FEHBlog

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A bipartisan quartet of House representatives have introduced a bill peeling back restrictions on new or expanded physician-owned hospitals.
    • “The Physician Led and Rural Access to Quality Care Act, brought late last week, would create an exception to an Affordable Care Act’s ban that aimed to reduce conflicts of interest in care. Specifically, it would permit new physician-owned hospitals to open in rural areas that are at least 35 miles from another existing hospital or critical access hospital (or 15 miles in difficult-to-traverse areas).
    • “The new bill would also sunset a prohibition on expanding any existing physician-owned hospitals.”
    • FEHBlog note: The bill pits the American Medical Association (pro) against the American Medical Association (con).
  • Per a Department of Health and Human Services press release,
    • “Today, CMS is releasing the final part two guidance – PDF regarding plan outreach and education for the Medicare Prescription Payment Plan, which aims to ensure that people with Medicare prescription drug coverage, especially those most likely to benefit, are aware of the payment option. Starting in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full at the pharmacy counter each time they fill a prescription. People with Medicare must opt into the Medicare Prescription Payment Plan to utilize the new benefit. Notably, this payment option launches at the same time that all individuals with Medicare prescription drug coverage will begin to have their annual out-of-pocket prescription drug costs capped at $2,000, providing needed financial relief for high prescription drug costs.” * * *
    • “Today’s Medicare Prescription Payment Plan final part two guidance, which complements the final part one guidance – PDF released on February 29, is also accompanied by the release of the final Medicare Prescription Payment Plan model materials. Medicare Part D plans can use the model materials when communicating to Part D enrollees about the Medicare Prescription Payment Plan.” * * *
    • “For the fact sheet on the final part two guidance for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-final-part-two-guidance.pdf – PDF
    • “For the updated Information Collection Request (ICR) for the Medicare Prescription Payment Plan model plan materials, please visit: https://www.cms.gov/files/zip/medicare-prescription-payment-plan-model-materials.zip
    • “For an updated implementation timeline for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/medicare-prescription-payment-plan-timeline.pdf – PDF“
  • Another HHS press release brings us up to date on improvements to the 988 mental health lifeline which was launched two years ago today.
  • Healio adds,
    • “Since the launch of the 988 Suicide & Crisis Lifeline in 2022, counselors have answered more than 10 million calls, texts and chats from people seeking help for suicidal thoughts and mental health crises, according to HHS officials.
    • “During a press conference, HHS Deputy Secretary Andrea Palm said the lifeline “has become one of the most effective first-line responses that we have to help individuals who feel alone and without options.” * * *
    • “HHS has invested nearly $1.5 billion into the lifeline, according to an agency press release. It has lines that are tailored to people who speak Spanish, veterans, American Sign Language (ASL) users and the LGBTQI+ community. Since these lines were added to the 988 lifeline in 2023, there have been about 20,000 chats and texts with Spanish speakers, more than 475,000 texts, calls and chats with LGBTQI+ individuals and approximately 20,000 videophone contacts with ASL users.
    • “Among all contacts over the past 2 years, about 1.7 million were texts, according to the release. In the past year, HHS reported a 51% increase in texts and a 34% increase in calls, with support provided by more than 200 contact centers nationwide.”
  • CMS shares the following statement from CMS Administrator Chiquita Brooks-LaSure:
    • “Remembering Gail R. Wilensky, Ph.D., a health care policy savant who knew how to work across the aisle. Her Influence and leadership can still be felt today. She was very generous to the CMS leaders who served after her, including me. My deepest condolences to her loved ones. CMS is grateful for her service to our country.”
    • FEHBlog note — Dr. Wilensky, who passed away on July 11 at age 81, served as CMS (then HCFA) Administrator for President George H. W. Bush.
  • Per the AHA News,
    • “The AHA July 16 urged the Center for Medicare and Medicaid Innovation not to implement its newly proposed Increasing Organ Transplant Access Model as currently constructed, expressing concerns about many of its design features. The proposed mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. AHA said that IOTA features could exacerbate inequities and negatively impact quality of care. Specifically, AHA said the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements.” 

From the public health and medical research front,

  • Per a press release, the Institute for Clinical and Economic Review published its Final Evidence Report on Treatment for Chronic Obstructive Pulmonary Disease 
    • “Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ensifentrine added to maintenance therapy compared to maintenance therapy alone; ICER calculated a health-benefit price benchmark (HBPB) for ensifentrine between $7,500 to $12,700 per year, and the therapy is priced at $35,400 per year.
  • The National Institutes of Health announced,
    • “In a new analysis of data, researchers at the National Institutes of Health (NIH) have found that taking a daily supplement containing antioxidant vitamins and minerals slows progression of late-stage dry age-related macular degeneration (AMD), potentially helping people with late-stage disease preserve their central vision. Researchers reviewed the original retinal scans of participants in the Age-Related Eye Diseases Studies (AREDS and AREDS2) and found that, for people with late-stage dry AMD, taking the antioxidant supplement slowed expansion of geographic atrophy regions towards the central foveal region of the retina. The study was published in the journal Ophthalmology.
    • “We’ve known for a long time that AREDS2 supplements help slow the progression from intermediate to late AMD. Our analysis shows that taking AREDS2 supplements can also slow disease progression in people with late dry AMD,” said Tiarnan Keenan, M.D., Ph.D., of NIH’s National Eye Institute (NEI) and lead author of the study. “These findings support the continued use of AREDS2 supplements by people with late dry AMD.”
  • Beckers Hospital Review shares ophthalmologist organization opinions on eye conditions and Ozempic use.
    • A week after a study connected Ozempic and Wegovy to an eye condition that can cause partial blindness, two ophthalmology organizations said they have “been aware of other vision changes for some time.”
    • Changing sugar levels can affect the shape of the eye’s lens, according to the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society. Because of this, semaglutide, the active ingredient of Type 2 diabetes drug Ozempic and weight loss medication Wegovy, might lead to blurry vision. 
    • The ophthalmology groups said previous studies have also found that semaglutide can exacerbate diabetic retinopathy and macular complications. 
    • “The medical community has been aware of other vision changes with semaglutide for some time,” the organizations said in a July 8 joint statement. However, the research associating the drug to non-arteritic anterior ischemic optic neuropathy [NAION] is the first of its kind. 
    • “The condition restricts blood flow to the optic nerve, which causes sudden, painless loss of vision in one eye, the statement said. The research did not confirm a causal relationship between the medications and NAION, but it identified a potential link.: * * *
    • “The subjects in this study were either overweight or obese or had Type 2 diabetes. People who have diabetes are already at risk of NAION,” the organizations said. “Other risk factors for NAION include heart disease, history of heart attack, high blood pressure and sleep apnea” — health risks that also are tied to diabetes and obesity. 
    • “In response to the study, Novo Nordisk, the manufacturer of Ozempic and Wegovy, said it takes adverse event reports seriously. 
    • “The ophthalmology groups said they recommend patients continue taking the medications unless they experience a sudden vision loss.”  
  • The AHA News points out,
    • “Antimicrobial-resistant infections remained above pre-pandemic levels in 2022, the Centers for Disease Control and Prevention reported July 16. CDC data show that infections, which increased 20% during the pandemic compared to the pre-pandemic period — peaked in 2021.
    • “The increases in antimicrobial resistance (AR) burden seen in 2020 and 2021 are likely due in part to the impact of COVID-19, which pushed healthcare facilities, health departments and communities near their breaking points,” the agency notes. “This resulted in longer hospital stays for hospitalized patients (including those diagnosed with COVID-19), challenged the implementation of infection prevention and control practices and increased inappropriate antibiotic use.” 
    • “The AHA provides resources which promote the appropriate use of medical resources.”
  • Medscape summarized the June meeting decisions of the CDC’s Advisory Committee on Immunization Practices and identifies the five immunizations that adults need beyond Covid and the flu vaccines.
  • Medscape also discusses the use of remote trials to accelerate the testing of new long Covid treatments.

From the U.S. healthcare business front,

  • Beckers Payer Issues and Fierce Healthcare report on UnitedHealthcare’s second quarter financial results announced today.
    • BPI – “UnitedHealth Group posted $4.2 billion in net income during the second quarter of 2024, a 23% decline year over year.
    • “The company said it has restored the majority of affected Change Healthcare services and has provided more than $9 billion in advance funding and loans to providers. The total full year impact of the breach is estimated at $1.90 to $2.05 per share, with the company raising the estimated total cost of the attack to around $2.45 billion.”
    • FH – “UnitedHealth saw an elevated medical loss ratio in Q2, and executives pointed to the Change Healthcare cyberattack as a key factor.
    • “UnitedHealthcare had an MLR of 85.1% in the second quarter, compared to 83.2% in the prior year quarter. The insurer called out multiple elements that contributed to the elevated ratio in its earnings call on Tuesday morning. For one, UHC CEO Brian Thompson said there’s a clear difference in coding intensity after the insurer ended care waivers offered following the cyberattack.
    • “Amid the cyberattack, UnitedHealth eased prior authorization and utilization management to support cash flow to providers.”
  • Beckers Hospital Review provides details on U.S. News and World Report’s latest U.S. hospital rankings by State and by specialty.
  • pwc reports,
    • “Commercial health care spending growth is estimated to grow to its highest level in 13 years, according to PwC’s newest research into annual medical cost trend. PwC’s Health Research Institute (HRI) is projecting an 8% year-on-year medical cost trend in 2025 for the Group market and 7.5% for the Individual market. This near-record trend is driven by inflationary pressure, prescription drug spending and behavioral health utilization.
    • “HRI is also restating the 2023 and 2024 medical cost trends as higher than previously reported based on the input of health plans we surveyed and their trend experience. This unfavorable trend reflects higher than expected utilization of glucagon-like peptide-1 (GLP-1) drugs as well as higher acuity (higher levels of care) inpatient and outpatient utilization. Inpatient and outpatient utilization were driven by demand from care deferred since the pandemic, which was met by newly created capacity as sites of care shifted to outpatient, professional and ambulatory care settings.
    • “The same inflationary pressure the healthcare industry has felt since 2022 is expected to persist into 2025, as providers look for margin growth and work to recoup rising operating expenses through health plan contracts. The costs of GLP-1 drugs are on a rising trajectory that impacts overall medical costs. Innovation in prescription drugs for chronic conditions and increasing use of behavioral health services are reaching a tipping point that will likely drive further cost inflation.
    • “Meanwhile, cost deflators are not enough to offset cost inflators. The growing adoption of biosimilar medications may provide some relief, while many health plans are looking inward to find opportunities across business operations to generate additional cost savings. Today’s medical cost trend is an urgent call to action for healthcare organizations to rethink their strategies to manage the total cost of care more effectively – a challenge that is inextricably linked to the broader challenge of affordability, defined by the Affordable Care Act as the percentage of a member’s household income used for healthcare expenses.”
  • FEHBlog note — OUCH!
  • MedCity News discusses the improving state of the digital health fundraising market.

