Friday Report

COVID-19

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, SCOTUS, Telehealth, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

From Washington, DC

  • Govexec tells us,
    • “A 50-page document, compiled by GOP members of the House Budget Committee and first reported by Politico, outlines a list of provisions that could be included in the [budget reconciliation] package, which would not be subject to the Senate’s 60-vote filibuster threshold, includes a litany of proposals increasing federal workers’ contribution to their retirement and health care benefits, in exchange for worse payouts.” * * *
    • “On health care benefits, the House GOP proposes replacing the current system, by which the federal government pays for a percentage of health care premiums through the Federal Employees Health Benefits Program and the new Postal Service Health Benefits program, with a “voucher model.”
    • “Under this option, the FEHB and PSHB programs would be reformed by replacing the current premium-sharing structure with a voucher, which would not be subject to income and payroll taxes,” the document states.
    • “And the document calls for enactment of a bill introduced last year to require the Office of Personnel Management to audit FEHBP for improper enrollments. But OPM has said that under the current “decentralized” nature of the program, the agency does not have the capabilities to conduct such an audit.
    • “Prior to the presidential transition, then-President Biden’s OPM sent Congress a legislative proposal, drawn on lessons learned in launching the PSHB program this year, to revamp how it administers FEHBP so that it can conduct better oversight.”
    • FEHBlog observation — Better oversight starts with giving FEHBP and FEDVIP carriers the HIPAA 820 enrollment roster transactions that would allow them to reconcile individual enrollees with premiums paid.
  • MedPage reports,
    • “Legislation providing more scrutiny for pharmacy benefit managers (PBMs) that failed to make it through Congress in the waning days of 2024 seems to still be viable for passage this year, according to a House staff member.
    • “I think there’s plenty of political will there; that’s what I’ve seen from members,” Preston Bell, a professional staff member on the House Ways & Means Committee, said Thursday at an event sponsored by the American Enterprise Institute (AEI) on the future of the Medicare prescription drug benefit. “I do think there are disparate ideas across Congress as to how much intervention within the PBM market is appropriate. What you’ve seen come through Congress in the [massive continuing resolution] package [released and rejected in December 2024] is probably the litmus test, or maximum, of what is feasible for that type of reform.”
  • Healthcare Dive informs us,
    • “Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator’s leadership biography page. * * *
    • “Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary as FDA commissioner, but he has not yet been confirmed by the Senate. Confirmation hearings for Robert F. Kennedy Jr., who, as Trump’s pick to run the Department of Health and Human Services, would be Makary’s boss, are scheduled for Jan. 29 and Jan. 30.
    • “Brenner worked in the FDA’s medical devices branch, most recently as chief medical officer for in vitro diagnostics and associate director for medical affairs. A preventive medicine physician, Brenner has been at the agency since 2019, according to her LinkedIn page, and helped coordinate diagnostic standards and policy as part of HHS’ COVID-19 response. 
    • “Brenner was previously a senior policy advisor at the White House Office of Science and Technology Policy under the first Trump administration.”
  • The Hill lets us know,
    • “The Food and Drug Administration (FDA) has withdrawn a rule that would have banned menthol cigarettes and flavored cigars, putting a formal end to a policy that had been indefinitely delayed under the Biden administration. 
    • “A regulatory filing showed the rule had been “withdrawn” on Jan. 21, President Trump’s second day in office. The move is a significant blow to public health groups who said banning menthol had the potential to save hundreds of thousands of lives, particularly among Black smokers.”
  • The IRS released its 2024 tax return edition of Publication 969 which concerns health savings accounts and other tax favored health plans.

From the judicial front,

  • Bloomberg Law reports,
    • “A former Johnson & Johnson executive’s allegations that the drug company overpaid for prescription drug benefits are “speculative and hypothetical,” and injuries she did suffer cannot be resolved by the court, a New Jersey federal judge ruled.
    • “The decision Friday dismissed most of Ann Lewandowski’s high-profile class action that argued the pharmaceutical giant violated its fiduciary duties under the Employee Retirement Income Security Act by not negotiating better drug prices with its pharmacy benefit manager, Express Scripts, or switching to a different PBM. 
    • “The lawsuit is one of several recent [actually it was the first] attempts to hold employers responsible through ERISA for monitoring and reducing health-care costs. The claims against J&J reveal that not even large drug companies are immune to complaints over high drug prices.
    • “Judge Zahid N. Quraishi in the US District Court for the District of New Jersey concluded that Lewandowski lacked standing to sue in dismissing two of her three claims. Lewandowski’s argument that J&J’s plan forced her to pay higher premiums and cost her higher wages was speculative “at best,” he said.
    • “And while Lewandowski did show that her copays for some drugs exceeded prices offered by other health plans, the court could not fulfill a key requirement for standing by making her whole, the judge said. Any amount refunded to her would have to go through the health plan for money it spent after she hit her out-of-pocket limit, Quraishi said.
    • “In straightforward terms, a favorable decision would not be able to compensate Plaintiff for the money she already paid,” he wrote.
    • “The judge did find that Lewandowski has standing to pursue her claim against J&J for not providing more information she requested around the plan’s drug prices, including the contract with Express Scripts, which was not a party to the suit. Quraishi invited Lewandowski to amend her complaint.”
  • The Wall Street Journal points out,
    • “Enforcement of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership, remains on hold despite a U.S. Supreme Court ruling in favor of the Treasury Department. 
    • “The Supreme Court on Thursday overturned a lower court order that was blocking enforcement of the CTA. However, a separate national injunction issued earlier this month by a federal judge apparently remains in place and continues to block the law’s implementation.
    • “The Treasury’s Financial Crimes Enforcement Network, which is overseeing the law’s implementation, issued an alert Friday confirming compliance with the CTA isn’t mandatory while the injunction remains in force.” 
  • Fierce Healthcare relates,
    • “The Centers for Medicare & Medicaid Services has changed course on plans to appeal a court ruling that determined it must recalculate UnitedHealthcare’s Medicare Advantage star ratings.
    • “The agency submitted a filing in Texas district court earlier this week saying it intended to file an appeal to the Fifth Circuit Court. In new court documents filed Friday, CMS has withdrawn its notice of appeal.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • Seasonal influenza activity remains elevated across the country and is increasing in most areas. COVID-19 activity is elevated in many areas of the country. RSV activity has peaked in many areas of the country.
    • COVID-19
      • COVID-19 activity is elevated in many areas of the country, though wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity has declined in the last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • 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 circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
      • Seasonal influenza activity remains elevated across the country and is increasing in many areas.
    • RSV
      • RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • Vaccination
      • Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • BioPharma Dive relates,
    • “An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development.  
    • ‘Novo said Friday it is planning “further clinical development” of the drug, called amycretin, but didn’t specify the design of additional trials or when they might begin. Amycretin affects the same two targets as a Novo drug called cagrisema that recently missed expectations in a Phase 3 trial but does so in a single molecule rather than a two-drug combination.”
       
  • Per Healio,
    • “Integrating lifestyle care into low back pain management resulted in greater improvements in disability, weight loss and physical quality of life vs. just guideline-recommended care, a randomized study showed.
    • “The findings, published in JAMA Network Open, “could influence future updates to back pain guidelines,” Emma Mudd, PhD, senior research officer at the University of Sydney in Australia and the analysis’ lead author, said in a press release. “Patients valued the holistic support, and the outcomes speak for themselves.”
  • Earlier this week, the CVS Health Foundation announced $4 million in grants related to its health aging initiative.

