Midweek Report

Midweek Report

Photo by Manasvita S on Unsplash

From Washington, DC,

  • Per HHS press releases,
  • and
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today released updated National Behavioral Health Crisis Care Guidance (National Guidance), comprised of three documents: 2025 National Guidelines for a Behavioral Health Coordinated System of Crisis Care; Model Definitions for Behavioral Health Emergency, Crisis, and Crisis-Related Services; and a draft Mobile Crisis Team Services: An Implementation Toolkit, which is being released today for public comment. The updated National Guidance now reflects the national transition to the 988 Suicide & Crisis Lifeline in 2022 and other progress and emerging needs related to behavioral health crisis care and provides a framework for transforming behavioral health crisis care systems in communities throughout the United States, at a time when the U.S. continues to face record high rates of suicide and overdose.”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with South Broward Hospital District d/b/a Memorial Healthcare System (Memorial Healthcare System), a Florida health system, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The settlement resolves litigation resulting from an investigation about a complaint alleging a lack of timely access to an individual’s protected health information (PHI). The HIPAA Right of Access provisions require that individuals or their personal representatives receive timely access to their health information for a reasonable cost. OCR’s investigation determined that Memorial Healthcare System failed to provide timely access within 30 calendar days. Memorial Healthcare System has agreed to pay $60,000. The agreement marks OCR’s 52nd Right of Access enforcement action.”
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services and Drug Enforcement Administration published a series of rules Jan. 15 related to telemedicine prescribing of controlled substances, including a special registration proposed rule and a final rule on telemedicine prescribing of buprenorphine
    • “The proposed rule for special registration outlines three types of registration to waive in-person visit requirements prior to virtual prescribing of controlled substances and a state registration for every state in which a patient is treated by the special registrant. Providers would need to apply for the special registrations. The DEA also proposes that providers be required to review nationwide prescription drug monitoring programs after three years. Comments on the proposed rule are due March 15. 
    • “The DEA’s final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation. Practitioners can then prescribe additional medication via other telemedicine encounters (real-time, two-way audio-visual) or after an in-person encounter. The agency finalized a stipulation that providers will need to complete a review of the PDMP for the state where the patient is located. Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD.”
  • and
    • “The Centers for Medicare & Medicaid Services announced Jan. 15 that 53.4% of people with Traditional Medicare are in an accountable care relationship with a provider, a 4.3% increase from last year. The agency said it is the largest increase since it began tracking accountable care relationships. 
    • “For 2025, CMS approved 228 applications for the Medicare Shared Savings Program, bringing the total number of accountable care organizations participating in MSSP to 476. Approved applicants included 55 new ACOs and 173 renewing or reentering ACOs, the most in the program’s history.  
    • “CMS said there was also a 16% increase from last year in federally qualified health centers, rural health clinics and critical access hospitals participating in the MSSP. In addition, 103 ACOs are continuing participation in CMS’ ACO Realizing Equity, Access, and Community Health Model, and 78 kidney contracting entities and 15 CMS Kidney Care First Practices are continuing participation in the Kidney Care Choices Model.”  
  • The Census Bureau has partnered with the Department of Defense to track how veterans fare in labor market when they return to civilian life. Check out their report.

From the Food and Drug Administration front,

  • The Wall Street Journal reports
    • Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely active Crohn’s disease, an inflammatory bowel disease that causes chronic abdominal pain.
    • “The treatment, developed by the pharmaceutical company under the brand name Omvoh, is now approved to treat two types of inflammatory bowel disease in the U.S., the Indianapolis company said Wednesday. The drug was previously approved to treat ulcerative colitis in adults in October 2023.
    • “Omvoh’s approval as a treatment for Crohn’s disease was based on results from a study in which 53% of patients treated with the drug achieved clinical remission, and 46% of patients had visible healing of the intestinal lining, at one year.”
  • and
    • The Food and Drug Administration is banning the use of Red No. 3, an artificial dye linked to cancer in animals, from food and ingested drugs.
    • The move will impact thousands of food products on the market in the U.S., including Betty Crocker’s loaded mashed potatoes and MorningStar Farms plant-based bacon strips. It is even in products that aren’t red, such as Brach’s candy corn. 
    • Food manufacturers will have until early 2027 to reformulate products that use Red 3. Consumer advocates pushed the agency to revoke authorization for the additive after two studies linked it to cancer in male laboratory rats. 
  • Roll Call adds,
    • “The Food and Drug Administration unveiled a proposal on Wednesday to limit the amount of nicotine allowed in cigarettes and some other combustible tobacco products, a final step for the agency before the Trump administration takes over next week.
    • The FDA first announced it would pursue regulatory changes to maximum nicotine levels in combustible smoking products in 2022 in an effort to reduce the public health effects related to addiction and minimize youth uptake.
    • “The agency is seeking public comment on the rule, but the proposal’s fate is unclear given the coming change in administration.”
  • STAT News described the last two FDA steps along with Tuesday’s proposal putting nutrition labels on the front of food packages as springing into Making America Healthy Again.

From the judicial front,

  • Beckers Payer Issues lets us know that insurer lawsuits over Medicare Advantage Star ratings are piling up.
  • STAT News relates,
    • “After years of sparring, the Biden administration and Gilead Sciences have settled a contentious lawsuit over patents for a pair of HIV prevention pills in a case that raised questions about the extent to which government-funded research should lead to affordably priced medicines.
    • “At issue was a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The Centers for Disease Control and Prevention, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company had refused to reach a licensing agreement despite several attempts to strike a deal.
    • “Gilead, however, maintained it had invented the pills and that the concept of using Truvada to prevent HIV was well-known by the time the CDC tried to obtain its patents. The company also insisted it negotiated in good faith with the government. After a May 2023 trial, a jury sided with Gilead, finding it did not infringe on patents held by the CDC and, moreover, that those patents were invalid. The Biden administration, which sought $1 billion in royalties, subsequently appealed the decision.
    • “In a statement, the company said Wednesday that it will receive a license to “certain” current and future patents concerning HIV prevention that “will protect Gilead’s freedom to operate for years to come.” Any additional terms were not disclosed, although a Gilead spokeswoman wrote to say the settlement does not contain any payments from Gilead or the federal government.”