Monday Roundup

David Ermer–CDC, Congress, COVID treatment, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Reuters reports,
    • “Democratic U.S. Senate aides will meet with Novo Nordisk executives on Tuesday to discuss fallout from its decision to stop selling one of its long-acting insulins in the country, two sources familiar with the meeting told Reuters.
    • “Novo Nordisk (NOVOb.CO), opens new tab will meet with the aides for Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren. In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.
    • “Novo said it has given patients enough time to switch to other options, according to a May letter seen by Reuters. The company is unaware of plans for drug manufacturers to produce a biosimilar version of the insulin, the letter said, adding Novo would not assert any patent against such a version.
    • “The sources declined to be named citing the sensitivity of the matter.”
  • STAT News lets us know,
    • “For now, the doctor groups are lobbying [Congress] in unison toward the same goal of increasing the pot of money for physician services, which stood at about $71 billion in 2022, or 16% of Medicare fee-for-service spending. A Medicare spokesperson said that number is expected to reach about $90 billion this year. Doctors would also like to get credit for saving money by keeping patients out of the hospital.
    • “Those demands would pit doctors against others in the health care system, including hospitals, because Congress typically requires that increases in Medicare spending be paid for by cuts elsewhere in the program. That’s a heavy lift. Congress has been considering equalizing certain Medicare payments between hospitals and physicians’ offices to save money, but that site-neutral policy has faltered.
    • “That’s not the only thing working against doctors. If Congress increases spending on physician services, seniors’ Medicare Part B premiums will go up, according to the nonpartisan research arm of Congress. Congress could prevent premiums from increasing, but that would add to the government tab.
    • “For those reasons, doctor lobbyists privately doubt Congress will meaningfully increase physician pay rates overall, leaving doctors to fight over how a fixed sum of money should be split up.
    • “Courtney Savage, founder of Savage Health Policy, said she sees signs of trouble ahead for specialists. Republicans and Democrats in the Senate want to boost primary care pay. Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) unveiled a plan to “improve the adequacy of pay for primary care providers in Medicare.” Two days later, Senate Finance Committee Chair Ron Wyden (D-Ore.) and the committee’s ranking Republican, Idaho’s Sen. Mike Crapo, published their plan to improve chronic care, which would likely favor primary care doctors, too.”
  • In this regard, the American Hospital News tells us,
    • The AHA July 15 commented to Sens. Sheldon Whitehouse, D-R.I., and Bill Cassidy, R-La., responding to a request for information based on the Pay PCPs Act, legislation designed to improve support and pay for primary care providers. The AHA expressed concerns that its proposed hybrid per-member-per-month and fee-for-service payment structure in the physician fee schedule for primary care could result in payment cuts, and that there may be variation in the PMPM depending on the type of provider. The bill also has language implying that there is latitude for the PMPM to not be risk-adjusted and possibly restrict what could be included in the risk adjustment, AHA said. 
    • The AHA voiced support for a provision in the legislation that would reduce beneficiary cost-sharing for primary care services by 50% under the hybrid payment model. The association also shared principles for Congress to consider when designing alternative payment models to make participation more attractive for potential participants.
  • Per Axios,
    • “The Centers for Medicare and Medicaid Services last week proposed creating three new payment codes that would allow physicians to get paid for incorporating digital therapies into patients’ mental health treatment, starting in 2025. 
    • “The codes would only apply to products approved by the Food and Drug Administration.
    • “Insurers have so far been reluctant to pay for apps, video games and other therapeutic software. There isn’t long-term data on the effectiveness, and differences in the therapies make it difficult to standardize billing.
    • “The first company to get FDA clearance for a digital therapy, Pear Therapeutics, declared bankruptcy last year after struggling to secure insurance coverage for its products.”

From the public health and medical research front,

  • The AHA News points out,
    • “The Centers for Disease Control and Prevention July 14 announced four confirmed human cases of H5N1 bird flu among farm workers who were working at a Colorado poultry facility. The agency is also aware of a fifth presumptive-positive case, which is pending confirmation. All of the workers who tested positive reported having a mild illness, with symptoms that include conjunctivitis, eye tearing, fever, chills, coughing, sore throat and a runny nose. The CDC said they believe a risk to the public remains low.” 
  • STAT News adds,
    • The announcement of the fourth [H5N1 bird flu] case, on the eve of the July 4 holiday, led Adam Kucharski, the co-director of the Centre for Epidemic Preparedness & Response, at the London School of Hygiene and Tropical Medicine, to ask on the social platform X: “What’s the plan?”
    • Kucharski posed a bunch of hypotheticals — What if there are clusters of cases? Cases among people who haven’t had contact with cows? Cases exported to other countries? — to convey the point that a mere four years after the start of the worst pandemic since the 1918 Spanish Flu, the world does not appear to be grappling with the fact that H5 virus spreading in cows could lead to H5 virus spreading in people.
    • “What, here in 2024, is the plan for dealing with an outbreak of a potentially pandemic pathogen like H5N1?” he asked.”
  • Medscape notes,
    • “Parkinson’s disease (PD) and dementia with Lewy bodies are currently defined by clinical features, which can be heterogeneous and do not capture the presymptomatic phase of neurodegeneration.
    • “Recent advances have enabled the detection of misfolded and aggregated alpha-synuclein protein (synucleinopathy) — a key pathologic feature of these diseases — allowing for earlier and more accurate diagnosis. This has led two international research groups to propose a major shift from a clinical to a biological definition of the disease.
    • “Both groups emphasized the detection of alpha-synuclein through recently developed seed amplification assays as a key diagnostic and staging tool, although they differ in their approaches and criteria.” * * *
    • “Commenting for Medscape Medical News, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, said the principle behind the proposed classifications is where “the field needs to go.”
    • “Right now, people with Parkinson’s take too long to get a confirmed diagnosis of their disease, and despite best efforts, clinicians can get it wrong, not diagnosing people or maybe misdiagnosing people,” Beck said. “Moving to a biological basis, where we have better certainty, is going to be really important.”
  • The New York Times reports, “Families pay thousands of dollars to store their children’s stem cells with the hope of a healthier future. But the cells are rarely useful, and sometimes contaminated.” No bueno.
  • A STAT News journalist observes,
    • If you read Derek Lowe — and come on, you must read the bearded chemist who has been blogging about pharma for two decades — you’ve already thought about ibuzatrelvir, Pfizer’s potential heir to Paxlovid, which would be given as a single pill and potentially without that metallic taste.
    • “I read this eagerly, but I had another question that I asked virologist Michael Mina when he posted Derek’s article on X. How do we test it?
    • “Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.“Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.
    • “It’s very hard to prove an antiviral drug works, a problem that has long dogged Tamiflu. The benefit only shows up if people are at very high risk, or if the study is very big. Otherwise, it just appears the drug is reducing symptoms a very tiny bit.
    • “On this, David Boulware of the University of Minnesota had one perspective: Shionogi’s drug failed because regulators wanted its study to contain too few high-risk patients. But my suspicion is that getting better Covid drugs will be less a problem of chemistry than of clinical trials. This is part of why we don’t have more monoclonal antibodies against new strains. Paxlovid sales have come in higher than many analysts were expecting so far this year. Maybe that will encourage drug.” companies to solve this problem.
  • The Washington Post and Consumer Reports explain “what to do when you need medical care fast,”
    e.g., self-triage.
  • Per MedPage Today,
    • “A mammography screening decision aid with information about the benefits and harms of screening increased the percentage of average-risk women in their 40s who wanted to delay mammography, according to a national online survey.
    • “Before viewing the decision aid, 27% of women ages 39 to 49 preferred to delay screening. The decision aid raised that percentage to 38.5%, reported Laura Scherer, PhD, of the University of Colorado in Aurora, and colleagues.
    • “The survey also showed a narrower majority of women preferred to undergo mammography at their current age after viewing the decision aid (57.2% vs 67.6% beforehand) and more preferred to wait until age 50 (18% vs 8.5%).
    • “As to what information shifted their view, 37.4% of women surveyed said they found the information about overdiagnosis in the decision aid “surprising,” and 28.1% said it differed from what their doctor had told them, Scherer and colleagues reported in the Annals of Internal Medicine.
    • “While the U.S. Preventive Services Task Force (USPSTF) recommends biennial screenings starting at age 40 years — compared with a previous recommendation that screening begin at 50 — it “endorses informed choice and shared decision making at all levels of its recommendations,” Scherer’s group wrote.
    • “However, “a lack of language promoting informed choice in the guideline itself may create confusion among clinicians about whether they should discuss both screening benefits and harms with patients or instead provide only information that maximizes screening uptake,” they added.”

From the U.S. healthcare business front,

  • AIS Daily reports,
    • “Blue Shield of California caught the attention of the industry last August when it announced a switch to a pharmacy benefits model using five vendors. While some insurers and plan sponsors have considered a similar move following Blue Shield’s revelation, benefits consultants tell AIS Health that most payers continue to have a traditional arrangement where one PBM handles all pharmacy-related activities. They add that Blue Shield’s so-called unbundled approach could be difficult to manage and may not achieve significant cost savings.”
  • Per Fierce Pharma,
    • “While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley.
    • “In the July 11 report, the analysts calculate that products losing exclusivity through 2030 are generating a combined $183.5 billion in annual sales, with Amgen, Bristol Myers Squibb and Merck facing the most exposure of their revenue.
    • “Meanwhile—citing company financial reports and data from Visible Alpha and FactSet—Morgan Stanley estimates that Big Pharma has $383.1 billion of firepower available for dealmaking. The companies sitting on the most dry powder are Johnson & Johnson, Merck and Novo Nordisk, the analysts said.
    • “We continue to see the conditions as generally favorable for bolt-on M&A as large-cap pharma companies have balance sheet capacity and a need to acquire outer-year revenue,” the Morgan Stanley team, led by Terence Flynn, Ph.D., wrote.”
  • BioPharma Dive offers a chart with “Years of expiration for principal patents protecting the top 30 pharmaceutical products by 2023 sales.”
  • Beckers Hospital Review discloses the gender breakdown of physicians across the fifty states and DC.
  • Per MedCity News, “Walgreens’ Finances Are in Dire Straits — But All Hope Is Not Lost. Walgreens’ financial performance is still rocky, but experts agree there is a good chance that CEO Tim Wentworth can lead the company to recovery. To make this happen, Walgreens will have to let go of its retail clinic dreams and focus more on making its core pharmacy business as strong as possible.”

