,” he added.”
  • Tammy Flanagan, writing in Govexec, discusses FEHB annuitant reactions to Part D EGWP offerings in various FEHB plans for 2024.
  • Federal News Network notes,
    • After a couple years of uncertainty, satisfaction among federal employees is beginning to rise at many agencies.
    • In a preview of the latest Best Places to Work in the Federal Government rankings, out of the top 10 agencies in each of the four categories — large, midsize and small agencies, as well as agency subcomponents — prioritizing employee engagement was the common thread, the Partnership for Public Service said.
    • “At a time when our nation faces both critical challenges and exciting opportunities at home and abroad, an engaged federal workforce is vitally important,” Max Stier, president and CEO of the Partnership for Public Service, said in a statement. “The top-ranked agencies have excelled at keeping their workforces engaged and motivated and, as a result, they are well positioned to deliver results for the public.” * * *
    • “The Environmental Protection Agency, Energy Department, Office of Personnel Management and National Credit Union Administration all moved up in the rankings and increased their overall scores.” 
  • The CDC is promoting its new and improved website.

From the public health and medical research front,

  • The New York Times informs us,
    • “With Pride events scheduled worldwide over the coming weeks, U.S. officials are bracing for a return of mpox, the infectious disease formerly called monkeypox that struck tens of thousands of gay and bisexual men worldwide in 2022. A combination of behavioral changes and vaccination quelled that outbreak, but a majority of those at risk have not yet been immunized.
    • “On Thursday, the Centers for Disease Control and Prevention warned of a deadlier version of mpox that is ravaging the Democratic Republic of Congo and urged people at risk to be vaccinated as soon as possible. No cases of that subtype have been identified outside Africa so far. But the escalating epidemic in Congo nevertheless poses a global threat, just as infections in Nigeria set off the 2022 outbreak, experts said.
    • “This is a very important example of how an infection anywhere is potentially an infection everywhere, and why we need to continue to improve disease surveillance globally,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles. * * *
    • “The C.D.C. is focusing on encouraging Americans at highest risk to become vaccinated before the virus resurges. The agency’s outreach efforts include engaging with advocacy groups and social media influencers who have broad appeal among the L.G.B.T.Q. community. In December, the agency urged clinicians to remain alert for possible cases in travelers from Congo.”
  • and
    • “Heart disease, diabetes and kidney disease are among the most common chronic illnesses in the United States — and they’re all closely connected.
    • “Adults with diabetes are twice as likely to have heart disease or a stroke compared with those who don’t have diabetes. People with diabetes — Type 1 and Type 2 — are also at risk of developing kidney disease. And when the kidneys don’t work well, a person’s heart has to work even harder to pump blood to them, which can then lead to heart disease.
    • “The three illnesses overlap so much that last year the American Heart Association coined the term cardiovascular-kidney-metabolic syndrome to describe patients who have two or more of these diseases, or are at risk of developing them. A new studysuggests that nearly 90 percent of American adults already show some early signs of these connected conditions.
    • “While only 15 percent of Americans meet the criteria for advanced stages of C.K.M. syndrome, meaning they have been diagnosed with diabetes, heart disease or kidney disease or are at high risk of developing them, the numbers are still “astronomically higher than expected,” said Dr. Rahul Aggarwal, a cardiology fellow at Brigham and Women’s Hospital in Boston and co-author of the study.
    • “The research suggests that people should pay attention to shared risk factors for these diseases early on — including excess body fat, uncontrolled blood sugar, high blood pressure and high cholesterol or triglyceride levels.”
  • BioPharma Dive points out,
    • “An experimental Roche drug helped people with obesity lose an average of nearly 19% of their body weight over six months, after adjusting for placebo, in an early-stage trial, the company said Thursday.
    • “Roche is awaiting additional data from a study of the drug, called CT-388, in people with diabetes as well as obesity. It also didn’t provide specifics on the drug’s side effect profile. CT-388 is currently only in a Phase 1 program involving 96 people. Larger and longer trials are needed before the company can ask the Food and Drug Administration for approval.
    • “Roche acquired CT-388 through a $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to capture a share of a market estimated to be worth more than $100 billion annually by early next decade.”
  • and
    • “A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.”A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.
    • “Lilly is betting that its experimental drug, dubbed insulin efsitora alfa, could provide a longer-lasting and more convenient option than daily treatment for managing diabetes. 
    • “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes,” said Jeff Emmick, a senior vice president of product development for Lilly, in a statement on the trial results.” 
  • The National Institutes of Health Director, in her blog, discusses “Speeding the Diagnosis of Rare Genetic Disorders with the Help of Artificial Intelligence.”
  • The National Institutes of Health announced,
    • “People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.”People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
    • “Factors linked to this increased risk included having less than a high school education; a household income less than $35,000; not seeing a friend or relative in the past month; not having someone to care for them if ill or disabled; lack of health insurance; living in a disadvantaged neighborhood; and living in a state with low public health infrastructure. Apparent treatment-resistant hypertension is defined as the need to take three or more types of anti-high blood pressure medication daily and is associated with an increased risk for stroke, coronary heart disease, heart failure, and all-cause mortality.”
