Tuesday Report

COVID-19

Tuesday Report

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “National Institutes of Health director Jay Bhattacharya on Monday asserted that the agency remains committed to research that advances the health of minorities — despite the Trump administration’s sharp focus on rolling back programs dealing with diversity, equity, and inclusion.
    • “Bhattacharya said that President Trump’s executive orders, which state that DEI programs are illegal and discriminatory and direct federal agencies to terminate any of their own such programs, are “misunderstood.”
    • “I don’t think that [the orders are] aimed at stopping fundamental research that advances the health and wellbeing of minority populations. I wouldn’t have accepted this job if that was the case,” he said. “I think that the health and wellbeing of minority populations, as well as every American, are a central focus of the NIH and will continue to be under my watch.”
  • The NIH’s understanding matches the FEHBlog’s reading of those DEI program executive orders, which are directed at workforces, not healthcare.
  • The Wall Street Journal adds,
    • “For months, investors have feared that Health and Human Services Secretary Robert F. Kennedy Jr. and his Make America Healthy Again movement would derail biomedical innovation. His ousting of Peter Marks—a senior official at the Food and Drug Administration and key proponent of faster drug approvals—sent biotech stocks tumbling last month and stoked concerns that the agency was being politicized and turned against science.
    • “A more nuanced narrative is now taking shape. 
    • “While heightened vaccine scrutiny and sweeping FDA staff cuts remain serious threats, recent signals have been more upbeat. In an interview late last week, newly appointed FDA Commissioner Marty Makary—a former Johns Hopkins surgeon—delivered a relatively bullish message for the biotech sector. Speaking with Megyn Kelly, Makary said he would speed up approvals for rare-disease treatments, cut reliance on animal testing by incorporating computational models and shorten the industry’s typical 10-year drug- development timeline.
    • “He also vowed to reduce pharmaceutical companies’ influence over the FDA approval process and end what he called the agency’s “cozy” relationship with the industry. Importantly, he emphasized a commitment to protecting innovation and maintaining a science-based approach to regulation.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again.
    • “The FDA is taking the following actions:
      • “Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
      • “Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
      • “Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
      • “Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
      • “Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
      • “Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.”
  • The U.S. Public Health Service Task Force posted the following draft grade B recommendation that applies to “Pregnant and postpartum women who are at increased risk of perinatal depression.”
    • “The USPSTF recommends that clinicians provide or refer those at increased risk of perinatal depression to counseling interventions during pregnancy and the postpartum period.”
    • The recommendation notes “When final, this recommendation will update the 2019 recommendation statement on interventions to prevent perinatal depression. The current draft recommendation is consistent with the 2019 recommendation; both are B recommendations”
    • The public comment period ends on May 19, 2025.

From the public health and medical research front,

  • The New York Times reports,
    • “The spread of measles in the Southwest now constitutes the largest single outbreak since the United States declared the disease eliminated in 2000, federal scientists told state officials in a meeting on Monday.
    • “The New York Times obtained a recording of the meeting. Until now, the Centers for Disease Control and Prevention had not publicly described the outbreak in such stark terms.
    • “More measles cases were reported mostly in Orthodox Jewish communities in New York City and New York State in 2019. But health officials regard those as separate outbreaks, because they were fueled by multiple introductions of the virus by international travelers.
    • “C.D.C. officials now view the spread of measles in Texas, Oklahoma and New Mexico as a single outbreak, Dr. Dan Filardo, who leads the agency’s task force for the measles response, told state health officials at the meeting.”
  • Medscape makes five long COVID predictions for 2025 and beyond.
  • The American Hospital Association News tells us,
    • “A study published April 17 by BMC Infectious Diseases found increased incidents of Acinetobacter baumanniiand carbapenem-resistant A. baumannii infections between 2018 to 2022. A. baumannii is a pathogen considered to be a major cause of health care-associated infections. The study found that A. baumannii cases per 100 hospitalization encounters grew from 1.15 in 2018 to 1.25 in 2021, before dropping to 1.11 in 2022. The CRAB incidence rate grew from 0.39 cases per 100 hospitalization encounters in 2018 to 0.53 cases in 2022. 
    • “Researchers said the pathogen’s ability to survive in hospitals and in patients not showing any symptoms for extended periods of time contributed to increased outbreaks.” 
  • MedPage Today points out,
    • “Cytisinicline increased biochemically confirmed abstinence [from smoking tobacco] nearly threefold versus placebo when taken for 6 weeks and more than fourfold when taken for 12 weeks.
    • “The drug was well tolerated with no treatment-related serious adverse events.
    • “The trial is expected to support filing with the FDA for a new drug indication as a tobacco-product cessation aid.”
  • Beckers Hospital Review notes,
    • “A recent study found that changing the default prescription length for statins to 90 days significantly increased the number of long-term prescriptions written, potentially improving patient adherence. 
    • “The intervention, which was implemented at the University of Pennsylvania’s health system in Philadelphia, set 90-day prescriptions as the default option in the electronic health record for statins. By the end of the study, the health system saw the proportion of 90-day prescriptions rise from 71% to 91%, according to an April 22 news release from Penn Medicine. 
    • “The study, published in JAMA Internal Medicine on April 7, found that the change designed as a “nudge” to guide doctors toward better prescribing behavior had helped to reduce the need for patients to visit the pharmacy multiple times a year. 
    • “The findings suggest that default settings in EHRs can be a tool in increasing medication adherence without additional effort from clinicians, the release said.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance posted mixed results for the first quarter but reaffirmed its 2025 earnings outlook, solidifying guidance it published early to pacify investors after UnitedHealth posted dismal results last week, leading to a selloff of health insurer stocks.
    • “UnitedHealth’s results were driven by unexpectedly high medical spending on Medicare Advantage members, a trend that Elevance on Tuesday said it had observed but wasn’t any more drastic than expected.
    • “Overall, Elevance beat Wall Street expectations in the quarter with revenue of $48.9 billion, up almost 15% year over year, in part due to the higher premiums it’s charging customers this year in a bid to resuscitate insurance margins. The insurer posted profit of $2.2 billion, down 3% year over year. Elevance’s stock was up slightly in morning trading following the results.”
  • Per MedCity News,
    • “With rising operational costs, major shifts in Medicaid, and other financial pressures bearing down on the healthcare system, forecasting revenue and allocating resources effectively has never been as important for health plans as it is today. And anticipating the future has probably never been so challenging.
    • “Health plans have been gradually deploying artificial intelligence programs and sophisticated analytics for years to make programs more effective while reducing costs and mitigating financial risk.
    • “But with today’s challenges, the gradual approach has become a luxury. According to McKinsey, health plans should pick up the pace.”
  • Modern Healthcare adds,
    • “Payers, providers and health technology companies may soon be asking accrediting organizations to sign off on their use of artificial intelligence.
    • “AI is being used across the industry but a lack of regulation at the state and federal levels is prompting industry stakeholders to create their own guidelines for safe and effective AI use. The next step might well see the issue addressed in accreditation programs.
    • “While the AI accreditation process could take years to develop, there is confidence that it will become commonplace. On top of the potential impact of AI on patient outcomes, there is a cost to develop and adopt products. This cost factor is driving the need for more transparency on model efficacy, said Dr. Lee Schwamm, chief digital health officer at New Haven, Connecticut-based Yale New Haven.”
  • The Wall Street Journal reports,
    • “Swiss pharmaceutical giant Roche ROG -0.31%decrease; red down pointing triangle
      plans to invest $50 billion in the U.S. over the next five years, the latest major spending commitment by a big drugmaker as the industry faces President Trump’s tariff threats.” * * *
    • “The investment by Roche will fund new research hubs and new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California, the company said Tuesday. The company said that investment would create 1,000 jobs at Roche and more than 11,000 elsewhere including nearly 6,500 construction jobs.
    • “The company currently has 15 R&D centers and 13 manufacturing sites in the U.S., employing more than 25,000 people.
    • “Roche said it would export more medicines from the U.S. than it imports once its new and expanded manufacturing site are in operation. The group’s diagnostics division currently already holds a surplus from the U.S., it said.”
  • MedCity News relates,
    • “Aeroflow Health, a health tech company, last week announced a new diabetes management program, which aims to improve adherence, outcomes and care coordination for health plan members.
    • “Asheville, North Carolina-based Aeroflow Health was founded in 2001 and offers an array of medical devices covered by insurance. The company has four lines: Aeroflow Breastpumps, Aeroflow Diabetes, Aeroflow Sleep and Aeroflow Urology. In addition to medical devices, it provides education and consultations. The company has partnerships with more than 1,000 insurance plans and serves more than 1.4 million patients annually.
    • “Through the new diabetes program, patients gain access to educational content on how to manage their condition, including medication adherence, lifestyle modifications and glucose monitoring strategies. They can also use a new AI-powered digital health tool that syncs with continuous glucose monitoring data. This allows patients to receive personalized insights on their health, AI-driven coaching and communication with their provider.”

Friday Report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “Agencies will not be able to fill or create any federal jobs for another three months, after President Donald Trump extended the current federal hiring freeze until July 15.
    • “But even after the hiring freeze lifts later this summer, agencies will still be limited in how many new employees they can hire, and how many new positions they can create. The White House said it will cap agencies to one new hire for every four federal employees who leave the civil service.”
    • Here’s a fact sheet on the hiring freeze extension.
  • Fierce Healthcare adds,
    • “President Donald Trump and the Office of Personnel Management (OPM) are moving forward with “Schedule F,” a policy to make it easier to remove workers from federal agencies like the Department of Health and Human Services (HHS), Fierce Healthcare has confirmed.
    • “Implementing Schedule F will deprive 50,000 federal employees of civil service protections by classifying them as “at-will” workers. Once a final rule is issued, another executive order will be released to directly move positions under the final rule’s authority.
    • “The OPM’s proposed rule will give authority to the government to cut workers over performance that does not align with the administration’s priorities without procedural delays.”
    • The proposed rule appeared in the Federal Register’s public inspection list today. The proposed rule will be published in the Federal Register on April 23, 2025.

In Food and Drug Administration news,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced Thursday.
    • “Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.
    • “These representatives don’t vote on questions put to the committee. They are meant to share the perspective of their industry broadly, rather than of the specific company that employs them. There are also usually patient or consumer representatives on the panels.
    • “Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.”
  • Per Fierce Pharma,
    • “On its way to generating sales of $14 billion in just its seventh full year on the market, Sanofi and Regeneron’s Dupixent has experienced few setbacks. One came in 2023, however, when the FDA rejected the immunosuppressant as a treatment for chronic spontaneous urticaria (CSU), asking for more data.
    • “Eighteen months later—and backed by more conclusive results—the companies have convinced the U.S. regulator to sign off on Dupixent for the difficult-to-treat skin condition. With the nod, Dupixent becomes the first new medicine for CSU in more than a decade. 
    • “The approval clears Dupixent to be used by those age 12 and older who remain symptomatic despite using histamine-1 (H1) antihistamines. It’s a population of more than 300,000 among the roughly 3 million in the U.S. who have CSU, the companies said in a release.”
  • Per Medscape,
    • “The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class prescription digital therapeutic for the preventive treatment of episodic migraine in adults, its development company announced in a statement.
    • “The mobile smartphone app uses biological, psychologic, and behavioral approaches to target pain processing and includes such tools as an eDiary tracker and short daily lessons. It is intended for use alongside other acute and preventive treatments for migraine. 
    • “The marketing authorization, which was reviewed through the FDA’s de novo pathway for medical devices, is based on results from two recent clinical trials: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. As reported by Medscape Medical News, the findings were presented at the recent American Academy of Neurology (AAN) 2025 Annual Meeting.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • RSV
      • “RSV activity continues to decline in most areas of the country.
    • 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.”
  • The University of Minnesota CIDRAP adds,
    • “The CDC confirmed 10 new pediatric flu deaths, bringing the season’s total to 198. This compares with 207 deaths last flu season. Nine of the new deaths were from influenza A and 1 from influenza B. Of the 8 influenza A cases for which scientists performed subtyping, 5 were caused by the H1N1 strain, and 3 were H3N2.”
  • The American Hospital Association (AHA) News tells us,
    • “The Centers for Disease Control and Prevention April 18 announced there have been 800 reported cases of measles across the country this year. Twenty-four states have reported cases and there have been 10 outbreaks. Most cases (94%) have been outbreak-associated. 
    • “Texas, which has the largest outbreak of any state, April reported a total of 597 cases. Michigan also reported an outbreak yesterday — the state’s first since 2019 — with three cases. CDC data shows that 11% of all cases have been hospitalized. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
  • The New York Times adds,
    • “As the United States struggles to contain a resurgence of measles that has swept through swaths of the Southwest, neighboring countries are responding to their own outbreaks.
    • “Canada has reported more than 730 cases this year, making this one of the worst measles outbreaks in the country since it declared the virus “eliminated” in 1998. Mexico has seen at least 360 measles cases and one death, most of them in the northern state of Chihuahua, according to Mexican health authorities.
    • “Many of the communities grappling with measles have large Mennonite populations that public health officials have linked to outbreaks. The multinational resurgence has concerned epidemiologists, who fear that simultaneous outbreaks near the U.S. border will make it more difficult to contain the virus.
    • “It’s just a line on the map that separates them — we share air, we share space,” said Lisa Lee, an epidemiologist at Virginia Tech.”
  • Medscape lets us know,
    • “Five classic risk factors for cardiovascular disease — high blood pressure, high cholesterol, obesity, diabetes, and smoking — at age 50 can reduce life expectancy by more than 10 years. This is the conclusion of an international study led by German researchers and presented at the 2025 American College of Cardiology Scientific Session.
    • “These five factors account for approximately 50% of the global burden of cardiovascular diseases. Our central question was how many additional years of life are possible if these factors are absent or modified in middle age,” said Christina Magnussen, MD, PhD, deputy director of the Department of Cardiology at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany, during her presentation in Chicago.
    • “The findings, also published in The New England Journal of Medicine, show that lifestyle changes and risk management in middle age can make a significant difference. Lowering blood pressure and quitting smoking had the most significant impacts.”
  • Diagnostic Imaging points out,
    • “Emerging research suggests that prior mammography screening within five years of breast cancer diagnosis for seniors significantly reduces the risks of later-stage diagnosis and breast cancer-specific mortality.
    • “For the study, recently published in JAMA Network Open, researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database for 13,028 women who had screening mammography-detected breast cancer. Over 77 percent of the cohort had at least one mammography screening in a five-year period prior to diagnosis and over 69 percent were in their 70s, according to the study. The researchers also noted that over 29 percent were diagnosed with later-stage (T2+ or N1+) disease.
    • “Multivariable analysis revealed that women having at least one mammography screening in the five years prior to diagnosis had a 54 percent lower risk of a later-stage presentation at diagnosis. The study authors found that these women also had a 36 percent lower risk of breast cancer-specific death.”
  • Per HealthDay,
    • “People might think they can reduce their risk of cancer by occasionally swapping their cigarettes for a vape pen — but they would be wrong, a new study says.
    • “So-called “dual users” — folks who both smoke and vape – are exposed to the same levels of nicotine and cancer-causing toxins as those who only smoke cigarettes, researchers reported in the journal Nicotine and Tobacco Research.”
  • Per the AHA News,
    • “A study published April 17 by JAMA Otolaryngology Head and Neck Surgery found that up to 32% of dementia cases from 2011-2019 could be attributed to hearing loss confirmed through testing. Self-reported hearing loss was not associated with higher dementia risk.”