From the public health and medical research front,

  • The Hill reports,
    • “Respiratory illnesses are spreading throughout the U.S., causing multiple states to see a spike in hospital visits. The latest data shows another virus, known as HMPV, has also been spiking in some parts of the country. 
    • “The Centers for Disease Control and Prevention previously confirmed it was monitoring a spike in cases of HMPV, or human metapneumovirus, in China’s northern provinces. The agency noted the cases of the virus, which is not new, were not a “cause for concern in the U.S.” and that rates of infection nationwide are at typical “pre-pandemic” levels.
    • “HMPV is considered relatively common, with most infected before age 5, according to Dr. Eileen Schneider, an epidemiologist with the CDC. It often circulates during flu season and causes symptoms similar to the common cold, including coughing, wheezing, congestion and shortness of breath.” * * *
    • “Across Iowa, Kansas, Missouri and Nebraska, more than 5.8% of tests submitted for HMPV tested positive through the first week of the year, data shows. That’s more than double the positivity rate across the next-highest region — Alaska, Washington, Oregon and Idaho — which sits at around 2.7%.” * * *
    • “HMPV is typically diagnosed based on symptoms, the Cleveland Clinic explains, and not testing, unless you have serious symptoms.
    • “There are no vaccines or treatment therapies for HMPV, which makes preventing the spread of HMPV especially important. Health experts recommend washing your hands often and avoiding contact with those who are infected with HMPV if possible.”
  • Becker Hospital Review tells us,
    • “The latest data from the American Society of Health-System Pharmacists reports that the active number of drug shortages in the U.S. has decreased to 271, down from a high of 323 in the first quarter of 2024. However, despite this decline, ongoing challenges continue to burden healthcare providers.” 
  • and
    • “Eli Lilly expects its experimental weight loss pill, orforglipron, to receive approval as early as next year, CEO David Ricks told Bloomberg Jan. 13.
    • “The company is preparing to release key late-stage trial data on the drug by mid-2025. The weight loss pill aims to compete with popular injectable treatments like Eli Lilly’s own Zepbound and Novo Nordisk’s Wegovy, which currently dominate the space. 
    • “If approved, orforglipron would offer a pill alternative to the current injectables, making it easier for patients to use while also addressing manufacturing challenges. 
    • “In mid-stage trials, the drug helped patients lose up to 14.7% of body weight, compared to just 2.3% for those who took a placebo.”
  • The National Cancer Institute points out,
    • “For people with a history of smoking, a diagnosis of lung cancer can cause feelings of guilt and shame due to the stigma that’s often associated with the disease. This stigma can hinder open communication between patients and health care providers and hinder patients’ use of tobacco cessation counseling. Researchers at Memorial Sloan Kettering Cancer Center have developed a training program to help health care providers reduce lung cancer–related stigma. In this interview, the trial’s leaders, Smita Banerjee, Ph.D., a behavioral scientist, and Jamie Ostroff, Ph.D., a psychologist, discuss the impact of stigma on people with lung cancer and an NCI-supported clinical trial that’s evaluating the training program.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports “As deadly fires continue to rage in Los Angeles, healthcare companies far and wide are stepping up to serve those affected. At least 24 people have died from the fires, and dozens remain missing.” Bravo.  
  • STAT News notes,
    • “When Eli Lilly last year started offering lower-priced vials of its blockbuster obesity drug Zepbound, which were previously sold in injectable pens, it framed the move as a way to expand patient access. But some experts weren’t convinced, noting that Lilly was only offering the lowest doses in vials, and the new prices, $399 or $549 a month, are still prohibitive for many patients.
    • “CEO Dave Ricks said Lilly is now considering expanding the vial offering. “We’d like to lower the entry cost, and we’d like to have more doses available. That’s not something we’re announcing today, but we see that as an option,” he said Tuesday at a taping of ”The Readout LOUD,” STAT’s biotech podcast.”
  • Kaufmann Hall shares its “Winter 2025 Kaufman Hall Report: Highlights from the 2024 Healthcare Leadership Conference.”
  • Per Healthcare Dive,
    • “Teladoc Health is joining an Amazon marketplace that aims to connect consumers with health benefits programs, the telehealth vendor said Monday.
    • “Now, eligible users can find and enroll in Teladoc’s diabetes, hypertension, pre-diabetes and weight management programs through Amazon’s Benefits Connector.
    • “The program could help drive enrollment in Teladoc’s chronic care offerings, executives said at the J.P. Morgan Healthcare Conference in San Francisco on Monday. “I wouldn’t count on it bringing revenue for us very quickly, but it is certainly something that we will continue to pursue in terms of growing our chronic care program,” Teladoc CFO Mala Murthy said.”
  • Medical Economics explains why 2024 was a ‘blockbuster year’ for concierge medicine.
  • Fierce Pharma offers news from the third day of JP Morgan healthcare conference.
  • Healthcare Dive discusses top healthcare technology trends in 2025. The shape of AI regulation will be uncertain under the Trump administration this year, while healthcare companies will continue bolstering cyber defenses to withstand increasing attacks, experts say.

Weekend update

From Washington, DC

  • A joint session of Congress will be held tomorrow to counting the votes received from the Electoral College. Thereafter, the House of Representatives and the Senate will resume organizing the 119th Congress.
  • On January 3, the President issued a “Memorandum on the Designation of Officials of the Office of Personnel Management to Act as Director.” Such a memorandum has been issued in advance of Presidential Inauguration Day pursuant to the Federal Vacancies Act of 1998.
  • The FEHBlog understands
    • “The [Presidential] signing ceremony of HR 82, [the Social Security Fairness Act of 2023 which repeals certain laws that reduce Social Security benefits for individuals who receive other benefits, such as a pension from a state or local government, has been moved up to Sunday, January 5 at 4 PM Eastern time.  
    • “We still don’t know whether the ceremony will be broadcast or streamed, but one possible outlet if it is live is https://www.whitehouse.gov/live/
  • The President also signed another raft load of bills into law yesterday.

From the public health and medical research front,

  • Fortune Well explains why it is particularly important for adults and children to receive the flu vaccine. What’s more,
    • “Don’t worry if you missed the unofficial “vaccine before Halloween” memo. We’re in the thick of cold and flu season and any protection you can provide yourself, your loved ones, and your community will benefit public health, says Dr. Robert Hopkins Jr., medical director of the National Foundation for Infectious Diseases.
    • “It’s not too late,” Hopkins told Fortune in December. “It is not a bad time when we’ve got risk in front of us. And I would certainly prefer that people were vaccinated earlier, but I’m not going to make perfection the enemy of the good.”
  • The Washington Post reports,
    • “People who receive physical therapy shortly after suffering concussions have better outcomes than those who wait longer to start rehabilitation programs, a recent analysis suggests.
    • “Published in the Physical Therapy & Rehabilitation Journal, the study reports on a randomized trial of 203 adults diagnosed with a mild traumatic brain injury, or concussion, who were within two to 12 weeks from their injury.
  • NPR Shots shares “nine unexpected things we learned about mental health and our brains in 2024.”
  • A commentator in the Wall Street Journal shares her personal experience with chronic pain. For context, she writes
    • “[W]e do know that relentless chronic pain is destabilizing,” says Dr. Scott Fishman, a pain specialist at the University of California, Davis, who founded its Center for Advancing Pain Relief, a rare center that focuses on both the treatment and prevention of pain. 
    • It would be absurd to say that chronic pain drives sufferers to become murderers; the only people pain patients are at any heightened risk of killing is themselves. Yet Fishman likens the effects of enduring pain to “driving on a slippery road. It puts everyone at risk.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health tech companies focused on behavioral health are confident that reimbursement trends favor them in 2025.
    • “Payment flexibilities for telehealth, hospital-at-home care and remote prescribing have been temporarily extended until March 31. The changes will prolong COVID-19-era payment for remote care across all specialties.
    • “For many in mental health tech, new reimbursement codes from the Centers for Medicare and Medicaid Services’ November physician payment rule are an even bigger deal.
    • “The codes reimburse providers for using digital mental health treatment applications or devices that have been cleared or granted De Novo authorization by the Food and Drug Administration.
    • “While the codes are narrow in scope, analysts said the move signifies a larger recognition among CMS and commercial insurers that virtual platforms treating mental health should be reimbursed.”

Monday report

Thanks to Justin Casey for sharing their work on Unsplash.

From Washington, DC

  • Per a press release,
    • “OPM joins the nation in mourning the passing of President Jimmy Carter. President Carter showed that public service isn’t just a line of work – it is life’s calling. From a young naval officer to a political leader, to leading as a humanitarian building homes and curing diseases, President Carter answered the call to public service. He set an example for every American to give back to their communities. He will truly be missed.” 
  • The Washington Post reports,
    • Memorial services for former president Jimmy Carter are expected to span several days and include public events in Atlanta and Washington.
    • Carter’s state funeral will be held Jan. 9 at 10 a.m. inside Washington National Cathedral after a procession from Georgia and a ceremony in which his body will lie in state in the U.S. Capitol, according to a news release from the Joint Task Force-National Capital Region.
    • “The 39th president will then be buried in a private ceremony in his hometown, Plains, Georgia.”
  • Govexec adds,
    • “President Biden issued an executive order on Monday to close federal agencies and offices next month in recognition of former President Jimmy Carter, who died Sunday at 100 in his home in Plains, Georgia.”
    • In accompanying guidance, Office of Personnel Management acting Director Rob Shriver said all federal employees would be excused from duty Jan. 9 “except those who, in the judgment of the head of the agency, cannot be excused for reasons of national security, defense, or other essential public business.” 
    • The day off applies to federal employees nationwide and will be treated like a holiday for purposes of pay and leave, the memorandum said.  