  • The U.S. Preventive Services Task Force released a final research plan for “Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions.”
  • Beckers Hospital Review alerts us,
    • “In 2023, patient falls were once again the most common sentinel event reported by healthcare organizations, according to a May 15 report from The Joint Commission.
    • “The Joint Commission defines a sentinel event as a patient safety event that results in death, permanent harm, severe temporary harm or intervention required to sustain life.
    • “The accrediting body received 1,411 reports of sentinel events in 2023, on par with the volume reported in 2022. Only a small portion of all sentinel events are reported to The Joint Commission, meaning conclusions about the events’ frequency and long-term trends should not be drawn from the dataset, the organization said.
    • “In total, 96% of healthcare organizations voluntarily reported sentinel events. About 18% of events were associated with patient death, 8% with permanent harm or loss of function, 57% with severe temporary harm and 12% with unexpected additional care or extended healthcare stays.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “One reason U.S. inflation is still high: Increases in prices for procedures to prop open clogged arteries, provide intensive care for newborns and biopsy breasts.
    • “Hospitals didn’t raise prices as early in the pandemic as supermarkets, retailers and restaurants. But they have been making up ground since then. Their increases have contributed to stubbornly high inflation readings from the consumer-price index, which in April increased 3.4% from a year ago. 
    • “Hospital prices specifically jumped 7.7% last month from a year ago, the highest increase in any month since October 2010, the Labor Department said Wednesday. * * *
    • Economists said they expect higher hospital inflation to persist as recent years’ labor-market disruption continues to ripple through wages and health-insurance contracts. 
    • “We’re not expecting much slowing,” said Alan Detmeister, an economist for UBS. “This was a very large shock that we saw in the healthcare industry over Covid, and it takes years for those to pass through to the prices.”
    • Hospital price increases are responsible for about 23% of the growth in U.S. health spending each year, on average, according to an analysis by federal actuaries for the Journal. Health-insurance premiums last year shot up at the fastest rate in a decade. 
    • Premiums rise with health spending. Public employees in California saw premiums increase 11% this year, largely because of rising prices, which alone raised their premiums by 8%, said the California Public Employees’ Retirement System. 
  • Healthcare Finance adds,
    • The Centers for Medicare and Medicaid Services’ January [2024] expansion of the two-midnight rule to include Medicare Advantage plans has contributed to higher inpatient volumes and revenue growth in the first quarter of the year, according to a Strata Decision Technology report.
    • This is because inpatient services have higher reimbursement levels compared to outpatient services and the two-midnight rule concerns inpatient care.
  • Per Fierce Healthcare,
    • “Though held in check by inflation, Cleveland Clinic’s first-quarter operations trickled past last year’s tally thanks to a jump in volumes and revenues.
    • The nonprofit system reported this week a $50.2 million operating gain (1.3% operating margin), as opposed to the prior year’s $32.3 million (0.9% operating margin). Operating revenues rose 10.2% year over year to nearly $3.9 billion while operating expenses followed close behind with a 9.8% increase.
    • “Cleveland Clinic enjoyed “strong demand for both inpatient and outpatient services” during the quarter, management wrote in commentary on its operations. Compared to the prior year, acute admissions rose 6.7%, total surgical cases by 3.7% and outpatient evaluation and management visits by 3.9%.
    • “The system’s 9.4% increase in net patient service revenue was also boosted by rate increases among Cleveland Clinic’s managed care contracts that went into effect with the new year. Additionally, management wrote, “over the last few years, the system initiated national, regional and local revenue management projects designed to improve patient access throughout the system while striving to ensure the safety of patients, caregivers and visitors.”
  • According to Healthcare Dive,
    • “[Philadelphia based] Jefferson Health and [Allentown, PA, based] Lehigh Valley Health Network signed a definitive agreement Wednesday to merge. The health systems expect the deal to close later this summer, pending regulatory approval, according to a press release. Deal terms were not disclosed.”
  • Fierce Healthcare adds,
    • “UnitedHealth Group’s investments in affordable housing have topped $1 billion, with the program a keystone in its overarching strategy to address health equity and disparities.
    • “The company has made investments in housing since 2011 and, in that time, has supported the development of affordable and mixed income units across 31 states and the District of Columbia, creating more than 25,000 homes for people and families who face housing insecurity.
    • “The investments include direct funding from the company as well as those made through Low-Income Housing Investment Tax Credits and Community Reinvestment Act loans, UnitedHealth said. The company has backed both new development and rehabilitation for older locations in urban, suburban and rural markets. * * *
    • “UnitedHealth is tracking the health benefits of these investments and spent two years measuring outcomes against a baseline set by Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. It found that people living in the properties it backed were more likely to receive annual checkups, with 95% having one in the past year.
    • “In addition, residents living in these locations reported better mental health compared to low-income individuals across the country.”