From the U.S. healthcare business front,

  • CBS News reports,
    • “Blue Cross Blue Shield of Massachusetts says it will soon stop covering popular drugs for weight loss, like Ozempic and Wegovy.
    • “The medications have skyrocketed in price and popularity, but they’re now being blamed for crippling budgets in the public and private sector. As one of the fastest growing classes of medications, GLP-1 weight-loss drugs were originally brought on the market to treat diabetes. But their secondary use as a way for users to suppress diets and slim down sent sales through the roof. 
    • “Blue Cross announced Thursday that starting on January 1, 2026, standard coverage plans will not cover GLP-1s for weight loss. The company will continue to cover patients who are using the drugs for diabetes treatment. 
    • “Studies suggest nearly 1 in 8 people have used GLP-1s as the drugs become more common. That’s given drug companies the reason to increase prices.” 
  • FEHB premiums continue to reverberate from OPM’s sudden decision in January 2023 to require all FEHB plans to cover GLP-1 drugs for obesity. Traditionally, OPM announces a mandate in the call letter for benefit proposals and allows the carrier to raise its premiums in advance of the mandate. OPM should stick with tradition and in any event curb its mandate habit. The FEHBlog wonders whether Lilly’s GLP-1 pill will reduce overall costs on obesity drugs.
  • Modern Healthcare relates,
    • Hospitals are zeroing in on alternative care models to improve the nursing work experience and patient outcomes while lowering costs.
    • Eight in 10 nurse leaders are piloting new care models in their organizations, ranging from virtual nursing to home health, according to a recent study by healthcare solutions company Wolters Kluwer.
  • Per an ICER news release,
    • “This week, ICER released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions. The report will be open to public comment until May 13th. Click here for information on submitting a public comment.“
  • Per Beckers Hospital Review,
    • “Several large health systems reported operating losses in 2024, underscoring ongoing financial strain despite rising patient volumes and revenue growth. While inpatient revenue is climbing, expense pressures, cybersecurity disruptions and shifting care dynamics continue to weigh on margins — leaving even some of the nation’s largest systems in the red.
    • “In February, average hospital operating margins fell to 2.5%, down from 3.4% in January, according to Kaufman Hall’s latest “National Hospital Flash Report.” Despite the dip, margins remained above 2024’s year-to-date average, suggesting that while performance has improved compared to recent years, financial stability remains fragile.
    • “In the early months of 2025, volumes remain strong across the board,” Erik Swanson, managing director and data and analytics group leader at Kaufman Hall, said in an April 8 report.  “Emergency visits are rising, which is leading to challenges with ED boarding for many organizations. Data also show that inpatient revenue is growing while outpatient revenue has slowed, which points to the rapid growth in outpatient care in the last few years reaching its peak.”
    • The article describes the results for 11 health systems.

Monday Report

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • Paul Wolfowitz, writing in the Wall Street Journal, shares “Reflections on Lincoln 160 Years After His Murder. America’s greatest president had moral vision, strategic genius, and astounding eloquence.” RIP.
    • “Tuesday is the 160th anniversary of Abraham Lincoln’s assassination. That grim milestone invites speculation about what might have been had he lived to serve out his second term. It is also an occasion to reflect on what made Lincoln great—why his example still matters.
    • “Lincoln is the greatest American president not because he was perfect, but because he had so many leadership qualities crucial for confronting the challenges facing him. He combined moral vision with strategic genius, a rare mix for any political leader.” * * *
    • “So, I am grateful to Providence that we had a leader of Lincoln’s stature at a time of our greatest need. And so should we all be.”

From Washington, DC,

  • From an FTC news release,
    • “Today, the Federal Trade Commission launched a public inquiry into the impact of federal regulations on competition, with the goal of identifying and reducing anticompetitive regulatory barriers. The FTC launched this inquiry in response to President Trump’s Executive Order on Reducing Anticompetitive Regulatory Barriers. * * *
    • “In a Request for Information, the FTC invites members of the public to comment on how federal regulations can harm competition in the American economy. The RFI seeks to understand what federal regulations have an anticompetitive effect. Members of the public—including consumers, workers, businesses, start-ups, potential market entrants, investors, and academics—are encouraged to comment.
    • “The public will have 40 days to submit comments at Regulations.gov, no later than May 27, 2025. Once submitted, comments will be posted to Regulations.gov.
    • “Comments submitted to the U.S. Department of Justice Anticompetitive Regulations Task Force at Regulations.gov that contain information falling within the scope of the FTC’s RFI do not need to be resubmitted in response to the FTC’s RFI.” 
  • When will OPM invite deregulatory ideas from the public? Speaking of OPM,
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a steep bill for employee relocation expenses, as it plans to bring staff working remotely back to the office.
    • “As part of its return-to-office plans, OPM is planning to spend nearly $42 million to relocate approximately 250 employees — spending about $166,000 per employee.
    • “The relocation cost per employee is higher than the annual salary of most federal employees, according to recent data analysis from the Pew Research Center. It also exceeds the maximum salary a career federal employee can receive under the General Schedule pay scale (not including locality pay). An OPM spokesperson declined a request for comment.
    • “OPM will pay certain mandatory relocation expenses. But the agency told employees in an April 4 email, first reported by Federal News Network, that “it is unlikely we will have the financial resources to relocate a significant number of employees who are greater than 50 miles from an OPM site.”
  • Govexec informs us,
    • “The Office of Personnel Management last week issued new guidance encouraging agencies to pay political appointees the maximum federal salary and removing career HR workers from the appointment process.
    • “The April 10 memo from acting OPM Director Charles Ezell to agency heads reminds them of the “great flexibility” they have when setting the pay of employees hired under Schedule C of the federal government’s excepted service, the portion of the federal workforce made up of low-level political appointees.
    • “Such flexibility is important to attract highly-qualified Schedule C employees to serve in important confidential, policy-determining, policy-making and policy-advocating roles,” Ezell wrote. “Well-qualified Schedule C employees are needed ‘to drive the unusually expansive and transformative agenda the American people elected President Trump to accomplish.’”
    • “The memo notes that Schedule C salaries cap out at $195,200. And it instructs agencies to “revoke delegations and sub-delegations” provided to agency HR employees as part of their work onboarding and vetting political appointees on behalf of the White House.”
  • Per an OPM news release,
    • “For the first time, U.S. Office of Personnel Management (OPM) personalized Retirement Booklets are now accessible online as digital downloads [at] servicesonline.opm.gov.”
  • MedTech Dive also points out,
    • “The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely to lay the foundation for sector-wide tariffs in the near future.
    • “The investigation, which was announced in a federal notice posted online, appears to be wide-ranging, covering branded and generic medicines, as well the active drug ingredients they contain. It will be conducted by the Department of Commerce under a legal authority known as Section 232, which President Donald Trump used earlier this year to expand duties on steel and aluminum.”
  • Per Beckers Clinical Leadership,
    • “CMS is proposing to modify several hospital quality measures and remove four others, including those focused on health equity and social drivers of health.
    • “The agency outlined the changes April 11 as part of its 2026 proposed rule for the Medicare payment systems that cover inpatient and long-term care hospitals.” 

From the judicial front,

  • Fierce Healthcare notes,
    • “Originally approved by the FDA in 1998, Amgen’s Enbrel is still sailing along without facing biosimilar competition in the United States. And unless a court rules otherwise, the Southern California company will retain its patent protection on the inflammatory disease medicine until 2029.
    • “Hoping to alter the timetable is Swiss generics and biosimilars specialist Sandoz, which has filed an antitrust lawsuit in federal court in Virginia claiming that Amgen has blocked competition to “unlawfully extend its monopoly,” according to the complaint.
    • “Amgen, according to the lawsuit, allegedly did this by purchasing patent rights from one of its competitors, Swiss pharma giant Roche, which was developing a product from the same drug class to compete with Enbrel. Without these patents, Enbrel would have been subject to competition from biosimilars—as was the case in Europe—by as early as 2016.
    • “Sandoz is seeking an injunction preventing Amgen from using the patent rights to block biosimilar competition. Sandoz wants to launch its Enbrel biosimilar Erelzi as soon as possible. The company also is pursuing treble damages, which could be tripled, according to antitrust law.”
  • and
    • “The Department of Justice will head to mediation with UnitedHealth Group and Amedisys April 18 as part of an ongoing antitrust lawsuit.
    • “Both companies are attempting to finalize a $3.3 billion merger, which was challenged under the Biden administration Nov. 12 for allegedly threatening competition in the home health and hospice industry. Now, mediation will occur Aug. 18, as signed by Magistrate Judge Susan Gauvey on April 10.” 

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about asthma. “Asthma can be life-threatening if you don’t get treatment. Two physicians, from Bayhealth and Rush University System for Health, share more.”
  • Cardiovascular Business relates,
    • “Following a Mediterranean-style diet that still leaves room for lean beef is associated with significant improvements in blood pressure (BP) and vascular health, according to new data published in Current Developments in Nutrition.
    • “The Mediterranean diet, named after the traditional eating habits of Greece and Italy, is based on whole grains, fruits, vegetables, legumes, nuts, seeds and olive oil. It primarily focuses on plant-based options, but does permits fish, seafood, poultry and dairy products to be eaten occasionally. 
    • “The Mediterranean diet is often viewed as one of the healthiest ways a person can eat. The team behind this latest analysis aimed to learn just how flexible these diets can be. If someone follows a Mediterranean-style diet, but wants to enjoy a little more meat, what does that mean for their cardiovascular health?
    • “Increasingly, the importance of customizing dietary choices to reflect personal preferences is recognized to promote sustained adherence to a healthy dietary pattern,” wrote first author Jennifer Fleming, PhD, an assistant teaching professor in the department of nutritional sciences at Penn State, and colleagues. “Therefore, although current dietary guidance consistently recommends limiting red meat, more clarity is needed about the amount of lean unprocessed red meat that can be incorporated into healthy dietary patterns that promote cardiovascular health.”
  • STAT News reports,
    • “Verve Therapeutics said initial data show that its investigational gene-editing therapy lowered cholesterol without inducing serious side effects, a positive step for the company after it paused development of an earlier treatment due to safety concerns.
    • “The early data from an ongoing Phase 1 study show that a single infusion of the therapy, called Verve-102, led to greater decreases in “bad” LDL cholesterol with higher doses, according to an announcement Monday. Among the four participants who received the highest dose of 0.6 mg/kg, they experienced an average 53% reduction in cholesterol.” * * *
    • “While the Verve-102 data are early, they move the company closer to its goal of using a one-time therapy to target a common condition that continues to be one of the leading killers in the developed world. The current chronic drugs that inhibit PCSK9 are not enough for patients with higher cholesterol, Verve argues, since patients often don’t take them consistently.”
  • The New York Times calls attention to a new study.
    • Middle-aged and older adults who sought hospital or emergency room care because of cannabis use were almost twice as likely to develop dementia over the next five years, compared with similar people in the general population, a large Canadian study reported on Monday.
    • When compared with adults who sought care for other reasons, the risk of developing dementia was still 23 percent higher among users of cannabis, the study also found.
    • The study included the medical records of six million people in Ontario from 2008 to 2021. The authors accounted for health and sociodemographic differences between comparison groups, some of which play a role in cognitive decline.
    • The data do not reveal how much cannabis the subjects had been using, and the study does not prove that regular or heavy cannabis use plays a causal role in dementia.
  • The Wall Street Journal considers whether long-Covid is rewriting the rules of aging. Brain decline alarms doctors. Millions of long-Covid patients continue to struggle with cognitive difficulties.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer is halting development of its experimental weight-loss pill, as the booming obesity drug market remains out of reach for the drug giant.
    • “The company said Monday the stoppage comes after it reviewed clinical data and a study subject developed a liver injury that might have been caused by the drug, called danuglipron.” 
  • The benefits consulting firm WTW offers a report titled “GLP-1 Drugs in 2025: Cost, access and the future of obesity treatment. “Employer health plans brace for another year of soaring costs as GLP-1 utilization continues to rise — per member per month spending on these medications nearly doubled each year since 2021.”
  • Per Beckers Payer Issues,
    • “Medicare Advantage plans spent $38 billion on non-Medicare benefits in 2024, according to a Medicare Payment Advisory Commission report. 
    • “The group, which advises Congress on Medicare issues, held a meeting April 10. According to a presentation, MA plans received $83 billion in rebates from the federal government. Plans used these rebates to cover non-Medicare, or supplemental, benefits. These benefits include hearing, vision and dental care alongside fitness reimbursements, over-the-counter allowances and other benefits. These rebates are also used to reduce cost sharing and provide prescription drug benefits. 
    • “According to MedPAC, current data on supplemental benefit use in MA is inadequate to determine the value the funding is providing.” 
  • Per Fierce Healthcare,
    • “Average physician pay rose 3.6% between 2023 and 2024, from $363,000 to $376,000—about in line with recent years but well behind increases from before the pandemic.
    • “That’s according to Medscape’s latest physician compensation report, which also highlighted particularly narrow increases in year-over-year compensation for primary care docs (1.4%, from $277,000 to $281,000) and specialists (1%, from $394,000 to $398,000).
    • “The annual survey also counted more specialties reporting pay drops than pay increases, as well as a shrinking percentage of doctors who feel fairly compensated and a widening of pay gaps across gender and racial and ethnic lines.”
  • Beckers Hospital Review adds,
    • “Annual average compensation for U.S. physicians in four medical specialties surpassed $500,000 in 2024, according to Medscape’s “Comparing Your Pay Against Your Peers’: Medscape Physician Compensation Report 2025.“
    • “Orthopedic specialists topped the list as the highest-paid physicians last year, while those practicing public health and preventive medicine reported the lowest earnings.
    • “With the exception of anesthesiology, all seven of the top-earning specialties in 2024 have consistently ranked among the 10 highest-paid specialties in each of the last five editions of the annual report.”

