Thursday Miscellany

COVID-19

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Republicans yanked another fiscal 2024 spending bill before a final vote scheduled for Thursday morning, leaving them empty-handed for the week and stuck at seven out of 12 annual appropriations bills passed.
    • “The $25 billion Financial Services bill [which funds OPM and the FEHBP] ran into trouble with GOP moderates over language that would block the District of Columbia from implementing its 2014 law preventing employment discrimination based on reproductive health decisions, including taking birth control or having an abortion.
    • “The simple analogy is they didn’t have the votes. Shocking,” said Rep. Ryan Zinke, R-Mont., who backs the bill. “Monday, we’ll see if we can have a consensus over the weekend for those people that have a problem with what I think is a very straightforward bill.”
    • “Another issue which contributed to the measure’s demise Thursday, according to a source familiar with the decision, was conservative opposition to allowing the General Services Administration to implement its plan to build a new FBI headquarters in Greenbelt, Md.”
  • As Rosanna Rosannadana would say, “If it’s not one thing, it’s another.”
  • The Society for Human Resource Management informs us,
    • “Employees can funnel an extra $150 into their health flexible spending accounts (FSAs) next year, the IRS announced Nov. 9.
    • “The annual contribution limit is rising to $3,200 in 2024, up from $3,050 in 2023. The hike is still significant, although it’s a smaller boost than the $200 hike seen this year.
    • “If the employer’s plan permits the carryover of unused health FSA amounts, employees can carry over up to $640 in 2024. That’s up $30 over the 2023 carryover amount, which is $610.”
  • Here’s a link to the IRS’s complete list of 2024 inflation adjustments to tax items.
  • STAT News tells us that the Ground Ambulance Committee created by the No Surprises Act wants to cap the cost-sharing for people who use ground ambulances at $100 per trip. The catch is that they have difficulty deciding how much health plans should pay for ground ambulance services.
    • “Some experts say a Medicare benchmark is the simplest administrative solution. Medicare’s payment system for ambulances is outdated, but it’s based on some measure of costs. But that shift would result in a lot of upheaval, especially for ambulance providers that currently are able to bill and collect large sums of money from the biggest insurance companies. * * *
    • “Early next year, the federal ambulance committee will deliver its recommendations to Congress. Key lawmakers have not shown a lot of interest in taking up surprise billing again because it requires a lot of political capital to confront the ambulance and insurance industries.”

In FEHBP news,

  • FedSmith offers its strategy for approaching the FEHB open season which begins next Monday.
  • FedWeek discusses coordinating benefits between FEHB plans and Medicare. The best resource is OPM’s chart found in Section 9 of every FEHB plan’s brochure.

From the public health and research front,

  • The Wall Street Journal reports,
    • “A team of New York surgeons has performed the world’s first whole-eye transplant on a human, a breakthrough that could change vision treatments even though the patient hasn’t regained sight in the grafted eye. 
    • “In the six months since the eye surgery was performed, in conjunction with a partial face transplant, the 46-year-old patient has shown promising signs of health in the eye, the surgical team at NYU Langone Health said Thursday. 
    • “The grafted eye is maintaining normal ocular pressure and has direct blood flow to the retina, the area at the back of the eye that receives light and sends images to the brain. It isn’t known if the patient will regain his sight, but the transplant is still a significant accomplishment, according to Dr. Eduardo D. Rodriguez, director of the Face Transplant Program at NYU Langone.  
    • “We’ve made one major step forward and have paved the way for the next chapter to restore vision,” Rodriguez said. Rodriguez led the May surgery, which lasted 21 hours and included more than 140 surgeons, nurses and other healthcare professionals.” 
  • The Food and Drug Administration announced,
    • “approving Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder.”
  • and
    • “approving Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
    • “The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.” 
  • and
    • clearing for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18. Today’s announcement follows clearance of a molecular home test earlier this year.
  • Per Beckers Hospital Review,
    • “Pneumonia patients who took an antibiotic that’s typically reserved as an alternative were less likely to develop Clostridioides difficile infections compared to those taking the recommended drug, according to a study from Veterans Affairs Hospitals. 
    • “The retrospective study analyzed 156,107 patients treated for pneumonia at a VA hospital between 2009 and 2022. Overall, less than 1% of pneumonia patients were diagnosed with a C. diff infection, but among those who had C. diff in the year before contracting pneumonia, 12% developed a new C. diff infection associated with their antibiotic treatment. 
    • “Clinical guidelines recommend azithromycin, and nearly 9 in 10 of the patient cohort received the drug. Of the 13% who received doxycycline, the alternative antibiotic, the drug was associated with reducing C. diff infections by 45%. 
    • “The researchers concluded that, if Legionella pneumonia can be ruled out, clinicians might consider doxycycline as a first-line treatment over azithromycin.”
  • The Wall Street Journal notes,
    • “There is hope for those of us who live (and sleep) in the real world: Getting less than 8 hours of shut-eye a night doesn’t mean you’re doomed to an early grave.
    • “A recent study looking at sleep and longevity found that sleep “regularity”—going to bed and waking up at consistent times with few mid-slumber interruptions—matters more than how long you sleep. Sleeping six hours every night on a consistent schedule was associated with a lower risk of early death than sleeping eight hours with very irregular habits.
    • “The study adds to a growing understanding of the links between sleep and longevity. Research in recent years has shown not only how important sleep is for health and lifespan, but also that the duration of sleep isn’t the only thing that matters.”

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “For-profit hospital operators strained by physician fees, payer relations in the third quarter of 2023. Except for HCA, the biggest U.S. health systems all reported lower year-over-year profits in the third quarter.”
  • and
    • “More than 85,000 Kaiser Permanente healthcare workers have a new four-year contract with the nonprofit system after union members overwhelmingly voted to ratify a compromise reached in October following months of labor negotiations and a high-profile strike.”
  • and
    • “Virgin Pulse announced on Thursday it closed its merger with third-party health plan administrator HealthComp. Private equity firms New Mountain Capital and Marlin Equity Partners are new majority and minority owners of the company, respectively, according to a release.”
  • Per Fierce Healthcare,
    • “Optum Rx is shifting eight different insulin products to its preferred formulary in a bid to address affordability, the company said Thursday.
    • “The product selection includes all rapid-acting and short-acting insulin products and some long-acting insulins, according to the announcement. It includes insulins manufactured by Sanofi, Novo Nordisk and Eli Lilly.
    • “Optum’s Tier 1 includes the lowest cash prices that its members will pay, the company said.”
  • and
    • A BCBSA study concludes that the Affordable Care Act’s risk adjustment system works, notwithstanding noteworthy failures.
  • The Wall Street Journal reports,
    • “AstraZeneca raised its full-year guidance for core earnings per share and total revenue excluding Covid-19 medicines despite a lower third-quarter profit that missed forecasts after booking a tax charge compared with a credit for the comparable period.
    • “The Anglo-Swedish pharmaceutical giant said Thursday that it expects core earnings per share to increase by a low double-digit percentage compared with previous guidance of a high single-digit to low double-digit percentage increase.
    • “Total revenue excluding COVID-19 medicines is now expected to increase by a low-teens percentage at constant-exchange rates compared with previous expectations of low double-digit percentage growth.
    • “Total revenue is expected to increase by a mid-single-digit percentage compared with previous guidance of low-to-mid single-digit, it said.”

