Monday Report

ACA

Monday Report

David Ermer–ACA, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reports,
    • “Top Republicans are signaling progress in government funding talks as leaders look to clinch a deal ahead of a looming Friday deadline. 
    • “House Appropriations Chair Tom Cole (R-Okla.) told reporters Monday that the “differences are narrowing” between all sides as they try to hash out the last significant funding deal in the divided Congress.
    • “It’s both between the House and the Senate and Republicans and Democrats. So, they’re both institutional differences, and there are partisan differences,” Cole said. But he added “there are a lot fewer of them than there were 24 hours ago.” * * *
    • “Pressed about the status of health care as leaders look to tie up loose ends in the CR, House Majority Leader Steve Scalise (R-La.) said Monday there are “big discussions on all of the remaining items.”
    • “But we’re trying to get it wrapped up,” he said. 
    • “According to a source familiar, a package of key health policies is expected to be attached to the stopgap funding bill. It will likely include a two-year extension of telehealth flexibilities for Medicare, as well as an overhaul of pharmacy benefit managers’ business practices.” 
  • Fierce Healthcare adds,
    • “Pharmacy benefit manager reform is included in a larger-than-anticipated healthcare package, but the PBM lobby is fighting the legislation at the eleventh hour.
    • “Lawmakers appear to have agreed to a lame-duck healthcare package which, in addition to PBM reform, will include key program extensions.
    • “As of last weekend, the package included an increase to the Medicare physician fee schedule of 2.5% for one year, bonuses to alternative payment models and a reauthorization of the SUPPORT Act for dealing with the opioid crisis.
    • “PBM policies will be used as budgetary offsets. The legislation would ban spread pricing in Medicaid, ensure Part D plan sponsors delink PBM fees from the price of a drug and includes other transparency requirements.
    • “The end-of-year health care package accompanying the Continuing Resolution has morphed into a massive 400-page bill that includes provisions that would undermine the role that PBMs play in lowering costs and providing choices for employers in the prescription drug marketplace,” said the PBM trade lobby, the Pharmaceutical Care Management Association (PCMA), in a statement Dec. 16. “The health care provisions included in the latest draft, as reported in the media, risk increasing costs for health plan sponsors, like employers and labor unions, patients, and families, and hiking up premiums for seniors.”
  • One Digital informs us that “Congress passed the Paperwork Reduction Act and the Employer Reporting Improvement Act, each of which modify the ACA’s provisions on 1094 and 1095 tax form reporting. President Biden is expected to sign both acts into law, significantly altering ACA reporting requirements.”
    • “The Paperwork Reduction Act amends the ACA by no longer requiring employers and health insurance providers to send tax forms to the covered individuals under their health plan. Previously employers and/or insurance providers had to send 1095-B/1095-C tax form to each covered individual showing proof of minimum essential coverage. Now, those forms must only be sent when requested by the covered individual. If a covered individual requests a form, the form must be provided by January 31 or 30 days after the date of the request, whichever is later. Employers and insurance providers must inform covered individuals of their right to request a form.”
    • “The Employer Reporting Improvement Act codifies IRS regulations that allow for an individual’s date of birth to be substituted if the individual’s Tax Identification Number is not available. The Act also amends the ACA to incorporate IRS regulations allowing employers and insurance providers to offer 1095-B and 1095-C tax forms to individuals electronically.
    • Additionally, and more importantly to employers, the Act requires the IRS to give large employers at least 90 days to respond to 226-J letters that issue a proposed employer shared responsibility payment. Previously, employers had only 30 days to respond. Finally, the Act establishes a six-year statute of limitations for collecting these payments.”
       
  • The Plan Sponsor Council of America tells us,
    • “The ERISA Advisory Council (EAC) voted on and approved 12 recommendations for the Department of Labor (DOL) to improve health insurance claim denials and related appeals. These reforms range from better oversight of AI determinations to requiring payouts for prior approvals.
    • “Lisa Gomez, head of the Employee Benefit Security Administration (EBSA), described these proposed reforms today as “strangely and somewhat tragically timely, with the events of last week,” in reference to the killing of UnitedHealthcare CEO Brian Thompson in Manhattan on Dec. 4.”
    • Due to the Affordable Care Act, ERISA appeal procedure changes embedded in regulations typically apply to FEHB carriers.
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Dec. 16 published a final rule implementing certain provisions related to information blocking exceptions. The rule revises defined terms related to protecting access to care for purposes of the information blocking regulations.
    • “The agency adopted select provisions first proposed in August as part of the much larger Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) rule. The adopted provisions are designed to address concerns from patients, health care providers and other stakeholders regarding patient privacy, access to care, preferences for electronic health information sharing, and methods for achieving a balance between certainty and flexibility for entities involved in enhancing EHI interoperability and exchange.
    • “The finalized “Protecting Care Access Exception” would allow entities to restrict EHI sharing under certain conditions to mitigate the risk of legal repercussions for patients, providers or care facilitators involved in lawful reproductive health services. The provisions will be effective immediately when published Dec. 17 in the Federal Register.
    • “This is the second rule in less than a week containing policies originally included in the proposed HTI-2 rule. As such, additional provisions of the HTI-2 rule, including prior authorization application programming interfaces, United States Core Data for Interoperability Version 4 standards and public health interoperability requirements — which are currently under review by the White House Office of Management and Budget — could be published soon.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 announced an extension to Dec. 18 for enrollment in federally facilitated marketplace coverage that begins Jan. 1. This applies to the 31 states that use HealthCare.gov for signups. Those consumers previously had until Dec. 15 to enroll for a full year of coverage. Individuals who enroll for 2025 coverage after Dec. 18 will have their plans begin Feb. 1. Individuals in Washington, D.C., and the 19 states that operate their own state-based marketplaces are advised to visit their state website for deadlines and effective dates for their coverage.”
  • and
    • “The Health Resources and Services Administration last week directed Sanofi to cease implementation of its 340B rebate proposal immediately and to inform HRSA of its plans no later than Dec. 20 in order to provide adequate notice to covered entities.
    • “By way of this correspondence, HRSA provides warning that this unapproved credit proposal violates Sanofi’s obligations under the 340B statute, and HRSA expects Sanofi to cease implementation of it,” wrote HRSA Administrator Carole Johnson.
    • “The letter says that the proposal, if implemented, would violate Sanofi’s obligations under the 340B statute and subject Sanofi to potential consequences, such as termination of Sanofi’s Pharmaceutical Pricing Agreement and civil monetary penalties.
    • “In its Nov. 22 letter to 340B covered entities, Sanofi said it would be effectuating 340B discounts via the new credit model as of Jan. 6, 2025, for disproportionate share hospitals, critical access hospitals, rural referral centers and sole community hospitals.”
  • Govexec points out,
    • “The Office of Personnel Management is set to publish a final rule Tuesday that would finally implement provisions of a seven-year-old law aimed at reducing agencies’ ability to put federal workers accused of misconduct on prolonged stints of administrative leave.
    • “In 2016, Congress enacted the Administrative Leave Act as part of the 2017 National Defense Authorization Act. The law tries to reduce agencies’ reliance on placing federal workers who are under investigation into employment limbo—paid but unable to work—for long stretches of time. It also updated the government’s policies on weather and safety leave.
    • “Though OPM proposed regulations to implement all of the law’s provisions in 2017, only the provisions governing weather and safety leave actually made it across the finish line. But earlier this year, the environmental advocacy group Public Employees for Environmental Responsibility sued the HR agency seeking to force it to act.
    • “In a final rule set for publication Tuesday in the Federal Register, OPM formally implemented the 2016 law’s restrictions on administrative leave. While the new rule will be effective Jan. 17, 2025, agencies have until October to comply with the new restrictions on administrative leave.”

In Food and Drug Administration news,

  • MedTech Dive relates
    • Zimmer Biomet received Food and Drug Administration clearance for a new stemless shoulder implant, called Osseofit.
    • The implant is shaped to match the anatomy of patients’ humerus, or upper shoulder bone, while preserving as much of their healthy bone as possible in total shoulder replacement procedures. Zimmer announced the clearance on Friday.
    • CEO Ivan Tornos highlighted stemless shoulder implants as a meaningful growth driver for the orthopedics company in an Oct. 30 investor call.
  • Per Fierce Pharma
    • “The FDA has blessed two previously approved medicines—one a cream and the other an injection—to treat atopic dermatitis (AD). Both products now will be available to a significantly larger patient population as roughly 26 million in the U.S. have the disorder, which is also known as eczema.
    • “Organon’s Vtama, a topical cream originally approved for plaque psoriasis in 2022, is now cleared to treat AD, the company said early Monday. The nod came three months after New Jersey-based Organon acquired the product in a $1.2 billion takeover of Dermavant. 
    • “Similarly, the FDA gave a thumbs-up to Galderma’s Nemluvio to treat AD. The drug, a monthly subcutaneous injection, was previously endorsed by the U.S. regulator for prurigo nodularis.” 
  • and
    • “After seven decades with no advances in the treatment of the genetic disorder classic congenital adrenal hyperplasia (CAH), Neurocrine Biosciences has scored FDA approval for its first-in-class, twice-daily oral medicine Crenessity (crinecerfont).
    • “The blessing came nearly two weeks before its FDA target date and is termed as “paradigm shifting” by the San Diego-based company. The selective oral corticotropin-releasing factor type 1 receptor (CRF) antagonist can be used by CAH patients ages 4 and older.
    • “Serving as an add-on to glucocorticoid replacement therapies, Crenessity reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.”
  • Cardiovascular Business alerts us,
    • “The U.S. Food and Drug Administration (FDA) and Boston Scientific today sent an urgent alert to patients and healthcare providers about the potential need for early device replacement of some Accolade pacemakers.
    • The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.
    • There have been two reported patient deaths in pacemaker dependent patients after the devices went into safety mode in an ambulatory outpatient medical setting. Boston Scientific said about 70% of safety mode events occurred during in-office interrogations from a Latitude programmer, and the remaining incidents took place in an ambulatory setting.
    • “The risk of harm may be greater when safety mode occurs in an ambulatory setting, as patients are not in a monitored clinical environment,” the company said in its recall notice.
  • Beckers Hospital Review adds,
    • “The FDA has recalled more than 233,000 bottles of antidepressant duloxetine, sold by Rising Pharmaceuticals, due to a potential cancer risk. 
    • “The recall, issued Dec. 5, was prompted by the discovery of a nitrosamine impurity, N-nitroso-duloxetine in the capsules which exceeds the FDA’s safety threshold. 
    • ‘The FDA has classified the recall as a Class II risk, its second most severe classification. The recall affects 233,000 bottles of duloxetine, which is used to treat conditions such as depression and generalized anxiety disorder. 
    • “The FDA also recalled 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe in October for similar concerns about nitrosamine impurities.” 

From the public health and medical research front,

  • MedPage Today reports,
    • “CDC could not confirm what was suspected to have been the first H5N1 bird flu case linked to raw milk.
    • “The patient, a child in Marin County, California, experienced fever and vomiting after drinking raw milk, as reported last week. The child initially tested positive for influenza A, with the local lab unable to find evidence of person-to person transmission between the child and her family members.
    • “The State Laboratory and the CDC conducted additional testing, “but due to low levels of viral RNA, they were unable to confirm whether the influenza A virus present was H5N1 (avian influenza) or seasonal influenza,” according to the Marin County public health department.”
  • The Washington Post tells us,
    • “Nearly a quarter of U.S. adults reported living with chronic pain in 2023, according to a recent report from the Centers for Disease Control and Prevention.
    • “Just over 24 percent (24.3 percent) of survey respondents said they experienced chronic pain either most days or every day, the CDC said, and nearly 9 percent of adults had “high-impact chronic pain” in the previous three months, meaning their pain frequently limited their life or work activities.” * * *
    • “Chronic pain and pain that often restricts life or work activities, referred to in this report as high-impact chronic pain are the most common reasons adults seek medical care, and are associated with decreased quality of life, opioid misuse, increased anxiety and depression, and unmet mental health needs,” co-authors Jacqueline W. Lucas and Inderbir Sohi wrote in a data brief on the numbers.”
  • Beckers Hospital Review adds,
    • “In 2023, the United States saw a slight decrease in obesity prevalence among adults, according to research findings published Dec. 13 in JAMA. 
    • “Amid projections of increasing obesity rates over the next decade, researchers from Boston Children’s Hospital and Optum Life Sciences analyzed body mass index data from 2013 to 2023. The dataset included nearly 48 million BMI measurements from 16.7 million nonpregnant adults. 
    • “Between 2013 and 2022, mean population BMI and obesity rates rose annually. Both figures slightly declined in 2023, the study found. 
    • “The researchers suggested this change could be due to weight loss GLP-1s such as semaglutide (Wegovy) and “pandemic-associated demographic and behavior changes.”
  • A recent National Health Statistics Reports shares characteristics of older Americans who fulfilled physical activity guidelines in 2022.
  • The American Medical Association lets us know what doctors wish their patients knew about hand, foot, and mouth disease.
  • MedPage Today notes,
    • “Diets higher in inflammatory foods were tied to an increased incidence of dementia in older adults, longitudinal data from the Framingham Heart Study Offspring cohort showed.
    • “Over 13 years of follow-up, higher Dietary Inflammatory Index (DII) scores averaged across three time points were linearly associated with an increased incidence of all-cause dementia (HR 1.21, 95% CI 1.10-1.33, P<0.001), reported Debora Melo van Lent, PhD, of UT Health San Antonio in Texas, and co-authors.
    • “Similarly, higher DII scores were linearly associated with an increase in Alzheimer’s disease dementia (HR 1.20, 95% CI 1.07-1.34, P=0.002), the researchers reported in Alzheimer’s & Dementia. Findings were adjusted for demographic, lifestyle, and clinical covariates.
    • “Although these promising findings need to be replicated and further validated, our results suggest that diets that correlate with low DII scores may prevent late-life dementia,” van Lent and colleagues noted.”
  • To that end, Consumer Reports, writing in the Washington Post, discusses “four ways to reduce inflammation for better health. It’s thought to be an underlying cause of diabetes, heart disease and more. Diet and lifestyle can help you control it.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness of tabelecleucel (“tab-cel”®, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “ICER’s report on this therapy was the subject of the November 2024 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • STAT News reports,
    • “Just over a year ago the PREVENT calculator to predict cardiovascular risk was released by the American Heart Association. It was acclaimed for improving on a 2013 model that didn’t take into account companion conditions such as kidney disease or type 2 diabetes, or include people from more diverse backgrounds.
    • “PREVENT soon drew attention for its potential to reduce the number of Americans eligible to receive widely prescribed cholesterol-lowering statins, projected in two analyses published in June and July. 
    • “A less noted change was the addition of heart failure to conditions estimated by the risk calculator, alongside the traditional targets of heart attack and stroke. Heart failure is a serious illness that means the heart can no longer pump blood through the body as well as it should. It’s different from diseases that narrow blood vessels that feed the heart or brain.
    • “Heart failure has no cure, making it more urgent to identify who’s at risk. PREVENT allows that risk to be estimated using information typically collected in a regular primary care visit.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Powerful weight-loss drugs are expanding use of U.S. health care as patients starting prescriptions are diagnosed with obesity-related conditions or take the drugs to become eligible for other services, health records and discussions with doctors show.
    • “An exclusive analysis of hundreds of thousands of electronic patient records by health data firm Truveta found slight, but measurable, increases in first-time diagnoses of sleep apnea, cardiovascular disease, and type 2 diabetes within 15 days of an initial prescription for a GLP-1 weight-loss drug between 2020 and 2024.
    • “In addition to obesity-related conditions, some patients are being prescribed the drugs to lose weight and become eligible for services, including organ transplants, fertility treatments or knee replacements, according to interviews with seven doctors and five other health experts.
    • “This is a population that previously felt stigmatized by health care providers and often didn’t return. But now that they’re actually seeing themselves get healthier, asking clinicians questions and engaging more, I do think we’re seeing new patients,” said Dr. Rekha Kumar, a New York endocrinologist and obesity medicine specialist.”
  • McKinsey and Company explore how the healthcare industry can weather current challenges.
    • “The healthcare industry has been buffeted by a growing number of challenges over the past few years. This turbulence struck provider organizations in 2022, while payers were initially sheltered from the storm (Exhibit 1). But conditions became more difficult for payers in 2023, which has continued into this year, and there’s limited respite on the horizon. Unlike the widespread challenges the provider and payer sectors have faced, the picture for pharmacy services has been more nuanced. Some organizations have been propelled by tailwinds from pharmaceutical innovation and new delivery models, while others have battled headwinds from increased regulatory scrutiny. The healthcare services and technology (HST) sector, in contrast, has benefited from continued demand for data, analytics, and software. Along with pressures on earnings, the healthcare sector has also faced challenges in the capital markets, with deal activity in 2024 lower than 2023, according to McKinsey analysis.”
  • Per the American Hospital Association News,
  • Healthcare IT News tells us “74% of hospital leaders say virtual nursing will become integral to acute care. A nurse expert [in the article] discusses the results of a new survey from AvaSure showing that, while virtual nursing has yet to gain traction in acute inpatient care, it holds much promise – and already is showing results that benefit both nurses and the bottom line.”
  • A recent National Health Statistics Report examines under age 65 enrollment in high deductible and consumer driven health plans in the U.S.
  • Per HR Brew,
    • “Despite a softening job market, US employers are expected to grant merit increases of 3.3% to non-unionized employees in 2025—the same rate as this year, according to a report by Mercer.
    • “It’s not surprising to us to see employers really kind of keeping up with the part of what they had done in the prior year,” said Jack Jones, principal consultant at Mercer. “I think what it shows is employers are still prioritizing the investment in their talent.”
    • “Next year, employers are expected to increase their total salary budgets—which includes money for promotions and adjustments to reach equity—to 3.7%, excluding unionized workers. The increase was 3.6% for this year. About one-tenth (9.3%) of employees are expected to receive promotions next year, compared to 8% in 2024.
    • “However, Jones noted the numbers could change because only 20% of the more than 850 organizations surveyed had finalized their budgets. Still, most organizations (69%) don’t expect to adjust their initial projections.”

