Thursday Report

Uncategorized

Thursday Report

David Ermer–ACA, CDC, FDA, Generative AI, Government Contracting, HSA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Mark Tegethoff on Unsplash

Happy first day of Spring!

From Washington, DC,

  • Per Becker’s Health IT,
    • The American Hospital Association and Health-ISAC are alerting hospitals to a social media post alleging plans for a coordinated, multi-city terrorist attack on healthcare facilities in the coming weeks.
    • The organizations said they are sharing the information as a precaution and remain in close contact with the FBI. They plan to provide updates as more details emerge, according to a March 20 news release.
    • The AHA and Health-ISAC said there is no information available to corroborate or discount the threat’s credibility.
    • “Generally, foreign terrorist groups do not publicize their upcoming attacks. However, this widely viewed post may encourage others to engage in malicious activity directed toward the health sector, so threats of this nature should be taken seriously,” the news release reads. “Security teams should review emergency management plans and spread awareness of the potential threat internally.”
  • Health Affairs Forefront offers reflections on the 15th anniversary of the Affordable Care Act, which will be marker on March 23, and an idea about how to add high deductible plans with health savings accounts to marketplace plans, which in the FEHBlog’s view is a great idea.
  • The American Hospital Association News tells us,
    • The Equal Employment Opportunity Commission and the Department of Justice yesterday announced the release of two documents warning against unlawful discrimination related to diversity, equity and inclusion in the workplace. A one-pager, “What To Do If You Experience Discrimination Related to DEI at Work,” and a Q&A, “What You Should Know About DEI-Related Discrimination at Work,” are based on Title VII, existing EEOC policy and Supreme Court precedent. 
    • “DEI is a broad term that is not defined in Title VII of the Civil Rights Act of 1964,” the agencies said. “In the past five years, DEI policies, programs, and practices have become increasingly prevalent in many of our nation’s largest and most prominent businesses, universities, and cultural institutions. The widespread adoption of DEI, however, does not change longstanding legal prohibitions against the use of race, sex, and other protected characteristics in employment.”
  • and
    • The Food and Drug Administration today issued an alert on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue.
  • Per an HHS news release,
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of chemical substances that may be present in food and that have the potential to cause harm.”
  • The President today signed an executive order implementing the following policy,
    • “The Federal Government spends approximately $490 billion per year on Federal contracts for common goods and services — the types of goods and services purchased by nearly every executive department and agency (agencies) — making it the largest buyer of goods and services in the world.  As a matter of sound management, these standardized procurement functions should be carried out in the most efficient and effective manner possible for the American taxpayer. The General Services Administration was established in 1949 through the Federal Property and Administrative Services Act, 40 U.S.C. 101 et seq., to provide “an economical and efficient system” for the core procurement services for agencies (40 U.S.C. 101).  It is time to return the General Services Administration to its original purpose, rather than continuing to have multiple agencies and agency subcomponents separately carry out these same functions in an uncoordinated and less economical fashion.”
  • Federal News Network discusses the EO here.
  • Bloomberg Law reports,
    • “The US Agriculture Department is preparing to spend as much as $100 million to combat bird flu by soliciting proposals for new poultry vaccines and virus detection methods.
    • “Officials plan to announce the funding opportunity for companies including vaccine manufacturers on Thursday, according to a USDA email obtained by Bloomberg Government and verified by two congressional staff granted anonymity to discuss the not-yet-public plan. 
    • “The solicitation announcement is expected to seek proposals that prevent, treat, or research bird flu infections, according to the Wednesday email signed by Tucker Stewart, the deputy assistant secretary for USDA’s Office of Congressional Relations.
    • “The money would be the agency’s latest step toward rolling out a $1 billion bird flu response plan that Agriculture Secretary Brooke Rollins announced in February. Rollins has downplayed the role vaccines will play in fighting the virus since announcing the strategy, citing high costs and low effectiveness rates.” 

From the public health and medical research front,

  • NBC News informs us,
    • “Prescriptions for ADHD medications have been spiking in recent years, with the sharpest increase among middle-aged and older women. They’re also the least likely to misuse the prescription stimulants, a new study found.
    • “The rise among women ages 35 to 64 has been substantial. At the end of 2022, 1.7 million women in this age group were prescribed stimulants such as Adderall and Ritalin for ADHD, compared to 1.2 million prescriptions in 2019.
    • “There’s been an overall jump in ADHD prescriptions since the pandemic and the rise of telehealth. The new analysis, published in JAMA Psychiatry by researchers at the National Institute on Drug Abuse, also looked into how the medications are being misused — that is, taking more of the drugs than prescribed, taking them at times that differed from what the doctor ordered or using medication from someone else’s prescription.” 
  • Cardiovascular Business points out,
    • “Using cannabis significantly raises a person’s myocardial infarction risk, even if they are young and otherwise quite healthy, according to the research team behind two new studies. The first is a retrospective analysis that was just published in JACC Advances, while the other is a meta-analysis being presented at ACC.25, the American College of Cardiology’s annual conference. 
    • “Asking about cannabis use should be part of clinicians’ workup to understand patients’ overall cardiovascular risk, similar to asking about smoking cigarettes,” Ibrahim Kamel, MD, clinical instructor at the Boston University Chobanian & Avedisian School of Medicine and the lead author of both studies, said in a statement. “At a policy level, a fair warning should be made so that the people who are consuming cannabis know that there are risks.”
    • “Kamel et al. performed a retrospective study of more than 4.6 million adults 50 years old or younger. All participants were free of significant cardiovascular comorbidities with no prior coronary artery disease. The average follow-up period was more than three years. Overall, the group found that cannabis use significantly increased a person’s risk of a myocardial infarction, ischemic stroke, heart failure and cardiovascular death.”
  • Per Healio,
    • “Markers of subclinical heart damage were observed among individuals who smoke cigarettes, even decades after quitting, according to a study published in the Journal of the American College of Cardiology.
    • “New data from the Cross-Cohort Collaboration-Tobacco Work Group showed that cigarette smoking was associated with elevated markers of inflammation, thrombosis and atherosclerosis, all of which decreased after cessation, except for coronary calcium, which remained elevated 30 years later.
    • “Understanding the mechanisms of smoking-related injury and the most sensitive biomarkers of subclinical harm is critical to clinical trial planning and tobacco regulatory policy, and might be important for planning studies and informing regulatory of new and emerging tobacco products as well,” Michael J. Blaha, MD, MPH, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Cardiovascular Disease at Johns Hopkins Medicine, told Healio. “The degree to which new and emerging tobacco products affect these same biomarkers will need to be explored.”
  • On the bright side, the Wall Street Journal illustrates how “Drug Overdoses Are on the Decline, in Charts. Fatalities from drugs including fentanyl are down from recent peaks.”
  • The AP reports,
    • “Nestle USA is recalling certain batches of its Lean Cuisine and Stouffer’s frozen meals for possible contamination with “wood-like material” after a report of potential choking. 
    • “The recall applies to limited quantities of meals with best-before dates between September 2025 and April 2026. They include Lean Cuisine Butternut Squash Ravioli, Lean Cuisine Spinach Artichoke Ravioli, Lean Cuisine Lemon Garlic Shrimp Stir Fry and Stouffer’s Party Size Chicken Lasagna. The products were distributed to major stores in the U.S. between September 2024 and this month. No products beyond those listed are affected. 
    • “Nestle officials said they are working with the U.S. Food and Drug Administration and the Agriculture Department and investigating the source of the wood-like material. The company said it launched the recall after consumers reported the problem, including at least one potential choking incident.”
  • Per Healio,
    • “Adults with insulin-treated type 2 diabetes had greater HbA1c reductions and larger improvement in time in range with use of an automated insulin delivery system compared with standard care, according to findings from a new trial.”
  • Per BioPharma Dive,
    • “On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene therapy Zolgensma.
    • “The drug, code-named OAV101, shares the same active ingredient as Zolgensma, which in 2019 gained U.S. approval for the treatment of a rare, muscle-wasting illness known as spinal muscular atrophy. Zolgensma, though, is injected into the veins, and is only cleared for use in patients under two years of age. Novartis has spent years trying to show OAV101, which is shot right into the spine, can be a safe and effective therapy for older kids.”

