FEHBlog

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson said Thursday that Republicans are considering a new approach to stopgap funding that would extend pieces of current appropriations for different time periods, effectively setting up a series of funding cliffs while avoiding a single deadline that could trigger a partial government shutdown for all agencies.
    • “With current funding for the entire government set to expire on Nov. 17, Johnson has proposed a CR to extend funding through Jan. 15, though that date is the federal Martin Luther King Day holiday. But the Louisiana Republican said at a press conference some GOP members raised the idea of a “laddered CR” to extend funding on a piecemeal basis.”
  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a discussion draft including policies aimed at expanding mental health care under Medicaid and Medicare and reducing prescription drug costs for seniors at the pharmacy counter. The package also includes essential Medicaid and Medicare provisions that will expire this year, as well as changes to Medicare payment to support physicians and other professionals. The Committee intends to advance these legislative proposals, in addition to pharmacy benefit manager (PBM) reforms previously passed out of the Committee in July, and pursue full Senate passage and enactment. As part of that process, the Committee intends to hold a markup on Wednesday, November 8 at 10 a.m. In keeping with Finance Committee rules, the Chairman’s Mark will be released 48 hours in advance of the markup.”
  • It was a very busy day for the Centers for Medicare and Medicaid Services. We learned from the American Hospital Association that
    • The Centers for Medicare & Medicaid Services Nov. 2 issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 3.1% in calendar year 2024 compared to 2023. This includes a 3.3% market basket update, offset by a 0.2% cut for productivity.
    • In a statement shared with the media, AHA Executive Vice President Stacey Hughes said “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments. Today’s increase for outpatient hospitals of only 3.1% comes in spite of persistent financial headwinds facing the field. Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.” 
    • The rule also finalizes several changes to the hospital price transparency rule, including requiring a new standard format with an additional data element and a completeness and accuracy affirmation statement. CMS also makes updates to streamline the enforcement process. Compliance dates for the changes range from Jan. 1, 2024, to Jan. 1, 2025. Most formatting changes take effect July 1, 2024.
  • and
    • “Following last year’s unanimous Supreme Court decision in favor of the AHA and others, the Department of Health and Human Services Nov. 2 issued a final rule outlining the agency’s remedy for the unlawful payment cuts to certain hospitals that participate in the 340B Drug Pricing Program. 
    • “HHS’ final rule contains two central components. First, HHS will repay 340B hospitals that were unlawfully underpaid from 2018 to 2022 in a single lump sum payment. The final rule contains the calculations of the amounts owed to the approximately 1,600 affected 340B covered entity hospitals. Second, HHS finalizes a policy to recoup funds from those hospitals that received increased rates for non-drug services from 2018 to 2022. HHS will recoup these funds by adjusting the outpatient prospective payment system conversion factor by minus 0.5% starting in calendar year 2026 (one year later than HHS had originally proposed and as AHA advocated), making this adjustment until the full amount is offset, which the department estimates to be 16 years.
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “Following years of litigation and a unanimous Supreme Court win, the AHA is very pleased that 340B hospitals finally will be reimbursed in full for what HHS unlawfully withheld from them for five years. The one-time, lump-sum repayment hospitals will soon receive will help them to continue providing high-quality care to their patients and communities. However, HHS made a grievous mistake in choosing to claw back billions of dollars from America’s hospitals, especially those that serve rural, low-income and other vulnerable communities. HHS decided to ignore hundreds of comments from hospitals and other providers explaining why this Medicare cut is both illegal and unwise. The AHA will continue to review this rule and consider all available options going forward.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 2 released its calendar year 2024 final rule for the physician fee schedule. The rule will cut the conversion factor by 3.4%, to $32.74 in CY 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a budget-neutrality adjustment. 
    • “As urged by the AHA, CMS addressed the fact that on Jan. 1 practitioners who render telehealth services from home would have been required to report their home address on enrollment and claims forms. The agency delayed this provision until Jan. 1, 2025, and solicits comments on the issue for future rulemaking.
    • “In addition, the agency finalized a revised definition of the substantive portion of a split (or shared) visit. Specifically, for CY 2024, for purposes of Medicare billing, the definition of “substantive portion” means more than half of the total time spent by the physician and non-physician practitioner performing the split (or shared) visit or a substantive part of the medical decision-making.
    • “CMS finalized its proposals to advance access to behavioral health services. First, CMS will implement regulations as directed by the Consolidated Appropriations Act of 2023 to create a new benefit category for marriage and family therapists and mental health counselors under Part B, who will be eligible to provide telehealth services and behavioral health integration services. CMS also established new payment codes for mobile psychotherapy for crisis services as required by the CAA. Separately, the agency will apply an adjustment to psychotherapy services payments billed with a new increased complexity code and will increase the payment rate for the substance use disorder bundle.”
  • What’s more, AHA News reports,
    • “The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, Nov. 2 sued the federal government to bar enforcement of an unlawful, harmful and counterproductive rule that has upended hospitals’ and health systems’ ability to share health care information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.  * * *  
    • “Today’s lawsuit challenges a “Bulletin” issued by HHS’ Office for Civil Rights. The December 2022 “Bulletin” restricts hospitals from using standard third-party web technologies that capture IP addresses on portions of hospitals’ public-facing webpages that address health conditions or health care providers. For example, under HHS’ new rule, if someone visited a hospital website on behalf of her elderly neighbor to learn more about Alzheimer’s disease, a hospital’s use of any third-party technology that captures an IP address from that visit would expose that hospital to federal enforcement actions and significant civil penalties.”  
  • The U.S. Office of Personnel Management announced “the recipients of the 2023 Presidential Rank Awards (PRA) chosen by President Joe Biden. The PRAs are one of the most prestigious awards in the career civil service, recognizing the important contributions of public servants across the federal government.” Congratulations to the recipients.   