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19 testing, Federal employment benefits, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call tells us, “The Senate on Wednesday voted 82-15 to pass the first three of its fiscal 2024 appropriations bills in a “minibus” as the House tees up votes this week on three of its remaining seven fiscal 2024 appropriations bills.”
    • The minibus included “the fiscal 2024 Military Construction-VA, Agriculture, and Transportation-HUD appropriations bills.” 
  • The Centers for Medicare and Medicaid Services issued its “calendar year 2024 Home Health Prospective Payment System (HH PPS) Rate Update final rule.”
  • Per Fierce Healthcare, the rule
    • increases the 2024 home health payments by 0.8%, or $140 million.
    • “The $140 million increase in estimated payments for CY 2024 reflects the effects of the CY 2024 home health payment update percentage of 3% ($525 million increase), an estimated 2.6% decrease that reflects the effects of the permanent behavioral assumption adjustment ($455 million) and an estimated 0.4% increase that reflects the effects of an updated FDL ($70 million increase),” the unpublished rule said.
    • “CMS expects increasing the rate will bring home health payments in line with statutory payment authority.”
  • BioPharma Dive informs us,
    • “An experimental sickle cell disease treatment made with CRISPR technology is one step closer to approval in the U.S., following a meeting Tuesday in which advisers to the Food and Drug Administration seemed generally comfortable with its safety.
    • “Made up of scientists and physicians, the advisory panel spent hours discussing highly technical questions around how best to assess the risk that CRISPR — the gene editing technique often likened to a pair of scissors — might make unwanted, or “off-target,” cuts to DNA.
    • “Ultimately, the panel appeared convinced that Vertex Pharmaceuticals, which developed the sickle cell treatment, had done enough to show the therapy is safe, although they pointed to several avenues for further study.”
  • Reuters adds, “Analysts have been optimistic the therapy, which is a first-of-its-kind product to reach the FDA for review, will win the health regulator’s nod by Dec. 8.”
  • On a related note, an article in Health Affairs Scholar prognosticates,
    • “Despite the potential of gene therapy to transform the lives of patients with rare genetic diseases, serious concern has been raised about the financing of the high up-front costs for such treatments and about the ability of the employer-sponsored insurance system in the United States, particularly in small firms, to pay for discoveries of this type. In this paper, we provide a conceptual framework and empirical evidence to support the proposition that, at present, private group insurance financing of cost-effective gene therapies is not only feasible and competitively necessary in the labor market for employers, regardless of group size, but also that, currently, the number of US workers in small firms who might be stressed by very high-priced claims is a tiny fraction of the group market for genetic treatments. The current system of employer-paid self-insurance supplemented by stop-loss coverage should be able to facilitate the use of new cost-effective gene therapies. Other alternative methods of financing that have been proposed may not be urgently needed. There are, however, some concerns about the long-term resilience of this system if stop-loss premiums continue to have high growth.”
  • The Society for Human Resource Management reminds us,
    • “Employers are required to use the latest version of Form I-9 beginning today.
    • “The new form from U.S. Citizenship and Immigration Services has been available for use since August but becomes mandatory for all employers as of Nov. 1. 
    • “The new I-9 does not make any new changes to employer or employee obligations involved in the verification of work authorization. Cosmetic changes include the reduction of Sections 1 and 2 to a single page, slight revisions to the Lists of Acceptable Documents, and a new box that eligible employers must check if the employee’s documents were examined remotely under the newly authorized alternative procedure for qualified E-Verify employers.”

In FEHB news, as we approach the Open Season,

  • FedSmith offers its perspective on factors to consider when selecting an FEHB plan during Open Season.
  • FedWeek offers retired OPM executive Reg Jones’s views on the upcoming Open Season.
  • The Federal Times highlights the fine points of fertility coverage in 2024 FEHB plans.

From the public health and research front,

  • The Centers for Disease Control reminds us,
    • Every U.S. household can order 4 more free COVID-19 self-tests. 
    • Self-tests (also called at-home tests and over-the-counter tests) are one of several tools that protect you and others by reducing the chances of spreading COVID-19.
    • Self-tests can be taken at home or anywhere, are easy to use, and produce rapid results.
    • You can place an order 
      • Online at COVIDTests.gov
      • By calling 1-800-232-0233 (TTY 1-888-720-7489)
      • By calling or emailing the Disability Information and Access Line (DIAL) at 1-888-677-1199 or DIAL@usaginganddisability.org (for people with disabilities)
  • The Washington Post reports,
    • “Dying from heart failure and ineligible for a human heart transplant, Lawrence Faucette knew that the last chance he had at extending his life was to receive a heart transplanted from a pig. The 58-year-old man said from his Baltimore hospital bed in September that he was “hoping for the absolute best,” but understood that he was the second person in the world to undergo the procedure — and the highly experimental surgery did not guarantee that he would get more time with his wife and two sons.
    • “We’re going to do the best we can,” he said in a video posted by the University of Maryland School of Medicine. “Now at least I have hope. And now I have a chance.”
    • “Faucette died Monday, nearly six weeks after the surgery, becoming the second patient to die after receiving a genetically modified pig heart, medical school officials announced Tuesday.”
  • RIP, Mr. Faucette.
  • The Wall Street Journal reports,
    • “The rate of babies dying in the U.S. increased significantly for the first time in two decades, raising new alarms about maternal-infant health in America.
    • “The nation’s infant mortality rate rose 3% from 2021 to 2022, reversing a decadeslong overall decline, the Centers for Disease Control and Prevention said Wednesday. The rate increased from 5.44 infant deaths for every 1,000 births to 5.6 in 2022, a statistically significant uptick. * * *
    • “The death rate increased significantly for babies born to American Indian and Alaska Native women, babies born to white women, babies born to women ages 25 to 29 years, male babies and preterm babies.
    • “Changes in the rates for other groups weren’t significant, though the agency’s data showed that mortality rates among racial groups in the U.S. remain wide. The rate for babies born to Black mothers was more than double that of white mothers.”
  • STAT New calls attention to the fact that
    • “Most lung cancer screening guidelines hinge on how much people smoked tobacco and when they last smoked, but the American Cancer Society now says it doesn’t matter how long ago they quit. On Wednesday, the ACS released guidance recommending that anyone with a significant smoking history get an annual low-dose CT scan for lung cancer.
    • “The new guidelines also expand the age range for lung cancer screening to 50 through 80, instead of 55 through 74, and lower the smoking history requirement from 30 cigarette pack years to 20 pack years or more. That means the equivalent of a pack a day for 20 years, which includes two packs a day for 10 years or four packs a day for five years. Most private insurance plans are required to cover screening guidelines with an A or B-grade recommendation from the U.S. Preventive Services Task Force, though some organizations do follow ACS guidelines.
    • “These recommendations bring the ACS’ new age range and smoking history requirements in line with that of the task force’s lung cancer guidelines, which were updated in 2021. However, the task force still only extends lung cancer screening eligibility to patients who quit smoking within the last 15 years. 
    • One of the main reasons the ACS wanted to strike the years-since-quit requirement from their guidelines was that many former smokers are still at high risk for lung cancer regardless of when they quit smoking. “The more we dug into the data, the more we saw there was no real evidence for that criterion,” said Robert Smith, the senior vice president of early detection science at the American Cancer Society.”
  • The Lown Institute issued a report on unnecessary heart stent procedures in the U.S.
    • “Every seven minutes, a Medicare patient receives an unnecessary coronary stent at a U.S. hospital, a new report finds. The Lown Institute, an independent think tank, examined the overuse of percutaneous coronary interventions (coronary stent or balloon angioplasty) at 1,733 general hospital inpatient and outpatient facilities and found more than 229,000 procedures met the criteria for overuse.
    • “While coronary stents can be lifesaving for someone having a heart attack, years of research shows that stents for stable heart disease provide no benefit over optimal medication therapy. Across all hospitals, Lown estimates that more than one in five stents were placed unnecessarily in Medicare patients from 2019 to 2021, at a cost of $2.44 billion.
    • “When physicians continue a practice despite the evidence against it, it becomes more dangerous than useful,” said Dr. Vikas Saini, a cardiologist and president of the Lown Institute. “The overuse of stents is incredibly wasteful and puts hundreds of thousands of patients in harm’s way.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • CVS Health beat Wall Street expectations for earnings and revenue in the third quarter, as growth in pharmacy benefits offset higher spending in its health insurance segment.
    • The Rhode Island-based healthcare behemoth continues to wrangle with headwinds including higher-than-expected healthcare utilization, a pharmacist strike and lost bonus payments in Medicare Advantage.
    • As a result, interim CFO Tom Cowhey cautioned investors on a Wednesday morning call to expect 2024 earnings at the low end of the company’s guidance.
  • and
    • “Humana reported growing medical costs in its insurance segment during the third quarter as a result of increased medical utilization among Medicare Advantage members and higher-than-anticipated COVID-19 admissions.
    • “The payer expects higher levels of utilization to continue for the remainder of the year, and is now forecasting its 2023 medical loss ratio (MLR) will outpace prior guidance. Humana is projecting an MLR of 87.5% for 2023, up from the 86.6% to 87.3% range it previously expected.
    • “Humana’s shares slid following the earnings release Wednesday, despite the insurer beating Wall Street expectations on revenue of $26.4 billion and profit of $1.1 billion.
  • Forbes reports that biopharma giant “GSK shares rose on Wednesday after the pharma giant upgraded its profit guidance for the second time this year amid booming demand for its new vaccine for respiratory syncytial virus (RSV).”