Weekend Update

David Ermer–Uncategorized–

From Washington, DC

  • Here is a link to OPM’s Postal Service Health Benefits Program final implementation rule as it will be published in the Federal Register on May 6.

From the public health and medical research front,

  • Fortune Well tells us,
    • “The number of patients hospitalized due to COVID-19 has hit its lowest weekly level since the start of the pandemic.
    • “The Centers for Disease Control and Prevention reports just 5,615 were hospitalized in the U.S. due to the coronavirus the week of April 20, the most recent data available. That’s far below the 150,650 who were admitted the week of Jan. 15, 2022, when the Omicron variant was at its peak.
    • “While the CDC will continue to monitor COVID cases, it is seemingly feeling comfortable enough with current levels and the effectiveness of vaccines that, as of May 1, it has stopped requiring hospitals to report COVID-19 admissions, capacity numbers and occupancy data. (It is, however, encouraging them to report that data voluntarily.)”
  • The New York Times provides four takeaways from its investigation of the side effects of Covid vaccines.
    • “For most people, the benefits of Covid vaccines outweigh any risks.
    • “Federal surveillance has found some side effects but may miss others.
    • “Proving vaccination led to an illness is complicated, and
    • “Understanding the full range of side effects may take years.”
  • The Washington Post reports,
    • Cancer drug trials are structured to promote high doses, which then become routine patient care. With evidence that thousands of patients become so ill that they skip doses or stop taking the drugs — risking resurgence of their cancers — the FDA has begun requiring companies to pinpoint the right dosage before drugs reach patients. The initiative, Project Optimus, [was] launched in 2021 * * *.
  • Fortune Well lets us know,
    • “Choosing the stairs over the elevator has been considered sage fitness advice for years, but new research backs up this health tip. A meta-analysis presented at a European Society of Cardiology conference this past weekend found that people who routinely climb stairs were 39% less likely to die from heart disease, compared to those who didn’t. They also had a lower risk of stroke and heart attack.
    • “I was surprised that such a simple form of exercise can reduce all-cause mortality,” study author Dr. Sophie Paddock, of the University of East Anglia and Norfolk and Norwich University Hospital Foundation Trust in the UK told NPR.
    • “Her team reviewed data from about 480,000 participants, analyzing their risk of heart disease based on factors like blood pressure, smoking history, cholesterol, and genetic risk factors. Participants, who ranged in age from mid-30s to mid-80s, also answered questions about their lifestyle and exercise habits. The stair climbers were better able to ward off heart disease over the course of 12 years. 
    • “A 2023 study, published in the journal Atherosclerosis, looked at exactly how many flights of stairs you need to climb daily to better your heart health. The short answer? Climbing just five flights per day could reduce your risk of cardiovascular disease by 20%.” 