In FEHB news, FedWeek discusses the relationship between FEHBP and FEDVIP plans.

  • “FEDVIP is the “secondary” payer to any benefits provided under an FEHB plan. If you are enrolled in both FEDVIP and FEHB, you must provide your FEHB enrollment information during the FEDVIP enrollment process (which takes place online, on www.benefeds.com). It’s a good idea to provide your FEHB information to the medical office that is providing the dental or vision services under FEDVIP.
  • “Also, if you change your FEHB health plan during the year, you need to notify BENEFEDS immediately. If you fail to provide this information, payment of claims will be delayed.”

From the public health and research front,

  • The U.S. Preventive Services Task Force released its final research plan for “Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions.”
  • The NIH Director’s Blog discusses “How Double-Stranded RNA Protects the Brain Against Infection While Making Damaging Neuroinflammation More Likely.”
    • “The findings show how this tricky balance between susceptibility to infection and inflammation in the brain works in both health and disease. It also leads to the tantalizing suggestion that treatments targeting these various players or others in the same pathways may offer new ways of treating brain infections or neuroinflammatory conditions, by boosting or dampening dsRNA levels and the associated immune responses. As a next step, the researchers report that they’re pursuing studies to explore the role of dsRNA-triggered immune responses in ALS and Alzheimer’s, as well as in neuropsychiatric symptoms sometimes seen in people with lupus.”
  • The Food and Drug Administration released
    • “data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
    • “Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.”
    • “It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”  

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Cigna has hiked its membership expectations for 2023. The health insurer previously expected to lose commercial members in the back half of the year, prepping for an economic downturn that might cause Americans to lose their jobs — and subsequently, their insurance.
    • “But the expected economic downturn has yet to materialize, leading Cigna to say on Thursday it expects to add at least 1.6 million members this year, up 200,000 lives from previous forecasts.
    • “We’ve not seen the disenrollment levels we incorporated into our prior outlook,” said CFO Brian Evanko on a Thursday call with investors. Cigna also raised its revenue and adjusted earnings per share outlook for 2023, after releasing third-quarter earnings.”
  • and
    • “Amwell posted a growing net loss in the third quarter as the telehealth firm notched another hefty goodwill impairment charge.
    • “The Boston-based company’s losses reached $137.1 million — a 94% increase from the same period in 2022 —  including $78.9 million in impairment charges linked to sustained decreases in its share price and market capitalization. Revenue declined 11% year over year to $61.9 million. 
    • “But a recent contract with the Department of Defense’s Health Agency that aims to digitize the military healthcare system “fortifies our path to profitability,” expanding Amwell’s reach within the public sector, CEO Ido Schoenberg said on a call with investors Wednesday.”
  • BioPharma Dive adds
    • “Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
    • “Both companies cautioned about potential supply constraints, however. Wegovy still has limited availability at the starter dose, and Lilly CEO David Ricks said there is a need to increase manufacturing capacity “pretty dramatically from the current levels.
    • “Wegovy sales jumped nearly five-fold to 21.7 billion Danish krone, or about $3.1 billion, through the first nine months of this year, according to Novo. Sales of Ozempic, which is approved as a diabetes drug but used off-label in weight loss, were 65.7 billion krone, a 58% rise. * * *
    • “Lilly on Thursday revealed equally promising sales numbers for Mounjaro, which is so far approved only as a blood sugar-lowering agent for people with Type 2 diabetes. Sales of the dual-acting drug were $3 billion for the first nine months of 2023, which will be its first full year on the market. It is now Lilly’s second-biggest seller after another GLP-1 drug called Trulicity, sales of which have declined as Mounjaro’s have grown.
    • “A Food and Drug Administration decision on approving Mounjaro, known also as tirzepatide, in obesity should come by the end of 2023 * * *.”
  • The Wall Street Journal points out
    • “Both Lilly and Denmarks Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up. * * *
    • “Keeping up with demand requires investments in factories that take years to build. Morgan Stanley analysts recently forecast the global anti-obesity market would be worth $77 billion by 2030. Mounjaro, Ozempic and Wegovy are injectables, which are complex to manufacture. Some oral medications currently in clinical trials, such as Lilly’s orforglipron, are smaller molecules, which are simpler to make. Supply constraints may only be truly remedied whenorals come to the market, the analysts 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.