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When President Jimmy Carter was diagnosed in 2015 with cancer in his liver and brain, he said that he would like to see the last Guinea worm die before he did.
    • “That just about came true.
    • “There were 3.5 million cases of the parasitic worm disease in 1986, when the 39th U.S. president took up the cause of eradicating it. In 2023, there were 14 human cases, and 11 from January through early December 2024, according to a provisional count.
    • “We’re not there yet, but thanks to him we’re very close,” said Dr. Donald R. Hopkins, former vice president of health programs and now special adviser on Guinea worm eradication to the Carter Center, the human-rights nonprofit the former president founded in 1982 with his wife, Rosalynn Carter.”
  • The Washington Post reports,
    • “Cases of the illness known as norovirus — which induces miserable bouts of vomiting and diarrhea — are surging across the United States, according to the Centers for Disease Control and Prevention. Ninety-one outbreaks of the gastrointestinal bug were reported the week of Dec. 5, the latest period for which data is available. That’s 22 more outbreaks than in the last week of November.
    • “While sometimes referred to as the stomach flu, the disease is not caused by the influenza virus, which results in respiratory illness.
    • “There are about 2,500 reported outbreaks each year in the United States, happening most frequently between November and April. When new strains of norovirus emerge, case counts usually rise, according to disease trackers.
    • “This year, the number of reported norovirus outbreaks have exceeded the numbers that we’ve seen recently and in the years before the pandemic,” according to the CDC.”
    • The article delves into signs and symptoms, treatment options, etc.
  • The American Medical Association tells us what doctors wish their patients knew about depression.
  • Neurology Advisor adds, “One in 6 women experienced symptoms of postpartum depression 2 months after cesarean delivery, according to study findings published in the American Journal of Obstetrics and Gynecology.
  • The Wall Street Journal tells us about a 24 year old man who is trying to “outrun” schizophrenia.
    • “For the past four years, Kevin has been part of a living experiment. Shortly after he began hallucinating, during his junior year at Syracuse University, his doctors recommended him for an intensive, government-funded program called OnTrackNY. It provided him with therapy, family counseling, vocational and educational assistance, medication management and a 24-hour hotline.
    • “Such programs — there are around 350 in the United States — challenge the old idea that psychotic disorders are degenerative, a long slide to permanent disability. They operate on the notion of a golden hour. By wrapping a young person in social supports early on, the theory goes, it may be possible to prevent the disorder from advancing.” * * *
    • “But now, after four years, his time in the program was up. An estimated 100,000 people experience a first episode of psychosis every year, roughly four times the number of spots available in early intervention programs. So in December, it would all go away: the team of five providers and the hotline and the therapist who reminded him of his mother.
    • “What would happen to him without their support? Even as enthusiasm for early intervention builds, long-term studies are casting doubt on whether its benefits last after discharge. For Kevin, leaving the program meant a sudden blast of autonomy and a million questions about what his future, with schizophrenia, would look like.
    • “The training wheels are coming off,” he said.”
  • Per MedPage Today,
    • “There was “low but improving uptake” of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters after voluntary guidance was issued in 2013, an analysis of public FDA records found.” * * *
    • “The most important finding is that although there were more mentions of skin color descriptors in performance testing after the FDA’s guidance, a majority of the public clearance documents for pulse oximeters did not include any mention of testing in diverse individuals,” Ferryman told MedPage Today in an email.
    • “Clinicians who work in hospital settings often do not get to choose which pulse oximeter device they use with their patients,” Ferryman said. “Because this research is based on the public record, it suggests that even if clinicians wanted to do their own research on the performance of pulse oximeters across diverse populations, the majority of FDA-cleared device records do not include any information about testing in different skin tones.”
    • Pulse oximeter readings in patients with darker skin tones tend to overestimate oxygen saturation, a long-standing issue described in multiple studies and discussed by an FDA advisory committee. * * *
    • “Newer FDA guidance on pulse oximeter testing that’s under development may correct some of these problems, but no single change in guidance “is likely to be sufficient to fully correct the problems of development, marketing, and dissemination of fully equitable pulse oximeters,” the [researchers] wrote.”
  • Per National Institutes of Health press releases,
    • A study of nearly 10,000 adolescents funded by the National Institutes of Health (NIH has identified distinct differences in the brain structures of those who used substances before age 15 compared to those who did not. Many of these structural brain differences appeared to exist in childhood before any substance use, suggesting they may play a role in the risk of substance use initiation later in life, in tandem with genetic, environmental, and other neurological factors.
    • “This adds to some emerging evidence that an individual’s brain structure, alongside their unique genetics, environmental exposures, and interactions among these factors, may impact their level of risk and resilience for substance use and addiction,” said Nora Volkow M.D., director of NIDA. “Understanding the complex interplay between the factors that contribute and that protect against drug use is crucial for informing effective prevention interventions and providing support for those who may be most vulnerable.”
    • “Among the 3,460 adolescents who initiated substances before age 15, most (90.2%) reported trying alcohol, with considerable overlap with nicotine and/or cannabis use; 61.5% and 52.4% of kids initiating nicotine and cannabis, respectively, also reported initiating alcohol. Substance initiation was associated with a variety of brain-wide (global) as well as more regional structural differences primarily involving the cortex, some of which were substance-specific. While these data could someday help inform clinical prevention strategies, the researchers emphasize that brain structure alone cannot predict substance use during adolescence, and that these data should not be used as a diagnostic tool.”
  • and
    • “Among people with dialysis-dependent kidney failure, a form of psychological therapy called pain coping skills training reduced how much pain got in the way of their daily lives, also known as pain interference. The clinical trial, funded by the National Institutes of Health (NIH), found that training people on how to manage pain reduced the extent to which pain affected their work and social activities, mood, and relationships. The pain coping skills training, which was adapted for people undergoing long-term dialysis, also improved other effects of pain, including the intensity of pain, depression, anxiety, and quality of life. Pain coping skills training is an approach widely used for chronic pain, but it had not previously been tested for people treated with dialysis.
    • “Very few interventions have been shown to improve the quality of life for people with end-stage kidney disease being treated with dialysis,” said Dr. Paul Kimmel, program director at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which led the study. “For example, opioids, which have been a main treatment for pain in this population, have side effects that can be more pronounced in the presence of kidney failure, making pain management challenging.” * * *
    • “The study results indicate that pain coping skills training may be an appealing alternative or complement to pain medications. Although the effect of the pain coping skills training on the overall cohort was modest, its high acceptability, tolerability, and safety and its observed benefits to pain, anxiety, depression, and quality of life support further research on developing nonpharmacologic, non-invasive strategies for managing pain in dialysis populations.
    • “Future work will focus on how to prolong the favorable effects of pain coping skills training and how to broadly implement this intervention in clinical practice,” said lead author Dr. Laura M. Dember, nephrologist and clinical investigator at the University of Pennsylvania Perelman School of Medicine, Philadelphia. “Based on the successful results of this study, our hope is that this intervention can be made available broadly to patients receiving dialysis.”
  • The Wall Street Journal offers a quiz about the FDA’s latest guidance on whether a particular food is healthy. For what it’s worth, the FEHBlog scored 100.

From the U.S. healthcare business front,

  • Fierce Pharma offers a “2025 forecast: After Novo, Lilly expansion sprees, ‘positive signals’ emerge around future supply of GLP-1 drugs.”
  • The Washington Post informs us,
    • “They don’t get fruitcakes or Christmas cards from grateful patients, but for decades robots have been helping doctors perform gallbladder removals, hysterectomies, hernia repairs, prostate surgeries and more. While patients lie unconscious on the operating table, robotic arms and grippers work on their bodies at certain stages in these procedures ― all guided by doctors using joystick-like controllers, a process that minimizes human hand tremor.
    • “Now, a team of Johns Hopkins University and Stanford University researchers has reported a significant advance, training robots with videos to perform surgical tasks with the skill of human doctors.
    • “The robots learned to manipulate needles, tie knots and suture wounds on their own. Moreover, the trained robots went beyond mere imitation, correcting their own slip-ups without being told ― for example, picking up a dropped needle. Scientists have already begun the next stage of work: combining all of the different skills in full surgeries performed on animal cadavers.
    • “A new generation of more autonomous robots holds the potential to help address a serious shortage of surgeons in the United States, the researchers said.
  • Check this out!
    • “As 2025 nears, healthcare is undergoing unprecedented transformation, particularly with headlines about artificial intelligence (AI) technologies shifting away from grandiose promises as the dust starts to settle around the potential of Generative AI (GenAI). These innovations and others aim to reshape how healthcare is delivered. 
    • “To shed light on anticipated trends, challenges and opportunities in healthcare technology in 2025, leading experts from Wolters Kluwer Health offer their outlook on 2025 across a variety of topics. Diffusing the hype, the predictions offer an eye-opening look at what’s ahead and lead us toward a smarter, more resilient future in healthcare technology.” 

Weekend Update

Jingle bells! The FEHBlog will be on a holiday break until next Thursday December 26.

