Midweek Update

COVID-19

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Federal agencies have not implemented roughly half of the 428 recommendations that the Government Accountability Office has made to improve preparedness following the COVID-19 pandemic, which has killed 1.2 million Americans. 
    • “In a report published on Aug. 1, the watchdog reviewed its oversight work concerning COVID-19 and the approximately $4.65 trillion Congress provided in response. GAO found that agencies haven’t addressed 220 of its recommendations. 
    • “Reflecting on federal agencies’ emergency response actions and our recommendations can reveal lessons from the COVID-19 pandemic for federal agencies. These lessons can help federal agencies identify actions that successfully facilitated the implementation of the federal response and should be incorporated into future emergency response plans. Other lessons can help federal agencies identify weaknesses in their response to the pandemic and identify areas for improvement,” GAO investigators wrote.”
  • Per an HHS press release,
    • “Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded nearly $9 million to 18 HRSA-funded health centers to improve access to life-saving cancer screenings in underserved communities. Health centers will partner directly with National Cancer Institute-Designated Cancer Centers to expedite patient access to cancer care and treatment. These awards advance the Biden Cancer Moonshot mission to prevent 4 million cancer deaths by 2047 and end cancer as we know it. This effort builds on work supported by the 21st Century Cures Act to expand use of proven cancer prevention and early detection strategies to reduce cancer risk in all populations.”
  • Federal News Network tells us about OPM telework guidance issued today.
    • “In the federal government’s case, remote work is distinct from telework. Federal employees with remote work agreements perform their job duties at a location away from their normal work site without the expectation of regularly returning to that site. In contrast, federal employees with telework agreements, by OPM’s definition, can perform their work away from the office — but are still expected to come to the worksite “on a regular and recurring basis.”
    • “OPM’s new guidance doesn’t change the definitions for federal remote work or telework, which are set in law, but rather provides additional clarifying guidance on how agencies should approach their workplace arrangements moving forward. In the document, OPM details what factors agencies should consider as they hammer out their remote work posture — both as it currently exists, as well as what it will look like in the future.
    • “The guidance builds on the Office of Management and Budget’s April 2023 memo that called on agencies to strike a balance between in-person work and telework, as well as 2021 OPM guidance that told agencies to weave telework and remote work into their workforce culture. Following those documents, OPM said human capital leaders and other senior executives asked for additional guidance on how to ensure agencies are relatively consistent as they consider changes to their remote work arrangements.
    • “OPM said it’s still up to each agency to determine the right balance for workplace flexibilities, such as remote work, for their employees. Agencies can decide if they want to offer remote work in the first place. They also have the authority to determine how they’d like to use the flexibility, and what positions are potentially good candidates for the alternative workplace arrangements.”

From the public health and medical research front,

  • American Hospital Association lets us know,
    • “The Centers for Disease Control and Prevention has updated respiratory syncytial virus vaccination recommendations for adults 60 and older. Adults aged 60-74 at increased risk for RSV and all aged 75 and older are recommended a single dose of the GSK, Pfizer or Moderna vaccine. Individuals who previously received a dosage should not seek another.” 
  • The New York Times reports,
    • “When exposed to a virus, the human body marshals the immune system to fend off the intruder. Sometimes, the defense goes awry, and the body mistakenly turns against itself instead of the attacker.
    • “This sort of friendly fire drives multi-inflammatory syndrome in children, or MIS-C, a mysterious condition that in rare cases strikes children who have had a severe bout of Covid-19, according to a new study.
    • “In a subset of children with the syndrome, immune cells become confused by the similarity between a protein carried by the coronavirus, and one found throughout the human body, said Joseph DeRisi, an infectious disease expert and the president of the Chan Zuckerberg Biohub in San Francisco, who led the study. This phenomenon is called molecular mimicry, Dr. DeRisi said.
    • The study was published on Wednesday in the journal Nature. The results offer the first direct proof that Covid-19 sets off an autoimmune reaction that leads to MIS-C.”
  • The Wall Street Journal alerts us,
    • “Antidepressants are one of several classes of medications that can make people more vulnerable to heat by tampering with the body’s internal thermostat or interfering with its cooling strategies. Others include antipsychotics, diuretics, stimulants and heart medications such as beta blockers and ACE inhibitors. 
    • “The risk is growing during longer, more frequent heat waves: Last summer was the hottest on record, and this one is setting records, too. The rate of emergency-room visits for heat-related illnesses was higher last summer than in the previous five.” * * *
    • “Many of these drugs are associated with an increased risk of heat-related hospitalizations, a study published in 2020 in the journal PLOS One found. But the extent to which these drugs pose risks isn’t well studied, said Dr. Soko Setoguchi, an epidemiologist at Rutgers University who co-wrote the study. Setoguchi said people should avoid heat, not their medication.”
  • Beckers Hospital Review informs us,
    • “Neuralink, a company co-founded by Elon Musk, has successfully implanted a second brain-computer interface device into a human subject, Nature reported Aug. 6.
    • “During a podcast released Aug. 2, Mr. Musk said the new implant is functioning well, with around 400 of its 1,042 electrodes actively transmitting signals from the person’s brain.
    • “Although details regarding the recipient or the specifics of the surgery were not disclosed, Mr. Musk said the individual, similar to the first recipient, suffers from a spinal cord injury. 
    • “The procedure comes after Neuralink’s first patient had a number of threads on the implant retracted from his brain shortly after the surgery.”
  • and
    • “New York City-based Hospital for Special Surgery has the lowest hospital wide readmission rate, according to CMS’s Unplanned Hospital Visits database.
    • “The data, released July 31, is based on provider data for hospital return days, including unplanned readmission measures in 2022.”
    • The article lists “the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.”
  • STAT News notes,
    • “Novo Nordisk is pulling its regulatory submissions to expand the use of its obesity drug Wegovy for a common type of heart failure, saying that waiting for more data on cardiovascular outcomes could bolster its case.
    • “Trials of Wegovy in the condition, heart failure with preserved ejection fraction (or HFpEF), have primarily looked at the drug’s effects on symptoms and physical function. The company plans to reapply to expand Wegovy’s label early next year when it has more data on complications such as hospitalizations and cardiovascular-related deaths, Martin Lange, Novo’s head of development, said Wednesday on an earnings call.” 
  • Per a National Institutes of Health press release,
    • “A National Institutes of Health (NIH)- supported study has found race- and sex-based differences in the increased chances of survival from people who received bystander cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. Average survival benefits for cardiac arrest, when the heart suddenly stops beating, could be three times as high for white adults compared to Black adults and twice as high for men compared to women. The findings published in Circulation.
    • “CPR saves lives — that, we know,” said Paula Einhorn, M.D., a program officer at NIH’s National, Heart, Lung, and Blood Institute (NHLBI). “Yet the disparities revealed in this research show we need to do more to understand how to ensure equitable outcomes for all patients needing CPR. We’re hoping new insights will lead to better survival * * *.” * * *
    • “Prior research already found inequities in the frequency with which bystander CPR was being performed in Black and Hispanic individuals compared to white individuals, and with women compared to men in public places. In response, CPR training awareness and programs have expanded nationally, as have online courses. Mannequins resembling a woman’s body have also been designed.
    • “Evaluating access to and the effectiveness of different types of CPR trainings could be one way to identify differences in survival outcomes and inform solutions, according to researchers. For example, future studies could inquire about whether a bystander received online or in-person training; if they practiced on women mannequins or models with black or brown skin; if multiple bystanders were around, which may indicate a person had additional support; and what kind of support from emergency dispatchers they had — and for how long — which may reveal whether a person was receiving CPR instructions for the first time. Since the arrival times of emergency medical responders were fairly similar among groups, the researchers don’t believe this factored into outcomes observed in the study. Future studies could also explore the role that underlying health conditions may have in the survival outcomes of those who needed CPR.”