From the U.S. healthcare business front,

  • The American Hospital Association finds that “America’s Hospitals and Health Systems Continue to Face Escalating Operational Costs and Economic Pressures as They Care for Patients and Communities.”
  • Per BioPharma Dive,
    • “Novartis is expanding its pipeline of radiopharmaceutical drugs, announcing Thursday it has agreed to pay $1 billion to acquire biotechnology company Mariana Oncology.
    • “Mariana, which specializes in the targeted radiation medicines, could receive up to $750 million more from Novartis if certain milestones are met. The deal hands Novartis several drug programs, including one candidate being tested as a treatment for small cell lung cancer.
    • “Novartis currently sells two approved radiopharmaceuticals, Pluvicto and Lutathera. Their success has helped spark a run of acquisitions by other large drug companies, including AstraZeneca’s planned purchase of Fusion Pharmaceuticals for $2.4 billion.”
  • Per MedTech Dive,
    • “Medical products supplier Medline has agreed to acquire Ecolab’s global surgical solutions business for $950 million in cash, to gain its sterile drapes and fluid temperature management systems, the companies said on Tuesday.
    • “Ecolab makes sterile drapes for surgeons, patients and operating room equipment.
    • “The St. Paul, Minnesota-based company said it will continue to serve hospitals through its infection prevention and instrument reprocessing businesses, and the sale of surgical solutions will allow it to better focus on those lines to drive profitable long-term growth.”
  • AHIP notes,
    • “AHIP is releasing a new survey conducted by NORC at the University of Chicago which highlights broad satisfaction with employer-provided coverage (EPC) and the value it brings, including convenient access to high-quality care.
    • “This report shines a light on how employer-provided coverage delivers high-quality, affordable health care for more than half of all Americans and their families,” said Jeanette Thornton, AHIP’s executive vice president of policy and strategy. “Serving every age, race, ethnicity, and income level, employer-provided coverage is the cornerstone for good health in America.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI, Uncategorized–

From the cybersecurity policy front,

  • Cybersecurity Dive reports,
    • “The U.S. government and its partners have slowed the swell of ransomware over the last three years, Jen Easterly, director of the Cybersecurity and Infrastructure Security Agency, said Wednesday at an event.
    • “But the cyclical and persistent threat ransomware poses requires new ways of thinking, Easterly said, speaking at the Institute for Security and Technology’s annual ransomware task force event. Defenders and stakeholders have to turn the lens to software and hardware vendors, according to Easterly.
    • “There’s a lot about the villains. There’s a lot about victims. We do not talk enough about vendors,” she said.
    • “The way we are going to actually drive down the number of attacks, and the number of successful attacks, is if we go upstream and ensure that technology that is deployed and delivered is in fact prioritized to be secure,” Easterly said. “Not features, not speed to market, not driving down costs, but secure.”
  • Here is a link to a related blog post from the CISA Director on this important topic.
  • Cyberscoop adds,
    • ‘The Cybersecurity and Infrastructure Security Agency’s vulnerability warning program has issued more than 2,000 alerts to date to organizations that are running software with vulnerabilities being exploited by ransomware gangs, the agency’s director, Jen Easterly, said Wednesday.
    • “Currently running in a pilot phase, the program is mandated by the Cyber Incident Reporting for Critical Infrastructure Act of 2022 and aims to reduce the number of ransomware attacks by getting the owners and operators of vulnerable systems to patch them before they can be infiltrated. 
    • “The warning pilot is focused on reducing the prevalence of ransomware by using our vulnerability scanning tools to let businesses know if they have vulnerabilities that need to be patched,” Easterly said at an event hosted by the Institute for Security and Technology.
    • “Easterly said that since the pilot was launched in January of last year, it has expanded to include CISA’s database of known exploited vulnerabilities as well as common misconfigurations that can be linked to ransomware attacks. 
    • “In a Thursday blog about the warning pilot, CISA found that of the more than 1,700 notifications of vulnerable devices in 2023, 49% were mitigated through either patching, taking offline, or through other measures. The blog also said organizations reduce cyber risk when using CISA’s free cyber hygiene vulnerability scanning service, which monitors the web for vulnerable devices.
    • “Organizations participating in this no-cost service typically reduce their risk and exposure by 40% within the first 12 months and most see improvements in the first 90 days,” CISA said.”