From the artificial intelligence front,

  • STAT News reports,
    • A panel of experts at a leading specialty society announced in a new clinical guideline that they have decided not to decide whether to recommend AI-assisted colonoscopies.
    • “After reviewing studies and using existing information to model outcomes, experts enlisted by the American Gastroenterological Association determined that using AI definitely increases adenoma detection rate (ADR), or colonoscopies that find polyps. But they figure, with low certainty, that using AI in screening only leads to 2 fewer colorectal cancer-related deaths per 10,000 people over 10 years. Citing a close call and fuzzy evidence, the panel decided not to issue a recommendation.”
  • MedTech Dive explains, “Quest, Google team on gen AI; GE Healthcare plans autonomous imaging; GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.” For details read the article.
  • RAND concludes “AI Models Are Skilled at Identifying Appropriate Responses to Suicidal Ideation, but Professionals Still Needed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “GE HealthCare launched its Invenia Automated Breast Ultrasound Premium system Thursday that features artificial intelligence tools.
    • “The system, which has premarket approval from the Food and Drug Administration, is designed to help better detect breast cancer in women with dense breasts.
    • “Detecting breast cancer in this patient population with mammography can be difficult for radiologists because both dense tissue and cancerous masses appear white in images, according to the American Cancer Society.
    • “Automated breast ultrasound produces clearer and more detailed images and has been shown in multiple studies to improve the sensitivity of detecting invasive cancer in dense breasts when used alongside mammography.”
  • and
    • “Post-acute care technology companies Medalogix and Forcura announced their merger Wednesday.
    • “The companies aim to create a platform for streamlining patient care transitions and better connect post-acute care providers to the broader healthcare system. Berkshire Partners, a Boston-based private equity firm, will be the majority owner of the combined company, which is not yet named, according to a news release. Chicago-based private equity firm The Vistria Group will be the largest minority shareholder, the release said.
    • “Financial terms of the deal were not disclosed.”
  • Per Fierce Pharma,
    • “Optum Rx is shifting its payment models to better meet the needs of pharmacies and consumers, the pharmacy benefit manager announced Thursday.
    • “The company said it will shift to a cost-based model, which will better align with “the costs pharmacies may face due to manufacturer pricing actions.” The PBM expects the change to be a positive one for the more than 24,000 independent and community pharmacies it works with, along with its members.
    • “Optum said it will begin to roll out the updated models now and intends to have a full implementation in place by January 2028.”
  • MedCity News lets us know,
    • “Evvy, a women’s health company, is now offering fertility insights through its vaginal microbiome test, the company announced on Tuesday.
    • “New York City-based Evvy is a direct-to-consumer company. Its vaginal microbiome test, starting at $129, checks for bacteria and fungi (or microbes) in people’s vaginas. After taking the test, people receive a report that explains the microbes found in the vagina and the health conditions related to those microbes. Based on the results, consumers receive a customized treatment plan and a one-on-one virtual session with a coach.
    • “Now, the test results include a section on fertility insights. Users of the test receive a “protective score,” which is a measure of protective bacteria like Lactobacillus. This is associated with improved fertility, lower inflammation and better pregnancy outcomes.”
  • Per BioPharma Dive,
    • “Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability to “reset” a patient’s immune system and ward off debilitating inflammatory diseases.
    • “The treatment, dubbed DR-0201, is known as a bispecific myeloid cell engager. It’s designed to engage specific immune cells that can prompt the body to deplete disease-causing B cells. It’s shown promise in preclinical and Phase 1 studies, Sanofi said. 
    • “As part of the deal announced Thursday, Sanofi agreed to pay as much as $1.3 billion more to privately held Dren Bio if DR-0201 succeeds in reaching certain development and launch goals. The French drugmaker expects to take over the DR-0201 program in the second quarter.”

Monday Report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg Law reports,
    • “Mehmet Oz, President Donald Trump’s nominee to lead the Centers for Medicare & Medicaid Services, used his Senate confirmation hearing Friday to tout the benefits of artificial intelligence to help streamline the prior approval process for Medicare managed care plans.
    • “But consumer policy watchers were immediately leery, noting the string of recent legal challenges stemming from AI-influenced coverage denials by Medicare Advantage plans.
    • “We are very concerned that increasing the use of AI will only make the prior authorization situation worse,” Alice Bers, litigation director at the Center for Medicare Advocacy, said in a statement.” * * *
    • “Sen. Tina Smith (D-Minn.) expressed similar concerns about lawsuits against MA insurers alleging use of AI to determine length of hospital stays and to deny claims. “This is a big concern,” Smith told Oz. “My view is that a human needs to have a final say in these decisions.”
    • “Oz said he agreed with Smith about the need for humans to make final coverage decisions. But Oz maintained that he thinks “AI can play a vital role in accelerating pre-authorization.”
    • “He also said the CMS should be using AI to identify insurers that are misusing the technology.”
  • Beckers Hospital Review adds,
    • “CMS will not change the Biden administration’s plan to negotiate prices for 15 previously named prescription drugs, and the agency’s next potential leader says he will defend the program in court.
    • “In January, CMS selected Ozempic, Rybelsus, Wegovy, Trelegy Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Breo Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, and Otezla to be included in the second round of negotiations aimed at reducing drug costs for Medicare beneficiaries. 
    • “On March 14, CMS said it had signed agreements with manufacturers, who will now participate in meetings and roundtables throughout 2025 to negotiate maximum fair prices for the 15 drugs, with final agreements due by Nov. 1.
    • “Mehmet Oz, MD, President Donald Trump’s pick for CMS administrator, told the Senate Finance Committee March 14 he would defend the negotiation program in court.
    • “It’s the law. I’m going to defend it and use it,” he said, adding that it is one of multiple approaches he would pursue to lower drug costs.
    • “The selected drugs account for approximately $41 billion in total spending under Medicare Part D between November 2023 and October 2024, or about 14% of Medicare Part D’s prescription drug costs, according to CMS. The negotiated prices for the drugs will take effect in 2027.”
  • HUB International tells us,
    • “Following on the enactment late last year of two bills to simplify employer reporting under the Affordable Care Act (“ACA”), the IRS has now released its first bit of guidance in the form of Notice 2025-15. The notice provides guidance on how employers can avoid providing individual Forms 1095-C to their employees. Perhaps unsurprisingly, it essentially piggybacks on existing guidance that applies to insurance carriers and other coverage providers.”
  • STAT News adds, “FTC highlights new concern over ‘pay-to-delay’ deals that determine when generics are sold. The agency noted restrictions on how many drugs a generic company may sell as part of a patent settlement.”
  • Per MedTech Dive,
    • “The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines.
    • “The letter said the disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
    • “The FDA linked to a letter B. Braun sent to customers in January. B. Braun said “additional supply and labor constraints over the holidays” had reduced production and it would run out of product on Jan. 20.”
  • Per Fierce Pharma,
    • “A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.
    • “The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls.” 

From the judicial front,

  • A panel of the U.S. Court of Appeals for the Ninth Circuit denied the Justice Department’s request for an immediate stay of the lower court’s decision to reinstate terminated probationary employees from six federal agencies. The panel set a briefing schedule on the Justice’s Department’s underlying motion to stay.
  • Bloomberg Law reports,
    • “Walmart Inc. is suing many of the nation’s largest pharmaceutical companies, alleging they colluded to inflate the price of hundreds of generic drugs and caused the retailer to pay more for the medications than it should have.
    • “Mylan Inc., Teva Pharmaceuticals USA Inc., and Glenmark Pharmaceuticals Inc. are among the defendant companies that exchanged drug price points and bid information as part of a conspiracy that specifically targeted Walmart, according to a nearly 700-page complaint filed Friday in the US District Court for the Eastern District of Pennsylvania.
    • “Walmart is one of the largest pharmacy providers in the US, purchasing hundreds of millions of dollars of prescription drugs every year. 
    • “The suit adds to similar cases against pharma companies brought by independent pharmacies, hospitals, and federal and state law enforcers.”
    • “The case is Walmart v. Actavis Elizabeth LLC, E.D. Pa., No. 2:25-cv-01383, 3/14/25″ 