From the U.S. healthcare business front,

  • MedCity News reports,
    • “Hospital finances seem to be stabilizing overall — but a closer look shows that there is a widening gap between the highest- and lowest-performing organizations, according to a report released by Kaufman Hall this week.
    • “For the report, Kaufman Hall examined data from more than 1,300 hospitals. It showed that hospitals’ year-to-date operating margin index held steady at 4.1% in June for the second month in a row.” * * *
    • “Kaufman Hall also released another report on healthcare finances this week, with this one showing that rising labor costs are here to stay.: * * *
    • “This aligns with recent research from Strata Decision Technology, which showed that healthcare providers’ labor expenses grew by 5.2% while their non-labor costs rose by 3.3% from June 2023 to June 2024. This resulted in a 4.8% increase in overall expenses during the 12-month period, according to the report.” 
  • Healthcare Dive adds
    • “Tenet Healthcare will sell its majority ownership in Birmingham, Alabama-based Brookwood Baptist Health for about $910 million to Orlando Health, the health system said Monday.
    • “The sale, which is expected to close in the fall of this year, includes 70% of Tenet’s interest in the five-hospital system, as well as affiliated physician practices and other related operations. 
    • “The deal continues Tenet’s streak of divestitures as it looks to deleverage its portfolio. This year, the system has sold nine hospitals to Novant Health, UCI Health and Adventist Health for a combined after-tax profit of $3 billion.”
  • Beckers Payer Issues discusses payer efforts to defend affiliated prescription benefit managers.
  • The Wall Street Journal reports
    • “CVS Health’s Medicare business continued to struggle in the second quarter, fueling yet another cut to its full-year earnings outlook, a new $2 billion cost-cutting plan and the departure of a top executive. 
    • “CVS bet big on attracting seniors to its Aetna Medicare Advantage health plans last year, adding one million new people to its insurance rolls in 2024. But the gamble began backfiring in the first quarter of the year as seniors used more healthcare services than in the past and the government has become stingier in how much it pays private insurers. 
    • “On Wednesday, CVS said the pressures continued into the second quarter. The company reported total revenue of $91.2 billion in the quarter, up 2.6% from a year ago, and driven in large part by growth in its Medicare and commercial insurance businesses. 
    • But much of the sales increase was eaten up by higher medical costs, and adjusted earnings per share of $1.83 in the quarter were down 17.2% from last year. 
  • Beckers Payer Issues adds,
    • “Medicare Advantage costs could rise in the second half of 2024, CVS Health CEO Tom Cowhey told investors. 
    • “On an Aug. 7 call, Mr. Cowhey said costs in inpatient care, dental and pharmacy all rose toward the end of the second quarter. The company’s guidance for the rest of the year reflects that costs in the second half of the year could be higher than the first, the CFO said.” * * *
    • “Revenues in the company’s health benefits segment are down 40% year over year. The company ousted Aetna President Brian Kane over the financial results. Ms. Lynch and Mr. Cowhey will oversee Aetna’s day-to-day operations until a successor is named.” 
  • Per BioPharma Dive,
    • “Novo Nordisk shares tumbled 7% in early trading Wednesday after the company reported lower-than-expected revenue from its blockbuster obesity franchise.
    • “Even as revenue from Wegovy and Ozempic continued to soar, the second-quarter numbers failed to reach the high expectations set by Wall Street, analysts said. Sales of the so-called GLP-1 obesity drugs were about 9% below consensus estimates, according to analysts with the investment bank Jefferies.
    • “Overall revenue for the second quarter was “borderline in line with expectations,” Stifel analyst Eric Le Berrigaud wrote in a note to clients. But the fact that older products in Novo Nordisk’s portfolio helped offset the disappointing results for obesity drugs “is not so reassuring in the long term,” he wrote. The company’s “sales composition is not good.”
  • and
    • “The first medicine approved for a liver disease known as MASH is off to a faster launch than Wall Street analysts expected, according to quarterly results disclosed Wednesday by developer Madrigal Pharmaceuticals.
    • “Madrigal said its drug Rezdiffra, which was approved by the Food and Drug Administration in March and became available the following month, generated $14.6 million in U.S. sales in the second quarter. As of June 30, more than 2,000 patients were on treatment and coverage policies were in place for more than 50% of people with commercial health insurance, the company said.
    • “While only an early snapshot, the results surpassed consensus analysts estimates of about $4 million and have encouraged Madrigal to commercialize Rezdiffra in Europe on its own. An approval decision there is expected next year. “We’re still in the early stages, but we are confident that we’re building the foundation needed to create a blockbuster medicine,” CEO Bill Sibold told analysts.”

Monday Roundup

David Ermer–CMS, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) released new data showing over 31 million total patients served at HRSA-funded health centers in 2023—an increase of 2.7 million since 2020.
    • “Community health centers play a pivotal, and growing, role in America’s health care system. They are especially important in our effort to reduce health care disparities in underserved communities,” said HHS Secretary Xavier Becerra. “More than 31 million people across the country – in every U.S. state, territory, and the District of Columbia – depend on health centers, making them a vital resource. The Biden-Harris Administration wants all Americans to have access to high-quality primary health care services, regardless of a patient’s ability to pay, and community health centers help make that possible.”
  • Beckers Hospital Review delves into the final Medicare acute inpatient prospective payment rule for fiscal year 2025 which was publicized last week.
  • The Wall Street Journal reports,
    • “Studies being used to decide whether the U.S. should authorize an ecstasy-based drug for traumatized patients missed serious side effects and were marked by bias.
    • “The Food and Drug Administration is expected within days to decide whether to approve the drug, known as MDMA, for treatment of post-traumatic stress disorder. Approval would be a milestone in decades of efforts to decriminalize the use of psychedelics. 
    • “Three people who were subjects in the studies told The Wall Street Journal that their thoughts of suicide worsened during or after testing, but their downward slides weren’t captured in trial data and therefore not reflected in the final results.” * * *
    • “FDA staffers have questioned the quality of the study results. Experts advising the agency recommended against approval, saying more safety and effectiveness evidence was needed. The Institute for Clinical and Economic Review, a nonprofit that reviews drugs and their prices, said the evidence was incomplete.
    • “The FDA told its advisers that it is looking into allegations of study misconduct and missing side effects. It told the Journal that it can’t comment on investigations until they are final, but its findings will be incorporated into its decision on the Lykos treatment.
    • “Problems with the trials mean the FDA might not be able to assess whether the treatment is safe and effective for everyone, or just some people, said experts advising the agency and bioethicists who spoke to the Journal about its findings.”