From Washington, DC

  • The President signed into law yesterday the skinny continuing resolution (H.R. 10545) funding the federal government through March 14, 2025, and creating funding for disaster relief and farmers. No shutdown. No PBM “reform.”
  • Healthcare Finance adds,
    • “Acute hospital-care-at-home and telehealth temporary waivers were continued but were not given the long-term extensions that were included in a Dec. 18 bipartisan resolution. Both received short-term extensions until March 31.
    • “The original bill extended telehealth for two years and acute hospital care at home by five years.
    • “Stripped out of the bill is a provision to prevent the Medicare pay cut to physicians. This means physicians get a 2.8% Medicare payment cut on January 1, 2025. 
    • Also excluded from the CR is a provision extending the ability of high deductible health plans to cover telemedicine services before the deductible beyond December 31, 2024.
  • The Senate also passed the Social Security Fairness Act on Saturday which benefits federal, state, and local government employees who receive Social Security retirement income. That bill now goes to the President for his signature. 
  • The 118th Congress has completed its work. The 119th Congress will be gaveled in on January 3, 2024.

In Food and Drug Administration News,

  • The New York Times shares the story of a woman “fighting to avoid her mother’s fate [early onset dementia], for her daughters’ sake. A mutant gene is coming to steal Linde Jacobs’s mind. Can she find a way to stop it?” Fascinating.
  • Per FDA press releases,
    • “The U.S. Food and Drug Administration approved Symvess [December 20], the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
    • “Vascular trauma occurs when a blood vessel is injured such as a rupture of an artery in the extremities, which can lead to serious, life-threatening complications such as hemorrhage or blood clotting. When damage to an artery in the extremity occurs, urgent surgical repair is needed to restore normal blood flow. The current standard of care for patients with extremity vascular injuries can include procedures such as autologous vein grafting (surgical repair using the patient’s own blood vessels) or implantation of a synthetic graft. These treatments are not suitable or available for every patient.
    • “Today’s approval provides an important additional treatment option for individuals with vascular trauma, produced using advanced tissue engineering technology,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The FDA remains committed to facilitating the development of innovative products that offer potentially life-saving benefits for patients with severe injuries.” 
  • and
    • “Today, the U.S. Food and Drug Administration approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older.
    • “Ryoncil is the first FDA-approved MSC therapy. It contains MSCs, which are a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isolated from the bone marrow of healthy adult human donors. 
    • “Today’s decision marks an important milestone in the use of innovative cell-based therapies to treat life-threatening diseases with devastating impacts on patients, including children,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “This first mesenchymal stromal cell therapy approval demonstrates the FDA’s commitment to supporting the development of safe and effective products that could improve the quality of life for patients with symptoms that are unresponsive to other therapies.”

From the public health and medical research front,

  • Fortune Well tells us,
    • “A drug already FDA-approved for people with a rare form of breast cancer has now been shown to improve patients’ long-term survival, new clinical trial data suggest.
    • Lynparza (olaparib), a product of Fortune 500 pharmaceutical firm Merck and Fortune 500 Europe company AstraZeneca, exhibited clinically meaningful improvements in overall survival, among other promising findings, in people with germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer. About 87.5% of patients treated with the drug were alive after six years, compared to 83.2% who received a placebo. Long-term results of the OlympiA phase 3 trial were presented Dec. 11 at the San Antonio Breast Cancer Symposium.
    • “The durable long-term efficacy seen in the OlympiA study reinforces Lynparza as an important treatment option for those living with this truly challenging, very aggressive form of breast cancer,” Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in a news release about the findings.”
  • A mother, writes in the Washington Post, about having a stroke soon after giving birth. According to the article, “postpartum strokes happen more often than you’d think.”
  • The Wall Street Journal lets us know,
    • Dabbing has emerged in recent years as a popular way to consume marijuana, especially among youths. But it is dangerous. Like other new forms of marijuana use that have proliferated in recent years, dabbing involves highly potent concentrates of cannabis.
    • Health authorities are sounding the alarm, warning that dabbing could addict users and is sending teenagers to emergency rooms with seizures, cyclical vomiting or psychosis. Some users and doctors call a cannabis overdose, with the accompanying sweaty nausea and disorientation, a “green out,” a term believed to be a play on “black out.” 
    • “People are consuming extremely high doses of THC,” the psychoactive component of cannabis, said Dr. Nora Volkow, director of the National Institute on Drug Abuse. “People can become psychotic.”
  • and
    • California OnTrack uses a skills-based therapy program called coordinated specialty care, which is offered through at least 381 programs in all 50 states. The program substantially reduces symptoms of psychosis, as well as hospitalizations and homelessness compared with traditional treatment, according to published studies.
    • “The premise of the treatment is simple: Teach people with psychosis to live with their imagined voices, hallucinations and false memories. With practice, such symptoms can be managed or ignored. The techniques taught in the program, in conjunction with medication, diminish symptoms over time and keep new ones at bay.
    • “People who enroll in the treatment within two years of their first psychotic episode fare the best, studies found. People with longer-term psychosis also improved but to a lesser degree.
    • “It’s not like a switch where all the symptoms subside. It’s like a dimmer switch,” said Carlos Larrauri, who completed a similar treatment in Florida after being diagnosed with schizophrenia in 2011 at age 24. He has since finished law school, trained as a nurse practitioner, married and now works as a lawyer.
    • “For more than a decade, the federal government and the American Psychiatric Association have identified coordinated specialty care as the gold standard to treat early psychosis. Yet few people know about it, and fewer still have a chance to benefit from it. Three of the largest private insurers only recently began covering the treatment, which has largely been limited to Medicaid patients. California OnTrack is one of the few providers in the U.S. that has secured coverage from private insurance.” 

Thursday Report

Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec tells us,
    • “Senate Majority Leader Chuck Schumer told unions and federal employee groups Wednesday that he will schedule a vote on the Senate floor on legislation to repeal two controversial tax provisions that reduce some public servants’ retirement benefits just weeks before the end of the congressional session and Democrats’ control of the chamber.
    • “Schumer’s remarks came at a rain-soaked rally, organized by lawmakers and organized labor on Capitol Hill in support of the Social Security Fairness Act (H.R. 82), which passed the House by a 327-75 vote last month.” * * *
    • “If enacted, the legislation would repeal Social Security’s windfall elimination provision and government pension offset. The windfall elimination provision reduces the Social Security benefits of retired federal employees who spent a portion of their careers in the private sector in addition to a federal, state or local government job where Social Security is not intended as an element of their retirement income, such as the Civil Service Retirement System. And the government pension offset reduces spousal and survivor Social Security benefits in families with retired government workers.”
  • FedSmith adds,
    • “The OPM retirement backlog has dropped to levels not seen since 2016. As of the end of November 2024, the total outstanding retirement claims at the Office of Personnel Management is 13,844. The last time it was at or below that level was June 2016 when it was 13,529.
    • “OPM received 6,808 new retirement claims in November and processed 7,872. It took an average of 55 days to process claims.
    • “So far in 2024, the average level of the OPM retirement backlog is 16,083. The average number of retirement claims submitted by federal employees to OPM each month has been 7,558, and the average number processed each month is 7,599.
    • “The end of a year is the peak time for federal employees to retire, so it’s good news for federal employees who plan to retire soon that the number of pending retirement claims at OPM has fallen as the end of 2024 approaches.
    • “However, even though most federal employees retire at the end of a calendar year, the impact on the processing doesn’t hit until January. The peak time at OPM for processing retirement claims is January through March, and January is typically the month with the largest spike in the retirement backlog based on past data. For example, the OPM retirement backlog grew by 46% last January.”
  • BioPharma Dive lets us know,
    • “When the Food and Drug Administration took Eli Lilly’s Zepbound and Mounjaro off of its drug shortage list in October, companies making cheap “compounded” versions found themselves in a bind.
    • “By ending compounders’ ability to manufacture and sell their off-brand versions in bulk, the FDA’s decision also left some patients wondering how they would be able to access the popular obesity and diabetes drugs at an affordable price. About 12% of American adults have taken a GLP-1 medication, according to a May poll from KFF Health. And compounded versions may account for as much as 20% of all GLP-1 prescriptions, CNN reported.
    • “But when the FDA backed down, letting compound pharmacies resume their activities for the time being, the industry was left in something of a limbo. * * *
    • “The FDA said it will issue another update Dec. 19, although it’s possible it will be another extension of the review. The agency said in a late November joint status update to a court hearing the compounders’ challenge that it had not yet made a determination, according to Beaver.
    • “In the interim period, FDA has indicated it does not intend to take enforcement action against the continued compounding of tirzepatide,” Beaver said.
    • “With a new presidential administration set to take over next month, the FDA may simply wait.”
  • STAT News adds,
    • “Eli Lilly, which has been directing patients to various telehealth sites as it sells its blockbuster obesity medication Zepbound, is broadening its reach, announcing a partnership Wednesday with major telehealth platform Ro.
    • “Under the new agreement, Ro patients who are prescribed Zepbound will be able to get vials of the drug through its app. Previously, Lilly had only made these vials, which are priced lower than its injectable pens, available to patients who filled prescriptions through an online portal created by Lilly, called LillyDirect.”
  • MedTech Dive offers “four takeaways from the FDA’s first digital health advisory committee. Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology.”