Friday Report

David Ermer–AHRQ, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC.

  • Medical Economics reports,
    • Health care is in crisis, but tying physician reimbursement to inflation is one way to stabilize the American health care system, according to the American Medical Association (AMA).
    • On April 10, the Medicare Payment Advisory Commission voted unanimously to recommend Congress replace current law updates to the physician fee schedule with an annual change based on the Medicare Economic Index, such as MEI minus 1%.
    • That is “a timely recommendation as lawmakers wrestle with how to handle yet another cut in physician pay,” according to AMA. Association President Bruce A. Scott, MD, issued a statement of support similar to previous ones because the issue has been under discussion for months. In fact, Scott noted MedPAC has suggested the same to Congress at least three consecutive years.
      The current baseline increase to physician reimbursement is 0.25%, or 0.75% for doctors participating in an alternative payment model. MedPAC said Congress should consider setting reimbursement at the rate of the Medicare Economic Index minus 1%, every year for the foreseeable future.
  • Fierce Healthcare lets us know,
    • “A new assessment of 18 Center for Medicare and Medicaid Innovation models reaffirms recent criticism of the agency’s aggregate cost savings—or more accurately, losses—while highlighting several individual payment models that appear effective in cutting down federal spending and improving care quality.
    • “The white paper published Wednesday by healthcare consulting and advisory firm Avalere Health looked at newer quality metrics for outcomes than prior CMMI model analyses and also dug into whether the agency had been transparent and provided opportunities for feedback when designing the models.
    • “The findings come in the wake of a damning late 2023 Congressional Budget Office assessment of the agency’s work, which found CMMI increased indirect spending by $5.4 billion between 2011 and 2020 (0.1% of net Medicare spending during that time) and spurred sharp scrutiny from cost-conscious lawmakers.”
  • and
    • “Disability protections against gender dysphoria implemented via rulemaking during the Biden administration will not be supported going forward, the Department of Health and Human Services (HHS) announced April 10.
    • “In a two-page clarification, HHS Secretary Robert F. Kennedy Jr. signed off on a rule update that declares language characterizing gender dysphoria as a disability to not be enforceable because its inclusion was in the preamble—not the regulatory text—to a final rule from May 2024.
    • “The Department is nonetheless concerned there has been significant confusion about the preamble language referencing gender dysphoria in the [final rule],” the update (PDF) in the Federal Register reads. “It is well-established that where, as here, the language included in the regulatory text itself is clear, statements made in the preamble to a final rule published in the Federal Register, lack the force and effect of law and are not enforceable.”
  • Federal News Network tells us, “OPM lacks funds to relocate ‘significant’ number of remote employees in return-to-office plans. OPM is joining many agencies in giving employees another chance to take a “deferred resignation” offer before it proceeds with nonvoluntary layoffs.”
  • Tammy Flanagan, writing in Govexec, informs us about “What to know about early retirement offers to federal employees.

From the Food and Drug Administration front,

  • Fierce Pharma relates
    • “Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line liver cancer.
    • “The company’s combination of Opdivo and Yervoy is now approved for patients with newly diagnosed unresectable or metastatic hepatocellular carcinoma, the FDA said Friday.
    • “The immunotherapy regimen combines two well-established agents and may offer the potential for a longer life compared with traditional targeted therapy, Wendy Short Bartie, Bristol Myers’ senior VP of U.S. oncology commercialization, said in an interview with Fierce Pharma.
    • “The first-line approval also converted a previous accelerated approval for Opdivo-Yervoy as a second-line liver cancer treatment. Further, it puts BMS toe to toe with two other immuno-oncology regimens—Roche’s Tecentriq and Avastin, and AstraZeneca’s Imfinzi and Imjudo.”
  • Per MedTech Dive,
    • “Intuitive said Thursday the Food and Drug Administration has cleared a stapler for use with its single-port robotic surgery system.
    • “The device, which Intuitive said is the first stapler designed for single-port robotic surgery, shares features found in the company’s multi-port products to reduce the risk of tissue damage.
    • “CFO Jamie Samath said in January that the stapler nod would trigger the start of “broad commercial efforts” for the single-port system in two indications recently authorized by the FDA.”
  • and
    • “Dexcom received Food and Drug Administration clearance for a 15-day version of its G7 glucose sensor, the company announced Thursday.
    • “Dexcom claims its continuous glucose monitor is the most accurate and has the longest wear time. The company also expects the shift from a 10-day to a 15-day sensor to improve its margins, executives said in a February earnings call.
    • “The announcement alleviated investor concerns that a recent FDA warning letter might delay the decision. Dexcom expects a full launch in the second half of 2025, giving the company time to integrate the updated device with insulin pumps.”

From the judicial front,

  • The Congressional Research Service offers a legal sidebar about the impending April 21 oral argument in the Kennedy v Braidwood Management case which concerns the Affordable Care Act’s preventive care services coverage mandate.
  • Bloomberg Law reports,
    • “A Maine woman can’t proceed with a suit claiming that her health insurance plan’s coverage exclusion for weight loss drugs unlawfully discriminates against obese people, a federal court said.
    • “Rebecca Holland didn’t allege any facts showing that Elevance Health Inc. ever regarded her or other obese plan members as disabled, the US District Court for the District of Maine said Wednesday. Her “bare conclusory allegations to the contrary” didn’t support a ruling that the exclusion was discriminatory, Chief Judge Lance E. Walker said.
    • “Medicare and private insurers generally cover the cost of drugs like Ozempic when used to treat Type 2 diabetes but have been reluctant to pay for it when used for weight loss purposes. Several state and federal plaintiffs are trying to change that by claiming that obesity qualifies as a disability, and the exclusions violate discrimination laws.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity is declining nationally. Wastewater levels are at low levels, emergency department visits are at very 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
    • “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 American Hospital News points out,
    • “There have been 712 confirmed cases of measles reported by 25 states so far this year, according to the latest figures released April 11 by the Centers for Disease Control and Prevention. The agency said 93% of those cases (660 of 712) are outbreak-associated and 11% of cases have been hospitalized. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • ProPublic adds,
    • “In the past six months, two babies in Louisiana have died of pertussis, the disease commonly known as whooping cough.
    • “Washington state recently announced its first confirmed death from pertussis in more than a decade.
    • “Idaho and South Dakota each reported a death this year, and Oregon last year reported two as well as its highest number of cases since 1950.
    • “While much of the country is focused on the spiraling measles outbreak concentrated in the small, dusty towns of West Texas, cases of pertussis have skyrocketed by more than 1,500% nationwide since hitting a recent low in 2021 amid the COVID-19 pandemic. Deaths tied to the disease are also up, hitting 10 last year, compared with about two to four in previous years. Cases are on track to exceed that total this year.”
  • The New York Times reports,
    • “Surgeons removed a genetically engineered pig’s kidney from an Alabama woman after she experienced acute organ rejection, NYU Langone Health officials said on Friday.
    • “Towana Looney, 53, lived with the kidney for 130 days, which is longer than anyone else has tolerated an organ from a genetically modified animal. She has resumed dialysis, hospital officials said.
    • “Dr. Robert Montgomery, Ms. Looney’s surgeon and the director of the NYU Langone Transplant Institute, said that the so-called explant was not a setback for the field of xenotransplantation — the effort to use organs from animals to replace those that have failed in humans.
    • “This is the longest one of these organs has lasted,” he said in an interview, adding that Ms. Looney had other medical conditions that might have complicated her prognosis.
    • “All this takes time,” he said. “This game is going to be won by incremental improvements, singles and doubles, not trying to swing for the fences and get a home run.”
  • Health Day notes,
    • “About one in 10 U.S. adults with substance use disorder (SUD) report past-year hospitalizations, according to a research letter published online April 1 in the Annals of Internal Medicine.
    • “Eden Y. Bernstein, M.D., M.P.H., from the University of Colorado School of Medicine in Aurora, and colleagues described the prevalence of hospitalizations among U.S. adults with SUD. Adults were classified into non-mutually exclusive groups by presence of any SUD, individual SUD, and two or more SUDs. The proportion and number of U.S. adults who reported hospitalizations was estimated for each group.
    • “The researchers identified 60 million U.S. adults with SUD, of whom 5.8 million (9.7 percent) reported past-year hospitalizations. The proportion of hospitalized adults ranged from 7.3 to 23.6 percent among those with alcohol use disorder (AUD) and opioid use disorder (OUD), respectively. Among adults with SUD, those with versus without past-year hospitalizations were more likely to be older and more likely to have two or more medical comorbid conditions. Hospitalized adults with AUD, cannabis use disorder, and tobacco use disorder were also more likely to have serious mental illness. Across all groups apart from AUD, hospitalized adults were less likely to be uninsured. Hospitalized adults with OUD were less likely to be non-Hispanic Black.”
  • Per a National Cancer Institute news release,
    • “Why do some cancers come back many years after treatments had eliminated all signs of the disease? The answer may involve rogue cancer cells that spread to other parts of the body early in the disease and then enter a sleeping, or dormant, state, according to a growing body of research. 
    • “These dormant cancer cells can survive in the body undetected for months, years, or even decades, the research suggests. At some point, however, the cells may awaken and begin the process of forming metastatic tumors.  
    • “What causes disseminated cancer cells to enter, and then to leave, a dormant state is not known. 
    • “But recent studies of tumor dormancy have yielded clues that scientists believe could one day help them find ways to prevent metastases, which account for most cancer deaths.”
  • Genetic Engineering and Biotechnology News adds,
    • “Cancer vaccines have been a tantalizing idea for decades, but the vast complexity of the human immune system has posed significant challenges. Now, technological advances like rapid DNA sequencing, lymph node targeting, and AI-informed antigen selection are enabling the creation of precision vaccines that target cancers effectively while minimizing harmful side effects.”
  • AHRQ’s Effective Health Care Program shares a paper about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • The University of Minnesota’s CIDRAP relates,
    • “A new smartphone-sized device can deliver tuberculosis (TB) test results at the point of care in less than an hour, an innovation that could improve diagnosis of the deadly disease in settings in which access to healthcare facilities and lab equipment is limited, its Tulane University developers reported yesterday in Science Translational Medicine.
    • “Over 90% of new TB cases occur in low- and middle-income countries.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review calls attention to the fact that CMS has approved seven new health systems to offer hospital at home programs.
  • Beckers Payer Issues informs us,
    • “CVS Health has named Benjamin Kornitzer, MD, as Aetna’s chief medical officer. 
    • “Most recently, Dr. Kornitzer was chief medical officer at agilon health, a primary care physician services company primarily serving Medicare Advantage patients.
    • “He also previously served as CMO of Mount Sinai Health System in New York.”
  • Fierce Healthcare reports,
    • “A better consumer experience has implications for clinical improvements, according to a new report from CVS Health.
    • “The healthcare giant is putting a focus on innovation in this area, and to identify opportunities conducted an analysis that compared Net Promoter System (NPS) scores with clinical outcomes. It found that, for example, patients who were highly satisfied with the experience at their pharmacies were more likely to be adherent to their medications.
    • “The white paper notes that nonadherence to prescribed medications drives 16% of U.S. health spending each year, or about $500 billion.” 
  • Modern Healthcare tells us,
    • “Eli Lilly is partnering with digital health companies to boost sales of its weight loss medications.
    • “The drugmaker added hybrid weight loss startup Knownwell to its third-party marketplace of telehealth offerings earlier this month. Eli Lilly has also signed deals with Ro, Form Health and 9am Health.” 
  • BioPharma Dive recently updated its prescription drug patent tracker.
  • Bloomberg Law adds,
    • “Novo Nordisk A/S and Eli Lilly & Co. are using dense clusters of patents to extend monopolies on blockbuster diabetes and weight-loss drugs including Ozempic, Wegovy, and Mounjaro, fueling high prices and health inequities, according to an advocacy group report.
    • “The pharmaceutical companies’ adoption of a “financialized business model” prioritizes profits and shareholder returns through an aggressive strategy for securing additional patents for minor changes to extend their drugs’ market exclusivity well beyond the expiration of its original patents, according to a report released Thursday by the Initiative for Medicines, Access and Knowledge on “the heavy price” of those glucagon-like peptide 1 therapies.” * * *
    • In a statement Friday, Lilly said the “report is grossly inaccurate and includes patents that have nothing to do with tirzepatide.”
    • “To date, Lilly has only listed three patents in the Orange Book for” its two tirzepatide products, it added.
    • “Our business model is built on the fact that patents are limited in scope and duration, and when they expire, we welcome generic and biosimilar manufacturers to develop lower-cost alternatives,” the statement continued. “Lilly is already focused on developing the next innovation for patients that will eventually become generic.”
    • “The Orange Book is a US Food and Drug Administration registry listing patents that cover approved drugs that allows branded-drug makers to trigger a 30-month delay of FDA approval by filing a suit alleging infringement of a listed patent.
    • “Novo in a Friday statement said it has no more than four patents listed in the Orange Book for Ozempic , no more than eight for Wegovy, and 11 for Rybelsus.
    • “While the US healthcare system is complex and there are many factors that play a role in determining what people will pay for medicines,” Novo said, “the net price of Ozempic has declined by 40% since launch in the US and Wegovy is following a similar trajectory.”

