Monday Report

CDC

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.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Tammy Flanagan, writing in Govexec, discusses, “The Social Security Fairness Act: What we know so far.  It may take time to implement this new law — here’s what you should know for now.”
    • “It will undoubtedly take time to implement this new law as it impacts about two million beneficiaries who have their earned Social Security benefits reduced because of the WEP, and close to 750,000 individuals who have had spousal and widow’s benefits payable based on the Social Security work record of their current, former or deceased spouse.  
    • “The repeal of the WEP and GPO will increase the Social Security benefit entitlements of the government worker or retiree who is receiving a pension from work not covered by Social Security. For most of you reading today’s column, this would be the CSRS employees and retirees who are married or were married to a spouse who paid Social Security taxes and the CSRS employee or retiree who earned their own Social Security retirement benefit in addition to receiving a CSRS retirement benefit.  
    • “The WEP can also affect CSRS Offset employees and retirees as well as some employees or retirees who transferred to FERS after more than five years of creditable service under CSRS.”
  • The American Hospital Association News tells us,
    • The Centers for Medicare & Medicaid Services will host a webinar Jan. 16 at 1 p.m. ET to provide an update on the No Surprises Act Good Faith Estimate requirements for uninsured and self-pay patients. Experts will discuss the recent GFE FAQs with a focus on implications for providers and facilities. REGISTER NOW” 

From the public health and medical research front,

  • Per Medical Economics,
    • Screening for physical inactivity during routine medical visits can play a pivotal role in the identification of patients at risk for chronic diseases, according to a study published in Preventing Chronic Disease, a journal of the U.S. Centers for Disease Control and Prevention (CDC). Using the Exercise Vital Sign (EVS), researchers found that patients screened for physical activity had healthier profiles and fewer comorbid conditions than those who were not screened.
  • WTW Consulting informs us,
    • More and more evidence show that GLP-1 medications are good for losing weight and reducing the amount of metabolic disease in people with obesity. But only about 52% of employers currently cover these drugs for obesity, and these employers are facing rising costs.
    • Previous research has shown that the cost of these drugs will exceed any medical cost savings, as is true for most medical interventions. For example, medical plans don’t save money by treating cancer or providing dialysis for patients with kidney failure.
    • JAMA Network Open recently published a study that showed that healthcare spending could decrease based on the type of weight loss seen with use of GLP-1 medications. However, the study demonstrates once again that even with their impressive impacts on patient weight and health, an employer-sponsored health insurance plan should not expect net medical savings from these medications.
    • The researchers looked at medical claims from over 13,000 commercially insured adults from the Medical Panel Expenditure Survey from 2001 to 2020 and found that medical spending was lower in those who weighed less. Therefore, cost effectiveness of an effective weight loss drug would be much higher in those with higher BMIs, especially in those with diabetes. 
    • However, the study didn’t evaluate people who had lost weight, but rather examined differences in costs based on BMI. Those who lose weight won’t necessarily have the same lower level of expense as those who weren’t previously obese. Even if their estimate of cost “savings” is correct, the net cost of semaglutide or tirzepatide is around $9,000 annually, which is more than the delta in costs for a person with diabetes who loses 25% of their body weight.
    • Implications for employers: 
      • An employer-sponsored health insurance plan should not expect net medical savings from these medications, even with their impressive impacts on patient weight and health.
      • The decision to cover these medications should be based on the benefit they offer, and not the hope of lower medical expenses. Lower prices would allow more people to benefit from these medications.
  • The Wall Street Journal warns us,
    • Wildfires in California aren’t all wild anymore. They often burn in urban areas, creating a toxic soup of smoke, ash and noxious substances that can be dangerous, even deadly. 
    • In Los Angeles this week, wildfires have burned buildings and roadways. Incinerating the plastics, metals and other materials that these structures are built from releases hazardous chemicals and gases into the air, doctors and public-health experts say. 
    • Wildfires which tear through urban landscapes release chemicals from human-made fuels, construction materials, household products and generate emissions which are chemically different from wildland fires, according to a 2022 report from the National Academies of Sciences, Engineering and Medicine. About 70,000 communities and 43 million homes are at risk from fires that could burn through both wild and urban landscapes, the report stated.
    • “The combination of wildfire smoke in conjunction with human elements might be even more dangerous,” said Dr. Sanjay Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute in Cleveland. “When you burn plastic, for instance, or you burn rubber, you get some pretty nasty stuff.”
    • Smoke from the Los Angeles wildfires could have far-reaching effects. Depending on weather patterns and geographic conditions, smoke can travel vast distances. Tens of thousands of Los Angeles County residents have already been ordered to evacuate.
  • BioPharma Dive points out,
    • “An experimental menopause drug from Bayer succeeded in a late-stage trial in women taking drugs to treat or prevent breast cancer, the company said Thursday.
    • “Bayer said the drug, elinzanetant, significantly reduced the frequency of hot flashes and improved sleep for women with breast cancer, or who are at high risk of developing it, and whose symptoms are caused by hormone therapy. The study randomized 474 women to receive treatment or a placebo and measured the effects after four and 12 weeks.
    • “The announcement represents the fourth positive late-stage study result for elinzanetant, but the first that isn’t in menopausal women. Bayer has already submitted the drug for U.S. approval in postmenopausal women, and the Food and Drug Administration accepted its application in October. If cleared by regulators, the drug would compete with Astellas Pharma’s Veozah.”
  • Per Fierce Pharma,
    • “Trailing Johnson & Johnson’s powerhouse Darzalex by roughly five years in its development timeline has made it challenging for Sanofi’s Sarclisa—the only other CD38 antibody on the market for multiple myeloma—to compete in the indication.
    • “But with an on-body delivery system (OBDS) to deliver its subcutaneous (SC) formulation of Sarclisa, Sanofi may be finding the edge it needs.
    • “The company has taken a major step in the development of its OBDS as a phase 3 trial has met its primary co-endpoints, showing non-inferiority to intravenous (IV) Sarclisa. The company reported the trial result in a press release Thursday.”