Monday Roundup

David Ermer–Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The American Medical Association News tells us,
    • “President Biden, Oct. 30, directed federal agencies to take certain actions to protect Americans from the potential risks of artificial intelligence systems while promoting innovation and competition. The executive order calls for the Department of Health and Human Services to establish a safety program to regulate healthcare AI practices and for developers of high-risk AI systems to share their safety testing results and other relevant information with the federal government. Among other actions, the order urges Congress to enact data privacy safeguards for Americans, and requires federal agencies to develop best practices to investigate and prosecute AI-related discrimination and guidelines to prevent fraudulent and deceptive AI-generated content.”
  • Federal News Network adds
    • “The Biden administration is calling for a “governmentwide AI talent surge” across the federal workforce to build up its capacity to lead on this emerging technology.
    • “President Joe Biden, in an executive order Monday, is requiring agencies to set comprehensive policies for how they will use AI tools internally to further the business of government.
    • “The White House, in a fact sheet, said the executive order also “directs the rapid hiring of AI professionals, as part of a governmentwide AI talent search.”
    • “Biden, speaking at the White House, said that “without the right safeguards in place, AI can lead to discrimination, bias and other abuses.”
  • MeriTalk points out,
    • “The Office of Personnel Management (OPM) is getting close to releasing a proposal that would offer “equity around pay and flexibilities in the workplace” for Federal government tech and cybersecurity personnel, OPM Director Kiran Ahuja said today.
    • “Speaking at ACT-IAC’s Imagine Nation conference in Hershey, Pa., the OPM director talked about the soon-to-be-issued proposal as part of a reply to a question about what she’s most proud of accomplishing at the agency since taking the helm at OPM in 2021.
    • “One of those points of pride, she said, was “that we’ve spent a lot of time thinking about cyber and tech talent,” including OPM’s efforts to recruit private sector tech and cyber personnel into service with the government.”
  • On a related note, the AHA News reports,
    • “The Department of Health and Human Services, Oct. 30, released a proposed rule intended to create disincentives for health care providers to interfere with the access, exchange or use of electronic health information. Under the rule, which implements a provision of the 21st Century Cures Act, healthcare providers that HHS’ Office of Inspector General determines have committed information blocking and refer that determination to the Centers for Medicare & Medicaid Services would be ineligible for certain incentives under the Medicare Promoting Interoperability Program and Shared Savings Program, HHS said. The agency will publish the proposed rule in the Nov. 1 Federal Register with comments accepted through Jan. 2.”  
  • The Food and Drug Administration announced the recall of certain eye drop products due to the risk of serious infection.
  • AHA News calls attention to the fact that
    • “The Food and Drug Administration, the week of Oct. 23, cleared for marketing the first over-the-counter test to detect fentanyl in urine. The five-minute test provides only preliminary results and includes a pre-addressed mailing box for shipping samples to the manufacturer’s laboratory for confirmation testing using an alternative chemical method. The agency expedited its review of the Alltest Fentanyl Urine Test Cassette, clearing it only 16 days after the submission was received.
    • “Opioid abuse, misuse and addiction is one of the most profound public health crises facing the U.S. today,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “…This test is an example of the FDA’s continued commitment to authorize tools that can reduce deaths associated with overdoses.”
  • On a related note, the Wall Street Journal calls our attention to effective over-the-counter treatments for congestion.

In FEHB news,

  • Govexec discusses the availability of Medicare Part D PDPs in nine “first out of the gate” FEHB plans (seventeen options) for 2024.

From the public health front,

  • The Institute for Clinical and Economic Review released a “Final Evidence Report on Gene Therapy for Metachromatic Leukodystrophy”
    • The Independent appraisal committee voted that across all patient subpopulations, arsa-cel demonstrated a net health benefit when compared to usual care; arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M and $3.9M.
  • The New York Times reports on a new surgical technique called component separation to resolve hernia conditions. A surgeon must undergo specialized training before operating on a living patient. Apparently, some surgeons jumped the gun, no doubt leading to malpractice lawsuits.
  • The American Health Association announced,
    • “Cardiovascular deaths from extreme heat in the United States are projected to increase by 162% by the middle of the century, based on a hypothetical scenario where currently proposed U.S. policies to reduce greenhouse gas emissions have been successfully implemented.
    • “A more dire scenario forecasts cardiovascular deaths from extreme heat could increase by 233% in the next 13-47 years if there are only minimal efforts to reduce emissions.
    • “The percentage increase in deaths will be greater among elderly people and non-Hispanic Black adults in either scenario.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Prices negotiated by health insurers vary widely between geographies — even for the same insurer, according to a new study that authors said is the first of its kind relying on federally mandated price transparency data.
    • “Humana members paid more for medical care in the Upper Midwest and Southeast than in the Central U.S. and Florida, according to the research published in JAMA Health Forum last week.
    • “More than half of Americans are covered by private insurers, which negotiate rates in local markets. The variability in cost between markets could be due to a number of factors, including imbalances in market power and negotiation leverage, anti-competitive practices and actual variation in clinical quality, study authors said.”
  • BioPharma Dive tells us,
    • “An experimental kidney disease drug Novartis acquired via a $3 billion deal earlier this year succeeded in a late-stage trial, the Swiss pharmaceutical company said Monday.
    • “The drug, called atrasentan, reduced protein in the urine of people with IgA nephropathy by significantly more than placebo, meeting the Phase 3 trial’s goal. IgA nephropathy is a leading cause of chronic kidney disease and often causes persistently high urine protein, or proteinuria.
    • “With the positive data in hand, Novartis plans to submit an application to U.S. regulators for accelerated approval of the drug. The company’s trial will continue to run for another two years to assess changes in kidney function over time.”
  • Fierce Healthcare explains how “Amazon Pharmacy’s focus on making it faster and more convenient for patients to get prescription medications comes as brick-and-mortar drugstores are limiting pharmacy hours and even closing locations across the country.”