From the U.S. healthcare business front,

  • Beckers Hospital Review notes,
    • “Mayo Clinic’s chief executive said at the World Economic Forum’s annual meeting in Davos, Switzerland, that he is fully committed to the adoption of artificial intelligence in healthcare, the Rochester (Minn.) Post Bulletin reported.
    • “I personally would not want to have my healthcare, in some specialties, without AI because I firmly believe I will get a better outcome,” said Gianrico Farrugia, MD, president and CEO of the Rochester-based health system, according to the newspaper’s coverage of the event Jan. 22.
    • “Mayo Clinic has been at the forefront of developing and deploying healthcare AI, with 320 algorithms in use, the news outlet reported.”
  • Beckers Payer Issues adds,
    • Insurers do not have to own every part of the healthcare system to improve connection, according to Jim Boyman, vice president of GuideWell Health. 
    • GuideWell is the parent company of Florida Blue. In December, the company launched an initiative to manage cancer care for Florida Blue ACA members. Through a partnership with Cerritos, Calif.-based The Oncology Institute and primary care organization Sanitas, Florida Blue members diagnosed with cancer will be connected with an oncology team to manage a personalized treatment plan. 
    • “Everyone talks about how fragmented healthcare is,” Mr. Boyman told Becker’s. “This shows how you don’t necessarily have to own all parts of the system to reduce that fragmentation. You can use technology and relationships to collaborate and overcome fragmentation through programs like this.” 
  • Fierce BioTech reports,
    • “Neomorph is building out its supply of Big Pharma partnerships, this time stamping down an option-to-license pact with AbbVie that centers around the biotech’s molecular glue platform.
    • “AbbVie will pay the San Diego biotech an undisclosed upfront sum and offer up to $1.64 billion in option fees and milestones, plus royalties, according to a Jan. 23 release.
    • “The new partners will look to develop molecular glue degraders—a novel class of small molecules designed to selectively degrade proteins that drive disease—for multiple targets across oncology and immunology.
    • “Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward,” Steven Elmore, Ph.D., AbbVie’s vice president of small molecule therapeutics and platform technologies, said in the release. “We are excited to collaborate with Neomorph to develop novel molecular glue degraders that could pave the way for new, effective therapies in the treatment of immune disorders and cancer.”
    • “Neomorph emerged in 2020 and quickly garnered a neuro deal worth up to $1.45 billion in biobucks with Biogen, plus a partnership with Novo Nordisk that offers up to $1.46 billion.” 
  • Per Fierce Healthcare,
    • “Self-funded employer health plan Centivo is announcing Centivo Care, a tech-forward virtual primary care platform integrated with behavioral health specialists.
    • “Centivo’s virtual offerings, which will be available in states where the company operates, are increasingly desired by its clients’ members, said Wayne Jenkins, M.D., chief medical officer for Centivo and president of Centivo Care, in an interview with Fierce Healthcare.
    • “He said at first, just 5% to 10% of people preferred the virtual option, but now it’s closer to 20%. For some employers, they see an even higher adoption rate. One of its clients, JetBlue Airlines, sees high utilization since their employees travel so often and can more easily text with a physician or schedule a video call than attend an appointment in person.
    • “Centivo Care is one of few primary care practices to earn a Patient-Centered Medical Home accreditation from the National Committee for Quality Assurance, the company said in a news release. These virtual appointments are free, and members receive personalized care plans, after-visit summaries, preventive care reminders and more.”
  • Per Beckers Hospital Review,
    • Telehealth utilization grew across most U.S. regions in October 2024, with the Midwest as the sole exception, according to FAIR Health’s monthly telehealth regional tracker.
    • Nationally, telehealth claim lines increased from 4.80% of medical claim lines in September to 4.89% in October, marking a 2% rise. Regional increases varied, with the West seeing the largest growth at 2.8%, while the Midwest experienced a 3.7% decrease.
    • Here are four things to know about telehealth utilization, according to FAIR Health’s tracker:
      • Psychiatric nurses moved up to the second-most common telehealth specialty nationally in October, overtaking family practice, which fell to fourth place.
      • Mental health conditions remained the leading telehealth diagnostic category nationally and regionally. 
      • The tracker revealed modest differences in telehealth costs compared to office visits. For instance, the median cost for a nutritional therapy reassessment was typically $1 to $2 lower via telehealth than in-office, except in the West, where telehealth costs were slightly higher.
      • Telehealth usage was highest among patients aged 31–40, followed by those aged 19–30, a pattern consistent across all regions.

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–

From Washington, DC,

  • The Hill reports, “Senate Republicans hit their full 53-member majority on Tuesday as Sens. John Husted (R-Ohio) and Ashley Moody (R-Fla.) were sworn into office by Vice President Vance.” 
  • Fierce Healthcare reviews how yesterday’s executive orders and other actions impact healthcare.
  • The U.S. Preventive Services Task Force highlights its most recent final recommendations.
  • Fierce Pharma tells us,
    • “Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has blessed the nasal spray to be used as a monotherapy for major depressive disorder (MDD).
    • “Spravato was originally approved in 2019 to be used along with an oral antidepressant for patients who have not seen results with other antidepressant medications.
    • “In 2020, the U.S. regulator tacked on another nod for Spravato to be used by patients with MDD who experience acute suicidal thoughts or behavior.
    • “The standalone endorsement allows patients to use Spravato without taking oral antidepressants. Spravato can work as quickly as 24 hours, Bill Martin, Ph.D., who heads up J&J neuroscience, said in a release.
    • “Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” Martin added. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement.”
  • and
    • “After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to move forward with its ambition to convert its erectile dysfunction med Cialis into an over-the-counter product.
    • “The agency previously placed a clinical hold on the company’s planned actual use trial (AUT) for the conversion, citing problems with protocol design. AUTs are a key step in the FDA’s process for switching drugs from prescription to OTC products and are meant to prove that consumers can adequately diagnose and treat themselves without the help of a healthcare provider.
    • “Now, after a review, the FDA’s green light marks a “significant step forward in Opella’s data-driven efforts to switch a PDE-5 inhibitor like Cialis,” Opella’s chief science officer Josephina Fubera, Ph.D., said in a company release.
    • “We look forward to continuing our work to bring safe and expanded access to the many consumers who will benefit from nonprescription Cialis,” Fubera added.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP lets us know today,
    • “Over the past few days, the US Department of Agriculture (USDA) confirmed more H5N1 avian flu outbreaks in poultry from eight states, including the first at a commercial farm in Georgia.
    • “Meanwhile, the Food and Drug Administration (FDA) and the USDA on January 17 announced new steps to step up the safety of raw pet food, following recent reports of H5N1 infections in household cats.”
  • and
    • “A new real-world study published in PLOS Medicine that looked at outcomes of 703,647 patients with COVID-19 seen at 34 US clinics in 2022 and 2023 found that Paxlovid use was correlated with lower rates of hospitalization and death, particularly among older patients. 
    • “Both vaccinated and unvaccinated patients benefitted from Paxlovid when administered within 5 days of COVID-19 infection confirmation, the authors said. But researchers observed lower rates of use among Black and Hispanic patients than among White patients. 
    • “The study was based on the National COVID Cohort Collaborative’s (N3C) electronic health record database. While clinical trials showed as high as an 88.9% reduction in the risk of COVID-related hospitalization or death among those who received Paxlovid compared to those who received placebos, limited real-world data has been gathered in the post-Omicron era on Paxlovid efficacy.”
  • Consumer Reports, writing in the Washington Post, discusses “What to look for — and what to avoid — in an energy bar. Many are little more than candy bars and don’t deliver the health benefits you might expect.”

From the U.S. healthcare business front,

  • RAND opines,
    • “The typical cost of developing new medications may not be as high as generally believed, with a few ultra-costly medications skewing public discussions about the cost of pharmaceutical research and development, according to a new RAND study.
    • “Using a novel method to assess spending on research and development for 38 drugs that were recently approved by the U.S. Food and Drug Administration, researchers found that the mean, or average, cost of developing a new drug was much higher than the mid-point (median) cost of development.
    • “Researchers estimated a median direct research and development cost of $150 million compared to a mean of $369 million.
    • “Costs were higher after adjusting for earnings drug developers could have made if they had invested these amounts in other activities and for drugs that never made it to the market. With these adjustments, researchers estimated a median research and development cost of $708 million across the 38 drugs examined, with the average cost rising to $1.3 billion driven by a small number of high-cost outliers.
    • “The average cost of developing a new drug was 26 percent lower when excluding just two drugs, dropping from $1.3 billion to $950 million. The findings are published in the journal JAMA Network Open.”
  • Employee Benefit News explains why “costly gene therapy is top of mind for benefits administrators.” Check it out.
  • Per Fierce Healthcare,
    • “Healthcare technology company Innovaccer announced its acquisition of Humbi AI, an actuarial software, services and analytics company used by providers, payers and life sciences companies.
    • “Innovaccer’s cloud powers a slew of healthcare AI features like an AI-assisted care management system, contract management, ambient documentation, pre-visit summary and AI-suggested differential diagnoses.
    • “Financial details of the deal were not disclosed.
    • “The Humbi AI acquisition will help build out Innovaccer’s data analytics capabilities. The Nashville-based company combines healthcare data analytics and actuarial consulting to help healthcare organizations improve value-based contracts, manage risk and design benefits.
    • “Humbi AI’s actuarial capabilities will be an integral component of Innovaccer’s cloud platform, and the company plans to launch its own actuarial copilot, executives said in a press release.”
  • Modern Healthcare adds,
    • “Digital health companies at last week’s J.P. Morgan Healthcare Conference weren’t just looking for investors. They were looking for dance partners.
    • “The desire of digital health companies to scale through mergers and acquisitions or partnerships was one of the most buzzed-about topics at the conference. Marissa Moore, principal at venture capital firm Omers Ventures, said potential buyers and sellers were trying to size up prospects during the event.
    • “People were soliciting us, ‘Hey, we’re trying to spin off this asset, do you know any good buyers?’ Every conversation we were having [at JPM] was an M&A conversation,” Moore said. “We were approached by corporate development executives from big tech companies…you could tell they were trying to get a pulse on what was struggling and what might fit into their growing portfolios, and where there might be an opportunity to partner.”
    • “That search was particularly active for companies selling digital health solutions to employers, a market that has become challenged as employers grapple with the rising cost of healthcare and low usage rates of their offerings. Employers are looking to reduce the number of companies they contract with to reduce costs and simplify the experience for their employees, said Jim Winkler, chief strategy officer at Business Group on Health, an industry group that represents large employers.”

Monday Report

David Ermer–ACA, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Fierce Healthcare lets us know,
    • “One week before President-elect Donald Trump’s inauguration, the Biden administration is finalizing a rule that sets new standards for the individual market under the Affordable Care Act.
    • “First proposed in October, the rule protects consumers from having their coverage swapped unwittingly. Brokers and agents that violate this policy, and pose other “unacceptable” risks, can be suspended. The rule will go into effect on Wednesday.
    • “The rule also amends the risk adjustment program through user fee rates, new calculations to the Basic Health Program (BHP) and reporting to the ACA Quality Improvement Strategy (QIS), designed to improve member outcomes.”
  • Here is a link to CMS’s fact sheet on the final Affordable Care Act (“ACA”) rule titled “HHS Notice of Benefit and Payment Parameters for 2026” and a link to the rule itself.
  • The ACA regulators today withdrew an October 28, 2024, proposed rule which would have “expand access to coverage of recommended preventive services without cost sharing in the commercial market, with a particular focus on reducing barriers to coverage of contraceptive services, including over the counter (OTC) contraceptives.”
  • FedSmith confirms,
    • “President-elect Donald Trump has nominated Scott Kupor as the Director of the Office of Personnel Management (OPM). 
    • “Kupor would lead an OPM organization that has grown under the Biden administration. It now has a larger budget and workforce. 
    • “For fiscal year 2025, the Biden administration proposed a budget of $465.8 million for OPM, which is an increase of about 21% compared to the enacted budget of $385.7 million in fiscal year 2023.”
  • The U.S. Office of Personnel Management posted on the Federal Register’s Public Inspection List a final rule which, according to Govexec, “will standardize the maps relied upon to determine the locality pay rates for white- and blue-collar federal workers across the U.S.” effective October 1, 2025.
  • Pew Research reports on what the data says about federal and postal workers.
  • Federal News Network notes,
    • “The Postal Service is offering early retirement buyouts to mail handlers who work in the agency’s mail processing facilities, and other USPS employees who work in a variety of support positions.
    • “USPS, in a memo obtained by Federal News Network, is offering lump-sum incentive payments worth up to $15,000 to eligible mail handlers who agree to a voluntary early retirement in the coming months.
    • “The agency reached an agreement with the National Postal Mail Handlers Union, which represents 47,000 mail handlers nationwide, as well as the American Postal Workers Union, which represents 222,000 active and retired postal clerks, mail processors and sorters, as well as other USPS occupations.
    • “Federal News Network reached out to both unions for comment.