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, FDA, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced,
    • “Take Action for Adolescents: A Call to Action for Adolescent Health and Well-Being a new effort to promote collaboration and spur action to improve the health and well-being of adolescents across the U.S.
    • “Young people today are facing significant challenges to their health and well-being,” said Admiral Rachel Levine, M.D., Assistant Secretary for Health. “We are committed to working closely with our allies and partners across the country to support improvements in adolescent health and well-being.”
    • “It is critical that we take action for adolescents now,” said Jessica Swafford Marcella, Deputy Assistant Secretary for Population Affairs. “This new Call to Action and accompanying toolkit will inspire collaborative efforts across youth-serving sectors to build a healthier future for America’s young people.”
    • “Take Action for Adolescents outlines a vision, key principles, eight goals, and a set of initial action steps. It is research-based and was developed with extensive input from adult and youth allies and partners, including nationally recognized adolescent health experts. It is accompanied by a Take Action Toolkit with tips and resources to spur collaboration in states and communities.” * * *
    • The Office of Population Affairs’ Take Action for Adolescents webpage features a suite of resources that are easy to download and share.
  • The Food and Drug Administration announced approving
    • “Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications: 
      • “Adult patients with:
        • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
        • active psoriatic arthritis;
        • moderately to severely active Crohn’s disease; and
        • moderately to severely active ulcerative colitis.
      • “Pediatric patients 6 years of age and older with:
        • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
        • active psoriatic arthritis.
    • “Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.”
  • Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez announced a proposed rule to improve retirement benefit security under ERISA.

From the public health front,

  • The Wall Street Journal reports,
    • “There’s some good news about flu season this year. Doctors and scientists don’t expect the worst. 
    • “The flu season in the Southern Hemisphere, where the cold-weather illness period wraps up as we head into ours, often serves as a harbinger of what’s to come for us. There, cases picked up a little earlier than usual in some countries but didn’t result in an especially large number of hospitalizations and deaths, say public health experts and doctors.
    • “Also encouraging: The components in this year’s flu vaccine are a good match to the predominant strain so far.” 
  • U.S. News and World Report tells us,
    • “COVID-19 hospitalizations in the U.S. remained relatively steady week over week following five weeks of larger declines, according to data from the Centers for Disease Control and Prevention.
    • “The U.S. tallied about 16,200 new hospitalizations of people with COVID-19 over the seven days ending Oct. 21, according to provisional data – only 40 hospitalizations less than the total for the previous week and effectively pausing a downward trend that began after hospitalizations totaled close to 21,000 during the week ending Sept. 9. Hospitalizations dipped to a low point of approximately 6,300 in late June before starting to trend back up.
    • “Relative to population, data points to 4.9 new COVID-19 hospital admissions per 100,000 people for the week through Oct. 21. Among states and territories, Montana saw the highest rate over the week at 10 per 100,000. West Virginia (8.3), the District of Columbia (8.1), and Colorado (7.6) had the next-highest rates. Compared with the week prior, Mississippi had the highest percentage increase in its COVID-19 hospitalization rate at 45%, followed by Kansas(41%), Indiana (40%) and Iowa (32%).
    • “Among patients visiting a subset of emergency departments, data indicates 1.3% were diagnosed with COVID-19 nationally – a rate down about 5% from the week before. New Mexico(3.1%), Colorado (2.4%) and Arizona (2.3%) saw the highest rates.”
  • MedPage Today informs us that
    • The CDC released new recommendations for hepatitis C virus (HCV) screening among perinatally exposed infants and children.
    • The four new recommendations are detailed in the MMWR Recommendations and Reports.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Tenet Healthcare beat Wall Street expectations on revenue in the third quarter due to cost control measures and sustained revenue growth at its facilities. 
    • “The for-profit operator’s ambulatory care and hospital segments both experienced volume growth, with both divisions’ earnings coming in “well above” Tenet’s expectations, said CFO Dan Cancelmi during a call with investors on Monday.
    • “Executives raised the lower end of Tenet’s full-year revenue guidance. The operator now expects to capture between $20.3 billion and $20.5 billion this year.”
  • Per Fierce Pharma,
    • “For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.
    • “In the third quarter of 2023, Pfizer recorded $5.6 billion in coronavirus-related inventory write-offs and other charges, plus a $4.2 billion revenue reversal tied to the planned return of some 7.9 million Paxlovid doses from the U.S. government.
    • “Concerning the inventory write-offs, $4.7 billion of the sum is tied to Pfizer’s antiviral Paxlovid, with the remaining $900 million stemming from the company’s BioNTech-partnered mRNA vaccine Comirnaty, Pfizer said Tuesday.”
  • Here’s a link to Pfizer’s third-quarter report.
  • Beckers Payer Issues informs us,
    • Employers are looking to deductible-free health plans as employees report increasing concerns about the cost of healthcare, according to Mercer’s 2023-2024 “Inside Employees’ Minds” survey. 
    • The survey, published Oct. 30, interviewed 4,505 full-time employees in the United States, working for organizations with more than 250 employees. 
    • In 2023, 15% of organizations are offering some employees no-cost health plans, and 18% are using salary-based contributions. 
    • Around 4 in 10 employers offer a medical plan with low or no deductible. 
    • Plans with no deductibles are growing in popularity — UnitedHealthcare’s fastest-growing commercial plans have no annual deductibles, COO Dirk McMahon told investors Oct. 30. 
    • “UnitedHealthcare members in these offerings are receiving more preventive care, while paying about 50% less out of pocket, compared to people enrolled in traditional offerings, and their employers can reduce the total cost of care with an average savings of 11%,” Mr. McMahon said. 
    • According to Mercer’s survey, 79% of workers making between $60,000 and $100,000 each year say they can afford the healthcare their family needs without hardship, compared to 51% of workers making less than $30,000 annually. 
    • See the full report here. 
  • Beckers Health IT identifies 121 unicorns (companies with at least a one billion dollar valuation) operating in the healthcare space.
  • KFF tells us what to watch for in the eleventh Affordable Care Act open enrollment period, which begins tomorrow. Here’s an interesting tidbit from that article:
    • Private health plans must permit young adults the option of remaining covered as a dependent under their parent’s policy until they turn age 26. Starting in 2024, though, federal Marketplace health plans will officially not be allowed to terminate coverage for young adult dependents mid-year on their 26th birthday. Instead, they will have to continue the dependent coverage through the end of the calendar year. The federal Marketplace has already been keeping these individuals on the plan until the end of the year, and then automatically enrolling them in their own exchange coverage the following year, but this rule codifies that practice.