From the public health and medical research front,

  • The Washington Post reports,
    • “By 2050, there will be an estimated 25.2 million people living with Parkinson’s disease worldwide, a 112 percent increase from 2021, according to a new study published in the journal BMJ.
    • “The World Health Organization estimated that 8.5 million people worldwide were living with Parkinson’s disease in 2019.
    • “Researchers used data from the 2021 Global Burden of Disease Study, pulling information from 195 countries and territories. They identified aging and population growth as the main contributors to the projected increase in Parkinson’s numbers, noting that growth rates would differ at regional and national levels.”
  • The American Medical Association lets us know what doctors wish their patients knew about pertussis.
  • MedPage Today tells us,
    • “A probiotic mixture reduced fever duration by 2 days versus placebo among children with upper respiratory tract infections.
    • “Probiotics have emerged as a new potential approach to managing infectious diseases.
    • “Adverse events were mild, and did not significantly differ between the two groups.
  • and fills us in on which adults need a measles booster in the U.S.
  • Beckers Hospital Review identifies the “10 most, least overweight and obese cities in the U.S.”
    • “McAllen, Texas, topped WalletHub’s 2025 ranking of the most overweight and obese cities in the U.S., published March 17, while Honolulu is the healthiest-weight city.”
  • Per a press release,
    • “The National Institute of Standards and Technology (NIST) has released a human stool reference material that will help scientists accurately measure the gut microbiome. The initiative aims to speed progress in a cutting-edge field of medical research targeting some of humanity’s most serious and intractable diseases.
    • “The human gut microbiome is a rich, teeming ecosystem of microorganisms and their byproducts that line the human gastrointestinal tract. Over the last decade, scientists have linked activity in the gut microbiome to obesity, diabetes, mental illness, cancer and other medical conditions. Researchers believe that a new class of drugs targeting the gut microbiome can treat many of these conditions.”
  • Per National Institutes of Health news releases,
    • “Surgical removal of enlarged tonsils and adenoids in children with mild sleep-disordered breathing (SDB) appears to significantly reduce the frequency of medical office visits and prescription medicine use in this group, according to a clinical study supported by the National Institutes of Health (NIH). The findings, published in JAMA Pediatrics, show that the surgery, called adenotonsillectomy, was tied to a 32% reduction in medical visits and a 48% reduction in prescription use among children with a mild form of the condition.”
  • and
    • In a preclinical study, rodents treated with uric acid showed improved long-term outcomes after acute ischemic stroke. The findings suggest that the treatment may work as an add-on therapy to standard stroke treatments in humans. The study was funded by the National Institutes of Health (NIH) and published in Stroke.
  • Consumer Reports, writing in the Washington Post, informs us about “Everything you need to know to keep your teeth healthy. Toothpaste matters, and you might want to consider adding a tongue scraper to your routine.”
  • Per BioPharma Dive,
    • “An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with several types of blood cancer by helping avert a potentially dangerous side effect. 
    • “According to clinical trial results announced by Orca on Monday, about three-quarters of people treated with the company’s T cell immunotherapy did not experience moderate-to-severe chronic graft-versus-host disease through one year, compared to only 38% of those given the standard transplant. 
    • “Graft-versus-host disease, or GvHD, is a serious complication of transplants involving cells sourced from matched donors. Orca aims to develop its therapy, which uses a purified mix of donor-derived T cells and stem cells, as a safer transplant alternative in cancers like acute myeloid leukemia.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Median hospital margins remained stable to kick off 2025, as many reported higher service volumes and expenses.
    • “Kaufman Hall’s “National Hospital Flash Report” revealed January median operating margins hit 4.4%, up from 3.7% in December and 0.6% last January. Without allocations, the median operating margin grew to 8%, a 12-month high. the averages are based on data from more than 1,300 hospitals and gathered by Strata Decision Technology. 
    • “January was a relatively stable month for hospitals, as more people received care due in part to seasonal challenges like flu and other respiratory diseases. Hospitals are also experiencing more rapid revenue growth from inpatient than outpatient services. Expenses are also rising, driven primarily by drug costs, though the rate of cost growth has slowed,” said Erik Swanson, managing director and group leader, data and analytics, of Kaufman Hall.”
  • Fierce Healthcare notes,
    • “Highmark Health reported $29.4 billion in revenue and $50 million in net income for 2024 as the organization continues to weather notable headwinds that have battered health insurers.
    • “Highmark also posted $209 million in operating losses, according to its earnings report released last week. The full year results “reflect the negative operating performance of Highmark Health Plans,” the company said in a press release, as the team faced cost pressures throughout the year.
    • “United Concordia Dental and HM Insurance Group, the company’s stop-loss division, were bright spots with steady performance. Highmark said that trend was backed by growing dental membership and a disciplined pricing approach.
    • “Its health system, Allegheny Health Network, also saw improvements as patient volumes increased across “all delivery areas.”
    • “While our consolidated revenue improved, we continue to face significant industry headwinds and medical cost trends, including high costs for prescription drugs, especially GLP-1s, the impact of Medicaid redeterminations and nationwide high utilization, especially within the Medicare Advantage portfolio,” said Carl Daley, chief financial officer and treasurer of Highmark Health.” 
  • Fierce Pharma points out “the top 10 drugs losing US exclusivity in 2025.”
    • “While each year features high-profile losses of exclusivity in the pharma industry, this year’s list is something of a doozy.”
  • The Wall Street Journal reports,
    • “Pfizer PFE had a problem. Doctors weren’t prescribing its migraine drug Nurtec because they assumed insurance coverage would be too much of a hassle.
    • “So last year the company created a phone line for doctors and patients to call Pfizer directly for help. Pfizer now credits that and other changes for a 31% increase in Nurtec’s U.S. sales last year.
    • “The beleaguered drugmaker’s shares still haven’t recovered from their post-Covid slump, and shareholders are wary. But sales of products such as Nurtec and the vaccine Abrysvo that the company has been counting on are rising, and an activist shareholder’s push has lost steam. 
    • “Pfizer did it by shaking up its U.S. sales strategy, shifting where it deploys its sales representatives, how they market to doctors and how the company helps patients pay for their prescriptions.”
  • Per Modern Healthcare,
    • “Scripps Health plans to build a $1.2 billion medical campus that will include a 200- to 250-bed hospital and outpatient facilities.
    • “The San Diego-based health system’s board last week approved the 13-acre development in San Marcos, California. The first phase of the project will feature space for specialty and primary care offices, ambulatory surgery, cancer care, imaging, lab and other services, and the second phase includes the hospital, according to a Monday news release.
    • “The outpatient center will be built in two to three years, and the hospital will take about six years, a spokesperson estimated.”
  • and
    • “Sharon Regional Medical Center is set to reopen Tuesday, about two months after the former Steward Health Care facility in Pennsylvania closed.
    • “On Friday, the Pennsylvania Department of Health approved Pasadena, California-based Tenor Health Foundation’s plans to reopen the 163-bed hospital. In January, Judge Christopher Lopez of the U.S. Bankruptcy Court for the Southern District of Texas in Houston signed off on the hospital management company’s takeover of the facility, which employed more than 800 workers“
  • From BioPharma Dive,
    • “AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.
    • “The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.”

Monday Report

David Ermer–Uncategorized–
Photo by Sven Read on Unsplash

From Washington DC,

  • Roll Call discusses events occurring on Capitol Hill this week.
  • STAT News reports,
    • “Marty Makary, President Trump’s pick to be Food and Drug Administration commissioner, promised to step down as an adviser to various health tech, medical device, and telehealth startups if confirmed, and to sell off stock holdings in the companies as well, according to financial disclosures filed ahead of his confirmation hearing. 
    • “According to the disclosures, Makary does not hold stock in any large pharmaceutical companies, unlike some previous FDA commissioners, including the last individual to hold that office, Robert Califf. Makary’s financial ties include holdings in a telehealth company that sells compounded drugs, a clinical stage company developing drugs for tissue injury, and a medical device company focused on cataract surgery.” 
  • Govexec lets us know,
    • “Some federal agencies are continuing to fire their recently hired or newly promoted staff despite a court ruling that deemed the justification for those firings unlawful, while others are responding to that decision by rehiring those they had already terminated. 
    • “A federal judge last week said the Trump administration—through the Office of Personnel Managment—directing the mass firings of employees on their probationary periods was illegal, though the judge did not directly call for the terminations to cease or for agencies to recall those they had already let go. The ruling applied to only a handful of agencies whose employees were party to the case brought by the American Federation of Government Employees and other groups.”
  • Here’s a Dropbox link to the Court decision issued last Friday.  
  • Per a press release,
    • The Institute for Clinical and Economic Review (ICER) today posted a Special Report evaluating the evidence of two Chronic Obstructive Pulmonary Disease (COPD) treatments, Trelegy Ellipta® and Breo Ellipta®, that will be sent as its public comment submission to Centers for Medicare & Medicaid Services (CMS) as part of its work on Medicare drug price negotiations. Both of the inhaler therapies were developed by GSK.
    • Downloads: Final Report 
    • “Over 15 million people in the United States suffer from COPD. Our special report focuses on the medical evidence and value of these two inhalers, specifically for COPD,” said ICER’s President and CEO Sarah K. Emond, MPP. “We recognize that our report will be one of many inputs CMS may consider, and we hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”
  • Per Fierce Pharma,
    • “Over nearly the last three decades, Genentech has had the lone medicine on the market for the acute treatment of stroke. Monday, the Roche subsidiary added a second stroke treatment to its repertoire, gaining an FDA endorsement for TNKase (tenecteplase).
    • “The tissue plasminogen activator, clot-dissolving, thrombolytic medicine has been approved for adults with acute ischemic stroke (AIS). TNKase can be shot into the arm in five seconds, making it a faster treatment option compared to its forerunner, Activase (alteplase), which was approved for heart attack in 1987 and for stroke in 1996. Activase is administered as an IV bolus followed by a 60-minute infusion.
    • “TNKase is not a new treatment. It was approved in 2000 to reduce the risk of death from heart attack—acute ST elevation myocardial infarction—which is what happens when a coronary artery is completely blocked.
    • “Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of global product development, said in a statement. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about atrial fibrillation.
  • The Wall Street Journal reports,
    • “Emulsifiers, used to improve food texture, have been linked to health risks such as heart disease, Type 2 diabetes, and some cancers.
    • “Research suggests that emulsifiers alter the gut microbiome, leading to inflammation and potentially contributing to chronic diseases.
    • “Consumers can reduce the potential health risks of emulsifiers by avoiding ultra-processed foods and opting for certain natural emulsifiers like soy lecithin over synthetic ones like carboxymethylcellulose.”
  • Per an NIH news release,
    • “A clinical trial has found that the medication omalizumab, marketed as Xolair, treated multi-food allergy more effectively than oral immunotherapy (OIT) in people with allergic reactions to very small amounts of common food allergens. OIT, the most common approach to treating food allergy in the United States, involves eating gradually increasing doses of a food allergen to reduce the allergic response to it. Thirty-six percent of study participants who received an extended course of omalizumab could tolerate 2 grams or more of peanut protein, or about eight peanuts, and two other food allergens by the end of the treatment period, but only 19% of participants who received multi-food OIT could do so. Researchers attributed this difference primarily to the high rate of allergic reactions and other intolerable side effects among the participants who received OIT, leading a quarter of them to discontinue treatment. When the participants who discontinued therapy were excluded from the analysis, however, the same proportion of each group could tolerate at least 2 grams of all three food allergens.
    • ‘The findings were published in an online supplement to The Journal of Allergy and Clinical Immunology and presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress in San Diego on Sunday, March 2, 2025.
    • “People with highly sensitive multi-food allergy previously had only one treatment option—oral immunotherapy—for reducing their allergic response to moderate amounts of those foods,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), the study’s funder and regulatory sponsor. “This study shows that omalizumab is a good alternative because most people tolerate it very well. Oral immunotherapy remains an effective option if treatment-related adverse effects are not an issue.”
  • Per Health Day,
    • “Many young women entering menopause suffer needlessly from symptoms related to the transition, a new study suggests.
    • “More than half of women aged 30 to 35 have already developed moderate to severe symptoms of impending menopause, researchers found.
    • “These include mood swings, delayed or absent periods, hot flashes, vaginal dryness, painful sex, heart palpitations and frequent urination.
    • “Unfortunately, most wait decades before seeking treatment, under the mistaken belief that menopause symptoms that shouldn’t appear until their 50s, researchers said.”
  • NFP adds,
    • “Mayo Clinic research reveals that menopause-related symptoms cost an estimated $1.8 billion in lost work time annually in the US, with total costs reaching $26.6 billion when medical expenses are included.
    • “Understanding how menopause affects women in the workplace has become crucial, as the study found that 13% of women experienced adverse work outcomes related to menopause symptoms, with 11% missing workdays specifically due to these symptoms. 
    • “Despite affecting approximately 17.5% of the US workforce, menopause in the workplace remains one of the most overlooked aspects of workplace health policy. With substantial financial implications, this oversight of menopause employee benefits is no longer sustainable in today’s competitive talent market.”
  • Per Fierce Pharma,
    • “AstraZeneca and Daiichi Sankyo’s Enhertu has become the first HER2-directed drug to mount a patient survival benefit in a randomized clinical trial in second-line metastatic stomach cancer, the partners said on Monday.
    • “Enhertu significantly extended the lives of patients with previously treated HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in the phase 3 Destiny-Gastric04 study, according to the partners’ press release. For the study, investigators pitted the HER2-targeted antibody-drug conjugate against Eli Lilly’s VEGFR inhibitor Cyramza and chemotherapy.
    • “An independent data monitoring committee noted the “statistically significant and clinically meaningful” overall survival improvement during a planned interim analysis and recommended unblinding the trial, the companies said Monday. 
    • ‘The latest trial win won’t affect Enhertu’s regulatory status in the U.S. Back in 2021, the FDA approved Enhertu in stomach cancer following prior treatment with a trastuzumab (Herceptin)-based regimen. That second-line nod was based on results from the phase 2 Destiny-Gastric01 trial in a third-line setting, which showed that Enhertu reduced the risk of death by 41% versus chemotherapy alone.”
  • and
    • “Already billed as a potential blockbuster, Amgen and AstraZeneca’s Tezspire has turned in strong clinical data in chronic rhinosinusitis with nasal polyps (CRSwNP). 
    • “Tezspire showed numerically better efficacy results in CRSwNP compared with two prominent rivals in the three drugs’ separate studies. However, separate teams of analysts at William Blair and Leerink Partners stopped short of handing Tezspire the crown in the indication, citing trial design differences that likely play into the cross-trial comparisons.
    • “As Amgen and AZ previously announced, Tezspire significantly improved total nasal polyp score (NPS) and nasal congestion score (NCS) in patients with CRSwNP compared with placebo after 52 weeks in the phase 3 Waypoint study.”