Weekend Update

David Ermer–Congress, Medical / Rx research, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare discusses a Senate Special Committee on Aging hearing about healthcare price transparency held last Thursday July 11.
    • “If consumers or business departments received a major charge on their monthly statements with no pricing breakdown or itemized receipts, many would demand more information if not outright refuse to pay.
    • “But that’s not the case in healthcare, where unexpected fees billed from insurers and hospitals and multiplicative markups are delivered after the fact and with little explanation.
    • “That was the message senators heard loud and clear during a Thursday morning hearing of policy researchers and purchasers of commercial insurance for employees and union members.” * * *
    • [Ranking Member Sen. Mike} Braun [R Ind.] kept the legislative focus squarely on price transparency, highlighting a bipartisan package he brought with Sens. John Hickenlooper, D-Colorado; Bernie Sanders, I-Vermont; Chuck Grassley, R-Iowa; and Tina Smith, D-Minnesota, earlier this year.
    • That bill, the Health Care PRICE Transparency Act 2.0 [S. 1130], received the explicit support of multiple witnesses and other price transparency advocacy groups whose written comments were entered into the hearing’s record. It would impose data sharing standards, require negotiated rates and cash prices on machine-readable files rather than estimates, increase maximum annual noncompliance penalties and give group health plans the right to audit and review claims data.

From the public health and medical research fronts,

  • MedPage Today discusses four exceptional papers from JAMA Open Forum.
    • Item 1: Smartphone App Decreases Distracted Driving
    • Item 2: Vaping and Secondhand Nicotine Exposure in Kids
    • Item 3: New Data Adds Confidence to RSV Vaccine Safety During Pregnancy
    • Item 4: Mental Health Care Access Via Telehealth Decreased After the COVID Emergency Period.
  • The Washington Post points out
    • “A study published in the journal Alcohol: Clinical & Experimental Research looked at the reasons young adults give for not drinking, which researchers say could help in crafting public health messaging aimed at reducing alcohol abuse.
    • “Researchers focused on 614 participants who took online surveys about their alcohol use from mid-February to mid-May 2022. Participants were an average of 21.5 years old, and the majority were White (64.5 percent) and male (54.2 percent). About 65 percent were college students.
    • “Among the respondents, 49.9 percent said they were moderate drinkers, with 31.5 percent reporting binge drinking five to nine drinks in a row in the prior two weeks and 18.6 percent reporting “high-intensity drinking” of 10 or more drinks on a day in the previous two weeks, researchers at the University of Michigan’s Institute for Social Research and Texas State University report. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.”
  • The Wall Street Journal warns,
    • “With their fitness-influencer endorsements and wellness sheen, energy drinks have become more appealing to women. They’ve also become a go-to for teenage girls and young women with eating disorders.  
    • “Overconsumption of low-cal, highly caffeinated energy drinks is on the rise among young women with unhealthy eating and exercise habits, say doctors at more than a dozen of the nation’s top hospitals and eating-disorder treatment centers. Taking in too much caffeine can cause serious health problems, especially for people who aren’t eating enough, doctors say.   
    • “Brands like Celsius and Alani Nu pitch themselves as fitness aids, and, in the case of Celsius, claim to boost metabolism and burn fat. Attaining a toned body, the brands’ social-media posts suggest, looks as easy as sipping a can of the sparkling sugar-free beverages before a sweat sesh.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The rural hospital collaborative in North Dakota has secured two value-based contracts with commercial insurers and more are expected this year, building momentum for those considering similar alliances.
    • “Cibolo Health in October created the Rough Rider High-Value Network comprised of 23 critical access hospitals in North Dakota. The rural hospital advisory firm has since helped launch a similar venture in Minnesota and is in early talks to expand the model in several other states, CEO Nathan White said.
    • “The Rough Rider network inked a Medicare shared savings contract with CVS Health and a contract with Blue Cross Blue Shield of North Dakota that includes quality-based payments and shared savings, White said. Other payers are interested in Medicare Advantage and accountable care organization contracts, he added.”
  • Healthcare Dive lets us know,
    • “Geisinger will begin a $880 million expansion of its Danville, Pennsylvania-based medical center next year, with plans to include a new 11-story medical tower, the system said Tuesday.
    • “The project will include a larger emergency department, expanded intensive care units and operating suites, as well as private rooms for each patient.
    • “The Risant Health-owned nonprofit plans to execute the expansion in phases, with a target completion date of 2028.” 
  • HR Dive informs us,
    • “With the Great Resignation far in the rearview mirror, companies now are facing another challenge: what to do when employees stay.
    • “The U.S. quit rate — often used as a measure of turnover — has remained steadily at 2.2% for the past seven months, according to the Bureau of Labor Statistics’ Job Openings and Labor Turnover Summary released July 2. 
    • “The lull in employee exits is the perfect time for employers to work on succession planning and enhancing their value proposition, according to Lauren Geer, senior vice president and chief human resources officer of IAC, a holding company to media and internet brands including Dotdash Meredith, Care.com and Angi.
    • “It’s quieter now, but I don’t think we can rest on our laurels by any means or pat ourselves on the back for what a great job we’re doing retaining our employees,” Geer said. “Now’s the time to get the house in order, because I do think there’ll be a time when the employee market picks up.” 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front –

  • The Wall Street Journal reports,
    • “[On July 9, 2024,] Australia, the U.S. and six other allies warned that a Chinese state-sponsored hacking group poses a threat to their networks, in an unusual, coordinated move by Western governments to call out a global hacking operation they say is directed by Beijing’s intelligence services.
    • “Tuesday’s advisory was a rare instance of Washington’s major allies in the Pacific and elsewhere joining to sound the alarm on China’s cyber activity. Australia led and published the advisory. It was joined by the U.S., U.K., Canada and New Zealand, which along with Australia are part of an intelligence-sharing group of countries known as the Five Eyes. Germany, Japan and South Korea also signed on.” * * *
    • “The technical advisory detailed a group known in cybersecurity circles as Advanced Persistent Threat 40, or APT40, which conducts cybersecurity operations for China’s Ministry of State Security and has been based in the southern island province of Hainan. The advisory detailed how the group targeted two networks in 2022—though it didn’t identify the organizations—and said the threat is continuing.”
  • Federal News Network informs us,
    • “A top Department of Homeland Security official says DHS is working to harmonize new cyber incident reporting rules, as industry and even some lawmakers criticize the draft rule’s scope and potential duplicative requirements.
    • “The comment period for the Cybersecurity and Infrastructure Security Agency’s draft rule closed July 3. The proposal would implement the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) of 2022. CISA expects to finalize the rule next spring. The rules will require organizations across the 16 critical infrastructure sectors to report cyber incidents to CISA within 72 hours.
    • “Iranga Kahangama, DHS assistant secretary for cyber, infrastructure, risk, and resilience, said officials are just starting to adjudicate all the feedback it received. But Kahangama acknowledged widespread comments from industry about the “burden” of duplicative cyber incident rules.
    • “We are going to be viewing and administering CIRCIA with an eye towards harmonization,” Kahangama said during a July 10 event in Washington hosted by the Homeland Security Defense Forum. “We’re also establishing conversations between the department and all the other agencies that have cyber reporting requirements to identify ways that we can harmonize reporting.”
    • “He pointed to interagency agreements that “allow for reciprocal sharing of information such that … a report to one will count as a report to another and vice versa through CISA.”
    • “We want to make sure we’re maximizing the ability to do that,” Kahangama said. “That’s quite complicated, because each agency has different requirements. And so, you need to make sure that they’re substantially similar enough and that those are fleshed out. But those are really wonky but interesting conversations that my office is actively having right now as we develop CIRCIA.”
  • The FEHBlog finds it interesting that recent cyberbreach news articles rely on Securities and Exchange Commission 8-K reports from public companies.
  • Cyberscoop summarizes a variety of criticisms levelled against the CIRCIA proposed rule in the public comments.
  • Cyberscoop adds,
    • “New legislation from a bipartisan pair of senators would create an interagency committee tasked with streamlining the country’s patchwork system of cybersecurity regulations if signed into law.
    • “The Streamlining Federal Cybersecurity Regulations Act [S. 4630] from Sens. Gary Peters, D-Mich., and James Lankford, R-Okla., calls on the White House’s national cyber director to create a committee that would harmonize the myriad cyber requirements imposed on companies by federal regulatory agencies, according to bill text shared with CyberScoop.
    • “The introduction of the bill comes a month after a Senate hearing in which Nicholas Leiserson, the assistant national cyber director for cyber policy and programs, warned lawmakers of increasing “fragmentation” of cybersecurity regulations. “It is a problem that requires leadership from ONCD and Congress informed by the private sector,” he said.”
  • Cybersecurity Dive tells us,
    • “The Cybersecurity and Infrastructure Security Agency and FBI advised software vendors to eliminate operating system command injection vulnerabilities from products before they ship. The agencies issued the advisory Wednesday [July 10, 2024] as part of their secure-by-design alert series.
    • “Threat groups have exploited several OS command injection vulnerabilities in widely used network devices this year, including CVE-2024-20399 in Cisco products, CVE-2024-21887 in Ivanti remote access VPNs and CVE-2024-3400 in Palo Alto Networks firewalls. 
    • “OS command injection vulnerabilities arise when manufacturers fail to properly validate and sanitize user input when constructing commands to execute on the underlying OS,” CISA and the FBI said in the advisory.” 
  • Per the HeathIT.gov website,
    • “ONC’s HTI-2 proposed rule [released July 10] implements provisions of the 21st Century Cures Act and reflects ONC’s focused efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.
    • “Key proposals include:
      • “Two sets of new certification criteria, designed to enable health IT for public health as well as health IT for payers to be certified under the ONC Health IT Certification Program. Both sets of certification criteria focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners (health care providers to public health and to payers, respectively).
      • “Technology and standards updates that build on the HTI-1 final rule, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support.
      • “Requiring the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028.
      • “Adjustments to certain “exceptions” to the information blocking regulations to cover additional practices that have recently been identified by the regulated community, including a new “Protecting Care Access” exception, which would cover practices an actor takes in certain circumstances to reduce its risk of legal exposure stemming from sharing information.
      • “Establishing certain Trusted Exchange Framework and Common AgreementTM (TEFCATM) governance rules, which include requirements that implement section 4003 of the 21st Century Cures Act.”
    • The public comment deadline will end in early September, depending on the date of the proposed rule’s publication in the Federal Register.