Midweek Update

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reported this morning
    • “A bipartisan group of lawmakers introduced legislation to break up pharmacy-benefit managers, the drug middlemen that have now faced yearslong scrutiny from Congress and the Federal Trade Commission.
    • “A Senate bill, sponsored by Sens. Elizabeth Warren (D., Mass.) and Josh Hawley (R., Mo.), would force the companies that own health insurers or pharmacy-benefit managers to divest their pharmacy businesses within three years.
    • “A companion bill, which sponsors say draws on a history of government prohibitions on joint ownership within industries, was also introduced in the House on Wednesday.
    • “If passed, the legislation would be the most far-reaching intervention yet into the operations of pharmacy-benefit managers, known as PBMs, and their parent companies, cutting off a major source of revenue for the companies and frustration for patients.”
  • STAT News added this afternoon,
    • “A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now.
    • “The bipartisan bill, which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the demise of independent pharmacies. A companion bill, that refers to a history of government prohibitions on joint ownership within industries, is scheduled to be introduced in the House.” * * *
    • Wall Street watchers believe the lower stock prices are an overreaction. Although the insurers are a juicy target, various factors suggest the bill is far from a sure bet, given the upcoming change in administrations. Securities analysts believe other legislative priorities will get more attention, despite a focus on health care matters more broadly.”
  • The Wall Street Journal also lets us know,
    • “The House voted Wednesday to approve a nearly $900 billion annual defense policy bill that includes a controversial provision that would block some transgender medical care for minors covered by the military’s healthcare program.
    • “The package, which sets national defense standards and priorities for the 2025 fiscal year, notably calls for a 14.5% pay raise for junior enlisted service members, dwarfing the 4.5% pay raise included for all other members of the armed forces. The package passed 281-140, with most Republicans voting for the bill but more than half of Democrats voting no.
    • “The 1,800-page National Defense Authorization Act would increase the national security budget to $895 billion, about a 1% increase from last year’s total, less than inflation. * * *
    • “The NDAA authorizes appropriations but doesn’t provide budget authority, making it a guide to what military spending is ultimately passed separately by Congress. It is set to be the 64th consecutive NDAA successfully passed through Congress—a rarity in what has increasingly become a divided and chaotic legislature. 
    • “The bill is now expected to be fast-tracked in the Senate, where the chamber will likely pass it before Congress leaves at the end of next week. From there, it would go to President Biden’s desk, where he is expected to sign it.”
  • Federal News Network tells us,
    • “With just a few weeks left in the year for President Joe Biden to finalize the 2025 federal pay raise, House and Senate Democrats are calling for a larger pay boost than the currently planned raise for civilian federal employees on the General Schedule.
    • “In a letter sent to Biden Wednesday morning, a group of 22 Democrats pushed for what they said should be “pay parity” between civilian and military federal employees. Currently, civilian and military personnel are slated for likely different pay raises for 2025.
    • “We believe it is imperative you revise your budget to align military and civilian employee pay raises,” the lawmakers, led by Sens. Tim Kaine (D-Va.) and Mark Warner (D-Va.), and Rep. Steny Hoyer (D-Md.), wrote in the letter, shared with Federal News Network.
    • “Currently, most civilian employees are on track to receive a 2% federal pay raise beginning in January, according to the alternative pay plan Biden sent to congressional leaders in August. In contrast, military personnel are expected to likely receive a 4.5% raise for 2025. Although the raise amounts appear to be heading in those two directions, neither raise amount is final just yet. Unless Congress or Biden opts for a different pay plan, the 2% raise is expected to become final through signing an executive order by the end of December.”
  • The American Hospital Association News informs us,
    • The Senate Dec. 10 unanimously passed legislation reauthorizing the Emergency Medical Services for Children Program (H.R. 6960) for an additional five years. The program provides funding for equipment and training to help hospitals and paramedics treat pediatric emergencies. The program was authorized at $24.3 million per year from 2025-2029. The bill was passed by the House in May.”
  • and
    • “The Department of Health and Human Services Dec. 11 published a final rule implementing provisions related to the Trusted Exchange Framework and Common Agreement. The rule is intended to advance equity, innovation and interoperability by promoting the use and exchange of electronically captured health information as specified in certain provisions of the Health Information Technology for Economic and Clinical Health Act of 2009.  
    • “The provisions today’s final rule adopts were first proposed in August as part of a much larger rule and will be effective 30 days after it is officially published in the Federal Register.”
  • The New York Times relates,
    • “In the final days of the Biden administration, the Food and Drug Administration is seeking White House approval to propose a drastic reduction in the amount of nicotine in cigarettes, a longstanding goal of public health experts that has faced stiff opposition from the powerful tobacco lobby.
    • “The F.D.A. submitted the proposal to the Office of Management and Budget only on Tuesday, a sign that the move was perhaps more wishful and symbolic than realistic for a White House juggling many late-term agenda items. And traditionally, the budget office’s review of agency proposals can take months.”
  • Per Fierce Pharma,
    • “As Donald J. Trump gradually fills out his cabinet, the President-elect’s latest pick could bode well for biopharma business development over the next four years.
    • “Trump on Tuesday nominated Andrew Ferguson to lead the U.S. Federal Trade Commission (FTC). Ferguson is one of two Senate-confirmed Republican FTC commissioners appointed by President Joe Biden, Reuters notes.
    • “At the same time, Trump said in a post on Truth Social that he plans to nominate Mark Meador, a partner at the law firm Kressin Meador Powers, to become an FTC commissioner. Should he be confirmed for the job, Meador will take over the spot currently filled by FTC chair Lina Khan, whose term at the antitrust agency has expired, the news agency said.”

From the public health and medical research front,

  • Per MedPage Today,
    • “A possible case of H5N1 bird flu virus in a California child has been linked to raw milk consumption and is under investigation by state health officials and the CDC.
    • “The patient experienced fever and vomiting after drinking raw milk and has since recovered, according to an announcement by Marin County Public Health. Officials said that the risk to the public remains low, as there was no evidence of person-to person transmission between the child and her family members.
    • “The case stands out for being outside the usual farm work setting.”
  • The New York Times adds,
    • “Domestic cats could provide an unexpected new route for the bird flu virus H5N1 to evolve into a more dangerous form, according to a new study published on Monday.
    • “In the year since the virus began circulating in dairy cattle, it has killed many cats, primarily on farms with affected herds. It has also sickened at least 60 people, most of whom had close contact with infected dairy cows or poultry.
    • “So far, H5N1 does not spread easily among people, although studies have suggested that just one or two key mutations could allow the virus to make that leap.
    • “There is no evidence that cats have spread H5N1 to people and they may not represent a major avenue for the evolution of bird flu, experts said. Still, if a cat were simultaneously infected with H5N1 and a seasonal flu virus, the H5N1 virus could potentially acquire the mutations it needed to spread efficiently among people.”
  • ABC News reports,
    • “The rates of late-stage breast cancer at diagnosis have risen among women in all racial and ethnic groups, but Black women have been hit the hardest, according to a new study published in the journal Radiology.
    • “The study, which looked at data from 2004 to 2021, found that advanced breast cancer rates have risen among women of all ages, with the sharpest increases in young women aged 20 to 39, and women over 75.
    • “Black women experience advanced diagnoses 55% more often than white women and are more likely to die from the disease, the study found.
    • “While mammography does save lives by catching cancer earlier, fewer than 70% of eligible women are up to date on their screenings, the study found.
    • “This trend is particularly alarming because early detection significantly improves survival. Five-year survival rates drop drastically from 99% for early-stage breast cancer to just 31% when the cancer is more advanced and has already spread to other parts of the body, the study found.”
  • BioPharma Dive adds,
    • “An experimental breast cancer drug developed by Eli Lilly met its main goal in a Phase 3 study, helping people with a form of HER2-negative, ER-positive disease stay alive and progression free for longer than standard hormone-suppressing therapies, according to data disclosed Wednesday.
    • “When combined with Lilly’s approved medicine Verezenio, the experimental drug, called imlunestrant, also helped women stay alive and progression free longer than treatment with imlunestrant alone regardless of their mutation status, according to results of the EMBER-3 trial presented at the San Antonio Breast Cancer Symposium. The data were also published in The New England Journal of Medicine.”
  • Per a National Institutes of Health press release,
    • “National Institute of Health (NIH) scientists have made a significant breakthrough in understanding how “bad” cholesterol, known as low-density lipoprotein-cholesterol or LDL-C, builds up in the body. The researchers were able to show for the first time how the main structural protein of LDL binds to its receptor – a process that starts the clearing of LDL from the blood – and what happens when that process gets impaired.
    • “The findings, published in Nature, further the understanding of how LDL contributes to heart disease, the world’s leading cause of death, and could open the door to personalizing LDL-lowering treatments like statins to make them even more effective.
    • “LDL is one of the main drivers of cardiovascular disease which kills one person every 33 seconds, so if you want to understand your enemy, you want to know what it looks like,” said Alan Remaley, M.D., Ph.D., co-senior author on the study who runs the Lipoprotein Metabolism Laboratory at NIH’s National Heart, Lung, and Blood Institute.” * * *
    • “The study findings could open new avenues to develop targeted therapies aimed at correcting these kinds of dysfunctional interactions caused by mutations. But, as importantly, the researchers said, they could also help people who do not have genetic mutations, but who have high cholesterol and are on statins, which lower LDL by increasing LDLR in cells. By knowing precisely where and how LDLR binds to LDL, the researchers say they may now be able to target those connection points to design new drugs for lowering LDL from the blood.” 
  • STAT News points out,
    • “Gilead said Tuesday that it will soon begin Phase 3 testing for a drug it believes could prevent HIV infection with just a single shot every year.
    • “Such a medicine, if proven effective, would be the closest thing to a vaccine the HIV field has produced in four decades of research. The company plans to begin the trial next year, with an eye toward regulatory filings in late 2027.”