From the public health and medical research front,

  • USA Today lets us know,
    • “The KP.3.1.1 COVID-19 variant is the dominant strain of the virus, the latest projections from the Centers for Disease Control and Prevention (CDC) show.
    • “The agency’s Nowcast data tracker, which displays COVID-19 estimates and projections for two-week periods, projects the KP.3.1.1 variant accounting for 27.8% of positive infections, followed by KP.3 at 20.1% in the two-week stretch starting July 21 and ending Aug. 3.
    • “The KP.3.1.1 variant is very similar to other circulating variants in the United States. All current lineages are descendants of JN.1, which emerged in late 2023,” Rosa Norman, a spokesperson at the CDC, previously told USA TODAY.
    • “At this time, we anticipate that COVID-19 treatments and vaccines will continue to work against all circulating variants. CDC will continue to monitor the severity of variants and will monitor vaccine effectiveness.”
  • Bloomberg reports,
    • “Some CVS Health Corp. pharmacies are selling out of at-home Covid tests as a summer surge in infections drives up demand.
    • “As of Friday afternoon [August 2], CVS’s website showed that all brands of tests were out of stock at many locations in cities including Houston, Austin and Reno, Nevada. 
    • “The company said that 91% of its stores have at least one brand of test in stock. While the company “has seen an uptick in purchases” of the tests, it’s “quickly sending product to impacted stores,” a spokesperson said in an email.”
  • Per MedPage Today,
    • “Intermittent calorie restriction improved executive function and memory measures in cognitively intact older adults, an exploratory pilot study suggested.
    • “The 8-week randomized clinical trial of 40 overweight, cognitively normal older adults with insulin resistance examined the effect of two interventions — a 5:2 intermittent fasting plan versus a “healthy living” diet based on portion control and calorie reduction guidelines from the U.S. Department of Agriculture — on brain health. The 5:2 intermittent fasting group had 2 days of food intake of 480 calories/day (two meal replacement shakes), and 5 days of a healthy living diet.
    • “Both interventions improved executive function and memory, with intermittent fasting showing better results on certain cognitive measures, said Dimitrios Kapogiannis, MD, of the National Institute on Aging (NIA) and the Johns Hopkins University School of Medicine in Baltimore, in a poster presented at the Alzheimer’s Association International Conference.” * * *
    • “Many people think that eating a healthy diet or following an intermittent fasting regimen are good ways to stave off cognitive decline during aging, but our study actually provided supporting evidence,” Kapogiannis told MedPage Today.
    • “Our study lays the groundwork for larger clinical trials that will examine a variety of dietary interventions that will help people have good brain health and live healthier, longer lives,” he said.”
  • Beckers Clinical Leadership informs us,
    • “More than half of patients hospitalized and treated for pneumonia receive differing diagnoses during their stays, according to a study published in Annals of Internal Medicine. 
    • “Researchers from the University of Utah Health and the nearby VA Healthcare System, both based in Salt Lake City, measured the rates of concordance and discordance in pneumonia diagnoses. They followed three states: initial diagnosis in the emergency department, initial chest image reports and discharge diagnosis. 
    • “Among more than 2 million admissions at VA hospitals across the U.S., 36% of patients were admitted with a pneumonia diagnosis but not a corresponding discharge diagnosis. Another 33% had a discharge diagnosis of pneumonia but not an admission diagnosis. The study focused on admissions between 2015 and 2022.” * * *
    • “In conclusion, the authors of the latest study said physicians and patients should be aware of this high level of uncertainty about pneumonia diagnoses.

From the U.S. healthcare business front,

  • The Peterson/KFF Health System Tracker considers what drives health spending in the U.S. compared to other countries.
    • “The United States spends significantly more on healthcare than comparable countries do, and yet has worse health outcomes. Much of the national conversation has focused on spending on retail prescription drugs and insurer profits and administrative costs as key drivers of health spending in the United States. The Inflation Reduction Act, signed into law by President Biden in 2022, includes several provisions aimed at lowering the cost of these prescription drugs. While it is true that many brand-name retail prescription drugs are priced higher in the U.S. than in peer countries, health spending data indicates that other spending categories – particularly hospital and physician payments – are primary drivers of the U.S.’s higher health spending.” 
  • Risk and Insurance points out,
    • “Only about half of U.S. employers effectively manage health care costs, with nearly all organizations experiencing health plan premium increases, according to Gallagher’s 2024 U.S. Physical & Emotional Wellbeing Report.
    • “The report, which surveyed 3,552 organizations, found that employers ranked the high costs of medical services (68%) and specialty drugs (44%) as their top health care cost management challenges.” * * *
    • “Access the report on Gallagher’s website.”
  • Per BioPharma Dive,
    • “All doses of tirzepatide, the drug Eli Lilly sells as Zepbound for obesity and Mounjaro for diabetes, are now available in the U.S. after months of shortages made the in-demand medicine hard to obtain.
    • “Two dose strengths of Zepbound and another two of Mounjaro had been listed in short supply on a database maintained by the Food and Drug Administration as recently as early last week, before the agency updated the drug’s status to available on Friday.
    • “Lilly reports second quarter earnings on Thursday, when sales and supply of tirzepatide are likely to be the main focus of analyst questions. The company in April raised its financial forecasts for the year by $2 billion due to revenue growth for Zepbound and Mounjaro, which together brought in $2.3 billion between January and March.”
  • Per Healthcare Dive,
    • “Walgreens has once again cut its stake in drug distributor Cencora as the struggling pharmacy chain looks to boost funding.
    • “The Illinois-based retailer announced last week it was selling more shares in Cencora for roughly $1.1 billion in proceeds. The sales lower Walgreens’ stake in Cencora to approximately 10% from 12%.
    • “Walgreens said it will use the money to pay down debt and to fund its operations as it continues to pivot to a health services strategy.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Friday [August 2] it launched Velys Spine, a surgical robot and standalone navigation platform. 
    • “The 510(k)-cleared system, which J&J developed with eCential Robotics, is designed to provide guidance on the placement of screws in freehand and robotic-assisted spine surgeries. 
    • “J&J’s Depuy Synthes plans to make the system available commercially in the first half of 2025. The system will join other Velys offerings J&J has cited as a growth driver in its hip and knee businesses.”
  • Per Fierce Healthcare,
    • “Steward Health Care will lay off about 1,200 workers in Massachusetts by the end of the month as it moves to close two hospitals in the state.
    • “The health system will let go 753 employees at its Carney Hospital and 490 workers at its Nashoba Valley Medical Center, according to a Worker Adjustment and Retraining Notification (WARN) report filed with state regulators on July 29.
    • “On Thursday, a federal judge cleared the way for embattled Steward Health Care to close Carney Hospital and Nashoba Valley Medical Center by the end of August. Those are two of the eight hospitals that the health system operates in the Bay State.”
  • and
    • “For the first time as a public company, Clover Health is announcing its first quarterly net profit, the company said ahead of its second quarter earnings call.
    • “Clover declared a net income of $7.2 million and an adjusted EBITDA of $36.2 million, both figures a substantial improvement year-over-year.
    • “I am delighted that our performance continues to validate Clover’s differentiated, technology-centric approach to healthcare, driven by our insurance offering and its ability to generate meaningful returns while leading with physician-choice for our members,” said Clover Health CEO Andrew Toy in a statement. “Through our Clover Assistant technology and integrated care management platform, we aim to empower physicians to improve clinical outcomes and lower the total cost of care for people with chronic diseases. This allows us to partner with a much wider range of physicians than other plans.”
    • “Insurance revenue also soared 11% higher year-over-year to $349.9 million due to member retention and growth, whereas the company’s medical cost ratio (MCR) improved to 71.3%, down from 77.9% the quarter before.”
  • and
    • “Cigna unveiled the first round of grant winners in a program announced earlier this year that seeks to address the rising tide of mental health needs among youth.
    • “The funding will be distributed to 22 awardees, Cigna said on Monday. For close to half of the recipients, it’s the first time they’re securing funding from Cigna or its philanthropic arm, the Cigna Group Foundation, according to an announcement.
    • “Cigna said it will distribute $9 million as part of the program. The organizations will focus on tackling post-pandemic stress and distress among kids aged five to 18, according to the release. There will be a particular emphasis on outreach in schools or related settings, Cigna said.”