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.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • The Cybersecurity and Infrastructure Security Agency and the Department of Health and Human Services held
    • “a roundtable discussion on the cybersecurity challenges that the U.S. healthcare and public health (HPH) sector system faces, and how government and industry can work together to close the gaps in resources and cyber capabilities. Ahead of the roundtable, CISA and HHS released a cybersecurity tool kit that includes resources tailored for the healthcare and public health sector. * * *
    • This toolkit is easy to navigate online at www.CISA.gov/healthcare and consolidates resources like:  
      • “CISA’s Cyber Hygiene Services, which use vulnerability scanning to help secure against known vulnerabilities, reduces the risk of cyberattacks and encourages the adoption of best practices.   
      • “HHS’s Health Industry Cybersecurity Practices, which was developed with industry, outlines effective cybersecurity practices healthcare organizations of all sizes can adopt to become more cyber resilient.  
      • “HHS and the HSCC’s HPH Sector Cybersecurity Framework Implementation Guide which helps organizations assess and improve their level of cyber resiliency and provide suggestions on how to link cybersecurity with their overall information security and privacy risk management activities.” 
  • Cybersecurity Dive informs us,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) on Thursday issued a request for comment on how to create a more harmonized system of software identification as part of a larger effort to make the software supply chain more secure. 
    • “Since President Joe Biden issued an executive order on improving cybersecurity in 2021, CISA and other federal agencies have been working to prioritize software security by improving vulnerability management and the use of software bill of materials (SBOMs). 
    • “The request for comment is designed to establish some uniform parameters to track critical information required to improve software security. Information on known vulnerabilities, what mitigations or security patches are available, and which software is approved for use are all part of the effort, according to a white paper released by CISA.” 
  • The Wall Street Journal tells us,
    • “President Biden is expected to sign an executive order next week addressing rapid advances in artificial intelligence, laying the groundwork for Washington’s embrace of AI as a tool in the national security arsenal while also pressuring companies to develop the technology safely.
    • “The order, which hasn’t been finalized and was described by people briefed on its expected contents, is aimed at establishing guideposts for federal agencies’ own use of AI, while also leveraging the government’s purchasing power to steer companies to what it considers best practices. 
    • “The White House began inviting people this week to an event on “safe, secure and trustworthy AI,” according to people familiar with the matter. A spokeswoman for the White House declined to comment.”