From the cyber vulnerabilities and breaches front,

  • Cybersecurity Dive tells us,
    • “UnitedHealth Group said [on April 22] it paid hackers a ransom in an attempt to protect patient information from disclosure after a cyberattack against its subsidiary Change Healthcare in February, the company confirmed to Healthcare Dive on Monday. 
    • “The healthcare behemoth also said patient data was compromised. UnitedHealth found files involved in the cyberattack containing protected health information or personally identifiable information that “could cover a substantial proportion of people in America,” according to a press release. 
    • “UnitedHealth also said 22 screenshots of allegedly stolen files, some containing patient health information, were posted on the dark web for about a week. The healthcare giant said it’s continuing to monitor the internet and the dark web for stolen data. * * *
    • “The company also said it would take on breach reporting and notification requirements for customers whose data may have been exposed in the attack — a big concern for provider groups.”
  • Tech Crunch reports,
    • “U.S. health conglomerate Kaiser is notifying millions of current and former members of a data breach after confirming it shared patients’ information with third-party advertisers, including Google, Microsoft and X (formerly Twitter).
    • “In a statement shared with TechCrunch, Kaiser said that it conducted an investigation that found “certain online technologies, previously installed on its websites and mobile applications, may have transmitted personal information to third-party vendors.”
    • “Kaiser said that the data shared with advertisers includes member names and IP addresses, as well as information that could indicate if members were signed into a Kaiser Permanente account or service and how members “interacted with and navigated through the website and mobile applications, and search terms used in the health encyclopedia.”
    • “Kaiser said it subsequently removed the tracking code from its websites and mobile apps. ***
    • “Kaiser spokesperson Diana Yee said that the organization would begin notifying 13.4 million affected current and former members and patients who accessed its websites and mobile apps. The notifications will start in May in all markets where Kaiser Permanente operates, the spokesperson said.
    • “The health giant also filed a legally required notice with the U.S. government on April 12 but made public on Thursday confirming that 13.4 million residents had information exposed.”
  • Help Net Security informs us,
    • “More organizations hit by ransomware gangs are starting to realize that it doesn’t pay to pay up: “In Q1 2024, the proportion of victims that chose to pay touched a new record low of 28%,” ransomware incident response firm Coveware has found.
    • “Victim organizations are increasingly able to withstand an encryption attack and restore operations without the need for a decryption key, they said, and the stolen data is often leaked or traded even after the victims have paid the ransom, which repeatedly proves that paying up is no guarantee.
    • “LockBit was found to still be holding the stolen data of victims that had paid a ransom, and we have also seen prior Hive victims that had paid the extortion, have their data posted on the Hunters International leak site (a reboot / rebrand of Hive),” the company said, noting that “future victims of data exfiltration extortion are getting more evidence daily that payments to suppress leaks have little efficacy in the short and long term.”