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive lets us know,
    • “A cyberattack targeting AT&T’s Snowflake environment compromised data on nearly all of the telecom provider’s wireless customers, the company said in a Friday filing with the Securities and Exchange Commission. Nearly 110 million customers are impacted, according to AT&T’s annual report for the period of compromised data.
    • “Data stolen during the intrusion includes records of AT&T customers’ calls and text messages spanning a six-month period ending Oct. 31, 2022, and records from Jan. 2, 2023, the company said in the SEC filing. 
    • “The attack did not expose the content of calls or text messages, customer names or personally identifiable information, according to AT&T. Yet, the stolen records include the phone numbers AT&T wireless customers interacted with, counts of those interactions and aggregate call duration for a day or month.”
  • Dark Reading adds,
    • “Nearly all” of AT&T’s wireless customers are affected, the company admitted, as well as customers of mobile virtual network operators (MVNOs) using AT&T’s network. According to public resources, those MVNOs likely include popular wireless service providers like Boost Mobile, Cricket Wireless, H2O, and Straight Talk Wireless.” * * *
    • “Earlier this year, data belonging to more than 70 million AT&T customers leaked to the Dark Web. The trove included all the hallmark personally identifying information (PII) types, like Social Security numbers, mailing addresses, and dates of birth.
    • “This time, none of the stolen data has as yet been observed on the public web, and customers’ most sensitive PII has remained untouched. [FEHBlog note the theft occurred in April — the public notice was delayed with Justice Department approval.]
    • Still, AT&T warned, “There are often ways, using publicly available online tools, to find the name associated with a specific telephone number.”
  • Cyberscoop notes that Snowflake “announced on Thursday that administrators can now enforce mandatory multi-factor authentication for Snowflake users.”  
  • On a related note, Help Net Security discloses,
    • “On July 1, Twilio – the company that develops the Authy MFA mobile app – shared with the public that attackers have leveraged one of its unauthenticated API endpoints to compile a list of phone numbers and other data belonging to Authy users.
    • “Company systems were not breached, Twilio said, and Authy accounts have not been compromised, but the company warned that “threat actors may try to use the phone number associated with Authy accounts for phishing and smishing attacks.”
    • “The list, which apparently holds data of 33 million Authy users, has been offered for sale by ShinyHunters, a threat actor that specializes in breaching companies and stealing their customers data, then holding it for ransom and/or selling it to the highest bidder on forums and markets frequented by cybercriminals.”
  • Cybersecurity Dive calls attention to a recent survey,
    • “Almost 60% of organizations can’t track what happens to their information once it goes out in an email or through another communication channel, a survey by data security company Kiteworks finds. 
    • “That’s a risk management problem because data breaches are correlated with how information leaves an organization. 
    • “The more communication tools an organization uses — email, file sharing, managed file transfer, secure file transfer protocol, web forms, among others — the higher the risk of information ending up where it wasn’t intended, the survey finds. 
    • “Respondents with over seven communication tools experienced 10-plus data breaches — 3.55x higher than the aggregate,” the survey report says. “
  • On July 9, 2024 —
    • “CISA added three new vulnerabilities to its Known Exploited Vulnerabilities Catalog, based on evidence of active exploitation.
      • “CVE-2024-23692 Rejetto HTTP File Server Improper Neutralization of Special Elements Used in a Template Engine Vulnerability
      • “CVE-2024-38080 Microsoft Windows Hyper-V Privilege Escalation Vulnerability”
      • “CVE-2024-38112 Microsoft Windows MSHTML Platform Spoofing Vulnerability”
    • Health IT Security pointed out recent breaches involving healthcare entities.
    • HHS’s Health Sector Cybersecurity Coordination Center (HC3) posted its bulletin on June 2024 vulnerabilities of interest to the health sector.
  • Health IT Security alerts us,
    • “Change Healthcare published a substitute data breach notice on its website [earlier this week] to inform affected individuals of the breach that resulted from the February 2024 cyberattack against the company. Change has publicly stated that the cyberattack involved the data of approximately one-third of Americans.
    • “Change Healthcare said that it would begin mailing written letters to affected individuals on June 20, once it completed its data review. Additional customers may be identified as impacted as the review continues.
    • “The company provided a brief timeline of events in its substitute notice, which was published on its website. Although the cyberattack began on February 21, it was not until March 13 that Change was able to obtain a dataset of exfiltrated files that was safe to investigate. * * *
    • “Any individual who believes that their information has been impacted by the data breach can enroll in two years of complimentary credit monitoring and identity theft protection services. Ahead of the breach notice, state attorneys general encouraged consumers to take advantage of these free resources.”

From the ransomware front,

  • Cyberscoop reports,
    • “The ransomware group linked to a June cyberattack against auto industry software provider CDK Global received a payment of more than $25 million two days after the attack that hobbled software used by roughly 15,000 car dealerships in the U.S. became public, researchers told CyberScoop. 
    • “A cryptocurrency wallet likely controlled by BlackSuit — the ransomware group believed to be responsible for the attack — received approximately 387 bitcoins on June 21, worth roughly $25 million, researchers with blockchain intelligence firm TRM Labs told CyberScoop. 
    • “The evidence uncovered by TRM Labs is firmest evidence yet to indicate that CDK Global paid a ransom in order to resolve the attack on its systems, though TRM’s findings do not conclusively prove that the payment came from CDK.”
  • SC Media and Bleeping Computer discuss RansomHub attacks on the Florida Department of Health and the Rite Aid pharmacy chain.
  • Dark Reading reports,
    • “Akira ransomware actors are now capable of squirreling away data from victims in just over two hours, marking a significant shift in the average time it takes for a cybercriminal to move from initial access to information exfiltration.
    • “That’s the word from the BlackBerry Threat Research and Intelligence Team, which today released a breakdown of a June Akira ransomware attack on a Latin American airline. According to BlackBerry’s anatomy of the attack, the threat actor, using Secure Shell (SSH) protocol, gained initial access via an unpatched Veeam backup server, and immediately set about heisting information before deploying the Akira ransomware the next day.
    • “The likely culprit is Storm-1567 (aka Punk Spider and Gold Sahara), a prolific user of the Akira ransomware-as-a-service (RaaS) platform and the group that maintains the Akira leak site, according to the report. The gang is known for using double-extortion tactics and has attacked more than 250 organizations across numerous industry verticals globally since emerging from the shadows in March 2023. It mainly sets its sites on Windows systems, but has developed Linux/VMware ESXi variants as well, and has consistently shown a high level of technical prowess.”
  • The Register (UK) tells us,
    • “As ransomware crews increasingly shift beyond just encrypting victims’ files and demanding a payment to unlock them, instead swiping sensitive info straight away, some of the more mature crime organizations are developing custom malware for their data theft.
    • “In a report published on Wednesday by Cisco Talos, the threat intelligence unit reviewed the top 14 ransomware groups and analyzed their tactics, techniques and procedures (TTPs). Talos selected the 14 based on volume and impact of attacks and “atypical threat actor behavior,” using data from the criminals’ leak sites, internal tracking, and other open-source reporting.
    • “The 14, listed here by number of victims on their respective shaming sites, are the ones you’d likely expect: LockBit, ALPHV, Play, 8base, BlackBasta, BianLian, CLOP, Cactus, Medusa, Royal/Blacksuit, Rhysida, Hunters International, Akira, and Trigona. 
    • “Over the past year, we have witnessed major shifts in the ransomware space with the emergence of multiple new ransomware groups, each exhibiting unique goals, operational structures and victimology,” the report’s authors note.”

From the cybersecurity defenses front,

  • Cybersecurity Dive discusses “What does your CEO need to know about cybersecurity? CEOs don’t necessarily have to become experts in the technical aspects of cybersecurity to be prepared in case of an attack or — hopefully — stop one before it starts.”
  • Per a July 11, 2024, CISA press release,
    • “CISA released CISA Red Team’s Operations Against a Federal Civilian Executive Branch Organization Highlights the Necessity of Defense-in-Depth in coordination with the assessed organization. This Cybersecurity Advisory (CSA) details key findings and lessons learned from a 2023 assessment, along with the red team’s tactics, techniques, and procedures (TTPs) and associated network defense activity.
    • “The CSA also provides recommendations to assist executives, leaders, and network defenders in all organizations with refining their cybersecurity, detection, response, and hunt capabilities.
    • “CISA encourages all organizations review the advisory and apply the recommendations and mitigations within, including applying defense-in-depth principles, using robust network segmentation, and establishing baselines of network traffic, application execution, and account authentication.”