Weekend update

David Ermer–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare, Uncategorized–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC,

  • The federal marketplace open enrollment period for Affordable Care Act coverage will open on November 1. This enrollment opportunity closes on December 15.
  • The Wall Street Journal reports, “Insurers spar With Biden Administration over coverage for mental-health care; New requirements aim to reduce out-of-pocket costs for treatment; insurers cite a shortage of mental-health providers.” Per the Journal,
    • “A landmark law, the Mental Health Parity and Addiction Equity Act of 2008, helped curtail arbitrary annual limits imposed by insurers on mental-health coverage. Insurers aren’t supposed to put such limits on mental-health visits if they don’t also have similar limits on doctor visits for a chronic condition like asthma. They also aren’t supposed to impose higher copayments and deductibles or more restrictive prior authorization requirements for mental health care.
    • “But the promise of out-of-pocket parity remains far more elusive. The reasons are complex: There is a shortage of mental health clinicians, with an estimated 350 individuals for every one mental-health provider, according to Mental Health America.”
  • The legal issue is that the law requires parity in quantitative treatment limits (QTL), which health plan compliance with the law has created. The regulators, however, created a separate nonquantitative treatment limitation category, which includes network adequacy, prior authorization, and many, many other factors. The regulators in the proposed rule demand that the QTL parity factors be applied to all NQTLs. That is an infeasible, pointless task, in the FEHBlog’s opinion. The regulators need to try again.
  • On a related note, the Washington Post informs us,
    • “Beginning in January, Medicare [Part B], for the first time, will allow marriage and family therapists and mental health counselors to provide services. This cadre of more than 400,000 professionals makes up more than 40 percent of the licensed mental health workforce and is especially critical in rural areas.
    • “Medicare is also adding up to 19 hours a week of intensive outpatient care as a benefit, improving navigation and peer-support services for those with severe mental illness, and expanding mobile crisis services that can treat people in their homes or on the streets.”

From the public health front,

  • NBC News notes,
    • “A new Covid variant has become dominant in the U.S., but relatively few people have thus far gotten the new shots that could offer some protection against it.
    • “The variant, called HV.1, replaced EG.5 as the country’s most prevalent this week, according to data released Friday by the Centers for Disease Control and Prevention.
    • “The two variants are genetically similar versions of omicron.
    • “HV.1 makes up around 25% of Covid cases now, up from around 1% at the beginning of August. EG.5, meanwhile, represents nearly 22% of cases, down from 24% at the start of the month.
    • “Both are descendants of the XBB variant. The updated Covid vaccines from Pfizer and Moderna, which became available last month, target a different XBB descendant, called XBB.1.5.
    • “But disease experts say the new shots should offer cross-protection against the currently dominant strains. Dr. Scott Roberts, an infectious disease specialist at Yale Medicine, said that although the vaccine is not a “perfect match” for HV.1, “it’s still a good match because it’s still within the same family of variants.”
  • WTOP, a news radio station in Washington DC, reports,
    • “We’ve already been receiving warnings from the CDC that there are RSV cases in the Southeast, which is kind of an indication to us that it’s going to be moving our way soon,” said Dr. Christine Ashburn, a pediatrician with Kaiser Permanente’s Mid Atlantic Group.
    • “While an increase in RSV cases could be coming soon,  Ashburn says she doesn’t think it’ll be as bad as last year, which saw hospital systems across the region — and the country — overrun with cases in infants. * * *
    • “Ashburn says looking for early signs of this illness in infants and small children is key.
    • “Watch for fast, rapid breathing,” she said. “Sometimes in babies, you’ll even see the area around their chest sinking in as they’re breathing.”
    • “She also said flared nostrils, prolonged fever, and even rhythmic grunting — or any signs of respiratory distress — are signs your baby is struggling to get air.
    • “If you think your child could be suffering from RSV, it’s imperative you make an appointment with your health care provider,” she said.
    • “Dr. Ashburn said she’s also optimistic about a new antibody treatment for RSV, AstraZeneca’s Beyfortus™ (or nirsevimab, generically), which is designed to help prevent and mitigate the illness’s effects.”
  • Vox adds
    • Demand for Beyfortus currently exceeds supply. But as the need for the drug becomes more predictable, and as other monoclonal RSV antibodies in development make it onto the market, we can expect supply to better meet that demand. 
    • It’s more complicated to fix the fragmented US health care system that creates big barriers to Beyfortus access for some kids, [Dr. Sean] O’Leary [a pediatric infectious disease specialist at the University of Colorado’s medical school] said. That system is structured such that many pediatricians have to take huge financial risks to keep Beyfortus in stock. For patients who get care at those practices, access will likely be a little touch-and-go until demand also stabilizes and pediatricians can better forecast how much to stock. * * *
    • One dose costs a doctor’s office nearly $500 — and as a totally novel immunization, its popularity was hard to forecast. “For a medium-sized practice, they might have to spend $250,000 to cover their [privately insured”] patient population,” O’Leary said. “And that is not money they have lying around.”
    • “It’s not that pediatricians and family docs don’t want to do the right thing,” he added — but the financial risk of just keeping Beyfortus on the shelves is a barrier.
  • However, according to a 2018 survey about vaccine financing billing practices at medical practices serving adults
    • Of 242 practices approached, 43% (n=104) completed the survey. Reported payment levels and perceived profit varied by payer type. Only for preferred provider organizations did a plurality of respondents report profiting on adult vaccination services. Over half of respondents reported losing money vaccinating adult Medicaid beneficiaries. One-quarter to one-third of respondents reported not knowing about Medicare Part D payment levels for vaccine purchase and vaccine administration, respectively. Few respondents reported negotiating with manufacturers or insurance plans on vaccine purchase prices or payments for vaccination.
  • FEHBlog note: It’s no wonder that chain pharmacies are the principal distributors of vaccines.

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “AbbVie Inc. raised its profit outlook for this year and next as demand for newer biologic drugs helped fill the gap left by falling Humira sales, but investors were disappointed as Botox sales missed estimates.
    • “Adjusted earnings will be $11.19 to $11.23 a share this year, up from the earlier range of $10.86 to $11.06, AbbVie said Friday in a statement. Profit for 2024 will be at least $11 a share, up from the earlier view of at least $10.70, the drugmaker said.
    • “However, sales of Botox, Juvaderm and other aesthetics products were $1.24 billion, missing the average sales estimate by about $100 million. Shares of the North Chicago, Illinois-based drugmaker dropped as much as 5.6% at the New York market open, their biggest intraday loss since April.”
  • Reuters points out,
    • “Healthcare companies who profit from treating obese and overweight patients are trying to convince investors that powerful new weight-loss drugs won’t shrink their businesses.
    • “The global market for obesity drugs could reach as much as $100 billion within a decade due to the effectiveness of Novo Nordisk’s (NOVOb.CO) Wegovy and similar medicines.
    • “Such forecasts have prompted a sell-off in a wide range of companies from makers of bariatric surgery devices to companies whose products address the health issues created by excess weight, from diabetes to sleep apnea.”