From the judicial front,

  • The American Hospital Association News reports,
    • The U.S. Chamber of Commerce Jan. 13 filed a lawsuit against the Federal Trade Commission, saying changes made by the FTC to premerger notification rules under the Hart-Scott-Rodino Act are “unnecessary and unlawful.”
    • In a statement, the Chamber said the FTC “has failed to justify the need to subject every merger filing to its new burden. During the rulemaking process it never contemplated alternative, less burdensome approaches and understates the costs and overstates the benefits of changing the rule as part of its final analysis. Subjecting thousands of routine mergers and acquisitions to these additional burdens will slow down normal business transactions and increase costs, hurting the economy in the process.”
    • The FTC finalized changes to the premerger notification rules, form and instructions under the HSR Act in October. The AHA expressed disappointment with the FTC’s changes, saying that the rule “functions as little more than a tax on mergers… The agency already has more than enough information about hospital transactions, and it has shown no hesitation in challenging them. The final rule will just require hospitals to divert time and resources away from patient care towards needless compliance costs.

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The long quest for powerful non-opioid drugs that treat pain without risk of addiction is nearing a milestone, in the form of a pill that could soon win approval from the Food and Drug Administration.
    • “If successful, the drug developed by Vertex Pharmaceuticals would offer a possible alternative to potent prescription painkillers such as oxycodone, which was once heavily marketed by drug companies and fueled an epidemic of dependency and death.
    • “Independent experts say it remains too early to know how revolutionary the Vertex drug, suzetrigine, will be. The company’s application that is pending before the FDA, which could be approved by the end of January, is for relatively short-term pain. It is based on successful clinical trials in people recovering from two types of surgeries, as well as a safety study that monitored participants over about six weeks.
    • “Vertex is still exploring whether the drug can be safely and effectively used for chronic, longer-lasting pain.”
  • Cardiovascular Business points out,
    • “The U.S. Food and Drug Administration (FDA) has announced that Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry (MCOT) devices after certain high-risk electrocardiogram (ECG) events were never routed to trained cardiology technicians as intended. This is a Class I recall, the FDA’s most serious classification.
    • “This issue, which lasted from July 2022 to July 2024, has been associated with 109 patient injuries and two patient deaths. Some of the health events included suspected cases of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia and second- or third-degree atrioventricular block.
    • “On Dec. 18, 2024, Philips and its subsidiary, Braemar Manufacturing, sent all customers impacted by the failure an Urgent Medical Device Correction and information on how to review which patients may need to have their data reprocessed.”
  • and
    • “The U.S. Food and Drug Administration (FDA) has now cleared more than 1,000 clinical artificial intelligence (AI)algorithms to be used commercially for direct patient care in the United States. Cardiology is No. 2 among all healthcare specialties with 161 FDA clearances; some of those are even approved for multiple specialties.
    • “Radiology is by far the king of AI FDA clearances with 758 algorithms, making up about 76% of all clinical AI in the U.S. Neurology comes in at an extremely distant third place with 35 algorithms. There are 15 other specialities with cleared AI, but they each number less than 20 algorithms.
    • “The FDA updated its AI-enabled device approval list in late December, which showed the agency technically reached the 1,000 mark back in September. The first AI algorithm was cleared in 1996, and the number of submissions to the FDA has accelerated very rapidly in the past few years. The agency is now clearing an average of about 20 AI algorithms per month, and the FDA says that number is expected to rise in the coming years.”
  • Fierce Healthcare adds,
    • “The Peterson Health Technology Institute launched an artificial intelligence task force to puzzle out the value of in-demand AI technologies for healthcare delivery organizations.
    • “The task force has been operational for six months, Caroline Pearson, executive director of the PHTI, said in an interview. It will be led by Prabhjot Singh, M.D., Ph.D., a physician and co-founder of CHW Cares, which sold to Oak Street Health in 2022, and Margaret McKenna, former chief technology officer at Devoted Health. Both Singh and McKenna are advisers to the PHTI.
    • “There are about 60 people on the task force from a dozen healthcare systems, including UC San Diego Health, Intermountain Health, Mass General Brigham, Providence, Ochsner Health and MultiCare. Pearson also said there are many C-suite executives on the task force including CEOs, chief financial officer and chief information officers.
    • “They’re not AI cheerleaders,” Pearson said. “They’re just trying to run effective, efficient healthcare systems.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19 activity has increased in most areas of the country. Seasonal influenza activity remains elevated across the country. RSV activity is very high in many areas of the country, particularly in young children.
    • “COVID-19
      • “COVID-19 activity has increased in most areas of the country, with high COVID-19 wastewater levels, increasing emergency department visits and elevated laboratory percent positivity. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “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 circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is very high in many areas of the country, particularly in young children. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.”
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • Speaking of wastewater, the Your Local Epidemiologist newsletter, to which the FEHBlog subscribes, explains,
    • We’re seeing a lot of [H5N1] virus in California’s cows and birds. California is the number one state for dairy cattle, and so far, 703 herds have tested positive for H5N1. That’s more than 2/3 of all the dairy farms in the state. Plus, 93 commercial or backyard poultry flocks, accounting for about 22 million animals, have also been infected.
    • Unfortunately, we don’t have the wastewater testing capabilities yet to differentiate between humans and animals. A recent preprint showed wastewater is picking up viruses from animals (rather than humans) through milk dumping, animal sewage, and bird contamination. We are also relying on epidemiologists’ accounts on the ground to sort through the signals.
  • Per an NIH news release,
    • “New findings from the National Institutes of Health’s (NIH) Researching COVID to Enhance Recovery (RECOVER) Initiative suggest that infection with SARS-CoV-2, the virus that causes COVID-19, may be associated with an increase in the number of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) cases. According to the results, 4.5% post-COVID-19 participants met ME/CFS diagnostic criteria, compared to 0.6% participants that had not been infected by SARS-CoV-2 virus.  RECOVER is NIH’s national program to understand, diagnose, prevent, and treat Long COVID.
    • “The research team, led by Suzanne D. Vernon, Ph.D., from the Bateman Horne Center in Salt Lake City, examined adults participating in the RECOVER adult cohort study to see how many met the IOM clinical diagnostic criteria for ME/CFS at least six months after their infection. Included in the analysis were 11,785 participants who had been infected by SARS-CoV-2 and 1,439 participants who had not been infected by the virus. Findings appear in the Journal of General Internal Medicine.
    • “ME/CFS is a complex, serious, and chronic condition that often occurs following an infection. ME/CFS is characterized by new-onset fatigue that has persisted for at least six months and is accompanied by a reduction in pre-illness activities; post-exertional malaise, which is a worsening of symptoms following physical or mental activity; and unrefreshing sleep plus either cognitive impairment or orthostatic intolerance, which is dizziness when standing. People with Long COVID also experience some or all of these symptoms.
    • “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least three months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems. People with Long COVID report a variety of symptoms including fatigue, pain, and cognitive difficulties.
    • “Dr. Vernon and her team determined that new incidence cases of ME/CFS were 15 times higher than pre-pandemic levels.
    • “These findings provide additional evidence that infections, including those caused by SARS-CoV-2, can lead to ME/CFS.”
  • The American Hospital Association News tells us,
    • The San Francisco Department of Public Health Jan. 10 announced a presumptive positive case of H5N1 bird flu in a child after they experienced symptoms of fever and conjunctivitis. The child was not hospitalized and has since fully recovered, the agency said. An initial investigation by SFDPH did not reveal how the child may have contracted the virus, and the department is continuing to investigate.
  • Per Medscape,
    • More than 15 million people, accounting for 4.6% of the US population, were diagnosed with at least one autoimmune disease from January 2011 to June 2022; 34% were diagnosed with more than one autoimmune disease.
    • Sex-stratified analysis revealed that 63% of patients diagnosed with autoimmune disease were women, and only 37% were men, establishing a female-to-male ratio of 1.7:1; age-stratified analysis revealed increasing prevalence of autoimmune conditions with age, peaking in individuals aged ≥ 65 years.
    • Among individuals with autoimmune diseases, 65% of patients had one condition, whereas 24% had two, 8% had three, and 2% had four or more autoimmune diseases (does not add to 100% due to rounding).
    • Rheumatoid arthritis emerged as the most prevalent autoimmune disease, followed by psoriasis, type 1 diabetes, Grave’s disease, and autoimmune thyroiditis; 19 of the top 20 most prevalent autoimmune diseases occurred more frequently in women.
    • Source: https://www.jci.org/articles/view/178722
  • The American Medical Associations shares what doctors wish their patients knew about Parkinson’s Disease.
  • The New York Times reports,
    • “The number of people in the United States who develop dementia each year will double over the next 35 years to about one million annually by 2060, a new study estimates, and the number of new cases per year among Black Americans will triple.
    • “The increase will primarily be due to the growing aging population, as many Americans are living longer than previous generations. By 2060, some of the youngest baby boomers will be in their 90s and many millennials will be in their 70s. Older age is the biggest risk factor for dementia. The study found that the vast majority of dementia risk occurred after age 75, increasing further as people reached age 95.
    • “The study, published Monday in Nature Medicine, found that adults over 55 had a 42 percent lifetime risk of developing dementia. That is considerably higher than previous lifetime risk estimates, a result the authors attributed to updated information about Americans’ health and longevity and the fact that their study population was more diverse than that of previous studies, which have had primarily white participants.
    • “Some experts said the new lifetime risk estimate and projected increase in yearly cases could be overly high, but they agreed that dementia cases would soar in the coming decades.”
  • Health Day considers whether “Doctors Can Estimate Life Expectancy After a Dementia Diagnosis?”
    • “Updated estimates give a better picture of how long a person will live following a dementia diagnosis.
    • “Age plays a factor in how long people have left.
    • “Women tend to have longer life expectancy than men.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Johnson & Johnson on Monday said it has agreed to acquire Intra-Cellular Therapies, a developer of drugs for diseases of the brain, for $132 per share, or about $14.6 billion.
    • “The announcement of the deal, which if completed would be the largest acquisition of a biotechnology company since early 2023, came on the first day of the J.P. Morgan Healthcare Conference, an industry meeting that’s known for dealmaking.
    • “The chief prize in buying Intra-Cellular is a medicine known as Caplyta that’s approved in the U.S. to treat schizophrenia and bipolar depression. The biotech recently asked the Food and Drug Administration to expand Caplyta’s clearance to include major depressive disorder, which affects about 10 times as many people as have schizophrenia and a little more than three times as many as have bipolar depression.”
  • and
    • “Eli Lilly has turned to a biotechnology startup for help building its pipeline of cancer drugs, agreeing on Monday to purchase an experimental cancer drug from privately held Scorpion Therapeutics for as much as $2.5 billion.
    • “As part of the deal, Scorpion will spin out a new, independent company that will hold its other assets as well as inherit its employees. Lilly will take a minority stake in the new company, which will be owned by Scorpion’s current shareholders, among them Atlas Venture, Vida Ventures and Omega Funds.
    • “Current Scorpion CEO Adam Friedman will lead the new company along with other members of the startup’s management.”
  • and
    • “Late last week, Biogen made an unsolicited offer to buy one of its partners, brain drug developer Sage Therapeutics.
    • “The two biotechnology companies have worked together over the past four years on a mood-stabilizing medicine known as Zurzuvae. They split research costs and, after the medicine got approved as a treatment for postpartum depression, began sharing profits.
    • B”ut Biogen now wants Zurzuvae all to itself. In a Jan. 10 letter to Sage’s top executive Barry Greene, Biogen CEO Christopher Viehbacher wrote that his company’s experience selling nervous system drugs would “enable more streamlined operations and efficient commercial execution” around Zurzuvae, which, in turn, should improve patient access.” 