From the U.S. healthcare business report,

  • Health Affairs reports,
    • “Numerous studies show that employer plans pay providers significantly more than Medicare, but less is known about prices in nongroup plans sold both on and off the Marketplaces established by the Affordable Care Act (ACA), where narrow networks and low-cost insurers are more prevalent.
    • “We estimated prices for three market segments (Marketplace nongroup, off-Marketplace nongroup, and employer small group) and three types of services (professional, outpatient hospital, and inpatient hospital) relative to a Medicare benchmark.
    • “We used 2021 claims data covering virtually all enrollment in ACA risk-adjusted plans. In aggregate, in 2021, Marketplace prices were 152 percent of Medicare prices, whereas the prices paid in small-group employer plans were 179 percent of Medicare prices.
    • “Comparing across market segments, relative to employer small-group plans, Marketplace professional prices were 6.9 percent lower, inpatient prices were 13.3 percent lower, and outpatient prices were 26.3 percent lower. Off-Marketplace prices fell between Marketplace and employer small-group prices.
    • “The finding that nongroup prices were significantly lower than prices paid by employer small-group plans—more so than indicated by prior research—is important for understanding federal subsidies and affordability for nongroup coverage and evaluating policies such as a nongroup public option with prices capped at a percentage of Medicare prices.”
  • Per Healthcare Dive,
    • “For the first time in 27 months, Fitch Ratings is revising its credit outlook for the nonprofit hospital sector — lifting it from deteriorating to neutral in its 2025 outlook report and adding that hospitals have made “enough meaningful strides” to warrant the revision.
    • “Hospitals have seen “steady improvement” on operating margins, according to the Monday report. The trend is attributable to providers’ success controlling labor expense growth, as well as stronger cash flows and equity returns.
    • “Fitch predicts margins will continue to improve, with operators reporting median operating figures between 1% and 2% in 2025. However, if President-elect Donald Trump announces cuts to Medicaid or supplemental Medicaid funds, margins could be adversely impacted and the sector’s outlook may be reverted to deteriorating.”
  • Modern Healthcare informs us,
    • “Labcorp has completed its acquisition of select non-hospital lab assets from Ballad Health, the independent laboratory company said Wednesday. A purchase price was not immediately available.
    • “Johnson City, Tennessee-based Ballad Health will retain operations of its inpatient and emergency department laboratory services, as well as lab services for hospital-based practices, according to a news release.” * * *
    • “The latest deal continues a trend of health systems selling off parts of their laboratory business to save on costs and focus on other areas of their operations. Independent lab companies often can provide a higher volume of tests at a lower cost compared with hospitals performing tests at their own facilities.” 

Tuesday Report

David Ermer–ACA, AHRQ, CDC, Congress, COVID-19, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Hill reports,
    • “Congress has just 10 days until government funding is set to run out, and lawmakers don’t have a deal to keep the lights on during the holidays.
    • “Members on both sides of the aisle expect the government will stay open past the Dec. 20 shutdown deadline. But negotiators are keeping their colleagues guessing about how that will be achieved as funding talks enter a critical stretch.” * * *
    • “Lawmakers are expecting leadership to land on a stopgap that runs through sometime next March, although some Republicans in both chambers have pushed for a CR that ends sooner to push Congress to finish up its funding work faster. 
    • Others are also concerned about taking up too much of President-elect Trump’s first months in office on finalizing fiscal 2025 spending bills.” 
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Dec. 10 amended the Public Readiness and Emergency Preparedness Act declaration for COVID-19, extending liability protections for certain COVID-19 countermeasure activities through 2029. Among other changes, the protections apply to all medical countermeasure activities provided through a federal agreement, as well as to pharmacists, pharmacy interns and pharmacy technicians who administer COVID-19 and seasonal flu vaccines and COVID-19 tests. These protections apply regardless of a federal agreement or emergency declaration.”
  • Per a Health and Human Services press release,
    • “The Scientific Report of the 2025 Dietary Guidelines Advisory Committee is now available on DietaryGuidelines.gov. The report contains the 2025 Dietary Guidelines Advisory Committee’s (Committee) independent, evidence-based findings and advice to the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). The Scientific Report, alongside public comments and federal agency input, will inform the two departments as they develop the Dietary Guidelines for Americans, 2025-2030, which is expected to be published in late 2025.” * * *
    • “HHS and USDA will open a 60-day public comment period and encourage the public to provide written comments on the Committee’s Scientific Report. The departments will also hold a public meeting on January 16, 2025, to listen to oral comments from the public on the Scientific Report. Pre-registration is required for the public meeting. More information on the public meeting and comment period is available on DietaryGuidelines.gov.”
  • The Wall Street Journal adds,
    • “The fight over what you should eat is escalating, with a new report out that moves the government closer to recommending Americans limit red meat, eat more beans, and cast a wary eye on ultra processed foods.
    • “Draft recommendations, by a committee of scientists advising the U.S. government on its next round of dietary guidelines, were first discussed in October. 
    • “Tuesday’s report comes at a time of growing debate about which foods are healthy—and who decides. For years, Americans largely accepted the guidelines, once dominated by the famous food pyramid. Now plenty of people are just as comfortable taking dietary advice from TikTok nutritionists and longevity podcasters as they are from mainstream doctors.
    • “Donald Trump’s election has further amped up the debate about what Americans should eat as more links are drawn between diet and chronic disease. Robert F. Kennedy Jr., the president-elect’s nominee to lead the Department of Health and Human Services, has criticized ultra processed foods and artificial dyes and other additives found in many foods. And there’s a battle brewing over the best source of protein, with red meat champions in one camp and plant-based supporters in another.
    • “Food is a hot-button issue,” said Christina A. Roberto, director of the Center for Food and Nutrition Policy at the University of Pennsylvania. “It’s wrapped up in tradition.” That’s part of what makes people resistant to being told they need to change how they eat, she notes.”
  • The U.S. Preventive Services Task Force proposed new Grade A cervical cancer screening recommendations for women aged 21 to 65.
    • The USPSTF recommends screening for cervical cancer every 3 years with cervical cytology alone in women ages 21 to 29 years and then every 5 years with clinician- or patient-collected high-risk human papillomavirus (HPV) primary screening in women ages 30 to 65 years.
    • As an alternative to HPV primary screening for women ages 30 to 65 years, the USPSTF recommends continued screening every 3 years with cervical cytology alone or screening every 5 years with high-risk HPV testing in combination with cytology (cotesting).
  • The second sub-bullet is a new recommendation. The comment period on the proposed recommendation ends on January 13, 2025.
  • The New York Times adds,
    • “The [USPSTF] advice was issued amid growing concern about a falloff in cancer screenings, and confusion resulting from changes over time in screening regimens and tests used for early detection and prevention of cervical cancer.
    • “Use of self-collected vaginal swabs for HPV tests is being recommended for the first time in the guidelines, partly in an effort to increase screening and make it easier.
    • “It’s important to emphasize that cervical cancer is one of the most treatable and preventable types of cancer,” because screening is so effective, said Dr. John Wong, vice chair of the task force.
    • “Cervical cancer tends to be slow-growing, he explained. Pap smears can pick up precancerous changes, while HPV tests pick up persistent infections that don’t resolve on their own and may trigger cancerous cellular changes over time.”
  • The Washington Post points out,
    • “The Environmental Protection Agency on Monday banned two known carcinogens used in a variety of consumer products and industrial settings that can seep into the environment through the soil and waterways.
    • “The new rules, which underscore President Joe Biden’s efforts to enact key protections against harmful chemicals before leaving office, include the complete ban of trichloroethylene — also known as TCE — a substance found in degreasing agents, furniture care and auto repair products. The agency also banned all consumer uses and many commercial uses of perc — also known as perchloroethylene and PCE — an industrial solvent long used in applications such as dry cleaning and auto repair.
    • “Both of these chemicals have caused too much harm for too long, despite the existence of safer alternatives,” said Jonathan Kalmuss-Katz, a senior attorney at Earthjustice.”
  • The Wall Street Journal adds,
    • “Nigel Brockton, vice president of research at the American Institute for Cancer Research, says the general population’s exposure to these chemicals is likely very limited.
    • ​“It’s a good thing that [the EPA] are eliminating these carcinogens but unless you’ve had substantial exposure, either through occupation or through industrial contamination of your environment, we would still say focus on the factors that you can control,” says Brockton, who recommends activities like eating a healthy diet and limiting alcohol.”

From the judicial front,

  • Reuters informs us,
    • “The U.S. Supreme Court on Monday declined to hear an appeal by the nation’s leading drug industry group challenging an Arkansas law requiring pharmaceutical companies to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations.
    • “The court’s decision comes as the industry group, Pharmaceutical Research and Manufacturers of America, known as PhRMA, and individual drugmakers have filed a series of similar lawsuits in recent months over other state laws meant to ensure that hospitals can use contract pharmacies while participating in the federal 340B discount program.”
  • STAT New lets us know,
    • “The Ohio Supreme Court ruled that three of the largest pharmacy chain operators in the U.S. could not be held liable under a state nuisance law for contributing to the long-running opioid crisis.
    • “In a 5-to-2 vote, the court determined that the law barred two Ohio counties from obtaining a $650.9 million judgment that was won in a federal court against CVS Health, Walgreens, and Walmart. In explaining the decision, the court maintained that a state product liability law, which had been amended in 2007, superseded the nuisance claims.”
  • The Wall Street Journal relates,
    • “A federal judge blocked Kroger from acquiring Albertsons, siding with Biden administration antitrust enforcers who said the $20 billion supermarket merger would erode competition and raise prices for consumers.
    • U.S. District Judge Adrienne Nelson agreed with the Federal Trade Commission’s argument that Kroger would become the dominant player in traditional supermarkets if allowed to add nearly 2,000 stores by taking over Albertsons, its smaller rival. Nelson rejected the companies’ counterargument that selling 579 stores to C&S Wholesale Grocers would replace the lost competition.
    • “Evidence shows that defendants engage in substantial head-to-head competition and the proposed merger would remove that competition,” Nelson wrote in the ruling.” * * *
    • “Representatives for Kroger and Albertsons said the companies were disappointed by the decision and that they are weighing their options.”
       
  • The New York Times reports,
    • “A suspect charged with murder in New York in the assassination of the chief executive of UnitedHealthcare in Midtown Manhattan will fight extradition to New York to face murder charges, potentially keeping him in custody in Pennsylvania for weeks.
    • “He is contesting it,” said his lawyer, Thomas Dickey.
    • “The suspect, Luigi Mangione, 26, was charged late Monday in Manhattan with second-degree murder, forgery and three gun charges.” 
  • and
    • “Brian Thompson, the chief executive of UnitedHealthcare who was gunned down in a brazen killing in New York, was laid to rest this week at a private funeral service in his Minnesota hometown.
    • “On Monday, while the nation was transfixed by the arrest of a 26-year-old man from Maryland who was charged with the murder, family and friends of the slain executive gathered at a Lutheran church in Maple Grove, Minn., to mourn the loss of a husband and father who ascended from modest roots in Iowa to one of the most powerful roles in the health care industry.”
    • RIP

From the public health and medical research front,

  • The American Hospital Association News lets us know,
    • “A study released Dec. 9 by FAIR Health shows an increase in cancer treatment rates for people aged 18-49. The study examined treatment rates for that age group between 2016 and 2023 and noted an overall decrease. From 2020-2023, however, patients aged 18-29 experienced the largest increase in treatment rates at 11.7%, followed by a 7.5% increase for patients aged 40-49 and a 7.2% increase for individuals aged 30-39.”
  • The Washington Post notes,
    • “Federal disease trackers reported Tuesday that the first child diagnosed with bird flu in an ongoing U.S. outbreak was infected with a virus strain moving rapidly through dairy cattle, even though there is no evidence the youngster was exposed to livestock or any infected animals.
    • “The finding by the Centers for Disease Control and Prevention about the child, who lives in California, deepened the mystery about the spread of H5N1 bird flu, a viral ailment that epidemiologists have watched warily for more than two decades, fearing it could spark a pandemic.”
  • KFF CEO Drew Altman discusses the twin problems of mental healthcare — access and affordability.
  • Per Infectious Disease Advisor,
    • “Severe outcomes are uncommon among children with pneumonia regardless of whether antibiotics are received, according to study results published in JAMA Network Open.” * * *
    • “These results suggest that some children diagnosed with pneumonia can likely be managed without antibiotics and highlight the need for prospective studies to identify these children,” the researchers concluded.”
  • Per a National Institutes of Health press release,
    • “The antiviral drug tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). There were no safety concerns associated with tecovirimat.
    • “Considering these definitive findings, the study’s Data Safety and Monitoring Board (DSMB) recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. As the study sponsor, the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) accepted the DSMB’s recommendation. Given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug’s efficacy.”
  • STAT News informs us,
    • New data suggests researchers may have found one of their most promising candidates yet for the next generation in immunotherapy drugs — bispecific antibodies targeting two key proteins in cancer, PD1 or PD-L1 and VEGF.
    • A small early trial on one such bispecific compound was presented by researchers working with BioNTech at the San Antonio Breast Cancer Symposium on Tuesday. The bispecific compound, called BNT-327, had positive results in patients with triple negative breast cancer. If future trials on the bispecific produce more positive data, it could become a critical part of how triple negative breast cancer — and potentially other cancers — are treated.
    • The research builds on the 1990s discovery of immunotherapy drugs called checkpoint inhibitors, which was “transformative” in oncology, BioNTech co-founder and CMO Özlem Türeci told STAT. Drugs like Merck’s Keytruda can help stimulate the immune system to find and kill cancer cells and have become a mainstay in the standard treatment of many different cancer types. 
    • “But there’s still space for improvement. We all were looking for the next-generation checkpoint inhibitors,” Türeci said. “I believe PD-L1 or PD1 and anti-VEGF bispecifics are exactly this next-generation compound.”
  • Per BioPharma Dive,
    • “An experimental drug from NewAmsterdam Pharma has shown it may protect heart health in a Phase 3 study, a finding Wall Street analysts believe boosts the medicine’s chances of improving the outcomes of people with cardiovascular disease in an ongoing, closely watched clinical trial. 
    • NewAmsterdam on Tuesday said the drug, obicetrapib, met its main goalin the third of three late-stage trials. People with either an inherited condition called heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who received obicetrapib alongside other medicines saw their levels of LDL, or “bad,” cholesterol fall by an average of 33% after 84 days when adjusted for placebo. That result is similar to what was observed in the two previous Phase 3 trials and will form the basis of approval filings NewAmsterdam intends to discuss with U.S. regulators next year, according to the company.
    • “Obicetrapib’s safety profile, including its potential impact on blood pressure — a concern for drugs of its kind, known as CETP inhibitors — were also comparable to a placebo. A higher percentage of patients in the placebo arm dropped out of the trial due to treatment-related side effects, NewAmsterdam said. 
    • “Notably, though the study wasn’t set up to definitively prove whether obicetrapib could lower the risk of heart disease-related complications, testing revealed signs of a possible benefit.” 
  • BioPharma Dive also brings us a report from the American Society of Hematology’s meeting in San Diego.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Walgreens is in talks to sell itself to a private-equity firm in a deal that would take the pharmacy chain off the public market after its shares have been on a downward slide for nearly a decade. 
    • “Walgreens Boots Alliance and Sycamore Partners have been discussing a deal that could be completed early next year, assuming talks don’t fall apart, according to people familiar with the matter.
    • “Walgreens’s market value reached a peak of over $100 billion in 2015 but had since shrunk to around $7.5 billion as of Monday. Mounting pressures on both its pharmacy and retail businesses had helped send its shares down nearly 70% so far this year before The Wall Street Journal reported on the deal talks Tuesday.
    • “Walgreens’s shares closed up 18% Tuesday after the report—marking the highest one-day jump in the company’s history and giving it a market value of around $9 billion.”
  • and
    • “Weight-loss drugs could be a boon for insurers, but it is too soon to tell whether the industry will be transformed, the head of Swiss Re’s life and health reinsurance arm said.
    • “The market for obesity drugs such as Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy is booming after studies found the treatments helped patients shed weight and showed promise for health problems ranging from heart-attack risk to alcohol abuse. Lower rates of obesity—which has long been a public health crisis in the U.S. and is linked to many chronic conditions—could lead to smaller health-related claims for insurers and better underwriting margins.
    • “While excitement about the drugs is high, Swiss Re Life & Health Chief Executive Paul Murray said in an interview that many questions remain unanswered.
    • “Often when you get new things, they look shiny and new and we learn over time that it’s best to kind of wait and see a bit what the impact is,” Murray said. Reinsurers like Swiss Re backstop insurance companies’ largest risks.
    • “The rising use of these therapies has the potential to accelerate improvements in life expectancy, which has implications for the life insurance market, Murray said. However, it remains to be seen how long the health benefits of the drugs last, whether people are willing to stay on them long term or can afford to do so, and what happens when they stop taking them, he added.
    • “As things stand today, I would bet pricing will improve, but of course we have to wait and see what the data tells us about the longer-term impact of these drugs,” Murray said.
    • “We don’t know if it’s unilaterally healthy for people to hold food in their stomach for longer,” the chief executive added. The main ingredient of these medications—which were originally developed for diabetes—mimics gut hormones, suppressing appetite and slowing digestion.”
  • MedPage Today identifies the hospitals which offer the most outstanding maternity care.
  • Per the American Hospital Association News,
    • “Baxter has resumed production on all of its 3-liter irrigation and peritoneal dialysis solutions manufacturing lines, the company announced Dec. 5. The company noted that despite production resuming for those lines, more time is needed to restore output to levels reached prior to Hurricane Helene. Baxter expects all manufacturing lines to resume operation by the end of the month.”