Friday Factoids

David Ermer–COVID treatment, COVID-19, Electronic health records, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Medical Association News informs us,
    • “The Departments of Health and Human Services, Labor and the Treasury Oct. 27 issued a proposed rule intended to improve how the No Surprises Act independent dispute resolution process functions in response to feedback and challenges shared by stakeholders. The public will have 60 days to submit comments. The rule would require plans to include claim adjustment reason codes and remittance advice remark codes, among other new information, with the initial payment or notice of payment denial for certain items and services subject to the NSA protections. The rule proposes changes to the batching requirements so that Items and services could be batched in the same payment determination if they are: furnished to a single patient on one or more consecutive dates of service and billed on the same claim form (a single patient encounter); billed under the same service code or a comparable code under a different procedural code system; or anesthesiology, radiology, pathology and laboratory items and services billed under service codes belonging to the same Category I CPT code section, as specified in the agencies’ guidance. Batched items would be limited to 25 items or services in a single dispute. Lastly, the proposed rule would amend certain requirements related to the open negotiation period preceding the IDR process, the initiation of the process, the dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees.”
  • The proposed rule will be published in the Federal Register next Friday, November 3, and the proposal creates a sixty-day public comment period.
  • Here’s a link to the government’s fact sheet on the proposed rule.
  • The FEHBlog noticed that the proposed rule would run open negotiations through the government’s IDR portal, which will increase the government’s administrative costs. It strikes the FEHBlog that the proposed rule could have established a process for the open negotiation for the parties to follow. The proposed rule will require health plan system changes, which is always expensive.
  • Also today, the Department of Health and Human Services wrote to stakeholders, including health plans, reminding them the cost of Paxlovid and other Covid drugs is shifting from the government to the private sector beginning on November 1.
  • STAT News reports,
    • “The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress.
    • “The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis. The drug’s approval comes after two late-stage trials found that patients taking Omvoh showed a significant improvement in symptoms after both three months and a year compared with those given a placebo, and that the therapy had minimal side effects.
    • “Omvoh’s list price will be $9,593 per month for intravenous delivery and $10,360 per dose injected beneath the skin. A company spokesperson told STAT that patients who have the drug covered by commercial insurance may pay as little as $5 per month for up to 30 months.”

From the public health front,

  • Health Payer Intelligence points out,
    • “Americans are feeling more optimistic about their well-being than last year, but financial concerns and mental health challenges are still negatively impacting their health, according to a report from The Cigna Group.
    • “The second annual Vitality in America study reflects responses from 10,000 adults collected in June 2023 by Morning Consult. The study uses the Evernorth Vitality Index, a subjective measure of health and well-being, to assess Americans’ experiences with personal health, finances, and job satisfaction.
    • “Almost half of respondents said they look forward to each new day, up from 43 percent in 2022. However, fewer adults said they prioritize their physical health (39 percent), feel capable of managing their emotions (45 percent), and can financially support themselves (40 percent).
    • “The top driver of stress among US adults was finances (40 percent), followed by housing conditions (25 percent), work (25 percent), family or social relationships (25 percent), and health (24 percent).”
  • Per Fierce Healthcare,
    • “More patients are accessing their medical records online via patient portals or apps and are doing so more often than in years past, according to the Office of the National Coordinator for Health IT (ONC).
    • “From 2020 to 2022, the portion of U.S. adults who reported being offered access to their medical records by a provider or insurer increased 24% to about 3 in 5, the office wrote in a recent data brief. The percentage who said they were offered access and used it jumped 50% during the same period, from 38% to 57%, according to ONC.
    • “Together these findings demonstrate increased patient demand for and use of online health information by individuals in recent years,” the office wrote in the brief, citing data from the 6,252-respondent 2022 Health Information National Trends Survey.
    • “Patients who were offered access to their online medical records also used them more frequently—54% reported accessing their records at least three times during 2022, compared to 38% in 2020 and 26% in 2017.”
  • Healthcare IT News notes,
    • “The emergence of telehealth during the COVID-19 pandemic and the resulting surge in the adoption of telemedicine are helping address patients’ needs without major signs of safety concerns, according to a study by Kaiser Permanente.
    • “The study, published in the Annals of Internal Medicine, analyzed more than 1.5 million adult patients at Kaiser Permanente Northern California in 2021, and compared treatment and follow-up visits among primary care telemedicine (video and telephone) and in-person office visits.
    • “Of the 2,357,598 primary care visits analyzed, just over half (50.8%) utilized telemedicine, which broke down to just under 20% composed of video visits and 31.3% telephone visits.
    • “The findings indicate that medication prescriptions were lower for video and telephone visits at 38.4% and 34.6%, respectively, compared to in-person visits at 46.8%. Additionally, follow-up appointments within seven days were less frequent for in-person visits (1.3%) compared to video (6.2%) and telephone (7.6%) visits.”
  • Per Medscape,
    • “Among the 3188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40–42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.
    • “These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.”
  • HR Dive offers advice to employers about how to extend a helping hand to employees in their first trimester of pregnancy.

From the U.S. healthcare business front,

  • Mercer Consulting offers plan design advice to self-fund health plan sponsors. For example,
    • “Commit to affordable plan designs. One of the biggest reasons people delay care is because they can’t afford to pay for care. Encourage use of preventive care and chronic condition management. 
    • “Provide advocacy support to help plan members get to the most appropriate care and setting. 
    • “Review the emerging spectrum of virtual care for options to help rein in costs while making care more accessible and affordable to plan members. 
    • “Now is the time to consider the long list of network options that exist in the market today and could result in cost savings.   
    • “If you haven’t explored reference-based pricing, you might want to do so. The protections offered by the No Surprises Act make this a more attractive and less risky option for plan members. 
    • “Make mental health a priority. People with medical conditions often have mental health needs. People with mental health needs often develop medical conditions. It is an investment you can’t afford to overlook. 
    • “Focus on pharmacy. Prescription drug costs are a top driver of medical plan cost increases mostly associated with new drugs and the cost of specialty drugs.” 
  • The Wall Street Journal reports,
    • Big Pharma is almost finished with the cough and cold medicine business.
    • French drug giant  Sanofi said Friday it plans to spin off its consumer-health business, which includes well-known brands like allergy medicine Allegra and the pain treatments IcyHot and Aspercreme.
    • — to hive off a division selling over-the-counter medicines and other retail products to focus on more commercially lucrative but scientifically riskier prescription drugs.
    • Once the split is completed as early as the fourth quarter of next year, there will be just one consumer-health business left under the umbrella of a big drugmaker parent. Germany’s Bayer will be the largest drugmaker with such a business. 
    • Sanofi and its rivals have made the moves in the hunt for higher margins and faster sales growth. “It allows Sanofi to become a pure-play biopharma company. We’ll be more agile and more focused in our areas of key areas of strength,” Chief Executive Paul Hudson said.
    • Yet the companies lose the crutch of a reliable source of cash flow and now face more pressure to hit on breakthrough medicines with large sales potential.

Midweek update

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

From Washington, DC

  • The Wall Street Journal reports,
    • “The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
    • “The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
  • STAT News tells us,
    • “A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
    • “The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
    • “Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
  • The NIH National Cancer Institute shares its weekly research highlights.
  • The American Hospital Association News points out,
    • “Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
  • FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.

From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.