From the U.S. healthcare business front,

  • Fierce Healthcare announced its Fierce 15 [healthcare innovators] of 2025.
  • BioPharma Dive informs us,
    • “AbbVie is joining the industry’s rush to develop new obesity medicines, announcing Monday a deal with Denmark-based Gubra to license a drug that could compete with experimental therapies being developed by Novo Nordisk, Eli Lilly and Zealand Pharma.
    • “Per deal terms, AbbVie will pay Gubra $350 million up front and offer up to $1.9 billion in additional payments tied to the achievement of development and sales milestones. AbbVie will assume responsibility for development and commercialization.
    • “Gubra is developing a type of drug called an amylin analog that regulates appetite and blood sugar levels. If successful, these drugs could be used as alternatives to or in combination with marketed drugs like Novo’s Wegovy and Lilly’s Zepbound to increase weight loss or reduce side effects.”
  • Modern Healthcare reports,
    • “UnitedHealth Group is taking another step to refine its prior authorization requirements as it continues to face public frustration.
    • “The healthcare giant’s insurance business, UnitedHealthcare, plans to cut nearly 10% of prior authorizations this year, the company said in a notice Saturday.
    • “As part of the initiative, the insurer said it will remove pre-approval requirements for home health services managed by its home and community division. The changes will apply to Medicare Advantage and dual special needs plans in 36 states and Washington, D.C., starting April 1.”
  • and
    • “Mayo Clinic is investing nearly $1.9 billion in its Phoenix campus as part of the Bold. Forward. Unbound. strategy being implemented across the system’s multistate footprint.
    • “The project covers 1.2 million square feet, including a new procedural building, an expanded specialty care building, 11 new operating rooms and two new patient units that support 48 beds, according to a Monday news release.
    • “A two-story indoor promenade will wrap around the front of the campus, and complementary clinical services will be clustered together in so-called care neighborhoods, according to the release. Mayo Clinic is starting the design phase this year and expects to complete the project in 2031.
    • “The project will increase the campus’ clinical space by nearly 60%, Dr. Richard Gray, CEO of Mayo Clinic in Arizona, said in the release.”
  • Beckers Hospital Review offers an interesting interview. Here’s the background:
    • “Since 2021, St. Louis-based Ascension has reduced risk-adjusted mortality by more than 20% across 88 hospitals through its Recognize and Rescue initiative, a systemwide effort to support care teams in identifying high-risk conditions and intervening quickly to prevent clinical deterioration. 
    • “Over a three-year period, the program prevented more than 4,000 deaths, outpacing a group of nearly 1,100 peer hospitals by 12%, according to findings recently published in The Joint Commission Journal on Quality and Patient Safety.
    • “This is an incredible achievement for Ascension,” Mohamed Fakih, MD, Ascension’s chief quality officer, said. 
    • “Becker’s recently spoke to Dr. Fakih to learn more about how the health system implemented Recognize and Rescue, what made it successful and how its structure can be applied to other quality initiatives.”

Friday Report

David Ermer–Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Fierce Healthcare tells us
    • “Friday morning, the HHS uploaded a policy statement that is set to be published in the Federal Register on March 3.
    • “Bylined by the secretary, it says the department is no longer required to undergo a public comment period it typically observes following the publication of proposed rulemaking in “matters relating to agency management or personnel or to public property, loans, grants, benefits or contracts.”
  • The FEHBlog has often wondered why CMS circulated draft Medicare Advantage call letters for public comment but OPM hasn’t circulated draft FEHB / PSHB call letters. This article explains why, but HHS is doing away with this practice.
  • Federal News Network informs us,
    • “SSA will offer employees voluntary separation incentives and early retirement options as part of a major reorganization.
    • “Through these massive reorganizations, offices that perform functions not mandated by statute may be prioritized for reduction-in-force actions that could include abolishment of organizations and positions, directed reassignments and reductions in staffing,” SSA stated in a Feb. 27 release. “The agency may reassign employees from non-mission critical positions to mission critical direct service positions (e.g., field offices, teleservice centers, processing centers). Reassignments may be involuntary and may require retraining for new workloads.”
    • “SSA says it’s looking to shed about 7,000 workers. The latest data from last March says SSA had 56,645 employees, up slightly from 2023 and down from 66,967 in 2010.”
  • Yesterday, OPM reminded FEHB plan carriers,
    • [A]n enrollee whose FEHB enrollment is terminated, other than by cancellation or discontinuance of the plan, is entitled to a 31-day extension of coverage without contributions by the enrollee or the Government. This applies to Self Only, Self Plus One, or Self and Family enrollments.   See 5 CFR 890.401(a)(1).  Carriers must provide the 31-day extension of coverage beyond the coverage end date provided by employing agencies in the SF-2810 action to all terminated enrollments cited in the regulation.”  
  • Cardiovascular Business lets us know,
    • “The U.S. Food and Drug Administration (FDA) has announced a new recall for the ablation catheters associated with Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) system. No devices need to be returned or removed from the market. Instead, the FDA is urging all customers to read updated instructions provided by Johnson & Johnson MedTech. 
    • “The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack shortly after treatment. The expected stroke rate is closer to 1%, the FDA explained, prompting this action. 
    • “In total, four serious injuries have been linked to this issue.
    • “This is a Class I recall, which means the FDA believes patients face a risk of serious injury or death if they use the devices without reviewing the updated instructions.” 