From the U.S. healthcare business front,

  • Health Dive relates,
    • “Blue Shield of California, one of the largest plans in the state, has revamped its corporate structure and named its first-ever female CEO.
    • “Blue Shield created a parent company called Ascendiun to oversee the insurer, along with its managed Medicaid subsidiary and clinical services firm Altais, starting Jan. 1, the company announced Wednesday. Ascendiun also includes a newly created health services business called Stellarus, which aims to scale and sell Blue Shield’s pharmacy and technology offerings to other insurers.
    • “Lois Quam, who has been Blue Shield’s president since last year, will step up as chief executive of the insurer. Quam will be the first woman to serve as Blue Shield’s CEO in the organization’s 86 years of operation. Paul Markovich, Blue Shield’s CEO for over a decade, will become president of Ascendiun and will also lead Stellarus on an interim basis.”
  • and
    • “Amwell is selling its virtual psychiatric care business to fellow telehealth provider Avel eCare for about $21 million in cash, the company said Thursday. 
    • “The divestiture, which includes an additional earn-out payment for Amwell if the business meets financial targets, includes the psychiatric care segment’s technology and personnel along with Asana, a clinical network that employs and contracts with the unit’s clinicians. 
    • “Amwell CEO Ido Schoenberg said in a statement the sale strengthens the telehealth firm’s balance sheet and “fortifies our confidence” to reach positive cash flow in 2026.”
  • The American Hospital Association announced,
    • “The AHA today released its 2025-2027 Strategic Plan, approved by the AHA Board of Trustees in November. The plan is rooted in four core disciplines — advocacy and representation, thought leadership, knowledge exchange, and agents of change. It also includes nine principles that serve as the foundation of the AHA’s work and strategies to help the field make progress on its mission of advancing health in America. View the 2025-2027 Strategic Plan for more information.”
  • Modern Healthcare notes,
    • Oakland, California-based Kaiser Permanente led a $275 million Series F funding round for Innovaccer, a company that sells technology to unify patient data across health systems.
    • Innovaccer said the round will help it introduce new artificial intelligence and cloud capabilities. The company also said the new capital will help it to continue scaling a developer ecosystem that can allow health systems to implement AI tools with other third-party vendors.
  • NCQA suggests “Health Care Trends to Watch in 2025.”
  • Per Fierce Healthcare,
    • “A new report from Press Ganey highlights the close relationship between patient experience and health plan star ratings.
    • “Researchers polled 450,000 people across 200 plans and combined those survey results with its database of 5.5 million patient encounters. It found that people who gave poor scores for safety and privacy in surveys following a visit to their primary care providers also frequently awarded their health plan one star on quality and access to needed care on Medicare consumer services.
    • “The report noted these are critical data for plans to consider, as they have traditionally focused on making improvements to customer service, benefit design and patient engagement. It suggests they should also be considering ways to address safety.
    • “In addition, the survey found that patients expect easy access to primary care, but their ability to reach specialists is a key differentiator. Plans that earned four or more stars connected a higher proportion of their members with specialty care.”
  • MedTech Dive points out “five medtech trends to watch in 2025. After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.”

Tuesday Report

David Ermer–CDC, Congress, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building
  • In a press release, OPM patted itself on the back for successfully launching the Postal Service Health Benefits Program.
  • Govexec adds,
    • “The Office of Personnel Management on Tuesday issued guidance to agencies reminding them of how to handle the pay and benefits of political appointees who are set to resign ahead of President-elect Trump’s inauguration on Jan. 20.
    • “In a memo to agency human resources directors, OPM associate director for workforce policy and innovation Veronica Hinton wrote that agencies should compensate appointees who are planning on resigning at noon on Inauguration Day—when Trump is slated to be sworn into office—for the hours they are scheduled to work before that time.” * * *
    • “Hinton’s memo also addresses the fact that Inauguration Day, which Washington, D.C., area federal workers receive as a holiday due to the congestion resulting from the proceedings, happens to fall on another federal holiday: Martin Luther King, Jr. Day.
    • “In short, there are no so-called “in-lieu-of” holidays entitling employees who typically work Mondays to an extra day off in light of the two holidays’ confluence. But if a D.C.-area employee’s normal work schedule does not include Mondays, they would receive one “in-lieu-of” holiday.”
  • Speaking of political appointees leaving on Inauguration Day, an HHS press release lets us know “United States Surgeon General Dr. Vivek Murthy released his Parting Prescription for America – PDF, weaving together reflections on his personal and professional experiences having spent six of the last ten years as our nation’s Surgeon General.”
  • Fierce Healthcare tells us,
    • “The Federal Consumer Financial Protection Bureau on Tuesday issued new regulations barring medical debts from American credit reports, enacting a major new consumer protection just days before President Joe Biden is set to leave office.
    • “The rules ban credit agencies from including medical debts on consumers’ credit reports and prohibit lenders from considering medical information in assessing borrowers.
    • “These rules, which the federal watchdog agency proposed in June, could be reversed after President-elect Donald Trump takes office Jan. 20. But by finalizing the regulations now, the CFPB effectively dared the incoming Trump administration and its Republican allies in Congress to undue rules that are broadly popular and could help millions of people who are burdened by medical debt.”
    • FEHBlog note — The rule does not take effect until early March. The FEHBlog hopes that the incoming Administration will cancel this rule making which is bound to disrupt the U.S. credit market.
  • Per a Senate press release,
    • Today, Senators Sheldon Whitehouse (D-RI) and Chuck Grassley (R-Iowa), in their respective capacities as Chairman and Ranking Member of the Senate Budget Committee during the 118th Congress, released a bipartisan staff report on the findings of their investigation into the ways in which private equity investment in health care has negative consequences for patients and providers. 
    • The Committee focused on two private equity firms—including the single-largest private equity investor in health care—that currently or previously invested in two prominent hospital operators.  Throughout the course of its investigation, the Committee reviewed more than one million pages of documents from Leonard Green & Partners, Prospect Medical Holdings, Medical Properties Trust, Apollo Global Management (Apollo), Lifepoint Health, and Ottumwa Regional Health Center, a for-profit Iowa hospital, that revealed new information about the business dealings of private equity-owned hospital operators.  Documents obtained by the Committee detailed how private equity’s ownership of hospitals earned investors millions, while patients suffered and hospitals experienced health and safety violations, understaffing, reduced quality of patient care, and closures. 
    • “Private equity has infected our health care system, putting patients, communities, and providers at risk,” said Chairman Whitehouse. “As our investigation revealed, these financial entities are putting their own profits over patients, leading to health and safety violations, chronic understaffing, and hospital closures.  Take private equity firm Leonard Green and hospital operator Prospect Medical Holdings: documents we obtained show they spent board meetings discussing profit maximization tactics—cost cutting, increasing patient volume, and managing labor expenses—with little to no discussion of patient outcomes or quality of care at their hospitals.  And while Prospect Medical Holdings paid out $645 million in dividends and preferred stock redemption to its investors—$424 million of which went to Leonard Green shareholders—it took out hundreds of millions in loans that it eventually defaulted on.  Private equity investors have pocketed millions while driving hospitals into the ground and then selling them off, leaving towns and communities to pick up the pieces.”
    • “The Ottumwa community has personally felt the impact of private equity on its health care system.  Under private equity ownership, wait times at Ottumwa Regional Health Center have gone up as patient experience has gone down. The diminishing quality of care, service availability and care capacity at the hospital is forcing Ottumwa residents to travel significant distances in order to receive appropriate treatment. Iowans deserve better,” Grassley said. “A dependable health care system is essential to the vitality of a community.  As always, sunshine is the best disinfectant.  This report is a step toward ensuring accountability, so that hospitals’ financial structures can best serve patients’ medical needs.”  
    • Read the full report here, and view the documents released by the Committee here and here.