Friday Report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC.

  • STAT News reports,
    • “The Biden administration’s [last] regulation affecting the Medicare Advantage industry would come with a much lighter touch than the past two years.
    • “President Biden’s Centers for Medicare and Medicaid Services on Friday proposed to increase the average benchmark payment to private Medicare Advantage plans by 2.2% for 2026. That compares to cuts of 0.2% for this year and 1.1% in 2024, although the Biden administration gave the Medicare Advantage industry one of the largest-ever payment hikes in 2023.
    • “The proposed rule was rolled out weeks earlier than normal, as the Trump administration gets ready to take over the White House and federal agencies later this month. It’s unclear what, if any, changes President Trump’s team will make to the proposal. Trump has picked Mehmet Oz to lead CMS, but it’s possible that the Senate won’t confirm him before the final rule is published by the beginning of April.
    • “But the Biden White House at least appears worried Trump will undo the latest proposal, warning that any “pauses” to some of its changes to how Medicare Advantage insurers are paid would result in an extra $10 billion windfall for the industry.”
  • Per HHS press releases,
    • “Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra declared a Public Health Emergency (PHE) for California to address the health impacts of the ongoing wildfires in Los Angeles County.
    • “The declaration follows President Biden’s major disaster declaration and gives the Centers for Medicare & Medicaid Services’ (CMS) health care providers and suppliers greater flexibility in meeting emergency health needs of Medicare and Medicaid beneficiaries.
    • “We will do all we can to assist California officials with responding to the health impacts of the devastating wildfires going on in Los Angeles County,” said Secretary Becerra. “We are working closely with state and local health authorities, as well as our partners across the federal government, and stand ready to provide public health and medical support. My thoughts and prayers are with the people impacted in my home state.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) has issued its AI Strategic Plan (hereafter referred to as “Strategic Plan” or “Plan”). The Plan establishes both the strategic framework and operational roadmap for responsibly leveraging emerging technologies to enhance HHS’s core mission, while maintaining our commitment to safety, effectiveness, equity, and access. Additionally, the Plan outlines the ways in which HHS will deliver on its goal of being a global leader in innovating and adopting responsible AI that achieves unparalleled advances in the health and well-being of all Americans.
    • “At HHS, we are optimistic about the transformational potential of AI,” said Deputy Secretary Andrea Palm. “These technologies hold unparalleled ability to drive innovation through accelerating scientific breakthroughs, improving medical product safety and effectiveness, improving health outcomes through care delivery, increasing access to human services, and optimizing public health. However, our optimism is tempered with a deep sense of responsibility. We need to ensure that Americans are safeguarded from risks. Deployment and adoption of AI should benefit the American people, and we must hold stakeholders across the ecosystem accountable to achieve this goal.”
  • The Wall Street Journal reports,
    • “New divisions have emerged among U.S. intelligence agencies over whether foreign adversaries have been developing devices that led to the illness known as Havana Syndrome, according to an intelligence report released Friday. 
    • “Most of the U.S. intelligence community still believes it is very unlikely that the wide range of symptoms that have been reported by more than 1,500 U.S. government employees since the first cases emerged in Havana in late 2016 were caused by a foreign power. 
    • “But in a notable shift, two intelligence agencies now say there is a “roughly even chance” U.S. adversaries have been developing a novel weapon that could cause the illness.
    • “One of the dissenting agencies says it might have already been used to harm a small number of American personnel and dependents who have reported Havana Syndrome symptoms, the report said. 
    • “Havana Syndrome is a set of unexplained medical symptoms that include dizziness, headache, fatigue, nausea, anxiety, cognitive difficulties and memory loss of varying severity.”
  • Per Federal News Network,
    • “The Office of Personnel Management’s retirement claims backlog remained basically the same in December as compared to November, but the number of days it took to process those claims ticked up to 57 from 55 days.
    • “OPM also hit a new low in retirement claims received last month with 5,020. This is the lowest amount of claims received since November 2023.”
  • Govexec tells us,
    • “The Office of Personnel Management on Wednesday sent guidance to agency heads outlining transition authorities that President-elect Donald Trump could use to immediately place his nominees in temporary positions at federal agencies and departments. 
    • “Although Trump is pushing Senate Republicans to expeditiously confirm his picks, he will have the authority to appoint individuals, for up to 30 days, to advisory or consultative senior executive service positions while they’re awaiting confirmation. 
    • “Likewise, cabinet-level agencies will be able to make five noncareer SES appointments and other agencies can institute up to three such appointments, which is standard. Such appointments must be made by Feb. 15 and also can only last for 30 days.”

From the judicial front,

  • Bloomberg informs us,
    • “The US Supreme Court agreed [today] to review a lower court ruling that found some Obamacare coverage requirements for preventative services unlawful, but kept them enforceable nationwide.
    • “In an order Friday, the court said it will hear the Biden administration’s appeal of that decision by the US Court of Appeals for the Fifth Circuit holding the structure of the US Preventive Services Task Force unconstitutional under the Appointments Clause.
    • “The task force is charged with recommending some of the medical services health insurers must cover free-of-charge under the Affordable Care Act.
    • “Task force members “are principal officers under Article II of the Constitution who must be—yet have not been—nominated by the President and confirmed by the Senate,” the Fifth Circuit said.”
  • FEHBlog note: It drives the FEHBlog nuts that the Biden Administration or Congress failed to moot the 5th Circuit opinion by making USPSTF recommendations subject to approval by the Centers for Disease Control and Prevention’s director.