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for two consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for two consecutive weeks. Data to date suggests the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • The University of Minnesota’s CIDRAP adds,
    • “Newly confirmed US Department of Agriculture (USDA) Secretary Brooke Rollins, JD, [on February 26] introduced new steps to battle avian flu in poultry and stabilize the egg supply, which includes $500 million to help poultry producers shore up biosecurity measures.
    • “Earlier this week, Rollins met with egg producers during a tour of an egg-laying facility in Texas, and today she detailed USDA’s strategy in an opinion piece in the Wall Street Journal. The USDA also detailed the plan today on its website.
    • “Since 2022, the H5N1 avian flu virus has led to the loss of more than 166 million poultry, including 19 million over the past 30 days. Outbreaks over the fall and winter have hit poultry farms hard, especially layer facilities in some of the top egg-producing states, such as Ohio.” 
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. said ending the measles outbreak in Texas is a top priority for him and listed the steps his agency had taken to combat the spread of disease, including supporting the state’s vaccine efforts.
    • “I recognize the serious impact of this outbreak on families, children, and healthcare workers,” Kennedy wrote Friday in a post on X.
    • “There have been at least 155 measles cases linked to the outbreak across West Texas and New Mexico, local health officials said Friday. Twenty patients have been hospitalized, and one school-age child died this past week. Most of those sickened weren’t vaccinated, or their vaccination status wasn’t known. 
    • “Kennedy said HHS had provided lab support to track the virus, offered technical assistance to local public health officials and updated federal advice on doctors offering vitamin A to manage measles cases.
    • “HHS communicated about the disease in Low German to the affected population in Texas’ Gaines County, Kennedy said, where the outbreak was concentrated among Mennonites.”
  • Medscape relates,
    • “For decades, physicians had little to offer patients who have heart failure with preserved ejection fraction (HFpEF), which is a growing global health problem with a grim death rate in the 5 years after diagnosis. But that started to change in 2021, when a drug trial showed benefits in preventing hospitalization and death.
    • “And each year since, has brought a new clinical trial that shows the value of yet another drug for HFpEF.
    • “It’s so wonderful,” said Michelle Kittleson, MD, PhD, professor of cardiology at the Smidt Heart Institute at Cedars-Sinai in Los Angeles and chair of the writing committee for the latest American College of Cardiology (ACC) update to the HFpEF management pathway.”
  • The Wall Street Journal points out “New Treatments Give Hope to Patients with One of the Deadliest Cancers. Half of all pancreatic cancer patients live less than a year after diagnosis. But researchers say there is potential for change.”
  • The American Hospital Association News tells us,
    • “A study published Feb. 26 by JAMA Psychiatry found that female physicians died by suicide at more than 1.5 times the rate of female nonphysicians from 2017-2021. During the same time, male physicians had a lower suicide risk than male nonphysicians. The study also found that physicians who died by suicide had higher odds of depressed mood and mental health, job and legal problems preceding suicide compared to the general population. 
    • “The AHA has a dedicated webpage with resources on preventing suicide in the health care workforce.”
  • Per MedPage Today,
    • “Rates of pancreatitis and liver-related complications from alcohol have increased in teens and young adults.
    • “Males were most affected, yet young females had changes in rates that were higher than males.
    • “These findings suggest a need for addiction medicine training in gastroenterology.”
  • and
    • “Diabetes prevalence in U.S. adults over the past decade has remained stable, with a small non-significant increase.
    • “HbA1c and rates of glycemic control significantly worsened from 2017-2020 to 2021-2023, with changes concentrated in adults ages 20 to 44.
    • “The changes observed in HbA1c and glycemic control among these younger adults would be expected to increase their lifetime risk of cardiovascular events, according to the researchers.”
  • and
    • “To improve mental health, risk factors related to “social determinants” like food insecurity or inadequate housing need to be addressed, according to some health experts. But even doing that doesn’t go far enough upstream, said one psychiatrist here on Thursday.
    • “It’s not enough to intervene at the level of the risk factors — [if you do], you’re actually intervening too late,” said Ruth Shim, MD, MPH, a professor of cultural and clinical psychiatry at the University of California Davis in Sacramento. “So, I started looking into and trying to understand what is actually happening before the risk factor.”
    • “Those upstream factors are sometimes known as the “causes of the causes,” Shim said at an event sponsored by the Johns Hopkins Center for Mental Health and Addiction Policy. “What’s the context that’s going to set you further upstream from the risk factor?”
    • “The answer is that there are two “very fundamental issues,” she noted. “Social norms, or the belief in common society, about who in our society is worthy of value and who is less worthy of such value, who in our society deserves advantage, and who is less deserving of this advantage. And what are the public policies or the laws that we pass that reflect those belief systems? Because those laws that we pass then create unfair and unjust distribution of opportunity, which set into motion the social determinants of mental health, which then lead to the risk factor, which then leads to poor outcomes.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Universal Health Services’ net income soared in 2024, rising to $1.1 billion from $717.8 million in 2023 on strong demand for services, particularly in the operator’s behavioral health division.
    • ‘The Pennsylvania-based hospital operator plans to expand its behavioral health offerings next year to drive revenue growth, with a specific focus on outpatient services, executives said on a Thursday earnings call.
    • “UHS expects to take in between $17 billion and $17.4 billion in net revenue in 2025. However, the company is contending with several possible headwinds, including potential healthcare policy changes in Washington, which could impact the company’s bottom line.”
  • Beckers Payer Issues informs us,
    • “Blue Cross Blue Shield of Massachusetts reported a $400 million operating loss in 2024, driven by spending on GLP-1 medications and other rising medical costs. 
    • “The nonprofit insurer reported its financial results for 2024 on Feb. 28. The company posted a -4.3% operating margin in 2024, compared to a 0.4% margin in 2023. 
    • “In a news release, CFO Ruby Kam said medical costs are rising at the fastest rate in more than a decade. Costs are rising across almost every category of services, but GLP-1 drugs have had the single largest impact, she said. GLP-1 drugs accounted for nearly 20% of the insurers’ pharmacy spending in 2024. 
    • “The insurer is repricing its plans to reflect higher costs and cutting administrative spending, including through hiring freezes and eliminating some jobs, according to the release. 
    • “In a statement, CEO Sarah Iselin said the company does not expect the trend to change any time soon.” 

AI News

  • Fierce Healthcare reports,
    • “Last week at the ViVE conference in Nashville, two topics seemed to dominate most conversations—artificial intelligence and the impending snowstorm. (Music City got about two inches of snow.)
    • “According to many executives who attended the digital health-focused conference, AI took the main stage at ViVE and discussions about adoption and use of the technology in healthcare has evolved significantly in just the past year.
    • “Many conversations centered around AI agents and sophisticated prompt engineering. Compared to HLTH, where conversations felt more theoretical, vendors and healthcare customers were speaking about concrete use cases. For a while now people healthcare incumbents have had robotic process automation, then intelligent automation and now AI on their roadmaps. It seems we’ve finally arrived at the final destination and most are piloting different AI tech now,” Neil Patel, Redesign Health’s head of ventures told Fierce Healthcare.”
  • Per Healthcare Dive,
    • “A private-public partnership formed to create standards for artificial intelligence adoption in healthcare is launching a new registry for hospitals and developers to access and share information on AI tools.
    • “The hub, known as a model card registry, was unveiled by the Coalition for Health AI (CHAI) and health system members of the group, including Providence, Cleveland Clinic and Kaiser Permanente, on Friday. The goal of the registry is to make it easier for healthcare companies to evaluate and shop between validated AI products, CHAI said.
    • “AI companies and other developers can input their tools into the registry regardless of whether they’re a member of CHAI, according to a spokesperson. There’s no cost to upload model cards or access the registry, though it could include paywalled features in the future, they said.”
  • and
    • “Cloud-based software company Salesforce is rolling out a library of prebuilt artificial intelligence tools meant to make it easier for providers, payers and other healthcare companies to apply digital labor to time-consuming tasks.
    • “Salesforce’s “Agentforce for Health” relies on agentic AI, which unlike older AI assistants can operate relatively autonomously.
    • “The product includes patient access and services capabilities, including answering questions and checking patient eligibility with insurers; public health capabilities, like helping organizations monitor the spread of infections; and clinical capabilities to accelerate research and development for drugs and medical devices.”

Thursday Report

David Ermer–CDC, Congress, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

Capitol Hill News

  • Roll Call reports,
    • “House GOP leaders cleared an important hurdle Thursday morning after cutting a deal with Freedom Caucus holdouts on a budget resolution amendment that would lock in a mechanism to enact deeper spending cuts in exchange for bigger tax cuts.
    • “The agreement paved the way for Budget Committee approval later in the day Thursday of the fiscal 2025 blueprint needed to unlock their “big, beautiful” reconciliation bill. House Republicans want to use the filibuster-proof process to enact large pieces of their legislative agenda, including extensions of the expiring 2017 tax cuts, domestic energy production incentives, immigration enforcement and defense spending.”
  • The American Hospital Association (AHA) News lets us know, “The Senate Feb. 13 by a vote of 52-48 confirmed Robert F. Kennedy Jr. as the new secretary of the Department of Health and Human Services.” 
  • An HHS news release adds
    • “Robert F. Kennedy, Jr. today was sworn in as the 26th Secretary of the U.S. Department of Health and Human Services (HHS) in the Oval Office by Associate Justice of the Supreme Court Neil Gorsuch.
    • “Immediately following the ceremony, President Trump with Secretary Kennedy by his side, signed the “Establishing the President’s Make America Healthy Again Commission” Executive Order to investigate and address the root causes of America’s escalating health crisis, with a focus on childhood chronic disease.”
  • The Journal of Accountancy informs us,
    • “A bill to extend the deadline for an estimated 32 million small businesses to report their beneficial ownership information (BOI) as mandated by the Corporate Transparency Act (CTA) passed the U.S. House unanimously.
    • “The House passed H.R. 736, Protect Small Businesses From Excessive Paperwork Act of 2025, 408–0, on Monday. The bill, which goes to the Senate next, extends the deadline for filing BOI reports to Jan. 1, 2026. The deadline for most reports previously was Jan. 1, 2025, but the reporting requirements have been caught up in numerous court cases and are now on hold.
    • “A companion bill was introduced Tuesday in the Senate by Tim Scott, R-S.C., the chairman of the Senate Banking Committee.
    • “This is a simple solution that we’ve worked on together, and it’s one of the most pressing concerns small businesses face,” Rep. Zach Nunn, R-Iowa, who sponsored the bill, said on the House floor before the vote. “So, whether you’re a Democrat or a Republican, we all have small businesses and a hometown responsibility to fight for them today.”
    • “Both bills affect only reporting companies existing before Jan. 1, 2024. Companies formed after that date are not affected.
    • “Melanie Lauridsen, the AICPA’s vice president–Tax Policy & Advocacy, said in a LinkedIn post that the proposed deadline extension is “hopeful information” – despite the possibility of court rulings changing reporting requirements at any moment.”