Friday Factoids

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

From Washington, DC,

  • Per a Congressional press release,
    • “U.S. Sen. Chuck Grassley (R-Iowa) today applauded the enactment of the bipartisan Maternal and Child Health Stillbirth Prevention Act, a bill [(H.R. 4581)] he championed alongside U.S. Rep. Ashley Hinson (R-Iowa) and U.S. Sens. Bill Cassidy (R-La.) and Jeff Merkley (D-Ore.). The law will help curb infant mortality by enabling evidence-based stillbirth efforts to qualify for federal funding.
    • “Stillbirth prevention researchers and advocates will now have more resources to advance their work. Especially given modern medical and technological capabilities, no family should have to endure the heartbreak of a stillbirth. Many thanks to everyone – Iowa organizations in particular – who’s had a hand in advancing our commonsense bill into law. Today’s win will have a domino effect for expectant families nationwide, for years to come,” Grassley said.  
    • “Today is a huge milestone in our fight to end stillbirth, the unexpected loss of a baby after more than 20 weeks of pregnancy. I am proud to have worked with so many incredible advocates, many of whom have endured the heartbreak of stillbirth, to bring this vital legislation across the finish line and expand federal resources for stillbirth prevention. I thank President Biden for signing this bipartisan legislation into law, and I will continue my work to improve maternal health care access for more healthy moms and healthy babies,” Hinson said. “
  • Fierce Pharma lets us know,
    • “Thursday, the Senate unanimously the bipartisan Affordable Prescriptions for Patients Act [(S. 150)], which looks to limit the number of patents drugmakers can assert in litigation on individual biological products. The bill aims to fight “patent thicketing,” a tactic the branded drug industry uses to delay or thwart competition.
    • “Patent thicketing occurs when drug companies stack secondary drug patents to create a complex web of intellectual property that’s hard for generic or biosimilars developers to navigate. AbbVie, for example, was able to keep its top-selling immunology drug Humira from U.S. competition for two decades by leveraging a web of 250 patents, patient access group Patients for Affordable Drugs Now (P4ADNow) said in a press release.
    • “This long-overdue legislation would promote competition and lower prices for patients without standing in the way of innovation, and I urge my colleagues in the House to pass it as soon as possible,” bill sponsor Sen. John Cornyn, R-Texas, said in a statement. 
    • “Reining in patent thickets would create $1.8 billion in taxpayer savings over the span of a decade, the Congressional Budget Office has forecast.”
  • AXIOS reports
    • “The Biden administration on Wednesday rolled out its latest election-year initiative on women’s health, proposing standards that would require the hospital industry to invest billions in maternity care improvements to remain in Medicare. * * *
    • “Hospitals would have to keep basic resuscitation equipment available in labor and delivery rooms, document maternal health training for staff and have written policies for transferring patients to other hospitals.
    • “All hospitals offering emergency services — even if they lack an obstetrics unit — would be required to have proper protocols and supplies for emergency deliveries and other needs.
    • “Hospitals not following these standards could eventually be booted from the Medicare and Medicaid programs.”
  • The American Hospital Association News adds,
    • “An infographic released by the University of Minnesota Rural Health Research Center highlights the decline of maternity care access in rural counties across the U.S. from 2010-2022, finding that nearly 59% of rural counties did not have any hospital-based obstetric services as of 2022.
    • “Researchers categorized rural counties based on population as micropolitan (having a town of 10,000-50,000 residents) and non-core (without a town of at least 10,000 residents). They found that micropolitan counties with hospital-based obstetric care declined from about 81% in 2010 to nearly 74% in 2022. Noncore counties declined from 34% in 2010 to nearly 26% in 2022.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Respiratory illness viruses as a whole remain at low levels, but many parts of the countries are experiencing consistent increases in COVID-19 activity, which has been trending upward from very low levels, the US Centers for Disease Control and Prevention (CDC) said today in its latest updates.
    • “Test positivity, emergency department (ED) visits, and hospitalizations—the main markers the CDC uses to gauge virus activity—are all rising, especially in both seniors and the western states. * * *
    • “The percentage of ED visits for COVID, considered an early indicator, rose 23.5% last week compared to the week before. Levels were higher in the West and the South than in the rest of the country.” * * *
    • “The dashboard at WastewaterSCAN a national wastewater monitoring system based at Stanford University in partnership with Emory University, shows SARS-CoV-2 detections at the high level, especially in the West, South, and East, with an upward trend over the past 21 days.
    • “In its latest variant update, posted on July 6, the CDC said the proportion of KP.3 detections continues to rise, up from 31.3% to 36.9% over the 2-week monitoring period. KP.3 is one of the JN.1 offshoots with mutations that allow it to better evade immunity from earlier infection or vaccination.” 
  • Per Fierce Pharma,
    • “Trials have already shown that Novo Nordisk’s semaglutide can cut the risk of cardiovascular events and kidney disease. Now a study from the University of Oxford indicates that the company’s semaglutide type 2 diabetes drug Ozempic can reduce the risk of dementia compared with another popular diabetes medicine.
    • “The research—which was designed to demonstrate if Ozempic could cause neurologic problems—showed instead that it produced a 48% decline in dementia when compared to Merck’s type 2 diabetes drug Januvia (sitagliptin).” * * *
    • “Prior studies have determined that diabetics have a greater risk of developing dementia. Those with type 2 diabetes are at an elevated risk for Alzheimer’s, according (PDF) to studies cited by the Alzheimer’s Association.” * * *
    • “Elsewhere, Lilly’s GLP-1/GIP therapy tirzepatide—which is the compound used to manufacture its type 2 diabetes drug Mounjaro and obesity treatment Zepbound—was recently shown to lower blood pressure. Researchers are still studying whether many of these benefits accrue from the treatment or from the weight loss they provide.”
  • The National Institutes of Health announced,
    • Using health data from almost 213,000 Americans who experienced reinfections, researchers have found that severe infections from the virus that causes COVID-19 tend to foreshadow similar severity of infection the next time a person contracts the disease. Additionally, scientists discovered that long COVID was more likely to occur after a first infection compared to a reinfection. The study, funded by the National Institutes of Health’s (NIH) Researching COVID to Enhance Recovery (RECOVER) Initiative, is published in Communications Medicine.
    • “About 27% of those with severe cases, defined as receiving hospital care for a coronavirus infection, also received hospital care for a reinfection. Adults with severe cases were more likely to have underlying health conditions and be ages 60 or older. In contrast, about 87% of those who had mild COVID cases that did not require hospital care the first time also had mild cases of reinfections.
    • “Reinfections were defined as having occurred at least two months after a first infection. They were found to occur most frequently when omicron variants were circulating in late 2021 and early 2022. Waning immunity and increased exposure to the coronavirus, including the highly-infectious variants, likely accounted for the uptick.
    • “Scientists also discovered that regardless of the variant, long COVID cases were more likely to occur after a first infection compared to a reinfection.”
  • The Wall Street Journal reports,
    • “Human lifespan has a limit and we might have reached it.
    • “S. Jay Olshansky, who studies the upper bounds of human longevity at the University of Illinois Chicago, believes people shouldn’t expect to live to 100. Most, he contends, will reach between 65-90.
    • “Biology is holding us back, Olshansky said. Human evolution favors growth and reproduction, not living to excessive ages. As people grow older, their cells and tissues accumulate damage. Breakdowns of one kind or another happen more frequently and get increasingly difficult to repair. Scientists believe there are likely many genes that affect lifespan. Aging is a complex process that isn’t well-understood.
    • “Olshansky knows his viewpoint isn’t popular. 
    • “The longevity business is booming. People are flocking to longevity meetings and taking compounds they hope will extend their lives. Investors are backing scientists researching techniques to reprogram cells to a younger state with the goal of restoring functions that diminish with age. Longevity influencers argue that if they can live long enough, scientific breakthroughs will keep them going indefinitely.” * * *
    • “Jan Vijg, chair of genetics at Albert Einstein College of Medicine in the Bronx, reached a similar conclusion from a different angle. He has studied the maximum verified age the oldest people died at in different countries. The maximum age at death increased gradually at least from the 1950s until the 1990s, when it appeared to plateau.
    • “He isn’t surprised that Jeanne Calment, a French woman who died in 1997 at 122, still holds the world record of the oldest verified age at death. There are now hundreds of millions more people who have reached old age under optimal conditions—benefiting from clean water, antibiotics, improved treatments for top killers such as heart disease and cancer, and healthier lifestyles. 
    • “If lifespan had no limit, some of those centenarians would have broken Calment’s record by now, he argued.” 
    • “It seems this is the end,” Vijg said.

From the U.S. healthcare business front,

  • Beckers Clinical Leadership identifies the 94 emergency departments across our country that the Emergency Nurses Association has recognized “for their commitment to quality, safety and a healthy work environment.”
  • Per Fierce Pharma,
    • “Even through an onslaught of biosimilar launches that began early last year, AbbVie’s big-selling Humira has been able to retain most of its lucrative market. Still, though, the drug’s star power is on the decline.
    • “Biosimilar manufacturer Samsung Bioeps has tracked the impact of Humira biosim launches in its latest market report, finding that Humira’s slice of the market has dropped to 82%.
    • “Sandoz’ Hyrimoz, under its Cordavis co-label, is responsible for “most biosimilar gains,” according to the report. Cordavis is CVS Health’s new biosimilar subsidiary, which launched with Hyrimoz as its first product.
    • “Back in April, CVS Caremark removed branded Humira from its national commercial formularies, causing Hyrimoz prescriptions to skyrocket, analysts at Evercore ISI noted at the time. Through April 25, Hyrimoz was responsible for 82% of Humira biosimilar prescriptions, IQVIA data revealed. The successful launch has so far pushed Sandoz to revenue gains of 6% during the first quarter.”
  • The Wall Street Journal arranged for a palliative medicine doctor to write an essay about dying at home. It’s worth a look.
    • Research suggests that 70% of Americans want to die at home. More seem to be doing so, at least partly owing to the Covid-19 pandemic. In a study of where people died in 32 countries between 2012 and 2021, published in Lancet’s eClinicalMedicine in January, the authors found a rise in home deaths in most countries, including the U.S., during the pandemic, which they largely interpreted as progress.
    • The truth is more complicated. Now, 10 years into my career as a palliative medicine physician, I know that there is much more to a “good” death than its location. Presuming a home death is a success obscures important questions about the process: Did this person die comfortably? Did their caregivers have the resources and guidance they needed? Was dying at home a choice or simply the only option?

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

From Washington, DC,

  • Govexec informs us,
    • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
    • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
  • and
    • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
    • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
    • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
  • The American Hospital Association News lets us know,
    • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
    • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
  • The AHA News adds,
    • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
  • and
    • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
    • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
    • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
  • and
    • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
    • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
    • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
  • NBC News informs us,
    • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
    • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
    • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
    • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
  • Neurology Advisor points out,
    • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
    • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
    • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
    • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
    • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
  • STAT News relates,
    • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
    • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
    • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
  • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
  • The National Institutes of Health announced,
    • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
    • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
    • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
  • Here is a link to the All of Us Program’s latest Medical Minutes.

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
    • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
    • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
  • BioPharma Dive reports,
    • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
    • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
    • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
  • Beckers Payer Issues adds,
    • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
    • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
    • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
  • STAT News informs us,
    • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
    • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”