From the public health and medical research front,

  • The CDC did not have time to update its weekly respiratory illnesses report due to the unexpected federal holiday for President Carter’s Day of Mourning yesterday. This week’s report will be posted on Monday January 13.
  • The University of Minnesota’s CIDRAP relates, “A first dose of COVID-19 vaccine accelerated relief of long-COVID symptoms such as fatigue and muscle aches in UK adults, but flu vaccination did not, suggests an observational University College London–led study published yesterday in the Journal of Infection.”
  • Per MedPage Today, “Hospitals doing fewer operative vaginal deliveries (OVDs) had higher rates of adverse perinatal outcomes for these cases than higher volume centers did, according to a population-based retrospective cohort study from California.”
  • The NIH Director, Dr Monica Bertagnolli, writes in her blog,
    • “Millions of people in the U.S. have an autoimmune disease, from type 1 diabetes to inflammatory bowel disease, in which the immune system attacks the body’s own organs, tissues, or cells to cause damage. While treatments that tamp down the immune system can help, they can increase risk for infection or cancer due to systemic immune suppression. Similarly, for people who’ve received an organ or tissue transplant, immunosuppressants used to prevent rejection can leave the whole body vulnerable. What if there was a way to suppress the immune system only right where it’s needed, in tissues or organs at risk for immune attack?
    • “An NIH-supported study reported in Science describes a way to do just that by using a cell-based therapy approach. The therapeutic approach involves taking a blood sample from a patient, modifying certain immune cells in the laboratory, and then reintroducing the engineered cells back into the body. Such cell-based therapeutics can be designed to recognize specific molecules to target tissues. This approach is already used to treat many cancers, utilizing a patient’s own engineered immune cells, known as CAR T cells, to attack and kill their cancer. Inspired by the success of the CAR T-cell example, the researchers behind this new work see the technology they’re developing as a potential platform for tackling many types of immune dysfunction.” * * *
    • “While much more study is needed, the researchers suggest that such synthetic suppressor T cells could serve as a readily customizable platform to potentially treat many autoimmune conditions. Engineered immune suppressor cells could also be used to fine-tune CAR T-cell therapies for cancer so that they only attack tumors and not normal tissues, making them less toxic. This paves the way for a future in which there may be many more possibilities for precisely tamping down the immune system in ways that could prove life-changing for transplant recipients and those with type 1 diabetes, as well as many other autoimmune conditions.”
  • Per BioPharma Dive,
    • “Pfizer on Friday said its PD-1 inhibitor sasanlimab, when combined with standard therapy in people with bladder cancer, delayed death and disease complications longer than standard therapy alone. The Phase 3 trial could give Pfizer’s subcutaneous immunotherapy an edge over rival drugs, like Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo, which are approved to treat people with more advanced disease. Pfizer tested sasanlimab with an immunotherapy called Bacillus Calmette-Guérin in people whose cancer hadn’t spread beyond the bladder lining after surgery. If sasanlimab wins Food and Drug Administration approval, it could be the fourth PD-1 or PD-L1 inhibitor cleared as an under-the-skin shot. The FDA has already approved subcutaneous versions of Roche’s Tecentriq and Opdivo, and Merck has positive Phase 3 data in hand for under-the-skin Keytruda” 

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies “100 great neuro and spine programs.”
  • The Wall Street Journal reports,
    • AbbVie on Friday said it will post a $3.5 billion impairment charge related to last year’s $8.7 billion bet on Cerevel Therapeutics following the failure of the deal’s key drug candidate.
    • AbbVie in November said the Cerevel drug, emraclidine, missed the key goal in a pair of mid-stage studies in schizophrenia, prompting the North Chicago, Ill., biopharmaceutical company to begin an evaluation of the emraclidine intangible asset for impairment.
    • AbbVie, in announcing the Cerevel deal in late 2023, said it believed emraclidine had the potential to transform the schizophrenia treatment landscape and represented a multibillion-dollar peak sales opportunity.
  • The American Hospital Association News tells us,
    • “Prices for the top 25 brand-name Medicare Part D drugs have increased by an average of 98% since entering the market, according to a report released Jan. 9 by the AARP Public Policy Institute. That price growth has often exceeded yearly rates of inflation, the organization said. The drugs highlighted in the report have not yet been selected for the Medicare Drug Price Negotiation program. The drugs accounted for nearly $50 billion in total Part D spending in 2022.”
  • Healthcare Dive informs us,
    • “Walgreens’ first quarter earnings were notably better than Wall Street feared, though the retail pharmacy operator continues to suffer heavy losses as it works to right the ship.
    • “On Friday, Walgreens posted financial results that beat analyst expectations with revenue of $39.5 billion, up 7.5% year over year. Still, Walgreens reported a net loss of $265 million, larger than its $67 million loss same time last year, mainly due to costs stemming from ongoing store closures and asset sales.
    • “Walgreens’ market value has plummeting in recent years, leading the company to explore a private equity buyout, according to the Wall Street Journal. Executives didn’t address the speculation on a call with investors Friday morning, but said Walgreens made progress on its $1 billion cost-cutting initiative in the quarter, including a pending sale of beleaguered medical chain VillageMD and closures of 70 underperforming retail stores.”

Monday Report

David Ermer–CDC, CMS, Congress, COVID treatment, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

From Washington, DC.

  • The Wall Street Journal reports, “Congress quickly and smoothly certified President-elect Donald Trump’s election victory Monday, a contrast to four years earlier, when a pro-Trump mob stormed the Capitol and temporarily halted the confirmation of President Biden’s win.” 
  • Federal News Network confirms,
    • “President Joe Biden signed the Social Security Fairness Act into law Sunday afternoon, the final step needed for nearly 3 million public sector employees, retirees, spouses and surviving spouses to begin receiving larger monthly Social Security payments.
    • “The legislation repeals the Windfall Elimination Provision and Government Pension Offset — two longstanding provisions of Social Security that reduce or eliminate benefits for certain government retirees, including Civil Service Retirement System annuitants, as well as teachers, firefighters, police officers and others who have worked in a public sector position.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Jan. 6 announced the 15 participants for its state Transforming Maternal Health Model: Alabama, Arkansas, California, Washington, D.C., Illinois, Kansas, Louisiana, Maine, Minnesota, Mississippi, New Jersey, Oklahoma, South Carolina, West Virginia and Wisconsin. The model will provide technical support and resources to state Medicaid agencies to develop programs that address new mothers’ physical health, mental health and social needs during pregnancy and postpartum. The model launched Jan. 1 and will run for 10 years.”
  • Per FiercePharma,
    • “In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory trials at least be underway at the time of these conditional nods. But, after hearing some mixed messaging from the agency, drugmakers were left wondering what exactly “underway” means in this context.
    • “Now, a new draft guidance document tries to clear the air on the agency’s interpretation of the term “underway.”
    • “The FDA on Monday posted a draft guidance document titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” Although the guidance doc was uploaded by the Oncology Center of Excellence, which has issued the majority of accelerated approvals, the policies are slated to apply to the entire FDA.”
  • BioPharma Dive points out “five FDA decisions to watch in the first quarter of 2025. Over the next three months, the regulator could approve new medicines for pain, a deadly heart disease and a rare condition that’s long bedeviled drugmakers.”

From the public health and medical research front,

  • The New York Times reports,
    • “A Louisiana patient who had been hospitalized with severe bird flu has died, the first such fatality in the United States, state health officials reported on Monday.
    • “The patient was older than 65 and had underlying medical conditions, the officials said. The individual became infected with the bird flu virus, H5N1, after exposure to a backyard flock and wild birds.
    • “There is no sign that the virus is spreading from person to person anywhere in the country, and Louisiana officials have not identified any other cases in the state. Pasteurized dairy products remain safe to consume.
    • “I still think the risk remains low,” said Dr. Diego Diel, a virologist at Cornell University.
    • “However, it is important that people remain vigilant and avoid contact with sick animals, sick poultry, sick dairy cattle, and also avoid contact with wild birds,” he added.”
  • The Washington Post informs us,
    • “The rate of triplet and higher-order multiple births in the United States declined 62 percent from 1998 to 2023, according to the Centers for Disease Control and Prevention. 
    • “Most of the downturn occurred since 2009. Triplet and higher-order births are pregnancies involving three or more babies. Because maternal and infant health problems are more frequently associated with higher-order multiple births than with twins and single births, the increase was of public health concern, the CDC report noted.” * * *
    • “The period that preceded the current study, 1980 to 1998, saw an extraordinary fivefold increase in births of triplets and higher-order multiple births — from 37 per 100,000 births in 1980 to 194 births per 100,000 in 1998. Researchers attributed the spike to higher maternal age and increased use of fertility treatments. Since that period, the rates of multiple births have trended in the opposite direction.”
  • Medscape adds,
    • “Respiratory syncytial virus prefusion F vaccine significantly reduced severe RSV-related lower respiratory tract disease (LRTD) requiring hospitalization or emergency department (ED) visits in an older adult population, including substantial representation from the oldest age groups.”
  • In related news,
    • Per the New York Times, “Can Paxlovid treat long Covid? A new report suggests it might help some patients, but which patients might benefit remains unclear. The report, published Monday in the journal Communications Medicine, describes the cases of 13 long Covid patients who took extended courses of the antiviral drug. Results were decidedly mixed: Nine patients reported some improvement, but only five said it lasted. Four reported no improvement at all.”
    • Per Infectious Disease Advisor, “Nirmatrelvir/ritonavir (PaxlovidTM) reduced COVID-19-related hospitalization and all-cause death, as well as the duration of COVID-19 symptoms and utilization of health care resources among patients at high risk for severe diseases, according to study findings published in Clinical Infectious Diseases.”
  • The Institute for Clinical and Economic Review announced today “that it will assess the comparative clinical effectiveness and value of apitegromab (Scholar Rock) for the treatment of spinal muscular atrophy (SMA). ICER will also assess new evidence (since ICER’s 2019 Final Evidence Report) on the clinical effectiveness of nusinersen (Spinraza®, Biogen) and onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), as well as the evidence for risdiplam (Evrysdi®, Genentech). Risdiplam was not evaluated in the 2019 report.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “All of the commercial prescriptions dispensed at CVS pharmacies will be processed through its CostVantage reimbursement model beginning this year, the healthcare giant announced on Monday.
    • “Under the model, prescriptions are priced based on the underlying cost with a delineated markup and dispensing fee to cover the services provided by CVS in the transaction. The company says that this model makes it less necessary to raise the cost for certain prescriptions to cover losses on other drugs.
    • “The model also seeks to increase transparency for insurers and pharmacy benefit managers, making it potentially easier for PBMs to establish their own more transparent programs for plans and clients.
    • “Prem Shah, group president for CVS Health, said that the team is also working with the Centers for Medicare & Medicaid Services to expand the program to Medicare and Medicaid prescriptions.”
  • Modern Healthcare relates,
    • “Although the pharmacy benefit manager market has long been controlled by three large, established players, many smaller PBMs are seeing a spike in interest. But the newer entrants will continue to face stiff competition this year as they seek more business.
    • “Smaller PBMs that advertise themselves as transparent have gained traction over the last few years as health insurers, employers and government entities look to deviate from the traditional spread pricing model. Many of these companies have said 2024 was their largest selling year, with an increasing number of large customers showing interest.”
    • “Companies that had never even spoken to us prior to this past year now are talking to us and are including us as a finalist,” said David Fields, president and CEO of Navitus Health Solutions, which serves employers with up to 500,000 workers and dependents. Navitus will manage pharmacy benefits for about 18 million people in 2025.”
  • McKinsey & Company notes,
    • Technology leaders and enthusiasts are convening in Las Vegas this week for CES—formerly known as the Consumer Electronics Show—to hear from industry leaders, get immersed in demos and interactives, and learn about the latest solutions to society’s greatest challenges. This year’s conference program features topics including artificial intelligence, digital health, vehicle technology and future mobility, and more. 
    • Whether you’re attending in-person or via livestream, prepare for #CES2025 by learning about the adoption, development, and effects of 15 top technology trends in an analysis by McKinsey’s Lareina Yee, Michael Chui, and Roger Roberts.