White House news

  • The AHA News tells us,
    • “President Trump Feb. 13 signed an executive order establishing the Make America Healthy Again Commission, to be chaired by Department of Health and Human Services Secretary Robert F. Kennedy Jr. The commission is tasked with “investigating and addressing the root causes of America’s escalating health crisis, with an initial focus on childhood chronic diseases.” 
    • “The commission has four main policy directives to reverse chronic disease:  
      • “Empower Americans through transparency and open-source data and avoid conflicts of interest in all federally funded health research. 
      • “Prioritize gold-standard research on why Americans are getting sick in all health-related research funded by the federal government. 
      • “Work with farmers to ensure that U.S. food is healthy, abundant and affordable. 
      • “Ensure expanded treatment options and health coverage flexibility for beneficial lifestyle changes and disease prevention. 
    • “Within 100 days, the White House said the commission will produce an assessment that summarizes what is known and what questions remain regarding the childhood chronic disease crisis, and within 180 days, the commission will produce a strategy, based on the findings of the assessment, to improve the health of America’s children.”
  • For those interested, here is a link to the new DOGE website.
  • The Washington Post reports,
    • “The Trump administration on Thursday moved swiftly to fire thousands of workers and directed agency heads to terminate most trial and probationary staff — a move that could affect as many as 200,000 employees, according to four people familiar with internal conversations who, like others interviewed for this report, spoke on the condition of anonymity because they are not authorized to speak publicly.
    • “It was not immediately clear how many of those hired by the federal government within the last two years would be affected. One person familiar with the matter said some employees, such as those working on public safety and law enforcement issues, would be spared, and agency heads could exempt others.”
  • Govexec adds,
    • “Recent hires at the Office of Personnel Management were terminated on Thursday afternoon, according to three people familiar with the matter and internal communications obtained by Government Executive.
    • “The firings come as agencies across government are purging employees in their probationary status from their rolls and the Trump administration is deploying a bevy of tools to slash their workforces. 
    • “On President Trump’s first day in office, OPM instructed agencies across government to collect names of probationary employees. Those workers typically were hired within the last one-to-two years, depending on their hiring mechanism. Agencies have since gathered lists of those employees and delivered them to OPM, and some subsequently sent notices to staff reminding them of their status and their vulnerability to rapid firings. 
    • “Recent hires in probationary status do not maintain the same protections against firings as do most other federal workers, though they can still appeal to the Merit Systems Protection Board if they allege the firings took place for partisan political reasons.”

From the judicial front,

  • The Associated Press via MedPage Today relates,
    • “A federal judge on Thursday temporarily blocked President Donald Trump’s recent executive order aimed at restricting gender-affirming healthcare for transgender people under age 19.
    • “The judge’s ruling came after a lawsuit was filed earlier this month on behalf of families with transgender or nonbinary children who allege their healthcare has already been compromised by the president’s order. A national group for family of LGBTQ+ people and a doctors organization are also plaintiffs in the court challenge, one of many lawsuits opposing a slew of executive orders Trump has issued as he seeks to reverse the policies of former President Joe Biden.
    • “Judge Brendan Hurson, who was nominated by Biden, granted the plaintiffs’ request for a temporary restraining order following a hearing in federal court in Baltimore. The ruling, in effect for 14 days, essentially puts Trump’s directive on hold while the case proceeds. The restraining order could also be extended.”

From the public health and medical research front,

  • The New York Times reports,
    • “Three dairy veterinarians, including one who worked only in states with no known bird flu outbreaks in cows, had recent, undetected bird flu infections, according to a new study from the Centers for Disease Control and Prevention. The results are based on antibody testing of 150 veterinarians working in 46 U.S. states.
    • “The findings were not entirely surprising, experts said, but did suggest that the virus, known as H5N1, could be infecting cows and people in more states than have been officially reported.
    • “We do not know the extent of this outbreak in the U.S.,” said Seema Lakdawala, a virologist at Emory University. “There are clearly infections happening that we’re missing.”
    • “Since the bird flu outbreak in dairy cows was first reported last March, the virus has been confirmed in more than 950 herds in 16 states. It has also been detected in 68 people, 41 of whom had contact with sick cows. Most people have had mild symptoms.”
  • The American Medical Association lets us know “What doctors wish patients knew about UTI prevention.”
  • The National Cancer Institute released Cancer Information Highlights about “Fructose Fuels Cancer Growth | Lung Cancer Stigma | Multiple Myeloma.”
  • The National Institutes of Health posted “Research in Context: Detecting Cancer.”
  • Per MedPage Today,
    • “The blood test achieved high accuracy, with 98% specificity and 73% sensitivity for detecting pancreatic cancer.
    • “When combined with CA 19-9 biomarker testing, the sensitivity increased to 85% while maintaining high specificity.
    • “The test successfully differentiated between cancer and non-cancer pancreatic conditions using protease activity detection.”
    • “Integrating an early test for pancreatic cancer into clinical practice will be difficult, Suneel Kamath, MD, of the Cleveland Clinic, continued. Although incidence and mortality continue to increase, the cancer is much less common than breast, colon, and lung cancers. In addition to targeting high-risk populations, another possible strategy would be a one-time screening at a certain age.
    • “Early-stage pancreatic cancer still carries a poor survival rate of just 44% at 5 years,” he told MedPage Today. “The majority of people with stage I or II pancreatic cancer will die of their cancer in the first 5 years after diagnosis. For breast, colorectal, and prostate cancers, those rates are over 90%, often over 95%, so we will not screen our way into curing pancreatic cancer. We will have to find better ways to treat it once it has occurred too because early detection alone is not enough.”
  • and
    • Epidural steroid shots for back pain had mixed results, an AAN review showed.
    • The treatment demonstrated promising short-term benefits for radiculopathy patients.
    • In other situations, benefits were unclear or limited.

From the U.S. healthcare business front,

  • Beckers Payer Issues offers more observations on how “CVS is working ‘tirelessly’ to improve Aetna.”
  • Healthcare Dive points out,
    • “Tenet Healthcare brought in profits of $3.2 billion in 2024, up from $611 million in 2023, on strong same-store revenue, growth in high-acuity care and effective cost management strategies, health system executives said during an investor call Wednesday.
    • “The earnings performance was stronger than expected based on Tenet’s full year guidance, which the company updated midway through the year.
    • “Still, Tenet faced challenges during the fourth quarter and underperformed on operating revenue compared to Wall Street’s expectations. Analysts also pressed executives during the call about the health system’s plans to weather possible regulatory changes in Washington moving forward, including proposed cuts to the Medicaid program.”
  • Per Fierce Pharma,
    • “As Alnylam Pharmaceuticals approaches its highly anticipated March 23 FDA decision date for a potential expansion of Amvuttra to treat patients in an increasingly competitive indication—transthyretin amyloid cardiomyopathy (ATTR-CM)—the company is emphasizing market dynamics.
    • “The category is rapidly growing and it’s been largely underserved,” Tolga Tanguler, Alnylam’s chief commercial officer said during a conference call Thursday.” This will be a market-growth story.”
    • “After Alnylam divulged last month at the J.P. Morgan Healthcare Conference that it expects Onpattro and Amvuttra to generate between $1.6 billion and $1.7 billion in 2025, there was little suspense left in Thursday’s fourth-quarter earnings presentation about the company’s expectation for its potential launch into the new indication.”
    • “The projection compares to the ATTR franchise’s combined 2024 sales of $1.23 billion, including $970 million for Amvuttra, which nearly achieved blockbuster status in just its second full year on the market.”

Weekend Update

David Ermer–Uncategorized–

From Washington, DC

  • The President’s nominee for Secretary of Health and Human Services, Robert F. Kennedy, Jr., will attend a Senate Finance Committee confirmation hearing on Wednesday and Senate Health, Education, Labor and Pensions Committee confirmation hearing on Thursday.
  • The Wall Street Journal reports,
    • “The Central Intelligence Agency has now concluded that the deadly Covid-19 pandemic most likely arose from a laboratory leak, lending credibility to a view that has been the focus of sharp debate among scientists and politicians for years.
    • “In doing so, the CIA has now joined the Federal Bureau of Investigation and the Energy Department in identifying a laboratory mishap in Wuhan, China, as the probable source of the Covid virus. It has killed more than 1.2 million Americans and over seven million people worldwide. 
    • “CIA assesses with low confidence that a research-related origin of the COVID-19 pandemic is more likely than a natural origin based on the available body of reporting,” an agency spokesman said in a statement released Saturday. 
    • “The spokesman added that the judgment was “low confidence” and that the CIA would continue to evaluate “any available credible new intelligence reporting or open-source information that could change CIA’s assessment.” 
    • “The agency had previously taken the stance that it didn’t have enough information to assess whether the virus had leapt from an animal to a human or arose from a laboratory mishap. 