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Senate over the weekend is expected to cast a final vote on its revised budget resolution for fiscal year 2025. Senate Republicans April 3 voted to proceed on the resolution which kicked off debate. Today the Senate was slated to debate and process a number of amendments before holding a final vote on the resolution. The budget resolution is expected to pass and move to the House for consideration next week.” 
  • Per a CMS fact sheet,
    • The Centers for Medicare & Medicaid Services (CMS) issued a final rule on April 4, 2025, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) programs. The Contract Year (CY) 2026 MA and Part D final rule implements changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the MA and Part D programs. 
    • CMS is not finalizing certain provisions from the proposed rule at this time. CMS may address these proposals in future rulemaking, as appropriate. CMS is also announcing that it is not finalizing three provisions from the proposed rule (Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies, Procedures and Ensuring Equitable Access to Medicare Advantage Services—Guardrails for Artificial Intelligence, and Part D Coverage of Anti-Obesity Medications (AOMs) and Application to the Medicaid Program). 
    • This fact sheet discusses the major provisions of the CY 2026 MA and the Part D final rule. The final rule can be downloaded here: https://www.federalregister.gov/public-inspection/2025-06008/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare. 
  • The Wall Street Journal emphasizes,
    • “The Trump administration said Friday that Medicare and Medicaid won’t expand coverage of popular anti-obesity drugs, rejecting a proposal issued late last year by the Biden administration.
    • “The decision deals a blow, at least for now, to Americans who are covered by the government health-insurance programs and wanted their help paying for the popular but pricey drugs. 
    • “Yet the administration left open the possibility of revisiting the decision later.
    • “Expanding coverage of the obesity medications “is not appropriate at this time,” a Centers for Medicare and Medicaid Services spokeswoman said.
    • “She said CMS may reconsider the policy after more review of the drugs’ “potential benefits” and “relevant costs,” including costs to state Medicaid agencies.”
  • For perspective, STAT News pointed out last September
    • A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.
  • Per a House Budget Committee news release,
    • “House Budget Committee Chairman Jodey Arrington (R-Texas) today appointed Budget Committee Member Rep. Blake Moore (R-Utah) to chair the Committee’s Health Care Task Force. 
    • “The Task Force will build on its work from the 118th Congress by examining opportunities to modernize and personalize the health care system and support policies to fuel innovation and increase patient access to quality and affordable care. One of the initial areas of focus for the Budget Health Care Task Force will be examining the budgetary effects of chronic disease and opportunities to Make America Healthy Again.” 
  • Per an HHS news release,
    • “HHS Secretary Robert F. Kennedy, Jr. will embark [next Monday through Wednesday] on a multi-state tour to celebrate MAHA initiatives in the Southwest. He will meet with elected officials, tribal leaders, nutrition experts, and charter school visionaries as he works to fulfill President Trump’s promise to Make America Healthy Again.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • COVID-19
      • “COVID-19 activity is declining nationally to low levels. Wastewater levels and 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
    • 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 AHA News tells us,
    • “There are 607 confirmed cases of measles across the U.S., according to the latest data released April 4 by the Centers for Disease Control and Prevention. The majority of cases are in Texas, as an outbreak in the state has grown to 481 cases, according to the Texas Department of State Health Services.  
    • “Cases have been reported by 21 states, with 93% being outbreak-associated, according to the CDC. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.” 
  • Per Health Day,
    • “Strokes caused by an artery tear are landing five times as many Americans in the hospital these days, a new study says.
    • “Cervical artery dissection involves a small tear in the inner lining of an artery in the neck that supplies blood to the brain.
    • “Blood can clot at the site of the tear. If the clot breaks loose, it can travel to the brain and cause a stroke.
    • “Hospitalizations for this sort of stroke have increased nearly fivefold during the past 15 years, according to findings published April 2 in the journal Neurology.
    • “Cervical artery dissection is an important cause of stroke, especially in people under 50, so it is crucial to detect it right away,” senior researcher Dr. Shadi Yaghi, a vascular neurologist at Brown University in Providence, R.I., said in a news release.
    • “Strokes that are not fatal can lead to long-term disability, poor mental health and reduced quality of life,” he said. “Our research found a dramatic increase in the number of hospitalizations for cervical artery dissection, with rates rising steadily year over year.” 
    • “These sort of tears in the cervical artery are most often caused by a motor vehicle crash or other accident that causes neck strain, researchers said. However, activities as simple as heavy lifting has been known to cause a cervical artery tear in some people.”
  • The New York Times shares “10 Small Things Neurologists Wish You’d Do for Your Brain. Easy everyday habits can help keep you sharp. And it’s never too late to start them.”
  • Per MedTech Dive,
    • “Boston Scientific’s pulsed field ablation catheter, Farapulse, was noninferior to Medtronic’s Arctic Front cryoballoon in a randomized trial, researchers found in a study published in The New England Journal of Medicine.
    • “The study, which was published Monday and funded by a Swiss hospital, randomized 210 patients with symptomatic paroxysmal atrial fibrillation to undergo PFA or cryoablation. Atrial tachyarrhythmia, a heart rhythm disorder where the atria beat too fast, recurred in 39 patients in the PFA cohort and 53 people in the cryoablation group.
    • “Medtronic reported declines in its cryoablation business last year but said the losses were offset by growth of its PulseSelect single-shot catheter, which competes with Farapulse for the growing PFA market.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “Rural areas are quickly losing independent physicians and medical practices amid the corporatization of healthcare, a new report finds.
    • “The report was commissioned by the Physicians Advocacy Institute (PAI), a nonprofit advocacy organization focused on fair and transparent payment policies. The research, conducted by Avalere Health, used the IQVIA OneKey database, which contains physician and practice location information on health system ownership.
    • “The number of independent doctors in rural areas fell 43% from January 2019 to January 2024, with rural areas losing 5% of all practicing physicians. Meanwhile, people in rural areas had access to 11% fewer medical practices as of January 2024.
    • “Nearly 9,500 doctors left independent practice in rural areas, predominantly in the Midwest and Northeast. States like Indiana, Massachusetts, New Jersey and Ohio lost more than 50% of independent docs.
    • “This decline in rural healthcare providers has been primarily driven by a drop in independent docs and practices as well as the acquisition of these practices by hospitals and corporate entities, the report said.” 
  • Beckers Hospital Review lets us know,
    • “South Bend, Ind.-based Beacon Health System has signed a definitive agreement to acquire Ascension Michigan’s southwest region, which includes four hospitals, 35 outpatient clinics and an ambulatory surgery center.
    • “The hospitals include:
      • “Ascension Borgess Hospital (Kalamazoo)
      • “Ascension Borgess Allegan Hospital
      • “Ascension Borgess-Lee Hospital (Dowagiac)
      • “Ascension Borgess-Pipp Hospital (Plainwell)
    • “Expanding our reach deeper into southwest Michigan broadens access to high-quality, affordable care for communities served by Ascension, extends our service area and provides growth opportunity to further strengthen the health system,” Beacon Health CEO Kreg Gruber said in an April 3 news release. “This acquisition will create a bright future for these communities by ensuring access to quality healthcare services for generations.”
  • Per Fierce Pharma,
    • “With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth out of another drug from its $27.8 billion Horizon Therapeutics buy. 
    • “Uplizna is the first drug to win an FDA approval for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can present in multiple organs and cause fibrosis and permanent organ damage, with or without symptoms.
    • “The CD19-targeted therapy made strides in treating the disease in its phase 3 MITIGATE trial. In the study, Uplizna demonstrated an 87% reduction in the risk of IgG4-RD flares over placebo during the 52-week placebo-controlled period, with 10.3% of those on Uplizna experiencing a flare-up compared to 59.7% of those taking placebo.
    • “With the approval, patients and physicians now have a “proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use,” Amgen’s executive vice president of R&D Jay Bradner, M.D., said in a company release. “This approval underscores Amgen’s ongoing commitment and leadership in developing innovative treatments targeting CD19+ B-cells across multiple therapeutic areas.”
    • “Now, the road ahead for Amgen’s success in IgG4-RD lays in raising awareness of the rare disease, which was only recently established with an International Classification of Diseases code in 2023. About 20,000 people are estimated to have the disease in the U.S., but the exact number is hard to pinpoint due to limited data, according to Amgen.”
  • and
    • “As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud.
    • “GSK and Pfizer have moved to scrap a patent lawsuit around their respective RSV vaccines, according to a filing in the U.S. District Court in Delaware.
    • “The settlement comes after a U.K. high court in November sided with Pfizer, ruling that two GSK RSV vaccine patents were invalid.”

From the artificial intelligence front,

  • Beckers Payer Issues discusses how health plans can use “AI to Drive Patient Outcomes & Health Plan ROI.”
  • Modern Healthcare adds,
    • “Artificial intelligence and other cutting-edge innovations could radically reshape how care is delivered, but tapping technology’s full potential and getting a return on investments is far off, according to industry executives.
    • “We need enduring, ambitious vision,” said Dr. Vivek Garg, chief medical officer at Humana’s CenterWell healthcare services division, during Modern Healthcare’s 2030 Playbook conference in Nashville Wednesday. “You’re going to need the leadership and the board to make trade-offs and to make investments. …They’ve got to do it because they know what they stand for, and they want to see what they can become and how much further they can go in their vision.” * * *
    • “More collaboration between payers and providers is imperative, said Mike Bennett, chief strategy and transformation officer at Highmark Health.
    • “If we both don’t start working together and using the tools we both have, we’re going to end up leaving [our populations] behind,” Bennett said. “AI doesn’t care whether you’re a payer or provider.”

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Fierce Healthcare lets us know,
    • Bipartisan lawmakers have introduced a bill that aims to more closely align Medicare insurers’ prior authorization denials with medical need, as determined by board-certified specialist physicians.
    • The Reducing Medically Unnecessary Delays in Care Act of 2025 was introduced in the House Thursday by Rep. Mark Green, M.D., R-Tennessee, and referred to committee. It is a reintroduction of similar bills brought by the lawmaker in 2023 and 2022.
    • Green—along with Reps Greg Murphy, M.D., R-North Carolina, and Kim Schrier, M.D., D-Washington, who also backed the bill—said the legislation will help streamline necessary care and reduce administrative burden and burnout among providers.
  • Roll Call tells us,
    • “President Donald Trump on Friday threw his support behind the funding fix needed to allow the District of Columbia’s government to avoid $1.1 billion in budget cuts squeezed in the remaining half of the fiscal year, all but ensuring House passage of legislation the Senate passed two weeks ago.
    • “The full-year stopgap spending law, drafted by House Republicans, did not include the typical provision that would allow the D.C. government to tap into its fiscal 2025 budget for operating costs. This would force D.C. to go back to the previous year’s funding levels for the remainder of the fiscal year, which runs through Sept. 30, which local officials say would require steep cuts in critical services like law enforcement and education.”
  • STAT News reports,
    • “Peter Marks, the top Food and Drug Administration official who oversaw vaccines, gene therapies, and the blood supply, resigned Friday after being told by Trump administration officials he would be fired if he did not step down, according to people familiar with the situation.”
  • and
    • “President Trump has selected Sara Carter, a conservative journalist and Fox News contributor, as the nation’s next drug czar.” * * *
    • “If confirmed by the Senate, Carter would oversee the White House Office of National Drug Control Policy, an executive office housed across the street from the West Wing that makes policy recommendations and coordinates efforts between various federal agencies focused on substance use, both from a law enforcement and public health perspective.” 
  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today joined West Virginia Governor Patrick Morrisey for a press conference at the St. Joseph School in Martinsburg, WV, to celebrate the signing of new legislation banning seven types of harmful food dyes from school lunches beginning August 2025. Governor Morrisey announced at the event that he intends to request a waiver to restrict taxpayer funds from being used to purchase soda through the SNAP program.”