Friday Factoids

David Ermer–CDC, Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “Lawmakers on the Senate Appropriations Committee unveiled and unanimously advanced spending legislation Thursday effectively endorsing President Biden’s planned 2% average pay increase for federal workers in January, to the chagrin of federal employee groups and advocates.
    • “The committee moved four of the 12 fiscal 2025 appropriations bills Thursday, including the Energy and Water Development; Defense; Labor, Health and Human Services; and Financial Services and General Government Appropriations acts. That last bill is traditionally the avenue by which lawmakers seek to override a president’s alternative pay plan, and the committee’s draft is silent on most federal workers’ compensation rates, effectively endorsing the White House’s plan.” * * *
    • “With the GOP-controlled House Appropriations Committee’s version of the Financial Services and General Government spending package, advanced by the panel last month on a party-line vote, similarly endorsing the White House proposal, it is unlikely federal employees will see a raise larger than 2% next year.”
  • Bloomberg Law lets us know,
    • “The Biden administration failed to persuade the Fifth Circuit to reinstate rules making median network rates a primary consideration in deciding payment disputes under a law meant to prevent “surprise” medical bills. 
    • “In a Friday ruling, the appeals court upheld a lower court decision in favor of health-care providers that had vacated the regulations implementing the No Surprises Act from the Departments of Health and Human Services, Labor, Treasury, and Office of Personnel Management.
    • “Judge Jeremy Kernodle of the US District Court for the Eastern District of Texas had ruled in 2022 that the agencies didn’t abide by the text of the health-care benefits statute in issuing requirements that arbitrators must follow in payment dispute cases between medical providers and health insurers.
    • “The US Court of Appeals for the Fifth Circuit panel’s decision agreeing that the regulations violate the Administrative Procedure Act creates another significant setback for the government in its attempt to defend the rules governing the arbitration system from a spate of litigation.” * * *
    • “The DOL, HHS, and Treasury Departments did not immediately respond to requests for comment on the decision Friday.”
  • The National Committee for Quality Assurance has released information on its measurement year 2025 HEDIS measures.
    • “For Measurement Year 2025, NCQA added three HEDIS measures, retired four measures and made smaller changes across multiple measures. We also continue the transition to Electronic Clinical Data Systems (ECDS) reporting.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Thursday approved a new type of cellular medicine, clearing a therapy developed by the biotechnology company Adaptimmune for a rare soft tissue cancer called synovial sarcoma.
    • “The agency granted Adaptimmune’s therapy, formerly known as afami-cel and to be sold as Tecelra, an accelerated approval for use in some people with metastatic synovial sarcoma who previously received chemotherapy. Those people must have certain immune signatures and tumors expressing a protein, MAGE-A4, that Tecelra is designed to target.
    • “The FDA based its decision on Tecelra’s ability to spur tumor responses in about 43% of people who received it in a clinical trial, with responses lasting a median of about 6 months, according to the therapy’s new labeling. Adaptimmune has to confirm those benefits in an ongoing study to maintain the approval. The company expects to submit those results next year, executives said on a Friday conference call with analysts.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • Summary
      • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity has increased in most areas.
    • COVID-19
      • Most areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
    • RSV
      • Nationally, RSV activity remains low.
    • Vaccination
  • Calculated Risk adds, “COVID in wastewater is increasing – especially in the West and South.” 
  • STAT News tells us,
    • “Untreated vision loss and high LDL cholesterol have been added as two new potentially modifiable risk factors for dementia in a report released Wednesday by the Lancet Commission.
    • “These new additions join 12 other risk factors outlined by the commission, affiliated with University College London, in previous reports on dementia prevention, intervention, and care in 2017 and 2020. The other risk factors are lack of education, hypertension, physical inactivity, diabetes, social isolation, excessive alcohol consumption, air pollution, smoking, obesity, traumatic brain injury, and depression.
    • “The commission’s latest findings suggest more ways of preventing dementia than previously known, according to Gill Livingston, a professor of psychiatry at University College London and co-author on the report.
    • “A lot of surveys have asked people of 50 and above what illnesses they most are concerned about, and dementia tends to come up as the highest one,” Livingston said. “And yet there’s really quite a lot that we can do to change the scales and make it less likely.”
  • Per Fierce Healthcare,
    • “CVS Health has launched an environmental health impact program to help vulnerable Americans during extreme weather events.
    • “The program, already live for a few weeks, initially focuses on extreme heat. Using advanced environmental data analytics and patients’ medical and pharmacy data, CVS Health offers timely excessive heat alerts and outreach to at-risk patients up to a week before the event. The initiative will expand to encompass air quality events this fall. It is initially available to members of Aetna with the goal of expanding to pharmacies and MinuteClinics.” * * *
    • “Heat waves and our changing environment is just such a pressing public health threat. I don’t think it’s appreciated nearly as much as it should be,” Dan Knecht, M.D., chief clinical innovation officer for CVS Caremark, told Fierce Healthcare.” * * *
    • “Consulting with experts in climate change and public health, CVS Health determined a wet bulb temperature threshold in the mid-80s Fahrenheit. Ingesting third-party weather data, it determines regions that surpass the limit and uses its own algorithm to stratify Aetna members by their vulnerability to extreme heat. Care managers who are registered nurses then reach out by phone, using an evidence-based framework for navigating the conversations. They provide information on the symptoms of heat stroke, how to minimize heat exhaustion and local resources such as cooling centers. Many Oak Street Health centers, now owned by CVS Health, can be used as a safe space to gather during extreme temperatures, Knecht said.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Contract disputes between hospitals and health plans have become routine, but they tend to be local, affecting a handful of hospitals and the people in the surrounding communities.
    • “This latest one is different. It involves the country’s biggest private health insurer, UnitedHealthcare, and its biggest hospital chain, HCA Healthcare. If they can’t strike a deal on prices by Sept. 1, 38 hospitals and their affiliated physician groups and surgery centers across four states — Texas, Colorado, South Carolina, and New Hampshire — would become out-of-network for UnitedHealthcare members. * * *
    • “UnitedHealthcare spokesperson Cole Manbeck said in a statement that HCA issued notices to end its contracts in four markets and demanded “significant price hikes that are not affordable or sustainable.” Manbeck said UnitedHealthcare shares the goal of reaching an agreement that ensures continued access to providers. He added that the parties could reach an agreement in one market and not another. “It’s not all or nothing,” he said.”
  • Per Healthcare Dive,
    • “Private equity firms TowerBrook Capital Partners and Clayton, Dubilier and Rice entered into a definitive agreement to acquire R1 RCM for about $8.9 billion and take the company private, the revenue cycle management firm said Thursday. 
    • “TowerBrook currently controls around 36% of the company’s shares, according to a press release. Under the deal, which will take R1 private, TowerBrook and CD&R will buy the rest of the company’s outstanding stock for $14.30 per share.
    • “The acquisition comes months after another private equity firm, New Mountain Capital, offered to buy out other investors for $13.75 a share— a price some analysts thought undervalued R1.” 
  • and
    • “Amwell boosted its adjusted earnings outlook for 2024 as the telehealth vendor works to cut costs and rein in expenses.
    • “The company now expects adjusted earnings before interest, taxes, depreciation and amortization to be a loss between $150 million and $145 million. It previously estimated adjusted EBITDA losses between $160 million and $155 million.
    • “Amwell also narrowed its net loss in the second quarter. The virtual care vendor reported a loss of $49.9 million, compared with $92.5 million during the same period last year.”