From the judicial front,

  • Reuters informs us,
    • “The U.S. Department of Health and Human Services overstepped its authority when it boosted Medicare reimbursements to hospitals in low-wage areas to help them recruit and retain staff, a divided federal appeals court ruled on Wednesday.
    • “A 2-1 panel of the San Francisco-based 9th U.S. Circuit Court of Appeals found that HHS’s 2020 policy shift ran afoul of the law governing Medicare, the federal health insurance program for seniors and some people with disabilities.
    • “The decision was a victory for a group of 53 California hospitals that sued HHS in 2020 in Los Angeles federal court, saying their Medicare reimbursements were cut by a total of about $3.8 million to make up for the increased payments to hospitals in low-wage areas.
    • “HHS said earlier this year that it would not continue the policy in 2025, meaning that Wednesday’s decision will affect only reimbursements for past years going back to 2020.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When a woman learns she has breast cancer, her reaction is often: take it out. Now doctors say that might not always be necessary.
    • “Some women with the earliest stages of breast cancer could be carefully monitored, undergoing surgery and radiation only if the disease advances, new data suggests.
    • “The strategy is akin to one already used in early prostate cancer, as doctors are increasingly looking at whether they can pull back on some cancer therapies, to spare patients side effects and costs.
    • “This is really the first study to confirm our suspicions that there’s a subset of low-risk patients that could do just as well without surgery,” said Dr. Nancy Chan, a breast-cancer specialist at NYU Langone’s Perlmutter Cancer Center, who wasn’t involved in the study“It’s really encouraging.” * * *
    • “It was a data-free zone because we already treated it like a cancer,” said Dr. E. Shelley Hwang, a breast-cancer surgeon at Duke Cancer Institute, who led the trial. “We didn’t know what we could dial back on.”
    • Hwang and her colleagues recruited some 950 women ages 40 and older with a type of low-risk DCIS that is sensitive to hormones. The women were split into two groups: One was recommended standard care—surgery with or without radiation—while the other was recommended mammograms every six months. The monitoring group could opt for surgery at any time and had to get surgery if the disease progressed.
    • Most women in both groups took hormone therapy to help keep cancer growth in check. Some 17% of women in the monitoring group ended up getting surgery, and some assigned to the treatment group declined to get an operation.
    • Two years later, the rates of women who developed invasive breast cancer were similar between the groups, less than 10%, the researchers found. The women also reported comparable rates of anxiety, a concern when doctors are considering dialing-back treatment.
    • Women who got standard care reported more arm problems and breast pain, but that resolved over time. The results were published in the academic journals JAMA and JAMA Oncology and presented at the San Antonio Breast Cancer Symposium on Thursday.
  • STAT News points out,
    • “Pfizer said Thursday its drug Ibrance showed efficacy in a group of breast cancer patients who do not currently have access to the medicine, potentially expanding its use.
    • “Ibrance, which generates annual sales of $4.3 billion, is currently used for patients whose tumors are positive for the estrogen receptor (ER) and negative for a second biomarker, called HER2. That population represents 70% of women with breast cancer. But the new results are in patients whose tumors test positive for both the estrogen receptor and HER2, a population that represents 10% of breast cancer patients.”
  • The New York Times relates,
    • “Over the last 20 years, clinicians have increasingly recognized that A.D.H.D. symptoms, which begin in childhood, can linger into adulthood, and that some groups — like women and people of color— are more likely to be underdiagnosed early in life. Now, with the rise of telemedicine, increased awareness of A.D.H.D. and changing attitudes about mental health treatment, new A.D.H.D. diagnoses are surging among older Americans.
    • An analysis by Truveta, a health care data and analytics company, shows that the rate of first-time A.D.H.D. diagnoses has been on the rise since 2021, but the increase has occurred only among people 30 and older. From January 2021 to October 2024, the rate of first-time diagnoses rose about 61 percent among those ages 30 to 44 and 64 percent among those ages 45 to 64.
    • “As a result, about 31 percent of first-time diagnoses are now among people ages 30 to 44, the largest proportion of any age group. (In 2018, younger adults took the top spot.)
    • “The analysis, which was done at the request of The New York Times, drew on Truveta’s database of 30 health systems, which included more than one million people who had received first-time A.D.H.D. diagnoses.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes,
    • “In people with brain tumors known as diffuse gliomas, cancerous cells often spread and invade nearby tissue to mix with healthy cells. As a result, it can be challenging for neurosurgeons to differentiate cancerous from healthy tissue during surgery as is required to safely remove as much of the cancer as possible. Many patients with glioma are found to have residual tumor after surgery, which can mean additional surgeries, earlier recurrence, and decreased survival. But research is showing that artificial intelligence (AI) tools could enable doctors to not only predict if a cancer will respond to treatment, but also to differentiate cancerous from healthy tissue rapidly enough to guide more brain surgeries in real time.
    • “In one promising example of this, an NIH-supported study in Nature  recently reported the development of an open-source, AI-based diagnostic system that can determine in just 10 seconds if part of a cancerous brain tumor that could be removed still remains. The new system, called FastGlioma, combines rapid, user-friendly, optical microscopy with AI models trained on diverse data, including over 11,000 surgical specimens and 4 million microscopy images, to give surgeons needed answers very quickly.
    • “Today, neurosurgical teams locate residual tumor during surgery guided by MRI or fluorescent imaging. The research team for this study—led by Todd Hollon , University of Michigan Health, Ann Arbor, and Shawn Hervey-Jumper , University of California, San Francisco—reports that the new system significantly outperforms current methods for identifying tumor remains, working faster and more accurately.” * * *
    • “The presence of residual tumor tissue following surgery is a significant and costly public health problem in the U.S. and around the world, for brain cancers and other solid cancers alike. The research team reports that FastGlioma can already accurately detect residual tumor in many other brain cancer types, including both adult and childhood brain cancers, suggesting it has potential to one day serve as a general-purpose tool for guiding brain tumor surgeries. The researchers also plan to explore the system’s application to other cancers, including lung, prostate, breast, and head and neck cancers. Through this kind of work, the researchers hope this tool and others like it can help unlock the potential of AI for improving cancer care in the years ahead.”
  • Per MedPage Today,
    • “Postmarketing data on obeticholic acid (Ocaliva) identified a risk for serious liver injury in primary biliary cholangitis (PBC) patients without cirrhosis, the FDA said in a safety communication on Thursday.
    • “The agency’s review of a mandated clinical trial “found that some cases of liver injury in patients without cirrhosis resulted in liver transplant. This risk was notably higher for patients taking Ocaliva compared with a placebo,” the FDA said.”
  • Per Beckers Hospital Review,
    • “The FDA has placed a hold on all clinical studies of vaccines for respiratory syncytial virus in infants due to safety concerns following a trial involving two mRNA-based vaccine candidates from Moderna. 
    • “A briefing document released by the FDA ahead of the Vaccine and Related Biological Products Advisory Committee revealed that a phase 1 trial evaluating two RSV vaccines in infants aged 5 to 8 months was paused in July after five severe cases of RSV-related illness were reported among infants receiving the vaccine candidates.” * * *
    • “VRBPAC will review the safety data and discuss implications for the future development of RSV vaccines for infants Dec. 12.” 