From the judicial front,

  • Healthcare Dive points out,
    • “The Department of Justice agrees that Claritev, formerly known as MultiPlan, conspired with health insurers to underpay doctors for medical care, according to a statement of interest filed by antitrust regulators on Wednesday in the consolidated lawsuit from providers against the cost management firm.
    • “Lawyers for the providers said the DOJ’s position affirms the validity of their case, while Claritev reiterated that it believes the lawsuits are without merit.
    • “The DOJ’s interest in the case signals antitrust regulators, including in the Trump administration, are still closely scrutinizing exchanges of potentially sensitive information between companies, along with their use of pricing algorithms.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “After much delay, Novartis has finally won a key FDA go-ahead for Pluvicto, opening up the radioligand therapy to a much broader prostate cancer population.
    • “The new approval, which triples Pluvicto’s eligible patient population, allows the radiopharmaceutical to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) before taxane-based chemotherapy, Novartis said Friday. Patients will have to have been treated with an androgen receptor pathway inhibitor (ARPI) to be considered.
    • “Pre-chemo mCRPC represents the most important indication in Novartis’ plan for Pluvicto to achieve more than $5 billion in peak sales. Initially cleared by the FDA in 2022 in the post-chemo setting, Pluvicto’s revenue is currently annualizing at about $1.5 billion based on its most recent quarterly number.”
  • and
    • Over the last three years, the FDA has approved six new hemophilia drugs, including three gene therapies.
    • Into this crowded treatment landscape comes another new medicine as the FDA has signed off on Sanofi’s Qfitlia (fitusiran), which sets itself apart as the only treatment for all types of hemophilia.
    • Not only is Qfitlia for those with hemophilia A and B, but unlike most treatments for the disorder, it also can be used by patients regardless of their inhibitor status.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.
    • “Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.” * * *
    • “This announcement follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.”
  • Per Managed Health Executive,
    • “Fresenius announced today [March 27, 2025] that the FDA has approved the biologics licensing applications (BLA) for denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), according to a news release. Prolia, the reference product for Conexxence, and Xgeva, the reference product for Bomyntra, were both developed by Amgen. As a result of a global settlement between Fresenius and Amgen, both biosimilars are expected to launch in the United States in mid 2025 and in the second half of 2025 in Europe.
    • “Bomyntra and Conexxence are the fourth pair of denosumab biosimilars. Other Prolia biosimilars include Jubbonti, Ospomyv and Stoboclo. Additional Xgeva biosimilars include Wyost, Xbryk and Osenvelt.
    • “Although the active drug ingredient in Conexxence and and Bomyntra is deosumab, they have different indications.
    • ‘Conexxence is approved for patients at high risk for fractures, including osteoporosis patients and patients undergoing cancer treatments that affect bone density. It comes as a 60 mg/mL single-dose prefilled injection to be administered every six months via subcutaneous injection. Adverse reactions varied by indication.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is declining nationally to low levels. Wastewater levels and 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 continues to decline; however, 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 American Hospital Association News adds,
    • “There are 483 confirmed cases of measles in 19 states across the country, according to the latest data from the Centers for Disease Control and Prevention. The agency said 93% of the cases are outbreak-associated. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • NBC News adds,
    • “We are experiencing an extremely concerning decline in measles vaccination in the very group most vulnerable to the disease,” said Benjamin Rader, a computational epidemiologist at Boston Children’s Hospital, an assistant professor at Harvard Medical School and the author of a recent study that looked at children’s vaccination rates.” * * *
    • “Rader said that the true MMR vaccination rate among young children can be misrepresented by publicly reported numbers, because MMR surveillance is drawn from older children who are already in kindergarten.
    • “Younger children under the age of 5 are not fully captured in surveillance data because they have not reached kindergarten age — although a 2021 estimate from the CDC notes a subset of younger children, namely those who received at least one MMR dose by 24 months, were 90.6% vaccinated for measles.
    • “In Rader’s study, published online in February in the American Journal of Public Health, his team surveyed approximately 20,000 parents of children under 5 from July 2023 through April 2024, finding only 71.8% reported that their children received at least 1 dose of MMR vaccine — much lower than CDC estimates.
    • “The researchers used a digital surveillance platform that the CDC has used to estimate things like at-home Covid testing, he said.  
    • “Rader downplayed the difference in numbers between his findings and the CDC data, emphasizing that, while accurate, the CDC data does not provide a complete picture — despite its best intentions.
    • “Dr. Scott Roberts, associate medical director of infection prevention at the Yale School of Medicine in New Haven, Connecticut, who was not part of the research, called the findings “worrisome.”   
  • Health Day relates,
    • “Tobacco control measures like anti-smoking campaigns and cigarette taxes have prevented nearly 4 million lung cancer deaths during the past five decades, a new American Cancer Society study estimates.
    • “More than 3.8 million lung cancer deaths were averted due to substantial reductions in smoking, gaining a little more than 76 million years of extra life among Americans, researchers say in CA: A Cancer Journal for Clinicians.
    • “The substantial estimated numbers of averted lung cancer deaths and person-years of life gained highlight the remarkable effect of progress against smoking on reducing premature mortality from lung cancer,” lead investigator Dr. Farhad Islami, the ACS’ senior scientific director for cancer disparity research, said in a news release. 
    • “In fact, the number of averted lung cancer deaths accounts for roughly one-half of all cancer deaths that were prevented in recent decades, researchers said.
    • “However,” Islami added, “Despite these findings, lung cancer is still the leading cause of cancer death in the United States, and smoking-attributable morbidity and mortality from other cancers or diseases remain high.”
  • Per Healio,
    • “There were 69 nonfatal fentanyl exposures in 2015 and 893 in 2023.
    • “Two-thirds of adolescents who were exposed to fentanyl used it intentionally.” * * *
    • “According to the researchers, nearly 39.4% of all overdoses and 65.7% of those among adolescents involved intentional misuse or abuse. In contrast, 81.7% of overdoses among younger children were reported to be unintentional.
    • “It was surprising that a large portion of adolescents used fentanyl intentionally,” Palamar said. “We often think of pediatric exposures to fentanyl as being unintentional.”

From the AI front,

  • Per an NSF news release,
    • “Powered exoskeletons that enable humans to move faster or lift heavy objects more easily have been envisioned for decades. In science fiction, advanced exoskeletons such as the power loader in the movie “Aliens” or Marvel Comics’ Iron Man’s suit provide the wearer with superhuman capabilities with nearly zero limitations.
    • “There are exoskeletons in use today, but current technology falls short of the vision laid out in science fiction, and widespread use of exoskeletons is hampered because to work properly, a suit must be tested and adapted to work with each user individually, a complicated and lengthy process.
    • “Now, engineering researchers supported by the U.S. National Science Foundation have made a breakthrough, creating a new method that takes advantage of artificial intelligence and computer simulations to improve the process of enabling users and exoskeletons to work together. This framework is compatible with a variety of assistive devices and could improve the lives of millions of able-bodied and mobility-impaired individuals.
    • “This marks a major advance in exoskeleton engineering by eliminating one of its biggest hurdles: individualized calibration,” said Alexander Leonessa, program director for the NSF Mind, Machine and Motor Nexus program. “Using AI and human-robot simulations, the team developed a scalable, adaptable system that assists a wide range of users without lengthy setup. It is a key step toward making exoskeletons practical, versatile and accessible for both industry and mobility-impaired individuals – smart, human-centered engineering at its best.”

From the U.S. healthcare business front,

  • FiercePharma reports,
    • “A rival bidder has emerged to acquire struggling gene therapy specialist bluebird bio.
    • Ayrmid has offered to buy bluebird for $4.5-apiece upfront, plus a one-time contingent value right (CVR) of $6.84 per share tied to a sales milestone, bluebird said Friday.
    • “The upfront tag is 50% higher than the $3-per-share selling price that bluebird has previously penned with Carlyle and SK Capital Partners. That private equity duo’s buyout offer also includes a $6.84-per-share CVR.
    • “For now, bluebird’s board has not changed its mind and the company remains bound by the original merger agreement. But it’s willing to look at the new unsolicited non-binding written proposal.
    • “Consistent with its fiduciary duties, the bluebird Board of Directors is carefully reviewing the Ayrmid proposal in consultation with its legal and financial advisors,” the Massachusetts biopharma said Friday.”
  • Beckers Hospital Review tells us,
    • “Insight Hospital and Medical Center Trumbull and Hillside Rehabilitation Hospital, both in Warren, Ohio, paused all inpatient, outpatient and emergency room services March 27 due to ongoing bankruptcy and financial disruptions from former owner Dallas-based Steward Health Care.
    • “Tom Connelly, local president of the American Federation of State, County and Municipal Employees, told NBC affiliate WFMJ March 28 that the hospitals also laid off the director of nursing, the assistant director of nursing, the administrative secretary and the human resources coordinator.
    • “A spokesperson for Insight Health refuted the claims to Becker’s and denied upper management layoffs.
    • “Existing patients at both Insight hospitals are being transferred, with appointments being canceled to protect patient safety, an Insight Health spokesperson said in a March 27 statement shared with Becker’s.
  • Beckers Payer Issues informs us,
    • “Enrollment in provider-sponsored Medicare Advantage plans declined by nearly 60,000 members for 2025, according to a report from Chartis. 
    • “The healthcare consulting firm published an analysis of CMS Medicare Advantage enrollment data March 25. 
    • “Overall, Medicare Advantage plans gained 1.3 million new enrollees, a smaller growth rate than the program has seen in previous years. 
    • “Kaiser Permanente saw the largest membership growth for 2025 among provider-sponsored plans, gaining 58,000 new members. Trinity Health and UPMC Health Plan each added 11,000 MA members.” 

Weekend update

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

From Washington, DC,

  • Roll Call adds,
    • Both the House and Senate come back from recess this week to begin a busy three-week period that’s expected to focus on Republicans’ budget reconciliation agenda, including extending and expanding tax cuts and tightening immigration policy.
    • The top items on the House agenda this week, meanwhile, will include more measures to overturn Biden administration rules. And the Senate will continue to vote on more of President Donald Trump’s nominations. The headliners this week are the nominees to lead the National Institutes of Health and the Food and Drug Administration.
    • With a stopgap spending law now in effect through Sept. 30, the Republican majorities in both the House and Senate can fully turn their attention to their budget reconciliation agenda.
    • This work period on Capitol has just three weeks, followed by the traditional two-week recess that coincides with Easter and Passover. By then, House and Senate Republicans will want to make progress on resolving differences on how to execute the process that allows them to pass legislation without the risk of filibusters in the Senate.
  • Roll Call also gives us the 119th Congress in numbers, mid-March edition.
  • On Tuesday morning at 10 am, the House Oversight and Government Reform Committee will mark up the following batch of bills,
    • H.R. 1295, the Reorganizing Government Act of 2025; 2) H.R. 1210, the Protecting Taxpayers’ Wallet Act; 3) H.R. ___, the Preserving Presidential Management Authority Act; 4) H.R. 2174, the Paycheck Protection Act; 5) H.R. 2193, the FEHB Protection Act of 2025; 6) H.R. ___, the Federal Accountability Committee for Transparency (FACT) Act; 7) H.R. 2056, District of Columbia Federal Immigration Compliance Act; 8) H. Res. 187, Of inquiry requesting the President to transmit certain information to the House of Representatives referring to the termination, removal, placement on administrative leave, moved to another department of Federal employees and Inspectors General of agencies; 9) H. Res. 186, Of inquiry requesting the President to transmit certain documents to the House of Representatives relating to the conflicts of interest of Elon Musk and related information.
  • Healthcare Dive tells us,
    • “A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and Human Services confirmed.
    • “The Advisory Committee on Immunization Practices, or ACIP, had originally been scheduled to meet Feb. 26 to Feb. 28, but was unexpectedly delayed soon after Robert F. Kennedy Jr., a longtime critic of U.S. vaccination policies, took office as health secretary. At that time, an HHS spokesperson said the rescheduling was to allow extra time for public comment.” * * *
    • “ACIP, which includes outside vaccine experts as well as federal health officials, will now convene on April 15 and April 16, Andrew Nixon, HHS’ director of communications, wrote in an email to BioPharma Dive.” 
    • “A notice posted Friday ahead of publication Monday in the federal register indicated that advisers will discuss the current measles outbreak, as well as vaccines for COVID-19, human papillomavirus, monkeypox, respiratory syncytial virus and other pathogens.”
  • The New York Times reports,
    • “Robert F. Kennedy Jr., the nation’s health secretary, on Saturday instructed leaders of the nonprofit he founded to take down a web page that mimicked the design of the Centers for Disease Control and Prevention’s site but laid out a case that vaccines cause autism.
    • “The page had been published on a site apparently registered to the nonprofit, the anti-vaccine group Children’s Health Defense. Mr. Kennedy’s action came after The New York Times inquired about the page and after news of it ricocheted across social media.
    • “The page was taken offline Saturday evening.” 
  • Pharmacy Practice News informs us,
    • “The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video.
    • “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.”
    • “These activities can result in “a thousand fraudulent prescriptions using an unsuspecting doctor’s DEA number within a 14-hour time frame,” Ms. Hager said.”