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Public service notice — January 3 is the statute of limitations for wishing another person Happy New Year, according to Larry David.

From Washington, DC,

  • The Wall Street Journal reports,
    • “Incumbent Mike Johnson won re-election as speaker of the House on the first ballot, after President-elect Donald Trump pressured GOP holdouts to change their votes, handing the Louisiana Republican the narrow majority needed to claim the gavel.
    • “Johnson’s dramatic victory clears the way for Republicans to charge headlong into Trump’s second term, taking on an ambitious agenda of tax cuts and border security. While Johnson avoided a repeat of the GOP’s calamitous January 2023 speaker vote, the tally underscored how little room he has to maneuver with the party’s razor-thin margin. It also showed the power of any small group of dissidents to derail the party’s plans.
    • “Working together, we have the potential to be one of the most consequential congresses in the history of this great nation,” Johnson said.
    • “The chain of events previewed how Trump and Johnson will need to move in lockstep to get legislation across the finish line and tamp down dissent, even though the party controls both chambers of Congress and the White House.”
  • Roll Call adds,
    • “A last-minute insertion into House Republicans’ rules package for the 119th Congress substantially raises the bar for voting on legislation under suspension of the rules late in the week or over the weekend, in a concession to conservatives upset about recent deals with Democrats on big-ticket spending bills.
    • “The change requires the House to adopt a special rule to consider bills under suspension of the rules — which bars amendments but requires the support of two-thirds of members present and voting for passage — on any days other than Mondays, Tuesdays or Wednesdays.” * **
    • The House adopted the new rules package on a 215-209 vote late Friday.
  • The Wall Street Journal tells us,
    • “The U.S. surgeon general said alcoholic beverages should carry cancer warnings to increase awareness that the drinks are a leading cause of preventable cancers.
    • “An act of Congress would be required to change the existing warning labels on bottles of beer, wine and liquor. Today, federal rules require only a warning against drunken driving and drinking while pregnant, as well as a general warning that alcohol “may cause health problems.”
    • “Alcohol is a well-established, preventable cause of cancer responsible for about 100,000 cases of cancer and 20,000 cancer deaths annually in the United States,” Dr. Vivek Murthy said in his advisory issued Friday. “Yet the majority of Americans are unaware of this risk.”
  • Per a Health and Human Services Department press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced it would award $306 million dollars to continue its H5N1 Avian Flu response. While CDC’s assessment of the risk of avian influenza to the general public remains low, USDA and HHS continue to closely collaborate with Federal, State, local, industry and other stakeholders to protect human health, animal health, and food safety.
    • “While the risk to humans remains low, we are always preparing for any possible scenario that could arise. These investments are critical to continuing our disease surveillance, laboratory testing, and monitoring efforts alongside our partners at USDA,” said Secretary Xavier Becerra. “Preparedness is the key to keeping Americans healthy and our country safe. We will continue to ensure our response is strong, well equipped, and ready for whatever is needed.”
  • MedTech Dive informs us that the “FDA closed 2024 with string of early alerts on device safety risks. Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.”

From the judicial front,

  • Fierce Healthcare lets us know,
    • “Aetna is taking legal action against Pfizer, Novartis, Teva Pharmaceuticals and others, saying the list of drugmakers conspired to overcharge the insurer, consumers and the federal government for generic drugs.
    • “The complaint, filed Dec. 31, claims the drugmakers communicated secretly at trade conferences or through phone calls, beginning in 2012, to determine the market share, prices and bids of certain drugs. If communication was in writing, they destroyed the evidence, Aetna claimed.
    • “They effectuated their market allocation by either refusing to bid for particular customers or providing outrageously high cover bids,” the complaint said. “This created an artificial equilibrium that enabled the conspirators to then collectively raise and/or maintain prices for a particular generic drug.”
    • “Aetna said that drug purchasers, predominantly insurers, suffered as a result of these actions. Insurers place generic drugs on their formularies to lower costs but instead were paying unfairly high prices for these products.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in most areas of the country. Seasonal influenza activity continues to increase and is elevated across most of the country. RSV activity is very high in many areas of the country, particularly in young children.
    • “COVID-19
      • “COVID-19 activity is increasing in most areas of the country, with high COVID-19 wastewater levels and increasing emergency department visits and laboratory percent positivity. Based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness will continue 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 circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is very high in many areas of the country, particularly in young children. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • Following up on the Surgeon General’s advisory, the Wall Street Journal considers,
    • “How much drinking is bad for you?
    • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
    • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
    • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
  • Per MedTech Dive,
    • “The Food and Drug Administration said a literature review found no safety concerns associated with tampon use and contaminant exposure.
    • “FDA officials commissioned the independent review in September in response to a study that found tampons may expose users to metals. After seeing the findings, the agency continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product.
    • “The FDA is still running an internal bench laboratory study designed to show if metals from tampon materials are released or absorbed in the body. That study will better enable the FDA to complete a risk assessment, the agency said in a Dec. 23 statement.”
  • The Wall Street Journal notes,
    • Researchers have identified a focal point for the forces they suspect of driving up cancer cases in young people: the gut. They are searching people’s bodies and childhood histories for culprits.
    • Rates of gastrointestinal cancers among people under 50 are increasing across the globe. In the U.S., colorectal cancer is the leading cause of cancer death in men under 50 and second for women behind breast cancer. Each generation born since the 1950s has had higher risk than the one before. 
    • “Everything you can think of that has been introduced in our society since really the 1960s, the post-World War II era, is a potential culprit,” said Dr. Marios Giannakis, a gastrointestinal oncologist at the Dana-Farber Cancer Institute in Boston.
    • “Robert F. Kennedy Jr., President-elect Donald Trump’s pick for Health and Human Services secretary, has pointed to ultra-processed foods and chemicals in medicines and the environment. Cancer doctors share some of his suspicionsabout diet and exposure to contaminants such as microplastics, shards that make their way from packaging or clothing into our bodies through water and food. They are scrutinizing those and other potential hazards including “forever chemicals” and even light.   
    • “We’re all concerned and want to do something quickly and act quickly, but we want to do so based on sound science,” said Dr. Andrew Chan, director of epidemiology at Mass General Cancer Center in Boston.” 
  • Per HealthDay,
    • “Not sure what’s causing your child’s asthma?
    • “A new quick-and-easy nasal swab test for kids can diagnose the specific immune system drivers behind their asthma, potentially opening the door to better treatments, researchers say.
    • “The test diagnoses a child’s asthma subtype, also called an endotype.
    • “Because asthma is a highly variable disease with different endotypes, which are driven by different immune cells and respond differently to treatments, the first step toward better therapies is accurate diagnosis of endotype,” senior researcher Dr. Juan Celedon, chief of pulmonary medicine at the UPMC Children’s Hospital of Pittsburgh, said in a news release from the hospital.”
  • A National Institutes of Health news release points out,
    • “A novel class of antibodies that binds to a previously untargeted portion of the malaria parasite could lead to new prevention methods, according to a study from researchers at the National Institutes of Health (NIH) published today in Science. The most potent of the new antibodies was found to provide protection against malaria parasites in an animal model. The researchers say antibodies in this class are particularly promising because they bind to regions of the malaria parasite not included in current malaria vaccines, providing a potential new tool for fighting this dangerous disease.
    • Malaria is a life-threatening disease caused by Plasmodium parasites, which are spread through the bites of infected mosquitoes. Although malaria is not common in the United States, its global impact is devastating, with 263 million cases and 597,000 deaths estimated by the World Health Organization in 2023. Of the five species of Plasmodium that cause malaria, Plasmodium falciparum is the most common in African countries where the burden of malaria is largest and where young children account for the majority of malaria deaths. Safe, effective countermeasures are critical for reducing the immense burden of this disease. * * *
    • “Findings from the study will inform future strategies for the prevention of malaria and may facilitate the development of new antibodies and vaccines against the disease, the researchers indicate. The scientists also note that more research is needed to examine the activity and effectiveness of the newly identified antibody class and epitope, according to their paper. The approach used in this study could also aid the development of a new generation of countermeasures against other pathogens, in addition to malaria.”  