From the public health and medical research front,

  • The Washington Post notes
    • “Ever since the novel coronavirus reached the United States five years ago, it has unleashed punishing winter waves of illness.
    • “But the usual covid uptick is much more muted this winter and appears to have peaked. The virus is less rampant in wastewater compared with winters past. Hospitalization rates have gone down.
    • “Instead, an unusual medley of ailments emerged this season — walking pneumonia, RSV, norovirus and bird flu — along with the more familiar foe: influenza, which is garnering more attention than covid this time around because the hospitalization rate is three times as high.”
  • The University of Minnesota’s CIDRAP points out,
    • “The estimated effectiveness of the respiratory syncytial virus (RSV) among older US veterans in the 2023-2024 respiratory virus season against infection, emergency department/urgent care (ED/UC) visits, and hospitalization was 78%, 79%, and 80%, respectively.
    • “The findings, published this week in The Lancet Infectious Diseases, come from a target trial emulation study led by researchers at the Veterans Affairs Portland Health Care System in Oregon. The observational study was designed to fill in knowledge gaps remaining after clinical trials (e.g., vaccine effectiveness (VE) in people with weakened immune systems, effects on healthcare use for infection).”
  • and
    • “In the largest trial of its kind, patients receiving oral versus intravenous (IV) antibiotics for fracture-related infections (FRIs) had similar reoperation and reinfection rates, US researchers reported this week in JAMA Surgery. 
    • “But the primary and secondary analyses of trial results came to different conclusions regarding noninferiority, leaving some uncertainty about the findings.”
  • Per Fierce Pharma,
    • “Old drugs from Bristol Myers Squibb and Pfizer have delivered what the companies and researchers believe could establish them as new standard treatments for certain colorectal cancer patients.
    • “In Bristol Myers’ case, the company’s dual immunotherapy of Opdivo and Yervoy showed it could work better than Opdivo alone in patients with certain metastatic colorectal cancer. The combo lowered the risk of disease progression or death by 38% in patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, according to data from the phase 3 CheckMate-8HW trial to be presented at the ASCO Gastrointestinal Cancers Symposium.
    • “The study randomized 707 patients across various lines of treatment, with 55% of participants in the Opdivo-Yervoy arm and 52% of the Opdivo monotherapy arm entering in the first-line setting.”
  • The Wall Street Journal discusses new approaches to treating minor injuries like sprains. “Updated methods for treating sprains, strains and bruises now focus on boosting your body’s natural healing process.”

From the U.S. healthcare business front,

  • Beckers Hospital Review shares 109 statistics on hospital margins, revenues, which are bumpy by region.”
  • Kauffman Hall offers an infographic on hospital and health system M&A trends in 2024.
  • Per HR Dive,
    • CFOs expect their companies to see a 7.3% rise in salaries and wages paid in the next 12 months, according to a Q4 Deloitte survey, which polled 200 finance chiefs at companies with a minimum of $1 billion in revenue shortly after the U.S. election in November. The pay projection was nearly double the 3.65% rise anticipated in Q3, according to the findings of the Big Four firm’s previous quarter’s report. 

Slow News Day

David Ermer–Uncategorized–

On Sunday, December 22, the FEHBlog announced his plan to take off December 23 through December 25. However, due to a flood of news on Monday, he issued a FEHBlog extra. In retrospect he should have taken off December 24 through December 26, Boxing Day. Due to Monday’s Extra and it being a very slow news day, the FEHBlog is continuing its hiatus until tomorrow.

Thursday Report

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

From Washington, DC,

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

From the judicial front,

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

In Food and Drug Administration News,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek update

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President-elect Donald Trump said he opposes the bipartisan deal struck by congressional leaders to avoid a partial government shutdown this weekend, insisting that lawmakers tear up the agreement and pass a narrower bill.
    • “Trump’s comments upended efforts to pass a stopgap spending bill to keep the government funded through mid-March, while also providing more than $100 billion in disaster and farm aid. Trump said Congress should craft a new deal that keeps the aid but leaves out other measures, and couple that with immediately raising the federal debt ceiling, ahead of a deadline on the nation’s borrowing limit looming next year.” * * *
    • “To keep the government funded, a bill must pass both chambers of Congress and be signed into law by President Biden before Friday’s midnight deadline.” 
  • Politico identifies the winners and losers in Tuesday night’s CR, FYI.
  • Federal News Network tells us,
    • “The Senate passed a defense bill Wednesday that authorizes significant pay raises for junior enlisted service members, aims to counter China’s growing power and boosts overall military spending to $895 billion while also stripping coverage of transgender medical treatments for children of military members.
    • “The annual defense authorization bill usually gains strong bipartisan support and has not failed to pass Congress in nearly six decades, but the Pentagon policy measure in recent years has become a battleground for cultural issues. Republicans this year sought to tack on to the legislation priorities for social conservatives, contributing to a months-long negotiation over the bill and a falloff in support from Democrats.
    • “Still, the bill passed comfortably 85-14, sending it to President Joe Biden. Eleven senators who caucus with Democrats, as well as three Republicans, voted against the legislation.”
  • Modern Healthcare informs us,
    • “The House Bipartisan Task Force on Artificial Intelligence [AI] has issued a comprehensive report outlining policy recommendations for AI’s in healthcare.
    • “AI development in healthcare has outpaced regulation of the technology, leaving the industry to create its own guidelines. Congressional leaders from both the Senate and House of Representatives have conducted hearings to learn how insurers and providers use AI, but they have not passed significant legislation to regulate it. 
    • “A bipartisan group of 12 Republican and 12 Democratic lawmakers led by co-chairs Rep. Ted Lieu (D-Calif.) and Rep. Jay Obernolte (R-Calif.) authored the report. The task force, formed in February, looked at AI in healthcare along with several other industries.”
  • The American Hospital News lets us know
    • “The Centers for Medicare & Medicaid Services today announced Michigan, New York, Oklahoma and South Carolina state Medicaid agencies were selected to participate in its state-based Innovation in Behavioral Health Model. The eight-year IBH Model is intended to improve care quality and behavioral and physical health outcomes for Medicare- and Medicaid-enrolled adults with moderate to severe mental health conditions and substance use disorders. The pre-implementation period will begin Jan. 1, 2025, when states will begin to conduct outreach and recruit specialty behavioral health practices to participate in the model.”
  • Modern Healthcare points out,
    • “The U.S. spent $4.9 trillion on healthcare in 2023, a 7.5% increase from the prior year, according to a report the Centers for Medicare and Medicaid Services Office of the Actuary published in the journal Health Affairs on Wednesday.
    • “National health expenditures, including the public and private sectors, constituted 17.6% of gross domestic product last year. That’s slightly higher than 17.4% in 2022 and 17.5% in 2019 — prior to the COVID-19 pandemic — but lower than 19.5% in 2020 and 18.3% in 2021 amid the public health crisis.
    • “The Office of the Actuary, which is independent from CMS leadership, mainly attributes the growth in 2023 to greater utilization and intensity. Hospital care, physician and clinical services, and retail prescription drugs were the three biggest categories of higher spending.
    • ‘Expenditures increased at a greater rate last year than during the prior two years, when pandemic-era funding flexibilities began to expire, according to the actuaries. Healthcare expenditures rose 4.6% in 2022 and 4.2% in 2021 after spiking 10.4% in 2020 because of COVID-19.”

In Food and Drug Association News,

  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) has announced that Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The issue has been linked to seven patient injuries and four deaths.
    • “The POLARx Cryoablation System is designed to treat recurrent, symptomatic atrial fibrillation that does not respond to treatment from medical therapy alone. It gained FDA approval back in August 2023.
    • ‘The FDA has ruled that this is a Class I recall, which means it is associated with the highest possible risk level. However, this recall does not involve removing the devices from the market. Instead, Boston Scientific has updated the instructions for use and is urging customers to follow these updated instructions moving forward. 
    • “The recall includes both the POLARx and POLARx FIT cryoablation catheters.”
  • Per MedTech Dive,
    • “Boston Scientific has recalled a group of Accolade pacemakers because of a malfunction that can permanently put devices in safety mode, limiting functionality and preventing devices from properly treating patients. The Food and Drug Administration said devices that permanently enter safety mode must be replaced.
    • “The recall has been tied to two deaths. Boston Scientific did not specify the number of injuries in its December recall notice. The FDA posted an alert for the recall on Monday.
    • “The subset of affected Accolade devices includes Accolade, Proponent, Essentio and Altrua 2 standard life and extended life pacemakers, as well as Visionist and Valitude cardiac resynchronization therapy pacemakers, according to the FDA’s notice.”