From the public health and medical research front,

  • Here is a link to the Centers for Disease and Control and Prevention’s respiratory virus updates.
  • STAT News reports
    • “At Tufts University in Medford, Mass., researchers loaded a tiny 3D model of the human brain into a plastic shell resting atop a spring-loaded platform. Inside this polymer skull, the donut-shaped ball of living brain tissue floated in a warm, salty bath, its neurons whispering to each other in the darkness. Then a piston struck the platform, whipping it back and forth, and sending the mini-brain sloshing.
    • “Days later, as the team assessed the damage, the results were stark. Some of the human brain-like tissue had been housing a latent infection with a herpes virus, the type that causes cold sores. And the impact of the piston — intended to mimic a concussion — had woken that virus up. In those tissues, the researchers found lots of inflammation, newly formed plaques of sticky amyloid proteins, and all around them dying neurons — the signature marks of Alzheimer’s disease. Meanwhile, infection-free brain tissues recovered from the concussion with just a bit of lingering inflammation. 
    • “Decades of epidemiological data have shown that infections with herpes simplex virus type 1, or HSV-1 can raise the risk of Alzheimer’s disease in certain people. So can a history of head injury. The new research, published Tuesday in Science Signaling, is the first to connect the dots between them, and adds to mounting evidence that this most common form of dementia can be caused by an everyday microbe.”
  • Per Fierce Pharma,
    • “It’s now official: Johnson & Johnson’s combination of Rybrevant and Lazcluze has racked up an overall survival (OS) victory against AstraZeneca’s standard-of-care Tagrisso as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC).
    • “In reporting positive top-line results from the phase 3 MARIPOSA study in 1,074 patients with NSCLC with EGFR exon 19 deletions or L858R substitution mutations, J&J’s combo is expected to keep patients alive for at least a year longer than Tagrisso.
    • “The results, details of which are yet to be revealed, show a statistically significant and clinically meaningful improvement in OS, according to J&J.” 
  • BioPharma Dive points out,
    • “A landmark study hoping to find new treatments for ALS has notched two more failures, as experimental medicines from Denali Therapeutics and Calico Life Sciences proved no better than a placebo at slowing the nerve-destroying disease or keeping patients alive longer.
    • “Denali disclosed high-level results from the study Monday. After about six months, treatment with the company’s drug didn’t result in any significant changes in the severity of the disease, nor did it substantially help patients’ muscle strength or respiratory function.
    • “Denali plans to further examine the data and look at biological markers of the disease, including one, “neurofilament light chain,” that’s become increasingly important to researchers focused on amyotrophic lateral sclerosis. The company expects to conduct those analyses later this year.”
  • and
    • “Privately-held biotechnology startup Metsera said Tuesday a long-acting GLP-1 shot it’s developing helped people who are overweight or have obesity lose more weight than placebo recipients in a Phase 2 trial. 
    • “Study participants who received the shot, dubbed MET-097i, lost on average 11% more of their body weight than those who got a placebo over the course of 12 weeks. Placebo-adjusted weight loss also reached around 20% in those who received the highest dose, comparable to what was observed in tests of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy over a similar period.
    • “Metsera also said data from the trial support plans to test MET-097i as a monthly injection, less frequent than the weekly shots Zepbound and Wegovy require. The announcement is the latest step forward for a company that has raised more than half a billion dollars since launching last April to support a bid to challenge Lilly and Novo’s medicines.” 
  • Cardiovascular Business adds,
    • “Semaglutide is associated with significant cardiovascular benefits for overweight and obese patients who have previously undergone coronary artery bypass graft (CABG) surgery, according to new data published in the Journal of the American College of Cardiology.
    • “Semaglutide is a popular GLP-1 receptor agonist being sold by Novo Nordisk under the brand names Wegovy and Ozempic. GLP-1 receptor agonists were originally developed to treat diabetes, but they are being used more and more to help obese and overweight patients lose weight. 
    • “For this latest analysis, researchers tracked data from the SELECT trial, originally designed to examine semaglutide’s impact among overweight/obese patients without diabetes, and focused exclusively on more than 2,000 patients with a prior history of CABG. The patients had a mean age of 65 years old, 84.2% were men and the mean BMI was 31.9 kg/m2. A history of hypertension was seen in 85.6% of patients. The rates of pre-existing atrial fibrillation and heart failure were 12.5% and 33.4%, respectively. 
    • ‘The study’s results confirmed that CABG patients still face an elevated risk of ischemic cardiovascular events following treatment. And once again, researchers wrote, semaglutide has been linked to “significant and consistent reductions” in the risk of such events.” 
  • The Wall Street Journal reports,
    • “A new study is helping to answer a pressing nutrition question: Which ultra-processed foods are harming our health—and which might not be so bad? 
    • “The problem is the way many packaged foods are made, researchers believe. Products such as many frozen pizzas, cereals and chips pack more calories per gram than less-processed foods do. And most ultra-processed foods have combinations of salt, fat, sugar and carbohydrates that aren’t generally found in nature, which can make us crave them. Diets high in packaged foods without those traits—such as canned peaches or refried beans—don’t seem to lead people to overeat and gain weight, at least not as much.
    • “Those are the findings so far of a continuing study investigating how ultra-processed food affects our bodies. Scientists presented their interim data at a workshop put on by the National Institutes of Health and the U.S. Food and Drug Administration in December. 
    • “There might be a way to create the quote, unquote healthy ultra-processed food that’s still convenient,” said Kevin D. Hall, the principal investigator of the study and a scientist at the NIH, giving an example of a frozen meal with brown rice, beans and a lot of vegetables.” 