Friday Factoids

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

From Washington, DC,

  • Medical Economics alerts us,
    • “The hot seat in Washington, D.C., could get hotter for pharmacy benefit managers (PBMs) when the Federal Trade Commission (FTC) meets next week to discuss its recent report on the drug price middlemen.
    • “Meanwhile, a consortium of pharmacy groups is demanding federal lawmakers pass reforms they say are needed to regain control of the pharmaceutical market. A PBM trade group countered that legislators need a balanced and accurate discussion, not just repetition of claims of Big Pharma, which stands to benefit if PBMs lose their price bargaining power.
    • “As public discourse about PBMs at times rises to a clamor, the FTC announced its Aug. 1 open meeting will include a presentation on the Commission’s Interim Report on Pharmacy Benefit Managers (PBMs).”
  • FEHBlog note — PBMs do a more than negotiate prices with drug manufacturers and wholesalers. For example, PBMs also seamlessly process drug claims for consumers.  
  • Beckers Hospital CFO Report tells us,
    • “The U.S. economy saw a 2.8% increase in gross domestic product in the second quarter of 2024, reflecting a spike in consumer spending, nonresidential fixed investment and private inventory investment. 
    • “The first quarter saw GDP grow only 1.4%, according to the Bureau of Economic Analysis.
    • “Consumer spending also increased in goods and services. Healthcare, utilities, recreation services, and housing led service contributors. Motor vehicles and parts, furnishing and durable household equipment, gasoline and recreational goods led goods contributors.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity has increased in most areas.
    • “COVID-19
      • “Most areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • The University of Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 have been at the high level over the past few weeks, with the highest levels in Western states over the summer months. However, the CDC’s latest data show though detections in the West are still the highest in the nation, the level declined in the most recent reporting week.
    • “Wastewater detections are still rising steadily in the South. In the Midwest and Northeast, detections are still increasing, but at a slower pace.”
  • STAT News points out,
    • “The number of confirmed human infections with the bird flu virus associated with the ongoing outbreak in dairy cattle has risen to 13, the Centers for Disease Control and Prevention announced Thursday, as it confirmed three additional cases in Colorado. They are currently designated simply as H5 and not H5N1 because CDC labs are still working on typing the neuraminidase, the N number in the virus’ name, STAT’s Helen Branswell reports.
    • “The cases — one of which Colorado had previously announced as a “presumptive positive” — are in people who were culling infected poultry on a farm in the state. Genetic analysis of the virus in that poultry outbreak shows that it is similar to the virus circulating in cows; it’s believed this is one of several instances where H5N1 in cow herds has spilled over into nearby poultry operations. Of the 13 human cases, 10 have been detected in Colorado, which also has the highest number of reported infected dairy herds — 51, according to the state’s Department of Agriculture. Michigan and Texas have reported two and one human case, respectively.”
  • The Detroit Free Press reports,
    • “Liverwurst and several other deli meat products produced by Boar’s Head Provisions Co., Inc., based in Jarratt, Virginia, are being recalled because they may be contaminated with the Listeria monocytogenes bacteria, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) on Friday announced.
    • “Additional deli meat products produced on the same line and same day as the liverwurst are also being recalled because of potential listeria contamination.
    • “In total, more than 207,000 pounds of products are being recalled.
    • “The FSIS is concerned because some products may be in consumers’ refrigerators and in retail deli cases.”
  • MedPage Today discusses issues with the CDC’s bird flu virus vaccine.
  • Mercer Consulting explains why GLP-1 drug dislocation calls for a holistic approach to weight-loss.
  • U.S. News and World Report informs us,
    • “Cancer growth can be fueled by flecks of ancient viral DNA lodged into the genetics of modern humans, a new study says.
    • “Overall, about 8% of the human genome is made of bits of DNA left behind by viruses that infected our primate ancestors, researchers say.
    • “Called “endogenous retroviruses,” these DNA fragments have long been considered harmless junk littering the modern human genetic profile, researchers said.
    • “But new research shows that when reawakened, these ancient viral strands can help cancer survive and thrive, researchers reported July 17 in the journal Science Advances.
    • “What’s more, shutting up these viral voices from the past can make cancer treatments more effective, researchers found.
    • “Our study shows that diseases today can be significantly influenced by these ancient viral infections that until recently very few researchers were paying attention to,” said senior researcher Edward Chuong. He’s an assistant professor of molecular, cellular and developmental biology at the University of Colorado, Boulder’s BioFrontiers Institute.”