From the cybersecurity defenses front,

  • Cybersecurity Dive lets us know,
    • “Global median dwell times — measured as the time that hackers remain undetected inside a targeted environment — have fallen to their lowest levels in more than a decade, according to the annual M-Trends report from Google Cloud’s Mandiant, released Tuesday. 
    • “Organizations were able to detect intrusions within a median of 10 days in 2023, compared with 16 days in 2022. Notably the largest improvements came in the Asia-Pacific region, where median dwell times fell to nine days in 2023, compared with 33 in 2022.  
    • :Zero-day vulnerabilities are a hot target for espionage actors as well as financially motivated threat groups. Zero-day usage rose 50% in 2023, compared with the prior year.”
  • and
    • “The majority of companies, 4 in 5, have suffered a cyberattack that wasn’t fully covered under their cyber insurance policy, according to an analysis by cyber risk quantification firm CYE.
    • “On average, each insurance gap left more than three-quarters of a breach uncovered, CYE said in a report released Wednesday. The research, which analyzed 101 breaches across various sectors, revealed an average of $27.3 million in uncovered losses per incident.
    • “This study underscores how many companies rely on cyber insurance to cover the losses incurred as a result of cyber incidents and are then taken by surprise when they find that their insurance only covers a small portion,” Nimrod Partush, vice president of data science at CYE, said in a press release.” 
  • Here is a link to Dark Reading’s latest CISO Corner.
  • SC Media considers whether the Change Healthcare case finally will make providers do a business impact analysis.

Midweek Update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NIH, OPM, U.S. Healthcare, Uncategorized–
Photo by Mel on Unsplash