From the U.S. healthcare business front,

  • STAT News reports,
    • “The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide, according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.
    • “The Food and Drug Administration approved generics for the diabetes drugs exenatide and liraglutide in November and December. While those drugs don’t work as well as semaglutide, their much lower costs could give Medicare leverage to push for lower prices for semaglutide, two experts said.
    • “It’s hard to make an argument that liraglutide is not clinically comparable to the other GLP-1,” said Institute for Clinical and Economic Review President Sarah Emond.
    • “Both the nonpartisan Congressional Budget Office and academic experts expect semaglutide, sold by Novo Nordisk under the brand names Ozempic and Wegovy, to be among the next 15 drugs up for price negotiation. Medicare will announce that list by Feb. 1, and the negotiated prices will take effect in 2027.” 
  • Fierce Pharma notes,
    • “With COVID vaccine sales in the doldrums and a respiratory syncytial virus (RSV) vaccine market in “contraction”, Moderna CEO Stéphane Bancel had the unenviable task of trying to put a positive spin on a sharp stock decline in his annual shareholder letter.
    • “After an unexpectedly limited RSV vaccination recommendation from the CDC resulted in a “contraction” in the U.S. market, Moderna will adjust its financial reporting traditions to exclude products in their launch year, Bancel said Monday in his annual letter to shareholders.
    • “The company was “too optimistic about our ability to break into the market given the headwinds from a midyear approval and launch,” the Moderna CEO wrote about the RSV launch. “We are taking those learnings to heart and going forward, we will not include revenue from products in their launch year in our financial framework,“ he added.”
  • Per MedTech Dive,
    • “Stryker has agreed to acquire Inari Medical for approximately $4.9 billion, the company announced late Monday. The transaction is expected to close in the first quarter.
    • “Under the deal, Stryker would acquire all of Inari’s shares for $80 per share in cash, a premium of more than $30 over Friday’s closing price. Inari’s stock price closed at $65 Monday after surging by more than 30% in day trading.
    • “Inari would continue a busy year of dealmaking for Stryker in 2024, which included acquisitions of the artificial intelligence company Care.ai, the back pain device maker Vertos Medical and Nico Corporation, which makes devices to remove brain tumors and clots. Stryker did not disclose financial terms for the three deals.”
  • The Drug Channels Blog headlines “Inflation-Adjusted U.S. Brand-Name Drug Prices Fell for the Seventh Consecutive Year as a New Era of Drug Pricing Dawns.” Check it out.
  • Health Day relates,
    • “Patients have more access to their own medical test results than ever before, thanks to legislation requiring results be released as soon as they’re available.
    • “But that’s not necessarily a good thing, a new study warns.
    • “Many patients are reading test results in their electronic medical record before their doctor has had a chance to go over them, researchers say in a study published Jan. 2 in the Journal of the American Medical Association.
    • “This is provoking a lot of confusion and anxiety, mainly because medical reports contain a lot of jargon the average patient doesn’t understand, researchers said.
    • “For example, “a standard pathology report is written by a pathologist for a clinical specialist like a surgeon or a cancer doctor or for other pathologists to read,” lead researcher Dr. Cathryn Lapedis, a pathologist at University of Michigan Health, said in a news release from the college.
    • “To address this, Lapedis and her colleagues tested whether patients might benefit from pathology reports written in a way they would better understand.”

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.” 

Happy New Year!

David Ermer–CDC, FDA, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Natalie Kinnear on Unsplash

Happy New Year, FEHBlog readers, and greetings to the Postal Service Health Benefits Program which launched today.

The New York Times offers “10 Ways to Keep Your Mind Healthy in 2025” and “12 Ways to Get Fitter in 2025.”

The Wall Street Journal advises “Want to Lose Weight This Year? Start With What You Drink. Sugary drinks are sneakier than equally high-calorie foods—and even diet soda can affect your metabolism.” Stick with water.