From the U.S. healthcare business front,

  • Per a press release,
    • The Institute for Clinical and Economic Review (ICER) today published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States, highlighting the top 10 drugs with substantial net price increases in 2023. ICER determined that five of those drugs lacked adequate evidence to support any price increase, which resulted in a total of $815 million incremental added costs to US payers in 2023. The five drugs with unsupported price increases are Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz.
    • Downloads: Final Report
    • “We continue to see list price increases that are far above the rate of inflation for many of the costliest drugs,” stated Foluso Agboola, MBBS, MPH, ICER’s Vice President of Research. “These price hikes resulted in over $800 million in excess costs to the US health care system in just one year alone. This impacts everyone in the country, especially patients and their families. Over the past few years, ICER has played a role in highlighting substantial price increases. Since launching this report in 2019, we have noticed a decrease in the number of drugs that have significant price hikes without any new clinical evidence. In this report, half of the drugs we assessed had price increases in the setting of new evidence of additional benefits or reduced harm, while the other half lacked such evidence to support their higher price tag.”
  • STAT News discusses “AI versus AI: The emerging arms race over health insurance denials. New startups are harnessing artificial intelligence to appeal denials by health insurers.
    • “Like many Americans, Holden Karau said she was fed up with health insurance. * * *
    • Karau’s company, FightHealthInsurance.com, is one of many upstart businesses seeking to harness the power of artificial intelligence to combat denials by health insurers that block access to medical services.
    • “There’s a lot of technology on the insurance side to automate denials,” Karau said. “I think it’s time to build the tools for patients and providers.”
    • “Her company, and its companions in the market, are just getting off the ground. But they promise to help automate appeals for providers and patients, making it much faster and easier to contest denials that often go unchallenged.”
  • Beckers Hospital Review shares weight loss drug fills by states.
    • “Alaska recorded the highest percentage of medication fills for weight loss drugs this year, according to data from GoodRx. 
    • “To assess state-level trends, GoodRx examined fill rates for all medications, excluding vaccines, from a nationally representative sample between Jan. 1 and Oct. 31. The figures below reflect the percentage of total medication fills for GIP and GLP-1 drugs prescribed for either diabetes or weight loss indications. Medications for Type 2 diabetes included Ozempic, Mounjaro, Victoza and liraglutide, while medications prescribed for weight loss included Wegovy, Zepbound, Saxenda, Qsymia and phentermine.
    • “Regionally, states in the South had higher fill rates for medications prescribed for diabetes while states in the Northeast had the highest fill rates for medications prescribed for weight loss.” 
  • and points out “US News’ 118 maternity care access hospitals.”
    • “On Dec. 10, U.S. News & World Report released its annual Best Hospitals for Maternity Care ratings, which also recognize hospitals providing services to underserved communities.
    • U.S. News identified 118 hospitals as Maternity Care Access Hospitals for providing maternity services in areas that would otherwise lack access to such care.
    • “To qualify, these hospitals met specific geographic and quality criteria. They were eligible if they were the only hospital providing maternity care within their county, and the county had fewer than 60 obstetric providers per 10,000 births. Alternatively, hospitals qualified if they were the only facility within a 15-mile radius and were located in a county with fewer than 128 obstetric providers per 10,000 births.”
  • Per Fierce Healthcare,
    • “Centene released its earnings guidance for 2025 as a part of its investor day on Thursday.
    • “The health insurer expects to bring in between $166.5 billion and $169.5 billion in revenue for the year, including between $154 billion and $156 billion in premium and service revenue, according to the announcement. It also estimates earnings per share of at least $7.25 in 2025.
    • “The company is bracing for elevated utilization trends to continue as well, according to the announcement. It projects a medical loss ratio of between 88.4% and 89%.”

Tuesday Report

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Factoids

From Washington, DC,

  • The Washington Post reports,
    • “In a flurry of Friday night announcements, President-elect Donald Trump said he had selected Scott Bessent, a financier who embraced MAGA, to head the Treasury Department; Russell Vought, a Project 2025 contributor, to run the White House budget office again; and Rep. Lori Chavez-DeRemer (R-Oregon) [who lost her bid for re-election] for labor secretary. The president-elect also said he had selected Janette Nesheiwat, a Fox News contributor, to serve as surgeon general; and former congressman Dave Weldon to head the Centers for Disease Control and Prevention.”
  • The HHS, Labor, and Treasury Secretaries are the principal Affordable Care Act regulators while the Office for Management and Budget carriers a lot of weight with the Office of Personnel Mangement.
  • The American Hospital Association News tells us,
    • “The AHA and 22 other organizations Nov. 22 urged Congress to pass an end-of-year health care package that includes action on alternative payment models and a scheduled physician payment cut. The organizations requested an extension of Medicare’s Advanced Alternative Payment Model incentive payments, ensure that APM qualifying thresholds remain attainable and replacement of a scheduled cut to Medicare physician payments with an update reflective of inflationary pressures.
    • “These payment reforms have generated more than $28 billion in gross savings for Medicare over the past decade,” the organizations wrote. “The Centers for Medicare & Medicaid Services (CMS) recently released results showing that the Medicare Shared Savings Program and [Accountable Care Organization] REACH Model, the largest APMs in Medicare, generated $2.8 billion in net savings for the Medicare program in 2023, while improving patient access and quality.”  
  • HHS’s HRSA shares information on federal government spending to improve rural healthcare.
  • Per MedTech Dive,
    • “The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls.
    • “The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when the public and healthcare providers are notified. The actions include when companies remove products from the market, correct products or update use instructions due to potentially high safety risks.
    • “The program will provide “early alerts” of potentially high-risk device removals or corrections related to cardiovascular, gastro renal, general hospital, obstetrics and gynecology and urology, according to the FDA’s Center for Devices and Radiological Health. The center added, “At this time, there is no change to any other recall process or recall communication timelines for other areas.”
    • “Michelle Tarver, the new CDRH director, said in a statement that the program is meant to increase transparency.”
  • Kevin Moss writing in Federal News Network offers an Open Season checklist for federal employees while FedWeek shares “11 FAQs: Open Season & PSHB/FEHB Switchover.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is stable or declining in most areas. Seasonal influenza activity remains low nationally. RSV activity is elevated and continues to increase in the southern, central, and eastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae remain elevated among young children in the United States.
    • “COVID-19
      • “Nationally, COVID-19 activity is stable or declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. COVID-19 activity is low with no meaningful changes in infection levels predicted.
      • “CDC expects that the 2024-2025 COVID-19 vaccine will work well for currently circulating variants. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is elevated and continues to increase in the southern and eastern United States. Activity is low in the rest of the country but increasing in the central and western United States. Emergency department visits and hospitalization rates are increasing in young children in the southern, central, and eastern United States.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections afforded by vaccines.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) said today that its tests have confirmed H5N1 avian flu in California’s recent suspected case, involving a child who had no known exposure to infected animals.
    • “Also, California announced another confirmed H5 case in a dairy farm worker. The new developments lift the state’s total to 29 human cases of H5 avian flu and the national total since the first of the year to 55.” * * *
    • “The child is recovering, and all family members tested negative for H5 avian influenza but positive for the same common respiratory virus as the child. Contact tracing continues, and there is no sign of human-to-human spread.
    • “Investigation into the child’s exposure to H5N1 is still under way, the CDC said.”
  • The New York Times reports,
    • “The number of deaths caused by alcohol-related diseases more than doubled among Americans between 1999 and 2020, according to new research. Alcohol was involved in nearly 50,000 deaths among adults ages 25 to 85 in 2020, up from just under 20,000 in 1999.
    • “The increases were in all age groups. The biggest spike was observed among adults ages 25 to 34, whose fatality rate increased nearly fourfold between 1999 and 2020.
    • “Women are still far less likely than men to die of an illness caused by alcohol, but they also experienced a steep surge, with rates rising 2.5-fold over 20 years.
    • “The new study, published in The American Journal of Medicine, drew on data from the Centers for Disease Control and Prevention.”
  • A Wall Street Journal reporter observes
    • “After years of pushing the benign myth that a glass of wine a day is good for the heart, it seems the medical establishment has abandoned hedonists and pleasure seekers. Is there a safe amount of alcohol? It turns out no. 
    • “For this and other more amorphous reasons, I have noticed increasing numbers of people around me are sober-ish. They drink only socially or only two glasses of wine a week or only in restaurants. They are not willing to give up drinking entirely, which feels like too vast and depressing a surrender of life’s pleasures. So they make rules for themselves. 
    • “Someone I know has a new ritual of drinking a nonalcoholic beer with nuts on her terrace. Another friend told me that she used to drop by for drinks at friends’ houses in the evenings, and now it is just as often tea.”
  • Medscape discusses the side effects of GLP-1 drugs.
    • “Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.
    • “But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).
    • “It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
    • “But that’s not really happening now,” she added.
    • “Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.”
  • KFF provides findings from its 2024 Women’s Health Survey concerning contraception.
  • Medical Economics informs us,
    • “More than one in five U.S. adults, which equates to 59.3 million people, were living with mental illnesses in 2022, yet just more than half of them (50.6%) had received treatment in the previous year. A new study, from West Health and Gallup, uncovered that 70% of Americans would prefer to be asked about both their physical health and their mental health during appointments with their primary care providers (PCPs).
    • ‘The West Health-Gallup Survey on Mental Health in America reported that 65% of men and 76% of women hoped to discuss both physical and mental health with their PCPs. The survey also found that 66% of U.S. adults have been asked about their mental health by their PCPs or family practitioners, whereas 32% of adults said that had never happened. Women were more likely than men (71% compared to 60%) to be asked about mental health.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “Yesterday, the US Centers for Disease Control and Prevention (CDC) closed its investigation into the multistate Listeria outbreak tied to Boar’s Head deli meat after 61 cases and 10 deaths were reported.”
  • The Food and Drug Administration announced,
    • “On Thursday, the FDA updated the outbreak advisory for E. coli O21:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. The update includes information about recalled product being distributed to markets outside the United States and additional recalls from companies that may have used or repackaged recalled carrots from Grimmway Farms. FDA’s investigation remains ongoing.”
  • The Washington Post reports,
    • “The Detroit-based Wolverine Packing Co. recalled more than 167,000 pounds of ground beef products because of concerns that the meat may be contaminated with E. coli, according to the U.S. Department of Agriculture. The recall affects fresh products that have a use-by date of Nov. 14 and frozen products whose labels contain a production date of Oct. 22, officials said.
    • “On Nov. 13, Minnesota’s Department of Agriculture alerted the Food Safety and Inspection Service, an agency of the USDA, about a group of people who had consumed ground beef before they fell ill.
    • ‘On Nov. 20, a ground beef sample collected by Minnesota officials tested positive for E. coli O157. Federal officials determined that the products from Wolverine Packing Co. were linked to the people who had become sickened in Minnesota.
    • “At least 15 patients have been identified, and the onset of their infections range from Nov. 2 to Nov. 10, the USDA said. At least two have been hospitalized, according to Minnesota officials.
    • “The recalled products have the establishment number EST. 2574B inside the USDA mark of inspection. The items were shipped to restaurant locations nationwide, according to officials.
    • Some products may be in restaurant refrigerators or freezers, officials said.
    • “Restaurants are urged not to serve these products.”