From the public health and medical research front,

  • The Washington Post reports,
    • “An individual in Louisiana has the first severe illness caused by bird flu in the United States, federal health officials said Wednesday.
    • “The patient, who is hospitalized, had been in contact with sick and dead birds in backyard flocks on their property, the Centers for Disease Control and Prevention said. It’s the first case of H5N1 bird flu in the United States that has been linked to exposure to a backyard flock, and news of the infection comes the same day California officials declared a state of emergency to confront the outbreak spreading among dairy cows.” * * *
    • “Emma Herrock, a spokeswoman for the Louisiana Health Department, said in an emailed statement Wednesday the patient is over 65 and has underlying medical conditions. She declined to describe the person’s symptoms or severity of illness. Citing patient confidentiality, she said there would be no updates about the patient’s condition at this time.”
  • The New York Times adds,
    • “The virus, H5N1, cannot yet spread easily among people, and it still poses little danger to the average American. Pasteurized dairy products are still safe to consume.
    • “But the past few weeks have brought a steady drumbeat of cases in people, dairy cattle, birds and other animals. Each infection gives the virus a chance to take on a form that could cause a pandemic, experts warned.
    • “All these infections in so many species around us is paving a bigger and bigger runway for the virus to potentially evolve to infect humans better and transmit between humans,” said Dr. Nahid Bhadelia, the director of the Boston University Center on Emerging Infectious Diseases.
    • “That represents an escalation in the situation, even if risk to general population remains low,” she said.
    • “California has borne the brunt of the outbreak in cattle.
    • “The first herds in the nation infected with the bird flu virus, H5N1, were identified in March. California identified its first infected herd in late August.
    • “But since then, the state’s agriculture department has found the virus in 645 dairies, about half of them in the past 30 days alone.
    • “California has also recalled raw milk products from two companies after the virus was detected in samples.”
  • STAT News informs us,
    • “A major report on alcohol’s health effects — which will inform the 2025 Dietary Guidelines for Americans — found moderate drinkers had lower all-cause mortality, and a lower risk of death from cardiovascular disease, than those who never drank. The findings are sure to cause a stir, especially once a separate panel of experts releases its own alcohol report in coming weeks. 
    • “For years, researchers and public health officials have been taking a harder stance on alcohol as evidence has emerged of its associations with various diseases, including certain cancers and liver disease. The head of the National Institute on Alcohol Abuse and Alcoholism, George Koob, has said there are “no health benefits to alcohol.” The new 230-page report, released Tuesday by the National Academies of Sciences, Engineering, and Medicine, seems to undermine those assertions. 
    • “The “Review of Evidence on Alcohol and Health” from NASEM does not make recommendations. Instead, it summarizes the available evidence published in the past five to 15 years on how moderate alcohol consumption is linked to lactation, weight, cancer, cardiovascular disease, neurocognition and all-cause mortality. Moderate drinking is defined as two drinks per day for men, or one drink per day for women. The committee’s conclusions are based on associations, so the report doesn’t explain whether alcohol consumption is directly responsible for the outcomes. 
    • “Recommendations will be made by the main dietary guidelines committee next year, using NASEM’s review and another, from a separate panel in the Department of Health and Human Services. That report has not been released yet but is expected by next month.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues names the “four health insurers earned a spot on the latest list of the 250 best-managed companies, as ranked by the Drucker Institute.”
  • BioPharma Dive reports,
    • “Merck & Co. has made its first big move in obesity treatment, announcing Wednesday it is paying Hansoh Pharma $112 million for rights outside China to a preclinical pill that works similarly to the popular injection Wegovy.
    • “Per deal terms, China-based Hansoh could receive up to $1.9 billion in additional payouts based on reaching clinical, regulatory and commercial milestones. Hansoh has an option to co-promote or solely commercialize the pill, code-named HS-10535, in China.
    • “Merck was one of the few big U.S. drugmakers that didn’t have an experimental obesity drug in development, and investors were therefore closely watching whether it would make a deal.”
  • Beckers Hospital Review ranks weight loss drugs by recent price changes for us.
  • Also, per BioPharma Dive,
    • “Almost 15 years ago, in the midst of an opioid epidemic that would kill more than half a million people in the U.S., a startup formed with the aim of creating new, non-addictive pain drugs.
    • “This goal could have been seen as noble. But for most investors, it was far too risky. Pain research was known to be exceedingly difficult and, even if successful, any resulting products would have to compete in a healthcare system that opioid makers had already gamed.
    • “The startup, SiteOne Therapeutics, has stayed afloat in the years since mostly through small grant funds. Yet, in a major reversal of fortune, it recently began to receive a huge influx of investment. The company on Wednesday announced the closing of a $100 million fundraising round,and plans to put the cash toward human studies designed to show its drugs work as intended.
    • “Pain has really been out of favor in the industry up until very recently,” said John Mulcahy, SiteOne’s cofounder and CEO. “Now is the time to add additional resources to really ramp things up.
    • “SiteOne’s research focuses on a kind of protein that’s embedded, by the thousands, in the perimeter of cells. Aptly named “ion channels,” these microscopic tunnels allow cells to communicate with one another through the rush of electrically charged particles. They are essential. Without them, our bodies wouldn’t be able to move muscles, sense surroundings or fight against germs.
    • “These functions also make ion channels attractive targets for drug researchers, who have already found ways to use them to combat seizures, infections, and problems with the heart and blood pressure. And over the past couple decades, technological advances have led to a better understanding of these proteins, such that some pharmaceutical companies now believe the field will, before too long, produce new treatments for pain, epilepsy, depression and many more neurological conditions.”

Friday report

David Ermer–Uncategorized–

From Washington, DC

  • CBS Sports reports,
    • “The United States Senate unanimously voted Tuesday to pass the HEARTS Act, a bill supported by Buffalo Bills safety Damar Hamlin that will provide grants to schools to support the purchase of automated external defibrillators, CPR and AED training, and the development of cardiac emergency response plans. The Cardiomyopathy Health Education, Awareness, Research and Training in Schools (HEARTS) Act, a bipartisan bill spearheaded by Hamlin and New York state Senator Chuck Schumer, will now only need to be signed by President Joe Biden to become law.
    • “In January 2023, Hamlin had made a routine tackle during a “Monday Night Football” game between the Bills and Cincinnati Bengals when he went into sudden cardiac arrest on the field, with the medical episode leaving him in critical condition as the game was suspended and ultimately never resumed. Hamlin’s life was saved by the response of team athletic trainers and other first responders, and he has since made a full recovery and is now a starter in Buffalo.
    • “Ever since his near-fatal incident, Hamlin has dedicated significant time promoting efforts on the importance of learning CPR and having accessible AEDs in different communities. The HEARTS ACT would create a grant program at the U.S. Department of Health and Human Services to support such efforts in elementary and secondary schools.”
  • Fierce Healthcare informs us,
    • “Congressional staffers have told lobbyists that a [healthcare] deal will be reached by the end of the weekend so the House and Senate can vote on the deal before government funding expires next Friday, Dec. 20.
    • “The latest healthcare deal, circulated among lobbyists Friday morning, is seen as solid and unlikely to change through the weekend, people who received the memo told Fierce Healthcare.
    • “The package includes a two-year extension of Medicare telehealth flexibilities and a one-year extension of pre-deductible coverage of telehealth for high-deductible health plans linked to health savings accounts. The package also is likely to include a five-year extension of the Centers for Medicare & Medicaid Services’ hospital-at-home waiver.
    • “As of Friday morning, the deal also included a physician pay bump and an alternative payment model bonus; funding for community health centers; a five-year reauthorization of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act; a one- to two-year reauthorization of the Pandemic and All-Hazards Preparedness Act; and the Medicare Multi-Cancer Early Detection Screening Coverage Act.
    • “The major offsets that Congress will use for the package are a five-month extension of the Medicare sequester, commercial pharmacy benefit manager transparency (PBM), banning Medicaid PBM spread pricing and Medicare Part D delinking, among others.
    • “It seems as though House and Senate leaders have come to an agreement on a wide-ranging end-of-year healthcare package, but the deal could still fall apart.
    • “Congress must pass a continuing resolution to fund the government by Dec. 20. The C.R. is likely to fund the government for 90 days, through March. The C.R. is separate from the health package, but, in the event that a healthcare deal falls apart, expiring healthcare programs may also be extended for 90 days as part of the C.R.”
  • Federal News Network informs us,
    • “As agencies work on innovations in their federal hiring and retention strategies, the Office of Personnel Management is taking steps to try to better support the employees working behind the scenes on those efforts.
    • “In a legislative proposal sent to Congress last week, OPM requested statutory authority over the nearly 40,000 federal employees working in human resources positions governmentwide. If enacted, OPM’s proposal would amend Title 5, giving OPM the ability to manage training and development of the HR workforce across all agencies.
    • “Although there has been strong interest in governmentwide efforts to mitigate skills gaps in technology positions and cybersecurity, acquisitions and other mission critical occupations, HR professionals have not received the same level of focus and prioritization, even though they are critical for assisting in the hiring and retention strategies for the entirety of the federal workforce,” OPM wrote in a draft of the legislative proposal, shared with Federal News Network.
  • The American Hospital Association News tells us,
    • “The Center for Medicare and Medicaid Innovation [on December 11] released its 2024 Report to Congress that includes updates on 37 models and initiatives (including nine new models), 52 evaluations and other activities from October 2022 through September 2024. During the report period, CMMI stated that more than 192,000 providers and/or plans participated in CMS Innovation Center models and initiatives, serving over 57 million beneficiaries.”
  • Modern Healthcare reports,
    • “The U.S. Supreme Court handed hospitals another victory when it declined drug manufacturers’ petition to limit contract pharmacies that dispense 340B drugs. But the legal fight is far from over.
    • “Drugmakers turned to the Supreme Court after a district and appellate court upheld an Arkansas law that ensures providers get the same 340B drug discounts for prescriptions dispensed at community pharmacies as they would for medication offered through in-house pharmacies. The 340B drug pricing program aims to bolster hospitals and clinics that treat low-income patients by offering estimated 25% to 50% discounts on prescription drugs.
    • “The high court on Monday denied the Pharmaceutical Research and Manufacturers of America’s request to review the case. That denial is expected to fuel other state legislation designed to protect 340B drug discounts and community contract pharmacies, healthcare lawyers said. The drug manufacturers may also shift their focus to enforcing a rebate program for 340B drug discounts, they said.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19 activity is beginning to increase from low levels in some areas of the nation. Seasonal influenza activity continues to increase across the country. RSV activity is moderate and continues to increase in most areas of the United States, particularly in young children.
    • “COVID-19
      • “COVID-19 activity, including wastewater levels, emergency department visits, and laboratory percent positivity, are beginning to increase from low levels in some areas of the nation. 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 circulating variants. 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 provided by vaccines.”