From the public health and medical research front,

  • Per an NIH news release,
    • “Since 1996, HPAI H5N1 influenza viruses have circulated in at least 23 countries. In late 2021, HPAI H5N1 spread from Europe to North America causing sporadic infections among wild birds and poultry farms. In 2022, the virus spread to South America where it devastated birds and marine mammals. In March 2024, USDA scientists identified HPAI H5N1 in U.S. dairy cows, and it subsequently reached herds in 16 states. The virus has been detected in dairy herds in three states over the past 30 days, according to USDA/APHIS. In 2024, the virus has caused 66 confirmed and 7 probable cases of influenza in people in the U.S. and one case in Canada. These human cases have been caused by either the H5N1 type circulating in birds (D1.1) or the type circulating in dairy cows (B3.13).
    • “Against this backdrop, Drs. Marrazzo and Ison say there are four keys to controlling the current outbreak. The first imperative is timely, effective collaborations among investigators in human and veterinary medicine, public health, health care, and occupational workers, such as dairy and poultry workers.
    • “This involves cultivating trust not only between numerous entities, but with people seeking care for symptoms of concern, including conjunctivitis, the authors write. Fortunately, so far most U.S. cases of HPAI H5N1 have been mild and resolved on their own without the need for treatment.
    • “Their second key is a focus on the Canadian HPAI H5N1 patient, who developed respiratory failure and required life-saving medical intervention and treatment before recovering. The authors write that mutations found in the virus in this patient highlight an urgent need for vigilant disease surveillance to identify and assess viral changes to evaluate the risk for person-to-person transmission. Effective surveillance, they say, requires that complete genomic sequencing data from animals and people are made rapidly and readily available.
    • Without information pertaining to where and when isolates were collected, the data cannot be linked phylogenetically to other reported sequences, limiting insight into how the virus is spreading, they write. These data would also provide opportunity for early detection of mutations that might portend avidity for human respiratory epithelium, which may require as little as one mutation in the virus.
    • “Third, researchers must continue to develop and test medical countermeasures—such as vaccines and therapies that eliminate or alleviate disease—against H5N1 and other influenza viruses. Fortunately, current vaccine candidates neutralize the circulating strains, which so far are susceptible to antivirals that could mitigate transmission and severity of illness, they write.
    • “Lastly, Drs. Marrazzo and Ison encourage people to take precautions to prevent exposure to the virus and minimize the risk of infection. For example, people who work with poultry and cows should use personal protective equipment and educate themselves about occupational risks when working with birds and mammals, as CDC and USDA have repeatedly recommended.
    • “Ideally, following these four steps will help scientists and public health officials investigating HPAI H5N1 to answer the many remaining questions more quickly about how the virus is spreading, evolving, and affecting people, other mammals, and birds.”
  • MedPage Today adds,
    • “A 13-year-old Canadian girl recovered after being hospitalized in critical condition with H5N1 avian influenza, researchers reported.
    • “The girl was hospitalized on Nov. 7 and transferred to BC Children’s Hospital the next day, where she was intubated and put on extracorporeal membrane oxygenation (ECMO) and treated with three different antivirals, David Goldfarb, MD, of BC Children’s Hospital in Vancouver, and colleagues reported in the New England Journal of Medicine (NEJM).”
  • Precision Vaccinations lets us know,
    • “A recent study found that 73% of adult Portuguese patients with urinary tract infections (UTIs) reported a reduction in symptom severity or duration of illness after treatment with Uromune™ (MV140). This inactivated oral spray serves as a novel sublingual mucosal-based bacterial vaccine.
    • “This prospective observational study, which involved 125 patients with complicated and uncomplicated recurrent UTIs, was published in the journal MDPI Vaccines (12(12), 1426) on December 18, 2024. In addition to the primary outcome of symptom reduction, the study assessed overall patient satisfaction, adverse events, and the effectiveness of Uromune in subgroups with specific UTI risk factors.
    • “During the 12 months following the start of treatment, 38% of patients were free of UTIs. Meanwhile, 34% reported experiencing one or two episodes, while the remaining 28% had three or more recurrent UTIs.”
  • Beckers Hospital Review informs us,
    • “The FDA approved a subcutaneous injection version of Bristol Myers Squibb nivolumab and hyaluronidase-nvhy for the treatment of several cancers including melanoma, non-small cell lung cancer and renal cell carcinoma. 
    • “The approval covers both monotherapy and combination therapy options, including use of chemotherapy and combination therapy options including use with chemotherapy or cabozantinib, according to a Dec. 27 news release from the agency. “
  • Here’s a link to the December NIH Office of Reseach on Women’s Health Pulse newsletter.
  • Per Medscape,
    • “Researchers are gaining new insight into the relationship between the human cytomegalovirus (HCMV), a common herpes virus found in the gut, and the immune response associated with CD83 antibody in some individuals with Alzheimer’s disease (AD).
    • ‘Using tissue samples from deceased donors with AD, the study showed CD83-positive (CD83+) microglia in the superior frontal gyrus (SFG) are significantly associated with elevated immunoglobulin gamma 4 (IgG4) and HCMV in the transverse colon (TC), increased anti-HCMV IgG4 in the cerebrospinal fluid (CSF), and both HCMV and IgG4 in the SFG and vagus nerve.
    • “Our results indicate a complex, cross-tissue interaction between HCMV and the host adaptive immune response associated with CD83+ microglia in persons with AD,” the investigators including Benjamin P. Readhead, MBBS, research associate professor, ASU-Banner Neurodegenerative Disease Research Center, Arizona State University, Tempe, Arizona, noted.
    • “The results suggest antiviral therapy in patients with biomarker evidence of HCMV, IgG4, or CD83+ microglia might ward off dementia.
    • “We’re preparing to conduct a clinical trial to evaluate whether careful use of existing antivirals might be clinically helpful in preventing or slowing progression of CD83+ associated Alzheimer’s disease,” Readhead told Medscape Medical News.”