Midweek update

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

From Washington, DC,

  • The American Hospital Association (“AHA”) News tells us,
    • “The House Appropriations Committee July 10 voted 31-25 to approve legislation that would provide $185.8 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2025, an 11% cut below the prior fiscal year. * * *
    • “The bill would also prohibit any funding from being used to implement or enforce the final rule issued by the Administration relating to minimum staffing levels for long-term care facilities.
    • “The full House may consider the bill in August.”
  • The AHA News also reports on several CMS/HHS rule makings that occurred today.
    • “The Centers for Medicare & Medicaid Services July 10 released its calendar year 2025 proposed rule for the physician fee schedule. The rule proposes to cut the conversion factor by 2.8%, to $32.36 in calendar year 2025, as compared to $33.29 in CY 2024. This reflects the expiration of the 2.93% statutory payment increase for CY 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a .05% budget-neutrality adjustment.” * * *
    • “CMS will accept comments on the proposed rule through Sept. 9.” 
      • Here is a link to the CMS fact sheet on the proposed rule plus a link to the CMS fact sheet on proposed rule’s shared savings program.
      • Per Fierce Healthcare,
        • “In statements quickly released after the proposed rule dropped, frustrated physician and industry groups contrasted the “dangerous” baseline reimbursement cut against financial pressures weighing on practices.”
    • “The Centers for Medicare & Medicaid Services July 10 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.6% in calendar year 2025 compared to 2024. This includes a proposed 3.0% market basket update, offset by a 0.4 percentage point cut for productivity.” * * *
    • “CMS will accept comments on the proposed rule through Sept. 9.” 
      • Here is a link to the CMS fact sheet on the proposed rule.
      • STAT News adds,
        • “The federal government will not modify regulations that dictate how hospitals publish their prices for consumers, ignoring pleas from patient advocates who have said hospitals still are not fully complying with the 3-year-old law.
        • “The Biden administration on Wednesday proposed an annual rule that sets payment rates for hospitals. This document is where the government has in the past rolled out changes to the so-called hospital price transparency rule, but the Biden administration did not address the issue in this edition.
      • Per Fierce Healthcare,
        • “In reaction statements, industry groups like the American Hospital Association (AHA) and hospital group purchasing organization Premier said that the “inadequate” pay update proposal and called for an upward adjustment in the final version of the rule.”
    • “The Department of Health and Human Services July 10 released a proposed rule designed to improve health information sharing and interoperability. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule includes two sets of certification criteria designed to enable health information technology for public health and payers to be certified under the Office of the National Coordinator for Health Information Technology’s Health IT Certification Program. The criteria would improve public health response, advance value-based care delivery and focus on standards-based application programming interfaces to improve end-to-end interoperability between health care providers and public health organizations or payers. 
    • The rule proposes a new set of certification criteria to support the technical requirements included in the Centers for Medicare & Medicaid Services’ Jan. 2024 Interoperability and Prior Authorization final rule to facilitate electronic prior authorization. The proposed rule also responds to patient, provider and other communities’ concerns about patient privacy and care access by expanding exceptions and clarifying the definitions of information blocking. HHS plans to publish the notice in the Federal Register with a 60-day comment period.
  • Following up on yesterday post about the FTC interim staff report on its PBM investigation, the Wall Street Journal reports,
    • “The Federal Trade Commission is preparing to sue the largest three pharmacy-benefit managers over their tactics for negotiating prices for drugs including insulin, after a two-year investigation into whether the companies steer patients away from less-expensive medicines. 
    • “The agency plans to file lawsuits taking aim at business practices related to rebates brokered with drug manufacturers, people familiar with the matter said. The FTC is also investigating the role that insulin manufacturers play in the negotiations, one of the people said.”
  • STAT News adds,
    • “The lawsuits are expected to focus on the controversial role of rebates, according to the source, who spoke on condition of anonymity. These are paid by drugmakers to PBMs to win favorable placement on formularies, which are the lists of medicines covered by health plans. In general, drugmakers argue they must raise prices to compensate for rebates, while PBMs maintain drug companies raise prices to boost profits.”
  • Bloomberg provides context to the situation by noting
    • “States and municipalities have also filed suits against both pharmacy benefit managers and drugmakers alleging that they drove up insulin costs for public-sector health plans. Many of those cases have been consolidated in a New Jersey federal court managing the litigation.”
  • Federal New Network digs into Fed Scope and discovers, among other things, that “Nearly half of all civilian feds are new hires since 2019. Agencies hired more than 1 million federal employees since October 2019, and it’s almost an even split between competitive and excepted service.”

From the public health and medical research front,

  • The New York Times reports,
    • “A 54-year-old New Jersey woman who was the second person to receive a kidney transplanted from a genetically modified pig, and who lived with the organ for 47 days, died on Sunday, surgeons at NYU Langone Health announced on Tuesday.
    • “The patient, Lisa Pisano, was critically ill, suffering from both kidney failure and heart failure. She received the pig kidney on April 12, just eight days after implantation of a mechanical heart pump.
    • “Surgeons were forced to remove the kidney on May 29 after it was damaged by inadequate blood flow related to the heart pump. After the explantation, Ms. Pisano resumed kidney dialysis but eventually was transitioned to hospice care.
    • “Ms. Pisano made medical history as the first person with a heart pump who is known to have also received an organ transplant. Patients with kidney failure are usually ineligible to receive a heart pump because of the high risk of dying.”
    • RIP, Ms. Pisano.
  • CNN tells us,
    • “An estimated 72 million women in the United States have skipped or delayed a recommended health screening, according to a new survey. This poll, conducted by Gallupfor medical technology company Hologic, found that 90% of women acknowledged the importance of regular health screenings — but more than 40% have skipped or delayed a test.
    • “Women have trouble prioritizing their own health, the survey found, with over 60% of women responding that it was hard to make their own health a priority. The numbers are particularly striking among younger women; 74% of women in Generation Z and 70% of millennials said it was hard to prioritize their health, compared with 52% of baby boomers and 39% of the Silent Generation.
    • The journalist also interviews CNN wellness expert Dr. Leana Wen about these findings.
  • Healio informs us,
    • “[R]esearchers utilized National Violent Death Reporting System (NVDRS) data to assess the number, circumstances and characteristics of violence-related deaths in 2021.
    • “Overall, there were 68,866 fatal incidents involving 70,688 deaths that occurred in 48 states and Washington, D.C. Among the deaths:
      • 58.2% were suicides;
      • 31.5% were homicides;
      • 8.2% were deaths of undetermined intent that could have been due to violence;
      • 1.3% were deaths due to “legal intervention,” like law enforcement using deadly force in the line of duty; and
      • less than 1% were unintentional firearm deaths.
    • “Nguyen and colleagues also found that 59.2% of deaths involved firearms.
    • “Among suicide victims, when the circumstances were known (84.4%), the suicide was often preceded by mental health conditions, as 49% of victims were currently diagnosed with a mental health problem and 29.2% experienced a depressed mood at the time of death.” * * *
    • “Violence is preventable and reducing deaths in communities is possible with evidence-based approaches,” the researchers wrote.
    • “They added that such interventions can include “social-emotional learning programs, enhanced parenting skills and family relationships, treatment for persons at risk for suicide, and treatment to prevent reattempts.”
  • and
    • “Patients with chronic kidney disease or transplant should have ongoing access to telehealth to help manage care, according to results of a qualitative meta-analysis. 
    • “One group in need of telemedicine services is chronic kidney disease (CKD) and transplant patients,” Christopher D. Manko, BS, of the Geisinger Commonwealth School of Medicine in Scranton, Pennsylvania, wrote with colleagues. They added, “[P]atients need frequent appointments to manage all related conditions. Similarly, transplant patients need close monitoring of the grafted organ and immunosuppressant therapy.” But Manko and colleagues noted that “prior systematic reviews focused on telehealth and eHealth interventions in dialysis patients have shown conflicting results with potential benefits [and] more adequately powered prospective studies are needed.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Fourth time’s the charm? Sanford Health is hoping so.
    • “Less than a year after scrapping its proposed merger with a Minnesota health system— its third failed deal since 2019 — South Dakota’s Sanford is attempting a new, multibillion-dollar mashup. The $7 billion, 45-hospital system plans to absorb Marshfield Clinic Health System, a $3 billion system of 11 hospitals across Wisconsin and northern Michigan.
    • “The proposed deal would make Sanford Marshfield’s parent company, creating a 56-hospital system with Sanford’s name, CEO, and headquarters in Sioux Falls, S.D. The combined system would have about 56,000 employees, 4,300 doctors and advanced practice providers, two health plans with more than 425,000 members, specialty pharmacies, and research institutions. The systems said they plan to close the deal by the end of the year.
    • “Sanford CEO Bill Gassen told STAT in an interview that Sanford and Marshfield are a good fit not only from a regulatory perspective — they have no overlapping coverage areas — but more importantly, from a cultural one. He said both nonprofit systems strive to deliver world-class care in rural areas. They both want strong physician leaders. They both have big health plans. They both do research and train doctors.”
  • Bloomberg relates,
    • “Purdue Pharma LP secured a two-month window to negotiate a new pact with members of the Sackler family as the OyxContin maker and its owners brace for a potential wave of civil opioid lawsuits after the US Supreme Court scuttled an earlier $6 billion settlement.
    • “Judge Sean Lane said during a Tuesday court hearing in New York that he’d extend for 60 days an injunction that, for years, has paused opioid litigation against the billionaire family while Purdue, government authorities and victims lawyers attempted to effectuate the earlier settlement.
    • “Advisers who negotiated the earlier deal will attempt to cut a new agreement during the two-month window that complies with the Supreme Court’s ruling. Such a settlement, if successful, would likely compensate victims and provide billions of dollars to fund programs to combat the nation’s opioid addiction crisis.” 
  • Healthcare Dive lets us know,
  • and
    • offers more insights into the 2024 Medicare Advantage star rating changes that CMS made recently in response to court decision.
  • The New York Times points out that “In Constant Battle With Insurers, Doctors Reach for a Cudgel: A.I. As health plans increasingly rely on technology to deny treatment, physicians are fighting back with chatbots that synthesize research and make the case.”
  • ICD-10 Monitor asks us whether we are ready for the new ICD-10 diagnosis codes that take effect October 1, 2024.
  • Drug Channel peers into its crystal ball to project prescription drug spending in 2032.

Tuesday Tidbits

David Ermer–AHRQ, Congress, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the Federal Trade Commission released an interim staff report on its ongoing investigation of prescription benefit managers. The report was favorably received by Senators Wyden and Grassley. Healthcare Dive summarizes the report here.
  • The FEHBlog recalls when around 2009 the State of New York went after UnitedHealthcare for offering a for profit service that provided usual, reasonable and customary rates for out-of-network providers. In a legal settlement, UnitedHealthcare transferred the service to a new not-for-profit company called Fair Health. Meanwhile most health plans had switched to the Medicare Part RBRVS pricing as base for its UCR reimbursements. Nevertheless, Fair Health is still around.
  • Today, the American Hospital Association News tells us,
    • “An op-ed published July 9 in Modern Healthcare written by AHA President and CEO Rick Pollack and Catholic Health Association President and CEO Sr. Mary Haddad discusses why nonprofit hospitals need positive margins. The commentary piece seeks to add important context and education to the conversation around nonprofit hospitals’ community benefit, tax-exempt status and other issues, arguing that positive margins are necessary to maintain basic services and advance care for all patients and communities 24/7. “Barely making ends meet or operating at a financial loss should never be the goal or an acceptable status quo for any nonprofit healthcare organization,” Pollack and Haddad write. “It’s not just bad economics; it also impedes institutions’ ability to deliver services and improve health outcomes.”
  • If the regulators are considering taking a page out of the Fair Health playbook, consider this finding from a USC-Brookings report issued last September:
    • “Pre-tax operating margins for the three largest PBMs averaged a bit more than 4% of their revenues in 2022. Since PBMs’ revenues encompass both the administrative fees charged to PBMs and payers’ net payments for claims, this implies that even completely eliminating PBMs’ margins [a no-no] would only modestly reduce payers’ drug-related costs. Achieving larger reductions would require reducing the revenue captured by pharmacies or, particularly, manufacturers. Ultimately, the amount of revenue that manufacturers capture depends principally on the extent of intellectual property protections related to drugs and whether and how the prices that drug manufacturers receive are regulated.”
  • The healthcare industry is complex, to say the least, and there are no simple answers.