From the public health front,

  • Politico reports,
    • “So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
    • “More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
  • From Fierce BioTech,
    • “As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
    • “The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
    • “In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
  • Morning Consult informs us,
    • “28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys. 
    • “Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
    • “The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
  • Per MedTech Dive,
    • “Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
    • “The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
  • BioPharma Dive lets us know,
    • “Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
    • “Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
    • “Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
  • The New York Times reports,
    • “In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
    • “This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”

From the U.S. healthcare business front,

  • Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.   
  • Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
  • Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
  • Per Fierce Healthcare,
    • “An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
  • and
    • “UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
    • “The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
    • “Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”

Monday Roundup

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “A bid by House Majority Whip Tom Emmer (R., Minn.) to serve as the House Republicans’ pick to be speaker will test whether the strong ties he built recruiting candidates and counting votes will overcome doubts from some anti-establishment lawmakers aligned with former President Donald Trump.
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning. Beyond winning the GOP ballot, the speaker nominee will face the uphill battle to unite almost all Republicans to have a chance of winning the House vote, given Republicans’ narrow 221-212 majority.  * * *
    • “To become House speaker designate, the winning candidate must garner a majority of the votes cast within the Republican conference. The internal House GOP conference voting could go multiple rounds, with the candidate receiving the fewest number of votes dropping out after each round until a candidate wins 50% of the vote plus one. After that, the House speaker-designate must win support from a majority in the House, hitting 217 of the 433 House votes if all members show up and cast a vote for an individual.
    • “In an effort to prevent holdout candidates from delaying the process, GOP Rep. Mike Flood of Nebraska is circulating a unity pledge, which lawmakers can sign saying that they promise to back the party’s speaker designee in a House floor vote. His spokeswoman on Monday morning said that all of the candidates except [Rep. Gary] Palmer [R Alabama] have signed on.”
  • Govexec tells us
    • “Lawmakers from both parties last week revived legislation that would allow most federal employees who began their careers as temporary or seasonal workers to make catch-up contributions to their pensions so that they can retire on time.
    • “The Federal Retirement Fairness Act (H.R. 5995), introduced by Reps. Derek Kilmer, D-Wash., Gerry Connolly, D-Va., Don Bacon, R-Neb., and David Valadao, R-Calif., would allow employees enrolled in the Federal Employees Retirement System who began their careers in government as temporary workers to make catch-up contributions to their defined benefit pensions to cover for the time before they had permanent positions and were unable to contribute to their retirement accounts. The legislation was last introduced in 2021 but failed to garner support.”
  • Labor Department Assistant Secretary for Employee Benefits Security Lisa Gomez writes in her blog about Breast Cancer Awareness Month.
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
    • “Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
  • EMPR adds that the “Food and Drug Administration (FDA) has approved Zituvio™ (sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
  • Per Medtech Dive,
    • Medtronic said Monday it received approval from the Food and Drug Administration for an extravascular defibrillator designed to treat abnormal heart rhythms and prevent sudden cardiac arrest, which can lead to death within minutes if not treated immediately.
    • Unlike traditional implantable cardioverter defibrillators, which have lead wires running between a pulse generator and the heart, Medtronic’s Aurora EV-ICD places a lead outside of the heart and veins.
    • The Aurora EV-ICD was a PMA submission to the FDA, Medtronic spokesperson Tracy McNulty said in an email. “We estimate the current global EV-ICD market to be between $300-$350 million, and expect the EV-ICD market to reach $1 billion 10 years out from the Aurora launch,” McNulty said.

From the public health / research front,

  • MedPage Today points out,
    • “Children infected with the Omicron variant of SARS-CoV-2 appear to be infectious for about 3 days after a positive test, researchers found.
    • “In a small study of 76 kids ages 7 to 18, the median duration of infectivity was 3 days for both vaccinated and unvaccinated children, Neeraj Sood, PhD, of the University of Southern California, and colleagues reported online in a JAMA Pediatrics research letter.
    • “The vast majority of children who get COVID are symptomatic for 1 to 3 days,” co-author Eran Bendavid, MD, MS, of Stanford University, told MedPage Today. “Basically that correlates with how long the virus is causing disease in their body.”
  • and
    • “Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.”
  • Health Day notes,
    • “Gun homicide rates went down in 2022, following increases reported during the pandemic.
    • “But race still played an outsized role, with Black people continuing to have the highest firearm homicide rates, and by a wide margin.
    • “American Indian/Alaska Natives were the only groups to see an increase again in 2022.
  • The Wall Street Journal reports
    • “The age women start taking menopausal hormone therapy and the kind they take might affect their chances of developing dementia later in life, a new study found.
    • “Women have struggled for years with whether to take hormone therapy when they go through menopause. The medication can help relieve troubling symptoms such as hot flashes and night sweats. However, years of conflicting research on whether the therapy can lead to other health problems, including breast cancer, dementia and heart attacks, has left many women confused about what to do.
    • “This new study suggests that hormone therapy might lower—or at least not raise—your dementia risk if you take it in midlife. For older women, the study found some signs that the medication might raise it.
  • mHealth Intelligence explains that “The shift to telebehavioral healthcare during the COVID-19 pandemic is linked to fewer disruptions in psychotherapy services, indicating telehealth can be effective in supporting the continuity of these services, a new study shows.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Physicians’ decisions to leave their practices is a complex choice “with multiple interdependent factors,” and is not solely impacted by burnout, pay or frustrations with electronic health records, according to a new qualitative study published in ​​the Journal of the American Board of Family Medicine.
    • “The study, which interviewed physicians who left their ambulatory care practices between 2018 and 2021, found that they were motivated to increase time off, have more flexibility or receive higher earnings. However, other departing physicians reported higher compensation would not have persuaded them to stay.
    • “Physician practices can better retain clinicians by addressing risk factors for departure including workflow distribution across team members and ensuring adequate staffing, the report said.”
  • The Wall Street Journal reports,
    • “Roche Holding has agreed to buy the developer of a bowel-disease treatment from Roivant Sciences, a company started by Republican presidential candidate Vivek Ramaswamy, and Pfizer in a deal worth more than $7 billion.
    • “The Swiss pharmaceutical giant said Monday it would pay $7.1 billion upfront for Telavant Holdings and make a near-term milestone payment of $150 million. Roche said the deal gives it rights to commercialize Telavant’s RVT-3101 drug candidate, which has shown promise for inflammatory bowel disease and could have potential in other indications in the U.S. and Japan. 
    • “The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs. Merck earlier this year agreed to pay more than $10 billion to buy Prometheus Biosciences, which is developing a drug for inflammatory bowel disease that would compete with Telavant’s candidate.”
  • Per Fierce Healthcare
    • “Folx Health, a virtual provider focused on LGBTQ+ health, is now in-network with Cigna, Evernorth and Blue Shield of California.
    • “Other payer partners include Blue Cross and Blue Shield of Texas and Optum for behavioral health service in Colorado and Florida, according to Folx Health’s website. Through the collaboration, insured patients can use therapy and mental health medication management with Folx’s LGBTQ-specialized clinicians. 
    • “Folx offers virtual primary care, gender-affirming care and mental health services. Making that care in-network will deliver its patients significantly lower out-of-pocket costs, per the company.”
  • Assured Partners offers HSA and FSA Account Reminders for Year-End.