From the cybersecurity vulnerabilities and defenses front,

  • Health Exec reports,
    • “A new report reveals there have been 480 healthcare data breaches in 2023 so far, with over 25% of Americans impacted. The estimated number of patients affected is 87 million this year so far, over double the 37 million in 2022. 
    • “The report comes from Atlas VPN, which utilized publicly available data from the U.S. Department of Health and Human Services (HHS), which keeps a running list of healthcare security incidents. Federal law requires data breaches that potentially leak more than 500 patient records to be reported to the HHS.  * * *
    • “The full report can be found here.”
  • HHS’s Health Sector Cybersecurity Coordination Center issued three warnings this week. Here are the executive summaries:
    • AI-Augments Phishing — “Phishing has historically been a very successful means for cyberattackers of any motivation to compromise an organization and launch a full-fledged cyberattack to achieve their goals. Phishing attacks are frequently utilized, and this is especially true with regard to the health sector. The two most common cyberattacks targeting the health sector are ransomware and data breaches. (And usually both together!)
    • “These attacks often begin with a successful phishing attack. The advent of artificial intelligence has only made phishing attempts more effective, especially since those tools are freely available to the public.
    • In this paper, we provide a brief overview of basic artificial intelligence concepts, phishing attacks, and the application of artificial intelligence to phishing. We conclude with efforts that should be made to reduce the likeliness of all phishing attacks, including those that have been augmented by the use of artificial intelligence.”
  • and
    • QR Code Based Phishing – Phishing – the use of phony e-mails to deliver malicious code – has historically been a successful means for cyber attackers to compromise victim organizations and launch full-fledged, multi-staged cyberattacks. Phishing attacks are frequently utilized as the first stage of an attack – the infection vector – and this is especially true for the health sector. A cyberattack that begins with phishing often ends with ransomware and/or a major healthcare data breach.
    • Quick response (QR) codes were designed to quickly read and transmit legitimate data but have become increasingly abused as part of phishing attacks, called “quishing”.
    • In this paper, we provide a brief overview of QR codes, phishing attacks, and the application of both of these to cyberattacks on the health sector. We conclude this analysis with recommended defense and mitigation actions to reduce the likeliness and effectiveness of phishing attacks, including those augmented by the use of QR codes.
  • and
    • SolarWinds has published security fixes for their Access Rights Manager (ARM). This update addressed eight vulnerabilities, with three of them being rated as critical (CVE-2023-35182, CVE-2023-35185, CVE-2023-35187) and can lead to remote code execution on the “SYSTEM” of a Windows computer. This could enable an attacker to operate with the highest level of privileges available on the machine. In early 2020, the SolarWinds Orion system was targeted by an attacker(s), which led to the supply chain compromise of up to 18,000 of its customers.
    • Due to the previous malicious targeting and wide use of SolarWinds, HC3 strongly encourages users to monitor and upgrade their systems to prevent serious damage from occurring to the Healthcare and Public Health (HPH) sector.

From the ransomware front,

  • Cybersecurity Dive reports,
    • “The threat group behind some of the most high profile, identity-based cyberattacks this year is also “one of the most dangerous financial criminal groups” currently in operation, Microsoft researchers said in a Wednesday report.
    • “The group, which Microsoft identifies as Octo Tempest and other researchers identify as Oktapus, Scattered Spider and UNC3944, uses multiple forms of social engineering to gain access to organizations’ infrastructure, steal corporate data and extort victims for ransom payments, according to Microsoft Threat Intelligence.
    • “The collection of young, native English-speaking threat actors, which was initially observed in 2022 and affiliated with the ransomware-as-a-service operation ALPHV or BlackCat in mid-2023, has claimed responsibility for major attacks against MGM Resorts, Caesars Entertainment and Clorox in the past few months. * * *
    • “The threat actors engage in aggressive communications with victims, such as leaving threatening notes within a text file on a system, contacting executives via text messages and emails, and infiltrating communication channels being used by victims to respond to incidents,” Mandiant, a Google Cloud unit, said last month in a report on UNC3944.
    • “We’ve seen very young individuals break into some of the biggest organizations by leveraging these techniques that are so hard to defend against,” Mandiant Consulting CTO Charles Carmakal said during an April briefing.
    • “They are incredibly disruptive and aggressive,” Carmakal told Cybersecurity Dive via email last month following the MGM Resorts attack.”

From the cybersecurity defenses front,

  • CISA announced,
    • “A new release of Logging Made Easy, a Windows-based, free and open log management solution designed to help organizations more effectively use available security data to detect and address cyber threats.
    • “In April 2023, CISA assumed Logging Made Easy from the United Kingdom’s National Cyber Security Centre (UK-NCSC). Following a period of transition and enhancement, it is now available with step-by-step installation instructions for both legacy and new users.
    • “Logging is critical for proactive monitoring of threats and retroactive investigation and remediation in the event of an incident. Logging Made Easy is a tested and reliable solution that can help organizations with limited resources needing a centralized logging capability,” said Chad Poland, Product Manager for Cyber Shared Services. “CISA is excited to offer this shared service capability to U.S. and international organizations that can help them mitigate risk and identify vulnerabilities.” * * *
    • For more information, visit CISA’s new Logging Made Easy webpage.
  • ISACA announced its “AI Survey Results: What Do Infosec Professionals REALLY Need to Know?”
  • “The HSCC Cybersecurity Working Group has reprinted its Health Industry Cybersecurity – Securing Telehealth and Telemedicine (HIC-STAT) document.” 

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.