From the U.S. healthcare business front,

  • The Wall Street Journal looks at the drug shortage problem from the perspective of a courageous American who invested in a failing Amoxicillin plant located in Bristol, TN.
    • “A cavernous factory in northeastern Tennessee, by the Virginia border, is one of the last in the country that makes a vitally important medicine.
    • “Each day the USAntibiotics plant churns out a million doses of the crucial antibiotic amoxicillin that promise to cure Americans of everything from earaches to pneumonia—and ease a pressing shortage for children.
    • “But the plant’s prospects are dim. It can’t charge enough to cover overhead, because competitors sell their wares at bargain prices. USAntibiotics isn’t close to breaking even.
    • “It’s not for lack of trying,” said Rick Jackson, a health-staffing businessman who rescued the factory from near bankruptcy two years ago and has poured more than $38 million into purchasing and refurbishing it.
    • “The generic drug business has become a hostile environment for American companies. Prices for the often-critical medicines have dropped so low that it has become difficult for U.S. manufacturers to compete with companies overseas.”  * * *
    • “Jackson is holding out hope the federal government will help the plant. But if it doesn’t in the next year and a half, he said would shut the factory down.
    • “It’s not a failure yet,” Jackson said. “If there is a way to do it, we’ll figure it out.”
    • FEHBlog note – Hopefully the front-page WSJ article will help generate outside investment.
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Friday raised its forecast for revenue and profit per share this year after a second quarter in which sales of its older products and new drugs surpassed analyst expectations.
    • “The “beat and raise” followed similarly strong earnings reports this week from AstraZeneca, Roche, Sanofi and AbbVie, all of which upped either their revenue or profit estimates for 2024. Shares in Bristol Myers rose by nearly 9% in Friday morning trading on the news.
    • “Between April and June, Bristol Myers reported earning $12.2 billion in sales, 6% higher than Wall Street consensus forecasts. Second quarter earnings per share were $2.07 on an adjusted basis, 27% higher than estimated, according to Leerink Partners analysts.”Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies.[1] The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.
  • Cardiovascular Business reports,
    • “Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies. The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • “A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • “If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.”
    • FEHBlog note: Bravo.

Friday Factoids

David Ermer–CDC, COVID-19, Cybersecurity, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “The Office of Personnel Management on Thursday encouraged federal agencies to conduct their own analyses to correct potential pay disparities within their workforces.
    • “In 2021, President Biden signed a sweeping executive order aimed at improving diversity, equity, inclusion and accessibility at federal agencies, including provisions requiring the creation of a governmentwide strategic plan on the issue and that the OPM director consider banning the use of past salary history to set pay during the hiring process. OPM followed through on that edict earlier this year.
    • “In a memo to agency heads Tuesday, acting OPM Director Ron Shriver highlighted OPM’s governmentwide study of pay gaps in the federal workforce, which found that in 2022, the gender pay gap was 5.6%, meaning women on average earned about 94 cents for every dollar male federal workers earned. The figure marks a slight improvement over the 2021 gender pay gap of 5.9% and is significantly better than the nationwide gender pay disparity of 16%.
    • “Shriver directed that federal agencies that operate their own pay systems governing at least 100 employees must now conduct the same review of pay policies that OPM did for the General Schedule, Federal Wage System and Senior Executive Service workforces. And he encouraged all agencies to conduct their own gap analyses to search for pay disparities along gender or racial and ethnic lines affecting their own workforces, regardless of pay system.”
  • HHS’s Administration for Strategic Preparedness and Response announced,
    • “awards totaling $18.5 million to two U.S. companies to expand the nation’s manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines. The awards are the first through ASPR’s BioMaP-Consortium, a public-private partnership established in January 2024.
    • “ASPR is committed to expanding our nation’s domestic manufacturing infrastructure,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “Today’s announcement advances our efforts to build resilient U.S.-based supply chains for pharmaceutical ingredients and mitigate risk and reliance on foreign supplies. Having this capability in the U.S. is critical for our emergency preparedness.”
    • “California-based Antheia will receive approximately $11 million to support U.S.-based production of pharmaceutical ingredients, and Virginia-based Capra Biosciences will receive approximately $7.5 million to leverage its bioreactor platform to manufacture three active pharmaceutical ingredients.” 
  • Mercer Consulting projects that for 2025 the health flexible spending account contribution limit will increase by $100 from $3200 to $3300 and the carryover limit will increase from $640 to $660.”

From the public health and medical research front,

  • The CDC tells us today
    • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in many areas.
    • COVID-19
      • Many areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. CDC will continue to closely monitor trends in COVID-19 activity.
    • Influenza
    • RSV
      • Nationally, RSV activity remains low.
    • Vaccination
  • The University of Minnesota’s CIDRAP notes,
    • Along with the CDC’s report of high wastewater levels of SARS-CoV-2, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, notes that detections are in the high category, with no significant trend up or downward over the past 3 weeks. It said all regions of the country are in the high category, except for the Midwest, which is at the medium level.
  • STAT News adds,
    • “STAT spoke with experts in infectious disease, virology, and public health to find out what people need to know about this summer’s Covid surge.
    • “One key message: Despite the increase in cases, the protection people have built up thanks to rounds of vaccination and prior infections is still sparing the vast majority of people from severe illness.”
    • “Once you really get a decent immunity, you may get the virus again, but you’re probably not going to get very sick from it,” said Aaron Glatt, chair and professor of medicine at Mount Sinai South Nassau.”