From the U.S. healthcare business front,

  • STAT News asked “Four digital health unicorns on what they expect in 2025.” For example,
    • “Sean Duffy, the CEO of Omada Health, jokes that 2024 was “the year of Gs” when GLP-1s and GPT were all anybody talked about. While the description could have just as easily applied to 2023, Omada’s most important move this year was all about GLP-1s: a deal with Cigna subsidiary Evernorth to offer its digital behavior change program as a key piece of EncircleRx, which helps employers manage the growing boom in interest for the weight loss drugs. In October, Cigna reported that it had 8 million covered lives in the program. 
    • “Looking ahead to 2025, Duffy said that by the end of the year, Omada hopes to have data that show the company’s lifestyle programs have a meaningful impact on the success of GLP-1s.
    • “Glen Tullman, the CEO of Transcarent, is elated that next year Apple, a company that’s legendarily fastidious about design, will be one of the first users of Transcarent’s new WayFinding tech. The AI chat interface answers questions about care and benefits and represents a sophisticated real-world example of patient-facing generative AI. 
    • “Transcarent already has plans to launch the tool to 1 million people, and Tullman said that ambitiously, he’d like to roll it out to 5 million members by the end of 2025. Tullman thinks of Transcarent as a more sophisticated health care benefit for self-insured employers. Over the last few years, he said the company has poured over $100 million into developing AI for its app that serves as the focal point for the company’s services including virtual care, pharmacy benefits, as well as specialized services for mental health, cancer, surgery and more.” 
    • “Maven Clinic has grown to be a vanguard in the women’s health space by taking a broad approach to fertility benefits, which includes access to additional family planning resources, menopause care, and support for men.
    • “CEO and founder Kate Ryder says in 2024, she’s proud the company launched a comprehensive fertility benefit offering that integrates care coordination, coaching, virtual care, and financial support. One stat the company often cites is that 30% of members in its fertility program conceive without IVF — which Ryder points out can save tens of thousands of dollars per family. * * *
    • “Looking ahead, Ryder said she believes the company can lean on artificial intelligence to create a more personalized experience for members.  “We know what great personalization looks like in other areas of consumer tech, but we haven’t seen that in health care yet,” she said.”
  • The Healthcare Management Financial Association tells us,
    • “Accelerating hospital-focused expenditures helped spur a 2023 increase in national health spending, according to newly released actuarial data.
    • ‘Spending on hospital services surged by 10.4% for the year, up from a 3.2% increase in 2022 and 3.4% for the three-year period spanning 2020-22. The 2023 increase was the biggest seen since a 10.8% jump in 1990.
    • “Partially as a result, total healthcare spending (including clinical research and public health activities) jumped by 7.5% to reach $4.9 trillion, or 17.6% of GDP. In 2022, spending had risen by 4.6% and amounted to 17.4% of GDP. The 2023 share of GDP still was lower than in the peak pandemic years of 2020-21 and roughly the same as it was in 2019.
    • “The spending increase dropped from 7.5% to 4.4% when accounting for healthcare price inflation, up from 1.4% using that adjustment in 2022. Spending per capita reached $14,570.”
  • Modern Healthcare reports,
    • “Elevance Health completed its acquisition of Indiana University Health Plans, according to a Tuesday news release from the insurance company’s subsidiary Anthem Blue Cross and Blue Shield.
    • “IU Health Plans — which will operate under Anthem Blue Cross and Blue Shield in Indiana — offers Medicare Advantage plans in 36 Indiana counties, with 19,000 members. It also offers fully insured commercial plans to employers, covering approximately 9,600 members.”
  • Per MedPage Today, “IV fluid shortage [created by Hurricane Helene is] likely to extend Into early 2025. Major supplier damaged by Hurricane Helene continues to bring production lines back online.”
  • Beckers Hospital Review reports,
    • “Several major pharmaceutical companies, including Pfizer, Bristol Myers Squibb and Sanofi, are set to raise prices on more than 250 branded medications in the U.S. starting Jan. 1, 2025, according to a Reuter’s exclusive report. 
    • “Data analyzed by healthcare research firm 3 Axis Advisors showed the price increases will affect a range of drugs, including Pfizer’s COVID-19 treatment Paxlovid, Bristol Myer Squibb’s cancer therapies and vaccines from Sanofi. 
    • “Most of the price hikes are below 10%, with the median increase across affected drugs at 4.5%. This aligns with the median price increase for 2024, as drugmakers have scaled back large price hikes over the years following public scrutiny. 
    • “The price adjustments apply to list prices, which do not include rebates or discounts negotiated with pharmacy benefit managers.”

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.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • This evening, the House of Representatives turned down the President-elect approved, 121-page long version of the Continuing Resolution this evening. The Wall Street Journal adds that “Talk circulated among lawmakers about a possible weeklong funding extension, which would push the shutdown deadline past Christmas. But that too would need bipartisan support to get through the Senate.” The current CR funding the federal government expires at 12:01 AM on December 21.
  • Govexec informs us,
    • “The House passed a compendium of veterans care proposals, packaged into a single bill, on Monday, sending it to the president’s desk in the waning days of the congressional session. 
    • “The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (S.141) — which provides the Veterans Affairs Department with everything from community care improvements to expanded home care and educational assistance benefits — cleared the chamber in a 382-12 vote Monday night after previously passing the Senate by unanimous consent on Dec. 12.
    • “The legislation serves as an omnibus package of previous House and Senate bills designed to improve VA community care offerings, quality care standards and other programs, while offering benefit increases for veterans and some providers. 
    • “We worked hard to craft this legislation to put veterans – not government bureaucracy – at the core of it,” said House Veterans Affairs Committee Chairman Mike Bost, R-Ill., in a statement. “The Dole Act will do that by expanding economic opportunities, simplifying the disability claims process, reforming services for aging veterans, opening more doors for mental health support and a lot more.”
  • Federal News Network lets us know,
    • “Federal agencies will be closed on Tuesday, Dec. 24, President Joe Biden announced, giving federal employees an extra day off the day before Christmas.
    • “The president made the announcement via an executive order that he signed Thursday.
    • “All executive departments and agencies of the Federal Government shall be closed and their employees excused from duty on Tuesday, December 24, 2024, the day before Christmas Day,” the executive order states.”
  • Modern Healthcare reports,
    • “A mandatory hospital payment model finalized this year by the Centers for Medicare and Medicaid Services could make earnings uncertain for providers, researchers said.
    • “Under the Transforming Episode Accountability Model, or TEAM, hospitals could lose out on an average of $500 per episode of care covered in the model, according to a December report from the Institute for Accountable Care. But the forecast results vary widely: Hospitals in the Minneapolis-St. Paul region could gain an average of $900 per episode of included care, the report said, while Denver providers stand to lose $1,300 per episode, on average. 
    • Beginning in 2026, TEAM sets 30-day episode-based payments for lower-extremity joint replacements, femur fracture surgeries, spinal fusions, coronary artery bypass grafts and major bowel procedures. CMS will set bundled payments for these services based on regional benchmarks. In other words, hospitals will need to reduce spending for select care to a threshold set by their neighbors, or risk having to make up the difference.  
    • “It creates a really strong incentive” to manage costs, said Rob Mechanic, executive director of the Institute for Accountable Care, an independent nonprofit initially funded by the National Association of ACOs. On the flip side, he said, the regional benchmarks mean hospitals can significantly reduce their costs but still lose money.
    • The government selected 741 hospitals to participate in the five-year model, which gives safety-net hospitals extra time to prepare before taking on downside risk. Since the model is mandatory, hospitals can’t opt out. Ambulatory surgical centers are not included. According to the IAC report, the covered services represent about 15% of Medicare revenue, on average, for participating hospitals.