Friday Report

David Ermer–ACA, CDC, Congress, COVID-19, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
  • Healthcare Dive lets us know,
    • “Major health insurers are deleting images of their top leadership from corporate websites or removing executive pages entirely following the brazen killing of UnitedHealthcare CEO Brian Thompson earlier this week.
    • “Thompson, 50, was shot multiple times in midtown Manhattan on Wednesday in what appeared to be a targeted attack. Though many of Thompson’s peers expressed grief, the killing set off a morbidly gleeful celebration on social media, where posters on sites like X and Reddit applauded and joked about the crime to vent frustration and anger with health insurers.
    • “The shooting and subsequent reaction has spurred healthcare companies to increase security around their executives, according to reports. Such measures appear to be extending online, as major insurers scrub identifying details of top personnel from their sites.”
  • The New York Times reports,
    • “Jessica Tisch, commissioner of the New York Police Department, said in an interview with CNN that investigators have “reason to believe” that the person they seek in the killing of Brian Thompson has left New York City. Joseph Kenny, the chief of detectives, said the police have video of him entering a bus terminal the day of the attack. “We don’t have any video of him exiting, so we believe he may have gotten on a bus,” he told CNN.” * * *
    • “The Atlanta Police Department is working with the New York police on the investigation into the killing of Brian Thompson. The Atlanta department said in a statement that it “will now be providing assistance as needed. The N.Y.P.D. is the lead agency.” The Greyhound bus that took the suspect to New York originated in Atlanta, law enforcement officials have said.”
  • Modern Healthcare adds,
    • “The New York Police Department is waiting on DNA test results that could help in the hunt for the killer of insurance chief Brian Thompson, who was fatally shot outside the New York Hilton Midtown Hotel on early Wednesday morning. 
    • “Investigators pulled DNA from an Ethos water bottle that was found in the alleyway of the building that used to house the Ziegfeld Theater, according to a person with knowledge of the matter. It was the same spot where the shooter is believed to have pre-positioned an e-bike used for his getaway and where he dropped a Motorola burner phone, the person said. Police also tested DNA from a Starbucks cup the suspect dropped in a garbage can before he gunned Thompson down.
    • “The items were sent for testing on Wednesday with results expected within three days, potentially bolstering an investigation that is centered on identifying a male suspect who checked into a hostel on Manhattan’s Upper West Side. Police and New York’s Mayor Eric Adams are appealing to the public for help in identifying the suspect, offering $10,000 for tips.”

From Washington, DC,

  • The Washington Post lets us know,
    • “Congressional Democrats have privately proposed a deal to Republicans that would extend expiring Affordable Care Act subsidies by one year, with lawmakers worried by new estimates that 2.2 million people will otherwise lose health coverage, according to five people who spoke on the condition of anonymity to discuss the proposal.
    • “The move accompanied a broader package of health-care proposals submitted to Republicans on Thursday night ahead of year-end spending negotiations.
    • “Lawmakers are fiercely hammering out a bill to fund the government, and health-care leaders are pushing to add priorities to one of the final pieces of legislation this Congress. Negotiations are also occurring on other measures, such as more funding for community health centers, proposals to address bipartisan frustrations about pharmacy benefit managers and other extensions of ongoing health-care programs, four of the people said.
    • “A one-year deal to extend the expiring ACA subsidies would avoid what was expected to be a bruising battle for both parties. Democrats, who crafted the subsidies and have fought to defend them, are set to lose control of the Senate and the White House next year, complicating their ability to make policy. Republicans, who are set to gain control of Washington, are wary of being punished by voters for any perception that they are rolling back health-care coverage, with the backlash to their ACA repeal efforts still fresh in many lawmakers’ minds.”
  • Govexec tells us,
    • “A Republican senator told the head of the U.S. Postal Service on Thursday that he would do everything he could to prevent the agency leader from instituting one of his key reforms, setting up a key divide between Congress and USPS. 
    • “Postmaster General Louis DeJoy faced bipartisan pushback from members of the Senate Homeland Security and Governmental Affairs, with multiple exchanges turning testy. DeJoy vehemently defended his efforts and said the senators standing in his way would bring about the end of the Postal Service. 
    • “Sen. Josh Hawley, R-Mo., became angry with DeJoy when discussing his plan to slow down delivery for some mail, which is expected to disproportionately impact rural areas.
    • “I hate this plan and I’m going to do everything I can to kill it,” Hawley said.”
  • Fierce Healthcare explains “How Trump could roll back Biden-era healthcare regulations.”
  • BioSpace relates,
    • “An appeals court on Wednesday ruled against Novartis in its bid to block the entry of MSN Pharmaceuticals’ generic competitor to the blockbuster heart failure drug Entresto (sacubitril/valsartan), according to Reuters and other outlets.
    • “First approved in 2015, Entresto is an oral drug indicated for the treatment of heart failure in adults. It combines the neprilysin blocker sacubitril with the angiotensin receptor inhibitor valsartan to lower blood pressure and vascular resistance. Since hitting the market, Entresto has become Novartis’ top-selling asset, raking in more than $6 billion in net sales globally last year.
    • “In its decision on Wednesday, the U.S. Court of Appeals for the Federal Circuit agreed with a lower court’s verdict that Novartis had not sufficiently proven that it could win a patent suit against MSN. The appellate judges saw “no clear error in the district court’s analysis,” as reported by Reuters.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity remains low in most areas but is expected to increase in the coming weeks. Seasonal influenza activity remains low nationally but continues to increase slowly. RSV activity is moderate and continues to increase in most areas of the United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae remain elevated among young children in the United States.
    • “COVID-19
      • “Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are stable or decreasing nationally while deaths remain at very low levels. However, based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness to increase in the coming weeks as it usually does in the winter.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is moderate nationally and continues to increase in most areas of the United States, particularly in young children. Emergency department visits and hospitalizations are increasing in children and hospitalizations are increasing among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections afforded by vaccines.
  • The Wall Street Journal reports,
    • “The Agriculture Department said it would launch national testing of cow’s milk for the presence of bird flu to help regulators monitor U.S. dairy processors.
    • “The USDA’s Animal and Plant Health Inspection Service said Friday that its “National Milk Testing Strategy” is designed to quickly find the presence of the disease in cow’s milk or in the cows themselves, by compiling random samples from different processing plants and testing them for the highly pathogenic H5N1 strain of avian influenza.
    • “The virus is widespread among bird flocks, having been detected in over 110 million poultry birds, as well as more wild birds. The disease spread to U.S. cattle herds and has been transmitted to humans, according to the federal Centers for Disease Control and Prevention. The CDC reported nearly 60 human cases, mostly among dairy and poultry workers.
    • “The testing regime is expected to provide more comprehensive data on the proliferation of the disease into cows, the USDA said. The first round of testing is scheduled to begin the week of Dec. 16.”
  • Cardiovascular Business tells us,
    • “Depression is associated with a heightened risk of cardiovascular disease (CVD) among women, according to new data published in Circulation: Genomic and Precision Medicine.[1] The same trend is not seen in men.
    • “The study’s authors focused on three different major psychiatric disorders: major depression (MD), bipolar disorder (BD) and schizophrenia. 
    • “Few studies have investigated the sex differences in the cardiovascular comorbidity of schizophrenia and BD, and observational studies have presented inconsistent findings on the sex-specific association between depression and CVD outcomes,” wrote first author Jiayue-Clara Jiang, PhD, with the Institute for Molecular Bioscience at the University of Queensland in Australia, and colleagues.
    • “Jiang et al. examined U.K. Biobank data from more than 345,000 patients, focused on MD, BD and schizophrenia may impact a patient’s long-term risk of developing atrial fibrillation (AFib), coronary artery disease or heart failure.” 

From the U.S. healthcare business front,

  • Modern Healthcare relates,
    • “The vast majority of people in the U.S. are dissatisfied with the cost of healthcare, according to researchers. Meanwhile, the percentage of those who would rate the quality of U.S. healthcare as excellent or good has hit its lowest point in more than two decades.
    • “Research and polling firm Gallup’s annual Health and Healthcare poll, released Friday, found that 11% of Americans said healthcare quality was excellent and 33% said it was good. Additionally, nearly 80% of respondents said they were dissatisfied with the cost of healthcare.
    • The survey was conducted through telephone interviews between Nov. 6 and Nov. 20 among a random sample of 1,001 adults across all 50 states.” * * *
    • “When asked about what they saw as the most urgent health problem facing the country, survey participants’ number one response was cost, followed by access and obesity.” 
  • Medical Economics adds,
    • “The Business Group on Health has identified health care costs as a major trend employers will need to navigate in 2025. With the cost of care growing at historic rates, businesses are preparing for a year of challenging decisions to manage expenses while maintaining quality care for their employees. Many of these changes could affect primary care physicians and their patients.
    • “A multitude of factors shape these 2025 trends, including the economy, technology, innovation, the political environment, and the evolving role of employers in the broader health and well-being landscape,” said Ellen Kelsay, president and CEO of the Business Group on Health, in a statement. “As employers head into the new year, they face formidable challenges stemming from climbing health care costs, which are putting pressure on how employers manage their overall health and well-being programs.”
    • “The 2025 Trends to Watch, outlined by the largest non-profit organization representing employer interests in health and workforce strategies, highlight the complexities businesses will encounter in addressing cost growth, mental health challenges, and an evolving relationship with vendors and health care partners.”
  • Per Kaufmann Hall,
    • “Following the release of Q3 financial reports, this week’s graphic takes stock of large health insurance companies’ recent financial performances. Nearly all the major payers reported higher medical loss ratios (MLRs) in Q3 2024 compared to Q4 2022. The MLR refers to the percentage of premium dollars spent on medical claims and quality improvements and is an important metric payers use to evaluate their operations. This upward trend has affected some payers more than others, with CVS’s MLR rising by more than 9% compared to UnitedHealth Group’s (UHG) 2.4% increase in this time frame. The only payer to report a decreased MLR was Cigna, which appears to be benefitting from its continued pullback from the Medicare Advantage (MA) market.
    • Notably, payers have often cited higher utilization among MA patients­­­­—their previous blueprint for growth—as the leading reason for these rising costs. Additionally, relying on the profitability of other business segments to fuel future strategic investments may not be a sustainable plan for the two largest vertically integrated payers. 
    • Despite directing substantial resources into their non-insurance segments, nearly all these companies’ other business units have also been less profitable through Q3 2024, compared to the same period last year. After riding high for several years, the payers are showing signs that, despite their size, they are running into many of the same challenges as providers: rising drug costs, an aging population, and higher labor costs.
  • Per Beckers Hospital Review,
    • “Blue Shield of California is set to launch a drug benefit initiative in January, partnering with Amazon Pharmacy and pharmacy benefit manager Abarca, Forbes reported Dec. 5. 
    • “The collaboration, called the Pharmacy Care Reimagined Initiative, aims to reduce prescription drug costs and improve transparency for the insurer’s 5 million health plan members.” 
    • This initiative was first announced in August 2023.

Thursday Report

David Ermer–ACA, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Telehealth, U.S. Healthcare–

Healthcare Dive shares observations and news about yesterday’s murder of United Healthcare’s CEO Brian Thompson.

Yahoo News delves into the investigation of Mr. Thompson murder by the New York City Police Department. The FEHBlog has the utmost confidence that this investigation will end with at least one arrest.