From the U.S. healthcare business front,

  • The American Hospital Association News lets us know,
    • “A non-malicious global technology outage that began in the early morning of July 19 is continuing to affect many industries and is having varying effects on hospitals and health systems across the country. The outage was caused by a faulty software update issued by the cybersecurity firm CrowdStrike, which is widely used by businesses and government agencies that run on Microsoft computers. 
    • “CrowdStrike is actively working with customers impacted by a defect found in a single content update for Windows hosts,” the organization posted on its website early today. “Mac and Linux hosts are not impacted. This is not a security incident or cyberattack. The issue has been identified, isolated and a fix has been deployed. We refer customers to the support portal for the latest updates and will continue to provide complete and continuous updates on our website. We further recommend organizations ensure they’re communicating with CrowdStrike representatives through official channels.
    • “CrowdStrike’s webpage includes more information about the issue and workaround steps organizations can take. The Cybersecurity and Infrastructure Security Agency also posted an alert on the incident.” 
  • The Hill reports,
    • “After peaking during the COVID-19 pandemic, physician burnout has dipped under 50 percent for the first time in four years, but doctors say working conditions in the medical field remain far from ideal. 
    • “A survey published by the American Medical Association (AMA) this month found that 48.2 percent of physicians in 2023 experienced at least one symptom of burnout, down nearly 15 percent from when this metric peaked in 2021. 
    • “Reported job satisfaction rose from 68 percent to 72.1 percent between 2022 and 2023, while job stress dropped in the same time frame, going from 55.6 percent to 50.7 percent. 
    • “It’s good news and it’s bad news,” Steven Furr, president of the American Academy of Family Physicians, told The Hill. “It’s good news that the numbers have gone down but still they’re higher than what we’d like them to be.” 
    • “The AMA has tracked physician burnout rates since 2011 along with the Mayo Clinic and Stanford Medicine. Prior to the pandemic, burnout rates ranged from 43.9 percent in 2017 to 54.4 percent in 2014.” 
  • mHealth Intelligence points out,
    • “Telehealth visits at United States hospitals skyrocketed during the COVID-19 pandemic, rising 75 percent between 2017 and 2021; however, adoption was uneven, with hospitals citing challenges to electronic health information exchange, according to a new study.
    • “Published in the Journal of General Internal Medicine, the study examined US hospitals’ adoption of telehealth before and during the pandemic, aiming to provide targeted policy implications.” * * *
    • “The researchers found that telehealth encounters increased from 111.4 million in 2020 to 194.4 million in 2021, a 75 percent jump. Additionally, hospitals offering at least one form of telehealth increased from 46 percent in 2017 to 72 percent in 2021.
    • “However, the adoption was not uniform across hospitals. Larger, nonprofit, and teaching hospitals were more likely to adopt telehealth than their counterparts. Notably, the study found no significant telehealth adoption disparities between hospitals in urban and rural areas.
    • “Further, more than 90 percent of hospitals allowed patients to view and download medical records, but only 41 percent permitted online data submission. One-quarter (25 percent) of hospitals identified certified health IT developers, such as EHR vendors, as frequent culprits in information blocking.
    • “Most US hospitals also reported challenges in exchanging health information electronically, with 85 percent citing barriers related to vendor interoperability.
    • “The researchers concluded that comprehensive policy interventions are necessary to address telehealth adoption and other IT-related disparities across the US healthcare system.”

Midweek Update

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal adds,
    • “A summer Covid wave is hitting the country, but there’s one consolation: Your chances of developing long Covid have fallen since the start of the pandemic. 
    • “That’s the finding from a new study in the New England Journal of Medicine. It concluded that about 10% of people infected with the virus’s original strain developed long Covid. By contrast, the risk of developing long Covid dropped to 3.5% with the virus’s Omicron variant among vaccinated people. For the unvaccinated, the risk was 7.7.%.
    • “Researchers defined long Covid as people who experienced persistent and debilitating symptoms such as a racing heartbeat or brain fog, or other new health problems linked to the initial illness, a month or more after their infection.
    • “About 70% of the drop in long Covid cases was due to vaccination and 30% because of changes in the virus itself, the study determined. 
    • “Four years since the start of the pandemic, we’re getting used to periodic waves of Covid cases, including the uptick we’re seeing now, driven by Omicron subvariants. The threats of severe illness and lingering health problems have significantly subsided, though they haven’t disappeared.”
  • Beckers Hospital Review reports,
    • “As the House Committee on Oversight and Accountability investigates pharmacy benefit managers regarding alleged anticompetitive practices, the committee scheduled a hearing with leaders of the top three PBMs. 
    • “On July 23, [at 10 am ET], members of the House Committee on Oversight and Accountability plan to ask executives at Express Scripts/Evernorth, CVS Caremark and OptumRx about the alleged anticompetitive policies, which committee members say raise prescription drug costs, harm independent pharmacies and obstruct patient care. 
    • “The three PBMs account for about 80% of the market share. 
    • “The called witnesses are Adam Kautzner, PharmD, president of Evernorth Care Management and Express Scripts; David Joyner, executive vice president of CVS Health and president of CVS Caremark; and Patrick Conway, MD, CEO of OptumRx.”
  • The FEHBlog discovered today that on July 11, 2024, Rep. Gary Palmer (R Ala.) introduced House Jt. Resolution 187 which reads,
    • “Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress disapproves the rule submitted by the Office of Personnel Management relating to Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program (89 Fed. Reg. 37061), and such rule shall have no force or effect.”
  • The cited rule is the OPM’s May 2024 supplemental rule implementing the PSHBP. In the FEHBlog’s opinion, the provision of the rule which offends Rep. Palmer (and the FEHBlog) for that matter is found in an OPM FAQ:
    • “While the proposed rule reflects that Medicare Part D-eligible annuitants and their Part D-eligible family members would be automatically group enrolled into the Part D EGWP, it reflects that they may choose to opt out of receiving prescription drug coverage through the PSHB Part D EGWP. This proposed rule provides, consistent with the statute, that the Part D EGWP offered by their PSHB plan is the only PSHB prescription drug benefit available for Part D-eligible PSHB annuitants and their Part D-eligible covered family members. As proposed, Medicare Part D-eligible annuitants and their family members who choose to opt out of or disenroll from the PSHB plan’s Part D EGWP would not have access to prescription drug benefits through their PSHB plan and would not pay a lower premium than those enrolled in the Part D EGWP.“
  • Nothing in the Postal Service Reform Act suggests that Congress intended to impose such a penalty. It’s a penalty because OPM does not reduce the premium for members who are deprived of their plan’s prescription drug benefits. Furthermore, when Congress included a mandate for PSHBP annuitants to enroll in Part B, it also provided grandfathering protections and exemptions. The Part D penalty applies across the board.
  • In any case, because Part D benefits will feature improvements such as a $2,000 out of pocket cost maximum for 2025, the carrot approach to incenting Part D EGWP enrollment should be tried first.
  • The American Hospital Association News lets us know,
    • “The Administration for Strategic Preparedness and Response July 16 announced it will work with the Department of Commerce on an assessment of the active pharmaceutical industrial base to better understand the pharmaceutical supply chain and how it has changed since the COVID-19 pandemic. The assessment is based on a survey conducted last winter. The study will inform federal strategies and funding decisions related to the API supply chain and raise awareness of potential supply chain issues, such as the current limited domestic manufacturing capabilities and other potential issues. The study will survey more than 200 companies, including manufacturers, distributors, suppliers and customers. A Bureau of Industry and Security webpage answers FAQs about the project.”