Thursday Miscellany

David Ermer–CDC, CMS, Congress, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec tells us,
    • “The Senate Homeland Security and Governmental Affairs Committee on Wednesday voted to advance a pair of measures aimed at improving federal employees’ death benefits and agency customer service more broadly.
    • “The Honoring Civil Servants Killed in the Line of Duty Act (S. 3029); sponsored by Sens. Kyrsten Sinema, I-Ariz., Bill Hagerty, R-Tenn., Alex Padilla, D-Calif., and Josh Hawley, R-Mo.; would increase the amount of money the family of a federal worker who died of injuries sustained while on the job for the first time since 1997. Death gratuity payments would increase from the current $10,000 to $100,000, while the amount the federal government covers for funeral expenses would increase from $800 to $8,800. * * *
    • “The committee also voted 10-1 to advance legislation aimed at improving public-facing federal agencies’ customer service. The Improving Government Services Act (S. 2866), introduced by Committee Chairman Gary Peters, D-Mich., and Sens. James Lankford, R-Okla., and John Cornyn, R-Texas, would require agencies that provide services to members of the public to develop annual customer service action plans that outline strategies to adopt “human-centered” practices that reduce administrative burdens as well as practices already employed in the private sector like online services and call-back functions at call centers.”
  • The House Budget Committee announced,
    • “Its Health Care Task Force (HCTF) hit the ground running with its inaugural Member roundtable. This roundtable brought together Director Phillip Swagel of the nonpartisan Congressional Budget Office (CBO), independent experts, and stakeholders to discuss CBO’s methods for analyzing policies that impact drug development in the United States, including the Inflation Reduction Act (IRA).
    • “Led by Rep. Michael Burgess M.D. (R-TX), the HCTF Member roundtable examined potential refinements and improvements to CBO’s drug development model to ensure future analysis is capturing additional factors and subsequent real-world effects of policies impacting medical innovation in the United States.
    • Health Care Task Force Chairman Michael Burgess (R-TX) published an op-ed in the Washington Times sharing the Task Force’s goals with the American people ahead of today’s roundtable.
  • MedPage Today informs us,
    • “By a 14-0 vote, the [Centers for Disease Control’s] Advisory Committee on Immunization Practices (ACIP) recommended the two-dose Jynneos vaccine for mpox prevention in adults at risk for infection, which typically passes through close skin-to-skin contact, including sex. * * *
    • “Groups considered at-risk for mpox include men who have sex with men (MSM) and transgender or nonbinary people who in the past 6 months have had a new diagnosis of a sexually transmitted disease, multiple sex partners, engaged in sex work, or who had sex in association with a large public event in a region where mpox is circulating. Also people who anticipate exposure to those risks and the partners of these individuals.
    • “The committee also voted 10-4 in favor of recommending the newly approved pentavalent meningococcal vaccine (Penbraya) when both the MenACWY and bivalent MenB vaccines are indicated at the same visit. It’s the first vaccine to provide protection against the five meningococcal serogroups (A, B, C, W, and Y; MenABCWY) responsible for most cases of invasive meningococcal diseases globally.
    • “The pentavalent vaccine gained approval earlier this month for individuals ages 10 to 25 years, based on phase III trial data in previously unvaccinated individuals that showed non-inferior immune responses and comparable safety with MenABCWY when compared with vaccination with the MenACWY (Menveo) and MenB (Trumenba) vaccines.
    • “While meningitis is rare in the U.S., mortality is 10% to 15%. Most cases occur among children younger than 1 year, adolescents and young adults ages 16 to 23, and adults older than 85.”
  • HR Dive reports,
    • “The National Labor Relations Board published Thursday a rule updating the standard for determining when multiple employers may be considered joint employers under the National Labor Relations Act.
    • “NLRB’s new joint employer rule retains much of the same details from its 2022 proposed rule, specifying that an entity may be considered a joint employer of another employer’s employees if the two share or codetermine essential terms and conditions of employment. Per the rule, joint employers may possess or exercise direct or indirect control over one or more essential terms and conditions of employment.
    • “Changes from the proposed rule include an exhaustive list of seven categories of employment terms or conditions that the board will consider essential for the purposes of its joint employer analysis, as well as a description of those it will consider “irrelevant” for such analysis. The final rule also addresses joint employers’ bargaining obligations. The rule is scheduled to be published in the Federal Register tomorrow; it will take effect 60 days after that.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “Contract negotiations between payers and providers are becoming more public, and the number of communities affected across the country is growing, according to data published Oct. 25 by FTI Consulting.
    • “Notably, disputes reported in the media during the third quarter involved Medicare Advantage plans more than ever previously recorded, standing at 15 total.
    • “In whole numbers, it may not be shocking, but each of these disputes can affect a few thousand to tens of thousands of people, so it’s significant,” Adam Broder, managing director of FTI’s strategic communications segment, told Becker’s. “Medicare Advantage is being scrutinized by federal regulators, and I think these disputes are a mirror of that on the local level with some hospitals feeling the pinch.”
  • The FEHBlog notes the number of Medicare Advantage plan disputes should be hardly surprising as those plan’s premiums, etc., are constrained by CMS.
  • Per Fierce Healthcare,
    • “Payers’ “increasingly aggressive behavior,” a spike in physician expenses and recruitment are front of mind for executives at Universal Health Services (UHS).
    • “The King of Prussia, Pennsylvania-based for-profit system came out slightly ahead of analyst estimates this quarter with a $167 million profit ($2.55 per diluted share).
    • “Much of the success came from a continued rise in patient volumes, particularly on the acute care side of the business where patients are seeking care after delaying procedures during the pandemic, Chief Financial Officer Steve Filton told investors during a Thursday morning earnings call. 
    • “While key to the company’s 6.8% year-over-year increase in net revenues, that recaptured care was largely lower acuity services that held same-facility revenue per adjusted admission to a “somewhat more muted” 0.4% year-over-year increase, Filton explained.
    • “That trend isn’t expected to last much longer. “Over time, we would expect our volumes to moderate a little bit, but also our revenue per adjusted admission to come up,” Filton told investors.” 
  • Per Healthcare Dive,
    • “Community Health Systems missed Wall Street expectations for earnings per share in its third quarter earnings this week, despite rising patient admissions and efforts to control labor expenses.
    • “The operator posted a net loss of $91 million in the third quarter, compared to net loss of $42 million from the prior year period. [For-profit CHS, which spans 76 owned or leased affiliate hospitals and more than 1,000 sites of care, has been in the red for the past three quarters.] 
    • “The losses come even as same facility admissions, which rose 3.7% year over year, reached their highest levels since the fourth quarter of 2019, CHS CEO Tim Hingtgen said during a Thursday morning call with investors.”