From the U.S. healthcare business front,

  • HR Dive relates,
    • “Insurers are projecting medical costs will increase globally in 2025 — by about 10.4%, according to WTW’s 2025 Global Medical Trends Survey.
    • “Specifically in the U.S., insurers project a 10.2% increase in 2025, up from 9.3% this year.
    • “Notably, WTW researchers said that public healthcare systems worldwide have been overwhelmed due to high demand and low resources, which has led to people turning to private providers.”
  • Health Leaders Media discusses an Oschner Health program with myLaurel which offers value-based medical care at home.
    • “Billing arrangements are a key difference between CMS’ Acute Hospital Care at Home program and Ochsner Health’s Acute Care at Home program.
    • “The Acute Care at Home program features virtual visits with physicians, nurses, and care managers as well as in-person visits with paramedics.
    • “By reducing hospital admissions and readmissions, the Acute Care at Home program is decreasing total cost of care.”
  • Investment News reports,
    • “Despite the benefits of health savings accounts as tax-advantaged retirement savings tools, employees are largely using them to meet current healthcare expenses, according to a new survey by the Plan Sponsor Council of America.
    • “The 2024 HSA Survey, sponsored by HSA Bank, reflects responses from more than 500 employers and shows modest growth in account balances and contributions. However, it also highlights a need for greater education around the long-term benefits of HSAs.
    • “While 90 percent of eligible employees had an HSA in 2023 and three-quarters made contributions, few are leveraging them for retirement planning.
    • “Among other key insights, the survey found that only one-third of employers educate workers about using HSAs as part of their retirement strategies, and fewer than 30 percent allow participants to view their HSA balances alongside retirement accounts for a more holistic view of savings. Less than 10 percent of employers mirror HSA investment options with those available in their 401(k) plans, though interest in doing so has grown.”
  • The Wall Street Journal reports,
    • “An industry fight against lucrative drug discounts for hospitals is intensifying as another drugmaker joins the battle: Sanofi.
    • “The pharmaceutical company plans to change its policy on how it gives discounts to certain hospitals. Sanofi will require institutions to provide pharmacy and medical claims information before receiving federally mandated discounts. The company sent a letter, which was viewed by The Wall Street Journal, to hospitals outlining its new model on Fridayaccording to people familiar with the matter. 
    • “The French company’s plan, which would take effect early next year, comes as the industry escalates its efforts to rein in the federal program known as 340B. Eli Lilly and Johnson & Johnson this month filed separate lawsuits against the federal government for rejecting the companies’ plans to tighten the way they provide the discounts to hospitals in the program.” 
  • Per BioPharma Dive,
    • “Medtronic received Food and Drug Administration clearance for its new InPen smart insulin pen app that can recommend corrections for missed or inaccurate insulin doses at mealtime.
    • “The authorization paves the way for the launch of Medtronic’s Smart MDI system, which combines InPen with the Simplera continuous glucose monitor (CGM), the company said Wednesday. 
    • “With the clearance, Medtronic said Smart MDI will be the first system on the market to provide personalized insights on when and how much insulin to dose in real-time for people who take multiple daily injections.”

Midweek Update

Photo by Tomasz Filipek on Unsplash

From Washington, DC

  • This afternoon the FEHBlog was listening to an OPM meeting about the PSHBP when someone mentioned a benefit administration letter. The FEHBlog realized that he was overdue in posting the 2025 FEHB and PSHBP Significant Plan Changes notices which appear under on OPM’s benefit administration letters page.
  • Kevin Moss, writing in Govexec, pitches the many advantages available to annuitants over age 65 who enroll in an FEHB or PSHB plan’s Medicare Part D EGWP for 2025. Mr. Moss warns readers about the income adjusted Part D premiums (IRMAA) and the Medicare bar against using manufacturer coupons. In the FEHBlog’s opinion, the combination of the Medicare Part D’s new features for 2025 — a $2000 out of pocket maximum and the Medicare Prescription Payment Plan — outclass manufacturer coupons and diminish the impact of IRMAA which in any case is much lower for Part D compared to Part B.
  • HUB International reminds us,
    • “Back in 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act first allowed HDHPs to cover telehealth and other remote care services on a first dollar basis through the end of 2021. This was initially designed to make medical care accessible during the COVID-19 pandemic, when it may not have been for many in need.
    • “Congress first resurrected this relief in April 2022 after a three-month hiatus. This relief was scheduled to end on December 31, 2022, until Congress extended it once again. This second extension is now coming to an end for plan years beginning on or after January 1, 2025.”
  • The lame duck session of Congress could pass a law extending this benefit beyond 2024.
  • The U.S. Preventive Services Taskforce presented its 14th annual report to Congress on “High-Priority Evidence Gaps Across the Lifespan, in All Communities” today.