From Washington, DC,

  • Here’s a link to a the brief text of Senate bill 4811 that would allow over 100,000 reservists and National Guard members who also are federal employees to transfer from the FEHB to the lower cost Tricare Reserve Select healthcare program effective January 1, 2025.
  • Kevin Moss, writing in Govexec, points out the advantages of FEHB high deductible health plans.
  • Beckers Hospital Review alerts us,
    • “A Senate committee opened an investigation into Novo Nordisk’s list prices for Ozempic and Wegovy, Novo Nordisk’s diabetes and weight loss drugs. 
    • “In an April 24 letter to Novo Nordisk’s CEO, the Senate Committee on Health, Education, Labor, and Pensions said Ozempic and Wegovy are “exorbitantly expensive,” which restricts access to the drugs for millions of Americans. 
    • “In the U.S., a four-week supply of Ozempic costs $969, and Wegovy is $1,349. That’s up to 15 times more than what Novo Nordisk charges in Canada, Europe and Japan, the letter said. 
    • “In 2023, pharmacies, clinics and hospitals spent more than $38 billion on the two products, which contain the same drug, semaglutide. They were the No. 1 pharmaceutical expense for U.S. healthcare, according to research published April 24.”
  • STAT News confirms,
    • “Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and they’re set to cost the U.S. health care system and the federal government still more this year and beyond, two new reports released Wednesday show.
    • “One study from the American Society of Health-System Pharmacists found that GLP-1 treatments were a main driver of the increase in overall drug spending by health entities such as pharmacies and hospitals last year. In particular, expenditures on Novo Nordisk’s semaglutide — sold as Ozempic for diabetes and Wegovy for obesity — doubled to $38.6 billion, making the drug the top-selling medicine in 2023.
    • “The other report, by health policy research organization KFF, looked at the impact of the recent approval of Wegovy to prevent cardiovascular complications. Medicare is barred from covering drugs for weight loss purposes, but the new approval means the federal payer can now cover Wegovy when prescribed to reduce heart risks. As a result, Medicare could spend $2.8 billion in a year on the single drug, the researchers conservatively estimate.
    • “Taken together, the reports provide a window into the pressure that GLP-1 drugs could place on overall health care spending going forward, especially as more people take the medications. The treatments have been in short supply, but drugmakers are ramping up manufacturing capacity to meet the unprecedented demand from patients. The pharma companies are also seeking approval for even more indications like heart failure and sleep apnea.”
  • The New York Times reports,
    • “The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs.
    • “The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often a first-line therapy for women with uncomplicated U.T.I.’s, meaning the infection is confined to the bladder and has not reached the kidneys. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older. * * *
    • “Utility Therapeutics, the U.S. company that acquired the rights to pivmecillinam, said it would be available in 2025. The company is also seeking F.D.A. approval for an intravenous version of the drug that is used for more serious infections and is usually administered in a hospital setting.
    • “Health practitioners said they were elated to have another tool in their arsenal given the growing challenge of antimicrobial resistance, which makes existing medications less effective as pathogens mutate in ways that allow them to survive a course of antibiotics.”
  • As we learned yesterday, “Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.” MedCity News adds,
    • “Ojemda is available as an immediate-release tablet or an oral suspension, both administered once weekly. Dosing of the Day One drug is according to body surface area, which is consistent with dosing for other pediatric medications, Blackman said. Day One has set a $33,816 wholesale price for a 28-day supply. That means the annual cost of the therapy will top $440,000. Ojemda’s price is the same for all packages of the drug and will not change as a child grows and needs higher doses, Chief Commercial Officer Lauren Merendino said.
    • “The two formulations of Ojemda can be taken at home, which minimizes disruption to the lives of patients and families, Merendino said. Day One’s goal is to establish Ojemda as the physician’s first choice of therapy for pLGG. Merendino said the drug should become available in about two weeks.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Dairy cows must be tested for bird flu before moving across state lines, under a federal order issued Wednesday, as evidence mounts that the virus is more widespread than feared among cows in the United States.
    • Biden administration officials said the move is meant to contain transmission of the virus known as H5N1 and to reduce the threat to livestock, but they maintained that the risk to humans remains low. * * *
    • “An order issued by the U.S. Agriculture Department that takes effect Monday requires every lactating dairy cow to be tested before moving across state lines. Cows carrying the virus would have to wait 30 days and test negative before being moved, officials said. Positive test results would trigger additional requirements for herd owners to disclose information, including the movement of animals, to aid epidemiologic investigations, and for laboratories and state veterinarians to report cases to the USDA.
    • “Requiring positive test reporting will help USDA better understand this disease and testing before interstate movement will limit the spread of the virus,” Mike Watson, administrator of the USDA’s Animal and Plant Health Inspection Service, told reporters.
    • “This is an evolving situation, and we are treating it seriously and with urgency,” he said.”
  • The International Foundation of Employee Benefit Plans discusses “What Health Plan Sponsors Should Know About the Emerging Mental Health Needs of Youth.”
  • The National Cancer Institute released its latest Cancer Information Highlights.
  • The National Institutes of Health announced,
    • “In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening and rare genetic disorder that affects a wide range of bodily systems, leading to severe cardiac, neurological, and psychiatric symptoms as well as physical differences such as webbed fingers and toes. The treatment restored typical cellular function in 3D structures created from cells of people with Timothy syndrome, known as organoids, which can mimic the function of cells in the body. These results could serve as the foundation for new treatment approaches for the disorder. The study, supported by the National Institutes of Health (NIH), appears in the journal Nature.