From Washington, DC

  • Federal News Network informs us,
    • “Enrollees in the new Postal Service Health Benefits program will have a few extra days of Open Season to review their plan options and make changes to their benefits for plan year 2025.
    • “The Office of Personnel Management officially extended Open Season for PSHB participants until Dec. 13, Federal News Network has learned. Participants in the Federal Employees Health Benefits program and other federal benefits programs will still see Open Season end on the original Dec. 9 deadline.
    • “OPM said the transition to the new PSHB program is “a big change” for enrollees, and it’s extending Open Season by four days to give Postal employees, annuitants and their family members additional time to look at plans and make changes as they see fit.
    • “We feel it is important to extend Open Season for customers of the PSHB program to give them ample time to shop for plans and change their elections if they want to,” OPM said.
  • Tammy Flanagan, writing in Govexec, discusses Open Season and tax savings.
  • Politico reports,
    • “The House is losing several health policy leaders after this Congress, and they’ll likely want to make their mark in their last two months on Capitol Hill.
    • “While Congress negotiates its end-of-year legislative package, some key departing lawmakers are rallying to pass projects before their terms end — although expectations for a health care package are low. Historically, Congress has sometimes shown a willingness to give outgoing lawmakers a win.”
    • Politico shares the legacy goals of the retiring House members.
  • Among the bills for possible inclusion in the lame duck health care package is S. 1339, Pharmacy Benefit Manager Reform Act. The Congressional Budget Office issued a report on this bill today.
  • The Washington Post informs us,
    • “A bipartisan group of senators grilled Food and Drug Administration officials Thursday on the agency’s failure to more tightly regulate ultra-processed foods and food dyes, highlighting a key part of the health agenda promoted by Robert F. Kennedy Jr.
    • “Kennedy, President-elect Donald Trump’s controversial pick to lead the sprawling Department of Health and Human Services, which oversees the FDA, has blamed the nation’s surge of chronic disease and declining life expectancy on ultra-processed foods — a position that aligns with Sen. Bernie Sanders (I-Vermont), who convened the hearing as chairman of the Senate health committee.
    • “Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra-processed food and beverages loaded up with sugar, salt and saturated fat,” Sanders said Thursday, pointing to the billions of dollars the food-and-beverage industry spends on advertising.”
  • Govexec notes,
    • “The leaders of President-elect Trump’s new advisory panel aiming to slash government spending, Elon Musk and Vivek Ramaswamy, met with Republican lawmakers at the Capitol on Thursday in what leaders pitched as an informational session to share ideas. 
    • “Congressional Republicans and a handful of Democrats have embraced Trump’s Department of Government Efficiency, which will function as a non-governmental commission, and on Thursday were eager to share their ideas for identifying areas for cuts. Some Republicans cautioned, however, that the advisory panel must work through the appropriate channels and win congressional support for their initiatives. 
    • “Nearly every House and Senate member that emerged from the various meetings called them productive and suggested a unifying idea supported by both lawmakers and Trump’s designated efficiency czars: recalling teleworking employees back to the office.”  
  • Per Department of Health and Human Services press releases,
  • and
    • “Today, the U.S. Department of Health & Human Services (HHS), Office for Civil Rights (OCR), issued a “Dear Colleague” letter – PDF to help federally funded health care providers, plan grantees, and others better understand their civil rights obligations under the new final rule on Section 1557 of the Affordable Care Act (“Section 1557”).  
    • “Section 1557 provides nondiscrimination protections by requiring covered entities (e.g., recipients of Federal financial assistance, programs administered by HHS, and entities established under Title I of the Affordable Care Act (ACA)) to provide language assistance to individuals with limited English proficiency (LEP) or disability.”
  • Modern Healthcare reports,
    • “Hospitals have expanded their legal push for the federal government to boost Medicare reimbursement.
    • “More than 500 hospitals last week sued the Health and Human Services Department for allegedly miscalculating a 40-year-old Inpatient Prospective Payment System base reimbursement rate that providers say has lowered years of subsequent Medicare payments to hospitals. The lawsuit is the latest in a series of similar complaints that allege the Health and Human Services Department must increase Medicare inpatient pay.
    • “Each lawsuit challenges different batches of denied requests to amend reimbursement rates, but the arguments are largely the same. Hundreds of millions of dollars are at stake, providers allege. If the federal government changes the inpatient base pay rate, hospitals stand to not only recoup money from prior fiscal years but also increase future reimbursement rates.”
  • The American Hospital Association News tells us,
    • “A $2.8 billion settlement from Blue Cross Blue Shield to health care providers resolving a 12-year antitrust lawsuit received preliminary approval yesterday from the U.S. District Court for the Northern District of Alabama. The settlement will also “significantly improve how Providers will interact with the Blues, bringing more transparency and efficiency to their dealings, and increase Blue Plan accountability,” according to the court filing. 
    • “The lawsuit alleged that BCBS member companies violated antitrust laws by agreeing to allocate markets via exclusive service areas and fixing prices paid to health care providers through the organization’s BlueCard Program.”
  • and
    • “Approximately 988,000 consumers who currently do not have health insurance coverage through the individual marketplace have signed up for a 2025 health plan through the federally facilitated Health Insurance Marketplace, the Centers for Medicare & Medicaid Services announced yesterday. Nearly 4.4 million returning consumers have selected 2025 plans. The open enrollment period began Nov. 1 and continues through Jan. 15.”
    • The deadline for January 1, 2025, enrollments is December 15, 2024. Later enrollments will begin on February 1, 2025.
  • and
    • “The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence. The guidance recommends information to include in a predetermined change control plan as part of a marketing submission for a medical device using AI. The PCCP should include a description of the device’s planned modifications; methods to develop, validate and implement the modifications; and an assessment of the modification’s impacts. FDA will then review the PCCP within the submission to ensure the device’s safety and effectiveness without needing additional marketing submissions for each modification.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “Scientists from the Scripps Research Institute are reporting that it would take just a single mutation in the version of bird flu that has swept through U.S. dairy herds to produce a virus adept at latching on to human cells, a much simpler step than previously imagined.
    • “To date, there have been no documented cases of one human passing avian influenza to another, the Scripps scientists wrote in their paper, which was published Thursday in the journal Science. The mutation they identified would allow the virus to attach to our cells by hitching itself to a protein on their surface, known as the receptor.
    • “William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center who did not participate in the study, called the research “sobering,” adding, “I had not known it would take just one mutation in the virus for it to attach itself to the receptors on human cells.
    • “However, he stressed that the H5N1 virus has been active for 20 years and “has multiplied billions upon billions upon billions of times and the spontaneous mutation that the authors describe,” has not been found, despite intense surveillance.
    • “Yoshihiro Kawaoka, a professor of virology at the University of Wisconsin, who was not involved in the latest research but has studied bird flu extensively, said that statistically, the mutation probably already exists in H5N1-infected cows and humans, given that 1 in 10,000 infectious particles of the influenza virus is a mutant.
    • “James C. Paulson, one of the paper’s authors, and several other top scientists agreed that it is statistically likely the mutation has occurred in the H5N1 virus but stressed that it has yet to be detected, and other barriers remain before the virus could be transmitted from one person to another. Paulson is a professor in the Department of Molecular Medicine at Scripps.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Your memories of life experiences are encoded in collections of neurons in the brain that were active at the time the event took place. Later, those same patterns of neural activity are replayed in your mind to help stabilize your memories of past events. But new research suggests those memories aren’t fixed. An NIH-supported study in male mice reveals how an older memory can be “refreshed” and altered by association with newer events.
    • “The findings, reported in Nature , show that a memory of a recent negative event can become linked to the memory of a neutral event that took place days earlier, changing the way it’s remembered. This provides important insight into what we know about how the brain updates and reorganizes memories based on new information. These findings could also have implications for our understanding of neurobiological processes that might occur in the brain in memory-related mental health conditions like post-traumatic stress disorder (PTSD), when people feel stress or fear even in situations that present no danger.” *. * *
    • “Although these findings were obtained in a mouse model, according to the researchers, the study results suggest that our brains may integrate memories to form a cohesive understanding of real-world experiences in ways that offer stability and flexibility. These insights suggest that memories of the past are constantly updated and refreshed by new experiences in ways that may help us function in a world marked by constant change.
    • “The findings also suggest that negative experiences can lead us to fear seemingly unrelated places or events in ways that are detrimental. This may help to explain why for people with PTSD, exposure therapy—in which people work to overcome fears through gradual exposures to them in a safe environment—can stop being effective. The hope is that findings like these might shed light on potential new ways to treat PTSD and related disorders.”
  • Per an NIH press release,
    • “Improvements in cancer prevention and screening have averted more deaths from five cancer types combined over the past 45 years than treatment advances, according to a modeling study led by researchers at the National Institutes of Health (NIH). The study, published Dec. 5, 2024, in JAMA Oncology, looked at deaths from breast, cervical, colorectal, lung, and prostate cancer that were averted by the combination of prevention, screening, and treatment advances. The researchers focused on these five cancers because they are among the most common causes of cancer deaths and strategies exist for their prevention, early detection, and/or treatment. In recent years, these five cancers have made up nearly half of all new cancer diagnoses and deaths.
    • “Although many people may believe that treatment advances are the major driver of reductions in mortality from these five cancers combined, the surprise here is how much prevention and screening contribute to reductions in mortality,” said co-lead investigator Katrina A. B. Goddard, Ph.D., director of NCI’s Division of Cancer Control and Population Sciences. “Eight out of 10 deaths from these five cancers that were averted over the past 45 years were due to advances in prevention and screening.”
    • “A single prevention intervention, smoking cessation, contributed the lion’s share of the deaths averted: 3.45 million from lung cancer alone. When considering each cancer site individually, prevention and screening accounted for most deaths averted for cervical, colorectal, lung, and prostate cancer, whereas treatment advances accounted for most deaths averted from breast cancer.
    • “To reduce cancer death rates, it’s critical that we combine effective strategies in prevention and screening with advances in treatment,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “This study will help us understand which strategies have been most effective in reducing cancer deaths so that we can continue building on this momentum and hopefully increase the use of these strategies across the United States.”
  • The AP adds,
    • “Many moms-to-be opt for blood tests during pregnancy to check for fetal disorders such as Down syndrome. In rare instances, these tests can reveal something unexpected — hints of a hidden cancer in the woman.
    • “In a study of 107 pregnant women whose test results were unusual, 52 were ultimately diagnosed with cancer. Most of them were treated and are now in remission, although seven with advanced cancers died.
    • “They looked like healthy, young women and they reported themselves as being healthy,” said Dr. Diana Bianchi, the senior author of the government study published Wednesday in the New England Journal of Medicine.
    • “Of the discovered cancers, lymphoma blood cancers were the most common, followed by colon and breast cancers.
    • “The blood test is called cell-free DNA sequencing. It looks for fetal problems in DNA fragments shed from the placenta into the mother’s bloodstream. It also can pick up DNA fragments shed by cancer cells.”
  • NBC News relates,
    • “Prescription fills for blockbuster weight loss medications in the U.S. more than doubled in 2024, even with limited insurance coverage and high out-of-pocket costs for the treatments.
    • “That’s according to new data from drug savings company GoodRx, which examined fill trends and spending patterns for weight loss drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.
    • “It offers more evidence of the insatiable demand for a buzzy class of medications called GLP-1 and GIP agonists, which have hefty list prices of roughly $1,000 per month before insurance or savings cards.”
  • More on prevention from Physicians’ Weekly,
    • “People with type 2 diabetes mellitus (T2DM) face a high risk of cardiovascular disease (CVD), but the timing of this elevated risk before diagnosis is not well understood.  
    • “Researchers conducted a retrospective study to examine CVD occurrence up to 30 years before and 5 years after a diagnosis of type 2 diabetes.  
    • ‘They included individuals diagnosed with type 2 diabetes in Denmark (2010 and 2015) n=127,092 and matched comparisons n=381,023. Conditional logistic regression was used to compute ORs for the prevalence of CVD in the 30 years before diagnosis, and Cox proportional hazards regression models to calculate HRs for 5-year CVD incidence after diagnosis.  
    • ‘The results showed that, in the 30 years before diagnosis, 14,179 (11.2%) individuals with type 2 diabetes and 17,871 (4.7%) comparisons experienced CVD. The odds of CVD were higher for individuals with type 2 diabetes, ranging from 2.18 (95% CI: 1.91-2.48) in the earliest period (25-30 years before diagnosis) to 2.96 (95% CI: 2.85-3.08) in the latest period (less than 5 years before diagnosis). After diagnosis, the 5-year CVD incidence was higher for individuals with type 2 diabetes (HR: 2.20; 95% CI: 2.12-2.27).  
    • “They concluded that individuals with type 2 diabetes experienced twice the number of CVD events compared to matched controls, starting up to 30 years before diagnosis, suggesting that early preventive strategies may be necessary.”  

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly said it would invest $3 billion to expand a recently acquired manufacturing facility to meet growing demand for its diabetes and weight-loss medicines.
    • “The drugmaker said the Kenosha County, Wis., plant expansion would extend the reach of its injectable-product manufacturing and add 750 jobs. The facility already employs around 100 people.
    • “Overall, the expanded facility would focus on manufacturing injectable medicines, device assembly and packaging for medicines across multiple therapeutic areas, the Indianapolis company said.
    • “The decision comes months after Lilly resolved shortages for its weight-loss and diabetes drugs, Zepbound and Mounjaro. Lilly’s rival, Novo Nordisk, has been expanding its production capacity to resolve shortages.”
  • Per Fierce Healthcare,
    • “Amazon has added digital musculoskeletal care company Hinge Health to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.
    • “Hinge Health is the first digital musclosketal platform to join Amazon Health Services’ offering that aims to help people discover and enroll in digital health programs available through their employer or health plan at no additional cost.
    • “It marks the fourth company to join Amazon Health Services’ digital health benefits program, following Omada Health, as its first launch partner, Talkspace and behavioral health company Rula Health.”
  • Per Fierce Pharma,
    • “AstraZeneca has picked off another label expansion for its cancer blockbuster Imfinzi (durvalumab) as the FDA has blessed the PD-L1 inhibitor for limited-stage small cell lung cancer (LS-SCLC) patients who have not had disease progression after concurrent chemotherapy and radiation treatments.
    • “With the nod, Imfinzi becomes the first immunotherapy for LS-SCLC, an aggressive form of the disorder with a survival rate between 15% and 30% after diagnosis. The subtype includes roughly 30% of all SCLC cases. It often recurs and progresses rapidly despite initial response to standard-of-care chemo and radiation treatment.
    • “The approval is backed by results from the ADRIATIC trial which showed that, compared to placebo, Imfinzi extended patients’ lives by 27% among those who had not progressed following chemoradiotherapy. The estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo.”
  • BioPharma Dive points out,
    • “Inside every human cell are thousands of snippets of genetic code that serve as the directions for creating proteins. And over the past four years, a small biotechnology company has been trying to prove that, by looking closely enough at this assembly of instructions, it can find new ways to treat diseases like Alzheimer’s, Parkinson’s and multiple sclerosis.
    • “The company, Muna Therapeutics, now has a nod of confidence from one of the world’s largest drugmakers, as it announced on Thursday a collaboration with GSK that could ultimately be worth hundreds of millions of dollars.
    • “Per deal terms, Muna will analyze brain tissue samples from a variety of sources, from healthy individuals to Alzheimer’s patients to centenarians with and without cognitive impairment. The company will then use different technologies to determine where protein instructions are (or aren’t) in those tissues, with the goal being to identify and validate new targets for Alzheimer’s drugs.”
  • RAND Healthcare shares its key findings on telehealth policy.