From the public health and medical research front,

  • MedPage Today tells us,
    • “Among adults with outpatient respiratory syncytial virus (RSV) infections across six RSV seasons, roughly one in 20 were hospitalized within 28 days, according to a large cohort study that used data from three health record databases.
    • “In the cohort of over 67,000 patients with outpatient medically attended RSV infections, hospitalization rates were 4.5% to 6.2%, and 6.5% to 8.5% in a high-risk subgroup, across the three databases, reported Joshua T. Swan, PharmD, MPH, of Pfizer in New York City, and colleagues in JAMA Network Open.
    • “High-risk features included age 65 and older, asthma, chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF). Across the patients in the three databases, comorbidity prevalence were 20% to 30.5% for COPD, 14.6% to 24.4% for CHF, 14.6% to 24.4% for asthma, and 14% to 54.5% for age 65 and over.
    • “Infection rates for RSV have been underestimated, partly due to underutilization of testing for the viruses, Swan and team noted. Although there are three available vaccines against RSV, there are few approved treatments for it.”
  • and
    • “Diagnoses of postpartum depression (PPD) increased significantly across all racial and ethnic groups and prepregnancy body mass index (BMI) categories over the past decade, according to a California-based cross-sectional study.
    • “An analysis of more than 400,000 pregnancies found that prevalence of PPD doubled from 2010 to 2021 (9.4% vs 19%), according to Darios Getahun, MD, PhD, MPH, of Kaiser Permanente Southern California in Pasadena, and co-authors.
    • “While rates increased across all groups, the largest increases were seen in those who identified as Asian and Pacific Islander (280% increase) and non-Hispanic Black (140% increase), they reported in JAMA Network Open.”
  • The National Cancer Institute released cancer information highlights about “B-Cell Lymphoma | Advanced Cancer | Skin Cancer and Darker Skin.”
  • Per Fierce Pharma,
    • “It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. Now with a new nod in hidradenitis suppurativa (HS), the drug seems to be carving the path to blockbuster land with five approved indications.
    • “Bimzelx, which is the first to selectively inhibit IL-17F as well as IL-17A, was cleared to treat adults with moderate to severe forms of the disease after proving it could help patients significantly reduce signs and symptoms of the condition. HS is characterized by chronic and recurring painful nodules, abscesses and pus-discharging fistulas that can have a major impact on quality of life.
    • “UCB is “thrilled” with the milestone, head of patient impact and chief commercial officer Emmanuel Caeymaex said in a company press release.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds.
    • “Many healthcare organizations are moving past early pilot successes to enterprise scaled solutions, but are balancing AI enthusiasm against pragmatism, according to the survey from Define Ventures of C-suite and senior executive leaders from more than 60 providers and payers.
    • “Define Ventures, a venture capital firm focused on early-stage health tech companies, conducted surveys and meetings with executives from 10 of the top 20 providers and three of the top 10 payers to check the industry’s pulse on AI adoption and investment. The survey took place from August through early November.”
  • Per BioPharma Dive,
    • “Pfizer on Wednesday said it will promote Chris Boshoff to chief scientific officer and president of research and development as the giant drugmaker struggles to win back the faith of investors.
    • “Boshoff will assume his new post on Jan. 1, succeeding Mikael Dolsten, who oversaw research at Pfizer for 15 years. The company announced Dolsten’s departure in July.
    • “Boshoff currently serves as chief oncology officer and is credited with delivering 24 approved new medicines and biosimilars during his 11-year tenure at the company. Boshoff has also worked as Pfizer’s head of development in Japan and as chief development officer for oncology and rare disease.”
  • Kauffman Hall discusses the misadventures of primary care.
  • Modern Healthcare reports,
    • “Three lawsuits filed against data analytics firm MultiPlan alleging antitrust law violations for reducing pay for out-of-network providers have been consolidated into one suit seeking class action status.
    • “The American Medical Association and the Illinois State Medical Society filed suit against the company in October in federal court in Illinois. Advanced Orthopedic Center, a medical practice in Poway, California filed its suit in June in federal court in New York. Orthopedic provider Dr. Curtis Robinson filed his suit in federal court in California.
    • “The complaints, all now in the U.S. District Court for the Northern District of Illinois, allege MultiPlan has contracts with 700 large insurers, which allows them to have unfair control of market rates for provider pay.” * * *
    • “A spokesperson for MultiPlan said the company intends to fight the allegations.

Weekend Update

From Washington, DC,

  • As we all know, the national election is Tuesday. The current Congress will return to Capitol Hill the following Tuesday November 12, to begin its lame duck session. The new Congress will begin on January 3, 2025.
  • In anticipation of the Federal Employee Benefits Open Season that begins on November 11, OPM has posted 2025 FEHBP and FEDVIP plan comparison tools on its website.
  • Modern Healthcare reports,
    • “Elevance Health is the latest Medicare Advantage insurer to dispute its star ratings quality scores in court.
    • “The health insurance company filed suit against the federal government in the U.S. District Court for the Northern District of Texas on Thursday. According to Elevance Health, the Centers for Medicare and Medicaid Services improperly assessed its quality performance, costing the insurer $375 million in bonus payments. The company won a case regarding its 2024-star ratings on different grounds, which led the agency to recalculate scores across the program.
    • “Elevance Health wants the court to order CMS to redo its ratings and to provide insurers with the data to “validate the 2025-star ratings calculations and future star ratings calculations,” according to its lawsuit. The insurer also seeks reimbursement the court deems appropriate.”

From the public health and medical research front,

  • CBS News asks and answers “Do I have COVID, the flu or something else? 2024 symptoms and testing to know.”
  • The New York Times lets us know,
    • “More than 80 percent of emergency departments in United States hospitals are not fully prepared for pediatric cases, a new study finds, despite the fact that children make up about 20 percent of visits each year.
    • “The new analysis, published Friday in the journal JAMA Network Open, estimated that if every emergency department in the United States had the core features of “pediatric readiness,” more than a quarter of the child deaths that follow E.R. visits could be prevented, a figure that equates to thousands of young lives each year.
    • “Even in the most ill-prepared states, the cost to ready every emergency room would be less than $12 per child living there, the researchers found.
    • “You can now find your state and see: How many children who would otherwise die could we expect to save if we implemented universal pediatric readiness at a high level?” said Dr. Craig Newgard, who was the lead author on the paper, and is the director of the Center for Policy and Research in Emergency Medicine at Oregon Health & Science University.”
  • The Washington Post informs us,
    • “Migraine is a surprisingly common problem, affecting an estimated 15 percent of the global population. Scientists don’t know how triggers lead to attacks but have made some progress in treatment: The latest drugs, inhibitors of a body signaling molecule called CGRP first approved for use in 2018, have been a blessing for many. For others, not so much. And it’s not clear why.”
    • * * * “Despite some failures, CGRP’s successes show that there’s hope for new medicines. CGRP has really paved the way,” says Andrew Russo, a neuroscientist at the University of Iowa in Iowa City who described CGRP as a new migraine target for the Annual Review of Pharmacology and Toxicology in 2015. “It’s a very exciting time for the field.”
  • Fortune Well informs us,
    • “Binge drinking is prevalent across generations, but the dangerous habit is growing among one age group in particular. 
    • “Long associated with college students, binge drinking, defined as having four or more drinks within two hours at least five times per month for women (five drinks for men) is on the rise among older adults. According to The National Survey on Drug Use and Health, 20% of adults aged 60 to 64, reported binge drinking in the last month. For those older than 65, the prevalence of binge drinking is 12%—a rate that has been increasing over the last decade, while binge drinking rates among young adults 18 to 25 have been going down.” * * *
    • “For more education on how to assess your—or a family member’s—drinking habits, visit the NIAAA Healthcare Professional’s Core Resource on Alcohol.”

From the U.S. healthcare business front,

  • Per Legal Dive,
    • “Pennsylvania’s attorney general sued Prospect Medical Holdings and its former parent company, alleging mismanagement by the hospital chain caused two hospital closures and widespread disruptions to patient care.
    • “The lawsuit Tuesday argues Prospect broke the terms of its 2016 purchase agreement of four-hospital system Crozer Health, which required Prospect to keep all acute care hospitals open for at least 10 years.
    • ‘In the suit, Attorney General Michelle Henry asks for a preliminary injunction barring Prospect from closing more hospitals and requests an official receiver step in and manage Crozer Health.”
  • Modern Healthcare tells us,
    • “Zoom, a company that rose to prominence during the COVID-19 pandemic, is looking to expand its presence in healthcare through artificial intelligence. 
    • “The company recently announced plans to incorporate ambient AI documentation technology from digital health company Suki in its clinical platform. Zoom plans to use the ambient AI technology, which turns a recording of a doctor-patient conversation into usable clinical notes in the electronic health record, for virtual and in-person visits. 
    • “It’s the latest move in healthcare from the video teleconferencing company, which has offered telehealth services since 2018.”
  • Per HR Dive,
    • “While the median salary increase stayed at 4% in 2024, average increases dropped from 4.3% to 3.9%, according to survey results collected by Salary.com from more than 1,000 HR professionals in the U.S. and Canada.
    • “The drop is due to fewer companies doling out higher raises, Salary.com found; only 14% of companies gave out raises between 5% and 6.9%, compared with 25% of companies in the previous survey. Additionally, more companies — 38% in 2024, compared to 25% in 2023 — returned to “typical” salary increases in the 3% to 3.9% range.
    • “Last year, we noted that salary increases might be at a peak, even with 4 percent becoming the norm,” Andy Miller, vice president of compensation consulting at Salary.com, said in an Oct. 29 news release. “While 4 percent remained the median in 2024, further analysis suggests a shift is happening.”