In judicial news,

  • Reuters reports,
    • “A U.S. appeals court has rejected legal challenges to a $2.67 billion settlement that resolves civil antitrust claims that Blue Cross Blue Shield Association and member plans conspired to drive up health insurance costs.
    • “A three-judge panel of the 11th U.S. Circuit Court of Appeals unanimously upheld Alabama-based U.S. District Judge R. David Proctor’s August 2022 approval of the settlement, which followed nearly a decade of litigation involving allegations from individual policyholders, businesses and others.
    • “The appeals court’s order on Wednesday spurned challenges to the insurance subscribers’ deal from Home Depot and others. One objector fought the $667 million in legal fees and expenses that are part of the settlement.
    • “Writing for the panel, Chief Circuit Judge William Pryor said Home Depot had not persuaded the court that the settlement would harm the power of antitrust enforcers or others to bring claims against Blue Cross Blue Shield in the future.”

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.”

Tuesday Tidbits

David Ermer–CMS, Congress, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “House Majority Whip Tom Emmer (R., Minn.) dropped his bid to serve as House speaker just hours after he was narrowly elected as the Republican nominee, as stiff resistance from hard-right conservatives reinforced by former President Donald Trump sank the party’s latest pick to run the chamber.
    • “His withdrawal put the Republicans back to square one for the fourth time, three weeks after hard-liners engineered the ouster of former Speaker Kevin McCarthy (R., Calif.). Republicans regrouped again late Tuesday to map out their next steps, assembling another slate of candidates and holding a fresh forum in the evening. A new vote was expected Tuesday evening.”
  • The Hill offers a potpourri of articles on this situation.
  • The American Hospital Association News informs us,
    • “The Centers for Disease Control and Prevention Oct. 23 released interim guidance for clinicians with limited access to the monoclonal antibody nirsevimab, recently approved to prevent respiratory syncytial virus in children aged 2 and under. The guidance calls for prioritizing 100 milligram doses of the treatment for infants under 6 months old and infants at high risk for severe disease due to underlying health conditions, among other recommendations.”
  • STAT News tells us,
    • “Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.
    • “Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.”
  • It’s worth adding that for 2024, OPM adopted a broad definition of fertility coverage for the FEHBP to serve this purpose.
  • Also from STAT News,
    • “People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home.
    • “AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children. FluMist is only licensed for use in children and adults from the age of 2 to 49 years old.”
    • “The application, which the FDA is considering, would not mean there would effectively be over-the-counter sales of FluMist, Lisa Glasser, head of AstraZeneca’s U.S. medical affairs for vaccines and immune therapies, told STAT in an interview. Rather, the vaccine, which must be stored at refrigerator temperatures, would be ordered and delivered under appropriate temperature controls, after consultation with a medical professional.
    • “Glasser said the program, if approved, would not replace the option of getting FluMist in a doctor’s office or at a pharmacy, but would be another alternative for busy families. “It is meant to enhance the ability to access influenza vaccination,” she said. “That’s the goal.”