From the public health and medical research front,

  • The New York Times reports, “Dementia May Not Always Be the Threat It Is Now. Here’s Why. The number of cases will increase, but the rates seem to be declining with every birth cohort that reaches advanced ages, researchers said.”
    • Eric Stallard, an actuary and co-director of the Biodemography of Aging Research Unit at Duke University, read the [recent dementia] study and thought the team “seemed very competent at their analysis” of individual risk.
    • But when it came to the projection that cases would double, which assumed that the incidence of dementia would remain stable over the next 40 years, “I don’t believe it,” Mr. Stallard said.
    • “The notion that the number of people with dementia will double over the next 25, 30 or 35 years due to the aging of baby boomers is widespread, it’s pervasive — and it’s wrong,” he added.
    • “He and two other Duke researchers recently published a commentary in JAMA pointing out that the age-specific prevalence of dementia in this country had steadily declined for 40 years.
    • “If your risks are lower than your parents’ risks and this trend continues, you won’t see the doubling or tripling of dementia that’s been projected,” said Dr. Murali Doraiswamy, director of the Neurocognitive Disorders Program at Duke and a co-author of the JAMA article.
    • “To be clear, experts agree that the number of people with dementia will climb in coming decades, simply because the disorder rises so steeply with age and the number of older adults in the United States will increase.
    • “But Mr. Stallard estimates that the increase will be more like 10 to 25 percent by 2050. “It will still be a significant challenge for the health system in the U.S.,” he said.”
  • The University of Minnesota CIDRAP lets us know,
    • Another study is raising questions about whether compliance with a federally mandated hospital protocol aimed at improving sepsis care and management is associated with better outcomes.
    • The study, published this week in JAMA Network Open, found that sepsis patients who received care that was noncompliant with the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) tended to be older, have more comorbidities, and have more complex clinical presentation than those who received compliant care. When those factors were accounted for, SEP-1 compliance was no longer associated with improved mortality.
    • The study comes on the heels of a systematic review and meta-analysis, published last month in the Annals of Internal Medicine, that found no evidence that SEP-1 compliance was associated with improved mortality.
  • and
    • “People who started taking the antiviral drug ensitrelvir within 72 hours after a household member tested positive for COVID-19 were significantly less likely to be infected, according to results from an international phase 3 clinical trial presented last week at the Conference on Retroviruses and Opportunistic Infections in San Francisco.
    • “Made by Japanese pharmaceutical firm Shionogi, ensitrelvir is approved in Japan for the treatment of mild to moderate COVID-19.  * * *
    • “In addition to vaccination, post-exposure prophylaxis with timely use of an oral antiviral would be a valuable way to help prevent COVID-19 illness in people who have been exposed, especially people at high risk for severe disease,” Frederick Hayden, MD, a University of Virginia School of Medicine professor emeritus who helped design the trial and presented the findings, said in a university news release.
    • “This is the first clinical trial of an oral antiviral drug to show significant protection against COVID-19 [infection],” he added. “If approved by the [US] Food and Drug Administration for this purpose, it would be an important addition to current preventive strategies.”
  • A Wall Street Journal reporter tells us “A Year After I Stopped Taking a [GLP-1} Weight-Loss Drug, I’ve Lost 20 More Pounds. I’m one of the millions of people trying to keep the weight off without taking expensive drugs like Mounjaro or Ozempic for life. It wasn’t easy, but I found ways.”
    • “My first mistake in stopping the medicine [after reaching his target weight in five months] was that I didn’t wean myself off it more slowly. I stopped cold turkey, and my hunger pangs and food noise came back with a vengeance. Some doctors and researchers have begun to recommend stopping more gradually, as well as taking appetite suppressants like phentermine to ease the transition. This has helped reduce weight regain in some patients.
    • “My second mistake was not having a structured nutrition plan at the ready. The medicine had helped winnow my bad habits down to a number I could actually manage, from perhaps 25 or 30 entrenched eating behaviors (really!) down to more like five or six (I still can’t shake my addiction to impulsive runs to the 7-Eleven, for example). But even a few bad habits—when they meet with what feels like insatiable hunger—can do a lot of damage.
    • “After a few months, I found a highly structured nutrition program, one with expert coaching that focused on a low-carb diet. While the transition was difficult, it eventually helped me bring my cravings under control. 
    • “Virta Health, a startup I turned to for a few months, has users test their blood daily. The results, which measure glucose levels and another indicator of dietary compliance, are beamed through an app to a nutrition coach. Being aware that someone was watching—and would know if I had cheated—was immensely helpful as I sought to improve my nutrition and manage hunger.
    • “Without wading into the nutrition wars over the keto or Atkins or Mediterranean diet or any other, I’ve found that I have generally been far less hungry when I’ve eaten more protein, fiber and healthy fats. Meanwhile, drastically limiting carbohydrates has had another benefit: forcing me to eat more vegetables. Gobs and gobs of them.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The Longevity Business Is Booming—and Its Scientists Are Clashing. The antiaging movement has raced ahead amid fierce debates; critics of a grandfather of the field, Leonard Guarente, include former protégés and rivals.”
  • and
    • “Doctors Are Just as Frustrated as You by Our Messed-Up Healthcare System. Trust between doctors and patients is fraying, but there are ways to mend it.”
      • “One of doctors’ biggest gripes: largely corporate institutions that effectively set patient quotas and require extensive documentation. One physician said he and other doctors are allowed 15 minutes with patients; exceeding that leads to poor performance reviews and “being out of compliance.”
      • “These doctors think patients lose trust because they don’t understand who or what is in control. “Physicians have lost autonomy,” says Dr. Corinne Rao, an internal medicine physician and hospitalist. “Their decisions are subject to the financial interests of their employer.” 
      • “Doctors also say that trust—and respect—go both ways. “It’s like a marriage,” says Dr.  James Schouten, a family physician. Each side has to give 100%. Implying that a loss of trust is entirely the doctor’s fault, he says, suggests the patient has no role in establishing or maintaining trust.
      • “They do, he and others say.”

Friday Report

David Ermer–CDC, COVID-19, FDA, NIH, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “President Trump on Thursday issued a presidential memorandum aiming to expand the power of the Office of Personnel Management to fire federal employees, alarming experts and federal employee groups.
    • “The memo, quietly published Thursday night alongside an executive order mandating agencies share data, particularly with Elon Musk’s Department of Government Efficiency, delegates to OPM the authority to fire federal employees based on “post-appointment conduct.”
    • “A federal employee’s appointment occurs at the conclusion of their one-year probationary period, when their full civil service protections kick in. Prior to that point, the Office of Personnel Management has authority to determine whether a federal job applicant or new hire is “suitable” for federal employment, which generally refers to questions of their “character or conduct.”
    • “But once an employee’s probationary period has ended, the authority to discipline or remove an employee rests solely with agency that employs them. Indeed, even if an employee threatens national security, only his or her employing agency may take action to suspend or remove them.
    • “Trump’s memo expands who may remove employees for “conduct and character” reasons to include OPM and tasks the HR agency with writing the regulations governing the agency’s ostensibly new power. Agencies may make referrals to OPM for approval, or the OPM director may reach down and order individual agencies to discipline or fire workers.”
  • Fierce Healthcare informs us,
    • “Former Republican House Representative Michael Burgess, M.D., is a top choice for the White House’s second try at a Centers for Disease Control and Prevention (CDC) director nomination, according to a Reuters report citing three anonymous sources.
    • “One of the sources described Burgess to Reuters as the likely nominee but said that the decision is not yet final. The administration has not yet commented on its next choice for the role.
    • “Burgess, 74, practiced as an obstetrics and gynecology doctor before stepping into Capitol Hill in 2003. He chose not to seek reelection this past year.”
  • Healthcare Finance offers more details on the terrorist threat against hospitals.
    • On March 18, user @AXactual made a post on X with details related to the active planning of a coordinated, multi-city terrorist attack on United States health sector organizations, according to the joint threat bulletin.
    • The terrorist attack on hospitals would reportedly be by ISIS-K, a division of the jihadist group Islamic State, according to The HIPAA Journal. The post was added to the X account of American Kinetix, which claims to be a Christian company in the United States that consists of JSOC (Joint Special OperationsCommand), the CIA and combat veterans, The HIPAA Journal said.
    • American Kinetix said it had received reports of possible pre-attack surveillance at hospitals.” * * *
    • “The primary targets would be mid-tier cities with low-security facilities, the joint threat bulletin said. With the information claiming multiple simultaneous targets, attackers would likely select health sector facilities with visibly weak security and conduct prior planning coordination.” 
  • The American Hospital Association (AHA) News lets us know,
    • “The Drug Enforcement Administration and Department of Health and Human Services yesterday announced that the effective date for the final rule regarding telemedicine prescribing of buprenorphine will be further delayed from March 21 to Dec. 31. The original effective date was Feb. 18 before the first delay to March 21. As outlined in the Jan. 20 White House memorandum announcing the regulatory freeze, the agencies decided to delay the implementation of rules to review any questions of fact, law and policy.
    • “The waiver provisions outlined in the third extension of telemedicine flexibilities for prescribing controlled substances will remain in effect to waive in-person visit requirements through Dec. 31.
    • “Once implemented, the final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation.”
  • STAT News points out,
    • “The Food and Drug Administration cleared Alnylam Pharmaceuticals’ treatment for a progressive heart condition Thursday, setting it up to compete with therapies from BridgeBio and Pfizer.
    • “Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular-related death and hospitalizations. This indication was widely expected among investors and is similar to the indications given for competing therapies.
    • “The treatment, which will be sold under the brand name Amvuttra, was additionally approved to reduce urgent heart failure visits.”
  • BioPharma Dive adds,
    • “Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available for the condition, company executives said Thursday.
    • “The price of the drug, Amvuttra, was revealed on a Thursday evening conference call discussing the Food and Drug Administration’s decision to clear the treatment in people with transthyretin amyloidosis, or ATTR, cardiomyopathy. Alnylam already markets the medicine for people with a form of the condition that affects the nerves but has long looked to an approval in cardiomyopathy as the kind of revenue driver that can help it turn a consistent profit.
    • Alnylam will begin selling Amvuttra as two other treatments, Pfizer’s tafamidis and BridgeBio Pharma’s Attruby, are already accessible. Both tafamidis and Attruby are taken orally, while Amvuttra is injected. Although none of the drugs have been tested directly against another and cross-trial comparisons come with caveats, Amvuttra’s benefits also don’t appear to be clearly superior to its rivals.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for five 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 and 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 five consecutive weeks. Data to date suggest 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 CIDRAP reports,
    • “The Texas Department of State Health Services (TDSHS) today reported 30 more cases in a measles outbreak in the western part of the state near the New Mexico border, as the New Mexico Department of health added 4 new cases to its total, pushing the outbreak total to 351.
    • “Meanwhile, as global cases surge, a handful of states reported new cases in people who had connections to international travel. In a weekly update today, the Centers for Disease Control and Prevention (CDC) said it has received reports of 378 cases this year, well past the 285 cases reported for all of 2024. 
    • “The cases are from 18 jurisdictions, and 90% are linked to three outbreaks. The CDC’s update includes the first cases of the year from Kansas, Ohio, and Michigan. Kansas last week reported its first measles infection since 2018, and media reports say at least six cases have been reported in the southwest part of the state in Grant and Stevens counties.”
  • The AP relates,
    • “A common blood test may miss ovarian cancer in some Black and Native American patients, delaying their treatment, a new study finds. It’s the latest example of medical tests that contribute to health care disparities.
    • “Researchers have been working to uncover these kinds of biases in medicine. Recently, the Trump administration’s crackdown on diversity, equity and inclusion has jeopardized such research as universities react to political pressure and federal agencies comb through grants looking for projects that violate the president’s orders.
    • “Native American women have the highest rate of ovarian cancer. Black women with ovarian cancer have lower rates of survival compared to white women. Finding ovarian cancer early can lead to better chances of survival.
    • ‘The new study, supported by grants from the National Cancer Institute and published Thursday in JAMA Network Open, looked at a test called CA-125. The test measures a tumor marker in the blood, and doctors use it to determine if a woman with a suspicious lump should be referred to a cancer specialist.” 
  • Per a National Cancer Institute news release,
    • “When people who smoke are screened for lung cancer, studies have suggested that the screening visit can be an opportune time for health care providers to offer them ways to stop smoking.
    • “Results from a large clinical trial now show that a comprehensive program that integrates intensive counseling and cessation medications may be a particularly effective way of accomplishing that goal.
    • “The study included more than 600 adults who were current smokers. By the end of the 3-month treatment period, nearly 40% of those randomly assigned to participate in an intensive cessation program had quit smoking and had not started up again. In contrast, about 25% of those referred to a tobacco use quitline hit that same benchmark.
    • “The results were published March 1 in JAMA Internal Medicine. 
    • “According to the study’s lead investigator, Paul Cinciripini, Ph.D., of the University of Texas MD Anderson Cancer Center, the findings confirm that when people who smoke are being screened for lung cancer, it “presents a critical opportunity” to support them in quitting. The type of support, however, appears to be particularly important, Dr. Cinciripini said.
    • “Another important takeaway is “the importance of having [dedicated cessation specialists] be a part of [cessation] treatment,” said Carolyn Reyes-Guzman, Ph.D., of NCI’s Tobacco Control Research Branch, which funded the study.” 
  • Per Healio,
    • “Risk for moderate to severe depressive symptoms during pregnancy varied widely across 20 different racial and ethnic groups, suggesting women from different cultural backgrounds view and report depression symptoms differently, data show.
    • “Our study found differences among racial and ethnic subgroups in several aspects of prenatal depression, including the likelihood of receiving a diagnosis and reporting symptoms when screened in prenatal care,” Kendria Kelly-Taylor, PhD, a research fellow with Kaiser Permanente Northern California Division of Research, told Healio. “We found most of the [racial] groups were less likely to have a diagnosis of prenatal care and more likely to report moderate-to-severe depressive symptoms when screened. Previous research provides some possible reasons for these findings, which include differences in how patients in various racial and ethnic subgroups experience symptoms, view their symptoms, and their comfort in discussing them with a clinician or having a diagnosis in their medical record.”
  • HealthDay reports,
    • “The total injury death rate in the United States increased from 2013 through 2021, then declined through 2023, according to a March data brief published by the National Center for Health Statistics.
    • “Sally C. Curtin, from the National Center for Health Statistics in Hyattsville, Maryland, presents trends in injury death rates overall and by three leading intents (unintentional, suicide, and homicide) for 2003 to 2023.
    • “Curtin found that the total age-adjusted injury death rate increased 21 percent from 2013 to 2019 (58.8 to 71.2 per 100,000 standard U.S. population) after a period of stability from 2003 to 2013; there was an additional 25 percent increase through 2021 (89.0), followed by a 4 percent decline through 2023 (85.3). From 2003 to 2019, there was a threefold increase in unintentional drug overdose death rates, followed by a 58 percent increase through 2022 and a 4 percent decline through 2023. From 2006 to 2018, there was an increase in firearm-involved suicide death rates, followed by a decline in 2019 and an increase through 2021; rates remained stable through 2023. The firearm-involved homicide death rate declined from 2003 to 2014, then increased through 2021, and declined through 2023.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Johnson & Johnson JNJ said it is increasing U.S investments to more than $55 billion over the next four years, boosting spending on manufacturing, R&D and technology in a move it says will create jobs and help speed up drug discovery and development.
    • “The healthcare conglomerate said Friday that the investment represents a 25% increase from the previous four-year period.
    • “Part of that will go toward four new manufacturing facilities in the U.S., and the expansion of existing sites, J&J said, adding that it is kick-starting the investment by breaking ground on a North Carolina biologics manufacturing facility on Friday.”
  • Beckers Hospital Review notes,
    • “East Ohio Regional Hospital, a 140-bed healthcare facility in Martins Ferry, has closed, local media outlets reported. 
    • “Signs posted at EORH entrances March 20 said “Hospital closed! Please go to the nearest hospital Trinity, Reynolds or Wheeling!” according to the outlets, including The Intelligencer and NBC and Fox affiliate WTOV.
    • “The closing is the latest chapter for the struggling hospital and comes as workers reported having not received their most recent paychecks. Employees were not paid as scheduled March 7 and said they remained unpaid as of March 20, according to The Intelligencer.”
  • Per Beckers Payer Issues,
    • The healthcare industry needs to have more conversations about patient experience, AI and preventive care, according to payer executives. 
    • Becker’s connected with 25 leaders to learn more about what they say is underdiscussed in healthcare. 
    • The leaders’ observations can be found in the article.