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec let us know,
    • “The top House Republicans for veterans’ issues are pushing a new measure to codify and expand privatized health care on the taxpayer dime, reigniting a controversial issue that is likely to come back to the fore under President-elect Trump. 
    • “The Complete the Mission Act would serve as a followup to the 2018 Mission Act that Trump signed into law, which streamlined and expanded veterans’ access to private sector care paid for by the Veterans Affairs Department. Congress passed the Mission Act on a bipartisan basis to follow a 2014 law with similar goals, but lawmakers have since disagreed over its implementation. 
    • “The new bill, introduced by House Veterans Affairs Committee Chairman Mike Bost, R-Ill., would ensure existing access standards for private sector “community care” are codified in law. Those rules allow veterans living more than a 30-minute drive on average from the nearest VA facility to access the community care network for services such as primary care, mental health and some extended care. For specialized care, veterans must live more than a one-hour drive from the nearest VA facility. They can also access private care when a close VA facility does not provide the service they are seeking, or when their VA doctor recommends it. 
    • “Bost’s measure would expand extended care options in the private sector and bar VA from considering telehealth availability when calculating community care eligibility. It would also require VA to consider veterans’ preference of where to seek treatment. The bill would create a three-year pilot in which patients could enroll in non-VA outpatient mental health or substance use treatment without requiring.”
  • Federal News Network informs us,
    • “Agency leaders in charge of combatting fraud are highlighting the importance of workforce training and data sharing, as the White House touts a deep decline in the governmentwide rate of improper payments.
    • “The Office of Management and Budget last week reported the governmentwide rate improper payment rate had fallen to 3.97%, the lowest since 2014. The rate has dropped by nearly 50% since fiscal 2021, when improper payments and fraud soared amid emergency COVID relief spending.
    • “The total amount of improper and unknown payments in fiscal 2024 was $161.5 billion, compared to just under $236 billion in fiscal 2023, according to data posted on PaymentAccuracy.gov.
    • “The White House said the past year’s progress was driven by “a government-wide approach focused on improving up-front controls, prioritizing fraud prevention, and driving increased collaboration between agencies and their inspectors general.”
  • The Internal Revenue Service announced that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2024, and before October 1, 2025, is $3.47.
  • The Office of Personnel Management’s Inspector General released her latest semi-annual report to Congress.
  • Adam Fein, writing in his Drug Channels blog, shares four revelations about Minnesota’s first 340B program transparency report.

From the public health and medical research front,

  • STAT News reports,
    • “At the annual meeting of the Menopause Society earlier this fall, researchers presented new evidence that hormone therapy can be beneficial to menopausal women’s heart health, reducing insulin resistance and other cardiovascular biomarkers. It was the latest in a long line of research showing the benefits of hormone therapy for women in menopause, which also includes alleviating symptoms like hot flashes, sleep disturbances, vaginal dryness, and pain during sex.
    • “But despite this evidence, hormone therapy’s use has plummeted over the past few decades. In 1999, almost 27% of menopausal women in the U.S. used estrogen. By 2020, less than 5% did. 
    • “So why aren’t more women in menopause taking advantage of treatments known to be effective? Misconceptions about the risks of hormone therapy are one reason, according to experts. So is the lingering cultural taboo around discussing menopause, which has created “a perfect storm for under-treatment,” said Theodoros Kapetanakis, an OB-GYN at Mount Auburn Hospital’s Endometriosis Center in Waltham, Mass.” 
  • Healio tells us.
    • “The beneficial impact of physical activity on mortality risk remained consistent across the adult lifespan, even growing stronger later in life, according to study results published in JAMA Open Network.
    • “In contrast, other modifiable health factors saw their effects on the risk for mortality decrease with increasing age.
  • RAND offers a report titled “Improving the Detection of Cognitive Impairment and the Pathway to Treatment.”‘
    • “Low cognitive ability, functional limitations, and poor physical health are strong predictors of dementia as many as 20 years before its onset. Lifestyle factors, such as never drinking alcohol or drinking excessively, never exercising, and low engagement in hobbies, are associated with cognitive impairment and dementia.
    • “Early detection of cognitive impairment helps people take mitigating actions to prepare for future loss of their financial and physical independence.
    • “Older adults’ take-up of cognitive testing is low, and many who do get tested exit the clinical care pathway before being diagnosed and receiving treatment. Take-up of cognitive tests would increase if tests were free and readily accessible. Treatments would be more palatable if they had fewer side effects and helped patients maintain independence longer.
    • “More engagement of primary care practitioners and team-based care in the clinical care pathway and the use of new technologies, such as blood-based biomarkers, could ease health care system capacity constraints on dementia specialists and reduce wait times for patients.”
  • McKinsey & Company offers ideas about “How to address healthcare inequities for people with disabilities.”
    • “Globally, people with disabilities have a mortality rate that is 2.24 times higher than those without disabilities. And although people with disabilities often have greater healthcare needs, they also experience more and higher barriers to care. McKinsey’s Dr. Mona Hammami and coauthors write that in the patient care pathway, people with disabilities are more likely to report:
      • “skipping or delaying care because of cost
      • “having difficulty securing transportation to a health facility
      • “encountering inaccessible facilities
      • “meeting workers with inadequate skills or flexibility to provide quality care
    • “This International Day of Persons with Disabilities (IDPD), examine inequities in the patient care pathway, potential interventions to overcome them, and a three-step approach to reducing inequities across communicable and non-communicable disease types.”
  • The New York Times reports
    • “Health officials have closed their investigations into an E. coli outbreak linked to raw onions on McDonald’s Quarter Pounder hamburgers that sickened more than a hundred people, the Food and Drug Administration (FDA) announced Tuesday.
    • “In total, 104 people from 14 states were sickened from the contaminated food and 34 were hospitalized. One older person in Colorado died.
    • “Officials said there did not appear to be a “continued food safety concern,” because McDonald’s had not served slivered onions — which investigators determined to be the “likely source of contamination”— on the Quarter Pounders for more than a month. The onions were recalled. And in many states, Quarter Pounders were removed from the menu altogether for several weeks.
    • “There have not been any new illnesses since McDonald’s decided to remove the onions from its menu on Oct. 22, according to the Centers for Disease Control and Prevention.”
  • Per an FDA announcement,
    • “On Monday, the FDA updated the outbreak advisory for Salmonella Typhimurium infections linked to cucumbers. As of November 26, 2024, a total of 68 people infected with the outbreak strain of Salmonella have been reported from 19 states. Of the 50 people for whom information is available, 18 have been hospitalized. No deaths have been reported. Of the 33 people interviewed, 27 (82%) reported eating cucumbers.
    • “On November 27, 2024, SunFed Produce, LLC initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. in Sonora, Mexico. On November 29, 2024, Baloian Farms of Arizona Co., Inc. initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. On December 1, 2024, Russ Davis Wholesale initiated a voluntary recall of American/slicer cucumbers and multiple products containing recalled cucumbers.
    • “The FDA is working with the recalling firms and their direct customers to determine if additional downstream customer recalls are necessary. The FDA’s investigation is ongoing.”

From the U.S. healthcare business front,

  • Modern Healthcare relates,
    • “Kaiser Permanente-backed Risant Health acquired Cone Health on Sunday, making it the second health system to join Risant in less than a year.
    • “Cone is following in the footsteps of Geisinger Health, which was folded into the newly-formed Risant in March. Kaiser created Washington, D.C.-based Risant earlier this year as a nonprofit entity to buy systems and form a national network for value-based care.” * * *
    • “Having two of these close in one year has made for a pretty busy year,” said Dr. Jaewon Ryu, CEO at Risant. “It’s great to get on the other side of the regulatory approvals and finalize welcoming [Cone] into Risant Health.”
  • Beckers Hospital Review notes,
    • “California was CommonSpirit’s top-performing market in terms of margins in the first quarter of fiscal year 2025 (the three months ending Sept. 30) but the Chicago-based system’s South region, which includes Texas and Kentucky, “remains challenged,” Benjie Loanzon, senior vice president and corporate controller, said during the company’s Dec. 2 earnings call. 
    • “We are taking a range of actions in this region, focusing on our ambulatory strategy,” Mr. Loanzon said. “We are encouraged by recent performance improvements, though a significant amount of work will be needed to reach an acceptable level [of] performance.”
    • “CFO Dan Morissette said the health system continues to look at ways to improve the South region’s performance. Key focus areas include contracting, efficiency, growth and cost containment. 
    • “Although Texas didn’t perform well in Q1, we are encouraged by other achievements in terms of the volume and cost containment,” Mr. Loanzon said. “Kentucky is the most improved market in terms of the financial performance. In terms of the volume and cost containment, it has a positive EBIDTA compared to the past.”
  • Per BioPharma Dive,
    • “Shares of Janux Therapeutics surged to record highs following the release of study results for a drug that, if ultimately successful in testing, would represent a new type of therapy for prostate cancer. 
    • “The findings come from an early-stage study testing the biotechnology company’s therapy, dubbed JANX007, in 16 people with a form of advanced prostate cancer. Data Janux first disclosed earlier this year vaulted the company’s market value past $2 billion. While early and from a small clinical trial, the new results announced Monday afternoon pushed Janux’s shares nearly 75% higher, changing hands Tuesday morning at more than $70 apiece.”‘
  • Beckers Payer Issues tells us how much health plans are paying for GLP-1 drugs.
    • The prices for some GLP-1s have dropped significantly in recent years for individuals covered by Medicare and commercial insurance, according to a new report from HHS,
    • In 2024, the U.S. list prices for a one-month supply for most GLP-1s are stable or increasing, but after payer negotiations and rebates, net prices for many GLP-1s have decreased since 2022. Net prices for GLP-1s are between 24% and 73% lower than list prices, indicating that most insurers are paying less than the manufacturer’s list price.
    • “In the net prices, we see evidence of the impact of competition as new drugs in the class enter the market,” HHS wrote. “While list prices are consistently stable or increasing, for many of these drugs, including Ozempic, Rybelsus, Saxenda, and Victoza, net prices fell.”
  • Healthcare Dive explains “Healthcare organizations must carefully vet AI tools, address patient concerns and keep an eye on standards and regulation, according to industry experts who spoke at a Healthcare Dive virtual event.”

Happy Veterans Day!

David Ermer–ACA, CDC, Congress, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Megan Lee on Unsplash

Thanks to all those who served our great country.

From Washington, DC,

  • The Washington Post reports,
    • “With Republicans on the cusp of unified control of Washington, Congress appears primed to extend the deadline for a government shutdown well past President-elect Donald Trump’s inauguration.
    • “Lawmakers are discussing a temporary measure that would fund the government into March, according to two people briefed on the discussions, who spoke on the condition of anonymity because they were not authorized to speak publicly.
    • “That would give the Senate plenty of time to begin confirming Trump’s Cabinet nominees, and the House time to plot out maneuvers on tax legislation, without the threat of an imminent government shutdown. Without new legislation, financing for federal agencies will expire Dec. 20.”
  • Modern Health informs us,
    • “A Centers for Disease Control and Prevention report released Friday shows 7.6% of Americans, or 25.3 million people, lacked health insurance during the time of data collection from April to June. Although the rate represents a 0.4 percentage point increase from the year-ago period, it is consistent with 2023’s full-year uninsured rate — a historic annual low.
    • “More people have health insurance coverage than ever before — and the peace of mind that comes with it,” Health and Human Services Department Secretary Xavier Becerra said in a statement Sunday. “That is all thanks to the Affordable Care Act’s expansion of Medicaid and creation of the Marketplace.”
  • The American Hospital Association News tells us,
    • In comments Nov. 11 to the Centers for Medicare & Services on its Notice of Benefit and Payment Parameters for 2026, the AHA expressed support for navigators and other assistance personnel as CMS explores how to expand their responsibilities. Navigators and non-navigator assistance personnel work with hospitals and health systems to help connect consumers to financial assistance resources. 
    • “Navigators are already trusted community resources for navigating health insurance coverage and would be a great asset in helping to reach patients who are otherwise not accessing available financial assistance,” the AHA wrote. “We also encourage navigators and assisters to expand their enrollment counseling to help patients enroll in plans with affordable deductible and cost-sharing requirements based on the patient’s financial resources.”
  • The FEHBlog wishes he knew the objectives of the PSHB navigators and the level of their success in achieving those objectives.

From the public health and medical research front,

  • The Washington Post lets us know,
    • “About 41 percent of U.S. adults with hypertension are unaware they have it, according to a report from the National Center for Health Statistics. Left untreated, high blood pressure can increase the risk for heart disease and stroke.
    • “The American College of Cardiology defines hypertension as having systolic blood pressure of 130 mm Hg or above, or diastolic blood pressure of 80 mm Hg or above.
    • The NCHS data is drawn from a two-year survey, from August 2021 to August 2023, of the U.S. population. The survey sample “is selected through a complex, multistage design,” the NCHS report says. The survey information was collected in stages, including interviews conducted in subjects’ homes and a standardized health examination in a mobile exam site. An average of up to three blood pressure readings were taken.
    • “In adults over age 18, 48 percent of the survey’s 6,084 subjects were found to have hypertension — 60 percent of whom were aware that they had high blood pressure.” 
  • HR Dive relates,
    • “Women’s use of health benefits can influence workplace outcomes such as attendance, retention and productivity, according to a Nov. 6 report from the Integrated Benefit Institute.
    • “For instance, 89% of employed U.S. women said employer benefits positively influence overall workplace satisfaction, and 85% said benefits play a crucial role in attracting and retaining talent.
    • “In particular, benefit use was associated with fewer missed workdays, with the greatest effects seen from mental health benefits, reproductive health services and maternity care.
  • The American Medical Association points out what doctors wish their patients knew about ultra processed foods.
  • Per Healio
    • “Low-level lead poisoning remains prevalent across the United States and globally, warranting screening and identification of those at highest risk, according to a recently published review.
    • “Such poisonings are especially dangerous in children because of their adverse links to cognitive and behavioral development, the researchers pointed out in The New England Journal of Medicine.“
  • Per MedPage Today
    • “Healthy lifestyle choices in midlife may offset genetic risks for dementia, stroke, and late-life depression.
    • “Brain Care Scores measure modifiable risk factors for age-related brain diseases.
    • “Compared with lower Brain Care Scores, higher scores were tied to reduced risk of brain disease in people with genetic predisposition to such diseases.”