From the public health and medical research front,

  • STAT News tells us,
    • “The Centers for Disease Control and Prevention just released a trove of data on Americans with disabilities that found that more than a quarter of U.S. adults have a disability — over 70 million people, a bump from prior years. This slice of the population was also much more likely to report long Covid symptoms such as chronic fatigue and brain fog. This comorbidity looms large for many disabled communities as another surge in Covid cases sweeps the country.
    • “The data, gathered in 2022, is part of the agency’s Disability and Health Data System, which has annual state and national-level data stretching back to 2016. This is the first year that the agency has released long Covid data, finding that 11% of people with disabilities had long Covid symptoms while only 7% of people without disabilities reported symptoms.
    • “For many disabilities, the highest populations exist in a swath that extends from the Deep South and Louisiana up to Appalachian communities in West Virginia and Ohio. Disability benefits claims are typically highest in these areas, but for long Covid, the geography shifted west. Idaho and other states along the Continental Divide saw much higher rates of symptoms, with Montana recording the highest prevalence at 18%.”
  • The New York Times adds,
    • “A large new study provides some of the strongest evidence yet that vaccines reduce the risk of developing long Covid.
    • “Scientists looked at people in the United States infected during the first two years of the pandemic and found that the percentage of vaccinated people who developed long Covid was much lower than the percentage of unvaccinated people who did. 
    • “Medical experts have previously said that vaccines can lower the risk of long Covid, largely because they help prevent severe illness during the infection period and people with severe infections are more likely to have long-term symptoms.
    • “But many individuals with mild infections also develop long Covid, and the study, published Wednesday in The New England Journal of Medicine, found that vaccination did not eliminate all risk of developing the condition, which continues to affect millions in the United States.”
  • STAT News also informs us,
    • “A study published Wednesday in the Journal of Clinical Oncology found that certain unmatched donors, or people whose bone marrow does not as closely resemble that of the patient’s, provided similar outcomes to matched donors so long as patients receive a key drug called cyclophosphamide to prevent dangerous complications. That suggests that patients who need a transplant might be able to safely consider both matched and some unmatched donors, vastly expanding the pool of potential acceptable donors for all patients, though particularly those of African, Latino, or Asian ancestry.
    • “It’s much harder to find a match for most of my patients. Looking to people who are donor unrelated and aren’t a perfect match for my patients has become the norm,” said Sekeres, who is the chief of hematology at Sylvester Cancer Center at the University of Miami and did not work on the study. “That’s why this study really resonated with me. The classic teaching is you want a perfect match as opposed to less than perfect. What this study suggests is, if you use the right drugs after transplant, it may not be as big of a deal.”
    • “If so, up to roughly 84% of African American patients might have a potential donor in the national registry. Currently, less than 30% of African American patients have a potential match in the NMDP registry, previously called the National Marrow Donor Program.”
  • Per BioPharma Dive,
    • “A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday.
    • “The data comes two months after the Swiss drugmaker disclosed trial results from another obesity drug in its pipeline, which showed the once-weekly injection helped reduce body weight by 19% over six months. Roche disclosed more detailed data for that drug, indicating none of the trial participants stopped taking it due to side effects — a reason users might quit taking Wegovy or Zepbound.
    • “The two drugs came from Roche’s $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to enter a market estimated to be worth more than $100 billion annually by early next decade.”
  • Beckers Hospital Review interviews NYU Langone’s bariatric surgery chief about the first GLP-1 generic and other GLP-1 issues.
  • Per a National Institutes of Health press release,
    • “A neuroimaging study of young people who exhibit a persistent pattern of disruptive, aggressive, and antisocial behavior, known as conduct disorder, has revealed extensive changes in brain structure. The most pronounced difference was a smaller area of the brain’s outer layer, known as the cerebral cortex, which is critical for many aspects of behavior, cognition and emotion. The study, co-authored by researchers at the National Institutes of Health (NIH), is published in The Lancet Psychiatry.
    • “Conduct disorder has among the highest burden of any mental disorder in youth. However, it remains understudied and undertreated. Understanding brain differences associated with the disorder takes us one step closer to developing more effective approaches to diagnosis and treatment, with the ultimate aim of improving long-term outcomes for children and their families,” said co-author Daniel Pine, M.D., chief of the Section on Development and Affective Neuroscience in NIH’s National Institute of Mental Health. “Critical next steps are to follow children over time to determine if differences in brain structure seen in this study are a cause of conduct disorder or a long-term consequence of living with the disorder.”
  • The National Cancer Institute posted its latest cancer information highlights.
  • The Institute of Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of acoramidis (BridgeBio Pharma, Inc.), tafamidis (Vyndamax®/Vyndaqel®, Pfizer Inc.), and vutrisiran (Amvuttra®, Alnylam Pharmaceuticals, Inc.) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).”
  • AHRQ’s Patient Safety Network informs us,
    • “Patients presenting to the emergency department (ED) are triaged to prioritize care based on level of illness. In this study, 2,543 patients presenting to an ED in Switzerland were asked to self-triage using an electronic symptom-checker. (Patients were triaged and treated based on standard-of-care nurse triage.) Recommendations were given regarding time to treat (e.g., emergency) and point-of-care (e.g., self-care) and subsequently evaluated by three panels of experts. Fifty of the 2,543 patients were judged as undertriaged, but none were judged as potentially hazardous.”

From the U.S. healthcare front,

  • Healthcare Dive points out,
    • “Elevance reported solid second-quarter results on Wednesday — including $2.3 billion in profit — but the company still lowered long-term revenue growth guidance for its health insurance business. That disconnect raised red flags for analysts.”
    • “Changing revenue growth forecasts for health benefits in the middle of the year “is unusual,” commented Jefferies analyst David Windley in a Wednesday note. “We can’t identify a single, large item that would compel [the reduction] off-cycle.”
    • “During a call with investors Wednesday, Elevance management cited several factors for dropping the guidance, including significant member losses from Medicaid redeterminations and Medicare Advantage bids for 2025 that could slow growth.”
  • Fierce Pharma reports,
    • “As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.”
    • “While J&J is “not in alignment” with IRA or its price setting process, the company has accepted the reality of the situation and baked assumptions about the future costs of its drugs into its growth projections through the end of the decade, Jennifer Taubert, EVP, worldwide chairman, innovative medicine at J&J, said on an analyst call Wednesday.
    • “As it stands, J&J currently expects to grow its business by 3% next year and then 5% to 7% out through 2030, Taubert said.”
  • Per Fierce Healthcare,
    • “Electronic health record messages to patients drafted by generative AI were of similar quality and accuracy to those written by healthcare professionals, according to a newly published study conducted using queries from NYU Langone Health patients.”
    • “The analysis, headed by researchers at the system’s affiliate NYU Grossman School of Medicine, had 16 primary care physicians rate AI and human drafts without knowing how each was written.
    • “Among a sample of 334 AI-drafted messages and 169 from professionals (both physicians and non-physicians), the raters found both sets to be on par regarding informational content, completeness and whether the grader would use the draft or start again from scratch.”
    • “The findings “suggest chatbots could reduce the workload of care providers by enabling efficient and empathetic responses to patients’ concerns,” study lead William Small, M.D., of the medical school, said in a release.”

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.”

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.”