Happy Pi Day!

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

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “The Senate March 14 approved by a vote of 54-46, a continuing resolution to fund the government through Sept. 30. The House passed, by a vote of 217-213, the bill earlier in the week. President Trump is expected to sign the measure.
    • “The bill extends certain key health care provisions that were set to expire at the end of March, including eliminating Medicaid disproportionate share hospital cuts, and extending the enhanced low-volume adjustment and Medicare-dependent hospital programs; key telehealth waivers; the hospital-at-home program; the Work Geographic Index Floor program; and add-on payments for ambulance services.”
  • Upshot — No government shutdown.
  • Fierce Healthcare adds,
    • “A last-ditch effort to pass a bipartisan healthcare package pushed aside at the end of 2024 that includes telehealth extensions and pharmacy benefit manager reform, reverses doc pay cuts and addresses the opioid crisis has failed.
    • “That legislation was brought to the floor by Senators Ron Wyden, D-Oregon and Bernie Sanders, I-Vermont, March 14 ahead of a key procedural vote [on the continuing resolution]. The senators’ bill required unanimous consent, or it would not advance. Sen. Rick Scott, R-Florida, quickly rejected the bill.”
  • Per a Senate news release,
    • “Today, the Senate overwhelmingly voted to pass the Halt All Lethal Trafficking of (HALT) Fentanyl Act. The bipartisan legislation, led by Judiciary Chairman Chuck Grassley (R-Iowa), Health, Education, Labor and Pensions Chairman Bill Cassidy, M.D. (R-La.) and Sen. Martin Heinrich (D-N.M.), would permanently classify fentanyl-related substances before their temporary Schedule I status expires on March 31, 2025. 
    • “Last month, the HALT Fentanyl Act was passed out of the Senate Judiciary Committee by a bipartisan vote of 16-5. Attorney General Pam Bondi has endorsed the legislation. President Trump’s Office of Management and Budget has confirmed that, if Congress passes the bill in its current form, the president will sign it. The legislation now heads to the House of Representatives.
    • “The HALT Fentanyl Act is a critical step towards ending the crisis that’s killing hundreds of thousands of precious American lives. I thank my Senate colleagues for passing this bill with broad, overwhelming support. I urge my House colleagues to swiftly pass the Senate version of this battle-tested, bipartisan bill to save lives, advance research and support our brave men and women in blue,” Grassley said.: * * *
    • “Download bill text HERE and a fact sheet HERE.”
  • The AHA News tells us,
    • “The Senate Finance Committee March 14 held a confirmation hearing on Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services. Oz, a doctor and former television show host, indicated that some of his priorities in the position, if confirmed, would be to reduce health care spending by improving poor health, increasing use of technology, incentivizing providers, and stopping wasteful spending, fraud and abuse. The committee will soon schedule a vote on whether to advance his nomination to the full Senate.”
  • The Wall Street Journal adds,
    • “Mehmet Oz, the Trump administration’s nominee to lead the Medicare agency, said some actions by private insurers in the Medicare Advantage program amounted to fraud and cheating, and he intended to go after them as head of the Centers for Medicare and Medicaid Services. 
    • “His comments, during his Senate confirmation hearing on Friday, were focused on industry practices that can boost insurers’ Medicare Advantage payments by documenting more diagnoses in their patients. Medicare Advantage insurers get higher payouts when patients have certain conditions. 
    • “There’s a new sheriff in town,” said Oz, a heart surgeon known for his long-running television show. He criticized “upcoding” in Medicare Advantage and said, “I pledge if confirmed I will go after it.”
  • Per Senate news releases,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, laid out his health care priorities during a hearing to consider Dr. Mehmet Oz’s nomination to be Administrator of the Centers for Medicare and Medicaid Services (CMS). Oz committed to supporting Grassley’s efforts to lower prescription drug costs, strengthen rural health care, help kids with exceptional medical needs, preserve transitional health plans and improve the agency’s responsiveness to Congress.”
  • and
    • “At a U.S. Senate Finance Committee hearing to consider the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator, Chairman Mike Crapo (R-Idaho) highlighted Dr. Oz’s wealth of firsthand experience as an accomplished physician and his clear vision for creating a healthier nation.  Crapo and Dr. Oz discussed how he would address the nation’s chronic disease epidemic, as well as how he might approach reforming payment programs to improve efficiency.
    • “Crapo concluded the hearing with, “There is no doubt you are qualified to serve as the next Administrator of [CMS], and I look forward to voting in favor of your nomination and am urging all of my colleagues to do the same.”
  • The AHA News informs us,
    • “The Medicare Payment Advisory Commission March 13 released its March report to Congress that includes recommendations for hospital and other Medicare payment systems for fiscal year 2026. Among the recommendations, MedPAC urged Congress to update the base payment rate for hospitals by current law plus 1%.  
    • “An update above current law is necessary given the combination of providers’ continued financial pressures, and almost two decades of sustained and substantial negative Medicare margins,” AHA wrote in a January letter to MedPAC. “Simply put, even after the recommended payment update, Medicare’s payments to hospitals would remain inadequate.” 
  • Per a Food and Drug Administration news release,
    • “Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.
    • “The new study, published in the peer-reviewed scientific journal American Journal of Preventive Medicine, found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.”

From the judicial front,

  • Politico reports,
    • “A federal appeals court has given President Donald Trump’s administration the go-ahead to enforce a pair of controversial executive orders that seek to root out diversity, equity and inclusion efforts in federal agencies and government contractors.
    • “The three-member appeals panel — including two judges appointed by Democratic presidents — lifted a lower court’s injunction that had put the policy on hold last month.
    • The ruling Friday from the panel of the Richmond, Virginia-based 4th Circuit Court of Appeals is not a final decision on the legality of Trump’s anti-DEI policy. It merely allows the government to administer the policy while litigation continues.
    • “In separate opinions explaining their votes, the three judges suggested the Trump administration should be allowed to demonstrate that it will abide by anti-discrimination laws and respect First Amendment rights as it implements the executive orders, which Trump issued on the first two days of his new term.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for four 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 and 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 four consecutive weeks. Data to date suggest 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 reports,
    • “The measles outbreak in Texas has risen by 36 cases, pushing the US case count for the year past the number for all of 2024.
    • “The outbreak of the highly contagious virus, which began in late January and is centered in the western part of the state, now stands at 259 cases, according to the latest update from the Texas Department of State Health Services (DSHS). Of those patients, 257 are either unvaccinated or have unknown vaccination status, and 201 are children ages 17 or younger. Thirty-four patients have been hospitalized, with one death in an unvaccinated child who had no known underlying conditions.
    • “Eleven counties to date have reported cases, but two thirds of the cases (174; 67%) are in Gaines County, which has one of the highest rates of school-aged children in Texas who have opted out of at least one vaccine. The county is home to a large Mennonite community with low vaccination rates.
    • “DSHS officials said they have determined that three of the case-patients previously listed as vaccinated were not vaccinated. Two had received their measles, mumps, and rubella (MMR) vaccine doses 1 to 2 days before their symptoms started and after they had been exposed to the virus. The third had a vaccine reaction that mimicked a measles infection and has been removed from the case count.”
  • The University of Minnesota CIDRAP also notes,
    • “The US Food and Drug Administration (FDA) yesterday announced the strains it recommends manufacturers include in seasonal flu vaccines for the 2025-26 flu season, and [as usual] they mirror recommendations announced by the World Health Organization (WHO) last month.” 
  • Gallup reports,
    • “Americans’ assessments of their mental and physical health are the least positive they have been in Gallup’s 24-year trend, reflecting a decadelong decline that began around 2013 and accelerated sharply with the onset of the COVID-19 pandemic in 2020.
    • “Three in four U.S. adults in Gallup’s latest annual reading rate their mental health (75%) and, separately, their physical health (76%) as either “excellent” or “good.” This contrasts with a record-high 89% rating their mental health positively as recently as 2012, and a high of 82% for physical health in 2003.
    • “As fewer Americans have rated their mental and physical health positively, most of the change has been in the percentages rating each aspect “excellent” — shrinking to 31% for mental health and 24% for physical health.”
  • The National Science Foundation points out,
    • “A team of researchers led by the recipient of a U.S. National Science Foundation Faculty Early Career Development grant has developed a new storage method for protein-based drugs that could potentially eliminate the need for refrigeration of important medicines. Using an oil-based solution and a molecule acting as a coating to enclose the proteins in these drugs, researchers demonstrated a technique to prevent the proteins from degrading rapidly — a protection that traditionally requires refrigeration.
    • “The research is led by Scott Medina at Pennsylvania State University and published in Nature Communications. It demonstrates a possible practical application to eliminate the need to refrigerate hundreds of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
    • “The work could eventually reduce the cost of refrigerating such drugs throughout the supply chain and enable greater use of protein-based therapies where constant refrigeration isn’t possible, including military environments. 
    • “Over 80% of biologic drugs and 90% of vaccines require temperature-controlled conditions. This approach could revolutionize their storage and distribution, making them more accessible and affordable for everyone,” says Medina.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have determined that dermatitis resulting from topical steroid withdrawal (TSW) is distinct from eczema and is caused by an excess of an essential chemical compound in the body. Scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) identified treatments that could be studied in clinical trials for the condition based on their potential to lower levels of the chemical compound—called nicotinamide adenine dinucleotide (NAD+), a form of vitamin B3. The findings were published today in the Journal of Investigative Dermatology.
    • “Dermatitis is characterized by inflammation, itching, or burning sensations on the skin, and can result from various conditions including TSW and eczema. Eczema, also known as atopic dermatitis, is a common cause of dermatitis and affects 10 to 30% of children and 2 to 10% of adults each year in the United States. Topical steroids—specifically glucocorticoids or topical corticosteroids—have long been used as a first-line treatment for dermatitis caused by eczema because the drugs are safe, effective, easy to apply, and considered well-tolerated.” * * *
    • “The scientists provisionally established criteria that can be used by health care providers to identify TSW in people. People who have stopped topical steroid treatment and meet the criteria may be diagnosed by practitioners as having TSW. The researchers suggest that patients identified as having TSW could be treated using the proposed mitochondrial complex I-blocking drugs.
    • “The results of this study may help practitioners identify TSW in patients and work towards developing safe and effective treatments. According to the researchers, more research is needed to determine whether all patients with TSW have an excess of NAD+, or if there are other features that define TSW. Additionally, the diagnostic criteria will help health care providers and researchers to better understand the prevalence of TSW and evaluate the effects of using topical steroids.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.
    • “But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?
    • “The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.
    • “To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)”
  • Per STAT News,
    • “Biotech company Altimmune announced in an investor call yesterday that it will study its obesity drug, which targets receptors of the GLP-1 and glucagon hormones, in alcohol use disorder, as mounting evidence supports the potential of GLP-1 drugs to help with addiction.
    • “Altimmune executives think that their molecule, called pemvidutide, could be particularly helpful for liver conditions, since there are glucagon receptors located in the liver. The company has already been studying the drug in weight loss and in the liver disease MASH, and are now expanding into alcohol-related conditions.
    • “The company plans to start a study in alcohol use disorder in the second quarter of this year, and another study in alcohol-related liver disease in the third quarter.
    • “Eli Lilly has also started studying mazdutide, a GLP-1/glucagon drug it’s developing with Chinese biotech Innovent, in alcohol use disorder. Lilly CEO Dave Ricks has said the company also plans to test obesity drugs in other areas of addiction, like nicotine and drug use disorders.
    • “Novo Nordisk is running a study of its obesity drugs in alcohol-related liver disease but has not yet started any trials in addiction.”
  • Per Beckers Hospital CFO Report,
    • As healthcare organizations continue to navigate shifting financial and operational landscapes, new data from Kaufman Hall and Strata highlights significant trends in physician productivity, compensation, and costs.
    • In the fourth quarter, median work relative value units per full-time physician varied across specialties, with medical specialties leading at 7,139 wRVUs. Physician compensation followed a similar pattern, with surgical specialists earning the highest median paid compensation at $491,000 per FTE.
    • Despite an encouraging increase in net revenue per physician, rising expenses remain a challenge. These figures underscore the mounting financial pressures and workforce challenges facing healthcare organizations. For executives, balancing rising costs, evolving productivity demands, and compensation structures will be critical in sustaining financial stability and operational efficiency.
  • Beckers Hospital Review points out ten drugs poised to be top sellers next year.