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Ardent Health has acquired 18 facilities from urgent care provider NextCare, following through on its plan to expand its urgent and ambulatory care presence.
    • “The for-profit health system, which went public in July, said Friday it acquired six facilities in New Mexico and 12 in Oklahoma. Financial details and terms of the agreement were not disclosed.
    • “An Ardent spokesperson said the deal was part of a larger growth strategy and the system planned to acquire more ambulatory facilities.”
  • Beckers Payer Issues relates,
    • UnitedHealth Group is the world’s largest insurer by net premiums written for a 10th year in a row, according to AM Best’s annual ranking published Jan. 2.
    • In 2025, UnitedHealth expects revenues of up to $455 billion and adjusted net earnings of $29.50 to $30.00 per share.
    • Top four insurers ranked by 2023 NPW:
      • UnitedHealth Group
      • Centene
      • Elevance Health
      • Kaiser Permanente
  • Per Beckers Hospital Review,
    • “The Women’s Choice Award has recognized 457 hospitals on its annual list of the Best Hospitals for Patient Safety.
    • “To compile the ranking, the organization analyzed hospitals’ performance on 13 surgical complication and infection measures from CMS, including central-line associated bloodstream infections, sepsis and serious blood clots after surgery. Hospitals had to report on at least six measures to be included in the analysis and could not rank worse than the national average on any measure.  
    • “Hospitals on the patient safety list were among the top 10% of organizations nationwide with the lowest incidence of adverse medical events and infections. See the full list of winners here.” 

Friday Report

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, NCQA, U.S. Healthcare–
Hanukkah greeting template. Nine candles and wishing. Hand drawn sketch illustration. White, yellow and blue colors

From Washington, DC,

  • The Washington Examiner reports,
    • Debate within the intelligence community over the origins of COVID-19 ran much deeper than previously known, particularly within the Pentagon’s Defense Intelligence Agency. 
    • Three scientists at the National Center for Medical Intelligence, a branch of the Defense Intelligence Agency, conducted a scientific investigation in the summer of 2021, concluding that COVID-19 was likely manipulated in a biolaboratory. But the information was suppressed by the Pentagon and not included in White House briefings on the virus, according to a new report from the Wall Street Journal.”  * * *
    • “The National Center for Medical Intelligence examines global health threats, including infectious diseases and bioweapons, to determine what threats could endanger troops. The agency received a significant boost in funding in the immediate aftermath of the 9/11 attacks on the World Trade Center as the threat of biowarfare increased in the 21st century. 
    • “Three scientists at the medical intelligence center determined through genetic testing that a segment of the novel bat coronavirus, known as the spike protein, had been manipulated to infect human cells. They argued these changes indicated that Chinese scientists at the Wuhan Institute of Virology were engaging in gain-of-function experiments to see if they could make the virus more dangerous for humans.” * * *
    • “Sen. Rand Paul (R-KY) has promised to pick up where the House investigation left off and said he plans to use his new chairmanship of the Senate Homeland Security and Governmental Affairs Committee to delve deeper into what happened at the Wuhan Institute of Virology and what occurred behind closed doors within federal public health agencies.”
  • NCQA shares its insights about a December 9, 2024, White House listening session concerning the ongoing opioid crisis.
  • Federal News Network lets us know,
    • “With an incoming presidential administration and a new Congress both starting up at the beginning of 2025, there are many unknowns about what’s to come for the federal workforce.
    • “But at least one thing is for certain — telework for the federal workforce will remain a high-priority topic for agencies, employees, lawmakers, unions and many others.
    • “Already, key Republicans in Congress are looking ahead to further investigations into telework options for federal employees. House Oversight and Accountability Committee Chairman James Comer (R-Ky.) announced plans to hold a hearing on federal telework once the 119th Congress begins.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Due to the holidays, a short summary of this week’s respiratory virus illness findings is presented here, and updated data are provided in subsequent pages. No additional data summaries will be provided this week. Regular updates will resume on Friday, January 3, 2025.
    • “COVID-19, seasonal influenza, and RSV activity continue to increase across the country.
    • ‘COVID-19
      • “COVID-19 activity is increasing in most areas of the country, with high COVID-19 wastewater levels and increasing emergency department visits and laboratory percent positivity. Based on CDC modeled estimates of epidemic growth, we predict COVID-19 illness will continue 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 circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is high and continues to increase in most areas of the country, 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. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota CIDRAP adds,
    • “The genetic analysis of the H5N1 avian flu virus in specimens from the nation’s first severely ill hospitalized patient in Louisiana reveals mutations that may enable upper-airway infection and greater transmission, concludes a technical summary from the Centers for Disease Control and Prevention (CDC).
    • ‘But the authors of the report, released late yesterday afternoon, say the risk of an influenza pandemic amid the ongoing outbreak remains low.
    • “In related news, Los Angeles County and Stanislaus County this week announced their first human H5N1 cases in two dairy workers. Both workers had mild symptoms and are recovering after receiving antiviral drugs. No related cases have been identified. 
    • “California, which has reported a total of 37 cases, recently announced a public health emergency for H5N1 to free up more resources with the virus now spreading to dairy farms beyond the Central Valley and further south.
    • “The US total for human cases is now at 65.”
  • The Washington Post reports,
    • “Whooping cough continues to surge in the United States, with reported cases soaring to more than 32,000 this year — nearly five times the 6,500 cases recorded during the same period last year — marking the highest levels in a decade.
    • “Health experts cite as main culprits for the increase waning vaccination rates and a loss of broad immunity tracing to coronavirus lockdown protocols.
    • “The disease, caused by the bacterium Bordetella pertussis, is highly transmissible from person to person through the air. Because of their immature immune systems, infants younger than 1 year old are at highest risk of contracting whooping cough — also known as pertussis — and are at most significant risk of severe illness.
    • “Vaccination rates with the DTaP shot — which protects against diphtheria, tetanus and pertussis — declined from March through September 2020 at the height of the coronavirus pandemic. But because people were following pandemic protocols such as masking and social distancing, cases did not soar. Some children who missed getting their shots during that period may never have received them, experts have said.”
  • The Wall Street Journal informs us about “What Your ‘Face Age’ Can Tell Doctors About Your Health Scans of face photos are estimating people’s ‘biological age’ and even predicting how long they’ll live.”
    • “The FaceAge test is an artificial intelligence model trained on tens of thousands of photos from patients and public-image databases to look for signs of aging in the face. [Dr. Raymond] Mak and his team ran a study that found that the algorithm did a better job than doctors at predicting how long cancer patients would live. 
    • “Their hope is that one day, the tool could be a standard part of assessing health. Already, separate versions of face-age tests exist online where anybody can upload a selfie and get an estimate of their biological age. 
    • “Your face reflects the wear and tear of your lifetime,” says Mak, a radiation oncologist at Brigham and Women’s Hospital, who co-led the study alongside other Mass General Brigham researchers. “We viewed this as a way to quantify a doctor’s clinical intuition.”
  • Per STAT News,
    • “Blood stem cell transplants have been central players in treating blood cancers for decades. These procedures can improve patients’ chances of survival and can even offer the opportunity for a cure in some cases.
    • “But over the last decade, physicians say they’ve started doing transplants for fewer cancer types, particularly lymphomas, and are instead reaching first for newer immune or targeted therapies that are safer and often more effective.
    • “That’s progress that experts hope will continue. “I know from my days as a transplanter, there was nothing better than when a patient didn’t have to be transplanted,” said Andy Kolb, the president and CEO of the Leukemia and Lymphoma Society. “Because it’s toxic.”
  • Per HealthDay,
    • “When supplies of certain generic, platinum-based cancer chemotherapies dwindled in 2023, oncologists feared it might lead to under-treatment and many more cancer deaths.
    • “Fortunately, that did not turn out to be the case, a new study published recently in the Journal of the National Cancer Institute shows.
    • “When we looked at the data on prescribing practices over the shortage period, compared to the previous year, we found that although reporting of the shortages was widespread, it didn’t affect as many patients as we had feared,” said lead study author Dr. Jacob Reibel. He’s a third-year fellow in hematology-oncology at Penn Medicine’s Abramson Cancer Center in Philadelphia.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “National health expenditures in 2025 are forecast to rise 2.2% over 2024 levels, according to the Centers for Medicare and Medicaid Office of the Actuary. But some analysts say the predictions should be taken with a measure of skepticism.
    • “The predictions, released annually from CMS actuaries, project changes to healthcare spending by governments, businesses and households several years into the future. The report’s methodology acknowledges limitations, including relying on law and government policy in force at the time the projections were made.
    • “The office, which is independent from CMS leadership, predicts personal healthcare spending — which includes provider and retail revenue from medical goods and services — will increase 2.3% in 2025.
    • “Kevin Holoran, a senior director with data and analytics firm Fitch Group, said the projected 1.7% increase in spending on hospital care “feels a little low.” In December, Fitch Ratings released a 2025 outlook for nonprofit hospitals and health systems suggesting the sector would benefit from boosted cash flows and improved equity market returns.
    • “The Office of the Actuary predicted a 4.5% increase in prescription drug spending. Fitch Senior Director Mark Pascaris — who, along with Holoran, is a lead nonprofit hospital analyst at the firm — said those projections are consistent with growth in the sector, which Fitch expects to continue in 2025. Actuaries’ predicted 3.7% boost in home healthcare spending also makes sense, Pascaris said.
    • “The personal healthcare spending category additionally includes dental services; nursing home and continual care facilities; durable and non-durable medical products; other health, residential and personal care; and “other” professional services not included in the other subcategories.”
  • and
    • “Per diem nursing is replacing travel nursing as the preferred solution to providers’ staffing issues.” * * *
    • “Many employers, including Franklin, Tennessee-based Community Health Systems and Dallas-based Tenet Healthcare have said they’ve lowered their contract labor costs. And a June survey from employment firm Incredible Health found 67% of health executives did not increase travel nurse positions in 2024. The survey also found nurse interest in travel work dropped by 22% in 2024.
    • “Per diem nurses typically operate “on-demand,” picking up shifts for permanent staff who call out, are on a short leave or when a hospital needs extra help when a patient population is high. They are usually local residents and do not require long-term contracts, compared with travel nurses who often require relocation assistance and guaranteed pay regardless of whether a facility needs extra nurses.”
  • The Healthcare Cost Institute updated its assessment of no value care in the employer sponsored and traditional Medicare health insurance markets.
    • “In this brief, we calculated the prevalence and spending among a subset of “no value care” services between 2018 and 2022 among the employer-sponsored insurance and Traditional Medicare populations.
    • “Vitamin D Screening in administrative claims accounted for nearly $708 million in ESI and $312 million in Traditional Medicare spending in 2022. In that year, we estimate that 23% of all Vitamin D Screenings had no evidence of clinical benefit in administrative claims data among those with Employer Sponsored Insurance, much higher than the estimated 4% no value tests among those with Traditional Medicare. The prevalence of arthroscopic knee surgeries for osteoarthritis amounted to $389 million in ESI and $30 million Traditional Medicare spending in 2022.
    • “Our analysis focused just on these three services and, accordingly, does not speak to the prevalence of “no value care” in the employer-sponsored insurance and Traditional Medicare population broadly. Due to absence of clinical and health care operation data elements, we are not able to identify and measure most “no value care” or related challenges, such as medical mistakes, preventable infections, lack of care coordination, and lack of access to care.”
  • Beckers Payer Issues explains why Premera Blue Cross wants its employees to get creative with artificial intelligence.
  • Beckers Hospital Review shares what’s on pharmacy leaders’ radar screens for 2025 and its updated list of 2024 hospital closures which merited a Beckers report.