From the public health and medical research front,

  • The NIH Directors blog points out,
    • When NIH launched The BRAIN Initiative® a decade ago, one of many ambitious goals was to develop innovative technologies for profiling single cells to create an open-access reference atlas cataloguing the human brain’s many parts. The ultimate goal wasn’t to produce a single, static reference map, but rather to capture a dynamic view of how the brain’s many cells of varied types are wired to work together in the healthy brain and how this picture may shift in those with neurological and mental health disorders.
    • So I’m now thrilled to report the publication of an impressive collection of work from hundreds of scientists in the BRAIN Initiative Cell Census Network (BICCN), detailed in more than 20 papers in Science, Science Advances, and Science Translational Medicine.1 Among many revelations, this unprecedented, international effort has characterized more than 3,000 human brain cell types. To put this into some perspective, consider that the human lung contains 61 cell types.2 The work has also begun to uncover normal variation in the brains of individual people, some of the features that distinguish various disease states, and distinctions among key parts of the human brain and those of our closely related primate cousins. * * *
    • All the data represented in this work has been made publicly accessible online  for further study. Meanwhile, the effort to build a more finely detailed picture of even more brain cell types and, with it, a more complete understanding of human brain circuitry and how it can go awry continues in the BRAIN Initiative Cell Atlas Network (BICAN). As impressive as this latest installment is—in our quest to understand the human brain, brain disorders, and their treatment—we have much to look forward to in the years ahead.”
  • Per STAT News,
    • “Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
    • “But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain disorder that affects more than a half million Americans.
    • “While there is no cure for Parkinson’s and treatment options can be daunting, people with the disease can now turn to technology spawned by the Apple Watch to take an active role in their care much as continuous glucose monitors have helped people manage diabetes better. Over the past year, the Food and Drug Administration has cleared three Apple Watch apps from independent developers to track symptoms associated with Parkinson’s that can help inform treatment decisions for people and their doctors.”
  • and
    • “If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting, a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates (ADC)
    • “The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one). Multiple ADC studies were presented at the meeting’s top sessions. ADCs were, in short, the belle of the cancer research ball.
    • “The thing is, ADCs are actually quite an old approach.
    • “The industry’s been putting ADCs into the clinic for 20 years, and it’s only recently that we’ve really had a breakthrough here,” Susan Galbraith, who leads AstraZeneca’s cancer work, told STAT.
    • “ADCs are designed to deliver chemotherapy directly to tumors, possibly one day replacing the blunt-force toxic therapies that have been the backbone of cancer care for generations. The idea is that these finely crafted shipments can pack the punch of chemo while minimizing side effects. Experts are still scrutinizing the safety profiles of ADCs — they come with their own side effect concerns, and trials have included some patient deaths — but some studies are showing that patients can tolerate ADCs better than traditional chemo.”

From the U.S. healthcare business front,

  • Beckers Hospital Review provides us with a link to Healthgrades’s latest rankings of specialty hospitals.
  • Moreover, Beckers Hospital Review reports,
    • “Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation’s hospitals and manufactures 80 drugs facing shortages, NBC affiliate KSL-TV reported Oct. 22. 
    • “Seven health systems formed the pharmaceutical company after struggling for years with recurring drug shortages. The first goal was to make 14 generics constantly in short supply for hospitals, and 19 systems were founding members. 
    • “Now, some governments and hundreds of hospitals are buying from Civica Rx. 
    • “Dan Liljenquist, the chief strategy officer for Salt Lake City-based Intermountain Health, volunteer board chair of Civica Rx and a former Utah senator, told KSL-TV Civica Rx plans to scale up operations at its Petersburg, Va.-based manufacturing plant.” 
  • and
    • “Pittsburgh-based UPMC said it has entered into an integration and affiliation agreement with Washington (Pa.) Health System, according to an Oct. 23 filing.
    • “The two signed a letter of intent in June regarding the partnership. Unions have criticized the move, saying it would harm both patients and workers.
    • “UPMC will appoint about one-third of the Washington Health board directors and the system will be renamed UPMC Washington, according to the filing.
    • “The proposed transaction still has to meet regulatory and closing conditions.”
  • Per Healthcare Dive,
    • “Centene raised its 2023 outlook on Tuesday after the health insurer handily beat Wall Street expectations for earnings and revenue in its third quarter, helped by lower medical costs.
    • “Centene reported a medical loss ratio — a marker of spending on patient care — of 87%, down from the year prior. On a call with investors Tuesday morning, executives chalked the lower medical spending up to significantly more members in Affordable Care Act marketplace plans, who generally require less expensive care than members in Medicaid and Medicare. Centene grew marketplace membership 76% year over year.
    • “The ongoing effect of Medicaid redeterminations — now almost halfway complete — on membership numbers and care acuity continues to track to Centene’s expectations, CEO Sarah London said on the call. Centene still expects to lose roughly two million members once redeterminations are complete.”
  • Per Fierce Healthcare,
    • “Teladoc’s third-quarter revenue grew 8% to reach $660 million, boosted by solid performance in its chronic condition management business and steady membership growth as the company now touts 90 million users.
    • “The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $57 million, or 35 cents per share, compared to a net loss of $73.5 million, or 45 cents per share, for the third quarter of 2022.” 
  • and
    • “Elevance Health’s CarelonRx is the latest pharmacy benefit manager to put biosimilars for popular drug Humira on its formulary, the company said this week.
    • “Beginning Dec. 1, adalimumab-adbm will be added to each of its commercial formularies, according to a blog post from CarelonRx. Cyltezo will also be added to certain formularies, and both will be offered at parity with Humira.
    • “Humira has been the bestselling drug in the U.S. for a decade, and PBMs have long awaited biosimilar products to challenge the drug’s dominance in the market. Drugs that treat inflammatory conditions, like Humira, represent a growing piece of overall drug spend.
    • “Other key PBMs, including Express Scripts and Optum, have taken similar steps. CVS Health launched a new subsidiary, called Cordavis, earlier this year that aims to work alongside drugmakers to bring additional biosimilars to market, with the first product a Humira biosimilar in collaboration with Sandoz.”