Tuesday Report

David Ermer–Congress, COVID-19 testing, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC

Capitol Hill News

  • The Wall Street Journal reports,
    • The House [of Representatives] narrowly approved a Republican proposal to fund the government into the fall, as GOP lawmakers remained largely united following a last-minute push from the White House, overcoming Democratic opposition and setting up a fight in the Senate. 
    • Funding for the federal government expires this weekend. The GOP proposal would extend funding through Sept. 30 at fiscal 2024 spending levels, but it includes $13 billion in cuts in nondefense spending and $6 billion in increased military spending. It allocates additional money for border enforcement and forces Washington, D.C., to cut $1 billion from its budget. 
    • The measure passed 217-213, with Rep. Thomas Massie of Kentucky being the only Republican to vote against it. Democrats were largely united in opposition, with one Democrat, Rep. Jared Golden of Maine, voting yes. * * *
    • “The matter now heads to the Senate, where Republicans will need Democratic support to advance the bill. Senate Democrats were wrestling over the matter Tuesday. Some saw the funding deadline as their only leverage to push back against GOP efforts to dismantle federal programs, while others were wary of playing hardball and triggering a government shutdown. 
    • The House left town after Tuesday’s vote, effectively giving the Senate the option of approving or blocking the House measure—but not revising it.” 
  • Fierce Healthcare adds,
    • “Rep. Greg Murphy, M.D., R-N.C., posted on X Monday night that Johnson and Senate Majority Leader John Thune have agreed to include a doc pay fix in Congress’ budget reconciliation, which is expected to be finished in May to align with President Donald Trump’s first 100 days.
    • “A doc pay fix, which would counteract a 2.83% cut to Medicare physicians’ payment rates that went into effect Jan. 1, has been a central focus for provider lobbying groups as well as for physician members of the legislature. It was seen as the driving force behind passing an expanded healthcare package.
    • “The Energy and Commerce committee has an $880 billion deficit reduction target. E&C will identify those cuts from programs within its jurisdiction like Medicaid and other healthcare programs. It could identify some of those savings from items in the December healthcare package that did not make it into last year’s funding bill, such as PBM reform.”
  • Per Govexec,
    • “Also on Tuesday, Sen. Jerry Moran, R-Kan., who chairs the Senate Veterans Affairs Committee, announced during a hearing he will put forward legislation that will also seek to put some constraints on the Trump administration’s efforts to remake the Veterans Affairs Department’s workforce. He said VA must work closely with Congress and stakeholders such as veterans service organizations when seeking to make staffing cuts. The Republican chairman added he has voiced his reservations to VA Secretary Doug Collins.”

HHS News

  • The Washington Post reports,
    • Robert F. Kennedy Jr. is making one of his first official moves aimed at increasing oversight of the chemicals found in the nation’s food supply — a key component of his “Make America Healthy Again” agenda to root out chronic disease and childhood illness.
    • On Monday, Kennedy, who serves as the nation’s top health official, announced he was directing the Food and Drug Administration to “explore potential rulemaking” to tighten a decades-old loophole allowing food companies to put chemicals in their products without notifying the nation’s food regulators.
    • The practice Kennedy is targeting, known as “generally recognized as safe” (GRAS), can occur when companies self-certify the safety of a food additive. Companies aren’t required to tell the FDA when they include some chemicals and substances in their products, meaning there are probably hundreds of such ingredients added to the food supply without government oversight.
  • Per a March 10, 2025, CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address the troubling amount of improper enrollments impacting Affordable Care Act (ACA) Health Insurance Marketplaces across the country. CMS’ 2025 Marketplace Integrity and Affordability Proposed Rule includes proposals that take critical and necessary steps to protect people from being enrolled in Marketplace coverage without their knowledge or consent, promote stable and affordable health insurance markets, and ensure taxpayer dollars fund financial assistance only for the people the ACA set out to support.” * * *
    • “View the 2025 Marketplace Integrity and Affordability Proposed Rule (CMS-9884-P) here: https://www.cms.gov/files/document/MarketplacePIRule2025.pdf
    • “For additional information on the rule and its proposals, view the CMS fact sheet:  https://www.cms.gov/newsroom/fact-sheets/2025-marketplace-integrity-and-affordability-proposed-rule” 
  • Per Modern Healthcare,
    • “The U.S. Department of Health and Human Services increased its voluntary buyout offer for some employees for further layoffs this week as the agency faces pressure to reduce headcount, according to an email viewed by Bloomberg. 
    • “In addition to a $25,000 lump-sum buyout offer, some HHS workers would also receive around two months of paid administrative leave if they chose to accept the buyout. * * *
    • “The buyout offer was available to employees this week and expires Friday. The original buyout offer was extended to a “broad population of HHS employees,” according to an email. However, the Food and Drug Administration told staff Monday that employees responsible for reviewing drugs, medical devices and tobacco products aren’t eligible for the buyout program. 
    • “The HHS buyout offers are in addition to an early retirement program that relaxed service requirements for retirement.”
  • The U.S. Preventive Services Task Force issued a final recommendation on screening for food insecurity which received an inconclusive “I” grade.
    • “For children, adolescents, and adults:
      “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.”
  • Per Axios,
    • “The federal government’s free at-home COVID test distribution program has been suspended and is no longer accepting orders” as of March 9, 2025.
    • “For some previously distributed tests, expiration dates were extended to account for data that revealed a longer-than-expected shelf life.
    • “A full list of approved tests and their revised expiration dates is posted on the FDA website.”

FDA News

  • Per Cardiovascular Business,
    • “Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. 
    • “Loss of Pulse Detection asks the user if they are OK when it first detects the loss of pulse. If no response is provided, it triggers an audio alarm and countdown to when emergency services will be notified. If the countdown reaches zero, the alert is officially sent out.
    • “This feature is already available in 14 different countries. It will be made available in the United States for Google’s Pixel Watch 3 in the weeks ahead.”
  • Per Modern Healthcare,
    • “Siemens Healthineers has received clearance from the Food and Drug Administration for its Naeotom Alpha class of photon-counting computed tomography scanners.
    • “The company unveiled the two scanners in December, touting the Naeotom Alpha.Pro and Naeotom Alpha.Prime as more affordable options to its original Naeotom Alpha photon-counting CT, which received FDA clearance in September 2021.
    • “Photon-counting CT is a new technology that uses lower radiation doses than conventional CT and produces clearer images with fewer distortions.
    • “Siemens Healthineers’ photon-counting CTs are the only commercially available scanners of their kind available for clinical use but competitors are working to bring their versions to market.”

From the judicial front,

  • Govexec reports,
    • “A federal judge has ordered the acting head of the Office of Personnel Management to testify at a court hearing examining the legality of the Trump administration’s mass firings of federal employees, but the key workforce official has informed the court he will ignore the order. 
    • “Acting OPM Director Charles Ezell was slated to appear in a U.S. District Court in San Francisco on Thursday after Judge William Alsup ruled Monday on Monday that he must do so, but he will now face a to-be-determined sanction. The Trump administration had sought to block his testimony, saying it would raise constitutional concerns, but the judge rejected the argument. Ezell has already submitted written testimony, Alsup said, and now must be subject to cross examination. 
    • “After initial publication of this story, the Trump administration Tuesday evening informed the court Ezell would not testify and withdrew his written declaration suggesting he did not order the probationary firings across government. It called live testimony “not necessary” for Ezell or any other official. The plaintiffs in the case are seeking testimony from human resources personnel throughout government.” 

From the public health and medical research front,

  • Healio lets us know,
    • “The diabetes mortality rate in the U.S. dropped from 28.1 deaths per 100,000 people in 2000 to 19.1 deaths per 100,000 in 2019.
    • “Reductions in diabetes mortality were observed for all racial and ethnic groups.”
  • The Wall Street Journal reports,
    • “GLP-1s, including Ozempic, show promise in preventing age-related conditions like Alzheimer’s, osteoarthritis and certain cancers.
    • “GLP-1s work by suppressing appetite and reducing inflammation, potentially contributing to their preventive health benefits.
    • “While promising, more robust studies are needed to confirm the causal effects of GLP-1s on longevity and healthspan.”
  • The National Institutes of Health offers a research bulletin on the following topics: “Predicting preeclampsia | Liver gene editing | Mapping MS-like brain lesions.”
  • MedPage Today tells us five things that patients with low back pain need from their doctors and
    • “BMI was lower in kids whose mothers received a responsive parenting intervention in the INSIGHT randomized clinical trial.
    • “Across ages 3 to 9 years, children in a responsive parenting group had a lower mean BMI than those in a control group.
    • “The impact appeared significant only for girls.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of brensocatib (Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “The assessment will be publicly discussed during a meeting of the CTAF in September 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The National Cancer Institute informs us,
    • “For men with metastatic castration-resistant prostate cancer, an initial treatment that combines enzalutamide (Xtandi) and talazoparib (Talzenna)may help them live longer than just getting enzalutamide alone, according to updated results from a large clinical trial. Enzalutamide is a type of drug known as an androgen receptor antagonist and talazoparib is part of a group of drugs called PARP inhibitors.” * * *
    • “More information about the trial, which was funded by Pfizer, the maker of talazoparib, is available in this Cancer Currents story.”
  • Fierce Pharma adds,
    • “After Gilead Sciences’ lenacapavir made waves with stellar clinical results as a twice-yearly HIV prevention candidate, the drug has shown promise being dosed even further apart at only once a year.
    • “Two different once-yearly formulations of lenacapavir achieved blood concentrations that exceeded those associated with the strong HIV prevention efficacy that twice-yearly lenacapavir showed in phase 3 preexposure prophylaxis (PrEP) studies.
    • “The pharmacokinetic results came from a small phase 1 trial presented at the Conference on Retroviruses and Opportunistic Infections and simultaneously published in The Lancet.
    • “Based on the early-stage data, Gilead plans to start a phase 3 program for once-yearly lenacapavir in the second half of this year, with the potential for regulatory filings in 2027, Jared Baeten, M.D., Ph.D., Gilead’s vice president of HIV clinical development, told Fierce Pharma.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Hinge Health filed Monday for a proposed initial public offering.
    • “The virtual musculoskeletal health company, which contracts with employers, pharmacy benefit managers and large insurance companies to provide physical therapy and pain relief services, has been considered a potential IPO candidate since last year.”
  • and
    • “Tampa General Hospital and Mass General Brigham are teaming up to open a radiation oncology center in Florida.
    • “The 10,000-square-foot facility in Palm Beach Gardens will be co-branded and jointly owned. Tampa General will handle daily operations, while Mass General Brigham will provide oversight on quality and safety, according to a Tuesday news release.
    • “The center is scheduled to open in early 2026, the release said.”
  • Per Fierce Pharma,
    • “At its sprawling complex in Durham, N.C., Merck has opened a new $1 billion, 225,000-square-foot manufacturing plant slated to produce bulk substance for its megablockbuster HPV vaccine Gardasil.
    • “Merck built the new plant on the 262-acre campus it has occupied since 2004, where the pharma giant produces a variety of vaccines including shots to prevent chickenpox, measles and rubella.
    • “The complex manufactured more than 70 million doses last year, with the figure expected to increase this year, a Merck spokesperson said in an email. The campus now employs more than 1,000 people.”
  • Per STAT News,
    • “In the last two years, hundreds of businesses have cropped up to meet the surge in demand for the obesity and diabetes medications known as GLP-1s. The majority prescribe compounded copies of the drugs — a tenuous business strategy as shortages of the branded versions of the medications have come to an end. 
    • “Now, some businesses are setting their sights on another opportunity in compounding: hormones.
    • “Dozens of wellness and direct-to-consumer telehealth companies offering GLP-1s have begun marketing cash-pay hormone replacement therapy to women in perimenopause and menopause, and testosterone replacement therapy to men. Noom, best-known for its weight loss app and more recent GLP-1 offering, launched an HRT program for menopause in late February, and telehealth company Hims & Hers plans to roll out at-home testing over the next year to enable care for low testosterone, perimenopause, and menopause.
    • “Patients and physicians have long advocated for better access to hormone-based care. Men with low testosterone levels due to hypogonadism can face stigma as they seek care, and many women struggle to receive medically appropriate estrogen and progesterone to address serious hot flashes and help prevent osteoporosis. But clinicians and health policy researchers expressed concern that the emerging commodification of hormone replacement therapies — often marketed as a personalized fix for low energy, libido, and other age-related concerns — could lead to inappropriate prescriptions and put patients at risk.” 
  • Beckers Hospital Review points out,
    • “In August, Kaiser Permanente embarked on the largest rollout of generative AI in healthcare to date.
    • “The Oakland, Calif.-based health system offered Abridge, an ambient AI listening tool that drafts clinical notes for the EHR, to tens of thousands of providers.
    • “Becker’s caught up with Brian Hoberman, MD, executive vice president of IT and CIO at the Permanente Federation, at the HIMSS conference in Las Vegas to find out how the implementation is going.”
    • Here’s a link to that interview.
  • The Wall Street Journal adds,
    • “Last year, some cancer patients in Tennessee and Mississippi got a startling offer: Instead of videoconferencing with oncology specialists located hours away, they could see a hologram doctor, courtesy of the same special effects that have projected the Jonas Brothers and other celebrities at concerts and live events.
    • “The offer came from West Cancer Center & Research Institute, a health system that employs about 61 doctors and serves about 19,240 new patients a year across 12 locations in Tennessee, Mississippi and Arkansas. The system’s main clinic is in Germantown, Tenn., a suburb of Memphis.
    • “Its doctors typically spend hours on the road each week getting to the satellite clinics to see patients in more rural locations, while also relying heavily on videoconferencing for check-ins. Now, however, two of those clinics are replacing the video calls with life-size hologram-like displays, part of a cross-industry push to take videoconferencing to the next level.”