From the public health and medical research front,

  • “Did you know that the U.S. Preventive Services Task Force (Task Force) has a free app called Prevention TaskForce? This app can help healthcare professionals identify which screenings, counseling interventions, and preventive medications are right for their patients. It includes all current Task Force recommendations and can be searched by specific patient characteristics, such as age, sex/gender, and selected behavioral risk factors. Download the app, on mobile or desktop, to find the preventive services that can help keep your patients healthy.”
    • “For more information and to download the app, click here.”
  • STAT News reports,
    • “In a long-awaited study, patients in Australia will soon receive an IV infusion designed to transform their own immune cells into swarms of cancer-fighting drones.
    • “The trial, announced on Tuesday by Interius Biotherapeutics, will be the first to test what’s known technically as in vivo CAR-T therapy. Researchers have long hoped the approach could provide a potentially cheaper, safer, and more scalable version of the cell therapies that are curative for some blood cancer patients but remain out of reach for many. 
    • “Interius received regulatory clearance on June 28 and will dose up to 30 patients, beginning in the fall. It beat out several competitors, including one with over $1 billion in funding, to the first-in-human trial.  
    • “There are absolutely people alive out there today that would not have been without the CAR technology,” said Dora Mitchell, Interius’ senior vice president for operations. But the therapy is still only delivered in some places in the U.S. and Europe and almost nowhere else. “The vision that catalyzed the formation of Interius was: can we bring this to the masses?”
  • Healio informs us,
    • “There is insignificant evidence to support recommendations that children with autism will benefit from intensive interventions, according to the results of a meta-analysis published in JAMA Pediatrics.
    • “One of the study’s authors told Healio that in reviewing standard intervention recommendations for autism in children, she found that one recommended that children receive at least 20 hours or up to 40 hours of intensive intervention per week.
    • “This recommendation originated initially from a quasi-experimental study conducted in the ’80s that, although remarkable for the time, was flawed,” Micheal P. Sandbank, PhD, director of The Brain and Language Lab at the University of Texas at Austin, told Healio. “There have been additional studies since then, but most were quasi-experimental and compared intensive intervention with different uncontrolled supports, failing to isolate the effect of intensity specifically from the effect of providing a systematic and comprehensive intervention approach.”
  • The Washington Post explains what to know about six popular home tests for urinary tract infections, menopause, allergies, colon cancer, A1c blood sugar and thyroid conditions.

From the U.S. healthcare business front,

  • Beckers Hospital CFO report informs us,
    • “Average hospital margins year to date remained steadfast in May at 3.8%, according to Kaufman Hall’s “National Hospital Flash Report,” released July 9.
    • “Hospital financial performance remained relatively unchanged during the month of May, and the rate of change slowed for margins and other key performance indicators, which reflects stabilization,” wrote Erik Swanson, senior vice president at Kaufman Hall.
    • “The stabilization is a positive sign for hospitals after ending the year with average margins at 1.9%. The average hospital margin shot up in January to 4.6% and then decreased slightly in February and March.
    • “From April to May, the monthly average operating margin index dipped from 4.2% to 3.7%. Operating margins increased 23% year to date over the same period last year.”
  • BioPharma Dive reports,
    • “Pfizer’s top scientist Mikael Dolsten is stepping down after leading the drugmaker’s research and development for the past 15 years, a period that includes Pfizer’s remarkable success developing a COVID-19 vaccine but ends with the company at a crossroads.
    • “On Tuesday, Pfizer said it has begun searching for a successor to Dolsten, who in 2010 became chief scientific officer as well as R&D head. The process is expected to last “probably through early next year,” Pfizer said.
    • “Dolsten will help with the search and continue to serve in his current position until a successor is in place and “any necessary transition is complete,” according to Pfizer.”

Monday Roundup

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call lets us know,
    • “Senate Appropriations Committee leaders have agreed to add $34.5 billion in emergency spending to their fiscal 2025 bills on top of levels agreed to in last year’s debt limit negotiations, sources familiar with the talks said Monday. 
    • “Under the pact between Senate Appropriations Chair Patty Murray, D-Wash., and ranking member Susan Collins, R-Maine, defense accounts would receive an extra $21 billion in emergency spending while nondefense programs would get $13.5 billion.” 
  • Taking a gander at reginfo.gov led the FEHBlog to discover that on July 1, the final version of the simply infeasible federal mental health parity rule changes was submitted to OIRA for its review.
  • In yesterday’s post, the FEHBlog called attention to the new CMS GUIDE program. The post noted that program details would be released in early July. What do you know? Those details were posted today. The American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services July 8 announced over 400 participants in a new model focused on improving dementia care. The Guiding an Improved Dementia Experience (GUIDE) Model began July 1 and seeks to reduce strain on unpaid caregivers as well as offer care coordination and management, caregiver education and support, and respite services. CMS will also test an alternative payment for participants delivering key support services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. People with dementia and their caregivers will have access to a care navigator to help them access services and support, including clinical services and non-clinical services such as meals and transportation through community-based organizations.”
  • The HHS Inspector General posted an impact brief on Medicare Advantage program fraud involving its risk adjustment program. The Wall Street Journal published an article the same type of fraud today.
  • STAT News informs us,
    • “The Biden administration has appealed a decision in which a federal court jury last year sided with Gilead Sciences over the rights to a pair of groundbreaking HIV pills — and at least $1 billion in royalties may be at stake.
    • “At issue is a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The U.S. Centers for Disease Control, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company refused to reach a licensing agreement despite several attempts to strike a deal.” * * *
    • “U.S. District Court Judge Maryellen Noreika narrowed the Gilead victory last March when she set aside the jury finding that CDC patents were not infringed. So the appeal filed by the U.S. Department of Justice — on behalf of HHS — refers to the only portion of the jury finding that remains, which is that the patents were invalid.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.” * * *
    • “Specifically, the revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain kinds of internet-based communications (“tailored responsive communications”) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, a company might choose to use this type of communication when a celebrity, healthcare provider or influencer, not acting on behalf of the company, posts false, inaccurate and/or misleading representations of fact about the company’s approved/cleared medical product on social media. Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored responsive communication, along with some considerations relevant to the current digital information environment.”
  • Govexec tells us,
    • “The Office of Personnel Management lost a small modicum of ground in its fight to reduce the backlog of pending retirement claims from federal employees as the agency’s backlog of cases inched back over 15,000.
    • “In June, OPM received 6,919 new retirement requests from departing federal workers, a slight increase over the 6,751 claims it received the previous month. But the agency’s pace in processing those claims fell precipitously, completing only 5,614 claims last month compared to the 8,793 it processed in May.
    • “That deficit led to OPM’s overall backlog of pending claims to climb from 14,035—an eight-year low—in May to 15,340 at the end of June. Consequently, the monthly average processing time for a retirement application ticked up four days, from 60 in May to 64 last month, though measured since the beginning of fiscal 2024, the average processing time has remained static at 61 days for four months running.”
  • The U.S. Preventive Services Task Force is celebrating its 40th anniversary. The FEHBlog is reminded that the FEHB Act will be 65 years old on September 28, 2024.