From the judicial front,

  • The Wall Street Journal reports,
    • “Federal prosecutors charged ex-Ivy Leaguer Luigi Mangione with murder and stalking Thursday for the Dec. 4 shooting of UnitedHealth executive Brian Thompson, alleging he was arrested with a notebook stating an intent to “wack” the CEO of an insurance company.” * * *
    • “The latest charges, brought by the Manhattan U.S. attorney’s office, mean federal prosecutors could pursue a death-penalty case against him.” * * *
    • The new federal charges capped a whirlwind day that began in Pennsylvania, where Mangione agreed at a hearing to waive his right to contest his transfer to New York. He had been detained in Pennsylvania since his arrest last week.”

In Food and Drug Administration News,

  • Healthcare Dive relates,
    • “The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity, are no longer in shortage,
    • “The agency’s decision will largely prevent so-called compounding pharmacies from making off-brand copies of the drug, closing a lucrative market niche that had opened as Eli Lilly, the drug’s maker, found itself unable to meet skyrocketing demand.
    • “However, the FDA won’t take enforcement action against compounding pharmacies until early next year, a grace period the agency said is to “avoid unnecessary disruption to patient treatment.”
  • Per STAT News,
    • “Ionis Pharmaceuticals on Thursday won Food and Drug Administration approval for a therapy that treats patients with a rare and deadly genetic disease that impedes the body’s ability to break down fats, setting the stage for the company to kick off the first solo drug launch in its 35-year history.
    • “The treatment, Tryngolza, also known by its scientific name of olezarsen, was approved for patients with familial chylomicronemia syndrome, or FCS, on the basis of late-stage trial results showing the therapy lowered triglyceride levels and was generally safe. Patients on the drug were less likely to develop an inflamed pancreas, an excruciating and sometimes life-threatening complication.
    • “Ionis executives believe the drug could also help patients with more common forms of sky-high triglycerides and have ongoing trials aiming to show that. If the drug is approved for more common conditions, market analysts have forecasted that Tryngolza could bring in $1.8 to $2 billion in peak sales.”
  • and
    • “Spinal cord injuries dramatically reduce a person’s mobility and independence, but a new device could aid rehabilitation efforts.
    • “Onward Medical received Food and Drug Administration clearance on Thursday for its non-invasive spinal cord stimulator, the ARC-EX. In a recent trial, the stimulator boosted hand sensation and strength in 72% of participants. While the treatment cannot replace rehabilitative therapy, device users rave about its effects.
    • “They tell patients the golden window of recovery is that first year or two,” said Sherown Campbell, one of the trial participants who signed up after he broke his neck wrestling in 2014. “I’ve made significant progress since then. I didn’t think that I would be able to move as much as I do, or I guess, as close to normal as I am.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related chronic diseases in the U.S. that requires immediate action. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities, which are part of a whole-of-government approach to address this crisis. This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.
    • “The “healthy” claim has been updated to help consumers find foods that are the foundation of a healthy dietary pattern and could also result in the development of healthier foods. Manufacturers can voluntarily use the “healthy” claim on a food package if a product meets the updated definition.”
  • The Wall Street Journal adds,
    • “Under the updated claim, eggs, nuts and seeds, olive oil and higher-fat fish such as salmon will now qualify to use the “healthy” claim. Examples of products that qualified as healthy under the original claim but not the updated one include fortified white bread, highly sweetened yogurt, and highly sweetened cereals.
    • The agency said it would work with interested parties to support use of the updated claim, adding it had entered a partnership with grocery-delivery company Instacart to help shoppers find products.
    • Both the original and updated claims have limits on saturated fat and sodium. The updated claim has a limit on added sugars, while ending the limit on total fat.