From the U.S. healthcare business front,

  • Beckers Payer Issues lets us know,
    • Cigna directly confirmed that it is not pursuing a merger with Humana. 
    • “The Cigna Group remains committed to its established M&A criteria and would only consider acquisitions that are strategically aligned, financially attractive, and have a high probability to close,” the company said in a Nov. 11 news release. 
  • Beckers Hospital Review relates,
    • “Oakland, Calif.-based Kaiser Permanente posted a $608 million operating loss (-2.1% operating margin) in the third quarter of 2024, down from an operating income of $156 million (0.6% operating margin) in the same quarter last year, according to its Nov. 8 financial report.  
    • “Kaiser posted an operating revenue of $29 billion in the three months ended Sept. 30, up from $24.9 billion over the same period in 2023. The system reported operating expenses of $29.6 billion in the third quarter, up from $24.7 billion over the same period last year. 
    • “The system said that it continues to experience “increased medical expenses due to higher-than-expected utilization of services, patient acuity and pharmacy costs.” Kaiser also said that its third-quarter performance also included the “impact of Medicaid and other true-ups of annual contracts that normally occur earlier in the year.”
  • STAT News reports,
    • “AbbVie said Monday that its experimental treatment for schizophrenia failed to significantly help patients in two trials, a blow to the company, which got the drug through its recent $9 billion acquisition of Cerevel Therapeutics.
    • “In Phase 2 studies, patients on different doses of the drug, called emraclidine, did not experience significant improvements on a test called the Positive and Negative Syndrome Scale (PANSS) compared with the placebo group.
    • “While we are disappointed with the results, we are continuing to analyze the data to determine next steps,” Roopal Thakkar, AbbVie’s chief scientific officer, said in a statement.”
  • Per Beckers Payer Issues,
    • “A mobile app offered to individuals covered by Centene’s Medicaid plan in Arizona improved medication adherence, and reduced healthcare visits and costs, according to a study published Oct. 21 in The American Journal of Managed Care.
    • “The study found that using the Wellth app helped Medicaid patients with chronic conditions stick to their medications more consistently and reduced unnecessary healthcare visits, ultimately leading to cost savings. The Wellth app uses financial incentives to encourage people to take their medications as prescribed.
    • “Managed care decision makers should consider these findings when deciding what types of behavioral interventions and supports to offer insurance plan members, particularly those managing chronic conditions, to reduce avoidable healthcare expenses,” the researchers wrote.”

Friday Factoids

David Ermer–ACA, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC

  • NBC 10 Buffalo NY reports
    • Capital District Physicians’ Health Plan (CDPHP) will no longer be offering its plan for Federal Government employees. A spokesperson for CDPHP said this affects about 6,000 members.
    • “At the beginning of 2024, due to compounding regulations and rising administrative costs, CDPHP made the difficult decision to exit the Federal plan at the end of this plan year,” said the spokesperson. “Federal plan employees will need to select a new plan/carrier during this year’s Open Season.”
    • The FEHBlog remembers an OPM FEHB carrier conference which featured a CDPHP speaker due to the quality of the Plan’s services.
    • OPM does pile benefit and administrative costs on FEHB carriers. The straw that may have broken the camel’s back was OPM’s January 2023 mandate to cover GLP-1 drugs for obesity. That unexpected cost still reverberates in FEHB premiums today.
    • The FEHBlog is not saying that OPM should not have mandated GLP-1 drugs for obesity. The FEHBlog is saying that OPM should have put that mandate in a call letter for benefit and rate proposals so that plans could build the cost into their premiums as federal procurement law requires.
  • The OPM Inspector General weighed in again on the Postal Service Health Benefits Program implementation process.
  • The Miller and Chevalier law firm lets us know,
    • “On October 17, 2024, the Internal Revenue Service (IRS) issued Notice 2024-75 to expand preventive care benefits permitted by a high deductible health plan (HDHP) under section 223(c)(2)(C) of the Internal Revenue Code. The guidance states that over-the-counter (OTC) contraceptives and male condoms, types of breast cancer screenings beyond mammography, and certain types of diabetes care all qualify as preventive care.” * * *
    • “Notice 2024-75 is generally effective for plan years that begin on or after December 30, 2022.”
    • “In related concurrent guidance, the IRS issued Notice 2024-71, which provides a safe harbor for amounts paid for condoms by use by the taxpayer, spouse, or dependent under section 213(d) of the Code. “
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 25 launched a preview of health coverage options available through the Open Enrollment Period for the HealthCare.gov marketplaces, set to open on Nov. 1. The Administration also announced Deferred Action for Childhood Arrivals recipients will be eligible to enroll in a marketplace plan and may be eligible for other benefits to lower health insurance out of pocket costs. As part of this year’s open enrollment, CMS updated the HealthCare.gov webpage and made it mobile-friendly to ease the enrollment process. The ACA marketplace open enrollment runs from Nov. 1 to Jan. 15.”
  • Here is a link to the related CMS fact sheet.
  • Per JD Supra,
    • “On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health programs for medically unnecessary urine drug tests and provided illegal kickbacks to physicians.
    • “Precision Toxicology, headquartered in San Diego, CA, is one of the nation’s largest urine drug testing laboratories. According to the fact recitation in the settlement documents, Precision allegedly submitted false claims for drug tests to Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Department of Veterans Affairs (VA) for a period of approximately 10 years. The drug test claims submitted to the programs were allegedly medically unreasonable and unnecessary. Specifically, Precision allegedly utilized nonallowable blanket orders for urine drug tests without physician authorization and offered free point-of-care drug test cups to physicians in exchange for referrals, in violation of the Anti-Kickback Statute.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. Nationally, COVID-19 infections are predicted to be growing slowly from a low level.
      • “The XEC variant is predicted to increase to 14-22% among circulating viruses as of October 26, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity is low. However, signs of increased RSV activity have been detected in the southeastern U.S., particularly in young children.
    • “Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • Wastewater detections [of the COVID virus] remain at low levels nationally, but detections tracking a bit higher in the West and Midwest compared to other regions, according to CDC data. Similarly, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, said its monitoring has the nation at the medium level, with a downward trend over the past 3 weeks. It said the South and West are now in the low category.
  • The Food and Drug Administration informs us,
    • “Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. McDonald’s has temporarily stopped using Quarter Pounder slivered onions and beef patties in affected states. Diced onions and other types of beef patties used at McDonald’s have not been implicated in this outbreak. Additionally, Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. Customers who are impacted have been contacted directly. As of Oct. 24, 75 people infected with the outbreak strain of E. coli O157:H7 have been reported from 13 states. Illnesses started on dates ranging from Sept. 27, 2024, to Oct. 10, 2024. Of 61 people with information available, 22 have been hospitalized and two people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. Of the 42 people interviewed, all 42 (100%) report eating at McDonald’s and 39 people report eating a beef hamburger. Consumers who have already eaten at McDonald’s and have symptoms of E. coli infection should contact their health care provider to report their symptoms and receive care immediately. The FDA is working closely with the U.S. Department of Agriculture, the Food Safety and Inspection Service, the Centers for Disease Control and Prevention and state partners to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. Additional information will be published in the advisory as it becomes available.” 
  • The American Medical Association offers “top health tips that pediatricians want parents to know.”
  • Per Fierce Pharma,
    • “Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem.
    • “Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options.
    • “The FDA nod—Iterum’s first—marks the second approval this year for a uUTI medicine after two decades of stagnation in the field. It also represents the first U.S. approval for an oral penem—a class of antibiotics.
    • “Back in April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam). The penicillin antibiotic underpinning Utility’s drug had never before been cleared in the U.S., despite being approved in Europe for more than 40 years.”
  • Medscape tells us,
    • “The incidence of atrial fibrillation (AF) is on the rise, and recent joint guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) stress the role of primary care clinicians in prevention and management.
    • “One in three White and one in five Black Americans will develop AF in their lifetime, and the projected number of individuals diagnosed with AF in the United States is expected to double by 2050.
    • “Cardiologists who spoke to Medscape Medical News said primary care clinicians can help control AF by focusing on diabetes and hypertension, along with lifestyle factors such as diet, exercise, and alcohol intake.
    • “It’s not just a rhythm abnormality, but a complex disease that needs to be addressed in a multidisciplinary, holistic way,” said Jose Joglar, MD, a professor in the Department of Internal Medicine at the UT Southwestern Medical Center in Dallas and lead author of the guidelines.
    • Joglar said primary care clinicians can play an important role in counseling on lifestyle changes for patients with the most common etiologies such as poorly controlled hypertension, diabetes, and obesity.”
  • STAT News lets us know,
    • “For people with obesity, surgeries that shrink, reshape, or otherwise alter the anatomy of the stomach have long reigned supreme as the surest way to weight loss. But in the last few years, with the approval of GLP-1 drugs like Wegovy and Zepbound, more and more people are opting for obesity medicines over gold-standard surgical treatments. 
    • “On a population level, among a subset of commercially insured individuals, that is the tradeoff that is happening” said Thomas Tsai, the lead author of a new study that looked at health records of 17 million privately insured Americans with obesity. It found that between 2022 and 2023, as prescriptions for GLP-1 drugs more than doubled, rates of bariatric surgery fell by 25.6%.
    • “The findings, published Wednesday in JAMA Network Open, mark a sharp turnaround from trends over the last decade, and spell an uncertain future for hospitals and clinics that derive a significant portion of their revenues from such procedures.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates,
    • “Centene reported $713 million in net income in the third quarter, per its earnings report published Oct. 25.
    • “Total revenues in the third quarter were $42 billion, up 10.5% year over year.
    • “Total net earnings in the third quarter were $713 million, up 52% since the same period last year.
    • “The company reaffirmed its year-end adjusted EPS guidance of greater than $6.80.
    • ‘The company’s medical loss ratio was 89.2% in the third quarter and 87% during the same period last year.”
  • Per Healthcare Dive,
    • “Medicaid payment rates have yet to catch up with rising costs in the safety-net insurance program. However, conservative planning — along with business growth — yielded a surprisingly positive third quarter for health insurer Molina, according to analysts.
    • “Molina beat Wall Street expectations for earnings and revenue with a topline of $10.3 billion in the quarter, up 21% year over year, thanks in part to higher premiums. Profit of $326 million was up 33% year over year.
    • “Molina appears to be “beating the odds again” in Medicaid, Jefferies analyst David Windley said in a note on the payer’s results.”
  • Beckers Hospital Review points out that “Nashville, Tenn.-based HCA Healthcare posted an operating income of $1.9 billion (10.9% operating margin) in the third quarter of 2024, up from an operating income of $1.6 billion (10.1% margin) over the same period last year, according to its Oct. 25 financial report.”
  • Per MedTech Dive,
    • “Baxter plans to restart its highest throughput manufacturing line for IV solutions within the next week, “barring any unanticipated developments,” the company said on Thursday.
    • “Baxter is working to restore production at a North Carolina plant that makes about 60% of the U.S. supply of IV fluids, and is an important supplier of peritoneal dialysis solutions, according to the American Hospital Association.
    • “The company still has not shared a timeline for restoring full production at the facility after it was flooded by Hurricane Helene in early October. Baxter’s goal is to begin resuming production in phases by the end of the year.”
  • The Washington Post offers an interview with JC Scott, president and CEO of the Pharmaceutical Care Management Association (PCMA), the PBM trade association.
  • Beckers Payers Issues shares executive opinions on “opportunities payers can seize next year.”
  • Per Healthcare Dive,
    • “Cost management company MultiPlan is facing yet another lawsuit for allegedly conspiring to underpay providers — this time, from the largest physician association in the United States.
    • “The American Medical Association’s complaint, filed Thursday in an Illinois district court, accuses MultiPlan of colluding with major health insurers to set artificially low reimbursement rates for out-of-network care, forcing providers to accept payments that often don’t cover their operating costs.
    • “The litigation, which asks the judge for an injunction requiring MultiPlan to halt the illegal practices, is the latest in a long string of suits against the company. Congress is also scrutinizing MultiPlan, which denies the allegations.”