Thursday Miscellany

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Washington, DC,

  • The Wall Street Journal reports,
    • Republican speaker nominee Rep. Jim Jordan was weighing whether to embark on a third-floor vote after a plan to temporarily put caretaker speaker Rep. Patrick McHenry in charge of the House ran into sharp objections from conservatives.
    • “I am still running for speaker, and I plan to go to the floor and get the votes and win this race,” Jordan said initially after leaving a heated closed-door meeting of House Republicans. The Ohio conservative said the plan to elect a temporary speaker didn’t have the support of the conference.
    • In the evening, Jordan met in a House office with detractors. As some trickled out, there was no sign he had managed to change their minds, and Jordan wouldn’t say after the meeting whether he still intended to hold another floor vote. 
  • The New York Times adds, “Mr. Jordan said he would push for another vote to become speaker, scheduled for Friday at 10 a.m., even though he was bleeding support and calls were increasing for him to step aside.”
  • The Society for Human Resource Management informs us,
    • “The U.S. Supreme Court has agreed to hear two cases that will impact the power of federal agencies to implement regulations on employers.
    • “On Oct. 13, the court decided to hear Relentless v. Department of Commerce, in which the owners of three fishing companies in Rhode Island and Massachusetts sued to challenge the federal government’s authority to require them to partially pay for federal monitors on their boats. The justices willconsider that case in tandem with a similar case, Loper Bright Enterprises v. Raimondo, which involves the same requirement for fishing companies in New Jersey.
    • “In both cases, the justices will decide whether to overturn the long-standing Chevron precedent, which holds that when Congress wrote a statute without a clear meaning, courts should defer to the federal agency applying the law, unless its directives were unreasonable. Federal departments and agencies that enforce employment laws could be impacted.”
  • In yesterday’s post, the FEHBlog called attention to AHIP’s public comments on the proposed rule, making changes to the current mental health parity rules. AHIP asked the regulators to try again. Per Fierce Healthcare,
    • “The Blue Cross Blue Shield Association (BCBSA) echoed AHIP in its comments, arguing that additional clarity around the changes is necessary. The organization said it could lead patients to care that is not recommended, worsening outcomes.
    • “We share the administration’s goal of expanding access to affordable mental health support, but we’re concerned it could become harder—not easier—for patients to get the care they need,” said David Merritt, BCBSA’s senior vice president of policy and advocacy, in a statement.
    • “This rule could push us in the wrong direction by forcing health plans to remove important protections that ensure patients are receiving safe, medically necessary, effective care,” Merritt added. “We’ll continue to work with our partners, the administration and Congress to improve both access and quality for Americans.”
    • “The Alliance for Community Health Plans said the updates create “an entirely new regulatory schema” that would actually impede insurers looking to address mental health parity.
    • “The ERISA Industry Committee, or ERIC, said many of the proposals “reflect an overreach of agency authority under the statute” and that they would be burdensome for employer-sponsored health plans. The changes, ERIC said, could drive up costs for families and force significant changes to benefit designs.
    • “Unfortunately, the proposed regulations are so unworkable, it is unclear how compliance could ever be achieved while continuing to offer these important benefits,” said James Gelfand, CEO of ERIC, in a statement. “The Departments’ proposals are written in a way that sets plans up to fail.”
  • The FEHBlog agrees.
  • Reuters tells us,
    • “The U.S. health regulator [the Food and Drug Administration] has approved Hyloris Pharmaceuticals’ drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year.
    • “The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally.
    • “Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.”

From the public health front,

  • HHS’s Agency for Healthcare Research and Quality posted for public comment an Effective Health Programs abstract on caring for Long Covid. The comment period ends on November 17, 2023.
  • Healio points out,
    • “Data show CMS’ Million Hearts CVD Risk Reduction Model, which provided payments for CVD risk assessment and reduction, reduced incidence of first-time MIs and strokes over 5 years without significant changes in Medicare spending.
    • “The results support clinical guidelines for CVD preventive care,” G. Greg Peterson, PhD, MPA, a principal researcher with Mathmatica, told Healio. “Current guidelines in the U.S., similar to those in other countries, recommend that health care practitioners calculate CVD risk scores and use the scores to engage patients in discussions about CVD prevention. Although previous studies of CVD risk scoring interventions have shown improvement in CVD risk factor control, this is the first study of a CVD risk score-focused intervention to demonstrate declines in CVD events.”
  • Health Day lets us know,
    • “Fluctuating blood pressure can be a harbinger for both dementia and heart disease, a new study finds.
    • “Ups and downs within 24 hours or even over several days or weeks were linked with impaired thinking, researchers from Australia reported.
    • “Higher variations in systolic blood pressure, the top number, were linked with stiffening of the arteries, which is associated with heart disease.
    • “Clinical treatments focus on hypertension while ignoring the variability of blood pressure,” said lead author Daria Gutteridge, a PhD candidate at the University of South Australia’s Cognitive Aging and Impairment Neuroscience Laboratory.”
  • The National Institutes of Health announced,
    • “A research team funded by the National Institutes of Health has developed a smartphone app that can track and analyze a person’s ability to move from one place to another, known as locomotion and other types of movements. Human motion analysis is used to evaluate patients with movement difficulties, to help clinicians plan surgery, and to assess the results of treatment procedures. The research team believes that using the app costs about 1% of conventional motion analysis techniques and works 25 times faster. The study appears in PLOS Computational Biology.
    • “Researchers tested their app, called OpenCap, with 100 participants. Using two or more smartphones, the app recorded sufficient quality videos to allow for web-based, artificial intelligence analysis of muscle activations, joint loads and joint movements. Data collection took 10 hours for the 100 participants, and computation of results took 31 hours. Traditionally, locomotion analysis requires fixed lab space and more than $150,000 worth of equipment, including eight or more specialized cameras to capture three-dimensional images. The captured data also takes several days to analyze by a trained expert.
    • “While current technology is too expensive for routine clinical use, according to the investigators, the app could potentially be used to help screen for disease risk, inform rehabilitation decisions, and track improvements in motion following treatment.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • CVS Health is pulling some of the most common decongestants from its shelves and will no longer sell them, after advisers to U.S. health regulators recently determined that an ingredient doesn’t work.
    • The products contain [as the only active ingredient] oral phenylephrine, an almost-century-old ingredient in versions of decongestants and over-the-counter pills, syrups and liquids to clear up congested noses.
    • An advisory panel to the Food and Drug Administration last month declared that the ingredient was ineffective when taken orally. The FDA had said in its own analysis that the oral phenylephrine formulations are safe but ineffective at standard or even higher doses.
    • The FDA hasn’t made a decision yet nor asked manufacturers or retailers to remove products from store shelves. CVS is removing phenylephrine products voluntarily.
  • Beckers Hospital Review informs us,
    • “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. 
    • “Rite Aid has more than 2,000 stores in 17 states. Of the 154 planned closures, about 40 are Pennsylvania locations. Many stores in California and New York will also close, and additional store closings may be forthcoming as Rite Aid looks to shed about $4 billion in debt. 
    • “The Philadelphia-based company previously said it secured $3.45 billion from lenders to fund operations through the bankruptcy restructuring, with McKesson Corp. as the largest creditor. Alongside the bankruptcy filing, Rite Aid announced Jeffrey Stein as its new CEO and chief restructuring officer.”

Midweek Update

David Ermer–ACA, Congress, COVID treatment, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • The Wall Street Journal reports,
    • “GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
    • “More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
  • The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
  • Govexec tells us,
    • “A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
    • “Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
    • “The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
  • MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
    • “In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
  • The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
  • HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
  • AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
  • Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.

From the public health front,

  • STAT News reports,
    • Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
    • “One way researchers are trying to figure this out is by focusing on genes.
    • “The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
  • Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
    • “The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy. 
    • “Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
  • The National Institutes of Health announced,
    • “Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Open, these findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
    • “In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
  • HealthDay points out,
    • “Researchers have identified a link between attention-deficit/hyperactivity disorder (ADHD) in adults and dementia.
    • “The risk of dementia is three times higher in adults with ADHD, according to a large study of Israelis who were followed for 17 years.
    • “More research is needed to verify the findings and understand the link.”
  • The Wall Street Journal reports,
    • “Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
    • “Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
    • “Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
    • “Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”

From the U.S. healthcare business front,

  • KFF reports,
    • “Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
    • “On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
    • “Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
    • “This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
  • Per WXYZ.com (Detroit MI),
    • “Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
    • “According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
    • According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
  • Healthcare Dive adds,
    • “Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall. 
    • “Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
    • “Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
  • Beckers Payer Issues notes,
    • “In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
    • “Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
  • and
    • “Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17. 
    • “Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.” 
  • Per Fierce Healthcare,
    • “Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
    • “The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
    • “Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
    • “Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”

Tuesday Tidbits

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Rep. Jim Jordan (R., Ohio) failed to win enough votes Tuesday to be elected House speaker after more Republicans than expected joined Democrats in declining to back him, setting up lawmakers for an unpredictable second round of balloting.
    • “The favorite of the Republican base and ally of former President Donald Trump saw 20 GOP lawmakers break with him in the first round Tuesday afternoon, many more than the handful the GOP nominee could afford to lose. Democrats backed their pick, Minority Leader Hakeem Jeffries (D., N.Y.), while the Republican holdouts scattered their votes among other GOP figures.
    • “The result deflated hopes for a quick resolution of intraparty fighting * * *.
    • “After the failed vote, Republicans huddled in small groups to discuss their options. One approach would be to give more power to Speaker Pro Tempore Patrick McHenry (R., N.C.), if enough Republicans and Democrats supported the idea.”
  • The Federal Times shares the dates and deadlines to remember for FEHB open enrollment.