From the public health and medical research front,

  • The American Hospital News lets us know,
    • “Life expectancy in the U.S. grew an average of 10.8 months in 2023, to 75.8 years for men and 81.1 years for women, according to a report by the Centers for Disease Control and Prevention. The overall death rate declined by 6%.  
    • “The 10 leading causes of death were unchanged from 2022, with heart disease, cancer and unintentional injuries remaining the top three. COVID-19 dropped from fourth to 10th, which moved stroke up to fourth, followed by chronic lower respiratory diseases, Alzheimer’s disease, diabetes, kidney disease, and chronic liver disease and cirrhosis.”
  • Per Healio,
    • “As many as 15 million adults in the United States have a 10% or greater risk for heart failure, results of a research letter published in Annals of Internal Medicine showed.
    • “The majority of those at higher risk for heart failure (HF) had uncontrolled modifiable risk factors for the condition, including obesity and hypertension, according to the researchers.
    • “Identifying populations at such a risk, along with implementing prevention strategies, “has the potential for dramatic public health impact,” the researchers wrote.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Clinical trials are essential for advancing new treatments that improve patient care and lives. But far too many clinical trials face challenges in identifying and enrolling eligible trial participants. Now, an NIH-led team has introduced an artificial intelligence (AI) tool that promises to speed up the process of matching patients to clinical trials to help boost enrollment. They call it TrialGPT.
    • “As reported in Nature Communications, TrialGPT takes advantage of large language models, a type of AI that can generate human-like responses to questions and explanations familiar to users of ChatGPT. The research team adapted it for matching patients to thousands of possible clinical trials in a data-efficient and transparent way. While earlier studies have shown the potential for using this type of AI for answering clinical questions, designing clinical trials, and retrieving initial lists of potential trials, TrialGPT is the first end-to-end solution, generating a list of potential trials before more precisely matching and ranking them. The team’s preliminary testing of this tool suggests TrialGPT can achieve a high degree of accuracy while cutting the time required of clinicians for screening patients. * * *
    • “In a pilot user study conducted at NCI, the researchers compared patient-trial evaluations based on short summaries about six patients made by one medical expert with TrialGPT and another who made the same evaluation manually without TrialGPT. Both experts conducted evaluations with and without AI to account for any differences in their speed or skill. The study found that clinicians using TrialGPT could generate similarly accurate lists of trial options in 40% less time.
    • “More study is needed to assess TrialGPT’s practical application in real-world settings across diverse groups of patients. But these findings already show the remarkable potential of AI technology for connecting patients to relevant trial opportunities, with tremendous potential for speeding trial recruitment and treatment advances while giving clinicians more time for other tasks only humans can do, including caring for their patients.”
  • The National Heart, Lung and Blood Institute offers an update featuring the “latest research on hypertension, educational resources on blood donation, and more.”
  • The Wall Street Journal reports,
    • “Roche said a Parkinson’s disease experimental drug missed its primary goal in a mid-stage trial, the second setback this week for candidate treatments for the neurodegenerative condition.
    • “The update from the Swiss pharmaceutical giant came after Belgian peer said a similar drug candidate for Parkinson’s developed jointly with Novartis failed to meet key goals in a clinical trial.
    • “Roche said Thursday that its drug candidate, prasinezumab, didn’t delay progression of motor symptoms in the trial, which included early-stage Parkinson’s patients, to an extent considered statistically significant.
    • “However, the company said the drug did show potential clinical efficacy, as well as positive trends on several other goals of the trial and was well tolerated. Roche will continue to evaluate the data and work together with health authorities to decide on next steps, it said.”
  • Per BioPharma Dive,
    • “Merck & Co. has long been dominant in cancer immunotherapy, with its drug Keytruda earning 40 approvals en route to becoming the world’s best-selling medicine. But the New Jersey-based drugmaker has had difficulty finding a successor, and a Monday announcement is the latest evidence.
    • “In a statement, Merck said it will end development of two experimental cancer drugs that are currently in late-stage testing. One, called vibostolimab, is aimed at a target called TIGIT. The other, favezelimab, homes in a protein named LAG-3. Both were being evaluated in combinations with Keytruda and have been touted by Merck as a way to extend Keytruda’s market advantage beyond 2028, when its main U.S. patent will expire.”

From the U.S. healthcare business front,

  • The Wall Street Journal explores the question “Why Are Americans Paying So Much More for Healthcare Than They Used To?”
    • “National healthcare spending increased 7.5% year over year in 2023 to $4.867 trillion, or $14,570 per person, according to data released Wednesday by the Centers for Medicare and Medicaid Services. 
    • “Total spending on healthcare goods and services, everything from prescription drugs to back surgeries, accounted for 17.6% of gross domestic product, a measure of goods and services produced by the U.S. economy.
    • “The 7.5% rise represented a much faster pace of growth than the 4.6% increase in 2022. It came as pandemic federal funding for the healthcare sector expired and private health insurance enrollment increased. More people with insurance led to increased demand for medical procedures, and spending on hospital care grew at the fastest pace since 1990. Spending on drugs also rose, including for medications to treat diabetes and obesity.  
    • “A full 92.5% of Americans were covered by insurance last year, and 175.6 million, or just over half the population, got it through their employer, according to the government’s new annual data. 
    • “Over 65 million Americans are on Medicare, a government health-insurance program mainly for people ages 65 and older, and nearly 92 million are on Medicaid, a state-federal program for the low-income and disabled.”
  • STAT News relates,
    • “Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found.
    • “Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other medicines before insurers approve a prescription. The formularies are run by health plans, pharmacy benefit managers, and the U.S. Department of Veterans Affairs.
    • “But only 81% of the formularies scored well on a fourth criterion: cost-sharing, which is the portion of expenses paid by insured individuals. Although there is a caveat: This particular metric was based on a subset of just three drugs that were deemed to be fairly priced based on a cost-effectiveness assessment — the Mounjaro type 2 diabetes treatment, and the Wegovy and Qsymia obesity drugs.
    • “Meanwhile, transparency into coverage information for three gene therapies — Zynteglo for combating beta thalassemia, the Hemgenix hemophilia B treatment, and Roctavian for treating hemophilia A — remains less than optimal. Of the six formularies covering the therapies, 83% provided clinical criteria, cost-sharing information was only available in two or three, and none provided site of care information.”
  • Per Fierce Healthcare,
    • “Tech platform Uno Health is rolling out a self-service guide that shows users financial savings they could be eligible to obtain.
    • “The tool boasts of its ability to save the average user $4,500 a year after asking just a few questions. It is designed to improve accessibility and simplify the application process for everything ranging from federal and state health programs, heating bills, phone and internet services and the Supplemental Nutritional Assistance Program.
    • ‘These programs and benefits can be difficult for individuals to sift through, potentially leaving hundreds, or thousands, of dollars on the table if they do not enroll. Uno Health CEO Anna de Paula Hanika, formerly at Clover Health and Google, says the tool is an encapsulation of the company’s broader offerings.
    • “She said at least 50% of Medicare members are eligible for, but not enrolled in, other financial assistance programs. That figure increases to nearly 90% for Medicaid members. Unused benefits strain health programs and insurers.”