Tuesday’s Tidbits

David Ermer–ACA, AHRQ, CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • OMB’s Office of Information and Regulatory Affairs disclosed it has completed its work on OPM’s supplemental Postal Service Health Benefits rule. That rule now should appear in the Federal Register’s public inspection list shortly. The rule by the way is not on today’s list.
  • The International Foundation of Employee Benefit Plans tells us,
    • The Internal Revenue Service (IRS) released annual inflation adjustments for more than 60 tax provisions in Revenue Procedure 2024-40. Many of these adjustments affect employee benefits.
    • For example,
      • Health flexible spending cafeteria plans. For the taxable years beginning in 2025, the dollar limitation for employee salary reductions for contributions to health flexible spending arrangements rises to $3,300, increasing from $3,200 in tax year 2024. For cafeteria plans that permit the carryover of unused amounts, the maximum carryover amount rises to $660, increasing from $640 in tax year 2024.
      • HSA/HDHP changes were announced before the call letter responses were due at the end of May 2024.
  • The Wall Street Journal adds,
    • “The brackets that determine how much Americans pay in taxes each year are moving up by their smallest amount in a few years.
    • “It will take more income to reach each higher tax bracket after the roughly 2.8% inflation adjustment for 2025, the Internal Revenue Service said Tuesday. The annual adjustments are based on formulas tied to inflation.
    • “This year’s adjustments slightly outpace the current inflation rate, which has been cooling. Still, average hourly earnings rose 4% from a year earlier in September, the Labor Department said.”
  • Per an HHS press release,
    • “Today, the Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. Thanks to the Inflation Reduction Act, some people with high drug costs have their out-of-pocket drug costs capped at around $3,500 in 2024. Next year that cap lowers to $2,000 for everyone with Medicare Part D. The report shows that if the $2,000 cap had been in effect this year, 4.6 million enrollees would have hit the cap by June 30 and would not have to pay any more out-of-pocket costs for the rest of the year.”
    • “To view the full ASPE issue brief, “Medicare Part D Enrollees Reaching the Out-of-Pocket Limit by June 2024” visit: https://aspe.hhs.gov/reports/medicare-part-d-oop-cap“
  • KFF offers a data note.
    • “Overall, just under half of individuals with job-based health coverage are enrolled as a dependent on a family member’s plan (47%). The likelihood of enrolling as a dependent decreases with age. Nearly all children (ages 0-17) with employer-sponsored coverage are enrolled as dependents, usually on a parent’s plan. Young adults, particularly those ages 18-25, are more likely to be covered as dependents than adults overall (72% vs. 32%).
    • “The Affordable Care Act (ACA) requires most employer plans allow young adults to remain on a parent’s plan until age 26. Before the ACA, employers typically limited dependent eligibility for young adults to an age less than 26 and often imposed additional eligibility requirements. This provision of the ACA maintains considerable popularity and has been credited with reducing the uninsured rate among young adults. In 2024, 56% or 19.3 million young adults aged 18-25 were covered on an employer-sponsored plan (Figure 1).
    • “As young adults age, a greater share of those with employer coverage transitions from dependent coverage to being policyholders. For instance, while a majority of 18 and 19-year-olds with employer-sponsored coverage are still covered as dependents, the proportion decreases among those aged 24 and 25 (93% vs. 50%) (Figure 2).”
  • Seeking Alpha lets us know,
    • “Sen. Dick Durbin (D-Ill.), chairman of the Senate Judiciary Committee, has sent letters to Pfizer and Eli Lilly regarding the two drug giants’ relationships with telehealth platforms.
    • “Durbin is seeking to find out whether the two pharmaceutical companies are violating federal anti-kickback laws, according to the letters.
    • “Both Pfizer and Lilly this year launched websites for consumers to find out about their medications, as well as links to talk to a physician online that can prescribe them and an online pharmacy to get prescriptions filled. Pfizer’s is called PfizerForAll, while Lilly’s is name LillyDirect.
    • “Durbin, along with Sens. Bernie Sanders (I-Vt.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.), argue that these setups are designed to push consumers to particular drugs “and create the potential for inappropriate prescribing that can increase spending for federal health programs.”
    • “Regarding Pfizer’s platform, the senators say the ease of getting meds prescribed “creates the impression that any patient interested in a particular medication can indeed receive it with just a few clicks, and the appearance of Pfizer’s approval that these chosen telehealth providers can ensure a patient receives the given medication.”
  • It strikes the FEHBlog as strange that these legislators are attacking the drug manufacturers for disintermediating the middlemen.
  • Fierce Pharma reports
    • “With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had appeared that the sides were speeding toward a resolution of the litigation through J&J’s third bankruptcy attempt.
    • “But the U.S. Department of Justice (DOJ) has called a foul.
    • “In federal bankruptcy court in Houston, Texas, the U.S. Trustee program—the DoJ’s unit that oversees bankruptcy cases—has filed a motion (PDF) to dismiss a Johnson & Johnson subsidiary’s Chapter 11 bid to settle the 60,000-plus talc lawsuits.”
  • MedTech Dive lets us know,
    • “The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center, first reported by Stat and confirmed by MedTech Dive.
    • “Tarver was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Jeff Shuren stepped down. 
    • “FDA Commissioner Robert Califf emphasized Tarver’s “passion about data, science, medicine, and the evidence” and work to build collaboration and transparency at the agency, in an email to staff announcing the new director’s appointment viewed by MedTech Dive.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Four workers at a commercial egg farm in Washington tested presumptively positive for H5N1 bird flu, the Washington State Department of Health announced Oct. 20. These are the first presumed human cases in the state. The individuals experienced mild symptoms and Benton-Franklin Health District officials have forwarded test samples to the Centers for Disease Control and Prevention for final confirmation and analysis. Washington is the sixth state with human H5N1 infection, which has caused outbreaks in poultry, dairy cattle and wildlife. The CDC considers the risk of H5N1 bird flu to the general public to be low.”
  • The New York Times tells us,
    • “New guidelines for preventing strokes spell out for the first time the risks faced by women, noting that pre-term births and conditions like endometriosis and early menopause can raise the risk.
    • “Prior guidelines tended to be sex-agnostic,” said Dr. Brian Snelling, director of the stroke program at Baptist Health South Florida’s Marcus Neuroscience Institute, who was not involved in writing the guidelines.
    • “Now we have more data about sex-specific subgroups, so you’re able to more appropriately screen those patients.”
    • “The focus of the recommendations by the American Stroke Association, published on Monday in the journal Stroke, is primary prevention — the effort to prevent strokes in individuals who have never had one. It represents the first such update in a decade, and it’s the playbook by which millions of Americans will be cared for.”
  • BioPharma Dive reports about “RNA editing: emerging from CRISPR’s shadow. Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.”
    • “RNA editing is a fast growing corner of the biotechnology sector. About a dozen companies, from privately held startups to established biotech firms, are pursuing the technology. One already has early, but promising, clinical trial results. Others could follow soon. And large pharmaceutical companies, such as Eli Lilly, Roche and Novo Nordisk, have taken an interest.
    • “RNA editing’s proponents say it may be safer and more flexible than DNA editing. Those advantages, they contend, will enable RNA editing to address more diseases, including common conditions that are now beyond genetic medicine’s reach.
    • “It has all the features of a technology that could leapfrog other editing technologies,” said Michael Ehlers, a general partner at Apple Tree Partners and the CEO of RNA editing startup Ascidian Therapeutics.”
  • The U.S. Preventive Services Task Force has opened for public comment its Grade B recommendation that doctors “provide or refer pregnant and postpartum persons to interventions that support breastfeeding.” This is a confirmation of a 2016 Grade B recommendation. The public comment period is open until November 18, 2024.
  • Per Food Navigator
  • The Centers for Disease Control and Prevention issued the following alert today.
    • CDC, FDA, USDA FSIS, and public health officials in multiple states are investigating an outbreak of E. coli O157:H7 infections. Most people in this outbreak are reporting eating the Quarter Pounder hamburger at McDonald’s before becoming sick. It is not yet known which specific food ingredient is contaminated.
    • McDonald’s is collaborating with investigation partners to determine what food ingredient in Quarter Pounders is making people sick [mostly in Colorado and Nebraska]. McDonald’s stopped using fresh slivered onions and quarter pound beef patties in several states while the investigation is ongoing to identify the ingredient causing illness.
  • The Washington Post reports,
    • TreeHouse Foods has expanded an earlier recall of frozen waffles to include all its griddle products, including Belgian waffles and pancakes, over possible listeria contamination.
    • Though no illnesses have been reported, TreeHouse Foods has previously said that the breakfast products were widely distributed throughout the United States and Canada, primarily as private-label offerings by Walmart, Target, Tops, Harris Teeter, Publix and other large merchants.
    • The suspected contamination was discovered through routine testing at a manufacturing facility in Ontario, according to the company announcement.
    • “We are working with our retail customers to retrieve and destroy the recalled products, and encourage consumers to check their freezers for any of the products subject to the recall and dispose of them, or return them to the place of purchase for a refund,” the company said in an unsigned email.

From the U.S. healthcare business front,

  • OptumRx discusses its efforts to “automate prior authorization process for prescription drugs to improve the patient and provider experience.”
  • MedTech Dive brings us up to date on what happened at the MedTech Conference held last week in Canada.

Monday Roundup

David Ermer–ACA, CDC, FDA, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Today, the Affordable Care Act (ACA) regulators issued ACA FAQ 68 and a related HHS fact sheet. This letter addresses ongoing preventive care coverage issues separate from the proposed ACA rule, also issued today along with an HHS fact sheet, to expand contraceptive coverage with no cost sharing to include the OTC contraceptive pill and more.  The proposed rule will be open for public comment for sixty days after publication in the Federal Register. Government actions like the proposed rule, in the FEHBlog’s opinion, are a principal cause of skyrocketing medical costs.
  • Govexec reports,
    • “More than 200,000 U.S. Postal Service employees will receive a nearly 5% pay raise over the next year if its largest letter carriers’ union agrees to the new contract its leaders have negotiated with agency management. 
    • “The employees will also have more opportunities for overtime and be able to reach the top slots of their pay scales more quickly, the National Association of Letter Carriers said of their new tentative agreement. The contract must still be approved by NALC members before it goes into effect. A failure to ratify the deal would likely result in arbitration. 
    • “The agreement would cover the period from May 2023 into November 2026, meaning the first two of the three scheduled 1.3% wage increases would apply retroactively. Employees would also receive a series of cost-of-living adjustments, the first three would also be paid retroactively and total around $2,300. 
    • “After almost 20 months of tireless negotiations, we are pleased to reach a fair agreement that rewards our members for their contributions to the Postal Service and their service to the American people,” NALC President Brian Renfroe said.” 
  • MedTech Dive informs us,
    • “Boston Scientific received Food and Drug Administration approval for Farawave Nav, a treatment for paroxysmal atrial fibrillation (AFib) that enables cardiac mapping and pulsed field ablation (PFA) therapy with a single integrated catheter.
    • “In tandem, the company gained 510(k) clearance for new software, called Faraview, to provide visualization for cardiac ablation procedures with its Farapulse PFA system, the medical device maker said Friday. Boston Scientific will immediately launch the Farawave Nav ablation catheter and Faraview software in the U.S. 
    • “In a race among medtech companies in the PFA space, Boston Scientific is now the first with mapping-integrated PFA, “a meaningful technology step-forward,” Stifel analyst Rick Wise said Sunday in a note to clients.”
  • and
    • “The Food and Drug Administration updated the recall notice for a Boston Scientific product that blocks blood flow.
    • “Boston Scientific recalled the product, Obsidio Conformable Embolic, in February in response to a problem then linked to seven injuries and two deaths. On Friday, the FDA updated its Class I recall notice, reporting an additional two deaths and eight injuries.
    • “The FDA provided the new information after Boston Scientific on Oct. 11 updated its instructions for use for the device, which stayed on the market after the recall. While the prior alert warned of risks for lower gastrointestinal (GI) bleeding, the revised instructions reflect evidence of risks when the product is used anywhere in the GI area.”

From the public health and medical research front,

  • Health Day tells us,
    • “Walking pneumonia cases are surging among young children in the United States, federal health officials warn.
    • “Bacterial infections caused by Mycoplasma pneumoniae increased in the United States since late spring and have remained high,” a statement issued Friday by the U.S. Centers for Disease Control and Prevention noted. “The proportion of patients discharged from emergency departments with a diagnosis of M. pneumoniae-associated pneumonia or acute bronchitis has been increasing over the past six months, peaking in late August.”
    • “The worst rates of the illness have been seen in young children ages 2 to 4, according to the agency.
    • “The increase in children ages 2–4 years is notable because M. pneumoniae historically hasn’t been recognized as a leading cause of pneumonia in this age group,” the CDC added.”
  • NBC News informs us,
    • “Since 2000, breast cancer incidence among Asian American and Pacific Islander women under 50 years old has increased by 50%, more than 2% every year since 2012, according to a new report from the American Cancer Society.
    • “Asian American and Pacific Islander women in this age cohort had the second-lowest rate of breast cancer among all racial groups in 2000. They now have the highest rate alongside white women, about 86 per 100,000.
    • “Breast cancer is still more common the older we get, but it’s alarming to see younger women being diagnosed,” said Dr. Helen Chew, director of the clinical breast cancer program at UC Davis Health.
    • “Breast cancer has risen sharply among younger Asian American women in the past quarter-century due in part to acculturation and greater awareness around screenings, though experts say more research is required to determine exact causes for specific ethnic groups.
    • “Asian women like Huang have a higher prevalence of dense breasts, meaning there are more glands and tissue than fat, than women of other races, likely due to genetic factors and lower body mass indexes, experts say. And women with dense breasts are four times as likely to develop breast cancer as those with fatty breasts, an issue experts say needs more awareness.”
  • MedPage Today points out,
    • “The American Heart Association and the American Stroke Association updated guidelines for the primary prevention of stroke, emphasizing primary care screening, lifestyle management, and risk factor control.
    • “The guideline, published in Stroke, replaced the 2014 version to guide management for individuals with no prior history of stroke.
    • “This guideline is important because new discoveries have been made since the last update 10 years ago. Understanding which people are at increased risk of a first stroke and providing support to preserve heart and brain health can help prevent a first stroke,” said writing group chair Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, in a press release.
  • The Wall Street Journal relates,
    • “Novo Nordisk’s once-daily pill to treat type 2 diabetes has shown it cuts the risk of heart attacks and strokes in patients by up to 14%, according to a new trial.
    • “Rybelsus is an oral form of semaglutide, the active ingredient in the company’s blockbuster Ozempic and Wegovy diabetes and weight-loss drugs, and was tested in the trial on diabetic patients who also suffered from established cardiovascular disease and/or chronic kidney disease.
    • “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
    • “The company said the drug appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials and showed it reduces the risk of major cardiovascular events such as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
    • “Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in both the U.S. and European Union around the turn of the year.”
  • The American Medical Association lets us know what doctors wish their patients knew about childhood obesity.
  • Consumer Reports discusses urinary tract infections that afflict older folks.
  • The Institute for Clinical and Economic Review published a Final Evidence Report on Treatments for Transthyretin Amyloid Cardiomyopathy.
    • An independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for tafamidis, acoramidis, and vutrisiran when compared to no disease-specific therapy; tafamidis and acoramidis would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Technology giant Amazon is partnering with a high-profile provider to expand its primary care offerings.
    • “Amazon One Medical will collaborate with Cleveland Clinic to open a primary care office in 2025, with plans for additional locations over the next few years, the organizations said Monday.
    • “We’re starting small with a couple of locations, … then we’ll see where it takes us,” said. Dr. Tomislav Mihaljevic, CEO and president at Cleveland Clinic. “We’re continuously evaluating potential partnerships, and this is the one that just rose to the top of what we think is the right thing for our patients.”
    • “Facilities will be staffed by One Medical clinicians. Although walk-in care will be publicly available, only One Medical members will be able to make appointments online or access telehealth, among other services.
    • “The affiliation will enable One Medical members to access specialty care at Cleveland Clinic via patient referrals, the organizations said.”
  • Per MedTech Dive,
    • “Intuitive Surgical is on track to take the da Vinci 5 robot from a limited rollout to a broader launch in mid-2025.
    • “Intuitive placed 110 da Vinci 5 systems in the third quarter, up from 70 in the second quarter, bringing the total installed base to 188, executives said on an earnings call Thursday. Customers so far have completed more than 12,000 procedures with the new platform over about the past six months, they added.
    • “Da Vinci 5 installations are “well ahead of lofty buy-side expectations,” said BTIG analyst Ryan Zimmerman. “Limited launch or not, that’s a lot of [da Vinci 5] demand,” the analyst wrote in a note to clients after the call. BTIG estimated the number of cases completed with da Vinci 5 equals nearly 32 procedures per system per quarter.”