From the public health and research front,

  • Beckers Hospital Review informs us,
    • New weekly COVID-19 admissions are down for the fourth week straight, according to the latest data from the CDC. Meanwhile, flu and respiratory syncytial virus are starting to rise. 
    • COVID-19: COVID-19 metrics declined in the U.S. for the week ending Oct. 7. A total of 16,766 new COVID-19 admissions were reported this week, marking an 8.2% decline from the week prior. Emergency department visits related to the disease were also down nearly 18%. The decline in activity comes after about three months of steady increases in hospitalizations. Based on past trends, however, experts predict the nation may see another winter uptick in December or January — the same time of the year flu tends to peak. 
    • RSV: Cases of RSV have been slowly rising in the U.S. Overall, the positivity rate remains much lower than this time last year, though some hospitals in the South have started to see RSV hospitalizations increase. Holtz Children’s Hospital in Miami has seen a “five-fold increase for influenza and a two-fold increase for RSV,” the hospital’s chief medical officer, Barry Gelman, MD, told a local news outlet in a report earlier this month. 
    • Flu: Flu activity remains low nationally, with a positivity rate of 1.1% for the week ending Oct. 7. CDC officials told NBC News activity will likely ramp up over the next few weeks. Just over 1,100 patients with lab-confirmed flu were admitted to the hospital for the week ending Oct. 7, up slightly from the week prior. Most cases reported so far this season are influenza A.
    • Hospitalizations for flu, COVID-19 and RSV are projected to peak at the end of January. With that timeline, hospitals may see similar levels of capacity and resource strain as last respiratory virus season since peaks may overlap. Health experts have been optimistic that a collection of vaccines and a new monoclonal antibody for RSV would largely prevent severe illness and minimize capacity strain on hospitals. However, significant hurdles in accessing the shots may prevent them from reaching those most at risk of severe illness before virus season is in full swing. 
  • CIDRAP from the University of Minnesota tells us,
    • “A meta-analysis today in Antimicrobial Stewardship & Healthcare Epidemiology estimates a vaccine effectiveness (VE) of 69% for three doses of COVID-19 vaccine against long COVID, while two doses offer 37% efficacy.
    • “Led by researchers at the University of Iowa, the meta-analysis involved 24 studies on COVID-19 VE against long COVID among recipients of at least two doses of a vaccine before or after infection from December 2019 to June 2023.
    • “With the ongoing COVID-19 pandemic, a considerable proportion of individuals who have recovered from COVID-19 infection have long-term symptoms involving multiple organs and systems,” the researchers wrote.”
  • Healio points out,
    • “Adhering to a healthy lifestyle could reduce coronary health disease risk [by 25%] regardless of genetic susceptibility to abdominal obesity.
    • “The more favorable lifestyle included factors like a healthy diet and sleep habits.”
  • The NIH Directors Blog lets us know,
    • “Each year in the U.S., more than 500,000 people receive treatment for burn injuries and other serious skin wounds. To close the most severe wounds with less scarring, doctors often must surgically remove skin from one part of a person’s body and use it to patch the injured site. However, this is an intensive process, and some burn patients with extensive skin loss do not have sufficient skin available for grafting. Scientists have been exploring ways to repair these serious skin wounds without skin graft surgery.
    • “An NIH-funded team recently showed that bioprinted skin substitutes may serve as a promising alternative to traditional skin grafts in preclinical studies reported in Science Translational Medicine. The approach involves a portable skin bioprinter system that deposits multiple layers of skin directly into a wound. The recent findings add to evidence that bioprinting technology can successfully regenerate human-like skin to allow healing. While this approach has yet to be tested in people, it confirms that such technologies already can produce skin constructs with the complex structures and multiple cell types present in healthy human skin.”
  • The Washington Post discusses improving the availability of primary care in our country.
  • STAT News interviews the scientist who made Novo Nordisk an obesity drug powerhouse, Dr. Lotte Bjerre Knudsen.
    • “When the company invented a once-weekly version of the drug, called semaglutide, she spearheaded research to understand its biological impact on metabolism, cardiovascular and kidney health, and the brain. In clinical trials, semaglutide cut a person’s food intake by up to 35%, more than double the effect of liraglutide.
    • “Knudsen’s team conducted studies suggesting it achieves such dramatic results by modifying overlapping neural pathways involved in food intake, reward drives, and energy expenditure — studies that have helped prove that one molecule can, in fact, have multiple biologies. What the brain does with GLP-1 and what the gut does are two very different things. Drugs like liraglutide and semaglutide just happen to harness them both, separately, at the same time.
    • “Those lessons have led Knudsen to ask if GLP-1 might have other roles in the brain that could be exploited to therapeutic ends. One of the most promising areas she’s now focusing on is Alzheimer’s disease. Other researchers have their sights set on seeing if these drugs might help people with addiction and alcohol use disorders control their cravings.
    • “The science here is still early, Knudsen emphasized. But the fact that it exists at all owes much to her singular determination. “I’m actually quite patient,” she said. “When it comes to slowly working to progress something that could be important in the future, that needs to take its time.”

From the U.S. healthcare business front,

  • STAT News notes,
    • “Here at ObesityWeek, one of the largest conferences on obesity, Novo Nordisk and Eli Lilly are displaying more than a dozen studies that together carry the message: Our blockbuster weight loss treatments will be worth it for society.
    • “But experts point out that much of this company-funded research does not include the cost of the drugs themselves, which sell at more than $10,000 per year in the U.S. and are meant to be taken indefinitely. * * *
    • “As more economic analyses emerge, these questions of how worth it the new obesity drugs are will continue to be top of mind for clinicians, said Jamy Ard, president-elect of The Obesity Society and co-director of the Atrium Health Wake Forest Baptist Weight Management Center.
    • “We are stewards of the resources,” said Ard, who has consulted for Novo and Lilly. “If we are skeptical about the cost-effectiveness of the treatment, where we know that our patient populations can’t afford a certain therapy, then we’re not going to prescribe it. We’re not going to encourage health plans to approve the treatment or make treatment available to people if we think that there are better ways to spend those health care dollars.”
    • In the FEHBlog’s view, the manufacturers are not taking into account the rapidly growing number of people who may receive a prescription for these drugs.
  • Per Healthcare Dive,
    • “One Medical has quietly rebranded the senior care clinics it acquired from its 2021 buy of Iora Health to “One Medical Seniors” in an effort to better synchronize the two businesses.
    • “The rebrand, and ongoing efforts to expand the ability of One Medical clinics to treat a wider variety of patient populations, are likely to help the primary care provider nab more clients, analysts said.
    • “People need to know who they’re doing business with or receiving care from. And that’s especially true when you look at the senior population,” said Arielle Trzcinski, a principal analyst at Forrester who focuses on the digital and retail health markets. “So being able to apply the One Medical brand to Iora — it’s a trusted brand. So there’s an opportunity for net new customers.”
  • MedCity News observes,
    • “Rite Aid filed for Chapter 11 bankruptcy protection on Sunday amid decreasing sales, billions of dollars in debt and more than a thousand lawsuits claiming the chain filled illegal prescriptions for opioids. In order for the company to get back on its feet, experts say it will have to start acting more like its competitors, such as Walgreens and CVS, by leaning more into care delivery, forging strong payer partnerships, and improving its digital offerings.”