From the public health and medical research front,

  • The New York Times reports,
    • “The process for diagnosing a child with autism heavily relies on a parent’s description of their child’s behavior and a professional’s observations. It leaves plenty of room for human error.
    • “Parents’ concerns may skew how they answer questionnaires. Providers may hold biases, leading them to underdiagnose certain groups. Children may show widely varying symptoms, depending on factors like culture and gender.
    • “A study published Monday in Nature Microbiology bolsters a growing body of research that suggests an unlikely path to more objective autism diagnoses: the gut microbiome.
    • “After analyzing more than 1,600 stool samples from children ages 1 to 13, researchers found several distinct biological “markers” in the samples of autistic children. Unique traces of gut bacteria, fungi, viruses and more could one day be the basis of a diagnostic tool, said Qi Su, a researcher at the Chinese University of Hong Kong and a lead author of the study.”
  • The American Medical Association tells us what doctors wish their patient knew about heat stroke.
  • The Wall Street Journal discusses the right and wrong ways for people to snack.
    • “America is a nation of snackers. A lot of us are doing it wrong. 
    • “Noshing outside of traditional mealtimes isn’t inherently bad. A snack can stave off hunger, boost energy, provide important nutrients and keep us from overeating later. But snacking can also lead us to eat extra calories and overdo it on sodium, added sugars and saturated fats, which can raise our risk of heart disease and obesity. 
    • “How to snack better? Reach for food combinations that keep you fuller longer: Pair carbs like apple slices with protein and fats, like peanut butter. Or try yogurt with berries. Then plan your snack times, and watch out for the minefield that is evening snacking.”
  • The Washington Post and Consumer Reports offer information about “an aggressive tick species spreading across the U.S. Lone star ticks don’t spread Lyme disease, but they can transmit other serious diseases and are linked to a mysterious meat allergy. And the threat is growing.”
    • “Lone star ticks have long been firmly established in the Southeastern United States. In recent decades, however, their numbers have been increasing in Midwestern and Northeastern states. Between 2017 and 2021, according to CDC data, nearly half of reported ehrlichiosis cases were in five states: Arkansas, Missouri, New York, North Carolina and Tennessee.”
  • The CDC has posted FAQs on infertility. “This page has definitions and frequently asked questions related to infertility. It has important information about infertility, including common misconceptions, risk factors, and treatment options.”
  • Beckers Hospital Review points out,
    • “GLP-1 drugs such as Ozempic and Wegovy may lower the risk of developing certain obesity-related cancers, according to a new study from researchers at Case Western Reserve University in Cleveland. 
    • “Researchers found people with type 2 diabetes who were being treated with the medications were significantly less likely to develop 10 of 13 obesity-associated cancers than those taking insulin, according to the findings published July 5 in JAMA Network Open. The retrospective study is based on an analysis of the medical records of over 1.6 million type 2 diabetes patients from 2005 to 2018.
    • “The risk was reduced by more than half for gallbladder cancer, meningioma, pancreatic cancer and hepatocellular carcinoma. Esophageal, colorectal, endometrial, ovarian, multiple myeloma and kidney were among the other cancers for which there was a significant risk reduction. The study did not find a difference in cancer risk reduction among those treated with GLP-1s compared with those taking metformin, an older diabetes drug. 
    • “In an interview with Bloomberg, Arif Kamal, MD, chief patient officer at the American Cancer Society and who was not involved in the research, called the new evidence on GLP-1s “compelling.”
  • Per Fierce Pharma,
    • “In examining the electronic records of more than 18,000 overweight or obese adults in the United States, health data analytics company Truveta found that Lilly’s tirzepatide helped patients lose more weight than Novo’s semaglutide, with the effects growing over time.
    • “Results of the study, which looked at data from May of 2022 and September of 2023, were published Monday in the JAMA Internal Medicine monthly review.
    • “”After use of tirzepatide for three months, patients lost an average of 5.9% of their body weight compared to 3.6% for semaglutide. Over a year’s time, those on tirzepatide lost an average of 15.3% of their body weight compared to 8.3% for semaglutide users.
    • Additionally, tirzepatide patients were much more likely to lose 15% of their body weight than those using semaglutide. While 42% of those on tirzepatide reached the benchmark after one year of treatment, only 18% of those on semaglutide could say the same. 
    • “Lilly’s tirzepatide is the active ingredient found in its diabetes product Mounjaro and its obesity treatment Zepbound, while Novo’s semaglutide is the compound used to make its diabetes blockbuster Ozempic and its obesity follow-on Wegovy.
    • “Importantly, the Truveta study looked at the drugs that are approved for diabetes. The authors noted that “future studies are needed to compare versions labeled for weight loss.”
  • Per an NIH press release,
    • “A series of experiments with highly pathogenic H5N1 avian influenza (HPAI H5N1) viruses circulating in infected U.S. dairy cattle found that viruses derived from lactating dairy cattle induced severe disease in mice and ferrets when administered via intranasal inoculation. The virus from the H5N1-infected cows bound to both avian (bird) and human-type cellular receptors, but, importantly, did not transmit efficiently among ferrets exposed via respiratory droplets. The findings, published in Nature, suggest that bovine (cow) HPAI H5N1 viruses may differ from previous HPAI H5N1 viruses and that these viruses may possess features that could facilitate infection and transmission among mammals. However, they currently do not appear capable of efficient respiratory transmission between animals or people.”
  • MedPage Today lets us know,
    • “Extended-release 7-day injectable buprenorphine was safe and tolerable for most patients who had minimal-to-mild opioid withdrawal, a nonrandomized trial found.
    • “Among 100 adult patients with minimal-to-mild opioid withdrawal scores who were given a 24-mg dose of extended-release buprenorphine, only 10 people (10%, 95% CI 4.9%-17.6%) saw a 5-point or greater jump in withdrawal symptoms within 4 hours of injection, reported Gail D’Onofrio, MD, of the Yale School of Medicine in New Haven, CT, and colleagues.” * * *
    • “The study examined whether patients with untreated opioid use disorder (OUD) and minimal-to-mild withdrawal could tolerate a 7-day dose of buprenorphine. Patients with OUD typically aren’t treated with medication until they are in significant withdrawal, due to fear of precipitated withdrawal. For that reason, “[n]o one has ever even attempted to give buprenorphine in that [0 to 7] range,” D’Onofrio said.” * * *
    • “[This is a real game-changer for emergency physicians and clinicians, even in the clinic, who would be able to induce people on buprenorphine much earlier than they previously could have,” D’Onofrio said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY has agreed to buy biopharmaceutical company Morphic Holding MORF for $3.2 billion in a deal that bolsters the drugmaker’s immunology pipeline.
    • “Eli Lilly on Monday said it would pay $57 a share for Morphic, a 79% premium to Friday’s closing price of $31.84 for the Waltham, Mass., company.
    • “Morphic is developing therapies for the treatment of serious chronic diseases, with a lead program targeting the inflammatory bowel diseases ulcerative colitis and Crohn’s disease.
    • “Eli Lilly late last year won U.S. Food and Drug Administration approval of its Omvoh treatment for moderately to severely active ulcerative colitis in adults.
    • “Indianapolis-based Eli Lilly said it expects to complete the acquisition, which isn’t subject to any financing conditions, in the third quarter.”
  • Modern Healthcare relates,
    • “More than half of people surveyed would feel just as safe getting hospital-level care at home as they would in a facility, according to the University of Southern California’s Schaeffer Center for Health Policy and Economics.
    • “Healthcare systems across the country are placing big bets on hospital-at-home programs, pushing access to more rural communities and lobbying state Medicaid programs to reimburse for the service. A Centers for Medicare and Medicaid Services waiver reimbursing for acute care at home expires at the end of this year, but bipartisan members of Congress are backing legislation that would provide Medicare reimbursement for another five years. More than 330 hospitals across 37 states offer hospital-level care at-home programs through the CMS Acute Hospital Care at Home waiver.” * * *
    • “The survey did not require participants to have prior experience with hospital-level care at home or knowledge of the service. It did provide participants with a brief explanation of how hospital-at-home programs operate.”
  • Per Fierce Healthcare,
    • “A recent proposal to report prior authorization to insurance plans through CPT codes was withdrawn at the eleventh hour when its physician advocate made an unexpected discovery: For certain codes and in very narrow circumstances, the prior auth requirements were already in place.
    • “Alex Shteynshlyuger, M.D., director of urology with New York Urology Specialists, had previously brought forward a time-based proposal that would ensure physicians are compensated for time spent on prior auth claims. He believed the changes would also reduce the number of claim requirements imposed by plans and limit the amount of appeals and could lead to better patient outcomes.
    • “Following the proposal, however, the American Medical Association (AMA) informed Shteynshlyuger that prior authorization is already explicitly mentioned in official procedure descriptions for half a dozen CPT codes. This required Shteynshlyuger to withdraw the proposal so he could revise and resubmit at a later date.
    • “Each CPT code includes a short description detailing the type of visit or examination. Longer descriptions—where the prior auth mentions were contained—are also stored in databases that can be purchased, but those are rarely encountered.
    • “As a matter of fact, I’ve never seen the long description in my lifetime,” said Shteynshlyuger.”
  • and
    • “Nearly 5 million fewer people delayed care from 2019 to 2022, a study from the Urban Institute with funding from the Robert Wood Johnson Foundation revealed.
    • “The study shows 4.75 million non-elderly Americans skipped necessary medical care, dropping from 12.1% to 9.7% in 2022.
    • “For families below 138% of the federal poverty line, there was a 27% reduction in cost barriers. A 19% reduction was evident for families between 138% and 249% of the federal poverty line.
    • “Researchers say these outcomes are a direct result of the Medicaid continuous coverage requirements and enhanced tax credits.
    • “Our findings show significant improvements in health insurance coverage and healthcare access under federal and state policy changes enacted during the public health emergency,” said Michael Karpman, principal research associate at the Urban Institute, in a statement. “The continued unwinding of the Medicaid continuous coverage requirement and the potential expiration of enhanced Marketplace subsidies after 2025 could make these gains in coverage and access difficult to sustain.”

Weekend Update

David Ermer–Congress, COVID-19, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC

  • NPR Shots lets us know,
    • “Medicare, the federal government’s health insurance program for people 65 and over, is launching an eight-year pilot project this summer with a groundbreaking plan. * * *
    • “Medicare’s pilot, called Guiding an Improved Dementia Experience – or GUIDE – is modeled on a handful of promising, smaller programs linked to academic institutions, including UCLA, UC-San Francisco, and Emory and Indiana universities.
    • “In Medicare’s version, each family will get a care coordinator — a sort of coach trained in dementia care, who knows the patient and the caregiver and can offer guidance and troubleshoot problems before they escalate. The coach or other member of the care team will be on call, 24/7. They will also help coordinate doctors’ visits and identify some adult day care or in-home care for the patient for up to a few hours a week, to lighten the caregiver’s load. * * *
    • “Medicare has yet to reveal exactly which health systems will be included in its pilot project, or how many families will be eligible; the agency promises more details in early July. In the meantime, Medicare has spelled out some eligibility criteria for patients:
      • “The patient must have a dementia diagnosis.”
      • “They must have traditional Medicare insurance — that’s only about half of people over 65. Seniors on a Medicare Advantage plan aren’t eligible.
      • “The patient must be living in their own home, in a family member’s home, or in an assisted care facility — but not in a nursing home. 
  • HR Dive offers updates on the status of three pending federal court lawsuits challenging the Fair Labor Standards Act changes that took effect last Monday.

From the public health and medical research front

  • The FEHBlog ran across this WasteWaterSCAN website which provides wastewater reporting on eleven infectious diseases including Covid.
    • We monitor infectious diseases through municipal wastewater systems to inform public health responses at a local, regional, and national level. Our goal is to show that a national wastewater monitoring system is a valuable part of our public health infrastructure, can inform public health responses, and will help us prepare for future pandemics.
    • WastewaterSCAN is based at Stanford University, in partnership with Emory University, and funded through philanthropy. We are committed to transparency, scientific rigor, and open science. We make our methods public and publish our research in scholarly journals to subject them to peer review.
  • Fortune Well points out that “July has the highest number of drowning deaths. Here’s how to keep kids safe around water.”
  • The New York Times discusses brain donation for medical research. The article focuses on an 82-year-old woman whose father recently passed away at age 110.
    • “[As] he was nearing death, enrolled in home hospice care, “In the middle of the night, I thought, ‘Dad’s brain is so great,’” said Ms. Hansen, 82, a retired librarian in Seattle. “I went online and looked up ‘brain donation.’”
    • “Her search led to a National Institutes of Health web page explaining that its NeuroBioBank, established in 2013, collected post-mortem human brain tissue to advance neurological research.
    • “Through the site, Ms. Hansen contacted the nonprofit Brain Donor Project. It promotes and simplifies donations through a network of university brain banks, which distribute preserved tissue to research teams.
    • “Tish Hevel, the founder of the project, responded quickly, putting Ms. Hansen and her brother in touch with the brain bank at the University of California, Los Angeles. Brain donors may have neurological and other diseases, or they may possess healthy brains, like Mr. Markoff’s.
    • “We’re going to learn so much from him,” Ms. Hevel said. “What is it about these super-agers that allows them to function at such a high level for so long?”
  • Medscape notes,
    • “Lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, has shown 100% efficacy in preventing HIV in women at a high risk for infection, according to an interim analysis of the phase 3 PURPOSE 1 trial.
    • “The results were so promising that the independent data monitoring committee recommended that Gilead Sciences stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
    • “The results were both unexpected and exciting. “I’ve been in the HIV field for a really long time, and there’s no other phase 3 PrEP trial that found zero infections,” said Moupali Das, MD, PhD, executive director of clinical development at Gilead Sciences, Foster City, California.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cano Health has emerged from bankruptcy as a private company, months after the primary care chain said it would restructure and delist from the New York Stock Exchange. 
    • “The company said Friday it converted more than $1 billion of funded debt into common stock and warrants as part of bankruptcy proceedings. The chain’s existing investors also committed to provide more than $200 million to support Cano’s business plan going forward. 
    • “Cano will take a “disciplined and strategic approach” to growth over the next few years, focusing on improving services at their 80 clinics in Florida, CEO Mark Kent said in a statement. The company had 172 medical centers at the end of 2022, according to a securities filing.”