    • “Not only do these findings offer a potential road map to treat Timothy syndrome, but research into this condition also offers broader insights into other rare genetic conditions and mental disorders,” said Joshua A. Gordon, M.D., Ph.D., director of the National Institute of Mental Health, part of NIH.”
  • A primary care expert writing in Medscape offers a commentary on the new Shield blood test available for colon cancer screening.
    • “We will need to be clear [to patients] that the blood test is not yet endorsed by the USPSTF or any major guideline group and is a second-line test that will miss most precancerous polyps. As with the stool tests, it is essential to emphasize that a positive result must be followed by diagnostic colonoscopy. To addend the cancer screening maxim I mentioned before, the blood test is not the best test for CRC, but it’s probably better than no test at all.”
  • Health IT Analytics tells us,
    • “Researchers from the University of Virginia (UVA) have developed a machine learning tool designed to assess and predict adverse outcome risks for patients with advanced heart failure with reduced ejection fraction (HFrEF), according to a recent study published in the American Heart Journal.
    • “The research team indicated that risk models for HFrEF exist, but few are capable of addressing the challenge of missing data or incorporating invasive hemodynamic data, limiting their ability to provide personalized risk assessments for heart failure patients.
    • “Heart failure is a progressive condition that affects not only quality of life but quantity as well,” explained Sula Mazimba, MD, an associate professor of medicine at UVA and cardiologist at UVA Health, in the news release. “All heart failure patients are not the same. Each patient is on a spectrum along the continuum of risk of suffering adverse outcomes. Identifying the degree of risk for each patient promises to help clinicians tailor therapies to improve outcomes.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Prices for surgery, intensive care and emergency-room visits rise after hospital mergers. The increases come out of your pay. 
    • “Hospitals have struck deals in recent years to form local and regional health systems that use their reach to bargain for higher prices from insurers. Employers have often passed the higher rates onto employees. 
    • “Such price increases added an average of $204 million to national health spending in the year after mergers of nearby hospitals, according to a study published Wednesday by American Economic Review: Insights. 
    • “Workers cover much of the bill, said Zack Cooper, an associate professor of economics at Yale University who helped conduct the study. Employers cut into wagesand trim jobs to offset rising insurance premiums, he said. “The harm from these mergers really falls squarely on Main Street,” Cooper said. 
    • “Premiums are rising at their fastest pace in more than a decade, driven up by persistently high inflation across the economy. Rising costs have fueled contentious negotiations that have led some hospitals and insurers to cancel contracts, leaving patients in the lurch. 
    • “Hospital mergers make the price pressures worse.” 
  • Per BioPharma Dive,
    • “Biogen has seen “encouraging early trends” in the launch of its postpartum depression pill Zurzuvae, revealing in first quarter earnings drug sales that surpassed the estimates of Wall Street analysts.
    • “Biogen said sales of Zurzuvae between January and March hit $12 million, up from $2 million in the fourth quarter of 2023 and doubling consensus estimates of $5 million to $6 million. The company didn’t, however, reveal the number of prescriptions filled for Zurzuvae, making demand for the drug difficult to track. 
    • “Zurzuvae, which was discovered by Biogen partner Sage Therapeutics and approved by the Food and Drug Administration last August, is the only pill available specifically meant to treat postpartum depression, or PPD. But its sales prospects are uncertain, as the condition often goes undiagnosed, and many who are diagnosed don’t receive treatment.”  
  • STAT News tells us,
    • “A year ago, when Novo Nordisk announced it would cut the price of multiple insulin products by up to 75%, President Biden, lawmakers, and patient groups all counted the move as a win.
    • But several months later, Novo decided to discontinue one of those products, the basal insulin Levemir.
    • “Though the insulin won’t officially be off the market until the end of this year, patients are already running into supply disruptions and insurance cutoffs, leaving them with few options. The discontinuation, which is happening only in the U.S., has now drawn alarm from some Democratic senators, who sent a letter to Novo last week demanding an explanation.
    • “The turn of events highlights a key gap in policy efforts: Even if officials can get drugmakers to cut prices, the companies can choose to just pull a drug off the market, without guaranteeing that other manufacturers will continue to make the compound.”
  • Beckers Payer Issues informs us,
    • “Humana reported $741 million in net income in the first quarter of 2024. 
    • “The company published its first quarter earnings report April 24, beating investor expectations. In Q1 2023, Humana posted $1.2 billion in net income.
    • “Total revenue in the first quarter was $29.6 billion, up 10.7% year over year. 
    • “Humana’s medical loss ratio was 88.9% in the first quarter, which the company projects will rise to about 90% for the full year.”
  • Beckers Hospital Review notes,
    • “Cleveland Clinic’s eHospital program has expanded and now monitors 248 patient beds in ICUs and other units across the organization’s network.
    • “The eHospital program launched in 2014 as a pilot in one intensive care unit. The program is centered around a component known as the “bunker,” an operations center on Cleveland Clinic’s main campus. The operations center is staffed from 7 p.m. to 7 a.m. daily by a team consisting of two critical care nurses and a physician. Their primary responsibility is to monitor patients across various ICU units within the Cleveland Clinic network.”
  • and identifies the 25 most expensive hospital drugs.
    • “Keytruda (pembrolizumab) was nonfederal hospitals’ costliest drug expense in 2023, according to research published April 24 in the American Journal of Health-System Pharmacy. 
    • “In 2021 and 2022, COVID-19 drug Veklury (remdesivir) was the No. 1 pharmaceutical expense for the nation’s hospitals. Most medicines on the list saw modest changes from the prior year except for TNKase (tenecteplase), a cardiovascular therapy that cost hospitals 87.9% more in 2023.”