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “The Republican-led House approved stopgap spending legislation to avert a government shutdown and provide more than $100 billion in disaster and farm aid, sending the measure to the Senate just hours ahead of the midnight deadline.
    • “Lawmakers voted 366 to 34 to approve the proposal, well above the two-thirds threshold needed under special fast-track procedures. 
    • “The bill marked House Speaker Mike Johnson’s third attempt to combine a three-month funding extension with emergency aid this week, after wrestling with competing demands from President-elect Donald Trump, his billionaire efficiency czar Elon Musk, internal GOP critics and Democrats.”
  • Govexec adds,
    • “The continuing resolution now heads to the Senate and Senate Majority Leader Chuck Schumer, D-N.Y., has indicated he is supportive of the bill. The White House has told lawmakers President Biden will sign it. Incoming Senate Majority Leader John Thune, R-S.D., said he expected his chamber could move the bill before the midnight deadline.” 
  • Fierce Healthcare lets us know,
    • “The Centers for Medicare and Medicaid Services announced Friday that 64 Part B drugs will have a reduced price for Medicare patients at the pharmacy counter in the first quarter of 2025.
    • “CMS said patients may save between $1 and $10,818 per day on co-insurance costs for the Part B drugs included on the list.
    • “As part of the Inflation Reduction Act, drug manufacturers must give rebates to the federal government for single source drugs and biological products, including certain biosimilar biological products, whose price increased more than the rate of inflation. The list of discounted drugs changes each quarter.
    • “The 64 drugs (PDF) with reduced co-insurance costs for Medicare patients include Kepivance, which treats mouth sores caused by chemotherapy, Talvey, used to treat patients with multiple myeloma, and Yescarta for recurrent or treatment-resistant blood cancer.”
  • Per HHS press releases,
    • “Today, the U.S. Department of Health and Human Services’ (HHS) launched the Let’s Get Real campaign to cut through the noise of misinformation and give parents the balanced information they need about childhood vaccines. The campaign provides verifiable facts so parents can get the information they want to make informed vaccine decisions, and it shares stories from doctors and peers on why most of us rely on vaccines to protect our children. Let’s Get Real also offers tools for health care professionals with pediatric patients.”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Office of Global Affair’s (OGA) U.S. Section of the U.S. – Mexico Border Health Commission (Commission), released Healthy Border 2030 – PDF.
    • “This framework includes an assessment of health data and priority issues that affect the health of the population on the U.S. side of the border as well as high-level strategic recommendations for federal, state and local governments, and community-based stakeholders on how to take action to address them. Building on previous reports in 2010 and 2020, the recommendations in the 2030 framework focus on the U.S. context and consider, when feasible, the importance of a binational approach in improving the health and well-being for populations along the U.S. southern border.”

In Food and Drug Administration News,

  • The New York Times reports,
    • “The Food and Drug Administration on Friday approved the weight loss drug Zepbound to treat obstructive sleep apnea. It is the first prescription medication approved to treat the common sleep disorder.
    • ‘The drug’s maker, Eli Lilly, announced that the agency authorized Zepbound for people with obesity and moderate to severe obstructive sleep apnea. Millions of Americans have the condition, and many of them also have obesity. The company said that the drug should be used with a reduced-calorie diet and increased physical activity. 
    • “When people have obstructive sleep apnea, they struggle to breathe properly during sleep and can wake up gasping for air. If untreated, obstructive sleep apnea raises the risk for a range of health issues, including cardiovascular problems, diabetes, stroke and dementia.
    • “In June, two studies found that people who took the drug saw a greater improvement in sleep apnea symptoms, including fewer interruptions in sleep, than those who took a placebo. Eli Lilly funded both studies.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing from low levels in some areas of the nation. Seasonal influenza activity is moderate and continues to increase across the country. RSV activity is high and continues to increase in most areas of the United States, particularly in young children.
    • “COVID-19
      • “COVID-19 activity, including wastewater levels, emergency department visits, and laboratory percent positivity, is increasing from low levels in some areas of the nation. 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 circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is high 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 provided by vaccines.
    • “Season Outlook
      • “As of December 19, CDC continues to expect the fall and winter virus season will have a similar or lower peak number of combined hospitalizations from COVID-19, influenza, and RSV compared to last year. However, peak hospitalizations from all respiratory viruses remain likely to be much higher than they were before the emergence of COVID-19.
      • “CDC has updated the outlook this week. This update uses historical data and COVID-19 scenario modeling to assess when peak hospital demand may occur nationally and regionally. Additional updates will occur if there are big changes in how COVID-19, flu, or RSV are spreading. Read the entire 2024-2025 Respiratory Season Outlook- December Update. (12/20/2024).”
  • The University of Minnesota’ CIDRAP tells us based on two new studies that “6% of US adults have long COVID, and many have reduced quality of life.”
  • Per Health Day,
    • “The sicker a senior becomes, the more likely they’re going to develop kidney problems on top of their other health challenges.
    • “A new study published Dec. 17 in Journal of the American Geriatrics Society (JAGS) shows that as a person’s number of chronic illnesses increases, a decline in their kidney function becomes both more likely and steeper.
    • “This is particularly true of people with many heart problems, and people with a large number of chronic illnesses that require lots of medication and treatments.
    • “Our findings emphasize the importance of a comprehensive assessment that considers not only the overall chronic disease burden, but also the complex interplay between diseases when evaluating the risk of kidney function decline in older adults,” said lead researcher Giorgi Beridze, a doctoral student in geriatric epidemiology with the Karolinska Institute.”
  • and
    • “Knee arthritis could become easier to detect and diagnose thanks to a new test involving the lubricating fluid inside the joint.
    • “A new study shows that arthritis of the knee often is diagnosed in its late stages, after cartilage has degraded and bones are rubbing against each other in the joint.
    • “At that point, it’s tough to tell whether knee arthritis has been caused by natural wear and tear, or if an inflammatory disease is behind a person’s joint problems, the researchers noted in a new study published Dec. 18 in the Journal of Orthopaedic Research.
    • “But a new test involving two markers found in the synovial fluid of patients’ joints might be able to help docs suss all this out more promptly.
    • “The test “addresses an unmet need for objective diagnosis of osteoarthritis to improve clinical decision-making and patient outcomes,” researcher Daniel Keter with CD Diagnostics, a division of Zimmer Biomet, said in a journal news release.”

From the U.S. healthcare business front,

  • HCPLAN shares summaries of reports presented at its recent summit.
  • Kaufmann Hall points out four trends to help health systems accelerate their 2025 strategies.
  • The Wall Street Journal reports,
    • “Novo Nordisk’s big bet to improve on the success of its weight-loss drug franchise hit a stumbling block Friday, wiping out nearly $100 billion of the drugmaker’s stock-market value.
    • “The Danish company—which had become Europe’s biggest by market capitalization on booming sales of Ozempic and Wegovy—reported disappointing results of a closely watched clinical trial testing an experimental anti-obesity treatment that the company hoped would be its next big weight-loss product.
    • ‘The two-drug combination, dubbed CagriSema, helped study volunteers lose a significant amount of weight, some 22.7% on average after more than a year’s treatment. And the drug might still make it to market. But the magnitude of weight loss it induced in the study fell short of the company’s and investors’ expectations.”
  • The American Hospital News informs us,
    • “After incurring damage from Hurricane Helene on Sept. 27, Baxter reports that as of Dec. 19, nearly all of its manufacturing lines in its North Cove, N.C., facility have been restarted. The producer of IV and peritoneal dialysis solutions says that the lines represent 85% of the site’s total pre-hurricane capacity.  
    • “Baxter officials say they expect production across the plant to rise to pre-hurricane levels early in the first quarter of 2025. “Note that it will take some time for product to flow through the distribution channels,” according to the Baxter website.”

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.